Internal Revenue Bulletin 2021-30 (PDF rendition): IRS Revenue Rulings

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Bulletin No. 2021–30
July 26, 2021
HIGHLIGHTS
OF THIS ISSUE
These synopses are intended only as aids to the reader in
identifying the subject matter covered. They may not be
relied upon as authoritative interpretations.
EMPLOYEE PLANS
Notice 2021-38, page 155.
Notice 2021-38 provides guidance under § 432(k) of the
Code to sponsors of multiemployer defined benefit pension
plans that are required to reinstate certain previously sus-
pended benefits as a condition of receiving special financial
assistance from the Pension Benefit Guaranty Corporation
under § 9704 of the American Rescue Plan Act of 2021.
The notice also provides guidance on whether make-up pay-
ments with respect to previously suspended benefits are el-
igible to be rolled over to another eligible retirement plan
under § 402(c), and the extent to which any special financial
assistance received by the plan is not taken into account in
determining contributions required under § 431.
EXCISE TAX
REG-107706-21, page 162.
This document sets forth proposed regulations regarding
certain requirements regarding implementation of the protec-
tions against balance billing provided under the No Surprises
Act. The text of the temporary regulations issued jointly with
the Department of Health and Human Services, the Depart-
ment of Labor, and the Office of Personnel Management
serves as the text of these proposed regulations.
TD 9951, page 25.
This document, issued jointly with the Department of Health
and Human Services, the Department of Labor, and the Of-
fice of Personnel Management, provides initial guidance re-
garding implementation of the protections against balance
billing provided under the No Surprises Act. The temporary
regulations protect consumers from surprise medical bills
for emergency services, air ambulance services furnished by
nonparticipating providers, and non-emergency services fur-
nished by nonparticipating providers at participating facilities
in certain circumstances.
INCOME TAX
Rev. Proc. 2021-14, page 158.
This revenue procedure provides guidance regarding elec-
tions and revocations related to § 2303(e) of the Coronavirus
Aid, Relief, and Economic Security Act, Public Law 116-136,
134 Stat. 281 (Mar. 27, 2020), as added by § 281 of the
COVID-related Tax Relief Act of 2020, which was enacted as
Subtitle B of Division N of the Consolidated Appropriations
Act, 2021 (CAA 2021), Public Law 116-260, 134 Stat. 1182
(Dec. 27, 2020). Section 2303(e) of the CARES Act provides
special rules for taxpayers with a net operating loss (NOL) for
any taxable year beginning in 2018, 2019, or 2020, all or a
portion of which consists of a “farming loss,” as defined by §
172(b)(1)(B)(ii) of the Internal Revenue Code.
Rev. Rul. 2021-13, page 152.
The revenue ruling explains that: (1) an acid gas removal
unit at an industrial facility is a component of carbon capture
equipment within the meaning of § 1.45Q-2(c); (2) an inves-
tor in certain components of carbon capture equipment at
an industrial facility is not required to own every component
of carbon capture equipment within a single process train
at an industrial facility to be the person to whom the sec-
tion 45Q credit is attributable under § 1.45Q-1(h), but must
own at least one component of carbon capture equipment
in the single process train of carbon capture equipment
at the industrial facility; (3) solely for purposes of section
45Q(a), the original placed-in-service date of a single pro-
cess train of carbon capture equipment at an industrial fa-
cility that includes the existing acid gas removal unit and
new components of carbon capture equipment is the date
that the single process train is placed in a condition or state
of readiness and availability for the capture, processing,
and preparation of carbon oxide for transport for disposal,
injection, or utilization; and (4) the original placed-in-service
date of the single process train for purposes of §§ 167
and 168.
Finding Lists begin on page ii.

The IRS Mission
Provide America’s taxpayers top-quality service by helping
them understand and meet their tax responsibilities and en-
force the law with integrity and fairness to all.
Introduction
The Internal Revenue Bulletin is the authoritative instrument
of the Commissioner of Internal Revenue for announcing of-
ficial rulings and procedures of the Internal Revenue Service
and for publishing Treasury Decisions, Executive Orders, Tax
Conventions, legislation, court decisions, and other items of
general interest. It is published weekly.
It is the policy of the Service to publish in the Bulletin all sub-
stantive rulings necessary to promote a uniform application
of the tax laws, including all rulings that supersede, revoke,
modify, or amend any of those previously published in the
Bulletin. All published rulings apply retroactively unless other-
wise indicated. Procedures relating solely to matters of inter-
nal management are not published; however, statements of
internal practices and procedures that affect the rights and
duties of taxpayers are published.
Revenue rulings represent the conclusions of the Service
on the application of the law to the pivotal facts stated in
the revenue ruling. In those based on positions taken in rul-
ings to taxpayers or technical advice to Service field offices,
identifying details and information of a confidential nature are
deleted to prevent unwarranted invasions of privacy and to
comply with statutory requirements.
Rulings and procedures reported in the Bulletin do not have the
force and effect of Treasury Department Regulations, but they
may be used as precedents. Unpublished rulings will not be
relied on, used, or cited as precedents by Service personnel in
the disposition of other cases. In applying published rulings and
procedures, the effect of subsequent legislation, regulations,
court decisions, rulings, and procedures must be considered,
and Service personnel and others concerned are cautioned
against reaching the same conclusions in other cases unless
the facts and circumstances are substantially the same.
The Bulletin is divided into four parts as follows:
Part I.—1986 Code.
This part includes rulings and decisions based on provisions
of the Internal Revenue Code of 1986.
Part II.—Treaties and Tax Legislation.
This part is divided into two subparts as follows: Subpart A,
Tax Conventions and Other Related Items, and Subpart B,
Legislation and Related Committee Reports.
Part III.—Administrative, Procedural, and Miscellaneous.
To the extent practicable, pertinent cross references to these
subjects are contained in the other Parts and Subparts. Also
included in this part are Bank Secrecy Act Administrative
Rulings. Bank Secrecy Act Administrative Rulings are issued
by the Department of the Treasury’s Office of the Assistant
Secretary (Enforcement).
Part IV.—Items of General Interest.
This part includes notices of proposed rulemakings, disbar-
ment and suspension lists, and announcements.
The last Bulletin for each month includes a cumulative index
for the matters published during the preceding months. These
monthly indexes are cumulated on a semiannual basis, and are
published in the last Bulletin of each semiannual period.
The contents of this publication are not copyrighted and may be reprinted freely. A citation of the Internal Revenue Bulletin as the source would be appropriate.
July 26, 2021 Bulletin No. 2021–30

Part I
26 CFR 54.9816-1T through 7T: Preventing Sur-
prise Medical Bills
T.D. 9951
DEPARTMENT OF THE
TREASURY
Internal Revenue Service
26 CFR Part 54
Requirements Related to
Surprise Billing; Part I
AGENCY: Office of Personnel Manage-
ment; Internal Revenue Service, Depart-
ment of the Treasury; Employee Benefits
Security Administration, Department of
Labor; Centers for Medicare & Medicaid
Services, Department of Health and Hu-
man Services.
ACTION: Interim final rules with request
for comments.
SUMMARY: This document sets forth
interim final rules implementing certain
provisions of the No Surprises Act, which
was enacted as part of the Consolidated
Appropriations Act, 2021. These interim
final rules amend and add provisions to
existing rules under the Internal Revenue
Code, the Employee Retirement Income
Security Act, the Public Health Service
Act, and the Federal Employees Health
Benefits Act. These interim final rules
implement provisions of the No Surprises
Act that protect participants, beneficia-
ries, and enrollees in group health plans
and group and individual health insur-
ance coverage from surprise medical bills
when they receive emergency services,
non-emergency services from nonpartici-
pating providers at participating facilities,
and air ambulance services from nonpar-
ticipating providers of air ambulance ser-
vices, under certain circumstances. In this
rulemaking, the Department of Health and
Human Services (HHS), the Department
of Labor (DOL), and the Department of
the Treasury (collectively, the Depart-
ments) are issuing interim final rules with
largely parallel provisions that apply to
group health plans and health insurance
issuers offering group or individual health
insurance coverage. HHS is also issuing
in this rulemaking additional interim final
rules that apply to emergency departments
of hospitals and independent freestanding
emergency departments, health care pro-
viders and facilities, and providers of air
ambulance services related to the protec-
tions against surprise billing. The Office
of Personnel Management (OPM) is issu-
ing in this rulemaking interim final rules
that specify how certain provisions of the
No Surprises Act apply to health benefits
plans offered by carriers under the Federal
Employees Health Benefits Act (FEHBA).
DATES: Effective date: These regulations
are effective on September 13, 2021.
Applicability date: The regulations are
generally applicable for plan years (in
the individual market, policy years) be-
ginning on or after January 1, 2022. The
HHS-only regulations that apply to health
care providers, facilities, and providers of
air ambulance services are applicable be-
ginning on January 1, 2022. The OPM-on-
ly regulations that apply to health benefits
plans are applicable to contract years be-
ginning on or after January 1, 2022.
Comment date: To be assured consider-
ation, comments must be received at one
of the addresses provided below, no later
than 5 p.m. on September 7, 2021.
ADDRESSES: Written comments may be
submitted to the addresses specified be-
low. Any comment that is submitted will
be shared among the Departments and
OPM. Please do not submit duplicates.
Comments will be made available
to the public. Warning: Do not include
any personally identifiable information
(such as name, address, or other contact
information) or confidential business in-
formation that you do not want publicly
disclosed. Comments are posted on the
internet exactly as received and can be
retrieved by most internet search engines.
No deletions, modifications, or redactions
will be made to the comments received,
as they are public records. Comments may
be submitted anonymously.
In commenting, refer to file code CMS-
9909-IFC. Because of staff and resource
limitations, we cannot accept comments
by facsimile (FAX) transmission.
Comments, including mass comment
submissions, must be submitted in one of
the following three ways (please choose
only one of the ways listed):
1. Electronically. You may submit elec-
tronic comments on this regulation
at https://www.regulations.gov by
entering the file code in the search
window and then clicking on “Com-
ment”.
2. By regular mail. You may mail writ-
ten comments to the following ad-
dress ONLY:
Centers for Medicare & Medicaid
Services,
Department of Health and Human
Services,
Attention: CMS-9909-IFC,
P.O. Box 8016,
Baltimore, MD 21244-8016.
Please allow sufficient time for mailed
comments to be received before the close
of the comment period.
3. By express or overnight mail. You
may send written comments to the
following address ONLY:
Centers for Medicare & Medicaid
Services,
Department of Health and Human
Services,
Attention: CMS-9909-IFC,
Mail Stop C4-26-05,
7500 Security Boulevard,
Baltimore, MD 21244-1850
For information on viewing public com-
ments, see the beginning of the “SUPPLE-
MENTARY INFORMATION” section.
FOR FURTHER INFORMATION
CONTACT: Padma Babubhai Shah, Of-
fice of Personnel Management, at 202-
606-4056; Kari DiCecco, Internal Reve-
nue Service, Department of the Treasury,
at 202-317-5500; Matt Litton or David
Sydlik, Employee Benefits Security Ad-
ministration, Department of Labor, at
202-693-8335; Lindsey Murtagh, Centers
for Medicare & Medicaid Services, De-
partment of Health and Human Services,
at 301-492-4106.
Customer Service Information: In-
formation from OPM on health benefits
plans offered under the Federal Employ-
Bulletin No. 2021–30 25 July 26, 2021

ees Health Benefits (FEHB) Program can
be found on the OPM website (www.
opm.gov/healthcare-insurance/health-
care/). Individuals interested in obtaining
information from the DOL concerning
employment-based health coverage laws
may call the Employee Benefits Security
Administration (EBSA) Toll-Free Ho-
tline at 1-866-444-EBSA (3272) or visit
the DOL’s website (www.dol.gov/ebsa).
In addition, information from HHS on
private health insurance coverage and
coverage provided by non-federal govern-
mental group health plans can be found on
the Centers for Medicare & Medicaid Ser-
vices (CMS) website (www.cms.gov/cci-
io), and information on health care reform
can be found at www.HealthCare.gov.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: Com-
ments received before the close of the
comment period are available for viewing
by the public, including any personally
identifiable or confidential business infor-
mation that is included in a comment. We
post comments received before the close
of the comment period on the following
website as soon as possible after they
have been received: https://regulations.
gov. Follow the search instructions on that
website to view public comments.
I. Background
A. Patient Protections and Requirements
Related to Emergency Services under
Section 2719A of the Public Health
Service Act
The Patient Protection and Affordable
Care Act (Pub. L. 111–148), was enacted
on March 23, 2010 and the Health Care
and Education Reconciliation Act of
2010, Public Law 111–152, was enacted
on March 30, 2010 (these statutes are col-
lectively known as the “Affordable Care
Act” or “ACA”). The Affordable Care
Act reorganizes, amends, and adds to the
provisions of part A of title XXVII of the
Public Health Service Act (PHS Act) re-
lating to group health plans and health in-
surance issuers in the group and individu-
al markets.
1
The Affordable Care Act adds
section 715(a)(1) to the Employee Retire-
ment Income Security Act (ERISA) and
section 9815(a)(1) to the Internal Revenue
Code (the Code) to incorporate the provi-
sions of part A of title XXVII of the PHS
Act into ERISA and the Code, and make
them applicable to group health plans and
health insurance issuers providing health
insurance coverage in connection with
group health plans. Sections 2701 through
2728 of the PHS Act are incorporated into
ERISA and the Code.
Under section 2719A of the PHS Act,
as added by the Affordable Care Act and
incorporated into ERISA and the Code,
if a non-grandfathered group health
plan or health insurance issuer offering
non-grandfathered group or individual
health insurance coverage provides any
benefits with respect to emergency ser-
vices in an emergency department of a
hospital, the plan or issuer must cover
emergency services without the individ-
ual or the health care provider having
to obtain prior authorization (including
when the emergency services are pro-
vided out-of-network) and without re-
gard to whether the health care provider
furnishing the emergency services is an
in-network provider with respect to the
services. The emergency services must
be provided without regard to any other
term or condition of the plan or health in-
surance coverage other than the exclusion
or coordination of benefits, an affiliation
or waiting period permitted under the
Code, ERISA, and the PHS Act, or ap-
plicable cost-sharing requirements. For a
plan or health insurance coverage with a
network of providers that provides ben-
efits for emergency services, the plan or
issuer may not impose any administrative
requirement or limitation on benefits for
out-of-network emergency services that
is more restrictive than the requirements
or limitations that apply to in-network
emergency services. In addition, carriers
offering FEHB plans must comply with
requirements described in section 2719A
of the PHS Act in the same manner as
they apply to a plan or issuer.
For purposes of the requirements under
section 2719A of the PHS Act, emergency
services mean, with respect to an emer-
gency medical condition, (1) a medical
screening examination (as required under
section 1867 of the Social Security Act)
that is within the capability of the emer-
gency department of a hospital, includ-
ing ancillary services routinely available
to the emergency department to evaluate
such emergency medical condition, and
(2) that is within the capabilities of the
staff and facilities available at the hospi-
tal, such further medical examination and
treatment as are required under section
1867 of the Social Security Act to stabi-
lize the patient.
Regulations implementing section
2719A of the PHS Act include these con-
sumer protections.
2
Section 2719A of the
PHS Act did not prohibit balance billing.
Balance billing refers to the practice of
out-of-network providers billing patients
for the difference between (1) the pro-
vider’s billed charges, and (2) the amount
collected from the plan or issuer plus the
amount collected from the patient in the
form of cost sharing (such as a copayment,
coinsurance, or amounts paid toward a de-
ductible). To avoid the circumvention of
the protections of section 2719A of the
PHS Act, in the implementing regulations,
the Departments determined it was neces-
sary that a reasonable amount be paid by
a plan or issuer before a patient becomes
responsible for a balance billing amount.
3

Therefore, under the Departments’ fi-
nal regulations published in the Federal
Register on November 18, 2015 (Patient
Protections Final Rule), a plan or issuer
satisfies the out-of-network emergency
care cost-sharing limitations in the statute
if it provides benefits for out-of-network
emergency services in an amount at least
equal to the greatest of the following three
amounts (adjusted for in-network cost
sharing): (1) the median amount nego-
tiated with in-network providers for the
emergency service; (2) the amount for
the emergency service calculated using
the same method the plan generally uses
to determine payments for out-of-network
services (such as the usual, customary,
1
The term “group health plan” includes both insured and self-insured group health plans.
2
26 CFR 54.9815-2719A(b); 29 CFR 2590.715-2719A(b); 45 CFR 147.138(b).
3
75 FR 37188, 37194 (June 28, 2010); see also 80 FR 72192 (Nov. 18, 2015). Additional clarification of these rules was also provided in 2018. See 83 FR 19431 (May 3, 2018).
July 26, 2021 26 Bulletin No. 2021–30

Bulletin No. 2021–30 27 July 26, 2021
and reasonable (UCR) amount); or (3) the
amount that would be paid under Medi-
care Part A or Part B for the emergency
service (collectively, minimum payment
standards).
4
The Departments’ regulations
clarify that the cost-sharing requirements
create a minimum payment requirement
for the plan or issuer.
5
The Departments
also clarified that the cost-sharing require-
ments do not prohibit a group health plan
or health insurance issuer from providing
benefits with respect to an emergency
service that are greater than the amounts
specified in the regulations. However,
those regulations address balance billing
with respect to only emergency services
and, even in that context, they serve only
to minimize the amount of a balance bill
by requiring that plans and issuers must
pay a reasonable amount for emergency
services before a patient becomes respon-
sible for a balance billing amount. Prior
to the enactment of the No Surprises Act,
these minimum payment standards were
the only federal consumer protections
to reduce potential amounts of balance
billing for individuals enrolled in group
health plans and group and individual
health insurance coverage.
The No Surprises Act added section
9816 of the Code, section 716 of ERI-
SA, and section 2799A-1 of the PHS Act,
which expand the patient protections re-
lated to emergency services under section
2719A of the PHS Act, in part, by provid-
ing additional consumer protections relat-
ed to balance billing.
6
The No Surprises
Act amended section 2719A of the PHS
Act to include a sunset provision effective
for plan years beginning on or after Janu-
ary 1, 2022, when the new protections un-
der the No Surprises Act take effect.
Additionally, the No Surprises Act re-
codified the patient protections regarding
choice of health care professional from
section 2719A(a), (c), and (d) of the PHS
Act at new section 9822 of the Code, sec-
tion 722 of ERISA, and section 2799A-
7 of the PHS Act. If a plan or issuer re-
quires or provides for designation by a
participant, beneficiary, or enrollee of a
participating primary care provider, these
provisions permit individuals to designate
any participating primary care providers
available to accept them, including pedi-
atricians, and prohibit the plan or issuer
from requiring authorization or referral
for obstetrical or gynecological care.
B. Surprise Billing and the Need for
Greater Consumer Protections
Most group health plans, and health
insurance issuers offering group or indi-
vidual health insurance coverage, have a
network of providers and health care facil-
ities (participating providers or preferred
providers) who agree by contract to accept
a specific amount for their services.
7
By
contrast, providers and facilities that are
not part of a plan or issuer’s network (non-
participating providers) usually charge
higher amounts than the contracted rates
that plans and issuers have negotiated
with participating providers and facilities.
When a participant, beneficiary, or enroll-
ee receives care from a nonparticipating
provider, the individual’s plan or issuer
may decline to pay for the service or may
pay an amount that is lower than the pro-
vider’s billed charges, and may subject
the individual to greater cost-sharing re-
quirements than would have been charged
had the services been furnished by a par-
ticipating provider. Prior to the No Sur-
prises Act, the nonparticipating provider
could generally balance bill the individual
for the difference between the provider’s
billed charges and the sum of the amount
paid by the plan or issuer and the cost
sharing paid by the individual, unless oth-
erwise prohibited by state law.
A balance bill may come as a surprise
for the individual. A surprise medical bill
is an unexpected bill from a health care
provider or facility that occurs when a
covered person receives medical services
from a provider or facility that, usually
unknown to the participant, beneficiary,
or enrollee, is a nonparticipating provid-
er or facility with respect to the individ-
ual’s coverage. Surprise billing occurs
both for emergency and non-emergency
care. In an emergency, a person usually
goes (or is taken by emergency trans-
port) to a nearby emergency depart-
ment. Even if they go to a participating
hospital or facility for emergency care,
they may receive care from nonpartici-
pating providers working at that facility.
For non-emergency care, a person may
choose a participating facility (and possi-
bly even a participating provider), but not
know that at least one provider involved
in their care (for example, an anesthesiol-
ogist or radiologist) is a nonparticipating
provider. In either circumstance, the per-
son might not be in a position to choose
the provider, or to ensure that the provid-
er is a participating provider. Therefore,
in addition to a bill for their cost-sharing
amount, which tends to be higher for out-
of-network services, the person might
receive a balance bill from the nonpartic-
ipating provider or facility. This scenario
also plays out frequently for air ambu-
lance services, where individuals gen-
erally do not have the ability to select a
provider of air ambulance services, and,
therefore, have little or no control over
whether the provider is in-network with
their plan or coverage.
When individuals are unable to avoid
nonparticipating providers, it raises health
care costs and exposes patients to finan-
cial risk.
8
The evidence suggests that the
ability to balance bill is used as leverage
by some providers to obtain higher in-net-
work payments, which results in higher
premiums, higher cost sharing for indi-
viduals, and increased health care expen-
4
26 CFR 54.9815-2719A(b)(3); 29 CFR 2590.715-2719A(b)(3); 45 CFR 147.138(b)(3).
5
If state law prohibits balance billing, or in cases in which a group health plan or health insurance issuer is contractually responsible for balance billing amounts, plans and issuers are not
required to satisfy the minimum payment standards set forth in the regulations, but may not impose any copayment or coinsurance requirement for out-of-network emergency services that
is higher than the copayment or coinsurance requirement that would apply if the services were provided in-network. See 26 CFR 54.9815-2719A(b)(3)(iii); 29 CFR 2590.715-2719A(b)(3)
(iii); 45 CFR 147.138(b)(3)(iii); FAQs about Affordable Care Act Implementation (Part I), Q15 (Sept. 20, 2010), available at https://www.dol.gov/agencies/ebsa/laws-and-regulations/laws/
affordable-care-act/for-employers-and-advisers/aca-implementation-faqs; www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs.html.
6
These new protections apply regardless of whether the plan or coverage is a grandfathered health plan under section 1251 of the Affordable Care Act. The No Surprises Act also amended 5
U.S.C. 8902(p) to ensure that covered individuals enrolled in FEHB plans receive these protections.
7
These interim final rules refer to providers both in terms of their participation (participating provider) and in terms of a network (in-network provider). In both situations, the intent is to
refer to a provider that has a contractual relationship or other arrangement with a plan or issuer to provide health care items and services for participants, beneficiaries, and enrollees of the
plan or issuer.
8
Cooper Z et al., Out-of-Network Billing and Negotiated Payments for Hospital-Based Physicians, Health Affairs 39, No. 1, 2020. doi: 10.1377/hlthaff.2019.00507.

July 26, 2021 28 Bulletin No. 2021–30
ditures overall.
9
Studies have shown that
surprise bills can be large. For example,
a recent study found that physicians col-
lected, on average, 65 percent of the total
charged amount for emergency depart-
ment visits that likely included surprise
bills, compared to 52 percent of the total
charged amount for emergency depart-
ment visits that likely did not include
surprise bills. The study also found that
nine percent of the individuals who likely
received surprise bills paid physicians an
amount more than $400, which may cause
financial hardship to many individuals.
10

In addition, out-of-network cost sharing
and payments for surprise bills usually do
not count towards an individual’s deduct-
ible and maximum out-of-pocket expen-
diture limits. Therefore, individuals with
surprise bills may have difficulty reaching
those limits, even after a significant health
care event.
Another study using claims data from
a large commercial issuer for the period
2010-2016 found that over 39 percent of
emergency department visits to in-net-
work hospitals resulted in an out-of-net-
work bill, and the incidence increased
from 32.3 percent in 2010 to 42.8 percent
in 2016. The average potential amount of
surprise medical bills also increased from
$220 in 2010 to $628 in 2016. During the
same period, 37 percent of inpatient ad-
missions to in-network hospitals resulted
in at least one out-of-network bill, in-
creasing from 26.3 percent in 2010 to 42
percent in 2016, and the average potential
surprise medical bill increased from $804
to $2,040.
11
Although some states have enacted
laws to reduce or eliminate balance bill-
ing, these efforts have created a patch-
work of consumer protections. Even
within a state that has enacted such pro-
tections, those protections typically apply
only to individuals enrolled in individual
and group health insurance coverage, as
ERISA generally preempts state laws that
regulate self-insured group health plans
sponsored by private employers. In addi-
tion, states are limited in their ability to
address surprise bills that involve an out-
of-state provider.
Surprise medical bills can lead to
medical debt for individuals who have
difficulty paying their bills. The impact
is most keenly felt by those communities
experiencing poverty and other social
risk factors, as surprise medical bills and
medical debt can negatively affect indi-
viduals’ abilities to eliminate debt and
create wealth, and ultimately can affect a
family for generations.
12
A recent survey
reported that while 68 percent of respon-
dents said that it was difficult to pay a sur-
prise bill, the likelihood of such difficulty
was higher for middle income respon-
dents (77 percent) and African Ameri-
cans (74 percent). In addition, while 11
percent of survey respondents were un-
able to pay the surprise bill, 21 percent
of low income respondents, 19 percent
of African Americans, and 17 percent of
respondents in rural areas were unable to
do so.
13
In addition, individuals are often
confused by medical bills. A 2016 survey
found that 61 percent of individuals are
confused by medical bills, and for 49 per-
cent of individuals surveyed, the amount
owed was a surprise.
14
These challenges
are exacerbated for underserved commu-
nities, which are more likely to experi-
ence poor communication, underlying
mistrust of the medical system, and lower
levels of patient engagement than other
populations.
15
Effective, culturally, and
linguistically tailored communication at
appropriate literacy levels, coupled with
policies that address the social risk fac-
tors and other barriers underserved com-
munities face to accessing, trusting, and
understanding health care costs and cov-
erage, can reduce disparities and promote
health equity.
16
Communication among providers,
plans, consumers, communities, and con-
sumer advocates must be consistent with
and reinforce all relevant consumer pro-
tections related to surprise bills. Such
communication must be accessible, lin-
guistically tailored, and at an appropriate
literacy level. This includes compliance
with requirements to provide effective
communication for individuals with dis-
abilities under the Americans with Dis-
abilities Act of 1990,
17
section 504 of the
Rehabilitation Act of 1973
18
and, where
applicable, section 1557 of the Affordable
Care Act,
19
as well as compliance with
race, color, and national origin protections
under title VI of the Civil Rights Act of
9
See Cooper, Z. et al., Surprise! Out-Of-Network Billing For Emergency Care in the United States, NBER Working Paper 23623, 20173623; Duffy, E. et al., Policies to Address Surprise
Billing Can Affect Health Insurance Premiums. The American Journal of Managed Care 26.9 (2020): 401–404.; and Brown E.C.F., et al., The Unfinished Business of Air Ambulance Bills,
Health Affairs Blog (March 26, 2021), DOI: 10.1377/hblog20210323.911379, available at https://www.healthaffairs.org/do/10.1377/hblog20210323.911379/full/.
10
Biener, A. et al., Emergency Physicians Recover a Higher Share of Charges From Out-Of-Network Care Than From In-Network Care, Health Affairs 40, No, 4 (2021): 622-628.
11
Sun EC, Mello MM, Moshfegh J, Baker LC, Assessment of Out-of-Network Billing for Privately Insured Patients Receiving Care in In-Network Hospitals. JAMA Intern Med. 2019;
179(11):1543–1550 (2019). doi:10.1001/jamainternmed.2019.3451.
12
Taylor, J. Racism, inequality, and health care for African Americans. The Century Foundation: Report (December 19, 2019). https://tcf.org/content/report/racism-inequality-health-care-af-
rican-americans/; Chavis, B. Op-Ed: Big insurance must help end surprise medical billing. blackpressUSA (February 24, 2020).
13
Families USA, Surprise Medical Bills, Results from a National Survey, November 2019. https://familiesusa.org/wp-content/uploads/2019/11/Surprise-Billing-National-Poll-Report-FINAL.
pdf.
14
Gooch, Kelly. 61% of patients confused by medical bills, survey finds. Becker’s Hospital Review (July 14, 2016). https://www.beckershospitalreview.com/finance/61-of-patients-confused-
by-medical-bills-survey-finds.html.
15
See Butler S, Sherriff N. How poor communication exacerbates health inequities and what to do about it. Brookings Institution: Report (February 22, 2021). https://www.brookings.edu/
research/how-poor-communication-exacerbates-health-inequities-and-what-to-do-about-it/; Hamel, L., Lopes, L., Muñana, C., Artiga, S., Brodie, M. Race, Health, and COVID-19: The
Views and Experiences of Black Americans. Kaiser Family Foundation (October 2020). https://files.kff.org/attachment/Report-Race-Health-and-COVID-19-The-Views-and-Experiences-
of-Black-Americans.pdf; Shen M.J., Peterson E.B., Costas-Muñiz R. et al. The Effects of Race and Racial Concordance on Patient-Physician Communication: A Systematic Review of the
Literature. J. Racial and Ethnic Health Disparities 5, 117–140 (2018). https://doi.org/10.1007/s40615-017-0350-4.
16
Pérez-Stable EJ, El-Toukhy S. Communicating with diverse patients: How patient and clinician factors affect disparities. Patient Educ Couns. 2018;101(12):2186-2194. doi:10.1016/j.
pec.2018.08.021; McNally, M. Confronting disparities in access to healthcare for underserved populations. MedCity News (February 22, 2021). https://medcitynews.com/2021/02/confront-
ing-disparities-in-access-to-healthcare-for-underserved-populations-in-2021/
17
42 U.S.C. 12101 et seq.
18
29 U.S.C. 794 and 794d.
19
42 U.S.C. 18116(a).

Bulletin No. 2021–30 29 July 26, 2021
1964
20
and section 1557 of the Affordable
Care Act. Section 1557 prohibits discrimi-
nation on the basis of race, color, national
origin, sex (including sexual orientation
and gender identity), age, or disability in
covered health programs or activities, in-
cluding requiring covered entities to take
reasonable steps to ensure meaningful ac-
cess for individuals with limited English
proficiency.
On January 20, 2021, President Biden
issued Executive Order 13985, “On Ad-
vancing Racial Equity and Support for
Underserved Communities Through the
Federal Government,”
21
directing that as
a policy matter, the federal government
should pursue a comprehensive approach
to advancing equity for all, including peo-
ple of color and others who have been his-
torically underserved, marginalized, and
adversely affected by persistent poverty
and inequality. Executive Order 13985
also directs HHS to assess whether, and to
what extent, its programs and policies per-
petuate systemic barriers to opportunities
and benefits for people of color and other
underserved groups. Consistent with Ex-
ecutive Order 13985, regulations issued
pursuant to the No Surprises Act must
ensure that communication from plans,
issuers, providers, facilities, and provid-
ers of air ambulance services recognizes
these inequities and upholds all relevant
consumer protections. Regulations issued
pursuant to the No Surprises Act should
ensure that all individuals, particular-
ly those from underserved and minority
communities, trust and believe informa-
tion they receive related to costs and net-
work coverage. Regulations and policies
should enable and encourage regulated
entities to address barriers to accessing
care, including mistrust of the health care
system. They should also encourage en-
tities to communicate with individuals in
a language they can understand, in a re-
spectful way that addresses cultural dif-
ferences, and at an appropriate literacy
level. To ensure all consumers, particu-
larly those in minority and underserved
communities, are able to understand and
benefit from these consumer protections,
deliberate attention must be paid to the
unique barriers and challenges under-
served communities face in understanding
and accessing health care. The Depart-
ments seek comment from those who are
members of, advocate for, and work with
underserved communities regarding the
impact of these interim final rules.
C. Preventing Surprise Medical Bills
under the Consolidated Appropriations
Act, 2021
On December 27, 2020, the Consoli-
dated Appropriations Act, 2021 (CAA),
which included the No Surprises Act,
was signed into law. The No Surprises
Act provides federal protections against
surprise billing and limits out-of-network
cost sharing under many of the circum-
stances in which surprise bills arise most
frequently.
22
The CAA added provisions that apply
to group health plans and health insurance
issuers in the group and individual market
in a new Part D of title XXVII of the PHS
Act, and also added new provisions to part
7 of ERISA, and subchapter B of chapter
100 of the Code. Section 102 of the No
Surprises Act added section 9816 of the
Code, section 716 of ERISA, and section
2799A-1 of the PHS Act, which contain
limitations on cost sharing, and require-
ments for initial payments for emergency
services and for non-emergency services
provided by nonparticipating providers
at certain participating health care facili-
ties.

Section 103 of the No Surprises Act
amended section 9816 of the Code, sec-
tion 716 of ERISA, and section 2799A-1
of the PHS Act to establish an indepen-
dent dispute resolution (IDR) process that
allows plans and issuers and nonpartic-
ipating providers and nonparticipating
emergency facilities to resolve disputes
over out-of-network rates. Section 105 of
the No Surprises Act added section 9817
of the Code, section 717 of ERISA, and
section 2799A-2 of the PHS Act, which
contain limitations on cost sharing and
requirements for initial payments to non-
participating providers of air ambulance
services, and allow plans and issuers and
such providers of air ambulance services
to access the IDR process. The CAA also
amended the FEHBA, as discussed in
more detail in section I.D. of this pream-
ble.
The CAA provisions that apply to
health care providers and facilities and
providers of air ambulance services, such
as cost-sharing requirements, prohibitions
on balance billing for certain items and
services, and requirements related to dis-
closures about balance billing protections,
were added to title XXVII of the PHS Act
in a new part E.
The Departments are issuing regula-
tions in several phases implementing pro-
visions of title I (No Surprises Act) and
title II (Transparency) of Division BB of
the CAA. Later this year, the Departments
intend to issue regulations regarding the
federal IDR process (sections 103 and
105 of Division BB), patient protections
through transparency and the patient-pro-
vider dispute resolution process (section
112), and price comparison tools (section
114). The Departments also intend to un-
dertake rulemaking this year to propose
the form and manner in which plans, is-
suers, and providers of air ambulance
services would report information regard-
ing air ambulance services (section 106).
In addition, HHS intends to undertake
rulemaking to implement requirements on
health insurance issuers offering individu-
al health insurance coverage or short-term,
limited-duration insurance to disclose and
report information regarding direct or in-
direct compensation provided to agents
and brokers (section 202(c)), as well as
provisions related to HHS enforcement of
requirements on issuers, non-federal gov-
ernmental group health plans, providers,
facilities, and providers of air ambulance
services.
The CAA also includes provisions re-
garding transparency in plan and insur-
ance identification cards (section 107),
continuity of care (section 113), accura-
cy of provider network directories (sec-
tion 116), and prohibition on gag clauses
(section 201) that are applicable for plan
years beginning on or after January 1,
2022; and pharmacy benefit and drug cost
reporting (section 204) that is required by
20
42 U.S.C. 2000d.
21
86 FR 7009 (Jan. 25, 2021).
22
Pub. L. 116-260.

July 26, 2021 30 Bulletin No. 2021–30
December 27, 2021. The Departments in-
tend to undertake rulemaking to fully im-
plement these provisions, but rulemaking
regarding some of these provisions might
not occur until after January 1, 2022. The
Departments note that any such rulemak-
ing to fully implement these provisions
will include a prospective applicability
date that provides plans, issuers, provid-
ers, and facilities, as applicable, a reason-
able amount of time to comply with new
or clarified requirements. Until rulemak-
ing to fully implement these provisions is
finalized and effective, plans and issuers
are expected to implement the require-
ments using a good faith, reasonable
interpretation of the statute. The Depart-
ments intend to issue guidance in the near
future regarding their expectations relat-
ed to good faith compliance with these
provisions.
D. Preventing Surprise Medical Bills for
Federal Employees Health Benefits Plans
The No Surprises Act also amended the
FEHBA, 5 U.S.C. 8901 et seq., by add-
ing a new subsection (p) to 5 U.S.C. 8902.
Under this new provision, each FEHB
Program contract must require a carrier to
comply with provisions of sections 9816,
9817, and 9822 of the Code; sections 716,
717, and 722 of ERISA; and sections
2799A–1, 2799A–2, and 2799A–7 of the
PHS Act (as applicable) in the same man-
ner as they apply with respect to a group
health plan or health insurance issuer of-
fering group or individual health insurance
coverage. Likewise, the provisions of sec-
tions 2799B–1, 2799B–2, 2799B–3, and
2799B–5 of the PHS Act apply to health
care providers, facilities, and providers
of air ambulance services with respect to
covered individuals in FEHB plans in the
same manner as they apply to participants,
beneficiaries, or enrollees in group health
plans or coverage offered by health insur-
ance issuers.
OPM is charged with administering the
FEHB Program and maintains oversight
and enforcement authority with respect
to FEHB health benefits plans, which
are federal governmental plans. General-
ly, under 5 U.S.C. 8902(p), each FEHB
contract must require a carrier to comply
with certain PHS Act, ERISA, and Code
requirements in the same manner as they
apply to a group health plan or health in-
surance issuer.
II. Executive Summary
These interim final rules implement
provisions of the No Surprises Act that:
(1) apply to group health plans, health
insurance issuers offering group or in-
dividual health insurance coverage, and
carriers in the FEHB Program to provide
protections against balance billing and
out-of-network cost sharing with respect
to emergency services, non-emergency
services furnished by nonparticipating
providers at certain participating health
care facilities, and air ambulance services
furnished by nonparticipating providers
of air ambulance services; (2) prohibit
nonparticipating providers, health care
facilities, and providers of air ambulance
services from balance billing participants,
beneficiaries, and enrollees in certain sit-
uations, and permit these providers and
facilities to balance bill individuals if cer-
tain notice and consent requirements in the
No Surprises Act are satisfied; (3) require
certain health care facilities and providers
to provide disclosures of federal and state
patient protections against balance billing;
(4) recodify certain patient protections
that initially appeared in the ACA and that
the No Surprises Act applies to grandfa-
thered plans; and (5) set forth complaints
processes with respect to violations of the
protections against balance billing and
out-of-network cost sharing under the No
Surprises Act.
These interim final rules protect in-
dividuals from surprise medical bills for
emergency services, air ambulance ser-
vices furnished by nonparticipating pro-
viders, and non-emergency services fur-
nished by nonparticipating providers at
participating facilities in certain circum-
stances. Among other requirements, these
interim final rules require emergency
services to be covered without any prior
authorization, without regard to whether
the health care provider furnishing the
emergency services is a participating pro-
vider or a participating emergency facility
with respect to the services, and without
regard to any other term or condition of
the plan or coverage other than the ex-
clusion or coordination of benefits or a
permitted affiliation or waiting period.
Additionally, emergency services include
certain services in an emergency depart-
ment of a hospital or an independent free-
standing emergency department, as well
as post-stabilization services in certain
instances.
With respect to emergency services, air
ambulance services furnished by nonpar-
ticipating providers, and non-emergency
services furnished by nonparticipating
providers at participating facilities, these
interim final rules limit cost sharing for
out-of-network services to in-network
levels, require such cost sharing to count
toward any in-network deductibles and
out-of-pocket maximums, and prohibit
balance billing, as required by the No Sur-
prises Act.
These interim final rules specify that
cost-sharing amounts for such services
furnished by nonparticipating emergency
facilities and nonparticipating providers at
participating facilities must be calculated
based on one of the following amounts:
(1) an amount determined by an appli-
cable All-Payer Model Agreement under
section 1115A of the Social Security Act;
(2) if there is no such applicable All-Payer
Model Agreement, an amount determined
by a specified state law; or (3) if there
is no such applicable All-Payer Model
Agreement or specified state law, the less-
er of the billed charge or the plan’s or is-
suer’s median contracted rate, referred to
as the qualifying payment amount (QPA).
Cost-sharing amounts for air ambulance
services provided by nonparticipating pro-
viders must be calculated using the lesser
of the billed charge or the QPA, and the
cost-sharing requirement that would apply
if such services were provided by a partic-
ipating provider.
Under these interim final rules, bal-
ance billing for services covered by the
rules generally is prohibited, and the total
amount to be paid to the provider or fa-
cility, including any cost sharing, is based
on: (1) an amount determined by an appli-
cable All-Payer Model Agreement under
section 1115A of the Social Security Act;
(2) if there is no such applicable All-Payer
Model Agreement, an amount determined
by a specified state law; (3) if there is no
such applicable All-Payer Model Agree-
ment or specified state law, an amount
agreed upon by the plan or issuer and the
provider or facility; or (4) if none of those

Bulletin No. 2021–30 31 July 26, 2021
three conditions apply, an amount deter-
mined by an IDR entity.
In general, under the No Surpris-
es Act and these interim final rules, the
protections that limit cost sharing and
prohibit balance billing do not apply to
certain post-stabilization services, or
to certain non-emergency services per-
formed by nonparticipating providers
at participating health care facilities, if
the provider or facility provides notice
to the participant, beneficiary, or enroll-
ee, and obtains the individual’s consent
to waive the balance billing protections.
However, providers and facilities may
not provide such notice or seek consent
from individuals in certain circumstances
where surprise bills are likely to occur,
such as for ancillary services provided by
nonparticipating providers in connection
with non-emergency care in a participat-
ing facility. In such circumstances, bal-
ance billing is prohibited, and the other
protections of the No Surprises Act, such
as in-network cost-sharing requirements,
continue to apply.
Neither the No Surprises Act, nor these
interim final rules, universally protect in-
dividuals from every high or unexpected
medical bill. For example, an individual
may be enrolled in a group health plan or
health insurance coverage that provides
little or no coverage for their particular
health care condition or the items and ser-
vices necessary to treat that condition. In
addition, balance billing continues to be
permitted, unless prohibited by state law
or contract, in circumstances where these
interim final rules do not apply, such as for
non-emergency items or services provided
at facilities that are not included within the
definition of health care facility in these
interim final rules. Nonetheless, the No
Surprises Act and these interim final rules
provide relief from some of the more com-
mon scenarios where a participant, benefi-
ciary, or enrollee might otherwise be faced
with high and unexpected medical costs.
These interim final rules establish a
complaints process for receiving and re-
solving complaints related to these new
balance billing protections.
These interim final rules also imple-
ment the requirement of the No Surprises
Act that certain health care providers and
facilities make publicly available, post on
a public website, and provide a one-page
notice to individuals regarding: (1) the
requirements and prohibitions applicable
to the provider or facility under sections
2799B-1 and 2799B-2 of the PHS Act and
their implementing regulations; (2) any
applicable state balance billing require-
ments; and (3) how to contact appropriate
state and federal agencies if the individ-
ual believes the provider or facility has
violated the requirements described in the
notice.
Section 116 of the No Surprises Act
also added section 9820(c) of the Code,
section 720(c) of ERISA, and section
2799A-5(c) of the PHS Act, which in-
clude similar disclosure requirements
applicable to plans and issuers. In gener-
al, under these provisions, plans and is-
suers must make publicly available, post
on a public website of the plan or issuer,
and include on each explanation of ben-
efits for an item or service with respect
to which the requirements under section
9816 of the Code, section 716 of ERI-
SA, and section 2799A-1 of the PHS Act
apply, information on the requirements
applied under these aforementioned sec-
tions, as applicable; on the requirements
and prohibitions applied under sections
2799B-1 and 2799B-2 of the PHS Act; on
other applicable state laws on out-of-net-
work balance billing; and on contacting
appropriate state and federal agencies in
the case that an individual believes that
such a provider or facility has violated
the prohibition against balance billing.
These disclosure requirements are appli-
cable for plan years beginning on or after
January 1, 2022. To reduce burden and
facilitate compliance with these disclo-
sure requirements, the Departments are
concurrently issuing a model disclosure
notice that health care providers, facil-
ities, group health plans, and health in-
surance issuers may, but are not required
to, use to satisfy the disclosure require-
ments regarding the balance billing pro-
tections. The Departments will consider
use of the model notice in accordance
with the accompanying instructions to be
good faith compliance with the disclo-
sure requirements of section 9820(c) of
the Code, section 720(c) of ERISA, and
section 2799A-5(c) of the PHS Act, if all
other applicable requirements are met.
In addition, HHS will consider use of
the model notice in accordance with the
accompanying instructions to be good
faith compliance with the disclosure re-
quirements of section 2799B-3 of the
PHS Act and 45 CFR 149.430, if all oth-
er applicable PHS Act requirements are
met. The Departments may address the
requirements under section 9820(c) of
the Code, section 720(c) of ERISA, and
section 2799A-5(c) of the PHS Act, as
added by the No Surprises Act, in more
detail in future guidance or rulemaking.
Until further guidance is issued, plans
and issuers are expected to implement
the requirements of section 9820(c) of
the Code, section 720(c) of ERISA, and
section 2799A-5(c) of the PHS Act using
a good faith, reasonable interpretation of
the law. The Departments will take into
account the statutory applicability date
and the timeframe for implementation
when determining good faith compliance
with the law.
These interim final rules generally ap-
ply to group health plans and health in-
surance issuers offering group or individ-
ual health insurance coverage (including
grandfathered health plans) with respect
to plan years (in the individual market,
policy years) beginning on or after Janu-
ary 1, 2022, as well as to health care pro-
viders and facilities, and providers of air
ambulance services beginning on January
1, 2022.
In the OPM interim final rules included
in this rulemaking, OPM adopts all pro-
visions of the Departments’ interim final
rules that address the sections of the Code,
ERISA, and the PHS Act that are refer-
enced in 5 U.S.C. 8902(p). In the OPM
interim final rules, OPM defines terms
unique to the FEHB Program, adapts
some of the Departments’ rules as neces-
sary to properly integrate with the existing
FEHB Program regulatory and contractu-
al structure, sets forth the circumstances
in which OPM will enforce these rules
against FEHB carriers, and sets forth the
types of court actions involving the FEHB
Program that may be brought against
OPM with respect to the No Surprises Act.
In effectuating compliance with 5
U.S.C. 8902(p), FEHB contract terms that
relate to the nature, provision, or extent
of coverage or benefits (including pay-
ments with respect to benefits) supersede
and preempt state law or local law, or any
regulation issued thereunder, which re-

July 26, 2021 32 Bulletin No. 2021–30
lates to health insurance or plans.
23
OPM
contracts with FEHB carriers may include
terms that adopt state law as governing for
a particular purpose.
III. Overview of the Interim Final
Rules – Departments of HHS, Labor,
and the Treasury
A. Definitions
The provisions of the Code, ERISA,
and the PHS Act added by the No Sur-
prises Act, as well as these interim final
rules, include defined terms that are spe-
cific to the requirements and implementa-
tion of the law. Definitions of these key
terms are described throughout this pre-
amble. These terms help define the scope
of the balance billing protections and how
cost-sharing amounts and payment levels
are determined.
The Departments note that these inter-
im final rules define the term “physician
or health care provider” to mean a phy-
sician or other health care provider who
is acting within the scope of practice of
that provider’s license or certification un-
der applicable state law, but the definition
specifically excludes providers of air am-
bulance services. The Departments recog-
nize that, although the No Surprises Act
does not define “provider,” it uses the term
in a manner that includes providers of air
ambulance services in some provisions.
For example, the No Surprises Act added
section 2799B-4 of the PHS Act, which
specifically includes providers of air am-
bulance services when referencing pro-
viders. However, certain other provisions
in the No Surprises Act apply only to pro-
viders of air ambulance services, or apply
to health care providers generally, but by
their terms are inapplicable to providers of
air ambulance services. As an example of
the latter, the No Surprises Act added sec-
tion 2799B-2 of the PHS Act, which gen-
erally prohibits balance billing by nonpar-
ticipating health care providers furnishing
non-emergency services at participating
health care facilities. Although this provi-
sion does not explicitly exclude providers
of air ambulance services, providers of
air ambulance services would not furnish
non-emergency services at participating
health care facilities. Therefore, the pro-
vision does not apply to providers of air
ambulance services (such providers are,
however, prohibited from balance billing
under section 2799B-5 of the PHS Act).
Similarly, section 2799B-3 of the PHS
Act, which requires a health care provider
to inform individuals of the requirements
and prohibitions on such health care pro-
vider in sections 2799B-1 and 2799B-2
of the PHS Act (neither of which apply
to providers of air ambulance services),
does not by its terms apply to providers of
air ambulance services. Therefore, these
interim final rules define “physician or
health care provider” to exclude provid-
ers of air ambulance services, in order to
help clarify which provisions of the No
Surprises Act and interim final rules apply
to providers of air ambulance services. In
instances where provisions under the No
Surprises Act, as implemented in these
interim final rules, apply to providers of
air ambulance services, the provisions
explicitly reference air ambulance pro-
viders. Conversely, where providers of
air ambulance services are not explicitly
mentioned, the provisions do not apply.
The Departments seek comment on the
terms defined in these interim final rules,
including the appropriateness and usabil-
ity of the definitions, and whether addi-
tional terms should be defined in future
rulemaking.
B. Preventing Surprise Medical Bills
1. Scope of the New Surprise Billing
Protections
i. Emergency Services
Under section 9816(a) of the Code,
section 716(a) of ERISA, and section
2799A-1(a) of the PHS Act, and these in-
terim final rules, if a group health plan, or
a health insurance issuer offering group or
individual health insurance coverage, pro-
vides or covers any benefits with respect
to services in an emergency department
of a hospital or with respect to emergen-
cy services in an independent freestanding
emergency department, the plan or issuer
must cover emergency services as defined
in these interim final rules and such cover-
age must be provided in accordance with
these interim final rules.
A plan or issuer providing coverage of
emergency services must do so without
the individual or the health care provid-
er having to obtain prior authorization
(including when the emergency services
are provided out-of-network) and without
regard to whether the health care provid-
er furnishing the emergency services is a
participating provider or a participating
emergency facility with respect to the
services. The emergency services must
be provided without regard to any other
term or condition of the plan or coverage
other than the exclusion or coordination
of benefits (to the extent not inconsistent
with benefits for an emergency medical
condition as defined in these interim final
rules), an affiliation or waiting period as
permitted under the Code, ERISA, or the
PHS Act, or applicable cost-sharing re-
quirements. For a plan or health insurance
coverage with a network of providers that
provides benefits for emergency services,
the plan or issuer may not impose any ad-
ministrative requirement or limitation on
coverage for emergency services received
from nonparticipating providers or non-
participating emergency facilities that is
more restrictive than the requirements or
limitations that apply to emergency ser-
vices received from participating provid-
ers or participating emergency facilities.
In addition, such plan or health insurance
coverage must comply with the require-
ments regarding cost sharing, payment
amounts, and processes for resolving bill-
ing disputes described elsewhere in this
preamble.
The terms “emergency medical condi-
tion,” “emergency services,” and “to sta-
bilize” generally have the meaning given
to them under the Emergency Medical
Treatment and Labor Act (EMTALA),
section 1867 of the Social Security Act.
24

Emergency services include: (1) an appro-
priate medical screening examination that
is within the capability of the emergency
23
5 U.S.C. 8902(m)(1); see Coventry Health Care of Missouri, Inc. v. Nevils, 137 S. Ct. 1190 (2017).
24
42 U.S.C. 1395dd.

Bulletin No. 2021–30 33 July 26, 2021
department of a hospital or of an indepen-
dent freestanding emergency department,
including ancillary services routinely
available to the emergency department,
to evaluate whether an emergency medi-
cal condition exists; and (2) such further
medical examination and treatment as
may be required to stabilize the individual
(regardless of the department of the hos-
pital in which the further medical exam-
ination and treatment is furnished) within
the capabilities of the staff and facilities
available at the hospital or the indepen-
dent freestanding emergency department.
Under section 2719A of the PHS Act,
emergency services were defined to in-
clude: (1) a medical screening examina-
tion (as required under section 1867 of
the Social Security Act) that is within the
capability of the emergency department of
a hospital, including ancillary services rou-
tinely available to the emergency depart-
ment to evaluate such emergency medical
condition; and (2) such further medical
examination and treatment as are required
under section 1867 of the Social Security
Act to stabilize the patient within the capa-
bilities of the staff and facilities available
at the hospital. HHS has previously inter-
preted the obligations on hospitals under
EMTALA to provide medical examination
and stabilization services to end when a
patient is formally admitted in good faith.
25

Section 9816(a) of the Code, section 716(a)
of ERISA, and section 2799A-1(a) of the
PHS Act expand the definition of emergen-
cy services (as compared to section 2719A
of the PHS Act) to include stabilization ser-
vices “regardless of the department of the
hospital in which the further medical exam-
ination and treatment is furnished.” There-
fore, the definition of emergency services
in these interim final rules includes pre-sta-
bilization services that are provided after
the patient is moved out of the emergency
department and admitted to a hospital, and
these services will be subject to the protec-
tions of the No Surprises Act.
Section 102 of the No Surprises Act
further broadens the definition of emer-
gency services to include emergency
services provided at an independent
freestanding emergency department. An
independent freestanding emergency de-
partment is a health care facility (not lim-
ited to those described in the definition of
health care facility at section 9816(b)(2)
(A)(ii) of the Code, section 716(b)(2)(A)
(ii) of ERISA, and section 2799A-1(b)
(2)(A)(ii) of the PHS Act, as applicable)
that provides emergency services, and is
geographically separate and distinct from
a hospital, and separately licensed as such
by a state. The definition of “independent
freestanding emergency department” is
intended to include any health care facili-
ty that is geographically separate and dis-
tinct from a hospital, and that is licensed
by a state to provide emergency services,
even if the facility is not licensed under
the term “independent freestanding emer-
gency department.”
Regulation of health care facilities var-
ies by state. In particular, state regulation
of urgent care centers varies significantly,
and is evolving as these types of centers
become more common.
26
If under state
licensure laws, urgent care centers are
permitted to provide emergency services,
then urgent care centers in that state that
are geographically separate and distinct
from a hospital would fall within the defi-
nition of independent freestanding emer-
gency department for purposes of these
interim final rules. In contrast, if state
licensure of urgent care centers does not
permit such facilities to provide emergen-
cy services as defined in these interim fi-
nal rules, then urgent care centers in that
state would not be treated as independent
freestanding emergency departments for
purposes of these interim final rules. Fi-
nally, the definition of emergency services
also includes additional post-stabilization
services, as discussed in section III.B.1.ii
of this preamble.
The term “emergency medical condi-
tion” means a medical condition manifest-
ing itself by acute symptoms of sufficient
severity (including severe pain) such that
a prudent layperson, who possesses an av-
erage knowledge of health and medicine,
could reasonably expect the absence of
immediate medical attention to result in a
condition described in EMTALA, includ-
ing (1) placing the health of the individual
(or, with respect to a pregnant woman, the
health of the woman or her unborn child)
in serious jeopardy, (2) serious impair-
ment to bodily functions, or (3) serious
dysfunction of any bodily organ or part.
27

This definition includes mental health
conditions and substance use disorders.
The Departments are aware that some
plans and issuers currently deny cover-
age of certain services provided in the
emergency department of a hospital by
determining whether an episode of care
involves an emergency medical condition
based solely on final diagnosis codes, such
as International Classification of Diseas-
es, Tenth Revision, Clinical Modification
(ICD-10-CM) codes. In addition, some
plans and issuers might automatically
deny coverage based on a list of final diag-
nosis codes initially, without regard to the
individual’s presenting symptoms or any
additional review. Following an initial de-
nial, plans and issuers might then provide
for complete consideration of the claim,
and apply the prudent layperson stan-
dard, only as part of an appeals process
if the participant, beneficiary, or enrollee
appeals. These practices are inconsistent
with the emergency services requirements
of the No Surprises Act and the ACA.
28

This is true even if the process for com-
plete consideration of the claim following
an initial denial is not designated as a for-
mal appeal. Instead, the determination of
whether the prudent layperson standard is
met must be made on a case-by-case basis
before an initial denial of an emergency
services claim.
25
42 CFR 489.24(a)(1)(ii); 68 FR 53221-53264 (Sept. 9, 2003); 73 FR 48654-48668 (Aug. 19, 2008).
26
Association of State and Territorial Health Officials. As Urgent Care Centers Increase, Licensing Authority Falling Under State Health Agencies, (Oct. 11, 2018) available at https://www.
astho.org/StatePublicHealth/As-Urgent-Care-Centers-Increase-Licensing-Authority-Falling-Under-State-Health-Agencies/10-11-18/.
27
See 42 U.S.C. 1395dd(e)(1)(A).
28
See also Am. Coll. of Emergency Physicians v. Blue Cross & Blue Shield of Georgia, No. 20-11511, 2020 WL 6165852 (11th Cir. Oct. 22, 2020) (per curiam) (reversing dismissal of plaintiffs’
ACA and ERISA claims alleging defendants violated prudent layperson standard where review process was based upon physician review of medical records and diagnostic codes; prudent
layperson standard ignores a patient’s final diagnosis and instead asks whether a person with average medical knowledge would reasonably think they need emergency services to address
their symptoms).

July 26, 2021 34 Bulletin No. 2021–30
These interim final rules make clear
that if a group health plan, or a health in-
surance issuer offering group or individ-
ual health insurance coverage, provides
or covers any benefits with respect to
services in an emergency department of
a hospital or with respect to emergency
services in an independent freestanding
emergency department, the plan or issuer
must cover emergency services without
limiting what constitutes an emergency
medical condition (as defined in these
interim final rules) solely on the basis of
diagnosis codes. When a plan or issuer de-
nies coverage, in whole or in part, for a
claim for payment of a service rendered
in the emergency department of a hospital
or independent freestanding emergency
department, including services rendered
during observation or surgical services,
the determination of whether the prudent
layperson standard has been met must
be based on all pertinent documentation
and be focused on the presenting symp-
toms (and not solely on the final diagno-
sis). This determination must take into
account that the legal standard regarding
the decision to seek emergency services
is based on whether a prudent layperson
(rather than a medical professional) would
reasonably consider the situation to be an
emergency.
29
In covering emergency ser-
vices, plans and issuers must also ensure
that they do not restrict the coverage of
emergency services by imposing a time
limit between the onset of symptoms and
the presentation of the participant, bene-
ficiary, or enrollee at the emergency de-
partment. Similarly, plans and issuers also
may not restrict the coverage of emergen-
cy services because the patient did not ex-
perience a sudden onset of the condition.
The Departments are also aware that
some plans and issuers that generally
provide coverage for emergency services
have nonetheless denied benefits for such
services based on other general plan ex-
clusions. For example, the Departments
are aware of some plans and issuers deny-
ing claims for emergency services provid-
ed to dependent women who are pregnant,
based on a general plan exclusion for de-
pendent maternity care. As explained pre-
viously, both the coverage of emergency
services rules issued under section 2719A
of the PHS Act and the new emergency
services requirements included in these
interim final rules provide, in part, that if a
plan or issuer provides or covers any bene-
fits with respect to services in an emergen-
cy department of a hospital (or under these
interim final rules, in an independent free-
standing emergency department), emer-
gency services must be provided “without
regard to any other term or condition of
the plan or coverage (other than the exclu-
sion or coordination of benefits...).” The
Departments clarify that this provision
does not permit plans and issuers to ex-
clude benefits for items and services that
would otherwise constitute benefits for an
emergency medical condition as defined
under these interim final rules. This provi-
sion does not permit plans and issuers that
cover emergency services to deny benefits
for a participant, beneficiary, or enrollee
with an emergency medical condition that
receives emergency services, based on a
general plan exclusion that would apply to
items and services other than emergency
services.
ii. Post-Stabilization Services
Under section 9816(a)(3)(C)(ii) of the
Code, section 716(a)(3)(C)(ii) of ERI-
SA, and section 2799A-1(a)(3)(C)(ii) of
the PHS Act, emergency services include
any additional items and services that are
covered under a plan or coverage and fur-
nished by a nonparticipating provider or
nonparticipating emergency facility (re-
gardless of the department of the hospi-
tal in which such items and services are
furnished) after a participant, beneficia-
ry, or enrollee is stabilized and as part
of outpatient observation or an inpatient
or outpatient stay with respect to the vis-
it in which the other emergency services
are furnished. Such additional items and
services (referred to in this preamble as
post-stabilization services) are considered
emergency services subject to surprise
billing protections unless the conditions
enumerated in section 9816(a)(3)(C)(ii)
(II)(aa)-(cc) of the Code, section 716(a)(3)
(C)(ii)(II)(aa)-(cc) of ERISA, or section
2799A-1(a)(3)(C)(ii)(II)(aa)-(cc) of the
PHS Act, as applicable, are met, as well
as such other conditions as specified by
the Departments under paragraph (dd) of
the respective sections. Therefore, these
interim final rules provide that post-stabi-
lization services are emergency services
unless all of the following conditions are
met.
First, the attending emergency physi-
cian or treating provider must determine
that the participant, beneficiary, or en-
rollee is able to travel using nonmedical
transportation or nonemergency medical
transportation to an available participating
provider or facility located within a rea-
sonable travel distance, taking into con-
sideration the individual’s medical condi-
tion. The HHS interim final rules codify
this requirement at 45 CFR 149.410(b)
(1). For this purpose, a treating provider
is a physician or health care provider who
has evaluated the individual. It is general-
ly expected that a treating provider with
medical training and experience related to
the individual’s specific medical condition
will determine if the individual is able to
travel using nonmedical transportation or
nonemergency medical transportation to
an available participating provider or fa-
cility located within a reasonable travel
distance. This determination is based on
all the relevant facts and circumstances
and the individual should be involved in
the decision-making process, if possible.
The determination by the attending emer-
gency physician or treating provider is
binding on the facility for purposes of this
requirement. This requirement is based on
the Departments’ understanding that such
provider is in the best position to make
this determination.
For individuals receiving care in or near
their plan’s or issuer’s covered service
area, as well as individuals with coverage
that uses a national network of providers
and facilities, the statutory criterion would
generally be sufficient to ensure that an in-
dividual can freely choose, based on their
medical condition, to receive post-stabili-
zation services at a participating facility or
participating provider. The additional re-
29
However, nothing in the statute or these interim final rules prevents a plan or issuer from approving coverage for emergency services solely on the basis of diagnosis codes, or from taking
diagnostic codes into account when deciding payment for a claim for emergency services, provided a denial of coverage is not based solely on diagnosis codes.

Bulletin No. 2021–30 35 July 26, 2021
quirement in these interim final rules that
the individual be able to travel to an avail-
able participating provider or facility lo-
cated within a reasonable travel distance,
taking into consideration the individual’s
medical condition, is necessary and ap-
propriate to carry out the provision of the
No Surprises Act, as the requirement is in-
tended to address the common situations
in which an individual has received emer-
gency services in a geographic region far
from where any participating providers or
facilities are located. In cases where the
individual cannot travel using nonmedical
transportation or nonemergency medical
transportation, or cases where there are
no participating facilities or participat-
ing providers located within a reasonable
travel distance, taking into account the
individual’s medical condition, the De-
partments are of the view that individuals
are unable to provide consent freely and,
therefore, balance billing protections con-
tinue to apply.
In addition, the Departments recognize
that an individual’s transportation options
may vary based on the individual’s loca-
tion, social risk, and other risk factors.
In cases of underserved and geograph-
ically isolated communities and those
with social risk factors related to income
and transportation options, individuals
may face additional barriers to obtaining
post-stabilization services without a dis-
ruption in care. For example, individuals
may not have the ability to pay for a taxi,
may not have access to a car, may not be
able to safely take public transit due to
their medical condition, or may not have
public transit options available. In these
cases, the net effect would be the same: the
individual would face unreasonable travel
burdens that could prevent them from be-
ing able to consent freely to a waiver of
the otherwise applicable balance billing
protections. The Departments expect the
attending emergency physician or treating
provider to consider such factors when
assessing the individual’s ability to trav-
el to a participating provider or facility.
The Departments seek comment on the
definition of “reasonable travel distance”
and whether specific standards or exam-
ples should be provided regarding what
constitutes an unreasonable travel burden.
For example, should reasonable travel dis-
tance take into account only mileage, or
also other factors, such as traffic or other
route conditions that might make traveling
difficult, time consuming, or hazardous?
In contrast to situations where a par-
ticipant, beneficiary, or enrollee is able to
travel using nonmedical transportation or
nonemergency medical transportation fol-
lowing stabilization, in the event that the
individual requires medical transportation
to travel, including transportation by ei-
ther ground or air ambulance vehicle, the
individual is not in a condition to receive
notice or provide consent. Therefore, the
surprise billing protections continue to ap-
ply to post-stabilization services provided
in connection with the visit for which the
individual received emergency services.
Second, the provider or facility furnish-
ing post-stabilization services must satisfy
the notice and consent criteria of section
2799B-2(d) of the PHS Act with respect to
such items and services (which are imple-
mented in HHS-only interim final rules at
45 CFR 149.410(b)(2), and incorporate by
reference the criteria for notice and con-
sent in 45 CFR 149.420(c) through (g)).
Third, the individual (or the individu-
al’s authorized representative) must be in
a condition to receive the information in
the notice described in section 2799B-2 of
the PHS Act (which is also implemented
in 45 CFR 149.410(b)(3)) and to provide
informed consent under such section,
in accordance with applicable state law.
Whether an individual is in a condition
to receive the information in the notice is
determined by the attending physician or
treating provider using appropriate medi-
cal judgment. It is generally expected that
an attending physician or treating provider
with medical training and experience re-
lated to the individual’s specific medical
condition will make this determination
based on all the relevant facts and circum-
stances. In addition to applying any re-
quirements under state law, such medical
professionals should apply the same prin-
ciples as they would when determining if
a patient is able to provide informed con-
sent for treatment.
30
They should assess
whether an individual is capable of under-
standing the information provided in the
notice and the implications of consenting.
Consideration must be given to the indi-
vidual’s state of mind after receiving the
emergency services and the individual’s
emotional state at the time of consent. For
example, consideration must be given to
the effect of any alcohol or drug use by the
individual, including the use or adminis-
tration of prescribed medications, as well
as to any pain the individual is experienc-
ing, and the impact of those factors on the
patient’s state of mind. If the individual
is experiencing a mental or behavioral
health episode or displaying symptoms
of a mental or behavioral health disor-
der, or is impaired by a substance abuse
disorder, consideration should also be
given as to whether the individual’s con-
dition impairs their ability to receive the
information in the notice and provide in-
formed consent. In addition, consideration
must be given to cultural and contextual
factors that may affect the informed de-
cision-making and consent process for
members of underserved communities,
including lack of trust arising from his-
torical inequities, misinformation about
the informed consent process, or barriers
to comprehension of the information giv-
en through the informed consent process
and after the informed consent document
is signed.
31
These barriers may include ac-
cessibility, language, and literacy barriers.
In addition, the informed consent must
be obtained in a way that adheres to all
civil rights protections cited within this
rulemaking, ensuring that all individuals
including those from underserved, un-
derrepresented communities, with limited
English proficiency, and with disabilities,
are able to understand and freely make in-
formed decisions.
Consent must be made voluntarily,
meaning the individual must be able to
30
Ethics guidance for physicians, published by the American Medical Association, states that physicians should “[a]ssess the patient’s ability to understand relevant medical information and
the implications of treatment alternatives and to make an independent, voluntary decision” as part of the process of seeking informed consent. American Medical Association, Code of Medical
Ethics Opinion 2.1.1, available at https://www.ama-assn.org/system/files/2019-06/code-of-medical-ethics-chapter-2.pdf (last visited April 5, 2021). See also Gostin, LO. Public Health Law,
217-218 (2000) (discussing the four elements of the doctrine of informed consent: information, competency, voluntariness, and specificity).
31
For a discussion of strategies to improve informed consent processes for minority communities, see Quinn, S.C., et al. Improving Informed Consent with Minority Participants: Results from
Researcher and Community Surveys, Journal of Empirical Research on Human Research Ethics, 7(5): 44-55 (Dec. 2012).

July 26, 2021 36 Bulletin No. 2021–30
consent freely, without undue influence,
fraud, or duress. If post-stabilization ser-
vices must be provided quickly after the
emergency services are provided, it may
be challenging for the individual or their
authorized representative to have ade-
quate time to make a clear-minded deci-
sion regarding consent. Consent obtained
through a threat of restraint or immediacy
of the need for treatment is not voluntary.
In addition, the emergency physician or
treating provider should consider wheth-
er the individual has reasonable options
regarding post-stabilization services,
transport, or service provider or facili-
ty. The Departments are of the view that
the post-stabilization notice and consent
procedures should generally be applied
in limited circumstances, where the indi-
vidual knowingly and purposefully seeks
care from a nonparticipating provider or
facility (such as deciding to go under the
care of a specific provider or facility that
the individual is familiar or comfortable
with), and that the process should not be
permitted to circumvent the consumer
protections in the No Surprises Act.
Fourth, the provider or facility must
satisfy any additional requirements or
prohibitions as may be imposed under
applicable state law. These interim final
rules include this criterion recognizing
that some state laws do not permit excep-
tions to state balance billing protections,
such as allowing individuals to consent to
waive protections. Thus, states may im-
pose stricter standards by which post-sta-
bilization services will be exempted from
the surprise billing protections under these
interim final rules, or states might not per-
mit exceptions at all. This requirement is
codified in the HHS interim final rules at
45 CFR 149.410(b)(5).
The No Surprises Act authorizes the
Departments to specify other conditions
that must be satisfied for post-stabilization
services to be excepted from the definition
of emergency services for purposes of the
No Surprises Act. The Departments solic-
it comments on the conditions described
earlier in this section. The Departments
also seek comment on whether there are
any additional conditions that would be
appropriate to designate under the defi-
nition of emergency services, such as
conditions relating to coordinating care
transitions to participating providers and
facilities. The Departments also solicit
comments on what guidelines, beyond
state laws regarding informed consent,
may be needed to determine when an in-
dividual is in a condition to receive the
written notice and provide consent. For
example, are standards needed to account
for individuals who are experiencing se-
vere pain, intoxication, incapacitation, or
dementia after being stabilized following
an emergency medical condition?
iii. Non-Emergency Services Performed
by Nonparticipating Providers at
Participating Health Care Facilities
Section 9816(b) of the Code, section
716(b) of ERISA, section 2799A-1(b) of
the PHS Act, and these interim final rules,
apply surprise billing protections in the
case of non-emergency services furnished
by nonparticipating providers during a
visit by a participant, beneficiary, or en-
rollee at a participating health care facil-
ity, unless the notice and consent require-
ments, as specified in these interim final
rules, have been met.
Specifically, if a group health plan, or
a health insurance issuer offering group
or individual health insurance coverage,
provides or covers benefits with respect to
items and services (other than emergency
services to which section 9816(a) of the
Code, section 716(a) of ERISA, or section
2799A-1(a) of the PHS Act applies), the
plan or issuer must cover such items and
services furnished to a participant, benefi-
ciary, or enrollee of the plan or coverage by
a nonparticipating provider with respect to
a visit at a participating health care facil-
ity in accordance with these interim final
rules, including the requirements regard-
ing cost sharing, payment amounts, and
processes for resolving billing disputes
described elsewhere in this preamble.
iv. Health Care Facilities
These interim final rules, consistent
with section 9816(b)(2)(A) of the Code,
section 716(b)(2)(A) of ERISA, and sec-
tion 2799A-1(b)(2)(A) of the PHS Act,
define a participating health care facili-
ty, in the context of non-emergency ser-
vices, as a health care facility that has a
contractual relationship directly or indi-
rectly with a group health plan or health
insurance issuer offering group or indi-
vidual health insurance coverage setting
forth the terms and conditions on which
a relevant item or service is provided to
a participant, beneficiary, or enrollee un-
der the plan or coverage, respectively.
These interim final rules also specify that
a single case agreement between a health
care facility and a plan or issuer, used to
address unique situations in which a par-
ticipant, beneficiary, or enrollee requires
services that typically occur out-of-net-
work constitutes a contractual relation-
ship for purposes of this definition, and
is limited to the parties to the agreement
with respect to the particular individu-
al involved. Thus, when non-emergency
services are furnished by a nonparticipat-
ing provider at a health care facility that
has a single case agreement in place with
respect to the individual being treated, as
opposed to an agreement or contract that
would apply to all the plan’s or issuer’s
participants, beneficiaries, or enrollees,
those non-emergency services would be
subject to the protections described in 26
CFR 54.9816-5T, 29 CFR 2590.716-5,
and 45 CFR 149.120, as applicable, and
the corresponding requirements on pro-
viders at 45 CFR 149.420. The Depart-
ments are of the view that it is reasonable
that an individual would expect items and
services delivered at a health care facility
that has a single case agreement in place
with respect to the individual’s care to be
delivered on an in-network basis. Thus,
these interim final rules apply the same
protections in this circumstance as would
apply at health care facilities that partic-
ipate in the plan or issuer’s network.
32

The facility is considered a participating
facility only with respect to items and ser-
vices furnished to the individual whose
care is covered by the single case agree-
ment. Similarly, these interim final rules
define a participating emergency facility
to include a facility that has a single case
agreement in place with a plan or issu-
32
In contrast, as discussed in section III.B.2.vi of this preamble, these interim final rules do not include negotiated rates under single-case agreements in the methodology for calculating the
qualifying payment amount.

Bulletin No. 2021–30 37 July 26, 2021
er with respect to a specific individual’s
care. The Departments seek comment on
this approach.
For this purpose, a health care facili-
ty described in the statute is each of the
following, in the context of non-emergen-
cy services: (1) a hospital (as defined in
1861(e) of the Social Security Act); (2) a
hospital outpatient department; (3) a crit-
ical access hospital (as defined in section
1861(mm)(1) of the Social Security Act);
or (4) an ambulatory surgical center de-
scribed in section 1833(i)(1)(A) of the So-
cial Security Act.
In addition, section 9816(b)(2)(A)(ii)
(V) of the Code, section 716(b)(2)(A)(ii)
(V) of ERISA, and section 2799A-1(b)(2)
(A)(ii)(V) of the PHS Act authorize the
Departments to designate additional facil-
ities as health care facilities. The Depart-
ments solicit comments on other facilities
that would be appropriate to designate as
health care facilities. The Departments
are interested in comments identifying
types of facilities in which surprise bills
frequently arise, and are particularly in-
terested in comments regarding whether
urgent care centers or retail clinics should
be designated as health care facilities for
purposes of these interim final rules.
The Departments recognize that state
regulation of urgent care centers varies
significantly, as does the type of services
they are permitted to provide under state
law. Under these interim final rules, emer-
gency services provided at urgent care
centers that are licensed in a manner that
brings them within the definition of inde-
pendent freestanding emergency depart-
ment would be subject to cost-sharing and
balance billing protections, among oth-
ers. However, given significant variation
in state law definitions, urgent care cen-
ters are not included within the definition
of health care facilities, in the context of
non-emergency services. Thus, in cases
where non-emergency services are fur-
nished at participating urgent care centers
by nonparticipating providers, those ser-
vices would not receive the protections
under these interim final rules. However,
the Departments are of the view that it is
possible that individuals may be using ur-
gent care centers (regardless of how they
are licensed) in a similar way to how they
use independent freestanding emergency
departments, in which case it may be ap-
propriate to designate urgent care centers
as health care facilities. The Departments
seek comment on the degree to which in-
dividuals may be using urgent care centers
in a similar way to how they use indepen-
dent freestanding emergency departments.
The Departments seek data on how fre-
quently surprise bills arise in the context
of urgent care centers. The Departments
also seek comment on whether plans and
issuers generally contract separately with
urgent care centers and the providers who
work at the centers, and how frequently
contracting practices result in nonpartic-
ipating providers furnishing services at
participating urgent care centers. The De-
partments also seek comment on potential
definitions of the term urgent care center.
v. Items and Services within the Scope of
a Visit
In addition to items and services fur-
nished by a provider at the facility, a “vis-
it” to a participating health care facility
includes the furnishing of equipment and
devices, telemedicine services, imaging
services, laboratory services, and preop-
erative and postoperative services, regard-
less of whether the provider furnishing
such items or services is at the facility.
These services are not limited based on
whether the provider furnishing the ser-
vices is physically located at the facili-
ty. For example, if a sample is collected
during an individual’s hospital visit and
sent to an off-site laboratory, the laborato-
ry services would be considered to be part
of the individual’s visit to a participating
health care facility, if laboratory services
are covered by the plan or coverage. Sim-
ilarly, if an individual receives a consul-
tation with a specialist via telemedicine
during a visit to a participating hospital,
those telemedicine services would be con-
sidered part of the individual’s visit to a
participating health care facility. The stat
-
utory definition of “visit” also provides
authority for the Departments to specify
other items and services. The Departments
solicit comments regarding other items
and services that would be appropriate to
include within the scope of a visit for pur-
poses of these interim final rules.
The No Surprises Act and these inter-
im final rules provide for exceptions to the
balance billing prohibitions and cost-shar-
ing requirements if the participant, benefi-
ciary, or enrollee is provided a compliant
written notice and consents to receive such
services from a nonparticipating provider
at a participating health care facility. How-
ever, these exceptions do not apply with
respect to certain ancillary services (in the
context of non-emergency services) and
other services under certain conditions, as
discussed later in this preamble.
vi. Air Ambulance Services
Section 105 of the No Surprises Act
added section 9817 of the Code, section
717 of ERISA, and section 2799A-2 of the
PHS Act to address surprise air ambulance
bills. These provisions apply in the case of
a participant, beneficiary, or enrollee who
receives services from a nonparticipating
provider of air ambulance services, mean-
ing medical transport by a rotary-wing air
ambulance, as defined in 42 CFR 414.605,
or fixed-wing air ambulance, as defined
in 42 CFR 414.605. These interim final
rules apply these provisions where a plan
or coverage generally has a network of
participating providers and provides or
covers any benefits for air ambulance ser-
vices, even if the plan or coverage does
not have in its network any providers of
air ambulance services. With respect to air
ambulance services furnished by nonpar-
ticipating providers (including inter-facili-
ty transports), plans and issuers must com-
ply with the requirements regarding cost
sharing, payment amounts, and processes
for resolving billing disputes described
elsewhere in this preamble, if such ser-
vices would be covered if provided by a
participating provider with respect to such
plan or coverage.
2. Determination of the Cost-Sharing
Amount and Payment Amount to
Providers and Facilities
i. In General
Under section 9816(a) of the Code, sec-
tion 716(a) of ERISA, section 2799A-1(a)
of the PHS Act, and these interim final
rules, if a plan or issuer provides or cov-
ers any benefits with respect to services in
an emergency department of a hospital or
with respect to emergency services in an
independent freestanding emergency de-

July 26, 2021 38 Bulletin No. 2021–30
partment, the cost-sharing requirement for
such services performed by a nonpartici-
pating provider or nonparticipating emer-
gency facility must not be greater than the
requirement that would apply if such ser-
vices were provided by a participating pro-
vider or a participating emergency facility.
Additionally, if a plan or issuer provides
or covers any benefits for non-emergency
items and services furnished by a nonpar-
ticipating provider with respect to a visit at
a participating health care facility, unless
the provider has satisfied certain notice
and consent criteria with respect to such
items and services, the plan or issuer may
not impose a cost-sharing requirement
for such items and services that is great-
er than the cost-sharing requirement that
would apply had such items or services
been furnished by a participating provid-
er. Similarly, if a plan or issuer provides or
covers benefits for air ambulance services,
the plan or issuer must cover such services
from a nonparticipating provider in such a
manner that the cost-sharing requirement
with respect to such services must be the
same requirement that would apply if such
services were provided by a participating
provider. For example, if a plan or issu-
er imposes a 20 percent coinsurance rate
for emergency services from participating
providers or participating emergency fa-
cilities, the plan or issuer may not impose
a coinsurance rate on emergency services
from nonparticipating providers or facil-
ities that exceeds 20 percent. Stakehold-
ers have reported that network participa-
tion rates are low among providers of air
ambulance services. In instances where a
plan or issuer does not have an established
cost-sharing requirement that applies spe-
cifically to participating providers, the
plan or issuer must calculate the cost-shar-
ing amount using the generally applicable
cost-sharing requirement for the relevant
item or service under the plan or coverage.
Under sections 9816(a) and (b) and
9817(a) of the Code, sections 716(a)
and (b) and 717(a) of ERISA, sections
2799A-1(a) and (b) and 2799A-2(a) of the
PHS Act, and these interim final rules, any
cost-sharing payments for emergency ser-
vices, non-emergency services furnished
by a nonparticipating provider in a partic-
ipating health care facility, and air ambu-
lance services furnished by a nonpartici-
pating provider must be counted toward
any in-network deductible or out-of-pock-
et maximums applied under the plan or
coverage (including the annual limitation
on cost sharing under section 2707(b) of
the PHS Act) (as applicable), respectively
(and these in-network deductibles and out-
of-pocket maximums must be applied) in
the same manner as if such cost-sharing
payments were made with respect to ser-
vices furnished by a participating provider
or facility.
ii. Cost-Sharing Amount
Section 9816(a)(1)(C)(iii) of the Code,
section 716(a)(1)(C)(iii) of ERISA, sec-
tion 2799A-1(a)(1)(C)(iii) of the PHS Act,
and these interim final rules also specify
that for emergency services furnished by
a nonparticipating emergency facility, and
for non-emergency services furnished by
nonparticipating providers in a partici-
pating health care facility, cost sharing is
generally calculated as if the total amount
that would have been charged for the ser-
vices by a participating emergency facility
or participating provider were equal to the
recognized amount for such services, as
defined by the statute and in these interim
final rules.
The “recognized amount” is: (1) an
amount determined by an applicable
All-Payer Model Agreement under sec-
tion 1115A of the Social Security Act; (2)
if there is no applicable All-Payer Mod-
el Agreement, an amount determined by
a specified state law; or (3) if there is no
applicable All-Payer Model Agreement
or specified state law, the lesser of the
amount billed by the provider or facility or
the QPA, which under these interim final
rules generally is the median of the con-
tracted rates of the plan or issuer for the
item or service in the geographic region.
By requiring plans and issuers to calcu-
late the cost-sharing amount using the rec-
ognized amount, rather than the amount
the plan or issuer ultimately pays the non-
participating provider or nonparticipating
emergency facility for the furnished items
or services, the No Surprises Act and
these interim final rules limit the effect
of provider-payer disputes about payment
amounts on participant, beneficiary, or en-
rollee cost sharing. Under the statute and
these interim final rules, the provider or
facility and plan or issuer separately deter-
mine the total payment amount for the fur-
nished items or services, but that amount
generally does not affect the cost-sharing
amount the individual must pay.
The Departments are aware that there
may be some instances where a nonpar-
ticipating health care provider or facility
might bill a plan or issuer for an item or
service that is subject to these surprise
billing protections in an amount less than
the QPA. For example, this might be a
relatively common occurrence for items
whose patent expires after 2019, in in-
stances where the QPA is based off the
median of the contracted rates from 2019.
In these instances, assuming the plan or
issuer would not pay more than the billed
charge, calculating cost sharing based on
the QPA would require a participant, ben-
eficiary, or enrollee to pay a higher per-
centage in cost sharing than if the items or
services had been furnished by a partici-
pating provider. However, section 9816(a)
(1)(C)(ii) of the Code, section 716(a)(1)
(C)(ii) of ERISA, and section 2799A-1(a)
(1)(C)(ii) of the PHS Act expressly pro-
hibit plans and issuers from applying a
cost-sharing requirement that is greater
than the requirement that would apply if
such services were provided by a partic-
ipating provider or a participating emer-
gency facility. Therefore, under these in-
terim final rules, in circumstances where
a specified state law or All-Payer Model
Agreement does not apply to determine
the cost-sharing amount, cost sharing
must be based on the lesser of the QPA or
the amount billed by the provider for the
item or service. The different methods for
determining the recognized amount are
discussed in separate sections of this sec-
tion III.B.2 of this preamble.
With respect to air ambulance services
furnished by nonparticipating providers,
the recognized amount is not used for pur-
poses of determining cost sharing. Rather,
the statute specifies that the cost-sharing
requirement with respect to such services
must be the same requirement that would
apply if such services were provided by a
participating provider, and any coinsur-
ance or deductible must be based on rates
that would apply for such services if they
were furnished by a participating provider.
These interim final rules require that plans
and issuers base any coinsurance and de-
ductible for air ambulance services pro-

Bulletin No. 2021–30 39 July 26, 2021
vided by a nonparticipating provider on
the lesser of the QPA or the billed amount.
The Departments have concluded that this
policy is consistent with the statute’s gen-
eral intent to protect participants, benefi-
ciaries, and enrollees from excessive bills,
and to remove the individuals as much
as possible from disputes between plans
and issuers and providers of air ambu-
lance services. In addition, using the QPA
is one method of ensuring that any coin-
surance or deductible is based on rates
that would apply for the services if they
were furnished by a participating provid-
er, given that the QPA is generally based
on median contracted rates, as opposed to
rates charged by nonparticipating provid-
ers, and is one basis used for determining
the cost-sharing amount in the context of
emergency services and items and services
furnished by nonparticipating providers at
participating health care facilities.
As discussed in this preamble, the
Airline Deregulation Act of 1978 (ADA)
broadly preempts state laws that relate to
air ambulance providers, and the Depart-
ments are unaware of any instances in
which an All-Payer Model Agreement or
a specified state law might apply. In ad-
dition, since an All-Payer Model Agree-
ment or a specified state law would not
need to follow an approach based on rates
that would apply for such services if they
were furnished by a participating provid-
er (for example, Medicare rates could be
used instead), it is the Departments’ view
that Congress did not intend to apply the
concept of the recognized amount to non-
participating providers of air ambulance
services. The Departments seek comment
on any potential alternate approaches for
calculating the cost-sharing amount for
air ambulance services furnished by non-
participating providers of air ambulance
services.
iii. Out-of-Network Rate
In addition to establishing requirements
related to cost sharing, the No Surprises
Act and these interim final rules also es-
tablish requirements related to the total
amount paid by a plan or issuer for items
and services subject to these provisions,
referred to as the out-of-network rate. The
plan or issuer must make a total payment
equal to one of the following amounts,
less any cost sharing from the participant,
beneficiary, or enrollee: (1) an amount de-
termined by an applicable All-Payer Mod-
el Agreement under section 1115A of the
Social Security Act; (2) if there is no such
applicable All-Payer Model Agreement,
an amount determined by a specified state
law; (3) in the absence of an applicable
All-Payer Model Agreement or specified
state law, if the plan or issuer and the pro-
vider or facility have agreed on a payment
amount, the agreed on amount; or (4) if
none of those three conditions apply, and
the parties enter into the IDR process and
do not agree on a payment amount before
the date when the IDR entity makes a de-
termination of the amount, the amount
determined by the IDR entity. These four
approaches for determining the out-of-
network rate are discussed more fully later
in this preamble.
The requirements related to cost shar-
ing and to the out-of-network rate apply
when a group health plan or coverage
provides or covers benefits for services
subject to these provisions. The Depart-
ments interpret this to mean that the re-
quirements apply when a plan or issuer
provides coverage for such items and ser-
vices, pursuant to the terms of the plan or
coverage, even in cases where an individ-
ual has not satisfied their deductible.
33
Be-
cause the cost-sharing amount is calculat-
ed using the recognized amount (or for air
ambulance services the lesser of the QPA
or the billed amount) that is calculated
separately from the determination of the
out-of-network rate, these requirements
may result in circumstances where a plan
or issuer must make payment prior to an
individual meeting their deductible. Spe-
cifically, where the surprise billing protec-
tions apply, and the out-of-network rate
exceeds the amount upon which cost shar-
ing is based, a plan or issuer must pay the
provider or facility the difference between
the out-of-network rate and the cost-shar-
ing amount (the latter of which in this case
would equal the recognized amount, or the
lesser of the QPA or the billed amount),
even in cases where an individual has not
satisfied their deductible, as illustrated in
the following example.
Example. An individual is enrolled in a
high deductible health plan with a $1,500
deductible and has not yet accumulated
any costs towards the deductible at the
time the individual receives emergen-
cy services at an out-of-network facility.
The plan determines that the recognized
amount for the services is $1,000. Because
the individual has not satisfied the deduct-
ible, the individual’s cost-sharing amount
is $1,000, which accumulates towards
the deductible. The out-of-network rate
is subsequently determined to be $1,500.
Under the requirements of the statute and
these interim final rules, the plan is re-
quired to pay the difference between the
out-of-network rate and the cost-sharing
amount. Therefore, the plan pays $500
for the emergency services, even though
the individual has not satisfied the deduct-
ible. The individual’s out-of-pocket costs
are limited to the amount of cost-sharing
originally calculated using the recognized
amount (that is, $1,000).
Although such a payment would gener-
ally cause a high deductible health plan to
lose its status as a high deductible health
plan, the No Surprises Act added section
223(c)(2)(F) to the Code to specify that a
plan shall not fail to be treated as a high
deductible health plan by reason of pro-
viding benefits for medical care in accor-
dance with section 9816 or 9817 of the
Code, section 716 or 717 of ERISA, or
section 2799A–1 or 2799A–2 of the PHS
Act (the provisions added by the No Sur-
prises Act related to surprise medical and
air ambulance bills), or any state law pro-
viding similar protections to individuals,
prior to the satisfaction of the deductible.
34
iv. Specified State Law
Under section 9816(a)(3)(I) of the
Code, section 716(a)(3)(I) of ERISA, sec-
tion 2799A-1(a)(3)(I) of the PHS Act, and
these interim final rules, a specified state
law is a state law that provides a method
for determining the total amount payable
33
Absent the balance billing protections under the No Surprises Act and these interim final rules, the plan or issuer would not generally be expected to make a payment to the provider or
facility prior to an individual satisfying the deductible.
34
See section IV.A.5 of this preamble for a discussion of HHS-only interim final rules addressing catastrophic plans’ compliance with these requirements.

July 26, 2021 40 Bulletin No. 2021–30
under a group health plan or group or
individual health insurance coverage to
the extent the state law applies. This in-
cludes instances where the Departments
have interpreted this term to include state
laws where the state law applies because
the state has allowed a plan that is not
otherwise subject to applicable state law
an opportunity to opt in to a program es-
tablished under state law, subject to sec-
tion 514 of ERISA, for an item or service
furnished by a nonparticipating provider
or nonparticipating emergency facility.
In cases where a specified state law ap-
plies, the recognized amount (the amount
upon which cost sharing is based) and
out-of-network rate for emergency and
non-emergency services subject to the
surprise billing protections is calculated
based on such specified state law.
In order for a state law to determine
the recognized amount or out-of-network
rate, any such law must apply to: (1) the
plan, issuer, or coverage involved, includ-
ing where a state law applies because the
state has allowed a plan that is not oth-
erwise subject to applicable state law an
opportunity to opt in, subject to section
514 of ERISA; (2) the nonparticipating
provider or nonparticipating emergency
facility involved (and in the case of state
out-of-network rate laws, the nonpartici-
pating provider of air ambulance services
involved); and (3) the item or service in-
volved. In instances where a state law does
not satisfy all of these criteria, the state
law does not apply to determine the recog-
nized amount or out-of-network rate. For
example, where a particular state surprise
billing law that governs the recognized
amount and out-of-network rate applies to
a particular plan or coverage but does not
apply to nonparticipating neonatologists,
who provide a specified ancillary service
under section 2799B-2(b)(2) of the PHS
Act, the consumer protections under fed-
eral law would determine the recognized
amount and out-of-network rate with re-
spect to neonatology services while the
state law would apply with respect to
other provider specialties covered under
that state law. Similarly, where a state’s
surprise billing laws apply only to health
maintenance organizations (HMOs), fed-
eral protections against surprise billing
would govern with respect to other types
of coverage while the state protections
would apply to HMOs for purposes of de-
termining the recognized amount and out-
of-network rate.
The same definition of “out-of-network
rate”— including the reference to speci-
fied state laws—applies to air ambulance
services as to other services. The Depart-
ments note, however, that the ADA states
in relevant part: “...a State, political sub-
division of a State, or political authority of
at least 2 States may not enact or enforce
a law, regulation, or other provision hav-
ing the force and effect of law related to a
price, route, or service of an air carrier that
may provide air transportation under this
subpart.”
35
Assuming that a provider of air
ambulance services is an “air carrier” cov-
ered by this provision, as is typical,
36
the
provision preempts state laws that would
limit the amount of payment that the pro-
vider of air ambulance services would oth-
erwise be entitled to receive.
37
Given the
applicability of the ADA, the Departments
are not aware of any state laws that would
meet the criteria to set the out-of-network
rate for nonparticipating providers of air
ambulance services when providing ser-
vices subject to the protections in the No
Surprises Act.
The Departments also seek comment
on whether health insurance issuers,
health care providers, or health care fa-
cilities, in instances where they are not
otherwise subject to a specified state law
that provides for a method for determin-
ing the total amount payable under a
group health plan or group or individual
health insurance coverage, should have
an opportunity, for purposes of these in-
terim final rules, to opt in to a program
established under state law, with respect
to an item or service furnished by a non-
participating provider or nonparticipating
emergency facility. The Departments seek
comment on whether this approach would
allow for more flexibility for state laws to
apply when, for example, by their terms,
they apply to the health insurance issuer
and item and service in question, but not
to the provider; whether an issuer, provid-
er, or facility would still be subject to any
specified state laws in their “home” state if
they opt in to a program established under
another state’s law; and whether an issuer,
provider, or facility should be permitted to
opt in on an episodic basis. The Depart-
ments are concerned that allowing pro-
viders and facilities to opt in to a program
established under state law could increase
health care prices if providers and facil-
ities selectively opt in to state programs
that favor providers and facilities in the
determination of the out-of-network rate.
The Departments seek comment on the
potential impact of expanding the ability
to opt in to a state program to providers
and facilities. The Departments specifical-
ly seek comment from health insurance is-
suers, health care providers, or health care
facilities located within or serving under-
served and rural communities, and other
communities facing a shortage of provid-
ers on the impact of these provisions on
services, coverage, and payment for and
within medically underserved, rural, and
urban communities.
a. State Law Interaction with ERISA
Under the general preemption clause
of section 514(a) of ERISA, state laws
are preempted to the extent that they “re-
late” to employee benefit plans subject to
title I of ERISA. There are, however, a
number of exceptions to this broad pre-
emption provision. Section 514(b)(2)(A),
referred to as the “savings clause,” pro-
vides in pertinent part that “nothing in this
title (title I of ERISA) shall be construed
to exempt or relieve any person from any
law of any State which regulates insur-
ance . . . .” Additionally, the preemption
provisions of section 731 of ERISA (im-
plemented in 29 CFR 2590.731(a)) apply
so that the requirements of part 7 of ERI-
SA are not to be “construed to supersede
35
49 U.S.C. 41713(b).
36
An air ambulance provider is a covered “air carrier” if it has economic authority from the Department of Transportation to provide interstate air transportation. Most air ambulance providers
have such authority under the provisions of 14 CFR Part 298. See, e.g., Scarlett v. Air Methods Corp., 922 F.3d 1053 (10th Cir. 2019); Air Evac EMS v. Cheatham, 910 F.3d 751 (4th Cir. 2018).
37
See, e.g., Guardian Flight LLC v. Godfread, 991 F.3d 916, 921 (8th Cir. 2021) (holding that ADA preempted state law prohibiting out-of-network air ambulance providers from balance
billing and requiring them to accept amounts paid by insurers); Bailey v. Rocky Mountain Holdings, LLC, 889 F.3d 1259, 1269-72 (11th Cir. 2018) (holding that ADA preempted state law that
prohibited air ambulance providers from collecting more than amount specified in fee schedule).

Bulletin No. 2021–30 41 July 26, 2021
any provision of state law which estab-
lishes, implements, or continues in effect
any standard or requirement solely relat-
ing to issuers in connection with group
health insurance coverage except to the
extent that such standard or requirement
prevents the application of a ‘require-
ment’ of a federal standard.” The con-
ference report accompanying the Health
Insurance Portability and Accountability
Act of 1996 (HIPAA), which applied this
preemption standard to state laws with
respect to its title I health insurance re-
form provisions, indicates that this pre-
emption is intended to be the “narrowest”
preemption of states’ laws.
38
States may
therefore continue to apply state law re-
quirements to issuers except to the extent
they prevent the application of ERISA re-
quirements. Additionally, states have sig-
nificant latitude to impose requirements
on issuers that are more restrictive than
the federal law. State laws that impose
comparable or additional requirements
on health insurance issuers would gener-
ally constitute a “specified state law” not-
withstanding section 514 of ERISA and
would continue to apply.
While section 514(b)(2)(A) saves from
ERISA preemption state laws regulating
insurance, section 514(b)(2)(B) of ERISA,
referred to as the “deemer clause,” pro-
vides that a state law “purporting to regu-
late insurance” generally cannot deem an
employee benefit plan to be an insurance
company (or in the business of insurance)
for the purpose of regulating such a plan
as an insurance company (section 514(b)
(6)(A) creates a partial exception to the
deemer clause for employee welfare ben-
efit plans that are also multiple employer
welfare arrangements (MEWAs)). Thus,
to the extent that a state law has a “refer-
ence to” or an impermissible connection
with ERISA plans (such as laws that gov-
ern the payment of benefits), these laws
are preempted, to the extent they apply
to self-insured plans sponsored by private
employers.
39
However, section 514 of ER-
ISA does not prevent states from expand-
ing access to a state program and allow-
ing self-insured, ERISA-covered plans to
choose to voluntarily comply with it. For
example, the Departments allowed such
plans to comply with their obligations for
external review under section 2719 of the
PHS Act by voluntarily opting in to the
state external review process.
40
Similarly,
these interim final rules allow self-insured
plans (including non-federal governmen-
tal plans) to voluntarily opt in to state law
that provides for a method for determining
the cost-sharing amount or total amount
payable under such a plan, where a state
has chosen to expand access to such plans,
to satisfy their obligations under section
9816(a)-(d) of the Code, section 716(a)-
(d) of ERISA, and section 2799A-1(a)-
(d) of the PHS Act. A group health plan
that opts in to such a state law must do
so for all items and services to which the
state law applies. Under these interim final
rules, a self-insured plan that has chosen
to opt in to a state law must prominent-
ly display in its plan materials describing
the coverage of out-of-network services a
statement that the plan has opted in to a
specified state law, identify the relevant
state (or states), and include a general
description of the items and services pro-
vided by nonparticipating facilities and
providers that are covered by the specified
state law.
b. Examples Involving Specified State
Laws
The following examples illustrate how
state laws may or may not apply. In each
example, assume there is no applicable
All-Payer Model Agreement that would
determine the recognized amount or out-
of-network rate.
Example 1. (i) Facts. A health insurance issuer
licensed in State A covers a specific non-emergen-
cy service that is provided to an enrollee by a non-
participating provider in a participating health care
facility, both of which are also licensed in State A.
State A has a law that prohibits balance billing for
non-emergency services provided to individuals by
nonparticipating providers in a participating health
care facility, and provides for a method for determin-
ing the cost-sharing amount and total amount pay-
able. The state law applies to health insurance issuers
and providers licensed in State A. The state law also
applies to the type of service provided.
(ii) Conclusion. In this Example 1, State A’s law
would apply to determine the recognized amount and
the out-of-network rate.
Example 2. (i) Facts. Same facts as Example 1, ex-
cept that the nonparticipating provider and participating
health care facility are located and licensed in State B.
State A’s law does not apply to the provider, because the
provider is licensed and located in State B.
(ii) Conclusion. In this Example 2, State A’s law
would not apply to determine the recognized amount
and out-of-network rate. Instead, the lesser of the
billed amount or QPA would apply to determine the
recognized amount, and either an amount determined
through agreement between the provider and issuer
or an amount determined by an IDR entity would ap-
ply to determine the out-of-network rate.
Example 3. (i) Facts. An individual receives
emergency services at a nonparticipating hospital lo-
cated in State A. The emergency services furnished
include post-stabilization services, as described in 26
CFR 54.9816-4T(c)(2)(ii), 29 CFR 2590.716-4(c)(2)
(ii), and 45 CFR 149.110(c)(2)(ii). The individual’s
coverage is through a health insurance issuer licensed
in State A, and the coverage includes benefits with
respect to services in an emergency department of a
hospital. State A has a law that prohibits balance bill-
ing for emergency services provided to an individual
at a nonparticipating hospital located in State A and
provides a method for determining the cost-sharing
amount and total amount payable in such cases. The
law applies to issuers licensed in State A. However,
State A’s law has a definition of emergency services
that does not include post-stabilization services.
(ii) Conclusion. In this Example 3, State A’s law
would apply to determine the cost-sharing amount
and out-of-network rate for the emergency ser-
vices, as defined under State A’s law. State A’s law
would not apply for purposes of determining the
cost-sharing amount and out-of-network rate for the
post-stabilization services. Instead, the lesser of the
QPA or billed amount would apply to determine the
recognized amount, and either an amount determined
through agreement between the hospital and issuer
or an amount determined by an IDR entity would
apply to determine the out-of-network rate, with re-
spect to post-stabilization services.
Example 4. (i) Facts. A self-insured plan, subject
to ERISA, covers a specific non-emergency service
that is provided to a participant by a nonparticipating
provider in a participating health care facility, both of
which are licensed in State A. State A has a law that
prohibits balance billing for non-emergency services
provided to individuals by nonparticipating provid-
ers in a participating health care facility, and pro-
vides for a method for determining the cost-sharing
amount and total amount payable. The law applies
to health insurance issuers and providers licensed in
State A, and provides that plans that are not other-
wise subject to the law may opt in. The law also ap-
plies to the type of service provided. The self-insured
plan has opted in.
(ii) Conclusion. In this Example 4, State A’s law
would apply to determine the recognized amount and
the out-of-network rate.
The Departments are of the view that
it would be uncommon for laws of more
38
See House Conf. Rep. No. 104-736, at 205, reprinted in 1996 U.S. Code Cong. & Admin. News 2018.
39
See Gobeille v. Liberty Mutual Ins. Co. 577 U.S. 312 (2015); Egelhoff v. Egelhoff, 532 U.S. 141 (2001).
40
See, e.g., Technical Release 2010-01; 76 FR 37208, 37211 fn. 13 (June 24, 2011).

July 26, 2021 42 Bulletin No. 2021–30
than one state to each apply to the same
health insurance issuer, and to the same
provider for a particular item or service.
Therefore, the Departments do not foresee
many instances where there might be a
question as to which state’s law applies to
determine the recognized amount or out-
of-network rate. However, in such uncom-
mon scenarios, one approach might be for
the states involved to make that decision.
Another approach might be that the law
enacted by the state in which the service
is provided would apply. Yet another ap-
proach would be for the QPA to apply to
determine the recognized amount, and
either a negotiated amount or an amount
determined by an IDR entity to apply to
determine the out-of-network rate. The
Departments seek comment on these and
any other approaches for resolving this
choice-of-law question. The Departments
also seek comment on how states have
handled such questions prior to the enact-
ment of the No Surprises Act, should these
types of conflicts exist.
The Departments are of the view that
Congress intended that where state law
provides a method for determining the to-
tal amount payable under a plan or cover-
age, the state law regarding balance billing
would govern, rather than the alternative
method for determining the out-of-net-
work rate under the No Surprises Act. The
Departments interpret the statutory phrase
“a State law that provides for a method
for determining the total amount payable
under such a plan, coverage, or issuer, re-
spectively” broadly as referring not only
to state laws that set a mathematical for-
mula for determining the out-of-network
rate, or that set a predetermined amount
for an out-of-network item or service.
Rather, the Departments interpret that lan-
guage to also include, for example, state
laws that require or permit a plan or issu-
er and a provider or facility to negotiate,
and then to engage in a state arbitration
process to determine the out-of-network
rate. Such state laws provide a process
for determining the total amount payable,
and in such instances, the timeframes and
processes under such a state law related to
negotiations and arbitration would apply,
as opposed to the timeframes and IDR
process under the No Surprises Act.
In addition, the Departments are of
the view that Congress did not intend
for the No Surprises Act to preempt pro-
visions in state balance billing laws that
address issues beyond how to calculate
the cost-sharing amount and out-of-net-
work rate. To the extent state laws do
not prevent the application of a federal
requirement or prohibition on balance
billing, the Departments are of the view
that such state laws are consistent with the
statutory framework of the No Surprises
Act and would not be preempted.
41
This
view extends to any state law that pro-
vides balance billing protections beyond
what these interim final rules provide. In
fact, Congress specifically indicated that
such state balance billing laws may con-
tinue in effect along with the balance bill-
ing protections set forth in the statute, by
requiring in new section 2799B-3 of the
PHS Act that providers must disclose to
participants, beneficiaries, and enrollees
information about federal balance billing
protections, plus any other protections
that apply under state law. A more detailed
discussion of the disclosure requirements
appears in section IV.A.3 of this preamble,
which discusses the provisions codified in
45 CFR 149.430.
v. All-Payer Model Agreements
As described earlier, in instances where
an All-Payer Model Agreement is applica-
ble, the recognized amount (the amount
upon which cost sharing is based with re-
spect to items and services furnished by
nonparticipating emergency facilities, and
nonparticipating providers of nonemer-
gency items and services in participating
facilities) and the out-of-network rate
are determined using the amount that the
state approves under the All-Payer Model
Agreement for such items or services.
An All-Payer Model Agreement is
an agreement between the Centers for
Medicare & Medicaid Services (CMS)
and a state to test and operate systems of
all-payer payment reform for the medical
care of residents of the state, under the
authority granted under section 1115A the
Social Security Act. Under the terms of
section 1115A of the Social Security Act,
such Agreements may waive specific pro-
visions of titles XI and XVIII and of sec-
tions 1902(a)(1), 1902(a)(13), 1903(m)(2)
(A)(iii), and 1934 (other than subsections
(b)(1)(A) and (c)(5) of such section) as
may be necessary solely for the purpos-
es of testing the Model. All-Payer Model
Agreements can vary significantly by state,
including in using different approaches
for approving payment amounts for items
or services covered by the Agreements.
The Departments are of the view that it
is important to maximally preserve states’
abilities to test all-payer payment reform
through these Agreements, including their
abilities to do so using varied approaches
to setting payment amounts. These interim
final rules defer to the state to determine
the circumstances under which, and how,
it will approve an amount for an item or
service under a payment system estab-
lished by an All-Payer Model Agreement.
Participating in an all-payer model gov-
erned by an All-Payer Model Agreement
may be voluntary or mandatory for a
given payer; the system of all-payer pay-
ment reform may apply statewide or only
in certain regions, such as rural regions;
and payments under the system of all-pay-
er payment reform may apply only to
certain providers or facilities and certain
items and services.
42
To account for po-
tential variations among All-Payer Model
Agreements, the Departments are propos-
ing to take a similar approach that these
interim final rules establish with respect
to state laws. Specifically, in order for an
All-Payer Model Agreement to determine
the recognized amount or out-of-network
rate, any such Agreement must apply to
the coverage involved; to the nonpartici-
pating provider or nonparticipating emer-
gency facility involved (and in the case of
the out-of-network rate, to the nonpartici-
41
Section 731(a) of ERISA and section 2724(a) of the PHS Act. As noted above, the HIPAA conference report indicates that this preemption standard is intended to be the “narrowest” pre-
emption of states’ laws. See House Conf. Rep. No. 104-736, at 205, reprinted in 1996 U.S. Code Cong. & Admin. News 2018.
42
See, e.g., CMS. Vermont All-Payer ACO Model, (updated Apr. 8, 2020) available at https://innovation.cms.gov/innovation-models/vermont-all-payer-aco-model; CMS. Pennsylvania
Rural Health Model, (updated Jan. 1, 2021) available at https://innovation.cms.gov/innovation-models/pa-rural-health-model; CMS. Maryland Total Cost of Care Model available at https://
innovation.cms.gov/innovation-models/md-tccm.

Bulletin No. 2021–30 43 July 26, 2021
pating provider of air ambulance services
involved); and to the item or service in-
volved. In instances where an All-Payer
Model Agreement does not satisfy all of
these criteria, the Agreement does not ap-
ply to determine the recognized amount or
out-of-network rate, and, unless a spec-
ified state law applies, the recognized
amount would be determined by the QPA
(or the billed charge if less than the QPA),
and the out-of-network rate would be the
amount determined through agreement
between the provider or facility and plan
or issuer or the IDR process.
Under these interim final rules, an
All-Payer Model Agreement is treated as
applicable to a given provider or facili-
ty and plan or issuer if the terms of the
Agreement, or any agreements described
in that Agreement, are binding upon the
provider, facility, plan, or issuer, which
may occur through different mechanisms.
For example, under the All-Payer Model
Agreement for the Maryland Total Cost
of Care Model and under the Maryland
state all-payer law, all payers (including
group health plans and health insurance
issuers offering group or individual health
insurance coverage) pay the amount deter-
mined under the Agreement with respect
to hospital services covered by the Agree-
ment.
43
However, the Agreement general-
ly does not apply to the amount paid to
a provider, such as a physician, who fur-
nishes services at a hospital. In Maryland,
therefore, the recognized amount and
out-of-network rate would be set by the
All-Payer Model Agreement for all plans
and issuers for hospital charges covered
under the Agreement. But, the All-Payer
Model Agreement would generally not
be used to set the recognized amount or
out-of-network rate with respect to a non-
participating provider’s charges, unless
the All-Payer Model Agreement, or any
agreements described in that Agreement,
specify the payment amount in a particu-
lar instance.
Although under state law plans and
issuers in Maryland do not have discre-
tion regarding whether to participate in
the all-payer rate setting system under
the Maryland Total Cost of Care Model,
participation in other state-based mod-
els governed by All-Payer Model Agree-
ments is voluntary. For example, under
the All-Payer Model Agreement for the
Vermont All-Payer Accountable Care Or-
ganization (ACO) Model, participation by
providers, facilities, group health plans,
and health insurance issuers is volun-
tary.
44
To the extent that both the provider
or facility and plan or issuer has opted to
participate in the Vermont All-Payer ACO
Model and the Vermont All-Payer Model
Agreement, or an agreement described
in that Agreement, applies to a specific
item or service, then that All-Payer Model
Agreement would determine the recog-
nized amount and out-of-network rate.
But, for example, if a plan has opted to
participate, but the provider furnishing
the service has not, then the All-Payer
Model Agreement would not be used to
determine either the recognized amount
or out-of-network rate. Instead, if a state
law is applicable, the state law would ap-
ply. If no state law is applicable, then the
recognized amount would be determined
using the QPA,
45
and the out-of-network
rate would be the amount agreed upon by
the parties or determined through the IDR
process established in the No Surprises
Act, as discussed further elsewhere in this
preamble.
vi. Methodology for Calculating the
Qualifying Payment Amount
The No Surprises Act directs the De-
partments to establish through rulemaking
the methodology that a group health plan
or health insurance issuer offering group or
individual health insurance coverage must
use to determine the qualifying payment
amount (QPA). As discussed earlier in this
preamble, the No Surprises Act and these
interim final rules require cost-sharing re-
quirements imposed by plans and issuers
in connection with emergency services
furnished by a nonparticipating emergen-
cy facility or nonparticipating provider,
or in connection with non-emergency
services performed by nonparticipating
providers at certain participating facili-
ties to be based on the lesser of the billed
charge or the QPA where an All-Payer
Model Agreement under section 1115A
of the Social Security Act or a specified
state law does not apply. In addition, IDR
entities are directed by statute to consider
the QPA when selecting between the offer
submitted by a plan or issuer and the of-
fer submitted by a facility or provider in
order to determine the total payment for
emergency services furnished by a non-
participating emergency facility or non-
participating provider, or non-emergency
services performed by nonparticipating
providers at certain participating facilities
that are items and services subject to the
IDR process.
In general, under section 9816(a)(3)(E)
of the Code, section 716(a)(3)(E) of ERI-
SA, and section 2799A-1(a)(3)(E) of the
PHS Act, for a given item or service, the
QPA is the median of the contracted rates
recognized by the plan or issuer on Janu-
ary 31, 2019, for the same or similar item
or service that is provided by a provider in
the same or similar specialty and provided
in a geographic region in which the item
or service is furnished, increased for in-
flation. The median contracted rate is de-
termined with respect to all group health
plans of the plan sponsor or all group or
individual health insurance coverage of-
fered by the health insurance issuer that
are offered in the same insurance market,
consistent with the methodology estab-
lished by the Departments.
The No Surprises Act specifies an al-
ternative methodology for determining the
QPA in cases where a plan or issuer has
insufficient information to calculate a me-
dian contracted rate for an item or service.
The statute, however, envisions that these
alternative methodologies, such as use of
a third-party database, will be used in only
limited circumstances where the plan or
issuer cannot rely on its contracted rates
as a reflection of the market dynamics in
a geographic region. Consistent with this
43
See CMS. Maryland Total Cost of Care Model, (updated Oct. 22, 2020) available at https://innovation.cms.gov/innovation-models/md-tccm. Under Maryland law, hospitals regulated by the
Maryland Health Services Cost Review Commission (HSCRC) must charge payers the rates set the by HSCRC, and payers, including group health plans and issuers offering individual or
group health insurance, must pay the rates set by HSCRC. Maryland Code, Health-General Article §§ 19-212 and 19-219(a)(3) and (b)(2)(i) and Maryland Code, Insurance Article §15-604.
44
https://innovation.cms.gov/innovation-models/vermont-all-payer-aco-model.
45
See prior explanation regarding the requirement that when the surprise billing protections apply, in the event the billed charge is less than the recognized amount, cost sharing would be
based on the billed charge.

July 26, 2021 44 Bulletin No. 2021–30
statutory goal, these interim final rules
generally seek to ensure that plans and is-
suers can meet the sufficient-information
standard when determining the QPA and
that use of alternative methodologies is
minimized wherever possible.
The Departments seek comment on all
aspects of the methodology established in
these interim final rules for determining
the QPA. In particular, the Departments
seek comment on whether there are any
considerations or factors that are not suffi-
ciently accounted for in the methodology
established in these interim final rules; the
impact of the methodology on cost shar-
ing, payment amounts, and provider net-
work participation; and whether there are
areas where commenters believe addition-
al rulemaking or guidance is necessary.
The Departments also seek comment as
to the impact of large consolidated health
care systems on contracted rates, and the
impact of such contracted rates on prices
and the QPA. The Departments are con-
cerned that the contracting practices of
such health care systems could inflate
the QPA, and seek comment on whether
adjustments to the QPA methodology are
needed.
a. Median Contracted Rate
These interim final rules establish the
methodology that plans and issuers must
use to calculate the median of contracted
rates. The plan or issuer will generally
then apply an inflation adjustment to de-
termine the QPA for items and services
furnished in the relevant year.
In general, the median contracted rate
for an item or service is calculated by ar-
ranging in order from least to greatest the
contracted rates of all plans of the plan
sponsor (or of the administering entity, if
applicable) or all coverage offered by the
issuer in the same insurance market for the
same or similar item or service that is pro-
vided by a provider in the same or similar
specialty or facility of the same or simi-
lar facility type and provided in the geo-
graphic region in which the item or ser-
vice is furnished, and selecting the middle
number. These interim final rules define
each of the relevant terms, as discussed in
more detail in this section of the preamble.
In determining the median contracted
rate, the amount negotiated under each
contract is treated as a separate amount.
For example, assume the contracted rates
for all plans of a sponsor in the same in-
surance market for a particular item or ser-
vice provided by a provider in the same or
similar specialty in a specified geograph-
ic region are $475, $490, and $510. The
median contracted rate for this service
is $490. If there are an even number of
contracted rates, the median contracted
rate is the average of the middle two con-
tracted rates. If, in the previous example,
there were a fourth contracted rate in the
amount of $515, the median contract-
ed rate would be the average of the two
middle amounts ($490 and $510), or $500
(($490+$510)⁄2). If the same amount is
paid under two or more separate contracts,
each contract is counted separately. Thus,
in the previous example, if there were a
fifth contracted rate also in the amount of
$515, the median contracted rate would be
$510, since there are two contracted rates
below that amount ($475 and $490) and
two contracted rates above that amount
($515 and $515).
Contracted Rate
The interim final rules define a “con-
tracted rate” as the total amount (includ-
ing cost sharing) that a group health plan
or health insurance issuer has contractu-
ally agreed to pay a participating provid-
er, facility, or provider of air ambulance
services for covered items and services,
whether directly or indirectly, including
through a third-party administrator or
pharmacy benefit manager.
46
The No Surprises Act envisions that
each contracted rate for a given item or
service be treated as a single data point
when calculating a median contracted
rate. Therefore, if a plan or issuer has a
contract with a provider group or facil-
ity, the rate negotiated with that provid-
er group or facility under the contract is
treated as a single contracted rate, if the
same rate applies to all providers of such
provider group or facility under the single
contract. Likewise, the rate negotiated un-
der a contract constitutes a single contract-
ed rate regardless of the number of claims
paid at that contracted rate. However, if a
plan or issuer has a contract with multiple
providers, with separate negotiated rates
with each particular provider for a given
item or service, each unique contracted
rate constitutes a single contracted rate
for purposes of determining the median
contracted rate.
47
Further, if a plan or is-
suer has separate contracts with individual
providers, the contracted rate under each
such contract constitutes a single contract-
ed rate (even if the same amount is paid to
other providers under separate contracts).
The Departments understand that some
plans or issuers may rent provider net-
works or otherwise contract with third
parties to manage provider networks. In
these situations, contracted rates between
providers and the entity responsible for
managing the provider network on behalf
of a plan or issuer would be treated as
the plan’s or issuer’s contracted rates for
purposes of calculating the QPA. The De-
partments seek comment on whether addi-
tional guidance or special rules are needed
regarding how to define a contract in this
situation.
The Departments also understand that
plans and issuers sometimes enter into
special agreements with providers and
facilities that generally are not otherwise
contracted to participate in any of the net-
works of the plan or issuer. For example, a
plan or issuer may negotiate an ad hoc ar-
rangement with a nonparticipating provid-
er or facility to supplement the network
of the plan or coverage for a specific par-
ticipant, beneficiary, or enrollee in unique
circumstances. These interim final rules
specify that solely for purposes of the
definition of contracted rate, a single case
agreement, letter of agreement, or other
similar arrangement between a plan or is-
46
This definition is substantially similar to the definition of “negotiated rate” used for purposes of the transparency in coverage regulations at 26 CFR 54.9815–2715A1(a)(2)(xvi), 29 CFR
2590.715–2715A1(a)(2)(xvi), and 45 CFR 147.210(a)(2)(xvi).
47
If a plan or issuer has a contract with multiple providers, with separate negotiated rates with several subgroups of providers, each unique contracted rate will generally constitute a single
contracted rate for purposes of determining the median contracted rate. However, as discussed later in this section of the preamble, these interim final rules specify that if a plan or issuer has
contracted rates that vary based on provider specialty for a service code, the median contracted rate is calculated separately for each provider specialty, as applicable. In such cases, the QPA for
the particular item or service would take into account only the contracted rates for the applicable provider specialty, and would disregard other unique contracted rates under the same contract.

Bulletin No. 2021–30 45 July 26, 2021
suer and a provider, facility, or provider of
air ambulance services does not constitute
a contract, and the rate paid under such an
agreement should not be counted among
the plan’s or issuer’s contracted rates. The
term “contracted rate” refers only to the
rate negotiated with providers and facil-
ities that are contracted to participate in
any of the networks of the plan or issuer
under generally applicable terms of the
plan or coverage and excludes rates nego-
tiated with other providers and facilities.
The Departments are of the view that this
definition most closely aligns with the
statutory intent of ensuring that the QPA
reflects market rates under typical contract
negotiations.
48
Insurance Market
In calculating the median contracted
rate for a given item or service, the plan or
issuer must take into account the contract-
ed rates under all group health plans of the
sponsor or all group or individual health
insurance coverage offered by the issu-
er that are offered in the same insurance
market.
49
The term “insurance market” for
purposes of these interim final rules means
one of the following: the individual mar-
ket, small group market, or large group
market (each as defined under section
2791(e) of the PHS Act). The relevant in-
surance market is determined irrespective
of the state. For example, in calculating
the QPA for an item or service furnished to
an enrollee in individual health insurance
coverage, an issuer must take into account
the contracted rates with providers or fa-
cilities in the applicable geographic re-
gion across the issuer’s individual market
offerings, inclusive of contracted rates for
all individual health insurance coverage
offered by the issuer in all states in which
the issuer offers coverage in the individual
market.
With respect to self-insured group
health plans, these interim final rules de-
fine the term “insurance market” to mean
all self-insured group health plans (other
than account-based plans and plans that
consist solely of excepted benefits) of
the plan sponsor, or at the option of the
plan sponsor, all self-insured group health
plans administered by the same entity (in-
cluding a third-party administrator con-
tracted by the plan), to the extent other-
wise permitted by law, that is responsible
for calculating the QPA on behalf of the
plan. The Departments understand that
many self-insured group health plans are
administered by entities other than the
plan sponsor (such as a third-party admin-
istrator contracted by the plan) that would
be responsible for calculating the QPA on
behalf of the sponsor. To reduce the burden
imposed on sponsors of self-insured group
health plans, these interim final rules per-
mit sponsors of self-insured group health
plans to allow their third-party administra-
tors to determine the QPA for the sponsor
by calculating the median contracted rate
using the contracted rates recognized by
all self-insured group health plans admin-
istered by the third-party administrator
(not only those of the particular plan spon-
sor). Under this approach, the Depart-
ments anticipate there will be fewer in-
stances where a self-insured group health
plan sponsor will lack sufficient informa-
tion to calculate a median contracted rate
for an item or service.
The Departments seek comment on the
definition of insurance market with respect
to self-insured group health plans and
whether any contractual or other issues
may prevent an entity, such as a third-par-
ty administrator, from using contracted
rates from the different self-insured plans
it administers to calculate the QPA for a
particular self-insured group health plan.
DOL also seeks comment on the ability of
self-insured group health plan fiduciaries
to monitor the calculation of the QPA by
the administering entities for compliance
with the applicable requirements (for ex-
ample, by ensuring the entities are using
the correct contracted rates).
The Departments have determined
that including rates negotiated under oth-
er more limited forms of coverage, such
as excepted benefits, short-term, limit-
ed-duration insurance, and account-based
plans, including health reimbursement
arrangements, could skew the calculation
of the median contracted rate, and these
forms of coverage should not be included
in the definition of the applicable insur-
ance market. Furthermore, the definition
of “qualifying payment amount” under
section 2799A-1(a)(3)(E)(i)(I) of the PHS
Act refers to individual health insurance
coverage, and the term individual health
insurance coverage, as defined under sec-
tion 2791(b)(5) of the PHS Act, excludes
short-term, limited-duration insurance.
50

Therefore, under these interim final rules,
when referring to coverage offered by an
issuer within the same insurance market
for purposes of determining the QPA, the
individual market excludes short-term,
limited-duration insurance (as defined in
26 CFR 54.9801-2, 29 CFR 2590.701-2,
and 45 CFR 144.103). In addition, un-
der these interim final rules, all markets
exclude coverage that consists solely of
excepted benefits (as described in section
9832 of the Code, section 733 of ERI-
SA, and section 2791 of the PHS Act).
While excepted benefits can be offered in
the individual or group markets, they are
exempt from the federal insurance mar-
ket reforms,
51
and Congress amended the
statutory exemption for these products
to include the additional coverage provi-
sions established under new Part D of title
XXVII of the PHS Act.
52
Account-based
plans, including health reimbursement
arrangements as described in 26 CFR
54.9815-2711(d)(6)(i), 29 CFR 2590.715-
2711(d)(6)(i), and 45 CFR 147.126(d)
(6)(i), make reimbursements subject to a
maximum fixed dollar amount for a peri-
od, such that the benefit design of these
48
In contrast, as discussed earlier in this preamble, these interim final rules specify that a single case agreement constitutes a contractual relationship for purposes of the definition of participat-
ing health care facility and participating emergency facility. The Departments are of the view that it is reasonable that an individual would expect items and services delivered at a health care
facility that has a single case agreement in place with respect to the individual’s care to be delivered on an in-network basis, and therefore, that the balance billing protections should apply.
49
The term “health insurance issuer” has the meaning given the term in section 2791(b) of the PHS Act, which, in relevant part, defines a health insurance issuer as an entity that is licensed to
engage in the business of insurance in a state. Thus, an issuer is the licensed entity and the contracted rates of separate licensees under the same holding company are not taken into account.
50
Since short-term, limited duration insurance is not individual health insurance coverage, it is also generally not subject to the federal individual market reforms. See, e.g., 81 FR 75316 at
75317 (Oct. 31, 2016) and 83 FR 38212 at 38213 (Aug. 3, 2018).
51
Section 9831 of the Code, section 732 of ERISA, and sections 2722 and 2763 of the PHS Act.
52
These amendments add the phrase “and Part D” to section 2722(b), (c)(1), (c)(2), and (c)(3) of the PHS Act.

July 26, 2021 46 Bulletin No. 2021–30
coverage options makes concepts related
to surprise billing and choice of health
care professionals inapplicable. There-
fore, under these interim final rules, for
purposes of calculating the QPA, all group
markets similarly exclude coverage pro-
vided under account-based plans.
The Departments also clarify that any
plan or coverage that is not a “group
health plan” or “group or individual health
insurance coverage” offered by a “health
insurance issuer,” as those terms are de-
fined in the Code, ERISA, and the PHS
Act, such as a Medicare Advantage or
Medicaid managed care organization plan,
must also not be included in any insurance
market for purposes of determining the
QPA. This approach is consistent with the
statutory requirement that the median con-
tracted rate is determined with respect to
all “group health plans” of the sponsor or
all “group or individual health insurance
coverage” offered by a health insurance
issuer in the same insurance market.
Same or Similar Item or Service
Section 9816(a)(3)(E) of the Code,
section 716(a)(3)(E) of ERISA, section
2799A-1(a)(3)(E) of the PHS Act, and
these interim final rules provide that a
plan or issuer must calculate the median
contracted rate for an item or service us-
ing contracted rates for the same or simi-
lar item or service. Under the interim final
rules, the term “same or similar item or
service” means a health care item or ser-
vice billed under the same service code,
or a comparable code under a different
procedural code system. Service code
means the code that describes an item or
service, including a Current Procedural
Terminology (CPT), Healthcare Common
Procedure Coding System (HCPCS), or
Diagnosis-Related Group (DRG) code.
A service code is a unique identifier, typ-
ically consisting of a string of numeric
digits or alphanumeric characters, that
corresponds to a standardized description,
which is used to identify with specificity
the item or service that was furnished to a
patient. Different codes may be assigned
to the same general service on the basis of
certain variations in the provider’s method
or approach, the complexity of the proce-
dure or medical decision-making, and pa-
tient acuity level. Payers, providers, and
facilities understand these service codes
and commonly use them for billing and
paying claims (including for both individ-
ual items and services, and for items and
services provided under a bundled pay-
ment arrangement). Thus, defining “same
or similar item or service” by service code
will make it easier for plans and issuers to
calculate the QPA, and for providers and
facilities to understand the QPA.
These interim final rules include spe-
cific requirements to account for modi-
fiers (when applicable), which are codes
applied to the service code that provide a
more specific description of the furnished
item or service and that may adjust the
payment rate or affect the processing or
payment of the code billed. For example,
modifiers include hospital revenue codes,
which indicate the department or place
in the hospital in which a procedure or
treatment is performed, as well as codes
indicating whether services or procedures
were performed by certain types of pro-
viders, such as physician assistants, nurse
practitioners, certified registered nurse
anesthetists, or assistant surgeons. In addi-
tion, modifiers can be used to indicate that
the work required to provide a service in a
particular instance was significantly great-
er – or significantly less – than the service
typically requires. The Departments are of
the view that it is important that the QPA
methodology account for modifiers that
affect payment rates under contracts with
participating providers and facilities.
Under the methodology established in
these interim final rules, plans and issuers
must calculate separate median contracted
rates for CPT code modifiers that distin-
guish the professional services compo-
nent (“26”) from the technical component
(“TC”). This will result in separate medi-
an contracted rates being calculated for
services when billed by a facility versus
a provider. In addition, where a plan’s or
issuer’s contracted rates otherwise vary
based on applying a modifier code, the
plan or issuer must calculate a separate
median contracted rate for each such ser-
vice code-modifier combination. Modifi-
ers that do not cause contracted rates to
vary must not be taken into account when
calculating the median contracted rate.
These rules are intended to ensure that if a
plan or issuer adjusts contracted rates with
participating providers and facilities based
on modifier codes, those payment adjust-
ments are appropriately reflected in the
median contracted rate.
Provider in the Same or Similar Specialty
These interim final rules specify that if
a plan or issuer has contracted rates for a
service code that vary based on provider
specialty, the median contracted rate is
calculated separately for each provider
specialty, as applicable. These interim fi-
nal rules define “provider in the same or
similar specialty” as the practice specialty
of a provider, as identified by the plan or
issuer consistent with the plan’s or issuer’s
usual business practice. This definition is
intended to provide plans or issuers with
the flexibility necessary to calculate the
median contracted rate, relying on their
contracting practices with participating
providers.

If a plan’s or issuer’s usual
business practice for identifying a provid-
er’s practice specialty differs for contract-
ing purposes and other business needs,
the plan or issuer should use the method
of identifying the practice specialty that it
uses for contracting purposes.
The Departments considered requiring
a plan or issuer to calculate separate me-
dian contracted rates for every provider
specialty, but concluded that this approach
would lead to more instances in which the
plan or issuer would not have sufficient
information to calculate the QPAs using
its contracted rates. In addition, the De-
partments understand that not all plans or
issuers vary contracted rates by provider
specialty, in which case requiring plans
and issuers to calculate separate median
contracted rates for each provider special-
ty would increase the burden associated
with calculating the QPA without adding
specificity to the QPA. Given that the No
Surprises Act generally relies on using
contracted rates to determine the QPA,
the Departments conclude that plans and
issuers should be required to calculate me-
dian contracted rates separately by provid-
er specialty only where the plan or issuer
otherwise varies its contracted rates based
on provider specialty.
With respect to air ambulance services,
all providers of air ambulance services
(including inter-facility transports) are
considered to be a single provider spe-
cialty for purposes of these interim final

Bulletin No. 2021–30 47 July 26, 2021
rules. The Departments understand that
contracted rates may vary depending
on whether the air ambulance services
are provided using a fixed-wing or rota-
ry-wing aircraft. However, these distinc-
tions based on vehicle type are accounted
for in the QPA methodology established
under these interim final rules through the
use of service codes that are specific to
fixed-wing or rotary-wing aircraft. There-
fore, the Departments anticipate that me-
dian contracted rates for fixed-wing and
rotary-wing aircraft would be determined
separately based on the requirement un-
der these interim final rules that median
contracted rates be based on the contract-
ed rates for the same or similar item or
service, and concluded that it would be
redundant to require plans and issuers to
also calculate separate median contracted
rates on the basis of vehicle type.
The Departments also understand that
hospital-based air ambulance providers
sometimes have lower contracted rates
than independent, non-hospital-based air
ambulance providers. The Departments,
however, are of the view that because par-
ticipants, beneficiaries, and enrollees fre-
quently do not have the ability to choose
their air ambulance provider, they should
not be required to pay higher cost-sharing
amounts (such as coinsurance or a deduct-
ible) solely because the air ambulance
provider assigned to them has negotiated
higher contracted rates in order to cover
its higher costs, or because it has a dif-
ferent revenue model, than other types of
air ambulance providers. This approach is
consistent with the approach these interim
final rules take with respect to facilities,
discussed in the following section of this
preamble, which also generally does not
provide for separate median contracted
rates to be calculated based on character-
istics of a particular facility. The Depart-
ments have concluded that this interpreta-
tion is consistent with the statute’s intent
to protect individuals from surprise med-
ical bills.
Facility of the Same or Similar
Facility Type
If a plan or issuer has contracted rates
for emergency services that vary based on
the type of facility (that is, whether a facil-
ity is an emergency department of a hos-
pital or an independent freestanding emer-
gency department), the median contracted
rate is calculated separately for each such
facility type. Plans and issuers subject to
the protections in the No Surprises Act
are required to cover emergency services
at both types of facilities. However, the
Departments are aware that plans and is-
suers have not typically contracted with
independent freestanding emergency de-
partments, which may be a reflection of
independent freestanding emergency de-
partments’ historical ability (prior to the
enactment of the No Surprises Act) to
charge higher rates for services furnished
on an out-of-network basis, and to balance
bill enrollees when the charges were de-
nied in part or in full.
53
The Departments
are also aware that there may be apprecia-
ble differences in the case-mix and level
of patient acuity between these types of
facilities.
54
Therefore, where a plan or is-
suer has established contracts with both
hospital emergency departments and inde-
pendent freestanding emergency depart-
ments, and its contracts vary the payment
rate based on the facility type, the median
contracted rate is to be calculated sepa-
rately for each facility type. The Depart-
ments are of the view that this approach
will maintain the ability of plans and issu-
ers to develop QPAs that are appropriate
to the different types of emergency facili-
ties specified by statute. The Departments
seek comment on this approach, and
whether it would be more appropriate for
plans and issuers to always calculate sepa-
rate QPAs for hospital emergency depart-
ments and independent freestanding emer-
gency departments regardless of whether
the plan or issuer varies the payment rate
based on facility type, or whether a plan
or issuer should never calculate separate
QPAs for hospital emergency departments
and independent freestanding emergency
departments.
However, these interim final rules do
not allow plans or issuers to separately
calculate a median contracted rate based
on other characteristics of facilities that
might cause contracted rates to vary, such
as whether a hospital is an academic med-
ical center or teaching hospital. Given that
participants, beneficiaries, and enrollees
with emergency medical conditions typ-
ically go (or are taken) to the nearest or
most convenient emergency department,
the Departments are of the view that, in-
dividuals generally should not be required
to pay higher cost sharing (such as coin-
surance or a deductible) based on features
of the emergency facility that may have a
bearing on its contracted rate with plans
and issuers, but which are unrelated or in-
cidental to the facility’s role as a provider
of emergency services.
Geographic Regions
Under the No Surprises Act, plans and
issuers must calculate the median con-
tracted rate for an item or service using
contracted rates for the same or similar
item or service provided in the geograph-
ic region in which the item or service is
furnished. The No Surprises Act directs
the Departments, in consultation with the
National Association of Insurance Com-
missioners (NAIC), to establish through
rulemaking the geographic regions to be
applied when determining the QPA, taking
into account access to items and services
in rural and underserved areas, including
health professional shortage areas, as de-
fined in section 332 of the PHS Act.
55
In consulting on the geographic regions
to be applied under the No Surprises Act,
the NAIC recommended that geographic
regions correspond to the applicable rat-
ing area used for purposes of the individ-
ual market and small group market rating
53
See Medicare Payment Advisory Commission, Report to the Congress: Medicare and the Health Care Delivery System, ch. 8, Stand-alone Emergency Departments, June 2017, available at
http://www.medpac.gov/docs/default-source/reports/jun17_ch8.pdf (last visited June 19, 2021).
54
See id.
55
Under section 332 of the PHS Act, a health professional shortage area is (A) an area in an urban or rural area (which need not conform to the geographic boundaries of a political subdivision
and which is a rational area for the delivery of health services) which the Secretary of HHS determines has a health manpower shortage and which is not reasonably accessible to an adequate-
ly served area, (B) a population group which the Secretary determines has such a shortage, or (C) a public or nonprofit private medical facility or other public facility which the Secretary
determines has such a shortage. All Federally qualified health centers and rural health clinics, as defined in section 1861(aa) of the Social Security Act (42 U.S.C. 1395x(aa)), that meet the
requirements of section 254g of title 42 shall be automatically designated as having such a shortage.

July 26, 2021 48 Bulletin No. 2021–30
rules under section 2701 of the PHS Act,
implemented at 45 CFR 147.102, while
allowing states the flexibility to establish
alternative geographic regions. However,
some states define rating area by county,
resulting in large numbers of rating areas
in a state, some of which might include
very few, if any, facilities and providers.
Therefore, adopting the rating area defi-
nitions as the standard for geographic
regions could lead to a large number of
geographic regions for which a plan or
issuer would have to calculate separate
median contracted rates, a large number
of geographic regions without sufficient
information, as well as a large number of
geographic regions in which the median
contracted rate is influenced by outliers.
After consultation with the NAIC, the
Departments are establishing geograph-
ic regions under these interim final rules
that reflect differences in health care costs
based on whether care is provided in urban
or rural areas. The Departments are of the
view that these geographic regions take
into account access to items and services
in rural and underserved areas, including
health professional shortage areas, as de-
fined at section 332 of the PHS Act. The
Departments intend to monitor the effect
of these geographic regions and periodi-
cally update such regions, as appropriate,
taking into account the findings of the
report submitted under section 109(a) of
the No Surprises Act, which addresses,
among other things, access to health care
items and services in rural areas and health
professional shortage areas.
In defining “geographic regions,” the
Departments have sought not only to min-
imize instances in which a plan or issuer
lacks sufficient information to calculate
the median of contracted rates in any par-
ticular geographic region, but also to lim-
it the instances in which a plan or issuer
has only the minimum amount of infor-
mation to meet the sufficient information
standard, as discussed later in this pream-
ble. Using larger geographic regions, for
which plans and issuers are likely to have
more information, is expected to reduce
the likelihood that the median of contract-
ed rates would be skewed by contracts un-
der which the parties have agreed to par-
ticularly high or low payment amounts.
Under these interim final rules, for
items and services other than air ambu-
lance services, a geographic region is
generally defined as one region for each
metropolitan statistical area (MSA) in a
state and one region consisting of all other
portions of the state. The delineations for
MSAs are described by the U.S. Office of
Management and Budget (OMB) and pub-
lished by the U.S. Census Bureau.
56
MSAs
encompass at least one urbanized area
with a population of 50,000 or more peo-
ple, plus adjacent territory that has a high
degree of social and economic integration
with the core as measured by commuting
ties. MSAs are always established along
county boundaries, but may include coun-
ties from more than one state. Under this
definition, MSAs that cross state bound-
aries are divided between the respective
states, with all the counties in a particular
MSA in each state counted as a geograph-
ic region.
However, under this definition, if a plan
or issuer does not have sufficient informa-
tion to calculate the median of contracted
rates for an item or service provided in an
MSA, the plan or issuer must consider all
MSAs in the state to be a single region
when calculating the median of contract-
ed rates for the item or service provided
in that MSA. In such cases, all MSAs in
the state will constitute one geographic
region, and all other portions of the state
will continue to constitute a different re-
gion. If after applying these broader re-
gions, a plan or issuer continues to have
insufficient information to calculate the
median of contracted rates, geographic re-
gions will be based on Census divisions,
with one region consisting of all MSAs in
the Census division, and one region con-
sisting of all other portions of the Census
division. There are nine Census divisions,
as published by the U.S. Census Bureau.
57

This approach will help to reduce instanc-
es in which a plan or issuer cannot rely
on its own contracted rates to determine
the QPA in cases where the plan or issuer
is not limited to operating within a single
state but instead has provider contracts in
a multi-state region.
These interim final rules establish al-
ternate geographic regions with respect to
air ambulance services. Given the nature
of air ambulance services, the infrequency
with which they are provided relative to
the other types of items and services sub-
ject to the No Surprises Act, and the lower
prevalence of participating providers of
air ambulance services, the Departments
have determined not to apply a definition
of geographic regions based on MSAs, as
narrow regions would result in more in-
stances of insufficient information.
Thus, for air ambulance services, a
geographic region means one region con-
sisting of all MSAs in the state, and one
region consisting of all other portions of
the state. If a plan or issuer does not have
sufficient information to calculate the
median of the contracted rates for an air
ambulance service using that definition
of a geographic region, these interim fi-
nal rules apply broader regions based on
Census divisions—that is, one region con-
sisting of all MSAs in each Census divi-
sion and one region consisting of all other
portions of the Census division. Because
air ambulance services can be furnished
over large distances, these interim final
rules provide that the geographic region
to be applied for air ambulance services is
determined based on the point of pick-up,
meaning the location of the individual at
the time the individual is placed on board
the air ambulance. This approach is gen-
erally consistent with prevailing market
practices among both private and public
payers.
Non-Fee-for-Service Contractual
Arrangements
The No Surprises Act provides that
rulemaking to establish the methodology
used to determine the QPA must take into
account payments that are made by a plan
or issuer that are not on a fee-for-service
basis. The Departments are aware that
many types of alternative reimbursement
56
OMB Bulletin No. 20-01. “Revised Delineations of Metropolitan Statistical Areas, Micropolitan Statistical Areas, and Combined Statistical Areas, and Guidance on Uses of the Delineations
of These Areas” (Mar. 6, 2020), available at https://www.whitehouse.gov/wp-content/uploads/2020/03/Bulletin-20-01.pdf. U.S. Census Bureau, Delineation Files, available at https://www.
census.gov/geographies/reference-files/time-series/demo/metro-micro/delineation-files.html.
57
U.S. Department of Commerce Economics and Statistics Administration, U.S. Census Bureau, available at https://www2.census.gov/geo/pdfs/maps-data/maps/reference/us_regdiv.pdf.

Bulletin No. 2021–30 49 July 26, 2021
models exist that are not standard fee-for-
service arrangements. For example, under
a bundled payment arrangement, plans
and issuers may reimburse a provider for
multiple items and services under a single
billing code. Other payers have capitation
arrangements, under which a provider or
panel of providers is paid a fixed amount
per member per month.
The Departments understand that when
a plan or issuer has a fully- or partial-
ly-capitated payment arrangement, the
plan or issuer also typically has an inter-
nal methodology used to value claims for
those payments made on a capitated basis.
For example, a plan or issuer with capita-
tion arrangements may have an underly-
ing fee schedule that is used to calculate
an individual’s cost sharing. The Depart-
ments are of the view that, when a plan or
issuer has an underlying fee schedule used
to determine cost sharing under non-fee-
for-service contracts, it is reasonable for
the plan or issuer to use the same method-
ology to assign a value to the item or ser-
vice for purposes of determining the QPA.
This approach is used by plans and issuers
in other similar contexts, including when
providing data for the risk adjustment pro-
gram
58
and when making publicly avail-
able in-network rates under the transpar-
ency in coverage regulations.
59
Therefore, in the case of these alterna-
tive payment models, such as bundled and
fully or partially capitated arrangements,
where payment made by a plan or issuer is
not fully on a fee-for-service basis, these
interim final rules provide that the plan
or issuer must calculate a median con-
tracted rate for each item or service using
the underlying fee schedule rates for the
relevant items and services, if underlying
fee schedule rates are available. The term
“underlying fee schedule rate” means the
rate for a covered item or service from a
particular participating provider, provid-
ers, or facility that a group health plan or
health insurance issuer uses to determine
a participant’s, beneficiary’s, or enrollee’s
cost-sharing liability for the item or ser-
vice, when that rate is different from the
contracted rate.
60
If there is no underlying
fee schedule rate for an item or service,
these interim final rules provide that the
plan or issuer must calculate the median
contracted rate using a derived amount,
which, consistent with the definition in
the transparency in coverage regulations,
is the price that a plan or issuer assigns an
item or service for the purpose of internal
accounting, reconciliation with providers,
or for the purpose of submitting data in ac-
cordance with the requirements of 45 CFR
153.710(c).
The Departments considered alterna-
tive approaches to account for non-fee-
for-service contractual arrangements,
such as requiring plans and issuers to cal-
culate median contracted rates for service
bundles, or allowing plans or issuers to
disregard certain types of non-fee-for-ser-
vice contracts for purposes of calculating
the median contracted rate. However, the
approach specified in these interim final
rules will ensure that the median contract-
ed rate calculation accounts for a range
of different contractual arrangements, in-
cluding instances where a plan or issuer
uses different types of contracting models
with different providers and facilities. Us-
ing an underlying fee schedule or derived
amount will allow plans or issuers to, in
essence, convert each of their non-fee-
for-service contracts into fee-for-service
arrangements for purposes of calculating
the median contracted rate. By avoiding
instances where plans or issuers might
have been required to disregard some of
their contracts, this approach minimizes
the number of instances in which a plan or
issuer would not have sufficient informa-
tion to calculate a median contracted rate
and ensures that arrangements that pay
for value over service volume are reflect-
ed in the QPA. In addition, this approach
will result in the calculation of a QPA that
aligns with a service code (or service-code
modifier combination). The Departments
anticipate this result will be helpful to
nonparticipating providers and facilities
in understanding how much cost sharing
they are permitted to charge for a given
item or service, and as they negotiate with
the plan or issuer to determine the out-of-
network rate.
It is the Departments’ understanding
that under certain capitated and bundled
payment arrangements, providers’ pay-
ments may be reconciled retrospectively
to account for utilization, value adjust-
ments, or other weighting factors that can
affect the final payment to a provider. In
addition, payers and providers may agree
to certain incentive payments during the
contracting process to promote the provi-
sion of higher-quality, lower-cost health
care to participants, beneficiaries, or en-
rollees over time. These interim final rules
specify that when calculating median con-
tracted rates, plans and issuers must ex-
clude risk sharing, bonus, or penalty, and
other incentive-based and retrospective
payments or payment adjustments. The
Departments are of the view that exclud-
ing these payments and payment adjust-
ments from the median contracted rates
used to determine cost sharing for items
and services furnished by nonparticipating
providers or facilities is consistent with
how cost sharing is typically calculated
for in-network items and services, where
the cost-sharing amount is customarily de-
termined at or near the time an item or ser-
vice is furnished, and is not subject to ad-
justment based on changes in the amount
ultimately paid to the provider or facility
as a result of any incentives or reconcilia-
tion process.
b. Indexing
The No Surprises Act provides that,
in instances when the median contracted
rate is determined as of January 31, 2019,
the QPA for items and services furnished
during 2022 is calculated by increasing
the median contracted rate by the percent-
age increase in the consumer price index
for all urban consumers (U.S. city aver-
age) (CPI-U) over 2019, the percentage
58
See 45 CFR 153.710(c) (requiring an issuer of a risk adjustment covered plan or a reinsurance-eligible plan in a state in which HHS is operating the risk adjustment or reinsurance program,
as applicable, that does not generate individual enrollee claims in the normal course of business to derive the costs of all applicable provider encounters using its principal internal method-
ology for purposes of pricing those encounters).
59
See 26 CFR 54.9815-2715A3(b)(1)(C); 29 CFR 2590.715–2715A3(b)(1)(C); 45 CFR 147.212(b)(1)(C) (requiring plans and issuers that use underlying fee schedule rates for calculating
cost sharing to make publicly available on an internet website the underlying fee schedule rates for all covered items and services).
60
This definition is substantially similar to the definition of “underlying fee schedule rate” in the transparency in coverage regulations at 26 CFR 54.9815-2715A1(a)(2)(xxii), 29 CFR
2590.715-2715A1(a)(2)(xxii), and 45 CFR 147.210(a)(2)(xxii).

July 26, 2021 50 Bulletin No. 2021–30
increase over 2020, and the percentage
increase over 2021. The No Surprises Act
further provides that the QPA for 2022
is then adjusted annually for items and
services furnished during 2023 or a sub-
sequent year. Therefore, the increase for
any year is the CPI-U for the year, as so
defined, divided by the CPI-U for the prior
year. The combined percentage increase
for 2019, 2020, and 2021 to determine
the amount for 2022 is the product of the
CPI-U increases for 2019, 2020, and 2021
multiplied together. For any year, the fac-
tor will be the quotient of CPI-U for the
current year divided by the CPI-U for the
prior year. For example, for an item or
service provided in 2023, the 2023 QPA
is the 2022 QPA multiplied by the CPI-U
2022/CPI-U 2021.
These interim final rules provide speci-
fications for calculating the percentage in-
crease in CPI-U to ensure that all plans and
issuers adjust the percentage in a uniform
manner. In order to ensure that uniformity,
these interim final rules provide that plans
and issuers will calculate the increases us-
ing the factors determined by the Treasury
Department and the IRS, and published in
guidance by the IRS. In determining the
factors, these interim final rules provide
that the percentage increase for any year is
calculated by using the CPI-U published
by the Bureau of Labor Statistics of the
DOL. For this purpose, the CPI-U for each
calendar year is the average of the CPI-U
as of the close of the 12-month period
ending on August 31 of the calendar year,
rounded to 10 decimal places. This allows
the Departments to provide the percentage
increase factor before January 1 of each
applicable year with sufficient time to ad-
just the QPAs for the year.
c. Special Rules for Unit-Based Services
These interim final rules provide spe-
cial rules for calculating the QPA for
items or services for which a plan or is-
suer generally determines the reimburse-
ment level for the same or similar items or
services by multiplying the contracted rate
by another unit, such as time or mileage.
In these cases, indexing the median con-
tracted rate to calculate the QPA would re-
sult in an amount that does not reflect the
other units that are generally considered
when calculating the in-network payment
amount. Therefore, when reimbursement
levels are determined using this approach,
these interim final rules specify that the
QPA is calculated by determining the
median contracted rate used for that item
or service, indexing that median amount
in accordance with the otherwise appli-
cable rules regarding indexing, and then
applying the pertinent multipliers. These
interim final rules also include specific
instructions for calculating the QPA for
anesthesia services and for certain service
codes for air ambulance services.
Anesthesia Services
Payers generally calculate payment
amounts for anesthesia services by multi-
plying the negotiated rate for the anesthe-
sia conversion factor that has been nego-
tiated between the payer and the provider
(expressed in dollars per unit) by (1) the
base unit for the anesthesia service code,
(2) the time unit, and (3) the physical status
modifier unit. The base unit, time unit, and
physical status modifier unit are specific
to the individual receiving the anesthesia
services. These units are not expressed in
dollars per unit, nor do they vary by con-
tract. The base units for an anesthesia ser-
vice code are the American Society of An-
esthesiologists Relative Value Guide base
units for that service code. The time unit
represents the length of time during which
the anesthesia services were furnished,
and for purposes of the QPA methodology,
is measured in 15-minute increments or a
fraction thereof. The physical status mod-
ifier on a claim is a standard modifier de-
scribing the physical status of the patient
and is used to distinguish between the var-
ious levels of complexity of the anesthe-
sia services provided, and is expressed as
a unit with a value between zero (0) and
three (3).
These interim final rules include a
methodology for calculating the QPA for
these anesthesiology services that reflects
the manner in which providers are gener-
ally paid for these services. To calculate
the QPA for anesthesia services furnished
during 2022, these interim final rules re-
quire the plan or issuer to, first, take the
median contracted rate for the anesthesia
conversion factor (determined in accor-
dance with the methodology for calcu
-
lating median contracted rates for service
code-modifier combinations) for the same
or similar item or service as of January 31,
2019, and increase that amount to account
for changes in the CPI-U, using the meth-
odology described earlier in this section of
the preamble. This amount is referred to as
the indexed median contract rate. The plan
or issuer must then multiply this indexed
median contracted rate for the anesthesia
conversion factor by the sum of the base
unit (using the value specified in the most
recently published edition (as of the date
of service) of the American Society of
Anesthesiologists Relative Value Guide),
time unit, and physical status modifier
units of the participant, beneficiary, or
enrollee to whom anesthesia services are
furnished to determine the QPA.
To calculate the QPA for anesthesia
services furnished during 2023 or a sub-
sequent year, the plan or issuer must use
the indexed median contracted rate for the
anesthesia conversion factor, and adjust
that amount by the percentage increase
in the CPI-U over the previous year using
the methodology described earlier in this
section of the preamble. The plan or issu-
er must then multiply that amount by the
sum of the base unit (using the value spec-
ified in the most recently published edition
(as of the date of service) of the American
Society of Anesthesiologists Relative Val-
ue Guide), time unit, and physical status
modifier units for the participant, benefi-
ciary, or enrollee to whom anesthesia ser-
vices are furnished to determine the QPA.
Air Ambulance Services
Payers often reimburse for air ambu-
lance services in part by using air mileage
service codes (A0435 and A0436) and re-
imbursement levels that reflect the num-
ber of miles an individual is transported
by the air ambulance, which are referred
to as loaded miles. Payment amounts are
calculated by multiplying the negotiated
rate for the service code, referred to in this
rule as the air mileage rate, by the number
of loaded miles. These interim final rules
include a methodology for calculating the
QPA for these air mileage service codes
that reflects the manner in which providers
are generally paid for the service codes.
To calculate the QPA for the portion of
air ambulance services billed using the air
mileage service codes that are furnished

Bulletin No. 2021–30 51 July 26, 2021
during 2022, the plan or issuer must first
increase the median contracted rate, in
accordance with 26 CFR 54.9816-6T(c)
(1)(i), 29 CFR 2590.716-6(c)(1)(i), or 45
CFR 149.140(c)(1)(i), as applicable. This
amount is referred to as the indexed me-
dian air mileage rate. The plan or issuer
must then multiply the indexed median
air mileage rate by the number of loaded
miles provided to the participant, benefi-
ciary, or enrollee to determine the QPA.
To calculate the QPA for air ambulance
services billed using the air mileage ser-
vice codes (A0435 and A0436) that are
furnished during 2023 or a subsequent
year, the plan or issuer must increase
the indexed median air mileage rate, de-
termined for such services furnished in
the immediately preceding year, using
the methodology described in 26 CFR
54.9816-6T(c)(1)(ii), 29 CFR 2590.716-
6(c)(1)(ii), or 45 CFR 149.140(c)(1)(ii),
as applicable. The plan or issuer must then
multiply the indexed median air mileage
rate by the number of loaded miles provid-
ed to the participant, beneficiary, or enroll-
ee to determine the QPA.
d. Cases with Insufficient Information
Section 9816(a)(3)(E)(iii) of the Code,
section 716(a)(3)(E)(iii) of ERISA, and
section 2799A-1(a)(3)(E)(iii) of the PHS
Act, as added by the No Surprises Act,
specify an alternative process to deter-
mine the QPA in cases where a group
health plan or health insurance issuer of-
fering group or individual health insur-
ance coverage lacks sufficient informa-
tion to calculate the median of contracted
rates in 2019, as well as for newly covered
items or services in the first coverage year
after 2019.
Definition of Sufficient Information
Under these interim final rules, a plan
or issuer is considered to have sufficient
information to calculate the median of
contracted rates if the plan or issuer has
at least three contracted rates on January
31, 2019, to calculate the median of the
contracted rates in accordance with the
methodology in these interim final rules.
In the Departments’ view, while a median
contracted rate could be calculated with
a smaller number of contracts, requiring
a minimum of three contracted rates is
supported by the statute’s direction to
calculate a median, rather than a mean.
Furthermore, the Departments have de-
termined that three contracted rates for a
particular item or service in a geographic
region represents the minimum number
of contracts necessary to reasonably re-
flect typical market negotiations while
reducing the potential for outlier rates to
unduly influence the calculation of the
QPA.
Under section 9816(a)(3)(E)(iii) of the
Code, section 716(a)(3)(E)(iii) of ERISA,
section 2799A-1(a)(3)(E)(iii) of the PHS
Act, and these interim final rules, where a
plan or issuer that initially does not have
sufficient information to calculate the me-
dian contracted rate based on January 31,
2019 contracted rates (or for new plans
and coverage or new service codes, as dis-
cussed in more detail in this section of the
preamble) later gains sufficient informa-
tion, the plan or issuer must calculate the
QPA using the median contracted rate for
the first sufficient information year. The
first sufficient information year is defined
as: (1) in the case of an item or service
for which a plan or issuer does not have
sufficient information to calculate the me-
dian of contracted rates in 2019, the first
year after 2022 for which the plan or issu-
er has sufficient information to calculate
the median of contracted rates in the year
immediately preceding that first year after
2022; and (2) in the case of a newly cov-
ered item or service, the first year after the
first coverage year for such item or service
with respect to such plan or coverage for
which the plan or issuer has sufficient in-
formation to calculate the median of the
contracted rates in the year immediately
preceding that first year.
In cases in which contracted rates for a
year after 2019 must be used to calculate
the median contracted rate, a plan or issuer
will be considered to have sufficient infor-
mation to calculate the median contract-
ed rate for a year if, with respect to that
year, both of the following conditions are
met: (1) the plan or issuer has at least three
contracted rates on January 31 of the year
immediately preceding that year to calcu-
late the median of the contracted rates in
accordance with the methodology in these
interim final rules; and (2) the contracted
rates account (or are reasonably expected
to account) for at least 25 percent of the
total number of claims paid for that item
or service for that year with respect to all
plans of the sponsor (or of the administer-
ing entity, if applicable) or all coverage
offered by the issuer that are offered in the
same insurance market.
The requirement that a plan or issuer
have at least three contracted rates for a
particular item or service in a geograph-
ic region is the same as the requirement
that applies when determining whether
there is sufficient information to calcu-
late a median contracted rate for items
and services furnished during 2022 using
the median of contracted rates as of Jan-
uary 31, 2019. The 25 percent minimum
claims volume requirement, however, ap-
plies where only contracted rates for years
after 2019 are used to determine whether
a plan or issuer has sufficient information
to calculate the median contracted rate in
the first sufficient information year. While
the Departments are not concerned about
manipulation of the QPA in the majori-
ty of cases where the median contracted
rate is based on 2019 contracted rates,
the Departments recognize the potential
for plans and issuers to engage in selec-
tive contracting practices that artificially
change the median contracted rate in cas-
es where subsequent year contracted rates
are used to determine the QPA. Therefore,
this requirement will help to ensure that
when contracted rates for years after 2019
are used to calculate a median contracted
rate, those network contracts represent a
reasonable proportion of a plan’s or issu-
er’s total claims and are not designed to
manipulate the QPA.
Eligible Databases
In cases in which a plan or issuer does
not have “sufficient information” to cal-
culate a median contracted rate, the No
Surprises Act directs the plan or issuer
to determine the QPA through use of any
database that is determined, in accordance
with rulemaking issued by the Depart-
ments, to not have any conflicts of interest
and to have sufficient information reflect-
ing allowed amounts paid to a health care
provider or facility for relevant services
furnished in the applicable geographic re-
gion (such as a state all-payer claims da-
tabase).

July 26, 2021 52 Bulletin No. 2021–30
These interim final rules establish stan-
dards for databases, referred to as eligible
databases, that may be used to determine
the QPA. State all-payer claims databas-
es are categorically eligible under these
interim final rules because they are spe-
cifically identified as not having any con-
flicts of interest and as having sufficient
information reflecting allowed amounts in
section 9816(a)(3)(E)(iii)(I) of the Code,
section 716(a)(3)(E)(iii)(I) of ERISA, and
section 2799-1(a)(3)(E)(iii)(I) of the PHS
Act. Other third-party databases may also
be eligible, provided all of the following
conditions are satisfied.
First, the database or the organization
maintaining the database cannot be affili-
ated with, or owned or controlled by, any
health insurance issuer, or a health care
provider, facility, or provider of air am-
bulance services, or any member of the
same controlled group as, or under com-
mon control with, any such entity. For
example, if a majority of the members on
the governing board of a database or the
organization maintaining the database are
associated with a health insurance issuer,
the database would be considered to have
a conflict of interest under these interim fi-
nal rules, since it is controlled by the issu-
er. As another example, if an issuer owns
40 percent of the stock of the organization
that maintains a database, and its subsidi-
ary owns an additional 20 percent of the
stock of the organization that maintains
the database, the database would be con-
sidered to have a conflict of interest under
these interim final rules, since it is effec-
tively controlled by the issuer. As a third
example, if an issuer and the organization
that maintains a database are both subsid-
iaries of the same parent organization, the
database would be considered to have a
conflict of interest under these interim fi-
nal rules, since it is affiliated with the issu-
er. In the Departments’ view, this standard
is critical to ensuring the independence of
any database used to determine the QPA.
The Departments solicit comment on
whether a database should not be affiliated
with, or owned or controlled by, other en-
tities, such as plan sponsors or third-party
administrators, in order to avoid a conflict
of interest. The Departments also seek
comment on whether to establish a specif-
ic threshold that a party’s minority owner-
ship interest must meet or exceed in order
to create a conflict of interest for purposes
of these interim final rules.
For purposes of applying the con-
trolled group rules to eligible databases,
a controlled group means a group of two
or more persons that is treated as a sin-
gle employer under Code sections 52(a),
52(b), 414(m), or 414(o). The Treasury
Department and the IRS are considering
whether further guidance is needed under
section 52(a) or (b) of the Code to address
either organizations exempt from tax un-
der section 501(a) of the Code or nonprof-
it organizations that, although not exempt
from tax under section 501(a) of the Code,
do not have members or shareholders that
are entitled to receive distributions of the
organization’s income or assets (including
upon dissolution) or that otherwise retain
equity interests similar to those generally
held by owners of for-profit entities. Until
further guidance is issued, those two types
of organizations may either rely on a rea-
sonable, good-faith application of section
52(a) and (b) of the Code (taking into ac-
count the reasons for which the controlled
group rules are incorporated into the defi-
nition of eligible database) or apply the
rules set forth in 26 CFR 1.414(c)-5(a)
through (d) (but substituting “more than
50 percent” in place of “at least 80 per-
cent” each place it appears in 26 CFR
1.414(c)-5).
Second, the database must have suf-
ficient information reflecting in-network
amounts paid by group health plans or
health insurance issuers offering group
or individual health insurance coverage
to providers, facilities, or providers of
air ambulance services for relevant items
and services furnished in the applicable
geographic region. The Departments rec-
ognize that for a database to be used to
calculate the QPA, the database should
contain sufficient data to reflect the true
market dynamics in a given geographic
region. However, in order to provide flex-
ibility in the initial implementation of the
No Surprises Act, these interim final rules
do not establish a specific definition of
when a database is considered to have suf-
ficient information. The Departments seek
comment on how to define when a data-
base has sufficient information, including
whether to establish specific criteria that a
claims database would need to satisfy in
order to demonstrate that it has sufficient
information reflecting in-network pay-
ment amounts for providers or facilities in
the applicable geographic region, such as
a requirement that the database represents
a specified minimum percentage of the
claims volume for the region.
Third, the database must have the
ability to distinguish amounts paid to
participating providers and facilities by
commercial payers, such as group health
plans and health insurance issuers offer-
ing group or individual health insurance
coverage, from all other claims data, such
as amounts billed by nonparticipating
providers or facilities and amounts paid
by public payers, including the Medicare
program under title XVIII of the Social
Security Act, the Medicaid program under
title XIX of the Social Security Act (or a
demonstration project under title XI of the
Social Security Act),
61
and the Children’s
Health Insurance Program under title XXI
of the Social Security Act.
To calculate the QPA for an item or ser-
vice furnished during 2022 (or in the case
of newly covered items or services, in the
first coverage year) using an eligible da-
tabase, the plan or issuer must first iden-
tify the rate in the database that is equal
to the median of the in-network allowed
amounts for the same or similar item or
service in the geographic region in the
year immediately preceding the year in
which the item or service is furnished (or
in the case of a newly covered item or ser-
vice, the year immediately preceding the
first coverage year). It is the Departments’
view that in-network allowed amounts for
items and services are a reasonable proxy
61
Under section 1115 of the Social Security Act, the Secretary of HHS has the authority to approve experimental, pilot, or demonstration projects that, in his judgment, are likely to assist in
promoting the objectives of the Medicaid statute. Under section 1115 authority, the Secretary may waive compliance with certain provisions of Medicaid and CHIP law and may authorize
federal matching funds for state expenditures that would not otherwise be federally matchable under the Medicaid and CHIP statutes. Many states have section 1115 demonstrations under
which they cover services that would not otherwise be covered under the Medicaid or CHIP programs.

Bulletin No. 2021–30 53 July 26, 2021
for contracted rates, and that where there
is insufficient information to calculate the
QPA based on the median of a plan’s or is-
suer’s own contracted rates, using the me-
dian of in-network allowed amounts for
all private payers in an eligible database
is a reasonable method for approximat-
ing the median contracted rate for items
and services in the applicable geographic
region. The Departments are also of the
view that determining the QPA for an item
or service using the median of in-network
allowed amounts for the same or similar
item or service in the geographic region in
the year immediately preceding the year
in which the item or service is furnished
is reasonably likely to result in levels of
cost sharing that are generally in line with
the cost-sharing liability incurred by par-
ticipants, beneficiaries, and enrollees in
plans with similar levels of in-network
cost-sharing for the same or similar items
or services.
Once the median in-network allowed
amount has been identified, that rate is
then increased by the percentage increase
in the CPI-U over the previous year us-
ing the methodology described earlier
in this section of the preamble. For each
subsequent year before the first sufficient
information year, the plan or issuer must
increase the QPA applicable to items or
services furnished in the immediately pre-
ceding year by the percentage increase in
CPI-U over the preceding year. Plans and
issuers must continue to use this method-
ology until the first sufficient information
year, at which point the plan or issuer
must calculate the median contracted rate
and determine the QPA using the standard
methodology discussed earlier in this sec-
tion of the preamble.
These interim final rules require that
plans and issuers use a consistent meth-
odology when relying on an eligible da-
tabase. Specifically, for any particular
item or service, a plan or issuer using a
database must use the same database to
determine the QPA for that item or service
through the last day of the calendar year,
and if a different database is selected for
some items or services, the basis for that
selection must be one or more factors not
directly related to the rate of those items
or services (such as sufficiency of data for
those items or services).
62
This consisten-
cy requirement is designed to ensure that
when relying on an eligible database to
determine the QPA for an item or service,
a plan or issuer cannot vary the database
selected due to the rates associated with
that item or service. The Departments
seek comment on this consistency require-
ment and whether additional standards or
guidance are needed to ensure compliance
and prevent abuse.
Finally, these interim final rules codify
section 9816(d) of Code, section 716(d)
of ERISA, and section 2799A-1(d) of
PHS Act, as added by the No Surprises
Act, which provide that a plan or issuer
that uses an eligible database to determine
the QPA by reason of having insufficient
information is responsible for any costs
associated with accessing such database.
The Departments solicit comment on
ways to help ensure that plans and issu-
ers are charged only reasonable costs for
accessing such databases and that entities
that provide eligible databases are trans-
parent about their fees and fee structures
associated with this process.
New Plans and Coverage
The No Surprises Act directs the De-
partments to establish a methodology for
the sponsor of a group health plan or a
health insurance issuer that did not offer
any plan or coverage in a geographic re-
gion in 2019 to determine QPAs for the
first year in which the plan or coverage
will be offered in the geographic region.
For each subsequent year, that amount is
increased by the percentage increase in
the consumer price index for all urban
consumers over the previous year.
The Departments recognize that while
a sponsor or issuer may be newly offering
coverage in a geographic region, the spon-
sor or issuer may have sufficient existing
provider contracts under other current
coverage in the geographic region where
an item or service is furnished to calculate
the QPA. The Departments clarify that it
is not necessary to establish special proce-
dures to calculate the QPA in these situa-
tions. Therefore, under these interim final
rules, if the plan or issuer newly offering
coverage in a geographic region for a year
after 2019 otherwise has sufficient infor-
mation to calculate a median contract-
ed rate in 2019 in the geographic region
where the item or service is furnished,
the QPA is determined using the standard
methodology for calculating median con-
tracted rates discussed earlier in this sec-
tion of the preamble.
The Departments recognize that the
standard methodology would not be avail-
able, however, in cases where the plan or
issuer does not have sufficient information
to calculate a median contracted rate in
the geographic region in which the item or
service is furnished, such as in situations
where the sponsor or issuer did not offer
any plan or coverage in 2019. In this case,
the plan or issuer must determine the QPA
in accordance with the rules applicable to
plans or issuers with insufficient informa-
tion, or for newly covered items and ser-
vices, including the use of an eligible da-
tabase, as discussed earlier in this section
of the preamble.
For each subsequent year the plan or
coverage is offered in the geographic re-
gion, the plan or issuer must increase the
QPA for items or services furnished in the
immediately preceding year by the per-
centage increase in the CPI-U over the pre-
vious year to determine the QPA for items
and services furnished in that year. Under
this approach, new plans and coverage
that initially do not have sufficient infor-
mation to calculate a median contracted
rate must use a QPA based on information
for the first year of coverage from an eligi-
ble database indefinitely, updated only by
the inflation adjustment. The Departments
seek comment on whether the methodol-
ogy should instead allow new plans and
coverage to transition to calculating a QPA
using median contracted rates in an appli-
cable first sufficient information year.
New Service Codes
When service codes are created, plans
and issuers may be unable to calculate
the QPA using the approaches discussed
earlier, because neither the plan or issuer
nor any eligible databases have sufficient
62
For example, these interim final rules permit a plan or issuer to rely on different state all-payer claims databases, based on the geographic region in which an item or service is furnished, as
state all-payer claims databases may not have sufficient data for items and service furnished outside of the state.

July 26, 2021 54 Bulletin No. 2021–30
information regarding the new service
code. This situation may occur for new
service codes when the service codes
describe items or services that have not
previously been widely furnished. This
situation may also occur when service
codes are substantially revised, resulting
in new service codes or new descriptors
for existing service codes that substantial-
ly alter the types of services that would be
billed using the original service codes. In
this case, the plan, issuer, or eligible data-
base may have sufficient information re-
garding rates for items and services billed
under the service code prior to the revi-
sion, but that information may no longer
reflect the rates associated with the items
and services billed under the revised ser-
vice code. The No Surprises Act does not
specify a methodology for calculating the
QPA in these circumstances. However, in
the Departments’ view, it is necessary that
these interim final rules establish a meth-
odology that plans and issuers can rely
on for calculating QPAs for new service
codes during periods of time when no el-
igible databases would reasonably be ex-
pected to have sufficient data to calculate
a QPA.
These interim final rules define “new
service code” to mean a service code that
was created or substantially revised in a
year after 2019. In situations in which a
plan or issuer is billed for a covered item
or service using a new service code, the
plan or issuer must first identify a reason-
ably related service code that existed in the
immediately preceding year. For example,
a reasonably related service code might
be another service code within the same
family of codes, or might involve services
that represent similar relative value units.
This related service code will be used as
a benchmark for determining the QPA for
the new service code. The Departments
seek comment on whether additional rules
are needed regarding how plans and issu-
ers should be required to identify a reason-
ably related service code, and on whether
the Departments should develop a cross-
walk methodology to identify related ser-
vice codes for each new service code.
The Departments are of the view that,
although Medicare payment rates may dif-
fer substantially from rates paid by plans
and issuers, it is reasonable to use Medi-
care payment rates to approximate the rel-
ative cost of two different but reasonably
related service codes. Therefore, if CMS
has established a payment rate under the
Medicare program for an item or service
billed under the new service code, the
plan or issuer must calculate the ratio of
the rate that Medicare pays for the item or
service billed under the new service code
compared to the rate that Medicare pays
for the item or service under the related
service code (with both rates disregarding
any adjustments for value-based purchas-
ing arrangements that could lead to bonus-
es or deductions), and multiply that ratio
by the QPA for the related service code
for the year in which the item or service
is furnished.
The Departments recognize that in
some cases the Medicare program might
not immediately establish a payment rate
for items and services billed under a new
service code. Therefore, these interim fi-
nal rules establish a secondary approach
to determine the QPA in these situations.
Specifically, for items and services billed
using a new service code for which Medi-
care has not established a payment rate,
the plan or issuer must calculate the QPA
by first calculating the ratio of the rate that
the plan or issuer reimburses for an item or
service billed under the new service code
compared to the rate that the plan or issuer
reimburses for an item or service under the
related service code (the relativity ratio),
and then multiplying the relativity ratio
by the QPA for the item or service billed
under the related service code. These in-
terim final rules do not specify a particular
method that plans and issuers must use to
calculate this relativity ratio. However,
the Departments expect plans and issu-
ers to use a reasonable method for mak-
ing the calculation, and seek comment on
whether future rulemaking should specify
additional requirements for determining
the relativity ratio. For example, plans and
issuers could be required to calculate the
ratio using the medians or means of the
contracted rates for each of the two ser-
vices. However, the Departments recog-
nize that it may take time for plans and is-
suers to enter into negotiated rates for new
service codes, and therefore the medians
or means may change over time. Alterna-
tively, plans and issuers could be required
to calculate the relativity ratio using rates
from one contract, based on the assump-
tion that negotiated rates within any given
contract would generally produce a simi-
lar relativity ratio. The Departments are of
the view that using rates from two differ-
ent contracts would not constitute a rea-
sonable method for calculating the relativ-
ity ratio, as this approach could introduce
into the relativity ratio, variation from fac-
tors that are unrelated to the relative cost
of furnishing the item or service, such as
the negotiating power of the parties to the
contract.
Under the methodology in these inter-
im final rules, for items or services fur-
nished in any subsequent year (before the
first sufficient information year for such
item or service with respect to such plan
or coverage or before the first year for
which an eligible database has sufficient
information in the immediately preceding
year), the plan or issuer must calculate the
QPA by increasing the QPA calculated for
the prior year by the percentage increase
in CPI-U over the immediately preceding
year.
However, for an item or service billed
using a new service code, and furnished
in the first sufficient information year for
such item or service with respect to such
plan or coverage, or furnished in the first
year for which an eligible database has
sufficient information to enable the plan
or issuer to calculate the QPA using the
processes that generally apply when an
issuer or plan has insufficient information,
the plan or issuer must calculate the QPA
in accordance with 26 CFR 54.9816-6T(c)
(3), 29 CFR 2590.716-6(c)(3), or 45 CFR
149.140(c)(3), as applicable. Thus, once
the plan or issuer or an eligible database
has sufficient information to calculate
a QPA, the QPA for a new service code
would be calculated using the median con-
tracted rate of the plan or issuer, or the me-
dian of the in-network allowed amounts in
the eligible database.
The Departments seek comment on any
alternate approaches that could be used to
determine the QPA for new service codes.
e. Information to be Shared about the
Q PA
The No Surprises Act directs the De-
partments to specify the information that a
plan or issuer must share with a nonpartic-
ipating provider or nonparticipating emer-

Bulletin No. 2021–30 55 July 26, 2021
gency facility, as applicable, when making
a determination of a QPA.
The Departments recognize that pro-
viders, emergency facilities, and air am-
bulance providers subject to the surprise
billing rules need transparency regarding
how the QPA was determined. This infor-
mation is also important in informing the
negotiation process. In addition, IDR enti-
ties are directed by statute to consider the
QPA when selecting an offer submitted
by the parties through the IDR process.
Therefore, to decide whether to initiate
the IDR process and what offer to submit,
a provider, emergency facility, or provider
of air ambulance services must know not
only the value of the QPA, but also certain
information on how it was calculated.
The Departments seek to ensure trans-
parent and meaningful disclosure about
the calculation of the QPA while minimiz-
ing administrative burdens on plans and
issuers. These interim final rules therefore
require that plans and issuers make cer-
tain disclosures with each initial payment
or notice of denial of payment, and that
plans and issuers must provide additional
information upon request of the provider
or facility. This information must be pro-
vided in writing, either on paper or elec-
tronically, to a nonparticipating provider,
emergency facility, or provider of air am-
bulance services, as applicable, when the
QPA serves as the recognized amount.
First, a plan or issuer must provide the
QPA for each item or service involved.
Second, a plan or issuer must provide
a statement certifying that, based on the
determination of the plan or issuer: (1) the
QPA applies for purposes of the recognized
amount (or, in the case of air ambulance
services, for calculating the participant’s,
beneficiary’s, or enrollee’s cost sharing),
and (2) each QPA shared with the provider
or facility was determined in compliance
with the methodology outlined in these in-
terim final rules. These interim final rules
require a statement from the plan or issuer
that the QPA applies for purposes of the
recognized amount so that providers and
facilities will understand that the plan
or issuer has determined that neither an
All-Payer Model Agreement nor a speci-
fied state law applies for purposes of cal-
culating a participant’s, beneficiary’s, or
enrollee’s cost-sharing liability, but rather
that cost-sharing liability has been calcu-
lated using the QPA. With respect to air
ambulance services, the statement will en-
sure providers of air ambulance services
understand that the QPA, rather than the
billed charge, applies for purposes of cal-
culating the cost-sharing liability, because
the plan or issuer has determined that the
QPA is lower than the billed charge. The
Departments expect that in most if not all
cases where the QPA serves as the basis
for determining the recognized amount,
the federal IDR process will govern any
dispute over payment instead of a speci-
fied state law or process. Therefore, this
notice will also serve to direct providers
or facilities to the federal IDR process if
the parties cannot agree on an out-of-net-
work rate.
Third, a plan or issuer must provide a
statement that if the provider or facility,
as applicable, wishes to initiate a 30-day
open negotiation period for purposes of
determining the amount of total payment,
the provider or facility may contact the
appropriate person or office to initiate
open negotiation, and that if the 30-day
open negotiation period does not result in
a determination, generally, the provider
or facility may initiate the IDR process
within 4 days after the end of the open
negotiation period. The plan or issuer
must also provide contact information,
including a telephone number and email
address, for the appropriate office or per-
son to initiate open negotiations for pur-
poses of determining an amount of pay-
ment (including cost sharing) for such
item or service.
In addition, upon request of the provid-
er or facility, a plan or issuer must provide,
in a timely manner, information about
whether the QPA includes contracted rates
that were not set on a fee-for-service basis
for the specific items and services at issue
and whether the QPA for those items and
services was determined using underlying
fee schedule rates or a derived amount. If
a related service code was used to deter-
mine the QPA for a new service code, a
plan or issuer must provide information
to identify which related service code was
used. Similarly, if an eligible database was
used to determine the QPA, a plan or is-
suer must provide information to identify
which database was used to determine the
QPA.
Finally, if applicable upon request, a
plan or issuer must provide a statement
that the plan’s or issuer’s contracted rates
include risk-sharing, bonus, penalty, or
other incentive-based or retrospective
payments or payment adjustments for
the items and services involved that were
excluded for purposes of calculating the
QPA. Having information about whether
the median contracted rate excludes these
types of payment adjustments will better
inform the open negotiation and IDR pro-
cess.
The Departments seek comment on
these disclosure requirements and on what
additional information a plan or issuer
should be required to share with a provid-
er or facility about the QPA, either in all
cases or upon request. The Departments
also seek comment on whether a specific
definition or standard is needed to ensure
that information provided upon request is
disclosed in a timely manner.
f. Audits
The No Surprises Act requires rulemak-
ing to establish a process under which
group health plans and health insurance
issuers offering group or individual health
insurance coverage are audited by the
applicable Secretary or applicable state
authority to ensure that such plans and
coverage are in compliance with the re-
quirement of applying a QPA and that the
QPA applied satisfies the definition under
the No Surprises Act with respect to the
year involved.
63
The enforcement responsibilities of
HHS and the states with respect to over-
sight of health insurance issuer compli-
ance with the federal insurance market
reforms are set forth in the PHS Act. Pur-
suant to section 2723(a)(1) of the PHS
Act, as amended by the No Surprises Act,
states have primary enforcement authori-
63
See section 9816(a)(2)(A) of the Code; section 2799A-1(a)(2)(A) of the PHS Act. The DOL and OPM will rely on the existing agency processes to ensure compliance with the No Surprises
Act, as discussed in this section of the preamble.

July 26, 2021 56 Bulletin No. 2021–30
ty over health insurance issuers regarding
the provisions of Parts A and D of title
XXVII of the PHS Act. Under this frame-
work, HHS has enforcement authority
over issuers in a state if the Secretary of
HHS makes a determination that the state
is failing to substantially enforce a provi-
sion (or provisions) of Part A or D of title
XXVII of the PHS Act.
64
DOL and the Treasury Department gen-
erally have primary enforcement authori-
ty over private sector employment-based
group health plans. The IRS has jurisdic-
tion over certain church plans. HHS also
has primary enforcement authority over
non-federal governmental plans, such as
those sponsored by state and local govern-
ment employers.
65
OPM has jurisdiction
over FEHB plans, which are federal gov-
ernmental plans.
The Departments will generally use
existing processes to ensure compli-
ance with Code, ERISA, and PHS Act
requirements that apply to group health
plans and health insurance issuers, in-
cluding the provisions added by the No
Surprises Act. HHS’s enforcement pro-
cedures related to the PHS Act federal
insurance market reforms are set forth in
section 2723 of the PHS Act and 45 CFR
150.101 et seq., including bases for initi-
ating investigations and performing mar-
ket conduct examinations. Section 504 of
ERISA provides DOL with authority to
determine whether any person has violat-
ed or is about to violate any provision of
ERISA or any regulation or order there-
under. The interim final rules include an
audit provision establishing that HHS’s
existing enforcement procedures will ap-
ply with respect to ensuring that a plan
or coverage is in compliance with the
requirement of determining and applying
a QPA consistent with these interim final
rules. HHS intends to amend its enforce-
ment regulations through future notice
and comment rulemaking to reflect the
amendments made to the PHS Act by the
No Surprises Act. OPM will audit FEHB
plans to ensure that such plans are in
compliance with the requirement of de-
termining and applying a QPA.
vii. Determination of Out-of-Network
Rate in the Absence of a Specified State
Law or an Applicable All-Payer Model
Agreement
In instances in which a specified state
law or All-Payer Model Agreement does
not apply for purposes of specifying the
out-of-network rate, the out-of-network
rate is determined either through agree-
ment between the provider or facility and
plan or issuer; or through an IDR process,
if agreement cannot be reached and such
process is initiated. If the parties agree to
an amount of payment prior to the date on
which a certified IDR entity makes a de-
termination with respect to such items or
services, that agreed upon amount is the
out-of-network rate. Otherwise, the out-
of-network rate is the amount of payment
determined by the certified IDR entity for
the items or services.
66
3. Additional Plan and Issuer
Requirements Regarding Making Initial
Payments or Providing a Notice of
Denial
The No Surprises Act and these inter-
im final rules establish several procedural
requirements that apply to group health
plans and health insurance issuers to en-
sure that billing disputes related to items
and services subject to the balance billing
protections in the No Surprises Act are re-
solved in a timely fashion. These include
timeframes for: a plan or issuer to send a
notice of denial of payment or make an
initial payment; the length of any open ne-
gotiation period regarding payment; and
initiating the IDR process following an
open negotiation period. However, those
three requirements do not apply under cer-
tain circumstances with regard to post-sta-
bilization services or to out-of-network
non-emergency services (other than out-
of-network air ambulance services) if the
provider or facility provided notice to, and
received consent from, the participant,
beneficiary, or enrollee (or their autho-
rized representative), as discussed later in
this preamble.
Therefore, it is critical that a group
health plan or health insurance issuer have
knowledge of any notice provided and
consent given under these interim final
rules for items and services that it covers,
and that would otherwise be subject to the
surprise billing provisions in the statute
and these interim final rules. As discussed
later in this preamble, the interim final
rules issued by HHS in this rulemaking
require providers and facilities to notify
plans and issuers when the notice and con-
sent criteria have been satisfied. Absent
receiving this information, a plan or issuer
must assume that the individual has not
waived the protections provided in these
interim final rules, and must therefore cal-
culate cost sharing, apply cost sharing to
deductibles and out-of-pocket limits, and
make any payments to providers and fa-
cilities before an individual has satisfied
the coverage deductible, accordingly. In
instances where a plan or issuer does re-
ceive this information, it may rely on the
provider’s or facility’s representation as
being true and accurate, unless and until
the plan or issuer knows or reasonably
should know otherwise. Thus, if a provid-
er or facility indicates to a plan or issuer
that the notice and consent described in
these interim final rules was properly and
timely given and received, the plan or is-
suer may rely on that information and, for
example, apply out-of-network cost shar-
ing for the applicable items and services,
unless and until the plan or issuer knows
or reasonably should know that the notice
and consent was not properly and time-
ly given and received. In cases where a
plan or issuer believes that notice was not
properly and timely given and received,
notwithstanding a provider’s or facility’s
assertion to the contrary, the plan or issuer
should apply the cost-sharing and other re-
quirements set forth in these interim final
rules and applicable state law by, among
other actions, reprocessing any claims that
were not processed consistently with those
requirements. The plan or issuer may also
submit a complaint against the provider or
facility as set forth in these interim final
rules at 45 CFR 149.450.
64
Section 2723(a)(2) and (b)(1)(A) of the PHS Act. See also 45 CFR 150.203.
65
See section 2723(b)(1)(B) of the PHS Act.
66
As noted previously, the Departments intend to implement the federal IDR process in future rulemaking.

Bulletin No. 2021–30 57 July 26, 2021
Sections 9816(a)(1)(iv)(I) and 9817(a)
(3)(A) of the Code, sections 716(a)(1)(iv)
(I) and 717(a)(3)(A) of ERISA, sections
2799A-1(a)(1)(iv)(I) and 2799A-2(a)(3)
(A) of the PHS Act, and these interim fi-
nal rules, require plans and issuers to send
“an initial payment or notice of denial of
payment” not later than 30 calendar days
after a nonparticipating provider or facil-
ity submits a bill related to the items and
services that fall within the scope of the
new surprise billing protections for emer-
gency services, non-emergency services
performed by nonparticipating providers
at participating facilities, and air ambu-
lance services furnished by nonparticipat-
ing providers of air ambulance services.
Given that plans and issuers cannot com-
ply with this requirement unless the plan
or issuer first determines that the billed
items and services are covered under the
plan or coverage, these interim final rules
require that the plan or issuer make such
determination not later than 30 calendar
days after a nonparticipating provider or
facility submits a bill related to the items
and services that fall within the scope of
the new surprise billing protections for
emergency services, non-emergency ser-
vices performed by nonparticipating pro-
viders at participating facilities, and air
ambulance services furnished by nonpar-
ticipating providers of air ambulance ser-
vices.
The Departments specify in these in-
terim final rules that the 30-calendar-day
period generally begins on the date the
plan or issuer receives the information
necessary to decide a claim for payment
for such services, commonly known as a
“clean claim” under many existing state
laws. To the extent feasible, the Depart-
ments encourage providers and facilities
to include information about whether the
surprise billing protections apply to an
item or service on the claim form itself.
With respect to non-emergency services,
HHS requires, under 45 CFR 149.420(i),
nonparticipating providers (or the partic-
ipating facility on behalf of the nonpar-
ticipating provider) to timely notify the
plan or issuer that the item or service was
furnished during a visit at a participating
health care facility. In addition, in all cas-
es, under either 45 CFR 149.410(e) or 45
CFR 149.420(i), providers and facilities
must notify the plan or issuer as to wheth-
er the requirements for notice and consent
have been met when transmitting the bill,
either on the bill or in a separate docu-
ment. The Departments seek comments
with recommendations on how HIPAA
standard transactions to submit claims
could be modified to accommodate the
submission of several types of information
on the claim itself. Specifically, the De-
partments seek comment on how HIPAA
standard transactions to submit claims
could be modified to include whether the
surprise billing protections apply to the
items and services included on a claim,
whether the item or service was furnished
during a visit at a participating health care
facility, and whether the requirements for
notice and consent have been met. The
30-calendar-day initial payment period
also does not prohibit payments outside
of the 30-calendar-day timeframe for any
future adjustments for errors in payment,
such as in cases of duplicate bills where
providers and plans or issuers reconcile
overpayments. The Departments expect
that plans and issuers will act reasonably
and in good faith when requesting addi-
tional information, by providing specific
detail to help ensure that the claimant,
provider, or facility understands what is
required to perfect the claim. The Depart-
ments may specify additional standards
if the Departments become aware of in-
stances of abuse and gaming where plans
and issuers are unduly delaying making an
initial payment or sending a notice of de-
nial to providers on the basis that the pro-
vider has not submitted a clean claim. The
Departments solicit comment on whether
any additional standards are necessary to
prevent abusive claims payment practices.
Under these interim final rules, a notice of
denial of payment means, with respect to
an item or service for which benefits are
subject to the surprise billing protections,
a written notice from the plan or issuer to
the provider or facility that payment for
the item or service will not be made by
the plan or coverage and which explains
the reason for denial. A notice of denial of
payment could be provided, for example,
if the item or service is covered but is sub-
ject to a deductible greater than the recog
-
nized amount.
In the Departments’ view, the statute’s
reference to an “initial” payment does not
refer to a first installment. Rather, this
initial payment should be an amount that
the plan or issuer reasonably intends to
be payment in full based on the relevant
facts and circumstances and as required
under the terms of the plan or coverage,
prior to the beginning of any open nego-
tiations or initiation of the IDR process.
In cases where the provider or facility is
willing to accept the cost-sharing amount
plus the initial payment (or the cost-shar-
ing amount alone, in cases where a denial
of payment is sent) as payment in full, this
amount will be treated as the out-of-net-
work rate. If plans and issuers make initial
payments that providers and facilities are
willing to accept (when combined with
the cost-sharing amount) as payment in
full, the administrative costs of determin-
ing the out-of-network amount will be sig-
nificantly reduced through the avoidance
of an open negotiation period and IDR
process.
These interim final rules do not require
plans and issuers, when making an initial
payment to providers or facilities, to make
any specific amount of minimum initial
payment. However, several state balance
billing laws set standards for minimum
initial payment amounts. For example,
in Washington State, issuers are required
to pay an out-of-network provider or fa-
cility a commercially reasonable amount,
reduced by the applicable cost-sharing
amount, within 30 calendar days of re-
ceipt of a claim to which the state’s bal-
ance billing protections apply. Requiring
a minimum initial payment amount may
help reduce the number of cases that go to
arbitration in some states, and could help
to reduce the number of cases that go to
the federal IDR process established under
the No Surprises Act.
The Departments seek comment on
whether to set a minimum payment rate or
methodology for a minimum initial pay-
ment in future rulemaking, and if so, what
that rate or methodology should be. For
example, a minimum payment rate could
be a specific percentage of the Medicare
rate, a specific percentage of the plan or
issuer’s QPA for the item or service, an
amount calculated in the same way the
plan or issuer typically calculates pay-
ment for the specific item or service to
nonparticipating providers or facilities, an
amount representing the highest amount
that would result from applying two or

July 26, 2021 58 Bulletin No. 2021–30
more of these or other methodologies, or
any other method. To the extent comments
suggest that a percentage of a rate calculat-
ed or determined in a specific way would
be appropriate, the Departments seek
comment regarding an appropriate specif-
ic percentage. The Departments also seek
comment on whether a minimum payment
rate should be defined as a commercially
reasonable rate based on payments for the
same or similar services in a similar area,
without requiring any specific method-
ology. In addition, the Departments seek
comment regarding the impact of these
provisions on underserved and rural com-
munities, and other communities facing a
shortage of providers.
The Departments are aware that the
timeframes for deciding post-service
claims under the claims and appeals rules
issued under section 2719 of the PHS Act
and the timeframes for sending an initial
payment or notice of denial of payment
under these final rules may not always
align. The Departments seek to minimize
confusion about which types of disputes
should be resolved through a plan or is-
suer’s internal claims and appeals process
instead of the IDR process established by
the No Surprises Act.
The ERISA claims procedure regula-
tion requires group health plans to notify
a claimant of a benefit determination for
post-service claims not later than 30 days
after receipt of the claim. A plan can gen-
erally extend this period once for up to 15
days for matters beyond the control of the
plan, including if the claimant fails to pro-
vide information necessary to decide the
claim. In such cases, the plan may noti-
fy the claimant they provided insufficient
information within 30 days, and the plan
must give the claimant at least 45 days to
provide additional information. After the
information is provided, the plan has 15
days to make a determination. Claims that
result in an adverse benefit determina-
tion (ABD) may be appealed within 180
days following receipt of the notice of
the ABD. The requirements of the ERISA
claims procedure regulation are incorpo-
rated by reference in the internal claims
and appeals and external review require-
ments added by the Affordable Care Act
to section 2719 of the PHS Act and, there-
fore, subject to limited exceptions, apply
to all non-grandfathered group health
plans and health insurance issuers offering
non-grandfathered coverage in the group
and individual markets.
If an initial claim submitted is a clean
claim, the timeframes for making the rel-
evant determinations would generally be
aligned under these interim final rules and
the ERISA claims procedure regulation.
However, if a claim is submitted without
sufficient information to make a benefit
determination, under the ERISA claims
procedure regulation, the plan would only
have 15 days to make a determination
once the claim is resubmitted with the
additional information. Yet, under the No
Surprises Act and these interim final rules,
the plan would have up to 30 calendar
days to send a notice of denial of payment
or an initial payment to the out-of-net-
work provider from the time the claim is
resubmitted with additional information.
Consistent with the requirement that plans
and issuers provide an initial payment or
notice of denial of payment within 30 cal-
endar days of a provider or facility sub-
mitting a clean claim, the Departments
clarify that while the ERISA claims pro-
cedure regulation would require plans to
make a benefit determination within 15
days of a claim being resubmitted with
additional information, plans and issuers
have 30 calendar days (which is an addi-
tional 15 days) to make an initial payment
to an nonparticipating provider or facility,
or send a separate notice of denial of pay-
ment.
The Departments note that there is also
a significant distinction between an ABD,
which may be disputed through a plan’s
or issuer’s claims and appeals process,
and a denial of payment or an initial pay-
ment that is less than the billed amount
under these interim final rules, which may
be disputed through the open negotia-
tion process or through the IDR process.
In general, when adjudication of a claim
results in a participant, beneficiary, or en-
rollee being personally liable for payment
to a provider or facility, this determina-
tion may be an ABD that can be disput-
ed through a plan’s or issuer’s claims and
appeals process. Conversely, when: (1)
the adjudication of a claim results in a de-
cision that does not affect the amount the
participant, beneficiary, or enrollee owes;
(2) the dispute only involves payment
amounts due from the plan to the provid-
er; and (3) the provider has no recourse
against the participant, beneficiary, or en-
rollee, the decision is not an ABD and the
payment dispute may be resolved through
the open negotiation or the IDR process.
This clarification is consistent with previ-
ous guidance included in FAQs related to
the ERISA claims procedure regulation,
which have explained that with respect to
in-network benefits, the regulation does
not apply to requests by health care pro-
viders for payments due to the provider,
rather than due to the claimant, where
the provider has no recourse against the
claimant for amounts, in whole or in part,
not paid by the plan.
67
The Departments
acknowledge that there may be instances
where a participant, beneficiary, or enroll-
ee appeals an ABD (such as, a determina-
tion of cost-sharing amounts) through the
claims and appeals process concurrently
with a provider’s challenge to a payment
amount through the IDR process.
4. Surprise Billing Complaints Regarding
Group Health Plans and Health
Insurance Issuers
Section 9816(a)(2)(B)(iv) of the Code,
section 716(a)(2)(B)(iv) of ERISA, and
section 2799A-1(a)(2)(B)(iv) of the PHS
Act direct the Departments to establish
a process to receive complaints regard-
ing violations of the application of QPA
requirements by group health plans and
health insurance issuers offering group
or individual health coverage. The De-
partments are of the view that, in order
to effectively enforce the No Surprises
Act balance billing protections, the com-
plaints process should extend to all of the
consumer protection and balance billing
requirements as described in these inter-
im final rules that apply to group health
plans and health insurance issuers offer-
67
See Benefit Claims Procedure Regulation FAQs, Q A-8, available at https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/faqs/benefit-claims-procedure-regulation;
see also Q C-12 (clarifying that failure to make payment in whole or in part due to the imposition of cost-sharing requirements is an ABD).

Bulletin No. 2021–30 59 July 26, 2021
ing group or individual health coverage.
As such, these interim final rules establish
a process by which the Departments will
receive complaints regarding violations
by plans and issuers of the requirements
under sections 9816 and 9817 of the Code,
sections 716 and 717 of ERISA, and sec-
tions 2799A-1 and 2799A-2 of the PHS
Act. The Departments seek comment on
whether the complaints process should be
restricted to the QPA or extended as de-
scribed in these interim final rules.
The No Surprises Act also adds section
2799B-4(b)(3) of the PHS Act, which di-
rects HHS to establish a process to receive
consumer complaints regarding violations
by health care providers, facilities, and
providers of air ambulance services re-
garding balance billing requirements un-
der sections 2799B-1, 2799B-2, 2799B-3,
and 2799B-5 of the PHS Act and to re-
spond to such complaints within 60 days.
As such, HHS is issuing HHS-only interim
final rules to establish a process by which
HHS will receive complaints regarding
violations of these requirements by health
care providers, facilities, and providers of
air ambulance services.
For purposes of the complaint pro-
cesses for plans and issuers, providers,
facilities, and providers of air ambulance
services, these interim final rules define a
complaint as a written or oral communi-
cation that indicates there has been a po-
tential violation by a plan or issuer of sec-
tions 9816 or 9817 of the Code, sections
716 or 717 of ERISA, or sections 2799A-
1, 2799A-2 of the PHS Act, or a potential
violation by a provider, facility, or provid-
er of air ambulance services of sections
2799B-1, 2799B-2, 2799B-3 and 2799B-5
of the PHS Act, whether or not a violation
actually occurred. A complainant means
any individual, or their authorized repre-
sentative, who files a complaint as defined
in these interim final rules.
The Departments seek to minimize the
burden of filing a complaint and seek to
require only the information necessary
to process the complaint and conduct an
investigation if deemed necessary. There-
fore, these interim final rules specify that
the Departments will consider a complaint
to be filed on the date on which the Depart-
ments receive an oral or written statement
with information about the complaint
sufficient to identify the parties involved
(including the plan sponsor, if the com-
plaint involves a group health plan), and
the action or inaction that is the subject of
the complaint. The information may also
include the timing of the alleged violation,
and the state where the alleged violation
occurred. The Departments seek comment
on the information needed to file a com-
plaint, and the definitions in this section.
The Departments have considered
whether a complaint should be filed with-
in a defined amount of time of the alleged
violation. The Departments understand
that timely action is necessary to inves-
tigate and adjudicate billing matters and
therefore considered whether complain-
ants should be required to file a complaint
regarding an alleged violation of the re-
quirements in these interim final rules
by a plan, issuer, health care provider or
provider of air ambulance services within
90 or 180 calendar days after learning of
the alleged violation. Without a time re-
quirement for filing a complaint, the De-
partments may be restricted in directing
the complainant to other state or federal
resolution processes with timing require-
ments such as the internal and external
claims review process as described in
section 2719 of the PHS Act, or an appro-
priate IDR process as defined in sections
9816 and 9817 of the Code, sections 716
and 717 of ERISA, and sections 2799A-
1 and 2799A-2 of the PHS Act. Howev-
er, the Departments are of the view that
every complaint should be processed and
investigated as appropriate to ensure that
any necessary enforcement action can be
taken. Therefore, these interim final rules
do not include a time period upon which a
complaint must be filed. The Departments
seek comment on whether a complainant
should be required to file a complaint
within a given time period and if so with-
in what time period a complaint should be
filed for the purpose of this section.
Section 2799B-4 of the PHS Act directs
HHS to respond to complaints regarding
violations of balance billing protections
by health care providers, facilities, and
providers of air ambulance services with
-
in 60 days of receipt. The Departments are
of the view that the timing for responding
to complaints regarding plans and issuers
should be the same as that for providers to
ensure timely resolution. Therefore, upon
receiving the information necessary to file
a complaint regarding a plan or issuer, the
Departments will respond to complainants
under section 9816(a)(2)(B)(iv) of the
Code, section 716(a)(2)(B)(iv) of ERISA,
and section 2799A-1(a)(2)(B)(iv) of the
PHS Act no later than 60 business days
after the complaint is received. Similarly,
HHS will respond to a processed com-
plaint regarding a health care provider,
facility, or provider of air ambulance ser-
vices under section 2799B-4 of the PHS
Act no later than 60 business days after
the complaint is received.
The response will be by oral or writ-
ten means, and will acknowledge receipt
of the complaint, notify the complainant
of their rights and obligations under the
complaints process, and describe the next
steps of the complaint resolution process.
The Departments may also request any
additional information needed to process
the complaint. The requested information
may include an explanation of benefits,
processed claims, information about the
health care provider, facility, or air ambu-
lance service involved; information about
the plan or issuer covering the individual;
information to support a determination re-
garding whether the service was an emer-
gency service or non-emergency service;
the summary plan description, policy,
certificate, contract of insurance, member-
ship booklet, outline of coverage or other
evidence of coverage the plan or issuer
provides to their participant, beneficiary,
or enrollee; documents regarding asserted
facts in the complaint that are in the pos-
session of or otherwise attainable by the
complainant; or any other information the
Departments may need to make a determi-
nation of facts for an investigation.
HHS may also request additional infor-
mation to process a complaint under sec-
tion 2799B-4 of the PHS Act regarding a
health care provider, facility, or provider
of air ambulance services. This informa-
tion may include, but is not limited to,
the bills or network status of a health care
provider, health care facility, or provider
of air ambulance services; information
regarding the health care plan or health
insurance coverage of a participant, ben-
eficiary or enrollee; information to sup-
port a determination regarding whether
the service was an emergency service or
non-emergency service; documents that
support the asserted facts in the complaint

July 26, 2021 60 Bulletin No. 2021–30
in the possession of, or otherwise attain-
able by the complainant; or any other
information HHS needs to make a deter-
mination of facts for an investigation. The
Departments seek comment on additional
information that may be required to pro-
cess a complaint.
The response may be provided directly
upon receipt of the complaint, or it may be
provided afterwards, though no later than
60 business days after the complaint is
received. The next steps of the complaint
resolution process may include referring
the complainant to another appropriate
state or federal resolution process, refer-
ring a complainant to the state or feder-
al regulatory authority with enforcement
jurisdiction, or initiating an investigation
for enforcement action. The Departments
will make reasonable efforts consistent
with agency practices to notify the com-
plainant of the outcome of such investiga-
tions or enforcement actions, including an
explanation of the findings, resolution, or
any corrective action taken. The Depart-
ments will also make reasonable efforts
to notify the complainant if the complaint
is transferred to another state or Federal
regulatory authority. The Departments
seek comment on whether a complainant
should receive the notification of the out-
come of the complaint within a given time
period and if so within what time period a
complainant should receive the notice for
the purpose of this section.
The Departments intend to provide
the public with a seamless experience for
filing complaints by creating one system
to intake all complaints on behalf of all
complainants under section 9816(a)(2)(B)
(iv) of the Code, section 716(a)(2)(B)(iv)
of ERISA, and sections 2799A-1(a)(2)(B)
(iv) and 2799B-4 of the PHS Act. The De-
partments understand that a complainant
may not know which Department has en-
forcement jurisdiction; therefore, the De-
partments intend to provide one system
that will direct complaints to the appropri-
ate Department for processing, investiga-
tion, and enforcement action as necessary.
The Departments will release guidance on
where the public can file complaints and
welcome comments on the operations,
protections, user experience, or other fac-
ets of this complaint system. The Depart-
ments also seek comment on ways to en-
sure consumers are aware and know how
to use this system.
The Departments seek to uphold Exec-
utive Order 13985 and all civil rights pro-
tections regarding non-discrimination and
accessibility, as noted in prior sections.
The Departments will make all reasonable
efforts to implement a robust complaint
process, including but not limited to, ac-
knowledgement of receipt of a complaint,
explanations of rights and information
requested, explanations of findings, and
referrals to other authorities. The Depart-
ments will ensure that the complaints pro-
cess is accessible to all individuals, that
communication and language needs are
met, and that all individuals are able to
understand the options available to them
and information required of them. The
Departments seek comment from individ-
uals in underserved and rural communi-
ties, minority communities, and persons
otherwise adversely affected by persistent
poverty or inequality on specific barriers
to the complaint process and solutions to
address these barriers and ensure equita-
ble access to all aspects of the complaint
processes.
C. Choice of Health Care Professionals
In the Patient Protections Final Rule,
the Departments finalized regulations ad-
dressing the provisions in section 2719A
of the PHS Act, regarding patient pro-
tections related to choice of health care
professional and emergency services.
68

As explained earlier, the No Surprises Act
amended section 2719A of the PHS Act
to sunset when the new emergency ser-
vices protections under the No Surprises
Act take effect. The provisions of section
2719A of the PHS Act will no longer ap-
ply with respect to plan years beginning
on or after January 1, 2022.
69
The No
Surprises Act re-codified the patient pro-
tections related to choice of health care
professional in newly added section 9822
of the Code, section 722 of ERISA, and
section 2799A-7 of the PHS Act.
To reflect these statutory amendments,
these interim final rules add a sunset
clause to the current patient protection
provisions codified in the Patient Protec-
tions Final Rule, and re-codify the provi-
sions related to choice of health care pro-
fessional without substantive change at 26
CFR 54.9822-1T, 29 CFR 2590.722, and
45 CFR 149.310. These interim final rules
make minor technical edits to the original
provisions for clarity.
The Departments note that, although
the substantive requirements of these
regulations have not changed, the No
Surprises Act extends the applicability
of the patient protections for choice of
health care professionals to grandfathered
health plans. The patient protections un-
der section 2719A of the PHS Act apply
to only non-grandfathered group health
plans and health insurance issuers offer-
ing non-grandfathered group or individual
health insurance coverage. In contrast, the
patient protections under the No Surpris-
es Act apply generally to all group health
plans and group and individual health
insurance coverage, including grandfa-
thered health plans.
70
Therefore, the re-
quirements regarding patient protections
for choice of health care professional
under these interim final rules will new-
ly apply to grandfathered health plans for
plan years beginning on or after January
1, 2022. Until the requirements under sec-
tion 9822 of the Code, section 722 of ER-
ISA, and section 2799A-7 of the PHS Act
and these interim final rules become ap-
plicable, non-grandfathered group health
plans and health insurance issuers offer-
ing non-grandfathered group or individual
health insurance coverage must continue
to comply with the applicable require-
ments under section 2719A of the PHS
Act and its implementing regulations.
68
80 FR 72191 (November 18, 2015).
69
Section 2719A(e) of the PHS Act states, “The provisions of this section shall not apply with respect to a group health plan, health insurance issuers, or group or individual health insurance
coverage with respect to plan years beginning on or on January 1, 2022.” The Departments interpret subsection (e) to sunset section 2719A for plan years beginning on or after January 1, 2022.
70
Section 2719A was added to the PHS Act by the Affordable Care Act. Section 1251 of the Affordable Care Act provides that certain requirements, including those in section 2719A of the
PHS Act, do not apply to grandfathered health plans. The No Surprises Act does not include a comparable exception for grandfathered health plans. Furthermore, section 103(d)(2) of the
No Surprises Act amends section 1251(a) of the Affordable Care Act to clarify that the new and recodified patient protections provisions, including those related choice of choice of health
care professional, apply to grandfathered health plans.

Bulletin No. 2021–30 61 July 26, 2021
D. Applicability
These interim final rules generally ap-
ply to group health plans and health insur-
ance issuers offering group or individual
health insurance coverage with respect to
plan years (in the individual market, pol-
icy years) beginning on or after January
1, 2022. The term “group health plan” in-
cludes both insured and self-insured group
health plans. Group health plans include
private employment-based group health
plans subject to ERISA, non-federal gov-
ernmental plans (such as plans sponsored
by states and local governments) subject
to the PHS Act, and church plans subject
to the Code. Individual health insurance
coverage includes coverage offered in the
individual market, through or outside of
an Exchange, and includes student health
insurance coverage as defined at 45 CFR
147.145. In addition, as discussed further
in section V of the preamble, under the
OPM interim final rules, FEHB carriers
must comply with the Departments’ inter-
im final rules, subject to OPM regulation
and contract provisions.
The No Surprises Act amended sec-
tion 1251(a) of the Affordable Care Act
to specify that sections 2799A-1, 2799A-
2, and 2799A-7 of the PHS Act apply to
grandfathered health plans for plan years
beginning on or after January 1, 2022.
Therefore, these interim final rules ap-
ply to grandfathered health plans (as de-
fined in 26 CFR 54.9815-1251, 29 CFR
2590.715-1251, and 45 CFR 147.140). In
addition, these interim final rules apply to
certain non-grandfathered health insur-
ance coverage in the individual and small
group markets with respect to which CMS
has announced it will not take enforce-
ment action with respect to certain speci-
fied market requirements even though the
coverage is out of compliance with those
requirements (sometimes referred to as
grandmothered or transitional plans).
71
These interim final rules do not apply
to health reimbursement arrangements, or
other account-based plans, as described
in 26 CFR 54.9815-2711(d)(6)(i), 29
CFR 2590.715-2711(d)(6)(i), and 45 CFR
147.126(d)(6)(i), that make reimburse-
ments subject to a maximum fixed dollar
amount for a period, as the benefit design
of such plans makes concepts related to
surprise billing and choice of health care
professionals inapplicable.
By statute, certain plans and coverage
are not subject to these interim final rules.
This includes a plan or coverage consist-
ing solely of excepted benefits,
72
as well
as short-term, limited-duration insurance.
Excepted benefits are described in section
9832 of the Code, section 733 ERISA,
and section 2791 of the PHS Act. Under
section 2791(b)(5) of the PHS Act, short-
term, limited-duration insurance is exclud-
ed from the definition of individual health
insurance coverage and is, therefore, ex-
empt from these interim final rules and the
statutory provisions the regulations imple-
ment. Short-term, limited-duration insur-
ance is defined in regulations at 26 CFR
54.9801–2, 29 CFR 2590.701–2, and 45
CFR 144.103.
These interim final rules do not apply to
retiree-only plans. ERISA section 732(a)
generally provides that part 7 of ERISA—
and section 9831(a) of the Code generally
provides that chapter 100 of the Code—
does not apply to plans with less than two
participants who are current employees
(including retiree-only plans, which cover
less than two participants who are current
employees). Title XXVII of the PHS Act,
as amended by the Affordable Care Act,
no longer contains a parallel provision
at section 2721(a) of the PHS Act. How-
ever, as explained in prior rulemaking,
HHS will not enforce the requirements of
title XXVII of the PHS Act with respect
to non-federal governmental retiree-on-
ly plans and encourages states to adopt
a similar approach with respect to health
insurance coverage of retiree-only plans.
73

HHS intends to continue to follow this
same approach, including with respect to
the new market reforms established in the
No Surprises Act.
These interim final rules are generally
applicable to traditional indemnity plans,
meaning plans that do not have networks
of providers or facilities. However, the
Departments recognize that indemnity
plans may have unique benefit designs
that cause certain provisions of these in-
terim final rules not to be relevant. For
example, the requirements regarding bal-
ance billing for non-emergency services
provided by nonparticipating providers at
certain participating facilities would nev-
er be triggered if a plan does not have a
network of participating facilities. On the
other hand, such requirements could be
triggered by plans that have participating
facilities but do not have participating
providers, either for certain provider types
or at all. In addition, requirements that are
unrelated to whether a plan or coverage
has a network of participating providers
or facilities, such as the requirement that
emergency services be covered without
the need for any prior authorization deter-
mination, even if the services are provided
on an out-of-network basis, are applicable
to traditional indemnity plans.
The Departments seek comment as to
whether there are any other plans with
unique benefit designs that should be ex-
empt from all or some of these interim fi-
nal rules.
IV. Overview of Interim Final Rules
– Department of Health and Human
Services
A. Preventing Surprise Medical Bills
1. In General
In addition to the new provisions appli-
cable to group health plans and health in-
surance issuers, discussed in section III of
this preamble, the No Surprises Act adds
a new Part E of title XXVII of the PHS
Act establishing requirements applicable
to health care providers, facilities, and
providers of air ambulance services. Spe-
cifically, the No Surprises Act adds new
sections 2799B-1, 2799B-2, 2799B-3, and
2799B-5 of the PHS Act, which protect
participants, beneficiaries, and enrollees
in group health plans and group and in-
dividual health insurance coverage from
balance bills by prohibiting nonpartici-
71
CMS Insurance Standards Bulletin Series—INFORMATION—Extension of Limited Non-Enforcement Policy through 2022 (January 19, 2021), available at https://www.cms.gov/files/
document/extension-limited-non-enforcement-policy-through-calendar-year
-2022.pdf.
72
Section 9831 of the Code, section 9832 of ERISA, and section 2722 of the PHS Act.
73
75 FR 34537, 34540 (June 17, 2010).

July 26, 2021 62 Bulletin No. 2021–30
pating providers, facilities, and providers
of air ambulance services from billing or
holding liable individuals for an amount
that exceeds in-network cost sharing de-
termined in accordance with the balance
billing provisions in circumstances where
the balance billing provisions apply. This
includes: (1) when emergency services
are provided by a nonparticipating provid-
er or nonparticipating emergency facility;
(2) when non-emergency services are pro-
vided by a nonparticipating provider at a
participating health care facility; and (3)
when air ambulance services are furnished
by a nonparticipating provider of air am-
bulance services.
Under 5 U.S.C. 8902(p), as added by
the No Surprises Act, sections 2799B-1,
2799B-2, 2799B-3, and 2799B-5 of the
PHS Act apply to a health care provider,
a facility, and a provider of air ambulance
services with respect to a covered individ-
ual in a health benefits plan offered by a
FEHB carrier in the same manner as they
apply with respect to a participant, benefi-
ciary, or enrollee in a group health plan or
group or individual health insurance cov-
erage offered by a health insurance issuer.
These interim final rules apply to a health
care provider, a facility, and a provider of
air ambulance services in this same man-
ner.
74
The applicability of these interim
final rules with respect to FEHB carriers
is discussed in more detail in section V of
this preamble.
With respect to post-stabilization
services provided by nonparticipating
emergency facilities or nonparticipating
providers, and non-emergency services
furnished by nonparticipating providers
at participating health care facilities (in-
cluding off-site nonparticipating provid-
ers who furnish items or services that an
individual receives as part of a visit to
such health care facility), the prohibitions
on balance billing do not apply if certain
notice is provided to the participant, ben-
eficiary, or enrollee, and the individual
acknowledges receipt of the information
in the notice and consents to waive the
balance billing protections with respect
to the nonparticipating emergency facility
or nonparticipating providers to which the
notice and consent apply. Under the No
Surprises Act and these interim final rules,
with respect to certain types of non-emer-
gency services furnished by nonparticipat-
ing providers in a participating health care
facility, the notice and consent provisions
do not apply, meaning the prohibitions on
balance billing apply without exception.
Given that the statute and these inter-
im final rules authorize HHS to impose
civil money penalties on facilities and
providers that violate these requirements,
nonparticipating providers should take
steps necessary to ensure compliance by,
among other actions, determining whether
a given item or service is being furnished
under circumstances that would trigger
the surprise billing protections. For exam-
ple, nonparticipating providers furnishing
non-emergency services at a facility must
determine whether the facility is a partic-
ipating health care facility to determine
whether balance billing protections apply.
Relatedly, nonparticipating providers and
nonparticipating emergency facilities will
need to timely communicate with plans
and issuers regarding when the limita-
tions on cost sharing in these interim fi-
nal rules do not apply because the notice
and consent criteria (described more ful-
ly elsewhere in this preamble) have been
satisfied. These HHS interim final rules
address the steps providers and facilities
must take to ensure the balance billing
and cost-sharing protections are applied
appropriately and consistently with the
statute.
HHS also recognizes that compliance
with these requirements may require
nonparticipating providers and nonpar-
ticipating emergency facilities to refrain
from billing an individual directly, even in
cases that are not subject to these require-
ments. For example, the protections appli-
cable to non-emergency services provided
by a nonparticipating provider in a partici-
pating health care facility apply only with
respect to services for which benefits are
provided or covered by the plan or cover-
age. A nonparticipating provider may not
have the information necessary to deter-
mine whether the services are a covered
benefit under the plan or coverage. As a
result, the nonparticipating provider may
need to bill the plan or issuer directly for
the services in order to determine whether
the protections apply. Otherwise, the pro-
vider risks violating the statute and these
interim final rules by billing individuals.
HHS understands that nonparticipating
providers and facilities frequently bill in-
dividuals directly for out-of-network ser-
vices, leaving the individual to submit the
bill to the plan or coverage. HHS seeks
comment on the impact this change will
have on nonparticipating providers and fa-
cilities, and on plans and issuers receiving
bills from nonparticipating providers and
facilities.
In instances where a provider or facility
does balance bill a participant, beneficiary,
or enrollee for services in violation of the
statute and these interim final rules, the
Secretary of HHS (the Secretary) may im-
pose civil money penalties in states where
HHS is directly enforcing the balance bill-
ing provisions with respect to health care
providers, facilities, and providers of air
ambulance services. However, the statute
provides that the Secretary shall waive
the penalties with respect to a health care
provider, facility, or provider of air ambu-
lance services who does not knowingly
violate, and should not have reasonably
known it violated, the provisions, with
respect to a participant, beneficiary, or en-
rollee, if such provider or facility, within
30 days of the violation, withdraws the
bill that was in violation of such provision
and reimburses the health plan or individ-
ual, as applicable, in an amount equal to
the difference between the amount billed
and the amount allowed to be billed under
the provision, plus interest, at an interest
rate determined by the Secretary. HHS
intends to address enforcement of the re-
quirements of the No Surprises Act appli-
cable to health care providers, facilities,
and providers of air ambulance services in
future rulemaking.
2. Notice and Consent Exception to
Prohibition on Balance Billing
Under the No Surprises Act and these
interim final rules, the protections that
limit cost sharing and prohibit balance
billing do not apply to certain non-emer-
gency services or to certain post-stabili-
zation services provided in the context of
emergency care, if the nonparticipating
provider or nonparticipating emergency
74
For purposes of these interim final rules, references to participants, beneficiaries, and enrollees should be construed to include covered individuals in a FEHB plan.

Bulletin No. 2021–30 63 July 26, 2021
facility furnishing those items or services
provides the participant, beneficiary, or
enrollee, with notice, the individual ac-
knowledges receipt of the information in
the notice, and the individual consents to
waive the balance billing protections with
respect to the nonparticipating emergen-
cy facility or nonparticipating providers
named in the notice.
Non-emergency services furnished
by a nonparticipating provider at a par-
ticipating health care facility are exempt
from cost sharing protections and balance
billing protections when the notice and
consent requirements are met. In contrast,
the notice and consent exception does not
apply to emergency services, other than
post-stabilization services, under certain
circumstances, or air ambulance services.
A nonparticipating provider or nonpar-
ticipating emergency facility may obtain
notice and consent from the individual in
order to balance bill for post-stabilization
services only in the case where a partici-
pant, beneficiary, or enrollee has received
emergency services and that individual’s
condition has stabilized, and then only if
certain additional conditions are met. Such
conditions are described later in this pre-
amble and codified at 45 CFR 149.410(b).
If an individual receives a notice, but
does not provide (or revokes) consent to
waive their balance billing protections,
those protections remain in place. A pro-
vider or facility may, subject to other state
or federal laws, refuse to treat the individ-
ual if the individual does not consent.
75

However, the cost-sharing and balance
billing protections applicable to plans, is-
suers, providers and facilities would apply
with respect to any items or services fur-
nished by the provider or facility subse-
quent to the provision of the notice, and
absent consent.
The requirements related to the notice
and consent exception are set forth in sec-
tion 2799B-2 of the PHS Act, as added by
the No Surprises Act, and implemented
at 45 CFR 149.410 and 45 CFR 149.420
of the HHS interim final rules, describing
the requirements for post-stabilization
services and non-emergency services, re-
spectively. These interim final rules out-
line the requirements related to the con-
tent, method, and timing of the notice and
consent communications; requirements
related to language access; exceptions to
the applicability of the notice and consent
process; requirements for the retention
of notice and consent documents; and
requirements to notify the plan or issuer
regarding consent provided by the partici-
pant, beneficiary, or enrollee.
i. Standards for Notice
The No Surprises Act and these in-
terim final rules allow an individual to
waive balance billing protections only
after receiving a written notice that in-
cludes detailed information designed to
ensure that individuals knowingly accept
out-of-pocket charges (including charges
associated with balance bills) for care re-
ceived from a nonparticipating provider
or nonparticipating emergency facility.
In HHS’s view, the option to consent to
waive balance billing protections may be
valuable to individuals in certain instanc-
es where they knowingly and purposeful-
ly seek care from a nonparticipating pro-
vider. For example, an individual with a
complex health condition may want to be
treated by a specialist who is not in their
plan’s network. If that specialist will not
treat the individual unless the specialist
can bill the individual directly for the care
(and balance bill the individual), that in-
dividual may want to waive the balance
billing protections. HHS seeks comment
on striking the appropriate balance be-
tween allowing a specialist to refuse to
treat an individual unless the specialist
can balance bill the individual, while
ensuring that the individual is not being
pressured into waiving the balance billing
protections. In HHS’s view, it is import-
ant that these consumer protections do
not present a barrier to obtaining out-of-
network care, when an individual know-
ingly seeks out such care. However, it is
equally important that individuals are not
unknowingly subject to balance billing.
Therefore, the No Surprises Act and these
interim final rules allow an individual to
waive balance billing protections in lim-
ited circumstances only, and only if the
nonparticipating providers or nonpartici-
pating emergency facility have provided
the participant, beneficiary, or enrollee
with appropriate notice explaining the
applicable consumer protections and the
implications of providing consent.
Section 2799B-2(d)(1)(A) of the PHS
Act requires providers and facilities to use
a written notice specified by HHS in guid-
ance. Therefore, these interim final rules
require providers and facilities to provide
the notice using the standard notice docu-
ment provided by HHS in guidance. The
standard notice document will contain
the elements required by the statute in a
manner that is intended to be easy to read
and comprehend. The notice must be pro-
vided in accordance with guidance issued
by HHS. HHS is of the view that requir-
ing use of the standard notice will help to
ensure that the notice includes the content
that is required to be included in the no-
tice under the No Surprises Act and these
interim final rules. Providers and facilities
will need to tailor the document in each
case to include information specific to the
individual (for example, by identifying
the provider or facility, as applicable, and
adding the good faith estimated amount).
HHS is concerned that individuals may
be less likely to review the notice careful-
ly if it is embedded within other informa-
tion or provided with additional consent
forms. Therefore, these interim final rules
require that the notice be provided with
the consent document, and together these
documents be given physically separate
from, and not attached to or incorporated
into any other documents. Providers and
facilities must provide the notice within
the required timeframe. The notice must
be written and provided on paper, or, as
practicable, electronically, as selected by
the individual. The notice must meet ap-
plicable language access requirements, as
described in this HHS interim final rule. A
participating health care facility may pro-
vide the notice on behalf of the nonpartic-
ipating provider.
76
75
HHS is aware that some providers and facilities charge fees for cancelled appointments. HHS is of the view that an individual cannot provide consent freely if a provider or facility will
require the individual to pay a fee if the appointment is cancelled because the individual refuses or revokes consent.
76
However, if a facility that has agreed to provide the notice on behalf of the nonparticipating provider fails to provide the notice and obtain consent, or provides notice and obtains consent
in a manner that does not satisfy the regulatory requirements in these interim final rules, the notice and consent criteria would not be considered to be met. Therefore, the cost-sharing and
balance billing protections would continue to apply to the items and services furnished by the nonparticipating provider.

July 26, 2021 64 Bulletin No. 2021–30
Authorized Representatives
The notice may be provided to the indi-
vidual’s authorized representative instead
of the individual, and consent may be
provided by the authorized representative
on behalf of the individual. These interim
final rules specify that for purposes of 45
CFR 149.410 and 149.420, an authorized
representative is an individual authorized
under state law to provide consent on be-
half of the participant, beneficiary, or en-
rollee, provided that the individual is not
a provider affiliated with the facility or an
employee of the facility, unless such pro-
vider or employee is a family member of
the participant, beneficiary, or enrollee.
Although treating providers may be au-
thorized under state law to provide con-
sent to treatment, HHS is of the view that
providers should generally not be permit-
ted to receive notice or provide consent
regarding treatment by a nonparticipating
provider or facility because of the strong
likelihood of an inherent financial or pro-
fessional conflict of interest. These same
concerns extend to employees of the facil-
ity at which the items or services are fur-
nished. HHS is also of the view that these
concerns are not warranted for providers
or facility employees that are family mem-
bers of the individual, because of their
presumed interest in the well-being of the
individual, or providers that are unaffili-
ated with the provider or facility furnish-
ing the care. HHS is of the view that these
limitations provide important consumer
protections to ensure that an individual’s
authorized representative is acting in the
individual’s best interest rather than the
interests of the provider or facility. HHS
seeks comment on whether and how the
term “family member” should be defined.
HHS is sensitive to concerns that some
individuals may not have a familial rela-
tion formally recognized under applicable
state law, or other documented legal part-
nership with individuals whom they con-
sider family. Therefore, when interpreting
this requirement, HHS will construe the
term “family member” broadly to include
such individuals prior to the issuance of
additional guidance.
Timing of Notice
In order to ensure that a participant,
beneficiary, enrollee, or authorized repre-
sentative has an opportunity to properly
review and consent to a notice to receive
items or services furnished by a nonpar-
ticipating provider or nonparticipating
emergency facility and waive balance
billing protections, the provider or fa-
cility must provide such a notice in the
timeframe specified in the statute and this
interim final rule. As specified in section
2799B-2(d) of the PHS Act, if an indi-
vidual schedules an appointment for such
items or services at least 72 hours before
the date of the appointment, the provider
or facility must provide the notice to the
individual, or their authorized representa-
tive, no later than 72 hours before the date
of the appointment; and if an individual
schedules an appointment for such items
or services within 72 hours of the date of
the appointment, the provider or facility
must provide the notice to the individual,
or their authorized representative, on the
day that the appointment is made. In addi-
tion, these interim final rules specify that
in the situation where an individual is pro-
vided the notice on the same day that the
items or services are furnished, providers
and facilities are required to provide the
notice no later than 3 hours prior to fur-
nishing items or services to which the no-
tice and consent requirements apply.
This 3-hour requirement is intended
to address situations where an individual
might be asked to provide consent im-
mediately before a provider furnishes the
item or service, which may prevent their
consent from being truly voluntary. Stake-
holders have recommended that notice and
consent procedures be unavailable when
an individual visits a participating facility
and receives care from a nonparticipating
provider from whom the individual did not
seek out services (for example, if a spe-
cialist furnishes an unexpected consulta-
tion on the recommendation of the attend-
ing physician). Stakeholders expressed
concern that such providers might provide
the notice at the time they appear for the
consultation, and the individual might feel
compelled to consent to receive care. HHS
is of the view that the requirement that the
notice be provided no later than 3 hours
prior to furnishing items or services helps
to ensure individuals can voluntarily pro-
vide informed consent, while not remov-
ing the informed consent option entirely
in instances where the appointment is
made the same day as the date the services
are scheduled. HHS seeks comment on
whether such a time limit is a reasonable
approach, as well as whether the 3 hours’
time requirement should be shorter or lon-
ger, in order to best ensure that consent is
freely given while also facilitating timely
access to care. For example, HHS is in-
terested in understanding if there are sit-
uations where this time requirement may
unduly delay access to urgently necessary
care, including in the post-stabilization
care context.
77
Alternatively, HHS is inter-
ested in understanding if more time may
be necessary for an individual to read,
understand, and consider their options,
including considering whether they can
resolve prior authorization or other care
management limitations, before voluntari-
ly consenting to treatment. HHS is also
interested in whether these timing require-
ments present barriers to providers’ and
facilities’ ability to comply with the re-
quirement that the notice and consent doc-
uments be provided to the individual in
paper or, as practicable, electronic form,
as selected by the individual.
Content of Notice
As stated previously, a provider or
facility must provide the written notice
using the form specified by HHS in guid-
ance, customized to include the informa-
tion specified in 45 CFR 149.420(d) (and
45 CFR 149.410(b)(2), for post-stabiliza-
tion services, as applicable).
The notice must state that the health
care provider furnishing the items or
services is a nonparticipating provider,
or that the health care facility furnishing
the items or services is a nonparticipating
emergency facility, as applicable, with re-
spect to the health plan or coverage. The
provider or facility will need to customize
77
A provider or facility is never required to provide notice and seek consent from a participant, beneficiary, or enrollee. To the extent a provider is concerned that the 3 hours’ prior requirement
will result in a delay in care that is detrimental to the individual, the provider or facility can furnish the items or services, subject to the balance billing protections, rather than providing
notice and seeking consent to waive the protections.

Bulletin No. 2021–30 65 July 26, 2021
the form to identify the provider or facility
by name. This will help ensure individuals
understand for which specific providers or
facilities they would be waiving their bal-
ance billing protections.
The notice must include the good faith
estimated amount that such nonparticipat-
ing provider or nonparticipating emergen-
cy facility may charge the individual for
the items and services involved, including
any item or service that the nonparticipat-
ing provider reasonably expects to pro-
vide in conjunction with such items and
services. In the case of a nonparticipating
emergency facility, the notice must include
the good faith estimate for such items or
services that would reasonably be expect-
ed to be provided by the nonparticipating
emergency facility or by nonparticipating
providers as part of the visit at such facil-
ity. HHS is including the requirement re-
garding disclosing items and services rea-
sonably expected to be provided in order
to ensure that the participant, beneficiary,
or enrollee has an accurate understanding
of the cost of care. As discussed in section
IV.A.2.iv of this preamble, individuals
cannot waive the balance billing protec-
tions for items or services furnished as a
result of unforeseen, urgent medical needs
that arise at the time an item or service is
furnished for which the nonparticipating
provider or nonparticipating facility satis-
fied the notice and consent criteria.
Nonparticipating providers who are
providing this notice are required to pro-
vide a good faith estimate for only the
items or services that they would be fur-
nishing and are not required to provide a
good faith estimate for items or services
furnished by other providers at the facili-
ty. However, if a nonparticipating provid-
er has not satisfied the notice and consent
criteria, balance billing and cost-sharing
protections will apply to the individual
with respect to items and services fur-
nished by that nonparticipating provider,
even if a different nonparticipating pro-
vider has satisfied the notice and consent
criteria with respect to the same visit.
If they choose, multiple nonparticipat-
ing providers that are furnishing related
items and services for an individual may
provide a single notice to the individual,
provided that: (1) each provider’s name is
specifically listed on the notice document;
(2) each provider includes in the notice
a good faith estimate for the items and
services they are furnishing, and the no-
tice specifies which provider is providing
which items and services within the good
faith estimate; and (3) the individual has
the option to consent to waive balance
billing protections with respect to each
provider separately.
HHS is of the view that an individual
cannot consent to waive balance billing
and cost-sharing protections unless they
have been informed of their potential li-
ability with respect to both the facility
and provider charges related to receiving
post-stabilization services at a nonpar-
ticipating emergency facility. Therefore,
nonparticipating emergency facilities
must include in the written notice the
good faith estimated amount that the par-
ticipant, beneficiary, or enrollee may be
charged for items or services furnished by
the nonparticipating emergency facility or
by nonparticipating providers with respect
to the visit at such facility (including any
item or service that is reasonably expect-
ed to be furnished by the nonparticipating
emergency facility or nonparticipating
providers in conjunction with such items
or services). HHS seeks comment regard-
ing potential challenges nonparticipating
emergency facilities may have in coor-
dinating the development of a good faith
estimate on behalf of both the facility and
providers. To the extent that the nonpartic-
ipating facility omits from the good faith
estimate information about items and ser-
vices provided by a nonparticipating pro-
vider, the notice and consent criteria will
be not be considered met for items and
services furnished by that provider, and
the requirements in 45 CFR 149.410(a)
(and the corresponding requirements on
plans and issuers) would apply.
HHS is aware that nonparticipating
providers and nonparticipating emergency
facilities generally are unable to calculate
what an individual’s final out-of-pocket
costs (inclusive of balance bills) will be
for items and services partially or wholly
covered by the individual’s plan or cov-
erage. Therefore, the good faith estimat-
ed amount should reflect the amount the
provider or facility expects to charge for
furnishing such items or services, even if
the provider or facility intends to bill the
plan or coverage directly. In calculating
this good faith estimated amount, the pro-
vider or facility is expected to apply the
same process and considerations used to
calculate the good faith estimate that is
required under section 2799B-6(2) of the
PHS Act. HHS seeks comment regarding
the method by which this good faith esti-
mated amount should be calculated, and
anticipates addressing this requirement in
future rulemaking. The notice must make
clear that the provision of the good faith
estimate in the notice, or the individual’s
consent to be treated, does not constitute
a contract with respect to the charges es-
timated for such items and services, or a
contract that binds the participant, ben-
eficiary, or enrollee to be treated by that
provider or facility. HHS seeks comment
regarding whether the provider or the
facility should be required to include in-
formation about what may be covered by
the individual’s plan or coverage and an
estimate of the individual’s out-of-pocket
costs.
The notice must provide information
about whether prior authorization or other
care management limitations may be re-
quired in advance of receiving such items
or services at the facility or from the pro-
vider. HHS recognizes that there may be
challenges for nonparticipating providers
or facilities to identify what prior authori-
zation and other care management limita-
tions may apply with respect to a plan or
coverage in which they do not participate.
Therefore, providers and facilities may
provide general information in order to
satisfy this requirement, but to the extent
possible, HHS encourages them to con-
tact the issuer or plan about any such lim-
itations so that they can include specific
information in the notice. HHS interprets
this statutory provision to require infor-
mation on prior authorization or care man-
agement requirements to extend to care
furnished by both providers and facilities,
in order for participants, beneficiaries, and
enrollees to understand all requirements
associated with their care before they
consent to treatment and balance billing.
Requiring that the notice include specific-
ity regarding prior authorization or care
management requirements could improve
the usefulness of the information to indi-
viduals compared to general information
about what requirements may apply, but
may make providing notices overly bur-
densome for providers and facilities. HHS

July 26, 2021 66 Bulletin No. 2021–30
seeks comment on whether providers and
facilities should instead be required to in-
clude in the notice specific information
about any prior authorization and care
management requirements that apply to
any items and services covered under the
notice. HHS also seeks comment on barri-
ers or other burdens facing nonparticipat-
ing providers or facilities in obtaining this
information from a plan or issuer.
The notice must clearly state that the
individual is not required to consent to re-
ceive such items or services from such non-
participating provider or nonparticipating
emergency facility. The notice must state
that the individual may instead seek care
from an available participating provider or
at a participating emergency facility, with
respect to the plan or coverage, as appli-
cable, and that in such cases, in-network
cost-sharing amounts will apply.
In cases where post-stabilization ser-
vices are being furnished by a nonpartici-
pating provider at a participating emergen-
cy facility, the notice must include a list of
any participating providers at the partici-
pating emergency facility who are able to
furnish the items or services involved. The
notice must inform the individual that they
may be referred, at their option, to such a
participating provider. HHS seeks com-
ment regarding the format and content of
the referral list to be included in the notice,
including any challenges that providers
may have in providing this information,
and any further requirements that should
be applied to providers when furnishing
this information to the individual.
ii. Standards for Consent
In order to meet the notice and consent
requirements of the No Surprises Act and
these interim final rules, the nonpartici-
pating provider, participating health care
facility on behalf of the nonparticipating
provider, or nonparticipating emergency
facility must obtain from the participant,
beneficiary, or enrollee the individual’s
acknowledgment that they consent to be
treated and balance billed by the nonpar-
ticipating emergency facility or nonpar-
ticipating provider under circumstances
where the individual elects to receive
such items or services. The consent must
be provided voluntarily, meaning that the
individual has consented freely, without
undue influence, fraud, or duress. An in-
complete consent document will be treat-
ed as a lack of consent and balance billing
protections will still apply.
As with the notice document, provid-
ers and facilities must use the standard
consent document specified by HHS in
guidance, and the consent document must
be provided in accordance with such guid-
ance. The consent document, specified
in guidance, contains the information (or
fillable fields for the information) required
to be included in the consent form under
these interim final rules, and described
further in this section of the preamble.
Providers and facilities will need to tailor
the document to include information spe-
cific to the individual. In addition, as dis-
cussed previously, these interim final rules
require that the consent be accompanied
by the notice document, and that these
documents be given together at the same
time, physically separate from and not at-
tached to or incorporated into any other
documents. The consent document must
be signed (including by electronic signa-
ture) by the individual, or the individual’s
authorized representative.
The nonparticipating provider, partici-
pating health care facility on behalf of the
nonparticipating provider, or nonpartic-
ipating emergency facility must provide
the individual with a copy of the signed
notice and consent in-person, or through
mail or email, as selected by the individ-
ual.
The notice and consent documents
must meet applicable language access re-
quirements, as described in these interim
final rules. The signed consent document
must acknowledge that the individual has
been provided with the written notice as
described in these interim final rules, in
the form selected by the individual. The
signed consent document must also ac-
knowledge that the individual has been
informed that the payment made by the in-
dividual might not accrue toward meeting
any limitation that the plan or coverage
places on cost sharing, including an expla-
nation that the payment might not apply to
an in-network deductible or out-of-pocket
maximum under the plan or coverage.
The consent document must state that,
by signing the consent document, the in-
dividual agrees to be treated by the non-
participating provider or nonparticipating
emergency facility and understands that
the individual may be balance billed and
subject to cost-sharing requirements that
apply to services furnished by nonpar-
ticipating providers or nonparticipating
emergency facilities. In the case of a non-
participating provider seeking consent,
by signing the consent document, the in-
dividual agrees to waive balance billing
and cost-sharing protections for only the
items or services furnished by the pro-
vider or providers specifically named in
the notice. In HHS’s view, an individual
cannot provide informed consent to waive
balance billing protections with respect
to an unnamed provider, as the individual
would not be on notice that the individual
may be balance billed for items or services
furnished by that provider. In addition, the
individual may choose to consent to waive
balance billing protections with respect to
items or services furnished by none, some,
or all of the nonparticipating providers
listed in the notice.
The signed consent document must in-
clude the date on which the individual re-
ceived the written notice and the date on
which the individual signed such consent to
be furnished the items or services covered
in the notice. In order to ensure that consent
is provided prior to when the item or ser-
vice is received, HHS also requires that the
signed consent document include the time
at which the individual signed the consent.
The signed consent provided by the
individual constitutes the individual’s
consent to the receipt of the information
contained in the notice document, and in-
cludes an acknowledgement that they may
be balance billed for the receipt of the
items or services. The consent does not
constitute a contractual agreement with
regard to any estimated charge or amount
included in the notice or consent docu-
ment, or a contract that binds the partic-
ipant, beneficiary, or enrollee to be treat-
ed by that provider or facility. Consent
obtained by the provider or facility under
this notice and consent process in no way
substitutes for or modifies requirements
for informed medical consent otherwise
required of the provider or facility, under
state law or codes of medical ethics.
The participant, beneficiary, or enrollee
may revoke consent by notifying the pro-
vider or facility in writing prior to the fur-
nishing of the items or services. If an indi-

Bulletin No. 2021–30 67 July 26, 2021
vidual revokes consent, the balance billing
protections apply to applicable items or
services provided after the revocation as if
consent was never provided. HHS is of the
view that the option to revoke consent is
a critical safeguard to ensure that balance
billing protections are waived only when
individuals knowingly, purposefully, and
freely provide informed consent. HHS
seeks comment on whether additional
rulemaking or guidance is needed on how
an individual can revoke consent.
iii. Language Access
A nonparticipating provider or non-
participating emergency facility pro-
viding a participant, beneficiary, or en-
rollee, or such individual’s authorized
representative, with a notice under section
2799B-2(d) of the PHS Act must make
the notice available in any of the 15 most
common languages in the geographic re-
gion in which the applicable facility is
located. HHS is of the view that individ-
uals cannot provide meaningful consent
if they cannot understand the information
provided in the written notice and con-
sent documents. These interim final rules,
therefore, also require that the notice and
consent document be made available in
any of the 15 most common languages in
the geographic region in which the appli-
cable facility is located. Providers and fa-
cilities will need to translate the standard
notice and consent documents specified
by HHS in guidance into the applicable 15
languages.
A provider or facility meets this re-
quirement if it provides the notice and
consent documents in the 15 most com-
mon languages in its state. However, HHS
recognizes that in some cases, particular-
ly in larger states or metropolitan areas,
these 15 languages may not adequately
represent the languages spoken by the
population served by the provider or fa-
cility.
78
Therefore, the provider or facility
may alternatively choose to provide the
notice and consent documents in the 15
most common languages in its geographic
region, which reasonably reflects the geo-
graphic region served by the applicable
facility. For example, a facility that serves
the greater Los Angeles area may choose
to provide the notice and consent docu-
ments in the 15 most common languag-
es within that geographic region, instead
of the 15 most common languages in the
state of California.
HHS considered different standards to
apply in defining such geographic regions,
and is seeking comment regarding the
appropriate standard. HHS’s objective is
to implement a standard that ensures that
the language accessibility requirement is
responsive to the needs of the individuals
served by the provider or facility, while
mitigating inconsistencies in the way that
such geographic regions are determined.
HHS is interested in comments regarding
the use of metropolitan statistical areas
(MSAs),
79
hospital service areas (HSAs),
80

hospital referral regions (HRRs),
81
and
public use microdata areas (PUMAs),
82
ap-
plied based on where the applicable facility
is located, as well as other standards that
may be well-suited for this purpose. HHS
also seeks comment on what language ac-
cess standards would be appropriate in cir-
cumstances where the applicable facility
serves populations in multiple states.
As noted earlier in this section, HHS
is of the view that individuals cannot pro-
vide meaningful consent if they cannot
understand the information provided in
the written notice and consent document.
These interim final rules, therefore, add a
language access requirement to address
circumstances in which the individual
cannot understand any of the 15 languages
in which the notice and consent document
are available. If the individual’s preferred
language is not among the 15 most com-
mon languages in which the documents
are made available by the nonparticipat-
ing provider or nonparticipating emergen-
cy facility, or the individual cannot un-
derstand the language in which the notice
and consent documents are provided, as
self-reported by the individual, the notice
and consent requirements described in
these interim final rules are not met unless
the provider or facility furnishes the indi-
vidual with a qualified interpreter.
The provider or facility should provide
the notice and consent documents, or the
qualified interpretive services, as appli-
cable, in the individual’s self-reported,
preferred language. Individuals should
be asked what language they prefer to
communicate in regarding health care in-
formation, for written or verbal commu-
nication, as applicable. An individual’s
preference might not be the same for writ-
ten and verbal communication, and an in-
dividual’s preference might not correlate
with the individual’s native language.
In interpreting the statutory require-
ments regarding language access in the
notice and consent process, HHS rec-
ognizes communication, language, and
literacy barriers are associated with de-
creased quality of care, poorer health out-
comes, and increased utilization.
83
Alter-
natively, the use of appropriate language
78
See, e.g., “Understanding Communication and Language Needs of Medicare Beneficiaries” (2017), https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Is-
sue-Briefs-Understanding-Communication-and-Language-Needs-of-Medicare-Beneficiaries.pdf (“The
common languages in a given region, city, or town may vary greatly from those spoken
in the state or in the U.S. as a whole.”).
79
https://www.census.gov/programs-surveys/metro-micro/about.html.
80
https://www.dartmouthatlas.org/faq/.
81
https://www.dartmouthatlas.org/faq/.
82
https://www.census.gov/programs-surveys/geography/guidance/geo-areas/pumas.html#:~:text=Public%20Use%20Microdata%20Areas%20(PUMAs)%20are%20non%2Doverlapping%2C,
and%20the%20U.S.%20Virgin%20Islands.
83
Batencourt, J.R., et al., Improving Patient Safety Systems for Patients with Limited English Proficiency: a Guide for Hospitals, Agency for healthcare Research and Quality, Publication No.
12-0041, September 2012; Proctor, K, et al., The Limited English Proficient Population: Describing Medicare, Medicaid, and Dual Beneficiaries, Health Equity Vol. 2.1, 2018; Green, AR,
and Nze, C, Language-Based Inequity in Health Care: Who is the “Poor Historian”?, American Medical Association Journal of Ethics, Vol. 19, Number 3: 263-271, March 2017; Shamsi, H,
et al., Implications of Language Barriers for Healthcare: A Systematic Review, Oman Medical Journal, Vol. 53, No. 2:e122, 2020; de Moissac, D., Bowen, S., Impact of Language Barriers on
Quality of Care and Patient Safety for Official Language Minority Francophones in Canada, Journal of Patient Experience, Vol. 6(1) 24-32, 2019; Napoles, A.N., et al., Inaccurate Language
Interpretation and its Clinical Significance in the Medical Encounters of Spanish-speaking Latinos, Med Care. 2015 November; 53(11): 940–947; Divi, C., et al., Language Proficiency and
Adverse Events in U.S. Hospitals: a Pilot Study, Int’l Journal for Quality in Health Care, vol. 19, no.2; Ali, P.A. and Watson, R., Language Barriers and their Impact of Provision of Care
to Patients with Limited English Proficiency: Nurses Perspective, J. Clin. Nurs., 2018 Mar;27(5-6); Flores G. Language barriers to health care in the United States. N Engl J Med 2006;
355:229-231. Ku L, and Flores G. Pay now or pay later: providing interpreter services in health care. Health Affairs. 2005;24(2): 435-444; Hampers L.C., et al. Language barriers and resource
utilization in a pediatric emergency department. Pediatrics. 1999; 103(6): 1253-1256; Dewalt D.A., et al. Literacy and health outcomes: a systematic review of the literature. J Gen Intern Med.
2004;19(12):1228-1239. doi:10.1111/j.1525-1497.2004.40153.x.

July 26, 2021 68 Bulletin No. 2021–30
services and at appropriate literacy levels
in health care settings is associated with
increased quality of care, improved pa-
tient safety outcomes, and lower utiliza-
tion of costly medical procedures.
84
HHS
is of the view that it is imperative that
health care providers and facilities take
these efforts to provide the required no-
tice and consent information in a manner
understandable to the participant, benefi-
ciary, or enrollee, to help achieve the goal
of the statute and ensure that individuals
are aware their rights and the options
available to them.
Providers and facilities are also re-
quired to comply with other state and
federal laws regarding language access,
to the extent applicable. HHS reminds
health care providers and facilities that
recipients of federal financial assistance
must comply with federal civil rights
laws that prohibit discrimination. These
laws include section 1557 of the Afford-
able Care Act,
85
title VI of the Civil Rights
Act of 1964,
86
section 504 of the Rehabil-
itation Act of 1973,
87
and the Americans
with Disabilities Act of 1990.
88
Section
1557 and title VI require covered entities
to take reasonable steps to ensure mean-
ingful access to individuals with limited
English proficiency, which may include
provision of language assistance services
such as written translation of written con-
tent in paper or electronic form into lan-
guages other than English. Section 1557
and section 504 require covered entities
to take appropriate steps to ensure ef-
fective communication with individuals
with disabilities, including provision of
appropriate auxiliary aids and services at
no cost to the individual. Auxiliary aids
and services may include interpreters,
large print materials, accessible infor-
mation and communication technology,
open and closed captioning, and other
aids or services for persons who are blind
or have low vision, or who are deaf or
hard of hearing. Information provided
through information and communication
technology also must be accessible to in-
dividuals with disabilities, unless certain
exceptions apply. Consistent with Execu-
tive Order 13985 and civil rights protec-
tions cited in these regulations, HHS par-
ticularly seeks comments from minority
and underserved communities including
those with limited English proficiency
and those with disabilities who prefer
information in alternate and accessible
formats, and stakeholders who serve such
communities, on whether the provisions
and protections related to communica-
tion, language, and literacy sufficiently
address barriers that exist to ensuring
all individuals can read, understand, and
consider their options related to notice
and consent. HHS also seeks comment
on what additional or alternate policies
HHS may consider to help address and
remove such barriers.
HHS understands that the technical na-
ture of these protections may inherently
pose barriers to individuals or their autho-
rized representatives as they consider their
options. Numerous studies have indicated
that consumer comprehension of common
health insurance concepts is varied and
that many are not able to accurately an-
swer questions about their health plan’s
benefit design or health care costs.
89
In-
dividuals may also face intersecting and
overlapping barriers (commonly referred
to as the Social Determinants of Health)
as they interact with the health care sys-
tem, in addition to numerous technical
forms and documents as part of receiving
care. HHS solicits comment on how to
best strike the balance between consumer
friendliness and usability of such docu-
ments, while ensuring that they are consis-
tent with these interim final rules and the
statutory intent. HHS specifically seeks
comment from those with experience in
supporting individuals with low health
literacy, including providers, patient ad-
vocates, and navigators, as well as those
with experience in user design, in order
to ensure that documents conveying these
protections and opportunities to convey
notice and consent are understandable and
accurate.
iv. Exceptions to the Availability of
Notice and Consent
The notice and consent exception is not
applicable with respect to some non-emer-
gency items or services.
90
Instead, the
prohibition on balance billing and the
in-network cost-sharing requirements,
as described in these interim final rules,
always apply with respect to those items
or services. In addition, the exception for
notice and consent is not applicable with
respect to emergency services, except for
post-stabilization services, under certain
conditions.
First, as specified in section 2799B-2(b)
of the PHS Act, with respect to non-emer-
gency services, the notice and consent
exception does not apply to ancillary ser-
vices, which include items and services
related to emergency medicine, anesthe-
siology, pathology, radiology, and neona-
tology, whether provided by a physician
or non-physician practitioner; items and
services provided by assistant surgeons,
hospitalists, and intensivists; diagnostic
services, including radiology and labora-
tory services; and items and services pro-
vided by a nonparticipating provider, only
if there is no participating provider who
can furnish such item or service at such
facility.
Additionally, as specified in section
2799B-2(c) of the PHS Act, the notice and
consent exception does not apply to items
or services furnished as a result of un-
foreseen, urgent medical needs that arise
at the time an item or service is furnished
for which a nonparticipating provider
satisfied the notice and consent criteria.
For example, even if an individual has
consented to waive balance billing and
in-network cost-sharing protections with
respect to items and services provided by
certain nonparticipating providers relat-
84
Id.
85
42 U.S.C. § 18116.
86
42 U.S.C. § 2000d et seq.
87
269 U.S.C. § 794.
88
42 U.S.C. § 12101 et seq.
89
https://www.policygenius.com/blog/health-insurance-literacy-survey-2019/; https://www.cmu.edu/dietrich/sds/docs/loewenstein/ConsumerMisUnderstandHealthIns.pdf
90
45 CFR 149.420(b) applies in cases of non-emergency services furnished by a nonparticipating provider at a participating facility and not in cases of emergency services. Additionally, 45
CFR 149.410(c) specifies that the notice and consent exception for post-stabilization services does not apply to items or services furnished as a result of unforeseen, urgent medical needs
that arise at the time a post-stabilization service is furnished for which the nonparticipating provider or nonparticipating emergency facility already satisfied the notice and consent criteria.

Bulletin No. 2021–30 69 July 26, 2021
ed to a knee surgery, that individual has
not consented, nor are providers permit-
ted to seek consent under the statute and
these interim final rules, to waive those
protections with respect to unforeseen,
urgent medical needs that arise during the
knee surgery. Because individuals lack
the requisite information to provide in-
formed consent to waive balance billing
and cost-sharing protections with respect
to unforeseen, urgent medical needs, HHS
has determined that the rationale for the
statutory exception for notice and consent
to not extend to unforeseen, urgent medi-
cal needs with respect to non-emergency
services also applies to unforeseen, urgent
post-stabilization services. Therefore,
these interim final rules provide that any
notice provided and consent obtained with
regard to the furnishing of certain items
or services does not extend to additional
items or services furnished in response to
unforeseen, urgent medical needs either in
the context of a nonparticipating provider
in a participating facility, or of post-stabi-
lization services.
The statute authorizes HHS to expand
the definition of ancillary services to in-
clude items and services provided by other
types of providers. HHS seeks comment
on other ancillary services that should be
considered to be made ineligible for the
notice and consent exception. In partic-
ular, HHS is interested in comments on
whether there are other ancillary services
for which individuals are likely to have
little control over the particular provider
who furnishes items or services. HHS is
of the view that it is with respect to these
types of providers that notice and consent
procedures are least appropriate. HHS is
also interested in comments regarding the
types of ancillary services for which sur-
prise bills are most common, and whether
they should be added to the definition of
ancillary services that are not subject to
the notice and consent exception. Final-
ly, HHS seeks comment on what criteria
HHS should use in determining whether
other ancillary services should be added to
the definition.
Furthermore, the statute authorizes
HHS to specify a list of advanced diag-
nostic laboratory tests that would not be
considered ancillary services under this
definition. Any such advanced diagnostic
laboratory tests would still be subject to
the surprise billing protections described
in these interim final rules, but the notice
and consent exemption process would
also be available for these tests. HHS
seeks comment on what criteria HHS
should consider in determining whether
an advanced diagnostic laboratory test
should be excepted from the definition
of ancillary services, and on any specific
advanced diagnostic laboratory tests that
should be considered to be made eligible
for the notice and consent exception.
v. Retention of Certain Documents
Under Section 2799B-2(e) of the PHS
Act and these interim final rules, nonpar-
ticipating emergency facilities, partici-
pating health care facilities, and nonpar-
ticipating providers are required to retain
written notice and consent documents
for at least a 7-year period after the date
on which the item or service in question
was furnished. Specifically, when a non-
participating emergency facility obtains
a signed consent from a participant, ben-
eficiary, or enrollee, or such individual’s
authorized representative, for an item
or service furnished to the individual by
the facility or any nonparticipating pro-
vider at such facility, the facility must
retain the written notice and consent for
the 7-year period. Similarly, when a par-
ticipating health care facility obtains a
signed consent from a participant, bene-
ficiary, or enrollee, or such individual’s
authorized representative, for an item or
service furnished to the individual by a
nonparticipating provider at such facility,
the facility must retain the written notice
and consent for a 7-year period. If a non-
participating provider obtains a signed
consent from a participant, beneficiary, or
enrollee, or such individual’s authorized
representative, where the facility does not
otherwise obtain the consent on behalf of
the provider, the provider may either co-
ordinate with the facility so that the facil-
ity retains the written notice and consent
for a 7-year period, or the provider must
retain the written notice and consent for a
7-year period. HHS interprets the reten-
tion requirement to apply to providers as
well as facilities, in order to ensure that
all notice and consent documents are ap-
propriately retained, regardless of how
they are obtained.
vi. Requirements to Notify the Plan or
Issuer
For each item or service furnished by
a nonparticipating provider or nonpartic-
ipating emergency facility, the provider
(or participating facility on behalf of the
nonparticipating provider) or nonpartici-
pating emergency facility, as applicable,
must timely notify the plan or issuer as to
whether balance billing and in-network
cost sharing protections apply to the item
or service, and provide to the plan or issu-
er a signed copy of any signed written no-
tice and consent documents. With respect
to non-emergency services described in
45 CFR 149.410(a), the nonparticipating
provider (or the participating facility on
behalf of the provider) must timely notify
the plan or issuer that the item or service
was furnished during a visit at a partici-
pating health care facility. With respect
to post-stabilization services, the nonpar-
ticipating provider or nonparticipating
emergency facility must notify the plan
or issuer as to whether all the conditions
described in 45 CFR 149.410(b) are met
with respect to each of the items and ser-
vices for which the bill is submitted. With
respect to non-emergency services only, in
instances where the nonparticipating pro-
vider bills the participant, beneficiary, or
enrollee directly (where permitted under
these interim final rules), the provider (or
participating health care facility on behalf
of the provider) may satisfy the require-
ment to timely notify the plan or issuer by
including the notification with the bill to
the individual.
In interpreting the statutory require-
ments, HHS recognizes that it is critical
that a group health plan or health insurance
issuer have knowledge of whether the bal-
ance billing and in-network cost-sharing
requirements apply, including whether an
item or service is furnished during a visit
at a participating health care facility and
if any notice was provided and consent
given what items and services were con-
sented to, where such items and services
would otherwise be subject to the balance
billing protections. This information is
crucial for the plan or issuer to be able to
appropriately assign cost sharing and ad-
judicate the claim in compliance with the
No Surprises Act. These interim final rules
require the provider or facility to notify

July 26, 2021 70 Bulletin No. 2021–30
the plan or issuer so that the plan or issu-
er is aware when the balance billing and
in-network cost sharing protections apply
and can process the claim appropriately.
91
HHS seeks comment on whether ad-
ditional rulemaking would be helpful re-
garding the process and timing for such
notification, including the definition of
‘timely,’ and what processes for conveying
the notification would be most efficient,
including existing processes that could be
leveraged to convey the information. HHS
is particularly interested in comments re-
garding the requirement that providers or
facilities provide to the plan or issuer a
copy of the signed written notice and con-
sent document, including comments on
barriers and burdens associated with such
requirement, and recommendations on
how best to ensure plans and issuers have
information regarding the notice and con-
sent documents without imposing undue
burden on providers and facilities.
3. Provider and Facility Disclosure
Requirements Regarding Patient
Protections against Balance Billing
Section 2799B-3 of the PHS Act, added
by the No Surprises Act, requires provid-
ers and facilities to provide disclosures re-
garding patient protections against balance
billing. Among other things, the statute
requires health care providers and facili-
ties (including an emergency department
of a hospital or independent freestanding
emergency department) to make public-
ly available, post on a public website of
the provider or facility (if applicable), and
provide to participants, beneficiaries, and
enrollees a one-page notice about the bal-
ance billing requirements and prohibitions
that apply to the provider or facility under
sections 2799B-1 and 2799B-2 of the PHS
Act. The notice must include information
about any applicable state requirements,
and about how to contact appropriate state
and federal agencies if the individual be-
lieves the provider or facility has violated
the balance billing rules. These interim
final rules codify the statutory require-
ments and information that these disclo-
sures must include. In addition, as stated
previously, under section 9820(c) of the
Code, section 720(c) of ERISA, and sec-
tion 2799A-5(c) of the PHS Act, plans and
issuers must provide information in plain
language on the prohibition against bal-
ance billing and information on contact-
ing appropriate state and federal agencies
in the case that an individual believes that
such a provider or facility has violated the
prohibition against balance billing. These
disclosure requirements are applicable for
plan years beginning on or after January
1, 2022. To reduce burden and facilitate
compliance with these disclosure require-
ments, the Departments are concurrent-
ly issuing a model disclosure notice that
health care providers, facilities, group
health plans, and health insurance issuers
may, but are not required to, use to satisfy
the disclosure requirements regarding the
balance billing protections. The Depart-
ments will consider use of the model no-
tice in accordance with the accompanying
instructions to be good faith compliance
with the disclosure requirements of sec-
tion 9820(c) of the Code, section 720(c)
of ERISA, and section 2799A-5(c) of the
PHS Act, if all other applicable require-
ments are met. The Departments may ad-
dress these requirements in more detail in
future guidance or rulemaking. Until such
guidance or rulemaking implementing the
requirements under section 9820(c) of the
Code, section 720(c) of ERISA, and sec-
tion 2799A-5(c) of the PHS Act becomes
effective and applicable, plans and issuers
should exercise good-faith compliance
with those statutory provisions.
These disclosures are critical to help-
ing raise awareness and enhance the pub-
lic’s understanding of state and federal
balance billing protections. The purpose
of these disclosures is to empower indi-
viduals to better understand the balance
billing protections afforded under applica-
ble state and federal law. In addition, these
disclosures are important in ensuring indi-
viduals are able to identify violations of
these interim final rules and related state
law requirements and, if necessary, file
complaints against providers and facili-
ties. These disclosures further the efforts
to help achieve the goals of the No Sur-
prises Act and ensure that individuals are
aware of their rights and the options avail-
able to them. These interim final rules
codify the provider and facility disclosure
requirements at 45 CFR 149.430. These
requirements apply to health care pro-
viders and health care facilities (includ-
ing independent freestanding emergency
departments). These interim final rules
outline requirements regarding the con-
tent of the one-page disclosure, methods
for disclosure, timing of disclosure to in-
dividuals, exceptions to the requirements,
and a special rule to prevent unnecessary
duplication with respect to providers.
These disclosure requirements do not ap-
ply to providers of air ambulance services,
as section 2799B-3 of the PHS Act re-
quires providers and facilities to disclose
information regarding the requirements
and prohibitions applicable to the provid-
er or facility under sections 2799B-1 of
the PHS Act (relating to balance billing
for emergency services) and 2799B-2 of
the PHS Act (relating to balance billing
for non-emergency services furnished by
nonparticipating providers at certain par-
ticipating facilities), but not under section
2799B-5 of the PHS Act (relating to bal-
ance billing for air ambulance services).
Although this provision does not apply
to providers of air ambulance services,
as the definition of health care providers
in 45 CFR 149.30 excludes providers of
air ambulance services, HHS encourag-
es providers of air ambulance services to
make available clear and understandable
information about the requirements and
prohibitions on balance billing for air am-
bulance services.
i. Content of Disclosure
The statute and these interim final rules
require that the disclosure must include a
clear and understandable statement that
explains the requirements and prohibi-
tions applicable to the provider or facility
under sections 2799B-1 and 2799B-2 of
the PHS Act and their implementing regu-
lations, relating to prohibitions on balance
billing in cases of emergency services and
non-emergency services performed by a
91
The Departments note that whether a provider or facility provides such a notification to the plan or issuer and whether a plan or issuer processes a claim as if notice and consent were obtained
based on a provider’s notification is not determinative of whether the balance billing protections apply. A participant, beneficiary, or enrollee who is balance billed or whose cost-sharing
responsibility is calculated at out-of-network rates would still be able to contend that they did not receive sufficient notice or did not provide consent, and challenge the provider or facility’s
right to balance bill them, as well as and the plan or issuer’s handling of the claim.

Bulletin No. 2021–30 71 July 26, 2021
nonparticipating provider at certain par-
ticipating facilities as described earlier in
this preamble.
In addition, the disclosure must include
clear and understandable language that
explains any applicable state law require-
ments regarding the amounts such pro-
vider or facility may charge a participant,
beneficiary, or enrollee after receiving
payment, if any, from a plan or coverage
(with which the provider or facility does
not have a contractual relationship) and
any applicable cost-sharing payment from
such participant, beneficiary, or enrollee.
HHS recognizes that there may be
some state laws that are more protective
of consumers than sections 2799B-1 and
2799B-2 of the PHS Act and their imple-
menting regulations. For example, a state
law might prohibit an individual from
providing consent to be balance billed
under more circumstances than those in
which balance billing are prohibited un-
der those sections and their implementing
regulations. If the more protective state
law causes certain provisions of sections
2799B-1 and 2799B-2 of the PHS Act and
their implementing regulations to be inap-
plicable to the provider or facility, the pro-
vider or facility is not required to include
language containing information on those
inapplicable provisions in the disclo-
sures regarding the federal requirements
and prohibitions, to the extent permitted
under state law. However, the provider
or facility would continue to be required
to include information in the disclosures
about any provisions in sections 2799B-
1 and 2799B-2 of the PHS Act and their
implementing regulations that remain ap-
plicable to the provider or facility.
Last, the statute and these interim final
rules require that the disclosure must in-
clude clear and understandable language
providing contact information for the ap-
propriate state and federal agencies that
an individual may contact if the individ-
ual believes the provider or facility has
violated a requirement described in the
notice. If only one federal or state agency
has oversight with respect to providers or
facilities in the state, the disclosure may
include contact information for only that
agency.
In an effort to reduce the burden on
health care providers and facilities, HHS
has developed a model notice that health
care providers and facilities may adopt,
but are not required to use. HHS would
consider a provider or facility that uses the
HHS-developed model notice to be com-
pliant with these federal disclosure rules
with respect to the information regarding
sections 2799B-1 and 2799B-2 of the PHS
Act and their implementing regulations.
HHS encourages states to develop model
language to assist health care providers
and facilities in fulfilling the disclosure
requirements related to applicable state
law requirements and contact informa-
tion. If a state develops model language
that is consistent with section 2799B-3 of
the PHS Act, HHS will consider a provid-
er or facility that makes appropriate use of
the state-developed model language to be
compliant with the federal requirement to
include information about state law pro-
tections.
To ensure clear and understandable
language for the required information,
HHS encourages health care providers
and facilities to utilize plain language in
the disclosure statements and to consider
user testing in the development of such
notices.
92
Providers and facilities must
comply with applicable state or federal
language access standards in providing
the disclosures.
93
Communication and
language barriers are associated with de-
creased quality of care and poorer health
outcomes.
94
Studies have shown the ben-
efits associated with the use of language
services in clinics and hospitals include
(1) increased quality of care, (2) improved
patient safety outcomes, and (3) lower uti-
lization of costly medical procedures. The
presence of a language barrier is associat-
ed with higher rates of costly resource uti-
lizations for diagnostic testing, increased
emergency department visits, decreased
use of preventive services, higher rates
of hospitalization, and higher rates of ad-
verse health outcomes.
95
HHS believes it is
imperative that health care providers and
facilities provide the required disclosure
information in a clear and understandable
manner to help achieve the goal of the No
Surprises Act and ensure that individuals
are aware of their rights related to protec-
tions against balance billing.
In addition, HHS reminds health care
providers and facilities that these notices
must comply with applicable federal civil
rights laws, including that providers and
facilities must take reasonable steps to
provide meaningful access for individu-
als with limited English proficiency and
appropriate steps to ensure effective com-
munication with individuals with disabili-
ties, including accessibility of information
and communication technology.
HHS seeks comment on the content of
the required disclosures. Consistent with
Executive Order 13985 and civil rights
protections cited in these interim final
rules, HHS particularly seeks comments
from minority and underserved communi-
ties, including from those with limited En-
glish proficiency, those who prefer infor-
mation in alternate and accessible formats,
those who are otherwise adversely affect-
ed by persistent poverty and inequality, as
well as from stakeholders who serve these
communities, on what additional barriers
may exist so as to ensure individuals can
read, understand, and consider disclosure
information and on what policies HHS
may consider for addressing and remov-
ing these barriers.
ii. Methods of Disclosure
The statute and these interim final rules
require that each health care provider and
facility must make the required disclosure
publicly available, and (if applicable) post
it on a public website of such provider or
92
See https://methods.18f.gov/ for information on user testing.
93
See section IV.2.iii of this preamble for discussion of select federal access standards.
94
https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Language-Access-Plan-508.pdf
95
See Dewalt DA, Berkman ND, Sheridan S, Lohr KN, Pignone MP. Literacy and health outcomes: a systematic review of the literature. J Gen Intern Med. 2004;19(12):1228-1239.
doi:10.1111/j.1525-1497.2004.40153.x; Scott TL, Gazmararian JA, Williams MV, Baker DW. Health literacy and preventive health care use among Medicare enrollees in a managed care
organization. Med Care. 2002;40:395–404; Baker DW, Parker RM, Williams MV, Clark WS. Health literacy and the risk of hospital admission. J Gen Intern Med. 1998;13:791–8; Neira L.
The importance of addressing language barriers in the US health system. Duke Center for Personalized Health Care (July 17, 2018), available at: https://dukepersonalizedhealth.org/2018/07/
the-importance-of-addressing-language-barriers-in-the-us-health-system/.

July 26, 2021 72 Bulletin No. 2021–30
facility. In addition, providers and facil-
ities must provide a one-page notice to
individuals who are participants, benefi-
ciaries, or enrollees of a group health plan
or individual health insurance coverage
offered by a health insurance issuer.
To satisfy the requirement to post the
disclosure on a public website, the disclo-
sure or a link to such disclosure must be
searchable on the provider’s or facility’s
public website. HHS is of the view that the
required disclosure information would not
be publicly available unless displayed in a
manner that is easily accessible, without
barriers, and that ensures that the infor-
mation is accessible to the general public,
including that it is findable through pub-
lic search engines. For example, HHS is
of the view that a public website must be
accessible free of charge, without having
to establish a user account, password,
or other credentials, accept any terms or
conditions, and without having to submit
any personal identifying information such
as a name or email address. HHS seeks
comment on whether additional regula-
tory standards are needed regarding what
constitutes disclosure on a provider’s or
facility’s public website to ensure the in-
formation is accessible to the public.
These interim final rules provide that a
health care provider or health care facility
that does not have its own website is not
required to make a disclosure on a public
website. HHS anticipates that most facil-
ities subject to the requirements in sec-
tions 2799B-1 and 2799B-2 of the PHS
Act would generally have a website, but
recognizes that providers who furnish ser-
vices at such facilities may not have their
own website.
To satisfy the required disclosure to the
public, providers and facilities must dis-
play the required disclosure information
on a sign posted prominently at the loca-
tion of the health care provider or health
care facility. HHS would consider a sign
to be posted prominently, if the sign were
posted in a central location, such as where
individuals schedule care, check-in for
appointments, or pay bills. Such locations
would allow individuals to be aware of the
protections available before or at the time
of service or payment. HHS is of the view
that ensuring the individual is aware of
the surprise billing protections is integral
to implementation of these requirements.
HHS recognizes that some providers may
not have publicly accessible locations and
has concluded that requiring a sign to be
posted prominently at a non-publicly ac-
cessible location would not further the
purpose of providing a disclosure. There-
fore, providers without a publicly accessi-
ble location are not required to make the
disclosure under 45 CFR 149.430(c)(2).
Lastly, the statute and these interim final
rules require that health care providers and
facilities must provide the required disclo-
sure information in a one-page notice to
individuals who are participants, beneficia-
ries, or enrollees of a group health plan or
group or individual health insurance cov-
erage offered by a health insurance issuer.
The notice must be provided in-person or
through mail or email, as selected by the
participant, beneficiary, or enrollee. As out-
lined in the statute, the required disclosure
to individuals must be limited to one page.
HHS interprets the statute such that the
disclosure notice may be one double-sided
page. These interim final rules specify that
the one-page disclosure must not include
print smaller than 12-point font. These
specifications are important to ensure that
the one-page document is both designed
in a form and presented in a manner that
is readable by the individual or their rep-
resentative and that it contains sufficient
content to meet the requirements of these
interim final rules.
HHS seeks comment on these disclo-
sure methods, including whether addi-
tional methods of providing information
should be required or permitted. In par-
ticular, HHS is interested in comments re-
garding whether posting of the disclosure
information could be in a location other
than a sign posted prominently at the loca-
tion of the provider or facility. In addition,
HHS seeks comment on ways to ensure
that the required disclosure information
posted on a public website is accessible to
individuals.
iii. Timing of Disclosure to Individuals
These interim final rules generally re-
quire a health care provider or health care
facility to provide the notice to partici-
pants, beneficiaries, or enrollees no later
than the date and time on which the pro-
vider or facility requests payment from
the individual (including requests for
copayment made at the time of a visit to
the provider or facility). In cases where
the facility or provider does not request
payment from the individual, the notice
must be provided no later than the date
on which the provider or facility submits
a claim for payment to the plan or issuer.
HHS is of the view that the notice will
be most effective in helping individuals
understand their rights and protections un-
der federal and state balance billing laws
and protecting individuals from being
improperly billed, if individuals receive
the notice in accordance with this timing
requirement. The requirement will ensure
the disclosures are meaningful and that
individuals are aware of their rights be-
fore or at the time of payment, which is
likely to help individuals to avoid paying
bills that are prohibited under state or fed-
eral balance billing rules. However, these
interim final rules offer providers and fa-
cilities flexibility regarding when the dis-
closure must be provided to individuals.
Providers and facilities may provide the
required disclosures to individuals earlier.
For example, they could provide the no-
tice when an individual schedules an ap-
pointment, or when other standard notice
disclosures (such as the Notice of Privacy
Practices for Protected Health Informa-
tion
96
) are shared with individuals.
In developing these interim final rules,
HHS considered allowing providers or fa-
cilities to provide the disclosure annually
or only at the time a patient schedules a
service, but wanted to ensure the timing of
the disclosure was relevant to when the in-
dividual may experience a violation of the
surprise billing protections. HHS encour-
ages providers and facilities to provide in-
dividuals with the notice at a time that will
maximize the notice’s effectiveness.
HHS seeks comment on this timing
requirement, and whether another timing
requirement would be more appropriate.
iv. Exceptions
Although section 2799B-3 of the PHS
Act could be interpreted to apply broad-
96
For requirements regarding when health care providers are required to provide the Notice of Privacy Practices, see 45 CFR 164.520(c).

Bulletin No. 2021–30 73 July 26, 2021
ly to all health care providers and facili-
ties, these interim final rules include two
exceptions to the general requirement to
provide disclosures regarding balance
billing protections. First, health care pro-
viders are not required to make the disclo-
sures required under this section if they do
not furnish items or services at a health
care facility, or in connection with visits
at health care facilities. Second, health
care providers are required to provide the
required disclosure only to individuals
to whom they furnish items or services,
and then only if such items or services
are furnished at a health care facility, or
in connection with a visit at a health care
facility. HHS further notes that, under sec-
tion 2799B-3 of the PHS Act, disclosure
is required only to individuals who are
participants, beneficiaries, or enrollees of
a group health plan or group or individu-
al health insurance coverage offered by a
health insurance issuer. However, as spec-
ified in 5 U.S.C. 8902(p), section 2799B-
3 of the PHS Act applies to a health care
provider and facility with respect to a cov-
ered individual in a FEHB plan, as well.
The disclosure requirement is not required
with respect to other individuals seeking
care from a provider or facility.
While the statute does not explicitly
provide for these exceptions, HHS is of
the view that these exceptions serve two
important purposes. First, they seek to
avoid unnecessary confusion among indi-
viduals who otherwise might receive the
disclosure under circumstances in which
the balance billing protections would nev-
er apply. For instance, providing the dis-
closure of balance billing protections in a
primary care provider’s office could lead
individuals to incorrectly assume balance
billing protections exist where they do not.
Second, by ensuring that the disclosures
are targeted narrowly to relevant individ-
uals, the exceptions aim to implement the
statutory requirement without creating
additional undue burden on providers and
facilities.
HHS is of the view that these excep-
tions are consistent with balance billing
requirements elsewhere in these interim
final rules, related to emergency services
or non-emergency services furnished by a
nonparticipating provider at a participat-
ing facility. Furthermore, HHS is of the
view that these exceptions do not lessen
the positive impact of the disclosure re-
quirement, as health care providers and
facilities are still required to make the
disclosures where balance billing is most
likely to occur, which will help to ensure
individuals are aware of their rights relat-
ing to consumer protections against bal-
ance billing.
HHS seeks comment on these excep-
tions and whether there are other scenari-
os that should be considered.
v. Special Rule to Prevent Unnecessary
Duplication with Respect to Providers
HHS realizes there may be some in-
stances where an individual may receive
two disclosure notices – one from a pro-
vider furnishing items or services at a
health care facility, and the other from the
health care facility itself. These interim
final rules include a special rule to stream-
line the provision of the required disclo-
sure to the public and one-page notice to
individuals and avoid unnecessary dupli-
cation of the disclosures with respect to
providers furnishing care at a health care
facility. This special rule does not apply
with respect to the requirement that each
health care provider and facility post the
required disclosure on a public website
of such provider or facility. While section
2799B-3 of the PHS Act does not explicit-
ly provide for a special rule to prevent un-
necessary duplication with respect to pro-
viders, HHS is of the view that this special
rule serves an important purpose in imple-
menting these requirements while reduc-
ing unnecessary burden and effort for pro-
viders. Furthermore, HHS is of the view
that this special rule will also help reduce
potential consumer confusion by allowing
individuals to receive only one disclosure
notice when receiving services from a
provider furnishing items or services at a
health care facility, both of which are sub-
ject to the disclosure requirement.
The special rule provides that to the
extent a provider furnishes an item or
service covered under the plan or cov-
erage at a health care facility (including
an emergency department of a hospital
or independent freestanding emergency
department), the provider satisfies the
disclosure requirements if the facility
agrees to provide the information, in the
required form and manner, pursuant to
a written agreement. In such instance,
the disclosure must include information
about the balance billing requirements
and prohibitions applicable to both the
facility and the provider. If a provider
and facility have a written agreement un-
der which the facility agrees to provide
the information required under these in-
terim final rules, and the facility fails to
provide full or timely disclosure informa-
tion, then the facility, but not the provid-
er, would violate the provider disclosure
requirements regarding balance billing
protections. HHS is of the view that this
will remove unnecessary burden and ef-
fort for the providers. HHS clarifies that
a “written agreement” may be an existing
contract between the provider and facility
to furnish care at the facility, if amended
to provide for this special rule. Alterna-
tively, a provider and facility may enter
into a new written agreement specifically
outlining the disclosure requirements re-
garding balance billing protections.
Providers that enter into these ar-
rangements with facilities are encour-
aged to monitor the facility’s adherence
to these requirements. In addition, if a
provider has knowledge that the required
disclosure information is not being pro-
vided in a manner specified in these inter-
im final rules, HHS encourages the pro-
vider to work with the facility to correct
the noncompliance as soon as practicable
or notify the applicable state authority or
HHS, in states where HHS is enforcing
this requirement.
97
HHS may provide ad-
ditional guidance if HHS becomes aware
of situations where participants, benefi-
ciaries, and enrollees are not being pro-
vided the required disclosure information
in accordance with these interim final
rules.
HHS recognizes that providers and fa-
cilities frequently bill separately for items
97
Pursuant to section 2799B-4 of the PHS Act, states have authority to enforce the requirements of Part E of title XXVII of the PHS Act against a provider or health care facility (including a
provider of air ambulance services), and HHS must enforce if a state has failed to substantially enforce the requirements. HHS intends to issue rulemaking in the future to implement section
2799B-4 of the PHS Act.

July 26, 2021 74 Bulletin No. 2021–30
and services furnished by the provider and
the facility, and considered whether to
make the special rule inapplicable in those
instances. However, HHS concluded that
applying the special rule is appropriate in
these situations, since the disclosures are
not required to be included with the bill
itself. Although these interim final rules
provide some flexibility around the timing
of the notice, HHS anticipates that the dis-
closure to the individual would generally
be provided at the point of care. Thus, re-
quiring the provider and facility to sepa-
rately provide notices whenever they bill
separately could result in the individual
receiving multiple notices for the same
visit. Duplicative paperwork could over-
whelm or confuse the receiving individu-
al, which could detract from the primary
purpose of clarifying and making known
the protections that may apply to the in-
dividual. In addition, HHS is of the view
that requiring a provider to separately post
a disclosure within a facility is of limited
additional benefit and may present com-
pliance challenges for providers who lack
designated space within a facility. There-
fore, the special rule applies regardless
of whether the provider and facility bill
jointly or separately.
Furthermore, since the special rule does
not apply with respect to the requirement
that each health care provider and facility
make the required disclosure available on
the public website of the provider or fa-
cility, HHS is of the view that this special
rule works to achieve the goals of prevent-
ing unnecessary duplication for providers
and facilities, while encouraging safe-
guards to ensure that individuals receive
the required disclosure information and
are aware of their rights. HHS is of the
view that this special rule does not lessen
the positive impact of the disclosure re-
quirement. This special rule will continue
to help to ensure individuals are aware of
their rights relating to patient protections
against surprise billing.
HHS seeks comment on this special
rule and whether there are other circum-
stances that may warrant a special rule to
prevent unnecessary duplication. In addi-
tion, HHS seeks comment on whether pro-
viders should be required, rather than en-
couraged, to monitor and report whether a
facility is not complying with the require-
ment outlined in these interim final rules.
4. Surprise Billing Complaints Regarding
Health Care Providers, Facilities, and
Providers of Air Ambulance Services
The No Surprises Act adds section
2799B-4(b)(3) of the PHS Act, which di-
rects HHS to establish a process to receive
consumer complaints regarding violations
by health care providers, facilities, and
providers of air ambulance services of
balance billing requirements under sec-
tions 2799B-1, 2799B-2, 2799B-3, and
2799B-5 of the PHS Act and to respond
to such complaints within 60 days. There-
fore, the interim final rules establish an
HHS-only complaints process for health
care providers, facilities and providers of
air ambulance services that parallels the
process that the Departments are estab-
lishing through these interim final rules
for plans and issuers. A more fulsome
discussion of the complaints process for
providers can be found in section III.B.4
of this preamble. HHS seeks comment
on the complaints process for health care
providers, facilities, and providers of air
ambulance services described in these in-
terim final rules.
5. Catastrophic Plans
As discussed earlier in this preamble,
where the surprise billing protections ap-
ply, and the out-of-network rate exceeds
the amount upon which cost sharing is
based (which for emergency services
provide by a nonparticipating emergency
facility and for non-emergency services
provided by a nonparticipating provider
at a participating health care facility is
the recognized amount, and for services
provided by a nonparticipating provider
of air ambulance services is the lesser of
the billed amount or the QPA), a group
health plan or health insurance issuer of-
fering group or individual health insur-
ance coverage must pay the provider or
facility the difference between the out-of-
network rate and the cost-sharing amount,
even in cases where an individual has not
satisfied their deductible (in which case
the cost-sharing amount is the recognized
amount, or the lesser of the billed amount
or the QPA, as applicable). Catastrophic
plans generally cannot provide benefits
for any plan year until the annual limita-
tion on cost sharing in section 1302(c)(1)
of ACA is reached, other than coverage
of preventive services under section 2713
of the PHS Act and at least three prima-
ry care visits. A catastrophic plan can-
not comply with the new balance billing
protections, specifically the obligation to
make a payment to a provider or facility
prior to the enrollee meeting the annual
limitation on cost sharing, while satisfy-
ing the definition of a catastrophic plan at
section 1302(e) of ACA. Because the No
Surprises Act does not contain language
eliminating catastrophic plans or exempt-
ing catastrophic plans from the law’s re-
quirements, HHS interprets the statute
as permitting catastrophic plans to make
payments required by sections 2799A-1
or 2799A-2 of the PHS Act without los-
ing their status as catastrophic plans. HHS
is, therefore, amending 45 CFR 156.155
in these interim final rules to specify that
a catastrophic plan must provide benefits
as required under sections 2799A-1 and
2799A-2 of the PHS Act and their imple-
menting regulations, or any applicable
state law providing similar surprise billing
protections to individuals. Additionally, a
health plan will not fail to be treated as
a catastrophic plan because the plan pro-
vides benefits prior to the annual limita-
tion on cost sharing in section 1302(c)(1)
of the ACA, as required under sections
2799A-1 and 2799A-2 of the PHS Act or
any applicable state law providing similar
protections to individuals.
V. Overview of Interim Final Rules –
Office of Personnel Management
A. Conforming Changes for FEHB
Program
The OPM interim final rules, through
new 5 CFR 890.114 in subpart A, protect
FEHB Program covered individuals from
surprise medical bills for emergency ser-
vices, air ambulance services furnished by
nonparticipating providers, and non-emer-
gency services furnished by nonpartici-
pating providers at participating health
care facilities in certain circumstances
in the same manner as the Departments’
rules protect participants, beneficiaries,
or enrollees. The Departments’ interim fi-
nal rules generally apply with respect to
FEHB carriers’ compliance with the No
Surprises Act, except to the extent that dif-

Bulletin No. 2021–30 75 July 26, 2021
ferences are necessitated for clarification
or appropriate application in the context
of the FEHB Program. In considering ap-
plication of the Departments’ interim rules
with respect to the FEHB Program, it is
important to recognize that all FEHB carri-
ers offer fully insured health benefits plans
in consideration of premium payments
pursuant to contract terms, and no health
benefits plan is self-insured by OPM or
the Federal government. OPM seeks com-
ment on this approach and whether there
should be any additional considerations in
the application of these interim final rules
in the context of the FEHB Program.
B. Preemption and OPM Enforcement
FEHB contract terms preempt state law
with respect to coverage or benefits (in-
cluding payments with respect to benefits)
pursuant to 5 U.S.C. 8902(m)(1). Such
preemption renders specified state law in-
applicable for the purposes of determining
recognized amounts and out-of-network
rates under 26 CFR part 54, 29 CFR part
2590, and 45 CFR part 149. However,
pursuant to bilateral negotiation of FEHB
contract terms, OPM and the carrier may
agree to apply state law to determine the
total amount payable, rendering the state
law amount, method, or process for de-
termining the total amount payable an
effective term of the Federally-regulated,
Federally-enforced contract. Accordingly,
in this instance, FEHB contract terms will
govern the methodology for determining
recognized amounts and out-of-network
rates. In the absence of a FEHB contract
term incorporating a state law amount,
method, or process for determining the to-
tal amount payable (including an amount
determined pursuant to an All-Payer
Model Agreement under section 1115A
of the Social Security Act), the lesser of
the billed amount or the QPA will serve
as the recognized amount under the FEHB
plan. Likewise, in the absence of a FEHB
contract term incorporating an applicable
state IDR process, the federal IDR process
will govern the determination of out-of-
network rates in cases of failed open ne-
gotiations.
Example A: A community-rated FEHB
plan covers a specific non-emergency ser-
vice that is provided to a covered individ-
ual in State A by a nonparticipating pro-
vider in a participating health care facility.
Both the provider and the facility are li-
censed in State A. State A has a law that
prohibits balance billing for non-emer-
gency services provided to individuals by
nonparticipating providers in a participat-
ing health care facility, and provides for
a method for determining the cost-sharing
amount and total amount payable. The
law applies to health insurance issuers
and providers licensed in State A and ap-
plies to the type of service provided. OPM
and the FEHB carrier, through the annual
contract negotiation cycle, have elected to
utilize State A’s law, and the FEHB health
benefits plan contains a term expressly
incorporating the State A law prohibit-
ing balance billing. In this Example, the
FEHB contract terms apply the state law
to determine the recognized amount and
the out-of-network rate.
Example B: Same facts as Example
A, except that the FEHB contract terms
do not incorporate or expressly refer to
the balance billing law of State A. In this
Example, State A’s law prohibiting bal-
ance billing would be preempted by the
terms of the FEHB contract. The lesser
of the billed amount or QPA would apply
to determine the recognized amount. The
out-of-network rate would be determined
through open negotiation between the
nonparticipating provider and the FEHB
carrier, or in the case of failed negotia-
tions, an amount determined under the
federal IDR process.
Enforcement of these interim final
rules with respect to FEHB carriers will
generally be governed by OPM authorities
set forth herein and 5 U.S.C. 8901 et seq.,
5 CFR part 890, 48 CFR chapter 16, or the
carrier’s FEHB contract. Any differences
in terminology or other clarification will
be set forth in the applicable FEHB con-
tract.
C. Definitions
The No Surprises Act and these inter-
im final rules include defined terms that
are specific to the law’s requirements and
implementation. Definitions of key terms
with respect to OPM’s enforcement of 5
U.S.C. 8902(p) generally align with the
Departments’ regulations, with certain ex-
ceptions. For compliance with these pro-
visions, the terms “group health plan or
plan,” “health insurance issuer or issuer,”
and “participant, beneficiary, or enrollee”
are respectively replaced with the terms
“health benefits plan,” “carrier,” and “en-
rollee or covered individual.”
D. Complaints
Complaints related to the provisions
under Part D of title XXVII of the PHS Act
with respect to carriers and FEHB plans
will generally be resolved in accordance
with the Departments’ interim final rules.
OPM will coordinate with the Depart-
ments to ensure that complaints appropri-
ate for OPM resolution under the FEHB
Program statute, regulations or contractu-
al authorities are referred to OPM.
E. Jurisdiction of Courts
Under 5 U.S.C. 8912, the district courts
of the United States have original jurisdic-
tion, concurrent with the United States
Court of Federal Claims, of a civil action
or claim against the United States founded
on FEHBA. Pursuant to new paragraph (e)
in 5 CFR 890.107, in the event of litigation
under these interim final rules, a suit for
equitable relief founded on 5 U.S.C. chap-
ter 89 that is based on 5 U.S.C. 8902(p)
and is governed by 5 CFR part 890 must
be brought against OPM by December 31
of the 3
rd
year after the year in which dis-
puted services were rendered. OPM seeks
comment on amendments to its regulation
on court review.
F. Applicability
OPM seeks comment on the appro-
priate manner of conforming compliance
with sections 9816, 9817, and 9822 of the
Code; sections 716, 717, and 722 of ERI-
SA; and sections 2799A–1, 2799A–2, and
2799A–7 of the PHS Act for application
to FEHB carriers, including the appro-
priateness and usability of the definitions
and any additional changes to the Depart-
ments’ regulatory provisions that must be
conformed for appropriate implementa-
tion in the FEHB Program.
For purposes of 5 U.S.C. 8902(p), the
HHS interim final rules apply to health
care providers, facilities, and providers
of air ambulance services with respect
to covered individuals in a FEHB plan

July 26, 2021 76 Bulletin No. 2021–30
in the same manner as they apply with
respect to participants, beneficiaries, and
enrollees in a group health plan or group
or individual health insurance cover-
age offered by a health insurance issuer.
OPM seeks comment on the appropriate
manner of conforming compliance with
5 U.S.C. 8902(p) and sections 2799B–1,
2799B–2, 2799B–3, and 2799B–5 of the
PHS Act.
Consistent with the Departments’ ap-
proach discussed in section III.D. of this
preamble, OPM will not apply these inter-
im final rules to health benefits plans that
are retiree-only plans.
VI. Waiver of Proposed Rulemaking
Section 9833 of the Code, section 734
of ERISA, and section 2792 of the PHS
Act authorize the Secretaries of the Trea-
sury, Labor, and HHS (collectively, the
Secretaries), respectively, to promulgate
any interim final rules that they determine
are necessary or appropriate to carry out
the provisions of chapter 100 of the Code,
part 7 of subtitle B of title I of ERISA, and
title XXVII of the PHS Act.
In addition, under section 553(b) of
the Administrative Procedure Act (APA)
(5 U.S.C. 551 et seq.) a general notice of
proposed rulemaking is not required when
an agency finds good cause that notice and
comment procedures are impracticable,
unnecessary, or contrary to the public in-
terest and incorporates a statement of the
finding and its reasons in the rule issued.
The Secretaries and OPM Director have
determined that it would be impracticable
and contrary to the public interest to de-
lay putting the provisions in these interim
final rules in place until after a full pub-
lic notice and comment process has been
completed.
The No Surprises Act was enacted on
December 27, 2020, as title I of Division
BB of the Consolidated Appropriations
Act, 2021. The cost-sharing and balance
billing requirements on plans, issuers,
health care providers, facilities, and pro-
viders of air ambulance services in the
No Surprises Act apply for plan years
(in the individual market, policy years)
beginning on or after January 1, 2022.
Although this effective date may have
allowed for the regulations, if promul-
gated with the full notice and comment
rulemaking process, to be applicable
in time for the applicability date of the
provisions in the No Surprises Act, this
timeframe would not provide sufficient
time for the regulated entities to imple-
ment the requirements. These interim
final rules require plans and issuers to
make significant changes to how they
pay for items and services that are sub-
ject to the cost-sharing and balance bill-
ing protections, including implementing
claims processing procedures to ensure
that claims for items and services sub-
ject to these protections are processed
in accordance with the requirements in
these interim final rules. Group health
plans and health insurance issuers offer-
ing group or individual health insurance
coverage will have to account for these
changes in establishing their premium or
contribution rates, and in making other
changes to the designs of plan or policy
benefits. In some cases, issuers will need
time to secure approval for these chang-
es in advance of the plan or policy year
in question. The Departments and OPM
anticipate the plans and issuers will have
already taken into consideration the stat-
utory provisions in the No Surprises Act
as they developed plan designs for 2022,
and preliminary rates. Issuing these rules
as interim final rules, rather than as a no-
tice of proposed rulemaking, may allow
plans and issuers to account for the final-
ized regulations as they finalize rates and
plan offerings.
The interim final rules place new re-
quirements on facilities, health care pro-
viders, and providers of air ambulance
services regarding when they are permit-
ted to balance bill for items and services.
Such requirements include new require-
ments related to how providers and fa-
cilities must bill for items and services
furnished on an out-of-network basis, re-
quirements related to providing notice and
obtaining consent regarding balance bill-
ing protections in certain circumstances,
and requirements to disclose information
on balance billing publicly, on a public
website and to participants, beneficiaries,
and enrollees. Health care providers and
facilities require time to implement these
new requirements to ensure compliance
by January 1, 2022.
These interim final rules contain criti-
cal protections for participants, beneficia-
ries, and enrollees against balance bill-
ing. For individuals who receive balance
bills, the costs can be astronomical and
devastating.
98
In addition, the recipients
of such bills are not the only ones who
feel their impact. As discussed elsewhere
in this preamble, providers have previ-
ously been able to leverage the ability to
balance bill to negotiate higher in-net-
work rates. This leads to higher premi-
ums, higher cost sharing for consumers,
and increased health expenditures.
99
One
study estimated that policies to address
surprise billing on a federal level could
decrease health insurance premiums
by one to five percent.
100
Additionally,
consumers may delay receiving needed
medical care, including for emergency
medical conditions, over concern about
surprise medical bills. It is therefore in
the public interest that individuals re-
ceive the protections under the No Sur-
prises Act on the date on which those
protections go into effect. Accordingly,
in order to allow plans, health insurance
issuers, facilities, health care providers,
and providers of air ambulance services
sufficient time to implement these new
requirements, these rules must be pub-
lished and available to the public well
in advance of the effective date of the
requirements in the No Surprises Act.
Allowing time for a full notice and com-
98
See, Greaney, T.L., Surprise Billing: A Window into the U.S. Health Care System, ABA Civil Rights and Social Justice Section, Human Rights Magazine (Sept. 8, 2020); Cooper, Z. et al.,
Surprise! Out-Of-Network Billing For Emergency Care in the United States, NBER Working Paper 23623, 20173623 (July 2017, Revised January 2018).
99
See Cooper, Z. et al., Surprise! Out-Of-Network Billing For Emergency Care in the United States, NBER Working Paper 23623, 20173623 (July 2017, Revised January 2018); Duffy, E.
et al., “Policies to Address Surprise Billing Can Affect Health Insurance Premiums.” The American Journal of Managed Care 26.9 (2020): 401–404; and Brown E.C.F., et al., The Unfinished
Business of Air Ambulance Bills, Health Affairs Blog, March 26, 2021. DOI: 10.1377/hblog20210323.911379, available at https://www.healthaffairs.org/do/10.1377/hblog20210323.911379/
full/.
100
Trish E. et al., Policies to Address Surprise Billing Can Effect Health Insurance Premiums, Am J Manag Care. 2020;26(9):401-404. https://doi.org/10.37765/ajmc.2020.88491.

Bulletin No. 2021–30 77 July 26, 2021
ment process prior to the requirements
taking effect would not provide sufficient
time for these entities to comply with the
requirements for plan years (in the indi-
vidual market, policy years) beginning
on or after January 1, 2022, which would
risk subjecting the public to prohibited
balance bills and excess cost sharing.
Additionally, plans and issuers need cer-
tainty regarding the standards of these re-
quirements in order to begin implementa-
tion, which these interim final rules seek
to provide.
Section 2723 of the PHS Act authorizes
states to enforce the requirements in Part
D of title XXVII of the PHS Act with re-
spect to issuers. Section 2799B-4 of the
PHS Act authorizes states to enforce the
requirements in Part E of title XXVII of
the PHS Act with respect to providers and
health care facilities (including a provid-
er of air ambulance services). Under both
sections, HHS is required to enforce such
requirements if a state fails to substantial-
ly enforce them. In order to ensure effec-
tive oversight of these new requirements
as soon as they go into effect, states re-
quire time to assess the requirements con-
tained in these interim final regulations,
and notify HHS if they have not enacted
legislation to enforce such requirements
or they otherwise will not be enforcing
such requirements. States that opt to en-
force the requirements may require time
to update their regulations or statutes and
develop processes for enforcing the new
requirements. Delaying the rules to allow
for notice and comment procedures would
not provide sufficient time for states to as-
sess the new requirements and notify HHS
of their ability to enforce.
In addition, the law requires the Sec-
retaries to issue rulemaking by July 1,
2021, regarding the QPA methodology
(including defining the geographic regions
for purposes of the methodology); infor-
mation plans or issuers must share with
nonparticipating providers or facilities, as
applicable, regarding the plan or issuer’s
determination of the QPA; and a process
to receive complaints related to the QPA.
Allowing time for a full notice and com-
ment process prior to July 1, 2021, would
not have provided sufficient time for the
Departments to develop and publish these
rules by the statutory deadline.
For the foregoing reasons, the Depart-
ments and OPM have determined that it
is impracticable and contrary to the public
interest to engage in full notice and com-
ment rulemaking before putting these in-
terim final rules into effect, and that it is in
the public interest to promulgate interim
final rules.
VII. Economic Impact and Paperwork
Burden
A. Summary
These interim final rules implement
provisions of the No Surprises Act, which
Congress enacted as part of the CAA, that
protect participants, beneficiaries, and en-
rollees in group health plans and group
and individual health insurance coverage
from surprise medical bills when they re-
ceive emergency services, non-emergency
services from nonparticipating providers
at certain participating facilities, and air
ambulance services, under certain circum-
stances.
The Departments and OPM
101
have
examined the effects of these interim fi-
nal rules as required by Executive Order
13563 (76 FR 3821, January 21, 2011,
Improving Regulation and Regulatory
Review); Executive Order 12866 (58 FR
51735, October 4, 1993, Regulatory Plan-
ning and Review); the Regulatory Flex-
ibility Act (September 19, 1980, Pub. L.
96–354); section 1102(b) of the Social
Security Act (42 U.S.C. 1102(b)); section
202 of the Unfunded Mandates Reform
Act of 1995 (March 22, 1995, Pub. L.
104–4); Executive Order 13132 (64 FR
43255, August 10, 1999, Federalism); and
the Congressional Review Act (5 U.S.C.
804(2)).
B. Executive Orders 12866 and 13563
Executive Order 12866 directs agen-
cies to assess all costs and benefits of
available regulatory alternatives and,
if regulation is necessary, to select reg-
ulatory approaches that maximize net
benefits (including potential economic,
environmental, public health and safety
effects, distributive impacts, and equity).
Executive Order 13563 is supplemental
to and reaffirms the principles, structures,
and definitions governing regulatory re-
view as established in Executive Order
12866.
Section 3(f) of Executive Order 12866
defines a “significant regulatory action” as
an action that is likely to result in a rule:
(1) having an annual effect on the econ-
omy of $100 million or more in any one
year, or adversely and materially affect-
ing a sector of the economy, productivi-
ty, competition, jobs, the environment,
public health or safety, or state, local or
tribal governments or communities (also
referred to as “economically significant”);
(2) creating a serious inconsistency or oth-
erwise interfering with an action taken or
planned by another agency; (3) materially
altering the budgetary impacts of entitle-
ment grants, user fees, or loan programs
or the rights and obligations of recipients
thereof; or (4) raising novel legal or policy
issues arising out of legal mandates, the
President’s priorities, or the principles set
forth in the Executive Order.
A regulatory impact analysis must be
prepared for major rules with economical-
ly significant effects (for example, $100
million or more in any one year), and a
“significant” regulatory action is subject
to review by OMB. The Departments an-
ticipate that this regulatory action is likely
to have economic impacts of $100 million
or more in at least 1 year, and thus meets
the definition of an “economically signif-
icant rule” under Executive Order 12866.
Therefore, the Departments have provided
an assessment of the potential costs, ben-
efits, and transfers associated with these
interim final rules. In accordance with
the provisions of Executive Order 12866,
these interim final rules were reviewed by
OMB.
1. Need for Regulatory Action
A surprise medical bill is an unex-
pected bill from a health care provider
101
All references to the Departments in the Economic Impact section of the preamble include OPM. The analysis includes FEHB plans.

July 26, 2021 78 Bulletin No. 2021–30
or facility that occurs when a participant,
beneficiary, or enrollee receives medi-
cal services from a provider (including
a provider of air ambulance services) or
facility that, generally unbeknownst to
the participant, beneficiary, or enrollee,
is a nonparticipating provider or facility
with respect to the individual’s coverage.
Surprise bills usually occur in situations
when a patient is unable to choose a pro-
vider (including a provider of air ambu-
lance services) or emergency facility and
ensure that they receive care from only
providers or emergency facilities that are
participating for their coverage. A recent
survey revealed that two-thirds of adults
worry about being able to afford unex-
pected medical bills for themselves and
their families, and 41 percent of adults
with health insurance received a surprise
medical bill in the previous 2 years.
102

Surprise bills can cause significant fi-
nancial hardship and cause individuals to
forgo care. A project carried out by Vox, a
news and opinion website, which collect-
ed emergency department medical bills
reported instances of accident victims re-
ceiving care at out-of-network hospitals
and receiving bills of over $20,000.
103

These challenges may be more keenly
experienced by minority and underserved
communities, which are more likely to
experience poor communication, under-
lying mistrust of the medical system, and
lower levels of patient engagement than
other populations.
104
Communities ex-
periencing poverty and other social risk
factors are particularly impacted as sur-
prise medical bills can negatively affect
individuals’ abilities to eliminate debt
and create wealth, and ultimately can
affect a family for generations.
105
Effec-
tive, culturally, and linguistically tailored
communication at appropriate literacy
levels, along with policies that address
the social risk factors and other barriers
underserved communities face to access-
ing, trusting, and understanding health
care costs and coverage can reduce dis-
parities and promote health equity.
106
The No Surprises Act provides feder-
al protections against surprise billing and
limits out-of-network cost sharing under
many of the circumstances in which sur-
prise medical bills arise most frequently.
These interim final rules implement provi-
sions of the No Surprises Act that protect
individuals from surprise medical bills
for emergency services, air ambulance
services furnished by nonparticipating
providers, and non-emergency services
furnished by nonparticipating providers at
participating facilities in certain circum-
stances.
2. Summary of Impacts
The provisions in these interim final
rules will ensure that participants, benefi-
ciaries, and enrollees with health coverage
are protected from surprise medical bills.
Individuals with health coverage will gain
peace of mind, experience a reduction in
out-of-pocket expenses, be able to meet
their deductible and out-of-pocket maxi-
mum limits sooner, and may experience in-
creased access to care. Plans, issuers, health
care providers, facilities, and providers of
air ambulance services will incur costs to
comply with the requirements in these in-
terim final rules. In accordance with OMB
Circular A–4, Table 1 depicts an accounting
statement summarizing the Departments’
assessment of the benefits, costs, and trans-
fers associated with this regulatory action.
The Departments are unable to quantify all
benefits, costs, and transfers of these interim
final rules but have sought, where possible,
to describe these non-quantified impacts.
The effects in Table 1 reflect non-quanti-
fied impacts and estimated direct monetary
costs resulting from the provisions of these
interim final rules.
102
Pollitz K., et al., US Statistics on Surprise Medical Billing. JAMA. 2020;323(6):498. doi:10.1001/jama.2020.0065
103
Kliff S., Surprise medical bills, the high cost of emergency department care, and the effects on patients [published online August 12, 2019]. JAMA Intern Med. doi:10.1001/jamaint-
ernmed.2019.3448.
104
Butler S., Sherriff N. How poor communication exacerbates health inequities and what to do about it. Brookings Institution: Report (February 22, 2021). https://www.brookings.edu/
research/how-poor-communication-exacerbates-health-inequities-and-what-to-do-about-it/; Hamel, L., Lopes, L., Muñana, C., Artiga, S., Brodie, M. Race, Health, and COVID-19: The
Views and Experiences of Black Americans. Kaiser Family Foundation (October 2020). https://files.kff.org/attachment/Report-Race-Health-and-COVID-19-The-Views-and-Experiences-of-
Black-Americans.pdf; and
Shen M.J., Peterson E.B., Costas-Muñiz R. et al. The Effects of Race and Racial Concordance on Patient-Physician Communication: A Systematic Review of the
Literature. J. Racial and Ethnic Health Disparities 5, 117–140 (2018). https://doi.org/10.1007/s40615-017-0350-4.
105
Taylor, J., Racism, inequality, and health care for African Americans. The Century Foundation: Report (December 19, 2019). https://tcf.org/content/report/racism-inequality-health-care-af-
rican-americans/; and Chavis, B., Op-Ed: Big insurance must help end surprise medical billing. blackpressUSA (February 24, 2020). https://blackpressusa.com/op-ed-big-insurance-must-
help-end-surprise-medical-billing/.
106
Pérez-Stable E.J., El-Toukhy S., Communicating with diverse patients: How patient and clinician factors affect disparities. Patient Educ Couns. 2018;101(12):2186-2194. doi:10.1016/j.
pec.2018.08.021; McNally, M., Confronting disparities in access to healthcare for underserved populations. MedCity News (February 22, 2021). https://medcitynews.com/2021/02/confront-
ing-disparities-in-access-to-healthcare-for-underserved-populations-in-2021/.
TABLE 1: Accounting Statement
Benefits:
Non-Quantified:
• Elimination of surprise medical bills for individuals from out-of-network medical care and air ambulance services.
• Reduction in financial anxiety, including anxiety associated with medical debt, for individuals with health coverage, due to a
reduction in surprise bills.
• Increased access to care for individuals with health coverage that may have otherwise forgone or neglected needed treatment due
to high out-of-pocket expenses, and better health outcomes as a result. Potential improved health outcomes for individuals with
grandfathered health coverage due to the ability to choose their own primary care physicians, the ability to choose a pediatrician
as the primary care physician for children, and the ability to receive obstetrical and gynecological care without a referral.

Bulletin No. 2021–30 79 July 26, 2021
Costs:EstimateYear DollarDiscount RatePeriod Covered
Annualized Monetized ($/year)
$ 2,252.23 million20217 percent2021 – 2025
$ 2,177.12 million20213 percent2021 – 2025
Quantitative:
• Costs to issuers and third-party administrators (TPAs) to comply with the requirements related to the recognized amount and
QPA, estimated to be one-time costs of approximately $4,958 million to make the necessary information technology system
changes in 2021 and ongoing operational costs of $2,047 million in 2022 and $724 million annually from 2023 onwards.
• Costs to issuers and TPAs to revise standard operating procedures and provide training to staff, estimated to be one-time costs
of approximately $12.1 million in 2021.
• Costs to health care facilities and emergency facilities to revise standard operating procedures and provide training to staff,
estimated to be one-time costs of $117.2 million in 2021.
• Costs to providers of air ambulance services to revise standard operating procedures and provide training to staff, estimated to
be one-time costs of $517,086 in 2021.
• Costs to issuers and TPAs to share information related to QPA, estimated to be approximately $55.4 million annually starting in 2022.
• Costs to self-insured plans opting in to state law to include disclosure in plan documents, estimated to be one-time costs of ap-
proximately $50,708 in 2022.
• Costs to grandfathered health plans to provide the notice of right to designate a primary care provider, estimated to be $4.5 mil-
lion in 2022.
• Costs to nonparticipating providers and nonparticipating emergency facilities to comply with requirements related to notice and
consent, recordkeeping, and notice to plans and issuers, estimated to be one-time costs of approximately $22.6 million in 2021
and ongoing costs of $117.2 million annually starting in 2022.
• Costs to individuals to read and understand the notice from nonparticipating providers and nonparticipating emergency facilities,
estimated to be approximately $99.1 million annually, starting in 2022.
• Costs to health care providers and facilities to provide disclosures on patient protections against balance billing, estimated to be
one-time costs of approximately $6.8 million in 2021 and $2.5 million annually starting in 2022.
• Costs to states to develop state-specific language for patient disclosures to be provided by health care providers and facilities,
estimated to be one-time costs of approximately $10,732 in 2021.
• Costs to health care facilities to enter into agreements for the facilities to provide the disclosure on patient protection on behalf
of the providers, estimated to be one-time costs of approximately $6.4 million in 2021.
• Costs to plans and issuers to provide disclosure on patient protections to participants, beneficiaries and enrollees, estimated to
be approximately $699,245 in 2021 and approximately $23.4 million annually starting in 2022.
• Costs to individuals and providers to submit complaints related to surprise bills, estimated to be approximately $97,452 annually
starting in 2022.
• Costs to the federal government to build a system to receive complaints and expand existing systems, estimated to be one-time
costs of approximately $19 million in 2021; and ongoing costs to process complaints, estimated to be approximately $1.6 million
in 2021, $9.9 million in 2022, $10.1 million in 2023 and $10.3 million in 2024 and subsequent years.
Transfers:
Non-Quantified:
• Increase in health care expenditures if health care utilization increases.
Non-Quantified:
• T ransfer from plans and issuers to participants, beneficiaries, and enrollees because plans and issuers will now pay additional
amounts for some services provided by nonparticipating providers and facilities and participants, beneficiaries, and enrollees
will experience a reduction in out-of-pocket expenditures.
• Potential transfer from providers, including air ambulance providers, and facilities to the participant, beneficiary or enrollee if
the out-of-network rate collected is lower than what would have been collected had the provider or facility balance billed the
participant, beneficiary or enrollee.
More detailed analysis forthcoming in future rulemaking:
• Potential reduction in negotiated rates for certain health care services and air ambulance services, leading to reductions in cost
sharing for individuals with health coverage.
• Potential change in premiums depending on the impact on provider payments.
• Potential transfer from individuals to the federal government in the form of reduced premium tax credits if premiums decrease
as a result of these interim final rules.
• Potential transfer from the federal government to individuals in the form of increased premium tax credits if premiums increase
as a result of these interim final rules.

July 26, 2021 80 Bulletin No. 2021–30
a. Prevalence of Surprise Billing
There is extensive research on the in-
cidence of out-of-network providers and
facilities billing patients for items and
services furnished at in-network and out-
of-network health care facilities. Most of
these studies analyze claims data to iden-
tify cases that may potentially result in a
surprise medical bill. The studies reveal
that surprise billing is a significant issue
for consumers across the country and
across all types of coverage. For example,
an analysis of claims data from large group
health plans revealed that while rates var-
ied by state, 18 percent of emergency de-
partment visits, on average, resulted in
individuals receiving a surprise medical
bill in 2017. The out-of-network charges
came either from facilities or providers, or
both, though the majority of the charges
were from individual providers, rather
than facilities.
107
In addition, in 2017, 16
percent of inpatient stays at in-network fa-
cilities resulted in out-of-network charges,
though the rate of out-of-network billing
varied by state and also between rural
and urban areas. Another study revealed
that admissions at in-network hospitals
for surgery and mental health/substance
use disorders are more likely to include
out-of-network charges, and women with
large-employer coverage who have had a
mastectomy at an in-network facility were
also more likely (21 percent) to be billed
for out-of-network charges.
108
An analysis
of commercial claims data for in-network
hospital admissions in 2016 found that
out-of-network claims occurred in 14.5
percent of admissions, with wide variation
between states.
109
A study using 2007-2014 claims data
for group health plans indicated that in
2014, 20 percent of hospital inpatient
admissions that originated in the emer-
gency department, 14 percent of outpa-
tient emergency department visits, and 9
percent of elective inpatient admissions
were likely to result in surprise medical
bills. In approximately 40 percent of in-
patient admissions and more than half of
outpatient cases with surprise bills, issu-
ers paid the claims at an in-network level,
so the patients were potentially billed for
the remaining amount.
110
Another study
using claims data from a large issuer for
the period 2010-2016 found that over 39
percent of emergency department visits
to in-network hospitals resulted in an out-
of-network bill, and that the incidence in-
creased from 32.3 percent in 2010 to 42.8
percent in 2016. The average potential
amount of the surprise medical bill also
increased from $220 in 2010 to $628 in
2016. During the same time period, 37
percent of inpatient admissions to in-net-
work hospitals resulted in at least one
out-of-network bill, increasing from 26.3
percent in 2010 to 42 percent in 2016 and
the average potential amount of the sur-
prise medical bill increased from $804 to
$2,040.
111
For elective surgeries, analysis of
claims data from a large issuer revealed
that between 2012 and 2017, an out-of-
network bill occurred in over 20 percent
of cases, when the primary surgeon and
facility were in-network, resulting in po-
tential balance bills ranging from $1,255
to $3,449. Occurrences of out-of-network
bills were associated with significantly
higher total charges and out-of-pocket
costs for patients, compared to cases with-
out out-of-network bills.
112
Researchers have also tried to estimate
the amounts of surprise bills patients re-
ceive. A study using 2015 claims data
from a large issuer for services provided
at in-network hospitals concluded that
average potential balance bills from an-
esthesiologists, pathologists, radiologists,
and assistant surgeons were $1,171, $177,
$115, and $7,420, respectively.
113
Another
study analyzing 2014-2017 data related
to ambulatory surgical centers from three
large issuers revealed that in 10 percent of
cases, patients treated at in-network facil-
ities received care from out-of-network
providers, and patients may have received
surprise bills in 8 percent of cases. On av-
erage, the amount of the surprise medical
bill was $1,141, and the amount increased
by 81 percent over the period, from $819
in 2014 to $1,483 in 2017.
114
Surprise billing is often associated with
certain physician specialties, especial-
ly those whose services are not actively
“shoppable” by consumers. Researchers
analyzing claims data from a large issu-
er for the period 2010-2016 found that
for emergency department visits, out-of-
network bills arose frequently within the
context of medical transport encounters
(resulting in out-of-network bills in 85.6
percent of incidents involving ambulanc-
es) and the following physician special-
ties: emergency medicine (32.6 percent),
anesthesiology (22.8 percent), internal
medicine (23.8 percent), cardiology (20.9
percent), family practice (20.1 percent),
radiology (18.1 percent), general surgery
(13.3 percent), and pediatrics (8.4 per-
cent). For inpatient admissions at in-net-
work hospitals, in addition to medical
transport (81.6 percent of cases involving
ambulances), the study found that out-
of-network bills arose most commonly
with the following physician specialties:
emergency medicine (42.6 percent of total
inpatient admissions with at least 1 claim
submitted by the given specialty), internal
medicine (25.3 percent), radiology (22.6
percent), pathology (22.2 percent), cardi-
ology (19.6 percent), anesthesiology (19.3
percent), family practice (18.2 percent),
107
Pollitz K., et al., An examination of surprise medical bills and proposals to protect consumers from them, Peterson‐KFF Health System Tracker, February 10, 2020, https://www.healthsys-
temtracker.org/brief/an-examination-of-surprise-medical-bills-and-proposals-to-protect-consumers-from-them-3/.
108
Pollitz, K. et al., Surprise Bills Vary by Diagnosis and Type of Admission, Peterson-KFF Health System tracker, December 9, 2019, https://www.healthsystemtracker.org/brief/surprise-
bills-vary-by-diagnosis-and-type-of-admission/.
109
Kennedy K. et al., Surprise out-of-network medical bills during in-network hospital admissions varied by state and medical specialty, 2016, Health Care Cost Institute, March 28, 2019,
https://healthcostinstitute.org/out-of-network-billing/oon-physician-bills-at-in-network-hospitals.
110
Garmon C. and Chatock B., One In Five Inpatient Emergency Department Cases May Lead to Surprise Bills, Health Affairs 36, No. 1 (2017): 177-181.
111
Sun EC, Mello MM, Moshfegh J, Baker LC. Assessment of Out-of-Network Billing for Privately Insured Patients Receiving Care in In-Network Hospitals. JAMA Intern Med.
2019;179(11):1543–1550. doi:10.1001/jamainternmed.2019.3451.
112
Chhabra K.R. et al., Out-of-Network Bills for Privately Insured Patients Undergoing Elective Surgery With In-Network Primary Surgeons and Facilities, 2020;323(6):538–547. doi:10.1001/
jama.2019.21463.
113
Cooper Z et al., Out-of-Network Billing And Negotiated Payments for Hospital-Based Physicians, Health Affairs 39, No. 1, 2020. doi: 10.1377/hlthaff.2019.00507.
114
Duffy E et al., Prevalence And Characteristics Of Surprise Out-of-Network Bills from Professionals in Ambulatory Surgery Centers, Health Affairs 39, No. 5, 2020. doi:10.1377/
hlthaff.2019.01138.

Bulletin No. 2021–30 81 July 26, 2021
and obstetrics and gynecology (0.8 per-
cent).
115
While emergency medicine phy-
sicians make up only approximately 5
percent of the total number of active phy-
sicians,
116
these studies show that emer-
gency medical physicians have the high-
est percentage of out-of-network claims.
Analysis of claims data for elective sur-
geries from a large issuer revealed that
between 2012 and 2017, out-of-network
claims were commonly associated with
anesthesiologists (in 37 percent of cases),
surgical assistants (37 percent), patholo-
gists (22 percent), radiologists (7 percent),
and medical consultants (3 percent).
117
An-
other study analyzing commercial claims
data for in-network inpatient admissions
in 2016 found that some specialties with
large shares of out-of-network bills were
anesthesiology (16.5 percent), primary
care (12.6 percent), and emergency med-
icine (11 percent) and that the specialties
that most often billed as out-of-network
at in-network facilities were independent
labs (22.1 percent), followed by emergen-
cy medicine (12 percent).
118
Another study
analyzing 2014-2017 data related to am-
bulatory surgical centers from three large
issuers revealed that out-of-network bills
often came from anesthesiologists (44
percent of bills), certified registered nurse
anesthetists (25 percent), independent lab-
oratories (10 percent) and pathologists (3
percent).
119
As discussed earlier in this preamble,
multiple studies have shown that a large
percentage of out-of-network bills come
from independent laboratories. An analy-
sis of 2008-2016 claims data for individ-
uals with group health insurance coverage
found that there was an increase in the
share of out-of-network laboratory spend-
ing, and that utilization and prices for out-
of-network laboratory tests increased rel-
ative to in-network tests during that time
period. The number of out-of-network
laboratory tests increased by 18.9 percent
each year, while the number of in-network
laboratory tests increased by 2.3 percent
per year. The study authors speculated
that large suppliers of laboratory services
have sufficient market power to set high
out-of-network prices and utilization by
clinicians may be influenced by financial
incentives.
120
Providers who choose to remain out-
of-network usually do so because it does
not affect their patient volume. The ability
to balance bill is often used as leverage
by such providers to obtain higher in-net-
work payments when they join plans’ or
issuers’ networks. Higher in-network pay-
ments lead to higher premiums,
121
higher
cost sharing for consumers, and increased
health care expenditures overall. For ex-
ample, hospitals often outsource the staff-
ing of their emergency departments to
outside firms. A study on out-of-network
billing in emergency departments looked
at the behavior of the two largest emer-
gency department staffing firms in the
United States.
122
The study found that one
firm exits networks when it enters into a
contract with a hospital, and bills as an
out-of-network provider. The other firm
temporarily exits networks and later re-
joins after negotiating higher in-network
payments.
Utilizations of air ambulance services
also frequently result in surprise bills. A
study by the Government Accountabili-
ty Office (GAO) analyzed private health
insurance claims from 2012 and 2017 to
describe the extent to which air ambu-
lance transports are out-of-network.
123

This study analyzed claims data from ap-
proximately 24,100 transports in 2012 and
another 33,800 transports in 2017 from all
50 states and the District of Columbia.
The study found that in 2012, 75 percent
of transports were out-of-network and in
2017, 69 percent were out-of-network.
The GAO also reported that the median
price charged by providers of air ambu-
lance services had increased from a rate
of $22,100 for rotary-wing and $24,900
for fixed-wing in 2012 to approximately
$36,400 for rotary-wing and $40,600 for a
fixed-wing transport in 2017.

The changes
in price between 2012 and 2017 indicate a
consistent rate of increase as a previously
published report by the GAO also noted
that between 2010 and 2014, the median
prices charged by providers of air ambu-
lance services for rotary-wing transports
approximately doubled.
124
Another study
found that for one of the largest providers
of air ambulance services (with a market
share of approximately 24 percent) the av-
erage charge increased from $17,262.23
in 2009 to approximately $50,199.24 by
2016.
125
As the costs associated with air ambu-
lance transports continue to increase, the
GAO reported that providers of air ambu-
lance services report entering into more
network contracts.
126
However, additional
115
Sun E. et al., Assessment of Out-of-Network Billing for Privately Insured Patients Receiving Care in In-Network Hospitals. JAMA Intern Med. 2019;179(11):1543–1550.
116
American Association of Medical Colleges. “Active Physicians by Age and Specialty.” Physician Specialty Data Report. (December 2019). https://www.aamc.org/data-reports/workforce/
interactive-data/active-physicians-age-and-specialty-2019. The American Association of Medical Colleges estimated that among the 935,136 active physicians in the U.S. in 2019, 45,134
were emergency physicians (4.8%).
117
Chhabra K.R. et al., Out-of-Network Bills for Privately Insured Patients Undergoing Elective Surgery With In-Network Primary Surgeons and Facilities, 2020;323(6):538–547. doi:10.1001/
jama.2019.21463.
118
Kennedy K et al., Surprise out-of-network medical bills during in-network hospital admissions varied by state and medical specialty, 2016, Health Care Cost Institute, March 28, 2019,
https://healthcostinstitute.org/out-of-network-billing/oon-physician-bills-at-in-network-hospitals.
119
Duffy E et al., Prevalence And Characteristics Of Surprise Out-of-Network Bills from Professionals in Ambulatory Surgery Centers, Health Affairs 39, No. 5, 2020. doi:10.1377/
hlthaff.2019.01138.
120
Song, Z. et al., JAMA, Out-of-Network Laboratory Test Spending, Utilization, and Prices in the US, JAMA. 2021;325(16):1674–1676. doi:10.1001/jama.2021.0720.
121
Duffy, E. et al., “Policies to Address Surprise Billing Can Affect Health Insurance Premiums.” The American Journal of Managed Care 26.9 (2020): 401–404.
122
Cooper, Z. et al., Surprise! Out-Of-Network Billing For Emergency Care in the United States, NBER Working Paper 23623, 2017, available at https://www.nber.org/papers/w23623.
123
GAO (2019) Report to Congressional Committees. Air Ambulance. Available Data Show Privately-Insured Patients Are at Financial Risk (GAO-19-292) available at: https://www.gao.
gov/assets/700/697684.pdf. The data analyzed included claims from over 50 payers in each year (including both fully- and self-insured plans) and accounted for 110.1 million covered lives
in 2012 and 145.0 million covered lives in 2017.
124
GAO (2017) Report to the Committee on Transportation and Infrastructure, House of Representatives. Air Ambulance. Data Collection and Transparency Needed to Enhance DOT Over-
sight. (GAO-17-637) available at: https://www.gao.gov/assets/gao-17-637.pdf.
125
Consumer Union. Up in the Air: Inadequate Regulation for Emergency Air Ambulance Transportation. Health Policy Report, March 2017.
126
GAO (2019) Report to Congressional Committees. Air Ambulance. Available Data Show Privately-Insured Patients Are at Financial Risk (GAO-19-292) available at: https://www.gao.
gov/assets/700/697684.pdf.

July 26, 2021 82 Bulletin No. 2021–30
analyses find that many providers of air
ambulance services, particularly those
not affiliated with a hospital, do not par-
ticipate in insurer networks and have lit-
tle incentive to do so, further noting that
network participation remains low and
provider avoidance of insurance network
participation combined with aggressive
collection practices has been described as
a business strategy of some providers of
air ambulance services.
127
A study using 2014-2017 data from
three large issuers to evaluate the share of
air ambulance claims that are out-of-net-
work and the prevalence and magnitude of
potential surprise balance bills, found that
77 percent of air ambulance transports
were out-of-network and approximately
40 percent of air ambulance transports re-
sulted in potential balance bills. The bills
averaged approximately $19,851 in addi-
tion to the standard out-of-network cost
sharing, which averaged $561. The study
also found that with out-of-network rota-
ry-wing claims, issuers paid the providers’
full billed charges approximately 48 per-
cent of the time, at an average of $35,733
and that for in-network providers, billed
charges were paid in full only 7 percent
of the time. They noted that self-insured
plans paid out-of-network claims in full
50 percent of the time, whereas fully in-
sured plans paid claims in full 38 percent
of the time.
128
A study using claims data from a large
issuer to evaluate the potential impact of
out-of-network emergency medical trans-
port services from 2013 to 2017 identified
a total of 1,498,600 ambulance encoun-
ters of which 29,972 (2 percent) were
air ambulance encounters, and of these
26,375 (88 percent) were rotary-wing and
3,597 (12 percent) were fixed-wing. The
study further noted that the prevalence
of potential surprise medical billing was
an estimated 73 percent for rotary-wing
(18,463) and 70 percent (2,518) for fixed-
wing transports.
129
The study determined
that the potential surprise billing amount
for the study period totaled approximately
$456 million for air ambulance services,
with a yearly average of $91 million and
a median potential surprise medical bill of
approximately $27,513.
130
A number of studies have reviewed
state investigations or consumer com-
plaints to obtain information on the amount
of balance billing, and costs, associated
with air ambulance transports. One study
reviewed state investigations and found
that in North Dakota, of 20 complaints
against one provider of air ambulance
services that charged a total of $884,244
(an average of $44,212 per flight), 33 per-
cent of the charges were covered by in-
surance. In an additional nine states, the
study found that 55 complaints resulted in
a combined $3.8 million in charges, or an
average of $77,000 per trip; and in Mon-
tana, the study found the average out-of-
network rate, of the 19 bills analyzed, was
$53,397.
131
The GAO further analyzed 60
consumer complaints related to air ambu-
lance services from Maryland and North
Dakota and found that from 24 complaints
in Maryland the balance billed amounts
ranged from $12,300 to $52,000 and from
36 complaints in North Dakota the bal-
ance bills ranged from $600 to $66,000.
132
b. Impact of Surprise Medical Bills
A study of out-of-network billing in
emergency departments considered how
some providers use the ability to bill
out-of-network to increase payments.
The study found that charges from out-
of-network physicians in emergency de-
partments were 637 percent of Medicare
payments, which is 2.4 times higher than
in-network payment rates, on average, for
identical services. The study also found
that emergency department physicians
were paid in-network rates of 266 percent
of Medicare payments, a higher percent-
age of Medicare payment than most other
specialists.
133
Another study using 2017 claims data
from 3 large issuers looked at expendi-
tures on ancillary and emergency services
that are most often associated with sur-
prise bills: emergency medicine profes-
sionals, radiologists, anesthesiologists,
pathologists, emergency outpatient facil-
ities, and emergency ground ambulance
services.
134
The study concluded that a
15 percent reduction in average payments
for these services would lower premiums
by 1.4 percent to 1.6 percent; while a re-
duction in average payments to 150 per-
cent of Medicare rates would likely lower
premiums by 4.5 percent to 5.1 percent.
The authors estimated that for all consum-
ers with commercial insurance coverage,
1.6 percent and 5.1 percent reductions
in premiums would result in total annual
savings of $12 billion and $38 billion, re-
spectively.
A study using 2015 claims data from a
large issuer for services provided at in-net-
work hospitals considered the impact of
policies that would prevent anesthesiol-
ogists, pathologists, radiologists, and as-
sistant surgeons from balance billing and
would reduce their in-network payments
to 164 percent of Medicare payments. The
study concluded that such a reduction in
payment would result in savings equal to
13.4 percent of spending on physicians
and 3.4 percent of spending for people
with employer-sponsored coverage, ap-
proximately $40 billion annually.
135
127
Missouri Department of Insurance, Financial Institutions & Professional Registration. Policy Brief: Health Coverage for Air Ambulance Transportation. January 2019; and New Mexico
Office of the Superintendent of Insurance. Air Ambulance Memorial Study Report. January 2017. Available at: https://www.nmlegis.gov/handouts/ERDT%20083117%20Item%208%20
NM%20Superintendent%20of%20Insurance%20Air%20Ambulance%20Memorial%20Study%20Report.pdf.
128
Brown, E.C.F. et al., Out-of-Network Air Ambulance Bills: Prevalence, Magnitude, and Policy Solutions. The Milbank Quarterly, Vol. 98, No. 3, 2020 (pp. 747-774).
129
Chhabra, H.R., McGuire, K., Scott, J.W., Nuliyalu, U., and Ryan, A. Most Patients Undergoing Ground And Air Ambulance Transportation Receive Sizable Out-Of-Network Bills. Health
Affairs 39, NO. 5 (2020): 777–782
130
This study found that potential surprise bills in the study period increased from $41 million in 2013 to $143 million in 2017. The study further found that the median potential surprise bill
from air transportation nearly doubled from $14,356 to $27,513, or an increase of 15 percent annually, on average, after adjustment for inflation and that the prevalence ranged from 25 percent
(Minnesota) to 93 percent (Massachusetts) with the size of potential surprise bills varying widely.
131
Consumer Union. Up in the Air: Inadequate Regulation for Emergency Air Ambulance Transportation. Health Policy Report, March 2017.
132
GAO (2019) Report to Congressional Committees. Air Ambulance. Available Data Show Privately-Insured Patients Are at Financial Risk (GAO-19-292) available at: https://www.gao.
gov/assets/700/697684.pdf.
133
Cooper, Z. et al., Surprise! Out-Of-Network Billing For Emergency Care in the United States, NBER Working Paper 23623, 2017, available at https://www.nber.org/papers/w23623.
134
Duffy, E. et al., “Policies to Address Surprise Billing Can Affect Health Insurance Premiums.” The American Journal of Managed Care 26.9 (2020): 401–404.
135
Cooper Z et al., Out-of-Network Billing And Negotiated Payments for Hospital-Based Physicians, Health Affairs 39, No. 1, 2020. doi: 10.1377/hlthaff.2019.00507.

Bulletin No. 2021–30 83 July 26, 2021
Surprise bills result in higher out-of-
pocket expenses and cause financial anx-
iety and medical debt for consumers.
136

As discussed earlier in this preamble, the
impact is most keenly felt by those com-
munities experiencing poverty and other
social risk factors. Potential surprise bills
can vary in size, and are often large, as
concluded by the studies discussed previ-
ously. A Federal Reserve report found that
about 37 percent of adults in the U.S. in
2019 would not be able to pay an unex-
pected expense of $400 using cash or its
equivalent.
137
In a 2016 survey, among
the respondents with health coverage who
reported having difficulty paying medical
bills, 75 percent reported that copayments,
deductibles or coinsurance were more
than they could afford and 32 percent had
received out-of-network bills that insur-
ance either did not cover or only partially
covered.
138
Of those who had difficulty
paying out-of-network bills, 69 percent
said that it was a surprise bill and they had
not been aware that the provider was out-
of-network for their plan. Respondents
also reported that bills from emergency
room visits and hospitalizations often
made up the largest share of the amount
they owed. In the survey, respondents re-
ported making sacrifices such as reducing
expenditures on food, clothing, and basic
household items, using up savings, work-
ing additional jobs or hours, borrowing,
changing living arrangements, and reduc-
ing or delaying vacations or major house-
hold purchases. Survey respondents also
reported being contacted by collection
agencies. Survey results indicated that
37 percent of individuals with household
incomes less than $50,000 (compared to
14 percent with incomes of $100,000 or
more), and 47 percent of individuals with
a disability (compared to 22 percent of
individuals without one) had difficulties
paying medical bills, demonstrating a
disproportionate impact on these popula-
tions.
In addition, out-of-network cost shar-
ing and surprise bills usually do not count
towards an individual’s deductible or max-
imum out-of-pocket expenditure limit.
Therefore, individuals with surprise bills
may have difficulty reaching those limits,
even though they may have high health
care expenses. This can result in reduced
access to care, since high medical expens-
es can cause individuals to delay or forgo
medical care. In a 2017 survey, 64 percent
of respondents reported that they had de-
layed care in the last year because of high
medical expenses and 44 percent stated that
they would forgo care if their out-of-pock-
et expenses would be more than $500.
139

Another study reported that 7 percent
of adults with health insurance delayed
or went without care in 2019 because of
cost reasons and adults who are in worse
health are twice as likely to delay or forgo
care because of cost reasons.
140
This study
also reported that while 10.5 percent of all
adults reported delaying or forgoing medi-
cal care due to costs, 15.1 percent of His-
panic adults and 13 percent of Non-Hispan-
ic Black adults and 17.7 percent of adults
with income below 200 percent of the fed-
eral poverty level reported the same, show-
ing the disparate effect of high cost of care
on these communities. Another survey con-
cluded that 65 million adults had a health
issue but did not seek treatment because of
cost reasons in 2018.
141
In addition to causing financial hard-
ship, surprise medical bills may also cause
consumers to change providers in the fu-
ture. Analysis of a large national sample
of claims for obstetrics patients who had
two deliveries covered by insurance found
that 11 percent of patients received a sur-
prise medical bill for their first delivery
and were 13 percent more likely to switch
hospitals for the second delivery com-
pared to patients who did not.
142
Individuals living in rural areas expe-
rience socioeconomic and health related
disparities.
143
Rural areas have fewer pri-
mary care and mental health providers
and higher rates of preventable hospital-
izations. Currently, there are 1,805 ru-
ral hospitals in the United States,
144
with
137 rural hospitals having closed since
2010.
145
Individuals who live in rural or
geographically remote areas often must
rely on air ambulance services for transfer
to facilities with equipment and expertise
to treat serious medical conditions. Often
these transports are costly due to lack of
options for in-network providers available
to provide lifesaving services.
146
It is es-
timated that a quarter of Americans, ap-
proximately 85 million people, are unable
to access health care in less than an hour
of travel time without an air ambulance,
and air ambulances may be the only via-
ble means of transporting patients to the
health care center they need.
147
One air
ambulance provider estimates that 90 per-
cent of their transports originate from ru-
ral areas, a defined by CMS.
148
The GAO
found that about 60 percent of rotary-wing
bases added between 2012 and 2017 were
located in rural areas, and about half of
fixed-wing bases added between 2012 and
136
Garmon C. and Chatock B. One In Five Inpatient Emergency Department Cases May Lead to Surprise Bills, Health Affairs 36, No. 1 (2017): 177-181.
137
Board of Governors of the Federal Reserve System, Report on the Economic Well-Being of U.S. Households in 2019 - May 2020, https://www.federalreserve.gov/publications/2020-eco-
nomic-well-being-of-us-households-in-2019-dealing-with-unexpected-expenses.htm.
138
Hamel, Liz et al., The Burden of Medical Debt: Results from the Kaiser Family Foundation/New York Times Medical Bills Survey, The Henry J. Kaiser Family Foundation, 2016, https://
www.kff.org/wp-content/uploads/2016/01/8806-the-burden-of-medical-debt-results-from-the-kaiser-family-foundation-new-york-times-medical-bills-survey.pdf.
139
Heath, Sara, 64% of Patients Avoid Care Due to High Patient Healthcare Costs, Patient Engagement HIT, 2018, https://patientengagementhit.com/news/64-of-patients-avoid-care-due-to-
of-high-patient-healthcare-costs.
140
Amin, K et al., How Does Cost Affect Access to Care?. Peterson-KFF Health System Tracker. January 5, 2021. https://www.healthsystemtracker.org/chart-collection/cost-affect-access-
care/#item-start.
141
Gallup and West Health, The U.S. Healthcare Cost Crisis. 2019. https://news.gallup.com/poll/248081/westhealth-gallup-us-healthcare-cost-crisis.aspx.
142
Chartock, B et al., Consumers’ Responses to Surprise Medical Bills in Elective Situations, Health Affairs 38, No.3 (2019): 425-430.
143
North Carolina Rural Health Research Program. Rural Health Snapshot (2017). May 2017. https://www.shepscenter.unc.edu/wp-content/uploads/dlm_uploads/2017/05/Snapshot2017.pdf.
144
American Hospital Association, Fast Facts on U.S. Hospitals, 2021. https://www.aha.org/statistics/fast-facts-us-hospitals.
145
Cecil G. Sheps Center for Health Services Research, UNC. Rural Hospital Closures. https://www.shepscenter.unc.edu/programs-projects/rural-health/rural-hospital-closures/.
146
Haer, A., Senate Bill 1264: The Texan Template for the National Fight Against Balance Billing. Texas Law Review, 99(4), 813–838 (2021).
147
Hinsdale, J.G. Report of the Council on Medical Services: Air Ambulance Regulations and Payments. American Medical Association. (2018), available at: https://www.ama-assn.org/
system/files/2018-12/i18-cms-report2.pdf.
148
Air Evac Lifeteam. https://lifeteam.net/history-and-mission/#:~:text=Approximately%2090%20percent%20of%20Air,are%20based%20in%20rural%20areas.

July 26, 2021 84 Bulletin No. 2021–30
2017 were rural.
149
As a result of the grow-
ing reliance on air ambulance services,
rural populations are disproportionately
affected by high costs of air ambulance
services.
c. Existing State Laws Regarding Balance
Billing
As of February 5, 2021, 33 states have
enacted legislation that provides some
protection for consumers with regard to
balance bills.
150
Laws vary by state; there
are differences in the types of networks,
plans, facilities, and providers that are sub-
ject to regulations, and in payment stan-
dards. While most of these states prohibit
balance billing for emergency services,
many of them also prohibit balance billing
for certain non-emergency care furnished
at in-network hospitals. It is possible that
states may enact new legislation or mod-
ify existing legislation in response to the
passage of the No Surprises Act and these
implementing regulations.
Even within a state that has enacted
such protections, those protections typi-
cally apply only to individuals enrolled
in group or individual health insurance
coverage, as ERISA generally preempts
state laws that regulate self-insured
group health plans sponsored by private
employers. (Some state laws allow ER-
ISA-covered plans to opt in to the con-
sumer protections and process for setting
payment under the state law.) In addition,
states are limited in their ability to ad-
dress surprise bills that involve out-of-
state providers.
The air ambulance industry current-
ly functions and operates within the
health care system unlike any other enti-
ty or service, only somewhat due to the
unique nature of the service. There are
limited avenues for states and the U.S.
Department of Transportation (DOT)
to regulate their operations. States and
the DOT have limited authority under
the ADA to regulate the prices, routes,
or services of an air carrier, including
an air ambulance operator, in air trans-
portation.
151
The intent of the ADA was
to allow the prices of air transportation
services to be controlled by market forc-
es.
152
The ADA defines an “air carrier”
as “a citizen of the United States un-
dertaking by any means, directly or in-
directly, to provide air transportation;”
defining “air transportation” to include
interstate air transportation.
153
The ADA
effectively limits the ability of states to
regulate the prices, routes, or services
of air carriers that provide transporta-
tion services,
154
explicitly stating that
states “may not enact or enforce a law,
regulation, or other provision having the
force and effect of law related to a price,
route, or service of an air carrier that
may provide air transportation.”
155
The
Departments are not aware of any state
laws regulating or limiting surprise bill-
ing or other price control measures with
regard to air ambulance providers or the
air ambulance industry.
State laws appear to have succeeded in
providing some protection to consumers
from balance billing. A study analyzing
the impact of New York State’s law con-
cluded that the law resulted in a 34 per-
cent reduction in surprise billing in the
state and lowered in-network emergency
department physician payments by 9 per-
cent.
156
In addition, between the imple-
mentation of the law in March 2015 and
the end of 2018, the law saved individ-
uals in the state over $400 million with
respect to emergency services.
157
These
savings were partly due to a reduction in
costs associated with emergency services
and a greater incentive to participate in
provider networks. In New Jersey, issu-
ers experienced a reduction in costs as-
sociated with emergency and inadvertent
out-of-network claims since the state law
took effect.
158
The total spending on in-
voluntary out-of-network services were
reduced by 56 percent for issuers in the
individual market and by 38 percent for
the issuers in the small group market. A
report on California law concluded that
patients were being protected from sur-
prise medical bills in the state and that is-
suers had broader networks such that 80
percent to 100 percent of their hospitals
and health care facilities had no nonpar-
ticipating providers practicing there.
159
A
study on the impact of California’s sur-
prise billing law analyzed claims data
for provider specialties most affected
by the law (anesthesiology, diagnostic
radiology, pathology, assistant surgeons,
and neonatal-perinatal medicine) for the
pre-implementation period from Janu-
ary 2014 to June 2017 and the post-im-
plementation period from July 2017 to
December 2018.
160
The study concluded
that the share of services delivered out-
of-network by the affected specialties at
inpatient hospitals and ambulatory sur-
gical centers decreased by 17 percent,
ranging from a 15 percent reduction for
pathology to a 31 percent decline for neo-
natal-perinatal medicine.
149
GAO (2019) Report to Congressional Committees. Air Ambulance. Available Data Show Privately-Insured Patients Are at Financial Risk (GAO-19-292), available at: https://www.gao.
gov/assets/700/697684.pdf.
150
The Commonwealth Fund, State Balance-billing Protections. https://www.commonwealthfund.org/sites/default/files/2021-03/Hoadley_state_balance_billing_protections_table_02052021.
pdf.
151
See https://www.transportation.gov/individuals/aviation-consumer-protection/air-ambulance-service.
152
Missouri Department of Insurance, Financial Institutions & Professional Registration. Policy Brief: Health Coverage for Air Ambulance Transportation. January 2019.
153
49 U.S.C. § 40102
154
49 U.S.C. § 41713
155
49 U.S.C. § 41713(b)
156
Cooper, Z. et al., Surprise! Out-Of-Network Billing For Emergency Care in the United States, NBER Working Paper 23623, 2017, available at https://www.nber.org/papers/w23623.
157
New York State Department of Financial Services. New York’s Surprise Out-of-Network Protection Law: Report on the Independent Dispute Resolution Process. September 2019.
158
State of New Jersey Department of Banking and Insurance. The Out-of-network Consumer Protection, Transparency, Cost Containment, and Accountability Act (P.L. 2018, c. 32) Data
Reporting. As of January 31, 2021. https://www.state.nj.us/dobi/division_insurance/oonarbitration/data/210131report.html.
159
Health Access California. Patients Protected, Providers Paid: Data From Three Years of California’s Compromise to Stop Surprise Medical Bills. September 2019. https://health-access.org/
wp-content/uploads/2019/09/ha-factsheet-AB72report-final.pdf.
160
Adler, L et al. California Saw Reduction In Out-Of-Network Care From Affected Specialties After 2017 Surprise Billing law. USC-Brookings Schaeffer Initiative for Health Policy,
September 26, 2019. https://www.brookings.edu/blog/usc-brookings-schaeffer-on-health-policy/2019/09/26/california-saw-reduction-in-out-of-network-care-from-affected-specialties-after-
2017-surprise-billing-law/.

Bulletin No. 2021–30 85 July 26, 2021
d. Benefits
Provisions in these interim final rules
will protect participants, beneficiaries, or
enrollees with health coverage from re-
ceiving surprise bills for emergency ser-
vices, air ambulance services furnished by
nonparticipating providers, and non-emer-
gency services furnished by nonparticipat-
ing providers at participating facilities in
certain circumstances. Providers will no
longer be able to balance bill an individu-
al for emergency services. A provider will
only be able to balance bill an individual
for certain post-stabilization services, and
for services performed by nonparticipat-
ing providers at certain participating fa-
cilities, if the provider or facility provides
notice to the participant, beneficiary, or
enrollee, and obtains the individual’s con-
sent to receive care on an out-of-network
basis and be balance billed. Further, pro-
visions ensuring all relevant civil rights
protections are upheld and communica-
tion with consumers is accessible, in a
language that is understandable, and at an
appropriate literacy level, help to effec-
tively confer these protections to minority
and underserved communities.
These interim final rules also specify
that for emergency services furnished by
a nonparticipating provider or emergency
facility, and for non-emergency services
furnished by nonparticipating providers
in a participating health care facility, cost
sharing is generally calculated as if the to-
tal amount that would have been charged
for the services by a participating emer-
gency facility or participating provider
were equal to the recognized amount for
such services, as defined by the statute and
in these interim final rules, while for non-
participating providers of air ambulance
services, cost sharing is generally cal-
culated as if the total amount that would
have been charged for the services by a
participating provider of air ambulance
services were equal to the lesser of the
billed amount or QPA, as defined by the
statute and in these interim final rules.
In addition, these interim final rules re-
quire that these cost-sharing amounts be
counted toward any in-network deductible
or in-network out-of-pocket maximums
applied under the plan or coverage in the
same manner as if such cost-sharing pay-
ments were made with respect to services
furnished by a participating provider, par-
ticipating facility, or participating provid-
er of air ambulance services.
Consider, for example, one case in-
cluded in the project by Vox,
161
where a
victim of a violent attack was taken to an
emergency facility. When the individual
was able, he checked to make sure that
the hospital was in-network for his plan.
He was not aware, however, that the
surgeon who performed emergency jaw
surgery was nonparticipating for his plan
and the individual received a surprise bill
of $7,924. Two other cases in the same
study included an individual involved in
a bike crash and another individual hit by
a public bus. Both individuals were treat-
ed at the same emergency facility, which
was out-of-network for both their plans
and received surprise bills of $20,243
and $27,660, respectively. In another
case, the parents of an infant who needed
an inter-facility air ambulance transport
for urgent surgery received a surprise
medical bill of approximately $64,000
from the air ambulance provider.
162
An-
other case reported in the media
163
in-
volved an expectant mother choosing an
in-network hospital and a participating
obstetrician for the birth of her baby.
However, a nonparticipating pediatrician
was called in due to a potential risk of
post-delivery complications for the baby.
The mother later received a surprise bill
of $636 from the pediatrician because
her plan had denied the claim. In each of
these situations, plans and issuers either
denied the claim or paid the nonpartici-
pating provider, nonparticipating facility,
or nonparticipating provider of air ambu-
lance services an amount that the plan or
issuer considered reasonable for the ser-
vices provided, and the nonparticipating
provider or nonparticipating facility sent
a balance bill to the individual. Under the
No Surprises Act and these interim final
rules, individuals in similar situations
will only be responsible for in-network
cost-sharing amounts and deductibles.
Nonparticipating providers and non-
participating facilities will not be able
to balance bill such individuals, but in-
stead will need to agree to an amount of
payment with plans and issuers or enter
into the independent dispute resolution
process to determine an appropriate pay-
ment amount, if agreement on a payment
amount cannot be reached.
Therefore, individuals with health
coverage, including members of minority
and underserved communities, are likely
to see a significant reduction in balance
billing, reducing one source of anxiety,
financial stress, and medical debt. They
will also experience a reduction in out-
of-pocket expenditures, because they
will only be liable for their in-network
cost-sharing amounts when receiving
care from nonparticipating providers,
emergency facilities, and providers of
air ambulance services, which will now
count towards their deductible and max-
imum out-of-pocket limits, allowing in-
dividuals to reach those limits sooner. As
discussed previously in this preamble, a
significant number of individuals forgo
or delay care due to the cost of care. A re-
duction in out-of-pocket expenses is like-
ly to improve access to care and allow
individuals to obtain needed treatment
that they may otherwise have neglected
or foregone due to concerns about the
cost of care.
These interim final rules also establish
a complaints process for receiving and re-
solving complaints related to these new
surprise billing protections. The Depart-
ments are of the view that this will result
in increased compliance with balance bill-
ing requirements and ensure that all indi-
viduals, including members of minority
and underserved communities, are able
to benefit from the protections provided
161
Kliff S. Surprise medical bills, the high cost of emergency department care, and the effects on patients [published online August 12, 2019]. JAMA Intern Med. doi:10.1001/jamaint-
ernmed.2019.3448.
162
Wingerter, Megan. $64K Air Ambulance Tab Shows Limits of Surprise Billing Law. Claims Journal. January 4, 2021. https://www.claimsjournal.com/news/national/2021/01/04/301271.
htm.
163
Herman, Bob. Billing squeeze: Hospitals in middle as insurers and doctors battle over out-of-network charges. Modern Healthcare, August 29, 2015. https://www.modernhealthcare.com/
article/20150829/MAGAZINE/308299987/billing-squeeze-hospitals-in-middle-as-insurers-and-doctors-battle-over-out-of-network-charges.

July 26, 2021 86 Bulletin No. 2021–30
by the No Surprises Act and these inter-
im final rules. The Departments also seek
comment from members of minority and
underserved communities to help identi-
fy barriers to individuals exercising their
rights under the No Surprises Act, as well
as policies to address and remove such
barriers.
The No Surprises Act extends the
applicability of the patient protections
for choice of health care professionals
to grandfathered health plans. Partic-
ipants, beneficiaries, and enrollees in
grandfathered plans will now be able to
designate any participating primary care
provider who is available to accept the
participant, beneficiary, or enrollee. If
patients are able to choose physicians
they trust and with whom they have a
good relationship, they are likely to have
better health outcomes.
164
Similarly, al-
lowing physicians specializing in pedi-
atrics to become primary care physicians
for children will also improve health
outcomes for children. The American
Academy of Pediatrics (AAP) strongly
supports the idea that the choice of pri-
mary care clinicians for children should
include pediatricians.
165
In addition, a fe-
male participant, beneficiary, or enrollee
in a grandfathered plan who seeks cover-
age for obstetrical or gynecological care
provided by a participating health care
professional who specializes in obstet-
rics or gynecology will not need an au-
thorization or referral by the plan, issuer,
or any person (including a primary care
provider), which will allow them to ob-
tain care without any delay.
The potential financial savings to
consumers as a result of the protections
in these interim final rules are signifi-
cant. As of January 1, 2022, individuals
across the country will no longer receive
surprise medical bills for out-of-net-
work emergency services, non-emergen-
cy services provided by nonparticipat-
ing providers at certain participating
health care facilities, or air ambulance
services. The Departments understand
that some of these savings will result in-
stead in cost transfers from participants,
beneficiaries, and enrollees to group
health plans or issuers, as discussed lat-
er in this preamble, or may ultimately
be paid for by individuals in the form
of increased health insurance premi-
ums, which will be discussed in future
rulemaking. However, the Departments
anticipate that there are potentially ad-
ditional cost savings for individuals,
but are unaware of comprehensive na-
tional data that quantifies the potential
financial benefits to individuals of the
surprise billing protections included in
these rules and invite stakeholders to
share relevant data that would help the
Departments quantify this potential con-
sumer financial benefit.
e. Costs
Plans, issuers, health care providers,
facilities, and providers of air ambulance
services will incur significant costs to
comply with the requirements of these in-
terim final rules.
These interim final rules specify that
for emergency services furnished by a
nonparticipating provider or emergency
facility, and for non-emergency services
furnished by nonparticipating provid-
ers in a participating health care facility,
cost sharing is generally calculated as if
the total amount that would have been
charged for the services by a participat-
ing emergency facility or participating
provider were equal to the recognized
amount for such services, as defined by
the No Surprises Act and these interim
final rules. For nonparticipating provid-
ers of air ambulance services, cost shar-
ing is generally calculated as if the total
amount that would have been charged for
the services by a participating provider of
air ambulance services were equal to the
lesser of the billed amount or the QPA, as
defined by the statute and in these interim
final rules. In addition, these interim final
rules require that such cost sharing must
also be counted toward any in-network
deductible or in-network out-of-pock-
et maximums applied under the plan or
coverage in the same manner as if such
cost sharing payments were made with
respect to services furnished by a partici-
pating provider, a participating facility, or
a participating provider of air ambulance
services.
Under these interim final rules,
cost-sharing for emergency services fur-
nished by a nonparticipating provider or
emergency facility, and for non-emer-
gency services furnished by nonpartici-
pating providers in a participating health
care facility, must be calculated based
on the “recognized amount,” which is:
(1) an amount determined by an appli-
cable All-Payer Model Agreement under
section 1115A of the Social Security Act,
(2) if there is no such applicable All-Pay-
er Model Agreement, an amount deter-
mined by a specified state law, or (3) if
there is no such applicable All-Payer
Model Agreement or specified state law,
the lesser of the billed amount for the ser-
vices or the QPA, which generally is the
median of the contracted rates of the plan
or issuer for the item or service furnished
in the applicable geographic region. For
air ambulance services, subject to these
interim final rules, plans and issuers gen-
erally must use the QPA to calculate cost
sharing.
Plans and issuers will incur significant
costs to calculate the recognized amount
and applicable cost-sharing amount. The
Departments assume that for self-in-
sured group health plans, the costs will
be incurred by third party administrators
(TPAs). The Departments estimate a to-
tal 1,758 entities – 1,553 issuers
166
and
205 TPAs
167
– will be required to comply
with these interim final rules with regard
164
Olaisen, R., et al., “Assessing the Longitudinal Impact of Physician-Patient Relationship on Functional Health.” The 18 Annals of Family Medicine 5 (2020). https://www.annfammed.
org/content/18/5/422.
165
See AAP Policy Statement, “Guiding Principles for Managed Care Arrangements for the Health Care of Newborns, Infants, Children, Adolescents, and Young Adults”. https://pediatrics.
aappublications.org/content/pediatrics/132/5/e1452.full.pdf.
166
Based on data from MLR annual report for the 2019 MLR reporting year, available at https://www.cms.gov/CCIIO/Resources/Data-Resources/mlr.
167
Non-issuer TPAs based on data derived from the 2016 Benefit Year reinsurance program contributions.

Bulletin No. 2021–30 87 July 26, 2021
to calculating the QPA and to calculate
an individual’s cost sharing liability. The
Departments anticipate that issuers and
TPAs will need to make changes to their
information technology (IT) systems to
include the capability to calculate the
QPA for all out-of-network claims sub-
ject to the surprise billing protections,
or the amount determined by state law
or All-Payer Model Agreement, if ap-
plicable, and provide the required infor-
mation related to the QPA to nonpartic-
ipating providers and nonparticipating
emergency facilities. In addition, system
changes will be necessary to accept and
process out-of-network claims, calculate
the appropriate cost-sharing amounts and
include them in deductible and out-of-
pocket maximum limits. The one-time
cost to make system changes to include
these new functionalities may be slight-
ly lower for plans (or TPAs) and issuers
already subject to state balance billing
laws. The Departments estimate that each
plan (or TPA) or issuer will incur one-
time costs of approximately $2.8 million,
on average, to make the necessary system
changes to automate the process. The to-
tal costs for all plans (or TPAs) and is-
suers will be approximately $4,958 mil-
lion. The Departments assume that these
one-time costs will be incurred in 2021.
In addition, each issuer or TPA will incur
ongoing costs related to system mainte-
nance, processing out-of-network claims
and to acquire external data necessary to
calculate the QPA when there is insuf-
ficient information to calculate median
contracted rates starting in 2022. The
Departments estimate each issuer or TPA
will incur, on average, ongoing costs of
$1.2 million in 2022 and approximately
$411,840 annually starting in 2023. The
total annual costs for all issuers and TPAs
will be $2,047 million in 2022 and $724
million annually starting in 2023. See Ta-
bles 2 and 3 for more details. The Depart-
ments seek comment on these estimates.
TABLE 2: One-time IT Costs Related Costs for Plans and Issuers in 2021
2021
Occupation:
Hourly
Wage Rate
Time
(hours)
Estimated
Labor Cost
IT Costs
Project Manager/Team Lead$110.002,080$228,800
Scrum Master$110.003,640$400,400
Senior Business Analysis$134.001,560$209,040
UX Researcher/Service Designer$129.002,080$268,320
Technical Architect/Sr. Developer$207.002,080$430,560
DevOps Engineer/Security Engineer$143.001,560$223,080
Application Developer$111.009,360$1,038,960
Total IT Costs for Each Issuer or TPA22,360$2,799,160
Total IT Costs for all Issuers and TPAs39,308,880$4,920,923,280
Management Costs
Chief Executives$190.2480$15,219
Lawyers$143.1840$5,727
Total120$20,946
Total Management Costs for all plans and issuers210,960$36,823,771
Total Costs for all Issuers and TPAs39,519,840$4,957,747,051
Note: All wage rates except those related to management costs use the Contract Awarded Labor Category (CALC) tool.
168
Wage rates for management costs are derived
using data from the Bureau of Labor Statistics to derive average labor costs (including a 100 percent increase for fringe benefits and overhead).
169
168
The CALC tool (https://calc.gsa.gov/) was built to assist acquisition professionals with market research and price analysis for labor categories on multiple U.S. General Services Adminis-
tration (GSA) & Veterans Administration (VA) contracts. Wages obtained from the CALC database are fully burdened to account for fringe benefits and overhead costs.
169
See May 2020 Bureau of Labor Statistics, Occupational Employment Statistics, National Occupational Employment and Wage Estimates, available at https://www.bls.gov/oes/current/
oes_nat.htm.

July 26, 2021 88 Bulletin No. 2021–30
TABLE 3: Ongoing Annual Operational Costs for Issuers and TPAs starting in 2022
20222023 onwards
Occupation:
Hourly Wage
Rate
Time (hours)
Estimated Labor
Cost
Time
(hours)
Estimated Labor
Cost
Project Manager/Team Lead$110.001,040$114,400520$57,200
Scrum Master$110.001,300$143,000520$57,200
Senior Business Analysis$134.00780$104,5200$0
UX Researcher/Service Designer$129.00780$100,6200$0
Technical Architect/Sr. Developer$207.001,040$215,280520$107,640
DevOps Engineer/Security Engineer$143.00780$111,540520$74,360
Application Developer$111.003,380$375,1801,040$115,440
Total for Each Plan or Issuer9,100$1,164,5403,120$411,840
Total Costs for all Issuers and TPAs15,997,800$2,047,261,3205,484,960$724,014,720
Issuers
and TPAs will also need to re-
vise their standard operating procedures
to include processes related to out-of-
network claims, recognized amount and
QPA, and provide training to their billing
personnel and customer service represen-
tatives. The Departments assume that, for
each issuer or TPA, a business operations
specialist will need 40 hours (at an hourly
labor cost of $81.06) and a senior man-
ager (at an hourly labor cost of $114.24)
will need 16 hours to revise the standard
operating procedures, with a total cost of
approximately $5,070. In addition, the
Departments assume that, on average, 10
staff at each issuer and TPA will receive 4
hours of training at a cost of $1,824. For
all 1,758 issuers and TPAs, the total cost
of revising standard operating procedures
and training will be $12.1 million. The
Departments assume that these one-time
costs will be incurred in 2021 and that
new staff will be trained as a part of the
usual on-boarding process at minimal ad-
ditional cost and burden.
Health care and emergency facilities
will also incur costs to revise their standard
operating procedures and provide training
to their staff regarding notice and consent
requirements, patient disclosures, and out-
of-network billing. The Departments esti-
mate that there are 16,992 emergency and
health care facilities (6,090 hospitals,
170

270 independent freestanding emergency
departments,
171
9,280 ambulatory surgical
centers,
172
and 1,352 critical access hospi-
tals) that will incur this cost. The Depart-
ments assume that for hospital-affiliated
freestanding emergency departments, the
disclosure will be developed by the parent
hospitals. The Departments estimate that,
on average, for each health care facility, a
business operations specialist will need 40
hours and a senior manager will need 16
hours to revise the standard operating pro-
cedures, with a total cost of approximately
$5,070. In addition, on average, 10 staff
at each hospital will receive 4 hours of
training at a cost of approximately $1,824.
This estimate is an average of the costs
and burden to be incurred by each health
care facility and the Departments recog-
nize that the costs and burden may vary
depending on the size of each health care
facility. The total one-time cost for 16,992
health care facilities is estimated to be ap-
proximately $117.2 million, to be incurred
in 2021, with the expectation that new
staff will be trained as a part of the usual
on-boarding process at minimal additional
cost and burden.
Providers of air ambulance services
will also incur costs to revise their stan-
dard operating procedures and provide
training to their staff regarding out-of-
network billing. The Departments assume
that for each air ambulance provider, a
business operations specialist will need 40
hours and a senior manager will need 16
hours to revise the standard operating pro-
cedures, with a total cost of approximately
$5,070. In addition, on average, 10 staff
for each provider will receive 4 hours of
training at a cost of approximately $1,824.
The total on-time cost for each provider
of air ambulance services will be approxi-
mately $6,894 in 2021. The total one-time
cost for 75 providers of air ambulance ser-
vices
173
is estimated to be approximately
$517,086, to be incurred in 2021, with the
expectation that new staff will be trained
as a part of the usual on-boarding process
at minimal additional cost and burden.
The Departments estimate that grand-
fathered plans and issuers will incur a total
cost of approximately $4,516,225 in 2022
to provide the notice of right to designate
a primary care provider to participants,
beneficiaries, and enrollees. Self-insured
plans opting in to state law will incur one-
time costs of $50,708 in 2022 to include
a disclosure in plan documents. TPAs and
issuers will also incur costs of approxi-
mately $55.4 million annually to share
information related to QPAs with non-
participating providers, nonparticipating
emergency facilities, and nonparticipating
providers of air ambulance services. Addi-
tionally, issuers and TPAs will incur costs
170
American Hospital Association, Fast Facts on U.S. Hospitals, 2021. Available at https://www.aha.org/statistics/fast-facts-us-hospitals.
171
Emergency Medicine Network, 2018 National Emergency Department Inventory – USA. Available at https://www.emnet-usa.org/research/studies/nedi/nedi2018/.
172
Moriarty, A., Definitive Healthcare, How Many Ambulatory Surgery Centers are in the US?. Blog. April 10, 2019. Available at: https://blog.definitivehc.com/how-many-ascs-are-in-the-
us#:~:text=Currently%2C%20there%20are%20more%20than,Healthcare’s%20platform%20on%20surgery%20centers.
173
Federal Aviation Administration, Fact Sheet – FAA Initiatives to Improve Air Ambulance Safety, 2014, https://www.faa.gov/news/fact_sheets/news_story.cfm?newsId=15794.

Bulletin No. 2021–30 89 July 26, 2021
to make publicly available, post on a pub-
lic website of the plan or issuer, and in-
clude on each explanation of benefits the
disclosure regarding patient protections
against balance billing. The Departments
estimate a one-time cost, incurred in 2021,
for all issuers and TPAs to be $699,245
and ongoing annual costs, to begin in
2022, of approximately $23.4 million.
These costs are discussed in detail in the
Paperwork Reduction Act section of this
preamble.
Nonparticipating providers and non-
participating emergency facilities may
balance bill a participant, beneficiary, or
enrollee if certain notice and consent re-
quirements have been met. Providers and
facilities will incur costs to prepare the
notice, provide notice and receive consent
from patients, retain records, and provide
notice to plans and issuers. HHS estimates
that the one-time cost to prepare the notice
and consent documents will be approxi-
mately $22.6 million in 2021. The ongo-
ing annual cost to provide the notice and
obtain consent, retain records and provide
notice to plans and issuers is estimated to
be approximately $117.2 million starting
in 2022. In addition, individuals receiving
the notice and consent, where applicable,
will incur costs of approximately $99.1
million annually, starting in 2022, to read
and understand the notice. These costs are
discussed in detail in the Paperwork Re-
duction Act section of this preamble.
Health care providers and facilities will
also incur costs to make publicly available,
post on a public website of the provider
or facility, and provide to participants,
beneficiaries, and enrollees a one-page
notice disclosure on patient protections
against surprise billing and for providers
and facilities to enter into agreements for
the facilities to provide the disclosure on
behalf of the providers, HHS estimates
the one-time total cost, to be incurred in
2021, to be approximately $13.1 million
and the ongoing annual cost, to begin in
2022, to be approximately $2.5 million.
HHS encourages states to develop lan-
guage to assist facilities in fulfilling this
disclosure requirement as it applies to dis-
closing state protections against balance
billing. HHS estimates that the 33 states
that currently have legislation to provide
some protection to consumers for surprise
billing will incur one-time costs of ap-
proximately $10,732 in 2021 to develop
the model language. These costs are dis-
cussed in detail in the Paperwork Reduc-
tion Act section of this preamble.
The No Surprises Act directs the De-
partments to establish a process to receive
complaints regarding violations of the
application of the QPA by group health
plans and health insurance issuers offer-
ing group or individual health coverage.
Individuals and entities that submit a com-
plaint related to surprise billing will also
incur costs to do so. As discussed in the
Paperwork Reduction Act section of the
preamble, the Departments estimate re-
lated costs to be approximately $97,452
annually starting in 2022. In addition, the
federal government will incur a one-time
cost of approximately $16 million in 2021
to build the IT system to receive and pro-
cess complaints, an additional $3 million
to update existing systems in 2021, and
ongoing annual costs of approximately
$1.6 million in 2021, $9.9 million in 2022,
$10.1 million in 2023 and $10.3 million in
2024 and subsequent years to process the
complaints received and for system main-
tenance.
As discussed previously, individuals
with protections against surprise billing
are likely to experience a reduction in out-
of-pocket expenses. This may increase
their use of health care, which could lead
to an increase in health care expenditures
overall.
The Departments seek comment on
these estimates and also on any additional
costs incurred by plans, issuers, providers,
and facilities.
f. Transfers
The provisions in these interim final
rules will result in lower out-of-pock-
et spending by individuals. In situations
where surprise bills currently occur, par-
ticipants, beneficiaries, and enrollees will
be responsible for only an approximation
of the cost-sharing amounts they would
have paid had the services been provid-
ed by a participating emergency facility,
participating provider, or participating
provider of air ambulance services. Plans
and issuers will now be required to pay
for some expenses for items and services
provided by nonparticipating facilities,
providers, and providers of air ambulance
services that they previously did not pay
for. Thus, expenditures will shift from
certain individuals to plans and issuers. In
addition, it is possible the out-of-network
rates collected by some providers, includ-
ing air ambulance providers, and facil-
ities will be lower than they would have
been if the providers and facilities were
able to balance bill the individuals. Such
situations will result in transfers from
providers and facilities to individuals. If
there is a decrease in payments to some
participating providers, as has happened
for in-network emergency department
physician payments in the state of New
York,
174
there will be a transfer from those
providers to plans, issuers, participants,
beneficiaries, and enrollees.
As discussed previously in this pream-
ble, these interim final rules are the first
of several rules implementing the No Sur-
prises Act and the transparency provisions
of title II of Division BB of the CAA.
Later this year, the Departments intend
to issue additional regulations including
regulations regarding the federal IDR pro-
cess. The impact of the provisions of the
No Surprises Act on premiums will de-
pend on provisions not included in these
interim final rules, and more detailed anal-
ysis will therefore be included in future
rulemaking.
175
C. Regulatory Alternatives
In developing the interim final rules,
the Departments considered various alter-
native approaches.
Determining the Cost-sharing Amount.
The No Surprises Act generally requires
that cost sharing for items and services
subject to the surprise billing protections
174
Cooper, Z. et al., Surprise! Out-Of-Network Billing For Emergency Care in the United States, NBER Working Paper 23623, 2017, available at https://www.nber.org/papers/w23623.
175
These interim final rules and the forthcoming regulations are interrelated, and in cases such as this, attribution of impacts is challenging. Inclusion of more detailed analysis in later rulemak-
ing, rather than these interim final rules—about, for example, changes in premiums incentivized by the suite of surprise billing policies—should not be interpreted as indicating certainty that
such impacts will not occur as a result of these interim final rules.

July 26, 2021 90 Bulletin No. 2021–30
be based on the recognized amount. In
instances where this requirement applies,
the Departments considered whether it
should apply where the billed charge
is less than the recognized amount. In
these instances, assuming the plan or is-
suer would not pay more than the billed
charge, calculating cost sharing based on
the QPA (which is one way in which the
recognized amount might be determined)
would require a participant, beneficiary,
or enrollee to pay a higher percentage in
cost sharing than if such items or services
had been furnished by a participating pro-
vider. However, sections 9816(a)(1)(C)
(ii) and 9816(b)(1)(A) of the Code, sec-
tions 716(a)(1)(C)(ii) and 716(b)(1)(A)
of ERISA, and sections 2799A-1(a)(1)
(C)(ii) and 2799A-1(b)(1)(A) of the PHS
Act expressly prohibit plans and issuers
from applying a cost-sharing requirement
that is greater than the requirement that
would apply if services were provided by
a participating provider or a participating
emergency facility. Therefore, under these
interim final rules, in circumstances where
an All-Payer Model Agreement or speci-
fied state law does not apply to determine
the recognized amount, cost sharing must
be based on the lesser of the QPA or the
amount billed by the provider for the item
or service.
Methodology for Calculating the QPA.
The No Surprises Act generally requires
the QPA to be calculated based on the
median of the contracted rates of the plan
or issuer. The Departments considered
whether plans and issuers should take
into account the number of claims paid
at the contracted rate under each contract
in calculating the QPA. Doing so, howev-
er, would not result in a pure median of
the contracted rates, which the Depart-
ments are of the view would most clearly
follow the language of the No Surprises
Act. In addition, the Departments are of
the view that this approach would likely
put upward pressure on the QPA, by giv-
ing greater weight to contracts of larger
provider groups and facilities, which are
more likely to have negotiated higher
rates than small provider groups and facil-
ities. This approach could lead to higher
out-of-pockets costs for individuals.
The Departments also considered re-
quiring plans and issuers to calculate sep-
arate median contracted rates for facilities
based on the characteristics of facilities,
such as by distinguishing teaching hos-
pitals from non-teaching hospitals, rath-
er than distinguishing only on the basis
of whether the facility is an emergency
department of a hospital or an indepen-
dent freestanding emergency department.
The Departments decided against this
approach, as doing so would result in a
higher median contracted rate for facili-
ties with higher operating costs and is not
clearly contemplated in the definition of
QPA under the No Surprises Act. The De-
partments are of the view that the different
operating costs among facilities with dif-
ferent characteristics should not have such
a dramatic impact on median contracted
rates. However, the Departments recog-
nize that payment amounts for facility
charges may vary depending on whether
an emergency facility is connected with
a hospital. Therefore, the interim final
rules allow separate median contracted
rates to be calculated for emergency ser-
vices based on whether the facility is an
emergency department of a hospital or an
independent freestanding emergency de-
partment.
With respect to calculating a separate
QPA for each item and service for each
geographic region, the Departments con-
sidered whether to define each geograph-
ic region as the applicable rating area as
defined for purposes of the individual
and small group market rating rules un-
der PHS Act 2701 section and 45 CFR
147.102, while allowing states the flex-
ibility to establish alternative geograph-
ic regions. However, some states define
rating area by county, resulting in large
numbers of rating areas in a state, some of
which might include few, if any, facilities
and providers. Therefore, adopting rating
area as the standard for geographic region
could lead to a large number of geograph-
ic regions for which a plan or issuer would
have to calculate separate median con-
tracted rates, a large number of geograph-
ic regions without sufficient information,
as well as a large number of geographic
regions in which the median contracted
rate is influenced by outliers. Therefore,
the interim final rules do not adopt this
approach to defining geographic regions.
With respect to the statutory require-
ment for plans and issuers to calculate
separate QPAs for each insurance market,
including for self-insured group health
plans, the Departments considered wheth-
er the market for self-insured group health
plans should be limited to only self-in-
sured group health plans offered by the
same plan sponsor. However, this could
lead to greater instances of a self-insured
plan lacking sufficient information, so
the interim final rules instead define the
self-insured market as all self-insured
group health plans offered by the same
plan sponsor, or at the option of the plan
sponsor, all self-insured group health
plans administered by the same entity that
is responsible for determining the QPA on
behalf of the plan (including a third-party
administrator contracted by the plan).
Participant, Beneficiary, and Enrollee
Responsibility to Pay Recognized Amount
Only. In instances where a participant,
beneficiary, or enrollee has not satisfied
their deductible, the Departments consid-
ered whether the plan or issuer should not
be required to pay any portion of the out-
of-network rate to the nonparticipating
provider or facility. However, these inter-
im final rules require that when the out-
of-network rate exceeds the recognized
amount (the amount upon which cost shar-
ing is based), a plan or issuer must pay the
provider or facility the difference between
the out-of-network rate and the cost-shar-
ing amount (the latter of which in this case
would equal the recognized amount), even
in instances where an individual has not
satisfied their deductible. This approach is
consistent with the purpose of the No Sur-
prises Act to protect participants, benefi-
ciaries, or enrollees from surprise balance
bills that exceed in-network cost- sharing
requirements. This approach is also con-
sistent with section 102 of the No Surpris-
es Act, which amends section 223 of the
Code to specify that these payments will
not prevent a plan from qualifying as a
high-deductible health plan or make an in-
dividual ineligible to contribute to a health
savings account.
Definition of Health Care Facility. The
No Surprises Act defines a health care fa-
cility as each of the following with respect
to non-emergency services: (1) a hospital
(as defined in 1861(e) of the Social Secu-
rity Act); (2) a hospital outpatient depart-
ment; (3) a critical access hospital (as de-
fined in section 1861(mm)(1) of the Social
Security Act); (4) an ambulatory surgical

Bulletin No. 2021–30 91 July 26, 2021
center described in section 1833(i)(1)(A)
of the Social Security Act; or (5) any other
facility, specified by the Departments, that
provides items or services for which cov-
erage is provided under the plan or cov-
erage, respectively. The Departments con-
sidered whether to expand the definition
of health care facility in this rulemaking,
but concluded that the facilities at which
balance billing are currently most frequent
are included in the current definition. The
Departments anticipate continuing to
monitor the prevalence of surprise billing
at various facilities and may expand the
definition in future rulemaking. In partic-
ular, as discussed earlier in this preamble,
the Departments considered including
urgent care centers in the definition of
health care facility. However, given the
variation across states in how urgent care
centers are licensed, including the scope
of services that the centers are permitted
to provide, the Departments decided to
instead seek comment regarding whether
the definition of health care facility should
be extended to urgent care centers, includ-
ing those that are not licensed as facilities
under state law.
With respect to the definition of partic-
ipating health care facility and participat-
ing emergency facility, the Departments
considered excluding facilities that had
only single case agreements in place with
a plan or issuer. However, the Depart-
ments are persuaded that doing so could
harm participants, beneficiaries or enroll-
ees. When individuals are provided with
care, generally non-emergency items or
services, under a single case agreement,
they should not have to worry about po-
tential surprise bills. Excluding facilities
with single case agreements from the defi-
nitions of participating facilities and par-
ticipating emergency facilities would be
inconsistent with the Departments’ intent
to protect individuals from surprise med-
ical bills.
Applicability of State Law. In determin-
ing how state laws around balance billing
would intersect with the No Surprises Act,
the Departments considered alternatives
to the approach taken under these inter-
im final rules, which seek to supplement,
rather than supplant state balance billing
laws. Specifically, the Departments con-
sidered whether to allow states to be more
protective of consumers than the No Sur-
prises Act with respect to whether individ-
uals are permitted to waive balance billing
protections upon notice and consent, and
concluded that it is in the public interest
to interpret the No Surprises Act as cre-
ating a floor regarding individuals’ ability
to waive balance billing protections. The
Departments also considered whether
state provisions allowing ERISA-covered
plans to opt in to the state requirements
should be considered specified state laws
for purposes of setting the recognized
amount and out-of-network rate regarding
ERISA-covered plans that have opted into
the state programs. The Departments have
concluded such deference to state law is
consistent with the overarching structure
of the No Surprises Act. The Departments
also considered allowing providers, facil-
ities and providers of air ambulance ser-
vices to opt in to state laws (as allowed
under state laws), but decided to instead
seek comments on this approach, as dis-
cussed earlier in this preamble.
Notice and Consent Exception to Pro-
hibition on Balance Billing. Under the No
Surprises Act and these interim final rules,
the protections that limit cost sharing and
prohibit balance billing do not apply to
certain non-emergency services or to cer-
tain post-stabilization services provided in
the context of emergency care, if the non-
participating provider or nonparticipating
emergency facility furnishing those items
or services provides the participant, bene-
ficiary, or enrollee, with certain notice, the
individual acknowledges receipt of the in-
formation in the notice, and the individual
consents to be treated by the nonpartici-
pating emergency facility or nonpartici-
pating provider. These interim final rules
establish the conditions under which no-
tice and consent may be provided for cer-
tain non-emergency and post-stabilization
services. The Departments considered a
number of additional conditions under
which the notice and consent exception
would not be permitted, such as if the in-
dividual were experiencing pain, or under
the influence of alcohol or drugs, includ-
ing the use or administration of prescribed
medications. The Departments are of the
view that these factors are critical consid-
erations for whether an individual is able to
provide informed consent, and concluded
that these are factors that a provider would
be expected to assess when determining if
the individual is capable of understanding
the information provided in the notice and
the implications of consenting. The HHS
interim final rules therefore establish re-
quirements related to the notice and con-
sent exception. HHS considered a number
of alternatives in developing these inter-
im final rules. HHS considered different
standards to apply in defining geographic
regions for purposes of language access
requirements. The HHS interim final rules
require providers and facilities to provide
the notice and consent documents in the
15 most common language in the state, or
in a geographic region, which reasonably
reflects the geographic region served by
the applicable facility. HHS also consid-
ered the use of MSAs,
176
hospital service
areas (HSAs),
177
hospital referral regions
(HRRs),
178
and public use microdata areas
(PUMAs),
179
applied based on where the
applicable facility is located. These geo-
graphic regions might better reflect a fa-
cility’s service area than a state. However,
HHS is of the view that allowing providers
and facilities to use the state as the geo-
graphic region would reduce burden, and
concluded that the standard in the HHS
interim final rules provides sufficient flex-
ibility for providers and facilities to deter-
mine how best to serve their population.
HHS considered requiring that a provider
or facility that uses a region other than a
state must use a geographic region smaller
than a state, but determined this approach
would not adequately address the needs to
facilities that serve populations that cross
state borders. HHS also considered alter-
natives regarding the inapplicability of the
176
https://www.census.gov/programs-surveys/metro-micro/about.html.
177
https://www.dartmouthatlas.org/faq/.
178
https://www.dartmouthatlas.org/faq/.
179
https://www.census.gov/programs-surveys/geography/guidance/geo-areas/pumas.html#:~:text=Public%20Use%20Microdata%20Areas%20(PUMAs)%20are%20non%2Doverlapping%2C,
and%20the%20U.S.%20Virgin%20Islands.

July 26, 2021 92 Bulletin No. 2021–30
notice and consent exception to ancillary
services. HHS considered expanding the
definition of ancillary services to include
other services for which surprise billing
frequently occurs. In particular, stake-
holders raised concerns about providers
who deliver services to individuals during
inpatient stays, but who the individual
has little involvement in selecting. These
included, for example, providers furnish-
ing mental health services, cardiology
services, and rehabilitative services. The
Departments are concerned about surprise
bills that arise in these situations, but pre-
fer to further consider the recommenda-
tion. Individuals may have strong prefer-
ences to select these types of providers for
out-of-network care, and it is therefore not
clear whether they would be appropriate
to include among the types of specialties
for which notice and consent to be balance
billed is prohibited.
Applicability date. The Departments
considered delaying the applicability
date of these interim final rules in re-
sponse to stakeholder feedback regard-
ing the challenges of coming into com-
pliance with these interim final rules by
January 1, 2022. The Departments rec-
ognize the challenges that providers (in-
cluding providers of air ambulance ser-
vices), facilities, plans, and issuers will
face in making the necessary changes
to comply with these new requirements.
However, delaying the applicability date
would have significant ramifications for
participants, beneficiaries, and enrollees
and would continue to leave them vul-
nerable to surprise bills. Therefore, the
Departments concluded that it is in the
public interest to require these interim
final rules to be applicable in accordance
with the applicability dates in the No
Surprises Act.
Provider Disclosure Requirements Re-
garding Patient Protections against Bal-
ance Billing. Section 2799B-3 of the PHS
Act, as added by the No Surprises Act, re-
quires providers and facilities to provide
disclosures regarding patient protections
against balance billing. These interim final
rules include provisions to limit this dis-
closure requirement to certain providers
and facilities, and with respect to certain
individuals. These interim final rules also
include a special rule to limit unnecessary
duplication, so that a facility’s disclosure
may satisfy the disclosure requirement
on behalf of providers in certain circum-
stances. HHS considered applying the
disclosure requirement more broadly.
However, HHS determined that a broader
application of the disclosure requirements
would increase the administrative costs
associated with the requirement, without
commensurate benefits to individuals.
Rather, HHS was concerned that requir-
ing the disclosure be made by facilities
and providers in circumstances where the
protections against balance billing would
not apply could create consumer confu-
sion about their rights under the No Sur-
prises Act. Additionally, HHS determined
that requiring providers to provide a dis-
closure when furnishing services at a fa-
cility that was also required to provide a
disclosure was unnecessary and could be
overwhelming to consumers. If providers
furnishing services at a facility were re-
quired to provide a disclosure as well, at
the very least, the cost of printing and ma-
terials for the notices would have doubled,
for an additional $2.5 million in costs. If,
in addition, providers had to develop the
notices they provided, there would have
been additional costs. If all providers were
required to provide a notice, regardless
of whether the services are furnished at a
provider’s office or a health care facility,
then in addition to the 39,690,940 indi-
viduals treated in the emergency facili-
ties,
180
526,685,200 individuals visiting a
provider’s office or a health care facility
would have been provided a disclosure,
for a total of 566,376,140 disclosures.
181

The cost to print the disclosures would
have been approximately $28.3 million,
approximately $25.8 million more than it
is estimated to be under the provisions in
these interim final rules.
D. Paperwork Reduction Act—
Department of Health and Human
Services
Under the Paperwork Reduction Act of
1995 (PRA), HHS is required to provide
30-day notice in the Federal Register and
solicit public comment before a collection
of information requirement is submitted to
OMB for review and approval. To fairly
evaluate whether an information collec-
tion should be approved by OMB, section
3506(c)(2)(A) of the PRA requires that
HHS solicit comment on the following
issues:
● The need for the information collec-
tion and its usefulness in carrying out
the proper functions of our agency.
● The accuracy of HHS’ estimate of the
information collection burden.
● The quality, utility, and clarity of the
information to be collected.
● Recommendations to minimize the
information collection burden on the
affected public, including automated
collection techniques.
HHS is soliciting public comment on
each of the required issues under section
3506(c)(2)(A) of the PRA for the follow-
ing information collection requirements
(ICRs).
1. Wage Estimates
To derive wage estimates, the Depart-
ments generally used data from the Bu-
reau of Labor Statistics to derive average
labor costs (including a 100 percent in-
crease for fringe benefits and overhead)
for estimating the burden associated with
the ICRs.
182
Table 4 presents the mean
hourly wage, the cost of fringe benefits
and overhead, and the adjusted hourly
wage.
As indicated, employee hourly wage
estimates have been adjusted by a factor
of 100 percent. This is necessarily a rough
adjustment, both because fringe bene-
fits and overhead costs vary significantly
across employers, and because methods of
180
Agency for Healthcare Research and Quality, HCUP Fast Stats – Trends in Emergency Department Visits. https://www.hcup-us.ahrq.gov/faststats/NationalTrendsEDServlet?mea-
sure1=01&characteristic1=14&measure2=&characteristic2=11&expansionInfoState=hide&dataTablesState=hide&definitionsState=hide&exportState=hide#export
181
Estimates based on data on postoperative office visits. Centers for Disease Control, National Ambulatory Medical Care Survey: 2016 National Summary Tables. Available at https://www.
cdc.gov/nchs/fastats/physician-visits.htm.
182
See May 2020 Bureau of Labor Statistics, Occupational Employment Statistics, National Occupational Employment and Wage Estimates, available at https://www.bls.gov/oes/current/
oes_nat.htm.

Bulletin No. 2021–30 93 July 26, 2021
estimating these costs vary widely across
studies. Nonetheless, there is no practical
alternative, and the Departments are of the
view that doubling the hourly wage to es-
timate total cost is a reasonably accurate
estimation method.
TABLE 4: Wage Rates
Occupation Title
Occupational
Code
Mean Hourly
Wage ($/hour)
Fringe Benefits and
Overhead ($/hour)
Adjusted Hourly
Wage ($/hour)
Secretaries and Administrative Assistants, Except
Legal, Medical, and Executive
43-6014$19.43$19.43$38.86
Lawyer
23-1011$71.59$71.59$143.18
All Occupations
00-0000$27.07$27.07$54.14
Computer Programmers
15-1251$45.98$45.98$91.96
Medical Secretaries and Administrative Assistants
43-6013$18.75$18.75$37.50
Human Resources Specialists
13-1071$33.38$33.38$66.76
Business Operations Specialist
13-1198$38.57$38.57$77.14
General and Operations Manager
11-1021$59.15$59.15$118.30
Compensation and Benefits Manager
11-3111$65.94$65.94$131.88
Computer and Information Systems Managers
11-3021$77.76$77.76$155.52
2. ICRs Regarding Information to be
Shared About QPA (45 CFR 149.140(d))
These interim final rules require plans
and issuers to provide certain information
regarding the QPA to nonparticipating
providers, or nonparticipating emergen-
cy facilities in cases in which the recog-
nized amount with respect to an item or
service furnished by the provider or facil-
ity is the QPA (and in all cases subject to
these rules for nonparticipating providers
of air ambulance services). Specifical-
ly, plans and issuers must provide the
following information to providers (in-
cluding air ambulance providers) and fa-
cilities, when making an initial payment
or notice of denial of payment: (1) the
QPA for each item or service involved;
(2) a statement certifying that the plan or
issuer has determined that the QPA ap-
plies for the purposes of the recognized
amount (or, in the case of air ambulance
services, for calculating the participant’s,
beneficiary’s, or enrollee’s cost sharing),
and each QPA was determined in compli-
ance with the methodology established in
these interim final rules; (3) a statement
that if the provider or facility, as appli-
cable, wishes to initiate a 30-day open
negotiation period for purposes of de-
termining the amount of total payment,
the provider or facility may contact the
appropriate person or office to initiate
open negotiation, and that if the 30-day
negotiation period does not result in a
determination, generally, the provider
or facility may initiate the independent
dispute resolution process within 4 days
after the end of the open negotiation pe-
riod; and (4) contact information, includ-
ing a telephone number and email ad-
dress, for the appropriate person or office
to initiate open negotiations for purposes
of determining an amount of payment
(including cost sharing) for such item
or service. Additionally, upon request of
the provider or facility, the plan or issuer
must provide, in a timely manner, the fol-
lowing information: (1) whether the QPA
for items and services involved included
contracted rates that were not on a fee-
for-service basis for those specific items
and services and whether the QPA for
those items and services was determined
using underlying fee schedule rates or a
derived amount; (2) if a related service
code was used to determine the QPA for a
new service code, information to identify
the related service code; (3) if the plan
or issuer used an eligible database to de-
termine the QPA, information to identify
which database was used; and (4) if ap-
plicable, upon request, a statement that
the plan’s or issuer’s contracted rates in-
clude risk-sharing, bonus, or other incen-
tive-based or retrospective payments or
payment adjustments for covered items
and services that were excluded for pur-
poses of calculating the QPA.
The Departments assume that TPAs
will provide this information on behalf of
self-insured plans. In addition, the Depart-
ments assume that issuers and TPAs will
automate the process of preparing and pro-
viding this information in a format similar
to an explanation of benefits as part of the
system to calculate the QPA. The cost to
issuers and TPAs of making the changes
to their IT systems is discussed previously
in the RIA.
The Departments estimate that a total
of 1,758 issuers and TPAs will incur bur-
den to comply with this provision. Cur-
rently, 14 states have established some
payment standards for services provided
by nonparticipating providers or nonpar-
ticipating emergency facilities. Therefore,
the Departments assume that issuers and
TPAs will potentially need to calculate the
QPA for two-thirds of the claims involv-
ing nonparticipating providers or nonpar-
ticipating emergency facilities.
In 2018, there were approximately
39,690,940 emergency department vis-
its for patients with individual market or

July 26, 2021 94 Bulletin No. 2021–30
group health coverage.
183
The Departments
estimate that approximately 18 percent of
these visits
184
will include services provided
by nonparticipating providers or nonpartic-
ipating emergency facilities and plans and
issuers will need to calculate the QPA for
two-thirds of such claims. Therefore, plans
and issuers will be required to provide the
specified information along with the initial
payment or denial notice for approximately
4,786,727 claims annually from nonpar-
ticipating providers or nonparticipating
emergency facilities for emergency depart-
ment visits. In addition, in 2018, there were
approximately 4,146,476 emergency de-
partment visits that resulted in hospital ad-
mission for patients with individual market
or group health coverage. Using this as an
estimate of post-stabilization services pro-
vided in emergency facilities, and assum-
ing that in 16 percent of cases the patient
is treated at a nonparticipating emergency
facility or by a nonparticipating provider at
a participating facility,
185
the Departments
estimate that approximately 663,436 indi-
viduals will have the potential to be treated
by a nonparticipating provider or facility.
In the absence of data, the Departments as-
sume that in 50 percent of cases services
will be provided by nonparticipating pro-
viders without satisfying the notice and con-
sent criteria in these interim final rules for
reasons such as unforeseen, urgent medical
needs and lack of participating providers in
the facility. The Departments estimate that
plans and issuers will need to calculate the
QPA for two-thirds of such claims. There-
fore, plans and issuers will be required to
provide the required information along
with the initial payment or denial notice for
approximately 222,251 claims from non-
participating providers or nonparticipating
emergency facilities for post-stabilization
services. Additionally, based on 2016 data,
the Departments estimate that there will be
11,107,056 visits to health care facilities
annually for surgical and non-surgical pro-
cedures for individuals with group health
coverage or individual market coverage.
186

The Departments assume that in 16 percent
of cases the patient will have the potential
to receive care from a nonparticipating
provider at a participating facility, and that
in approximately 5 percent of those cases
services will be provided by nonparticipat-
ing providers without satisfying the notice
and consent criteria in these interim final
rules for reasons such as the services be-
ing ancillary services or related to unfore-
seen, urgent medical needs, and plans and
issuers will need to calculate the QPA for
two-thirds of such claims. Therefore, plans
and issuers will be required to provide the
required information along with the initial
payment or denial notice for approximately
59,534 claims annually for non-emergen-
cy services furnished by a nonparticipat-
ing provider at a participating health care
facility. In total, plans and issuers will be
required to provide documents related
to QPAs along with the initial payment
or denial of payment for approximately
5,068,512 claims annually from nonpartic-
ipating providers or facilities.
The Departments estimate that for
each issuer or TPA it will take a medical
secretary 10 minutes (at an hourly rate of
$37.50) to prepare the documentation and
attach it to each payment or denial no-
tice or explanation of benefits sent to the
nonparticipating provider or facility. The
Departments assume that this information
will be sent electronically at minimal cost.
The total annual burden for all issuers and
TPAs to provide the QPA information and
certification along with 5,068,512 pay-
ments or denial notices, is estimated to be
approximately 844,752 hours, with an as-
sociated equivalent cost of approximately
$31.7 million.
The Departments assume that for the
5,068,512 QPA information sent to non-
participating providers or nonparticipating
emergency facilities, 50 percent will result
in requests to provide additional informa-
tion and plans and issuers will be required
to send additional information to approx-
imately 2,534,256 providers or facilities.
The Departments estimate that it will take
a medical secretary 15 minutes (at an hour-
ly rate of $37.50) to prepare the document
and provide it to the provider or facility that
requested it. The Departments assume that
this information will be delivered electron-
ically with minimal additional cost. The
total estimated burden, for all issuers and
TPAs, will be approximately 633,564 hours
annually, with an associated equivalent cost
of approximately $23.8 million.
The total annual burden for all issuers
and TPAs for providing the initial and ad-
ditional information related to QPA will be
1,478,316 hours, with an equivalent cost
of $55,436,853. As DOL, the Treasury
Department and HHS share jurisdiction,
HHS will account for 50 percent of the
burden, or approximately 739,158 burden
hours with an equivalent cost of approx-
imately $27,718,427. The Departments
seek comment on these burden estimates.
TABLE 5: Annual Burden and Cost for Plans and Issuers to Provide Information Related to QPA to Nonparticipating
Providers and Nonparticipating Emergency Facilities
Estimated Number
of Respondents
Estimated Number
of Responses
Burden per
Response (Hours)
Total Annual
Burden (Hours)
Total Estimated
Cost
Initial information8792,534,2560.167422,376$15,839,100.93
Additional Information8791,267,1280.25316,782$11,879,325.70
Total8793,801,384739,158$27,718,427.63
183
Agency for Healthcare Research and Quality, HCUP Fast Stats – Trends in Emergency Department Visits. https://www.hcup-us.ahrq.gov/faststats/NationalTrendsEDServlet?mea-
sure1=01&characteristic1=14&measure2=&characteristic2=11&expansionInfoState=hide&dataTablesState=hide&definitionsState=hide&exportState=hide.
184
Estimate from Pollitz, K et al., Surprise Bills Vary by Diagnosis and Type of Admission, Peterson-KFF Health System tracker, December 9, 2019, https://www.healthsystemtracker.org/
brief/surprise-bills-vary-by-diagnosis-and-type-of-admission/.
185
Estimate from Pollitz, K et al., Surprise Bills Vary by Diagnosis and Type of Admission, Peterson-KFF Health System tracker, December 9, 2019, https://www.healthsystemtracker.org/
brief/surprise-bills-vary-by-diagnosis-and-type-of-admission/.
186
Estimates based on data on postoperative office visits. Centers for Disease Control, National Ambulatory Medical Care Survey: 2016 National Summary Tables. Available at https://www.
cdc.gov/nchs/fastats/physician-visits.htm.

Bulletin No. 2021–30 95 July 26, 2021
3. ICRs Regarding Audits of QPA (45
CFR 149.140(f))
The No Surprises Act provides that
rulemaking must establish a process under
which group health plans and health in-
surance issuers offering group or individ-
ual health insurance coverage are audited
by the applicable Secretary or applicable
state authority to ensure that such plans
and coverage are in compliance with the
requirement of applying a QPA and that
the QPA applied satisfies the definition un-
der the No Surprises Act with respect to
the year involved.
These interim final rules include an au-
dit provision establishing that the Depart-
ments’ existing enforcement procedures
will apply with respect to ensuring that a
plan or coverage is in compliance with the
requirement of determining and applying
a QPA consistent with these interim final
rules.
HHS has primary enforcement author-
ity over issuers (in a state if the Secretary
of HHS makes a determination that a state
is failing to substantially enforce a provi-
sion (or provisions) of Part A or D of title
XXVII of the PHS Act) and non-federal
governmental plans, such as those spon-
sored by state and local government em-
ployers and expects to conduct no more
than 9 audits annually. Therefore, this col-
lection is exempt from the PRA under 44
U.S.C. 3502(3)(A)(i).
4. ICRs Regarding Disclosure for Self-
Insured Plans Opting-in to State Law (45
CFR 149.30)
These interim final rules allow self-in-
sured group health plans, including self-in-
sured non-federal governmental plans, to
voluntarily opt in to state law that provides
for a method for determining the cost-shar-
ing amount or total amount payable under
such a plan, where a state has chosen to ex-
pand access to such plans, to satisfy their
obligations under section 9816(a)-(d) of
the Code, section 716(a)-(d) of ERISA, and
section 2799A-1(a)-(d) of the PHS Act. A
self-insured plan that has chosen to opt-in
to a state law must prominently display in
its plan materials describing the coverage
of out-of-network services a statement that
the plan has opted in to a specified state law,
identify the relevant state (or states), and
include a general description of the items
and services provided by nonparticipating
facilities and providers that are covered by
the specified state law.
Based on available data, HHS esti-
mates that approximately 84 self-insured
non-federal governmental plans in New
Jersey, Nevada, Virginia and Washing-
ton
187
will opt-in and incur the one-time
burden and cost to include the disclosure
in their plan documents in 2022. It is esti-
mated that for each plan an administrative
assistant will spend 1 hour (at an hourly
rate of $38.86) and a compensation and
benefits manager will spend 30 minutes
(at an hourly rate of $131.88) to prepare
the disclosure. The estimated total bur-
den for each plan will be 1.5 hours with
an equivalent cost of approximately $105.
The estimated total annual burden for all
84 plans will be approximately 126 hours
with an equivalent cost of approximately
$8,783. HHS estimates that there are ap-
proximately 11,956 policyholders in these
plans that will be provided the disclosure.
HHS assumes that only printing and ma-
terial costs are associated with the disclo-
sure requirement, because the notice can
be incorporated into existing plan docu-
ments. HHS estimates that the disclosure
will require one-half of a page, at a cost of
$0.05 per page for printing and materials,
and 34 percent of plan documents will be
delivered electronically at minimal cost.
188

Therefore, the cost to deliver 66 percent
of these disclosures in print is estimated
to be approximately $197. The total one-
time cost for all plans, incurred in 2022,
is estimated to be approximately $8,981.
TABLE 6: One-time Burden and Cost to Provide Disclosure Regarding Opting in to State Law
Year
Estimated
Number of
Respondents
Estimated
Number of
Responses
Burden Per
Response
(Hours)
Total Annual
Burden
(Hours)
Total
Estimated
Labor Cost
Total
Estimated
Printing and
Materials Cost
Total
Estimated
Cost
202284841.5126$8,783$197$8,981
5. ICRs Regarding Complaints Process
for Surprise Medical Bills (45 CFR
149.150, 45 CFR 149.450)
The No Surprises Act directs the De-
partments to establish a process to re-
ceive complaints regarding violations of
the application of the QPA requirements
by group health plans and health insur-
ance issuers offering group or individual
health coverage under section 9816(a)(2)
(B)(iv) of the Code, section 716(a)(2)(B)
(iv) of ERISA, and section 2799A-1(a)
(2)(B)(iv) of the PHS Act, and violations
by health care provider, facilities, and
providers of air ambulance services of
the requirements under sections 2799B-
1, 2799B-2, 2799B-3, and 2799B-5 of
the PHS Act. The Departments are of the
view that the complaints process should
extend to all of the balance billing re-
quirements and define a complainant as
any individual, or their authorized rep-
resentative, who files a complaint, as
187
Based on data on self-insured plans that have opted in available at: https://www.insurance.wa.gov/self-funded-group-health-plans, https://www.dol.gov/sites/dolgov/files/EBSA/research-
ers/data/health-and-welfare/health-insurance-coverage-bulletin-2019.pdf, https://scc.virginia.gov/balancebilling.
188
According to data from the National Telecommunications and Information Agency, 34 percent of households in the United States accessed health records or health insurance online. https://
www.ntia.doc.gov/blog/2020/more-half-american-households-used-internet-health-related-activities-2019-ntia-data-show.

July 26, 2021 96 Bulletin No. 2021–30
described and defined in these interim
final rules. This regulatory action is tak-
en as required by the No Surprises Act,
which directs the Departments to create
a process for balance billing complaints
regarding plans and issuers, and directs
HHS to create a process for balance bill-
ing complaints regarding providers and
facilities.
HHS estimates that there will be, on aver-
age, 3,600 balance billing complaints against
providers, facilities, providers of air ambu-
lance services, plans, and issuers submitted
annually. HHS estimates that it will take each
complainant 30 minutes (at an hourly rate of
$54.14)
189
to collect all relevant documen-
tation related to the alleged violation and to
access and complete the provided complaint
form, with an equivalent cost of approxi-
mately $27. The total burden for all com-
plainants is estimated to be 1,800 hours, with
an equivalent annual cost of approximately
$97,452. As DOL, the Treasury Department
and HHS share jurisdiction, HHS will ac-
count for 50 percent of the burden, approx-
imately 900 burden hours with an equivalent
cost of approximately $48,726.
TABLE 7: Annual Burden and Costs for Complaints Related to Surprise Billing
Estimated Number
of Respondents
Estimated Number
of Responses
Burden Per
Response (Hours)
Cost per Response
Total Annual
Burden (Hours)
Total Estimated
Cost
1,8001,800
0.5$27.07
900$48,726
6. ICRs Regarding Notice of Right to
Designate a Primary Care Provider
(45 CFR 149.310(a)(4))
These interim final rules continue to re-
quire that if a group health plan or health
insurance issuer requires the designation
by a participant, beneficiary, or enrollee of
a primary care provider, the plan or issu-
er must provide a notice informing each
participant (in the individual market, pri-
mary subscriber) of the terms of the plan
or coverage and their right to designate a
primary care provider. For group health
plans and group health insurance cover-
age, the notice must be included whenever
the plan or issuer provides a participant
with a summary plan description or other
similar description of benefits under the
plan or coverage. For individual health
insurance coverage, the notice must be in-
cluded whenever the issuer provides a pri-
mary subscriber with a policy, certificate,
or contract of health insurance. These
interim final rules continue to include
model language to satisfy the notice re-
quirements. The No Surprises Act extends
the applicability of the patient protections
for choice of health care professionals to
grandfathered health plans. The patient
protections under section 2719A of the
PHS Act apply to only non-grandfathered
group health plans and health insurance
issuers offering non-grandfathered group
or individual health insurance coverage.
In contrast, the patient protections under
the No Surprises Act apply generally to all
group health plans and group and individ-
ual health insurance coverage, including
grandfathered health plans. Therefore,
the requirements regarding patient pro-
tections for choice of health care profes-
sional under these interim final rules will
newly apply to grandfathered health plans
for plan years beginning on or after Janu-
ary 1, 2022.
In order to satisfy the patient protection
disclosure requirement, state and local
government plans and issuers in the indi-
vidual market will need to notify policy
holders of their plans’ policy in regards
to designating a primary care physician
and for obstetrical or gynecological vis-
its and will incur a one-time burden and
cost to incorporate the notice into plan
documents. Non-federal governmental
plans and individual market plans that are
currently not grandfathered have already
incurred the one-time cost to prepare and
incorporate this notice in their existing
plan documents.
There are an estimated 90,126 non-fed-
eral governmental employers offering
health plans to employees and 388 health
insurance issuers in the individual market.
HHS estimates that there are approxi-
mately 14,417 grandfathered non-federal
government employer-sponsored plans
and approximately 837,543 grandfathered
individual market policies, with approxi-
mately 6,055 grandfathered non-federal
governmental plans offering HMO and
point-of-service (POS) options.
190
HHS
assumes that all individual market issuers
offer at least one HMO, exclusive provid-
er organization (EPO) or POS options.
It is estimated that in 2022, 5,450 grand-
fathered non-federal governmental plans
and individual market policies will be sub-
ject to this notice requirement. While not
all HMO, EPO, and POS options require
the designation of a primary care physician
or a prior authorization or referral before
an OB/GYN visit, HHS is unable to esti-
mate this number. Therefore, this estimate
should be considered an overestimate of
the number of affected entities.
These interim final rules continue to
provide model language for the notice.
It is estimated that each plan or issuer
will require a compensation and benefits
manager (at an hourly rate of $131.88) to
spend 10 minutes customizing the model
notice to fit the plan’s specifications. Each
plan or issuer will also require clerical
staff (at an hourly rate of $38.86) to spend
5 minutes adding the notice to the plan’s
documents. The estimated total burden for
each plan or issuer will be 0.25 hours with
an equivalent cost of approximately $25.
In 2022, the estimated total annual bur-
den for all 5,450 plans and issuers will be
approximately 1,362 hours with an equiv-
alent cost of approximately $137,430.
There will be no additional burden and
189
The Departments use the average wage rate for all occupations.
190
According to 2020 Kaiser/HRET survey of Employer Health Benefits, 11 percent of employers offer a health maintenance organization (HMO) option and that 31 percent of employers
offer a point-of-service (POS) option. Available at https://www.kff.org/health-costs/report/2020-employer-health-benefits-survey/.

Bulletin No. 2021–30 97 July 26, 2021
cost in 2023 to prepare the notice, since
all plans and issuers will have incurred the
burden and cost by 2022.
HHS estimates that there are approx-
imately 1.8 million non-federal govern-
mental plan policyholders in grandfa-
thered plans, with an estimated 413,976
policyholders enrolled in grandfathered
HMO and POS plans options.
191
In addi-
tion, there are an estimated 837,543 pol-
icyholders with grandfathered individual
market plans. It is estimated that approx-
imately 75 percent of individual market
enrollees are enrolled in HMO, EPO, and
POS options.
192
Therefore, an estimated
627,146 policyholders in the individu-
al market have grandfathered plans with
HMO, EPO, and POS options. It is esti-
mated that approximately 937,010 pol-
icyholders will remain in grandfathered
non-federal government employer spon-
sored and individual market plans with
HMO, EPO, and POS options in 2022 and
will receive the required notice for the
first time in 2022. HHS assumes that only
printing and material costs are associated
with the disclosure requirement, because
the notice can be incorporated into exist-
ing plan documents. HHS estimates that
the notice will require one-half of a page,
at a cost of $0.05 per page for printing and
materials, and 34 percent of the notices
will be delivered electronically at minimal
cost.
193
Therefore, the cost to deliver 66
percent of these notices in print is estimat-
ed to be approximately $15,461.
194
TABLE 8 One-time Burden and Cost to Provide Notice of Right to Designate a Primary Care Provider
Year
Estimated
Number of
Respondents
Estimated
Number of
Responses
Burden Per
Response
(Hours)
Total
Annual
Burden
(Hours)
Total Estimated
Labor Cost
Total Estimated
Printing and
Materials Cost
Total
Estimated
Cost
20225,4505,4500.251,362$137,430$15,461$152,891
HHS will revise the burden currently
approved under OMB Control Number
0938-1094, (Notice of Rescission of Cov-
erage and Disclosure Requirements for
Patient Protection under the Affordable
Care Act, CMS-10330, expiration: July
31, 2022) to account for this burden.
7. ICRs Regarding Notice and Consent
to Waive Balance Billing Protections,
Retention of Certain Documents, and
Notice to Plan or Issuer (45 CFR
149.410(b)-(e), 45 CFR 149.420(c)-(i))
The No Surprises Act and these inter-
im final rules require that a plan or issuer
providing coverage of emergency services
do so without the individual or the health
care provider having to obtain prior autho-
rization and without regard to whether the
health care provider furnishing the emer-
gency services is a participating provider
or a participating emergency facility with
respect to the services (regardless of the
department of the hospital in which such
items and services are furnished). Emer-
gency services include any additional
items and services that are covered under a
plan or coverage after a participant, bene-
ficiary, or enrollee is stabilized (referred to
as post-stabilization services) unless cer-
tain notice and consent requirements are
met. The No Surprises Act and these inter-
im final rules further apply surprise billing
protections in the case of non-emergency
services furnished by nonparticipating
providers during a visit by a participant,
beneficiary, or enrollee at participating
health care facilities unless notice and
consent as specified in these interim final
rules have been met. The requirements re-
lated to the notice and consent, applicable
exceptions, and timing are set forth in sec-
tion 2799B-2 of the PHS Act, and imple-
mented at 45 CFR 149.410 and 45 CFR
149.420 of these interim final rules.
In order to meet the notice and consent
requirements of these interim final rules,
nonparticipating providers and nonpartic-
ipating emergency facilities must provide
the participant, beneficiary, or enrollee
with a notice, meet certain timing require-
ments, and obtain consent from the partic-
ipant, beneficiary, or enrollee as described
in 45 CFR 149.420 and these interim final
rules. The provided notice must: (1) state
the health care provider or facility is a
nonparticipating provider or facility; (2)
include the good faith estimate of what the
individual may be charged, including any
item or service that is reasonably expected
to be provided in conjunction with such
items and services; (3) provide informa-
tion about whether prior authorization or
other care management limitations may be
required; and (4) clearly state that consent
to receive such items or services is option-
al and that the participant, beneficiary, or
enrollee may instead seek care from an
available participating provider, in which
case the individual’s cost-sharing respon-
sibility would be at the in-network level.
In cases where post-stabilization services
are furnished by a nonparticipating pro-
vider at a participating emergency facili-
ty, the notice must also include a list of
participating providers at the participating
emergency facility who are able to furnish
the items or services involved and inform
the individual that they may be referred,
at their option, to such a participating
191
According to the 2020 Kaiser/HRET Survey of Employer Sponsored Health Benefits, 12 percent of covered workers in non-federal government plans have an HMO option and that 11
percent of covered workers have a POS option.
192
Estimate based of data reported in Unified Review Template Submissions for 2018 plan. Rate review data available at https://www.cms.gov/CCIIO/Resources/Data-Resources/ratereview.
html.
193
According to data from the National Telecommunications and Information Agency, 34 percent of households in the United States accessed health records or health insurance online. https://
www.ntia.doc.gov/blog/2020/more-half-american-households-used-internet-health-related-activities-2019-ntia-data-show.
194
937,010 notices x 66% = 618,427 notices printed x $0.05 per page x 1/2 pages per notice = approximately $15,461.

July 26, 2021 98 Bulletin No. 2021–30
provider. Additionally, a nonparticipating
provider or nonparticipating emergency
facility must provide the participant, ben-
eficiary, or enrollee, or such individual’s
authorized representative, with the notice
and consent documents in any of the 15
most common languages in the state, or
a geographic region that reasonably re-
flects the geographic region served by the
applicable facility. If the individual’s pre-
ferred language is not among the 15 most
common languages made available or the
individual cannot understand the language
in which the notice and consent document
are provided the individual must be pro-
vided with a qualified interpreter.
In addition to providing the required
notice and consent, nonparticipating
emergency facilities, participating health
care facilities, and nonparticipating pro-
viders are obligated to retain written no-
tice and consent documents for at least a
7-year period after the date on which the
item or service in question was furnished.
Where the notice and consent require-
ments described in this interim final rule
have been met, the nonparticipating pro-
vider, the participating health care facility
on behalf of the nonparticipating provider,
or the nonparticipating emergency facil-
ity, as applicable, must timely notify the
plan or issuer, respectively, that the notice
and consent criteria have been met, and if
applicable, provide to the plan or issuer a
copy of the signed notice and consent doc-
uments. In instances where, to the extent
permitted by these rules, the nonpartici-
pating provider bills the participant, ben-
eficiary, or enrollee directly, the provider
may satisfy the requirement to notify the
plan or issuer by including the notice and
consent documents with the bill to the
participant, beneficiary, or enrollee. In
addition, for items and services furnished
by a nonparticipating provider at a partici-
pating health care facility, the provider (or
the participating facility on behalf of the
provider) must timely notify the plan or is-
suer that the item or service was furnished
during a visit at a participating health care
facility.
In order to meet the notice and consent
requirements of the statute and these inter-
im final rules, nonparticipating providers
and nonparticipating emergency facilities
must provide the participant, beneficiary,
or enrollee with a notice. HHS is speci-
fying in guidance mandatory notice and
consent forms that will require customiza-
tion by the provider or facility.
HHS assumes that emergency facili-
ties and health care facilities will provide
the notice and obtain consent on behalf
of nonparticipating providers, retain re-
cords and notify plans and issuers. HHS
estimates that a total of 17,467 health care
facilities and emergency departments (in-
cluding 475 hospital-affiliated satellite
and 270 independent freestanding emer-
gency departments) will be subject to
these requirements. HHS assumes that for
hospital-affiliated satellite freestanding
emergency departments, the notice and
consent will be developed by the parent
hospital. Therefore, the burden to develop
the notice and consent documents will be
incurred by 16,992 emergency facilities
and health care facilities. HHS estimates
that for each facility it will take a lawyer 1
hour (at an hourly rate of $143.18) to read
and understand the notice and consent
forms and make any required and applica-
ble alteration, an administrative assistant
half an hour (at an hourly rate of $38.86)
to make any alterations to the provided
notice and consent documents and pre-
pare the final documentation, a computer
programmer 1 hour (at an hourly rate of
$91.96) to digitize and post on a shared
network server or push to networked com-
puters fillable versions of the notice and
consent documents, and a Computer and
Information Systems Manager half an
hour (at an hourly rate of $155.52) to ver-
ify accessibility to, and ensure functional-
ity of, the notice and consent documents.
HHS also estimates each facility will in-
cur an additional cost of approximately
$1,000 (at $500 per document) to contract
with an outside firm to translate the notice
and consent documents into the 15 most
common languages in the state or a geo-
graphic region that reasonably reflects the
geographic region served by the applica-
ble facility. HHS estimates the one-time
first-year burden, to be incurred in 2021,
to make alterations, prepare the final ver-
sions, translate and make accessible to the
providers within the facility the notice and
consent documentation, for each facility
will be approximately 3 hours, with an as-
sociated equivalent cost of approximately
$1,332. For all 16,992 emergency facili-
ties and health care facilities, HHS esti-
mates a total one-time first-year burden of
50,976 hours, with an associated equiva-
lent cost of approximately $22.6 million.
In order to meet the notice and consent
requirements of 45 CFR 149.420 with re-
spect to post-stabilization services, when
emergency services are provided by non-
participating providers or nonparticipat-
ing emergency facilities, the provider
or facility must provide the participant,
beneficiary, or enrollee with a notice and
obtain consent to be treated by the non-
participating emergency facility or non-
participating provider. HHS estimates
there are approximately 5,533 emergency
departments (including hospital-affiliat-
ed satellite and independent freestanding
emergency departments)
195
that could be
subject to the notice and consent require-
ments in these interim final rules and will
incur ongoing annual costs and burdens,
beginning in 2022. In 2018, there were
approximately 4,146,476 emergency de-
partment visits that resulted in hospital
admission for patients with individual
market or group health coverage.
196
Us-
ing this as an estimate of post-stabili-
zation services provided in emergency
facilities, and assuming that in 16 per-
cent of cases the patient is treated at a
nonparticipating emergency facility or
by a nonparticipating provider at a par-
ticipating facility, HHS estimates that ap-
proximately 663,436 individuals will be
provided with a notice and consent docu-
ment for post-stabilization services. HHS
anticipates that the notice and consent
will be used infrequently for post-sta-
bilization services, so this estimate is
195
Emergency Medicine Network, 2018 National Emergency Department Inventory – USA. Available at https://www.emnet-usa.org/research/studies/nedi/nedi2018/.
196
Agency for Healthcare Research and Quality, HCUP Fast Stats – Trends in Emergency Department Visits. Available at https://www.hcup-us.ahrq.gov/faststats/NationalTrendsEDServ-
let?measure1=01&characteristic1=14&measure2=&characteristic2=11&expansionInfoState=hide&dataTablesState=hide&definitionsState=hide&exportState=hide.

Bulletin No. 2021–30 99 July 26, 2021
an upper bound. HHS estimates it will
take a medical secretary 2 hours (at an
hourly rate of $37.50) to customize the
required notice and consent documents,
generate a list of participating providers,
provide and explain the documents to the
individual (or authorized representative),
answer questions, and obtain the signed
consent if the individual agrees, provide
the signed documents on paper or, as
practicable, electronically, as selected by
the individual, and retain the documen-
tation as required by these interim final
rules. The total burden for providing the
notice and consent documents to individ-
uals at all emergency facilities will be
1,326,872 hours with an equivalent cost
of approximately $49.8 million. HHS as-
sumes that these documents will be pro-
vided directly to each affected individual
(or authorized representative) in paper
format and will be 4 pages (2 pages print-
ed double-sided) on average. Assuming a
cost of $0.10 (at $0.05 per page for print-
ing and material cost) for each notice and
consent document, the total printing and
material costs for all notices will be ap-
proximately $66,344. The total ongoing
cost for all emergency facilities will be
approximately $49.8 million annually.
HHS assumes that nonparticipating pro-
viders and nonparticipating emergency
facilities will notify the plan or issuer and
provide a copy of the signed notice and
consent documents along with the claim
form electronically at minimal cost.
HHS estimates that each individual that
receives notice and consent from an emer-
gency facility will require, on average, 45
minutes (at an hourly rate of $54.14) to
read and understand and sign the required
notice and consent documents, with a total
cost of approximately $41. For all 663,436
individuals that could potentially receive
the notice and consent documents, HHS
estimates a total annual burden of 497,577
hours, with an associated total annual cost
of approximately $26.9 million.
In order to meet the notice and con-
sent requirements of 45 CFR 149.420
with respect to non-emergency services
furnished by a nonparticipating provider
at a participating health care facility, if an
individual schedules an appointment for
such items or services at least 72 hours
before the date of the appointment, the
provider or facility must provide the no-
tice to the individual, or their authorized
representative, no later than 72 hours
before the date of the appointment. If an
individual schedules an appointment for
such items or services within 72 hours of
the date of the appointment, the provider
or facility must provide the notice to the
individual, or their authorized represen-
tative, on the day that the appointment is
made. In the situation where an individu-
al is provided the notice on the same day
that the items or services are furnished,
providers and facilities are required to
provide the notice no later than 3 hours
prior to furnishing items or services to
which the notice and consent require-
ments applies.
HHS estimates there are approximate-
ly 16,722 health care facilities that will
be subject to the notice requirement de-
scribed in these interim final rules and
will incur ongoing annual costs and bur-
dens beginning in 2022. Based on 2016
data, HHS estimates that there will be
11,107,056 visits to health care facilities
annually for surgical and non-surgical
procedures for individuals with group
health coverage or individual market
coverage
197
and that approximately 16
percent of those visits will involve a non-
participating provider.
198
This estimate
is a lower bound since it is based on the
number of postoperative office visits and
potentially excludes situations where
such visits were not needed or such fol-
low-up was conducted at a different set-
ting. HHS therefore estimates that ap-
proximately 1,777,129 individuals could
potentially face balance billing and will
be subject to the notice requirements of
these interim final rules. With respect to
non-emergency services furnished by a
nonparticipating provider at a participat-
ing health care facility, HHS estimates it
will take a medical secretary 1 hour (at an
hourly rate of $37.50) to customize the
required notice, generate a list of partic-
ipating providers, provide the document
via e-mail or mail, as selected by the in-
dividual, and answer any questions. For
all health care facilities, HHS estimates
a total annual ongoing annual burden of
approximately 1,777,129 hours, with an
associated annual cost of approximately
$66.6 million. HHS estimates that ap-
proximately 66 percent of the notices will
be mailed to individuals (34 percent sent
electronically) at a cost of $0.65 (at $0.05
per page for printing and material cost
and $0.55 postage).
199
Assuming minimal
cost for electronic delivery, the total cost
of printing and mailing the notice and
consent documents will be approximate-
ly $762,388 annually. The total ongoing
cost for all health care facilities will be
approximately $67.4 million annually.
HHS estimates that each individual
that receives the notice will require, on
average, 45 minutes (at an hourly rate of
$54.14) to read and understand the re-
quired notice, with a total cost of $41.
For all 1,777,129 individuals that could
receive the notice document, HHS esti-
mates a total annual burden of 1,332,847
hours, with an associated total annual cost
of $72.2 million. HHS assumes that non-
participating providers (or the participat-
ing facilities on behalf of the providers)
will notify the plan or issuer and provide
a copy of the signed notice and consent
documents along with the claim from the
participating facility electronically at min-
imal cost.
For all emergency and health care fa-
cilities, the total ongoing burden will be
3,104,001 hours annually and the total
cost, including printing and materials cost,
will be approximately $117,228,780annu-
ally starting in 2022. For all consumers,
the total annual burden to read and under-
stand the notice will be 1,830,424 hours
with an equivalent cost of $99,099,147
starting in 2022.
197
Estimates based on data on postoperative office visits. Centers for Disease Control, National Ambulatory Medical Care Survey: 2016 National Summary Tables. Available at https://www.
cdc.gov/nchs/fastats/physician-visits.htm.
198
Estimated based on information provided by KFF. Available at: https://www.kff.org/health-costs/poll-finding/data-note-public-worries-about-and-experience-with-surprise-medical-bills/.
199
According to data from the National Telecommunications and Information Agency, 34 percent of households in the United States accessed health records or health insurance online. https://
www.ntia.doc.gov/blog/2020/more-half-american-households-used-internet-health-related-activities-2019-ntia-data-show.

July 26, 2021 100 Bulletin No. 2021–30
TABLE 9: One-time and Annual Burden and Cost for Emergency Departments and Facilities Related to Notice and
Consent
Year
Estimated
Number of
Respondents
Estimated
Number of
Responses
Total Annual
Burden
(hours)
Total
Estimated
Labor Cost
Total Estimated
Translating, Printing
and Materials Cost
Total Estimated
Cost
202116,99216,99250,976$5,646,951$16,992,000$22,638,951
202217,4672,440,5653,104,001$116,400,048$828,732$117,228,780
202317,4672,440,5653,104,001$116,400,048$828,732 $183,634$117,228,780
3 Year Average17,3091,632,7072,086,326$79,482,349$6,216,488$85,698,837

TABLE 10: Annual Burden and Cost for Individuals Related to Notice and Consent Starting in 2022
Estimated Number of
Respondents
Estimated Number of
Responses
Total Annual Burden
(hours)
Total Estimated Labor
Cost
Total Estimated Cost
2,440,5652,440,5651,830,424$99,099,147$99,099,147
8. ICRs Regarding Provider Disclosure
on Patient Protections Against Balance
Billing (45 CFR 149.430)
Section 2799B-3 of the PHS Act, as
added by the No Surprises Act and cod-
ified at 45 CFR 149.430, requires provid-
ers and facilities to provide disclosures
regarding patient protections against
balance billing. Specifically, health care
providers and facilities (including an
emergency department of a hospital or
independent freestanding emergency de-
partment) are required to make publicly
available, post on a public website of the
provider or facility, and provide to partic-
ipants, beneficiaries, and enrollees a one-
page notice about surprise billing protec-
tions, which must include information
about any applicable state requirements,
and about how to contact appropriate
state and federal agencies if the individ-
ual believes the provider or facility has
violated the balance billing rules. The
required notice must include clear and
understandable language that explains the
requirements and prohibitions relating
to the prohibitions on balance billing in
cases of emergency services and in cas-
es of non-emergency services performed
by a nonparticipating provider at certain
participating facilities, explain any other
applicable state laws, and provide con-
tact information for the appropriate state
and federal agencies that an individual
may contact if they believe the provider
or facility has violated a requirement de-
scribed in the notice.
Health care providers and facilities
are required to publicly post and make
the disclosure publicly available through
a public website accessible free of charge
that is easily accessible, without barri-
ers, including via search engines, and
that ensures that the information is ac-
cessible to the general public. HHS as-
sumes that providers and facilities will
enter into agreements for the facilities to
provide the disclosure on behalf of the
providers and that the required language
and information will be developed, post-
ed within the facility, and posted on a
public website by the facility. This will
ameliorate the burden and cost for the
individual provider. Many facilities and
providers will be able to enter into an
agreement at minimal cost if they renew
their contracts prior to 2022. For each fa-
cility whose contracts with providers are
not due to be renewed before 2022, the
burden to enter into agreements related
to this disclosure will vary based on the
number of providers that practice within
the facility. HHS estimates that for each
facility, on average, it will take a lawyer
2 hours (at an hourly rate of $143.18) to
draft an agreement and an administra-
tive assistant 2 hours (at an hourly rate
of $38.86) to provide electronic copies to
all providers to sign. The total burden for
all 17,467 facilities will be 69,868 hours
with an equivalent cost of approximately
$6,359,385, to be incurred as one-time
costs in 2021. HHS is unable to estimate
how many providers will incur burden to
sign the agreement, but anticipates that
the burden to sign each agreement will
be minimal. In future years, this agree-
ment can be included in the contract be-
tween the facilities and providers at no
additional cost.
HHS estimates a total of 17,467 health
care facilities (including 475 hospital-af-
filiated satellite and 270 independent
freestanding emergency departments)
will incur burden and costs to comply
with this provision. HHS assumes that
for hospital-affiliated satellite freestand-
ing emergency departments, the dis-
closure will be developed by the parent
hospital. HHS estimates that for each
facility, on average, it will take a lawyer
2 hours (at an hourly rate of $143.18) to
read and understand the provided notice
and draft any additional, clear, and un-
derstandable language as may be needed,
an administrative assistant 30 minutes (at
an hourly rate of $38.86) to prepare the
final document for distribution and make
the information publicly available within
the facility, and a computer programmer
1 hour (at an hourly rate of $91.96) to
post the information on a separate or ex-
isting webpage, in a searchable manner,
and to make the content available in an

Bulletin No. 2021–30 101 July 26, 2021
easily downloadable format. The burden
will be higher for facilities in states with
state laws or All-Payer Model Agree-
ments, but lower for facilities in states
without any state laws. HHS assumes
that each facility will post a single page
document in at least two prominent loca-
tions, such as where individuals schedule
care, check-in for appointments, or pay
bills, and estimates that each facility will
incur a printing cost of $0.10 (at $0.05
per page for printing and materials) in or-
der to post the required disclosure infor-
mation prominently at each health care
facility. HHS anticipates that hospitals
will post 6 notices on average, and incur
an additional cost of $0.20 each. In addi-
tion, HHS assumes that each of the 475
hospital-affiliated satellite freestanding
emergency departments will post two no-
tices on average and incur a cost of $0.10
each. HHS estimates the one-time bur-
den, to be incurred in 2021, to develop,
prepare, and post the required disclosure
information, for each facility will be ap-
proximately 3.5 hours, with an associated
equivalent cost of approximately $398.
For all facilities, HHS estimates a total
one-time burden of 59,472 hours, with
an associated cost of approximately $6.8
million, including materials and print-
ing costs. HHS recognizes that there are
some small providers and facilities that
do not maintain or provide a publicly
available website. Such entities are not
required to make a disclosure on a public
website. Therefore, HHS considers the
estimate to be a high-end estimate.
HHS encourages states to develop
language to assist providers and facilities
in fulfilling this disclosure requirement.
There are currently 33 states that have
enacted laws to provide some protection
to consumers for surprise billing. Some
or all of these states may choose to devel-
op model language. HHS assumes that it
will take a lawyer 2 hours (at an hourly
rate of $143.18) and an administrative
assistant 1 hour (at an hourly rate of
$38.86) to develop and amend the model
language. The total one-time burden, to
be incurred in 2021, for each state will
be 3 hours with an equivalent cost of ap-
proximately $325. For all 33 states, HHS
estimates the total one-time burden will
be 99 hours with an equivalent cost of
approximately $10,732.
In addition to requiring providers and
facilities to publicly post and make the
required disclosure publicly available
through a public website, providers and
facilities are required to provide individ-
uals the required disclosure information
in a one-page notice. The required notice
must be provided in-person, through the
mail or via email, as selected by the par-
ticipant, beneficiary, or enrollee no later
than the date on which the health care
provider or health care facility requests
payment from the individual (including
requests for copayment made at the time
of a visit to the provider or facility), or
with respect to individual from whom the
health care facility or health care provid-
er does not request payment, no later than
the date on which the health care provid-
er or health care facility submits a claim
to the group health plan or health insur-
ance issuer. HHS assumes that, in order
to reduce burden and costs, facilities will
choose to provide the required disclosure
to the individual (or their selected rep-
resentative) at the time the individual is
processed for any visit, upon check-in,
or when other standard disclosures are
shared with individuals with minimal
additional burden. HHS estimates that
there will be approximately 39,690,940
emergency department visits
200
and
11,107,056 visits to health care facili-
ties annually for surgical and non-sur-
gical procedures
201
for individuals with
group health coverage or individual mar-
ket coverage. This is a lower bound for
the number of patients who will receive
the disclosure since HHS lacks compre-
hensive data on patients who receive
services on all health care facilities. In
order to provide the required disclosure
to individuals each facility will incur a
cost of approximately $0.05 for printing
and materials for each disclosure. HHS
assumes that this disclosure will be pro-
vided along with other forms and notices
usually provided to individuals without
incurring significant labor cost. For all
facilities, HHS estimates a total annu-
al ongoing annual cost of $2.5 million,
starting in 2022. HHS recognizes that the
number of notices provided by each fa-
cility will vary depending on the number
of annual visits and that some facilities
could incur higher costs to provide the
disclosure while others could incur lower
costs. HHS assumes that all disclosures
will be provided in-person; however,
HHS acknowledges that some individu-
als will choose to have this notice pro-
vided to them via email, at a minimal cost
to the facility, and others may choose to
receive the disclosure via mail, in which
case the facility will incur additional
postage costs.
HHS seeks comment on these burden
estimates. Specifically, HHS seeks com-
ment on the costs and burdens associated
with posting the required information on a
public website. HHS also seeks comment
on the number of facilities that will be af-
fected by these requirements and the num-
ber of individuals that would be required
to receive the required notice.
TABLE 11: One-time Burden and Costs Related to Agreements between Facilities and Providers
Year
Estimated Number
of Respondents
Estimated Number
of Responses
Burden Per
Response (Hours)
Cost per
Response
Total Annual
Burden (Hours)
Total Estimated
Cost
202117,46717,4674$364.0869,868$6,359,385
200
Agency for Healthcare Research and Quality, HCUP Fast Stats – Trends in Emergency Department Visits.
201
Estimates based on data on postoperative office visits. Centers for Disease Control, National Ambulatory Medical Care Survey: 2016 National Summary Tables. Available at https://www.
cdc.gov/nchs/fastats/physician-visits.htm.
Estimated based on information provided by KFF. Available at: https://www.kff.org/health-costs/poll-finding/data-note-public-worries-about-and-experience-with-surprise-medical-bills/.

July 26, 2021 102 Bulletin No. 2021–30
TABLE 12: One-time and Annual Burden and Cost for Facilities to Provide Disclosure on Patient Protections against
Balance Billing
YearEstimated
Number of
Respondents
Estimated
Number of
Responses
Total Annual
Burden
(hours)
Total
Estimated
Labor Cost
Total Estimated
Printing and
Materials Cost
Total
Estimated
Cost
202117,46717,46759,472$6,758,568$2,965$6,761,533
202217,46750,797,9960$0$2,539,900$2,539,900
202317,46750,797,9960$0$2,539,900$2,539,900
3 Year Average17,46733,871,15319,824$2,252,856$1,694,255$3,947,111

TABLE 13: One-time Burden and Cost for States to Develop State Specific Language for Facilities to Provide Disclosure on
Patient Protections against Balance Billing
Year
Estimated Number of
Respondents
Estimated Number of
Responses
Total Annual Burden
(hours)
Total Estimated Labor
Cost
2021333399$10,732.26
9. ICRs Regarding Plan and Issuer
Disclosure on Patient Protections Against
Balance Billing
Section 9820(c) of the Code, section
720(c) of ERISA, and section 2799A-5(c)
of the PHS Act require plans and issuers to
make publicly available, post on a public
website of the plan or issuer, and include
on each explanation of benefits for an
item or service with respect to which the
requirements under section 9816 of the
Code, section 716 of ERISA, and section
2799A-1 of the PHS Act apply, informa-
tion in plain language on the provisions in
these sections, and sections 2799B-1 and
2799B-2 of the PHS Act, and other appli-
cable state laws on out-of-network bal-
ance billing, and information on contact-
ing appropriate state and federal agencies
in the case that an individual believes that
such a provider or facility has violated the
prohibition against balance billing.
The Departments assume that plans
and issuers will use the model notice
developed by HHS, and that TPAs will
develop the notice for self-insured plans.
The Departments estimate that on average
for each plan or issuer it will take a lawyer
2 hours (at an hourly rate of $143.18) to
read and understand the provided notice
and draft any additional, clear, and un-
derstandable language as may be needed,
an administrative assistant 30 minutes (at
an hourly rate of $38.86) to prepare the
final document for distribution and make
the information publicly available with-
in the facility, and a computer program-
mer 1 hour (at an hourly rate of $91.96)
to post the information on a separate or
existing webpage, in a searchable man-
ner, and to make the content available in
an easily downloadable format. The total
burden for an individual plan or issuer
will be 3.5 hours with an equivalent cost
of approximately $398. The burden will
be higher for issuers and TPAs in states
with applicable state laws or All-Payer
Model Agreements, but lower for issuers
and TPAs in states without any applica-
ble state laws. The Departments estimate
that there are 1,553 issuers and 205 TPAs.
The total burden for all issuers and TPAs
will be 6,153 hours with an equivalent
cost of $699,245, to be incurred as a one-
time cost in 2021. As DOL, the Treasury
Department, and HHS share jurisdiction,
HHS will account for 50 percent of the
burden, or approximately 3,077 hours
with an equivalent cost of approximately
$349,622.
The Departments assume that plans
and issuers will also include the disclo-
sure along with the explanation of bene-
fits at no additional cost. Under the same
assumptions used to estimate the number
of disclosures provided by nonparticipat-
ing facilities and nonparticipating provid-
ers, the Departments estimate that issuers
and TPAs will include the disclosure to
approximately 39,690,940 individuals
who receive services at emergency facil-
ities and 11,107,056 individuals who re-
ceived non-emergency services at health
care facilities, for a total of 50,797,996
disclosures. The Departments assume
that 66 percent of these notices will be
provided by mail and the cost of print-
ing is $0.05 per page.
202
Therefore, the
total printing and materials cost for send-
ing 33,526,677 notices by mail will be
$1,676,334 annually, starting in 2022.
The Departments assume that for the
disclosures sent by mail, it will take an
administrative assistant 1 minute (at an
hourly rate of $38.86) to print and en-
close the notice with the explanation of
benefits. The disclosures sent electron-
ically can be sent at minimal cost. The
total burden for all issuers and TPAs is
estimated to be 558,778 hours with an
equivalent cost of $21,714,111. There
will be no additional mailing costs, since
the disclosure will be enclosed with the
explanation of benefits. The total annual
cost to all issuers and TPAs for sending
202
According to data from the National Telecommunications and Information Agency, 34 percent of households in the United States accessed health records or health insurance online. https://
www.ntia.doc.gov/blog/2020/more-half-american-households-used-internet-health-related-activities-2019-ntia-data-show.

Bulletin No. 2021–30 103 July 26, 2021
the notices is estimated to be approxi-
mately $23,390,445 starting in 2022. As
DOL, the Treasury Department and HHS
share jurisdiction, HHS will account for
50 percent of the burden, or approximate-
ly 279,389 hours, with an equivalent cost
of $10,857,056, and printing and mate-
rials cost of $838,167, for a total annual
cost of $11,695,223 starting in 2022.
TABLE 14: One-time and Annual Burden and Cost for Plans and Issuers to Provide Disclosure on Patient Protections
against Balance Billing
Year
Estimated
Number of
Respondents
Estimated
Number of
Responses
Total Annual
Burden (hours)
Total Estimated
Labor Cost
Total Estimated
Printing and
Materials Cost
Total Estimated
Cost
20218798793,077$349,6220$349,622
202287925,398,998279,389$10,857,056$838,167$11,695,223
202387925,398,998279,389$10,857,056$838,167$11,695,223
3 year Average87916,932,958187,285$7,354,578$558,778$7,913,356
10. Summary of Annual Burden Estimates for Information Collection Requirements
TABLE 15: Annual Recordkeeping and Reporting Requirements
Regulation
Section
OMB
Control
Number
RespondentsResponses
Burden
per
Response
(hours)
Total
Annual
Burden
(hours)
Hourly
Labor
Cost of
Reporting
Total Labor
Cost of
Reporting
Printing
and
Materials
Cost
Total Cost
45 Cfr 149.140(D)0938-NEW8793,801,3840.19739,158$37.50$27,718,4270$27,718,427
45 Cfr 149.300938-NEW84841.50126$69.87$8,783$197$8,981
45 Cfr 149.150,
149.450
0938-NEW1,8001,8000.5900$54.14$48,7260$48,726
45 Cfr 149.310(A)
(4)
0938-10945,4505,4500.251362$100.87$137,430$15,461$152,891
45 Cfr
149.410(B)-(E),
149.420(C) - (I) –
Facilities And
Providers
0938-NEW17,3091,632,7071.282,086,326$38.10$79,482,349$6,216,488$85,698,837
45 Cfr
149.410(B)-(E),
149.420(C) - (I) –
Consumers
0938-NEW2,440,5652,440,5650.751,830,424$54.14$99,099,1470$99,099,147
45 Cfr 149.430 –
Facilities And
Providers
0938-NEW17,46733,871,1533.5*19,824$113.67*$2,252,856$1,694,255$3,947,111
45 Cfr 149.430 –
Facility And
Provider
Agreements
0938-NEW17,46717,467469,868$91.02$6,359,3850$6,359,385
45 Cfr 149.430 –
States
0938-NEW3333399$108.41$10,7320$10,732
Section
2799A-5(C) Of
The Phs Act
0938-NEW87916,932,9580.01187,285$39.27$7,354,578558,778$7,913,356
Total2,501,93358,703,6024,935,372$222,472,414$8,485,179$230,957,592
*: Estimate based on burden incurred in first year only.

July 26, 2021 104 Bulletin No. 2021–30
11. Submission of PRA-Related Comments
HHS has submitted a copy of this final
rule to OMB for its review of the rule’s
information collection requirements. The
requirements are not effective until they
have been approved by OMB.
To obtain copies of the supporting
statement and any related forms for the
collections discussed in this rule (CMS-
9909-IFC), please visit the CMS Web site
at www.cms.hhs.gov/PaperworkReduc-
tionActof1995, or call the Reports Clear-
ance Office at 410–786–1326.
E. Paperwork Reduction Act –
Department of Labor and Department of
the Treasury
As part of the continuing effort to reduce
paperwork and respondent burden, the De-
partments conduct a preclearance consulta-
tion program to provide the general public
and federal agencies with an opportunity to
comment on proposed and continuing col-
lections of information in accordance with
the PRA. This helps to ensure that the pub-
lic understands the Departments’ collection
instructions, respondents can provide the
requested data in the desired format, re-
porting burden (time and financial resourc-
es) is minimized, collection instruments are
clearly understood, and the Departments
can properly assess the impact of collection
requirements on respondents.
Under the PRA, an agency may not
conduct or sponsor, and an individual is
not required to respond to, a collection
of information unless it displays a valid
OMB control number.
The information collections are sum-
marized as follows:
1. ICRs Regarding Notice of Right to
Designate a Primary Care Provider (26
CFR 54.9822-1T, 29 CFR 2590.722)
These interim final rules require that
if a group health plan or health insurance
issuer requires the designation by a partic-
ipant, beneficiary, or enrollee of a primary
care provider, the plan or issuer must pro-
vide a notice informing each participant
(in the individual market, primary sub-
scriber) of the terms of the plan or cover-
age and their right to designate a primary
care provider. For group health plans and
group health insurance coverage, the no-
tice must be included whenever the plan
or issuer provides a participant with a
summary plan description or other similar
description of benefits under the plan or
coverage. For individual health insurance
coverage, the notice must be included
whenever the issuer provides a primary
subscriber with a policy, certificate, or
contract of health insurance. These inter-
im final rules include model language to
satisfy the notice requirements. The No
Surprises Act extends the applicability of
the patient protections for choice of health
care professionals. The patient protections
under section 2719A of the PHS Act apply
to only non-grandfathered group health
plans and health insurance issuers offer-
ing non-grandfathered group or individual
health insurance coverage. In contrast, the
patient protections under the No Surpris-
es Act apply generally to all group health
plans and group and individual health in-
surance coverage, including grandfathered
health plans. Therefore, the requirements
regarding patient protections for choice of
health care professional under these inter-
im final rules will newly apply to grandfa-
thered health plans for plan years begin-
ning on or after January 1, 2022.
DOL estimates that there are 2.5 mil-
lion ERISA-covered plans. Data obtained
from the 2020 Kaiser/HRET Survey of
Employer Sponsored Health Benefits finds
that 16 percent of firms offering health
benefits offer at least one grandfathered
health plan. DOL estimates that five per-
cent of plans will relinquish their grand-
fathered status in 2021. The data from the
2020 Kaiser/HRET Survey of Employer
Sponsored Health Benefits also finds that
11 percent of plans have an HMO option
and that 31 percent of plans offer a POS
option. Thus, DOL estimates that in 2022,
161,148 grandfathered plans will be sub-
ject to this notice requirement.
203
While not all HMO and POS options
require the designation of a primary care
physician or a prior authorization or re-
ferral before an OB/GYN visit, DOL is
unable to estimate this number. Therefore,
these estimates should be considered an
overestimate of the number of affected
entities.
Each of the plans will require a com-
pensation and benefits manager to spend
10 minutes individualizing the model no-
tice to fit the plan’s specifications at an
hourly rate of $134.21.
204
In 2022, this
results in 26,858 hours of burden at an
equivalent cost of $3,604,602.
Each plan will also require clerical
staff to spend 5 minutes adding the notice
to the plan’s documents at an hourly rate
of $55.14. In 2022, this results in 13,429
hours of burden at an equivalent cost of
$740,473.
Thus, the total hour burden associated
with this ICR is 40,287 hours at an equiv-
alent cost of $4,345,075. DOL shares this
burden equally with the Department of the
Treasury. Therefore, the total hour burden
for DOL and the Treasury Department is
each approximately 20,143 hours at an
equivalent cost of $2,172,537.
The Departments assume that only
printing and material costs are associated
with the disclosure requirement, because
the final regulations provide model lan-
guage that can be incorporated into exist-
ing plan documents, such as an SPD. The
Departments estimate that the notice will
require one-half of a page, five cents per
page printing and material cost will be in-
curred, and 58.2 percent of the notices will
be delivered electronically.
205
DOL estimates that there are 62.6 mil-
lion ERISA-covered policyholders. Data
obtained from the 2020 Kaiser/HRET
Survey of Employer Sponsored Health
203
2.5 million ERISA-covered plans x 16% grandfathered plans x (100% minus 5% newly non-grandfathered plans) x (11% HMOs + 31% POSs) = 161,148 affected plans.
204
For more information on how the Department estimates labor costs see: https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/rules-and-regulations/technical-appendices/
labor-cost-inputs-used-in-ebsa-opr-ria-and-pra-burden-calculations-june-2019.pdf
205
According to data from the National Telecommunications and Information Agency (NTIA), 40.0 percent of individuals age 25 and over have access to the Internet at work. According to
a Greenwald & Associates survey, 84 percent of plan participants find it acceptable to make electronic delivery the default option, which is used as the proxy for the number of participants
who will not opt-out of electronic disclosure that are automatically enrolled (for a total of 33.6 percent receiving electronic disclosure at work). Additionally, the NTIA reports that 40.4
percent of individuals age 25 and over have access to the internet outside of work. According to a Pew Research Center survey, 61.0 percent of internet users use online banking, which is
used as the proxy for the number of internet users who will affirmatively consent to receiving electronic disclosures (for a total of 24.7 percent receiving electronic disclosure outside of
work). Combining the 33.6 percent who receive electronic disclosure at work with the 24.7 percent who receive electronic disclosure outside of work produces a total of 58.2 percent who
will receive electronic disclosure overall.

Bulletin No. 2021–30 105 July 26, 2021
Benefits finds that 14 percent of covered
workers are enrolled in a grandfathered
plan. DOL estimates that 5 percent of
plans would relinquish their grandfa-
thered status annually in 2021. The data
from the 2020 Kaiser/HRET Survey of
Employer Sponsored Health Benefits also
finds that 13 percent of covered workers
have an HMO option and that 8 percent
of covered workers have a POS option.
DOL estimates that plans will produce
730,346 notices in 2022.
206
This results in
a cost burden of approximately $18,259
in 2022.
207
DOL shares this burden equal-
ly with the Department of the Treasury.
Therefore, the total cost burden for DOL
is approximately $9,129 and the total cost
burden for the Treasury Department is
$9,129. The summary of burden for this
information collection has also been pro-
vided below.
Summary of Burden
Type of Review: Revised Collection.
Agency: DOL–EBSA, Treasury-IRS
Title: Affordable Care Act Patient Protec-
tion Notice
OMB Numbers: 1210-0142, 1545–2181
Affected Public: Businesses or other
for-profits, Not-for-profit institutions.
Total Respondents: 161,148
Total Responses: 730,346
Frequency of Response: Occasionally.
Estimated Total Annual Burden Hours:
40,287 (DOL- 20,143; Treasury- 20,143)
Estimated Total Annual Burden Cost:
$18,259 (DOL- $9,129; Treasury- $9,129)
2. ICRs Regarding Information to be
Shared about QPA (26 CFR 54.9816-
6T(d), 29 CFR 2590.716-6(d))
These interim final rules require plans
and issuers to provide certain information
to nonparticipating providers or nonpar-
ticipating emergency facilities in cases in
which the recognized amount with respect
to an item or service furnished by a non-
participating provider or nonparticipating
emergency facility is the QPA. Specifi-
cally, plans and issuers must provide the
following information to providers (in-
cluding air ambulance providers) and fa-
cilities, when making an initial payment
or notice of denial of payment: (i) the QPA
for each item or service involved; and (ii)
a statement certifying that the plan or is-
suer has determined that the QPA applies
for the purposes of the recognized amount
(or, in the case of air ambulance services,
for calculating the participant’s, beneficia-
ry’s, or enrollee’s cost sharing), and that
each QPA was determined in compliance
with 26 CFR 54.9816-6T(d), 29 CFR
2590.716-6, or 45 CFR 149.140, as ap-
plicable. Additionally, upon request of the
provider or facility, the plan or issuer must
provide in a timely manner the following
information: (i) whether the QPA for items
and services involved included contracted
rates that were not on a fee-for-service
basis for those specific items and services
and whether the QPA for those items and
services was determined using underlying
fee schedule rates or a derived amount;
(ii) if applicable, information to identify
which database was used to determine the
QPA; and (iii) if applicable, a statement
that the plan’s or issuer’s contracted rates
include risk-sharing, bonus, or incentive
based payments for covered items and
services (as applicable) that were exclud-
ed for purposes of calculating the QPA.
As discussed earlier in HHS’ PRA sec-
tion, the total annual burden for all issu-
ers and TPAs for providing the initial and
additional information related to QPA will
be 1,478,316 hours, with an equivalent
cost of $55,436,853. As HHS, DOL, and
the Treasury Department share jurisdic-
tion, it is estimated that 50 percent of the
burden will be accounted for by the HHS,
25 percent of the burden will be account-
ed for by the Treasury Department, and
the remaining 25 percent will be account-
ed for by DOL. Thus, HHS will account
for approximately 739,158 burden hours
with an equivalent cost of approximately
$27,718,427. DOL and the Treasury De-
partment will each account for 369,579
burden hours with an equivalent cost of
approximately $13,859,214.
3. ICRs Regarding Complaints Process
for Surprise Medical Bills (26 CFR
54.9816-7T, 29 CFR 2590.716-7)
The No Surprises Act directs the De-
partments to establish a process to receive
complaints regarding violations of the
application of the QPA by group health
plans and health insurance issuers offering
group or individual health coverage, and
violations by health care providers, facil-
ities, and providers of air ambulance ser-
vices of the requirements under sections
2799B-2 and 2799B-3 of the PHS Act. The
Departments define a complainant as any
individual, or their authorized representa-
tive, who files a complaint, as described
and defined in these interim final rules.
This regulatory action is taken as required
by the No Surprises Act, which directs the
Departments to create a process for bal-
ance billing complaints regarding plans
and issuers, and directs HHS to create a
process for balance billing complaints re-
garding providers and facilities.
As discussed earlier in HHS’ PRA sec-
tion, the total burden for all complainants
is estimated to be 1,800 hours, with an
equivalent annual cost of approximately
$97,452. As HHS, DOL, and the Treasury
Department share jurisdiction, it is esti-
mated that 50 percent of the burden will
be accounted for by the HHS, 25 percent
of the burden will be accounted for by the
Treasury Department, and the remaining
25 percent will be accounted for by DOL.
HHS will account for approximately 900
burden hours with an equivalent cost of
approximately $48,726. DOL and the
Treasury Department will each account
for approximately 450 burden hours
with an equivalent cost of approximately
$24,363.
4. ICRs Regarding Opt-In State Balance
Bill Process (26 CFR 54.9816-3T, 29
CFR 2590.716-3)
The interim final rules allow plans to
voluntarily opt in to state law that pro-
vides for a method for determining the
cost-sharing amount or total amount pay-
206
2022: 62.6 million ERISA-covered policyholders x 14% of covered employees in grandfathered plans x (100% minus 5% newly non-grandfathered plans) x (13% in HMOs + 8% in POSs)
*41.8% = 730,346 notices
207
2022: $0.05 per page*1/2 pages per notice * 730,346 notices = $18,259

July 26, 2021 106 Bulletin No. 2021–30
able under such a plan, where a state has
chosen to expand access to such plans,
to satisfy their obligations under section
9816(a)-(d) of the Code, section 716(a)-
(d) of ERISA, and section 2799A-1(a)-(d)
of the PHS Act. A plan that has chosen
to opt into a state law must prominently
display in its plan materials describing
the coverage of out-of-network services
a statement that the plan has opted into a
specified state law, identify the state (or
states), and include a general description
of the items and services provided by non-
participating facilities and providers that
are covered by the specified state law.
Currently, there are four states that al-
low self-insured plans to opt in: Nevada,
New Jersey, Washington, and Virginia.
According to the Nevada Department of
Health and Human Services’ 2020 Annual
Report, 20 private entities or organizations
have elected to participate in the state’s
balance billing law. In addition, according
to the Virginia State Corporation Com-
mission, 231 private self-insured plans
in Virginia have elected to participate in
the state’s balance billing law.
208
Further-
more, according to Washington’s Office of
the Insurance Commissioner, 309 private
self-insured plans in Washington have
elected to participate in the state’s balance
billing law.
209
DOL does not have data on
the number of self-insured plans that have
opted into New Jersey’s balance billing
law. In order to estimate the number of
self-insured plans that have opted into the
balance billing law for New Jersey, DOL
has scaled Washington’s estimate by the
number of participants with self-insured
ERISA-covered plans.
210
According to the
2019 Health Insurance Coverage Bulletin,
there are respectively, 0.7 million, 2.1 mil-
lion, and 2.7 million with self-insured ER-
ISA-covered plans in Nevada, Virginia,
and New Jersey. Additionally, according
to the Washington’s Office of Insurance
Commissioner, about 0.5 million self-in-
sured participants have opted into Wash-
ington’s balance billing law.
211
This

results
in a total of 6 million participants.
212
Thus,
DOL estimates that 20, 231, 309, and 57
private self-insured plans will opt in re-
spectively in Nevada, Virginia, Washing-
ton, and New Jersey, resulting in a total
of 617 self-insured plans.
213
These plans
will incur the one-time burden and cost to
include the disclosure in their plan docu-
ments in 2022.
DOL estimates that it will take 1 hour
for an administrative assistant, with a
wage rate of $55.14, to gather information
and review information.
214
This results in
hour burden of 617 hours, with an equiv-
alent cost of $34,023. DOL estimates that
it will take 30 minutes for a benefits man-
ager, with a wage rate of $134.21, to gath-
er information and review information.
215

This results in hour burden of 309 hours,
with an equivalent cost of $41,406. In
2022, the total hour burden is 926 hours,
with an equivalent cost of $75,430.
The average number of participants in
a self-insured ERISA-covered plan that
will opt into the four states’ balance billing
laws is 9,724.
216
DOL assumes that only
printing and material costs are associated
with the disclosure requirement, because
the notice can be incorporated into exist-
ing plan documents. DOL estimates that
the disclosure will require one-half of a
page, at a cost of $0.05 per page for print-
ing and materials, and 34 percent of plan
documents will be delivered electronically
at minimal cost.
217
Thus, in 2022, the cost
to deliver 66 percent of these disclosures
in print is estimated to be approximately
$321.
218
Thus, the 3-year average hour burden
is 309 hours, with an equivalent cost of
$25,143. The 3-year average cost burden
is $107.
5. ICRs Regarding Plan and Issuer
Disclosure on Patient Protections Against
Balance Billing
Section 9820(c) of the Code, section
720(c) of ERISA, and section 2799A-5(c)
of the PHS Act require plans and issuers to
make publicly available, post on a public
website of the plan or issuer, and include
on each explanation of benefits for an
item or service with respect to which the
requirements under section 9816 of the
Code, section 716 of ERISA, and section
2799A-1 of the PHS Act apply, informa-
tion in plain language on the provisions in
these sections, and sections 2799B-1 and
2799B-2 of the PHS Act, and other appli-
cable state laws on out-of-network bal-
ance billing, and information on contact-
ing appropriate state and federal agencies
in the case that an individual believes that
such a provider or facility has violated the
prohibition against balance billing.
As discussed earlier in HHS’ PRA
section, the total burden for all issuers
and TPAs will be 6,153 hours with an
equivalent cost of $699,245 in 2021. As
HHS, DOL, and the Treasury Department
share jurisdiction, it is estimated that 50
percent of the burden will be accounted
for by the HHS, 25 percent of the burden
will be accounted for by the Treasury De-
partment, and the remaining 25 percent
will be accounted for by DOL. HHS will
208
Virginia State Corporation Commission. https://scc.virginia.gov/balancebilling#
209
Washington’s Office of Insurance Commissioner. “Self-Funded Group Health Plans Participating in the Balance Billing Protection Act.” https://www.insurance.wa.gov/self-funded-group-
health-plans
210
Nevada Department of Health and Human Services’ Office of Consumer Health Assistance. “Payment for Medically Necessary Emergency Services Provided Out-of-Network 2020 Annual
Report.” (2020). https://dhhs.nv.gov/uploadedFiles/dhhsnvgov/content/Programs/CHA/AB469%20LCB%20Annual%20Report%202020.pdf
211
Washington’s Office of Insurance Commissioner. “Self-Funded Group Health Plans Participating in the Balance Billing Protection Act.” https://www.insurance.wa.gov/self-funded-group-
health-plans
212
Employee Benefits Security Administration. “Health Insurance Coverage Bulletin: Abstract of Auxiliary Data for the March 2019 Annual Social and Economic Supplement to the Current
Population Survey.” (2019). https://www.dol.gov/sites/dolgov/files/EBSA/researchers/data/health-and-welfare/health-insurance-coverage-bulletin-2019.pdf
213
New Jersey: 335 x (0.5/2.7) = 62 self-insured plans; 62 self-insured plans – 5 non-federal self-insured plans = 57 private self-insured plans
214
For more information on how the Department estimates labor costs see: https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/rules-and-regulations/technical-appendices/
labor-cost-inputs-used-in-ebsa-opr-ria-and-pra-burden-calculations-june-2019.pdf
215
For more information on how the Department estimates labor costs see: https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/rules-and-regulations/technical-appendices/
labor-cost-inputs-used-in-ebsa-opr-ria-and-pra-burden-calculations-june-2019.pdf
216
(6,000,000 participants with self-insured ERISA-covered plans)/ 617 self-insured ERISA-covered plans= 9,724 participants per self-insured ERISA-covered plan
217
According to data from the National Telecommunications and Information Agency, 34 percent of households in the United States accessed health records or health insurance online. https://
www.ntia.doc.gov/blog/2020/more-half-american-households-used-internet-health-related-activities-2019-ntia-data-show.
218
9,724 participants x 0.66 x $0.05 = $321

Bulletin No. 2021–30 107 July 26, 2021
account for approximately 3,077 hours
with an equivalent cost of approximately
$349,622. DOL and the Treasury Depart-
ment will each account for approximately
1,539 hours with an equivalent cost of ap-
proximately $174,811.
Starting in 2022, the total burden for
all issuers and TPAs is estimated to be
558,778 hours with an equivalent cost of
$21,714,111. The total printing and mate-
rials cost for sending 33,526,677 notices
by mail will be $1,676,334 annually. As
HHS, DOL, and the Treasury Department
share jurisdiction, it is estimated that 50
percent of the burden will be accounted
for by the HHS, 25 percent of the burden
will be accounted for by the Treasury De-
partment, and the remaining 25 percent
will be accounted for by DOL. Thus, HHS
will account for 279,389 hours, with an
equivalent cost of $10,857,056, and print-
ing and materials cost of $838,167 starting
in 2022. DOL and the Treasury Depart-
ment will each account for 139,695 hours
with an equivalent cost of $419,084.
Thus, the 3-year average hour burden
associated with this requirement for DOL
and the Treasury Department is 93,643
hours each with an equivalent cost of
$7,354,578. The 3-year average cost bur-
den for DOL and Treasury is $279,389
each.
The summary of burden below encom-
passes the following ICRs: (1) Informa-
tion to be Shared about the QPA (26 CFR
54.9816-6T(d), 29 CFR 2590.716-6(d)),
(2) Complaints Process for Surprise Med-
ical Bills (26 CFR 54.9816-7T, 29 CFR
2590.716-7), (3) Opt-In State Balance
Bill Process (26 CFR 54.9816-3T, 29
CFR 2590.716-3), and (4) Plan and Issuer
Disclosure on Patient Protections Against
Balance Billing.
Summary of Burden
Type of Review: New Collection.
Agency: DOL–EBSA, Treasury
Title: No Surprise Billing
OMB Numbers: 1210-NEW, 1545-NEW
Affected Public: Businesses or other
for-profits, Not-for-profit institutions.
Total Respondents: DOL- 1,985; Trea-
sury- 1,779
Total Responses: DOL- 10,368,277; Trea-
sury- 10,368,071
Frequency of Response: Occasionally.
Estimated Total Annual Burden Hours:
927,652 (DOL- 463,980, Treasury-
463,672)
Estimated Total Annual Burden Cost:
$558,885 (DOL- $279,496, Treasury-
$279, 389)
F. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA),
(5 U.S.C. 601 et seq.), requires agencies
to analyze options for regulatory relief of
small entities to prepare an initial regula-
tory flexibility analysis to describe the im-
pact of the proposed rule on small entities,
unless the head of the agency can certify
that the rule will not have a significant
economic impact on a substantial number
of small entities. The RFA generally de-
fines a “small entity” as (1) a proprietary
firm meeting the size standards of the
Small Business Administration (SBA),
(2) a not-for-profit organization that is not
dominant in its field, or (3) a small gov-
ernment jurisdiction with a population of
less than 50,000. States and individuals
are not included in the definition of “small
entity.” HHS uses a change in revenues of
more than 3 to 5 percent as its measure of
significant economic impact on a substan-
tial number of small entities. Individuals
and states are not included in the defini-
tion of a small entity. These interim final
rules are not preceded by a general notice
of proposed rulemaking, and thus the re-
quirements of RFA do not apply.
G. Unfunded Mandates Reform Act
Section 202 of the Unfunded Man-
dates Reform Act of 1995 (UMRA) re-
quires that agencies assess anticipated
costs and benefits and take certain other
actions before issuing a proposed rule or
any final rule for which a general notice
of proposed rulemaking was published
that includes any Federal mandate that
may result in expenditures in any 1 year
by state, local, or Tribal governments, in
the aggregate, or by the private sector, of
$100 million in 1995 dollars, updated an-
nually for inflation. In 2021, that thresh-
old is approximately $158 million. These
interim final rules were not preceded by
a general notice of proposed rulemaking,
and thus the requirements of UMRA do
not apply.
H. Federalism
Executive Order 13132 outlines fun-
damental principles of federalism. It re-
quires adherence to specific criteria by
federal agencies in formulating and im-
plementing policies that have “substantial
direct effects” on the states, the relation-
ship between the national government and
states, or on the distribution of power and
responsibilities among the various levels
of government. Federal agencies promul-
gating regulations that have these federal-
ism implications must consult with state
and local officials, and describe the extent
of their consultation and the nature of the
concerns of state and local officials in the
preamble to the interim final rules.
These interim final rules protect partic-
ipants, beneficiaries, or enrollees in group
health plans and group and individual
health insurance coverage, and covered
individuals in FEHB plans, from surprise
medical bills for emergency services, air
ambulance services furnished by nonpar-
ticipating providers, and non-emergency
services furnished by nonparticipating
providers at participating facilities in cer-
tain circumstances. A number of states
currently have laws related to surprise
medical bills. The Departments are of
the view that Congress did not intend to
supplant state laws regarding balance bill-
ing, but rather to supplement such laws.
The provisions in these interim final rules
are consistent with the statute’s general
approach of supplementing state law. In
addition, the No Surprises Act and these
interim final rules recognize states’ tra-
ditional role as the primary regulators of
health insurance issuers, providers, and
facilities. The No Surprises Act authorizes
states to enforce the new requirements re-
garding health insurance coverage, includ-
ing those related to balance billing, with
respect to issuers, providers, facilities, and
providers of air ambulance services, with
HHS enforcing only in cases where the
state has notified HHS that the state does
not have the authority to enforce or is not
otherwise enforcing, or HHS has made
a determination that a state has failed to
substantially enforce the requirements.
In compliance with the requirement
of Executive Order 13132 that agencies
examine closely any policies that may
have federalism implications or limit the

July 26, 2021 108 Bulletin No. 2021–30
policy making discretion of the states, the
Departments have engaged in efforts to
consult with and work cooperatively with
affected states, including participating in
conference calls with and attending con-
ferences of the NAIC, and consulting with
state insurance officials on a state-by-state
basis. In addition, the Departments con-
sulted with the NAIC, as required by the
No Surprises Act, to establish the geo-
graphic regions to be used in the method-
ology for calculating the QPA.
OPM concluded that it would be inap-
propriate for FEHB plans to adopt varying
state standards, and consistent with the
FEHBA, it would adopt state laws where
appropriate pursuant to bilaterally negoti-
ated FEHB contracts.
While developing these interim final
rules, the Departments attempted to bal-
ance the states’ interests in regulating
health insurance issuers, providers, and
facilities with the need to ensure at least
the minimum federal consumer protec-
tions in every state. By doing so, the De-
partments complied with the requirements
of Executive Order 13132.
I. Congressional Review Act
These interim final rules are subject to
the Congressional Review Act provisions
of the Small Business Regulatory En-
forcement Fairness Act of 1996 (5 U.S.C.
801 et seq.) and will be transmitted to the
Congress and to the Comptroller General
for review in accordance with such pro-
visions.
Statutory Authority
The Office of Personnel Management
regulations are adopted pursuant to the au-
thority contained in 5 U.S.C. 8902(p) and
5 U.S.C. 8913.
The Department of the Treasury regu-
lations are adopted pursuant to the author-
ity contained in sections 7805 and 9833 of
the Code.
The Department of Labor regulations
are adopted pursuant to the authority con-
tained in 29 U.S.C. 1002, 1135, 1182,
1185d, 1191a, 1191b, and 1191c; Secre-
tary of Labor’s Order 1-2011, 77 FR 1088
(Jan. 9, 2012).
The Department of Health and Human
Services regulations are adopted pursu-
ant to the authority contained in sections
2701 through 2763, 2791, 2792, 2794,
2799A-1 through 2799B-9 of the PHS Act
(42 U.S.C. 300gg–300gg-63, 300gg-91,
300gg-92, 300gg-94, 300gg–300gg139),
as amended; sections 1311 and 1321 of
the ACA (42 U.S.C. 13031 and 18041).
List of Subjects
5 CFR Part 890
Administrative practice and procedure,
Government employees, Health facilities,
Health insurance, Health professions,
Hostages, Iraq, Kuwait, Lebanon, Military
personnel,
Reporting and recordkeeping require-
ments, Retirement.
26 CFR Part 54
Excise taxes, Health care, Health in-
surance, Pensions, Reporting and record-
keeping requirements.
29 CFR Part 2590
Continuation coverage, Disclosure,
Employee benefit plans, Group health
plans, Health care, Health insurance,
Medical child support, Reporting and re-
cordkeeping requirements.
45 CFR Part 144
Health care, Health insurance, Report-
ing and recordkeeping requirements.
45 CFR Part 147
Health care, Health insurance, Report-
ing and recordkeeping requirements, and
State regulation of health insurance.
45 CFR Part 149
Balance billing, Health care, Health
insurance, Reporting and recordkeeping
requirements, Surprise billing, State reg-
ulation of health insurance, Transparency
in coverage.
45 CFR Part 156
Administrative practice and proce-
dure, Advertising, Advisory committees,
Age discrimination, Alaska, Brokers, Cit-
izenship and naturalization, Civil rights,
Conflict of interests, Consumer pro-
tection, Grant programs-health, Grants
administration, Health care, Health in-
surance, Health maintenance organiza-
tion (HMO), Health records, Hospitals,
Indians, Individuals with disabilities,
Intergovernmental relations, Loan pro-
grams-health, Medicaid, Organization
and functions (Government agencies),
Prescription drugs, Public assistance
programs, Reporting and recordkeeping
requirements, Sex discrimination, State
and local governments, Sunshine Act,
Technical assistance, Women, Youth.
Laurie Bodenheimer,
Associate Director
Healthcare and Insurance
Office of Personnel Management.
_________________________________
Douglas W. O’Donnell,
Deputy Commissioner for Services and
Enforcement,
Internal Revenue Service.
_________________________________
Mark J. Mazur,
Acting Assistant Secretary of the Treasury
(Tax Policy).
_________________________________
Ali Khawar
Assistant Secretary,
Employee Benefits Security Administra-
tion,
Department of Labor.
_________________________________
Xavier Becerra,
Secretary,
Department of Health and Human Ser-
vices.
OFFICE OF PERSONNEL
MANAGEMENT
For the reasons stated in the pream-
ble, the Office of Personnel Management
amends 5 CFR part 890 as follows:
PART 890—FEDERAL EMPLOYEES
HEALTH BENEFITS PROGRAM
1. The authority citation for part 890
continues to read as follows:
Authority: 5 U.S.C. 8913; Sec.
890.102 also issued under sections
11202(f), 11232(e), and 11246 (b) of Pub.

Bulletin No. 2021–30 109 July 26, 2021
L. 105-33, 111 Stat. 251; Sec. 890.111
also issued under section 1622(b) of Pub.
L. 104-106, 110 Stat. 521 (36 U.S.C.
5522); Sec. 890.112 also issued under
section 1 of Pub. L. 110-279, 122 Stat.
2604 (2 U.S.C. 2051); Sec. 890.113 also
issued under section 1110 of Pub. L. 116-
92, 133 Stat. 1198 (5 U.S.C. 8702 note);
Sec. 890.301 also issued under section
311 of Pub. L. 111-3, 123 Stat. 64 (26
U.S.C. 9801); Sec. 890.302(b) also is-
sued under section 1001 of Pub. L. 111-
148, 124 Stat. 119, as amended by Pub.
L. 111-152, 124 Stat. 1029 (42 U.S.C.
300gg-14); Sec. 890.803 also issued un-
der 50 U.S.C. 3516 (formerly 50 U.S.C.
403p) and 22 U.S.C. 4069c and 4069c-1;
subpart L also issued under section 599C
of Pub. L. 101-513, 104 Stat. 2064 (5
U.S.C. 5561 note), as amended; and sub-
part M also issued under section 721 of
Pub. L. 105-261 (10 U.S.C. 1108), 112
Stat. 2061.
Subpart A - Administration and
General Provisions
2. Section 890.107 is amended by add-
ing paragraph (e) to read as follows:
§ 890.107 Court review.
* * * * *
(e) A suit for equitable relief founded
on 5 U.S.C. chapter 89 that is based on 5
U.S.C. 8902(p) and is governed by 5 CFR
part 890 must be brought against OPM by
December 31 of the 3
rd
year after the year
in which disputed services were rendered.
3. Section 890.114 is added to subpart
A to read as follows:
§ 890.114 Surprise billing.
(a) A carrier must comply with require-
ments described in 26 CFR 54.9816-3T
through 54.9816-6T, 54.9817-1T, and
54.9822-1T, 29 CFR 2590.716-3 through
2590.716-6, 2590.717-1, and 2590.722,
and 45 CFR 149.30, 149.110 through
149.140, and 149.310 in the same manner
as such provisions apply to a group health
plan or health insurance issuer offering
group or individual health insurance cov-
erage, subject to 5 U.S.C. 8902(m)(1), and
the provisions of the carrier’s contract. For
purposes of application of such sections,
all carriers are deemed to offer health ben-
efits in the large group market.
(b) For purposes of the provisions ref-
erenced in paragraph (a) of this section:
Group health plan or plan shall
mean a “health benefits plan” defined
at 5 U.S.C. 8901(6), which is a Federal
governmental plan offered pursuant to 5
U.S.C. chapter 89.
Health insurance issuer or issuer
shall include a carrier defined at 5 U.S.C.
8901(7). Where the carrier for a health
benefits plan is a voluntary association,
an association of organizations or enti-
ties, or is otherwise comprised of mul-
tiple entities, each entity is responsible
for compliance in the same manner as
such sections apply to group health plans
and issuers. If and to the extent an enti-
ty offering a health benefits plan under 5
U.S.C. chapter 89 is licensed under state
law and is properly considered an issuer
as defined at section 2791 of the Public
Health Service Act, the entity is consid-
ered a carrier to the extent of its FEHB
health benefits plan contractual and regu-
latory compliance.
Participant, beneficiary, or enrollee
shall include an “enrollee” or “covered in-
dividual” as defined by 5 CFR 890.101, as
appropriate.
(c) When a complaint challenges a car-
rier’s action or inaction with respect to the
surprise billing provisions, OPM will co-
ordinate with the Departments of Health
and Human Services, Labor, and the Trea-
sury to resolve the complaint.
DEPARTMENT OF THE TREASURY
Internal Revenue Service
Accordingly, 26 CFR part 54 is amend-
ed as follows:
PART 54—PENSION EXCISE TAXES
Paragraph 4. The authority citation
for part 54 continues to read, in part, as
follows:
Authority: 26 U.S.C. 7805, unless oth-
erwise noted.
* * * * *
Par. 5. Section 54.9801-1T is added to
read as follows:
§ 54.9801-1T Basis and scope
(temporary).
(a) Statutory basis. This section and §§
54.9801-2 through 54.9801-6, 54.9802-
1, 54.9802-2, 54.9802-3T, 54.9802-4,
54.9811-1, 54.9812-1, 54.9815-1251,
54.9815-2704, 54.9815-2705, 54.9815-
2708, 54.9815-2711, 54.9815-2712,
54.9815-2713, 54.9815-2713A, 54.9815-
2714, 54.9815-2715, 54.9815-2715A1,
54.9815-2715A2, 54.9815-2715A3,
54.9815-2719, 54.9815-2715A, 54.9816-1
through 9816-7, 54.9831-1, and 54.9833-
1 implement Chapter 100 of Subtitle K of
the Internal Revenue Code of 1986.
(b) Scope. A group health plan or
health insurance issuer offering group
health insurance coverage may provide
greater rights to participants and bene-
ficiaries than those set forth in the por-
tability and market reform sections of
this part. This part sets forth minimum
requirements for group health plans and
group health insurance issuers offering
group health insurance coverage con-
cerning certain consumer protections
of the Health Insurance Portability and
Accountability Act (HIPAA), including
special enrollment periods and the prohi-
bition against discrimination based on a
health factor, as amended by the Patient
Protection and Affordable Care Act (Af-
fordable Care Act). Other consumer pro-
tection provisions, including other pro-
tections provided by the Affordable Care
Act, the Mental Health Parity and Addic-
tion Equity Act, and the No Surprises Act
are set forth in this part.
(c) Similar requirements under the Em-
ployee Retirement Income Security Act
and the Public Health Service Act. Sec-
tions 701, 702, 703, 711, 712, 716, 717,
732, and 733 of the Employee Retirement
Income Security Act of 1974 and sections
2701, 2702, 2704, 2705, 2721, 2791,
2799A-1, and 2799A-2 of the Public
Health Service Act impose requirements
similar to those imposed under Chapter
100 of Subtitle K with respect to health
insurance issuers offering group health in-
surance coverage. See 29 CFR part 2590
and 45 CFR parts 144, 146, 148, and 149.
See also part B of Title XXVII of the Pub-
lic Health Service Act and 45 CFR parts
148 and 149 for other rules applicable to

July 26, 2021 110 Bulletin No. 2021–30
health insurance offered in the individual
market (defined in § 54.9801-2).
Par. 6. Section 54.9801-2T is added to
read as follows:
§ 54.9801-2T Definitions (temporary).
Unless otherwise provided, the defini-
tions in this section and § 54.9801-2 gov-
ern in applying the provisions of sections
9801 through 9825 and 9831 through
9834.
Affiliation period means a period of
time that must expire before health in-
surance coverage provided by an HMO
becomes effective, and during which the
HMO is not required to provide benefits.
COBRA definitions:
(1) COBRA means title X of the Con-
solidated Omnibus Budget Reconciliation
Act of 1985, as amended.
(2) COBRA continuation cover-
age means coverage, under a group health
plan, that satisfies an applicable COBRA
continuation provision.
(3) COBRA continuation provi-
sion means section 4980B (other than
paragraph (f)(1) of section 4980B insofar
as it relates to pediatric vaccines), sections
601-608 of ERISA, or title XXII of the
PHS Act.
(4) Exhaustion of COBRA continuation
coverage means that an individual’s CO-
BRA continuation coverage ceases for any
reason other than either failure of the indi-
vidual to pay premiums on a timely basis,
or for cause (such as making a fraudulent
claim or an intentional misrepresentation
of a material fact in connection with the
plan). An individual is considered to have
exhausted COBRA continuation coverage
if such coverage ceases—
(i) Due to the failure of the employer or
other responsible entity to remit premiums
on a timely basis;
(ii) When the individual no longer re-
sides, lives, or works in the service area
of an HMO or similar program (whether
or not within the choice of the individual)
and there is no other COBRA continuation
coverage available to the individual; or
(iii) When the individual incurs a claim
that would meet or exceed a lifetime limit
on all benefits and there is no other CO-
BRA continuation coverage available to
the individual.
Condition means a medical condition.
Creditable coverage means creditable
coverage within the meaning of §54.9801-
4(a).
Dependent means any individual who
is or may become eligible for coverage
under the terms of a group health plan be-
cause of a relationship to a participant.
Employee Retirement Income Securi-
ty Act of 1974 (ERISA) means the Em-
ployee Retirement Income Security Act
of 1974, as amended (29 U.S.C. 1001 et
seq.).
Enroll means to become covered for
benefits under a group health plan (that
is, when coverage becomes effective),
without regard to when the individual
may have completed or filed any forms
that are required in order to become cov-
ered under the plan. For this purpose,
an individual who has health coverage
under a group health plan is enrolled in
the plan regardless of whether the indi-
vidual elects coverage, the individual is
a dependent who becomes covered as a
result of an election by a participant, or
the individual becomes covered without
an election.
Enrollment date means the first day of
coverage or, if there is a waiting period,
the first day of the waiting period. If an in-
dividual receiving benefits under a group
health plan changes benefit packages, or
if the plan changes group health insurance
issuers, the individual’s enrollment date
does not change.
Excepted benefits means the benefits
described as excepted in §54.9831(c).
First day of coverage means, in the
case of an individual covered for benefits
under a group health plan, the first day of
coverage under the plan and, in the case of
an individual covered by health insurance
coverage in the individual market, the first
day of coverage under the policy or con-
tract.
Genetic information has the meaning
given the term in §54.9802-3T(a)(3).
Group health insurance cover-
age means health insurance coverage of-
fered in connection with a group health
plan. Individual health insurance coverage
reimbursed by the arrangements described
in 29 CFR 2510.3-1(l) is not offered in
connection with a group health plan, and
is not group health insurance coverage,
provided all the conditions in 29 CFR
2510.3-1(l) are satisfied.
Group health plan or plan means
a group health plan within the meaning of
§54.9831-1(a).
Group market means the market for
health insurance coverage offered in con-
nection with a group health plan. (Howev-
er, certain very small plans may be treated
as being in the individual market, rather
than the group market; see the definition
of individual market in this section.)
Health insurance coverage means ben-
efits consisting of medical care (provided
directly, through insurance or reimburse-
ment, or otherwise) under any hospital
or medical service policy or certificate,
hospital or medical service plan contract,
or HMO contract offered by a health in-
surance issuer. Health insurance coverage
includes group health insurance coverage,
individual health insurance coverage,
and short-term, limited-duration insur-
ance. However, benefits described in
§54.9831(c)(2) are not treated as benefits
consisting of medical care.
Health insurance issuer or issu-
er means an insurance company, insur-
ance service, or insurance organization
(including an HMO) that is required to
be licensed to engage in the business of
insurance in a State and that is subject to
State law that regulates insurance (within
the meaning of section 514(b)(2) of ERI-
SA). Such term does not include a group
health plan.
Health maintenance organiza-
tion or HMO means—
(1) A federally qualified health mainte-
nance organization (as defined in section
1301(a) of the PHS Act);
(2) An organization recognized under
State law as a health maintenance organi-
zation; or
(3) A similar organization regulated
under State law for solvency in the same
manner and to the same extent as such a
health maintenance organization.
Individual health insurance cover-
age means health insurance coverage
offered to individuals in the individual
market, but does not include short-term,
limited-duration insurance. Individual
health insurance coverage can include de-
pendent coverage.
Individual market means the market
for health insurance coverage offered to
individuals other than in connection with
a group health plan. Unless a State elects

Bulletin No. 2021–30 111 July 26, 2021
otherwise in accordance with section
2791(e)(1)(B)(ii) of the PHS Act, such
term also includes coverage offered in
connection with a group health plan that
has fewer than two participants who are
current employees on the first day of the
plan year.
Issuer means a health insurance issuer.
Late enrollee means an individual
whose enrollment in a plan is a late en-
rollment.
Late enrollment means enrollment of an
individual under a group health plan other
than on the earliest date on which cover-
age can become effective for the individu-
al under the terms of the plan; or through
special enrollment. (For rules relating to
special enrollment, see §54.9801-6.) If an
individual ceases to be eligible for cover-
age under a plan, and then subsequently
becomes eligible for coverage under the
plan, only the individual’s most recent
period of eligibility is taken into account
in determining whether the individual is a
late enrollee under the plan with respect
to the most recent period of coverage.
Similar rules apply if an individual again
becomes eligible for coverage following a
suspension of coverage that applied gen-
erally under the plan.
Medical care has the meaning given
such term by section 213(d), determined
without regard to section 213(d)(1)(C)
and so much of section 213(d)(1)(D) as re-
lates to qualified long-term care insurance.
Medical condition or condition means
any condition, whether physical or mental,
including, but not limited to, any condi-
tion resulting from illness, injury (whether
or not the injury is accidental), pregnancy,
or congenital malformation. However, ge-
netic information is not a condition.
Participant means participant within
the meaning of section 3(7) of ERISA.
Placement, or being placed, for adop-
tion means the assumption and retention
of a legal obligation for total or partial
support of a child by a person with whom
the child has been placed in anticipation
of the child’s adoption. The child’s place-
ment for adoption with such person ends
upon the termination of such legal obliga-
tion.
Plan year means the year that is des-
ignated as the plan year in the plan doc-
ument of a group health plan, except that
if the plan document does not designate a
plan year or if there is no plan document,
the plan year is—
(1) The deductible or limit year used
under the plan;
(2) If the plan does not impose deduct-
ibles or limits on a yearly basis, then the
plan year is the policy year;
(3) If the plan does not impose deduct-
ibles or limits on a yearly basis, and either
the plan is not insured or the insurance
policy is not renewed on an annual basis,
then the plan year is the employer’s tax-
able year; or
(4) In any other case, the plan year is
the calendar year.
Preexisting condition exclusion means
a limitation or exclusion of benefits (in-
cluding a denial of coverage) based on the
fact that the condition was present before
the effective date of coverage (or if cover-
age is denied, the date of the denial) under
a group health plan or group or individual
health insurance coverage (or other cover-
age provided to federally eligible individ-
uals pursuant to 45 CFR part 148), wheth-
er or not any medical advice, diagnosis,
care, or treatment was recommended or
received before that day. A preexisting
condition exclusion includes any limita-
tion or exclusion of benefits (including a
denial of coverage) applicable to an indi-
vidual as a result of information relating
to an individual’s health status before the
individual’s effective date of coverage (or
if coverage is denied, the date of the deni-
al) under a group health plan, or group or
individual health insurance coverage (or
other coverage provided to federally eli-
gible individuals pursuant to 45 CFR part
148), such as a condition identified as a
result of a pre-enrollment questionnaire or
physical examination given to the individ-
ual, or review of medical records relating
to the pre-enrollment period.
Public health plan means public health
plan within the meaning of §54.9801-4(a)
(1)(ix).
Public Health Service Act (PHS
Act) means the Public Health Service Act
(42 U.S.C. 201, et seq.).
Short-term, limited-duration insur-
ance means health insurance coverage
provided pursuant to a contract with an
issuer that:
(1) Has an expiration date specified in
the contract that is less than 12 months af-
ter the original effective date of the con-
tract and, taking into account renewals or
extensions, has a duration of no longer
than 36 months in total;
(2) With respect to policies having a
coverage start date before January 1, 2019,
displays prominently in the contract and in
any application materials provided in con-
nection with enrollment in such coverage
in at least 14 point type the language in the
following Notice 1, excluding the heading
“Notice 1,” with any additional informa-
tion required by applicable state law:
Notice 1:
This coverage is not required to com-
ply with certain federal market require-
ments for health insurance, principally
those contained in the Affordable Care
Act. Be sure to check your policy care-
fully to make sure you are aware of any
exclusions or limitations regarding cov-
erage of preexisting conditions or health
benefits (such as hospitalization, emer-
gency services, maternity care, preventive
care, prescription drugs, and mental health
and substance use disorder services). Your
policy might also have lifetime and/or
annual dollar limits on health benefits. If
this coverage expires or you lose eligibil-
ity for this coverage, you might have to
wait until an open enrollment period to get
other health insurance coverage. Also, this
coverage is not “minimum essential cov-
erage.” If you don’t have minimum essen-
tial coverage for any month in 2018, you
may have to make a payment when you
file your tax return unless you qualify for
an exemption from the requirement that
you have health coverage for that month.
(3) With respect to policies having a
coverage start date on or after January 1,
2019, displays prominently in the contract
and in any application materials provid-
ed in connection with enrollment in such
coverage in at least 14 point type the lan-
guage in the following Notice 2, exclud-
ing the heading “Notice 2,” with any addi-
tional information required by applicable
state law:
Notice 2:
This coverage is not required to com-
ply with certain federal market require-
ments for health insurance, principally
those contained in the Affordable Care

July 26, 2021 112 Bulletin No. 2021–30
Act. Be sure to check your policy care-
fully to make sure you are aware of any
exclusions or limitations regarding cov-
erage of preexisting conditions or health
benefits (such as hospitalization, emer-
gency services, maternity care, preven-
tive care, prescription drugs, and mental
health and substance use disorder ser-
vices). Your policy might also have life-
time and/or annual dollar limits on health
benefits. If this coverage expires or you
lose eligibility for this coverage, you
might have to wait until an open enroll-
ment period to get other health insurance
coverage.
(4) If a court holds the 36-month
maximum duration provision set forth in
paragraph (1) of this definition or its ap-
plicability to any person or circumstances
invalid, the remaining provisions and their
applicability to other people or circum-
stances shall continue in effect.
Significant break in coverage means
a significant break in coverage within the
meaning of §54.9801-4(b)(2)(iii).
Special enrollment means enrollment
in a group health plan under the rights de-
scribed in §54.9801-6 or in group health
insurance coverage under the rights de-
scribed in 29 CFR 2590.701-6 or 45 CFR
146.117.
State health benefits risk pool means
a State health benefits risk pool within the
meaning of §54.9801-4(a)(1)(vii).
Travel insurance means insurance
coverage for personal risks incident to
planned travel, which may include, but is
not limited to, interruption or cancellation
of trip or event, loss of baggage or person-
al effects, damages to accommodations
or rental vehicles, and sickness, accident,
disability, or death occurring during trav-
el, provided that the health benefits are not
offered on a stand-alone basis and are inci-
dental to other coverage. For this purpose,
the term travel insurance does not include
major medical plans that provide compre-
hensive medical protection for travelers
with trips lasting 6 months or longer, in-
cluding, for example, those working over-
seas as an expatriate or military personnel
being deployed.
Waiting period means waiting pe-
riod within the meaning of §54.9815-
2708(b).
Par. 7. Section 54.9815-2719AT is
added to read as follows:
§ 54.9815-2719AT Patient protections
(temporary).
(a) – (b) [Reserved]
(c) Applicability date. The provisions of
this section are applicable to group health
plans and health insurance issuers for plan
years beginning before January 1, 2022.
See also §§ 54.9816-4T through 54.9816-
7T, 54.9817-1T, and 54.9822-1T for rules
applicable with respect to plan years begin-
ning on or after January 1, 2022.
Par. 8. Sections 54.9816-1T, 54.9816-
2T, 54.9816-3T, 54.9816-4T, 54.9816-5T,
54.9816-6T, 54.9816-7T, 54.9817-1T, and
54.9822-1T are added to read as follows:
Sec.
54.9816-1T Basis and scope (temporary).
54.9816-2T Applicability (temporary).
54.9816-3T Definitions (temporary).
54.9816-4T Preventing surprise medical
bills for emergency services (temporary).
54.9816-5T Preventing surprise medical
bills for non-emergency services per-
formed by nonparticipating providers at
certain participating facilities (temporary).
54.9816-6T Methodology for calculating
qualifying payment amount (temporary).
54.9816-7T Complaints process for sur-
prise medical bills regarding group health
plans (temporary).
54.9817-1T Preventing surprise medical
bills for air ambulance services (tempo-
rary).
54.9822-1T Choice of health care profes-
sional (temporary).
* * * * *
§ 54.9816-1T Basis and scope
(temporary).
(a) Basis. This section and §§ 54.9816-
2T through 54.9816-7T, 54.9817-1T, and
54.9822-1T implement subchapter B of
chapter 100 of the Internal Revenue Code
of 1986.
(b) Scope. This part establishes stan-
dards for group health plans with respect
to surprise medical bills, transparency in
health care coverage, and additional pa-
tient protections.
§ 54.9816-2T Applicability
(temporary).
(a) In general. The requirements in §§
54.9816-4T through 54.9816-7T, 54.9817-
1T, and 54.9822-1T apply to group health
plans (including grandfathered health plans
as defined in § 54.9815-1251T), except as
specified in paragraph (b) of this section.
(b) Exceptions. The requirements
in §§ 54.9816-4T through 54.9816-7T,
54.9817-1T, and 54.9822-1T do not apply
to the following:
(1) Excepted benefits as described in §
54.9831-1(c).
(2) Short-term, limited-duration insur-
ance as defined in § 54.9801-2.
(3) Health reimbursement arrange-
ments or other account-based group health
plans as described in § 54.9815-2711(d).
§ 54.9816-3T Definitions (temporary).
The definitions in § 54.9801-2T apply
to §§ 54.9816-4T through 54.9816-7T,
54.9817-1T, and 54.9822-1T unless oth-
erwise specified. In addition, for purpos-
es of §§ 54.9816-4T through 54.9816-7T,
54.9817-1T, and 54.9822-1T, the follow-
ing definitions apply:
Air ambulance service means medical
transport by a rotary wing air ambulance,
as defined in 42 CFR 414.605, or fixed
wing air ambulance, as defined in 42 CFR
414.605, for patients.
Cost sharing means the amount a par-
ticipant, beneficiary, or enrollee is respon-
sible for paying for a covered item or ser-
vice under the terms of the group health
plan or health insurance coverage. Cost
sharing generally includes copayments,
coinsurance, and amounts paid towards
deductibles, but does not include amounts
paid towards premiums, balance billing
by out-of-network providers, or the cost
of items or services that are not covered
under a group health plan or health insur-
ance coverage.
Emergency department of a hospital
includes a hospital outpatient department
that provides emergency services.
Emergency medical condition has the
meaning given the term in § 54.9816-
4T(c)(1).
Emergency services has the meaning
given the term in § 54.9816-4T(c)(2).
Health care facility, with respect to
a group health plan, in the context of
non-emergency services, is each of the
following:
(1) A hospital (as defined in section
1861(e) of the Social Security Act);

Bulletin No. 2021–30 113 July 26, 2021
(2) A hospital outpatient department;
(3) A critical access hospital (as defined
in section 1861(mm)(1) of the Social Se-
curity Act); and
(4) An ambulatory surgical center de-
scribed in section 1833(i)(1)(A) of the So-
cial Security Act.
Independent freestanding emergency
department means a health care facility
(not limited to those described in the defi-
nition of health care facility with respect
to non-emergency services) that—
(1) Is geographically separate and dis-
tinct and licensed separately from a hospi-
tal under applicable State law; and
(2) Provides any emergency services as
described in § 54.9816-4T(c)(2)(i).
Nonparticipating emergency facili-
ty means an emergency department of a
hospital, or an independent freestanding
emergency department (or a hospital,
with respect to services that pursuant to §
54.9816-4T(c)(2)(ii) are included as emer-
gency services), that does not have a con-
tractual relationship directly or indirectly
with a group health plan, with respect to
the furnishing of an item or service under
the plan.
Nonparticipating provider means any
physician or other health care provider
who does not have a contractual relation-
ship directly or indirectly with a group
health plan, with respect to the furnishing
of an item or service under the plan.
Notice of denial of payment means,
with respect to an item or service for which
benefits subject to the protections of §§
54.9816-4T, 54.9816-5T, and 54.9817-1T
are provided or covered, a written notice
from the plan to the health care provider,
facility, or provider of air ambulance ser-
vices, as applicable, that payment for such
item or service will not be made by the
plan and which explains the reason for de-
nial. The term notice of denial of payment
does not include a notice of benefit denial
due to an adverse benefit determination as
defined in 29 CFR 2560.503-1.
Out-of-network rate means, with re-
spect to an item or service furnished by a
nonparticipating provider, nonparticipat-
ing emergency facility, or nonparticipat-
ing provider of air ambulance services—
(1) Subject to paragraph (3) of this defi-
nition, in a State that has in effect a spec-
ified State law, the amount determined in
accordance with such law;
(2) Subject to paragraph (3) of this
definition, in a State that does not have in
effect a specified State law—
(i) Subject to paragraph (2)(ii) of this
definition, if the nonparticipating provider
or nonparticipating emergency facility and
the plan agree on an amount of payment
(including if the amount agreed upon is
the initial payment sent by the plan under
§ 54.9816-4T(b)(3)(iv)(A), § 54.9816-
5T(c)(3), or § 54.9817-1T(b)(4)(i); 29
CFR 2590.716-4(b)(3)(iv)(A), 2590.716-
5(c)(3), or 2590.717-1(b)(4)(i); or 45
CFR 149.110(b)(3)(iv)(A), 149.120(c)
(3), or 149.130(b)(4)(i), as applicable, or
is agreed on through negotiations with re-
spect to such item or service), such agreed
on amount; or
(ii) If the nonparticipating provider or
nonparticipating emergency facility and
the plan enter into the independent dispute
resolution (IDR) process under section
9816(c) or 9817(b) of the Internal Reve-
nue Code, section 716(c) or 717(b) of ER-
ISA, or section 2799A-1(c) or 2799A-2(b)
of the PHS Act, as applicable, and do not
agree before the date on which a certified
IDR entity makes a determination with re-
spect to such item or service under such
subsection, the amount of such determina-
tion; or
(3) In a State that has an All-Payer
Model Agreement under section 1115A of
the Social Security Act that applies with
respect to the plan; the nonparticipating
provider or nonparticipating emergen-
cy facility; and the item or service, the
amount that the State approves under the
All-Payer Model Agreement for the item
or service.
Participating emergency facility means
any emergency department of a hospital,
or an independent freestanding emergency
department (or a hospital, with respect to
services that pursuant to § 54.9816-4T(c)
(2)(ii) are included as emergency ser-
vices), that has a contractual relationship
directly or indirectly with a group health
plan setting forth the terms and conditions
on which a relevant item or service is pro-
vided to a participant or beneficiary under
the plan. A single case agreement between
an emergency facility and a plan that is
used to address unique situations in which
a participant or beneficiary requires ser-
vices that typically occur out-of-network
constitutes a contractual relationship for
purposes of this definition, and is limited
to the parties to the agreement.
Participating health care facility means
any health care facility described in this
section that has a contractual relationship
directly or indirectly with a group health
plan setting forth the terms and conditions
on which a relevant item or service is pro-
vided to a participant or beneficiary under
the plan. A single case agreement between
a health care facility and a plan that is
used to address unique situations in which
a participant or beneficiary requires ser-
vices that typically occur out-of-network
constitutes a contractual relationship for
purposes of this definition, and is limited
to the parties to the agreement.
Participating provider means any phy-
sician or other health care provider who
has a contractual relationship directly or
indirectly with a group health plan setting
forth the terms and conditions on which a
relevant item or service is provided to a
participant or beneficiary under the plan.
Physician or health care provider
means a physician or other health care
provider who is acting within the scope of
practice of that provider’s license or cer-
tification under applicable State law, but
does not include a provider of air ambu-
lance services.
Provider of air ambulance services
means an entity that is licensed under ap-
plicable State and Federal law to provide
air ambulance services.
Same or similar item or service has
the meaning given the term in § 54.9816-
6T(a)(13).
Service code has the meaning given the
term in § 54.9816-6T(a)(14).
Qualifying payment amount has the
meaning given the term in § 54.9816-
6T(a)(16).
Recognized amount means, with re-
spect to an item or service furnished by
a nonparticipating provider or nonpartic-
ipating emergency facility—
(1) Subject to paragraph (3) of this defi-
nition, in a State that has in effect a spec-
ified State law, the amount determined in
accordance with such law.
(2) Subject to paragraph (3) of this
definition, in a State that does not have in
effect a specified State law, the lesser of—
(i) The amount that is the qualifying
payment amount (as determined in accor-
dance with § 54.9816-6T); or

July 26, 2021 114 Bulletin No. 2021–30
(ii) The amount billed by the provider
or facility.
(3) In a State that has an All-Payer
Model Agreement under section 1115A of
the Social Security Act that applies with
respect to the plan; the nonparticipating
provider or nonparticipating emergency fa-
cility; and the item or service, the amount
that the State approves under the All-Payer
Model Agreement for the item or service.
Specified State law means a State law
that provides for a method for determin-
ing the total amount payable under a group
health plan to the extent such State law ap-
plies for an item or service furnished by a
nonparticipating provider or nonparticipat-
ing emergency facility (including where it
applies because the State has allowed a plan
that is not otherwise subject to applicable
State law an opportunity to opt in, subject
to section 514 of the Employee Retirement
Income Security Act of 1974). A group
health plan that opts into such a specified
State law must do so for all items and ser-
vices to which the specified State law ap-
plies and in a manner determined by the
applicable State authority, and must promi-
nently display in its plan materials describ-
ing the coverage of out-of-network services
a statement that the plan has opted into the
specified State law, identify the relevant
State (or States), and include a general de-
scription of the items and services provided
by nonparticipating facilities and providers
that are covered by the specified State law.
State means each of the 50 States, the
District of Columbia, Puerto Rico, the Vir-
gin Islands, Guam, American Samoa, and
the Northern Mariana Islands.
Treating provider is a physician or
health care provider who has evaluated
the individual.
Visit, with respect to items and services
furnished to an individual at a health care
facility, includes, in addition to items and
services furnished by a provider at the facili-
ty, equipment and devices, telemedicine ser-
vices, imaging services, laboratory services,
and preoperative and postoperative services,
regardless of whether the provider furnish-
ing such items or services is at the facility.
§ 54.9816-4T Preventing surprise
medical bills for emergency services
(temporary).
(a) In general. If a group health plan
provides or covers any benefits with re-
spect to services in an emergency de-
partment of a hospital or with respect to
emergency services in an independent
freestanding emergency department, the
plan must cover emergency services, as
defined in paragraph (c)(2) of this sec-
tion, and this coverage must be provided
in accordance with paragraph (b) of this
section.
(b) Coverage requirements. A plan
described in paragraph (a) of this section
must provide coverage for emergency ser-
vices in the following manner—
(1) Without the need for any prior au-
thorization determination, even if the ser-
vices are provided on an out-of-network
basis.
(2) Without regard to whether the
health care provider furnishing the emer-
gency services is a participating provider
or a participating emergency facility, as
applicable, with respect to the services.
(3) If the emergency services are pro-
vided by a nonparticipating provider or a
nonparticipating emergency facility—
(i) Without imposing any administra-
tive requirement or limitation on coverage
that is more restrictive than the require-
ments or limitations that apply to emer-
gency services received from participat-
ing providers and participating emergency
facilities.
(ii) Without imposing cost-sharing
requirements that are greater than the re-
quirements that would apply if the services
were provided by a participating provider
or a participating emergency facility.
(iii) By calculating the cost-sharing
requirement as if the total amount that
would have been charged for the services
by such participating provider or partici-
pating emergency facility were equal to
the recognized amount for such services.
(iv) The plan—
(A) Not later than 30 calendar days
after the bill for the services is trans-
mitted by the provider or facility (or, in
cases where the recognized amount is
determined by a specified State law or
All-Payer Model Agreement, such other
timeframe as specified by the State law or
All-Payer Model Agreement), determines
whether the services are covered under the
plan and, if the services are covered, sends
to the provider or facility, as applicable,
an initial payment or a notice of denial of
payment. For purposes of this paragraph
(b)(3)(iv)(A), the 30-calendar-day period
begins on the date the plan receives the in-
formation necessary to decide a claim for
payment for the services.
(B) Pays a total plan payment directly
to the nonparticipating provider or non-
participating facility that is equal to the
amount by which the out-of-network rate
for the services exceeds the cost-sharing
amount for the services (as determined in
accordance with paragraphs (b)(3)(ii) and
(iii) of this section), less any initial pay-
ment amount made under paragraph (b)
(3)(iv)(A) of this section. The total plan
payment must be made in accordance
with the timing requirement described in
section 9816(c)(6), or in cases where the
out-of-network rate is determined under
a specified State law or All-Payer Model
Agreement, such other timeframe as spec-
ified by the State law or All-Payer Model
Agreement.
(v) By counting any cost-sharing pay-
ments made by the participant or benefi-
ciary with respect to the emergency ser-
vices toward any in-network deductible
or in-network out-of-pocket maximums
(including the annual limitation on cost
sharing under section 2707(b) of the Pub-
lic Health Service Act) (as applicable) ap-
plied under the plan (and the in-network
deductible and in-network out-of-pocket
maximums must be applied) in the same
manner as if the cost-sharing payments
were made with respect to emergency ser-
vices furnished by a participating provider
or a participating emergency facility.
(4) Without limiting what constitutes
an emergency medical condition (as de-
fined in paragraph (c)(1) of this section)
solely on the basis of diagnosis codes.
(5) Without regard to any other term or
condition of the coverage, other than—
(i) The exclusion or coordination of
benefits (to the extent not inconsistent
with benefits for an emergency medical
condition, as defined in paragraph (c)(1)
of this section).
(ii) An affiliation or waiting period
(each as defined in § 54.9801-2).
(iii) Applicable cost sharing.
(c) Definitions. In this section—
(1) Emergency medical condition
means a medical condition, including
a mental health condition or substance
use disorder, manifesting itself by acute
symptoms of sufficient severity (including
severe pain) such that a prudent layperson,
who possesses an average knowledge of

Bulletin No. 2021–30 115 July 26, 2021
health and medicine, could reasonably ex-
pect the absence of immediate medical at-
tention to result in a condition described in
clause (i), (ii), or (iii) of section 1867(e)(1)
(A) of the Social Security Act (42 U.S.C.
1395dd(e)(1)(A)). (In that provision of
the Social Security Act, clause (i) refers
to placing the health of the individual (or,
with respect to a pregnant woman, the
health of the woman or her unborn child)
in serious jeopardy; clause (ii) refers to se-
rious impairment to bodily functions; and
clause (iii) refers to serious dysfunction of
any bodily organ or part.)
(2) Emergency services means, with
respect to an emergency medical condi-
tion—
(i) In general. (A) An appropriate med-
ical screening examination (as required
under section 1867 of the Social Security
Act (42 U.S.C. 1395dd) or as would be re-
quired under such section if such section
applied to an independent freestanding
emergency department) that is within the
capability of the emergency department of
a hospital or of an independent freestand-
ing emergency department, as applicable,
including ancillary services routinely
available to the emergency department to
evaluate such emergency medical condi-
tion; and
(B) Within the capabilities of the staff
and facilities available at the hospital or
the independent freestanding emergency
department, as applicable, such further
medical examination and treatment as are
required under section 1867 of the So-
cial Security Act (42 U.S.C. 1395dd), or
as would be required under such section
if such section applied to an indepen-
dent freestanding emergency department,
to stabilize the patient (regardless of the
department of the hospital in which such
further examination or treatment is fur-
nished).
(ii) Inclusion of additional services.
(A) Subject to paragraph (c)(2)(ii)(B) of
this section, items and services—
(1) For which benefits are provided or
covered under the plan; and
(2) That are furnished by a nonpartici-
pating provider or nonparticipating emer-
gency facility (regardless of the depart-
ment of the hospital in which such items
or services are furnished) after the partic-
ipant or beneficiary is stabilized and as
part of outpatient observation or an in-
patient or outpatient stay with respect to
the visit in which the services described
in paragraph (c)(2)(i) of this section are
furnished.
(B) Items and services described in
paragraph (c)(2)(ii)(A) of this section are
not included as emergency services if all
of the conditions in 45 CFR 149.410(b)
are met.
(3) To stabilize, with respect to an emer-
gency medical condition, has the mean-
ing given such term in section 1867(e)
(3) of the Social Security Act (42 U.S.C.
1395dd(e)(3)).
(d) Applicability date. The provisions
of this section are applicable with respect
to plan years beginning on or after January
1, 2022.
§ 54.9816-5T Preventing surprise
medical bills for non-emergency
services performed by nonparticipating
providers at certain participating
facilities (temporary).
(a) In general. If a group health plan
provides or covers any benefits with re-
spect to items and services described in
paragraph (b) of this section, the plan
must cover the items and services when
furnished by a nonparticipating provider
in accordance with paragraph (c) of this
section.
(b) Items and services described. The
items and services described in this para-
graph (b) are items and services (other
than emergency services) furnished to a
participant or beneficiary by a nonpartic-
ipating provider with respect to a visit at
a participating health care facility, unless
the provider has satisfied the notice and
consent criteria of 45 CFR 149.420(c)
through (i) with respect to such items and
services.
(c) Coverage requirements. In the case
of items and services described in para-
graph (b) of this section, the plan—
(1) Must not impose a cost-sharing re-
quirement for the items and services that
is greater than the cost-sharing require-
ment that would apply if the items or ser-
vices had been furnished by a participat-
ing provider.
(2) Must calculate the cost-sharing
requirements as if the total amount that
would have been charged for the items
and services by such participating provid-
er were equal to the recognized amount
for the items and services.
(3) Not later than 30 calendar days after
the bill for the items or services is trans-
mitted by the provider (or in cases where
the recognized amount is determined by
a specified State law or All-Payer Mod-
el Agreement, such other timeframe as
specified under the State law or All-Pay-
er Model Agreement), must determine
whether the items and services are cov-
ered under the plan and, if the items and
services are covered, send to the provider
an initial payment or a notice of denial of
payment. For purposes of this paragraph
(c)(3), the 30-calendar-day period begins
on the date the plan receives the informa-
tion necessary to decide a claim for pay-
ment for the items or services.
(4) Must pay a total plan payment di-
rectly to the nonparticipating provider that
is equal to the amount by which the out-
of-network rate for the items and services
involved exceeds the cost-sharing amount
for the items and services (as determined
in accordance with paragraphs (c)(1) and
(2) of this section), less any initial payment
amount made under paragraph (c)(3) of
this section. The total plan payment must
be made in accordance with the timing re-
quirement described in section 9816(c)(6)
or in cases where the out-of-network rate
is determined under a specified State law
or All-Payer Model Agreement, such oth-
er timeframe as specified by the State law
or All-Payer Model Agreement.
(5) Must count any cost-sharing pay-
ments made by the participant or benefi-
ciary toward any in-network deductible
and in-network out-of-pocket maximums
(including the annual limitation on cost
sharing under section 2707(b) of the Pub-
lic Health Service Act) (as applicable) ap-
plied under the plan (and the in-network
deductible and out-of-pocket maximums
must be applied) in the same manner as
if such cost-sharing payments were made
with respect to items and services fur-
nished by a participating provider.
(d) Applicability date. The provisions
of this section are applicable with respect
to plan years beginning on or after January
1, 2022.
§ 54.9816-6T Methodology for
calculating qualifying payment amount
(temporary).
(a) Definitions. For purposes of this
section, the following definitions apply:

July 26, 2021 116 Bulletin No. 2021–30
(1) Contracted rate means the total
amount (including cost sharing) that a
group health plan has contractually agreed
to pay a participating provider, facili-
ty, or provider of air ambulance services
for covered items and services, whether
directly or indirectly, including through
a third-party administrator or pharmacy
benefit manager. Solely for purposes of
this definition, a single case agreement,
letter of agreement, or other similar ar-
rangement between a provider, facility, or
air ambulance provider and a plan, used
to supplement the network of the plan
for a specific participant or beneficiary in
unique circumstances, does not constitute
a contract.
(2) Derived amount has the meaning
given the term in § 54.9815-2715A1.
(3) Eligible database means—
(i) A State all-payer claims database; or
(ii) Any third-party database which—
(A) Is not affiliated with, or owned or
controlled by, any health insurance issuer,
or a health care provider, facility, or pro-
vider of air ambulance services (or any
member of the same controlled group as,
or under common control with, such an
entity). For purposes of this paragraph
(a)(3)(ii)(A), the term controlled group
means a group of two or more persons
that is treated as a single employer under
sections 52(a), 52(b), 414(m), or 414(o)
of the Internal Revenue Code of 1986, as
amended;
(B) Has sufficient information reflect-
ing in-network amounts paid by group
health plans or health insurance issuers
offering group or individual health insur-
ance coverage to providers, facilities, or
providers of air ambulance services for
relevant items and services furnished in
the applicable geographic region; and
(C) Has the ability to distinguish
amounts paid to participating providers
and facilities by commercial payers, such
as group health plans and health insurance
issuers offering group or individual health
insurance coverage, from all other claims
data, such as amounts billed by nonpartic-
ipating providers or facilities and amounts
paid by public payers, including the Medi-
care program under title XVIII of the So-
cial Security Act, the Medicaid program
under title XIX of the Social Security Act
(or a demonstration project under title XI
of the Social Security Act), or the Chil-
dren’s Health Insurance Program under
title XXI of the Social Security Act.
(4) Facility of the same or similar facil-
ity type means, with respect to emergency
services, either—
(i) An emergency department of a hos-
pital; or
(ii) An independent freestanding emer-
gency department.
(5) First coverage year means, with re-
spect to an item or service for which cov-
erage is not offered in 2019 under a group
health plan, the first year after 2019 for
which coverage for such item or service is
offered under that plan.
(6) First sufficient information year
means, with respect to a group health plan
—
(i) In the case of an item or service for
which the plan does not have sufficient in-
formation to calculate the median of the
contracted rates described in paragraph (b)
of this section in 2019, the first year after
2022 for which the plan has sufficient in-
formation to calculate the median of such
contracted rates in the year immediately
preceding that first year after 2022; and
(ii) In the case of a newly covered item
or service, the first year after the first cov-
erage year for such item or service with
respect to such plan for which the plan
has sufficient information to calculate the
median of the contracted rates described
in paragraph (b) of this section in the year
immediately preceding that first year.
(7) Geographic region means—
(i) For items and services other than air
ambulance services—
(A) Subject to paragraphs (a)(7)(i)(B)
and (C) of this section, one region for each
metropolitan statistical area, as described
by the U.S. Office of Management and
Budget and published by the U.S. Census
Bureau, in a State, and one region consist-
ing of all other portions of the State.
(B) If a plan does not have sufficient
information to calculate the median of the
contracted rates described in paragraph
(b) of this section for an item or service
provided in a geographic region described
in paragraph (a)(7)(i)(A) of this section,
one region consisting of all metropolitan
statistical areas, as described by the U.S.
Office of Management and Budget and
published by the U.S. Census Bureau, in
the State, and one region consisting of all
other portions of the State.
(C) If a plan does not have sufficient
information to calculate the median of the
contracted rates described in paragraph
(b) of this section for an item or service
provided in a geographic region described
in paragraph (a)(7)(i)(B) of this section,
one region consisting of all metropolitan
statistical areas, as described by the U.S.
Office of Management and Budget and
published by the U.S. Census Bureau, in
each Census division and one region con-
sisting of all other portions of the Census
division, as described by the U.S. Census
Bureau.
(ii) For air ambulance services—
(A) Subject to paragraph (a)(7)(ii)(B)
of this section, one region consisting of all
metropolitan statistical areas, as described
by the U.S. Office of Management and
Budget and published by the U.S. Census
Bureau, in the State, and one region con-
sisting of all other portions of the State,
determined based on the point of pick-up
(as defined in 42 CFR 414.605).
(B) If a plan does not have sufficient
information to calculate the median of the
contracted rates described in paragraph
(b) of this section for an air ambulance
service provided in a geographic region
described in paragraph (a)(7)(ii)(A) of
this section, one region consisting of all
metropolitan statistical areas, as described
by the U.S. Office of Management and
Budget and published by the U.S. Census
Bureau, in each Census division and one
region consisting of all other portions of
the Census division, as described by the
U.S. Census Bureau, determined based on
the point of pick-up (as defined in 42 CFR
414.605).
(8) Insurance market is, irrespective of
the State, one of the following:
(i) The individual market (other than
short-term, limited-duration insurance or
individual health insurance coverage that
consists solely of excepted benefits).
(ii) The large group market (other than
coverage that consists solely of excepted
benefits).
(iii) The small group market (other
than coverage that consists solely of ex-
cepted benefits).
(iv) In the case of a self-insured group
health plan, all self-insured group health
plans (other than account-based plans,
as defined in § 54.9815-2711(d)(6)(i),
and plans that consist solely of excepted

Bulletin No. 2021–30 117 July 26, 2021
benefits) of the same plan sponsor, or at
the option of the plan sponsor, all self-in-
sured group health plans administered by
the same entity (including a third-party
administrator contracted by the plan), to
the extent otherwise permitted by law,
that is responsible for calculating the
qualifying payment amount on behalf of
the plan.
(9) Modifiers mean codes applied to the
service code that provide a more specific
description of the furnished item or ser-
vice and that may adjust the payment rate
or affect the processing or payment of the
code billed.
(10) Newly covered item or service
means an item or service for which cover-
age was not offered in 2019 under a group
health plan, but that is offered under the
plan in a year after 2019.
(11) New service code means a service
code that was created or substantially re-
vised in a year after 2019.
(12) Provider in the same or similar
specialty means the practice specialty
of a provider, as identified by the plan
consistent with the plan’s usual business
practice, except that, with respect to air
ambulance services, all providers of air
ambulance services are considered to be a
single provider specialty.
(13) Same or similar item or service
means a health care item or service billed
under the same service code, or a compa-
rable code under a different procedural
code system.
(14) Service code means the code that
describes an item or service using the Cur-
rent Procedural Terminology (CPT) code,
Healthcare Common Procedure Coding
System (HCPCS), or Diagnosis-Related
Group (DRG) codes.
(15) Sufficient information means, for
purposes of determining whether a group
health plan has sufficient information to
calculate the median of the contracted
rates described in paragraph (b) of this
section—
(i) The plan has at least three contract-
ed rates on January 31, 2019, to calculate
the median of the contracted rates in ac-
cordance with paragraph (b) of this sec-
tion; or
(ii) For an item or service furnished
during a year after 2022 that is used to
determine the first sufficient information
year—
(A) The plan has at least three contract-
ed rates on January 31 of the year imme-
diately preceding that year to calculate the
median of the contracted rates in accor-
dance with paragraph (b) of this section;
and
(B) The contracted rates under para-
graph (a)(15)(ii)(A) of this section ac-
count (or are reasonably expected to ac-
count) for at least 25 percent of the total
number of claims paid for that item or ser-
vice for that year with respect to all plans
of the sponsor (or the administering entity
as provided in paragraph (a)(8)(iv) of this
section, if applicable) that are offered in
the same insurance market.
(16) Qualifying payment amount
means, with respect to a sponsor of a
group health plan, the amount calculated
using the methodology described in para-
graph (c) of this section.
(17) Underlying fee schedule rate
means the rate for a covered item or ser-
vice from a particular participating provid-
er, providers, or facility that a group health
plan uses to determine a participant’s or
beneficiary’s cost-sharing liability for the
item or service, when that rate is different
from the contracted rate.
(b) Methodology for calculation of
median contracted rate—(1) In general.
The median contracted rate for an item or
service is calculated by arranging in order
from least to greatest the contracted rates
of all group health plans of the plan spon-
sor (or the administering entity as provid-
ed in paragraph (a)(8)(iv) of this section,
if applicable) in the same insurance mar-
ket for the same or similar item or service
that is provided by a provider in the same
or similar specialty or facility of the same
or similar facility type and provided in the
geographic region in which the item or
service is furnished and selecting the mid-
dle number. If there are an even number
of contracted rates, the median contract-
ed rate is the average of the middle two
contracted rates. In determining the medi-
an contracted rate, the amount negotiated
under each contract is treated as a separate
amount. If a plan or issuer has a contract
with a provider group or facility, the rate
negotiated with that provider group or
facility under the contract is treated as a
single contracted rate if the same amount
applies with respect to all providers of
such provider group or facility under the
single contract. However, if a plan or issu-
er has a contract with multiple providers,
with separate negotiated rates with each
particular provider, each unique contract-
ed rate with an individual provider con-
stitutes a single contracted rate. Further,
if a plan or issuer has separate contracts
with individual providers, the contracted
rate under each such contract constitutes
a single contracted rate (even if the same
amount is paid to multiple providers under
separate contracts).
(2) Calculation rules. In calculating the
median contracted rate, a plan must:
(i) Calculate the median contracted rate
with respect to all plans of such sponsor
(or the administering entity as provided
in paragraph (a)(8)(iv) of this section, if
applicable) that are offered in the same in-
surance market;
(ii) Calculate the median contracted
rate using the full contracted rate appli-
cable to the service code, except that the
plan must—
(A) Calculate separate median con-
tracted rates for CPT code modifiers “26”
(professional component) and “TC” (tech-
nical component);
(B) For anesthesia services, calculate a
median contracted rate for the anesthesia
conversion factor for each service code;
(C) For air ambulance services, cal-
culate a median contracted rate for the
air mileage service codes (A0435 and
A0436); and
(D) Where contracted rates otherwise
vary based on applying a modifier code,
calculate a separate median contracted
rate for each such service code-modifier
combination;
(iii) In the case of payments made by a
plan that are not on a fee-for-service basis
(such as bundled or capitation payments),
calculate a median contracted rate for
each item or service using the underlying
fee schedule rates for the relevant items or
services. If the plan does not have an un-
derlying fee schedule rate for the item or
service, it must use the derived amount to
calculate the median contracted rate; and
(iv) Exclude risk sharing, bonus, pen-
alty, or other incentive-based or retrospec-
tive payments or payment adjustments.
(3) Provider specialties; facility types.
(i) If a plan has contracted rates that vary
based on provider specialty for a service
code, the median contracted rate is calcu-

July 26, 2021 118 Bulletin No. 2021–30
lated separately for each provider special-
ty, as applicable.
(ii) If a plan has contracted rates for
emergency services that vary based on fa-
cility type for a service code, the median
contracted rate is calculated separately for
each facility of the same or similar facility
type.
(c) Methodology for calculation of the
qualifying payment amount—(1) In gener-
al. (i) For an item or service (other than
items or services described in paragraphs
(c)(1)(iii) through (vii) of this section)
furnished during 2022, the plan must cal-
culate the qualifying payment amount by
increasing the median contracted rate (as
determined in accordance with paragraph
(b) of this section) for the same or similar
item or service under such plans, on Janu-
ary 31, 2019, by the combined percentage
increase as published by the Department
of the Treasury and the Internal Revenue
Service to reflect the percentage increase
in the CPI-U over 2019, such percentage
increase over 2020, and such percentage
increase over 2021.
(A) The combined percentage increase
for 2019, 2020, and 2021 will be pub-
lished in guidance by the Internal Reve-
nue Service. The Department of the Trea-
sury and the Internal Revenue Service will
calculate the percentage increase using the
CPI-U published by the Bureau of Labor
Statistics of the Department of Labor.
(B) For purposes of this paragraph (c)
(1)(i), the CPI-U for each calendar year is
the average of the CPI-U as of the close of
the 12-month period ending on August 31
of the calendar year, rounded to 10 deci-
mal places.
(C) The combined percentage increase
for 2019, 2020, and 2021 will be calcu-
lated as:
(CPI-U 2019/CPI-U 2018) x (CPI-U
2020/CPI-U 2019) x (CPI-U 2021/CPI-U
2020)
(ii) For an item or service (other than
items or services described in paragraphs
(c)(1)(iii) through (vii) of this section) fur-
nished during 2023 or a subsequent year,
the plan must calculate the qualifying
payment amount by increasing the quali-
fying payment amount determined under
paragraph (c)(1)(i) of this section, for such
an item or service furnished in the imme-
diately preceding year, by the percentage
increase as published by the Department
of the Treasury and the Internal Revenue
Service.
(A) The percentage increase for any
year after 2022 will be published in guid-
ance by the Internal Revenue Service. The
Department of the Treasury and Internal
Revenue Service will calculate the per-
centage increase using the CPI-U pub-
lished by the Bureau of Labor Statistics of
the Department of Labor.
(B) For purposes of this paragraph (c)
(1)(ii), the CPI-U for each calendar year is
the average of the CPI-U as of the close of
the 12-month period ending on August 31
of the calendar year, rounded to 10 deci-
mal places.
(C) The combined percentage increase
for any year will be calculated as CPI-U
present year/CPI-U prior year.
(iii) For anesthesia services furnished
during 2022, the plan must calculate the
qualifying payment amount by first in-
creasing the median contracted rate for
the anesthesia conversion factor (as deter-
mined in accordance with paragraph (b) of
this section) for the same or similar item
or service under such plans, on January
31, 2019, in accordance with paragraph
(c)(1)(i) of this section (referred to in this
section as the indexed median contracted
rate for the anesthesia conversion factor).
The plan must then multiply the indexed
median contracted rate for the anesthesia
conversion factor by the sum of the base
unit, time unit, and physical status modifi-
er units of the participant or beneficiary to
whom anesthesia services are furnished to
determine the qualifying payment amount.
(A) The base units for an anesthesia
service code are the base units for that
service code specified in the most recent
edition (as of the date of service) of the
American Society of Anesthesiologists
Relative Value Guide.
(B) The time unit is measured in
15-minute increments or a fraction there-
of.
(C) The physical status modifier on a
claim is a standard modifier describing the
physical status of the patient and is used
to distinguish between various levels of
complexity of the anesthesia services pro-
vided, and is expressed as a unit with a
value between zero (0) and three (3).
(D) The anesthesia conversion factor is
expressed in dollars per unit and is a con-
tracted rate negotiated with the plan.
(iv) For anesthesia services furnished
during 2023 or a subsequent year, the plan
must calculate the qualifying payment
amount by first increasing the indexed
median contracted rate for the anesthesia
conversion factor, determined under para-
graph (c)(1)(iii) of this section for such
services furnished in the immediately pre-
ceding year, in accordance with paragraph
(c)(1)(ii) of this section. The plan must
then multiply that amount by the sum of
the base unit, time unit, and physical sta-
tus modifier units for the participant or
beneficiary to whom anesthesia services
are furnished to determine the qualifying
payment amount.
(v) For air ambulance services billed
using the air mileage service codes (A0435
and A0436) that are furnished during
2022, the plan must calculate the quali-
fying payment amount for services billed
using the air mileage service codes by first
increasing the median contracted rate (as
determined in accordance with paragraph
(b) of this section), in accordance with
paragraph (c)(1)(i) of this section (referred
to in this section as the indexed median air
mileage rate). The plan must then multiply
the indexed median air mileage rate by the
number of loaded miles provided to the
participant or beneficiary to determine the
qualifying payment amount.
(A) The air mileage rate is expressed in
dollars per loaded mile flown, is expressed
in statute miles (not nautical miles), and is
a contracted rate negotiated with the plan.
(B) The number of loaded miles is the
number of miles a patient is transported in
the air ambulance vehicle.
(C) The qualifying payment amount
for other service codes associated with air
ambulance services is calculated in accor-
dance with paragraphs (c)(1)(i) and (ii) of
this section.
(vi) For air ambulance services billed
using the air mileage service codes (A0435
and A0436) that are furnished during 2023
or a subsequent year, the plan must cal-
culate the qualifying payment amount by
first increasing the indexed median air
mileage rate, determined under paragraph
(c)(1)(v) of this section for such services
furnished in the immediately preceding
year, in accordance with paragraph (c)
(1)(ii) of this section. The plan must then
multiply the indexed median air mileage
rate by the number of loaded miles provid-

Bulletin No. 2021–30 119 July 26, 2021
ed to the participant or beneficiary to de-
termine the qualifying payment amount.
(vii) For any other items or services for
which a plan generally determines pay-
ment for the same or similar items or ser-
vices by multiplying a contracted rate by
another unit value, the plan must calculate
the qualifying payment amount using a
methodology that is similar to the meth-
odology required under paragraphs (c)(1)
(iii) through (vi) of this section and rea-
sonably reflects the payment methodology
for same or similar items or services.
(2) New plans. With respect to a spon-
sor of a group health plan in a geographic
region in which the sponsor did not offer
any group health plan during 2019—
(i) For the first year in which the group
health plan is offered in such region—
(A) If the plan has sufficient informa-
tion to calculate the median of the con-
tracted rates described in paragraph (b)
of this section, the plan must calculate the
qualifying payment amount in accordance
with paragraph (c)(1) of this section for
items and services that are covered by the
plan and furnished during the first year;
and
(B) If the plan does not have sufficient
information to calculate the median of the
contracted rates described in paragraph
(b) of this section for an item or service
provided in a geographic region, the plan
must determine the qualifying payment
amount for the item or service in accor-
dance with paragraph (c)(3)(i) of this sec-
tion.
(ii) For each subsequent year the group
health plan is offered in the region, the
plan must calculate the qualifying pay-
ment amount by increasing the qualifying
payment amount determined under this
paragraph (c)(2) for the items and services
furnished in the immediately preceding
year, in accordance with paragraph (c)(1)
(ii), (iv), or (vi) of this section, as appli-
cable.
(3) Insufficient information; newly
covered items and services. In the case
of a plan that does not have sufficient in-
formation to calculate the median of the
contracted rates described in paragraph
(b) of this section in 2019 (or, in the case
of a newly covered item or service, in the
first coverage year for such item or service
with respect to such plan or coverage if
the plan does not have sufficient informa-
tion) for an item or service provided in a
geographic region—
(i) For an item or service furnished
during 2022 (or, in the case of a newly
covered item or service, during the first
coverage year for the item or service with
respect to the plan or coverage), the plan
must calculate the qualifying payment
amount by first identifying the rate that
is equal to the median of the in-network
allowed amounts for the same or similar
item or service provided in the geographic
region in the year immediately preceding
the year in which the item or service is
furnished (or, in the case of a newly cov-
ered item or service, the year immediately
preceding such first coverage year) deter-
mined by the plan through use of any eligi-
ble database, and then increasing that rate
by the percentage increase in the CPI-U
over such preceding year. For purposes of
this section, in cases in which an eligible
database is used to determine the quali-
fying payment amount with respect to an
item or service furnished during a calendar
year, the plan must use the same database
for determining the qualifying payment
amount for that item or service furnished
through the last day of the calendar year,
and if a different database is selected for
some items or services, the basis for that
selection must be one or more factors not
directly related to the rate of those items
or services (such as sufficiency of data for
those items or services).
(ii) For an item or service furnished in a
subsequent year (before the first sufficient
information year for such item or service
with respect to such plan), the plan must
calculate the qualifying payment amount
by increasing the qualifying payment
amount determined under paragraph (c)
(3)(i) of this section or this paragraph (c)
(3)(ii), as applicable, for such item or ser-
vice for the year immediately preceding
such subsequent year, by the percentage
increase in CPI-U over such preceding
year;
(iii) For an item or service furnished
in the first sufficient information year for
such item or service with respect to such
plan, the plan must calculate the qualify-
ing payment amount in accordance with
paragraph (c)(1)(i), (iii), or (v) of this sec-
tion, as applicable, except that in applying
such paragraph to such item or service,
the reference to ‘furnished during 2022’ is
treated as a reference to furnished during
such first sufficient information year, the
reference to ‘in 2019’ is treated as a ref-
erence to such sufficient information year,
and the increase described in such para-
graph is not applied; and
(iv) For an item or service furnished in
any year subsequent to the first sufficient
information year for such item or service
with respect to such plan, the plan must
calculate the qualifying payment amount
in accordance with paragraph (c)(1)(ii),
(iv), or (vi) of this section, as applicable,
except that in applying such paragraph
to such item or service, the reference to
‘furnished during 2023 or a subsequent
year’ is treated as a reference to furnished
during the year after such first sufficient
information year or a subsequent year.
(4) New service codes. In the case of
a plan that does not have sufficient infor-
mation to calculate the median of the con-
tracted rates described in paragraph (b) of
this section and determine the qualifying
payment amount under paragraphs (c)(1)
through (3) of this section because the
item or service furnished is billed under a
new service code—
(i) For an item or service furnished
during 2022 (or, in the case of a newly
covered item or service, during the first
coverage year for the item or service with
respect to the plan), the plan must identi-
fy a reasonably related service code that
existed in the immediately preceding year
and—
(A) If the Centers for Medicare & Med-
icaid Services has established a Medicare
payment rate for the item or service billed
under the new service code, the plan must
calculate the qualifying payment amount
by first calculating the ratio of the rate
that Medicare pays for the item or service
billed under the new service code com-
pared to the rate that Medicare pays for
the item or service billed under the related
service code, and then multiplying the ra-
tio by the qualifying payment amount for
an item or service billed under the related
service code for the year in which the item
or service is furnished.
(B) If the Centers for Medicare &
Medicaid Services has not established
a Medicare payment rate for the item or
service billed under the new service code,
the plan must calculate the qualifying pay-
ment amount by first calculating the ratio

July 26, 2021 120 Bulletin No. 2021–30
of the rate that the plan reimburses for
the item or service billed under the new
service code compared to the rate that the
plan reimburses for the item or service
billed under the related service code, and
then multiplying the ratio by the qualify-
ing payment amount for an item or service
billed under the related service code.
(ii) For an item or service furnished in a
subsequent year (before the first sufficient
information year for such item or service
with respect to such plan or coverage or
before the first year for which an eligible
database has sufficient information to a
calculate a rate under paragraph (c)(3)(i)
of this section in the immediately preced-
ing year), the plan must calculate the qual-
ifying payment amount by increasing the
qualifying payment amount determined
under paragraph (c)(4)(i) of this section or
this paragraph (c)(4)(ii), as applicable, for
such item or service for the year immedi-
ately preceding such subsequent year, by
the percentage increase in CPI-U over
such preceding year;
(iii) For an item or service furnished
in the first sufficient information year for
such item or service with respect to such
plan or the first year for which an eligible
database has sufficient information to cal-
culate a rate under paragraph (c)(3)(i) of
this section in the immediately preceding
year, the plan or issuer must calculate the
qualifying payment amount in accordance
with paragraph (c)(3) of this section.
(d) Information to be shared about
qualifying payment amount. In cases in
which the recognized amount with respect
to an item or service furnished by a non-
participating provider, nonparticipating
emergency facility, or nonparticipating
provider of air ambulance services is the
qualifying payment amount, the plan must
provide in writing, in paper or electronic
form, to the provider or facility, as appli-
cable—
(1) With an initial payment or notice of
denial of payment under § 54.9816-4T, §
54.9816-5T, or § 54.9817-1T:
(i) The qualifying payment amount for
each item or service involved;
(ii) A statement to certify that, based on
the determination of the plan—
(A) The qualifying payment amount
applies for purposes of the recognized
amount (or, in the case of air ambulance
services, for calculating the participant’s,
beneficiary’s, or enrollee’s cost sharing);
and
(B) Each qualifying payment amount
shared with the provider or facility was
determined in compliance with this sec-
tion;
(iii) A statement that if the provider
or facility, as applicable, wishes to initi-
ate a 30-day open negotiation period for
purposes of determining the amount of to-
tal payment, the provider or facility may
contact the appropriate person or office to
initiate open negotiation, and that if the
30-day negotiation period does not result
in a determination, generally, the provid-
er or facility may initiate the independent
dispute resolution process within 4 days
after the end of the open negotiation pe-
riod; and
(iv) Contact information, including a
telephone number and email address, for
the appropriate person or office to initiate
open negotiations for purposes of deter-
mining an amount of payment (including
cost sharing) for such item or service.
(2) In a timely manner upon request of
the provider or facility:
(i) Information about whether the qual-
ifying payment amount for items and ser-
vices involved included contracted rates
that were not on a fee-for-service basis
for those specific items and services and
whether the qualifying payment amount
for those items and services was deter-
mined using underlying fee schedule rates
or a derived amount;
(ii) If a plan uses an eligible database
under paragraph (c)(3) of this section to
determine the qualifying payment amount,
information to identify which database
was used; and
(iii) If a related service code was used
to determine the qualifying payment
amount for an item or service billed under
a new service code under paragraph (c)(4)
(i) or (ii) of this section, information to
identify the related service code; and
(iv) If applicable, a statement that the
plan’s contracted rates include risk-shar-
ing, bonus, penalty, or other incen-
tive-based or retrospective payments or
payment adjustments for the items and
services involved (as applicable) that were
excluded for purposes of calculating the
qualifying payment amount.
(e) Certain access fees to databases.
In the case of a plan that, pursuant to this
section, uses an eligible database to deter-
mine the qualifying payment amount for
an item or service, the plan is responsible
for any costs associated with accessing
such database.
(f) Audits. See 45 CFR 149.140(f) for
audit procedures that apply with respect to
ensuring that a plan is in compliance with
the requirement of applying a qualifying
payment amount under §§ 54.9816-4T,
54.9816-5T, 54.9817-1T, and this section,
and ensuring that such amount so applied
satisfies the requirements under this sec-
tion, as applicable.
(g) Applicability date. The provisions
of this section are applicable with respect
to plan years beginning on or after January
1, 2022.
§ 54.9816-7T Complaints process for
surprise medical bills regarding group
health plans (temporary).
See 45 CFR 149.150 for the process
to receive and resolve complaints that a
specific group health plan may be fail-
ing to meet the requirement of applying
a qualifying payment amount under §§
54.9816-4T, 54.9816-5T, 54.9816-6T, and
54.9817-1T, which may warrant an inves-
tigation.
§ 54.9817-1T Preventing surprise
medical bills for air ambulance services
(temporary).
(a) In general. If a group health plan
provides or covers any benefits for air am-
bulance services, the plan must cover such
services from a nonparticipating provider
of air ambulance services in accordance
with paragraph (b) of this section.
(b) Coverage requirements. A plan
described in paragraph (a) of this section
must provide coverage of air ambulance
services in the following manner—
(1) The cost-sharing requirements with
respect to the services must be the same
requirements that would apply if the ser-
vices were provided by a participating
provider of air ambulance services.
(2) The cost-sharing requirement must
be calculated as if the total amount that
would have been charged for the services
by a participating provider of air ambu-
lance services were equal to the lesser of
the qualifying payment amount (as deter-

Bulletin No. 2021–30 121 July 26, 2021
mined in accordance with § 54.9816-6T)
or the billed amount for the services.
(3) The cost-sharing amounts must be
counted towards any in-network deduct-
ible and in-network out-of-pocket maxi-
mums (including the annual limitation on
cost sharing under section 2707(b) of the
Public Health Service Act) (as applicable)
applied under the plan (and the in-network
deductible and out-of-pocket maximums
must be applied) in the same manner as
if the cost-sharing payments were made
with respect to services furnished by a
participating provider of air ambulance
services.
(4) The plan must—
(i) Not later than 30 calendar days af-
ter the bill for the services is transmitted
by the provider of air ambulance services,
determine whether the services are cov-
ered under the plan and, if the services
are covered, send to the provider an initial
payment or a notice of denial of payment.
For purposes of this paragraph (b)(4)(i),
the 30-calendar-day period begins on the
date the plan receives the information nec-
essary to decide a claim for payment for
the services.
(ii) Pay a total plan payment directly
to the nonparticipating provider furnish-
ing such air ambulance services that is
equal to the amount by which the out-of-
network rate for the services exceeds the
cost-sharing amount for the services (as
determined in accordance with paragraphs
(b)(1) and (2) of this section), less any
initial payment amount made under para-
graph (b)(4)(i) of this section. The total
plan payment must be made in accordance
with the timing requirement described in
section 9817(b)(6), or in cases where the
out-of-network rate is determined under
a specified State law or All-Payer Model
Agreement, such other timeframe as spec-
ified by the State law or All-Payer Model
Agreement.
(c) Applicability date. The provisions
of this section are applicable with respect
to plan years beginning on or after January
1, 2022.
§ 54.9822-1T Choice of health care
professional (temporary).
(a) Choice of health care profession-
al—(1) Designation of primary care pro-
vider—(i) In general. If a group health
plan, requires or provides for designation
by a participant or beneficiary of a partici-
pating primary care provider, then the plan
must permit each participant or beneficia-
ry to designate any participating primary
care provider who is available to accept
the participant or beneficiary. In such a
case, the plan must comply with the rules
of paragraph (a)(4) of this section by in-
forming each participant of the terms of
the plan regarding designation of a prima-
ry care provider.
(ii) Construction. Nothing in paragraph
(a)(1)(i) of this section is to be construed
to prohibit the application of reasonable
and appropriate geographic limitations
with respect to the selection of primary
care providers, in accordance with the
terms of the plan, the underlying provider
contracts, and applicable State law.
(iii) Example. The rules of this para-
graph (a)(1) are illustrated by the follow-
ing example:
(A) Facts. A group health plan requires individ-
uals covered under the plan to designate a primary
care provider. The plan permits each individual to
designate any primary care provider participating
in the plan’s network who is available to accept the
individual as the individual’s primary care provider.
If an individual has not designated a primary care
provider, the plan designates one until the individual
has made a designation. The plan provides a notice
that satisfies the requirements of paragraph (a)(4) of
this section regarding the ability to designate a pri-
mary care provider.
(B) Conclusion. In this Example, the plan has sat-
isfied the requirements of this paragraph (a).
(2) Designation of pediatrician as pri-
mary care provider—(i) In general. If a
group health plan requires or provides for
the designation of a participating primary
care provider for a child by a participant or
beneficiary, the plan must permit the par-
ticipant or beneficiary to designate a phy-
sician (allopathic or osteopathic) who spe-
cializes in pediatrics (including pediatric
subspecialties, based on the scope of that
provider’s license under applicable State
law) as the child’s primary care provider
if the provider participates in the network
of the plan and is available to accept the
child. In such a case, the plan must com-
ply with the rules of paragraph (a)(4) of
this section by informing each participant
of the terms of the plan regarding designa-
tion of a pediatrician as the child’s prima-
ry care provider.
(ii) Construction. Nothing in para-
graph (a)(2)(i) of this section is to be
construed to waive any exclusions of
coverage under the terms and conditions
of the plan with respect to coverage of
pediatric care.
(iii) Examples. The rules of this para-
graph (a)(2) are illustrated by the follow-
ing examples:
(A) Example 1—(1) Facts. A group health
plan’s HMO designates for each participant a phy-
sician who specializes in internal medicine to serve
as the primary care provider for the participant and
any beneficiaries. Participant A requests that Pedia-
trician B be designated as the primary care provid-
er for A’s child. B is a participating provider in the
HMO’s network and is available to accept the child.
(2) Conclusion. In this Example 1, the HMO
must permit A’s designation of B as the primary care
provider for A’s child in order to comply with the
requirements of this paragraph (a)(2).
(B) Example 2—(1) Facts. Same facts as Exam-
ple 1 (paragraph (a)(2)(iii)(A) of this section), except
that A takes A’s child to B for treatment of the child’s
severe shellfish allergies. B wishes to refer A’s child
to an allergist for treatment. The HMO, however,
does not provide coverage for treatment of food al-
lergies, nor does it have an allergist participating in
its network, and it therefore refuses to authorize the
referral.
(2) Conclusion. In this Example 2, the HMO has
not violated the requirements of this paragraph (a)(2)
because the exclusion of treatment for food allergies
is in accordance with the terms of A’s coverage.
(3) Patient access to obstetrical and
gynecological care—(i) General rights—
(A) Direct access. A group health plan
described in paragraph (a)(3)(ii) of this
section, may not require authorization or
referral by the plan, or any person (in-
cluding a primary care provider) in the
case of a female participant or beneficia-
ry who seeks coverage for obstetrical or
gynecological care provided by a partici-
pating health care professional who spe-
cializes in obstetrics or gynecology. In
such a case, the plan must comply with
the rules of paragraph (a)(4) of this sec-
tion by informing each participant that
the plan may not require authorization or
referral for obstetrical or gynecological
care by a participating health care pro-
fessional who specializes in obstetrics or
gynecology. The plan may require such a
professional to agree to otherwise adhere
to the plan’s policies and procedures, in-
cluding procedures regarding referrals
and obtaining prior authorization and
providing services pursuant to a treat-
ment plan (if any) approved by the plan.
For purposes of this paragraph (a)(3), a
health care professional who specializes
in obstetrics or gynecology is any indi-

July 26, 2021 122 Bulletin No. 2021–30
vidual (including a person other than a
physician) who is authorized under ap-
plicable State law to provide obstetrical
or gynecological care.
(B) Obstetrical and gynecological
care. A group health plan described in
paragraph (a)(3)(ii) of this section must
treat the provision of obstetrical and gy-
necological care, and the ordering of re-
lated obstetrical and gynecological items
and services, pursuant to the direct access
described under paragraph (a)(3)(i)(A) of
this section, by a participating health care
professional who specializes in obstetrics
or gynecology as the authorization of the
primary care provider.
(ii) Application of paragraph. A group
health plan is described in this paragraph
(a)(3) if the plan—
(A) Provides coverage for obstetrical
or gynecological care; and
(B) Requires the designation by a par-
ticipant or beneficiary of a participating
primary care provider.
(iii) Construction. Nothing in para-
graph (a)(3)(i) of this section is to be con-
strued to—
(A) Waive any exclusions of coverage
under the terms and conditions of the plan
with respect to coverage of obstetrical or
gynecological care; or
(B) Preclude the group health plan in-
volved from requiring that the obstetrical
or gynecological provider notify the pri-
mary care health care professional or the
plan of treatment decisions.
(iv) Examples. The rules of this para-
graph (a)(3) are illustrated by the follow-
ing examples:
(A) Example 1—(1) Facts. A group health plan
requires each participant to designate a physician to
serve as the primary care provider for the participant
and the participant’s family. Participant A, a female,
requests a gynecological exam with Physician B, an
in-network physician specializing in gynecological
care. The group health plan requires prior authori-
zation from A’s designated primary care provider for
the gynecological exam.
(2) Conclusion. In this Example 1, the group
health plan has violated the requirements of this
paragraph (a)(3) because the plan requires prior au-
thorization from A’s primary care provider prior to
obtaining gynecological services.
(B) Example 2—(1) Facts. Same facts as Exam-
ple 1 (paragraph (a)(3)(iv)(A) of this section) except
that A seeks gynecological services from C, an out-
of-network provider.
(2) Conclusion. In this Example 2, the group
health plan has not violated the requirements of this
paragraph (a)(3) by requiring prior authorization be-
cause C is not a participating health care provider.
(C) Example 3—(1) Facts. Same facts as Ex-
ample 1 (paragraph (a)(3)(iv)(A) of this section)
except that the group health plan only requires B to
inform A’s designated primary care physician of
treatment decisions.
(2) Conclusion. In this Example 3, the group
health plan has not violated the requirements of
this paragraph (a)(3) because A has direct access
to B without prior authorization. The fact that the
group health plan requires the designated primary
care physician to be notified of treatment decisions
does not violate this paragraph (a)(3).
(D) Example 4—(1) Facts. A group health plan
requires each participant to designate a physician to
serve as the primary care provider for the participant
and the participant’s family. The group health plan
requires prior authorization before providing benefits
for uterine fibroid embolization.
(2) Conclusion. In this Example 4, the plan re-
quirement for prior authorization before providing
benefits for uterine fibroid embolization does not
violate the requirements of this paragraph (a)(3)
because, though the prior authorization requirement
applies to obstetrical services, it does not restrict
access to any providers specializing in obstetrics or
gynecology.
(4) Notice of right to designate a pri-
mary care provider—(i) In general. If a
group health plan requires the designa-
tion by a participant or beneficiary of a
primary care provider, the plan must pro-
vide a notice informing each participant
of the terms of the plan regarding desig-
nation of a primary care provider and of
the rights—
(A) Under paragraph (a)(1)(i) of this
section, that any participating primary
care provider who is available to accept
the participant or beneficiary can be des-
ignated;
(B) Under paragraph (a)(2)(i) of this
section, with respect to a child, that any
participating physician who specializes in
pediatrics can be designated as the prima-
ry care provider; and
(C) Under paragraph (a)(3)(i) of this
section, that the plan may not require
authorization or referral for obstetrical
or gynecological care by a participating
health care professional who specializes
in obstetrics or gynecology.
(ii) Timing. In the case of a group health
plan, the notice described in paragraph
(a)(4)(i) of this section must be included
whenever the plan provides a participant
with a summary plan description or other
similar description of benefits under the
plan.
(iii) Model language. The following
model language can be used to satisfy the
notice requirement described in paragraph
(a)(4)(i) of this section:
(A) For plans that require or allow for
the designation of primary care providers
by participants or beneficiaries, insert:
[Name of group health plan] general-
ly [requires/allows] the designation of
a primary care provider. You have the
right to designate any primary care pro-
vider who participates in our network
and who is available to accept you or
your family members. [If the plan des-
ignates a primary care provider auto-
matically, insert: Until you make this
designation, [name of group health
plan] designates one for you.] For in-
formation on how to select a primary
care provider, and for a list of the par-
ticipating primary care providers, con-
tact the [plan administrator] at [insert
contact information].
(B) For plans that require or allow for
the designation of a primary care provider
for a child, add:
For children, you may designate a pe-
diatrician as the primary care provider.
(C) For plans that provide coverage for
obstetric or gynecological care and require
the designation by a participant or benefi-
ciary of a primary care provider, add:
You do not need prior authorization
from [name of group health plan] or
from any other person (including a pri-
mary care provider) in order to obtain
access to obstetrical or gynecological
care from a health care profession-
al in our network who specializes in
obstetrics or gynecology. The health
care professional, however, may be
required to comply with certain pro-
cedures, including obtaining prior
authorization for certain services,
following a pre-approved treatment
plan, or procedures for making refer-
rals. For a list of participating health
care professionals who specialize in
obstetrics or gynecology, contact the
[plan administrator] at [insert contact
information].
(b) Applicability date. The provisions
of this section are applicable with respect
to plan years beginning on or after January
1, 2022.

Bulletin No. 2021–30 123 July 26, 2021
DEPARTMENT OF LABOR
Employee Benefits Security
Administration
29 CFR Chapter XXV
For the reasons set forth in the pream-
ble, the Department of Labor amends 29
CFR part 2590 as set forth below:
PART 2590—RULES AND
REGULATIONS FOR GROUP
HEALTH PLANS.
9. The authority citation for part 2590
is revised to read as follows:
Authority: 29 U.S.C. 1027, 1059, 1135,
1161-1168, 1169, 1181-1183, 1181 note,
1185, 1185a-n, 1191, 1191a, 1191b, and
1191c; sec. 101(g), Pub. L.104-191, 110
Stat. 1936; sec. 401(b), Pub. L. 105-200,
112 Stat. 645 (42 U.S.C. 651 note); sec.
512(d), Pub. L. 110-343, 122 Stat. 3881;
sec. 1001, 1201, and 1562(e), Pub. L. 111-
148, 124 Stat. 119, as amended by Pub. L.
111-152, 124 Stat. 1029; Division M, Pub.
L. 113-235, 128 Stat. 2130; Pub. L. 116-
260 134 Stat. 1182; Secretary of Labor’s
Order 1-2011, 77 FR 1088 (Jan. 9, 2012).
10. Section 2590.715-2719A is amend-
ed by revising paragraph (c) to read as
follows:
§ 2590.715-2719A Patient protections.
* * * * *
(c) Applicability date. The provisions of
this section are applicable to group health
plans and health insurance issuers for plan
years beginning before January 1, 2022.
See also §§ 2590.716-4 through 2590.716-
7, 2590.717-1, and 2590.722 of this part for
rules applicable with respect to plan years
beginning on or after January 1, 2022.
Subpart D [Redesignated as Subpart E]
11. Redesignate subpart D as subpart E
and add a new subpart D to read as fol-
lows:
Subpart D-Surprise Billing and
Transparency Requirements
Sec.
2590.716-1 Basis and scope.
2590.716-2 Applicability.
2590.716-3 Definitions.
2590.716-4 Preventing surprise medical
bills for emergency services.
2590.716-5 Preventing surprise medical
bills for non-emergency services per-
formed by nonparticipating providers at
certain participating facilities.
2590.716-6 Methodology for calculating
qualifying payment amount.
2590.716-7 Complaints process for sur-
prise medical bills regarding group health
plans and group health insurance cover-
age.
2590.717-1 Preventing surprise medical
bills for air ambulance services.
2590.722 Choice of health care profes-
sional.
Subpart D-Surprise Billing and
Transparency Requirements
§ 2590.716-1 Basis and scope.
(a) Basis. Sections 2590.716-1 through
2590.722 implement section 716-722 of
ERISA.
(b) Scope. This part establishes stan-
dards for group health plans and health
insurance issuers offering group health in-
surance coverage with respect to surprise
medical bills, transparency in health care
coverage, and additional patient protec-
tions.
§ 2590.716-2 Applicability.
(a) In general. The requirements in
§§ 2590.716-4 through 2590.716-7,
2590.717-1, and 2590.722 apply to group
health plans and health insurance issuers
offering group health insurance coverage
(including grandfathered health plans
as defined in § 2590.715-1251), except
as specified in paragraph (b) of this
section.
(b) Exceptions. The requirements
in §§ 2590.716-4 through 2590.716-7,
2590.717-1, and 2590.722 do not apply to
the following:
(1) Excepted benefits as described in §
2590.732.
(2) Short-term, limited-duration insur-
ance as defined in § 2590.701-2.
(3) Health reimbursement arrange-
ments or other account-based group health
plans as described in § 2590.715-2711(d).
§ 2590.716-3 Definitions.
The definitions in this part apply to §§
2590.716 through 2590.722, unless other-
wise specified. In addition, for purposes
of §§ 2590.716 through 2590.722, the fol-
lowing definitions apply:
Air ambulance service means medical
transport by a rotary wing air ambulance,
as defined in 42 CFR 414.605, or fixed
wing air ambulance, as defined in 42 CFR
414.605, for patients.
Cost sharing means the amount a par-
ticipant or beneficiary is responsible for
paying for a covered item or service under
the terms of the group health plan or health
insurance coverage. Cost sharing general-
ly includes copayments, coinsurance, and
amounts paid towards deductibles, but
does not include amounts paid towards pre-
miums, balance billing by out-of-network
providers, or the cost of items or services
that are not covered under a group health
plan or health insurance coverage.
Emergency department of a hospital
includes a hospital outpatient department
that provides emergency services.
Emergency medical condition has the
meaning given the term in § 2590.716-
4(c)(1).
Emergency services has the meaning
given the term in § 2590.716-4(c)(2).
Health care facility, with respect to a
group health plan or group health insur-
ance coverage, in the context of non-emer-
gency services, is each of the following:
(1) A hospital (as defined in section
1861(e) of the Social Security Act);
(2) A hospital outpatient department;
(3) A critical access hospital (as defined
in section 1861(mm)(1) of the Social Se-
curity Act); and
(4) An ambulatory surgical center de-
scribed in section 1833(i)(1)(A) of the So-
cial Security Act.
Independent freestanding emergency
department means a health care facility
(not limited to those described in the defi-
nition of health care facility with respect
to non-emergency services) that—
(1) Is geographically separate and dis-
tinct and licensed separately from a hospi-
tal under applicable State law; and
(2) Provides any emergency services as
described in § 2590.716-4(c)(2)(i).
Nonparticipating emergency facili-
ty means an emergency department of a

July 26, 2021 124 Bulletin No. 2021–30
hospital, or an independent freestanding
emergency department (or a hospital,
with respect to services that pursuant to §
2590.716-4(c)(2)(ii) are included as emer-
gency services), that does not have a con-
tractual relationship directly or indirectly
with a group health plan or group health
insurance coverage offered by a health in-
surance issuer, with respect to the furnish-
ing of an item or service under the plan or
coverage, respectively.
Nonparticipating provider means any
physician or other health care provider
who does not have a contractual relation-
ship directly or indirectly with a group
health plan or group health insurance cov-
erage offered by a health insurance issuer,
with respect to the furnishing of an item
or service under the plan or coverage, re-
spectively.
Notice of denial of payment means,
with respect to an item or service for which
benefits subject to the protections of §§
2590.716-4, 2590.716-5, and 2590.717-1
are provided or covered, a written notice
from the plan or issuer to the health care
provider, facility, or provider of air am-
bulance services, as applicable, that pay-
ment for such item or service will not be
made by the plan or coverage and which
explains the reason for denial. The term
notice of denial of payment does not in-
clude a notice of benefit denial due to an
adverse benefit determination as defined
in § 2560.503-1 of this chapter.
Out-of-network rate means, with re-
spect to an item or service furnished by a
nonparticipating provider, nonparticipat-
ing emergency facility, or nonparticipat-
ing provider of air ambulance services—
(1) Subject to paragraph (3) of this defi-
nition, in a State that has in effect a spec-
ified State law, the amount determined in
accordance with such law;
(2) Subject to paragraph (3) of this
definition, in a State that does not have in
effect a specified State law—
(i) Subject to paragraph (2)(ii) of this
definition, if the nonparticipating provider
or nonparticipating emergency facility and
the plan or issuer agree on an amount of
payment (including if the amount agreed
upon is the initial payment sent by the plan
or issuer under 26 CFR 54.9816-4T(b)(3)
(iv)(A), 54.9816-5T(c)(3), or 54.9817-
1T(b)(4)(i); § 2590.716-4(b)(3)(iv)(A),
§ 2590.716-5(c)(3), or § 2590.717-1(b)
(4)(i); or 45 CFR 149.110(b)(3)(iv)(A),
149.120(c)(3), or 149.130(b)(4)(i), as ap-
plicable, or is agreed on through negotia-
tions with respect to such item or service),
such agreed on amount; or
(ii) If the nonparticipating provider or
nonparticipating emergency facility and
the plan or issuer enter into the indepen-
dent dispute resolution (IDR) process
under section 9816(c) or 9817(b) of the
Internal Revenue Code, section 716(c) or
717(b) of ERISA, or section 2799A-1(c)
or 2799A-2(b) of the PHS Act, as appli-
cable, and do not agree before the date on
which a certified IDR entity makes a de-
termination with respect to such item or
service under such subsection, the amount
of such determination; or
(3) In a State that has an All-Payer
Model Agreement under section 1115A of
the Social Security Act that applies with
respect to the plan or issuer; the nonpartic-
ipating provider or nonparticipating emer-
gency facility; and the item or service, the
amount that the State approves under the
All-Payer Model Agreement for the item
or service.
Participating emergency facility means
any emergency department of a hospital,
or an independent freestanding emergency
department (or a hospital, with respect to
services that pursuant to § 2590.716-4(c)
(2)(ii) are included as emergency ser-
vices), that has a contractual relationship
directly or indirectly with a group health
plan or health insurance issuer offering
group health insurance coverage setting
forth the terms and conditions on which
a relevant item or service is provided to
a participant or beneficiary under the plan
or coverage, respectively. A single case
agreement between an emergency facility
and a plan or issuer that is used to address
unique situations in which a participant or
beneficiary requires services that typically
occur out-of-network constitutes a con-
tractual relationship for purposes of this
definition, and is limited to the parties to
the agreement.
Participating health care facility means
any health care facility described in this
section that has a contractual relationship
directly or indirectly with a group health
plan or health insurance issuer offering
group health insurance coverage setting
forth the terms and conditions on which
a relevant item or service is provided to
a participant or beneficiary under the plan
or coverage, respectively. A single case
agreement between a health care facility
and a plan or issuer that is used to address
unique situations in which a participant or
beneficiary requires services that typically
occur out-of-network constitutes a con-
tractual relationship for purposes of this
definition, and is limited to the parties to
the agreement.
Participating provider means any phy-
sician or other health care provider who
has a contractual relationship directly
or indirectly with a group health plan or
health insurance issuer offering group
health insurance coverage setting forth the
terms and conditions on which a relevant
item or service is provided to a participant
or beneficiary under the plan or coverage,
respectively.
Physician or health care provider
means a physician or other health care
provider who is acting within the scope of
practice of that provider’s license or cer-
tification under applicable State law, but
does not include a provider of air ambu-
lance services.
Provider of air ambulance services
means an entity that is licensed under ap-
plicable State and Federal law to provide
air ambulance services.
Same or similar item or service has the
meaning given the term in § 2590.716-
6(a)(13).
Service code has the meaning given the
term in § 2590.716-6(a)(14).
Qualifying payment amount has the
meaning given the term in § 2590.716-
6(a)(16).
Recognized amount means, with re-
spect to an item or service furnished by
a nonparticipating provider or nonpartic-
ipating emergency facility—
(1) Subject to paragraph (3) of this defi-
nition, in a State that has in effect a spec-
ified State law, the amount determined in
accordance with such law.
(2) Subject to paragraph (3) of this
definition, in a State that does not have in
effect a specified State law, the lesser of—
(i) The amount that is the qualifying
payment amount (as determined in accor-
dance with § 2590.716-6); or
(ii) The amount billed by the provider
or facility.
(3) In a State that has an All-Payer
Model Agreement under section 1115A of

Bulletin No. 2021–30 125 July 26, 2021
the Social Security Act that applies with
respect to the plan or issuer; the nonpartic-
ipating provider or nonparticipating emer-
gency facility; and the item or service, the
amount that the State approves under the
All-Payer Model Agreement for the item
or service.
Specified State law means a State law
that provides for a method for determining
the total amount payable under a group
health plan or group health insurance cov-
erage offered by a health insurance issuer
to the extent such State law applies for an
item or service furnished by a nonpartici-
pating provider or nonparticipating emer-
gency facility (including where it applies
because the State has allowed a plan that
is not otherwise subject to applicable
State law an opportunity to opt in, subject
to section 514 of ERISA). A group health
plan that opts into such a specified State
law must do so for all items and services
to which the specified State law applies
and in a manner determined by the appli-
cable State authority, and must prominent-
ly display in its plan materials describing
the coverage of out-of-network services a
statement that the plan has opted into the
specified State law, identify the relevant
State (or States), and include a general
description of the items and services pro-
vided by nonparticipating facilities and
providers that are covered by the specified
State law.
State means each of the 50 States, the
District of Columbia, Puerto Rico, the Vir-
gin Islands, Guam, American Samoa, and
the Northern Mariana Islands.
Treating provider is a physician or
health care provider who has evaluated
the individual.
Visit, with respect to items and services
furnished to an individual at a health care
facility, includes, in addition to items and
services furnished by a provider at the
facility, equipment and devices, telemed-
icine services, imaging services, laborato-
ry services, and preoperative and postop-
erative services, regardless of whether the
provider furnishing such items or services
is at the facility.
§ 2590.716-4 Preventing surprise
medical bills for emergency services.
(a) In general. If a group health plan,
or a health insurance issuer offering
group health insurance coverage, pro-
vides or covers any benefits with respect
to services in an emergency department
of a hospital or with respect to emergen-
cy services in an independent freestanding
emergency department, the plan or issuer
must cover emergency services, as defined
in paragraph (c)(2) of this section, and this
coverage must be provided in accordance
with paragraph (b) of this section.
(b) Coverage requirements. A plan or
issuer described in paragraph (a) of this
section must provide coverage for emer-
gency services in the following manner—
(1) Without the need for any prior au-
thorization determination, even if the ser-
vices are provided on an out-of-network
basis.
(2) Without regard to whether the
health care provider furnishing the emer-
gency services is a participating provider
or a participating emergency facility, as
applicable, with respect to the services.
(3) If the emergency services are pro-
vided by a nonparticipating provider or a
nonparticipating emergency facility—
(i) Without imposing any administra-
tive requirement or limitation on coverage
that is more restrictive than the require-
ments or limitations that apply to emer-
gency services received from participat-
ing providers and participating emergency
facilities.
(ii) Without imposing cost-sharing
requirements that are greater than the re-
quirements that would apply if the services
were provided by a participating provider
or a participating emergency facility.
(iii) By calculating the cost-sharing
requirement as if the total amount that
would have been charged for the services
by such participating provider or partici-
pating emergency facility were equal to
the recognized amount for such services.
(iv) The plan or issuer—
(A) Not later than 30 calendar days af-
ter the bill for the services is transmitted by
the provider or facility (or, in cases where
the recognized amount is determined by
a specified State law or All-Payer Model
Agreement, such other timeframe as spec-
ified by the State law or All-Payer Model
Agreement), determines whether the ser-
vices are covered under the plan or cover-
age and, if the services are covered, sends
to the provider or facility, as applicable,
an initial payment or a notice of denial of
payment. For purposes of this paragraph
(b)(3)(iv)(A), the 30-calendar-day period
begins on the date the plan or issuer re-
ceives the information necessary to decide
a claim for payment for the services.
(B) Pays a total plan or coverage pay-
ment directly to the nonparticipating pro-
vider or nonparticipating facility that is
equal to the amount by which the out-of-
network rate for the services exceeds the
cost-sharing amount for the services (as
determined in accordance with paragraphs
(b)(3)(ii) and (iii) of this section), less any
initial payment amount made under para-
graph (b)(3)(iv)(A) of this section. The to-
tal plan or coverage payment must be made
in accordance with the timing requirement
described in section 716(c)(6) of ERISA,
or in cases where the out-of-network rate
is determined under a specified State law
or All-Payer Model Agreement, such oth-
er timeframe as specified by the State law
or All-Payer Model Agreement.
(v) By counting any cost-sharing pay-
ments made by the participant or benefi-
ciary with respect to the emergency ser-
vices toward any in-network deductible
or in-network out-of-pocket maximums
(including the annual limitation on cost
sharing under section 2707(b) of the PHS
Act) (as applicable) applied under the plan
or coverage (and the in-network deduct-
ible and in-network out-of-pocket maxi-
mums must be applied) in the same man-
ner as if the cost-sharing payments were
made with respect to emergency services
furnished by a participating provider or a
participating emergency facility.
(4) Without limiting what constitutes
an emergency medical condition (as de-
fined in paragraph (c)(1) of this section)
solely on the basis of diagnosis codes.
(5) Without regard to any other term or
condition of the coverage, other than—
(i) The exclusion or coordination of
benefits (to the extent not inconsistent
with benefits for an emergency medical
condition, as defined in paragraph (c)(1)
of this section).
(ii) An affiliation or waiting period
(each as defined in § 2590.701-2).
(iii) Applicable cost sharing.
(c) Definitions. In this section—
(1) Emergency medical condition
means a medical condition, including
a mental health condition or substance
use disorder, manifesting itself by acute

July 26, 2021 126 Bulletin No. 2021–30
symptoms of sufficient severity (including
severe pain) such that a prudent layperson,
who possesses an average knowledge of
health and medicine, could reasonably ex-
pect the absence of immediate medical at-
tention to result in a condition described in
clause (i), (ii), or (iii) of section 1867(e)(1)
(A) of the Social Security Act (42 U.S.C.
1395dd(e)(1)(A)). (In that provision of
the Social Security Act, clause (i) refers
to placing the health of the individual (or,
with respect to a pregnant woman, the
health of the woman or her unborn child)
in serious jeopardy; clause (ii) refers to se-
rious impairment to bodily functions; and
clause (iii) refers to serious dysfunction of
any bodily organ or part.)
(2) Emergency services means, with
respect to an emergency medical condi-
tion—
(i) In general. (A) An appropriate med-
ical screening examination (as required
under section 1867 of the Social Security
Act (42 U.S.C. 1395dd) or as would be re-
quired under such section if such section
applied to an independent freestanding
emergency department) that is within the
capability of the emergency department of
a hospital or of an independent freestand-
ing emergency department, as applicable,
including ancillary services routinely
available to the emergency department to
evaluate such emergency medical condi-
tion; and
(B) Within the capabilities of the staff
and facilities available at the hospital or
the independent freestanding emergency
department, as applicable, such further
medical examination and treatment as are
required under section 1867 of the So-
cial Security Act (42 U.S.C. 1395dd), or
as would be required under such section
if such section applied to an indepen-
dent freestanding emergency department,
to stabilize the patient (regardless of the
department of the hospital in which such
further examination or treatment is fur-
nished).
(ii) Inclusion of additional services.
(A) Subject to paragraph (c)(2)(ii)(B) of
this section, items and services—
(1) For which benefits are provided or
covered under the plan or coverage; and
(2) That are furnished by a nonpartici-
pating provider or nonparticipating emer-
gency facility (regardless of the depart-
ment of the hospital in which such items
or services are furnished) after the partici-
pant or beneficiary is stabilized and as part
of outpatient observation or an inpatient or
outpatient stay with respect to the visit in
which the services described in paragraph
(c)(2)(i) of this section are furnished.
(B) Items and services described in
paragraph (c)(2)(ii)(A) of this section are
not included as emergency services if all
of the conditions in 45 CFR 149.410(b)
are met.
(3) To stabilize, with respect to an emer-
gency medical condition, has the mean-
ing given such term in section 1867(e)
(3) of the Social Security Act (42 U.S.C.
1395dd(e)(3)).
(d) Applicability date. The provisions
of this section are applicable with respect
to plan years beginning on or after January
1, 2022.
§ 2590.716-5 Preventing surprise
medical bills for non-emergency
services performed by nonparticipating
providers at certain participating
facilities.
(a) In general. If a group health plan,
or a health insurance issuer offering group
health insurance coverage, provides or
covers any benefits with respect to items
and services described in paragraph (b) of
this section, the plan or issuer must cover
the items and services when furnished by
a nonparticipating provider in accordance
with paragraph (c) of this section.
(b) Items and services described. The
items and services described in this para-
graph (b) are items and services (other
than emergency services) furnished to a
participant or beneficiary by a nonpartic-
ipating provider with respect to a visit at
a participating health care facility, unless
the provider has satisfied the notice and
consent criteria of 45 CFR 149.420(c)
through (i) with respect to such items and
services.
(c) Coverage requirements. In the
case of items and services described in
paragraph (b) of this section, the plan or
issuer—
(1) Must not impose a cost-sharing re-
quirement for the items and services that
is greater than the cost-sharing require-
ment that would apply if the items or ser-
vices had been furnished by a participat-
ing provider.
(2) Must calculate the cost-sharing
requirements as if the total amount that
would have been charged for the items
and services by such participating provid-
er were equal to the recognized amount
for the items and services.
(3) Not later than 30 calendar days
after the bill for the items or services is
transmitted by the provider (or in cases
where the recognized amount is deter-
mined by a specified State law or All-Pay-
er Model Agreement, such other time-
frame as specified under the State law or
All-Payer Model Agreement), must deter-
mine whether the items and services are
covered under the plan or coverage and,
if the items and services are covered, send
to the provider an initial payment or a no-
tice of denial of payment. For purposes of
this paragraph (c)(3), the 30-calendar-day
period begins on the date the plan or is-
suer receives the information necessary to
decide a claim for payment for the items
or services.
(4) Must pay a total plan or coverage
payment directly to the nonparticipat-
ing provider that is equal to the amount
by which the out-of-network rate for the
items and services involved exceeds the
cost-sharing amount for the items and ser-
vices (as determined in accordance with
paragraphs (c)(1) and (2) of this section),
less any initial payment amount made un-
der paragraph (c)(3) of this section. The to-
tal plan or coverage payment must be made
in accordance with the timing requirement
described in section 716(c)(6) of ERISA,
or in cases where the out-of-network rate
is determined under a specified State law
or All-Payer Model Agreement, such other
timeframe as specified by the State law or
All-Payer Model Agreement.
(5) Must count any cost-sharing pay-
ments made by the participant or benefi-
ciary toward any in-network deductible
and in-network out-of-pocket maximums
(including the annual limitation on cost
sharing under section 2707(b) of the PHS
Act) (as applicable) applied under the plan
or coverage (and the in-network deduct-
ible and out-of-pocket maximums must
be applied) in the same manner as if such
cost-sharing payments were made with re-
spect to items and services furnished by a
participating provider.
(d) Applicability date. The provisions
of this section are applicable with respect

Bulletin No. 2021–30 127 July 26, 2021
to plan years beginning on or after January
1, 2022.
§ 2590.716-6 Methodology for
calculating qualifying payment
amount.
(a) Definitions. For purposes of this
section, the following definitions apply:
(1) Contracted rate means the total
amount (including cost sharing) that a
group health plan or health insurance issu-
er has contractually agreed to pay a partic-
ipating provider, facility, or provider of air
ambulance services for covered items and
services, whether directly or indirectly, in-
cluding through a third-party administra-
tor or pharmacy benefit manager. Solely
for purposes of this definition, a single
case agreement, letter of agreement, or
other similar arrangement between a pro-
vider, facility, or air ambulance provider
and a plan or issuer, used to supplement
the network of the plan or coverage for
a specific participant or beneficiary in
unique circumstances, does not constitute
a contract.
(2) Derived amount has the meaning
given the term in § 2590.715-2715A1.
(3) Eligible database means—
(i) A State all-payer claims database; or
(ii) Any third-party database which—
(A) Is not affiliated with, or owned or
controlled by, any health insurance issuer,
or a health care provider, facility, or pro-
vider of air ambulance services (or any
member of the same controlled group as,
or under common control with, such an
entity). For purposes of this paragraph
(a)(3)(ii)(A), the term controlled group
means a group of two or more persons
that is treated as a single employer under
sections 52(a), 52(b), 414(m), or 414(o)
of the Internal Revenue Code of 1986, as
amended;
(B) Has sufficient information reflect-
ing in-network amounts paid by group
health plans or health insurance issuers
offering group health insurance coverage
to providers, facilities, or providers of air
ambulance services for relevant items and
services furnished in the applicable geo-
graphic region; and
(C) Has the ability to distinguish
amounts paid to participating providers
and facilities by commercial payers, such
as group health plans and health insurance
issuers offering group health insurance
coverage, from all other claims data, such
as amounts billed by nonparticipating
providers or facilities and amounts paid
by public payers, including the Medicare
program under title XVIII of the Social
Security Act, the Medicaid program under
title XIX of the Social Security Act (or
a demonstration project under title XI of
the Social Security Act), or the Children’s
Health Insurance Program under title XXI
of the Social Security Act.
(4) Facility of the same or similar facil-
ity type means, with respect to emergency
services, either—
(i) An emergency department of a hos-
pital; or
(ii) An independent freestanding emer-
gency department.
(5) First coverage year means, with re-
spect to an item or service for which cov-
erage is not offered in 2019 under a group
health plan or group health insurance cov-
erage offered by a health insurance issuer,
the first year after 2019 for which cover-
age for such item or service is offered un-
der that plan or coverage.
(6) First sufficient information year
means, with respect to a group health plan
or group health insurance coverage of-
fered by a health insurance issuer—
(i) In the case of an item or service for
which the plan or coverage does not have
sufficient information to calculate the me-
dian of the contracted rates described in
paragraph (b) of this section in 2019, the
first year after 2022 for which the plan or
issuer has sufficient information to calcu-
late the median of such contracted rates in
the year immediately preceding that first
year after 2022; and
(ii) In the case of a newly covered item
or service, the first year after the first cov-
erage year for such item or service with
respect to such plan or coverage for which
the plan or issuer has sufficient informa-
tion to calculate the median of the con-
tracted rates described in paragraph (b) of
this section in the year immediately pre-
ceding that first year.
(7) Geographic region means—
(i) For items and services other than air
ambulance services—
(A) Subject to paragraphs (a)(7)(i)(B)
and (C) of this section, one region for each
metropolitan statistical area, as described
by the U.S. Office of Management and
Budget and published by the U.S. Census
Bureau, in a State, and one region consist-
ing of all other portions of the State.
(B) If a plan or issuer does not have
sufficient information to calculate the me-
dian of the contracted rates described in
paragraph (b) of this section for an item
or service provided in a geographic region
described in paragraph (a)(7)(i)(A) of this
section, one region consisting of all met-
ropolitan statistical areas, as described
by the U.S. Office of Management and
Budget and published by the U.S. Census
Bureau, in the State, and one region con-
sisting of all other portions of the State.
(C) If a plan or issuer does not have
sufficient information to calculate the me-
dian of the contracted rates described in
paragraph (b) of this section for an item
or service provided in a geographic region
described in paragraph (a)(7)(i)(B) of this
section, one region consisting of all met-
ropolitan statistical areas, as described
by the U.S. Office of Management and
Budget and published by the U.S. Census
Bureau, in each Census division and one
region consisting of all other portions of
the Census division, as described by the
U.S. Census Bureau.
(ii) For air ambulance services—
(A) Subject to paragraph (a)(7)(ii)(B)
of this section, one region consisting of all
metropolitan statistical areas, as described
by the U.S. Office of Management and
Budget and published by the U.S. Census
Bureau, in the State, and one region con-
sisting of all other portions of the State,
determined based on the point of pick-up
(as defined in 42 CFR 414.605).
(B) If a plan or issuer does not have
sufficient information to calculate the me-
dian of the contracted rates described in
paragraph (b) of this section for an air am-
bulance service provided in a geographic
region described in paragraph (a)(7)(ii)(A)
of this section, one region consisting of all
metropolitan statistical areas, as described
by the U.S. Office of Management and
Budget and published by the U.S. Census
Bureau, in each Census division and one
region consisting of all other portions of
the Census division, as described by the
U.S. Census Bureau, determined based on
the point of pick-up (as defined in 42 CFR
414.605).
(8) Insurance market is, irrespective of
the State, one of the following:

July 26, 2021 128 Bulletin No. 2021–30
(i) The individual market (other than
short-term, limited-duration insurance or
individual health insurance coverage that
consists solely of excepted benefits).
(ii) The large group market (other than
coverage that consists solely of excepted
benefits).
(iii) The small group market (other
than coverage that consists solely of ex-
cepted benefits).
(iv) In the case of a self-insured group
health plan, all self-insured group health
plans (other than account-based plans,
as defined in § 2590.715-2711(d)(6)(i),
and plans that consist solely of excepted
benefits) of the same plan sponsor, or at
the option of the plan sponsor, all self-in-
sured group health plans administered by
the same entity (including a third-party
administrator contracted by the plan), to
the extent otherwise permitted by law,
that is responsible for calculating the
qualifying payment amount on behalf of
the plan.
(9) Modifiers mean codes applied to the
service code that provide a more specific
description of the furnished item or ser-
vice and that may adjust the payment rate
or affect the processing or payment of the
code billed.
(10) Newly covered item or service
means an item or service for which cover-
age was not offered in 2019 under a group
health plan or group health insurance cov-
erage offered by a health insurance issuer,
but that is offered under the plan or cover-
age in a year after 2019.
(11) New service code means a service
code that was created or substantially re-
vised in a year after 2019.
(12) Provider in the same or similar
specialty means the practice specialty of a
provider, as identified by the plan or issuer
consistent with the plan’s or issuer’s usual
business practice, except that, with respect
to air ambulance services, all providers of
air ambulance services are considered to
be a single provider specialty.
(13) Same or similar item or service
means a health care item or service billed
under the same service code, or a compa-
rable code under a different procedural
code system.
(14) Service code means the code that
describes an item or service using the Cur-
rent Procedural Terminology (CPT) code,
Healthcare Common Procedure Coding
System (HCPCS), or Diagnosis-Related
Group (DRG) codes.
(15) Sufficient information means, for
purposes of determining whether a group
health plan or health insurance issuer of-
fering group health insurance coverage
has sufficient information to calculate the
median of the contracted rates described
in paragraph (b) of this section—
(i) The plan or issuer has at least three
contracted rates on January 31, 2019, to
calculate the median of the contracted
rates in accordance with paragraph (b) of
this section; or
(ii) For an item or service furnished
during a year after 2022 that is used to
determine the first sufficient information
year —
(A) The plan or issuer has at least three
contracted rates on January 31 of the year
immediately preceding that year to cal-
culate the median of the contracted rates
in accordance with paragraph (b) of this
section; and
(B) The contracted rates under para-
graph (a)(15)(ii)(A) of this section ac-
count (or are reasonably expected to ac-
count) for at least 25 percent of the total
number of claims paid for that item or ser-
vice for that year with respect to all plans
of the sponsor (or the administering entity
as provided in paragraph (a)(8)(iv) of this
section, if applicable) or all coverage of-
fered by the issuer that are offered in the
same insurance market.
(16) Qualifying payment amount
means, with respect to a sponsor of a
group health plan or health insurance is-
suer offering group health insurance cov-
erage, the amount calculated using the
methodology described in paragraph (c)
of this section.
(17) Underlying fee schedule rate
means the rate for a covered item or ser-
vice from a particular participating pro-
vider, providers, or facility that a group
health plan or health insurance issuer uses
to determine a participant’s or beneficia-
ry’s cost-sharing liability for the item or
service, when that rate is different from
the contracted rate.
(b) Methodology for calculation of
median contracted rate—(1) In general.
The median contracted rate for an item
or service is calculated by arranging in
order from least to greatest the contract-
ed rates of all group health plans of the
plan sponsor (or the administering entity
as provided in paragraph (a)(8)(iv) of this
section, if applicable) or all group health
insurance coverage offered by the issuer
in the same insurance market for the same
or similar item or service that is provided
by a provider in the same or similar spe-
cialty or facility of the same or similar fa-
cility type and provided in the geographic
region in which the item or service is fur-
nished and selecting the middle number.
If there are an even number of contracted
rates, the median contracted rate is the av-
erage of the middle two contracted rates.
In determining the median contracted
rate, the amount negotiated under each
contract is treated as a separate amount. If
a plan or issuer has a contract with a pro-
vider group or facility, the rate negotiated
with that provider group or facility under
the contract is treated as a single contract-
ed rate if the same amount applies with
respect to all providers of such provider
group or facility under the single contract.
However, if a plan or issuer has a contract
with multiple providers, with separate
negotiated rates with each particular pro-
vider, each unique contracted rate with an
individual provider constitutes a single
contracted rate. Further, if a plan or issu-
er has separate contracts with individual
providers, the contracted rate under each
such contract constitutes a single con-
tracted rate (even if the same amount is
paid to multiple providers under separate
contracts).
(2) Calculation rules. In calculating
the median contracted rate, a plan or is-
suer must:
(i) Calculate the median contracted rate
with respect to all plans of such sponsor
(or the administering entity as provided in
paragraph (a)(8)(iv) of this section, if ap-
plicable) or all coverage offered by such
issuer that are offered in the same insur-
ance market;
(ii) Calculate the median contracted
rate using the full contracted rate appli-
cable to the service code, except that the
plan or issuer must—
(A) Calculate separate median con-
tracted rates for CPT code modifiers “26”
(professional component) and “TC” (tech-
nical component);
(B) For anesthesia services, calculate a
median contracted rate for the anesthesia
conversion factor for each service code;

Bulletin No. 2021–30 129 July 26, 2021
(C) For air ambulance services, cal-
culate a median contracted rate for the
air mileage service codes (A0435 and
A0436); and
(D) Where contracted rates otherwise
vary based on applying a modifier code,
calculate a separate median contracted
rate for each such service code-modifier
combination;
(iii) In the case of payments made by a
plan or issuer that are not on a fee-for-ser-
vice basis (such as bundled or capitation
payments), calculate a median contracted
rate for each item or service using the un-
derlying fee schedule rates for the relevant
items or services. If the plan or issuer does
not have an underlying fee schedule rate
for the item or service, it must use the de-
rived amount to calculate the median con-
tracted rate; and
(iv) Exclude risk sharing, bonus, pen-
alty, or other incentive-based or retrospec-
tive payments or payment adjustments.
(3) Provider specialties; facility types.
(i) If a plan or issuer has contracted rates
that vary based on provider specialty for
a service code, the median contracted rate
is calculated separately for each provider
specialty, as applicable.
(ii) If a plan or issuer has contracted
rates for emergency services that vary
based on facility type for a service code,
the median contracted rate is calculated
separately for each facility of the same or
similar facility type.
(c) Methodology for calculation of the
qualifying payment amount—(1) In gener-
al. (i) For an item or service (other than
items or services described in paragraphs
(c)(1)(iii) through (vii) of this section)
furnished during 2022, the plan or issu-
er must calculate the qualifying payment
amount by increasing the median con-
tracted rate (as determined in accordance
with paragraph (b) of this section) for the
same or similar item or service under such
plans or coverage, respectively, on Janu-
ary 31, 2019, by the combined percentage
increase as published by the Department
of the Treasury and the Internal Revenue
Service to reflect the percentage increase
in the CPI-U over 2019, such percentage
increase over 2020, and such percentage
increase over 2021.
(A) The combined percentage increase
for 2019, 2020, and 2021 will be pub-
lished in guidance by the Internal Reve-
nue Service. The Department of the Trea-
sury and the Internal Revenue Service will
calculate the percentage increase using the
CPI-U published by the Bureau of Labor
Statistics of the Department of Labor.
(B) For purposes of this paragraph (c)
(1)(i), the CPI-U for each calendar year is
the average of the CPI-U as of the close of
the 12-month period ending on August 31
of the calendar year, rounded to 10 deci-
mal places.
(C) The combined percentage increase
for 2019, 2020, and 2021 will be calcu-
lated as:
(CPI-U 2019/CPI-U 2018) x (CPI-U
2020/CPI-U 2019) x (CPI-U 2021/CPI-U
2020)
(ii) For an item or service (other than
items or services described in paragraphs
(c)(1)(iii) through (vii) of this section) fur-
nished during 2023 or a subsequent year,
the plan or issuer must calculate the qual-
ifying payment amount by increasing the
qualifying payment amount determined
under paragraph (c)(1)(i) of this section,
for such an item or service furnished in
the immediately preceding year, by the
percentage increase as published by the
Department of the Treasury and the Inter-
nal Revenue Service.
(A) The percentage increase for any
year after 2022 will be published in guid-
ance by the Internal Revenue Service. The
Department of the Treasury and Internal
Revenue Service will calculate the per-
centage increase using the CPI-U pub-
lished by the Bureau of Labor Statistics of
the Department of Labor.
(B) For purposes of this paragraph (c)
(1)(ii), the CPI-U for each calendar year is
the average of the CPI-U as of the close of
the 12-month period ending on August 31
of the calendar year, rounded to 10 deci-
mal places.
(C) The combined percentage increase
for any year will be calculated as CPI-U
present year/CPI-U prior year.
(iii) For anesthesia services furnished
during 2022, the plan or issuer must cal-
culate the qualifying payment amount by
first increasing the median contracted rate
for the anesthesia conversion factor (as
determined in accordance with paragraph
(b) of this section) for the same or similar
item or service under such plans or cov-
erage, respectively, on January 31, 2019,
in accordance with paragraph (c)(1)(i) of
this section (referred to in this section as
the indexed median contracted rate for the
anesthesia conversion factor). The plan
or issuer must then multiply the indexed
median contracted rate for the anesthesia
conversion factor by the sum of the base
unit, time unit, and physical status modifi-
er units of the participant or beneficiary to
whom anesthesia services are furnished to
determine the qualifying payment amount.
(A) The base units for an anesthesia
service code are the base units for that
service code specified in the most recent
edition (as of the date of service) of the
American Society of Anesthesiologists
Relative Value Guide.
(B) The time unit is measured in
15-minute increments or a fraction there-
of.
(C) The physical status modifier on a
claim is a standard modifier describing the
physical status of the patient and is used
to distinguish between various levels of
complexity of the anesthesia services pro-
vided, and is expressed as a unit with a
value between zero (0) and three (3).
(D) The anesthesia conversion factor
is expressed in dollars per unit and is a
contracted rate negotiated with the plan or
issuer.
(iv) For anesthesia services furnished
during 2023 or a subsequent year, the plan
or issuer must calculate the qualifying
payment amount by first increasing the
indexed median contracted rate for the
anesthesia conversion factor, determined
under paragraph (c)(1)(iii) of this section
for such services furnished in the immedi-
ately preceding year, in accordance with
paragraph (c)(1)(ii) of this section. The
plan or issuer must then multiply that
amount by the sum of the base unit, time
unit, and physical status modifier units
for the participant or beneficiary to whom
anesthesia services are furnished to deter-
mine the qualifying payment amount.
(v) For air ambulance services billed
using the air mileage service codes
(A0435 and A0436) that are furnished
during 2022, the plan or issuer must cal-
culate the qualifying payment amount for
services billed using the air mileage ser-
vice codes by first increasing the median
contracted rate (as determined in accor-
dance with paragraph (b) of this section),
in accordance with paragraph (c)(1)(i)
of this section (referred to in this section

July 26, 2021 130 Bulletin No. 2021–30
as the indexed median air mileage rate).
The plan or issuer must then multiply the
indexed median air mileage rate by the
number of loaded miles provided to the
participant or beneficiary to determine the
qualifying payment amount.
(A) The air mileage rate is expressed in
dollars per loaded mile flown, is expressed
in statute miles (not nautical miles), and is
a contracted rate negotiated with the plan
or issuer.
(B) The number of loaded miles is the
number of miles a patient is transported in
the air ambulance vehicle.
(C) The qualifying payment amount
for other service codes associated with air
ambulance services is calculated in accor-
dance with paragraphs (c)(1)(i) and (ii) of
this section.
(vi) For air ambulance services billed
using the air mileage service codes (A0435
and A0436) that are furnished during 2023
or a subsequent year, the plan or issuer
must calculate the qualifying payment
amount by first increasing the indexed
median air mileage rate, determined under
paragraph (c)(1)(v) of this section for such
services furnished in the immediately pre-
ceding year, in accordance with paragraph
(c)(1)(ii) of this section. The plan or issu-
er must then multiply the indexed median
air mileage rate by the number of loaded
miles provided to the participant or ben-
eficiary to determine the qualifying pay-
ment amount.
(vii) For any other items or services
for which a plan or issuer generally de-
termines payment for the same or sim-
ilar items or services by multiplying a
contracted rate by another unit value, the
plan or issuer must calculate the qualify-
ing payment amount using a methodology
that is similar to the methodology required
under paragraphs (c)(1)(iii) through (vi)
of this section and reasonably reflects the
payment methodology for same or similar
items or services.
(2) New plans and coverage. With re-
spect to a sponsor of a group health plan
or health insurance issuer offering group
health insurance coverage in a geographic
region in which the sponsor or issuer, re-
spectively, did not offer any group health
plan or health insurance coverage during
2019—
(i) For the first year in which the group
health plan or group health insurance
coverage, respectively, is offered in such
region—
(A) If the plan or issuer has sufficient
information to calculate the median of the
contracted rates described in paragraph
(b) of this section, the plan or issuer must
calculate the qualifying payment amount
in accordance with paragraph (c)(1) of
this section for items and services that are
covered by the plan or coverage and fur-
nished during the first year; and
(B) If the plan or issuer does not have
sufficient information to calculate the me-
dian of the contracted rates described in
paragraph (b) of this section for an item or
service provided in a geographic region,
the plan or issuer must determine the qual-
ifying payment amount for the item or ser-
vice in accordance with paragraph (c)(3)
(i) of this section.
(ii) For each subsequent year the group
health plan or group health insurance cov-
erage, respectively, is offered in the re-
gion, the plan or issuer must calculate the
qualifying payment amount by increasing
the qualifying payment amount deter-
mined under this paragraph (c)(2) for the
items and services furnished in the imme-
diately preceding year, in accordance with
paragraph (c)(1)(ii), (iv), or (vi) of this
section, as applicable.
(3) Insufficient information; newly cov-
ered items and services. In the case of a
plan or issuer that does not have sufficient
information to calculate the median of the
contracted rates described in paragraph
(b) of this section in 2019 (or, in the case
of a newly covered item or service, in the
first coverage year for such item or service
with respect to such plan or coverage if
the plan or issuer does not have sufficient
information) for an item or service provid-
ed in a geographic region—
(i) For an item or service furnished
during 2022 (or, in the case of a newly
covered item or service, during the first
coverage year for the item or service
with respect to the plan or coverage), the
plan or issuer must calculate the qualify-
ing payment amount by first identifying
the rate that is equal to the median of
the in-network allowed amounts for the
same or similar item or service provid-
ed in the geographic region in the year
immediately preceding the year in which
the item or service is furnished (or, in the
case of a newly covered item or service,
the year immediately preceding such first
coverage year) determined by the plan or
issuer, respectively, through use of any
eligible database, and then increasing
that rate by the percentage increase in the
CPI-U over such preceding year. For pur-
poses of this section, in cases in which an
eligible database is used to determine the
qualifying payment amount with respect
to an item or service furnished during a
calendar year, the plan or issuer must use
the same database for determining the
qualifying payment amount for that item
or service furnished through the last day
of the calendar year, and if a different da-
tabase is selected for some items or ser-
vices, the basis for that selection must be
one or more factors not directly related to
the rate of those items or services (such
as sufficiency of data for those items or
services).
(ii) For an item or service furnished in a
subsequent year (before the first sufficient
information year for such item or service
with respect to such plan or coverage),
the plan or issuer must calculate the qual-
ifying payment amount by increasing the
qualifying payment amount determined
under paragraph (c)(3)(i) of this section or
this paragraph (c)(3)(ii), as applicable, for
such item or service for the year immedi-
ately preceding such subsequent year, by
the percentage increase in CPI-U over
such preceding year;
(iii) For an item or service furnished
in the first sufficient information year for
such item or service with respect to such
plan or coverage, the plan or issuer must
calculate the qualifying payment amount
in accordance with paragraph (c)(1)(i),
(iii), or (v) of this section, as applicable,
except that in applying such paragraph
to such item or service, the reference to
‘furnished during 2022’ is treated as a ref-
erence to furnished during such first suf-
ficient information year, the reference to
‘in 2019’ is treated as a reference to such
sufficient information year, and the in-
crease described in such paragraph is not
applied; and
(iv) For an item or service furnished
in any year subsequent to the first suffi-
cient information year for such item or
service with respect to such plan or cov-
erage, the plan or issuer must calculate the
qualifying payment amount in accordance
with paragraph (c)(1)(ii), (iv), or (vi) of

Bulletin No. 2021–30 131 July 26, 2021
this section, as applicable, except that in
applying such paragraph to such item or
service, the reference to ‘furnished during
2023 or a subsequent year’ is treated as a
reference to furnished during the year af-
ter such first sufficient information year or
a subsequent year.
(4) New service codes. In the case of a
plan or issuer that does not have sufficient
information to calculate the median of the
contracted rates described in paragraph
(b) of this section and determine the qual-
ifying payment amount under paragraphs
(c)(1) through (3) of this section because
the item or service furnished is billed un-
der a new service code—
(i) For an item or service furnished
during 2022 (or, in the case of a newly
covered item or service, during the first
coverage year for the item or service with
respect to the plan or coverage), the plan
or issuer must identify a reasonably relat-
ed service code that existed in the imme-
diately preceding year and—
(A) If the Centers for Medicare &
Medicaid Services has established a
Medicare payment rate for the item or
service billed under the new service
code, the plan or issuer must calculate
the qualifying payment amount by first
calculating the ratio of the rate that Medi-
care pays for the item or service billed
under the new service code compared to
the rate that Medicare pays for the item
or service billed under the related service
code, and then multiplying the ratio by
the qualifying payment amount for an
item or service billed under the related
service code for the year in which the
item or service is furnished.
(B) If the Centers for Medicare & Med-
icaid Services has not established a Medi-
care payment rate for the item or service
billed under the new service code, the plan
or issuer must calculate the qualifying
payment amount by first calculating the
ratio of the rate that the plan or issuer re-
imburses for the item or service billed un-
der the new service code compared to the
rate that the plan or issuer reimburses for
the item or service billed under the related
service code, and then multiplying the ra-
tio by the qualifying payment amount for
an item or service billed under the related
service code.
(ii) For an item or service furnished in
a subsequent year (before the first suffi-
cient information year for such item or
service with respect to such plan or cov-
erage or before the first year for which an
eligible database has sufficient informa-
tion to a calculate a rate under paragraph
(c)(3)(i) of this section in the immediate-
ly preceding year), the plan or issuer must
calculate the qualifying payment amount
by increasing the qualifying payment
amount determined under paragraph (c)
(4)(i) of this section or this paragraph (c)
(4)(ii), as applicable, for such item or ser-
vice for the year immediately preceding
such subsequent year, by the percentage
increase in CPI-U over such preceding
year;
(iii) For an item or service furnished
in the first sufficient information year for
such item or service with respect to such
plan or coverage or the first year for which
an eligible database has sufficient infor-
mation to calculate a rate under paragraph
(c)(3)(i) of this section in the immediate-
ly preceding year, the plan or issuer must
calculate the qualifying payment amount
in accordance with paragraph (c)(3) of
this section.
(d) Information to be shared about
qualifying payment amount. In cases in
which the recognized amount with respect
to an item or service furnished by a non-
participating provider, nonparticipating
emergency facility, or nonparticipating
provider of air ambulance services is the
qualifying payment amount, the plan or
issuer must provide in writing, in paper or
electronic form, to the provider or facility,
as applicable—
(1) With each initial payment or notice
of denial of payment under § 2590.716-4,
§ 2590.716-5, or § 2590.717-1 of this part:
(i) The qualifying payment amount for
each item or service involved;
(ii) A statement to certify that, based on
the determination of the plan or issuer—
(A) The qualifying payment amount
applies for purposes of the recognized
amount (or, in the case of air ambulance
services, for calculating the participant’s
or beneficiary’s cost sharing); and
(B) Each qualifying payment amount
shared with the provider or facility was
determined in compliance with this sec-
tion;
(iii) A statement that if the provider
or facility, as applicable, wishes to initi-
ate a 30-day open negotiation period for
purposes of determining the amount of to-
tal payment, the provider or facility may
contact the appropriate person or office to
initiate open negotiation, and that if the
30-day negotiation period does not result
in a determination, generally, the provid-
er or facility may initiate the independent
dispute resolution process within 4 days
after the end of the open negotiation pe-
riod; and
(iv) Contact information, including a
telephone number and email address, for
the appropriate person or office to initiate
open negotiations for purposes of deter-
mining an amount of payment (including
cost sharing) for such item or service.
(2) In a timely manner upon request of
the provider or facility:
(i) Information about whether the qual-
ifying payment amount for items and ser-
vices involved included contracted rates
that were not on a fee-for-service basis
for those specific items and services and
whether the qualifying payment amount
for those items and services was deter-
mined using underlying fee schedule rates
or a derived amount;
(ii) If a plan or issuer uses an eligi-
ble database under paragraph (c)(3) of
this section to determine the qualifying
payment amount, information to identify
which database was used; and
(iii) If a related service code was used
to determine the qualifying payment
amount for an item or service billed under
a new service code under paragraph (c)(4)
(i) or (ii) of this section, information to
identify the related service code;
(iv) If applicable, a statement that the
plan’s or issuer’s contracted rates include
risk-sharing, bonus, penalty, or other in-
centive-based or retrospective payments
or payment adjustments for the items and
services involved (as applicable) that were
excluded for purposes of calculating the
qualifying payment amount.
(e) Certain access fees to databases. In
the case of a plan or issuer that, pursuant
to this section, uses an eligible database to
determine the qualifying payment amount
for an item or service, the plan or issuer is
responsible for any costs associated with
accessing such database.
(f) Applicability date. The provisions
of this section are applicable with respect
to plan years beginning on or after January
1, 2022.

July 26, 2021 132 Bulletin No. 2021–30
§ 2590.716-7 Complaints process
for surprise medical bills regarding
group health plans and group health
insurance coverage.
(a) Scope and definitions—(1) Scope.
This section establishes a process to re-
ceive and resolve complaints regarding in-
formation that a specific group health plan
or health insurance issuer offering group
health insurance coverage may be failing
to meet the requirements under subpart D
of this part, which may warrant an inves-
tigation.
(2) Definitions. In this section—
(i) Complaint means a communica-
tion, written or oral, that indicates there
has been a potential violation of the re-
quirements under subpart D of this part,
whether or not a violation actually oc-
curred.
(ii) Complainant means any individu-
al, or their authorized representative, who
files a complaint as defined in paragraph
(a)(2)(i) of this section.
(b) Complaints process. (1) DOL will
consider the date a complaint is filed to be
the date upon which DOL receives an oral
or written statement that identifies infor-
mation about the complaint sufficient to
identify the parties involved and the ac-
tion or inaction complained of.
(2) DOL will notify complainants, by
oral or written means, of receipt of the
complaint no later than 60 business days
after the complaint is received. DOL will
include a response acknowledging re-
ceipt of the complaint, notifying the com-
plainant of their rights and obligations un-
der the complaints process, and describing
the next steps of the complaint resolution
process. As part of the response, DOL may
request additional information needed to
process the complaint. Such additional in-
formation may include:
(i) Explanations of benefits;
(ii) Processed claims;
(iii) Information about the health care
provider, facility, or provider of air ambu-
lance services involved;
(iv) Information about the group health
plan or health insurance issuer covering
the individual;
(v) Information to support a determi-
nation regarding whether the service was
an emergency service or non-emergency
service;
(vi) The summary plan description,
policy, certificate, contract of insurance,
membership booklet, outline of coverage,
or other evidence of coverage the plan or
issuer provides to participants or benefi-
ciaries;
(vii) Documents regarding the facts in
the complaint in the possession of, or oth-
erwise attainable by, the complainant; or
(viii) Any other information DOL may
need to make a determination of facts for
an investigation.
(3) DOL will make reasonable efforts
consistent with agency practices to noti-
fy the complainant of the outcome of the
complaint after the submission is pro-
cessed through appropriate methods as
determined by DOL. A complaint is con-
sidered processed after DOL has reviewed
the complaint and accompanying informa-
tion and made an outcome determination.
Based on the nature of the complaint and
the plan or issuer involved, DOL may—
(i) Refer the complainant to another
appropriate Federal or State resolution
process;
(ii) Notify the complainant and make
reasonable efforts to refer the complainant
to the appropriate State or Federal regula-
tory authority if DOL receives a complaint
where another entity has enforcement ju-
risdiction over the plan or issuer;
(iii) Refer the plan or issuer for an in-
vestigation for enforcement action; or
(iv) Provide the complainant with an
explanation of the resolution of the com-
plaint and any corrective action taken.
§ 2590.717-1 Preventing surprise
medical bills for air ambulance
services.
(a) In general. If a group health plan
or a health insurance issuer offering group
health insurance coverage provides or
covers any benefits for air ambulance ser-
vices, the plan or issuer must cover such
services from a nonparticipating provider
of air ambulance services in accordance
with paragraph (b) of this section.
(b) Coverage requirements. A plan or
issuer described in paragraph (a) of this
section must provide coverage of air am-
bulance services in the following man-
ner—
(1) The cost-sharing requirements with
respect to the services must be the same
requirements that would apply if the ser-
vices were provided by a participating
provider of air ambulance services.
(2) The cost-sharing requirement
must be calculated as if the total amount
that would have been charged for the
services by a participating provider of
air ambulance services were equal to the
lesser of the qualifying payment amount
(as determined in accordance with §
2590.716-6) or the billed amount for the
services.
(3) The cost-sharing amounts must be
counted towards any in-network deduct-
ible and in-network out-of-pocket maxi-
mums (including the annual limitation on
cost sharing under section 2707(b) of the
PHS Act) (as applicable) applied under
the plan or coverage (and the in-network
deductible and out-of-pocket maximums
must be applied) in the same manner as
if the cost-sharing payments were made
with respect to services furnished by a
participating provider of air ambulance
services.
(4) The plan or issuer must—
(i) Not later than 30 calendar days af-
ter the bill for the services is transmitted
by the provider of air ambulance services,
determine whether the services are cov-
ered under the plan or coverage and, if the
services are covered, send to the provider
an initial payment or a notice of denial of
payment. For purposes of this paragraph
(b)(4)(i), the 30-calendar-day period be-
gins on the date the plan or issuer receives
the information necessary to decide a
claim for payment for the services.
(ii) Pay a total plan or coverage pay-
ment directly to the nonparticipating pro-
vider furnishing such air ambulance ser-
vices that is equal to the amount by which
the out-of-network rate for the services
exceeds the cost-sharing amount for the
services (as determined in accordance
with paragraphs (b)(1) and (2) of this
section), less any initial payment amount
made under paragraph (b)(4)(i) of this
section. The total plan or coverage pay-
ment must be made in accordance with the
timing requirement described in section
717(b)(6) of ERISA, or in cases where the
out-of-network rate is determined under
a specified State law or All-Payer Model
Agreement, such other timeframe as spec-
ified by the State law or All-Payer Model
Agreement.

Bulletin No. 2021–30 133 July 26, 2021
(c) Applicability date. The provisions
of this section are applicable with respect
to plan years beginning on or after January
1, 2022.
§ 2590.722 Choice of health care
professional.
(a) Choice of health care profession-
al—(1) Designation of primary care pro-
vider—(i) In general. If a group health
plan, or a health insurance issuer offering
group health insurance coverage, requires
or provides for designation by a partici-
pant or beneficiary of a participating pri-
mary care provider, then the plan or issuer
must permit each participant or beneficia-
ry to designate any participating primary
care provider who is available to accept
the participant or beneficiary. In such a
case, the plan or issuer must comply with
the rules of paragraph (a)(4) of this section
by informing each participant of the terms
of the plan or health insurance coverage
regarding designation of a primary care
provider.
(ii) Construction. Nothing in paragraph
(a)(1)(i) of this section is to be construed
to prohibit the application of reasonable
and appropriate geographic limitations
with respect to the selection of primary
care providers, in accordance with the
terms of the plan or coverage, the under-
lying provider contracts, and applicable
State law.
(iii) Example. The rules of this para-
graph (a)(1) are illustrated by the follow-
ing example:
(A) Facts. A group health plan requires individ-
uals covered under the plan to designate a primary
care provider. The plan permits each individual to
designate any primary care provider participating
in the plan’s network who is available to accept the
individual as the individual’s primary care provider.
If an individual has not designated a primary care
provider, the plan designates one until the individual
has made a designation. The plan provides a notice
that satisfies the requirements of paragraph (a)(4) of
this section regarding the ability to designate a pri-
mary care provider.
(B) Conclusion. In this Example, the plan has
satisfied the requirements of paragraph (a) of this
section.
(2) Designation of pediatrician as primary care
provider—(i) In general. If a group health plan, or
a health insurance issuer offering group health in-
surance coverage, requires or provides for the des-
ignation of a participating primary care provider
for a child by a participant or beneficiary, the plan
or issuer must permit the participant or beneficiary
to designate a physician (allopathic or osteopathic)
who specializes in pediatrics (including pediatric
subspecialties, based on the scope of that provider’s
license under applicable State law) as the child’s pri-
mary care provider if the provider participates in the
network of the plan or issuer and is available to ac-
cept the child. In such a case, the plan or issuer must
comply with the rules of paragraph (a)(4) of this sec-
tion by informing each participant (in the individual
market, primary subscriber) of the terms of the plan
or health insurance coverage regarding designation
of a pediatrician as the child’s primary care provider.
(ii) Construction. Nothing in paragraph
(a)(2)(i) of this section is to be construed
to waive any exclusions of coverage un-
der the terms and conditions of the plan or
health insurance coverage with respect to
coverage of pediatric care.
(iii) Examples. The rules of this para-
graph (a)(2) are illustrated by the follow-
ing examples:
(A) Example 1—(1) Facts. A group health
plan’s HMO designates for each participant a phy-
sician who specializes in internal medicine to serve
as the primary care provider for the participant and
any beneficiaries. Participant A requests that Pedia-
trician B be designated as the primary care provid-
er for A’s child. B is a participating provider in the
HMO’s network and is available to accept the child.
(2) Conclusion. In this Example 1, the HMO
must permit A’s designation of B as the primary care
provider for A’s child in order to comply with the
requirements of this paragraph (a)(2).
(B) Example 2—(1) Facts. Same facts as Exam-
ple 1 (paragraph (a)(2)(iii)(A) of this section), except
that A takes A’s child to B for treatment of the child’s
severe shellfish allergies. B wishes to refer A’s child
to an allergist for treatment. The HMO, however,
does not provide coverage for treatment of food al-
lergies, nor does it have an allergist participating in
its network, and it therefore refuses to authorize the
referral.
(2) Conclusion. In this Example 2, the HMO has
not violated the requirements of this paragraph (a)(2)
because the exclusion of treatment for food allergies
is in accordance with the terms of A’s coverage.
(3) Patient access to obstetrical and gynecolog-
ical care—(i) General rights—(A) Direct access. A
group health plan, or a health insurance issuer of-
fering group health insurance coverage, described
in paragraph (a)(3)(ii) of this section, may not re-
quire authorization or referral by the plan, issuer, or
any person (including a primary care provider) in
the case of a female participant or beneficiary who
seeks coverage for obstetrical or gynecological care
provided by a participating health care professional
who specializes in obstetrics or gynecology. In such
a case, the plan or issuer must comply with the rules
of paragraph (a)(4) of this section by informing each
participant that the plan may not require authoriza-
tion or referral for obstetrical or gynecological care
by a participating health care professional who spe-
cializes in obstetrics or gynecology. The plan or is-
suer may require such a professional to agree to oth-
erwise adhere to the plan’s or issuer’s policies and
procedures, including procedures regarding referrals
and obtaining prior authorization and providing ser-
vices pursuant to a treatment plan (if any) approved
by the plan or issuer. For purposes of this paragraph
(a)(3), a health care professional who specializes in
obstetrics or gynecology is any individual (including
a person other than a physician) who is authorized
under applicable State law to provide obstetrical or
gynecological care.
(B) Obstetrical and gynecological
care. A group health plan or health insur-
ance issuer described in paragraph (a)(3)
(ii) of this section must treat the provision
of obstetrical and gynecological care, and
the ordering of related obstetrical and
gynecological items and services, pursu-
ant to the direct access described under
paragraph (a)(3)(i)(A) of this section, by a
participating health care professional who
specializes in obstetrics or gynecology as
the authorization of the primary care pro-
vider.
(ii) Application of paragraph. A group
health plan, or a health insurance issuer
offering group health insurance coverage,
is described in this paragraph (a)(3) if the
plan or issuer—
(A) Provides coverage for obstetrical
or gynecological care; and
(B) Requires the designation by a par-
ticipant or beneficiary of a participating
primary care provider.
(iii) Construction. Nothing in para-
graph (a)(3)(i) of this section is to be con-
strued to—
(A) Waive any exclusions of coverage
under the terms and conditions of the plan
or health insurance coverage with respect
to coverage of obstetrical or gynecologi-
cal care; or
(B) Preclude the group health plan or
health insurance issuer involved from re-
quiring that the obstetrical or gynecologi-
cal provider notify the primary care health
care professional or the plan or issuer of
treatment decisions.
(iv) Examples. The rules of this para-
graph (a)(3) are illustrated by the follow-
ing examples:
(A) Example 1—(1) Facts. A group health plan
requires each participant to designate a physician to
serve as the primary care provider for the participant
and the participant’s family. Participant A, a female,
requests a gynecological exam with Physician B, an
in-network physician specializing in gynecological
care. The group health plan requires prior authori-
zation from A’s designated primary care provider for
the gynecological exam.
(2) Conclusion. In this Example 1, the group
health plan has violated the requirements of this
paragraph (a)(3) because the plan requires prior au-
thorization from A’s primary care provider prior to
obtaining gynecological services.

July 26, 2021 134 Bulletin No. 2021–30
(B) Example 2—(1) Facts. Same facts as Exam-
ple 1 (paragraph (a)(3)(iv)(A) of this section) except
that A seeks gynecological services from C, an out-
of-network provider.
(2) Conclusion. In this Example 2, the group
health plan has not violated the requirements of this
paragraph (a)(3) by requiring prior authorization be-
cause C is not a participating health care provider.
(C) Example 3—(1) Facts. Same facts as Ex-
ample 1 (paragraph (a)(3)(iv)(A) of this section)
except that the group health plan only requires B to
inform A’s designated primary care physician of
treatment decisions.
(2) Conclusion. In this Example 3, the group
health plan has not violated the requirements of
this paragraph (a)(3) because A has direct access
to B without prior authorization. The fact that the
group health plan requires the designated primary
care physician to be notified of treatment decisions
does not violate this paragraph (a)(3).
(D) Example 4—(1) Facts. A group health plan
requires each participant to designate a physician to
serve as the primary care provider for the participant
and the participant’s family. The group health plan
requires prior authorization before providing benefits
for uterine fibroid embolization.
(2) Conclusion. In this Example 4, the plan re-
quirement for prior authorization before providing
benefits for uterine fibroid embolization does not
violate the requirements of this paragraph (a)(3)
because, though the prior authorization requirement
applies to obstetrical services, it does not restrict
access to any providers specializing in obstetrics or
gynecology.
(4) Notice of right to designate a pri-
mary care provider—(i) In general. If
a group health plan or health insurance
issuer requires the designation by a par-
ticipant or beneficiary of a primary care
provider, the plan or issuer must provide
a notice informing each participant (in
the individual market, primary subscrib-
er) of the terms of the plan or health in-
surance coverage regarding designation
of a primary care provider and of the
rights—
(A) Under paragraph (a)(1)(i) of this
section, that any participating primary
care provider who is available to accept
the participant or beneficiary can be des-
ignated;
(B) Under paragraph (a)(2)(i) of this
section, with respect to a child, that any
participating physician who specializes in
pediatrics can be designated as the prima-
ry care provider; and
(C) Under paragraph (a)(3)(i) of this
section, that the plan may not require
authorization or referral for obstetrical
or gynecological care by a participating
health care professional who specializes
in obstetrics or gynecology.
(ii) Timing. In the case of a group
health plan or group health insurance
coverage, the notice described in para-
graph (a)(4)(i) of this section must be
included whenever the plan or issuer pro-
vides a participant with a summary plan
description or other similar description
of benefits under the plan or health in-
surance coverage. In the case of individ-
ual health insurance coverage, the notice
described in paragraph (a)(4)(i) of this
section must be included whenever the
issuer provides a primary subscriber with
a policy, certificate, or contract of health
insurance.
(iii) Model language. The following
model language can be used to satisfy the
notice requirement described in paragraph
(a)(4)(i) of this section:
(A) For plans and issuers that require
or allow for the designation of primary
care providers by participants, or benefi-
ciaries, insert:
[Name of group health plan or health
insurance issuer] generally [requires/
allows] the designation of a primary
care provider. You have the right to
designate any primary care provider
who participates in our network and
who is available to accept you or your
family members. [If the plan or health
insurance coverage designates a pri-
mary care provider automatically, in-
sert: Until you make this designation,
[name of group health plan or health
insurance issuer] designates one for
you.] For information on how to se-
lect a primary care provider, and for
a list of the participating primary care
providers, contact the [plan adminis-
trator or issuer] at [insert contact in-
formation].
(B) For plans and issuers that require or
allow for the designation of a primary care
provider for a child, add:
For children, you may designate a pe-
diatrician as the primary care provider.
(C) For plans and issuers that provide
coverage for obstetric or gynecological
care and require the designation by a par-
ticipant or beneficiary of a primary care
provider, add:
You do not need prior authorization
from [name of group health plan or
issuer] or from any other person (in-
cluding a primary care provider) in
order to obtain access to obstetrical or
gynecological care from a health care
professional in our network who spe-
cializes in obstetrics or gynecology.
The health care professional, however,
may be required to comply with certain
procedures, including obtaining prior
authorization for certain services, fol-
lowing a pre-approved treatment plan,
or procedures for making referrals. For
a list of participating health care pro-
fessionals who specialize in obstetrics
or gynecology, contact the [plan ad-
ministrator or issuer] at [insert contact
information].
(b) Applicability date. The provisions
of this section are applicable with respect
to plan years beginning on or after January
1, 2022.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
45 CFR Subtitle A, Subchapter B
For the reasons stated in the preamble,
the Department of Health and Human Ser-
vices amends 45 CFR parts 144, 147, 149,
and 156 as set forth below:
PART 144—REQUIREMENTS
RELATING TO HEALTH
INSURANCE COVERAGE
12. The authority citation for part 144
is revised to read as follows:
Authority: 42 U.S.C. 300gg through
300gg-63, 300gg-91, 300gg-92, and
300gg-111 through 300gg-139, as amend-
ed.
13. Section 144.101 is amended by:
a. Redesignating paragraphs (d) and (e)
as paragraphs (e) and (f), respectively; and
b. Adding new paragraph (d).
The addition reads as follows:
§ 144.101 Basis and purpose.
* * * * *
(d) Part 149 of this subchapter imple-
ments the provisions of parts D and E of
title XXVII of the PHS Act that apply to
group health plans, health insurance issu-
ers in the group and individual markets,
health care providers and facilities, and
providers of air ambulance services.

Bulletin No. 2021–30 135 July 26, 2021
* * * * *
14. Section 144.102 is revised to read
as follows:
§ 144.102 Scope and applicability.
(a) For purposes of 45 CFR parts 144
through 149, all health insurance coverage
is generally divided into two markets—
the group market and the individual mar-
ket. The group market is further divided
into the large group market and the small
group market.
(b) The protections afforded under 45
CFR parts 144 through 149 to individu-
als and employers (and other sponsors
of health insurance offered in connec-
tion with a group health plan) are deter-
mined by whether the coverage involved
is obtained in the small group market,
the large group market, or the individual
market.
(c) Coverage that is provided to associ-
ations, but not related to employment, and
sold to individuals is not considered group
coverage under 45 CFR parts 144 through
149. If the coverage is offered to an asso-
ciation member other than in connection
with a group health plan, the coverage is
considered individual health insurance
coverage for purposes of 45 CFR parts
144 through 149. The coverage is consid-
ered coverage in the individual market, re-
gardless of whether it is considered group
coverage under state law. If the health
insurance coverage is offered in connec-
tion with a group health plan as defined
at 45 CFR 144.103, it is considered group
health insurance coverage for purposes of
45 CFR parts 144 through 149.
(d) Provisions relating to CMS en-
forcement of parts 146, 147, 148, and
149 are contained in part 150 of this sub-
chapter.
15. Section 144.103 is amended by
revising the introductory text to read as
follows:
§ 144.103 Definitions.
For purposes of parts 146 (group mar-
ket), 147 (group and individual market), 148
(individual market), 149 (surprise billing
and transparency), and 150 (enforcement)
of this subchapter, the following definitions
apply unless otherwise provided:
* * * * *
PART 147—HEALTH INSURANCE
REFORM REQUIREMENTS FOR
THE GROUP AND INDIVIDUAL
HEALTH INSURANCE MARKETS
16. The authority citation for part 147
is revised to read as follows:
Authority: 42 U.S.C. 300gg through
300gg-63, 300gg-91, 300gg-92, and
300gg-111 through 300gg-139, as amend-
ed, and section 3203, Pub. L. 116-136,
134 Stat. 281.
17. Section 147.138 is amended by re-
vising paragraph (c) to read as follows:
§ 147.138 Patient protections.
* * * * *
(c) Applicability date. The provisions
of this section are applicable to group
health plans and health insurance issuers
for plan years (in the individual market,
policy years) beginning before January 1,
2022. See also subparts B and D of part
149 of this subchapter for rules applicable
with respect to plan years (in the individ-
ual market, policy years) beginning on or
after January 1, 2022.
18. Add part 149 to read as follows:
PART 149 – SURPRISE BILLING
AND TRANSPARENCY
REQUIREMENTS
Subpart A – General Provisions
Sec.
149.10 Basis and scope.
149.20 Applicability.
149.30 Definitions.
Subpart B – Protections against
Balance Billing for the Group and
Individual Health Insurance Markets
149.110 Preventing surprise medical bills
for emergency services.
149.120 Preventing surprise medical bills
for non-emergency services performed by
nonparticipating providers at certain par-
ticipating facilities.
149.130 Preventing surprise medical bills
for air ambulance services.
149.140 Methodology for calculating
qualifying payment amount.
149.150 Complaints process for surprise
medical bills regarding group health plans
and group and individual health insurance
coverage.
Subpart C – [Reserved]
Subpart D – Additional Patient
Protections
149.310 Choice of health care profession-
al.
Subpart E – Health Care Provider,
Health Care Facility, and Air
Ambulance Service Provider
Requirements
149.410 Balance billing in cases of emer-
gency services.
149.420 Balance billing in cases of
non-emergency services performed by
nonparticipating providers at certain par-
ticipating health care facilities.
149.430 Provider and facility disclosure
requirements regarding patient protec-
tions against balance billing.
149.440 Balance billing in cases of air
ambulance services.
149.450 Complaints process for balance
billing regarding providers and facilities.
Authority: 42 U.S.C. 300gg-111
through 300gg-139, as amended.
Subpart A – General Provisions
§ 149.10 Basis and scope.
(a) Basis. This part implements parts D
and E of title XXVII of the PHS Act.
(b) Scope. This part establishes standards
for group health plans, health insurance is-
suers offering group or individual health in-
surance coverage, health care providers and
facilities, and providers of air ambulance
services with respect to surprise medical
bills, transparency in health care coverage,
and additional patient protections.
§ 149.20 Applicability.
(a) In general. (1) The requirements
in subparts B and D of this part apply to
group health plans and health insurance
issuers offering group or individual health
insurance coverage (including grandfa-
thered health plans as defined in § 147.140
of this subchapter), except as specified in
paragraph (b) of this section.

July 26, 2021 136 Bulletin No. 2021–30
(2) The requirements in subpart E of
this part apply to health care providers,
health care facilities, and providers of air
ambulance services.
(b) Exceptions. The requirements in
subparts B and D of this part do not apply
to the following:
(1) Excepted benefits as described in §§
146.145 and 148.220 of this subchapter.
(2) Short-term, limited-duration insur-
ance as defined in § 144.103 of this sub-
chapter.
(3) Health reimbursement arrange-
ments or other account-based group health
plans as described in § 147.126(d) of this
subchapter.
§ 149.30 Definitions.
The definitions in part 144 of this sub-
chapter apply to this part, unless otherwise
specified. In addition, for purposes of this
part, the following definitions apply:
Air ambulance service means medical
transport by a rotary wing air ambulance,
as defined in 42 CFR 414.605, or fixed
wing air ambulance, as defined in 42 CFR
414.605, for patients.
Cost sharing means the amount a par-
ticipant, beneficiary, or enrollee is respon-
sible for paying for a covered item or ser-
vice under the terms of the group health
plan or health insurance coverage. Cost
sharing generally includes copayments,
coinsurance, and amounts paid towards
deductibles, but does not include amounts
paid towards premiums, balance billing
by out-of-network providers, or the cost
of items or services that are not covered
under a group health plan or health insur-
ance coverage.
Emergency department of a hospital
includes a hospital outpatient department
that provides emergency services.
Emergency medical condition has the
meaning given the term in § 149.110(c)
(1).
Emergency services has the meaning
given the term in § 149.110(c)(2).
Health care facility, with respect to a
group health plan or group or individual
health insurance coverage, in the context
of non-emergency services, is each of the
following:
(1) A hospital (as defined in section
1861(e) of the Social Security Act);
(2) A hospital outpatient department;
(3) A critical access hospital (as defined
in section 1861(mm)(1) of the Social Se-
curity Act); and
(4) An ambulatory surgical center de-
scribed in section 1833(i)(1)(A) of the So-
cial Security Act.
Independent freestanding emergency
department means a health care facility
(not limited to those described in the defi-
nition of health care facility with respect
to non-emergency services) that—
(1) Is geographically separate and dis-
tinct and licensed separately from a hospi-
tal under applicable State law; and
(2) Provides any emergency services as
described in § 149.110(c)(2)(i).
Nonparticipating emergency facili-
ty means an emergency department of a
hospital, or an independent freestanding
emergency department (or a hospital,
with respect to services that pursuant to §
149.110(c)(2)(ii) are included as emergen-
cy services), that does not have a contrac-
tual relationship directly or indirectly with
a group health plan or group or individual
health insurance coverage offered by a
health insurance issuer, with respect to the
furnishing of an item or service under the
plan or coverage, respectively.
Nonparticipating provider means any
physician or other health care provider
who does not have a contractual relation-
ship directly or indirectly with a group
health plan or group or individual health
insurance coverage offered by a health in-
surance issuer, with respect to the furnish-
ing of an item or service under the plan or
coverage, respectively.
Notice of denial of payment means, with
respect to an item or service for which ben-
efits subject to the protections of §§ 149.110
through 149.130 are provided or covered, a
written notice from the plan or issuer to the
health care provider, facility, or provider of
air ambulance services, as applicable, that
payment for such item or service will not
be made by the plan or coverage and which
explains the reason for denial. The term no-
tice of denial of payment does not include
a notice of benefit denial due to an adverse
benefit determination as defined in 29 CFR
2560.503-1.
Out-of-network rate means, with re-
spect to an item or service furnished by a
nonparticipating provider, nonparticipat-
ing emergency facility, or nonparticipat-
ing provider of air ambulance services—
(1) Subject to paragraph (3) of this defi-
nition, in a State that has in effect a spec-
ified State law, the amount determined in
accordance with such law;
(2) Subject to paragraph (3) of this
definition, in a State that does not have in
effect a specified State law—
(i) Subject to paragraph (2)(ii) of this
definition, if the nonparticipating provider
or nonparticipating emergency facility and
the plan or issuer agree on an amount of
payment (including if the amount agreed
upon is the initial payment sent by the plan
or issuer under 26 CFR 54.9816-4T(b)(3)
(iv)(A), 54.9816-5T(c)(3), or 54.9817-
1T(b)(4)(i); 29 CFR 2590.716-4(b)(3)
(iv)(A), 2590.716-5(c)(3), or 2590.717-
1(b)(4)(i); or § 149.110(b)(3)(iv)(A), §
149.120(c)(3), or § 149.130(b)(4)(i), as
applicable, or is agreed on through nego-
tiations with respect to such item or ser-
vice), such agreed on amount; or
(ii) If the nonparticipating provider or
nonparticipating emergency facility and
the plan or issuer enter into the indepen-
dent dispute resolution (IDR) process
under section 9816(c) or 9817(b) of the
Internal Revenue Code, section 716(c) or
717(b) of ERISA, or section 2799A-1(c)
or 2799A-2(b) of the PHS Act, as appli-
cable, and do not agree before the date on
which a certified IDR entity makes a de-
termination with respect to such item or
service under such subsection, the amount
of such determination; or
(3) In a State that has an All-Payer
Model Agreement under section 1115A of
the Social Security Act that applies with
respect to the plan or issuer; the nonpartic-
ipating provider or nonparticipating emer-
gency facility; and the item or service, the
amount that the State approves under the
All-Payer Model Agreement for the item
or service.
Participating emergency facility means
any emergency department of a hospital,
or an independent freestanding emergency
department (or a hospital, with respect to
services that pursuant to § 149.110(c)(2)
(ii) are included as emergency services),
that has a contractual relationship direct-
ly or indirectly with a group health plan
or health insurance issuer offering group
or individual health insurance coverage
setting forth the terms and conditions on
which a relevant item or service is provid-
ed to a participant, beneficiary, or enrollee

Bulletin No. 2021–30 137 July 26, 2021
under the plan or coverage, respectively.
A single case agreement between an emer-
gency facility and a plan or issuer that is
used to address unique situations in which
a participant, beneficiary, or enrollee re-
quires services that typically occur out-of-
network constitutes a contractual relation-
ship for purposes of this definition, and is
limited to the parties to the agreement.
Participating health care facility
means any health care facility described
in this section that has a contractual re-
lationship directly or indirectly with a
group health plan or health insurance is-
suer offering group or individual health
insurance coverage setting forth the terms
and conditions on which a relevant item or
service is provided to a participant, benefi-
ciary, or enrollee under the plan or cover-
age, respectively. A single case agreement
between a health care facility and a plan or
issuer that is used to address unique situ-
ations in which a participant, beneficiary,
or enrollee requires services that typically
occur out-of-network constitutes a con-
tractual relationship for purposes of this
definition, and is limited to the parties to
the agreement.
Participating provider means any phy-
sician or other health care provider who
has a contractual relationship directly
or indirectly with a group health plan or
health insurance issuer offering group
or individual health insurance coverage
setting forth the terms and conditions on
which a relevant item or service is provid-
ed to a participant, beneficiary, or enrollee
under the plan or coverage, respectively.
Physician or health care provider
means a physician or other health care
provider who is acting within the scope of
practice of that provider’s license or cer-
tification under applicable State law, but
does not include a provider of air ambu-
lance services.
Provider of air ambulance services
means an entity that is licensed under ap-
plicable State and Federal law to provide
air ambulance services.
Same or similar item or service has the
meaning given the term in § 149.140(a)
(13).
Service code has the meaning given the
term in § 149.140(a)(14).
Qualifying payment amount has the
meaning given the term in § 149.140(a)
(16).
Recognized amount means, with re-
spect to an item or service furnished by
a nonparticipating provider or nonpartic-
ipating emergency facility—
(1) Subject to paragraph (3) of this defi-
nition, in a State that has in effect a spec-
ified State law, the amount determined in
accordance with such law.
(2) Subject to paragraph (3) of this
definition, in a State that does not have in
effect a specified State law, the lesser of—
(i) The amount that is the qualifying
payment amount (as determined in accor-
dance with § 149.140); or
(ii) The amount billed by the provider
or facility.
(3) In a State that has an All-Payer
Model Agreement under section 1115A of
the Social Security Act that applies with
respect to the plan or issuer; the nonpartic-
ipating provider or nonparticipating emer-
gency facility; and the item or service, the
amount that the State approves under the
All-Payer Model Agreement for the item
or service.
Specified State law means a State law
that provides for a method for determining
the total amount payable under a group
health plan or group or individual health
insurance coverage offered by a health in-
surance issuer to the extent such State law
applies for an item or service furnished
by a nonparticipating provider or nonpar-
ticipating emergency facility (including
where it applies because the State has al-
lowed a plan that is not otherwise subject
to applicable State law an opportunity to
opt in, subject to section 514 of the Em-
ployee Retirement Income Security Act of
1974). A group health plan that opts in to
such a specified State law must do so for
all items and services to which the speci-
fied State law applies and in a manner de-
termined by the applicable State authority,
and must prominently display in its plan
materials describing the coverage of out-
of-network services a statement that the
plan has opted into the specified State law,
identify the relevant State (or States), and
include a general description of the items
and services provided by nonparticipating
facilities and providers that are covered by
the specified State law.
State means each of the 50 States, the
District of Columbia, Puerto Rico, the Vir-
gin Islands, Guam, American Samoa, and
the Northern Mariana Islands.
Treating provider is a physician or
health care provider who has evaluated
the individual.
Visit, with respect to items and services
furnished to an individual at a health care
facility, includes, in addition to items and
services furnished by a provider at the
facility, equipment and devices, telemed-
icine services, imaging services, laborato-
ry services, and preoperative and postop-
erative services, regardless of whether the
provider furnishing such items or services
is at the facility.
Subpart B – Protections Against
Balance Billing for the Group and
Individual Health Insurance Markets
§ 149.110 Preventing surprise medical
bills for emergency services.
(a) In general. If a group health plan,
or a health insurance issuer offering
group or individual health insurance cov-
erage, provides or covers any benefits
with respect to services in an emergency
department of a hospital or with respect
to emergency services in an independent
freestanding emergency department, the
plan or issuer must cover emergency ser-
vices, as defined in paragraph (c)(2) of
this section, and this coverage must be
provided in accordance with paragraph
(b) of this section.
(b) Coverage requirements. A plan or
issuer described in paragraph (a) of this
section must provide coverage for emer-
gency services in the following manner—
(1) Without the need for any prior au-
thorization determination, even if the ser-
vices are provided on an out-of-network
basis.
(2) Without regard to whether the
health care provider furnishing the emer-
gency services is a participating provider
or a participating emergency facility, as
applicable, with respect to the services.
(3) If the emergency services are pro-
vided by a nonparticipating provider or a
nonparticipating emergency facility—
(i) Without imposing any administra-
tive requirement or limitation on coverage
that is more restrictive than the require-
ments or limitations that apply to emer-
gency services received from participat-
ing providers and participating emergency
facilities.

July 26, 2021 138 Bulletin No. 2021–30
(ii) Without imposing cost-sharing
requirements that are greater than the re-
quirements that would apply if the services
were provided by a participating provider
or a participating emergency facility.
(iii) By calculating the cost-sharing
requirement as if the total amount that
would have been charged for the services
by such participating provider or partici-
pating emergency facility were equal to
the recognized amount for such services.
(iv) The plan or issuer—
(A) Not later than 30 calendar days af-
ter the bill for the services is transmitted by
the provider or facility (or, in cases where
the recognized amount is determined by
a specified State law or All-Payer Model
Agreement, such other timeframe as spec-
ified by the State law or All-Payer Model
Agreement), determines whether the ser-
vices are covered under the plan or cover-
age and, if the services are covered, sends
to the provider or facility, as applicable,
an initial payment or a notice of denial of
payment. For purposes of this paragraph
(b)(3)(iv)(A), the 30-calendar-day period
begins on the date the plan or issuer re-
ceives the information necessary to decide
a claim for payment for the services.
(B) Pays a total plan or coverage pay-
ment directly to the nonparticipating pro-
vider or nonparticipating facility that is
equal to the amount by which the out-of-
network rate for the services exceeds the
cost-sharing amount for the services (as
determined in accordance with paragraphs
(b)(3)(ii) and (iii) of this section), less any
initial payment amount made under para-
graph (b)(3)(iv)(A) of this section. The to-
tal plan or coverage payment must be made
in accordance with the timing requirement
described in section 2799A-1(c)(6) of the
PHS Act, or in cases where the out-of-net-
work rate is determined under a specified
State law or All-Payer Model Agreement,
such other timeframe as specified by the
State law or All-Payer Model Agreement.
(v) By counting any cost-sharing pay-
ments made by the participant, beneficiary,
or enrollee with respect to the emergency
services toward any in-network deductible
or in-network out-of-pocket maximums
(including the annual limitation on cost
sharing under section 2707(b) of the PHS
Act) (as applicable) applied under the plan
or coverage (and the in-network deduct-
ible and in-network out-of-pocket maxi-
mums must be applied) in the same man-
ner as if the cost-sharing payments were
made with respect to emergency services
furnished by a participating provider or a
participating emergency facility.
(4) Without limiting what constitutes
an emergency medical condition (as de-
fined in paragraph (c)(1) of this section)
solely on the basis of diagnosis codes.
(5) Without regard to any other term or
condition of the coverage, other than—
(i) The exclusion or coordination of
benefits (to the extent not inconsistent
with benefits for an emergency medical
condition, as defined in paragraph (c)(1)
of this section).
(ii) An affiliation or waiting period
(each as defined in § 144.103 of this sub-
chapter).
(iii) Applicable cost sharing.
(c) Definitions. In this section—
(1) Emergency medical condition
means a medical condition, including
a mental health condition or substance
use disorder, manifesting itself by acute
symptoms of sufficient severity (including
severe pain) such that a prudent layperson,
who possesses an average knowledge of
health and medicine, could reasonably ex-
pect the absence of immediate medical at-
tention to result in a condition described in
clause (i), (ii), or (iii) of section 1867(e)(1)
(A) of the Social Security Act (42 U.S.C.
1395dd(e)(1)(A)). (In that provision of
the Social Security Act, clause (i) refers
to placing the health of the individual (or,
with respect to a pregnant woman, the
health of the woman or her unborn child)
in serious jeopardy; clause (ii) refers to se-
rious impairment to bodily functions; and
clause (iii) refers to serious dysfunction of
any bodily organ or part.)
(2) Emergency services means, with
respect to an emergency medical condi-
tion—
(i) In general. (A) An appropriate med-
ical screening examination (as required
under section 1867 of the Social Security
Act (42 U.S.C. 1395dd) or as would be re-
quired under such section if such section
applied to an independent freestanding
emergency department) that is within the
capability of the emergency department of
a hospital or of an independent freestand-
ing emergency department, as applicable,
including ancillary services routinely
available to the emergency department to
evaluate such emergency medical condi-
tion; and
(B) Within the capabilities of the staff
and facilities available at the hospital or
the independent freestanding emergency
department, as applicable, such further
medical examination and treatment as are
required under section 1867 of the So-
cial Security Act (42 U.S.C. 1395dd), or
as would be required under such section
if such section applied to an indepen-
dent freestanding emergency department,
to stabilize the patient (regardless of the
department of the hospital in which such
further examination or treatment is fur-
nished).
(ii) Inclusion of additional services.
(A) Subject to paragraph (c)(2)(ii)(B) of
this section, items and services—
(1) For which benefits are provided or
covered under the plan or coverage; and
(2) That are furnished by a nonpartici-
pating provider or nonparticipating emer-
gency facility (regardless of the depart-
ment of the hospital in which such items
or services are furnished) after the partic-
ipant, beneficiary, or enrollee is stabilized
and as part of outpatient observation or an
inpatient or outpatient stay with respect to
the visit in which the services described
in paragraph (c)(2)(i) of this section are
furnished.
(B) Items and services described in
paragraph (c)(2)(ii)(A) of this section are
not included as emergency services if all
of the conditions in § 149.410(b) are met.
(3) To stabilize, with respect to an emer-
gency medical condition, has the mean-
ing given such term in section 1867(e)
(3) of the Social Security Act (42 U.S.C.
1395dd(e)(3)).
(d) Applicability date. The provisions
of this section are applicable with respect
to plan years (in the individual market,
policy years) beginning on or after Janu-
ary 1, 2022.
§ 149.120 Preventing surprise medical
bills for non-emergency services
performed by nonparticipating
providers at certain participating
facilities.
(a) In general. If a group health plan,
or a health insurance issuer offering group
or individual health insurance coverage,
provides or covers any benefits with re-

Bulletin No. 2021–30 139 July 26, 2021
spect to items and services described in
paragraph (b) of this section, the plan or
issuer must cover the items and services
when furnished by a nonparticipating pro-
vider in accordance with paragraph (c) of
this section.
(b) Items and services described. The
items and services described in this para-
graph (b) are items and services (other
than emergency services) furnished to a
participant, beneficiary, or enrollee by a
nonparticipating provider with respect to
a visit at a participating health care facil-
ity, unless the provider has satisfied the
notice and consent criteria of § 149.420(c)
through (i) with respect to such items and
services.
(c) Coverage requirements. In the
case of items and services described in
paragraph (b) of this section, the plan or
issuer—
(1) Must not impose a cost-sharing re-
quirement for the items and services that
is greater than the cost-sharing require-
ment that would apply if the items or ser-
vices had been furnished by a participat-
ing provider.
(2) Must calculate the cost-sharing
requirements as if the total amount that
would have been charged for the items
and services by such participating provid-
er were equal to the recognized amount
for the items and services.
(3) Not later than 30 calendar days
after the bill for the items or services is
transmitted by the provider (or in cases
where the recognized amount is deter-
mined by a specified State law or All-Pay-
er Model Agreement, such other time-
frame as specified under the State law or
All-Payer Model Agreement), must deter-
mine whether the items and services are
covered under the plan or coverage and,
if the items and services are covered, send
to the provider an initial payment or a no-
tice of denial of payment. For purposes of
this paragraph (c)(3), the 30-calendar-day
period begins on the date the plan or is-
suer receives the information necessary to
decide a claim for payment for the items
or services.
(4) Must pay a total plan or coverage
payment directly to the nonparticipat-
ing provider that is equal to the amount
by which the out-of-network rate for the
items and services involved exceeds the
cost-sharing amount for the items and ser-
vices (as determined in accordance with
paragraphs (c)(1) and (2) of this section),
less any initial payment amount made un-
der paragraph (c)(3) of this section. The
total plan or coverage payment must be
made in accordance with the timing re-
quirement described in section 2799A-1(c)
(6) of the PHS Act, or in cases where the
out-of-network rate is determined under
a specified State law or All-Payer Model
Agreement, such other timeframe as spec-
ified by the State law or All-Payer Model
Agreement.
(5) Must count any cost-sharing pay-
ments made by the participant, benefi-
ciary, or enrollee toward any in-network
deductible and in-network out-of-pocket
maximums (including the annual lim-
itation on cost sharing under section
2707(b) of the PHS Act) (as applicable)
applied under the plan or coverage (and
the in-network deductible and out-of-
pocket maximums must be applied) in
the same manner as if such cost-shar-
ing payments were made with respect to
items and services furnished by a partici-
pating provider.
(d) Applicability date. The provisions
of this section are applicable with respect
to plan years (in the individual market,
policy years) beginning on or after Janu-
ary 1, 2022.
§ 149.130 Preventing surprise medical
bills for air ambulance services.
(a) In general. If a group health plan,
or a health insurance issuer offering group
or individual health insurance coverage,
provides or covers any benefits for air am-
bulance services, the plan or issuer must
cover such services from a nonparticipat-
ing provider of air ambulance services in
accordance with paragraph (b) of this sec-
tion.
(b) Coverage requirements. A plan or
issuer described in paragraph (a) of this
section must provide coverage of air am-
bulance services in the following man-
ner—
(1) The cost-sharing requirements with
respect to the services must be the same
requirements that would apply if the ser-
vices were provided by a participating
provider of air ambulance services.
(2) The cost-sharing requirement must
be calculated as if the total amount that
would have been charged for the services
by a participating provider of air ambu-
lance services were equal to the lesser of
the qualifying payment amount (as deter-
mined in accordance with § 149.140) or
the billed amount for the services.
(3) The cost-sharing amounts must be
counted towards any in-network deduct-
ible and in-network out-of-pocket maxi-
mums (including the annual limitation on
cost sharing under section 2707(b) of the
PHS Act) (as applicable) applied under
the plan or coverage (and the in-network
deductible and out-of-pocket maximums
must be applied) in the same manner as
if the cost-sharing payments were made
with respect to services furnished by a
participating provider of air ambulance
services.
(4) The plan or issuer must—
(i) Not later than 30 calendar days af-
ter the bill for the services is transmitted
by the provider of air ambulance ser-
vices, determine whether the services are
covered under the plan or coverage and,
if the services are covered, send to the
provider an initial payment or a notice of
denial of payment. For purposes of this
paragraph (b)(4)(i), the 30-calendar-day
period begins on the date the plan or issu-
er receives the information necessary to
decide a claim for payment for the ser-
vices.
(ii) Pay a total plan or coverage pay-
ment directly to the nonparticipating
provider furnishing such air ambulance
services that is equal to the amount by
which the out-of-network rate for the ser-
vices exceeds the cost-sharing amount
for the services (as determined in ac-
cordance with paragraphs (b)(1) and (2)
of this section), less any initial payment
amount made under paragraph (b)(4)(i)
of this section. The total plan or cover-
age payment must be made in accordance
with the timing requirement described in
section 2799A-2(b)(6) of the PHS Act, or
in cases where the out-of-network rate is
determined under a specified State law or
All-Payer Model Agreement, such other
timeframe as specified by the State law or
All-Payer Model Agreement.
(c) Applicability date. The provisions
of this section are applicable with respect
to plan years (in the individual market,
policy years) beginning on or after Janu-
ary 1, 2022.

July 26, 2021 140 Bulletin No. 2021–30
§ 149.140 Methodology for calculating
qualifying payment amount.
(a) Definitions. For purposes of this
section, the following definitions apply:
(1) Contracted rate means the total
amount (including cost sharing) that a
group health plan or health insurance issu-
er has contractually agreed to pay a partic-
ipating provider, facility, or provider of air
ambulance services for covered items and
services, whether directly or indirectly, in-
cluding through a third-party administra-
tor or pharmacy benefit manager. Solely
for purposes of this definition, a single
case agreement, letter of agreement, or
other similar arrangement between a pro-
vider, facility, or air ambulance provider
and a plan or issuer, used to supplement
the network of the plan or coverage for a
specific participant, beneficiary, or enroll-
ee in unique circumstances, does not con-
stitute a contract.
(2) Derived amount has the meaning
given the term in § 147.210 of this sub-
chapter.
(3) Eligible database means—
(i) A State all-payer claims database; or
(ii) Any third-party database which—
(A) Is not affiliated with, or owned or
controlled by, any health insurance issuer,
or a health care provider, facility, or pro-
vider of air ambulance services (or any
member of the same controlled group as,
or under common control with, such an
entity). For purposes of this paragraph
(a)(3)(ii)(A), the term controlled group
means a group of two or more persons
that is treated as a single employer under
sections 52(a), 52(b), 414(m), or 414(o)
of the Internal Revenue Code of 1986, as
amended;
(B) Has sufficient information reflect-
ing in-network amounts paid by group
health plans or health insurance issuers
offering group or individual health insur-
ance coverage to providers, facilities, or
providers of air ambulance services for
relevant items and services furnished in
the applicable geographic region; and
(C) Has the ability to distinguish
amounts paid to participating providers
and facilities by commercial payers, such
as group health plans and health insurance
issuers offering group or individual health
insurance coverage, from all other claims
data, such as amounts billed by nonpartic-
ipating providers or facilities and amounts
paid by public payers, including the Medi-
care program under title XVIII of the So-
cial Security Act, the Medicaid program
under title XIX of the Social Security Act
(or a demonstration project under title XI
of the Social Security Act), or the Chil-
dren’s Health Insurance Program under
title XXI of the Social Security Act.
(4) Facility of the same or similar facil-
ity type means, with respect to emergency
services, either—
(i) An emergency department of a hos-
pital; or
(ii) An independent freestanding emer-
gency department.
(5) First coverage year means, with re-
spect to an item or service for which cov-
erage is not offered in 2019 under a group
health plan or group or individual health
insurance coverage offered by a health in-
surance issuer, the first year after 2019 for
which coverage for such item or service is
offered under that plan or coverage.
(6) First sufficient information year
means, with respect to a group health plan
or group or individual health insurance
coverage offered by a health insurance
issuer—
(i) In the case of an item or service for
which the plan or coverage does not have
sufficient information to calculate the me-
dian of the contracted rates described in
paragraph (b) of this section in 2019, the
first year after 2022 for which the plan or
issuer has sufficient information to calcu-
late the median of such contracted rates in
the year immediately preceding that first
year after 2022; and
(ii) In the case of a newly covered item
or service, the first year after the first cov-
erage year for such item or service with
respect to such plan or coverage for which
the plan or issuer has sufficient informa-
tion to calculate the median of the con-
tracted rates described in paragraph (b) of
this section in the year immediately pre-
ceding that first year.
(7) Geographic region means—
(i) For items and services other than air
ambulance services—
(A) Subject to paragraphs (a)(7)(i)(B)
and (C) of this section, one region for each
metropolitan statistical area, as described
by the U.S. Office of Management and
Budget and published by the U.S. Census
Bureau, in a State, and one region consist-
ing of all other portions of the State.
(B) If a plan or issuer does not have
sufficient information to calculate the me-
dian of the contracted rates described in
paragraph (b) of this section for an item
or service provided in a geographic region
described in paragraph (a)(7)(i)(A) of this
section, one region consisting of all met-
ropolitan statistical areas, as described
by the U.S. Office of Management and
Budget and published by the U.S. Census
Bureau, in the State, and one region con-
sisting of all other portions of the State.
(C) If a plan or issuer does not have
sufficient information to calculate the me-
dian of the contracted rates described in
paragraph (b) of this section for an item
or service provided in a geographic region
described in paragraph (a)(7)(i)(B) of this
section, one region consisting of all met-
ropolitan statistical areas, as described
by the U.S. Office of Management and
Budget and published by the U.S. Census
Bureau, in each Census division and one
region consisting of all other portions of
the Census division, as described by the
U.S. Census Bureau.
(ii) For air ambulance services—
(A) Subject to paragraph (a)(7)(ii)(B)
of this section, one region consisting of all
metropolitan statistical areas, as described
by the U.S. Office of Management and
Budget and published by the U.S. Census
Bureau, in the State, and one region con-
sisting of all other portions of the State,
determined based on the point of pick-up
(as defined in 42 CFR 414.605).
(B) If a plan or issuer does not have
sufficient information to calculate the me-
dian of the contracted rates described in
paragraph (b) of this section for an air am-
bulance service provided in a geographic
region described in paragraph (a)(7)(ii)(A)
of this section, one region consisting of all
metropolitan statistical areas, as described
by the U.S. Office of Management and
Budget and published by the U.S. Census
Bureau, in each Census division and one
region consisting of all other portions of
the Census division, as described by the
U.S. Census Bureau, determined based on
the point of pick-up (as defined in 42 CFR
414.605).
(8) Insurance market is, irrespective of
the State, one of the following:

Bulletin No. 2021–30 141 July 26, 2021
(i) The individual market (other than
short-term, limited-duration insurance or
individual health insurance coverage that
consists solely of excepted benefits).
(ii) The large group market (other than
coverage that consists solely of excepted
benefits).
(iii) The small group market (other
than coverage that consists solely of ex-
cepted benefits).
(iv) In the case of a self-insured group
health plan, all self-insured group health
plans (other than account-based plans, as
defined in § 147.126(d)(6)(i) of this sub-
chapter, and plans that consist solely of
excepted benefits) of the same plan spon-
sor, or at the option of the plan sponsor,
all self-insured group health plans admin-
istered by the same entity (including a
third-party administrator contracted by the
plan), to the extent otherwise permitted by
law, that is responsible for calculating the
qualifying payment amount on behalf of
the plan.
(9) Modifiers mean codes applied to the
service code that provide a more specific
description of the furnished item or ser-
vice and that may adjust the payment rate
or affect the processing or payment of the
code billed.
(10) Newly covered item or service
means an item or service for which cover-
age was not offered in 2019 under a group
health plan or group or individual health
insurance coverage offered by a health
insurance issuer, but that is offered under
the plan or coverage in a year after 2019.
(11) New service code means a service
code that was created or substantially re-
vised in a year after 2019.
(12) Provider in the same or similar
specialty means the practice specialty of a
provider, as identified by the plan or issuer
consistent with the plan’s or issuer’s usual
business practice, except that, with respect
to air ambulance services, all providers of
air ambulance services are considered to
be a single provider specialty.
(13) Same or similar item or service
means a health care item or service billed
under the same service code, or a compa-
rable code under a different procedural
code system.
(14) Service code means the code that
describes an item or service using the Cur-
rent Procedural Terminology (CPT) code,
Healthcare Common Procedure Coding
System (HCPCS), or Diagnosis-Related
Group (DRG) codes.
(15) Sufficient information means, for
purposes of determining whether a group
health plan or health insurance issuer of-
fering group or individual health insurance
coverage has sufficient information to cal-
culate the median of the contracted rates
described in paragraph (b) of this section—
(i) The plan or issuer has at least three
contracted rates on January 31, 2019, to
calculate the median of the contracted
rates in accordance with paragraph (b) of
this section; or
(ii) For an item or service furnished
during a year after 2022 that is used to
determine the first sufficient information
year—
(A) The plan or issuer has at least three
contracted rates on January 31 of the year
immediately preceding that year to cal-
culate the median of the contracted rates
in accordance with paragraph (b) of this
section; and
(B) The contracted rates under para-
graph (a)(15)(ii)(A) of this section ac-
count (or are reasonably expected to ac-
count) for at least 25 percent of the total
number of claims paid for that item or ser-
vice for that year with respect to all plans
of the sponsor (or the administering entity
as provided in paragraph (a)(8)(iv) of this
section, if applicable) or all coverage of-
fered by the issuer that are offered in the
same insurance market.
(16) Qualifying payment amount
means, with respect to a sponsor of a
group health plan or health insurance is-
suer offering group or individual health
insurance coverage, the amount calculated
using the methodology described in para-
graph (c) of this section.
(17) Underlying fee schedule rate
means the rate for a covered item or ser-
vice from a particular participating pro-
vider, providers, or facility that a group
health plan or health insurance issuer uses
to determine a participant’s, beneficiary’s,
or enrollee’s cost-sharing liability for the
item or service, when that rate is different
from the contracted rate.
(b) Methodology for calculation of
median contracted rate—(1) In general.
The median contracted rate for an item
or service is calculated by arranging in
order from least to greatest the contract-
ed rates of all group health plans of the
plan sponsor (or the administering entity
as provided in paragraph (a)(8)(iv) of this
section, if applicable) or all group or indi-
vidual health insurance coverage offered
by the issuer in the same insurance mar-
ket for the same or similar item or ser-
vice that is provided by a provider in the
same or similar specialty or facility of the
same or similar facility type and provid-
ed in the geographic region in which the
item or service is furnished and selecting
the middle number. If there are an even
number of contracted rates, the median
contracted rate is the average of the mid-
dle two contracted rates. In determining
the median contracted rate, the amount
negotiated under each contract is treated
as a separate amount. If a plan or issuer
has a contract with a provider group or
facility, the rate negotiated with that pro-
vider group or facility under the contract
is treated as a single contracted rate if the
same amount applies with respect to all
providers of such provider group or facil-
ity under the single contract. However, if
a plan or issuer has a contract with mul-
tiple providers, with separate negotiated
rates with each particular provider, each
unique contracted rate with an individual
provider constitutes a single contracted
rate. Further, if a plan or issuer has sep-
arate contracts with individual providers,
the contracted rate under each such con-
tract constitutes a single contracted rate
(even if the same amount is paid to mul-
tiple providers under separate contracts).
(2) Calculation rules. In calculating
the median contracted rate, a plan or is-
suer must:
(i) Calculate the median contracted rate
with respect to all plans of such sponsor
(or the administering entity as provided in
paragraph (a)(8)(iv) of this section, if ap-
plicable) or all coverage offered by such
issuer that are offered in the same insur-
ance market;
(ii) Calculate the median contracted
rate using the full contracted rate appli-
cable to the service code, except that the
plan or issuer must—
(A) Calculate separate median con-
tracted rates for CPT code modifiers “26”
(professional component) and “TC” (tech-
nical component);
(B) For anesthesia services, calculate a
median contracted rate for the anesthesia
conversion factor for each service code;

July 26, 2021 142 Bulletin No. 2021–30
(C) For air ambulance services, cal-
culate a median contracted rate for the
air mileage service codes (A0435 and
A0436); and
(D) Where contracted rates otherwise
vary based on applying a modifier code,
calculate a separate median contracted
rate for each such service code-modifier
combination;
(iii) In the case of payments made by a
plan or issuer that are not on a fee-for-ser-
vice basis (such as bundled or capitation
payments), calculate a median contracted
rate for each item or service using the un-
derlying fee schedule rates for the relevant
items or services. If the plan or issuer does
not have an underlying fee schedule rate
for the item or service, it must use the de-
rived amount to calculate the median con-
tracted rate; and
(iv) Exclude risk sharing, bonus, pen-
alty, or other incentive-based or retrospec-
tive payments or payment adjustments.
(3) Provider specialties; facility types.
(i) If a plan or issuer has contracted rates
that vary based on provider specialty for
a service code, the median contracted rate
is calculated separately for each provider
specialty, as applicable.
(ii) If a plan or issuer has contracted
rates for emergency services that vary
based on facility type for a service code,
the median contracted rate is calculated
separately for each facility of the same or
similar facility type.
(c) Methodology for calculation of the
qualifying payment amount—(1) In gener-
al. (i) For an item or service (other than
items or services described in paragraphs
(c)(1)(iii) through (vii) of this section)
furnished during 2022, the plan or issu-
er must calculate the qualifying payment
amount by increasing the median con-
tracted rate (as determined in accordance
with paragraph (b) of this section) for the
same or similar item or service under such
plans or coverage, respectively, on Janu-
ary 31, 2019, by the combined percentage
increase as published by the Department
of the Treasury and the Internal Revenue
Service to reflect the percentage increase
in the CPI-U over 2019, such percentage
increase over 2020, and such percentage
increase over 2021.
(A) The combined percentage increase
for 2019, 2020, and 2021 will be pub-
lished in guidance by the Internal Reve-
nue Service. The Department of the Trea-
sury and the Internal Revenue Service will
calculate the percentage increase using the
CPI-U published by the Bureau of Labor
Statistics of the Department of Labor.
(B) For purposes of this paragraph (c)
(1)(i), the CPI-U for each calendar year is
the average of the CPI-U as of the close of
the 12-month period ending on August 31
of the calendar year, rounded to 10 deci-
mal places.
(C) The combined percentage increase
for 2019, 2020, and 2021 will be calcu-
lated as:
(CPI-U 2019/CPI-U 2018) x (CPI-U
2020/CPI-U 2019) x (CPI-U 2021/CPI-U
2020)
(ii) For an item or service (other than
items or services described in paragraphs
(c)(1)(iii) through (vii) of this section) fur-
nished during 2023 or a subsequent year,
the plan or issuer must calculate the qual-
ifying payment amount by increasing the
qualifying payment amount determined
under paragraph (c)(1)(i) of this section,
for such an item or service furnished in
the immediately preceding year, by the
percentage increase as published by the
Department of the Treasury and the Inter-
nal Revenue Service.
(A) The percentage increase for any
year after 2022 will be published in guid-
ance by the Internal Revenue Service. The
Department of the Treasury and Internal
Revenue Service will calculate the per-
centage increase using the CPI-U pub-
lished by the Bureau of Labor Statistics of
the Department of Labor.
(B) For purposes of this paragraph (c)
(1)(ii), the CPI-U for each calendar year is
the average of the CPI-U as of the close of
the 12-month period ending on August 31
of the calendar year, rounded to 10 deci-
mal places.
(C) The combined percentage increase
for any year will be calculated as CPI-U
present year/CPI-U prior year.
(iii) For anesthesia services furnished
during 2022, the plan or issuer must cal-
culate the qualifying payment amount by
first increasing the median contracted rate
for the anesthesia conversion factor (as
determined in accordance with paragraph
(b) of this section) for the same or similar
item or service under such plans or cov-
erage, respectively, on January 31, 2019,
in accordance with paragraph (c)(1)(i) of
this section (referred to in this section as
the indexed median contracted rate for the
anesthesia conversion factor). The plan
or issuer must then multiply the indexed
median contracted rate for the anesthesia
conversion factor by the sum of the base
unit, time unit, and physical status modi-
fier units of the participant, beneficiary, or
enrollee to whom anesthesia services are
furnished to determine the qualifying pay-
ment amount.
(A) The base units for an anesthesia
service code are the base units for that
service code specified in the most recent
edition (as of the date of service) of the
American Society of Anesthesiologists
Relative Value Guide.
(B) The time unit is measured in
15-minute increments or a fraction there-
of.
(C) The physical status modifier on a
claim is a standard modifier describing the
physical status of the patient and is used
to distinguish between various levels of
complexity of the anesthesia services pro-
vided, and is expressed as a unit with a
value between zero (0) and three (3).
(D) The anesthesia conversion factor
is expressed in dollars per unit and is a
contracted rate negotiated with the plan or
issuer.
(iv) For anesthesia services furnished
during 2023 or a subsequent year, the plan
or issuer must calculate the qualifying
payment amount by first increasing the
indexed median contracted rate for the
anesthesia conversion factor, determined
under paragraph (c)(1)(iii) of this section
for such services furnished in the immedi-
ately preceding year, in accordance with
paragraph (c)(1)(ii) of this section. The
plan or issuer must then multiply that
amount by the sum of the base unit, time
unit, and physical status modifier units for
the participant, beneficiary, or enrollee to
whom anesthesia services are furnished to
determine the qualifying payment amount.
(v) For air ambulance services billed
using the air mileage service codes
(A0435 and A0436) that are furnished
during 2022, the plan or issuer must cal-
culate the qualifying payment amount
for services billed using the air mileage
service codes by first increasing the me-
dian contracted rate (as determined in ac-
cordance with paragraph (b) of this sec-
tion), in accordance with paragraph (c)

Bulletin No. 2021–30 143 July 26, 2021
(1)(i) of this section (referred to in this
section as the indexed median air mile-
age rate). The plan or issuer must then
multiply the indexed median air mileage
rate by the number of loaded miles pro-
vided to the participant, beneficiary, or
enrollee to determine the qualifying pay-
ment amount.
(A) The air mileage rate is expressed in
dollars per loaded mile flown, is expressed
in statute miles (not nautical miles), and is
a contracted rate negotiated with the plan
or issuer.
(B) The number of loaded miles is the
number of miles a patient is transported in
the air ambulance vehicle.
(C) The qualifying payment amount
for other service codes associated with air
ambulance services is calculated in accor-
dance with paragraphs (c)(1)(i) and (ii) of
this section.
(vi) For air ambulance services billed
using the air mileage service codes (A0435
and A0436) that are furnished during 2023
or a subsequent year, the plan or issuer
must calculate the qualifying payment
amount by first increasing the indexed
median air mileage rate, determined under
paragraph (c)(1)(v) of this section for such
services furnished in the immediately pre-
ceding year, in accordance with paragraph
(c)(1)(ii) of this section. The plan or issu-
er must then multiply the indexed median
air mileage rate by the number of loaded
miles provided to the participant, benefi-
ciary, or enrollee to determine the qualify-
ing payment amount.
(vii) For any other items or services
for which a plan or issuer generally de-
termines payment for the same or sim-
ilar items or services by multiplying a
contracted rate by another unit value, the
plan or issuer must calculate the qualify-
ing payment amount using a methodology
that is similar to the methodology required
under paragraphs (c)(1)(iii) through (vi)
of this section and reasonably reflects the
payment methodology for same or similar
items or services.
(2) New plans and coverage. With re-
spect to a sponsor of a group health plan
or health insurance issuer offering group
or individual health insurance coverage in
a geographic region in which the sponsor
or issuer, respectively, did not offer any
group health plan or health insurance cov-
erage during 2019—
(i) For the first year in which the group
health plan, group health insurance cov-
erage, or individual health insurance
coverage, respectively, is offered in such
region—
(A) If the plan or issuer has sufficient
information to calculate the median of the
contracted rates described in paragraph
(b) of this section, the plan or issuer must
calculate the qualifying payment amount
in accordance with paragraph (c)(1) of
this section for items and services that are
covered by the plan or coverage and fur-
nished during the first year; and
(B) If the plan or issuer does not have
sufficient information to calculate the me-
dian of the contracted rates described in
paragraph (b) of this section for an item or
service provided in a geographic region,
the plan or issuer must determine the qual-
ifying payment amount for the item or ser-
vice in accordance with paragraph (c)(3)
(i) of this section.
(ii) For each subsequent year the group
health plan, group health insurance cover-
age, or individual health insurance cover-
age, respectively, is offered in the region,
the plan or issuer must calculate the qual-
ifying payment amount by increasing the
qualifying payment amount determined
under this paragraph (c)(2) for the items
and services furnished in the immediately
preceding year, in accordance with para-
graph (c)(1)(ii), (iv), or (vi) of this section,
as applicable.
(3) Insufficient information; newly cov-
ered items and services. In the case of a
plan or issuer that does not have sufficient
information to calculate the median of the
contracted rates described in paragraph
(b) of this section in 2019 (or, in the case
of a newly covered item or service, in the
first coverage year for such item or service
with respect to such plan or coverage if
the plan or issuer does not have sufficient
information) for an item or service provid-
ed in a geographic region—
(i) For an item or service furnished
during 2022 (or, in the case of a newly
covered item or service, during the first
coverage year for the item or service
with respect to the plan or coverage), the
plan or issuer must calculate the qualify-
ing payment amount by first identifying
the rate that is equal to the median of the
in-network allowed amounts for the same
or similar item or service provided in the
geographic region in the year immediate-
ly preceding the year in which the item or
service is furnished (or, in the case of a
newly covered item or service, the year
immediately preceding such first cover-
age year) determined by the plan or issuer,
respectively, through use of any eligible
database, and then increasing that rate by
the percentage increase in the CPI-U over
such preceding year. For purposes of this
section, in cases in which an eligible da-
tabase is used to determine the qualifying
payment amount with respect to an item or
service furnished during a calendar year,
the plan or issuer must use the same data-
base for determining the qualifying pay-
ment amount for that item or service fur-
nished through the last day of the calendar
year, and if a different database is selected
for some items or services, the basis for
that selection must be one or more factors
not directly related to the rate of those
items or services (such as sufficiency of
data for those items or services).
(ii) For an item or service furnished in a
subsequent year (before the first sufficient
information year for such item or service
with respect to such plan or coverage),
the plan or issuer must calculate the qual-
ifying payment amount by increasing the
qualifying payment amount determined
under paragraph (c)(3)(i) of this section or
this paragraph (c)(3)(ii), as applicable, for
such item or service for the year immedi-
ately preceding such subsequent year, by
the percentage increase in CPI-U over
such preceding year;
(iii) For an item or service furnished
in the first sufficient information year for
such item or service with respect to such
plan or coverage, the plan or issuer must
calculate the qualifying payment amount
in accordance with paragraph (c)(1)(i),
(iii), or (v) of this section, as applicable,
except that in applying such paragraph
to such item or service, the reference to
‘furnished during 2022’ is treated as a ref-
erence to furnished during such first suf-
ficient information year, the reference to
‘in 2019’ is treated as a reference to such
sufficient information year, and the in-
crease described in such paragraph is not
applied; and
(iv) For an item or service furnished
in any year subsequent to the first suffi-
cient information year for such item or
service with respect to such plan or cov-

July 26, 2021 144 Bulletin No. 2021–30
erage, the plan or issuer must calculate the
qualifying payment amount in accordance
with paragraph (c)(1)(ii), (iv), or (vi) of
this section, as applicable, except that in
applying such paragraph to such item or
service, the reference to ‘furnished during
2023 or a subsequent year’ is treated as a
reference to furnished during the year af-
ter such first sufficient information year or
a subsequent year.
(4) New service codes. In the case of a
plan or issuer that does not have sufficient
information to calculate the median of the
contracted rates described in paragraph
(b) of this section and determine the qual-
ifying payment amount under paragraphs
(c)(1) through (3) of this section because
the item or service furnished is billed un-
der a new service code—
(i) For an item or service furnished
during 2022 (or, in the case of a newly
covered item or service, during the first
coverage year for the item or service with
respect to the plan or coverage), the plan
or issuer must identify a reasonably relat-
ed service code that existed in the imme-
diately preceding year and—
(A) If the Centers for Medicare & Med-
icaid Services has established a Medicare
payment rate for the item or service billed
under the new service code, the plan or
issuer must calculate the qualifying pay-
ment amount by first calculating the ratio
of the rate that Medicare pays for the item
or service billed under the new service
code compared to the rate that Medicare
pays for the item or service billed under
the related service code, and then multi-
plying the ratio by the qualifying payment
amount for an item or service billed un-
der the related service code for the year
in which the item or service is furnished.
(B) If the Centers for Medicare & Med-
icaid Services has not established a Medi-
care payment rate for the item or service
billed under the new service code, the plan
or issuer must calculate the qualifying
payment amount by first calculating the
ratio of the rate that the plan or issuer re-
imburses for the item or service billed un-
der the new service code compared to the
rate that the plan or issuer reimburses for
the item or service billed under the related
service code, and then multiplying the ra-
tio by the qualifying payment amount for
an item or service billed under the related
service code.
(ii) For an item or service furnished in
a subsequent year (before the first suffi-
cient information year for such item or
service with respect to such plan or cov-
erage or before the first year for which an
eligible database has sufficient informa-
tion to a calculate a rate under paragraph
(c)(3)(i) of this section in the immediate-
ly preceding year), the plan or issuer must
calculate the qualifying payment amount
by increasing the qualifying payment
amount determined under paragraph (c)
(4)(i) of this section or this paragraph (c)
(4)(ii), as applicable, for such item or ser-
vice for the year immediately preceding
such subsequent year, by the percentage
increase in CPI-U over such preceding
year;
(iii) For an item or service furnished
in the first sufficient information year for
such item or service with respect to such
plan or coverage or the first year for which
an eligible database has sufficient infor-
mation to calculate a rate under paragraph
(c)(3)(i) of this section in the immediate-
ly preceding year, the plan or issuer must
calculate the qualifying payment amount
in accordance with paragraph (c)(3) of
this section.
(d) Information to be shared about
qualifying payment amount. In cases in
which the recognized amount with respect
to an item or service furnished by a non-
participating provider, nonparticipating
emergency facility, or nonparticipating
provider of air ambulance services is the
qualifying payment amount, the plan or
issuer must provide in writing, in paper or
electronic form, to the provider or facility,
as applicable—
(1) With each initial payment or notice
of denial of payment under § 149.110, §
149.120, or § 149.130:
(i) The qualifying payment amount for
each item or service involved;
(ii) A statement to certify that, based on
the determination of the plan or issuer—
(A) The qualifying payment amount
applies for purposes of the recognized
amount (or, in the case of air ambulance
services, for calculating the participant’s,
beneficiary’s, or enrollee’s cost sharing);
and
(B) Each qualifying payment amount
shared with the provider or facility was
determined in compliance with this sec-
tion;
(iii) A statement that if the provider
or facility, as applicable, wishes to initi-
ate a 30-day open negotiation period for
purposes of determining the amount of to-
tal payment, the provider or facility may
contact the appropriate person or office to
initiate open negotiation, and that if the
30-day negotiation period does not result
in a determination, generally, the provid-
er or facility may initiate the independent
dispute resolution process within 4 days
after the end of the open negotiation pe-
riod; and
(iv) Contact information, including a
telephone number and email address, for
the appropriate person or office to initiate
open negotiations for purposes of deter-
mining an amount of payment (including
cost sharing) for such item or service.
(2) In a timely manner upon request of
the provider or facility:
(i) Information about whether the qual-
ifying payment amount for items and ser-
vices involved included contracted rates
that were not on a fee-for-service basis
for those specific items and services and
whether the qualifying payment amount
for those items and services was deter-
mined using underlying fee schedule rates
or a derived amount;
(ii) If a plan or issuer uses an eligi-
ble database under paragraph (c)(3) of
this section to determine the qualifying
payment amount, information to identify
which database was used; and
(iii) If a related service code was used
to determine the qualifying payment
amount for an item or service billed un-
der a new service code under paragraph
(c)(4)(i) or (ii) of this section, informa-
tion to identify the related service code;
and
(iv) If applicable, a statement that the
plan’s or issuer’s contracted rates include
risk-sharing, bonus, penalty, or other in-
centive-based or retrospective payments
or payment adjustments for the items and
services involved (as applicable) that were
excluded for purposes of calculating the
qualifying payment amount.
(e) Certain access fees to databases. In
the case of a plan or issuer that, pursuant
to this section, uses an eligible database to
determine the qualifying payment amount
for an item or service, the plan or issuer is
responsible for any costs associated with
accessing such database.

Bulletin No. 2021–30 145 July 26, 2021
(f) Audits. The procedures described
in part 150 of this subchapter apply with
respect to ensuring that a plan or cover-
age is in compliance with the require-
ment of applying a qualifying payment
amount under this subpart and ensuring
that such amount so applied satisfies the
requirements under this section, as appli-
cable.
(g) Applicability date. The provisions
of this section are applicable with respect
to plan years (in the individual market,
policy years) beginning on or after Janu-
ary 1, 2022.
§ 149.150 Complaints process for
surprise medical bills regarding group
health plans and group and individual
health insurance coverage.
(a) Scope and definitions—(1) Scope.
This section establishes a process to re-
ceive and resolve complaints regarding in-
formation that a specific group health plan
or health insurance issuer offering group
or individual health insurance coverage
may be failing to meet the requirements
under this subpart, which may warrant an
investigation.
(2) Definitions. In this section—
(i) Complaint means a communica-
tion, written or oral, that indicates there
has been a potential violation of the re-
quirements under subpart B of this part,
whether or not a violation actually oc-
curred.
(ii) Complainant means any individu-
al, or their authorized representative, who
files a complaint as defined in paragraph
(a)(2)(i) of this section.
(b) Complaints process. (1) HHS will
consider the date a complaint is filed to be
the date upon which HHS receives an oral
or written statement that identifies infor-
mation about the complaint sufficient to
identify the parties involved and the ac-
tion or inaction complained of.
(2) HHS will notify complainants, by
oral or written means, of receipt of the
complaint no later than 60 business days
after the complaint is received. HHS
will include a response acknowledging
receipt of the complaint, notifying the
complainant of their rights and obliga-
tions under the complaints process, and
describing the next steps of the com-
plaints resolution process. As part of the
response, HHS may request additional
information needed to process the com-
plaint. Such additional information may
include:
(i) Explanations of benefits;
(ii) Processed claims;
(iii) Information about the health care
provider, facility, or provider of air ambu-
lance services involved;
(iv) Information about the group health
plan or health insurance issuer covering
the individual;
(v) Information to support a determi-
nation regarding whether the service was
an emergency service or non-emergency
service;
(vi) The summary plan description,
policy, certificate, contract of insurance,
membership booklet, outline of coverage,
or other evidence of coverage the plan or
issuer provides to participants, beneficia-
ries, or enrollees;
(vii) Documents regarding the facts in
the complaint in the possession of, or oth-
erwise attainable by, the complainant; or
(viii) Any other information HHS may
need to make a determination of facts for
an investigation.
(3) HHS will make reasonable efforts
consistent with agency practices to no-
tify the complainant of the outcome of
the complaint after the submission is
processed through appropriate methods
as determined by HHS. A complaint is
considered processed after HHS has re-
viewed the complaint and accompany-
ing information and made an outcome
determination. Based on the nature of
the complaint and the plan or issuer in-
volved, HHS may—
(i) Refer the complainant to another
appropriate Federal or State resolution
process;
(ii) Notify the complainant and make
reasonable efforts to refer the com-
plainant to the appropriate State or Fed-
eral regulatory authority if HHS receives
a complaint where another entity has en-
forcement jurisdiction over the plan or
issuer;
(iii) Refer the plan or issuer for an in-
vestigation for enforcement action under
45 CFR part 150; or
(iv) Provide the complainant with
an explanation of the resolution of the
complaint and any corrective action
taken.
Subpart C – [Reserved]
Subpart D – Additional Patient
Protections
§ 149.310 Choice of health care
professional.
(a) Choice of health care profession-
al—(1) Designation of primary care pro-
vider—(i) In general. If a group health
plan, or a health insurance issuer offering
group or individual health insurance cov-
erage, requires or provides for designation
by a participant, beneficiary, or enrollee of
a participating primary care provider, then
the plan or issuer must permit each partic-
ipant, beneficiary, or enrollee to designate
any participating primary care provider
who is available to accept the participant,
beneficiary, or enrollee. In such a case, the
plan or issuer must comply with the rules
of paragraph (a)(4) of this section by in-
forming each participant (in the individual
market, primary subscriber) of the terms
of the plan or health insurance coverage
regarding designation of a primary care
provider.
(ii) Construction. Nothing in paragraph
(a)(1)(i) of this section is to be construed
to prohibit the application of reasonable
and appropriate geographic limitations
with respect to the selection of primary
care providers, in accordance with the
terms of the plan or coverage, the under-
lying provider contracts, and applicable
State law.
(iii) Example. The rules of this para-
graph (a)(1) are illustrated by the follow-
ing example:
(A) Facts. A group health plan requires individ-
uals covered under the plan to designate a primary
care provider. The plan permits each individual to
designate any primary care provider participating
in the plan’s network who is available to accept the
individual as the individual’s primary care provider.
If an individual has not designated a primary care
provider, the plan designates one until the individual
has made a designation. The plan provides a notice
that satisfies the requirements of paragraph (a)(4) of
this section regarding the ability to designate a pri-
mary care provider.
(B) Conclusion. In this Example, the plan has
satisfied the requirements of paragraph (a) of this
section.
(2) Designation of pediatrician as pri-
mary care provider—(i) In general. If a
group health plan, or a health insurance
issuer offering group or individual health

July 26, 2021 146 Bulletin No. 2021–30
insurance coverage, requires or provides
for the designation of a participating pri-
mary care provider for a child by a par-
ticipant, beneficiary, or enrollee, the plan
or issuer must permit the participant, ben-
eficiary, or enrollee to designate a physi-
cian (allopathic or osteopathic) who spe-
cializes in pediatrics (including pediatric
subspecialties, based on the scope of that
provider’s license under applicable State
law) as the child’s primary care provider if
the provider participates in the network of
the plan or issuer and is available to accept
the child. In such a case, the plan or issuer
must comply with the rules of paragraph
(a)(4) of this section by informing each
participant (in the individual market, pri-
mary subscriber) of the terms of the plan
or health insurance coverage regarding
designation of a pediatrician as the child’s
primary care provider.
(ii) Construction. Nothing in paragraph
(a)(2)(i) of this section is to be construed
to waive any exclusions of coverage un-
der the terms and conditions of the plan or
health insurance coverage with respect to
coverage of pediatric care.
(iii) Examples. The rules of this para-
graph (a)(2) are illustrated by the follow-
ing examples:
(A) Example 1—(1) Facts. A group health
plan’s HMO designates for each participant a phy-
sician who specializes in internal medicine to serve
as the primary care provider for the participant and
any beneficiaries. Participant A requests that Pedia-
trician B be designated as the primary care provid-
er for A’s child. B is a participating provider in the
HMO’s network and is available to accept the child.
(2) Conclusion. In this Example 1, the HMO
must permit A’s designation of B as the primary care
provider for A’s child in order to comply with the
requirements of this paragraph (a)(2).
(B) Example 2—(1) Facts. Same facts as Exam-
ple 1 (paragraph (a)(2)(iii)(A) of this section), except
that A takes A’s child to B for treatment of the child’s
severe shellfish allergies. B wishes to refer A’s child
to an allergist for treatment. The HMO, however,
does not provide coverage for treatment of food al-
lergies, nor does it have an allergist participating in
its network, and it therefore refuses to authorize the
referral.
(2) Conclusion. In this Example 2, the HMO has
not violated the requirements of this paragraph (a)(2)
because the exclusion of treatment for food allergies
is in accordance with the terms of A’s coverage.
(3) Patient access to obstetrical and
gynecological care—(i) General rights—
(A) Direct access. A group health plan, or
a health insurance issuer offering group
or individual health insurance coverage,
described in paragraph (a)(3)(ii) of this
section, may not require authorization or
referral by the plan, issuer, or any person
(including a primary care provider) in the
case of a female participant, beneficiary,
or enrollee who seeks coverage for ob-
stetrical or gynecological care provided
by a participating health care profession-
al who specializes in obstetrics or gyne-
cology. In such a case, the plan or issuer
must comply with the rules of paragraph
(a)(4) of this section by informing each
participant (in the individual market, pri-
mary subscriber) that the plan may not
require authorization or referral for ob-
stetrical or gynecological care by a par-
ticipating health care professional who
specializes in obstetrics or gynecology.
The plan or issuer may require such a
professional to agree to otherwise adhere
to the plan’s or issuer’s policies and pro-
cedures, including procedures regarding
referrals and obtaining prior authoriza-
tion and providing services pursuant to a
treatment plan (if any) approved by the
plan or issuer. For purposes of this para-
graph (a)(3), a health care professional
who specializes in obstetrics or gynecol-
ogy is any individual (including a person
other than a physician) who is authorized
under applicable State law to provide ob-
stetrical or gynecological care.
(B) Obstetrical and gynecological
care. A group health plan or health insur-
ance issuer described in paragraph (a)(3)
(ii) of this section must treat the provision
of obstetrical and gynecological care, and
the ordering of related obstetrical and
gynecological items and services, pursu-
ant to the direct access described under
paragraph (a)(3)(i)(A) of this section, by a
participating health care professional who
specializes in obstetrics or gynecology as
the authorization of the primary care pro-
vider.
(ii) Application of paragraph. A group
health plan, or a health insurance issuer
offering group or individual health insur-
ance coverage, is described in this para-
graph (a)(3) if the plan or issuer—
(A) Provides coverage for obstetrical
or gynecological care; and
(B) Requires the designation by a par-
ticipant, beneficiary, or enrollee of a par-
ticipating primary care provider.
(iii) Construction. Nothing in para-
graph (a)(3)(i) of this section is to be con-
strued to—
(A) Waive any exclusions of coverage
under the terms and conditions of the plan
or health insurance coverage with respect
to coverage of obstetrical or gynecologi-
cal care; or
(B) Preclude the group health plan or
health insurance issuer involved from re-
quiring that the obstetrical or gynecologi-
cal provider notify the primary care health
care professional or the plan or issuer of
treatment decisions.
(iv) Examples. The rules of this para-
graph (a)(3) are illustrated by the follow-
ing examples:
(A) Example 1—(1) Facts. A group health plan
requires each participant to designate a physician to
serve as the primary care provider for the participant
and the participant’s family. Participant A, a female,
requests a gynecological exam with Physician B, an
in-network physician specializing in gynecological
care. The group health plan requires prior authori-
zation from A’s designated primary care provider for
the gynecological exam.
(2) Conclusion. In this Example 1, the
group health plan has violated the require-
ments of this paragraph (a)(3) because the
plan requires prior authorization from A’s
primary care provider prior to obtaning
gynecological services.
(B) Example 2—(1) Facts. Same facts
as Example 1 (paragraph (a)(3)(iv)(A) of
this section) except that A seeks gyneco-
logical services from C, an out-of-net-
work provider.
(2) Conclusion. In this Example 2, the group
health plan has not violated the requirements of this
paragraph (a)(3) by requiring prior authorization be-
cause C is not a participating health care provider.
(C) Example 3–(1) Facts. Same facts
as Example 1 (paragraph (a)(3)(iv)(A) of
this section) except that the group health
plan only requires B to inform A’s desig-
nated primary care physician of treatment
decisions.
(2) Conclusion. In this Example 3, the
group health plan has not violated the
requirements of this paragraph (a)(3)
because A has direct access to B with-
out prior authorization. The fact that the
group health plan requires the designated
primary care physician to be notified of
treatment decisions does not violate this
paragraph (a)(3).
(D) Example 4—(1) Facts. A group health plan
requires each participant to designate a physician to
serve as the primary care provider for the participant
and the participant’s family. The group health plan
requires prior authorization before providing benefits
for uterine fibroid embolization.
(2) Conclusion. In this Example 4, the plan re-
quirement for prior authorization before providing

Bulletin No. 2021–30 147 July 26, 2021
benefits for uterine fibroid embolization does not vio-
late the requirements of this paragraph (a)(3) because,
though the prior authorization requirement applies to
obstetrical services, it does not restrict access to any
providers specializing in obstetrics or gynecology.
(4) Notice of right to designate a pri-
mary care provider—(i) In general. If a
group health plan or health insurance issu-
er requires the designation by a participant,
beneficiary, or enrollee of a primary care
provider, the plan or issuer must provide
a notice informing each participant (in the
individual market, primary subscriber) of
the terms of the plan or health insurance
coverage regarding designation of a pri-
mary care provider and of the rights—
(A) Under paragraph (a)(1)(i) of this
section, that any participating primary
care provider who is available to accept
the participant, beneficiary, or enrollee
can be designated;
(B) Under paragraph (a)(2)(i) of this
section, with respect to a child, that any
participating physician who specializes in
pediatrics can be designated as the prima-
ry care provider; and
(C) Under paragraph (a)(3)(i) of this
section, that the plan may not require
authorization or referral for obstetrical
or gynecological care by a participating
health care professional who specializes
in obstetrics or gynecology.
(ii) Timing. In the case of a group health
plan or group health insurance coverage,
the notice described in paragraph (a)(4)(i)
of this section must be included whenev-
er the plan or issuer provides a participant
with a summary plan description or other
similar description of benefits under the
plan or health insurance coverage. In the
case of individual health insurance cov-
erage, the notice described in paragraph
(a)(4)(i) of this section must be included
whenever the issuer provides a primary
subscriber with a policy, certificate, or
contract of health insurance.
(iii) Model language. The following
model language can be used to satisfy the
notice requirement described in paragraph
(a)(4)(i) of this section:
(A) For plans and issuers that require
or allow for the designation of primary
care providers by participants, beneficia-
ries, or enrollees, insert:
[Name of group health plan or health
insurance issuer] generally [requires/
allows] the designation of a primary
care provider. You have the right to
designate any primary care provider
who participates in our network and
who is available to accept you or your
family members. [If the plan or health
insurance coverage designates a prima-
ry care provider automatically, insert:
Until you make this designation, [name
of group health plan or health insur-
ance issuer] designates one for you.]
For information on how to select a pri-
mary care provider, and for a list of the
participating primary care providers,
contact the [plan administrator or issu-
er] at [insert contact information].
(B) For plans and issuers that require or
allow for the designation of a primary care
provider for a child, add:
For children, you may designate a pe-
diatrician as the primary care provider.
(C) For plans and issuers that provide
coverage for obstetric or gynecological
care and require the designation by a par-
ticipant, beneficiary, or enrollee of a pri-
mary care provider, add:
You do not need prior authorization
from [name of group health plan or issu-
er] or from any other person (including a
primary care provider) in order to obtain
access to obstetrical or gynecological
care from a health care professional in
our network who specializes in obstet-
rics or gynecology. The health care pro-
fessional, however, may be required to
comply with certain procedures, includ-
ing obtaining prior authorization for cer-
tain services, following a pre-approved
treatment plan, or procedures for mak-
ing referrals. For a list of participating
health care professionals who specialize
in obstetrics or gynecology, contact the
[plan administrator or issuer] at [insert
contact information].
(b) Applicability date. The provisions
of this section are applicable with respect
to plan years (in the individual market,
policy years) beginning on or after Janu-
ary 1, 2022.
Subpart E—Health Care Provider,
Health Care Facility, and Air Ambulance
Service Provider Requirements
§ 149.410 Balance billing in cases of
emergency services.
(a) In general. In the case of a partic-
ipant, beneficiary, or enrollee with ben-
efits under a group health plan or group
or individual health insurance coverage
offered by a health insurance issuer and
who is furnished emergency services (for
which benefits are provided under the plan
or coverage) with respect to an emergency
medical condition with respect to a visit
at an emergency department of a hospital
or an independent freestanding emergency
department—
(1) A nonparticipating emergency facil-
ity must not bill, and must not hold liable,
the participant, beneficiary, or enrollee for
a payment amount for such emergency
services (as defined in 26 CFR 54.9816-
4T(c)(2), 29 CFR 2590.716-4(c)(2), and §
149.110(c)(2), as applicable) that exceeds
the cost-sharing requirement for such ser-
vices (as determined in accordance with
26 CFR 54.9816-4T(b)(3)(ii) and (iii), 29
CFR 2590.716-4(b)(3)(ii) and (iii), and §
149.110(b)(3)(ii) and (iii), as applicable).
(2) A nonparticipating provider must
not bill, and must not hold liable, the par-
ticipant, beneficiary, or enrollee for a pay-
ment amount for an emergency service (as
defined in 26 CFR 54.9816-4T(c)(2), 29
CFR 2590.716-4(c)(2), and § 149.110(c)
(2), as applicable) furnished to such in-
dividual by such provider with respect to
such emergency medical condition and
visit for which the individual receives
emergency services at the hospital or in-
dependent freestanding emergency de-
partment that exceeds the cost-sharing re-
quirement for such service (as determined
in accordance with 26 CFR 54.9816-4T(b)
(3)(ii) and (iii), 29 CFR 2590.716-4(b)(3)
(ii) and (iii), and § 149.110(b)(3)(ii) and
(iii), as applicable).
(b) Notice and consent to be treated by
a nonparticipating provider or nonpartic-
ipating emergency facility. The require-
ments in paragraph (a) of this section do
not apply with respect to items and ser-
vices described in 26 CFR, 54.9816-4T(c)
(2)(ii)(A), 29 CFR 2590.716-4(c)(2)(ii)
(A), § 149.110(c)(2)(ii)(A), as applicable,
and are not included as emergency ser-
vices if all of the following conditions are
met:
(1) The attending emergency physician
or treating provider determines that the
participant, beneficiary, or enrollee is able
to travel using nonmedical transportation
or nonemergency medical transportation
to an available participating provider or

July 26, 2021 148 Bulletin No. 2021–30
facility located within a reasonable trav-
el distance, taking into account the indi-
vidual’s medical condition. The attending
emergency physician’s or treating provid-
er’s determination is binding on the facili-
ty for purposes of this requirement.
(2) The provider or facility furnishing
such additional items and services satis-
fies the notice and consent criteria of §
149.420(c) through (g) with respect to
such items and services, provided that
the written notice additionally satisfies
paragraphs (b)(2)(i) and (ii) of this sec-
tion, as applicable. In applying this para-
graph (b)(2), a reference in § 149.420 to
a nonparticipating provider is deemed
to include a nonparticipating emergency
facility.
(i) In the case of a participating emer-
gency facility and a nonparticipating pro-
vider, the written notice must also include
a list of any participating providers at the
facility who are able to furnish such items
and services involved and notification that
the participant, beneficiary, or enrollee
may be referred, at their option, to such a
participating provider.
(ii) In the case of a nonparticipating
emergency facility, the written notice
must include the good faith estimated
amount that the participant, beneficiary,
or enrollee may be charged for items or
services furnished by the nonparticipating
emergency facility or by nonparticipating
providers with respect to the visit at such
facility (including any item or service that
is reasonably expected to be furnished by
the nonparticipating emergency facility or
nonparticipating providers in conjunction
with such items or services).
(3) The participant, beneficiary, or
enrollee (or an authorized representa-
tive of such individual) is in a condition
to receive the information described in §
149.420, as determined by the attending
emergency physician or treating provider
using appropriate medical judgment, and
to provide informed consent under such
section, in accordance with applicable
State law. For purposes of this section and
§ 149.420, an authorized representative is
an individual authorized under State law
to provide consent on behalf of the par-
ticipant, beneficiary, or enrollee, provided
that the individual is not a provider affil-
iated with the facility or an employee of
the facility, unless such provider or em-
ployee is a family member of the partic-
ipant, beneficiary, or enrollee.
(4) The provider or facility satisfies any
additional requirements or prohibitions as
may be imposed under State law.
(c) Inapplicability of notice and consent
exception to certain items and services. A
nonparticipating provider or nonpartici-
pating facility specified in paragraph (a)
of this section will always be subject to
the prohibitions in paragraph (a) of this
section, with respect to items or services
furnished as a result of unforeseen, urgent
medical needs that arise at the time an
item or service is furnished, regardless of
whether the nonparticipating provider or
nonparticipating emergency facility sat-
isfied the notice and consent criteria in §
149.420(c) through (g).
(d) Retention of certain documents. A
nonparticipating emergency facility (with
respect to such facility or any nonpartic-
ipating provider at such facility) that ob-
tains from a participant, beneficiary, or
enrollee of a group health plan or group
or individual health insurance coverage
(or an authorized representative of such
an individual) a written consent in accor-
dance with § 149.420(e), with respect to
furnishing an item or service to such an
individual, must retain the written notice
and consent for at least a 7-year period af-
ter the date on which the item or service
is so furnished. If a nonparticipating pro-
vider obtains a signed consent from a par-
ticipant, beneficiary, or enrollee, or such
individual’s authorized representative, the
provider may either coordinate with the
facility to retain the written notice and
consent for a 7-year period, or the provid-
er must retain the written notice and con-
sent for a 7-year period.
(e) Notification to plan or issuer. In the
case of a participant, beneficiary, or en-
rollee who is stabilized and furnished ad-
ditional items and services described in §
149.110(c)(2)(ii), a nonparticipating pro-
vider or nonparticipating emergency facil-
ity must notify the plan or issuer, respec-
tively, when transmitting the bill for such
items and services, either on the bill or in
a separate document, as to whether all of
the conditions described in paragraph (b)
of this section are met with respect to each
of the items and services for which the bill
is submitted, and if applicable, provide
to the plan or issuer a copy of the signed
written notice and consent document de-
scribed in paragraph (b)(2) of this section.
(f) Applicability date. The provisions
of this section are applicable with respect
to emergency services furnished during a
plan year (in the individual market, poli-
cy year) beginning on or after January 1,
2022.
§ 149.420 Balance billing in cases of
non-emergency services performed by
nonparticipating providers at certain
participating health care facilities.
(a) In general. A nonparticipating pro-
vider of a group health plan or group or
individual health insurance coverage who
provides items or services (other than
emergency services) for which benefits
are provided under the plan or coverage
at a participating health care facility must
not bill, and must not hold liable, a partic-
ipant, beneficiary, or enrollee of such plan
or coverage for a payment amount for such
an item or service furnished by such pro-
vider with respect to a visit at the facility
that exceeds the cost-sharing requirement
for such item or service (as determined in
accordance with 26 CFR 54.9816-5T(c)
(1) and (2), 29 CFR 2590.717-1(c)(1) and
(2), and § 149.120(c)(1) and (2), as appli-
cable), unless the provider (or the partici-
pating health care facility on behalf of the
provider) satisfies the notice and consent
criteria of paragraph (c) of this section.
(b) Inapplicability of notice and con-
sent exception to certain items and ser-
vices. The notice and consent criteria in
paragraphs (c) through (i) of this section
do not apply, and a nonparticipating pro-
vider specified in paragraph (a) of this sec-
tion will always be subject to the prohibi-
tions in paragraph (a) of this section, with
respect to the following services:
(1) Ancillary services, meaning—
(i) Items and services related to emer-
gency medicine, anesthesiology, patholo-
gy, radiology, and neonatology, whether
provided by a physician or non-physician
practitioner;
(ii) Items and services provided by as-
sistant surgeons, hospitalists, and inten-
sivists;
(iii) Diagnostic services, including ra-
diology and laboratory services; and
(iv) Items and services provided by a
nonparticipating provider if there is no

Bulletin No. 2021–30 149 July 26, 2021
participating provider who can furnish
such item or service at such facility.
(2) Items or services furnished as a re-
sult of unforeseen, urgent medical needs
that arise at the time an item or service is
furnished, regardless of whether the non-
participating provider satisfied the notice
and consent criteria in paragraph (c) of
this section.
(c) Notice and consent to be treated by
a nonparticipating provider. Subject to
paragraph (f) of this section, and unless
prohibited by State law, a nonparticipating
provider satisfies the notice and consent
criteria of this paragraph (c) with respect
to items or services furnished by the pro-
vider to a participant, beneficiary, or en-
rollee of a group health plan or group or
individual health insurance coverage, if
the provider (or a participating health care
facility on behalf on a nonparticipating
provider)—
(1) Provides to the participant, benefi-
ciary, or enrollee a written notice in paper
or, as practicable, electronic form, as se-
lected by the individual, that contains the
information required under paragraph (d)
of this section, provided such written no-
tice is provided:
(i) In accordance with guidance issued
by HHS, and in the form and manner spec-
ified in such guidance;
(ii) With the consent document, and is
provided physically separate from other
documents and not attached to or incorpo-
rated into any other document; and
(iii) To such participant, beneficiary, or
enrollee—
(A) Not later than 72 hours prior to the
date on which the individual is furnished
such items or services, in the case where
the appointment to be furnished such
items or services is scheduled at least 72
hours prior to the date on which the indi-
vidual is to be furnished such items and
services; or
(B) On the date the appointment to be
furnished such items or services is sched-
uled, in the case where the appointment
is scheduled within 72 hours prior to the
date on which such items or services are
to be furnished. Where an individual is
provided the notice on the same date that
the items or services are to be furnished,
providers and facilities are required to
provide the notice no later than 3 hours
prior to furnishing items or services to
which the notice and consent require-
ments apply.
(2) Obtains from the participant, ben-
eficiary, or enrollee the consent described
in paragraph (e) of this section to be treat-
ed by the nonparticipating provider. An
authorized representative may receive the
notice on behalf of a participant, beneficia-
ry, or enrollee, and may provide consent
on behalf of the participant, beneficiary, or
enrollee. For purposes of this section and
§ 149.410, an authorized representative is
an individual authorized under State law
to provide consent on behalf of the par-
ticipant, beneficiary, or enrollee, provided
that the individual is not a provider affili-
ated with the facility or an employee of the
facility, unless such provider or employee
is a family member of the participant, ben-
eficiary, or enrollee. The consent must—
(i) Be provided voluntarily, meaning
the individual is able to consent freely,
without undue influence, fraud, or duress;
(ii) Be obtained in accordance with,
and in the form and manner specified in,
guidance issued by HHS; and
(iii) Not be revoked, in writing, by the
participant, beneficiary, or enrollee pri-
or to the receipt of items and services to
which the consent applies.
(3) Provides a copy of the signed
written notice and consent to the partici-
pant, beneficiary, or enrollee in-person or
through mail or email, as selected by the
participant, beneficiary, or enrollee.
(d) Information required under written
notice. The written notice described in
paragraph (c)(1) of this section must be
provided in the form and manner specified
by HHS in guidance, and must—
(1) State that the health care provider is
a nonparticipating provider, with respect
to the health plan or coverage.
(2) Include the good faith estimated
amount that such nonparticipating provid-
er may charge the participant, beneficia-
ry, or enrollee for the items and services
involved (including any item or service
that is reasonably expected to be fur-
nished by the nonparticipating provider in
conjunction with such items or services),
including notification that the provision
of the estimate or consent to be treated
under paragraph (e) of this section does
not constitute a contract with respect to
the charges estimated for such items and
services or a contract that binds the partic-
ipant, beneficiary, or enrollee to be treated
by that provider or facility.
(3) Provide a statement that prior au-
thorization or other care management
limitations may be required in advance
of receiving such items or services at the
facility.
(4) Clearly state that consent to receive
such items and services from such non-
participating provider is optional and that
the participant, beneficiary, or enrollee
may instead seek care from an available
participating provider, with respect to the
plan or coverage, as applicable, and that in
such cases the cost-sharing responsibility
of the participant, beneficiary, or enrollee
would not exceed the responsibility that
would apply with respect to such an item
or service that is furnished by a participat-
ing provider, as applicable, with respect to
such plan.
(e) Consent described to be treated by
a nonparticipating provider. The consent
described in this paragraph (e), with re-
spect to a participant, beneficiary, or en-
rollee of a group health plan or group or
individual health insurance coverage who
is to be furnished items or services by a
nonparticipating provider, must be docu-
mented on a form specified by the Secre-
tary, in consultation with the Secretary of
Labor, through guidance and provided in
accordance with such guidance, that must
be signed by the participant, beneficiary,
or enrollee before such items and services
are furnished and that –
(1) Acknowledges in clear and under-
standable language that the participant,
beneficiary, or enrollee has been—
(i) Provided with the written notice
under paragraph (c) of this section, in the
form selected by the participant, benefi-
ciary, or enrollee.
(ii) Informed that the payment of such
charge by the participant, beneficiary, or
enrollee might not accrue toward meeting
any limitation that the plan or coverage
places on cost sharing, including an expla-
nation that such payment might not apply
to an in-network deductible or out-of-
pocket maximum applied under the plan
or coverage.
(2) States that by signing the consent,
the individual agrees to be treated by the
nonparticipating provider and understands
the individual may be balance billed and
subject to cost-sharing requirements that

July 26, 2021 150 Bulletin No. 2021–30
apply to services furnished by the nonpar-
ticipating provider.
(3) Documents the time and date on
which the participant, beneficiary, or
enrollee received the written notice de-
scribed in paragraph (c) of this section and
the time and date on which the individual
signed the consent to be furnished such
items or services by such nonparticipating
provider.
(f) Language access. (1) A nonpartici-
pating provider (or the participating health
care facility on behalf of the nonpartici-
pating provider) must provide the individ-
ual with the choice to receive the written
notice and consent document in any of the
15 most common languages in the State
in which the applicable facility is located,
except that the notice and consent docu-
ment may instead be available in any of
the 15 most common languages in a geo-
graphic region that reasonably reflects the
geographic region served by the applica-
ble facility; and
(2) If the individual’s preferred lan-
guage is not among the 15 most common
languages in which the nonparticipating
provider (or the participating health care
facility on behalf of the nonparticipating
provider) makes the notice and consent
document available and the individual
cannot understand the language in which
the notice and consent document are pro-
vided, the notice and consent criteria in
paragraph (c) of this section are not met
unless the nonparticipating provider (or
the participating health care facility on be-
half of the nonparticipating provider) has
obtained the services of a qualified inter-
preter to assist the individual with under-
standing the information contained in the
notice and consent document.
(g) Scope of consent. The consent de-
scribed in paragraph (e) of this section will
constitute consent only to the receipt of
the information provided pursuant to this
section and will not constitute a contractu-
al agreement of the participant, beneficia-
ry, or enrollee to any estimated charge or
amount included in such information, or
to be treated by that provider or facility.
(h) Retention of certain documents.
A participating health care facility (with
respect to nonparticipating providers at
such facility) that obtains from a partic-
ipant, beneficiary, or enrollee of a group
health plan or group or individual health
insurance coverage a written consent in
accordance with paragraph (e) of this sec-
tion, with respect to furnishing an item or
service to such an individual, must retain
the written notice and consent for at least
a 7-year period after the date on which the
item or service is so furnished. If a non-
participating provider obtains a signed
consent from a participant, beneficiary, or
enrollee, where the facility does not oth-
erwise obtain the consent on behalf of the
provider, the provider may either coordi-
nate with the facility to retain the written
notice and consent for a 7-year period, or
the provider must retain the written notice
and consent for a 7-year period.
(i) Notification to plan or issuer. For
each item or service furnished by a non-
participating provider described in para-
graph (a) of this section, the provider (or
the participating facility on behalf of the
nonparticipating provider) must timely
notify the plan or issuer that the item or
service was furnished during a visit at a
participating health care facility, and, if
applicable, provide to the plan or issuer a
copy of the signed written notice and con-
sent document described in paragraphs (c)
and (e) of this section. In instances where,
to the extent permitted by this section, the
nonparticipating provider bills the partic-
ipant, beneficiary, or enrollee directly, the
provider may satisfy the requirement to
notify the plan or issuer by including the
notice with the bill to the participant, ben-
eficiary, or enrollee.
(j) Applicability date. The provisions
of this section are applicable with respect
to items and services furnished during a
plan year (in the individual market, poli-
cy year) beginning on or after January 1,
2022.
§ 149.430 Provider and facility
disclosure requirements regarding
patient protections against balance
billing.
(a) In general. Each health care pro-
vider and health care facility (including
an emergency department of a hospital
and an independent freestanding emer-
gency department) must make publicly
available, post on a public website of such
provider or facility (if applicable), and
provide to any individual who is a partic-
ipant, beneficiary, or enrollee of a group
health plan or group or individual health
insurance coverage offered by a health in-
surance issuer and to whom the provider
or facility furnishes items or services, the
information described in paragraph (b) of
this section regarding patient protections
against balance billing, except as provided
in paragraphs (e) and (f) of this section.
A provider or facility must make the dis-
closures in accordance with the method
and timing requirements set forth in para-
graphs (c) and (d) of this section.
(b) Content. The disclosures required
under this section must include, in clear
and understandable language, all the in-
formation described in this paragraph (b)
(and may include any additional informa-
tion that does not conflict with that infor-
mation).
(1) A statement that explains the re-
quirements of and prohibitions applica-
ble to the health care provider or health
care facility under sections 2799B-1 and
2799B-2 of the PHS Act and their imple-
menting regulations in §§ 149.410 and
149.420;
(2) If applicable, a statement that ex-
plains any State law requirements regard-
ing the amounts such provider or facility
may, with respect to an item or service,
charge a participant, beneficiary, or enroll-
ee of a group health plan or group or indi-
vidual health insurance coverage offered
by a health insurance issuer with respect
to which such provider or facility does
not have a contractual relationship, after
receiving payment, if any, from the plan
or coverage, respectively, for such item
or service and any applicable cost-sharing
payment from such participant, beneficia-
ry, or enrollee; and
(3) A statement providing contact in-
formation for the appropriate State and
Federal agencies that an individual may
contact if the individual believes the pro-
vider or facility has violated a requirement
described in the notice.
(c) Required methods for disclosing
information. Health care providers and
health care facilities must provide the
disclosure required under this section as
follows:
(1) With respect to the required disclo-
sure to be posted on a public website, the
information described in paragraph (b) of
this section, or a link to such information,
must appear on a searchable homepage of

Bulletin No. 2021–30 151 July 26, 2021
the provider’s or facility’s website. A pro-
vider or facility that does not have its own
website is not required to make a disclo-
sure under this paragraph (c)(1).
(2) With respect to the required dis-
closure to the public, a provider or facil-
ity must make public the information de-
scribed in paragraph (b) of this section on
a sign posted prominently at the location
of the provider or facility. A provider that
does not have a publicly accessible loca-
tion is not required to make a disclosure
under this paragraph (c)(2).
(3) With respect to the required disclo-
sure to individuals who are participants,
beneficiaries, or enrollees of a group
health plan or group or individual health
insurance coverage offered by a health
insurance issuer, a provider or facility
must provide the information described
in paragraph (b) of this section in a one-
page (double-sided) notice, using print
no smaller than 12-point font. The notice
must be provided in-person or through
mail or email, as selected by the partici-
pant, beneficiary, or enrollee.
(d) Timing of disclosure to individuals.
A health care provider or health care facil-
ity is required to provide the notice to in-
dividuals who are participants, beneficia-
ries, or enrollees of a group health plan or
group or individual health insurance cov-
erage offered by a health insurance issuer
no later than the date and time on which
the provider or facility requests payment
from the individual, or with respect to an
individual from whom the provider or fa-
cility does not request payment, no later
than the date on which the provider or fa-
cility submits a claim to the group health
plan or health insurance issuer.
(e) Exceptions. A health care provider
is not required to make the disclosures re-
quired under this section—
(1) If the provider does not furnish
items or services at a health care facility,
or in connection with visits at health care
facilities; or
(2) To individuals to whom the pro-
vider furnishes items or services, if such
items or services are not furnished at a
health care facility, or in connection with
a visit at a health care facility.
(f) Special rule to prevent unnecessary
duplication with respect to health care pro-
viders. To the extent a provider furnishes
an item or service covered under the plan
or coverage at a health care facility (includ-
ing an emergency department of a hospital
or independent freestanding emergency
department), the provider satisfies the re-
quirements of paragraphs (c)(2) and (3) of
this section if the facility makes the infor-
mation available, in the required form and
manner, pursuant to a written agreement.
Accordingly, if a provider and facility en-
ter into a written agreement under which
the facility agrees to make the information
required under this section available on a
sign posted prominently at the facility and
to provide the one-page notice to individu-
als in compliance with this section, and the
facility fails to do so, then the facility, but
not the provider, violates the disclosure re-
quirements of this section.
(g) Applicability date. The provisions
of this section are applicable beginning on
January 1, 2022.
§ 149.440 Balance billing in cases of air
ambulance services.
(a) In general. In the case of a partici-
pant, beneficiary, or enrollee with benefits
under a group health plan or group or indi-
vidual health insurance coverage offered
by a health insurance issuer who is fur-
nished air ambulance services (for which
benefits are available under such plan or
coverage) from a nonparticipating provid-
er of air ambulance services, with respect
to such plan or coverage, the provider
must not bill, and must not hold liable,
the participant, beneficiary, or enrollee for
a payment amount for the air ambulance
services furnished by the provider that
is more than the cost-sharing amount for
such service (as determined in accordance
with 26 CFR 54.9817-1T(b)(1) and (2),
29 CFR 2590.717-1(b)(1) and (2), and §
149.130(b)(1) and (2), as applicable).
(b) Applicability date. The provisions
of this section are applicable with respect
to air ambulance services furnished during
a plan year (in the individual market, pol-
icy year) beginning on or after January 1,
2022.
§ 149.450 Complaint process for
balance billing regarding providers
and facilities.
(a) Scope and definitions—(1) Scope.
This section establishes a process for HHS
to receive and resolve complaints regard-
ing information that a health care provid-
er, provider of air ambulance services, or
health care facility may be failing to meet
the requirements under subpart E of this
part, which may warrant an investigation.
(2) Definitions. In this section—
(i) Complaint means a communication,
written, or oral, that indicates there has
been a potential violation of the require-
ments under this subpart, whether or not a
violation actually occurred.
(ii) Complainant means any individu-
al, or their authorized representative, who
files a complaint as defined in paragraph
(a)(2)(i) of this section.
(b) Complaints process. (1) HHS will
consider the date a complaint is filed to
be the date upon which HHS receives an
oral, written, or electronic statement that
identifies information about the complaint
sufficient to identify the parties involved
and the action or inaction complained of.
(2) HHS will notify complainants, by
oral or written means, of receipt of the
complaint no later than 60 business days
after the complaint is received. HHS will
include a response acknowledging re-
ceipt of the complaint, notifying the com-
plainant of their rights and obligations un-
der the complaints process, and describing
the next steps of the complaints resolution
process. HHS may request additional in-
formation that may be needed to process
the complaint as part of the response.
Such additional information may include:
(i) Health care provider, air ambulance
provider, or health care facility bills;
(ii) Health care provider, air ambulance
provider, or health care facility network
status;
(iii) Information regarding the partici-
pant’s, beneficiary’s, or enrollee’s health
care plan or health insurance coverage;
(iv) Information to support a determi-
nation regarding whether the service was
an emergency service or non-emergency
service;
(v) Documents regarding the facts in
the complaint in the possession of, or oth-
erwise attainable by, the complainant; or
(vi) Any other information HHS needs
to make a determination of facts for an in-
vestigation.
(3) HHS will make reasonable efforts
consistent with agency practices to noti-
fy the complainant of the outcome of the

July 26, 2021 152 Bulletin No. 2021–30
complaint after the submission is pro-
cessed through appropriate methods as
determined by HHS. A complaint is con-
sidered processed after HHS has reviewed
the complaint and accompanying infor-
mation and made an outcome determina-
tion. Based on the nature of the complaint,
HHS may—
(i) Refer the complainant to another
appropriate Federal or State resolution
process;
(ii) Notify the complainant and make
reasonable efforts to refer the complainant
to the appropriate State or Federal regula-
tory authority if HHS receives a complaint
where another entity has enforcement ju-
risdiction over the health care provider, air
ambulance provider or health care facility;
(iii) Refer the health care provider, air
ambulance provider or health care facility
for an investigation for enforcement ac-
tion under 45 CFR part 150; or
(iv) Provide the complainant with an
explanation of resolution and any correc-
tive action taken.
PART 156 – HEALTH INSURANCE
ISSUER STANDARDS UNDER
THE AFFORDABLE CARE
ACT, INCLUDING STANDARDS
RELATED TO EXCHANGES
19. The authority citation for part 156
continues to read as follows:
Authority: 42 U.S.C. 18021-18024,
18031-18032, 18041-18042, 18044,
18054, 18061, 18063, 18071, 18082, and
26 U.S.C. 36B.
20. Section 156.155 is amended by:
a. Revising paragraph (a)(3);
b. Redesignating paragraph (c) as para-
graph (d); and
c. Adding a new paragraph (c).
The revision and addition read as fol-
lows:
§ 156.155 Enrollment in catastrophic
plans.
(a) * * *
(3) Provides coverage of the essential
health benefits under section 1302(b) of
the Affordable Care Act, except that the
plan provides no benefits for any plan year
(except as provided in paragraphs (a)(4),
(b), and (c) of this section) until the an-
nual limitation on cost sharing in section
1302(c)(1) of the Affordable Care Act is
reached.
* * * * *
(c) Coverage to prevent surprise med-
ical bills. A catastrophic plan must pro-
vide benefits as required under sections
2799A-1 and 2799A-2 of the Public
Health Service Act and their implement-
ing regulations in §§149.110, 149.120,
and 149.130 or any applicable State law
providing similar protections to individu-
als, and will not violate paragraph (a)(3)
of this section solely because of the pro-
vision of such benefits before the annual
limitation on cost sharing is reached.
* * * * *
(Filed by the Office of the Federal Register on July
6, 2021, 4:15p.m., and published in the issue of the
Federal Register for July 13, 2021, TBD F.R. TBD)
Section 45Q.—Credit
for Carbon Oxide
Sequestration
26 CFR 1.45Q-1: Credit for Carbon Oxide Seques-
tration
(Also: 26 CFR 1.45Q-2, 26 CFR 1.45Q-3, 26 CFR
1.45Q-4, 26 CFR 1.45Q-5)
Rev. Rul. 2021-13
ISSUES
(1) For purposes of section 45Q(a) of
the Internal Revenue Code (Code), is the
acid gas removal unit at Facility X carbon
capture equipment within the meaning of
§ 1.45Q-2(c) of the Income Tax Regula-
tions?
(2) Is Investor required to own every
component of carbon capture equipment
within a single process train at Facility X
to be the person to whom the credit under
§ 45Q(a) (section 45Q credit) is attribut-
able under § 1.45Q-1(h)?
(3) For purposes of § 45Q(a), what is
the original placed-in-service date of the
single process train of carbon capture
equipment at Facility X that includes the
existing acid gas removal unit and new
components of carbon capture equipment?
(4) How, if at all, does the original
placed-in-service date of the single pro-
cess train affect the placed-in-service date
of the existing acid gas removal unit for
depreciation purposes under §§ 167 and
168 of the Code?
FACTS
Facility X, a methanol plant, produc-
es methanol from petroleum coke in a
multistep industrial process. First, the
petroleum coke is gasified with very high
temperature steam to create a raw syn-
thesis gas (syngas). The raw syngas is a
mixture of several components including
carbon monoxide, carbon dioxide (CO
2
),
methane, hydrogen, and hydrogen sul-
fide. Second, particulate matter and some
sulfur is removed from the raw syngas.
Third, the raw syngas is purified in an acid
gas removal (AGR) unit. Fourth, the pu-
rified syngas, which is comprised of car-
bon monoxide, hydrogen, and methane, is
converted into methanol in the methanol
unit.
An AGR unit is commonly installed at
any industrial facility that processes “sour
gas” (that is, gas containing CO
2
and/or
hydrogen sulfide) such as syngas from
gasification of coal or coke and natural gas
produced from certain deposits. The spe-
cific design of an AGR unit is based on the
nature of the input gases and the desired
final product of a particular industrial fa-
cility. A methanol unit installed at an in-
dustrial facility requires the input syngas
to be of high purity and the proportions of
the syngas components to be within cer-
tain ranges. An AGR unit installed at that
industrial facility removes the unwanted
components, including CO
2,
from the raw
syngas stream with a process that uses
chilled methanol as a physical solvent at
low temperatures to absorb and then sep-
arate the gas constituents to specification.
At the completion of the purification pro-
cess, nearly all hydrogen sulfide has been
isolated, and CO
2
is either released into
the atmosphere or captured.
The AGR unit at Facility X was placed
in service on January 1, 2017, for purposes
of §§ 167 and 168. Since January 1, 2017,
the CO
2
separated by this AGR unit has
been released into the atmosphere and no
taxpayer has claimed a section 45Q cred-
it regarding Facility X. In 2021, Investor
purchased and installed new components
of carbon capture equipment necessary
to create a single process train capable of

Bulletin No. 2021–30 153 July 26, 2021
capturing, processing, and preparing for
transport the CO
2
that was being released
into the atmosphere at Facility X. Investor
did not acquire an ownership interest in
the AGR unit or Facility X.
LAW AND ANALYSIS
Section 45Q(a)(3) allows a credit of the
applicable dollar amount (as determined
under § 45Q(b)(1)) per metric ton of
qualified carbon oxide (i) captured by the
taxpayer using carbon capture equipment
which is originally placed in service at a
qualified facility on or after February 9,
2018, during the 12-year period beginning
on the date the equipment was originally
placed in service; (ii) disposed of by the
taxpayer in secure geological storage; and
(iii) neither used by the taxpayer as a ter-
tiary injectant in a qualified enhanced oil
or natural gas recovery project nor utilized
in a manner described in § 45Q(f)(5).
Section 45Q(a)(4) allows a credit of
the applicable dollar amount (as deter-
mined under § 45Q(b)(1)) per metric ton
of qualified carbon oxide (i) captured by
the taxpayer using carbon capture equip-
ment which is originally placed in service
at a qualified facility on or after February
9, 2018, during the 12-year period begin-
ning on the date the equipment was origi-
nally placed in service; and (ii) either (A)
used by the taxpayer as a tertiary injectant
in a qualified enhanced oil or natural gas
recovery project and disposed of by the
taxpayer in secure geological storage, or
(B) utilized by the taxpayer in a manner
described in § 45Q(f)(5).
Section 45Q(b)(1)(A)(i)(I) and (ii)
(I) provides that the applicable dollar
amount for activities under § 45Q(a)(3)
for any taxable year beginning in a calen-
dar year (1) after 2016 and before 2027, is
an amount equal to the dollar amount es-
tablished by linear interpolation between
$22.66 and $50 for each calendar year
during such period, and (2) after 2026 is
an amount equal to the product of $50 and
the inflation adjustment factor for such
calendar year determined under § 43(b)(3)
(B) for such calendar year, determined by
substituting “2025” for “1990.”
Section 45Q(b)(1)(A)(i)(II) and (ii)
(II) provides that the applicable dollar
amount for activities under § 45Q(a)(4)
for any taxable year beginning in a calen-
dar year (1) after 2016 and before 2027, is
an amount equal to the dollar amount es-
tablished by linear interpolation between
$12.83 and $35 for each calendar year
during such period, and (2) after 2026, is
an amount equal to the product of $35 and
the inflation adjustment factor for such
calendar year determined under § 43(b)(3)
(B) for such calendar year, determined by
substituting “2025” for “1990.”
For purposes of § 45Q and depreci-
ation, property is considered placed in
service in the taxable year in which the
property is placed in a condition or state
of readiness for a specifically assigned
function, whether in a trade or business,
in the production of income, in a tax-ex-
empt activity, or in a personal activity. See
§ 1.46-3(d)(1)(ii).
Carbon capture equipment
Under § 1.45Q-2(c), carbon capture
equipment generally includes all compo-
nents of property that are used to capture
or process carbon oxide until the carbon
oxide is transported for disposal, injec-
tion, or utilization. Except as described
in § 1.45Q-2(c)(2), carbon capture equip-
ment generally does not include compo-
nents of property used for transporting
qualified carbon oxide for disposal, injec-
tion, or utilization. Section 1.45Q-2(c)(1)
provides that carbon capture equipment
is equipment used for the purpose of (i)
separating, purifying, drying, and/or cap-
turing carbon oxide that would otherwise
be released into the atmosphere from an
industrial facility; (ii) removing carbon
oxide from the atmosphere via direct air
capture; or (iii) compressing or otherwise
increasing the pressure of carbon oxide.
Under § 1.45Q-2(c)(2), carbon capture
equipment generally includes compo-
nents of property necessary to compress,
treat, process, liquefy, pump or perform
some other physical action to capture
qualified carbon oxide. For purposes of
§ 1.45Q-2(c), carbon capture equipment
includes a system of gathering and distri-
bution lines that collect carbon oxide cap-
tured from a qualified facility or multiple
qualified facilities that constitute a single
project (as described in section 8.01 of
Notice 2020-12, 2020-11 I.R.B. 495) for
the purpose of transporting that carbon
oxide away from the qualified facility or
single project to a pipeline used to trans-
port carbon oxide to or from one or more
taxpayers and projects.
Section 1.45Q-2(c)(3) provides that all
components that make up an independent-
ly functioning process train capable of
capturing, processing, and preparing car-
bon oxide for transport will be treated as
a single unit of carbon capture equipment
(single process train).
The preamble to TD 9944 (86 FR 4728,
January 15, 2021) (final regulations)
states that those regulations do not adopt
a primary purpose test, and do not allow
taxpayers to elect to exclude “dual pur-
pose” property from the definition of car-
bon capture equipment. Instead, the final
regulations provide a functionality-based
definition of carbon capture equipment.
An AGR unit is characteristic of phys-
ical acid gas removal processes. It can
purify the raw synthesis gas down to ex-
tremely low levels of total sulfur, includ-
ing hydrogen sulfide, carbonyl sulfide, and
carbon dioxide. It is also able to remove
impurities such as hydrocarbons, ammo-
nia, and hydrogen cyanide. Because one
of the functions of the AGR unit is to sep-
arate CO
2
from a gas stream, it is carbon
capture equipment for purposes of § 45Q.
Eligibility requirements for the credit
Section 45Q(f)(3)(A)(ii) and §
1.45Q-1(h)(1)(ii) provide that in the case
of qualified carbon oxide captured using
carbon capture equipment that is original-
ly placed in service at a qualified facility
on or after February 9, 2018, the section
45Q credit is attributable to the person that
owns the carbon capture equipment and
physically or contractually ensures the
capture and disposal, injection, or utiliza-
tion of such qualified carbon oxide.
The final regulations provide that
for each single process train of carbon
capture equipment (as described in §
1.45Q-2(c)(3)), only one taxpayer will be
considered the person to whom the credit
is attributable under § 1.45Q-1(h)(1)(ii).
That person will be the taxpayer who ei-
ther physically ensures the capture and
disposal, injection, or utilization of such
qualified carbon oxide or contracts with
others to capture and dispose, inject, or
utilize such qualified carbon oxide. This
requirement, which ensures that only the

July 26, 2021 154 Bulletin No. 2021–30
person who is responsible for compliance
with the requirements of § 45Q may be
the person to whom the section 45Q cred-
it is attributable, would be unnecessary if
all components of carbon capture equip-
ment within a single process train were
required to be owned by the same per-
son. Therefore, a person is not required to
own every component of carbon capture
equipment within a single process train
to be the person to whom the section 45Q
credit is attributable. However, to be the
person to whom the section 45Q credit is
attributable, a person must own at least
one component of carbon capture equip-
ment in the single process train of carbon
capture equipment.
Carbon capture equipment placed-in-
service dates
The credit period under § 45Q(a)(3)(A)
and (4)(A) is the 12-year period beginning
on the date the carbon capture equipment
was originally placed in service. Under
§ 1.45Q-2(c)(3), all components that make
up an independently functioning process
train capable of capturing, processing, and
preparing carbon oxide for transport will
be treated as a single unit of carbon cap-
ture equipment. Accordingly, the relevant
placed-in-service date for purposes of §
45Q is the original placed-in-service date
of the single process train. That unit of car-
bon capture equipment will be considered
originally placed in service for purposes
of § 45Q on the date that any person first
places it in a condition or state of read-
iness and availability for the specifically
designed function of capturing, process-
ing, and preparing carbon oxide for trans-
port for disposal, injection, or utilization.
In the case of Facility X, that cannot occur
until the new components of carbon cap-
ture equipment are added to allow Facility
X to capture, process, and prepare carbon
oxide for transport for disposal, injection,
or utilization, rather than release it into the
atmosphere.
However, the single process train as a
unit of property and its original placed-in-
service date for purposes of § 45Q are not
relevant for depreciation purposes under
§§167 and 168. For depreciation purpos-
es, the single process train at Facility X
consists of two separate assets: the exist-
ing AGR unit that was placed in service
in January 1, 2017, and the new carbon
capture equipment components purchased
and installed in 2021 by Investor to com-
plete the single process train. Because the
AGR unit at Facility X continues to be
used in the taxpayer’s trade or business,
this AGR unit is not yet disposed of. As
a result, the AGR unit’s placed-in-service
date for depreciation purposes remains
January 1, 2017. The new carbon capture
equipment components purchased and in-
stalled in 2021 by Investor to complete the
single process train are considered a sep-
arate asset for depreciation purposes and,
consequently, will be placed in service by
Investor for depreciation purposes when
such components are placed in a condition
or state of readiness and availability for
the specifically designed function of cap-
turing, processing, and preparing carbon
oxide for transport for disposal, injection,
or utilization.
HOLDINGS
(1) For purposes of § 45Q(a), the acid
gas removal unit at Facility X is carbon
capture equipment within the meaning of
§ 1.45Q-2(c).
(2) Investor is not required to own every
component of carbon capture equipment
within a single process train at Facility X
to be the person to whom the section 45Q
credit is attributable under § 1.45Q-1(h).
However, Investor must own at least one
component of carbon capture equipment
in the single process train of carbon cap-
ture equipment at Facility X.
(3) Solely for purposes of § 45Q(a), the
original placed-in-service date of a single
process train of carbon capture equipment
at Facility X that includes the existing acid
gas removal unit and new components of
carbon capture equipment is the date that
the single process train is placed in a con-
dition or state of readiness and availability
for the capture, processing, and prepara-
tion of carbon oxide for transport for dis-
posal, injection, or utilization. Under the
facts provided, this means that the placed-
in-service date of the single process train
would be 2021.
(4) The original placed-in-service date
of the single process train for purposes of
§ 45Q has no effect on the placed-in-ser-
vice date of the existing acid gas removal
unit or new components of carbon capture
equipment for depreciation purposes un-
der §§ 167 and 168, although the placed-
in-service date of the new components of
carbon capture equipment for depreciation
purposes under §§ 167 and 168 may be the
same date as the original placed-in-service
date of the single process train for purpos-
es of § 45Q.
DRAFTING INFORMATION
The principal author of this revenue
ruling is David Selig of the Office of As-
sociate Chief Counsel (Passthroughs &
Special Industries). For further informa-
tion regarding this revenue ruling, contact
Mr. Selig at (202) 317-6853 (not a toll-
free number).

Bulletin No. 2021–30 155 July 26, 2021
Part III
Issues Relating to Special
Financial Assistance
from the Pension Benefit
Guaranty Corporation to
Certain Multiemployer
Defined Benefit Pension
Plans
Notice 2021-38
I. PURPOSE
This notice provides guidance under
§ 432(k) of the Internal Revenue Code
(Code) to sponsors of multiemployer
defined benefit pension plans that are re-
quired to reinstate certain previously sus-
pended benefits as a condition of receiv-
ing special financial assistance under §
4262 of the Employee Retirement Income
Security Act of 1974, Pub. L. 93-406 (88
Stat. 829 (1974)), as amended (ERISA).
This notice also provides guidance on
whether make-up payments with respect
to previously suspended benefits under
§ 432(k)(2)(A)(ii) of the Code are eligible
to be rolled over to another eligible retire-
ment plan under § 402(c). In addition, this
notice provides guidance on how to apply
the rule in § 432(k)(2)(D)(i) under which
any special financial assistance received
by the plan is not taken into account in
determining contributions required under
§ 431.
II. BACKGROUND
A. Special financial assistance
Section 4262 of ERISA and § 432(k)
of the Code were enacted by § 9704 of the
American Rescue Plan Act of 2021 (the
ARP), Pub. L. 117-2, 135 Stat. 4 (March
11, 2021).
Under § 4262 of ERISA, the sponsor of
an eligible multiemployer plan as defined
in § 4262(b) may apply to the Pension
Benefit Guaranty Corporation (PBGC)
to receive special financial assistance,
provided certain conditions are satisfied.
Under § 4262(d), PBGC may provide, in
regulations or guidance, for a temporary
priority period that does not extend be-
yond March 11, 2023, during which only
certain eligible multiemployer plans may
apply for special financial assistance.
Section 432(k) of the Code provides
rules relating to an eligible multiemploy-
er plan that applies to PBGC for special
financial assistance. Section 432(k)(1)
(A) provides that the application must be
made in accordance with PBGC guidance.
Section 432(k)(1)(B) requires that, in the
case of an eligible multiemployer plan for
which benefits have been suspended un-
der § 432(e)(9), the application must de-
scribe the manner in which the plan will
reinstate suspended benefits in accordance
with § 432(k)(2)(A). Section 432(k)(1)(C)
describes the actuarial assumptions that a
plan must use in an application for spe-
cial financial assistance. Under § 432(k)
(1)(D), in the case of a plan applying to
PBGC for special financial assistance
during any temporary priority period es-
tablished pursuant to § 4262(d) of ERISA,
the application must also be submitted to
the Department of the Treasury (Treasury
Department).
Section 432(k)(2)(A)(i) of the Code
provides that an eligible multiemployer
plan receiving special financial assistance
must reinstate any benefits that were sus-
pended under § 432(e)(9) of the Code or
§ 4245(a) of ERISA effective as of the
first month in which the effective date for
the special financial assistance occurs, for
participants and beneficiaries as of that
month. In addition, under § 432(k)(2)(A)
(ii), the plan must provide payments equal
to the amount of benefits previously sus-
pended to any participants or beneficiaries
in pay status as of the effective date of the
special financial assistance. These make-
up payments must be paid, as determined
by the plan, either as a lump sum within 3
months of the effective date of the special
financial assistance or in equal monthly
installments over a period of 5 years, com-
mencing within 3 months of that effective
date, with no adjustment for interest.
1
Section 432(k)(2)(B) provides that
the special financial assistance received
by the plan may be used to make bene-
fit payments and pay plan expenses. The
special financial assistance must be segre-
gated from other plan assets and invested
by the plan in investment-grade bonds (or
other investments as permitted by PBGC
in regulations or other guidance). Section
432(k)(2)(C) describes conditions that
PBGC, in consultation with the Treasury
Department, may impose, by regulation
or other guidance, on an eligible multiem-
ployer plan that receives special financial
assistance.
Section 432(k)(2)(D)(i) provides that
any special financial assistance received
by a multiemployer plan is not taken into
account in determining contributions re-
quired under § 431. Furthermore, under §
432(k)(2)(D)(ii), if the plan becomes in-
solvent (within the meaning of § 418E) af-
ter receiving special financial assistance,
the plan will be subject to all rules appli-
cable to insolvent plans. Section 432(k)(2)
(E) provides that a plan receiving special
financial assistance is not eligible to apply
for a new suspension of benefits under §
432(e)(9).
Under § 432(k)(3)(A), a multiemploy-
er defined benefit pension plan is eligible
to apply for special financial assistance
pursuant to section 4262 of ERISA if:
(i) In any plan year beginning in 2020
through 2022, the plan is in criti-
cal and declining status (within the
meaning of § 432(b)(6) of the Code);
(ii) As of March 11, 2021 (the date of en-
actment of the ARP), a suspension of
benefits under § 432(e)(9) has been
approved with respect to the plan;
(iii) In any plan year beginning in 2020
through 2022, the plan is certified by
the plan’s actuary to be in critical sta-
1
Section 4262(k) of ERISA provides rules that are parallel to § 432(k)(2)(A) of the Code. Under § 4262(k)(1) of ERISA and § 432(k)(1)(B) of the Code, the Secretary of the Treasury must
issue guidance relating to the rules for determining the benefit reinstatement and make-up payments that must be made by a multiemployer plan receiving special financial assistance, for
purposes of ERISA as well as the Code. Accordingly, the guidance in this notice applies for purposes of § 4262(k) of ERISA as well as § 432(k) of the Code. Section 4262(k) of ERISA also
requires the Secretary of Labor, in coordination with the Secretary of the Treasury, to ensure that plans reinstate the suspended benefits and pay the make-up payments in accordance with the
guidance issued under § 432(k) of the Code.

July 26, 2021 156 Bulletin No. 2021–30
tus under § 432(b)(3), has a modified
funded percentage (as defined under §
432(k)(3)(B)) of less than 40 percent,
and has a ratio of active to inactive
participants that is less than 2 to 3; or
(iv) The plan became insolvent within the
meaning of § 418E after December
16, 2014, has remained insolvent, and
has not been terminated as of March
11, 2021.
B. Benefit suspensions
Section 305(e)(9) of ERISA and §
432(e)(9) of the Code permit the sponsor
of a multiemployer defined benefit plan
in critical and declining status to suspend
benefits in certain situations.
Section 4245 of ERISA and § 418E
of the Code provide rules with respect to
insolvent multiemployer defined benefit
pension plans. Under those sections, in
any case in which benefit payments un-
der an insolvent multiemployer plan ex-
ceed the resource benefit level (within the
meaning of § 4245(b)(2) of ERISA and §
418E(b)(2) of the Code), any payment of
benefits that are not basic benefits (within
the meaning of § 4001(a)(6) of ERISA)
must be suspended to the extent neces-
sary to reduce the total benefits paid to the
greater of the resource benefit level or the
level of basic benefits.
C. Eligible Rollover Distributions
Under § 401(a)(31)(A) of the Code, a
qualified plan must provide that if a par-
ticipant or beneficiary receiving an eli-
gible rollover distribution elects that the
distribution be paid directly to an eligible
retirement plan (as defined under § 402(c)
(8)(B)), then the distribution must be made
in the form of a direct trustee-to-trustee
transfer to the eligible retirement plan
specified by the participant or beneficiary.
Section 402(c) provides rules applica-
ble to the rollover of a distribution from a
qualified retirement plan, including a mul-
tiemployer defined benefit pension plan.
Subject to certain exclusions, § 402(c)(4)
provides that an eligible rollover distribu-
tion means any distribution to an employ-
ee of all or any portion of the balance to
the credit of the employee in a qualified
plan. Section 402(c)(4)(A) excludes from
the definition of an eligible rollover dis-
tribution any distribution that is one of a
series of substantially equal periodic pay-
ments payable for life, over life expectan-
cy, or for a specified period of 10 years or
more.
Section 402(f)(1) requires a plan ad-
ministrator to provide a written explana-
tion to the recipient of an eligible rollover
distribution within a reasonable period of
time before making the distribution. The
written explanation must describe, among
other items, (i) the provisions under which
the recipient may have the distribution di-
rectly transferred to an eligible retirement
plan and that the automatic distribution
by direct transfer applies to certain distri-
butions in accordance with § 401(a)(31)
(B), (ii) the provision which requires the
withholding of tax on the distribution if
it is not directly transferred to an eligible
retirement plan, and (iii) the provisions
under which the distribution will not be
subject to tax if transferred to an eligible
retirement plan within 60 days after the
date on which the recipient received the
distribution.
Under § 3405(c)(1), if an eligible roll-
over distribution is not directly rolled over
into another eligible retirement plan, the
distribution is subject to withholding at
the rate of 20 percent.
Section 1.402(c)-2, Q&A-6(a) of the
Income Tax Regulations provides that,
except as provided under paragraph (b)
of that Q&A, a payment is treated as in-
dependent of the payments in a series of
substantially equal payments (and thus not
part of the series) if the payment is sub-
stantially larger or smaller than the other
payments in the series. Section 1.402(c)-2,
Q&A-6(b)(2) provides that a supplemen-
tal payment from a defined benefit plan
to retirees or beneficiaries will be treated
as part of a series of substantially equal
payments, rather than as an independent
payment, provided that the supplemen-
tal payment satisfies certain conditions.
These conditions are: (i) the supplement
is a benefit increase for annuitants, (ii) the
amount of the supplement is determined
in a consistent manner for all similarly
situated annuitants, (iii) the supplement
is paid to annuitants who are otherwise
receiving payments that would constitute
substantially equal periodic payments, and
(iv) the aggregate supplement is less than
or equal to the greater of 10 percent of the
annual rate of payment for the annuity, or
$750 or any higher amount prescribed by
the Commissioner in guidance of general
applicability.
D. Minimum Funding Requirements
Section 412(a)(2)(C) provides that a
multiemployer plan satisfies the minimum
funding standard for a plan year if the em-
ployers make contributions to or under the
plan for any plan year that, in the aggre-
gate, are sufficient to ensure that the plan
does not have an accumulated funding de-
ficiency under § 431 as of the end of that
plan year. Section 431(a) provides that the
accumulated funding deficiency of a mul-
tiemployer plan for any plan year is the
amount, determined as of the end of that
plan year, equal to the excess (if any) of (i)
the total for all plan years of the charges to
the funding standard account of the plan
under § 431(b)(2), over (ii) the credits to
that account under § 431(b)(3) (including
employer contributions under § 431(b)(3)
(A)) for those plan years. Accordingly, the
contributions required under § 431 for a
plan year (that is, the contributions nec-
essary to avoid an accumulated funding
deficiency under § 431) are the employer
contributions (determined as of the end of
that plan year) that would enable the total
credits to the funding standard account un-
der § 431(b)(3) to be no less than the total
charges to that account under § 431(b)(2).
2

III. GUIDANCE
A. Reinstatement of suspended benefits
Under § 432(k)(2)(A)(i) of the Code,
if an eligible multiemployer plan re-
ceiving special financial assistance was
previously amended to suspend benefits
pursuant to § 432(e)(9) of the Code or §
4245(a) of ERISA (which corresponds
to § 418E(a) of the Code), the plan must
be amended to reinstate those suspend-
2
Sections 302 and 304 of ERISA provide rules that are parallel to §§ 412 and 431 of the Code. Under § 101 of Reorganization Plan No. 4 of 1978 (43 FR 47713), the Secretary of the Treasury
has interpretive jurisdiction over those provisions for purposes of ERISA as well as the Code. Accordingly, the guidance in this notice applies for purposes of §§ 302 and 304 of ERISA.

Bulletin No. 2021–30 157 July 26, 2021
ed benefits, effective as of the month in
which the special financial assistance is
paid to the plan, for individuals who are
participants or beneficiaries as of that
month. Accordingly, that month’s benefit
payment and any future payment of ben-
efits to a participant or beneficiary must
be made as if the amendment suspending
benefits had never been adopted. If a plan
has been amended to suspend benefits
under § 432(e)(9), then the benefits that
must be reinstated pursuant to § 432(k)
(2)(A)(i) include all benefits suspended
pursuant to that plan amendment, without
regard to whether those benefits would
have been reduced or eliminated in the
absence of the suspension.
3
If an eligible multiemployer plan re-
ceiving special financial assistance had
suspended benefits operationally under §
418E(a) without adopting a plan amend-
ment, the plan must be amended to rein-
state suspended benefits, effective as of
the month in which the special financial
assistance is paid to the plan, for individ-
uals who are participants or beneficiaries
as of that month. The reinstatement will
apply through the end of the plan year in
which the effective date of the special fi-
nancial assistance occurs. For subsequent
plan years, the plan must apply § 418E by
taking into account all plan assets, includ-
ing the special financial assistance.
Under § 432(k)(2)(A)(ii), an eligible
multiemployer plan that receives special
financial assistance must also be amended
to provide make-up payments to individ-
uals who are participants or beneficiaries
on, and who have commenced benefits by,
the date the special financial assistance is
paid to the plan. The make-up payments
to a participant are equal to the total
amount of benefits that were not paid to
the participant because of the suspension
under § 432(e)(9) or § 418E. Similarly,
the make-up payments to a beneficiary are
equal to the total amount of benefits that
would have been paid to the beneficiary in
the absence of the suspension that were not
paid to the beneficiary because of the sus-
pension. Thus, without regard to whether
the benefits are paid to a participant or to
a beneficiary, the make-up payments equal
the total amount of benefits that were not
paid to that individual on account of the
suspension, with no actuarial adjustments
(such as for interest).
The make-up payments to a partici-
pant or a beneficiary must be paid, as de-
termined by the plan sponsor, either as a
lump sum within 3 months of the date the
special financial assistance is paid to the
plan or in equal monthly installments over
a period of 5 years, commencing within 3
months of the date of the special financial
assistance is paid. The plan amendment
providing for the make-up payments must
also specify which distribution form (that
is, as a lump-sum payment or as monthly
installments) will apply for the make-up
payments to a participant or beneficiary.
If the make-up payments are paid over 5
years, then the installments do not include
any adjustment for interest and must be
paid without regard to whether the partic-
ipant or beneficiary survives to the end of
the 5-year period.
B. Rollover eligibility of make-up
payments
Because a multiemployer plan that
receives SFA is required to be amended
to provide make-up payments to retirees
and beneficiaries in addition to the an-
nuity payments those individuals already
receive, these make-up payments are in-
dependent payments under § 1.402(c)-2,
Q&A-6(a) for purposes of §§ 401(a)(31),
402(c) and (f), and § 3405(c)(1) unless the
payments satisfy the requirements of §
1.402(c)-2, Q&A-6(b)(2) to be treated as
supplemental payments that are part of a
series of substantially equal periodic pay-
ments.
A make-up payment paid in monthly
installments satisfies the requirements of
§ 1.402(c)-2, Q&A-6(b)(2)(i) (that the
supplement is a benefit increase for annui-
tants); § 1.402(c)-2, Q&A-6(b)(2)(ii) (that
the amount of the supplement is deter-
mined in a consistent manner for all simi-
larly situated annuitants); and § 1.402(c)-
2, Q&A-6(b)(2)(iii) (that the supplement
is paid to annuitants who are otherwise
receiving payments that would constitute
substantially equal periodic payments).
However, because the make-up payments
vary in size relative to the size of a partic-
ipant’s or beneficiary’s annuity payments,
a make-up payment could fail to satisfy
the maximum payment condition under §
1.402(c)-2, Q&A-6(b)(2)(iv) (that the ag-
gregate supplement is less than or equal to
the greater of 10 percent of the annual rate
of payment for the annuity, or $750 or any
higher amount prescribed by the Commis-
sioner in guidance of general applicabili-
ty). Pursuant to this authority to increase
the $750 limit, this notice provides that,
with respect to a make-up payment under
§ 432(k)(2)(A)(ii) that is paid in the form
of monthly installments over 5 years, to
the extent that the aggregate supplement
exceeds the limit set forth in § 1.402(c)-2,
Q&A-6(b)(2)(iv), that limit is increased to
the amount of the make-up payment. Ac-
cordingly, make-up payments that are paid
in the form of monthly installments over
5 years are treated as part of a series of
substantially equal periodic payments and
are not eligible rollover distributions sub-
ject to the requirements of §§ 401(a)(31),
402(f), or 3405(c)(1).
A make-up payment under § 432(k)(2)
(A)(ii) that is paid in the form of a lump
sum also satisfies the requirements of
§ 1.402(c)-2, Q&A-6(b)(2)(i) – (iii) and,
if the lump sum is less than or equal to
the greater of 10 percent of the annual rate
of payment for the annuity or $750 (de-
termined without regard to the increase
in the preceding paragraph), the lump
sum also satisfies the requirements of §
1.402(c)-2, Q&A-6(b)(2)(iv). In that case,
the lump sum is treated as part of a series
of substantially equal periodic payments
and, accordingly, is not an eligible roll-
over distribution. By contrast, a make-up
payment paid in the form of a lump sum
that exceeds the limit under § 1.402(c)-2,
Q&A-6(b)(2)(iv) is not a supplemental
payment that is part of a series of periodic
payments and retains its character as an
independent payment that is an eligible
rollover distribution. As a result, the plan
administrator must provide the partici-
pant or beneficiary who is receiving the
make-up payment in the form of a lump
3
If, after a suspension under § 432(e)(9), the plan has been amended to restore some or all of the benefits that were suspended, then the benefits that are reinstated pursuant to § 432(k)(2)(A)
(i) do not include the benefits that were previously restored.

July 26, 2021 158 Bulletin No. 2021–30
sum exceeding that limit with the § 401(a)
(31) election to make a direct rollover to
an eligible retirement plan and the notice
described under § 402(f). Unless that par-
ticipant or beneficiary elects to roll over
that payment to an eligible retirement plan
within the meaning of § 402(c)(4), the
make-up payment will be subject to with-
holding under § 3405(c)(1) at the rate of
20 percent. This notice does not exercise
the Commissioner’s authority to increase
the limit under § 1.402(c), Q&A-6(b)(2)
(iv) with respect to make-up payments
paid as lump sums.
C. Submission of certain applications
to the Treasury Department
Section 432(k)(1)(D) of the Code re-
quires, in the case of a plan applying for
special financial assistance under PBGC’s
rules providing for temporary priority
consideration, that the plan’s application
be submitted to the Treasury Department.
In the case of an application to which that
provision applies, the requirement will be
satisfied by submission to PBGC in accor-
dance with guidance issued by PBGC. See
29 CFR 4262.10(c)(2), which provides
PBGC will transmit the application to
the Treasury Department on behalf of the
plan.
D. Disregard of special financial
assistance
As described above, § 432(k)(2)(D)
(i) of the Code provides that any special
financial assistance received by a multi-
employer plan is not taken into account
in determining contributions required un-
der § 431. Accordingly, the amounts in
the special financial assistance account
established pursuant to § 4262 of ERISA
are not included in the plan’s assets for
purposes of determining the contributions
required under § 431 of the Code. This ex-
clusion of the special financial assistance
account applies for all purposes under §
431, including the determination of the
fair market value of assets used under §
431(c)(6) and the determination of the ac-
tuarial value of assets under § 431(c)(2)
(based on the fair market value of assets).
The amount in the special financial as-
sistance account is equal to the initial spe-
cial financial assistance paid by PBGC as
adjusted by the investment return on the
assets held in that account and reduced
by benefit payments and expenses that
are paid from that account. To the extent
that a liability for benefits or expenses is
satisfied by payments from the special fi-
nancial assistance account, there will be
no corresponding reduction in the portion
of the plan’s assets that are taken into ac-
count for purposes of § 431. As a result,
any benefit or plan expenses paid from the
special financial assistance account during
a plan year will generate an actuarial gain
for that plan year. If the funding method
used by the plan includes a determina-
tion of an actuarial gain or loss for each
plan year, then the actuarial gain generat-
ed from any benefit or plan expense paid
from the special financial assistance ac-
count in a plan year will be included in the
actuarial gain or loss for that plan year and
amortized over 15 years in accordance
with § 431(b)(3)(B)(ii).
IV. DRAFTING INFORMATION
The principal author of this notice is
Diane S. Bloom of the Office of Associ-
ate Chief Counsel, Employee Benefits,
Exempt Organizations, and Employment
Taxes. For further information, please
contact Ms. Bloom at (202) 317-6700.
This telephone call is not toll-free.
26 CFR 601.105:

Examination of returns and
claims for refund, credit or abatement; determina-
tion of correct tax liability.
(Also Part I. § 172)
Special elections for
taxpayers with Farming
Loss NOLs
Rev. Proc. 2021-14
SECTION 1. PURPOSE
.01 This revenue procedure provides
guidance regarding elections and revoca-
tions related to § 2303(e) of the Corona-
virus Aid, Relief, and Economic Security
Act (CARES Act), Public Law 116-136,
134 Stat. 281 (Mar. 27, 2020), as added by
§ 281 of the COVID-related Tax Relief Act
of 2020 (CTRA 2020), which was enacted
as Subtitle B of Division N of the Con-
solidated Appropriations Act, 2021 (CAA
2021), Public Law 116-260, 134 Stat.
1182 (Dec. 27, 2020). Section 2303(e) of
the CARES Act provides special rules for
taxpayers with a net operating loss (NOL)
for any taxable year beginning in 2018,
2019, or 2020, all or a portion of which
consists of a “farming loss,” as defined by
§ 172(b)(1)(B)(ii) of the Internal Revenue
Code (Code) (Farming Loss NOL).
.02 Specifically, this revenue proce-
dure prescribes when and how to make
an election with regard to all NOLs of the
taxpayer, regardless of whether the NOL
is a Farming Loss NOL. This revenue
procedure also provides that a taxpayer is
treated as having made a deemed election
under § 2303(e)(1) of the CARES Act if
the taxpayer, before December 27, 2020,
filed one or more original or amended
Federal income tax returns, or applica-
tions for tentative refund, that disregard
the CARES Act Amendments with regard
to a Farming Loss NOL. This revenue pro-
cedure further prescribes when and how to
revoke an election made under § 172(b)
(1)(B)(iv) or § 172(b)(3) of the Code to
waive the two-year carryback period for
the farming loss portion of a Farming Loss
NOL incurred in a taxable year beginning
in 2018 or 2019.
SECTION 2. BACKGROUND
.01 TCJA Modifications of NOL De-
duction and NOL Carryback Rules—(1)
Enactment of 80-percent Limitation. Sec-
tion 13302(a)(1) of Public Law 115-97,
131 Stat. 2054 (Dec. 22, 2017), common-
ly referred to as the Tax Cuts and Jobs
Act (TCJA), amended § 172(a)(2) of the
Code to provide that, with regard to NOLs
arising in a taxable year beginning after
December 31, 2017, the amount allowed
as a “net operating loss deduction,” as de-
fined in § 172(a) (NOL deduction), cannot
exceed 80 percent of the taxable income
of the taxpayer computed without regard
to any NOL deduction (80-percent limita-
tion). The 80-percent limitation does not
apply in the case of an insurance compa-
ny, as defined in § 816(a), other than a life
insurance company. See § 172(f) (as add-
ed by § 13302(d)(2) of the TCJA).
(2) Two-year carryback period for
farming losses. Section 13302(b) of the

Bulletin No. 2021–30 159 July 26, 2021
TCJA amended § 172(b)(1) of the Code
to generally eliminate NOL carrybacks.
However, § 13302(c)(1) of the TCJA
amended § 172(b)(1) to provide a two-
year carryback period for the portion of
an NOL that is a farming loss. Section
13302(c)(1) of the TCJA further amend-
ed § 172(b)(1) to provide that taxpayers
entitled to this two-year carryback peri-
od may make an irrevocable election to
waive it. See § 172(b)(1)(B)(iv). In ad-
dition, § 172(b)(3), which predates the
TCJA amendments, separately provides
that any taxpayer entitled to an NOL car-
ryback period under § 172(b)(1) may ir-
revocably elect to relinquish the entire
carryback period with respect to that NOL
for any taxable year. The TCJA changes
relating to loss carrybacks apply to NOLs
arising in taxable years beginning after
December 31, 2017. See § 13302(e)(2) of
the TCJA, as amended by § 2303(c)(1) of
the CARES Act.
.02 CARES Act Amendments to TCJA
80-percent Limitation and NOL Carry-
back Rules—(1) Temporary suspension
of 80-percent limitation. Section 2303(a)
of the CARES Act amended § 172(a) of
the Code to provide that the 80-percent
limitation applies only to NOLs arising
in taxable years beginning after Decem-
ber 31, 2017, that are deducted in taxable
years beginning after December 31, 2020.
(2) Five-year carryback periods. Sec-
tion 2303(b) of the CARES Act amended
§ 172(b)(1) of the Code to provide a five-
year carryback period for any NOL arising
in a taxable year beginning after Decem-
ber 31, 2017 and before January 1, 2021.
See § 172(b)(1)(D). Section 172(b)(1)(D)
(i)(II), as added by section 2303(b) of the
CARES Act, provides, in part, that the
two-year carryback period provided by §
172(b)(1)(B) for farming losses does not
apply to any such NOL.
.03 CTRA 2020 Amendments to CARES
Act. Section 281(a) of the CTRA 2020
amended § 2303 of the CARES Act by
adding a new subsection (e), which took
effect as if originally included in that
CARES Act section. See § 281(b) of
the CTRA 2020. New § 2303(e) of the
CARES Act contains the following pro-
visions:
(1) Election to disregard the CARES
Act Amendments. Section 2303(e)(1) of
the CARES Act provides that a taxpayer
with a Farming Loss NOL for any taxable
year beginning in 2018, 2019, or 2020,
may make an election to disregard the
amendments made by section 2303(a) and
(b) of the CARES Act (that is, the CARES
Act Amendments).
(2) Consequences of Election. If a tax-
payer makes the election under § 2303(e)
(1), the following consequences will re-
sult:
(a) Application of 80-percent limita-
tion. The 80-percent limitation will apply
to determine the NOL deduction for each
taxable year beginning in 2018, 2019, or
2020 to the extent the deduction is attrib-
utable to NOLs arising in taxable years
beginning after December 31, 2017. The
80-percent limitation will not apply to de-
termine the NOL deduction for any tax-
able year beginning before 2018.
(b) Application of modified taxable in-
come rules. Section 172(b)(2)(C) of the
Code, as added by the TCJA and effective
prior to enactment of the CARES Act,
provides a modified taxable income rule
to account for the 80-percent limitation.
This rule will apply with regard to each
taxable year beginning in 2018, 2019, or
2020.
(c) NOL carryback period. The NOL
carryback period will be determined un-
der § 172(b) of the Code, as amended by
the TCJA and effective prior to enactment
of the CARES Act, for any NOL arising
in any taxable year beginning in 2018,
2019, or 2020. For example, if a taxpayer
with a Farming Loss NOL in 2018 makes
the election under § 2303(e)(1), only the
portion of the Farming Loss NOL that
consists of a farming loss can be carried
back two taxable years. In addition, for
taxpayers other than insurance companies,
as defined in section 816(a) of the Code,
that are not life insurance companies, no
portion of any NOL that does not consti-
tute a farming loss can be carried back to
any taxable year beginning before January
1, 2018.
(3) Making the Election—(a) Over-
view. Section 2303(e)(1)(B)(i) of the
CARES Act provides that, except in the
case of a deemed election described in
3.02(3)(b) of this revenue procedure,
an election to disregard the CARES Act
amendments (Affirmative Election) under
§ 2303(e)(1) must be made in the manner
prescribed by the Secretary. Once made,
an election under § 2303(e)(1) is irrevo-
cable. Section 2303(e)(1)(B)(ii)(I) of the
CARES Act generally provides that an
Affirmative Election must be made by the
due date, including extensions of time, for
filing the taxpayer’s Federal income tax
return for the taxpayer’s first taxable year
ending after December 27, 2020.
(b) Deemed election. In the case of any
taxpayer with a Farming Loss NOL that
files a Federal income tax return before
December 27, 2020, that disregards the
CARES Act Amendments, the taxpayer is
treated as having made a deemed election
(Deemed Election) under § 2303(e)(1)
unless the taxpayer amends such return to
reflect such amendments by the due date
(including extensions of time) for filing
the taxpayer’s Federal income tax return
for the first taxable year ending after De-
cember 27, 2020.
(4) Revocation of election to waive two-
year carryback period. Section 2303(e)
(2) of the CARES Act provides taxpayers
with the ability to revoke an election made
under § 172(b)(1)(B)(iv) or § 172(b)(3) of
the Code to waive the two-year carryback
period if the election—
(i) was made by the taxpayer before
December 27, 2020; and
(ii) relates to the two-year carryback
period for the portion of any Farming Loss
NOL that is a farming loss arising in tax-
able years beginning in 2018 or 2019.
SECTION 3. ELECTIONS TO
DISREGARD CARES ACT
AMENDMENTS
.01 Affirmative Election—(1) Over-
view. A taxpayer with a Farming Loss
NOL, other than a taxpayer making a
Deemed Election described in section
2.03(3)(b) of this revenue procedure, may
make an Affirmative Election under sec-
tion 2303(e)(1) of the CARES Act if—
(a) the Farming Loss NOL arose in any
taxable year of the taxpayer beginning in
2018, 2019, or 2020; and
(b) the taxpayer satisfies all of the con-
ditions described in section 3.01(2) of this
revenue procedure.
(2) Time and manner for making an Af-
firmative Election. To make a valid Affir-
mative Election under section 3.01(1) of
this revenue procedure, a taxpayer must
satisfy the following conditions:

July 26, 2021 160 Bulletin No. 2021–30
(a) Election deadline. The taxpayer
must make the Affirmative Election on a
statement described in section 3.01(2)(b)
of this revenue procedure by the due date,
including extensions of time, for filing the
taxpayer’s Federal income tax return for
the taxpayer’s first taxable year ending af-
ter December 27, 2020.
(b) Required statement. The taxpayer
must attach a statement to the taxpayer’s
Federal income tax return for the taxpay-
er’s first taxable year ending after Decem-
ber 27, 2020. The statement must provide
in type or legible writing at the top of the
statement the following: “The taxpayer
elects under § 2303(e)(1) of the CARES
Act and Revenue Procedure 2021-14
to disregard the amendments made by §
2303(a) of the CARES Act for taxable
years beginning in 2018, 2019, and 2020,
and the amendments made by § 2303(b)
of the CARES Act that would otherwise
apply to any net operating loss arising in
any taxable year beginning in 2018, 2019,
or 2020. The taxpayer incurred a Farming
Loss NOL, as defined in section 1.01 of
Revenue Procedure 2021-14, in [list each
applicable taxable year beginning in 2018,
2019, or 2020].” The taxpayer should
also attach a copy of the statement to any
original or amended Federal income tax
return or application for tentative refund
on which the taxpayer claims a deduction
attributable to a two-year NOL carryback
pursuant to the Affirmative Election.
.02 Deemed Election—(1) Overview.
Except as provided in section 3.02(3) of
this revenue procedure, a taxpayer is treat-
ed as having made a Deemed Election
under section 2303(e)(1) of the CARES
Act if the taxpayer, before December 27,
2020, filed one or more original or amend-
ed Federal income tax returns, or applica-
tions for tentative refund, that disregard
the CARES Act Amendments with regard
to a Farming Loss NOL.
(2) Special procedure for certain tax-
payers whose two-year carryback claims
filed before December 27, 2020 were re-
jected. Some taxpayers may have had
their two-year carryback claims, as re-
flected on their applications for tentative
refund or claims for refund that were filed
before December 27, 2020, rejected by the
Internal Revenue Service (IRS). If such a
taxpayer wants to continue to pursue those
claims, the taxpayer should submit com-
plete copies of their rejected applications
or claims, including the original or amend-
ed Federal income tax returns for the tax-
able years in which the NOLs arose, in the
manner set forth in this section 3.02(2),
which will enable the IRS to review their
cases as expeditiously as possible.
(a) The taxpayer should submit a com-
plete copy of each rejected application for
tentative refund or claim for refund based
on a two-year carryback period, including
the original or amended Federal income
tax return for the taxable year in which
the NOL arose, to the IRS Service Center
at which the taxpayer previously filed the
application or claim and return.
(b) The taxpayer should provide in
type or legible writing at the top of the
first page of a complete copy of each ap-
plication or claim the following: “Deemed
Election under section 3.02(2) of Revenue
Procedure 2021-14.”
(c) The complete copy of each appli-
cation or claim and return should be sub-
mitted on or before the due date, including
extensions of time, for filing the taxpay-
er’s Federal income tax return for the
taxpayer’s first taxable year ending after
December 27, 2020.
(3) Exception to Deemed Election.
A taxpayer will not be treated as having
made a Deemed Election if, for each tax-
able year for which the taxpayer filed an
original or amended Federal income tax
return or an application for tentative re-
fund that treated a Farming Loss NOL in
a manner that disregards the CARES Act
Amendments, the taxpayer subsequent-
ly files either an amended return by the
due date, including extensions of time,
for filing the taxpayer’s Federal income
tax return for the taxpayer’s first taxable
year ending after December 27, 2020, or
an application for tentative refund within
the required time for filing such an appli-
cation and also by the due date, including
extensions of time, for filing the taxpay-
er’s Federal income tax return for the
taxpayer’s first taxable year ending after
December 27, 2020, that properly reflects
the treatment of each Farming Loss NOL
under the CARES Act Amendments.
For example, a taxpayer who disre-
garded the CARES Act Amendments by
using a 2-year carryback for the farming
loss portion of the taxpayer’s only Farm-
ing Loss NOL and filed Forms 1120X for
the two carryback years, and who subse-
quently timely files a Form 1139 with a
5-year carryback that accounts for that
Farming Loss NOL in a manner consis-
tent with the CARES Act Amendments
for each of the five carryback years, will
not be treated as having made a Deemed
Election. Similarly, a taxpayer who filed
a Form 1139 prior to December 27, 2020,
and disregarded the CARES Act Amend-
ments by using a 2-year carryback for
the farming loss portion of the taxpayer’s
only Farming Loss NOL and subsequent-
ly timely files a Form 1139 with a 5-year
carryback that accounts for that Farming
Loss NOL in a manner consistent with the
CARES Act for each of the five carryback
years, will not be treated as having made a
Deemed Election.
SECTION 4. REVOCATIONS
REGARDING WAIVERS OF
CARRYBACK PERIODS
.01 Revocation of election not to apply
the two-year carryback period for farm-
ing losses—(1) Overview. A taxpayer that,
pursuant to § 172(b)(1)(B)(iv) or § 172(b)
(3) of the Code, elected not to have the
two-year carryback period apply to the
farming loss portion of a Farming Loss
NOL incurred in a taxable year beginning
in 2018 or 2019 may revoke that election
if the taxpayer—
(a) made that election before Decem-
ber 27, 2020; and
(b) satisfies all of the conditions de-
scribed in section 4.01(2) of this revenue
procedure.
(2) Time and manner for filing a revo-
cation. To make a valid revocation under
section 4.01(1) of this revenue procedure,
a taxpayer must satisfy the following con-
ditions:
(a) Revocation deadline. A taxpay-
er must make the revocation described
in section 4.01(1) of this revenue proce-
dure by the date that is 3 years after the
due date, including extensions of time, for
filing the return for the taxable year the
Farming Loss NOL was incurred.
(b) Required statement. The taxpay-
er must attach a statement to an amend-
ed return for the loss year. The statement
must provide in type or legible writing
at the top of the statement the following:
“Pursuant to section 4.01 of Rev. Proc.

Bulletin No. 2021–30 161 July 26, 2021
2021-14 the taxpayer is revoking a prior
§172(b)(1)(B)(iv) or § 172(b)(3) election
not to have the two-year carryback period
provided by § 172(b)(1)(B)(i) apply to the
Farming Loss NOL, as defined in section
1.01 of Rev. Proc. 2021-14, incurred in the
taxable year.”
SECTION 5. CONSOLIDATED
GROUPS
.01 In general—(1) Defined terms. For
purposes of this revenue procedure, with
regard to an affiliated group of corpora-
tions, as defined in section 1504 of the
Code, filing, or required to file, a consoli-
dated return for the taxable year (consoli-
dated group)—
(a) Taxpayer. The term “taxpayer” in-
cludes a consolidated group.
(b) NOL. The term “NOL” includes,
with regard to a consolidated taxable year,
the excess of deductions over gross in-
come, as determined under § 1.1502-11(a)
of the Income Tax Regulations without
regard to any consolidated net operating
loss (CNOL) deduction.
(2) Manner of making elections. An
Affirmative Election under section 3.01 of
this revenue procedure and a revocation
described in section 4.01 of this revenue
procedure are made by the agent for the
consolidated group. An amended return
described in section 3.02(3) of this rev-
enue procedure is filed, and a Deemed
Election under section 3.02 of this rev-
enue procedure is deemed made, by the
agent for the consolidated group. See §
1.1502-77(a) and (c).
.02 Consequences of Affirmative and
Deemed Elections. If the agent for the
consolidated group makes an Affirmative
Election or a Deemed Election, the con-
sequences described in section 2.03(2) of
this revenue procedure apply to the con-
solidated group. Therefore, for example, if
a consolidated group has a CNOL a por-
tion of which is a farming loss, and if the
agent for the consolidated group makes an
Affirmative Election or a Deemed Elec-
tion, then the portion of the CNOL that
is a farming loss can be carried back two
taxable years, and the 80-percent limita-
tion will apply to determine the deduction
for the entire CNOL for each taxable year
beginning in 2018, 2019, or 2020.
.03 Reliance on rules in § 1.1502-21
regarding application of the 80-percent
limitation. If a consolidated group makes
an Affirmative Election or a Deemed
Election, the consolidated group may
choose to apply § 1.1502-21(a), (b)(1), (b)
(2)(iv), and (c)(1)(i)(E), as revised by TD
9927 (85 FR 67966, Oct. 27, 2020), for its
taxable years beginning in 2018, 2019, or
2020.
SECTION 6. EFFECTIVE DATE
This revenue procedure is effective on
[INSERT DATE OF RELEASE].
SECTION 7. DRAFTING
INFORMATION
The principal author of this revenue
procedure is Forest Boone of the Office
of Associate Chief Counsel (Income Tax
& Accounting). For further information
regarding this revenue procedure, contact
Lewis Saideman at (202) 317-5414, or
(concerning consolidated groups) Russell
Jones at (202) 317-5357 (not a toll-free
number).

July 26, 2021 162 Bulletin No. 2021–30
Part IV
Notice of Proposed
Rulemaking
Requirements Related to
Surprise Billing; Part I
REG-107706-21
AGENCY: Internal Revenue Service
(IRS), Treasury.
ACTION: Notice of proposed rulemaking.
SUMMARY: The IRS is proposing reg-
ulations that protect consumers from
surprise medical bills for emergency
services, air ambulance services fur-
nished by nonparticipating providers,
and non-emergency services furnished
by nonparticipating providers at partici-
pating facilities in certain circumstances.
Elsewhere in this issue of the Internal
Revenue Bulletin, the IRS is issuing
the temporary regulations that corre-
spond to this proposal at the same time
that the Office of Personnel Management
(OPM), the Employee Benefits Security
Administration of the Department of La-
bor (DOL), and the Office of Consumer
Information and Insurance Oversight of
the Department of Health and Human
Services (HHS) are issuing substantially
similar interim final rules with request
for comments. The text of those tempo-
rary regulations also serves as the text of
these proposed regulations.
DATES: Comment date: To be assured
consideration, comments must be received
at one of the addresses provided below, no
later than 5 p.m. on September 13, 2021.
Applicability date: It is proposed that
these regulations apply on and after plan
years beginning on or after January 1,
2022.
ADDRESSES: In commenting, please
refer to file code REG-107706-21. Com-
ments, including mass comment submis-
sions, must be submitted in one of the
following three ways (please choose only
one of the ways listed):
1. Electronically. You may submit elec-
tronic comments on this regulation to
http://www.regulations.gov. Follow
the “Submit a comment” instructions.
2. By regular mail. You may mail writ-
ten comments to the following ad-
dress ONLY:
Centers for Medicare & Medicaid
Services,
Department of Health and Human
Services,
Attention: CMS-9909-IFC,
P.O. Box 8016,
Baltimore, MD 21244-8016.
Please allow sufficient time for mailed
comments to be received before the close
of the comment period.
3. By express or overnight mail. You
may send written comments to the
following address ONLY:
Centers for Medicare & Medicaid
Services,
Department of Health and Human
Services,
Attention: CMS-9909-IFC,
Mail Stop C4-26-05,
7500 Security Boulevard,
Baltimore, MD 21244-1850
FOR FURTHER INFORMATION
CONTACT: Kari DiCecco, (202) 317-
5500, Internal Revenue Service, Depart-
ment of the Treasury, for issues related to
Surprise Billing.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All
comments received before the close of the
comment period are available for viewing
by the public, including any personally
identifiable or confidential business in-
formation that is included in a comment.
We post all comments received before the
close of the comment period on the fol-
lowing website as soon as possible after
they have been received: http://regula-
tions.gov. Follow the search instructions
on that website to view public comments.
Background and Regulatory Impact
Analysis
The Treasury Department and the IRS
propose to add §§ 54.9816-1, 54.9816-
2, 54.9816-3, 54.9816-4, 54.9816-5,
54.9816-6, 54.9817-1, and 54.9822-1 to
the Miscellaneous Excise Tax Regula-
tions to protect consumers from surprise
medical bills for emergency services, air
ambulance services furnished by nonpar-
ticipating providers, and non-emergency
services furnished by nonparticipating
providers at participating facilities in cer-
tain circumstances.
The temporary regulations published
elsewhere in this issue of the Internal
Revenue Bulletin add §§ 54.9816-1T,
54.9816-2T, 54.9816-3T, 54.9816-4T,
54.9816-5T, 54.9816-6T, 54.9817-1T, and
54.9822-1T to the Miscellaneous Excise
Tax Regulations. The proposed and tem-
porary regulations are being published as
part of a joint rulemaking with the OPM,
DOL, and HHS. The text of temporary
sections added elsewhere also serves as
the text of the corresponding sections
proposed in this document. The preamble
to the temporary regulations contains the
agency’s rationale and provides a regula-
tory impact analysis.
Drafting Information
The principal author of this notice of
proposed rulemaking is Kari DiCecco, Of-
fice of Associate Chief Counsel (Employee
Benefits, Exempt Organizations and Em-
ployment Taxes). The proposed regula-
tions, as well as the temporary regulations,
have been developed in coordination with
personnel from the OPM, DOL, and HHS.
List of Subjects in 26 CFR Part 54
Excise taxes, Pensions, Reporting and
recordkeeping requirements.
Proposed Amendments to the
Regulations
Accordingly, 26 CFR part 54 is pro-
posed to be amended as follows:
PART 54—PENSION EXCISE TAXES
Paragraph. 1. The general authority
citation for part 54 continues to read as
follows:

Bulletin No. 2021–30 163 July 26, 2021
Authority: 26 U.S.C. 7805, unless oth-
erwise noted.
* * * * *
Par. 2. Section 54.9801-1 is revised to
read as follows:
§54.9801-1 Basis and scope.
[The text of proposed § 54.9801-1 is
the same as the text of § 54.9801-1T pub-
lished elsewhere in this issue of the Inter-
nal Revenue Bulletin].
Par. 3. Section 54.9801-2 is amended
by revising the introductory text to read as
follows:
§54.9801-2 Definitions.
[The text of proposed § 54.9801-2 in-
troductory text is the same as the text of
§ 54.9801-2T introductory text published
elsewhere in this issue of the Internal Rev-
enue Bulletin].
Par. 4. Section 54.9815-2719A is
amended by revising paragraph (c) to read
as follows:
§54.9815-2719A Patient protections.
[The text of proposed § 54.9815-
2719A(c) is the same as the text of §
54.9815-2719AT(c) published elsewhere
in this issue of the Internal Revenue Bul-
letin].
Par. 5. Sections 54.9816-1, 54.9816-
2, 54.9816-3, 54.9816-4, 54.9816-5,
54.9816-6, 54.9816-7, 54.9817-1, and
54.9822-1 are added to read as follows:
Sec.
54.9816-1 Basis and Scope.
54.9816-2 Applicability.
54.9816-3 Definitions.
54.9816-4 Preventing surprise medical
bills for emergency services.
54.9816-5 Preventing surprise medical
bills for non-emergency services per-
formed by nonparticipating providers
at certain participating facilities.
54.9816-6 Methodology for calculating
qualifying payment amount.
54.9816-7 Complaints process for sur-
prise medical bills regarding group
health plans.
54.9817-1 Preventing surprise medical
bills for air ambulance services.
54.9822-1 Choice of health care profes-
sional.
* * * * *
§ 54.9816-1 Basis and Scope.
[The text of proposed § 54.9816-1 is
the same as the text of § 54.9816-1T pub-
lished elsewhere in this issue of the Inter-
nal Revenue Bulletin].
§ 54.9816-2 Applicability.
[The text of proposed § 54.9816-2 is
the same as the text of § 54.9816-2T pub-
lished elsewhere in this issue of the Inter-
nal Revenue Bulletin].
§ 54.9816-3 Definitions.
[The text of proposed § 54.9816-3 is
the same as the text of § 54.9816-3T pub-
lished elsewhere in this issue of the Inter-
nal Revenue Bulletin].
§ 54.9816-4 Preventing surprise
medical bills for emergency services.
[The text of proposed § 54.9816-4 is
the same as the text of § 54.9816-4T pub-
lished elsewhere in this issue of the Inter-
nal Revenue Bulletin].
§ 54.9816-5 Preventing surprise
medical bills for non-emergency
services performed by nonparticipating
providers at certain participating
facilities.
[The text of proposed § 54.9816-5 is
the same as the text of § 54.9816-5T pub-
lished elsewhere in this issue of the Inter-
nal Revenue Bulletin].
§ 54.9816-6 Methodology for
calculating qualifying payment
amount.
[The text of proposed § 54.9816-6 is
the same as the text of § 54.9816-6T pub-
lished elsewhere in this issue of the Inter-
nal Revenue Bulletin].
§ 54.9816-7 Complaints process for
surprise medical bills regarding group
health plans.
[The text of proposed § 54.9816-7 is
the same as the text of § 54.9816-7T pub-
lished elsewhere in this issue of the Inter-
nal Revenue Bulletin].
§ 54.9817-1 Preventing surprise
medical bills for air ambulance
services.
[The text of proposed § 54.9817-1 is
the same as the text of § 54.9817-1T pub-
lished elsewhere in this issue of the Inter-
nal Revenue Bulletin].
§ 54.9822-1 Choice of health care
professional.
[The text of proposed § 54.9822-1 is
the same as the text of § 54.9822-1T pub-
lished elsewhere in this issue of the Inter-
nal Revenue Bulletin].
Douglas W. O’Donnell,
Deputy Commissioner for Services
and Enforcement.
(Filed by the Office of the Federal Register on July
6, 2021, 4:15p.m., and published in the issue of the
Federal Register for July 13, 2021, TBD F.R. TBD)

Bulletin No. 2021–30 i July 26, 2021
Definition of Terms
Revenue rulings and revenue procedures
(hereinafter referred to as “rulings”) that
have an effect on previous rulings use the
following defined terms to describe the
effect:
Amplified describes a situation where
no change is being made in a prior pub-
lished position, but the prior position is
being extended to apply to a variation of
the fact situation set forth therein. Thus, if
an earlier ruling held that a principle ap-
plied to A, and the new ruling holds that
the same principle also applies to B, the
earlier ruling is amplified. (Compare with
modified, below).
Clarified is used in those instances
where the language in a prior ruling is be-
ing made clear because the language has
caused, or may cause, some confusion. It
is not used where a position in a prior rul-
ing is being changed.
Distinguished describes a situation
where a ruling mentions a previously pub-
lished ruling and points out an essential
difference between them.
Modified is used where the substance
of a previously published position is being
changed. Thus, if a prior ruling held that a
principle applied to A but not to B, and the
new ruling holds that it applies to both A
and B, the prior ruling is modified because
it corrects a published position. (Compare
with amplified and clarified, above).
Obsoleted describes a previously pub-
lished ruling that is not considered deter-
minative with respect to future transactions.
This term is most commonly used in a ruling
that lists previously published rulings that
are obsoleted because of changes in laws or
regulations. A ruling may also be obsoleted
because the substance has been included in
regulations subsequently adopted.
Revoked describes situations where the
position in the previously published ruling
is not correct and the correct position is
being stated in a new ruling.
Superseded describes a situation where
the new ruling does nothing more than
restate the substance and situation of a
previously published ruling (or rulings).
Thus, the term is used to republish under
the 1986 Code and regulations the same
position published under the 1939 Code
and regulations. The term is also used
when it is desired to republish in a single
ruling a series of situations, names, etc.,
that were previously published over a
period of time in separate rulings. If the
new ruling does more than restate the sub-
stance of a prior ruling, a combination of
terms is used. For example, modified and
superseded describes a situation where the
substance of a previously published ruling
is being changed in part and is continued
without change in part and it is desired to
restate the valid portion of the previous-
ly published ruling in a new ruling that is
self contained. In this case, the previously
published ruling is first modified and then,
as modified, is superseded.
Supplemented is used in situations in
which a list, such as a list of the names of
countries, is published in a ruling and that
list is expanded by adding further names
in subsequent rulings. After the original
ruling has been supplemented several
times, a new ruling may be published that
includes the list in the original ruling and
the additions, and supersedes all prior rul-
ings in the series.
Suspended is used in rare situations to
show that the previous published rulings
will not be applied pending some future
action such as the issuance of new or
amended regulations, the outcome of cas-
es in litigation, or the outcome of a Ser-
vice study.
Abbreviations
The following abbreviations in current use
and formerly used will appear in material
published in the Bulletin.
A—Individual.
Acq.—Acquiescence.
B—Individual.
BE—Beneficiary.
BK—Bank.
B.T.A.—Board of Tax Appeals.
C—Individual.
C.B.—Cumulative Bulletin.
CFR—Code of Federal Regulations.
CI—City.
COOP—Cooperative.
Ct.D.—Court Decision.
CY—County.
D—Decedent.
DC—Dummy Corporation.
DE—Donee.
Del. Order—Delegation Order.
DISC—Domestic International Sales Corporation.
DR—Donor.
E—Estate.
EE—Employee.
E.O.—Executive Order.
ER—Employer.
ERISA—Employee Retirement Income Security Act.
EX—Executor.
F—Fiduciary.
FC—Foreign Country.
FICA—Federal Insurance Contributions Act.
FISC—Foreign International Sales Company.
FPH—Foreign Personal Holding Company.
F.R.—Federal Register.
FUTA—Federal Unemployment Tax Act.
FX—Foreign corporation.
G.C.M.—Chief Counsel’s Memorandum.
GE—Grantee.
GP—General Partner.
GR—Grantor.
IC—Insurance Company.
I.R.B.—Internal Revenue Bulletin.
LE—Lessee.
LP—Limited Partner.
LR—Lessor.
M—Minor.
Nonacq.—Nonacquiescence.
O—Organization.
P—Parent Corporation.
PHC—Personal Holding Company.
PO—Possession of the U.S.
PR—Partner.
PRS—Partnership.
PTE—Prohibited Transaction Exemption.
Pub. L.—Public Law.
REIT—Real Estate Investment Trust.
Rev. Proc.—Revenue Procedure.
Rev. Rul.—Revenue Ruling.
S—Subsidiary.
S.P.R.—Statement of Procedural Rules.
Stat.—Statutes at Large.
T—Target Corporation.
T.C.—Tax Court.
T.D.—Treasury Decision.
TFE—Transferee.
TFR—Transferor.
T.I.R.—Technical Information Release.
TP—Taxpayer.
TR—Trust.
TT—Trustee.
U.S.C.—United States Code.
X—Corporation.
Y—Corporation.
Z—Corporation.

July 26, 2021 ii Bulletin No. 2021–30
Numerical Finding List
1
Bulletin 2021–30
Notices:
2021-39, 2021-27 I.R.B. 3
2021-40, 2021-28 I.R.B. 15
2021-41, 2021-29 I.R.B. 17
2021-42, 2021-29 I.R.B. 19
2021-38, 2021-30 I.R.B. 155
Proposed Regulations:
REG-107705-21, 2021-30 I.R.B. 162
Revenue Procedures:
2021-28, 2021-27 I.R.B. 5
2021-29, 2021-27 I.R.B. 12
2021-24, 2021-29 I.R.B. 19
2021-14, 2021-30 I.R.B. 158
Revenue Rulings:
2021-12, 2021-27 I.R.B. 1
2021-13, 2021-30 I.R.B. 152
Treasury Decisions:
9951, 2021-30 I.R.B. 25
1
A cumulative list of all revenue rulings, revenue procedures, Treasury decisions, etc., published in Internal Revenue Bulletins 2021–27 through 2021–52 is in Internal Revenue Bulletin
2021–52, dated December 27, 2021.

Bulletin No. 2021–30 iii July 26, 2021
Finding List of Current Actions on
Previously Published Items
1
Bulletin 2021–30
1
A cumulative list of all revenue rulings, revenue procedures, Treasury decisions, etc., published in Internal Revenue Bulletins 2021–27 through 2021–52 is in Internal Revenue Bulletin
2021–52, dated December 27, 2021.

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