Internal Revenue Bulletin 2024-47 (PDF rendition): IRS Revenue Procedures

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Bulletin No. 2024–47
November 18, 2024
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 2024-80, page 1120.
Section 415 of the Internal Revenue Code (the Code) provides
for dollar limitations on benefits and contributions under qual-
ified retirement plans. Section 415(d) requires that the Sec-
retary of the Treasury annually adjust these limits for cost of
living increases. Other limitations applicable to deferred com-
pensation plans are also affected by these adjustments under
§ 415. Under § 415(d), the adjustments are to be made under
adjustment procedures similar to those used to adjust benefit
amounts under § 215(i)(2)(A) of the Social Security Act.
EMPLOYEE PLANS, EXCISE TAX
REG-110878-24, page 1125.
These proposed rules would amend the regulations regard-
ing coverage of certain preventive services under section
2713 of the Public Health Service Act. The proposed rules
also contain separate requirements applicable to coverage
of contraceptive items that are preventive services. Specif-
ically, these proposed rules would require plans and issu-
ers to cover recommended over the-counter contraceptive
items without requiring a prescription and without impos-
ing cost-sharing requirements. In addition, the proposed
rules would require plans and issuers to cover certain rec-
ommended contraceptive items that are drugs and drug-
led combination products without imposing cost sharing
requirements, unless a therapeutic equivalent of the drug
or drug-led combination product is covered without cost
sharing. Finally, these proposed rules would amend the reg-
ulations implementing section 2715A of the Public Health
Service Act and section 1311(e)(3) of the Affordable Care
Act by adding a disclosure requirement pertaining to cov-
erage and cost-sharing requirements for over-the-counter
contraceptive items. These proposed rules would not mod-
ify Federal conscience protections related to contraceptive
coverage for employers, plans, issuers, and providers.
EXEMPT ORGANIZATIONS
Announcement 2024-37, page 1124.
Revocation of IRC 501(c)(3) Organizations for failure to
meet the code section requirements. Contributions made to
the organizations by individual donors are no longer deduct-
ible under IRC 170(b)(1)(A).
INCOME TAX
Rev. Proc. 2024-41, page 1122.
This revenue procedure publishes the amounts of unused
housing credit carryovers allocated to qualified states
under § 42(h)(3)(D) of the Internal Revenue Code for calen-
dar year 2024.
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
enforce 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 offi-
cial 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.
November 18, 2024 Bulletin No. 2024–47

Part III
2025 Amounts Relating to
Retirement Plans and IRAs,
as Adjusted for Changes in
Cost-of-Living
Notice 2024-80
Section 415 of the Internal Revenue
Code (“Code”) provides for limitations
on benefits and contributions under qual-
ified retirement plans. Section 415(d)
requires that the Secretary of the Trea-
sury annually adjust these limitations for
cost-of-living increases. Under section
415(d), the adjustments are to be made
under adjustment procedures similar
to those used to adjust benefit amounts
under section 215(i)(2)(A) of the Social
Security Act. Other amounts applica-
ble to deferred compensation plans are
also adjusted for cost-of-living increases
using a variation of the methodology
used for the adjustments under section
415(d).
Cost-of-Living Adjusted Limitations
for 2025
Effective January 1, 2025, the limita-
tion on the annual benefit under a defined
benefit plan under section 415(b)(1)(A) of
the Code is increased from $275,000 to
$280,000.
For a participant who separated from
service before January 1, 2025, the par-
ticipant’s limitation under a defined ben-
efit plan under section 415(b)(1)(B) is
computed by multiplying the participant’s
compensation limitation, as adjusted
through 2024, by 1.0262.
The limitation for defined contribu-
tion plans under section 415(c)(1)(A)
is increased in 2025 from $69,000 to
$70,000.
The Code provides that various other
amounts are to be adjusted at the same
time and in the same manner as the lim-
itation of section 415(b)(1)(A). After tak-
ing into account the applicable rounding
rules, the amounts for 2025 are as follows:
The limitation under section 402(g)(1)
on the exclusion for elective deferrals
described in section 402(g)(3), which
includes elective deferrals made to the
Thrift Savings Plan, is increased from
$23,000 to $23,500.
The limitation on deferrals under sec-
tion 457(e)(15) concerning deferred
compensation plans of state and local
governments and tax-exempt organi-
zations is increased from $23,000 to
$23,500.
The limitation under section 414(v)
(2)(B)(i) for catch-up contributions
to an applicable employer plan other
than a plan described in section 401(k)
(11) or section 408(p) that gener-
ally applies for individuals aged 50
or over remains $7,500. The limita-
tion under section 414(v)(2)(E)(i) for
catch-up contributions to an applica-
ble employer plan other than a plan
described in section 401(k)(11) or
section 408(p) that applies for indi-
viduals who attain age 60, 61, 62,
or 63 in 2025 is $11,250. The Roth
catch-up wage threshold for 2024,
which under section 414(v)(7)(A) is
used to determine whether an indi-
vidual’s catch-up contributions to an
applicable employer plan (other than
a plan described in section 408(k) or
(p)) for 2025 must be designated Roth
contributions, remains $145,000.
The limitation under section 408(p)
(2)(E)(i)(III) that generally applies to
salary reduction contributions under a
SIMPLE retirement account or elec-
tive contributions under a SIMPLE
401(k) plan is increased from $16,000
to $16,500. The limitation for certain
of those accounts or plans under sec-
tion 408(p)(2)(E)(i)(I) or (II) remains
$17,600.
The limitation under section 414(v)
(2)(B)(ii) for catch-up contribu-
tions to an applicable employer
plan described in section 401(k)
(11) or section 408(p) that generally
applies for individuals aged 50 or
over remains $3,500. The limitation
under section 414(v)(2)(E)(ii) for
catch-up contributions to an applica-
ble employer plan described in sec-
tion 401(k)(11) or section 408(p) that
applies for individuals who attain age
60, 61, 62, or 63 in 2025 is $5,250. The
limitation under section 414(v)(2)(B)
(iii) for catch-up contributions to cer-
tain accounts or plans described in
section 401(k)(11) or section 408(p)
that generally applies for individuals
aged 50 or over remains $3,850.
The limitation under section 401(k)
(16)(D)(i)(II) and 403(b)(16)(D)(i)
(II) that generally applies for elective
contributions made to a starter 401(k)
deferral-only arrangement described
in section 401(k)(16)(B) or a safe har-
bor deferral-only plan described in
section 403(b)(16)(B), respectively,
remains $6,000. This limitation is
increased for individuals who attain
age 50 before the end of the taxable
year by $1,000.
The threshold used in the definition of
“highly compensated employee” under
section 414(q)(1)(B) is increased from
$155,000 to $160,000.
The threshold under section 416(i)
(1)(A)(i) concerning the definition of
“key employee” for top-heavy plan
purposes is increased from $220,000 to
$230,000.
The annual compensation limitation
under sections 401(a)(17), 404(l),
408(k)(3)(C), and 408(k)(6)(D)(ii) is
increased from $345,000 to $350,000.
The annual compensation limitation
under section 401(a)(17) for eligible
participants in certain governmental
plans that, under the plan as in effect
on July 1, 1993, allowed cost-of-liv-
ing adjustments to the compensa-
tion limitation under the plan under
section 401(a)(17) to be taken into
account, is increased from $505,000
to $520,000.
The limitation under section 402A(e)
(3)(A)(i) concerning pension-linked
emergency savings accounts that may
be included in certain types of defined
contribution plans remains $2,500.
November 18, 2024 1120 Bulletin No. 2024–47

The compensation threshold under sec-
tion 408(k)(2)(C) regarding simplified
employee pensions remains $750.
The amount under section 409(o)(1)
(C)(ii) for determining the maximum
account balance in an employee stock
ownership plan subject to a 5-year
distribution period is increased from
$1,380,000 to $1,415,000, while the
dollar amount used to determine the
lengthening of the 5-year distribution
period is increased from $275,000 to
$280,000.
The limitation on the aggregate amount
of length of service awards accruing
with respect to any year of service
for any bona fide volunteer under
section 457(e)(11)(B)(ii) concerning
deferred compensation plans of state
and local governments and tax-exempt
organizations remains $7,500.
The limitation under section 664(g)
(7) concerning the qualified gratuitous
transfer of qualified employer securi-
ties to an employee stock ownership
plan remains $60,000.
The compensation amount under §
1.61-21(f)(5)(i) of the Income Tax
Regulations concerning the definition
of “control employee” for fringe ben-
efit valuation purposes is increased
from $135,000 to $140,000. The com-
pensation amount under § 1.61-21(f)
(5)(iii) is increased from $275,000 to
$285,000.
The limitation on premiums paid for
a qualifying longevity annuity con-
tract under § 1.401(a)(9)-6(q)(2)(ii) is
increased from $200,000 to $210,000.
The $1,000,000,000 threshold used
to determine whether a multiemployer
plan is a systemically important plan
under section 432(e)(9)(H)(v)(III)(aa) is
adjusted using the cost-of-living adjust-
ment provided under section 432(e)(9)(H)
(v)(III)(bb). After taking the applicable
rounding rule into account, the threshold
used to determine whether a multiem-
ployer plan is a systemically important
plan under section 432(e)(9)(H)(v)(III)
(aa) is increased from $1,369,000,000 to
$1,441,000,000.
The Code also provides that several
retirement-related amounts are to be
adjusted using a variation of the method-
ology used for the cost-of-living adjust-
ments under section 1(f)(3). After taking
the applicable rounding rules into account,
the amounts for 2025 are as follows:
The adjusted gross income limitation
under section 25B(b)(1)(A) for deter-
mining the retirement savings contri-
butions credit for married taxpayers
filing a joint return is increased from
$46,000 to $47,500; the limitation
under section 25B(b)(1)(B) is increased
from $50,000 to $51,000; and the lim-
itation under sections 25B(b)(1)(C)
and 25B(b)(1)(D) is increased from
$76,500 to $79,000.
The adjusted gross income limitation
under section 25B(b)(1)(A) for deter-
mining the retirement savings contri-
butions credit for taxpayers filing as
head of household is increased from
$34,500 to $35,625; the limitation
under section 25B(b)(1)(B) is increased
from $37,500 to $38,250; and the lim-
itation under sections 25B(b)(1)(C)
and 25B(b)(1)(D) is increased from
$57,375 to $59,250.
The adjusted gross income limitation
under section 25B(b)(1)(A) for deter-
mining the retirement savings contri-
butions credit for all other taxpayers
is increased from $23,000 to $23,750;
the limitation under section 25B(b)
(1)(B) is increased from $25,000 to
$25,500; and the limitation under
sections 25B(b)(1)(C) and 25B(b)
(1)(D) is increased from $38,250 to
$39,500.
The deductible amount under section
219(b)(5)(A), which limits the amount
of an individual’s deductible qualified
retirement contributions for a taxable
year remains $7,000. The increase
in the deductible amount pursuant to
section 219(b)(5)(B)(ii) for individ-
uals who have attained age 50 before
the close of the taxable year remains
$1,000.
The applicable amount under section
219(g)(3)(B)(i) for determining the
deductible amount of an IRA contri-
bution for taxpayers who are active
participants filing a joint return or as
a qualifying widow(er) is increased
from $123,000 to $126,000. The appli-
cable amount under section 219(g)(3)
(B)(ii) for all other taxpayers who are
active participants (other than married
taxpayers filing separate returns) is
increased from $77,000 to $79,000.
If an individual or the individual’s
spouse is an active participant, the
applicable amount under section
219(g)(3)(B)(iii) for a married indi-
vidual filing a separate return is not
subject to an annual cost-of-living
adjustment and remains $0. The appli-
cable amount under section 219(g)
(7)(A) for a taxpayer who is not an
active participant but whose spouse is
an active participant is increased from
$230,000 to $236,000.
In light of the changes to the appli-
cable amounts, under section 219(g)
(2)(A), the deduction for taxpayers
making contributions to a traditional
IRA is phased out for single individ-
uals and heads of household who are
active participants in a qualified plan
(or another retirement plan speci-
fied in section 219(g)(5)) and have
adjusted gross incomes (as defined
in section 219(g)(3)(A)) between
$79,000 and $89,000, increased from
between $77,000 and $87,000. For
married couples filing jointly, if the
spouse who makes the IRA contri-
bution is an active participant, the
income phase-out range is between
$126,000 and $146,000, increased
from between $123,000 and $143,000.
For an IRA contributor who is not an
active participant and is married to
someone who is an active participant,
the deduction is phased out if the cou-
ple’s income is between $236,000 and
$246,000, increased from between
$230,000 and $240,000. For a married
individual filing a separate return who
is an active participant, the phase-
out range is not subject to an annual
cost-of-living adjustment and remains
$0 to $10,000.
Bulletin No. 2024–47 1121 November 18, 2024

November 18, 2024 1122 Bulletin No. 2024–47
The adjusted gross income limitation
under section 408A(c)(3)(B)(ii)(I)
for determining the maximum Roth
IRA contribution for married taxpay-
ers filing a joint return or for taxpay-
ers filing as a qualifying widow(er) is
increased from $230,000 to $236,000.
The adjusted gross income limitation
under section 408A(c)(3)(B)(ii)(II) for
all other taxpayers (other than married
taxpayers filing separate returns) is
increased from $146,000 to $150,000.
The applicable amount under section
408A(c)(3)(B)(ii)(III) for a married
individual filing a separate return is
not subject to an annual cost-of-living
adjustment and remains $0.
In light of the changes to the adjusted
gross income limitations, under sec-
tion 408A(c)(3)(A), the adjusted gross
income phase-out range for taxpayers
making contributions to a Roth IRA is
between $236,000 and $246,000 for
married couples filing jointly, increased
from between $230,000 and $240,000.
For singles and heads of household,
the income phase-out range is between
$150,000 and $165,000, increased
from between $146,000 and $161,000.
For a married individual filing a sep-
arate return, the phase-out range is
not subject to an annual cost-of-living
adjustment and remains between $0
and $10,000.
The aggregate amount of qualified
charitable distributions that are not
includible in gross income under sec-
tion 408(d)(8)(A) is increased from
$105,000 to $108,000. The amount of
qualified charitable distributions made
directly to a split-interest entity that are
not includible in gross income under
section 408(d)(8)(F)(i)(II) pursuant to
a one-time election is increased from
$53,000 to $54,000.
The annual compensation limitation
under section 45E(f)(2)(C) for employ-
ees excluded from the calculation of the
additional small employer pension plan
startup cost credit for certain employer
contributions is $105,000.
1
The limitation under section 72(t)(2)
(K)(ii)(I) for eligible distributions
to victims of domestic abuse from
applicable eligible retirement plans is
increased from $10,000 to $10,300.
The limitation under section 401(a)
(39)(B)(i)(III) on a qualified long-
term care distribution from a qualified
defined contribution plan with respect
to certified long-term care insurance
applicable for distributions made after
December 29, 2025, is $2,600.
The limitation under section 408(p)(2)
(A)(iv) for additional nonelective con-
tributions for an employee to a SIM-
PLE retirement account or a SIMPLE
401(k) plan is increased from $5,000 to
$5,100.
Drafting Information
The principal author of this notice is
Tom Morgan of the Office of Associ-
ate Chief Counsel (Employee Benefits,
Exempt Organizations, and Employment
Taxes). However, other personnel from
the IRS participated in the development
of this guidance. For further information
regarding this notice, contact Mr. Morgan
at (202) 317-6700 (not a toll-free number).
Rev. Proc. 2024-41
SECTION 1. PURPOSE
This revenue procedure publishes the
amounts of unused housing credit carry-
overs allocated to qualified states under
§ 42(h)(3)(D) of the Internal Revenue
Code for calendar year 2024.
SECTION 2. BACKGROUND
Rev. Proc. 2019-45, 2019-48 I.R.B.
524, provides guidance to state housing
credit agencies of qualified states on the
procedure for requesting an allocation of
unused housing credit carryovers under
§ 42(h)(3)(D). The amount of unused
housing credit carryovers allocated to
qualified states for a calendar year from
a national pool of unused credit authority
(the National Pool) is published by the
Internal Revenue Service in the Internal
Revenue Bulletin. This revenue procedure
publishes these amounts for calendar year
2024.
SECTION 3. PROCEDURE
The unused housing credit carryover
amount allocated from the National Pool
by the Secretary to each qualified state for
calendar year 2024 is as follows:
1
Pursuant to section 45E(f)(2)(C)(iii), for a taxable year beginning in a calendar year after 2023, this limitation is equal to the initial limitation of $100,000, multiplied by the cost-of-living
adjustment determined under section 1(f)(3) for the calendar year in which the taxable year begins, determined by substituting “calendar year 2007” for “calendar year 2016” in section
1(f)(3)(A)(ii). Because the specification of a 2007 base period to be used for computing an adjustment that is first made for 2024 appears to be an error that has been identified as the subject
of future legislative correction, the IRS will calculate and apply the limitation in section 45E(f)(2)(C) by substituting “calendar year 2022” for “calendar year 2007” in section 45E(f)(2)(C)
(iii). Using that substitution, the limitation for 2024 was $105,000.

Bulletin No. 2024–47 1123 November 18, 2024
Qualified StateAmount Allocated
Alaska10,879
California577,985
Connecticut53,655
Delaware15,306
Florida335,393
Georgia163,601
Illinois186,154
Iowa47,571
Kansas43,618
Maryland91,674
Massachusetts103,854
Michigan148,886
Minnesota85,113
Nebraska29,346
New Jersey137,815
New Mexico31,363
New York290,307
North Carolina160,727
Ohio174,825
Oregon62,795
Pennsylvania192,266
Rhode Island16,257
South Dakota13,637
Texas452,467
Utah50,697
Vermont9,604
Virginia129,283
Washington115,891
West Virginia26,256
EFFECTIVE DATE
This revenue procedure is effective
for allocations of housing credit dollar
amounts attributable to the National Pool
component of a qualified state’s housing
credit ceiling for calendar year 2024.
DRAFTING INFORMATION
The principal author of this revenue
procedure is Waheed Olayan of the Office
of Associate Chief Counsel (Passthroughs
and Special Industries). For further infor-
mation regarding this revenue procedure,
contact Mr. Olayan at (202) 317-6239 (not
a toll-free number).
Section 42 - Low-Income Housing Credit.
26 CFR 1.42-14. Allocation rules for post-1989 State housing credit ceiling amounts.
Guidance is provided to state housing credit agencies of qualified states that request an allocation of unused housing credit carryover
under section 42(h)(3)(D) of the Internal Revenue Code. See Rev. Proc. 2023-32.

November 18, 2024 1124 Bulletin No. 2024–47
Part IV
Deletions From Cumulative
List of Organizations,
Contributions to Which are
Deductible Under Section
170 of the Code
Announcement 2024-37
Table of Contents
The Internal Revenue Service has
revoked its determination that the organi-
zations listed below qualify as organiza-
tions described in sections 501(c)(3) and
170(c)(2) of the Internal Revenue Code
of 1986.
Generally, the IRS will not disallow
deductions for contributions made to a
listed organization on or before the date
of announcement in the Internal Revenue
Bulletin that an organization no longer
qualifies. However, the IRS is not pre-
cluded from disallowing a deduction for
any contributions made after an organiza-
tion ceases to qualify under section 170(c)
(2) if the organization has not timely filed
a suit for declaratory judgment under sec-
tion 7428 and if the contributor (1) had
knowledge of the revocation of the ruling
or determination letter, (2) was aware that
such revocation was imminent, or (3) was
in part responsible for or was aware of the
activities or omissions of the organization
that brought about this revocation.
If on the other hand a suit for declaratory
judgment has been timely filed, contri-
butions from individuals and organiza-
tions described in section 170(c)(2) that
are otherwise allowable will continue
to be deductible. Protection under sec-
tion 7428(c) would begin on November
01, 2024, and would end on the date the
court first determines the organization is
not described in section 170(c)(2) as more
particularly set for in section 7428(c)(1).
For individual contributors, the maximum
deduction protected is $1,000, with a hus-
band and wife treated as one contributor.
This benefit is not extended to any indi-
vidual, in whole or in part, for the acts or
omissions of the organization that were
the basis for revocation.
Name Of OrganizationEffective Date of RevocationLocation
Out of the Closet Foundation Inc1/1/2021New York, NY
Saved in America incorporated1/1/2019Valley Center, CA

Bulletin No. 2024–47 1125 November 18, 2024
Notice of Proposed
Rulemaking
Enhancing Coverage of
Preventive Services Under
the Affordable Care Act
REG-110878-24
AGENCY: Internal Revenue Service,
Department of the Treasury; Employee
Benefits Security Administration, Depart-
ment of Labor; Centers for Medicare &
Medicaid Services, Department of Health
and Human Services.
ACTION: Proposed rule.
SUMMARY: This document sets forth
proposed rules that would amend the
regulations regarding coverage of cer-
tain preventive services under the Public
Health Service Act. Specifically, this doc-
ument proposes rules that would provide
that medical management techniques
used by non-grandfathered group health
plans and health insurance issuers offer-
ing non-grandfathered group or individual
health insurance coverage with respect
to such preventive services would not
be considered reasonable unless the plan
or issuer provides an easily accessible,
transparent, and sufficiently expedient
exceptions process that would allow an
individual to receive coverage without
cost sharing for the preventive service
that is medically necessary with respect to
the individual, as determined by the indi-
vidual’s attending provider, even if such
service is not generally covered under the
plan or coverage. These proposed rules
also contain separate requirements that
would apply to coverage of contraceptive
items that are preventive services under
the Public Health Service Act. Specifi-
cally, these proposed rules would require
plans and issuers to cover certain recom-
mended over-the-counter contraceptive
items without requiring a prescription and
without imposing cost-sharing require-
ments. In addition, the proposed rules
would require plans and issuers to cover
certain recommended contraceptive items
that are drugs and drug-led combination
products without imposing cost-shar-
ing requirements, unless a therapeutic
equivalent of the drug or drug-led com-
bination product is covered without cost
sharing. Finally, this document proposes
to require a disclosure pertaining to cov-
erage and cost-sharing requirements for
over-the-counter contraceptive items in
plans’ and issuers’ Transparency in Cov-
erage internet-based self-service tools or,
if requested by the individual, on paper.
These proposed rules would not modify
Federal conscience protections related
to contraceptive coverage for employers,
plans and issuers.
DATES: To be assured consideration,
comments must be received at one of the
addresses provided below by December
27, 2024.
ADDRESSES: Written comments may be
submitted to the address specified below.
Any comment that is submitted will be
shared with the Department of the Treasury,
Internal Revenue Service, and the Depart-
ment of Health and Human Services (HHS).
Commenters should 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 infor-
mation) or confidential business infor-
mation that you do not want publicly dis-
closed. All 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, please refer to file
code 1210-AC25.
Comments must be submitted in one
of the following two ways (please choose
only one of the ways listed):
1. Electronically. You may submit
electronic comments on this regulation to
https://www.regulations.gov. Follow the
“Submit a comment” instructions.
2. By mail. You may mail written com-
ments to the following address ONLY:
Office of Health Plan Standards and
Compliance Assistance,
Employee Benefits Security Adminis-
tration,
Room N-5653,
U.S. Department of Labor,
Washington, DC 20210,
Attention: 1210-AC25.
Always allow sufficient time for mailed
comments to be received before the close
of the comment period. Because of staff
and resource limitations, the Departments
cannot accept comments by facsimile
(FAX) transmission.
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 infor-
mation that is included in a comment. The
comments are posted on the following
website as soon as possible after they have
been received: https://www.regulations.
gov. Follow the search instructions on that
website to view public comments.
Plain Language Summary: In accor-
dance with 5 U.S.C. 553(b)(4), a summary
of these proposed rules of not more than
100 words in length, in plain language,
may be found at https://www.regulations.
gov/.
FOR FURTHER INFORMATION
CONTACT: Regan Rusher, Internal Rev-
enue Service, Department of the Treasury,
at (202) 317-5500. Matthew Meidell,
Employee Benefits Security Administra-
tion, Department of Labor, at (202) 693-
8335. Rebecca Miller, Employee Bene-
fits Security Administration, Department
of Labor, at (202) 693-8335. Geraldine
Doetzer, Centers for Medicare & Medic-
aid Services, Department of Health and
Human Services at (667) 290–8855. Ken-
dra May, Centers for Medicare & Medic-
aid Services, Department of Health and
Human Services at (301) 448-3996.
Customer Service Information: Indi-
viduals interested in obtaining information
from the Department of Labor (DOL) con-
cerning employment-based health cover-
age laws may call the Employee Benefits
Security Administration (EBSA) Toll-Free
Hotline 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 on non-Fed-
eral governmental plans can be found on
the Centers for Medicare & Medicaid Ser-
vices (CMS) website (www.cms.gov/cciio),
and information on health care reform can
be found at www.HealthCare.gov.

November 18, 2024 1126 Bulletin No. 2024–47
SUPPLEMENTARY INFORMATION:
I. Background
A. Coverage of Preventive Services
Under the Affordable Care Act and
Implementing Regulations
The Patient Protection and Affordable
Care Act (Pub. L. 111-148) was enacted
on March 23, 2010. The Health Care
and Education Reconciliation Act of
2010 (Pub. L. 111-152) was enacted on
March 30, 2010. These statutes are collec-
tively known as the Affordable Care Act
(ACA). The ACA reorganized, amended,
and added to the provisions of part A of
title XXVII of the Public Health Service
Act (PHS Act) relating to group health
plans and health insurance issuers in the
group and individual markets. The ACA
added section 715(a)(1) to the Employee
Retirement Income Security Act of 1974
(ERISA)
1
and section 9815(a)(1) to the
Internal Revenue Code (Code)
2
to incor-
porate the provisions of part A of title
XXVII of the PHS Act into ERISA and
the Code, and to make them applicable to
group health plans and health insurance
issuers providing health insurance cover-
age in connection with group health plans.
Section 2713 of the PHS Act,
3
as added
by section 1001 of the ACA and incor-
porated into ERISA and the Code, and
its implementing regulations require that
non-grandfathered group health plans
and health insurance issuers offering
non-grandfathered group or individual
health insurance coverage (plans and issu-
ers) provide coverage without imposing
any cost-sharing requirements for the fol-
lowing items and services:
4
Evidence-based items or services that
have in effect a rating of “A” or “B” in the
current recommendations of the United
States Preventive Services Task Force
(USPSTF) with respect to the individual
involved, except for the recommendations
of the USPSTF regarding breast cancer
screening, mammography, and prevention
issued in or around November 2009;
5,6

Immunizations for routine use in chil-
dren, adolescents, and adults that have
in effect a recommendation from the
Advisory Committee on Immunization
Practices (ACIP) of the Centers for Dis-
ease Control and Prevention (CDC) with
respect to the individual involved;
7

With respect to infants, children, and
adolescents, evidence-informed preven-
tive care and screenings provided for
in comprehensive guidelines supported
by the Health Resources and Services
Administration (HRSA); and
With respect to women,
8
such addi-
tional preventive care and screenings not
described in the USPSTF recommenda-
tions in PHS Act section 2713(a)(1), as
provided for in comprehensive guidelines
supported by HRSA.
9
On August 1, 2011, HRSA established
the HRSA-supported Women’s Preventive
Services Guidelines (HRSA-supported
Guidelines) based on recommendations
from a Department of Health and Human
Services’ (HHS) commissioned study
by the Institute of Medicine.
10
Among
other recommended items and services,
the 2011 HRSA-supported Guidelines
addressed contraceptive methods and
counseling as a type of preventive service
and included all Food and Drug Admin-
istration (FDA)-approved “contraceptive
methods, sterilization procedures, and
patient education and counseling for all
women with reproductive capacity.”
11
The
HRSA-supported Guidelines’ recommen-
dation on contraception has been updated
several times, including in 2016,
12
and
most recently in 2021.
13
The 2011
HRSA-supported Guidelines included for
each type of preventive service a column
labeled “Frequency,” which for contra-
1
29 U.S.C. 1185d.
2
26 U.S.C. 9815.
3
42 U.S.C. 300gg–13.
4
The items and services described in these recommendations and guidelines are referred to in this preamble as “recommended preventive services.”
5
The USPSTF published updated breast cancer screening recommendations in April 2024. However, section 223 of title II of Division D of the Further Consolidated Appropriations Act,
2024 (Pub. L. 118–47) requires that for purposes of PHS Act section 2713, USPSTF recommendations relating to breast cancer screening, mammography, and prevention issued before 2009
remain in effect until January 1, 2026.
6
On September 19, 2024, the Departments filed a petition for a writ of certiorari requesting U.S. Supreme Court review of the decision of the U.S. Court of Appeals for the Fifth Circuit in
Braidwood Management v. Becerra, which found in part that the actions taken by the Departments under section 2713(a) of the PHS Act to require coverage of certain preventive services
recommended by the USPSTF are unconstitutional and unenforceable by the Departments as to the named plaintiffs. See 104 F.4th 930 (5th Cir. 2024), petition for cert. filed (U.S. Sept. 19,
2024) (No. 24-316).
7
In addition, under section 3203 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), enacted on March 27, 2020 (Pub. L.116-136), plans and issuers must cover, without
cost-sharing requirements, any qualifying coronavirus preventive service pursuant to section 2713(a) of the PHS Act and its implementing regulations (or any successor regulations). The
term “qualifying coronavirus preventive service” means an item, service, or immunization that is intended to prevent or mitigate coronavirus disease 2019 (COVID-19) and that is (1) an
evidence-based item or service that has in effect a rating of “A” or “B” in the current USPSTF recommendations; or (2) an immunization that has in effect a recommendation from ACIP
with respect to the individual involved. See FAQs about Families First Coronavirus Response Act, Coronavirus Aid, Relief, and Economic Security Act, and Health Insurance Portability and
Accountability Act Implementation Part 58, Q4 (Mar. 29, 2023), available at https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-58.pdf and
https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/faqs-part-58.pdf.
8
Consistent with the terminology in the statute, for purposes of coverage of contraceptive items, these proposed rules use the term “women” to refer to all individuals potentially capable of
becoming pregnant. Plans and issuers are required to cover contraceptive services for all such individuals consistent with the requirements in 26 CFR 54.9815-2713, 29 CFR 2590.715-2713,
and 45 CFR 147.130. See FAQs about Affordable Care Act Implementation Part XXVI, Q5 (May 11, 2015), available at https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/
resource-center/faqs/aca-part-xxvi.pdf and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf.
9
For accommodations and exemptions with respect to coverage of recommended contraceptive services, see 26 CFR 54.9815-2713A, 29 CFR 2590.715-2713A, and 45 CFR 147.131 through
147.133.
10
See HRSA (2011), “Women’s Preventive Services: Required Health Plan Coverage,” available at: https://web.archive.org/web/20130526033922/https:/www.hrsa.gov/womensguidelines/
index.html; see also Institute of Medicine, “Clinical Preventive Services for Women: Closing the Gaps” (2011), available at https://nap.nationalacademies.org/read/13181/chapter/7.
11
The references in this preamble to “contraception,” “contraceptive,” “contraceptive coverage,” “contraceptive services,” “contraceptive product,” or “contraceptive item” generally
include all contraceptives, sterilization, and related patient education and counseling recommended by the currently applicable HRSA-supported Guidelines, unless otherwise indicated.
12
The HRSA-supported Guidelines, as amended in December 2016, refer, under the header “Contraception,” to: “the full range of female-controlled U.S. Food and Drug Administration-ap-
proved contraceptive methods, effective family planning practices, and sterilization procedures,” “contraceptive counseling, initiation of contraceptive use, and follow-up care (e.g., man-
agement, and evaluation as well as changes to and removal or discontinuation of the contraceptive method),” and “instruction in fertility awareness-based methods, including the lactation
amenorrhea method.” See https://www.hrsa.gov/womens-guidelines-2016/index.html.
13
See HRSA, “Women’s Preventive Services Guidelines: Current Guidelines,” available at https://www.hrsa.gov/womens-guidelines.

Bulletin No. 2024–47 1127 November 18, 2024
ceptive methods and counseling, stated,
“as prescribed.” The “Frequency” column
does not appear in the 2016, 2019, or 2021
updated HRSA-supported Guidelines for
any preventive service, and the updated
HRSA-supported Guidelines do not con-
tain language that specifies frequency in
accordance with a prescription for contra-
ceptive methods (or contraceptives) by a
health care provider Plans and issuers are
required to provide coverage of women’s
preventive services, including contracep-
tive items and services, without cost shar-
ing, consistent with the 2021 HRSA-sup-
ported Guidelines, for plan years and
policy years beginning on or after Decem-
ber 30, 2022.
14
The 2021 HRSA-sup-
ported Guidelines refer, under the header
“Contraception,” to “the full range of
contraceptives and contraceptive care
to prevent unintended pregnancies and
improve birth outcomes.” The term “con-
traceptive methods” was replaced in 2021
by “contraceptives.”
15
With the removal of
the phrase “female-controlled,” as HRSA
explained,
16
male condoms are included
in the 2021 HRSA-supported Guidelines,
which also include “screening, education,
counseling, and provision of contracep-
tives (including in the immediate post-
partum period)” including “follow-up
care (e.g., management, evaluation and
changes, including the removal, contin-
uation, and discontinuation of contra-
ceptives).”
17
The 2021 HRSA-supported
Guidelines recommend “the full range
of U.S. Food and Drug Administration
(FDA)-approved, -granted, or -cleared
contraceptives, effective family planning
practices, and sterilization procedures be
available as part of contraceptive care.”
18
The Departments of the Treasury,
Labor, and HHS (the Departments) pre-
viously issued rulemaking to implement
the preventive services requirements of
section 2713 of the PHS Act, using their
authority under section 9833 of the Code,
section 734 of ERISA, and section 2792
of the PHS Act.
19
On July 19, 2010, the
Departments issued interim final rules
(July 2010 interim final rules) at 26 CFR
54.9815-2713T, 29 CFR 2590.715-2713,
and 45 CFR 147.130, which require that
plans and issuers provide coverage of
recommended preventive services gen-
erally for plan years or policy years that
begin on or after September 23, 2010; or,
if later, for plan years or policy years that
begin on or after the date that is one year
after the recommendation or guideline
is issued.
20
Among other provisions, the
July 2010 interim final rules allow plans
and issuers to rely on the relevant clini-
cal evidence base to impose reasonable
medical management techniques to deter-
mine the frequency, method, treatment, or
setting for coverage of a recommended
preventive health item or service, to the
extent not specified in the applicable rec-
ommendation or guideline.
21
Additionally,
if a plan or issuer has a provider in its
network that can provide a recommended
preventive service, the July 2010 interim
final rules specify that the plan or issuer is
not required to provide coverage or waive
cost sharing for the item or service when
delivered by an out-of-network provider.
22

However, if a plan or issuer does not have
in its network a provider who can provide
a recommended preventive service (or the
plan or coverage does not have a network),
the plan or issuer must cover the item or
service when performed by an out-of-net-
work provider, and may not impose any
cost-sharing requirements with respect
to the item or service. The Departments
finalized these rules on July 14, 2015.
23
The Departments have also previously
issued rules that provide exemptions from
the contraceptive coverage requirement
for entities and individuals with moral
or religious objections to contraceptive
coverage, and accommodations through
which objecting entities are not required
to contract, arrange, pay, or provide a
referral for contraceptive coverage, while
at the same time ensuring that partici-
pants, beneficiaries, and enrollees enrolled
in coverage sponsored or arranged by an
objecting entity could separately obtain
contraceptive services at no additional
cost.
24
Most recently, on February 2, 2023,
the Departments issued proposed rules
(2023 proposed rules) to rescind the moral
exemption to the contraceptive cover-
age requirement and to establish a new
“individual contraceptive arrangement,”
an independent pathway that individuals
enrolled in plans or coverage sponsored,
arranged, or provided by objecting entities
could use to obtain contraceptive services
at no cost directly from a provider or facil-
ity that furnishes contraceptive services.
25
B. Guidance Related to the Coverage of
Recommended Preventive Services
Since publishing the July 2010 interim
final rules, the Departments have issued
extensive guidance related to the require-
ment to cover recommended preventive
services, including contraceptive ser-
vices, without cost sharing under section
14
The Departments’ regulations under section 2713 of the PHS Act at 26 CFR 54.9815-2713T, 29 CFR 2590.715-2713, and 45 CFR 147.130 require that plans and issuers provide coverage
of recommended preventive services generally for plan years (in the individual market, policy years) that begin on or after September 23, 2010, or, if later, for plan years (in the individual
market, policy years) that begin on or after the date that is one year after the date the recommendation or guideline is issued.
15
See 86 FR 59741, 59742 (Oct. 28, 2021).
16
HRSA stated that this change was made to allow women to purchase male condoms for pregnancy prevention. See id.
17
See HRSA, Women’s Preventive Services Guidelines, available at https://www.hrsa.gov/womens-guidelines/index.html (version last reviewed March 2024, accessed September 25, 2024).
18
Id.
19
26 U.S.C. 9833, 29 U.S.C. 1191c, and 42 U.S.C. 300gg-92.
20
75 FR 41726 (July 19, 2010).
21
26 CFR 54.9815-2713T(a)(4); 29 CFR 2590.715-2713(a)(4); and 45 CFR 147.130(a)(4).
22
26 CFR 54.9815-2713T(a)(3); 29 CFR 2590.715-2713(a)(3); and 45 CFR 147.130(a)(3).
23
80 FR 41318 (July 14, 2015).
24
These proposed rules would not modify Federal conscience protections related to contraceptive coverage for employers, plans and issuers. The rules related to optional accommodations
for certain eligible entities (26 CFR 54.9815-2713A, 29 CFR 2510.3-16 and 2590.715-2713A, and 45 CFR 147.131) and religious (45 CFR 147.132) and moral (45 CFR 147.133) exemptions
in connection with the coverage of certain recommended preventive services—as well as the conscience protections that apply to certain health care providers, patients, and other partici-
pants (45 CFR part 88)—are outside the scope of these proposed rules. For a detailed overview of the regulatory and judicial history of Departmental rules specifically related to optional
accommodations and religious and moral exemptions from the contraceptive coverage requirement, see 88 FR 7236, 7237-40 (Feb. 2, 2023). For additional information on the Department
of Health and Human Services’ final rule on enforcement of religious freedom and conscience laws, see 89 FR 2078 (Jan. 11, 2024).
25
88 FR 7236.

November 18, 2024 1128 Bulletin No. 2024–47
2713 of the PHS Act and its implementing
regulations. These guidance documents
respond to questions from interested par-
ties regarding the requirement to provide
coverage for recommended preventive
services without cost sharing.
26
Cumula-
tively, this body of guidance interprets key
elements of the preventive health services
recommendations and guidelines and
coverage requirements, including with
respect to the allowed use of reasonable
medical management techniques.
27
These
guidance documents include:
Frequently Asked Questions on Feb-
ruary 20, 2013 (FAQs Part XII), which,
among other things, clarified the scope
of reasonable medical management with
respect to recommended preventive ser-
vices, including contraceptive items and
services. The FAQs specified that plans
and issuers must cover “the full range
of FDA-approved contraceptive meth-
ods” and must design reasonable med-
ical management techniques to include
accommodations for the specific medical
needs of an individual. FAQs Part XII,
Q14 noted that plans may, for example,
cover a generic drug without cost shar-
ing and impose cost sharing for equiva-
lent branded drugs. If, however, a generic
version is not available, or would not be
medically appropriate for the patient (as
determined by the attending provider, in
consultation with the patient), then a plan
or issuer must have a mechanism to pro-
vide coverage for the brand name drug
without any cost sharing.
28
FAQs Part XII
also interpreted the statutory and regula-
tory requirements to cover recommended
preventive services without cost sharing
to mean that recommended preventive
services (including contraceptive prod-
ucts) that are generally available without a
prescription must be covered without cost
sharing only when prescribed by a health
care provider.
29
Frequently Asked Questions on
May 11, 2015 (FAQs Part XXVI), which
clarified that plans and issuers must cover,
without cost sharing, at least one form
of contraception in each method
30
that is
identified by the FDA in its Birth Control
Guide.
31
FAQs Part XXVI further clarified
the scope of reasonable medical manage-
ment techniques by specifying that if mul-
tiple services and FDA-approved items
within a contraceptive category are med-
ically appropriate for an individual, the
plan or issuer may use reasonable medi-
cal management techniques to determine
which specific products to cover without
cost sharing with respect to that individ-
ual and, subject to the relevant facts and
circumstances, generally may impose cost
sharing (including full cost sharing) on
some items and services to encourage an
individual to use other specific items and
services within the chosen contraceptive
category.
32
However, if the individual’s
attending provider
33
recommends a partic-
ular service or FDA-approved, -cleared,
or -granted item based on a determination
of medical necessity with respect to that
individual, the plan or issuer must defer to
the determination of the attending provider
26
See FAQs about Affordable Care Act Implementation Part XII (Feb. 20, 2013), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/
aca-part-xii.pdf and www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs12.html; FAQs about Affordable Care Act Implementation Part XXVI (May 11, 2015),
available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xxvi.pdf and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-
FAQs/Downloads/aca_implementation_faqs26.pdf; FAQs about Affordable Care Act Implementation Part 31, Mental Health Parity Implementation, and Women’s Health and Cancer Rights
Act Implementation (April 20, 2016), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-31.pdf and https://www.cms.gov/cciio/
resources/fact-sheets-and-faqs/downloads/faqs-31_final-4-20-16.pdf; FAQs about Affordable Care Act Implementation Part 51, Families First Coronavirus Response Act, and Coronavirus
Aid, Relief, and Economic Security Act Implementation (Jan. 10, 2022), available at https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-51.
pdf and https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/FAQs-Part-51.pdf; FAQs about Affordable Care Act Implementation Part 54 (July 28, 2022), available
at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf and https://www.cms.gov/files/document/faqs-part-54.pdf.; and FAQs about
Affordable Care Act Implementation Part 64 (Jan. 22, 2024) available at https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-64 and https://www.
cms.gov/files/document/faqs-part-64.pdf.
27
As noted in section I.A of the preamble to these proposed rules, under 26 CFR 54.9815-2713T(a)(4), 29 CFR 2590.715-2713(a)(4), and 45 CFR 147.130(a)(4), plans and issuers may use
“reasonable medical management techniques” to determine the frequency, method, treatment, or setting for a recommended preventive service, to the extent this information is not specified
in a recommendation or guideline. Plans and issuers may rely on established techniques and the relevant clinical evidence base to determine the frequency, method, treatment, or setting
for coverage of a recommended preventive health item or service where cost sharing must be waived. Whether a medical management technique is reasonable depends on all the relevant
facts and circumstances. See FAQs Part 54, Q8 (July 28, 2022), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf and
https://www.cms.gov/files/document/faqs-part-54.pdf.
28
See FAQs Part XII, Q14 (Feb. 20, 2013), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xii.pdf and https://www.cms.gov/
cciio/resources/fact-sheets-and-faqs/aca_implementation_faqs12.
29
See id. at Q4 and Q15. As noted elsewhere in this section I.B, the language “as prescribed” appeared in the HRSA-supported Guidelines until 2016.
30
As noted in FDA’s Birth Control Guide (Chart), published in May 2024, available at https://www.fda.gov/media/150299/download, the FDA approves, clears, and grants marketing autho-
rization for individual contraceptive products, not “methods.” However, for purposes of this chart, which includes birth control options broader than products, the term “methods” is used.
Similarly, FAQs Part XXVI used the term “methods” consistent with the then-current FDA Birth Control Guide.
31
FAQs Part XXVI referenced the then-current 2015 FDA Birth Control Guide, which identified 18 contraceptive methods for women, but noted that the “FDA Birth Control Guide addi-
tionally lists sterilization surgery for men and male condoms, but the HRSA Guidelines exclude services relating to a man’s reproductive capacity.” See FAQs Part XXVI, fn. 12, available at
https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-xxvi.pdf and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/
aca_implementation_faqs26.pdf. The 2021 HRSA-supported Guidelines incorporated by reference a subsequent update of the FDA Birth Control Guide (as published on December 22,
2021), and now describes the full range of contraceptives to include: “(1) sterilization surgery for women, (2) implantable rods, (3) copper intrauterine devices, (4) intrauterine devices
with progestin (all durations and doses), (5) injectable contraceptives, (6) oral contraceptives (combined pill), 7) oral contraceptives (progestin only), (8) oral contraceptives (extended
or continuous use), (9) the contraceptive patch, (10) vaginal contraceptive rings, (11) diaphragms, (12) contraceptive sponges, (13) cervical caps, (14) condoms, (15) spermicides, (16)
emergency contraception (levonorgestrel), and (17) emergency contraception (ulipristal acetate), and any additional contraceptives approved, granted, or cleared by the FDA.” See FAQs
Part 64 (Jan. 22, 2024), available at https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-64.pdf and https://www.cms.gov/files/document/
faqs-part-64.pdf. The 2021 HRSA-supported Guidelines also state: “Additionally, instruction in fertility awareness-based methods, including the lactation amenorrhea method, although less
effective, should be provided for women desiring an alternative method.”
32
See FAQs Part XXVI, Q3 (May 11, 2015), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xxvi.pdf and https://www.cms.
gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf. For example, a plan could use cost sharing to encourage use of one of several FDA-approved
intrauterine devices (IUDs) with progestin by imposing cost sharing on the more costly IUD with progestin while waiving cost sharing for a less costly IUD with progestin.
33
See id. at Q1, fn. 13 (“An attending provider means an individual who is licensed under applicable State law, who is acting within the scope of the provider’s license, and who is directly
responsible for providing care to the patient relating to the recommended preventive services. Therefore, a plan, issuer, hospital, or managed care organization is not an attending provider.”)

Bulletin No. 2024–47 1129 November 18, 2024
with respect to the individual involved,
and cover that item or service without cost
sharing.
34
Additionally, FAQs Part XXVI
specified that to the extent a plan or issuer
uses reasonable medical management
techniques within a specified method of
contraception, the plan or issuer must
have an easily accessible, transparent, and
sufficiently expedient exceptions process
that is not unduly burdensome on the indi-
vidual or a provider (or other individual
acting as a patient’s authorized represen-
tative) to ensure coverage without cost
sharing of any service or FDA-approved
item within the specified method of con-
traception that has been recommended by
the individual’s attending provider based
on a determination of medical necessity.
35
Frequently Asked Questions on
April 20, 2016 (FAQs Part 31), which
further clarified the requirements on plans
and issuers with respect to the develop-
ment and implementation of an exceptions
process, including that plans and issuers
that meet all other requirements are per-
mitted to develop and utilize a standard
exceptions process form (such as the
Medicare Part D Coverage Determination
Request Form) and instructions as part of
the exceptions process.
36
Frequently Asked Questions on
July 19, 2021 (FAQs Part 47), which fol-
lowed USPSTF’s release on June 11, 2019
of a recommendation with an “A” rating
that clinicians offer preexposure prophy-
laxis (PrEP) with “effective antiretroviral
therapy to persons who are at high risk
of human immunodeficiency virus (HIV)
acquisition.”
37
FAQs Part 47 clarified that
plans and issuers are required to cover,
without cost sharing, all items and ser-
vices that USPSTF recommends should
be received prior to being prescribed PrEP
and for ongoing follow-up and monitor-
ing. These items and services include
specific baseline and monitoring services,
such as laboratory testing and adherence
counseling. The FAQs also clarified that
plans and issuers utilizing reasonable
medical management must have an easily
accessible, transparent, and sufficiently
expedient exceptions process that is not
unduly burdensome on the individual or a
provider (or other individual acting as an
authorized representative).
Frequently Asked Questions on Jan-
uary 10, 2022 (FAQs Part 51), which
acknowledged complaints received about
compliance with the contraceptive cov-
erage requirement and clarified currently
applicable guidance. Specifically, FAQs
Part 51, Q9 was issued in response to
complaints and public reports of poten-
tial violations of the contraceptive cover-
age requirement, including that plans and
issuers and pharmacy benefit managers
(PBMs) were not adhering to requirements
for utilizing reasonable medical manage-
ment techniques. The FAQs also high-
lighted several examples of such potential
violations, including denying coverage
for all or particular brand name contracep-
tives, even after the individual’s attending
provider determines and communicates to
the plan or issuer that a particular service
or FDA-approved, -cleared, or -granted
contraceptive product is medically neces-
sary with respect to that individual; requir-
ing individuals to fail first using numerous
other services or FDA-approved, -cleared,
or -granted contraceptive products within
the same method of contraception before
the plan or issuer will approve coverage
for a service or FDA-approved, -cleared,
or -granted contraceptive product that is
medically appropriate for the individual,
as determined by the individual’s attend-
ing health care provider; requiring indi-
viduals to fail first using numerous other
services or FDA-approved, -cleared, or
-granted contraceptive products in other
contraceptive methods before the plan or
issuer will approve coverage for a service
or FDA-approved, -cleared, or -granted
contraceptive product that is medically
appropriate for the individual, as deter-
mined by the individual’s attending health
care provider; and failing to provide an
acceptable exceptions process (for exam-
ple, by requiring individuals to appeal
an adverse benefit determination using
the plan’s or issuer’s internal claims and
appeals process, rather than providing an
exceptions process that is easily accessi-
ble, transparent, sufficiently expedient,
and not unduly burdensome).
38
Frequently Asked Questions on
July 28, 2022 (FAQs Part 54), which
further clarified the contraceptive cover-
age requirement and currently applicable
guidance. These FAQs clarified that plans
and issuers must cover, without imposing
cost-sharing requirements, items and ser-
vices that are integral to a recommended
contraceptive service.
39
The FAQs also
stated that plans and issuers must cover
any FDA-approved, -cleared, or -granted
contraceptive products and services that
an individual and their attending provider
have determined to be medically appro-
priate for the individual, regardless of
whether those products or services are spe-
cifically identified in the categories listed
in the HRSA-supported Guidelines.
40
For
contraceptive services or FDA-approved,
-cleared, or -granted contraceptive prod-
ucts not included in a category described
in the HRSA-supported Guidelines, the
FAQs stated that plans and issuers may
use reasonable medical management tech-
niques to determine which specific prod-
ucts to cover without cost sharing only if
multiple, substantially similar services or
products that are not included in a cate-
gory described in the HRSA-supported
34
See id. at introduction and Q3.
35
Id. at Q2.
36
FAQs Part 31, Q2 (April 20, 2016), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-31.pdf and https://www.cms.gov/
CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-31_Final-4-20-16.pdf.
37
FAQs about Affordable Care Act Implementation Part 47 (July 19, 2021), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-
part-47.pdf and https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/faqs-part-47.pdf. Note that USPSTF subsequently updated the recommendation referenced in FAQs
Part 47. See USPSTF, Prevention of Acquisition of HIV: Preexposure Prophylaxis, updated August 22, 2023, available at https://www.uspreventiveservicestaskforce.org/uspstf/recommenda-
tion/prevention-of-human-immunodeficiency-virus-hiv-infection-pre-exposure-prophylaxis.
38
FAQs Part 51, Q9 (Jan. 10, 2022), available at https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-51.pdf and https://www.cms.gov/CCIIO/
Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-51.pdf.
39
FAQs Part 54, Q1 (July 28, 2022), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf and https://www.cms.gov/files/
document/faqs-part-54.pdf.
40
Id. at Q2.

November 18, 2024 1130 Bulletin No. 2024–47
Guidelines are medically appropriate for
the individual. The FAQs further stated
that if the individual’s attending pro-
vider recommends a particular service
or FDA-approved, -cleared, or -granted
product not included in a category
described in the HRSA-supported Guide-
lines based on a determination of medical
necessity with respect to that individual,
the plan or issuer must cover that service
or product without cost sharing. The plan
or issuer must defer to the determination
of the attending provider and must make
available an easily accessible, transpar-
ent, and sufficiently expedient exceptions
process that is not unduly burdensome
so the individual or their provider (or
other individual acting as the individual’s
authorized representative) can obtain cov-
erage for the medically necessary service
or product for the individual without cost
sharing as required under PHS Act section
2713 and its implementing regulations
and guidance.
41
The FAQs also encour-
aged plans and issuers to cover over-the-
counter (OTC) emergency contraceptive
products with no cost sharing when they
are purchased by consumers without a
prescription.
42
FAQs Part 54, Q8 further
acknowledged that the Departments con-
tinued to receive complaints and reports
that participants, beneficiaries, and enroll-
ees were being denied contraceptive cov-
erage, in some cases due to the application
of medical management techniques that
were not reasonable based on all of the
relevant facts and circumstances. In addi-
tion to summarizing ongoing complaints
similar to those highlighted in FAQs Part
51, Q9, the Departments also noted that
they were aware of complaints that plans
and issuers or PBMs were imposing age
limits on contraceptive coverage rather
than providing these benefits to all indi-
viduals with reproductive capacity. FAQs
Part 54, Q13 also described actions within
the scope of the authority of the Depart-
ments of Labor and HHS to enforce the
requirements of PHS Act section 2713.
43
Frequently Asked Questions on Jan-
uary 22, 2024 (FAQs Part 64), which
provided further clarifications regarding
contraceptive coverage requirements,
including providing guidance regarding
a therapeutic equivalence approach. The
FAQs explained that plans and issuers
could adopt a therapeutic equivalence
approach (in combination with an eas-
ily accessible, transparent, and suffi-
ciently expedient exceptions process that
is not unduly burdensome) to ensure the
plan’s or issuer’s medical management
techniques for contraceptive drugs and
drug-led devices
44
that are required to be
covered under PHS Act section 2713 are
reasonable.
45
Specifically, with respect
to FDA-approved contraceptive drugs
and drug-led devices, if a plan or issuer
utilizes medical management techniques
within a specified category described in
the HRSA-supported Guidelines (or group
of substantially similar products that are
not included in a specified category), the
Departments will generally consider such
medical management techniques to be
reasonable if the plan or issuer covers all
FDA-approved contraceptive drugs and
drug-led devices in that category (or group
of substantially similar products) without
cost sharing, other than those for which
there is at least one therapeutic equivalent
drug or drug-led device that the plan or
issuer covers without cost sharing.
C. Executive Orders on the Affordable
Care Act and Reproductive Health
On January 28, 2021, President Biden
issued Executive Order 14009, “Strength-
ening Medicaid and the Affordable Care
Act” (E.O. 14009).
46
Section 3 of E.O.
14009 directs the Secretaries of the
Departments (the Secretaries) to review
all existing regulations, guidance docu-
ments, and policies to determine whether
such actions are inconsistent with protect-
ing and strengthening Medicaid and the
ACA and making high-quality health care
accessible and affordable for every Amer-
ican.
On April 5, 2022, President Biden
issued Executive Order 14070, “Con-
tinuing To Strengthen Americans’ Access
to Affordable, Quality Health Coverage”
(E.O. 14070).
47
Section 2 of E.O. 14070
reaffirms the goals and policy of E.O.
14009 and further directs agencies with
responsibilities related to Americans’
access to health coverage to consider and
pursue agency actions that improve the
comprehensiveness of coverage and pro-
tect consumers from low-quality cover-
age.
Following the U.S. Supreme Court
decision in Dobbs v. Jackson Women’s
Health Organization (Dobbs),
48
Pres-
ident Biden issued Executive Order
14076, “Protecting Access to Reproduc-
tive Healthcare Services” (E.O. 14076)
on July 8, 2022. Section 3 of E.O. 14076
requires the Secretary of HHS to identify
potential actions to “protect and expand
access to the full range of reproductive
healthcare services, including actions to
enhance family planning services such
as access to emergency contraception”
and identify “ways to increase outreach
and education about access to reproduc-
tive healthcare services, including by
launching a public awareness initiative
to provide timely and accurate informa-
tion about such access, which shall...
include promoting awareness of and
access to the full range of contraceptive
services.”
49
41
Id. at Q3.
42
Id. at Q5.
43
See FAQs Part 54, Q5, Q8, and Q13 (July 28, 2022), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf and https://
www.cms.gov/files/document/faqs-part-54.pdf.
44
In FAQs Part 64, the term “drug-led device” referred to a combination product, as defined under 21 CFR 3.2(e), that is comprised of a drug and a device, and for which the drug component
provides the primary mode of action. The primary mode of action of a combination product is the single mode of action (that is, the action provided by the drug, device, or biological product)
that provides the most important therapeutic action of the combination product. See 21 U.S.C. 353(g)(1)(C) and 21 CFR 3.2(m). As further discussed in section II.A.2 of the preamble to
these proposed rules, the Departments propose a substantially similar definition of the term “drug-led combination product” in these proposed rules to refer to the same products for which
the term “drug-led device” was used in FAQs Part 64.
45
FAQs Part 64 (Jan. 22, 2024), available at https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-64.pdf and https://www.cms.gov/files/docu-
ment/faqs-part-64.pdf.
46
86 FR 7793.
47
87 FR 20689.
48
597 U.S. 215 (2022).
49
87 FR 42053.

Bulletin No. 2024–47 1131 November 18, 2024
On June 23, 2023, President Biden
issued Executive Order 14101, “Strength-
ening Access to Affordable, High-Quality
Contraception and Family Planning Ser-
vices” (E.O. 14101).
50
Section 2 of E.O.
14101 directs the Secretaries to consider
issuing guidance “to further improve
Americans’ ability to access contraception,
without out-of-pocket expenses, under
the Affordable Care Act” and to consider
additional actions “to promote increased
access to affordable over-the-counter con-
traception, including emergency contra-
ception.”
51
D. FDA Approval of Daily Over-the-
Counter Oral Contraceptive
On July 13, 2023, the FDA announced
that it had approved a progestin-only birth
control pill as the first daily oral contracep-
tive for use in the United States available
without a prescription.
52, 53
Interested par-
ties, including health care provider asso-
ciations, have supported the availability
of a daily OTC oral contraceptive for its
potential to improve access to affordable
contraception, thereby improving man-
agement of family planning and reducing
unintended pregnancies.
54
Studies have
shown that challenges with access and
costs are among the most common rea-
sons cited by women for not using con-
traception or having gaps in contraceptive
use.
55
One large, nationally representative
study found 29 percent of women reported
encountering barriers to obtaining or fill-
ing an initial prescription or refills of oral
contraceptive pills, specifically citing
insurance coverage, getting an appoint-
ment, not having a regular provider, and
difficulty accessing a pharmacy.
56
Accord-
ingly, the availability of a daily OTC
oral contraceptive could improve access
to contraception if the product is afford-
able, including if it is covered by insur-
ance without cost sharing, and as a result,
could reduce the number of unintended
pregnancies.
57
Beginning in March 2024,
an OTC oral contraceptive has become
widely available for sale online and in
stores under the brand name Opill
®
, with
a manufacturer’s suggested retail price
ranging from $19.99 for a 1-month supply
to $89.99 for a 6-month supply.
58
E. OTC Preventive Products Request for
Information
As discussed in sections I.A and I.C of
this preamble, the Biden-Harris Adminis-
tration has prioritized access to compre-
hensive, high-quality contraception and
family planning services as critical com-
ponents of women’s reproductive health
and overall public health. In response
to E.O. 14009, E.O. 14070, E.O.14076,
and E.O. 14101, and following the FDA
approval of an OTC oral contraceptive,
as discussed in section I.D of this pream-
ble, the Departments issued a “Request
for Information; Coverage of Over-the-
Counter Preventive Services” on Octo-
ber 4, 2023 (OTC Preventive Products
RFI).
59
The Departments issued the OTC
Preventive Products RFI to gather public
feedback regarding the potential benefits
and costs of requiring plans and issuers
to cover OTC preventive products
60
with-
out cost sharing and without a prescrip-
tion; learn of any potential challenges
associated with providing such coverage;
understand whether and how providing
such coverage would benefit consum-
ers; and assess any potential burden that
plans and issuers would face if required
to provide such coverage.
The Departments received 376 unique
comments in response to the OTC Pre-
ventive Products RFI, including com-
ments from individuals; plans and issu-
ers; PBMs; State government agencies;
and advocacy organizations representing
consumers, health care providers, group
health plans, hospitals, and durable medi-
cal equipment suppliers. The Departments
reviewed comments received in response
to the OTC Preventive Products RFI as
part of the development of these proposed
rules. However, these proposed rules do
not address all the issues on which infor-
mation was requested.
50
88 FR 41815.
51
Id.
52
FDA (July 13, 2023). “FDA Approves First Nonprescription Daily Oral Contraceptive,” available at https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonpre-
scription-daily-oral-contraceptive.
53
Progestin-only oral contraceptives are a product that is already available in a prescription form and are a category of contraceptives listed in the FDA Birth Control Guide, as referenced
in the HRSA-supported Guidelines.
54
See American Medical Association (2023). “AMA Applauds FDA Approval of OTC Birth Control,” available at https://www.ama-assn.org/press-center/press-releases/ama-applauds-fda-
approval-otc-birth-control; The American College of Obstetricians and Gynecologists (2023). “ACOG Praises FDA Approval of Over-the-Counter Access to Birth Control Pill,” available
at https://www.acog.org/news/news-releases/2023/07/acog-praises-fda-approval-of-over-the-counter-access-to-birth-control-pill.
55
See Key, K., Wollum, A., Asetoyer, C., Cervantes, M., Lindsey, A., Rivera, R., Robinson Flint, J., Zuniga, C., Sanchez, J., and Baum, S. (2023). “Challenges accessing contraceptive care and
interest in over-the-counter oral contraceptive pill use among Black, Indigenous, and people of color: An online cross-sectional survey,” Contraception, available at https://doi.org/10.1016/j.
contraception.2023.109950; Thompson, E. L., Galvin, A. M., Garg, A., Diener, A., Deckard, A., Griner, S. B., and Kline, N. S. (2023). “A socioecological perspective to contraceptive access
for women experiencing homelessness in the United States,” Contraception, available at https://doi.org/10.1016/j.contraception.2023.109991; Bessett, D., Prager, J., Havard, J., Murphy,
D. J., Agénor, M., and Foster, A. M. (2015). “Barriers to contraceptive access after health care reform: Experiences of young adults in Massachusetts,” Women’s Health Issues, available at
https://doi.org/10.1016/j.whi.2014.11.002; and Johnson, E. R. (2022). “Health care access and contraceptive use among adult women in the United States in 2017,” Contraception, available
at https://doi.org/10.1016/j.contraception.2022.02.008.
56
Grindlay, K., Grossman, D. (2016). “Prescription Birth Control Access Among U.S. Women At Risk of Unintended Pregnancy,” Journal of Women’s Health, available at https://www.
liebertpub.com/doi/10.1089/jwh.2015.5312.
57
A recent study found that over 12 million adult women and nearly two million young women aged 15-17 would likely be interested in using an OTC oral contraceptive if it were free to them,
but the numbers declined to 7.1 million adult women and 760,000 young women if the out-of-pocket cost of the contraceptive was $15. The same study indicated that the levels of interest
would translate to an estimated eight percent decrease in unintended pregnancies (approximately 320,000 fewer) in one year among adult women when cost sharing was $0, and an estimated
five percent decrease (approximately 199,000 fewer unintended pregnancies) if there were a monthly out-of-pocket cost of $15. See Wollum, A., Trussell, J., Grossman, D., and Grindlay, K.
(2020). “Modeling the Impacts of Price of an Over-the-Counter Progestin-Only Pill on Use and Unintended Pregnancy among U.S. Women,” Women’s Health Issues, available at https://
www.sciencedirect.com/science/article/pii/S1049386720300037/pdfft?md5=903aee27ef3468f62abaf9091e0a957c&pid=1-s2.0-S1049386720300037-main.pdf.
58
Lupkin, S., NPR (March 18, 2024). “First over-the-counter birth control pill now for sale online,” available at https://npr.org/sections/health-shots/2024/03/04/1235404522/opill-over-
counter-birth-control-pill-contraceptive-shop.
59
88 FR 68519 (Oct. 4, 2023).
60
For consistency with the OTC Preventive Products RFI, this preamble uses the term “OTC preventive products” to refer to recommended preventive services that may be made available
to an individual without a prescription.

November 18, 2024 1132 Bulletin No. 2024–47
Many commenters stated that requir-
ing plans and issuers to cover all recom-
mended preventive services would pro-
mote health equity and improve health
outcomes by reducing costs and admin-
istrative barriers to accessing preventive
health care. Many commenters high-
lighted that prescription and cost-sharing
requirements represent a particular barrier
for people with lower incomes and Black,
Indigenous, and People of Color (BIPOC)
communities, and that requiring cover-
age of OTC preventive products without
cost sharing and without a prescription
would significantly lower these barriers,
thereby increasing access to OTC preven-
tive products in a manner that would be
especially beneficial to lower-income and
underserved populations.
Many commenters highlighted the par-
ticular benefit to women of requiring plans
and issuers to cover OTC contraceptive
items without requiring a prescription and
without cost-sharing requirements. Sev-
eral commenters pointed out that neither
section 2713 of the PHS Act nor its imple-
menting regulations impose a specific pre-
scription requirement on recommended
contraceptive items. These commenters
also highlighted HRSA’s removal of “as
prescribed” language which appeared in
the 2011 HRSA-supported Guidelines but
does not appear in the 2016 or any sub-
sequent version of the HRSA-supported
Guidelines.
61
In the view of these com-
menters, the existing prescription require-
ment is therefore based only on agency
guidance that is within the authority of the
Departments to revise.
62
Another commenter noted that, in the
United States, approximately one-third
of childbearing-aged women and those
capable of becoming pregnant expe-
rience difficulties obtaining hormonal
contraception, and that coverage of OTC
oral contraception without a prescription
and without cost sharing would improve
access to reproductive care for this group.
Several commenters highlighted the bur-
dens of a prescription requirement on
people seeking contraception, including
requesting time off from work, unnec-
essary visits to the doctor, appointment
wait times, and finding childcare, while
a few other commenters specifically
emphasized the importance of waiving
cost sharing to make OTC contraceptive
services truly accessible. One commenter
noted that access to affordable contracep-
tion was particularly important within the
context of widespread Medicaid cover-
age losses following the termination on
March 31, 2023 of the continuous enroll-
ment condition previously associated with
the COVID-19 public health emergency
(PHE).
63
Many other commenters sup-
ported requiring coverage of OTC con-
traceptive services in order to ensure that
women can access effective, affordable
means of preventing unintended pregnan-
cies in the wake of the Dobbs decision.
In addition to comments highlighting
the benefits to women of removing pre-
scription and cost-sharing requirements
for coverage of OTC contraceptive items,
several commenters noted that consumers
would benefit from increased access to
other specific OTC preventive products if
plans and issuers were required to cover
those other products without a prescription
and without cost sharing. For example,
several commenters stated that coverage
based on prescription requirements limits
access to OTC tobacco cessation prod-
ucts. One of these commenters empha-
sized that prescription requirements are a
particular barrier with respect to tobacco
cessation because of the nature of nicotine
addiction, which typically requires mul-
tiple quit attempts. In that commenter’s
view, removing cost-sharing and prescrip-
tion requirements would allow people to
access evidence-based treatment when
they are motivated to make a quit attempt,
without having to wait for a medical
appointment. Conversely, another com-
menter who acknowledged that removing
cost sharing on OTC tobacco cessation
products could have a positive effect on
access to these products, particularly for
people with low incomes, also empha-
sized the role of clinicians in screening
for and diagnosing tobacco use disorder
and recommending or prescribing effec-
tive treatments. This commenter encour-
aged the Departments to make an effort to
preserve the clinician-patient relationship
with respect to tobacco cessation products
to ensure that patients are properly con-
nected to care, including biomedical and
psychiatric services that may be comorbid
with tobacco use disorder.
Another commenter noted that a
woman who is not pregnant or planning
to become pregnant may not be under the
care of a prescribing health care provider
but could still benefit from the USPSTF
recommendation that women who could
become pregnant should consume a daily
folic acid supplement. A few comment-
ers described the disparate occurrence of
spina bifida in newborns born to Span-
ish-speaking people, which commenters
believe could be reduced if plans and
issuers were required to cover OTC folic
acid without cost sharing or prescription
requirements.
However, several commenters iden-
tified operational barriers to widespread
implementation of a requirement to cover
all recommended OTC preventive prod-
ucts without cost sharing or a prescrip-
tion. A few commenters noted potential
strains on pharmacies, retailers, and the
existing health care delivery system;
fraud and abuse threats; and potential cost
increases for plan sponsors and plan par-
ticipants. For example, one commenter
cited the administrative and cost burdens
that pharmacies and retailers could incur
if they were required to cover the upfront
costs of OTC preventive products and
pursue post-claim reimbursements. In
that commenter’s view, requiring plans
and issuers to provide coverage of OTC
preventive products without cost sharing
could also facilitate fraudulent behavior,
including sale to unauthorized persons or
re-sale outside of the health care market,
that could in turn create a shadow mar-
ket based on overuse and misuse. This
commenter highlighted the existing sig-
nificant clinical and administrative bur-
61
See section I.A of this preamble for a discussion of the “as prescribed” language.
62
See, e.g., FAQs Part XII, Q4 (Feb. 20, 2013), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xii.pdf and www.cms.gov/
CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs12.html.
63
See Center for Medicare and Medicaid Services (CMS), Center for Consumer Information and Insurance Oversight, Temporary Special Enrollment Period (SEP) for Consumers Los-
ing Medicaid or the Children’s Health Insurance Program (CHIP) Coverage Due to Unwinding of the Medicaid Continuous Enrollment Condition— Frequently Asked Questions (FAQ)
(Jan. 27, 2023), available at https://www.cms.gov/technical-assistance-resources/temp-sep-unwinding-faq.pdf.

Bulletin No. 2024–47 1133 November 18, 2024
dens that already strain pharmacist and
retailer resources (ranging from filling
and dispensing medications to provid-
ing immunizations, patient counseling,
and information about insurance eligi-
bility and coverage), and expressed con-
cern that the responsibility for educating
consumers about potential access to and
appropriateness of OTC contraceptives
would fall to pharmacists and retailers
at the point of sale. Another commenter
noted that requiring coverage of OTC
preventive products such as contracep-
tives, OTC naloxone, and smoking ces-
sation products without cost sharing or
a prescription would increase access
to such products but advised that such
requirements would increase administra-
tive burden on pharmacists by increasing
workload and costs and decreasing reim-
bursement for vital patient counseling
and additional services. One commenter
indicated that using a credit card (rather
than a debit card or paper reimburse-
ment system) would facilitate coverage
of OTC preventive products, but also
noted that the use of a credit card with-
out a fixed spending limit would be more
likely to lead to fraud and would neces-
sitate implementing systems for freezing
or repaying cards in the case of misuse.
Another commenter indicated general
support for access to recommended pre-
ventive products without cost sharing
but stated that prescription requirements
were necessary for many products to
ensure that individual patients receive
appropriate care. In that commenter’s
view, the cost associated with applying
a market-wide OTC preventive products
coverage requirement would disrupt and
likely outweigh any benefits of chang-
ing long-established coverage patterns.
This commenter recommended that the
Departments consider establishing a
standing order for Opill
®
only, in order to
conduct a targeted roll-out of a potential
broader OTC preventive products cover-
age requirement without overburdening
the health care system by attempting to
implement the changes for all OTC pre-
ventive products at once. The same com-
menter, however, warned against requir-
ing coverage of OTC products that do
not have meaningful market competition,
such as Opill
®
, to avoid inadvertently
driving up retail prices. Another com-
menter shared similar concerns regarding
the potential for generating demand for
preventive items and services that would
ultimately be unused. A few commenters
noted the particular cost and negative
environmental impact that could be real-
ized if OTC breastfeeding supplies with
no cost sharing led to overconsumption
of such products. One commenter urged
the Departments to avoid rushing to
require coverage of all OTC preventive
products in order to provide sufficient
advanced notice to allow plan sponsors
to address operational and implementa-
tion issues.
While several commenters expressed
concern that current prescription require-
ments restrict access to breastfeeding
services and supplies, many comment-
ers stated that removing the prescription
requirement for breastfeeding services
and supplies could have a detrimental
effect on breastfeeding parents and new-
borns. These commenters stated that con-
sumers currently benefit from the exper-
tise provided by lactation consultants and
other specially trained staff at durable
medical equipment suppliers contracted
with plans and issuers to provide breast
pumps. These commenters also expressed
the view that removing the prescription
requirement would make it more likely
that a consumer would be forced to select
breastfeeding supplies in a retail environ-
ment with fewer breast pump options and
less privacy and support.
In the OTC Preventive Products RFI,
the Departments also requested feed-
back from interested parties based on
their experiences with the requirement to
cover OTC COVID-19 diagnostic tests
during the COVID-19 PHE.
64
During
the COVID-19 PHE, plans and issuers
were required to cover OTC COVID-19
diagnostic tests without a prescription
from a health care provider and without
imposing any cost-sharing requirements,
prior authorization, or other medical
management requirements. However, the
Departments permitted plans and issuers
that met certain safe harbor requirements
to implement cost and quantity limits to
contain costs and combat potential fraud
and abuse with respect to coverage of
OTC COVID-19 diagnostic tests. A few
commenters encouraged the Depart-
ments to use experiences with coverage
of OTC COVID-19 diagnostic tests as
a roadmap for future coverage of other
recommended preventive services. How-
ever, another commenter cautioned the
Departments against regulating the rou-
tine use of recommended preventive
services by applying requirements used
during an unprecedented public health
emergency, in order to avoid issues the
commenter reported taking place during
the COVID-19 PHE, such as overcon-
sumption of COVID-19 diagnostic tests,
price gouging of products by manufactur-
ers, and limited opportunities for health
plans to contain waste and abuse. Another
commenter acknowledged that coverage
requirements for OTC COVID-19 diag-
nostic tests improved patient access to
the tests by removing the barriers related
to out-of-pocket costs and obtaining
prescriptions but described a number of
other issues associated with the testing
coverage requirement. According to this
commenter, implementation challenges
included below-cost reimbursement,
inconsistent requirements across plans
and providers, and lack of reimburse-
ment for pharmacies. In particular, this
commenter noted that the average cost to
a retail pharmacy provider to dispense a
drug – separate from the cost of acquiring
the medication itself – is $12.40, and that
any future OTC coverage requirements
should reimburse pharmacies for both the
acquisition and dispensing of products.
Another commenter, citing the speed
with which the OTC COVID-19 diag-
nostic testing program was implemented,
urged the Departments to proceed delib-
erately with the implementation of any
broader OTC preventive products cover-
age requirements. According to this com-
menter, the rapid implementation of the
testing coverage requirements during the
PHE contributed to consumer confusion
and led to many thousands of consumers
failing to seek reimbursement for tests
that were eligible to be covered.
64
See 88 FR 68519, 68523-24 (Oct. 4, 2023).

November 18, 2024 1134 Bulletin No. 2024–47
F. Transparency in Coverage Under the
ACA and Implementing Regulations
Section 2715A of the PHS Act
65
pro-
vides that non-grandfathered group health
plans and health insurance issuers offer-
ing non-grandfathered group or individual
health insurance coverage must comply
with section 1311(e)(3) of the ACA,
66

which addresses transparency in health
coverage and imposes certain reporting
and disclosure requirements for health
plans that are seeking certification as qual-
ified health plans (QHPs) to be offered on
an American Health Benefits Exchange
(generally referred to as an Exchange
or Marketplace) (as defined by section
1311(b)(1) of the ACA). A plan or issuer
of coverage that is not offered through
an Exchange and that is subject to sec-
tion 2715A of the PHS Act is required
to submit the required information to the
Secretary of HHS and the relevant State’s
insurance commissioner, and to make that
information available to the public.
Section 1311(e)(3)(C) of the ACA
requires plans, as a requirement of certi-
fication as a QHP, to permit individuals
to learn about the amount of cost sharing
(including deductibles, copayments, and
coinsurance) that the individual would be
responsible for paying with respect to the
furnishing of a specific item or service by
an in-network provider in a timely manner
upon the request of the individual. Section
1311(e)(3)(C) of the ACA specifies that,
at a minimum, such information must be
made available to the individual through
an internet website and through other
means for individuals without access to
the internet.
On March 27, 2012, HHS issued the
“Patient Protection and Affordable Care
Act; Establishment of Exchanges and
Qualified Health Plans; Exchange Stan-
dards for Employers” final rule (Exchange
Establishment final rule) that implemented
sections 1311(e)(3)(A) through (C) of the
ACA at 45 CFR 155.1040(a) through (c)
and 156.220.
67
The Exchange Establish-
ment final rule created standards for QHP
issuers to submit specific information
related to transparency in coverage.
On November 12, 2020, the Depart-
ments issued “Transparency in Coverage”
final rules (Transparency in Coverage final
rules) implementing transparency report-
ing requirements for non-grandfathered
group health plans and health insurance
issuers offering non-grandfathered group
and individual health insurance cover-
age.
68
Implementing section 1311(e)(3)(C)
of the ACA and section 2715A of the PHS
Act, these rules require plans and issuers
to disclose cost-sharing information for
all covered items and services available
to a participant, beneficiary, or enrollee
through an internet-based self-service tool
via the plan’s or issuer’s member portal or,
if requested by the individual, on paper.
70

The requirement to disclose cost-sharing
information for all covered items and
services includes covered contraceptive
items or services.
The Transparency in Coverage final
rules enumerate seven cost-related ele-
ments that plans and issuers must disclose
in response to a search query by a partici-
pant, beneficiary, or enrollee for a covered
item or service furnished by a provider
or providers. The self-service tool must
provide an estimate of the participant’s,
beneficiary’s, or enrollee’s cost-sharing
liability for the covered item or service,
which is calculated based on the follow-
ing elements: (a) accumulated amounts
with respect to any deductibles or maxi-
mum out-of-pocket limits; and either (b)
the in-network rate, comprising a negoti-
ated rate or underlying fee schedule rate
as applicable to the payment model; or
(c) an out-of-network allowed amount or
any other rate that provides a more accu-
rate estimate of an amount a plan or issuer
will pay for the requested covered item or
service from an out-of-network provider.
Self-service tool results must also reflect a
list of the items and services included in a
bundled payment arrangement, if applica-
ble; notification that coverage of a specific
item or service is subject to a prerequisite,
as applicable; and certain disclaimers in
plain language describing the limitations
of the estimate or other qualifications
regarding the cost-sharing information
disclosed.
With respect to requests for cost-shar-
ing information for items or services that
are recommended preventive services
under section 2713 of the PHS Act, if the
plan or issuer cannot determine whether
the request is for preventive or non-pre-
ventive purposes, the plan or issuer must
display the cost-sharing liability that
applies for non-preventive purposes along
with a statement that the item or service
may not be subject to cost sharing if it is
billed as a preventive service. Display-
ing a non-zero cost-sharing liability in
these circumstances helps protect against
unexpected medical bills by ensuring
participants, beneficiaries, and enrollees
are aware of their potential cost-shar-
ing liability while the statement ensures
that consumers are made aware they can
access recommended preventive ser-
vices without cost sharing. Alternatively,
the Transparency in Coverage final rules
permit a plan or issuer to allow a partic-
ipant, beneficiary, or enrollee to request
cost-sharing information for the specific
preventive or non-preventive item or ser-
vice by including terms such as “preven-
tive,” “non-preventive,” or “diagnostic”
as a means to request the most accurate
cost-sharing information.
Plans and issuers must ensure users
can search for cost-sharing information
for a covered item or service by a specific
in-network provider or by all in-network
providers using either a descriptive term
or a billing code. For covered items or ser-
vices furnished by out-of-network provid-
ers, users can search for an out-of-network
allowed amount, percentage of billed
charges, or other rate that provides a rea-
sonably accurate estimate of the amount
a plan or issuer will pay for a covered
item or service provided by out-of-net-
work providers. Users must also be able
65
42 U.S.C. 300gg-15a.
66
42 U.S.C. 18031(e)(3).
67
77 FR 18310 (Mar. 27, 2012).
68
85 FR 72158 (Nov. 12, 2020).
69
The Consolidated Appropriations Act, 2021 imposed a largely duplicative requirement and added a requirement that the information also be provided by telephone, upon request. See also
FAQs Part 49, Q3 (Aug. 20, 2021), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-49.pdf and https://www.cms.gov/CCIIO/
Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-49.pdf.

Bulletin No. 2024–47 1135 November 18, 2024
to input other factors utilized by the plan
or issuer that are relevant for determining
the applicable cost-sharing information or
out-of-network allowed amount, such as
location of service, facility name, or dos-
age and permit refining and reordering of
search results.
II. Overview of the Proposed Rules
A. Coverage of Recommended Preventive
Services
1. Reasonable Medical Management
of Recommended Preventive Services:
Exceptions Process
The Departments’ regulations imple-
menting section 2713 of the PHS Act aim
to strike a balance between ensuring par-
ticipants, beneficiaries, and enrollees do
not face undue barriers to accessing their
coverage of recommended preventive
services as required by law and allowing
plans and issuers to contain costs, pro-
mote efficient delivery of care, and min-
imize risks of fraud, waste, and abuse. To
this end, current regulations permit plans
and issuers to use reasonable medical
management techniques to determine the
frequency, method, treatment, or setting
for coverage of a recommended preven-
tive service, to the extent not specified
in the applicable recommendation or
guideline.
70
The Departments have previ-
ously explained, in the context of certain
recommended preventive services, that
they generally do not consider medical
management techniques with respect to
recommended preventive services to be
reasonable absent the availability of an
exceptions process.
71
As noted in previously issued guidance
and described in section I.B of this pream-
ble, the Departments continue to receive
complaints of potential violations related
to the application of medical manage-
ment techniques that are not reasonable,
including failing to provide an exceptions
process that meets the standards set forth
in guidance.
72
Further, the U.S. House of
Representatives’ Committee on Oversight
and Reform (Oversight Committee) pub-
lished a report in October 2022 document-
ing the findings of its investigation into
contraceptive coverage for individuals
enrolled in private health coverage. The
Oversight Committee found that insurers
and PBMs surveyed denied an average of
at least 40 percent of exception requests
related to contraceptive coverage, with
one PBM denying more than 80 per-
cent of requests in a year.
73
To reinforce
the requirement that medical manage-
ment techniques must be reasonable, the
Departments propose to codify that plans
and issuers that utilize reasonable medical
management techniques with respect to
recommended preventive services would
be required to accommodate any individ-
ual for whom a particular item or service
would not be medically appropriate, as
determined by the individual’s attending
provider, by having a mechanism for cov-
ering or waiving the otherwise applicable
cost sharing for the medically necessary
item or service. Specifically, under these
proposed rules, consistent with previous
guidance,
74
if utilizing reasonable medical
management techniques, a plan or issuer
would be required to have an easily acces-
sible, transparent, and sufficiently expedi-
ent exceptions process that is not unduly
burdensome on the individual or a provider
(or other person acting as the individual’s
authorized representative) under which
the plan or issuer covers without cost shar-
ing the recommended preventive service
according to the frequency, method, treat-
ment, or setting determined to be med-
ically necessary with respect to the indi-
vidual, as determined by the individual’s
attending provider. The exceptions pro-
cess would ensure that an individual can
access medically necessary recommended
preventive services without cost sharing
and would prevent medical management
from functioning as an unreasonable bar-
rier to coverage under section 2713 of the
PHS Act. The Departments are authorized
to issue this proposal, implementing sec-
tion 2713 of the PHS Act, by section 9833
of the Code, section 734 of ERISA, and
section 2792 of the PHS Act. Nothing in
this proposal, if finalized, would require
an entity to provide coverage or payments
for a contraceptive for which they have an
exemption under 26 CFR 54.9815-2713A,
29 CFR 2590.715-2713A, and 45 CFR
147.131 through 45 CFR 147.133.
While prior guidance has generally
focused on the use of an exceptions pro-
cess in the context of coverage of contra-
ceptive services, it has not been limited
to that context. For example, the Depart-
ments’ guidance with respect to coverage
of PrEP to prevent HIV acquisition has
similarly stated that where a plan or issuer
uses reasonable medical management
techniques – such as covering a generic
version of PrEP without cost sharing and
imposing cost sharing on an equivalent
branded version – a plan or issuer must
have an easily accessible, transparent, and
sufficiently expedient exceptions process
that is not unduly burdensome on the indi-
70
26 CFR 54.9815-2713(a)(4); 29 CFR 2590.715-2713(a)(4); and 45 CFR 147.130(a)(4).
71
See FAQs Part XXVI, Q2 (May 11, 2015), available at https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-xxvi.pdf and https://www.cms.
gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf; FAQs Part 64, Q4 (Jan. 22, 2024), available at https://www.dol.gov/sites/dolgov/files/ebsa/about-
ebsa/our-activities/resource-center/faqs/aca-part-64.pdf and https://www.cms.gov/files/document/faqs-part-64.pdf.
72
See, e.g., FAQs Part 51, Q9 (Jan. 10, 2022), available at https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-51.pdf and https://www.cms.
gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-51.pdf; FAQs Part 54, Q8 (July 28, 2022), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-ac-
tivities/resource-center/faqs/aca-part-54.pdf and https://www.cms.gov/files/document/faqs-part-54.pdf.
73
U.S. House of Representatives Committee on Oversight and Reform, (Oct. 25, 2022). “Barriers to Birth Control: An Analysis of Contraceptive Coverage and Costs for Patients with Private
Insurance,” available at https://oversightdemocrats.house.gov/sites/evo-subsites/democrats-oversight.house.gov/files/2022-10-25.COR%20PBM-Insurer%20Report.pdf.
74
See FAQs Part XXVI, Q3 (May 11, 2015), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xxvi.pdf and https://www.cms.
gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf; FAQs Part 31, Q2 (Apr. 20, 2016), available at https://www.dol.gov/sites/dolgov/files/EBSA/
about-ebsa/our-activities/resource-center/faqs/aca-part-31.pdf and https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/faqs-31_final-4-20-16.pdf. See also FAQs Part XII,
Q14 (Feb. 20, 2013), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xii.pdf and www.cms.gov/CCIIO/Resources/Fact-
Sheets-and-FAQs/aca_implementation_faqs12.html; FAQs Part 51, Q8-9 (Jan. 10, 2022), available at https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/
faqs/aca-part-51.pdf and https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/FAQs-Part-51.pdf; FAQs Part 54, Q9, (July 28, 2022), available at https://www.dol.gov/
sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf and https://www.cms.gov/files/document/faqs-part-54.pdf; FAQs Part 64 (Jan. 22, 2024) available at
https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-64 and https://www.cms.gov/files/document/faqs-part-64.pdf.

November 18, 2024 1136 Bulletin No. 2024–47
vidual or a provider (or other individual
acting as an authorized representative)
that waives otherwise applicable cost
sharing for the particular PrEP medication
(generic or branded) for any individual
for whom the plan’s or issuer’s preferred
medication “would be medically inappro-
priate, as determined by the individual’s
health care provider.”
75
Therefore, the Departments propose to
reorganize and amend 26 CFR 54.9815-
2713(a)(4), 29 CFR 2590.715-2713(a)(4),
and 45 CFR 147.130(a)(4) by adding a
new paragraph (a)(4)(i) to include existing
language with minor technical edits for
clarity and to add a new paragraph (a)(4)
(ii) to specify that, in order for a plan’s or
issuer’s medical management techniques
with respect to a recommended preven-
tive service to be considered reasonable,
the plan or issuer would be required to
have an easily accessible, transparent, and
sufficiently expedient exceptions process
that is not unduly burdensome on a partic-
ipant, beneficiary, or enrollee or attending
provider
76
(or other person acting as the
individual’s authorized representative).
Under this proposal, an exceptions pro-
cess would be required to ensure that an
individual can receive coverage, without
cost-sharing requirements, for a recom-
mended preventive service according
to the frequency, method, treatment, or
setting that is medically necessary with
respect to the individual, as determined
by the individual’s attending provider. For
example, a plan or issuer may typically
provide coverage without cost sharing for
only a generic version of a recommended
preventive service; an individual who
experiences side effects from the covered
generic version and whose attending pro-
vider has determined that the brand-name
version of the recommended preventive
services is medically necessary for the
individual would be able to use the excep-
tions process to obtain the brand-name
version without cost sharing, even though
the plan or issuer typically does not pro-
vide coverage for the brand-name version
(or provides coverage with cost sharing)
This proposed change is necessary to
effectuate the statutory requirement under
PHS Act section 2713 that plans and issu-
ers provide coverage of recommended
preventive services without cost sharing,
because without such an exceptions pro-
cess, a plan’s or issuer’s medical manage-
ment techniques could have the effect of
preventing an individual from receiving
coverage without cost sharing of medi-
cally necessary recommended preventive
services.
Under this proposal and consistent with
previous guidance, a plan or issuer would
be required to defer to the determination of
an individual’s attending provider regard-
ing medical necessity with respect to the
individual. Previously issued guidance
has used the terms “medically necessary”
and “medically appropriate” interchange-
ably when referring to the appropriate
standard for this clinical determination.
However, in these proposed rules, the
Departments propose to use the phrase
“medically necessary” to establish uni-
form terminology and avoid confusion
from the use of different terms.
77
The
Departments have determined that a stan-
dard based on “medical necessity” would
more accurately comport with the goal of
allowing plans and issuers to use reason-
able medical management techniques to
control costs, while ensuring every par-
ticipant, beneficiary, and enrollee receives
coverage without cost sharing for a form
of a recommended preventive service that
is suitable for the individual.
These proposed rules use the term
“medically appropriate” to refer to a
range of potential options that are gener-
ally acceptable to address a condition or
achieve a preventive health goal. How-
ever, a preventive service that is medi-
cally appropriate for most individuals (to
whom the recommendation or guidelines
applies) may not be medically appro-
priate to address a condition or achieve
a preventive health goal in the context
of other health factors specific to a cer-
tain individual. In these cases, another
form of the preventive service would be
medically necessary for that individual.
In making a determination of whether a
service is medically necessary, a provider
might consider factors such as severity of
side effects, differences in permanence
and reversibility of a recommended pre-
ventive service, and ability to adhere to
the appropriate use of the recommended
preventive service, as determined by the
attending provider. Under these proposed
rules, if the recommended preventive ser-
vice covered by the plan or issuer is not
medically appropriate for the individual,
as determined by the individual’s attend-
ing provider, the plan or issuer would be
required, through the exceptions process,
to cover without cost sharing an alterna-
tive recommended preventive service that
the individual’s attending provider deter-
mines is medically necessary for that indi-
vidual.
78

For example, if a plan typically covers
a generic tobacco cessation product (Gum
A) without cost sharing, but an individ-
75
See FAQs Part 47, introduction to Q3 (July 19, 2021), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-47.pdf and https://
www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/faqs-part-47.pdf (“[T]he Departments have clarified in previous guidance that plans and issuers must accommodate any
individual for whom a particular medication (generic or brand name) would be medically inappropriate, as determined by the individual’s health care provider, by having a mechanism for
waiving the otherwise applicable cost sharing for the brand or non-preferred brand version. If utilizing reasonable medical management techniques, plans and issuers must have an easily
accessible, transparent, and sufficiently expedient exceptions process that is not unduly burdensome.”)
76
For purposes of these proposed rules, consistent with previous guidance described in section I.B of this preamble, an attending provider would mean an individual who is licensed under
applicable State law, who is acting within the scope of the provider’s license, and who is directly responsible for providing care to the patient relating to the recommended preventive services.
Therefore, a plan, issuer, hospital, or managed care organization would not be an attending provider. The reference to an “attending provider” (rather than simply a “provider,” as referenced
in previously issued guidance) is based on the Departments’ understanding that an attending provider is likely to act as an individual’s authorized representative when pursuing an exceptions
process, and for consistency with the requirement that an attending provider determine medical necessity. See also, fn. 33.
77
The Departments proposal to use the term and standard of “medically necessary” with respect to the exceptions process in these proposed rules should not be interpreted as changing the
standard or meaning of the Departments’ previously published guidance with respect to the coverage of preventive services.
78
Similarly, if the plan or issuer uses reasonable medical management techniques to limit the frequency or setting under which a recommended preventive service is covered without cost shar-
ing and the individual’s attending provider makes a determination that a different frequency or setting is medically necessary for a participant, beneficiary, or enrollee, under these proposed
rules, the plan or issuer would be required to provide coverage without cost sharing for the recommended preventive service according to the frequency or setting the individual’s attending
provider determines to be medically necessary with respect to the individual.

Bulletin No. 2024–47 1137 November 18, 2024
ual is allergic to an inactive ingredient in
Gum A and the individual’s attending pro-
vider determines that Gum B is medically
necessary for the individual to achieve
the preventive health benefits of the rec-
ommended preventive service without
adverse side effects, then the plan or issuer
would be required to provide coverage of
Gum B without cost sharing through the
exceptions process. However, if Gum A is
medically appropriate for the individual,
the plan would not be required to provide
coverage of Gum B without cost sharing
through the exceptions process solely on
the basis that Gum B is also medically
appropriate for the individual.
The Departments request comment on
the terminology used in the context of the
exceptions process. The Departments also
request comment generally on any opera-
tional or technical barriers to implement-
ing the proposed requirement that plans
and issuers defer to the attending provid-
er’s determination of medical necessity
using an exceptions process for recom-
mended preventive services separate from
the required internal claims and appeals
process,
79
and what additional guidance or
requirements would support implementa-
tion of this requirement (for example, with
respect to documentation of the determi-
nation or communication with the indi-
vidual or their attending provider or other
representative regarding a request for a
coverage exception).
Consistent with prior guidance, the
Departments would determine whether a
plan’s or issuer’s exceptions process is easily
accessible, transparent, sufficiently expedi-
ent, and not unduly burdensome based on all
relevant facts and circumstances, including
whether and how a plan or issuer provides
notice of the availability of an exceptions
process and what steps an individual or their
provider or other authorized representative
is required to initiate and complete in order
to seek an exception.
80
For this purpose, the Departments
would consider an exceptions process to
be easily accessible if plan documentation
includes relevant information regarding
the exceptions process under the plan or
coverage, including how to access the
exceptions process without initiating an
appeal pursuant to the plan’s or issuer’s
internal claims and appeals procedures,
the types of reasonable information the
plan or issuer requires as part of a request
for an exception, and contact information
for a representative of the plan or issuer
who can answer questions related to the
exceptions process. The Departments
would also encourage plans and issuers to
make this information available in a for-
mat and manner that is readily accessible,
such as electronically (on a website, for
example) and on paper. The Departments
request comment on how plans and issuers
could ensure that this information is read-
ily available and accessible, such as any
specific formats, mechanisms, or other
best practices that could promote access to
information about the exceptions process.
The Departments would consider an
exceptions process to be transparent if, at
a minimum, the information relevant to
the exceptions process (including, if used,
a standard exceptions process form with
instructions) is included and prominently
displayed in plan documents (including in,
or along with, the summary plan descrip-
tion for plans subject to ERISA), and in
any other plan materials, including on the
plan’s or issuer’s website, that describe
the terms of the plan’s or issuer’s cover-
age of preventive services. The Depart-
ments request comment on the extent to
which plans and issuers currently make
such information available and accessible
and to whom (for example, to prospective
and current participants, beneficiaries, and
enrollees and their providers), whether
any additional individuals or groups
should have access to this information
if this proposal is finalized, and whether
the Departments should finalize more
specific standards regarding transparency
or accessibility of information about the
exceptions process in regulation.
The Departments would consider an
exceptions process to be sufficiently expe-
dient if it makes a determination of a claim
according to a timeframe and in a manner
that takes into account the nature of the
claim (for example, pre-service or post-ser-
vice) and the medical exigencies involved
for a claim involving urgent care. The
Departments request comment on appro-
priate additional standards for an excep-
tions process to be considered sufficiently
expedient under these proposed rules. Spe-
cifically, the Departments request comment
on whether the regulations should contain
specific timeframes, and if so, what time-
frames would be appropriate, as well as
whether the regulations should specify the
manner in which plans and issuers should
issue a determination (for example, on
paper, electronically, or both).
For example, as the Departments spe-
cifically noted in prior guidance, it would
be unduly burdensome on participants,
beneficiaries, and enrollees for a plan
or issuer to deny coverage without cost
sharing and require an individual or their
authorized representative to file an appeal
under the plan’s or issuer’s process for
appealing adverse benefit determinations
in order to obtain an exception to the
standard contraceptive coverage policy.
81

Under 26 CFR 54.9815-2719, 29 CFR
2560.503-1, 29 CFR 2590.715-2719, and
45 CFR 147.136, plans and issuers must
render a determination on an internal
appeal in no more than 15 calendar days
(in the case of a pre-service claim) or no
more than 30 calendar days (in the case
of a post-service claim). Because most
claims for recommended preventive ser-
vices likely would not meet the defini-
tion of a “claim involving urgent care,”
82

79
See section 2719 of the PHS Act (42 U.S.C. 300gg-19); 26 CFR 54.9815-2719; 29 CFR 2590.715-2719; and 45 CFR 147.136.
80
FAQs Part 54, Q9 (July 28, 2022), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf and https://www.cms.gov/files/
document/faqs-part-54.pdf.
81
FAQs Part 54, Q10 (July 28, 2022), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf and https://www.cms.gov/files/
document/faqs-part-54.pdf. An adverse benefit determination means an adverse benefit determination as defined in 29 CFR 2560.503-1, as well as any rescission of coverage, as described in
45 CFR 147.128 (whether or not, in connection with the rescission, there is an adverse effect on any particular benefit at that time). See 26 CFR 54.9815-2719, 29 CFR 2560.503-1, 29 CFR
2590.715-2719, and 45 CFR 147.136 for regulations related to internal claims and appeals processes.
82
A “claim involving urgent care,” defined at 29 CFR 2560.503-1(m)(1) and adopted at 26 CFR 54.9815-2719(b)(2)(ii)(B), 29 CFR 2590.715-2719(b)(2)(ii)(B), and 45 CFR 147.136(b)(2)(ii)
(B), is “any claim for medical care or treatment with respect to which the application of the time periods for making non-urgent care determinations—(A) Could seriously jeopardize the life
or health of the claimant or the ability of the claimant to regain maximum function, or, (B) In the opinion of a physician with knowledge of the claimant’s medical condition, would subject the
claimant to severe pain that cannot be adequately managed without the care or treatment that is the subject of the claim.” Plans and issuers generally must render determinations regarding
claims involving urgent care as soon as possible, accounting for medical exigencies, and not later than 72 hours after receipt of the claim by the plan.

November 18, 2024 1138 Bulletin No. 2024–47
the expedited timelines that apply to an
appeal of a claim involving urgent care
likely would not apply to a claim for a
recommended preventive service. In the
absence of a separate exceptions process,
an individual could therefore be required
to pursue a standard internal appeals pro-
cess to seek coverage of a recommended
preventive service, which could result
in a coverage delay of up to 30 calendar
days for a post-service claim or 15 calen-
dar days for a pre-service claim. Such a
delay, when combined with the ability of
plans and issuers to use medical manage-
ment techniques to limit coverage of rec-
ommended preventive services outside of
an exceptions process, is not aligned with
the statutory requirement to provide cov-
erage without cost sharing for all required
preventive services, because many indi-
viduals would be compelled to pay out-of-
pocket for the recommended preventive
service determined by their attending pro-
vider to be medically necessary or accept
the form of the recommended preventive
service covered by the plan or issuer as a
result of medical management techniques,
even if it may cause adverse effects that
an alternate form of the recommended
preventive service would not cause.
Therefore, a plan or issuer would not
have an easily accessible, transparent, and
sufficiently expedient exceptions process
that is not unduly burdensome on the
individual (or provider or other person
acting as the individual’s authorized rep-
resentative) under these proposed rules
if the plan or issuer requires participants,
beneficiaries, or enrollees to appeal an
adverse benefit determination using the
plan’s or issuer’s internal claims and
appeals process as the means to obtain an
exception. The Departments request com-
ment on whether plans and issuers should
be permitted to require an individual or
their authorized representative to use the
existing process for urgent care claims
under 26 CFR 54.9815-2719(b)(2)(ii)
(B), 29 CFR 2560.503-1(b)(2)(ii)(B), and
45 CFR 147.136(b)(2)(ii)(B) (regardless
of whether the recommended preventive
service meets the definition of a “claim
involving urgent care”) to obtain an
exception to the standard preventive ser-
vices coverage policy. The Departments
also request comment on whether a health
plan that is subject to the essential health
benefit (EHB) prescription drug exception
process standards at 45 CFR 156.122(c)
83

should be permitted to require an indi-
vidual or their authorized representative
to use the existing standard or expedited
prescription drug exception request pro-
cess when seeking an exception for a
recommended preventive service that is
a prescription drug, or all recommended
preventive services.
The Departments previously noted that
plans and issuers may develop a standard
exceptions process form with instructions
as part of ensuring that the plan’s or issu-
er’s exceptions process is easily accessi-
ble, transparent, sufficiently expedient,
and not unduly burdensome on the individ-
ual or provider (or other individual acting
as a patient’s authorized representative).
84

A standardized form that is not unneces-
sarily long and that has clear instructions
could reduce burden on individuals or
their authorized representative. The pro-
posed amendments at 26 CFR 54.9815-
2713(a)(4)(ii), 29 CFR 2590.715-2713(a)
(4)(ii), and 45 CFR 147.130(a)(4)(ii)
would not require that plans and issuers
develop and utilize a standard exceptions
process form. However, the Departments
continue to encourage plans and issuers to
make any such standard exceptions pro-
cess form, whether developed by a plan or
issuer, or the Medicare Part D Coverage
Determination form, readily available,
both in paper and electronically (such as
on a website). The Departments request
comment on whether the Medicare Part D
Coverage Determination form, or another
existing format, would be an appropriate
model for plans and issuers implementing
a standardized exceptions process under
these proposed rules. Alternatively, the
Departments request comment on whether
it would be beneficial to interested par-
ties if the Departments developed and
made available a new standard form for
an exceptions process, what information
should be included in any such form,
and whether use of such a standardized
form should be required or optional. The
Departments anticipate that most, if not
all, plans and issuers have an existing
exceptions process for recommended pre-
ventive services, or a process for other
services that can be adapted to meet these
requirements for recommended preventive
services at minimal cost. The Departments
request comment on this assumption and
on all other aspects of this proposal.
2. Coverage of Contraceptive Items
Section 2713(a)(4) of the PHS Act was
enacted to ensure that plans and issuers
cover women’s preventive health needs.
Contraceptive coverage is an essential
component of women’s health care, as rec-
ognized by its inclusion in the HRSA-sup-
ported Guidelines, in part because contra-
ception is effective at reducing unintended
pregnancies and associated negative
maternal-infant outcomes.
85
Unintended
pregnancies, which account for approxi-
mately 42 percent of pregnancies annually
in the United States, are a major public
health concern.
86, 87
Coverage requirements
that promote equitable access to medi-
cally appropriate contraceptive items and
83
Separately from requirements related to appeals of adverse benefit determinations, HHS regulations at 45 CFR 156.122(c) state that a health plan does not provide essential health benefits
(EHBs) unless it provides a standard and expedited exceptions process for prescription drugs through which an enrollee, the enrollee’s designee, or the enrollee’s prescribing physician (or
other prescriber) can receive a coverage determination within 72 hours (for a standard exception) or no later than 24 hours (for an expedited exception, in the case of exigent circumstances).
84
FAQs Part 54, Q9 (July 28, 2022), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf and https://www.cms.gov/files/
document/faqs-part-54.pdf.
85
Nelson, H., Darney, B., Ahrens, K., Burgess, A., Jungbauer, R., Cantor, A., Atchison, C., Eden, K., Goueth, R., Fu, R. (2002). “Associations of Unintended Pregnancy With Maternal and
Infant Health Outcomes: A Systematic Review and Meta-analysis,” JAMA, available at https://jamanetwork.com/journals/jama/fullarticle/2797874.
86
See CDC, “Reproductive Health, Unintended Pregnancy,” available at https://www.cdc.gov/reproductive-health/hcp/unintended-pregnancy/index.html.
87
See Bradford, K., Costanza, K., Fouladi, F., Hill, T., Nguyen, K., and Speer, K., NCSL (2023). “Supporting Moms’ Health in the Postpartum Period,” available at https://www.ncsl.org/
health/supporting-moms-health-in-the-postpartum-period; Nelson, et al., supra fn. 75; Cruz-Bendezú, A., Lovell, G. Roche, B., Perkins, M., Blake-Lamb, T., Taveras, E., and Simione M.
(2020). “Psychosocial status and prenatal care of unintended pregnancies among low-income women,” BMC Pregnancy and Childbirth, available at https://bmcpregnancychildbirth.
biomedcentral.com/articles/10.1186/s12884-020-03302-2; Blake, S., Kiely, Gard, C., El-Mohandes, A., El-Khorazaty, M.N. (2007). “Pregnancy Intentions and Happiness Among Pregnant
Black Women at High Risk for Adverse Infant Health Outcomes,” American Journal of Public Health, available at https://doi.org/10.1363/3919407; Finer, L., and Zolna, M. (2014). “Shifts
in intended and unintended pregnancies in the United States, 2001-2008,” American Journal of Public Health, available at https://pubmed.ncbi.nlm.nih.gov/24354819.

Bulletin No. 2024–47 1139 November 18, 2024
services are an essential component of
high-quality reproductive health care with
wide-ranging social and economic bene-
fits.
88
Research shows that many women
are not using their contraceptive of choice,
for reasons that include concerns about
side effects, cost, lack of availability, or
inability to get a provider appointment.
89

Coverage that allows individuals to iden-
tify and obtain a medically necessary con-
traceptive (accounting for variables such
as hormonal properties, side effects, and
delivery mechanisms, among other fac-
tors) without cost sharing could improve
quality of life, reduce behaviors such as
discontinuing contraception, and result
in more effective use of contraception to
prevent unintended pregnancy.
90
As noted
in the preamble to the 2023 proposed
rules, increased contraceptive coverage
can improve access to care, and therefore
also help to address racial inequities in
reproductive health care that contribute to
lifelong disproportionate health outcomes
for women in underserved communities,
including disparate maternal health out-
comes.
91
Additionally, there has been significant
activity related to coverage of contracep-
tive services and several new develop-
ments, including legal developments, that
have affected women’s needs regarding
access to affordable contraception since
the publication of the July 2010 interim
final rules. The Departments continue to
receive complaints and are aware of other
reports documenting plans’ and issuers’
failure to provide coverage of the full
range of contraceptive services. Coverage
issues leading to lack of access to contra-
ception were also substantiated in com-
ments received in response to the OTC
Preventive Products RFI. Other develop-
ments have included the Dobbs decision
and subsequent State-level restrictions
on access to abortion and emergency
contraception, which have made it more
challenging for women in some States to
obtain contraception and quality family
planning care, including because health
care providers have been forced to close
or chosen to relocate to a different State;
92

Executive Orders related to reproductive
health care; and FDA approval of the first
daily OTC oral contraceptive. As a result,
the Departments have determined that it is
necessary to propose amendments to the
regulations governing how plans and issu-
ers cover contraception and, as discussed
in section II.B of this preamble, how they
communicate information about this cov-
erage to participants, beneficiaries, and
enrollees.
The Departments are interested in min-
imizing barriers to coverage and expand-
ing the scope of coverage without cost
sharing for all recommended preventive
services, in alignment with section 2713
of the PHS Act. The Departments also rec-
ognize that the proposals described in this
section II.A.2 of this preamble, if final-
ized, could require significant changes
to current plan and issuer operations.
Therefore, the Departments propose an
incremental approach in this rulemaking
with respect to the types of recommended
services addressed that is focused initially
on expanding coverage of contraception.
This incremental approach would facil-
itate implementation for plans, issuers,
and other interested parties and allow the
Departments to gather additional feedback
on challenges and benefits of adopting
these proposed policies before consider-
ing whether and how to propose similar
requirements with respect to other rec-
ommended preventive services. Focusing
first on contraceptive items is appropriate
due to ongoing and widely reported con-
cerns regarding challenges faced by con-
sumers in accessing contraceptive items
and services without cost sharing, as well
as recent developments affecting access to
reproductive health care.
93
As described in FAQs Part 51, Q9,
FAQs Part 54, Q8, and sections I.B and
II.A.2 of this preamble, the Departments
continue to receive complaints and are
aware of other credible reports that some
plans and issuers frequently restrict access
to contraceptive items and services that
should be covered without cost sharing.
For instance, in addition to widespread
denials of exceptions process requests as
described in section II.A.1 of this pream-
ble, the October 2022 Oversight Commit-
tee report identified at least 34 different
contraceptive items that were commonly
excluded from coverage or for which
cost-sharing requirements often were
applied.
94
Additionally, a recent investiga-
88
Id., see also Sonfield, A., Hasstedt, K., Kavanaugh, M., and Anderson, R., (2013). “The Social and Economic Benefits of Women’s Ability to Determine Whether and When to Have Children,”
Guttmacher Institute, available at https://www.guttmacher.org/sites/default/files/report_pdf/social-economic-benefits.pdf.
89
Frederiksen, B., Ranji, U., Long, M., Diep, K., and Salganicoff, A., KFF (2022). “Contraception in the United States: A Closer Look at Experiences, Preferences, and Coverage,” available
at https://www.kff.org/report-section/contraception-in-the-united-states-a-closer-look-at-experiences-preferences-and-coverage-findings.
90
Steinberg, J., Marthey, D., Xie, L., Boudreaux, M. (2021). “Contraceptive method type and satisfaction, confidence in use, and switching intentions,” Contraception, available at https://
www.ncbi.nlm.nih.gov/pmc/articles/PMC8286312.
91
See 88 FR 7236, 7241 (Feb. 2, 2023), citing Sutton, M. Y., Anachebe, N. F., and Skanes H. (2021). “Racial and Ethnic Disparities in Reproductive Health Services and Outcomes, 2020,”
Obstetrics and Gynecology, available at https://doi.org/10.1097/AOG.0000000000004224; White House Blueprint for Addressing the Maternal Health Crisis (2022), available at https://
www.whitehouse.gov/wp-content/uploads/2022/06/Maternal-Health-Blueprint.pdf.
92
See, e.g., Murphy, C., Shin, P., Jacobs, F., and Johnson, K. (2024). “In States with Abortion Bans, Community Health Center Patients Face Challenges Getting Reproductive Health Care,”
Commonwealth Fund, available at https://www.commonwealthfund.org/blog/2024/states-abortion-bans-community-health-center-patients-face-challenges-getting; Harper, C., Brown, K.,
and Arora, K. (2024). “Contraceptive Access in the US Post-Dobbs,” JAMA Internal Medicine, available at https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2823682;
Qato, D., Myerson, R., Shooshtari, A., Guadamuz, J., Alexander, G.C., (2024). “Use of Oral and Emergency Contraceptives After the US Supreme Court’s Dobbs Decision,” available at
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2820370.
93
See, e.g., Adler, A., Biggs, A.M., Kaller, S., Schroeder, R., Ralph, L. (2023). “Changes in the Frequency and Type of Barriers to Reproductive Health Care from 2017 to 2021,” JAMA
Network Open, available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10087056; Qato, D., Myerson, R., Shooshtari, A., Guadamuz, J., Alexander, G.C., (2024). “Use of Oral and
Emergency Contraceptives After the US Supreme Court’s Dobbs Decision,” available at https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2820370; Harper, C., Brown, K.,
and Arora, K. (2024). “Contraceptive Access in the US Post-Dobbs,” JAMA Internal Medicine, available at https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2823682;
Kavanaugh, M. and Friedrich-Karnik, A. (2024). “Has the Fall of Roe changed contraceptive access and use? New research from four US states offers critical insights,” Health Affairs
Scholar, available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10986283; and American Academy of Pediatrics, (updated July 2023) “The Importance of Access to Contraception
– Barriers to accessing contraception”, available at https://www.aap.org/en/patient-care/adolescent-sexual-health/equitable-access-to-sexual-and-reproductive-health-care-for-all-youth/
the-importance-of-access-to-contraception.
94
U.S. House of Representatives Committee on Oversight and Reform, “Barriers to Birth Control: An Analysis of Contraceptive Coverage and Costs for Patients with Private Insurance” (Oct.
25, 2022), available at https://oversightdemocrats.house.gov/sites/evo-subsites/democrats-oversight.house.gov/files/2022-10-25.COR%20PBM-Insurer%20Report.pdf.

November 18, 2024 1140 Bulletin No. 2024–47
tion by the Vermont Department of Finan-
cial Regulation, the agency responsible
for regulating issuers in that State, found
that three issuers in Vermont violated
State and Federal law by failing to provide
coverage of contraceptive services with-
out cost sharing. The investigation found
that between 2017 and 2021, the issuers
inappropriately charged patients $1.5 mil-
lion for contraceptive items and services
that should have been provided free of
any out-of-pocket costs, resulting in a
finding that 9,000 people were entitled
to receive restitution for cost sharing that
was incorrectly applied for contraceptive
services.
95
The investigation prompted a
Congressional request to the Government
Accountability Office for an investiga-
tion into plan and issuer compliance with
ACA requirements to cover contraceptive
items without cost sharing.
96
In addition,
the Centers for Medicare & Medicaid
Services, as part of targeted market con-
duct examinations conducted on behalf of
HHS, has identified multiple violations of
the requirements of section 2713(a)(1) of
the PHS Act and implementing regulations
related to contraceptive coverage and con-
tinues to investigate additional complaints
alleging violations.
97
Additional reports of
noncompliance documented by members
of Congress, advocacy organizations, and
media reports were cited by the Secretar-
ies in their June 27, 2022 letter to group
health plan sponsors and issuers.
98
Given
these reported instances of continued
obstacles for women in accessing contra-
ception, and within the context of several
States’ efforts to restrict access to repro-
ductive health care following the Dobbs
decision, the Departments have deter-
mined it is appropriate for these proposed
rules to begin with addressing barriers to
contraceptive services.
Furthermore, focusing on contracep-
tion is consistent with recent Executive
Orders. As described in section I.C of this
preamble, President Biden issued E.O.
14101, which directed the Secretaries to
consider actions that would, to the great-
est extent permitted by law, ensure cover-
age of comprehensive contraceptive care,
including all contraceptives approved,
cleared, or granted by the FDA, without
cost sharing for participants, beneficiaries,
and enrollees; and streamline the process
for patients and health care providers to
request coverage, without cost sharing, of
medically necessary contraception. Fur-
ther, section 2(b) of E.O. 14101 instructed
the Secretaries to consider actions that
would promote increased access to afford-
able OTC contraception.
99
Consistent with
E.O. 14101, and in consideration of the
availability of OTC oral contraceptives,
these proposed rules would promote cov-
erage and streamline access to all medi-
cally necessary contraception, including
the newly FDA-approved OTC daily oral
contraceptive, by removing prescription
and cost barriers for consumers.
The Departments acknowledge the
possibility that increasing coverage with-
out cost sharing for recommended pre-
ventive services, as discussed in this sec-
tion II.A.2 of this preamble, could lead
to greater demand for those services and
potentially higher prices charged by pro-
viders. These increased costs could result
in higher costs to consumers, both in the
form of higher premiums for people with
insurance and in the form of higher out-
of-pocket costs for people who do not use
insurance coverage to obtain OTC contra-
ceptive products. The potential increases
in cost further justify the incremental
approach taken in these proposed rules.
In addition, comments in response to the
OTC Preventive Products RFI suggested
that requiring coverage of all OTC pre-
ventive products may be challenging for
some types of preventive care. For these
reasons, the Departments propose to
amend the preventive services regulations
with respect to only contraceptive items
100

at this time by inserting a new paragraph
(a)(6) at 26 CFR 54.9815-2713, 29 CFR
2590.715-2713, and 45 CFR 147.130. The
Departments’ issuance of these proposals
implementing section 2713 of the PHS
Act is authorized by section 9833 of the
Code, section 734 of ERISA, and section
2792 of the PHS Act.
First, the Departments propose to
define the terms “drug-led combination
product”
101
in proposed new paragraph (a)
(6)(i)(A) and “therapeutic equivalent” in
proposed new paragraph (a)(6)(i)(B) for
purposes of the proposed new paragraph
(a)(6). Second, the Departments propose
in proposed new paragraph (a)(6)(ii) to
require that plans and issuers cover, with-
out requiring a prescription and without
imposing cost-sharing requirements, rec-
ommended contraceptive items that are
available OTC and for which the applica-
ble recommendation or guideline does not
require a prescription. Third, the Depart-
ments propose in proposed new para-
graph (a)(6)(iii) that, in order for medical
management techniques to be considered
reasonable, plans and issuers would be
required to utilize a therapeutic equiva-
lence approach for recommended contra-
ceptive drugs and drug-led combination
products.
95
State of Vermont Department of Financial Regulation (Nov. 13, 2023). “Contraceptive Services Claims Restitution Information,” available at https://dfr.vermont.gov/contraceptive-
services-claims-restitution-information.
96
Sen. Bernie Sanders (June 17, 2024). Letter to Hon. Gene Dodaro, Comptroller General of the United States, available at https://www.documentcloud.org/documents/24764790-61724-
gao-aca-contraception-coverage-letter.
97
CMS, “Compliance and Enforcement, Federal Market Conduct Examination Final Reports,” available at https://www.cms.gov/marketplace/private-health-insurance/consumer-protec-
tions-enforcement.
98
See, e.g., Secretaries Becerra, Yellen, and Walsh (June 27, 2022). Letter on the ACA contraceptive coverage requirement, available at https://www.dol.gov/sites/dolgov/files/ebsa/laws-
and-regulations/laws/affordable-care-act/for-employers-and-advisers/letter-from-secretaries-becerra-yellen-and-walsh-on-the-aca-contraceptive-coverage-requirement.pdf (highlighting
reports of noncompliance documented by Members of the U.S. House of Representatives (in 2021 and 2022) and the U.S. Senate (in 2021 and 2022), the National Women’s Law Center, other
nonprofit organizations, and media reports).
99
88 FR 41815 at 41816 (June 23, 2023).
100
See section II.A.2 of the preamble to these proposed rules for comment solicitation regarding whether to expand the proposed coverage requirements to other recommended preventive
services.
101
The Departments are proposing to define the term “drug-led combination products” in these proposed rules instead of the term “drug-led devices” used in FAQs Part 64 to align these pro-
posed rules with existing definitions at 21 CFR 3.2(e). The change in terminology should not be interpreted to suggest that the terms are interchangeable, as the term “drug-led combination
products” encompasses “drug-led devices” as well as other drug-led combination products for which the FDA evaluates therapeutic equivalence.

Bulletin No. 2024–47 1141 November 18, 2024
The Departments request comment
on whether to finalize these policies only
with respect to contraception as proposed,
or to instead finalize these policies with
respect to all preventive services, or with
respect to a larger subset of preventive
services. In particular, the Departments
request comment on issues related to cov-
erage of additional specific OTC preven-
tive products without a prescription (for
example, tobacco cessation items) in addi-
tion to OTC contraceptive items, or all
OTC preventive products without a pre-
scription. The Departments also request
comment on the experiences (particularly
with respect to administrative challenges,
consumer experiences, and costs) of any
plans and issuers that currently provide
coverage for any OTC preventive prod-
ucts without requiring a prescription, and
how those experiences could inform the
implementation of these proposed rules, if
finalized. The Departments further request
comment on whether and to what extent
these proposals could affect the ability of
plans and issuers to negotiate or otherwise
limit costs for contraceptive items, includ-
ing OTC contraceptive items and contra-
ceptive drugs and drug-led combination
products, and what additional rulemaking
or guidance would be necessary to ensure
that plans and issuers retain the ability to
do so.
Along with the incremental approach
proposed in this rulemaking focused on
contraception, the Departments antici-
pate issuing another notice of proposed
rulemaking in the near future to address
additional issues related to coverage of
preventive services more generally.
a. Coverage of OTC Contraceptive Items
Without Cost Sharing
As discussed in section I.B of this pre-
amble, the Departments’ previously issued
guidance provides that preventive health
care items generally available OTC to
patients (such as folic acid and certain con-
traceptive products, including contracep-
tive sponges, spermicides, and emergency
contraception (levonorgestrel)) must be
covered without cost sharing under sec-
tion 2713 of the PHS Act only when pre-
scribed by a health care provider.
102
This
approach reflected the traditional role of
health coverage in providing benefits for
health care items and services for which
there is provider involvement. However,
the FDA’s approval of a daily OTC oral
contraceptive without a prescription, in
combination with the reasons outlined
earlier in this preamble, have prompted
the Departments to revisit this approach.
As commenters to the OTC Preventive
Products RFI noted, neither section 2713
of the PHS Act and its implementing reg-
ulations nor the current HRSA-supported
Guidelines require a prescription as a con-
dition of coverage without cost sharing
for recommended preventive services that
are available OTC, except to the extent a
particular recommendation or guideline
requires that an individual is prescribed
an item or service. Therefore, with respect
to contraceptive items that can be law-
fully obtained
103
by a participant, benefi-
ciary, or enrollee without a prescription
and for which the applicable recommen-
dation or guideline does not require a
prescription, the Departments propose
in new paragraph (a)(6)(ii) that a plan or
issuer would not be considered to com-
ply with 26 CFR 54.9815-2713(a)(1), 29
CFR 2590.715-2713(a)(1), and 45 CFR
147.130(a)(1), unless the plan or issuer
provides coverage for the contraceptive
item without requiring a prescription
and without imposing any cost-sharing
requirements. As noted by many com-
menters to the OTC Preventive Products
RFI, out-of-pocket costs and prescription
requirements make it more difficult for
women to access contraception, includ-
ing contraceptive items that are available
without a prescription, such as oral con-
traceptives recently approved by the FDA
for OTC sale. The Departments agree with
commenters that these obstacles present
greater challenges to women in under-
served communities, including those with
lower incomes and who are members of
underserved racial and ethnic groups,
reinforcing structural barriers to health
care and contributing to reproductive
health disparities. Although some plans
and issuers have voluntarily, or as required
by State law,
104
provided coverage of OTC
contraceptive items without a prescription
and without cost-sharing requirements or
with limits on cost sharing, the Depart-
ments understand that many women lack
such coverage. In response to a specific
question regarding how commonly plans
and issuers provide coverage for OTC
preventive products without requiring a
prescription, many commenters asserted
that most plans and issuers cover OTC
preventive products only when they are
prescribed. The Departments have deter-
mined, therefore, that requiring (rather
than encouraging) coverage of OTC con-
traceptive items without cost sharing and
without a prescription, as proposed in
these rules, is critical to ensuring that cov-
erage requirements provide women with
access to contraceptives as required under
section 2713 of the PHS Act and the appli-
cable HRSA-supported Guidelines, and to
realizing the goal of promoting access to
reproductive health care.
Under this proposal, the requirement to
cover OTC contraceptive items would be
subject to the specific coverage require-
ments applicable to all recommended
preventive services in 26 CFR 54.9815-
2713, 29 CFR 2590.715-2713, and 45
CFR 147.130. However, the Departments
recognize that the provision and cover-
age of OTC contraceptive items present
unique issues that plans and issuers may
102
See FAQs Part XII, Q4 and Q15 (Feb. 20, 2013), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xii.pdf and www.cms.
gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs12.html; FAQs Part 54, Q5-6 (July 28, 2022), available at https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/
our-activities/resource-center/faqs/aca-part-54.pdf and https://www.cms.gov/files/document/faqs-part-54.pdf.
103
The Departments intend for this proposal to apply only to contraceptive items that are legally sold without a prescription. Nothing in this proposal would require a plan or issuer to provide
coverage without cost sharing for a contraceptive item for which the FDA requires a prescription, if a participant, beneficiary, or enrollee acquires the item without a prescription.
104
CA, CO, MD, NM, NJ, NY, and WA require some coverage of OTC contraceptive items. See KFF (Updated March 2024). “State Private Insurance Coverage Requirements for OTC Con-
traception Without a Prescription,” available at https://www.kff.org/other/state-indicator/state-private-insurance-coverage-requirements-for-otc-contraception-without-a-prescription. See,
e.g., Cal. Health & Saf. Code section 1367.25(b)(1)(A) (barring prescription requirements for OTC FDA-approved contraceptive drugs, devices, and products and requiring point-of-sale
coverage of OTC contraception at in-network pharmacies); Md. Code, Ins. section 15-826.1 (requiring coverage without a prescription for all FDA-approved contraceptive drugs available
OTC and limiting cost-sharing for OTC contraceptive drugs to the amount that would apply to the same drug dispensed under a prescription).

November 18, 2024 1142 Bulletin No. 2024–47
not encounter when covering other recom-
mended services. Therefore, the following
sections of this preamble discuss how
plans and issuers would be expected to
comply with certain existing requirements
with respect to coverage of OTC contra-
ceptive items.
105
(1) In-Network and Out-of-Network
Coverage of OTC Contraceptive Items
Under section 2713 of the PHS Act
and its implementing regulations at 26
CFR 54.9815-2713(a)(3)(i) and (ii), 29
CFR 2590.715-2713(a)(3)(i) and (ii), and
45 CFR 147.130(a)(3)(i) and (ii), a plan
or issuer is not required to provide cover-
age for recommended preventive services
delivered by an out-of-network provider if
the plan or issuer has a network of provid-
ers. Similarly, nothing precludes a plan or
issuer that has a network of providers from
imposing cost-sharing requirements on
recommended preventive services deliv-
ered by an out-of-network provider. How-
ever, if a plan or issuer does not have a
provider in its network who can provide a
recommended preventive service, the plan
or issuer must cover the recommended
preventive service, without cost sharing,
when furnished by an out-of-network pro-
vider.
106
Nothing under section 2713 of the
PHS Act nor its implementing regulations
requires a plan or issuer to establish a pro-
vider network.
The Departments are not proposing to
amend these requirements with respect
to OTC contraceptive items. Therefore, a
plan or issuer that has a network of pro-
viders that can provide OTC contraceptive
items would not be required to provide
coverage, or waive cost sharing, for OTC
contraceptive items that are provided by
an out-of-network provider. For example,
if a plan or issuer has a network of phar-
macies (including mail-order pharmacies)
that can provide OTC contraceptive items
without a prescription, the plan or issuer
would not be required to provide coverage
(nor waive cost sharing) if a participant,
beneficiary, or enrollee obtains a covered
OTC contraceptive item at an out-of-net-
work pharmacy or other retailer.
107
The Departments understand, based on
responses to the OTC Preventive Prod-
ucts RFI and communications with plans
and issuers regarding coverage of OTC
COVID-19 diagnostic tests during and
after the COVID-19 PHE, that network
contracts between plans and issuers and
pharmacies that are located in a retail store
typically include only the pharmacies as
the in-network providers. The retail stores
at which the pharmacies are located are
treated as separate entities. In these cases,
the pharmacy point of sale would be con-
sidered an in-network provider at which
an OTC contraceptive would be covered
without cost sharing, but a non-pharmacy
point of sale (for example, a cash register,
self-check-out, or vending machine in the
front of a retail store, unaffiliated with the
pharmacy department) would not be con-
sidered an in-network provider. Although
participants, beneficiaries, and enrollees
would typically be able to purchase OTC
contraceptives from the front of the retail
store, these proposed rules would not
require a plan or issuer with a network
of pharmacies to also cover without cost
sharing OTC contraceptive items that are
purchased at a retail store that is co-lo-
cated with an in-network pharmacy. If the
plan or issuer has a network of pharmacies
that provide coverage for OTC contracep-
tive items without cost sharing, that plan
or issuer would be considered to have a
network of providers to provide benefits
for OTC contraceptive items and therefore
would not be required to cover OTC con-
traceptive items purchased at a retail store
that is not part of its network. For exam-
ple, emergency contraception could be
available in multiple locations in the same
retail store: behind the pharmacy counter
through an in-network pharmacy where a
consumer typically provides health cover-
age information to allow the pharmacy to
process a claim for coverage; and “off the
shelf” in a non-pharmacy section of the
same store. This could result in a partic-
ipant, beneficiary, or enrollee being able
to access an OTC contraceptive item at
an in-network pharmacy without paying
any out-of-pocket costs at the pharmacy
counter point of sale, while being liable
for the full cost of the identical OTC con-
traceptive item if it was purchased at a
non-pharmacy point of sale. The Depart-
ments request comment on the potential
impact on consumers, pharmacies, and
retail stores with this proposed approach.
The Departments would expect that
in-network coverage for OTC contracep-
tive items and services would be provided
in a manner that is comparable to cover-
age for other recommended preventive
services. For example, the Departments
would expect that a plan or issuer that
does not preference the use of a mail-or-
der pharmacy for coverage of prescrip-
tion-only recommended preventive ser-
vices would not preference the use of
a mail-order pharmacy for coverage of
OTC contraceptives. As another exam-
ple, a plan or issuer should not impose
shipping costs on an OTC contraceptive
item that is furnished via mail order if the
plan or issuer would not impose shipping
costs on a comparable prescription prod-
uct. Likewise, to the extent that a plan or
issuer generally covers a recommended
preventive service that requires a prescrip-
tion without cost sharing at the in-network
pharmacy point of sale, without requir-
ing consumers to pursue post-purchase
reimbursement, the Departments would
expect that the plan or issuer would gen-
erally cover OTC contraceptive items at
the in-network pharmacy point of sale
in the same manner. Plans and issuers
that require participants, beneficiaries, or
enrollees to present information, such as
an insurance card, to allow an in-network
pharmacy to process a claim for a pre-
scription-only recommended preventive
service may require similar information to
process a claim for an OTC contraceptive
item. The Departments request comment
on the appropriate approach for coverage
105
The requirements regarding office visits would not be relevant with respect to coverage of OTC contraceptive items, and the requirements regarding timing do not raise unique issues with
respect to OTC contraceptive items.
106
See FAQs Part XXII, Q3 (Feb. 20, 2013), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xii.pdf and https://www.cms.
gov/cciio/resources/fact-sheets-and-faqs/aca_implementation_faqs12.
107
Nothing in the statute or preventive services regulations prevents a plan or issuer from providing coverage without cost sharing for out-of-network recommended preventive services, and
the Departments encourage plans and issuers to do so.

Bulletin No. 2024–47 1143 November 18, 2024
in a scenario in which a plan’s or issuer’s
preferred OTC contraceptive item is out
of stock at an in-network pharmacy, while
a non-preferred version is available. Spe-
cifically, the Departments request com-
ment on whether plans or issuers should
be required to cover the non-preferred
version without cost-sharing require-
ments at the in-network pharmacy, with-
out requiring the consumer to pursue
an exceptions process when a preferred
version is unavailable at an in-network
pharmacy. The Departments also request
comment on whether and how plans and
issuers should document the unavailabil-
ity of a preferred OTC contraceptive for
coverage purposes.
As noted earlier, plans and issuers are
not required to establish a provider net-
work in order to provide coverage of rec-
ommended preventive services and would
not be required to contract with providers
for the purpose of providing in-network
coverage of OTC contraceptive items if
these proposed rules are finalized. Under
26 CFR 54.9815-2713(a)(3)(ii), 29 CFR
2590.715-2713(a)(3)(ii), and 45 CFR
147.130(a)(3)(ii), a plan or issuer that
lacks an in-network provider who can pro-
vide an OTC contraceptive item would be
obligated to cover the OTC contraceptive
item when provided by an out-of-network
provider without imposing cost sharing.
In the absence of a provider network,
the Departments encourage plans and
issuers to establish processes to ensure
that participants, beneficiaries, and enroll-
ees can obtain OTC contraceptive items
from out-of-network providers without
incurring out-of-pocket costs and with-
out encountering significant barriers to
access.
108
The Departments are not propos-
ing to specify in these proposed rules how
a plan or issuer would do so, but would
encourage plans and issuers to establish
a robust approach with multiple entry
points to ensure that participants, benefi-
ciaries, and enrollees can access out-of-
network OTC contraceptive items with no
out-of-pocket costs and without friction at
the point of sale. The Departments request
comment on what additional standards or
guidance would be helpful to ensure that
participants, beneficiaries, and enrollees
can use their health coverage to access
OTC contraceptive items from out-of-
network providers without cost sharing,
while allowing plans and issuers flexibil-
ity to effectively implement the require-
ment to cover OTC contraceptive items,
if finalized.
If these requirements are finalized,
plans and issuers should ensure that pro-
cesses that require participants, benefi-
ciaries, or enrollees to pay out-of-pocket
for OTC contraceptive items and pursue
reimbursement do not present unrea-
sonable barriers to accessing OTC con-
traceptive items provided by either an
in-network or out-of-network provider. A
traditional post-purchase reimbursement
process might require consumers to bear
the upfront cost of an OTC contraceptive
item as well as the administrative burden
of requesting reimbursement, providing
documentation either on paper or electron-
ically, and absorbing the financial impact
of a delayed reimbursement while a reim-
bursement request is being reviewed and
processed by the plan or issuer. For exam-
ple, while it would be reasonable for a
plan or issuer to require a form and receipt
or other proof of purchase, post-purchase
reimbursement programs that require an
individual to submit multiple documents
or involve numerous steps that unduly
delay an individual’s reimbursement for
an OTC contraceptive item would not be
reasonable under these proposed rules.
Further, the Departments would
strongly encourage plans and issuers to
consider implementing additional meth-
ods for providing coverage of OTC con-
traceptive items without cost sharing,
in addition to or in lieu of a traditional
post-purchase reimbursement process. For
example, plans and issuers could consider
providing access to pre-paid accounts
that are programmed to cover upfront
costs associated with OTC contraceptive
items at the point of sale, either by issuing
physical debit or credit cards or providing
access to a linked smartphone application
or QR code to participants, beneficiaries,
or enrollees, provided funds were suffi-
cient to cover costs associated with OTC
contraceptive items, the mechanism for
delivery was programmed with sufficient
guardrails to prevent funds from being
applied to items that were not covered,
and the method of access was otherwise
implemented consistent with applicable
law. Subject to the requirements for utiliz-
ing reasonable medical management tech-
niques
109
and consistent with previously
issued guidance
110
(including providing
access to an easily accessible, transparent,
and sufficiently expedient exceptions pro-
cess that is not unduly burdensome on the
individual, a provider, or other authorized
representative),
111
plans and issuers would
be able to utilize reasonable medical man-
agement techniques to contain costs and
promote efficient delivery of care, and
could consider how to do so within the
context of such an approach for out-of-
network coverage of OTC contraceptive
items. For example, a plan or issuer would
be able to program a debit or credit card
or linked account to limit reimbursement
to a set amount within a specified period
of time, provided such limitations do not
unreasonably limit coverage of covered
OTC contraceptive items.
The Departments are aware that some
OTC contraceptive items, such as software
applications granted marketing authoriza-
tion by the FDA for use as contraception,
are typically not furnished by in-network
providers (for example, because consum-
ers purchase them directly from a manu-
108
The Departments note that plans and issuers would not be required to reimburse the cost of OTC contraceptive items that have already been reimbursed by an account-based plan, such as
a health flexible spending arrangement (FSA) or health reimbursement arrangement (HRA). As of January 2020, section 3702 of the CARES Act amended the definition of qualifying medical
expenses so that the expenses for certain OTC medications purchased without a prescription are eligible for reimbursement under certain arrangements, such as health savings accounts
(HSAs), HRAs, and health FSAs. An individual generally may not submit claims to multiple sources of coverage to be reimbursed more than once for the same medical expense. Therefore, the
cost (or the portion of the cost) of OTC contraception that has already been paid or reimbursed by a plan or issuer cannot also be reimbursed by an HSA, HRA, or health FSA.
109
26 CFR 54.9815-2713(a)(4), 29 CFR 2590.715-2713(a)(4), and 45 CFR 147.130(a)(4).
110
See, e.g., FAQs Part XII, Q14 (Feb. 20, 2013), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xii.pdf and www.cms.gov/
CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs12.html; FAQs Part XXVI (May 11, 2015), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activ-
ities/resource-center/faqs/aca-part-xxvi.pdf and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf.
111
See section II.A of the preamble to these proposed rules for a description of existing guidance regarding the use of an exceptions process and the proposal in these proposed rules to require
plans and issuers to provide an exceptions process when utilizing reasonable medical management for recommended preventive services.

November 18, 2024 1144 Bulletin No. 2024–47
facturer or vendor website). As with other
recommended preventive services for
which a plan or issuer does not have an
in-network provider who can provide the
item or service, the plan or issuer would
be required to cover the item or service
when delivered by an out-of-network pro-
vider and could not impose cost sharing
with respect to the item or service. The
Departments request comment on whether
additional guidance is necessary to ensure
that individuals would be able to use their
health coverage to obtain OTC contracep-
tive items that are typically obtained out-
side of the traditional system of network
providers with zero cost sharing and with-
out unnecessarily burdensome reimburse-
ment requirements, while permitting plans
and issuers to utilize reasonable medical
management techniques.
The Departments request comment on
how plans and issuers would likely oper-
ationalize out-of-network coverage and
whether the Departments should adopt
specific standards for out-of-network cov-
erage with respect to OTC contraceptive
items. In addition, participants, beneficia-
ries, and enrollees would benefit if plans
and issuers provide access to a broad net-
work of providers with the capacity to
provide the full range of OTC contracep-
tive items, and the Departments request
comment on how to support and incen-
tivize plans and issuers to develop such
networks.
(2) Reasonable Medical Management
Techniques for OTC Contraceptive
Services
As discussed in section II.A.1 of this
preamble, to the extent not specified in
the applicable recommendation or guide-
line, plans and issuers may rely on the
relevant clinical evidence base and estab-
lished reasonable medical management
techniques to determine the frequency,
method, treatment, or setting for cover-
age of a recommended preventive health
service.
112
In prior guidance, the Depart-
ments have stated that if a plan or issuer
utilizes medical management techniques
within a specified category of contracep-
tion (or, with respect to contraceptive cat-
egories not specifically described in the
HRSA-supported Guidelines, a group of
substantially similar services or products),
the use of those techniques will not be
considered reasonable unless the plan or
issuer has an easily accessible, transpar-
ent, and sufficiently expedient exceptions
process that is not unduly burdensome on
the individual or their attending provider
(or other individual acting as the individ-
ual’s authorized representative) allowing
such individual to obtain coverage for a
service or FDA-approved, -cleared, or
-granted product determined to be med-
ically necessary, as determined by the
individual’s attending provider.
113
The
Departments are not proposing amend-
ments to the medical management provi-
sions specific to OTC contraceptive items.
Therefore, these standards, as well as the
new standards proposed in these rules,
114

would apply to a plan’s or issuer’s use
of medical management techniques with
respect to OTC contraceptive items in the
same manner and to the same extent as
they would apply to other recommended
preventive services.
The Departments recognize that plans
and issuers may encounter unique issues
related to medical management if the
Departments finalize the proposed require-
ments to cover OTC contraceptive items.
In the OTC Preventive Products RFI, the
Departments requested comment on what
types of reasonable medical management
techniques plans and issuers would con-
sider implementing if recommended OTC
preventive products were required to be
covered without cost sharing. In response,
some commenters suggested plans and
issuers could limit the number of prod-
ucts an individual could obtain during a
given period as a guardrail for OTC con-
traceptive services. One commenter stated
that quantity limits would help prevent
inequitable distribution and stockpiling
for resale of OTC contraceptive services.
Another commenter urged the Depart-
ments to allow plans and issuers to limit
the initial purchase of OTC contraceptive
services until there is more understanding
of the cost implications and distribution
channels for OTC preventive services.
Other commenters discouraged the use of
quantity limits as a medical management
technique out of concern that such limits
would discourage continuation of use, by
creating new access barriers for individu-
als that already face challenges engaging
with the health care system, in particular
individuals that are members of under-
served communities. In addition, a com-
menter expressed concern about the diffi-
culty in predicting the need for emergency
contraception.
Some commenters advocated for
12-month quantity limits for monthly
OTC contraceptive services in order to
balance the health equity concerns of
individuals with the implementation
challenges that may arise for retailers and
plans and issuers transitioning to cover-
ing OTC contraceptive services without
a prescription and without cost sharing.
Some commenters noted that there is
already ample precedent for requiring
coverage of extended supplies of contra-
ceptives, with at least 25 States and the
District of Columbia requiring Medicaid
and private payers to cover the dispens-
ing of an extended (usually 12-month)
supply of prescription contraceptives.
115

One commenter to the OTC Preventive
Products RFI stated that purchasing
contraceptive items in larger dispensing
quantities may create opportunities for
plans and issuers to negotiate pricing dis-
counts that will decrease per-unit costs
for plans and issuers as well as suppli-
ers and distributors. The Departments
note that when the OTC oral contracep-
tive became available in March 2024 for
sale online and in stores under the brand
name Opill
®
, the manufacturer’s sug-
gested retail price for a 6-month supply
was cheaper (per-month) than the man-
112
26 CFR 54.9815-2713(a)(4); 29 CFR 2590.715-2713(a)(4); and 45 CFR 147.130(a)(4).
113
See FAQs Part 54, Q3 (July 28, 2022), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf.
114
See sections II.A.1 (for discussion of proposal to amend the general requirements related to reasonable medical management) and II.A.2.b (for discussion of proposed amendment regarding
reasonable medical management for contraceptive drugs and drug-led combination products, including OTC contraceptive items) of the preamble to these proposed rules.
115
In States that have implemented a 12-month prescription limitation, plans and issuers are required to cover without cost sharing a supply of up to 12 months when indicated by the pre-
scribing provider. See Power to Decide (August 2023), “Coverage for an Extended Supply of Contraception,” available at https://powertodecide.org/sites/default/files/2023-08/Extended%20
Supply%20of%20Contraception.pdf. Since the comment submission period for the OTC Preventive Products RFI closed, additional States have enacted coverage requirements related to
extended contraceptive supplies. See NCSL, “State Contraception Policies,” available at https://www.ncsl.org/health/state-contraception-policies.

Bulletin No. 2024–47 1145 November 18, 2024
ufacturer’s suggested retail price for a
1-month supply.
116
Literature on contraception shows that
dispensing a multi-month supply of pre-
scription oral contraceptive pills at one
time during the plan year is generally
associated with increased continuation of
contraception use, decreased occurrence
of unintended pregnancy, and greater cost
savings, but also more pill waste, com-
pared to dispensing a single month’s sup-
ply.
117,118
Research also shows that advance
provision of emergency contraception
significantly increases its use without
adversely affecting the use of routine con-
traception,
119
which suggests that it may
be beneficial for women to receive more
than one unit of emergency contraception
at a time, in order to realize the benefits
of advance provision for future use. Lim-
itations on the supply of OTC contracep-
tion dispensed at one time should take into
account the clinical evidence base regard-
ing benefits to consumers, including as
described in this section II.a.2.
Given the evidence regarding benefits
to consumers of a multi-month supply of
prescription oral contraceptive pills, the
Departments would generally not consider
coverage limitations that only allow for a
1-month supply of an OTC oral contra-
ception per instance of dispensing to be
reasonable or consistent with the require-
ment to cover recommended preventive
services under 26 CFR 54.9815-2713(a)
(4), 29 CFR 2590.715-2713(a)(4), and
45 CFR 147.130(a)(4) if there is no clin-
ical basis for limiting the quantity to be
dispensed at one time. The Departments
seek comment, with respect to all forms
of OTC contraceptives, on whether other
quantity limits (such as a 6-month limit on
OTC oral contraception or a 3-unit limit
on OTC emergency contraception per
instance of dispensing) should be consid-
ered reasonable or unreasonable, and what
additional facts and circumstances should
be considered when determining the rea-
sonableness of a particular quantity limit
with respect to OTC contraception, such
as initial success with a shorter supply of
OTC contraception. The Departments also
request comment on the circumstances
under which participants, beneficia-
ries, and enrollees who receive an initial
extended quantity of OTC contraception
could access a different form of contra-
ception without incurring cost sharing
before finishing the initial extended quan-
tity (for example, before a 6-month supply
is exhausted).
Some commenters to the OTC Preven-
tive Products RFI suggested individuals
should be required to submit evidence
to a plan or issuer that a particular form
of prescription birth control is inappro-
priate before receiving coverage for an
OTC contraceptive service. The Depart-
ments previously issued guidance that
it is not a reasonable medical manage-
ment technique to require individuals to
fail first using numerous other services
or FDA-approved, -cleared, or -granted
contraceptive products before the plan
or issuer will approve coverage for the
service or FDA-approved, -cleared, or
-granted contraceptive product that is
medically necessary for the individual, as
determined by the individual’s attending
provider.
120
Within the context of medical
management of OTC contraceptive items,
the Departments would not consider it
reasonable either to impose a prescription
requirement for OTC contraception as a
form of medical management, including
requiring an individual to fail first using
a prescription-only contraceptive item
before providing coverage of an OTC
contraceptive item without cost sharing,
or to require an individual to fail first with
numerous prescription or OTC contracep-
tive items before the plan or issuer will
approve coverage for a medically neces-
sary OTC contraceptive item.
Other commenters suggested that a
plan or issuer could consider implement-
ing age-based limitations or gender-based
requirements instead of offering benefits
to all individuals with reproductive capac-
ity. The Departments would not consider
age- and gender-based medical manage-
ment with respect to OTC contracep-
tive services to be reasonable unless the
medical management technique relies on
a clinical rationale for limiting access to
individuals of a certain age or gender and
is consistent with FDA approvals of any
particular OTC contraceptive product.
The Departments have stated in previous
guidance that imposing an age limit on
contraceptive coverage instead of provid-
ing these benefits to all women would not
be considered a reasonable medical man-
agement technique.
121
A commenter suggested that imple-
menting prior authorization requirements
with respect to certain OTC items would
not be an unreasonable medical manage-
ment technique. However, such medical
management techniques create barriers
for consumers accessing contraceptive
services with a prescription
122
and would
create similar barriers for consumers
accessing contraceptives services without
a prescription, with the added challenge
that consumers seeking to obtain OTC
contraceptive items are likely navigating
such requirements without the assistance
of a provider. Such requirements could
be used as a means of circumventing the
requirement to provide coverage of con-
traception without cost sharing and with-
116
Lupkin, S., NPR (March 18, 2024). “First over-the-counter birth control pill now for sale online,” available at https://npr.org/sections/health-shots/2024/03/04/1235404522/opill-over-
counter-birth-control-pill-contraceptive-shop.
117
See Steenland, M., Rodriguez, M., Marchbanks, P., and Curtis, K. (2013). “How does the number of oral contraceptive pill packs dispensed or prescribed affect continuation and other
measures of consistent and correct use? A systematic review,” Contraception, available at https://www.sciencedirect.com/science/article/pii/S0010782412007317?via%3Dihub.
118
See Judge-Golden, C. P., Smith, K. J., Mor, M. K., and Borrero, S. (2019). “Financial Implications of 12-Month Dispensing of Oral Contraceptive Pills in the Veterans Affairs Health Care
System,” JAMA Internal Medicine, available at https://doi.org/10.1001/jamainternmed. 2019.1678 (study of the Veterans Affairs health care system finding that a 12-month supply better
supports continuous usage of contraceptive items than a 3-month supply and decreases the risk of unwanted pregnancies, and concluding that a 12-month dispensing option would likely
result in a $2 million dollar annual cost-savings for the Veterans Affairs health care system).
119
See Kripke, C. (2000). “Advance Provision for Emergency Oral Contraception,” American Family Physician, available at https://www.aafp.org/pubs/afp/issues/2007/0901/p654.html;
Jackson R.A., Bimla Schwarz, E., Freedman L, Darney P. (2003). “Advance supply of emergency contraception: effect on use and usual contraception—a randomized trial,” Obstetrics and
Gynecology, available at https://pubmed.ncbi.nlm.nih.gov/12850599.
120
See FAQs Part 54, Q8 (July 28, 2022), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf and https://www.cms.gov/
files/document/faqs-part-54.pdf.
121
Id.
122
See U.S. House of Representatives Committee on Oversight and Reform (Oct. 25, 2022). “Barriers to Birth Control: An Analysis of Contraceptive Coverage and Costs for Patients with
Private Insurance,” available at https://oversightdemocrats.house.gov/sites/evo-subsites/democrats-oversight.house.gov/files/2022-10-25.COR%20PBM-Insurer%20Report.pdf.

November 18, 2024 1146 Bulletin No. 2024–47
out a prescription. Therefore, under these
proposed rules, coverage requirements
that, in practice, operate as substitutes for
a prescription coverage requirement by
requiring the involvement of a provider
(such as prior authorization processes
that require provider involvement or
other clinical expertise or a requirement
that individuals receive counseling from
a pharmacist prior to accessing an OTC
contraceptive item) would not be con-
sidered reasonable medical management
techniques with respect to OTC contra-
ceptive items.
Under these proposed rules, plans
and issuers generally could adopt medi-
cal management techniques with respect
to OTC contraceptive items that are not
described as unreasonable in this pream-
ble as long as they are otherwise consistent
with proposed 26 CFR 54.9815-2713(a)
(4), 29 CFR 2590.715-2713(a)(4), and 45
CFR 147.130(a)(4) and existing guidance
and the plan or issuer makes available an
exceptions process as described in these
proposed rules. The Departments request
comment on what other medical manage-
ment techniques plans and issuers would
consider applying to OTC contraceptive
items, including whether such techniques
should be considered reasonable or unrea-
sonable. The Departments request com-
ment on the proposed interpretation of
reasonable medical management require-
ments with respect to OTC contraceptive
items, including whether any final regu-
lations should specify or use examples to
illustrate in the regulatory text the Depart-
ments’ interpretation of reasonable med-
ical management for OTC contraceptive
items.
(3) Other Considerations
The Departments acknowledge the
concerns raised by commenters to the
OTC Preventive Products RFI, such as
risks to patient privacy, of overconsump-
tion, and of fraud, waste, or abuse, that
some commenters believe could be exac-
erbated with increased coverage with no
cost sharing of OTC contraceptive items.
These concerns could be heightened with
respect to OTC items and services that do
not require the input of a provider in the
form of a prescription and may be further
increased within the context of out-of-
network providers with whom plans and
issuers do not have contractual relation-
ships. For example, plans and issuers may
wish to ensure that individuals are obtain-
ing OTC contraceptive items to prevent
pregnancy rather than solely to address
another underlying condition (such as
to treat anemia or manage premenstrual
symptoms) or to ensure that an individ-
ual is obtaining condoms for the use of
a woman covered under the plan, rather
than for use by another individual. Several
commenters to the OTC Preventive Prod-
ucts RFI highlighted concerns that cover-
age of OTC preventive products without
cost sharing could incentivize overcon-
sumption or waste of such products. Addi-
tionally, OTC contraceptive items may
present particular challenges with respect
to patient privacy, given the deeply per-
sonal nature of reproductive health care
and the dynamic nature of State laws gov-
erning access to reproductive health care.
The Departments anticipate that plans
and issuers with a network of provid-
ers would mitigate these risks by using
existing claims processing systems with
respect to in-network coverage, but
acknowledge that coverage through path-
ways other than an in-network pharmacy
may present privacy challenges (for exam-
ple, because non-provider retailers are not
required to implement the same privacy
and security safeguards as they are with
respect to back-pharmacy transactions).
The Departments request comment on
how best to encourage plans and issuers to
develop mechanisms that promote access
to OTC contraceptive items in accordance
with these proposed regulations, if final-
ized, while protecting patient privacy and
allowing plans and issuers to identify and
address risks including waste, fraud, and
abuse.
The Departments further request com-
ment on how the proposed exceptions
process requirement should apply with
respect to OTC contraceptives items, for
which no provider involvement is gener-
ally required. The proposed exceptions
process requirement described in sec-
tion II.A.1 of this preamble refers to the
determination of an individual’s attending
provider. Thus, the Departments request
comment on what information individuals
should be required to provide to seek an
exception to access coverage for an OTC
contraceptive item that is not typically
covered, including how plans and issuers
could determine whether an OTC contra-
ceptive item is medically necessary, and
whether any additional changes are neces-
sary for an exceptions process when used
to seek coverage, without cost sharing, for
an OTC contraceptive item.
The Departments also request comment
on whether it would be beneficial to define
a new term to refer to contraception that
would be subject to the proposed amend-
ments to 26 CFR 54.9815-2713(a)(6), 29
CFR 2590.715-2713(a)(6), and 45 CFR
147.130(a)(6); and if so, request feedback
on the appropriate term and scope of the
definition. For example, the Departments
request comment on whether to define
“contraceptive item,” “contraceptive
product,” or “contraceptive items and
services” within the context of these pro-
posed rules; and whether the term would
refer to all contraceptive items and ser-
vices recommended under the HRSA-sup-
ported Guidelines, all contraceptive items
and services recommended under 26 CFR
54.9815-2713(a)(1), 29 CFR 2590.715-
2713(a)(1), and 45 CFR 147.130(a)(1); or
another subset of recommended preven-
tive services.
b. Therapeutic Equivalence Approach
to Reasonable Medical Management
for Contraceptive Drugs and Drug-Led
Combination Products
As discussed in section II.A.2 of this
preamble, despite repeated clarification in
guidance, the Departments have contin-
ued to receive complaints and reports that
participants, beneficiaries, and enrollees
are being denied coverage for contracep-
tives that their attending providers have
prescribed, in some cases due to the appli-
cation of medical management techniques
that are not reasonable based on all the
relevant facts and circumstances.
123
The
Departments are also aware of investiga-
123
See also FAQs Part 54, Q8 (July 28, 2022), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf and https://www.cms.
gov/files/document/faqs-part-54.pdf.

Bulletin No. 2024–47 1147 November 18, 2024
tions and other credible reports that have
documented plans and issuers using poten-
tially unreasonable medical management
techniques.
124
In response to these reports,
the Departments issued FAQs Part 64 on
January 22, 2024, which set forth a ther-
apeutic equivalence approach that plans
and issuers can, but are not required to,
use (in combination with an easily accessi-
ble, transparent, and sufficiently expedient
exceptions process) to comply with PHS
Act section 2713 and its implementing
regulations with respect to FDA-approved
contraceptive drugs and drug-led devices,
as an alternative to standards that had
been set forth in previous guidance and
described in section II.A.1 of this pream-
ble.
125
The Departments have determined
that it is necessary to require the therapeu-
tic equivalence approach to ensure cov-
erage of the full range of FDA-approved
contraceptive items that are drugs and
drug-led combination products. The pro-
posed therapeutic equivalence approach
would serve as a guardrail against the
widespread use of narrow drug formular-
ies, which the Departments understand
plans and issuers use to limit costs, but can
have the effect of limiting access to medi-
cally appropriate contraceptive drugs and
drug-led combination products.
126
This
proposed regulation would limit the use
of such techniques with respect to recom-
mended contraceptive drugs and drug-led
combination products.
Therefore, the Departments propose
to amend 26 CFR 54.9815-2713, 29 CFR
2590.715-2713, and 45 CFR 147.130 to
add a new paragraph (a)(6)(iii) that would
specify that a plan’s or issuer’s medi-
cal management techniques are not con-
sidered to be reasonable unless the plan
or issuer provides coverage for recom-
mended preventive services that are con-
traceptive drugs and drug-led combination
products, other than those items for which
there is at least one therapeutic equivalent
drug or drug-led combination product, as
applicable, for which the plan or issuer
provides coverage without imposing any
cost-sharing requirements, consistent
with the therapeutic equivalence approach
described in FAQs Part 64. The Depart-
ments also propose to define “therapeutic
equivalent” for purposes of this proposed
provision as having the meaning given
the term “therapeutic equivalents” in 21
CFR 314.3(b), which defines “therapeutic
equivalents” as “approved drug products
that are pharmaceutical equivalents for
which bioequivalence has been demon-
strated, and that can be expected to have
the same clinical effect and safety profile
when administered to patients under the
conditions specified in the labeling.”
Under this proposal, consistent with
FAQs Part 64, a therapeutic equivalent
drug or drug-led combination product
would be one that is designated with a
code with the first letter “A” in the FDA’s
Approved Drug Products with Thera-
peutic Equivalence Evaluations (Orange
Book).
127
If the Orange Book does not
identify a therapeutic equivalent for a
given drug or drug-led combination prod-
uct, that drug or drug-led combination
product would have no therapeutic equiv-
alent for purposes of these proposed rules,
and a plan or issuer would not be permitted
to use medical management techniques to
deny coverage of (or impose cost sharing
on) that drug or drug-led combination
product. For example, assume that there
are six oral contraceptives (Pill A, Pill
B, Pill W, Pill X, Pill Y, and Pill Z) listed
in the Orange Book that are within the
HRSA-supported Guidelines category of
contraceptives known as “oral contracep-
tives (combined pill).” If the Orange Book
does not identify a therapeutic equivalent
for either Pill A or Pill B, but identifies
the latter four (Pill W, Pill X, Pill Y, and
Pill Z) as therapeutic equivalents of each
other, then under these proposed rules, the
plan would be required to cover without
cost sharing Pill A and Pill B, for which
there are no therapeutic equivalents. The
plan could utilize reasonable medical
management techniques that result in it
covering only one of Pill W, Pill X, Pill Y,
or Pill Z without cost sharing because all
four are therapeutically equivalent to each
other (provided the plan has an exceptions
process that ensures an individual can
receive coverage, without cost sharing, for
any of Pill W, Pill X, Pill Y, or Pill Z, in
the circumstances discussed in more detail
in section II.A.1 of this preamble).
In the Orange Book, the FDA evalu-
ates only multisource prescription drug
products for therapeutic equivalence.
128

Therefore, the FDA does not evaluate
therapeutic equivalence for OTC drugs or
OTC drug-led combination products and
the Orange Book does not categorize such
products as a “therapeutic equivalent” of
any other drug or drug-led combination
product. As described in section II.A.2,
the Departments are proposing to require
plans and issuers to provide coverage of
OTC contraceptives without cost sharing
and without requiring a prescription. If
both the therapeutic equivalence proposal
described in this preamble section and
the OTC contraceptive coverage proposal
are finalized, plans and issuers would be
required to cover all OTC contraceptive
items that are drugs and drug-led com-
bination products without cost sharing.
The Departments request comment on
the potential impacts to interested parties,
including participants, beneficiaries, and
enrollees and plans and issuers, if both
proposals are finalized. The Departments
further request comment on whether an
alternative approach to therapeutic equiv-
alence would be appropriate for OTC
contraceptive drugs and drug-led combi-
nation products. If so, the Departments
request comment on what medical man-
agement techniques would be appropriate
and reasonable while balancing the goals
of increasing consumer access to OTC
contraceptive drugs and drug-led combi-
124
See U.S. House of Representatives Committee on Oversight and Reform (Oct. 25, 2022). “Barriers to Birth Control: An Analysis of Contraceptive Coverage and Costs for Patients with
Private Insurance,” available at https://oversightdemocrats.house.gov/sites/evo-subsites/democrats-oversight.house.gov/files/2022-10-25.COR%20PBM-Insurer%20Report.pdf.
125
FAQs Part 64 (Jan. 22, 2024), available at https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-64 and https://www.cms.gov/files/document/faqs-
part-64.pdf.
126
See Dieguez, G., Sawhney, T., and Mirchandani, H., Milliman (2016). “Evolution of the Use of Restrictions in Commercial Formularies,” available at https://www.milliman.com/-/media/
milliman/importedfiles/uploadedfiles/insight/2016/evolution-restrictions-commercial-formularies.ashx; Rucker, J., Benfield, M., Jenkins, N., Enright, D., Henderson, R., Chambers, J. (2023).
“Commercial Coverage of Specialty Drugs, 2017-2021” Health Affairs Scholar, available at https://academic.oup.com/healthaffairsscholar/article/1/2/qxad030/7236995.
127
FAQs Part 64, Q2 (Jan. 22, 2024), available at https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-64 and https://www.cms.gov/files/document/
faqs-part-64.pdf.
128
FDA, “Orange Book Preface,” available at https://www.fda.gov/drugs/development-approval-process-drugs/orange-book-preface.

November 18, 2024 1148 Bulletin No. 2024–47
nation products and containing costs. For
example, the Departments seek comment
on whether plans and issuers should be
permitted to provide coverage without
cost-sharing or prescription requirements
of a preferred generic version of an OTC
contraceptive, while only covering the
brand version without cost-sharing or
prescription requirements subject to an
exceptions process.
In addition to satisfying the therapeutic
equivalence approach, the Departments
would not consider a plan’s or issuer’s
medical management techniques with
respect to recommended contraceptive
services to be reasonable unless the plan
or issuer meets existing standards under
applicable regulations and guidance, to the
extent not superseded by the other propos-
als in these proposed rules. For example, as
described in FAQs Part 54, Q8, a plan’s or
issuer’s medical management techniques
would generally be considered reasonable
only if the plan or issuer utilizes reason-
able medical management techniques
within a specified category described in
the HRSA-supported Guidelines (or group
of substantially similar products that are
not included in a specified category).
129, 130

Therefore, if a plan or issuer provided
coverage consistent with the proposed
therapeutic equivalence approach, but
used medical management techniques
to deny coverage or impose cost sharing
for all contraceptives in another category
(or other groups of substantially similar
products), such as the category for steril-
ization surgery for women, the plan’s or
issuer’s medical management techniques
would not be considered to be reasonable.
Similarly, consistent with FAQs Part 54,
Q8, the Departments would not consider
a plan’s or issuer’s medical management
techniques to be reasonable if the plan or
issuer requires an individual to fail first
using numerous contraceptives within
a category prior to providing coverage
consistent with the proposed therapeutic
equivalence approach.
In addition, consistent with FAQs Part
64, the Departments would not consider
the use of medical management tech-
niques to be reasonable where a plan or
issuer provides coverage consistent with
the proposed therapeutic equivalence
approach but fails to provide an excep-
tions process that meets the standards
proposed in these rules. Requiring plans
and issuers that utilize reasonable medical
management to both apply the therapeu-
tic equivalence approach and provide an
exceptions process would be particularly
important in instances where the plan’s or
issuer’s preferred method is not medically
appropriate for an individual. Consider an
example in which there are three products
within the HRSA-supported Guidelines
category of “the contraceptive patch”
(Patch A, Patch B, and Patch C) and the
Orange Book identifies all three products
as therapeutic equivalents to each other.
Under the proposed therapeutic equiva-
lence approach, a plan or issuer would be
permitted to utilize reasonable medical
management techniques that result in it
generally covering only one of Patch A,
Patch B, or Patch C without cost sharing
because all are therapeutically equivalent
to each other. However, without an excep-
tions process, a person who, for example,
has an allergy to a non-therapeutic ingre-
dient in Patch A such as a dye or an adhe-
sive could not access an alternative such
as Patch B or Patch C that is determined to
be medically necessary by the individual’s
attending provider, and as a result, would
be denied the coverage required under
PHS Act section 2713.
The Departments propose to define
“drug-led combination product” at 26
CFR 54.9815-2713(a)(6)(i)(A), 29 CFR
2590.715-2713(a)(6)(i)(A), and 45 CFR
147.130(a)(6)(i)(A) as “a combination
product, as defined under 21 CFR 3.2(e),
that comprises a drug and a device, and for
which the drug component provides the
primary mode of action.” The term “com-
bination products” refers to the existing
FDA definition of “combination product”
at 21 CFR 3.2(e), and would apply only
to drug-led combination products within
the context of the proposed therapeutic
equivalence approach discussed in this
section II.A.2.b of this preamble. While
this proposal would not prevent plans and
issuers from applying a therapeutic equiv-
alence approach to other recommended
preventive services, the Departments
request comment on whether plans and
issuers utilizing reasonable medical man-
agement of recommended preventive ser-
vices other than contraceptive drugs and
drug-led combination products should be
required to apply the therapeutic equiva-
lence approach as described in these pro-
posed rules.
B. Communicating OTC Contraceptive
Coverage Requirements
Because plans and issuers have not
traditionally provided coverage for health
items that can be purchased directly by a
consumer without a prescription, partic-
ipants, beneficiaries, and enrollees may
not be aware that their health plan or cov-
erage would cover OTC contraceptive
items without cost sharing and without
a prescription if these proposed rules are
finalized. The Departments expect that
without sufficient communication about
this new coverage requirement from plans
129
FAQs Part 54, Q8 (July 28, 2022), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf and https://www.cms.gov/files/
document/faqs-part-54.pdf.
130
The Departments acknowledge that the proposed therapeutic equivalence standard would require plans and issuers to cover more contraceptive drugs and drug-led combination products
than under FAQs Part XXVI, Q2, which specified that a plan or issuer must cover at least one form of contraception in each method that is identified by the FDA. The Departments have
determined that this approach is necessary to ensure coverage of the full range FDA-approved contraceptive drugs and drug-led combination products, as required under section 2713 of
the PHS Act, while still permitting plans and issuers to contain costs by not requiring plans and issuers to cover items for which there is at least one therapeutic equivalent drug or drug-led
combination product, as applicable, for which the plan or issuer provides coverage without imposing any cost-sharing requirements. The FDA defines “therapeutic equivalents” at 21 CFR
314.3(b) as approved drug products that are pharmaceutical equivalents (meaning, in general, that they contain identical amounts of the identical active drug ingredient in the identical
dosage form and route of administration) and bioequivalents (meaning, in general, that the rate and extent of the active ingredient at the site of action are the same), and that can be expected
to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling. The contraceptives described in the HRSA-supported Guidelines
do not refer to therapeutic equivalence, and as a result, there may be multiple drugs or drug-led combination products within a category that are not therapeutically equivalent to each other.
For example, within the “oral contraceptives (combined pill)” category identified in the HRSA-supported Guidelines, there could exist multiple products that are oral contraceptive combined
pills but are not therapeutically equivalent because, for example, they contain different amounts of the same active ingredients. Under this proposal, a plan or issuer would be required to
cover, without cost sharing, at least one oral contraceptive combined pill that has a therapeutic equivalent, as well as each non-therapeutic equivalent oral contraceptive combined pill, rather
than at least one form of an oral contraceptive combined pill in the category.

Bulletin No. 2024–47 1149 November 18, 2024
and issuers, consumers’ lack of awareness
may lead to minimal use of this benefit.
Therefore, these proposed rules propose
new requirements under 26 CFR 54.9815-
2715A2, 29 CFR 2590.715-2715A2, and
45 CFR 147.211 that would ensure par-
ticipants, beneficiaries, and enrollees are
informed of this new coverage.
Section 2715A of the PHS Act pro-
vides that non-grandfathered group health
plans and health insurance issuers offer-
ing non-grandfathered group or indi-
vidual health insurance coverage must
comply with section 1311(e)(3) of the
ACA. Through section 1311(e)(3)(C) of
the ACA, section 2715A of the PHS Act
requires plans and issuers to permit indi-
viduals to learn the amount of cost sharing
(including deductibles, copayments, and
coinsurance) associated with a specific
item or service furnished by an in-network
provider upon the individual’s request.
Under the Departments’ rulemaking
authority in section 9833 of the Code,
section 734 of ERISA, and 2792 of the
PHS Act to implement section 2715A of
the PHS Act, the Departments propose to
require that plans and issuers permit indi-
viduals to learn the amount of cost shar-
ing associated with OTC contraceptive
items covered by their plan or coverage
without a prescription. Specifically, the
Departments propose to amend 26 CFR
54.9815-2715A2, 29 CFR 2590.715-
2715A2, and 45 CFR 147.211 to add
a new paragraph (b)(1)(vi) that would
require plans and issuers to provide infor-
mation to participants, beneficiaries, and
enrollees explaining that OTC contra-
ceptive items are covered without cost
sharing and without a prescription con-
sistent with these proposed rules when
participants, beneficiaries, and enrollees
request cost-sharing information for any
covered contraceptive item or service. By
promoting awareness of coverage of OTC
contraceptive items without cost-sharing
or prescription requirements, these pro-
posals serve as important companions to
proposed 26 CFR 54.9815-2713(a)(6),
29 CFR 2590.715-2713(a)(6), and 45
CFR 147.130(a)(6), described in section
II.A.2.a of this preamble.
In accordance with PHS Act sec-
tion 2715A and ACA section 1311(e)
(3)(C), under current 26 CFR 54.9815-
2715A2(b), 29 CFR 2590.715-2715A2(b),
and 45 CFR 147.211(b), plans and issu-
ers must disclose an estimate of the par-
ticipant’s, beneficiary’s, or enrollee’s
cost-sharing liability for all covered items
or services furnished by a provider or pro-
viders, through the Transparency in Cov-
erage internet-based self-service tool or, if
requested by the individual, paper. Under
current rules, if a participant, beneficiary,
or enrollee uses the self-service tool to
look up contraceptive items or services
with respect to an in-network pharmacy
(or to look up the out-of-network cost shar-
ing for these items or services for a plan or
issuer that does not have a provider in its
network that can provide the preventive
item), the self-service tool would display
the non-zero dollar cost-sharing liability
for the individual that is associated with
being billed as non-preventive (if appli-
cable), along with a statement that the
contraceptive item or service may not be
subject to cost sharing if it is billed as pre-
ventive. For contraceptive items that are
only covered by the plan or coverage for
preventive purposes (including because
they are only indicated for preventive pur-
poses), current rules require the self-ser-
vice tool to reflect a zero-dollar cost-shar-
ing liability. The Departments note also
that some contraceptive items may be cov-
ered for non-preventive purposes (either
with or without a prescription), and in this
case the self-service tool would reflect the
non-zero dollar cost-sharing liability. The
Departments also note that under current
rules, plans and issuers are not required
to disclose any cost-sharing information
through the self-service tool for non-cov-
ered items and services, including with
respect to contraceptive items and ser-
vices. Nothing in these proposed rules
alters these disclosure requirements.
As discussed in section II.A.2 of this
preamble, the Departments are proposing
to require plans and issuers to cover OTC
contraceptive items without a prescrip-
tion and without imposing cost-sharing
requirements. To ensure individuals are
aware that OTC contraceptive items are
covered consistent with these proposed
rules, plans and issuers would be required
to inform individuals of this benefit under
the plan or coverage. Participants, benefi-
ciaries, and enrollees should have access
to more robust information to ensure they
understand their plan’s or issuer’s policies
regarding coverage of OTC contraceptive
items without a prescription and without
cost sharing, and in the Departments’
view, the self-service tool would offer an
effective means of communicating such
information. Therefore, the Departments
propose to require plans and issuers to
make an additional cost-sharing infor-
mation disclosure to participants, benefi-
ciaries, and enrollees in new proposed 26
CFR 54.9815-2715A2(b)(1)(vi), 29 CFR
2590.715-2715A2(b)(1)(vi), and 45 CFR
147.211(b)(1)(vi). Specifically, if a par-
ticipant, beneficiary, or enrollee requests
cost-sharing information for any covered
contraceptive item or service through a
self-service tool, the proposed rules would
require the response through the self-ser-
vice tool or, if requested, on paper to
include with the information a statement
explaining that OTC contraceptive items
are covered without cost sharing and with-
out a prescription. This statement would
be required to include a phone number and
internet link that a participant, beneficiary,
or enrollee could use to learn more infor-
mation about the plan’s or policy’s con-
traception coverage. This could be a link
to an existing webpage and a general cus-
tomer service line that the plan or issuer
already maintains.
The requirement to provide this infor-
mation would be triggered by a search
in the self-service tool for any covered
contraceptive items or services, includ-
ing items or services that are not drugs or
drug-led combination products or are not
available without a prescription, so that
any user seeking options to prevent preg-
nancy would be made aware that OTC
contraceptive items are covered without
cost sharing. Under this proposed require-
ment, the disclosure would be required
regardless of whether the user is searching
for cost-sharing information for contra-
ceptive items and services from an in-net-
work or out-of-network provider, or if the
plan or coverage maintains no network
of providers. As such, plans and issuers,
including those without a network of
providers, would be required to disclose
that they will cover OTC contraceptive
items without cost sharing or a prescrip-
tion in accordance with proposed 26 CFR
54.9815-2713(a)(6), 29 CFR 2590.715-
2713(a)(6), and 45 CFR 147.130(a)(3)
(ii). The Departments note that because

November 18, 2024 1150 Bulletin No. 2024–47
the self-service tool requirements apply
to covered items and services, the disclo-
sure requirements proposed in this section
would not apply to plans and issuers that
do not cover contraceptive items or ser-
vices based on an objection under 45 CFR
147.132 or 147.133.
131
The Departments
request comment on whether and how
these proposed requirements should apply
to entities that have an objection to only
some contraceptive items and services.
The Departments also request com-
ment on whether plans and issuers should
have the option to include in the state-
ment either a phone number or an inter-
net link—rather than both—to where a
participant, beneficiary, or enrollee can
learn more about the plan’s or policy’s
contraception coverage. The Departments
are interested in better understanding the
benefits and burdens associated with each
approach.
The Departments also request com-
ment on whether plans and issuers should
be required to include in this statement
the general names or types of OTC con-
traceptive items that are covered without
a prescription and without cost sharing
(for example, “daily oral contraceptive,”
“Plan B (levonorgestrel),” or “condoms”).
Under this approach, users would not need
to call the provided phone number or navi-
gate to the linked webpage and could sim-
ply copy and paste the provided product
names into the self-service tool’s search
field to find local pharmacies where they
can access the product without a prescrip-
tion and without cost sharing. In particu-
lar, the Departments request comment on
the burdens on plans and issuers to pro-
vide a list that may need to be updated in
the self-service tool’s statement as circum-
stances change (such as if additional OTC
contraceptive items come to market or
new therapeutic equivalents become avail-
able) or that could require multiple alter-
native disclosures for a plan or issuer that
has coverage options across geographic
regions based on availability in the spe-
cific market. In addition, the Departments
request comment on potential benefits to
consumers of listing in the tool itself the
OTC contraceptive items covered without
a prescription and without cost sharing,
rather than having to gather this informa-
tion by clicking an internet link or calling
a customer service line.
The Departments also request comment
on whether plans and issuers should be
required to include in the statement infor-
mation on coverage of therapeutic equiv-
alents or the exceptions process under
these proposed rules and, if so, how dis-
closures should be presented to ensure the
additional information is meaningful and
actionable for consumers.
132
For exam-
ple, the Departments request comment
on whether the statement should indicate
that an exceptions process is available so
individuals can receive coverage for any
recommended preventive service, includ-
ing an OTC contraceptive item, that is
medically necessary for the individual;
and, if so, how to present this information
in a way that would be meaningful and
actionable for consumers. Similarly, the
Departments request comment on whether
the statement should disclose that plans
and issuers must cover all FDA-approved
contraceptive drugs and drug-led com-
bination products without cost sharing,
other than those for which there is at least
one therapeutic equivalent drug or drug-
led combination product that the plan or
issuer covers without cost sharing; and,
if so, how to present this information in a
way that would be meaningful and action-
able for consumers.
The Departments also request comment
regarding the challenges of implementing
and maintaining such statements, infor-
mation about their potential effectiveness
in improving access to OTC contraceptive
items, and other information that could
help inform potential future disclosures
related to other recommended preventive
services. The Departments also request
comment on whether additional self-ser-
vice tool requirements need to be specified
to ensure plans and issuers fully inform
participants, beneficiaries, and enrollees
of the availability of covered OTC contra-
ceptive items without cost sharing.
Lastly, the Departments believe that
broadly disseminating information on the
availability and coverage of OTC contra-
ceptive items without cost sharing to eli-
gible individuals and members of the pub-
lic would increase access to this benefit,
if finalized as proposed, and would allow
individuals to select the plan that best
meets their needs. Therefore, the Depart-
ments request comment on how plans and
issuers could efficiently and effectively
provide such information to eligible indi-
viduals, participants, beneficiaries, enroll-
ees, and members of the public, including
the relative benefits and burdens of doing
so. For example, the Departments are
interested in whether it would be feasible
for plans and issuers to provide general
coverage and cost-sharing information on
a public website. Similarly, the Depart-
ments are interested in whether plans
and issuers should be required to provide
more tailored cost and benefit information
to participants, beneficiaries, or enrollees
when they provide other relevant plan
documents, such as Summaries of Bene-
fits and Coverage (SBCs) or drug formu-
laries. The Departments also request com-
ment on how plans and issuers can make
information available to participants, ben-
eficiaries, and enrollees about the specific
steps they would need to take to access
OTC contraceptive items without cost
sharing, particularly when plans and issu-
ers do not have network providers avail-
able that can provide access to such items.
Lastly, the Departments request comment
on additional ways to communicate this
information effectively to individuals in
vulnerable and underserved communities.
C. Applicability
The proposed amendments to 26 CFR
54.9815-2713(a)(4), 29 CFR 2590.715-
2713(a)(4), and 45 CFR 147.130(a)(4)
regarding an exceptions process would
apply on the effective date of the final
rules. The Departments assume that most
plans and issuers generally already have
in place an exceptions process for rec-
ommended preventive services to align
with previously issued guidance, although
the Departments acknowledge in section
IV.B.2.d of this preamble that some plans
and issuers could incur costs to develop
or update an exceptions process to com-
ply with these proposed rules, if final-
ized. While prior guidance has generally
131
The Departments issued proposed rules to rescind the moral exemption to the contraceptive coverage requirement under 45 CFR 147.133. 88 FR 7236 (Feb. 2, 2023).
132
See sections II.A.1 and II.A.2.b of the preamble to these proposed rules, respectively, for a discussion of the exceptions process and therapeutic equivalence approach proposals.

Bulletin No. 2024–47 1151 November 18, 2024
focused on the use of an exceptions pro-
cess in the context of contraceptive cov-
erage and coverage of PrEP to prevent
HIV, the Departments expect that plans
and issuers could adapt existing excep-
tions processes to accommodate addi-
tional recommended preventive services
as necessary to comply with the proposed
amendments by the effective date of the
final rules.
The Departments propose delayed
applicability dates for the proposed
amendments to the preventive services
regulations that are specific to contra-
ceptive items. Specifically, the Depart-
ments propose that the proposed provi-
sions of 26 CFR 54.9815-2713(a)(6), 29
CFR 2590.715-2713(a)(6), and 45 CFR
147.130(a)(6) would apply for plan years
(in the individual market, policy years)
beginning on or after January 1, 2026.
These proposed rules, if finalized,
would mandate the use of the currently
optional therapeutic equivalence approach
described in FAQs Part 64, where appli-
cable, and newly require the coverage of
OTC contraceptive items without a pre-
scription. In the Departments’ view, the
proposed applicability dates appropriately
balance the need for improved access to
coverage of recommended preventive ser-
vices with the time necessary for plans
and issuers to make the systems and oper-
ational changes to implement these pro-
posals.
Until any final rules are issued and
applicable, the Departments would con-
tinue to consider plans and issuers that
provide coverage consistent with the ther-
apeutic equivalence approach and have an
easily accessible, transparent, and suffi-
ciently expedient exceptions process that
is not unduly burdensome as outlined in
FAQs Part 64 to be in compliance with
section 2713 of the PHS Act and its imple-
menting regulations with respect to cov-
erage of recommended contraceptives that
are drugs and drug-led devices.
To align with applicability dates for
the proposed requirements for OTC con-
traceptive items and therapeutic equiv-
alents, the proposed requirements in 26
CFR 54.9815-2715A2, 29 CFR 2590.715-
2715A2 and 45 CFR 147.211 that would
direct plans and issuers to disclose infor-
mation related to contraceptive coverage
in the self-service tool would be appli-
cable to plans and issuers for plan years
(or in the individual market, policy years)
beginning on or after January 1, 2026.
The Departments request comment
on the proposed applicability dates. With
respect to the proposed delayed applica-
bility dates, the Departments request com-
ment on whether an earlier applicability
date (such as the effective date of any final
rules) would be feasible.
III. Severability
In the event that any provision of these
proposed rules, if finalized, is held to be
invalid or unenforceable by its terms, or
as applied to any person or circumstance,
the Departments intend that these rules
shall be construed so as to continue to
give maximum effect to these rules as per-
mitted by law, unless the holding shall be
one of utter invalidity or unenforceabil-
ity. In the event a provision is found to be
utterly invalid or unenforceable, the pro-
vision shall be severable from these pro-
posed rules as finalized, as well as the final
rules they amend and shall not affect the
remainder thereof or the application of the
provision to persons not similarly situated
or to dissimilar circumstances.
In these rules, the Departments are
proposing several amendments to reduce
barriers to coverage and promote access to
recommended preventive services, includ-
ing OTC contraceptive items. The Depart-
ments’ authority under section 9833 of
the Code, section 734 of ERISA, sections
2713, 2715A, and 2792 of the PHS Act,
and sections 1311(e)(3)(C) and 1321 of
the ACA to propose these amendments is
well-established in law and long-standing
practice and should be upheld in any legal
challenge. However, in the event that any
portion of the final rules related to any of
the proposals in these rules, if finalized, is
declared invalid, the Departments intend
that the other provisions would be sever-
able, except as described in this section of
the preamble. For example, if a court were
to find unlawful (1) the requirement that
plans and issuers utilizing medical man-
agement techniques provide an exceptions
process in order for such techniques to be
considered reasonable; (2) the requirement
to provide coverage for OTC contracep-
tive items without requiring a prescription
or imposing cost sharing; or (3) the thera-
peutic equivalence approach to reasonable
medical management for contraceptive
items that are drugs and drug-led combina-
tion products, the Departments intend the
remaining provisions of the rules to stand.
Additionally, the Departments intend for
the proposed amendments to the pre-
ventive services regulations to remain in
place in the event that a court were to find
unlawful any portion of the rules, if final-
ized, with respect to the proposals related
to disclosing information related to con-
traceptive coverage through the self-ser-
vice tool. However, the Departments do
not intend for the disclosure through the
self-service tool to remain in place in the
event that a court were to find unlawful
the requirement to provide coverage for
OTC contraceptive items without requir-
ing a prescription or imposing cost shar-
ing, as the disclosure requirements would
not provide meaningful information to
consumers in the absence of these under-
lying coverage requirements.
IV. Regulatory Impact Analysis
A. Summary – Departments of Health and
Human Services and Labor
133
These proposed rules would make
several changes to the requirements for
non-grandfathered group health plans
and health insurance issuers offering
non-grandfathered group or individual
health insurance coverage to provide
coverage of certain recommended pre-
ventive services without cost sharing
under section 2713 of the PHS Act and
its implementing regulations. First,
these proposed rules would provide
that medical management techniques
used by plans and issuers with respect
to recommended preventive services,
including contraceptive items, would
not be considered reasonable unless the
plan or issuer provides an easily acces-
sible, transparent, and sufficiently expe-
133
In sections IV.A, IV.B, and IV.C of this preamble, “the Departments” refers to the Departments of HHS and Labor.

November 18, 2024 1152 Bulletin No. 2024–47
dient exceptions process that allows an
individual to receive coverage without
cost-sharing requirements for a recom-
mended preventive service according
to the frequency, method, treatment, or
setting that is medically necessary with
respect to the individual, as determined
by the individual’s attending provider.
These proposed rules also would require
plans and issuers to cover recommended
OTC contraceptive items without a
prescription and without imposing
cost-sharing requirements. These pro-
posed rules would further require plans
and issuers to cover all recommended
contraceptive items that are drugs and
drug-led combination products without
imposing cost-sharing requirements,
unless a therapeutic equivalent of the
drug or drug-led combination product
is covered without cost sharing. Lastly,
these proposed rules would amend the
Transparency in Coverage final rules
implementing section 2715A of the PHS
Act and section 1311(e)(3) of the ACA
by requiring plans and issuers to provide
information related to contraceptive
coverage and cost-sharing requirements,
including a statement explaining the
coverage of OTC contraceptive items
without cost sharing, in their Trans-
parency in Coverage internet-based
self-service tool or, if requested by the
individual, on paper.
The Departments have examined
the impacts of these proposed rules as
required by Executive Order 12866 on
Regulatory Planning and Review (Sep-
tember 30, 1993),
134
Executive Order
13563 on Improving Regulation and
Regulatory Review (January 18, 2011),
135

Executive Order 14094 on Modernizing
Regulatory Review (April 6, 2023),
136
the
Regulatory Flexibility Act (RFA) (Sep-
tember 19, 1980, Pub. L. 96–354), section
1102(b) of the Social Security Act, section
202 of the Unfunded Mandates Reform
Act of 1995 (March 22, 1995, Pub. L.
104–4), and Executive Order 13132 on
Federalism (August 4, 1999).
137
B. Executive Orders 12866, 13563, and
14094 – Departments of Health and
Human Services and Labor
Executive Orders 12866 and 13563
direct agencies to assess all costs and ben-
efits of available regulatory alternatives
and, if regulation is necessary, to select
regulatory approaches that maximize net
benefits (including potential economic,
environmental, public health and safety
effects, distributive impacts, and equity).
Executive Order 14094 (Modernizing
Regulatory Review) amends section 3(f)
of Executive Order 12866 (Regulatory
Planning and Review). The amended
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 $200 million or more in any 1 year
(adjusted every 3 years by the Adminis-
trator of the Office of Information and
Regulatory Affairs (OIRA) in the Office
of Management and Budget (OMB) for
changes in gross domestic product), or
adversely affecting in a material way the
economy, a sector of the economy, produc-
tivity, competition, jobs, the environment,
public health or safety, or State, local, Ter-
ritorial, or Tribal governments or commu-
nities; (2) creating a serious inconsistency
or otherwise interfering with an action
taken or planned by another agency; (3)
materially altering the budgetary impacts
of entitlement grants, user fees, or loan
programs or the rights and obligations
of recipients thereof; or (4) raising legal
or policy issues for which centralized
review would meaningfully further the
President’s priorities or the principles set
forth in Executive Order 12866, as specifi-
cally authorized in a timely manner by the
Administrator of OIRA in each case.
138
A regulatory impact analysis (RIA)
must be prepared for rules deemed sig-
nificant under section 3(f). Based on the
Departments’ estimates, OMB’s OIRA
has determined this rulemaking is signif-
icant under section 3(f)(1) as measured
by the $200 million or more in any 1 year
threshold. Therefore, OMB has reviewed
these proposed rules, and the Departments
have provided the following assessment
of their impact.
1. Need for Regulatory Action
As discussed in section II of this pre-
amble, ongoing complaints and reports of
noncompliance with section 2713 of the
PHS Act and its implementing regulations
indicate that participants, beneficiaries,
and enrollees face barriers when attempt-
ing to use their coverage to access recom-
mended preventive services without cost
sharing. As a result of these concerns and
other significant activity related to preven-
tive services, the Departments are propos-
ing to amend the regulations governing
coverage of recommended preventive ser-
vices in order to ensure that participants,
beneficiaries, and enrollees would be able
to access the full range of recommended
preventive services to which they are enti-
tled, with particular focus on strengthen-
ing coverage requirements with respect
to recommended contraceptive items for
women, as summarized in section IV.A of
this preamble. The Departments consider
these provisions to be timely and neces-
sary given the ongoing documented chal-
lenges faced by consumers in accessing
recommended preventive services, as dis-
cussed further in section IV.B.2.a of this
preamble.
2. Summary of Impacts
In accordance with Executive Order
12866 and OMB Circular A–4, table 1
depicts an accounting statement summa-
rizing the Departments’ assessment of the
benefits, costs, and transfers associated
with these regulatory actions. The Depart-
ments are unable to quantify all benefits,
costs, and transfers associated with these
proposed rules, but have sought, where
possible, to describe these non-quantified
impacts.
134
Executive Order 12866 of September 30, 1993, 58 FR 51735 (October 4, 1993).
135
Executive Order 13563 of January 18, 2011, 76 FR 3821 (January 21, 2011).
136
Executive Order 14094 of April 6, 2023, 88 FR 21879 (April 11, 2023).
137
Executive Order 13132 of August 4, 1999, 64 FR 43255 (August 10, 1999).
138
Executive Order 14094 of April 6, 2023, 88 FR 21879 at 21879 (April 11, 2023).

Bulletin No. 2024–47 1153 November 18, 2024
TABLE 1: Accounting Table
Benefits:
Non-Quantified:
• Potential reduction in unintended pregnancies and improved health outcomes for covered individuals.
• Increased convenience and decreased costs for covered individuals who no longer need to obtain a prescription to obtain rec-
ommended OTC contraceptive items without cost sharing.
• Decreased costs to plans and issuers due to improved health outcomes associated with increased coverage of recommended
preventive services without cost sharing and avoided unintended pregnancies.
• Potential benefits associated with increased awareness of coverage of OTC contraceptive items without a prescription and
without cost sharing.
Costs: EstimateYear DollarDiscount RatePeriod Covered
Annualized Monetized ($/year)$9.9 million20242 percent2026 – 2035
Quantified:
• Costs to issuers and TPAs, on behalf of self-insured group health plans, associated with the disclosure of coverage and
cost-sharing requirements for OTC contraceptive items, including one-time costs of approximately $35.1 million for integrat-
ing the contraception statement language into the existing Transparency in Coverage internet-based self-service tool and cre-
ating or updating a webpage to provide information about coverage benefits, and annual costs of approximately $6.1 million
for programming updates, webpage maintenance, training customer service representatives, and responding to calls to provide
assistance; these costs would ultimately be incurred by plans and issuers.
139
Non-Quantified:
• Increased costs to plans and issuers due to changes in utilization of recommended preventive services.
• Potential administrative costs to plans and issuers associated with the establishment of or use of an existing exceptions process
that allows an individual to receive coverage without cost-sharing requirements for a medically necessary recommended pre-
ventive service.
• Cost to pharmacies, plans, and issuers to update billing processes and systems for covered OTC products.
Transfers:EstimateYear DollarDiscount RatePeriod Covered
Annualized Monetized (Excluding
Federal Budgetary) ($/year)
$468.6 million20242 percent2026–2035
Annualized Monetized Federal
Budgetary ($/year)
$300.1 million20242 percent2026– 2035
Quantified:
• Transfers totaling approximately $768.7 million per year from plans and issuers to covered individuals caused by reduced out-
of-pocket costs for contraceptive items, which plans and issuers would recoup in the form of higher premiums.
oThe increase in premiums could increase the cost of employer-sponsored insurance and reduce the share of total employee
compensation subject to taxation, reducing Federal tax revenue by approximately $217 million per year.
oNet Federal spending on premium tax credits for Exchange plans could increase by approximately $83.1 million per year.
oPremiums paid (directly or indirectly, through declines in after-tax wages) by covered individuals could increase by
approximately $468.6 million per year.
Non-Quantified:
• Transfers from plans and issuers to covered individuals caused by reduced out-of-pocket costs for other recommended pre-
ventive services for which coverage without cost sharing would be accessible through an exceptions process, which plans and
issuers would recoup in the form of higher premiums. This could result in an increase in premiums paid by covered individu-
als and an increase in net Federal spending on premium tax credits for Exchange plans.
• Potential transfers from plans and issuers to firms in the medicine and medical device supply chain due to decreased bargain-
ing leverage on prices for contraceptive items.
139
The Departments expect self-insured group health plans to rely on TPAs to implement the proposed requirements and compensate them accordingly and thereby bear any implementation
costs.

November 18, 2024 1154 Bulletin No. 2024–47
a. Background
Nine in ten women report using contra-
ception at some point in their lifetime.
140

Estimates from the CDC indicate that 65.3
percent of women ages 15-49 used some
form of contraception between 2017 and
2019, including permanent or one or more
forms of reversible contraception listed
in the FDA’s Birth Control Guide.
141
The
majority of women used reversible con-
traception such as oral contraceptive pills
(14 percent), long-acting reversible con-
traceptives (LARCs) such as intrauterine
device (IUDs) (10.4 percent), or the male
condom (8.4 percent). The most common
form of contraception is female steril-
ization (18.1 percent), a nonreversible
method.
142
The 2022 KFF Women’s Health Sur-
vey (of U.S. women ages 18-49) found
that nearly two-thirds of survey respon-
dents who were not currently trying to
get pregnant reported avoiding a preg-
nancy in the next month as being “very
important.”
143
The same survey found
that among women who use contracep-
tion, 61 percent use it only to prevent
pregnancy, 24 percent use it both to
prevent pregnancy and for some other
reason, and 15 percent use it solely for
a reason not related to preventing preg-
nancy (for example, managing a medi-
cal condition or preventing a sexually
transmitted infection).
144
Individuals’
contraceptive needs, including because
of side effects, can vary depending on
their health history, medical needs, aller-
gies, and other factors. A recent study
that reviewed two decades of literature
on contraception found that hormonal
contraceptives can impact medical con-
ditions associated with hormonal fluc-
tuations, including acne, endometriosis,
and premenstrual dysphoric disorder.
145

This and other studies detail that com-
bined hormonal contraceptives and pro-
gestin-only pills often have different
side effects for women with varying
backgrounds or medical conditions.
146

Studies emphasize that it is difficult to
predict how individuals will react to
oral contraceptives, with one noting that
“certain side effects...may be considered
beneficial by some people but unaccept-
able by others,” and that “different for-
mulations have different side effect pro-
files, so patients may need to try another
formulation if an undesirable side effect
occurs.”
147
Studies point to the fact that
optimal contraception selection depends
on a person’s health needs and personal
factors and preferences.
148
A growing body of research finds
there is a mismatch between preferred
and commonly used contraception meth-
ods.
149
These studies find that LARCs and
hormonal methods generally have higher
rates of satisfaction than condoms, with-
drawal, and no method of contraception.
Nearly 25 percent of all people, and nearly
30 percent of people earning under 200
percent of the Federal Poverty Line, are
not using their preferred method. People
report using less preferred methods due to
issues with side effects, cost and afford-
ability, inadequate counseling, and other
access barriers such as facilities not offer-
ing the preferred method.
150
The mismatch
between preferred and used method was
found to be less common among those
with higher incomes, those with insur-
ance coverage, and those that have a usual
source of care.
151
The literature also finds
that unsatisfied preferences were associ-
ated with discontinuation of contraception
method and subsequently higher rates of
pregnancy, indicating that reducing bar-
riers that contribute to this satisfaction
mismatch has the potential to reduce
unwanted pregnancies, especially among
underserved communities such as women
of color and low-income communities.
152
The 2022 KFF Women’s Health Sur-
vey found that 77 percent of respondents
(and 79 percent of respondents with pri-
vate health insurance coverage) favored
making oral contraceptive pills available
OTC without a prescription if research
showed they are safe and effective, and
39 percent of respondents indicated they
would be likely to use oral contraceptive
pills available OTC without a prescrip-
tion.
153
The survey further found that 29
percent of respondents currently using
oral contraceptive pills would be “very
likely” to use OTC oral contraceptive
pills that do not require a prescription, as
would 19 percent of respondents currently
using other contraceptive methods and 15
percent of respondents currently not using
140
Frederiksen, B., Ranji, U., Long, M., Diep, K., and Salganicoff, A., KFF (2022). “Contraception in the United States: A Closer Look at Experiences, Preferences, and Coverage,” available
at https://www.kff.org/report-section/contraception-in-the-united-states-a-closer-look-at-experiences-preferences-and-coverage-findings/.
141
Daniels, K. and Abma, J.C., CDC (2020). “Current Contraceptive Status Among Women Aged 15–49: United States, 2017–2019,” NCHS Data Brief No. 388, available at https://www.
cdc.gov/nchs/products/databriefs/db388.htm.
142
Id.
143
Frederiksen, B, Ranji, U., Long, M., Diep, K., and Salganicoff, A., KFF (2022). “Contraception in the United States: A Closer Look at Experiences, Preferences, and Coverage,” available
at https://www.kff.org/report-section/contraception-in-the-united-states-a-closer-look-at-experiences-preferences-and-coverage-findings/.
144
Id.
145
Teal, S. and Edelman, A. (2021). “Contraception Selection, Effectiveness, and Adverse Effects: A Review,” JAMA, available at https://pubmed.ncbi.nlm.nih.gov/34962522.
146
Britton, L. E., Alspaugh, A., Greene, M.Z., and McLemore, M.R. (2020). “An Evidence-Based Update on Contraception,” American Journal of Nursing, available at https://www.ncbi.nlm.
nih.gov/pmc/articles/PMC7533104.
147
Id.
148
Id.
149
Burke, K. and Potter, J. (2023). “Meeting Preferences for Specific Contraceptive Methods: An Overdue Indicator,” Studies in Family Planning, available at https://onlinelibrary.wiley.
com/doi/full/10.1111/sifp.12218.
150
Frederiksen, B., Ranji, U., Long, M., Diep, K., and Salganicoff, A., KFF (2022). “Contraception in the United States: A Closer Look at Experiences, Preferences, and Coverage,” available
at https://www.kff.org/report-section/contraception-in-the-united-states-a-closer-look-at-experiences-preferences-and-coverage-findings and Burke, K. and Potter, J. (2023). “Meeting Pref-
erences for Specific Contraceptive Methods: An Overdue Indicator,” Studies in Family Planning, available at https://onlinelibrary.wiley.com/doi/full/10.1111/sifp.12218.
151
Burke, K. and Potter, J. (2023). “Meeting Preferences for Specific Contraceptive Methods: An Overdue Indicator,” Studies in Family Planning, available at https://onlinelibrary.wiley.
com/doi/full/10.1111/sifp.12218.
152
Id.
153
This figure was the same (39 percent) among the subset of respondents with private health insurance coverage. See Long, M., Frederiksen, B., Ranji, U., Diep, K., and Salganicoff, A.,
KFF (2022). “Interest in Using Over-the-Counter Oral Contraceptive Pills: Findings from the 2022 KFF Women’s Health Survey,” available at https://www.kff.org/womens-health-policy/
issue-brief/interest-using-over-the-counter-oral-contraceptive-pills-findings-2022-kff-womens-health-survey.

Bulletin No. 2024–47 1155 November 18, 2024
any contraceptive method.
154
These fig-
ures indicate that take-up of OTC contra-
ceptive items available without a prescrip-
tion and without cost sharing might be
fairly high. When asked why they would
be likely to use OTC oral contraceptive
pills, most respondents reported that it is
because they are more convenient (59 per-
cent) or faster (15 percent), while 8 per-
cent reported that they do not want a phys-
ical or pelvic exam, 7 percent reported
that OTC oral contraceptive pills are more
confidential, 6 percent reported that they
think it would save money, and 3 percent
reported that they do not want to have to
use health insurance.
155
Coverage of OTC
contraceptive items without cost sharing
or a prescription requirement would be
particularly beneficial for certain contra-
ceptive users considering that 33 percent
of hormonal contraceptive users indicated
that they missed taking their birth control
on time because they were not able to get
their next supply on time
156
and 36 percent
of oral contraceptive users have missed
taking it on time for the same reason.
157
More generally, as discussed in section
II of this preamble, cost sharing reduces
the use of preventive care, and some indi-
viduals may forego a preventive service
entirely rather than being forced to choose
between a form of care that their provider
has determined would not be medically
appropriate for them or to pay out-of-
pocket for the care they need.
b. Number of Affected Entities
This section addresses entities that
would be directly affected by these pro-
posed rules. These proposed rules would
apply to non-grandfathered group health
plans and health insurance issuers offer-
ing non-grandfathered group or individ-
ual health insurance coverage.
158
For the
purposes of this RIA, the term covered
plans refers to these plan and coverage
types. Health insurance company refers to
a single entity that offers health insurance
coverage in one or multiple States, which
might own or be affiliated with one or mul-
tiple entities that are separately required
to be licensed to engage in the business of
insurance in each such State. Health insur-
ance issuer or issuer means an insurance
company, insurance service, or insurance
organization (including a health mainte-
nance organization (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.
The Departments estimate that there
are 499,299 ERISA-covered self-insured,
non-grandfathered group health plans
159

and 1,844,520 ERISA-covered fully-in-
sured, non-grandfathered group health
plans.
160
The Departments further estimate
that there are 76,345 non-grandfathered
non-Federal governmental plans spon-
sored by State and local governmental
entities.
161
Issuers and third-party administrators
(TPAs) provide key support for plan com-
pliance with laws and regulations. Plans
often have TPAs provide expertise in plan
design, establish networks, and administer
claims. For medications, issuers and TPAs
often provide these services via contracted
or affiliated PBMs.
The Departments assume that issuers
and TPAs would be the organizations per-
forming the work of redesigning prescrip-
tion drug formularies, negotiating new
or amended network arrangements with
pharmacies, and developing any neces-
sary amendments and changes to billing
systems and procedures.
The Departments estimate that these
proposed rules would affect 479 health
insurance companies nationwide that pro-
vide coverage in the group and individual
health insurance markets, with 1,467 issu-
ers (health insurance company/State com-
binations).
162
These proposed rules would also affect
pharmacies, given the coverage require-
ments for OTC contraceptives proposed
in these proposed rules. According to the
Census Bureau’s Statistics of U.S. Busi-
nesses, there are 19,234 firms in the phar-
macies and drug stores sector in the U.S.
as of 2017.
163

Because these proposed rules have the
potential to impact the gross premiums
of covered plans—either directly as paid
by plan participants and enrollees and/or
154
Id.
155
Id.
156
Frederiksen, B., Ranji, U., Long, M., Diep, K., and Salganicoff, A., KFF (2022). “Contraception in the United States: A Closer Look at Experiences, Preferences, and Coverage,” available
at https://www.kff.org/report-section/contraception-in-the-united-states-a-closer-look-at-experiences-preferences-and-coverage-findings.
157
Long, M., Diep, K., Sobel, L. and Salganicoff, A., KFF (2023). “Over-the-Counter Oral Contraceptive Pills,” available at https://www.kff.org/womens-health-policy/issue-brief/over-the-
counter-oral-contraceptive-pills.
158
As noted in section I.A, these proposed rules would not modify Federal conscience protections related to contraceptive coverage for employers, plans and issuers. See fn. 24.
159
The Departments estimate that there are 594,404 ERISA-covered self-insured group health plans based on data from the 2022 Medical Expenditure Panel Survey Insurance Component
(MEPS-IC) and the 2020 County Business Patterns from the Census Bureau. The 2020 KFF Employer Health Benefits Survey reported that in 2020, 16 percent of firms offering health
benefits offered at least one grandfathered health plan (see KFF, 2020 Kaiser Employer Health Benefits Survey, available at https://files.kff.org/attachment/Report-Employer-Health-Ben-
efits-2020-Annual-Survey.pdf). Thus, the Departments have calculated the number of self-insured, non-grandfathered plans in the following manner: 594,404 ERISA-covered self-insured
group health plans x (100 percent minus 16 percent) = 499,299.
160
The Departments estimate that there are 2,195,857 ERISA-covered fully-insured group health plans based on data from the 2022 Medical Expenditure Panel Survey Insurance Compo-
nent (MEPS-IC) and the 2020 County Business Patterns from the Census Bureau. The 2020 KFF Employer Health Benefits Survey reported that in 2020, 16 percent of firms offering health
benefits offered at least one grandfathered health plan (see KFF, 2020 Kaiser Employer Health Benefits Survey, available at https://files.kff.org/attachment/Report-Employer-Health-Bene-
fits-2020-Annual-Survey.pdf). Thus, the Departments have calculated the number of fully-insured, non-grandfathered plans in the following manner: 2,195,857 ERISA-covered fully-insured
group health plans x (100 percent minus 16 percent) =1,844,520.
161
According to data from the 2022 Census of Governments, there are 90,887 State and local governmental entities (see U.S. Census Bureau, 2022 Census of Governments, available at https://
www.census.gov/data/tables/2022/econ/gus/2022-governments.html). The Departments assume that each State and local governmental entity sponsors one health plan on average. Therefore,
the Departments estimate that there are 90,887 non-Federal governmental health plans. The 2020 KFF Employer Health Benefits Survey reported that 16 percent of employers offer at least
one grandfathered plan (see KFF, 2020 Kaiser Employer Health Benefits Survey, available at https://files.kff.org/attachment/Report-Employer-Health-Benefits-2020-Annual-Survey.pdf). The
Departments therefore estimate there are approximately 76,345 non-grandfathered non-Federal governmental plans.
162
The Departments’ estimate of the number of health insurance companies and the number of issuers (issuer/State combinations) is based on medical loss ratio reports submitted by issuers
for the 2022 reporting year (see Centers for Medicare & Medicaid Services, “Medical Loss Ratio Data and System Resources (2022),” available at https://www.cms.gov/CCIIO/Resources/
Data-Resources/mlr).
163
U.S. Census Bureau (2017). 2017 SUSB Annual Data Tables by Establishment Industry (Data by Enterprise Receipts Size), available at https://www.census.gov/data/tables/2017/econ/
susb/2017-susb-annual.html.

November 18, 2024 1156 Bulletin No. 2024–47
indirectly by their employers in lieu of
salary or other benefits—all participants,
beneficiaries, and enrollees in affected
plans may potentially be affected by these
proposed rules, regardless of their use of
contraceptive items. For purposes of this
RIA, covered individuals refers to partici-
pants, beneficiaries, and enrollees in cov-
ered plans that are subject to the proposed
rules.
There are an estimated 181.4 million
individuals in plans that would be affected
by these proposed rules.
164
Within this
total, there are an estimated 21 million
covered individuals enrolled in cover-
age provided through an Exchange (with
approximately 16 million policyhold-
ers).
165
This separate tally of Exchange
enrollees is used as an input to the estima-
tion of the net Federal spending impact of
these proposed rules in the transfers sec-
tion IV.B.2.e of this preamble.
Among individuals in covered plans,
the Departments estimate that 51.71
million individuals (28.5 percent) are
women of reproductive age (15-49).
166

The Departments calculate, based on data
from the 2017-2019 National Survey of
Family Growth (NSFG),
167
that 29.4 per-
cent of women of reproductive age who
have private health insurance are using
contraceptive items that are (only now, in
the case of oral contraceptive pills) avail-
able OTC (oral contraception pills, con-
doms, and/or emergency contraception) in
a given enrollment month. This estimate
is somewhat higher than the 2020 estimate
by the National Center for Health Statis-
tics (approximately 22.4 percent), given
that the Departments’ analysis restricts its
calculations to women who report enroll-
ment in private health insurance cover-
age.
168
Thus, the Departments estimate
that 15.2 million individuals (8.4 percent
of all individuals in covered plans) are
women of reproductive age using these
forms of contraceptives.
169
The Depart-
ments request comment on this analysis.
Table 2 summarizes the number of
entities that would be affected by these
proposed rules.
164
The calculation (approximately 181,412,000 individuals) is based on reports of private insurance coverage in the 2023 Current Population Survey Annual Social and Economic Supplement
(CPS-ASEC). Private coverage in that survey includes employment-based (including non-government, non-Federal government, and Federal government employment), directly purchased
(Exchange and non-Exchange), and TRICARE coverage. To arrive at the number of covered individuals (which excludes TRICARE enrollees), the Departments remove from the count respon-
dent households for which the respondent is a member of the military. It also removes respondents who are over 65 or who report government insurance (such as Medicare, Medicaid, or
VA) in addition to private insurance. The Departments view this calculation as an upper bound because the data are not sufficient to identify and exclude enrollees in grandfathered plans or
individuals in non-ACA compliant individually purchased plans. The Departments do not have an estimate of the relevant number of enrollees in either of these plan types; the latest available
data on percentage of enrollees in grandfathered plans is from the 2020 KFF Employer Health Benefits Survey. See KFF, 2020 Kaiser Employer Health Benefits Survey, available at https://
files.kff.org/attachment/Report-Employer-Health-Benefits-2020-Annual-Survey.pdf, reporting that 14 percent of individuals were enrolled in grandfathered plans. However, the number has
been declining since 2011, falling from 56 percent in 2011. See KFF, 2018 Kaiser Employer Health Benefits Survey, Figure 13.3, available at https://files.kff.org/attachment/Report-Employ-
er-Health-Benefits-Annual-Survey-2018). In the absence of more recent data, the Departments cannot rule out that the rate has continued to fall.
165
See CMS, “Open Enrollment Period Report: Final National Snapshot,” available at https://www.cms.gov/newsroom/fact-sheets/marketplace-2024-open-enrollment-period-report-fi-
nal-national-snapshot (reporting 21,310,538 Exchange enrollees). The estimated conversion between total enrollees and policyholders—15 enrollees per 11 policyholders—is based on
medical loss ratio reports submitted by issuers for the 2021 reporting year, in which the number of policyholders in individual health insurance coverage offered in the individual market
was approximately 11 million, and the number of enrollees was approximately 15,000,000. See CMS (2022), “Medical Loss Ratio Data and System Resources,” https://www.cms.gov/CCIIO/
Resources/Data-Resources/mlr.
166
The calculation is based on the reports of private insurance coverage in the 2023 CPS-ASEC. The calculation specifically includes all individuals who report their sex as female and are
of age 15 to 49 years. Private insurance coverage includes those covered by directly purchased (Exchange and non-Exchange) and employment-based health insurance. Those in the armed
services are excluded from the calculation.
167
See CDC, “2017-2019 NSFG: Public-Use Data Files, Codebooks, and Documentation,” available at https://www.cdc.gov/nchs/nsfg/nsfg_2017_2019_puf.htm.
168
See CDC, “Current Contraceptive Status Among Women Aged 15–49: United States, 2017–2019,” available at https://www.cdc.gov/nchs/data/databriefs/db388-H.pdf (estimating that
approximately 65 percent of women ages 15-49 were currently using contraception. By method, these included female sterilization (18.1 percent), oral contraceptive pills (14.0 percent),
LARCs (10.4 percent), male condoms (8.4 percent), male sterilization (5.6 percent), Depo-Provera, contraceptive ring, or patch (3.1 percent), and 5.7 percent across all other methods
(includes diaphragm, withdrawal, periodic abstinence with safe period assessed via calendar rhythm, temperature, or cervical mucus test)).
169
Approximately 181.4 million individuals in covered plans, times 28.5 percent who are women of reproductive age, times 29.4 percent of these who are assumed to use recommended OTC
contraceptives, per the NSFG analysis (see https://www.cdc.gov/nchs/nsfg/nsfg_2017_2019_puf.htm).
TABLE 2: Number of Affected Entities
Affected EntityNumber of Entities
ERISA-covered non-grandfathered group health plans2,343,819
ERISA-covered self-insured, non-grandfathered group health plans499,299
ERISA-covered fully-insured, non-grandfathered group health plans1,844,520
Non-grandfathered non-Federal governmental plans76,345
Issuers (health insurance company/State combinations)1,467
Pharmacies and drug stores19,234
Covered individuals181,412,000
c. Benefits
This analysis provides a qualitative dis-
cussion of the benefits associated with these
proposed rules, as the Departments do not
have the data necessary to quantify these
benefits. The Departments request comment
and data on how to quantify these benefits.
(1) Enhanced Coverage of a Wider
Range of Preventive Services Without
Cost Sharing for Eligible Individuals
Leading to a Potential Reduction in Unin-
tended Pregnancies and Improved Health
Outcomes for Individuals

Bulletin No. 2024–47 1157 November 18, 2024
The potential for these proposed rules
to facilitate greater coverage of a wider
range of preventive services without cost
sharing for eligible individuals could
lead to important benefits to health and
satisfaction (for example, in the form of
better matches between chosen contra-
ceptive items and individuals’ medical
needs and preferences). There is clear
evidence that many contraceptive users
are not using their preferred form of con-
traception because of concerns about side
effects, cost, or availability, for exam-
ple.
170
Greater flexibility in contraceptive
choice could directly improve quality of
life, including by minimizing side effects
and facilitating covered individuals in
optimizing contraceptive use according
to their unique needs and preferences.
Improved satisfaction with one’s con-
traceptive method, including by reduc-
ing unwanted side effects, would be an
important benefit of these proposed rules.
Given the many variations of contracep-
tive drugs or drug-led combination prod-
ucts, each with different hormonal prop-
erties, dosage levels, physical properties,
delivery mechanisms, side effects, and
benefits, there is significant need for indi-
vidual tailoring and choice. Better aligning
contraceptive use with a method or prod-
uct with preferred health outcomes could
be a source of major health improvements
for covered individuals, as discussed fur-
ther in this section. The ability to select
among more contraceptive options at zero
cost may facilitate such alignment, help-
ing more women find a contraceptive that
works best for their medical needs.
Increased coverage of medically
necessary preventive services without
cost-sharing requirements through the use
of an exceptions process would have a
similar effect of expanding covered indi-
viduals’ ability to access and use appropri-
ate recommended preventive services by
eliminating a financial barrier to receiving
medically necessary care.
The Departments recognize the poten-
tial for a reduction in unintended preg-
nancies and improved health outcomes
as a result of these proposed rules. First,
a reduction in unintended pregnancies and
improved health outcomes could result
from increases in the share of covered
women who use contraception.
171
Second,
these proposed rules could induce some
contraceptive switching among covered
women already using reversible contra-
ception that could create a closer match
between the contraceptive method or
product with the best medical outcomes
for the individual and the method or
product they currently use. In such cases,
individuals able to switch to a method or
product with the best medical outcome for
them may more reliably adhere to the rel-
evant usage recommendations.
172
Any benefit of reducing unintended
or unplanned pregnancies would scale in
proportion to the extent of new (or more
reliable) use of contraception. The Depart-
ments do not have the data necessary to
precisely estimate the extent of such an
expansion in contraception use along both
the extensive (new use) and intensive
(more reliable use) margins, but anticipate
relatively small effects on the number of
women newly using any contraceptives as
a result of the proposed rules, as discussed
later in this section.
Studies have consistently shown that
approximately 70 percent of privately
insured women who use contraception
have the cost of their method covered in
full by private health insurance.
173
These
studies include evidence on the share of
privately-insured women who do not pay
cost sharing for oral contraceptives after
passage of the ACA.
174
That these proposed
rules would apply to a population of pri-
vately-insured women who already have
coverage of certain contraceptives without
cost sharing suggests the possibility of a
small net effect on any contraception use
for covered individuals. For example, in
the 2022 KFF Women’s Health Survey,
only 4 percent of respondents reported
cost as a reason for not using birth control,
and this figure included individuals who
did not have health insurance.
175
Nonetheless, it is plausible that by pro-
viding coverage without cost sharing for a
wider variety of contraceptive items, these
proposed rules could induce new take-up
among covered individuals who were pre-
viously dissuaded from contraceptive use
because of cost and accessibility consid-
erations related to their preferred method,
as discussed in section IV.B.2.a of this
RIA. Further, medication adherence and
consistent use of contraception could be
improved if more covered individuals
have coverage of their preferred method
without cost sharing. In the 2022 KFF
Women’s Health Survey, among female
contraceptive users ages 18-49 who were
not using their preferred contraceptive
method, 12 percent of survey respon-
dents indicated that the primary reason for
not doing so was because they could not
afford it.
176
A third of women report not
using contraception due to concerns over
side effects,
177
the burden of which could
be lessened by expanding the selection
of covered contraceptive product choice
available without cost sharing. Such con-
siderations could be important given that
women using contraception—especially
170
Frederiksen, B, Ranji, U., Long, M., Diep, K., and Salganicoff, A., KFF (2022). “Contraception in the United States: A Closer Look at Experiences, Preferences, and Coverage,” available
at https://www.kff.org/report-section/contraception-in-the-united-states-a-closer-look-at-experiences-preferences-and-coverage-findings.
171
See CDC, “Reproductive Health, Unintended Pregnancy,” available at https://www.cdc.gov/reproductive-health/hcp/unintended-pregnancy/index.html (finding that 41.6 percent of preg-
nancies were unintended).
172
Fiffick, A.N., Iyer, T.K., Cochran, T., and Batur, P. (2023). “Update on Current Contraceptive Options: A Case-based Discussion of Efficacy, Eligibility, and Use.” Cleveland Clinic Journal
of Medicine, available at: https://www.ccjm.org/content/ccjom/90/3/181.full.pdf.
173
Frederiksen, B., Ranji, U., Long, M., Diep, K., and Salganicoff, A., KFF (2022). “Contraception in the United States: A Closer Look at Experiences, Preferences, and Coverage,” available
at https://www.kff.org/report-section/contraception-in-the-united-states-a-closer-look-at-experiences-preferences-and-coverage-findings/#Contraceptive-Coverage.
174
Sonfield, A., Tapales, A., Jones, R. K., and Finer, L. B. (2015). “Impact of the Federal Contraceptive Coverage Guarantee on Out-of-Pocket Payments for Contraceptives: 2014 Update,”
Contraception, available at https://pubmed.ncbi.nlm.nih.gov/25288034/.
175
Frederiksen, B., Ranji, U., Long, M., Diep, K., and Salganicoff, A., KFF (2022). “Contraception in the United States: A Closer Look at Experiences, Preferences, and Coverage,” available
at https://www.kff.org/report-section/contraception-in-the-united-states-a-closer-look-at-experiences-preferences-and-coverage-findings.
176
Id.
177
Id. (“Among reproductive age females who are able to conceive and are not pregnant or trying to become pregnant who are not using contraception, four in ten say it is because they did
not want to use birth control (42 [percent]). One in three females who are not currently using contraception report concern about side effects (32 [percent]), and one in five (22 [percent])
say they don’t really mind if they become pregnant.”)

November 18, 2024 1158 Bulletin No. 2024–47
women with low incomes and women
using less effective contraceptive meth-
ods—often report a mismatch between
their most preferred contraceptive method
and the method they usually use.
178
Historically, more comprehensive cov-
erage of contraceptive services has been
shown to improve the consistent use of
the most effective short-acting methods
of contraception, and the removal of cost
sharing also increases the use of more
effective LARC methods.
179
One study
found that following the implementa-
tion of the ACA contraceptive coverage
requirement, the discontinuation of use
of oral contraceptive pills fell and nonad-
herence to brand-name oral contraceptive
pills also declined.
180
Therefore, beyond the direct benefits of
improved satisfaction with contraceptive
method—due to, for example, reductions
in side effects—remedying the misalign-
ment between contraceptive preference
and contraceptive use could lead to fewer
unplanned pregnancies because of lower
rates of discontinuation.
181
While the Departments do not antic-
ipate that the proposed requirement in
these proposed rules to cover OTC contra-
ception without cost sharing would sub-
stantially affect the overall rate of birth
control use, to the extent that access to
and use of OTC and other contraceptive
items, without cost sharing, is increased,
it is expected to provide better matching
of preferred contraceptive items and thus
may ultimately improve health outcomes.
The Departments also anticipate that
improved health outcomes would result
from enhanced coverage of a wider range
of recommended preventive services
without cost sharing through the use of
an exceptions process for recommended
preventive services offered by plans and
issuers. Covered individuals would have
coverage of medically necessary preven-
tive services because of this provision,
whereas under current regulations they
might be more likely to pay for such ser-
vices out-of-pocket or forgo such services.
The Departments request comment on
this analysis.
(2) Increased Convenience and
Decreased Costs for Covered Individuals
Who No Longer Need a Prescription to
Obtain Recommended OTC Contracep-
tive Items
The Departments anticipate that some
covered individuals would benefit from
the provision of these proposed rules
that would require plans to cover rec-
ommended OTC contraceptive items
without a prescription and without cost
sharing because these individuals would
face reduced transportation costs, child-
care costs, and/or time costs that would
otherwise be incurred due to scheduling,
travelling to, and attending health care
provider visits in order to obtain prescrip-
tions for contraceptives. Some covered
individuals would also benefit from this
provision if they cannot secure timely
access to appointments to obtain a pre-
scription, particularly if the individuals
are in areas with primary care shortages.
Out-of-pocket visit costs, if any, would
also be avoided. Any such effects would
be proportional to the number of covered
individuals forgoing such provider visits
as a result of this proposed provision, and
therefore dependent on both the share of
contraceptive users who switch methods
from a prescription contraceptive to an
OTC product and on the subset of these
switchers who forgo provider visits that
would otherwise have been needed for a
contraceptive prescription.
As discussed further in section IV.B.2.f
of this preamble, the Departments do
not anticipate a significant share of cov-
ered individuals to both switch methods
from prescription contraceptives to OTC
contraceptives and make fewer preven-
tive health care visits. The Departments
assume that even among covered women
who would avail themselves of the new
OTC benefit in these proposed rules,
nearly all would continue to utilize pre-
ventive care visits. Therefore, while the
benefits of reduced burdens associated
with reduced health care visits could be
significant for any individuals who see
providers less frequently as a result of
this proposed provision, the Departments
do not anticipate such averted benefits (or
costs) would accrue to a significant frac-
tion of covered individuals. The Depart-
ments request comment on this analysis.
(3) Potential Benefits of Increased
Transparency by Expanding Awareness
of Coverage of OTC Contraceptive Items
Without a Prescription and Without Cost
Sharing
Studies have found that increased trans-
parency about contraceptive care options
and service costs are essential for improv-
ing contraceptive access by increasing
public awareness and understanding about
current health care policy and opportuni-
ties, and when women are fully informed
about available contraceptive methods
and find them affordable, they are more
likely to use them consistently.
182
Overall, making information about
OTC contraceptive coverage without a
prescription and without cost sharing
available to participants, beneficiaries,
and enrollees can result in better health
outcomes, as discussed in more detail in
this section IV.B.2.c of this preamble.
The Departments request comment on
this analysis.
d. Costs
This section provides a qualitative
and quantitative discussion of the costs
associated with these proposed rules. The
178
He, K., Dalton, V. K., Zochowski, M. K., and Hall, K. S. (2017). “Women’s Contraceptive Preference-Use Mismatch,” Journal of Women’s Health, available at https://pubmed.ncbi.nlm.
nih.gov/27710196 and Burke, K. and Potter, J. (2023). “Meeting Preferences for Specific Contraceptive Methods: An Overdue Indicator,” Studies in Family Planning, available at https://
pubmed.ncbi.nlm.nih.gov/36705876.
179
Behn, M., Pace L.E., and Leighton, K. (2019). “The Trump Administration’s Final Regulations Limit Insurance Coverage of Contraception,” Women’s Health Issues, available at https://
www.whijournal.com/article/S1049-3867(18)30751-5/fulltext.
180
Pace, L., Dusetzina, S., and Keating, N. (2016). “Early Impact of the Affordable Care Act on Oral Contraceptive Cost Sharing, Discontinuation, and Nonadherence,” Health Affairs,
available at https://www.healthaffairs.org/doi/10.1377/hlthaff.2015.1624.
181
Burke, K. and Potter, J. (2023). “Meeting Preferences for Specific Contraceptive Methods: An Overdue Indicator,” Studies in Family Planning, available at https://pubmed.ncbi.nlm.nih.
gov/36705876.
182
Swan, L.E.T. (2021). “The Impact of US Policy on Contraceptive Access: A Policy Analysis,” Reproductive Health, available at https://reproductive-health-journal.biomedcentral.com/
articles/10.1186/s12978-021-01289-3 and Planned Parenthood Federation of America (2014). “New Study on Birth Control Use Shows That, When Fully Implemented, the Affordable Care
Act Could Dramatically Reduce Unintended Pregnancy in the U.S.,” available at https://www.plannedparenthood.org/about-us/newsroom/press-releases/new-study-birth-control-use-shows-
when-fully-implemented-affordable-care-act-could-dramatically.

Bulletin No. 2024–47 1159 November 18, 2024
Department request comment and data on
how to better quantify these costs.
(1) Increased Costs to Plans and Issuers
Due to a Change in Utilization of Preven-
tive Services, and Decreased Costs Due to
Improved Health Outcomes and Avoided
Unintended Pregnancies
Previous analysis by the Office of
the Assistant Secretary for Planning and
Evaluation (ASPE), which evaluated the
impacts of the ACA’s original contra-
ceptive coverage requirements, found
no likely net impact on gross costs of
expanding utilization for contraception:
“While the costs of contraceptives for
individual women can be substantial and
can influence choice of contraceptive
methods, available data indicate that pro-
viding contraceptive coverage as part of
a health insurance benefit does not add
to the cost of providing insurance cov-
erage.”
183
This conclusion was reached
based on a review of the literature and of
case studies on how expanding access to
reproductive care affected insurance costs
and gross premiums. For example, in
1999, Congress required the health plans
in the Federal Employees Health Benefits
(FEHB) program to cover the full range
of FDA-approved contraceptive methods.
ASPE concluded: “When medical costs
associated with unintended pregnancies
are taken into account, including costs of
prenatal care, pregnancy complications,
and deliveries, the net effect on premi-
ums is close to zero.”
184
This conclusion
echoes the conclusion of earlier studies.
185

The Departments are aware that the health
insurance market has evolved since the
publication of this study but are of the
view that the general results of this analy-
sis are still relevant today.
The Departments assume that, unlike
the initial introduction of contraceptive
coverage requirements under the ACA,
these proposed rules would have small
impacts on the fraction of covered women
using contraception, as approximately
70 percent of this population of covered
women that uses contraception already
has coverage for contraception through
private insurance without cost sharing.
Nonetheless, in line with the findings of
ASPE and others, the Departments assume
that any increase in contraception utiliza-
tion, however small, induced by these pro-
posed rules would not increase net insurer
claims costs and thus not increase gross
premiums. This effect is separate from the
transfers created by shifting the out-of-
pocket cost burden from the covered indi-
vidual to the plan, which are accounted for
separately. The Departments request com-
ment on this analysis.
The Departments also anticipate that
the establishment or use of an existing
exceptions process by plans and issuers
that would allow covered individuals to
access coverage of certain recommended
preventive services without cost sharing
would also lead to a decrease in out-of-
pocket costs for these preventive services
and a corresponding increase in utilization
or switching from other preventive ser-
vices. The Departments expect that this
change would increase net claims costs
initially and potentially over time. Plans
and issuers could experience claims cost
savings that at least partially offset these
new costs, due to improved health out-
comes associated with increased utiliza-
tion of certain recommended preventive
services.
The Departments request comment and
data on how the costs to plans and issuers
would change due to a change in utiliza-
tion of preventive services associated with
these proposed rules.
(2) Costs to Pharmacies and Plans and
Issuers to Update Billing Processes and
Systems for Covered OTC Products
The Departments anticipate that phar-
macies, as well as plans and issuers, would
incur some upfront and annual operational
and administrative costs in order to com-
ply with the coverage requirements for
OTC contraceptives in these proposed
rules, but do not have information neces-
sary to estimate such costs.
For pharmacies, the Departments
anticipate costs would include updating
real-time claims adjudication systems and
processes for their point-of-sale systems.
The Departments are aware that there are
uncertainties regarding how pharmacies
could adapt existing systems, including
the requirements in some point-of-sale
systems to fill in a “prescriber NPI,” which
would not exist in its usual form for OTC
products. The Departments are aware of
at least one large pharmacy chain that has
already implemented insurance coverage
for an OTC oral contraceptive pill at the
pharmacy counter by setting up codes for
insurance reimbursement with real-time
claim adjudication. The Departments lack
information regarding how widespread
such existing capabilities are among phar-
macies and thus the costs of transitioning
systems and processes that do not yet have
these capabilities.
186
The Departments
request comment on the potential changes
that pharmacies would have to make to
their systems and processes and the corre-
sponding burden and costs.
The Departments anticipate that plans
and issuers would incur costs associated
with updating IT systems and processes to
process claims. Plans and issuers would
also have to develop, if they have not
already, processes aimed at preventing
fraud, waste, and abuse for OTC products,
which could include processes to monitor
utilization. Plans and issuers routinely do
such monitoring for prescription products
in order to, for example, enforce reason-
able quantity limits. The Departments
request comment on the costs and any
associated burden that would be borne by
plans and issuers to update their systems
and processes.
The Departments do not anticipate
significant costs associated with formu-
lary redesign to accommodate OTC prod-
183
Bertko, J., Glied, S., Miller, E., Simmons, A., and Wilson, L., ASPE (2012). “The Cost of Covering Contraceptives through Health Insurance,” available at https://aspe.hhs.gov/reports/
cost-covering-contraceptives-through-health-insurance.
184
Id.
185
Trussell, J., Leveque, J.A., Koenig, J.D., London, R., Borden, S., Henneberry, J., LaGuardia, K., Stewart, F., Wilson, G., Wysocki, S., and Strauss, M. (1995). “The Economic Value of
Contraception: A Comparison of 15 Methods,” American Journal of Public Health, available at http://ajph.aphapublications.org/doi/pdf/10.2105/AJPH.85.4.494
186
One analogous example of widespread implementation of over-the-counter insurance coverage is the recent COVID-19 pandemic when COVID tests were available over-the-counter at
no cost sharing. See Huber, K., T. Roades, A. Higgins, M. Aspinall, C. Silcox, and M. McClellan, Duke University Margolis Center for Health Policy, (2022). “Over the Counter COVID-19
Testing: Insurance Coverage Strategies to Support Equitable Access,” available at https://healthpolicy.duke.edu/sites/default/files/2022-05/Margolis%20OTC%20Testing.pdf. It remains
unclear how these preparations might affect the cost of implementation of these proposed rules, but it is likely that this prior work may—to some extent—mitigate costs.

November 18, 2024 1160 Bulletin No. 2024–47
ucts, as formularies are regularly updated
even in the absence of any relevant policy
changes and plans and issuers are already
required to cover OTC products without
cost sharing when the patient has a pre-
scription. For the same reason, the Depart-
ments do not anticipate significant costs
associated with formulary redesign to
comply with the provision of the proposed
rules requiring coverage of every recom-
mended contraceptive drug and drug-led
combination product without cost sharing
unless a therapeutic equivalent is covered
without cost sharing.
The Departments also anticipate some
costs to pharmacies, as well as plans and
issuers, associated with negotiating new
contract terms for OTC coverage.
Despite the costs to pharmacies identi-
fied in this section, the Departments antic-
ipate that pharmacies would see increased
revenues from sales of covered OTC
contraceptives, and that associated profit
increases (if they occur) might offset these
costs from the pharmacies’ perspective.
The Departments request comment on
the potential costs (and revenues) to phar-
macies and costs to plans and issuers asso-
ciated with the changes in these proposed
rules.
(3) Potential Administrative Costs
to Plans and Issuers Associated with
the Establishment or Use of an Existing
Exceptions Process
Plans and issuers could incur admin-
istrative costs associated with the estab-
lishment or use of an existing excep-
tions process that allows an individual
to receive coverage without cost-sharing
requirements for a medically necessary
recommended preventive service. The
Departments assume that most plans and
issuers have an exceptions process in
place that they would be able to adapt
for the provision in these proposed rules.
However, those that do not would incur
costs to develop one. The Departments do
not have information about the percentage
of plans and issuers that currently have
an exceptions process in place that could
be adapted for the provision in these pro-
posed rules or the upfront and recurring
costs that plans and issuers would incur
to establish one. The Departments request
comment on the potential costs to plans
and issuers associated with this provision.
(4) Costs to Issuers and TPAs (on
Behalf of Self-Insured Group Health
Plans) Associated with the Disclosure of
Coverage and Cost-Sharing Requirements
for OTC Contraceptive Items
As detailed in section IV.D of this pre-
amble, issuers and TPAs,
187
on behalf of
self-insured group health plans, would
incur costs associated with the disclosure
of coverage and cost-sharing requirements
for OTC contraceptive items. Specifically,
issuers and TPAs would incur one-time
costs of $35,089,261 to integrate the con-
traception statement language into the
existing Transparency in Coverage inter-
net-based self-service tool,
188
and to cre-
ate or update a webpage to provide infor-
mation about coverage of contraceptive
items and services. Additionally, issuers
and TPAs would incur annual costs of
$6,091,096 for programming updates,
webpage maintenance, training customer
service representatives, and responding
to calls to provide assistance. These costs
would ultimately be incurred by plans and
issuers and, in turn, by covered individuals
through a minimal impact on premiums.
The Departments request comment on the
costs to issuers and TPAs associated with
this provision.
e. Transfers
Eliminating cost sharing for some con-
traceptive items has the potential to affect
transfers associated with contraceptive
items and insurance coverage. Specifi-
cally, the Departments expect these pro-
posed rules would result in transfers from
plans and issuers to covered individuals
resulting from reduced out-of-pocket
costs for contraceptive items, which are
estimated to be mostly paid by covered
individuals experiencing higher premi-
ums, with a smaller portion paid by the
Federal government through premium tax
credit (PTC) spending. The Departments
also expect these proposed rules would
result in transfers from plans and issu-
ers (and potentially premium-payers and
the Federal government) to pharmacies,
drug wholesalers, and drug manufactur-
ers resulting from anticipated shifts in
formulary design and utilization manage-
ment that could affect plan-paid prices
for some contraceptive items. Lastly, the
Departments expect these proposed rules
would result in transfers associated with
the use of an exceptions process for cov-
ered individuals to access coverage with-
out cost sharing of certain recommended
preventive services but are unable to
quantify the magnitudes of these transfers
due to a lack of data, as discussed later in
this section.
(1a) Transfers From Plans and Issuers
to Covered Individuals Resulting from
Reduced Out-of-Pocket Costs for Contra-
ceptive Items
The Departments expect that the pro-
posed elimination of cost sharing for
a wider variety of contraceptive items
would lead to transfers from plans and
issuers to covered individuals due to
reduced out-of-pocket spending on con-
traceptive services. (Analysis of who ulti-
mately pays these transfers is presented
in the next sub-section.) These transfers
would accrue to covered individuals who
are women of reproductive age, who use
a contraceptive method, who—in the
absence of the proposed changes—would
otherwise pay some non-zero cost-sharing
amount for contraceptives, and whose out-
of-pocket costs would be reduced by these
proposed rules. As per the calculation in
section IV.B.2.b of this preamble, approx-
imately 15.2 million individuals (8.4 per-
cent of individuals in covered plans) are
women of reproductive age using those
noted forms of contraceptives. The 2022
KFF Women’s Health Survey showed
that among privately-insured women
using contraception, 70 percent reported
that insurance covered their contracep-
tive method with no cost sharing, and 16
percent reported that insurance paid some
187
The Departments assume that fully-insured group health plans would depend on health insurance issuers and self-insured group health plans would rely on TPAs to implement the proposed
requirements. The Departments expect self-insured group health plans would compensate TPAs accordingly and thereby bear any implementation costs.
188
The Departments expect that while participants, beneficiaries, and enrollees will continue to request cost-sharing information on paper in certain circumstances, the proposed additional
disclosure would impose negligible additional burden on plans and issuers as the disclosure will likely be no more than one or two sentences and would only be required when a participant,
beneficiary, or enrollee requests cost-sharing information for a subset of covered items and services, covered contraceptive items and services.

Bulletin No. 2024–47 1161 November 18, 2024
but not all of the cost.
189
The remaining 13
percent of respondents paid out-of-pocket
despite being insured, believed contracep-
tion not to be covered by insurance, or
replied in some other way.
190
In terms of consumer response, lack of
knowledge about plan benefits and fea-
tures as well as preference for non-cov-
ered contraceptive items (for example, a
branded drug in the presence of a generic
drug with no cost sharing) may explain
some of the incomplete take-up of zero
cost-sharing options under the status quo,
and such frictions and preferences might
persist to some degree under the proposed
rules.
Therefore, the Departments assume
that—as under the status quo—some cov-
ered women would continue to pay out-
of-pocket for contraceptives, including
by not using insurance when insurance
could cover some or all of the out-of-
pocket costs. The Departments operation-
alize this assumption by assuming that the
16 percent of women who currently use
insurance but face non-zero cost sharing
due to partial insurance coverage would
instead face zero cost sharing under these
proposed rules, while the 13 percent
191
of
contraceptive users who are insured but do
not use insurance coverage for their con-
traceptive items would continue to not use
insurance coverage.
192
The Departments
estimate that among the subset of covered
individuals for whom contraceptives are
covered with non-zero cost sharing (16
percent of contraceptive users and there-
fore estimated to be approximately 1.3
percent of the total covered population)
193

these proposed rules would decrease aver-
age cost sharing by a maximum of $316
per year.
194
Therefore, the Departments
estimate a total transfer of approximately
$768.7 million per year to contraceptive
users in the form of reduced out-of-pocket
payments.
195
(1b) Transfers From Covered Individ-
uals and From the Federal Government to
Plans and Issuers in the Form of Higher
Premiums (Analysis of Who Pays for the
Transfers Estimated Above)
The Departments assume these pro-
posed provisions would cause plans and
issuers to increase premiums to approxi-
mately offset the new net costs incurred
by lower cost sharing. In other words, the
Departments assume the cost of decreased
cost sharing would be passed on to pre-
mium payers. From a total decline in
out-of-pocket payments of $768.7 mil-
lion per year, the Departments estimate
that these proposed rules would increase
annual gross premiums by about $4.24 per
covered individual or less than 0.1 per-
cent.
196
Premium payers include employer
plan participants—both directly through
employee contributions to premiums and
indirectly by reductions in salary compen-
sation or other benefits—and individuals
purchasing plans outside of the employ-
ment context (on or off an Exchange).
Because these proposed provisions would
increase the cost of employer-spon-
sored insurance and reduce the share of
total compensation subject to taxation,
the Departments estimate these changes
would reduce Federal tax revenue by $217
million annually. Because these proposed
provisions are expected to increase gross
premiums for individual health insurance
coverage purchased on the Exchanges, the
Departments estimate and anticipate an
$83.1 million annual increase in net Fed-
eral premium tax credit (PTC) spending.
197

189
Frederiksen, B, Ranji, U., Long, M., Diep, K., and Salganicoff, A., KFF (2022). “Contraception in the United States: A Closer Look at Experiences, Preferences, and Coverage,” available
at https://www.kff.org/report-section/contraception-in-the-united-states-a-closer-look-at-experiences-preferences-and-coverage-findings/.
190
The Departments note that studies of out-of-pocket spending for contraception based on examination of health care claims cannot speak to the issue of an insured woman not making use
of insurance for a contraceptive purchase—a case that would not generate an insurance claim.
191
This is the sum of the 6 percent of users whose plan does not cover contraception, the 4 percent of users who reported “Other,” and the 3 percent of users who had coverage but did not
use it. The Departments note that these proposed rules could induce this final category of users to switch to a covered OTC method, but the Departments do not assume this is the case.
192
Frederiksen, B, Ranji, U., Long, M., Diep, K., and Salganicoff, A., KFF (2022). “Contraception in the United States: A Closer Look at Experiences, Preferences, and Coverage,” Fig. 14,
available at https://www.kff.org/report-section/contraception-in-the-united-states-a-closer-look-at-experiences-preferences-and-coverage-findings.
193
8.4 percent of covered individuals are women of reproductive age who are currently using contraception, and 16 percent of these women face some out-of-pocket costs for contraception
= 1.3 percent.
194
The Departments calculate the typical monthly out-of-pocket costs for those individuals who use insurance but pay a non-zero amount by estimating a weighted average of out-of-pocket
amounts as reported in the KFF survey: 24 percent reporting $50 or more, 13 precent reporting $25-$49, 19 percent reporting $15-$24, 26 percent reporting $5-$14, and 6 percent reporting
$1-$4, and 12 percent reporting “Don’t know.” Taking midpoints of these ranges, assuming a $50 monthly payment for the top category, and excluding individuals who report “don’t know”
yields $26.29 per month (=((.24*50)+(.13*37)+(0.19*19.5)+(.26*9.5)+(.06*2.5))/(1-.12)) or $315.50 annually. The Departments assume that the estimated 16 percent of covered women
with partial coverage would face zero cost sharing under these proposed rules, while the remaining 14 percent of covered women, who currently do not report using insurance for contracep-
tives, would not experience a significant decline in out-of-pocket costs.
195
Approximately 1.3 percent of the covered population (approximately 181.4 million individuals) times a $316 reduction in out-of-pocket costs = $768.7 million.
196
Approximately $768.7 million in new plan costs divided across 181.4 million covered individuals = $4.24 in annual premiums. Of the 181.4 million covered individuals, the CMS 2023 Open
Enrollment Report indicates there are 16.4 million consumers enrolled in health insurance plans purchased through an Exchange and that the average annual premium for single coverage
for Exchange coverage is $7,260 ($605 per individual per month). The Departments assume that the average annual premium for off-Exchange single coverage would be comparable to this
figure. 2023 KFF data indicate that the average annual premium for (single) group comprehensive insurance is $8,435. The Departments assume that the average annual premium for (single)
non-Federal government plan coverage would be comparable to this figure. Based on these figures and assumptions, the weighted average annual premium would be expected to increase by
about 0.05 percent. See CMS, “Health Insurance Marketplaces 2023 Open Enrollment Report,” available at https://www.cms.gov/files/document/health-insurance-exchanges-2023-open-en-
rollment-report-final.pdf and KFF, “2023 Employer Health Benefits Survey,” available at https://www.kff.org/health-costs/report/2023-employer-health-benefits-survey.
197
The Departments have estimated this net Federal spending transfer effect by assuming that the expected $4.24 increase in annual gross premiums will apply to the second-lowest-cost
silver plans in each market, and that each dollar of increased silver plan premiums generates exactly a dollar of additional net Federal PTC spending for individuals receiving PTCs. A
$4.24 increase in per capita annual gross premiums, times 21,310,538 Exchange annual enrollees (as reported above), times 92 percent of enrollees receiving PTCs, equals approximately
$83.1 million. This estimate does not account for the expiration of the enhanced PTC subsidies at the end of 2025, which would likely reduce the level of Exchange enrollment (or at least
reduce enrollment growth), reduce the share of enrollees receiving PTCs, and therefore reduce net Federal PTC spending. Source of fraction receiving PTCs: Effectuated Enrollment: Early
2024 Snapshot and Full Year 2023 Average, available at https://www.cms.gov/files/document/early-2024-and-full-year-2023-effectuated-enrollment-report.pdf. 197 The Departments have
estimated this net Federal spending transfer effect by assuming that the expected $4.24 increase in annual gross premiums will apply to the second-lowest-cost silver plans in each market, and
that each dollar of increased silver plan premiums generates exactly a dollar of additional net Federal PTC spending for individuals receiving PTCs. A $4.24 increase in per capita annual
gross premiums, times 21,310,538 Exchange annual enrollees (as reported above), times 92 percent of enrollees receiving PTCs, equals approximately $83.1 million. This estimate does not
account for the expiration of the enhanced PTC subsidies at the end of 2025, which would likely reduce the level of Exchange enrollment (or at least reduce enrollment growth), reduce the
share of enrollees receiving PTCs, and therefore reduce net Federal PTC spending. Source of fraction receiving PTCs: Effectuated Enrollment: Early 2024 Snapshot and Full Year 2023
Average, available at https://www.cms.gov/files/document/early-2024-and-full-year-2023-effectuated-enrollment-report.pdf.

November 18, 2024 1162 Bulletin No. 2024–47
The annual Federal budgetary transfers
would therefore amount to an estimated
$300.1 million ($217 million reduction
in Federal tax revenue plus $83.1 million
increase in net Federal PTC spending).
The remainder of the estimated $768.7
million in annual transfers, or approxi-
mately $468.6 million ($768.7 million
minus $300.1 million), is expected to be
paid by covered participants and enroll-
ees (directly or indirectly, as discussed
earlier in this section) through increased
premiums paid to plans and issuers and
subsequent reductions to employees’ tax-
able wages. However, the Departments
acknowledge that employers could also
offset plan or coverage cost increases
through increased prices for consumers,
reduced production costs (for example,
layoffs, other reductions to labor costs,
or other production cost reductions), or
lower profits, for example. The Depart-
ments request comment on and evidence
regarding the extent to which new net
costs incurred by lower cost sharing for
contraceptive items would be passed along
to covered individuals through increases
in premiums.
(2) Transfers Associated with the Use
of an Exceptions Process
The Departments anticipate that the
increased access to coverage without cost
sharing of other recommended preventive
services through the use of an exceptions
process would generate transfers caused
by reduced out-of-pocket costs for other
recommended preventive services for
which coverage without cost sharing
would be accessible through an excep-
tions process.
More specifically, the Departments
anticipate that the increased access to cov-
erage without cost sharing of other preven-
tive services through the use of an excep-
tions process would generate transfers;
on an intermediate basis, they would flow
from plans and issuers to covered indi-
viduals, but these transfers are expected
to be ultimately paid by a combination of
other covered individuals, experiencing
higher premiums, and by the Federal gov-
ernment in the form of higher net Federal
PTC spending for Exchange plans caused
by higher premiums (approximately equal
in size to the total reduction in out-of-
pocket costs for other preventive services
for which coverage without cost sharing
would be accessible through the use of an
exceptions process).
It is uncertain how plan and issuer
expenditure would change due to use of
an exceptions process to allow covered
individuals to access coverage of recom-
mended preventive services without cost
sharing. The Departments do not have
data that would allow for a quantification
of these effects. The Departments request
comment on the transfers associated with
the exceptions process and their likely
magnitudes.
(3) Potential Transfers from Plans and
Issuers to Pharmacies, Drug Wholesalers,
and Drug Manufacturers Resulting from
Anticipated Shifts in Formulary Design
That Could Affect Plan-Paid Prices for
Some Contraceptive Items
These proposed rules would require
plans and issuers to cover a wider range of
recommended contraceptive items with-
out cost sharing. This is likely to affect the
relative price negotiating power between
entities in the drug supply chain (manu-
facturers, wholesalers, and pharmacies)
and plans and issuers, including their affil-
iated or subcontracted PBMs. This could
lead to higher negotiated prices to plans,
issuers, and their PBMs. If so, it would
increase total plan costs for recommended
contraceptive items and would ultimately
cause increases in plan premiums.
Plans and issuers place downward
pressure on negotiated prices for drugs
and devices and limit spending in several
ways:
198
through the threat of exclusion of
a product from a drug formulary; through
the threat of setting high consumer cost
sharing that would steer covered indi-
viduals away from high cost or ineffec-
tive products; and through the threat of
erecting non-price barriers to access,
such as prior authorization, step-therapy,
or requirements for a provider-requested
exception to access a product.
199
Plans and
issuers also place downward pressure on
negotiated prices for drugs and devices
and limit spending by contracting with
providers whose prescribing patterns align
with the cost-control goals of the plans
and issuers.
Because drug and device suppliers
desire favorable coverage and favorable
provider prescribing behavior in order to
attract higher volumes of covered individ-
uals to use their products, these tools place
powerful downward pressures on negoti-
ated (net-of-rebate) prices paid by plans.
Research has shown that when plans and
issuers are unable to use cost sharing,
they rely on non-price barriers to access,
such as prior authorization and step ther-
apy, to steer consumers across medication
options, and ultimately constrain overall
plan costs.
200
The provisions of these proposed rules
would clarify the use of reasonable medi-
cal management that plans and issuers can
use with respect to covering recommended
preventive services, including contracep-
tive items, without cost sharing under the
ACA. This clarification could impact their
bargaining power against drug suppliers,
removing some sources of downward pres-
sure on prices. The Departments do not have
sufficient data to estimate the magnitude of
these effects. The Departments anticipate
that they are unlikely to be significant for
contraceptive products for which there are
available therapeutic equivalents. For such
products, competition across two or more
therapeutic equivalents is a key constraint
on prices even in the absence of cost shar-
ing and other plan and issuer tools. The
Departments anticipate that price effects
could be larger for products for which there
is no therapeutic equivalent. The Depart-
ments request comment and data regarding
these potential transfers.
198
For a useful overview of the management tools employed by managed care organizations, see Glied, S., National Bureau of Economic Research (1999), “Managed Care,” available at
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=202746
199
Lakdawalla, D. and Yin, W., National Bureau of Economic Research (2009). “Insurer Bargaining and Negotiated Drug Prices in Medicare Part D,” available at https://www.nber.
org/papers/w15330; Lakdawalla, D. N. (2018). “Economics of the Pharmaceutical Industry,” Journal of Economic Literature, available at https://www.aeaweb.org/articles?id=10.1257/
jel.20161327.
200
See Geruso, M., Layton, T., and Prinz, D. (2019). “Screening in Contract Design: Evidence from the ACA Health Insurance Exchanges,” American Economic Journal: Economic Pol-
icy, available at https://www.aeaweb.org/articles/pdf/doi/10.1257/pol.20170014 (finding that when plans are limited in their ability to expose their enrollees to cost-sharing, as with cost-shar-
ing-reduction enrollees in Exchange plans, plans may respond by relying more heavily on non-price barriers to access, such as step-therapy and prior authorization).

Bulletin No. 2024–47 1163 November 18, 2024
f. Uncertainty
As noted throughout this RIA, due to
a lack of data and information, there are
several areas of uncertainty regarding the
potential impacts of these proposed rules.
The Departments are unable to forecast
with high confidence how the provisions
of these proposed rules would affect the
choice of contraceptive method or prod-
uct among covered women or how many
covered women would continue to use
contraceptives with non-zero cost shar-
ing. Further, the Departments are unable
to forecast with high confidence whether
or the extent to which the pharmaceutical
and medical device supply chain entities
(including manufacturers, wholesalers,
and pharmacies) might respond in pricing
negotiations with PBMs and issuers to both
the new patterns of consumer take-up of
contraceptive items—as the set of options
without cost sharing would expand under
these proposed rules—and to the provi-
sions of these proposed rules that would
clarify plans’ and issuers’ ability to use
reasonable medical management. As a
result, there is some uncertainty about the
potential impact on premiums.
The Departments expect that the admin-
istrative and operational costs associated
with these proposed rules would primar-
ily fall on plans, issuers, and pharmacies.
As discussed in section IV.B.2.d of this
preamble and discussed in comments in
response to the OTC Preventive Products
RFI, these entities would incur costs asso-
ciated with updating IT systems and pro-
cesses to accommodate insurance cover-
age of OTC contraceptives. Commenters
noted that various systems would likely
need to be updated or created, such as to
accommodate new information require-
ments for claims, but provided no further
information related to any associated bur-
dens or costs. Therefore, the Departments
lack information on the scope and size of
such activities and costs.
The Departments are uncertain about
the number of women who would switch
contraceptive methods to OTC contracep-
tives as a result of these proposed rules.
Since the first FDA-approved daily OTC
oral contraceptive pill was approved in
July 2023 and became widely available
for purchase (including by being carried
by major pharmacy chains and online
retailers) beginning in March 2024, it is
too soon to predict with confidence the
extent of switching to an OTC contracep-
tive from other prescription products.
A reasonable analog to daily OTC oral
contraception is the increased use of emer-
gency contraception since its approval for
OTC use in the early 2000s. The FDA
approved nonprescription availability of
emergency contraception (Plan B) for
women 18 years or older in August 2006.
201

This was expanded to women 17 years and
older in 2009 and without age restrictions
in 2013. The Guttmacher Institute reports
that between 2008 and 2015, the use of
emergency contraceptive pills increased
significantly across nearly all social and
demographic groups.
202
For example, the
report shows that use among 25–29-year-
olds more than doubled during this time,
increasing from 16 percent of women ever
having used emergency contraception to
36 percent. While these data do not allow
us to forecast switching from prescription
to OTC birth control, they do suggest that
take-up of OTC contraceptive items may
increase.
There is also insufficient data to fore-
cast the extent to which take-up of OTC
oral contraception would result in fewer
visits to health care providers and the
scope for potential negative health con-
sequences due to this reduction in contact
with health care providers. Research finds
that fewer primary care visits may lead
to less interaction with preventive care
services such as mammograms, vaccina-
tions, and colonoscopies, and may result
in more emergency room visits and hos-
pitalizations, all of which could lead to
greater health care expenditures in the
future.
203
However, the same work finds
that the likelihood of preventive services
uptake does not increase with respect to
the number of visits, suggesting that while
increased engagement with primary care
improves compliance with these preven-
tive interventions, the benefits of visits
may diminish in value past a certain fre-
quency.
204
Applied to this uncertain set-
ting, this body of research suggests a pos-
sibility that covering recommended OTC
contraceptive items without cost sharing
and without a prescription could be asso-
ciated with negative health consequences
if it leads to a reduction in provider vis-
its that specifically reduces interaction
with preventive services. However, there
is no evidence to suggest that such a pol-
icy to increase coverage of recommended
OTC contraceptive items would affect the
strong incentives for women to continue
to seek preventive care, via a provider
visit, outside of their need to obtain a pre-
scription for contraception. Among these
incentives, the ACA requires plans and
issuers to cover, without cost sharing, an
annual well-woman visit as well as other
recommended preventive services.
Further, there is significant uncertainty
about the potential changes in take-up of
OTC contraceptives that would be caused
by these proposed rules and the impact
of any such change on the frequency of
provider visits. In a survey about hypo-
thetical use that predated the introduction
of an FDA-approved daily OTC oral con-
traceptive pill, many female respondents
indicated they would be likely to switch to
an OTC contraceptive if it was available
to them.
205
Women may be motivated to
201
FDA, Center for Drug Evaluation and Research, “Plan B One-Step Information,” available at https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/
plan-b-one-step-15-mg-levonorgestrel-information.
202
Guttmacher Institute (2021). “Use of Emergency Contraception in the United States,” available at https://www.guttmacher.org/fact-sheet/use-emergency-contraception-united-states.
203
Rose, A.J., Timble, J.W., Setoldji, C., Friedberg, M.W., Malsberger, R., and Kahn, K.L. (2019). “Primary Care Visit Regularity and Patient Outcomes: an Observational Study,” Journal
of General Internal Medicine, available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6318173 and Hostetter, J., Schwarz, N., Klug, M., Wynne, J., and Basson, M.D. (2020), “Primary
Care Visits Increase Utilization of Evidence-Based Preventative Health Measures,” BMC Family Practice, available at https://bmcprimcare.biomedcentral.com/articles/10.1186/s12875-
020-01216-8.
204
Gao, J., Moran, E., Grimm, R., Toporek, A., Ruser, C. (2022). “The Effect of Primary Care Visits on Total Patient Care Cost: Evidence from the Veterans Health Administration,” Journal
of Primary Care Community Health, available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9793026 (examining the correlation between additional in-person primary care visits and
total health care costs among Veterans Health Administration patients and finding that the first visit was associated with the largest savings, with diminishing returns for subsequent visits).
205
Frederiksen, B., Ranji, U., Long, M., Diep, K., and Salganicoff, A., KFF (2022). “Contraception in the United States: A Closer Look at Experiences, Preferences, and Coverage,” available
at https://www.kff.org/report-section/contraception-in-the-united-states-a-closer-look-at-experiences-preferences-and-coverage-findings (finding that 60 percent of reproductive age females
who have used birth control pills in the past 12 months said they would be likely or very likely to use over-the-counter birth control pills).

November 18, 2024 1164 Bulletin No. 2024–47
make such a switch by the potential reduc-
tion in required provider visits to maintain
a prescription. The costs of seeing a pro-
vider include costs such as transportation
and childcare during the appointment
time, or the opportunity costs of time
associated with the visit. If these proposed
rules reduce the frequency or likelihood of
health care provider visits among women,
the revenue of providers who otherwise
would have performed and billed for ser-
vices would be impacted, representing
a cost of at least $100 per visit, on aver-
age.
206
Nonetheless, practical considerations
surrounding OTC contraceptive items
may limit the number of covered indi-
viduals who take up this option in prac-
tice. First, contraceptives have numerous
side effects, which vary by person and
product.
207
Women are likely to have a
preference for a given contraceptive they
have already become accustomed to; in
this case, they may perceive switching as
involving some risk of generating a worse
match.
208
A commenter to the OTC Pre-
ventive Products RFI noted these consid-
erations in explaining why the extent of
switching to OTC products would likely
be moderate.
One way to understand how important
such factors may be is to examine the expe-
rience with pharmacist-prescribed contra-
ceptives. As of 2023, 28 states and the
District of Columbia allowed pharmacists
to provide contraceptives, 21 of which do
not require any physician follow-up.
209

However, less than 10 percent of women
currently opt to take advantage of phar-
macist provision.
210
Some women may be
unaware of this option, while others might
find that the added convenience may not
be enough to offset a significant preference
towards consulting with a physician and
obtaining a prescription for contraception.
There are several considerations that may
explain this preference: first, most women
(73 percent) see a family or internal medi-
cine doctor as their usual source of care.
211

Thus, it is likely that many women are
prescribed birth control through their pri-
mary care physician (PCP), and that these
visits are likely to continue on a semi-reg-
ular basis regardless of how birth control
is obtained.
212
Next, practitioners are able
to renew birth control pills over the phone
or via telemedicine applications, eliminat-
ing the net potential benefit of reducing
follow-up visits by switching to an OTC
pill. Finally, some women currently pro-
cure contraception from a clinical visit
that does not include a significant medical
exam, thus lowering the health benefit of
such a provider interaction (other than its
prescribing function)—in contrast to other
visit types with PCPs. Therefore, despite
the potential time and money savings of
forgone visits that would be enabled by
wider OTC contraceptive coverage with-
out cost sharing, this evidence suggests
these factors may not significantly impact
the use of recommended preventive ser-
vices.
Informed by the existing research dis-
cussed in this section, the Departments
anticipate approximately no impact of
the proposed rules on the frequency of
recommended preventive services visits
with PCPs, nurse practitioners, or physi-
cian assistants, and thus approximately
no impact on health outcomes of covered
women through this channel. Similarly,
the Departments anticipate approximately
no impact of the proposed rules on reve-
nues of these health care providers. The
Departments note that although the option
of switching to OTC contraception may
not provide significant value to all con-
traceptive users, the option may provide
particularly high value for the subset of
covered women in contraception deserts.
The Departments request comment on this
analysis.
Finally, the Departments acknowl-
edge the potential for long-term economic
effects of increased coverage of certain rec-
ommended preventive services. Research
suggests that access to contraception can
increase educational attainment and labor
force participation, for example, with fol-
low-on potential to improve career out-
comes and lifetime earnings.
213
It is also
possible that overall health outcomes
might improve because of increased cov-
erage of certain recommended preventive
services, which, in turn, could reduce
health care expenditures and therefore
premiums in the future. Further long-term
economic effects could be seen by entities
and individuals directly or indirectly (pub-
lic health insurance programs, uninsured
or self-pay individuals, and suppliers in
the pharmaceutical industry, for exam-
ple) affected by these proposed rules, to
the extent that prices for different recom-
mended preventive services change as a
result of these proposed rules. However,
due to a lack of data and clear understand-
ing of how preventive services utilization
will evolve given these proposed rules, the
Departments are unable to develop mone-
tized estimates of these potential benefits,
costs, and transfers.
206
In 2016, the average cost per visit to a primary care physician was $106 compared to $103 for an office visit to a NP or PA. See Hargraves, J., Frost A. (2018). “HCCI Brief: Trends in
Primary Care Visits,” available at https://healthcostinstitute.org/hcci-originals-dropdown/all-hcci-reports/trends-in-primary-care-visits.
207
Frederiksen, B., Ranji, U., Long, M., Diep, K., and Salganicoff, A., KFF (2022). “Contraception in the United States: A Closer Look at Experiences, Preferences, and Coverage,” available
at https://www.kff.org/report-section/contraception-in-the-united-states-a-closer-look-at-experiences-preferences-and-coverage-findings.
208
Switching oral contraceptives can increase the chance of pregnancy and can often cause side effects. See Lesnewski, R., Prine, L., and Ginzburg, R. (2011). “Preventing Gaps When Switch-
ing Contraceptives,” American Family Physician Journal, available at https://www.aafp.org/pubs/afp/issues/2011/0301/p567.html and Burgess, L. (2023). “How to Switch Birth Control Pills
Properly,” Medical News Today, available at https://www.medicalnewstoday.com/articles/322356.
209
Guttmacher Institute (2023). “Pharmacist-Prescribed Contraceptives,” available at https://www.guttmacher.org/state-policy/explore/pharmacist-prescribed-contraceptives.
210
The 2022 KFF Women’s Health Survey finds that 8 percent of women ages 18-49 get their birth control from places other than the doctor’s office, a clinic, or online, where “other” includes
pharmacies. When asked about where women would prefer to get their birth control, only 12 percent said “other”. See Frederiksen, B., Ranji, U., Long, M., Diep, K., and Salganicoff, A.,
KFF (2022). “Contraception in the United States: A Closer Look at Experiences, Preferences, and Coverage,” available at https://www.kff.org/report-section/contraception-in-the-unit-
ed-states-a-closer-look-at-experiences-preferences-and-coverage-findings.
211
Long, M., Frederickson, B., Ranji, U., and Salganicoff A., KFF (2020). “Women’s Health Care Utilization and Costs: Findings from the 2020 KFF Women’s Health Survey,” available at
https://www.kff.org/womens-health-policy/issue-brief/womens-health-care-utilization-and-costs-findings-from-the-2020-kff-womens-health-survey/.
212
Frederiksen, B., Ranji, U., Long, M., Diep, K., and Salganicoff, A., KFF (2022). “Contraception in the United States: A Closer Look at Experiences, Preferences, and Coverage,” available
at https://www.kff.org/report-section/contraception-in-the-united-states-a-closer-look-at-experiences-preferences-and-coverage-findings.
213
See, e.g., Bernstein, A. and Jones, K.M. (2019). “The Economic Effects of Contraceptive Access: A Review of the Evidence,” Institute for Women’s Policy Research, available at https://
iwpr.org/wp-content/uploads/2020/07/B381_Contraception-Access_Final.pdf.

Bulletin No. 2024–47 1165 November 18, 2024
Due to the lack of data, the Depart-
ments are unable to develop monetized
estimates of the benefits to covered indi-
viduals anticipated to arise from these
proposed rules, including a potential
reduction in unintended pregnancies and
improved health outcomes for individ-
uals and greater flexibility in utilizing a
wider range of recommended preventive
services without cost sharing for eligible
individuals.
g. Regulatory Review Cost Estimation
Due to the uncertainty involved with
quantifying the number of entities that
will review these proposed rules, the
Departments assume that the total number
of unique entities that may review these
proposed rules will equal the number of
health insurance companies (479) plus
the number of TPAs (205) (on behalf of
self-insured group health plans) plus the
States, Territories, and Washington D.C.
(56) plus the number of unique comment-
ers (364) to the OTC Preventive Products
RFI.
214
That sum yields 1,104 unique enti-
ties. The Departments acknowledge that
this assumption may understate or over-
state the number of reviewers and there-
fore the costs of reviewing these proposed
rules. The Departments request comment
on the approach in estimating the number
of entities which will review these pro-
posed rules.
Using the median wage information
from the BLS for business operations
specialist (13-1199) to account for labor
costs (including a 100 percent increase to
account for the cost of fringe benefits and
other indirect costs), the Departments esti-
mate that the cost of reviewing this rule is
$76.52 per hour, including overhead and
fringe benefits.
215
Assuming an average
reading speed of 200 words per minute,
the Departments estimate that it would
take approximately 3.25 hours for the staff
to review these proposed rules. For each
entity that reviews the rule, the estimated
cost is $248.69 (3.25 hours x $76.52).
Therefore, the Departments estimate that
the total cost of reviewing this regulation
is approximately $274,554 ($248.69 x
1,104).
C. Regulatory Alternatives – Departments
of Health and Human Services and Labor
In developing these proposed rules, the
Departments considered various alterna-
tive approaches.
The Departments considered propos-
ing to require plans and issuers to cover
all recommended preventive services,
with no cost sharing and without applying
reasonable medical management tech-
niques. However, as discussed in section
II.A of this preamble, the Departments
have determined that allowing plans and
issuers to utilize reasonable medical man-
agement techniques, when paired with
requirements to provide an exceptions
process, as proposed in these rules, strikes
an appropriate balance between the stat-
utory requirement that plans and issuers
cover recommended preventive services
at no cost and the importance of allow-
ing plans and issuers to impose reason-
able limitations in order to contain costs
(including costs that would be passed on
to consumers in the form of increased pre-
miums) and promote efficient delivery of
care. The provision of an easily accessi-
ble, transparent, and sufficiently expedient
exceptions process that is not unduly bur-
densome on the individual or a provider
(or other person acting as the individual’s
authorized representative) would ensure
that covered individuals can access cover-
age of medically necessary recommended
preventive services without cost sharing
even if such services are typically not cov-
ered or are otherwise subject to reasonable
medical management techniques.
With respect to the proposal to require
plans and issuers utilizing reasonable
medical management techniques to pro-
vide an easily accessible, transparent, and
sufficiently expedient exceptions process
that is not unduly burdensome, the Depart-
ments considered limiting this proposal to
contraceptive items only or to a subset of
recommended preventive services rather
than to all preventive services. However,
the Departments concluded that an excep-
tions process should be required for all
recommended preventive services in order
to fully implement the requirements under
section 2713 of the PHS Act to ensure that
plans and issuers provide coverage of rec-
ommended preventive services without
cost-sharing requirements, consistent with
prior guidance. Without such a process,
individuals could be forced to pay out-
of-pocket or forego the medically neces-
sary form of a recommended preventive
service if it differs from the form covered
by their plan or issuer. While prior guid-
ance has generally focused on the use of
an exceptions process in the context of
contraceptive coverage, it has not been
exclusively limited to that context, nor
are the Departments aware of any legal or
policy reason for limiting applicability of
an exceptions process to one or a subset of
recommended preventive services. There-
fore, the Departments determined it was
appropriate to propose that a plan or issuer
would be required to provide an excep-
tions process with respect to any recom-
mended preventive service for which it
utilizes medical management techniques
in order for such techniques to be consid-
ered reasonable.
The Departments considered whether
to propose to require plans and issuers to
provide coverage without cost sharing of
all or a subset of recommended OTC pre-
ventive products. The Departments simi-
larly considered whether to propose that
the therapeutic equivalence approach be
applicable to all or some broader subset of
recommended preventive services that are
drugs and drug-led combination products,
rather than only to contraceptive drugs
and drug-led combination products. How-
ever, the Departments decided to take an
incremental approach, beginning first with
recommended contraceptive items. As dis-
cussed in section II.A.2 of this preamble,
section 2713 of the PHS Act and its imple-
menting regulations do not exclude from
their coverage requirement coverage of
OTC recommended preventive services.
However, in consideration of comments
in response to the OTC Preventive Prod-
ucts RFI cautioning against swift imple-
mentation of a coverage requirement for
all OTC preventive products, the Depart-
ments determined it would be advisable
to propose an initial implementation of
such a requirement, applicable only to
recommended OTC contraceptive items.
214
See 88 FR 68519 (Oct. 4, 2023).
215
BLS, “May 2023 National Occupational Employment and Wage Estimates, United States,” available at https://www.bls.gov/oes/current/oes_nat.htm

November 18, 2024 1166 Bulletin No. 2024–47
Similarly, the Departments are of the
view that it is advisable to initially pro-
pose to require the use of a therapeutic
equivalence approach for the same set
of recommended preventive services—
that is, to contraceptive drugs and drug-
led combination products—as in prior
guidance. This incremental approach
to coverage, with respect to recom-
mended OTC contraceptive items and
therapeutic equivalence, would provide
plans and issuers, providers, retailers,
and other interested parties with the
opportunity to gather implementation
data before the Departments deter-
mine whether additional guidance or
rulemaking is appropriate. Further, for
the reasons outlined in sections I and
II.A of this preamble, it is particularly
necessary to support access to contra-
ceptive items at this time.
With respect to the Departments’ effort
to ensure individuals are made aware that
OTC contraceptive items are covered
without cost sharing and without a pre-
scription, the Departments also consid-
ered proposing to require plans and issu-
ers to create a public-facing webpage with
comprehensive information about their
contraceptive coverage policy, including
related to therapeutic equivalents, excep-
tions processes, network information,
and OTC coverage. However, the Depart-
ments understand that at least some group
health plans do not maintain a website for
employee health benefit plans, and the
Departments believe more information
is needed to assess whether it would be
feasible for plans and issuers to provide
information about contraceptive coverage
on a public website in cases where they
do not maintain such a website, such as
by entering into a written agreement under
which a plan’s health insurance issuer or
TPA, as applicable, posts the information
on its public website where information is
normally made available to participants,
beneficiaries, and enrollees, on the plan’s
behalf. The Departments also considered
proposing to require the statement to
include more information about coverage
of therapeutic equivalents and requested
comment on this approach, given the
Departments’ desire to maximize the state-
ment’s effectiveness by keeping it brief,
and that therapeutic equivalent coverage
policies will not differ between plans and
thus a plan-specific disclosure may be less
essential.
The Departments also considered pro-
posing to require that information about
coverage of OTC contraceptive items
without cost sharing and without a pre-
scription be included on SBCs. However,
due to the space limitations, the Depart-
ments are concerned that the SBC would
not provide a sufficiently robust disclo-
sure. The Departments decided to seek
comment on the SBC’s utility for inform-
ing participants, beneficiaries, and enroll-
ees of coverage of OTC contraceptive
items without cost sharing and without a
prescription.
D. Paperwork Reduction Act
Under the Paperwork Reduction Act
of 1995 (PRA), the Departments are
required to provide 60-day notice in the
Federal Register and solicit public com-
ment before a collection of information
requirement is submitted to OMB for
review and approval. To fairly evaluate
whether an information collection should
be approved by OMB, section 3506(c)(2)
(A) of the PRA requires that the Depart-
ments solicit comment on the following
issues:
• The need for the information collection
and its usefulness in carrying out the
proper functions of an agency.
• The accuracy of the Departments’ esti-
mate of the information collection bur-
den.
• 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.
As part of the continuing effort to
reduce paperwork and respondent burden,
the Departments conduct a preclearance
consultation program to provide the gen-
eral public and Federal agencies with an
opportunity to comment on proposed and
continuing collections of information in
accordance with the PRA. This helps to
ensure that the public understands the
Departments’ collection instructions,
respondents can provide the requested
data in the desired format, reporting
burden (time and financial resources) is
minimized, collection instruments are
clearly understood, and the Departments
can properly assess the impact of collec-
tion 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 Departments have submitted a
copy of these proposed rules to OMB in
accordance with 44 U.S.C. 3507(d) for
review of the proposed (revised) infor-
mation collections described in this sec-
tion. The Departments request public
comment on these information collec-
tions. Commenters may submit their com-
ments on the Departments’ PRA analysis
in the same way they send comments in
response to this NPRM as a whole (for
example, through the https://www.reg-
ulations.gov website), including as part
of a comment responding to the broader
NPRM. To obtain copies of the supporting
statements and any related forms for the
proposed collections, please visit https://
www.reginfo.gov.
1. Wage Estimates
The Departments generally used data
from the Contract Awarded Labor Cate-
gory (CALC) database tool
216
to derive
average labor costs for estimating the bur-
den and equivalent costs associated with
the information collection requirements
(ICRs). Table 3 presents the estimated
mean hourly wages, which include both
base pay and benefits, used in the burden
and equivalent cost estimates.
216
The CALC tool was built to assist acquisition professionals with market research and price analysis for labor categories on multiple U.S. General Services Administration (GSA) & Vet-
erans Administration (VA) contracts. The Departments chose to use wages derived from the CALC database because, even though the Bureau of Labor Statistics (BLS) data set is valuable
to economists, researchers, and others that would be interested in larger, more macro-trends in parts of the economy, the CALC data set is meant to help market research based on existing
government contracts in determining how much a project/product will cost based on the required skill sets needed. The CALC data set factors the fully burdened hourly rates (base pay +
benefits) into the wages whereas BLS does not. CALC occupations and wages provide the Departments with data that aligns more with, and provides more detail related to, the occupations
required for the implementation of the requirements in these proposed rules. CALC information and wage rates are available at https://buy.gsa.gov/pricing/.

Bulletin No. 2024–47 1167 November 18, 2024
TABLE 3: Hourly Wages Used in Burden and Equivalent Cost Estimates
CALC Occupation TitleMean Hourly Wage ($/hour)
Project Manager/Team Lead$146.15
Sr. Developer/Lead$197.27
Designer$107.10
Training Specialist$99.95
Customer Service Representative$45.83
Web Database/Application Developer IV$170.35
2. ICR Regarding Requirements for
Contraceptive Disclosure to Participants,
Beneficiaries, or Enrollees on the
Internet-Based Self-Service Tool
(26 CFR 54.9815-2715A2, 29
CFR 2590.715-2715A2, and
45 CFR 147.211)
The Departments propose in new 26
CFR 54.9815-2715A2(b)(1)(vi), 29 CFR
2590.715-2715A2(b)(1)(vi), and 45 CFR
147.211(b)(1)(vi) that if a participant, ben-
eficiary, or enrollee requests cost-sharing
information for any covered contraceptive
item or service using a plan’s or issuer’s
internet-based self-service tool or requests
such information be provided on paper, a
plan or issuer would be required to pro-
vide a statement explaining the availabil-
ity of OTC contraceptive items without
a prescription and without cost sharing,
along with a phone number and internet
link to where a participant, beneficiary, or
enrollee can learn more information about
the plan’s or policy’s contraception cover-
age. The Departments propose to require
plans and issuers to incorporate this dis-
closure into their existing self-service tool
for plan years (in the individual market,
policy years) beginning on or after Janu-
ary 1, 2026.
The Departments assume that fully-in-
sured group health plans would depend on
health insurance issuers and self-insured
group health plans would rely on TPAs
to implement the proposed requirements.
Based on recent data, the Departments
estimate that approximately 1,467 issu-
ers
217
and 205 TPAs
218
would implement
the proposed requirements on behalf of
plans and issuers.
The Departments assume that issuers
and TPAs have already built self-service
tools (first applicable for plan years (or
policy years) beginning on or after Janu-
ary 1, 2023) and would only be required
to modify their existing tools to incor-
porate the proposed new contraceptive
statement. This statement would explain
that OTC contraceptive items are covered
without a prescription and without cost
sharing and would provide a customer
service phone number and internet link
for a participant, beneficiary, or enrollee
that wishes to speak with a customer
service representative or gain additional
information about the plan’s or policy’s
contraception coverage. The introduction
of the new contraception statement would
impose the following additional bur-
den on issuers and TPAs
219
: (1) first-year
one-time development costs needed to
integrate the contraception statement lan-
guage into the existing self-service tool.
This would involve design changes to the
existing web user interface to enable iden-
tification of services that would trigger the
static statement to the consumer. Addi-
tionally, the statement would be required
to include a link to information about the
participant’s, beneficiary’s, or enrollee’s
contraception coverage benefits. Issuers
and TPAs would incur one-time costs to
create or update a webpage to provide this
information; (2) annual costs of program-
ming updates, webpage maintenance,
and maintaining the list of contraceptive
items and services required to be coded
to trigger the statement; (3) annual costs
associated with training customer service
representatives to assist consumers with
inquiries related to the new contraceptive
statement, and (4) annual costs for cus-
tomer service representatives to respond
to calls.
The Departments estimate that for each
issuer or TPA, on average, it would take a
Project Manager/Team Lead 40 hours (at
$146.15 per hour), a Senior Developer/
lead 20 hours (at $197.27 per hour), a
Designer 25 hours at ($107.10 per hour),
and a Web Database/Application Devel-
oper IV 50 hours (at $170.35 per hour)
to integrate the contraception statement
language into the existing self-service
tool, make design changes, and create
or update a webpage to provide further
details regarding the plan’s or policy’s
contraceptive coverage. The Departments
estimate the total hour burden per issuer or
TPA would be approximately 135 hours,
with an equivalent cost of approximately
$20,986 per issuer or TPA. For all 1,672
issuers and TPAs, the total first-year one-
time total hour burden is estimated to be
225,720 hours, with an equivalent total
cost of approximately $35,089,261 as
shown in table 4.
217
The Departments’ estimate of the number of health insurance companies and the number of issuers (issuer/State combinations) is based on medical loss ratio reports submitted by issuers
for the 2022 reporting year. See CMS (2022), “Medical Loss Ratio Data and System Resources,” available at https://www.cms.gov/CCIIO/Resources/Data-Resources/mlr.
218
Non-issuer TPAs estimate is based on data derived from the 2016 benefit year reinsurance program contributions.
219
Note that the Departments expect self-insured group health plans would rely on TPAs to implement the proposed requirements and compensate them accordingly and thereby bear any
implementation costs.

November 18, 2024 1168 Bulletin No. 2024–47
TABLE 4: Total First Year Estimated One-time Cost and Hour Burden to Incorporate the New Contraceptive Statement in
the Internet-Based Self-service Tool, Make Design Changes, and Develop or Update a Webpage to Provide Further Details
Regarding the Plan’s or Policy’s Contraception Coverage for All Health Insurance Issuers and TPAs
Number of
Respondents
Number of Responses
Burden Hours Per
Respondent
Total Burden HoursTotal Cost
1,6721,672135225,720$35,089,261
In addition to the one-time cost and
hour burden estimated above, issuers and
TPAs would incur ongoing annual costs
for website maintenance, programming
updates, and updates to the list of con-
traceptive items and services required
to be coded to trigger the statement. The
Departments estimate that for each issuer
and TPA, it would take a Web Database/
Application Developer IV 5 hours (at
$170.35 per hour) to complete this task.
For all 1,672 issuers and TPAs, the total
annual maintenance burden related to the
new contraceptive statement would be
8,360 hours with an equivalent total cost
of approximately $1,424,126 as shown in
table 5.
TABLE 5: Estimated Annual Cost and Hour Burden for Maintenance of Internet-based Self-Service Tool Related to the
New Contraceptive Statement for All Issuers and TPAs
Number of
Respondents
Number of Responses
Burden Hours Per
Respondent
Total Burden HoursTotal Cost
1,6721,67258,360$1,424,126
Issuers and TPAs would also incur an
ongoing annual burden and cost associ-
ated with customer service representative
training related to the new contraceptive
statement. The Departments assume that
the introduction of the new contracep-
tion statement would not necessitate hir-
ing additional full-time customer service
representatives. Instead, the Departments
expect issuers and TPAs would utilize their
existing customer service representatives
for this task. Therefore, the Departments
estimate that for each issuer and TPA, one
Training Specialist would spend 5 hours
at a cost of $99.95 per hour to train 5 cus-
tomer service representatives on how to
respond to participants, beneficiaries, and
enrollees if they call in because of the new
contraception statement, who would also
require 5 hours to complete the training
at a cost of $45.83 per hour. For all 1,672
issuers and TPAs, the total annual training
hour burden would be 50,160 hours, with
an equivalent total annual cost of approx-
imately $2,751,276 as shown in table 6.
TABLE 6: Estimated Annual Cost and Hour Burden for All Issuers and TPAs to Train Customer Service Representatives to
Provide Assistance to Consumers Related to New Contraceptive Statement in the Internet-based Self-Service Tool
Number of
Respondents
Number of Responses
Burden Hours Per
Respondent
Total Burden HoursTotal Cost
1,6721,6723050,160$2,751,276
After the training, customer service rep-
resentatives would be expected to respond
to the potential increase in calls resulting
from the new contraception statement. The
Departments estimate that for each issuer
and TPA, it would take 5 customer service
representatives 5 hours (at $45.83 per hour)
to complete this task. For all 1,672 issuers
and TPAs, the total annual cost of respond-
ing to these calls would be 41,800 hours,
with an equivalent total cost of approxi-
mately $1,915,694 as shown in table 7.
TABLE 7: Estimated Annual Cost and Hour Burden for All Issuers and TPAs to Respond to Calls regarding the New
Contraceptive Statement on the Internet-based Self-Service Tool
Number of
Respondents
Number of Responses
Burden Hours Per
Respondent
Total Burden HoursTotal Cost
1,6721,6722541,800$1,915,694

Bulletin No. 2024–47 1169 November 18, 2024
Taking into account their segment of
jurisdiction over issuers and TPAs, HHS
would assume 50 percent of the total bur-
den, while the Departments of Labor and
the Treasury would each assume 25 per-
cent. Tables 8 to 10 display the share of
each Department’s total burden hours to
implement the new contraceptive state-
ment.
TABLE 8: Estimated HHS Share of Total Burden Hours for Implementing the New Contraceptive Statement
Year
Number of
RespondentsNumber of Responses
Burden Hours Per
RespondentTotal Burden Hours
Year 1836836 135 112,860
Year 2836836 60 50,160
Year 3836836 60 50,160
3-Year Average836836 85 71,060
TABLE 9: Estimated Department of Labor’s Share of Total Burden Hours for Implementing the New Contraceptive
Statement
Year
Number of
RespondentsNumber of Responses
Burden Hours Per
RespondentTotal Burden Hours
Year 1418418 135 56,430
Year 2418418 60 25,080
Year 3418418 60 25,080
3-Year Average418418 85 35,530
TABLE 10: Estimated Department of the Treasury’s Share of Total Burden Hours for Implementing the New Contraceptive
Statement
Year
Number of
RespondentsNumber of Responses
Burden Hours Per
RespondentTotal Burden Hours
Year 1418418 135 56,430
Year 2418418 60 25,080
Year 3418418 60 25,080
3-Year Average418418 85 35,530
The burden related to the Transpar-
ency in Coverage disclosure of certain
cost-sharing information for HHS is
currently approved under OMB control
number 0938-1429 (CMS-10715, Trans-
parency in Coverage).
220
HHS will revise
this information collection request to
account for the additional burden asso-
ciated with the contraceptive disclosure.
This information collection request was
approved as a host for common forms.
The burden related to the Transpar-
ency in Coverage disclosure of certain
cost-sharing information for DOL and
Treasury was submitted to OMB for each
respective Department under 0938-1429
as Request for Common Form (RCF)
submissions. Upon OMB approval of
the RCF submissions, DOL and Treasury
will update and submit their information
collection requests.
220
Available at https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202410-0938-006.

November 18, 2024 1170 Bulletin No. 2024–47
TABLE 11. Summary of Proposed 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 Cost
45 CFR 47.2110938-14298368368571,060$119 $8,721,124
26 CFR 54.9815-2715A20938-14294184188535,530$119 $4,360,562
29 CFR 2590.715-2715A20938-14294184188535,530$119 $4,360,562
Total 1,6721,672 142,120 $17,442,248
The Departments seek comment on the
assumptions made and the burden esti-
mates discussed in this section.
E. Regulatory Flexibility Act
The Regulatory Flexibility Act
(RFA)
221
requires agencies to analyze
options for regulatory relief of small enti-
ties and to prepare an initial regulatory
flexibility analysis to describe the impact
of a proposed rule on small entities, unless
the head of the agency can certify that
the rule will not have a significant eco-
nomic impact on a substantial number of
small entities. The RFA generally defines
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 domi-
nant in its field, or (3) a small government
jurisdiction with a population of less than
50,000. States and individuals are not
included in the definition of “small entity.”
The data and conclusions presented in this
section amount to the Departments’ initial
regulatory flexibility analysis under the
RFA.
1. Need for Regulatory Action,
Objectives, and Legal Basis
As discussed in section II of this pre-
amble, ongoing complaints and reports of
noncompliance with section 2713 of the
PHS Act and its implementing regulations
indicate that consumers face barriers when
attempting to use their health plan or cov-
erage to access recommended preventive
services without cost sharing. As a result
of these concerns and other significant
activity related to preventive services, the
Departments are proposing to amend the
regulations governing coverage of rec-
ommended preventive services in order
to ensure that participants, beneficiaries,
and enrollees can access the full range
of recommended preventive services to
which they are entitled, with particular
focus on strengthening coverage require-
ments with respect to recommended con-
traceptive items for women, as summa-
rized in section IV.A of this preamble. The
Departments consider these provisions to
be timely and necessary given the docu-
mented challenges faced by consumers in
accessing recommended preventive ser-
vices, as discussed in section IV.B.2.a of
this preamble.
2. Number of Affected Small Entities and
Compliance Requirements and Costs
The provisions in these proposed rules
would affect small entities including
health insurance issuers, ERISA-covered
non-grandfathered group health plans,
non-grandfathered non-Federal govern-
mental plans, and pharmacies.
The Departments anticipate that health
insurance issuers, many of which are part
of larger health insurance companies or
holding groups, would incur costs associ-
ated with the provisions in these proposed
rules, as described in section IV.B.2.d of
this preamble. Health insurance compa-
nies are generally classified under the
North American Industry Classification
System (NAICS) code 524114 (Direct
Health and Medical Insurance Carri-
ers). According to SBA size standards,
222

entities with average annual receipts of
$47 million or less are considered small
entities for this NAICS code. The Depart-
ments expect that few, if any, insurance
companies underwriting health insurance
policies fall below these size thresholds.
Based on data from medical loss ratio
annual report submissions for the 2022
reporting year, approximately 87 out of
487 health insurance companies nation-
wide had total premium revenue of $47
million or less.
223
This estimate may over-
state the actual number of small health
insurance companies that may be affected,
since over 76 percent of these small com-
panies belong to larger holding groups,
and many, if not all, of these small compa-
nies are likely to have non-health lines of
business that will result in their revenues
exceeding $47 million.
Plans and plan sponsors would incur
some costs associated with meeting the
requirements of these proposed rules,
whether directly or indirectly through
compensation paid to a TPA. However,
the Departments anticipate that most of
these costs would ultimately be passed on
to plan participants, as discussed in section
IV.B.2.e of this preamble. As noted in sec-
tion IV.B.2.b of this preamble, the Depart-
ments estimate that there are 499,299
ERISA-covered self-insured, non-grandfa-
thered group health plans
224
and 1,844,520
221
5 U.S.C. § 601, et seq.
222
Small Business Administration (2023). “Table of Size Standards (last updated March 2023),” available at https://www.sba.gov/document/support--table-size-standards.
223
Based on internal calculations. See CMS, Medical Loss Ratio Data and System Resources, available at https://www.cms.gov/CCIIO/Resources/Data-Resources/mlr.html.
224
The Departments estimate that there are 594,404 ERISA-covered self-insured group health plans based on data from the 2022 Medical Expenditure Panel Survey Insurance Component
(MEPS-IC) and the 2020 County Business Patterns from the Census Bureau. The 2020 KFF Employer Health Benefits Survey reported that in 2020, 16 percent of firms offering health
benefits offered at least one grandfathered health plan (see KFF, 2020 Kaiser Employer Health Benefits Survey, available at https://files.kff.org/attachment/Report-Employer-Health-Ben-
efits-2020-Annual-Survey.pdf). Thus, the Departments have calculated the number of self-insured, non-grandfathered plans in the following manner: 594,404 ERISA-covered self-insured
group health plans x (100 percent minus 16 percent) = 499,299.

Bulletin No. 2024–47 1171 November 18, 2024
ERISA-covered fully-insured, non-grand-
fathered group health plans.
225
The Depart-
ments further estimate that there are 76,345
non-grandfathered non-Federal govern-
mental plans sponsored by State and local
governmental entities.
226
Due to limited data, the Departments
are unable to quantify the percentages
of these plans whose sponsors might be
considered small entities under the RFA
but anticipate that most could be.
227
The
Departments request comment and data
on the number of plan sponsors that might
be small entities, as well as the potential
economic impacts of these proposed rules
on plan sponsors.
The Departments anticipate that phar-
macies would incur costs to update billing
processes and systems for covered OTC
contraceptive items, as discussed in sec-
tion IV.B.2.d of this preamble. Pharmacies
are classified under NAICS code 456110
(Pharmacies and Drug Retailers) with
a size standard of $37.5 million or less.
According to the Census Bureau’s Statis-
tics of U.S. Businesses, there are 19,234
firms in the pharmacies and drug stores
sector in the U.S. as of 2017.
228
Based on
these firms’ receipts in 2017 (adjusted for
inflation between 2017 and 2023), 18,879,
or 98.2 percent, of these firms, accounting
for 22.0 percent of receipts in the sector,
operate below the SBA size standard and
are therefore considered small entities.
229

The Departments request comment on this
analysis.
3. Duplication, Overlap, and Conflict
with Other Rules and Regulations
The Departments do not anticipate that
these proposed rules would cause any
duplication, overlap, or conflict with other
rules and regulations.
4. Significant Alternatives
The Departments considered various
alternatives to the provisions proposed in
these proposed rules in section IV.C. In
light of this discussion of regulatory alter-
natives, the Departments are of the view
that there are no significant alternatives
that would both achieve the policy objec-
tives and goals of these proposed rules and
be less burdensome to small entities.
F. Special Analyses – Department of the
Treasury
Pursuant to the Memorandum of
Agreement, Review of Treasury Regula-
tions under Executive Order 12866 (June
9, 2023), tax regulatory actions issued by
the IRS are not subject to the requirements
of section 6 of Executive Order 12866, as
amended. Therefore, a regulatory impact
assessment is not required. Pursuant to
section 7805(f) of the Code, these regu-
lations have been submitted to the Chief
Counsel for Advocacy of the Small Busi-
ness Administration for comment on their
impact on small business.
G. Unfunded Mandates Reform Act
Section 202 of the Unfunded Man-
dates Reform Act of 1995 (UMRA)
requires that agencies assess anticipated
costs and benefits before issuing a pro-
posed rule that includes any Federal
mandate that may result in expenditures
in any one year by State, local, or Tribal
governments, in the aggregate, or by the
private sector, of $100 million in 1995
dollars, updated annually for inflation.
That threshold is approximately $183
million in 2024. These proposed rules
would not impose a mandate that will
result in the expenditure by State, local,
and Tribal governments, in the aggregate,
or by the private sector, of more than $183
million in any one year. As discussed in
section IV.B.2.e of this preamble, the
Departments expect that most, if not all,
of the transfer effects would be incurred
by covered individuals (directly or indi-
rectly) and the Federal government. The
Departments also anticipate that the total
costs to plans, issuers, and pharmacies
identified in section IV.B.2.d of this pre-
amble would be below the threshold. The
Departments therefore anticipate that
State, local, and Tribal governments, in
the aggregate, or the private sector would
not experience an increase in expenditure
that meets this threshold.
H. Federalism
Executive Order 13132 outlines funda-
mental principles of federalism. It requires
adherence to specific criteria by Federal
agencies in formulating and implement-
ing policies that have “substantial direct
effects” on the States, the relationship
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 proposed rules.
225
The Departments estimate that there are 2,195,857 ERISA-covered fully-insured group health plans based on data from the 2022 Medical Expenditure Panel Survey Insurance Compo-
nent (MEPS-IC) and the 2020 County Business Patterns from the Census Bureau. The 2020 KFF Employer Health Benefits Survey reported that in 2020, 16 percent of firms offering health
benefits offered at least one grandfathered health plan (see KFF, 2020 Kaiser Employer Health Benefits Survey, available at https://files.kff.org/attachment/Report-Employer-Health-Bene-
fits-2020-Annual-Survey.pdf). Thus, the Departments have calculated the number of fully-insured, non-grandfathered plans in the following manner: 2,195,857 ERISA-covered fully-insured
group health plans x (100 percent minus 16 percent) =1,844,520.
226
According to data from the 2022 Census of Governments, there are 90,887 State and local governmental entities (see U.S. Census Bureau, 2022 Census of Governments, available at https://
www.census.gov/data/tables/2022/econ/gus/2022-governments.html). The Departments assume that each State and local governmental entity sponsors one health plan on average. Therefore,
the Departments estimate that there are 90,887 non-Federal governmental health plans. The 2020 KFF Employer Health Benefits Survey reported that 16 percent of employers offer at least
one grandfathered plan (see KFF, 2020 Kaiser Employer Health Benefits Survey, available at https://files.kff.org/attachment/Report-Employer-Health-Benefits-2020-Annual-Survey.pdf). The
Departments therefore estimate there are approximately 76,345 non-grandfathered non-Federal governmental plans.
227
Based on data from the 2022 MEPS-IC, the 2020 County Business Patterns from the Census Bureau, and the 2020 Kaiser Employer Health Benefits Survey, the Departments estimate
that approximately 2,189,444 ERISA-covered non-grandfathered group health plans have less than 100 participants, or approximately 93 percent of the total number of ERISA-covered
non-grandfathered group health plans.
228
U.S. Census Bureau (2017). 2017 SUSB Annual Data Tables by Establishment Industry (Data by Enterprise Receipts Size), available at https://www.census.gov/data/tables/2017/econ/
susb/2017-susb-annual.html.
229
Adjusted for inflation between 2017 and 2023 using the consumer price index for all urban consumers (CPI-U). See U.S. Bureau of Labor Statistics (2024), Consumer Price Index, available
at https://www.bls.gov/cpi/tables/supplemental-files/ (Historical CPI-U, August 2024).

November 18, 2024 1172 Bulletin No. 2024–47
In the Departments’ view, these pro-
posed rules have federalism implications
because they may have direct effects
on the States, the relationship between
the Federal government and the States,
or on the distribution of power and
responsibilities among various levels of
government. However, the federalism
implications are substantially mitigated
because, with respect to health insurance
issuers, 45 States are either enforcing
the requirements related to coverage of
specified preventive services (including
contraception) without cost sharing pur-
suant to State law or otherwise are work-
ing collaboratively with HHS to ensure
that issuers meet these standards. In five
States, HHS ensures that issuers com-
ply with these requirements. In addition,
seven States have passed laws requiring
State-regulated health plans to cover,
without cost sharing, certain OTC con-
traceptive items without a prescription.
230

Therefore, these proposed rules would
not be likely to require substantial addi-
tional oversight of States by HHS.
In general, through section 514,
ERISA supersedes State laws to the
extent that they relate to any covered
employee benefit plan, and preserves
State laws that regulate insurance,
banking, or securities. While ERISA
prohibits States from regulating a plan
as an insurance or investment company
or bank, the preemption provisions of
section 731 of ERISA and section 2724
of the PHS Act (implemented in 29 CFR
2590.731(a) and 45 CFR 146.143(a))
apply so that the ACA’s preventive
service requirements are not to be
“construed to supersede any provision
of State law which establishes, imple-
ments, or continues in effect any stan-
dard or requirement solely relating to
health insurance issuers in connection
with” group or individual health insur-
ance coverage “except to the extent that
such standard or requirement prevents
the application of” a Federal require-
ment. The conference report accom-
panying the Health Insurance Porta-
bility and Accountability Act of 1996
(HIPAA) indicates that this is intended
to be the “narrowest” preemption of
State laws.
231
States may continue to apply State
law requirements except to the extent
that such requirements prevent the
application of the preventive services
requirements in section 2713 of the PHS
Act.
232
State insurance laws that are more
stringent than the Federal requirements
are unlikely to prevent the application
of the preventive services requirements
and be preempted. Accordingly, States
have significant latitude to impose
requirements on health insurance issuers
that are more restrictive than the Federal
law.
The Departments request comment on
the potential impacts on States (if any)
associated with these proposed rules.
Throughout the process of developing
these proposed rules, to the extent feasible
within the specific preemption provisions
of HIPAA as it applies to the preventive
services requirements, the Departments
have attempted to balance the States’
interests in regulating health insurance
issuers, and Congress’ intent to provide
uniform minimum protections to consum-
ers in every State. By doing so, it is the
Departments’ view that they have com-
plied with the requirements of Executive
Order 13132.
Statutory Authority
The Department of the Treasury regu-
lations are proposed to be adopted pursu-
ant to the authority contained in sections
7805 and 9833 of the Code.
The Department of Labor regulations
are proposed to be adopted pursuant to
the authority contained in 29 U.S.C. 1002,
1135, 1182, 1185d, 1191a, 1191b, and
1191c; Secretary of Labor’s Order 1-2011,
77 FR 1088 (Jan. 9, 2012).
The Department of Health and Human
Services regulations are proposed to be
adopted pursuant to the authority contained
in sections 2701 through 2763, 2791, 2792,
and 2794 of the PHS Act (42 U.S.C. 300gg-
63, 300gg-91, 300gg-92 and 300gg-94),
as amended; sections 1311 and 1321 of
PPACA (42 U.S.C. 13031 and 18041).
List of Subjects
26 CFR Part 54
Excise taxes, Health care, Health insur-
ance, 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
recordkeeping requirements.
45 CFR Part 147
Health care, Health insurance, Report-
ing and recordkeeping requirements, and
State regulation of health insurance.
DEPARTMENT OF THE TREASURY
Internal Revenue Service
Proposed Amendments to the
Regulations
Accordingly, the Treasury Department
and IRS propose to amend 26 CFR part 54
as follows:
PART 54—PENSION EXCISE TAXES
Paragraph 1. The authority citation
for part 54 continues to read in part as fol-
lows:
Authority: 26 U.S.C. 7805 * * *
* * * * *
230
CA, CO, MD, NJ, NM, NY, WA. KFF, (March 2024). “State Private Insurance Coverage Requirements for OTC Contraception Without a Prescription,” available at https://www.kff.org/
other/state-indicator/state-private-insurance-coverage-requirements-for-otc-contraception-without-a-prescription.
231
See Conf. Rep. No. 104-736, pg. 205, reprinted in 1996 U.S. Code Cong. & Admin. News 2018, available at https://www.congress.gov/congressional-report/104th-congress/house-re-
port/736/1.
232
See ERISA section 731 and PHS Act section 2724(a); 29 CFR 2590.731(a) and 45 CFR 146.143(a) and 148.210. See also FAQs Part 54, Q11 and Q12 (July 28, 2022), available at https://
www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf and https://www.cms.gov/files/document/faqs-part-54.pdf.

Bulletin No. 2024–47 1173 November 18, 2024
Par. 2. Section 54.9815-2713 is
amended by revising paragraph (a)(4),
adding paragraph (a)(6), and revising
paragraph (d) to read as follows:
§ 54.9815-2713 Coverage of preventive
health services.
(a) * * *
(4) Reasonable medical man-
agement. (i) Nothing prevents
a plan or issuer from using reasonable
medical management techniques to deter-
mine the frequency, method, treatment,
or setting for an item or service described
in paragraph (a)(1) of this section to the
extent not specified in the relevant recom-
mendation or guideline. To the extent not
specified in a recommendation or guide-
line described in paragraph (a)(1) of this
section, a plan or issuer may rely on the
relevant clinical evidence base and estab-
lished reasonable medical management
techniques to determine the frequency,
method, treatment, or setting for coverage
of a recommended preventive health ser-
vice.
(ii) For a medical management tech-
nique to be considered reasonable under
paragraph (a)(4)(i) of this section, a plan
or issuer must have an easily accessible,
transparent, and sufficiently expedient
exceptions process that is not unduly bur-
densome on a participant, beneficiary, or
attending provider (or other person act-
ing as the individual’s authorized repre-
sentative) that ensures the individual can
receive coverage, without cost-sharing
requirements, for the item or service spec-
ified in a recommendation or guideline
described in paragraph (a)(1) of this sec-
tion, according to the frequency, method,
treatment, or setting, that is medically
necessary with respect to the individual,
as determined by the individual’s attend-
ing provider.
* * * * *
(6) Contraceptive items—(i) Defini-
tions. For purposes of this paragraph (a)
(6)—
(A) Drug-led combination product
means a combination product, as defined
under 21 CFR 3.2(e), that comprises a
drug and a device, and for which the drug
component provides the primary mode of
action.
(B) Therapeutic equivalent has the
meaning given the term therapeutic equiv-
alents in 21 CFR 314.3(b).
(ii) Over-the-counter contraception.
Subject to § 54.9815-2713A and 45 CFR
147.132 and 147.133, a plan or issuer is
not considered to comply with paragraph
(a)(1) of this section with respect to a
contraceptive item that can be lawfully
obtained by a participant or beneficiary
without a prescription and for which the
applicable recommendation or guideline
does not require a prescription, unless
the plan or issuer provides coverage for
the contraceptive item without requiring
a prescription and without imposing any
cost-sharing requirements in accordance
with paragraph (a)(1) of this section.
(iii) Therapeutic equivalents. For pur-
poses of paragraph (a)(4) of this section,
a plan’s or issuer’s medical management
techniques are not considered to be rea-
sonable unless the plan or issuer pro-
vides coverage, without imposing any
cost-sharing requirements, for all contra-
ceptive items recommended under para-
graph (a)(1) of this section that are drugs
or drug-led combination products, other
than those items for which there is at least
one therapeutic equivalent drug or drug-
led combination product, as applicable,
for which the plan or issuer provides cov-
erage without imposing any cost-sharing
requirements.
* * * * *
(d) Applicability date. The provisions
of this section apply for plan years begin-
ning on or after September 23, 2010.
Notwithstanding the previous sentence,
the provisions of paragraph (a)(4)(ii) of
this section apply beginning on [EFFEC-
TIVE DATE OF FINAL RULE] and the
provisions of paragraph (a)(6) of this
section apply for plan years beginning on
or after January 1, 2026. See §54.9815-
1251 for determining the applica-
tion of this section to grandfathered
health plans (providing that these rules
regarding coverage of preventive health
services do not apply to grandfathered
health plans).
Par. 3. Section 54.9815-2715A2 is
amended by:
a. Redesignating paragraphs (b)(1)(vi)
and (vii) as paragraphs (b)(1)(vii) and
(viii);
b. Adding new paragraph (b)(1)(vi);
and
c. Revising paragraph (c)(1).
The addition and revision read as fol-
lows:
§ 54.9815-2715A2 Transparency in
coverage—required disclosures to
participants and beneficiaries.
* * * * *
(b) * *
(1) * * *
(vi) If a participant or beneficiary
requests cost-sharing information for any
covered contraceptive item or service, a
statement explaining that over-the-counter
contraceptive items are covered without a
prescription and without cost sharing in
accordance with § 54.9815-2713(a)(6),
along with a phone number and internet
link to where a participant or beneficiary
can learn more information about the plan
or policy’s contraception coverage.
* * * * *
(c) * * *
(1) The provisions of this section apply
for plan years beginning on or after Janu-
ary 1, 2023, with respect to the 500 items
and services to be posted on a publicly
available website, and with respect to all
covered items and services, for plan years
beginning on or after January 1, 2024.
Notwithstanding the previous sentence,
the provisions of paragraph (b)(1)(vi) of
this section apply for plan years beginning
on or after January 1, 2026.
* * * * *
DEPARTMENT OF LABOR
Employee Benefits Security
Administration
For the reasons stated in the pream-
ble, the Department of Labor proposes
to amend 29 CFR part 2590 as set forth
below:
PART 2590—RULES AND
REGULATIONS FOR GROUP
HEALTH PLANS
1. The authority citation for part 2590
continues to read as follows:

November 18, 2024 1174 Bulletin No. 2024–47
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).
2. Section 2590.715–2713 is amended
by revising paragraph (a)(4), adding para-
graph (a)(6), and revising paragraph (d) to
read as follows:
§ 2590.715-2713 Coverage of
preventive health services.
(a) * * *
(4) Reasonable medical man-
agement. (i) Nothing prevents
a plan or issuer from using reasonable
medical management techniques to deter-
mine the frequency, method, treatment,
or setting for an item or service described
in paragraph (a)(1) of this section to the
extent not specified in the relevant recom-
mendation or guideline. To the extent not
specified in a recommendation or guide-
line described in paragraph (a)(1) of this
section, a plan or issuer may rely on the
relevant clinical evidence base and estab-
lished reasonable medical management
techniques to determine the frequency,
method, treatment, or setting for coverage
of a recommended preventive health ser-
vice.
(ii) For a medical management tech-
nique to be considered reasonable under
paragraph (a)(4)(i) of this section, a plan
or issuer must have an easily accessible,
transparent, and sufficiently expedient
exceptions process that is not unduly bur-
densome on a participant, beneficiary, or
attending provider (or other person act-
ing as the individual’s authorized repre-
sentative) that ensures the individual can
receive coverage, without cost-sharing
requirements, for the item or service spec-
ified in a recommendation or guideline
described in paragraph (a)(1) of this sec-
tion, according to the frequency, method,
treatment, or setting, that is medically
necessary with respect to the individual,
as determined by the individual’s attend-
ing provider.
* * * * *
(6) Contraceptive items—(i) Defini-
tions. For purposes of this paragraph (a)
(6)—
(A) Drug-led combination product
means a combination product, as defined
under 21 CFR 3.2(e), that comprises a
drug and a device, and for which the drug
component provides the primary mode of
action.
(B) Therapeutic equivalent has the
meaning given the term therapeutic equiv-
alents in 21 CFR 314.3(b).
(ii) Over-the-counter contraception.
Subject to § 2590.715-2713A and 45 CFR
147.132 and 147.133, a plan or issuer is
not considered to comply with paragraph
(a)(1) of this section with respect to a
contraceptive item that can be lawfully
obtained by a participant or beneficiary
without a prescription and for which the
applicable recommendation or guideline
does not require a prescription, unless
the plan or issuer provides coverage for
the contraceptive item without requiring
a prescription and without imposing any
cost-sharing requirements in accordance
with paragraph (a)(1) of this section.
(iii) Therapeutic equivalents. For pur-
poses of paragraph (a)(4) of this section,
a plan’s or issuer’s medical management
techniques are not considered to be rea-
sonable unless the plan or issuer pro-
vides coverage, without imposing any
cost-sharing requirements, for all contra-
ceptive items recommended under para-
graph (a)(1) of this section that are drugs
or drug-led combination products, other
than those items for which there is at least
one therapeutic equivalent drug or drug-
led combination product, as applicable,
for which the plan or issuer provides cov-
erage without imposing any cost-sharing
requirements.
* * * * *
(d) Applicability date. The provisions
of this section apply for plan years begin-
ning on or after September 23, 2010. Not-
withstanding the previous sentence, the
provisions of paragraph (a)(4)(ii) of this
section apply beginning on [EFFECTIVE
DATE OF FINAL RULE] and the provi-
sions of paragraph (a)(6) of this section
apply for plan years beginning on or after
January 1, 2026. See § 2590.715-1251 for
determining the application of this section
to grandfathered health plans (providing
that these rules regarding coverage of
preventive health services do not apply to
grandfathered health plans).
* * * * *
3. Section 2590.715-2715A2 is
amended by—
a. Redesignating paragraphs (b)(1)(vi)
and (vii) as paragraphs (b)(1)(vii) and
(viii);
b. Adding new paragraph (b)(1)(vi);
and
c. Revising paragraph (c)(1).
The addition and revision read as fol-
lows:
§ 2590.715–2715A2 Transparency in
coverage—required disclosures to
participants and beneficiaries.
* * * * *
(b) * * *
(1) * * *
(vi) If a participant or beneficiary
requests cost-sharing information for
any covered contraceptive item or
service, a statement explaining that
over-the-counter contraceptive items
are covered without a prescription and
without cost sharing in accordance with
§ 2590.715–2713(a)(6), along with a
phone number and internet link to where
a participant or beneficiary can learn
more information about the plan or pol-
icy’s contraception coverage.
* * * * *
(c) * * *
(1) The provisions of this section apply
for plan years beginning on or after Janu-
ary 1, 2023, with respect to the 500 items
and services to be posted on a publicly
available website, and with respect to all
covered items and services, for plan years
beginning on or after January 1, 2024.
Notwithstanding the previous sentence,
the provisions of paragraph (b)(1)(vi) of
this section apply for plan years beginning
on or after January 1, 2026.
* * * * *

Bulletin No. 2024–47 1175 November 18, 2024
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
For the reasons stated in the preamble,
the Department of Health and Human Ser-
vices proposes to amend 45 CFR part 147
as set forth below:
PART 147 – HEALTH INSURANCE
REFORM REQUIREMENTS FOR
THE GROUP AND INDIVIDUAL
HEALTH INSURANCE MARKETS
1. The authority citation for part 147
continues to read as follows:
Authority: 42 U.S.C. 300gg through
300gg-63, 300gg-91, 300gg-92, and
300gg-111 through 300gg-139, as
amended, and section 3203, Pub. L. 116-
136, 134 Stat. 281.
2. Section 147.130 is amended by
revising paragraph (a)(4), adding para-
graph (a)(6), and revising paragraph (d) to
read as follows:
§ 147.130 Coverage of preventive
health services.
(a) * * *
(4) Reasonable medical man-
agement. (i) Nothing prevents
a plan or issuer from using reasonable
medical management techniques to deter-
mine the frequency, method, treatment,
or setting for an item or service described
in paragraph (a)(1) of this section to the
extent not specified in the relevant recom-
mendation or guideline. To the extent not
specified in a recommendation or guide-
line described in paragraph (a)(1) of this
section, a plan or issuer may rely on the
relevant clinical evidence base and estab-
lished reasonable medical management
techniques to determine the frequency,
method, treatment, or setting for coverage
of a recommended preventive health ser-
vice.
(ii) For a medical management tech-
nique to be considered reasonable under
paragraph (a)(4)(i) of this section, a plan
or issuer must have an easily accessible,
transparent, and sufficiently expedient
exceptions process that is not unduly bur-
densome on a participant, beneficiary,
enrollee, or attending provider (or other
person acting as the individual’s autho-
rized representative) that ensures the
individual can receive coverage, without
cost-sharing requirements, for the item or
service specified in a recommendation or
guideline described in paragraph (a)(1) of
this section, according to the frequency,
method, treatment, or setting, that is med-
ically necessary with respect to the indi-
vidual, as determined by the individual’s
attending provider.
* * * * *
(6) Contraceptive items—(i) Defini-
tions. For purposes of this paragraph (a)
(6)—
(A) Drug-led combination product
means a combination product, as defined
under 21 CFR 3.2(e), that comprises a
drug and a device, and for which the drug
component provides the primary mode of
action.
(B) Therapeutic equivalent has the
meaning given the term therapeutic equiv-
alents in 21 CFR 314.3(b).
(ii) Over-the-counter contraception.
Subject to §§ 147.131, 147.132, and
147.133, a plan or issuer is not consid-
ered to comply with paragraph (a)(1) of
this section with respect to a contracep-
tive item that can be lawfully obtained
by a participant, beneficiary, or enrollee
without a prescription and for which the
applicable recommendation or guideline
does not require a prescription, unless
the plan or issuer provides coverage for
the contraceptive item without requiring
a prescription and without imposing any
cost-sharing requirements in accordance
with paragraph (a)(1) of this section.
(iii) Therapeutic equivalents. For pur-
poses of paragraph (a)(4) of this section,
a plan’s or issuer’s medical management
techniques are not considered to be rea-
sonable unless the plan or issuer pro-
vides coverage, without imposing any
cost-sharing requirements, for all contra-
ceptive items recommended under para-
graph (a)(1) of this section that are drugs
or drug-led combination products, other
than those items for which there is at least
one therapeutic equivalent drug or drug-
led combination product, as applicable,
for which the plan or issuer provides cov-
erage without imposing any cost-sharing
requirements.
* * * * *
(d) Applicability date. The provisions
of this section apply for plan years (in
the individual market, for policy years)
beginning on or after September 23, 2010.
Notwithstanding the previous sentence,
the provisions of paragraph (a)(4)(ii) of
this section apply beginning on [EFFEC-
TIVE DATE OF FINAL RULE] and the
provisions of paragraph (a)(6) of this sec-
tion apply for plan years (in the individual
market, for policy years), beginning on or
after January 1, 2026. See § 147.140 of this
part for determining the application of this
section to grandfathered health plans (pro-
viding that these rules regarding coverage
of preventive health services do not apply
to grandfathered health plans).
* * * * *
3. Section 147.211 is amended by—
a. Redesignating paragraphs (b)(1)(vi)
and (vii) as paragraphs (b)(1)(vii) and
(viii);
b. Adding new paragraph (b)(1)(vi);
and
c. Revising paragraph (c)(1).
The addition and revision read as fol-
lows:
§ 147.211 Transparency in coverage—
required disclosures to participants,
beneficiaries, or enrollees.
* * * * *
(b) * * *
(1) * * *
(vi) If a participant, beneficiary, or
enrollee requests cost-sharing informa-
tion for any covered contraceptive item
or service, a statement explaining that
over-the-counter contraceptive items
are covered without a prescription and
without cost sharing in accordance with
§ 147.130(a)(6), along with a phone num-
ber and internet link to where a partic-
ipant, beneficiary, or enrollee can learn
more information about the plan or poli-
cy’s contraception coverage.
* * * * *
(c) * * *
(1) The provisions of this section
apply for plan years (in the individual
market, for policy years) beginning on
or after January 1, 2023, with respect to
the 500 items and services to be posted
on a publicly available website, and with
respect to all covered items and services,

November 18, 2024 1176 Bulletin No. 2024–47
for plan years (in the individual mar-
ket, for policy years) beginning on or
after January 1, 2024. Notwithstanding
the previous sentence, the provisions of
paragraph (b)(1)(vi) of this section apply
for plan years (in the individual market,
for policy years) beginning on or after
January 1, 2026.
* * * * *
Douglas W. O’Donnell,
Deputy Commissioner,
Internal Revenue Service
Lisa M. Gomez,
Assistant Secretary,
Employee Benefits Security
Administration,
Department of Labor
Xavier Becerra,
Secretary,
Department of Health and
Human Services
(Filed by the Office of the Federal Register October
23, 2024, 4:15 p.m., and published in the issue of
the Federal Register for October 28, 2024, 89 FR
85750).

Bulletin No. 2024–47 i November 18, 2024
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
applied 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
being made clear because the language
has caused, or may cause, some confu-
sion. It is not used where a position in a
prior ruling 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 previously
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 rul-
ings will not be applied pending some
future action such as the issuance of new
or amended regulations, the outcome of
cases in litigation, or the outcome of a
Service 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.

November 18, 2024 ii Bulletin No. 2024–47
Numerical Finding List
1
Bulletin 2024–47
Announcements:
2024-26, 2024-27 I.R.B. 14
2024-27, 2024-27 I.R.B. 14
2024-28, 2024-28 I.R.B. 39
2024-29, 2024-29 I.R.B. 71
2024-31, 2024-34 I.R.B. 533
2024-32, 2024-35 I.R.B. 535
2024-30, 2024-36 I.R.B. 581
2024-39, 2024-39 I.R.B. 639
2024-34, 2024-41 I.R.B. 758
2024-35, 2024-43 I.R.B. 1013
2024-36, 2024-44 I.R.B. 1073
2024-37, 2024-47 I.R.B. 1124
Notices:
2024-47, 2024-27 I.R.B. 1
2024-52, 2024-27 I.R.B. 2
2024-53, 2024-27 I.R.B. 4
2024-54, 2024-28 I.R.B. 24
2024-55, 2024-28 I.R.B. 31
2024-56, 2024-29 I.R.B. 64
2024-57, 2024-29 I.R.B. 67
2024-58, 2024-30 I.R.B. 120
2024-59, 2024-32 I.R.B. 348
2024-60, 2024-34 I.R.B. 515
2024-61, 2024-34 I.R.B. 520
2024-62, 2024-36 I.R.B. 570
2024-63, 2024-36 I.R.B. 573
2024-64, 2024-39 I.R.B. 632
2024-65, 2024-39 I.R.B. 633
2024-66, 2024-40 I.R.B. 682
2024-67, 2024-41 I.R.B. 726
2024-68, 2024-41 I.R.B. 729
2024-69, 2024-41 I.R.B. 733
2024-70, 2024-43 I.R.B. 1001
2024-72, 2024-43 I.R.B. 1005
2024-73, 2024-43 I.R.B. 1007
2024-71, 2024-44 I.R.B. 1026
2024-75, 2024-44 I.R.B. 1026
2024-74, 2024-45 I.R.B. 1089
2024-76, 2024-45 I.R.B. 1089
2024-77, 2024-45 I.R.B. 1093
2024-78, 2024-46 I.R.B. 1111
2024-80, 2024-47 I.R.B. 1120
Proposed Regulations:
REG-124593-23, 2024-28 I.R.B. 40
REG-109032-23, 2024-31 I.R.B. 332
REG-120137-19, 2024-31 I.R.B. 336
REG-119283-23, 2024-32 I.R.B. 351
REG-102161-23 2024-33 I.R.B. 502
REG-103529-23, 2024-33 I.R.B. 512
REG-105128-23, 2024-35 I.R.B. 536
Proposed Regulations:—Continued
REG-108920-24, 2024-38 I.R.B. 607
REG-111629-23, 2024-39 I.R.B. 640
REG-106851-21, 2024-40 I.R.B. 684
REG-116787-23, 2024-40 I.R.B. 709
REG-119683-22, 2024-40 I.R.B. 716
REG-118269-23, 2024-41 I.R.B. 761
REG-112129-23, 2024-42 I.R.B. 787
REG-113628-21, 2024-44 I.R.B. 1074
REG-110878-24, 2024-47 I.R.B. 1125
Revenue Procedures:
2024-26, 2024-27 I.R.B. 7
2024-29, 2024-30 I.R.B. 121
2024-30, 2024-30 I.R.B. 183
2024-27, 2024-31 I.R.B. 300
2024-28, 2024-31 I.R.B. 326
2024-32, 2024-34 I.R.B. 523
2024-34, 2024-38 I.R.B. 604
2024-35, 2024-39 I.R.B. 638
2024-36, 2024-41 I.R.B. 737
2024-37, 2024-41 I.R.B. 755
2024-38, 2024-43 I.R.B. 1010
2024-33, 2024-44 I.R.B. 1030
2024-39, 2024-45 I.R.B. 1097
2024-40, 2024-45 I.R.B. 1100
2024-31, 2024-46 I.R.B. 1113
2024-41, 2024-47 I.R.B. 1122
Revenue Rulings:
2024-13, 2024-28 I.R.B. 18
2024-14, 2024-28 I.R.B. 18
2024-15, 2024-32 I.R.B. 340
2024-16, 2024-35 I.R.B. 534
2024-17, 2024-36 I.R.B. 568
2024-18, 2024-37 I.R.B. 584
2024-20, 2024-40 I.R.B. 646
2024-21, 2024-41 I.R.B. 724
2024-22, 2024-43 I.R.B. 980
2024-23, 2024-43 I.R.B. 981
2024-24, 2024-45 I.R.B. 1086
Treasury Decisions:
10002, 2024-29 I.R.B. 56
9999, 2024-30 I.R.B. 72
10000, 2024-31 I.R.B. 185
10003, 2024-32 I.R.B. 342
10001, 2024-33 I.R.B. 412
10004, 2024-33 I.R.B. 489
9998, 2024-34 I.R.B. 412
10005, 2024-34 I.R.B. 510
9991, 2024-40 I.R.B. 646
10007, 2024-43 I.R.B. 981
9994, 2024-44 I.R.B. 1014
10008, 2024-45 I.R.B. 1082
1
A cumulative list of all revenue rulings, revenue procedures, Treasury decisions, etc., published in Internal Revenue Bulletins 2024–27 through 2024–52 is in Internal Revenue Bulletin
2024–52, dated December 30, 2024.

Bulletin No. 2024–47 iii November 18, 2024
Finding List of Current Actions on
Previously Published Items
1
Bulletin 2024–47
1
A cumulative list of all revenue rulings, revenue procedures, Treasury decisions, etc., published in Internal Revenue Bulletins 2024–27 through 2024–52 is in Internal Revenue Bulletin
2024–52, dated December 30, 2024.

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