100-04 Medicare Claims Processing Manual: Chapter 16 - Laboratory Services

Medicare Claims Processing Manual
Chapter 16 - Laboratory Services
Table of Contents
(Rev. 13746; Issued: 04-17-26)
Transmittals for Chapter 16
10 - Background
10.1 - Definitions
10.2 - General Explanation of Payment
20 - Calculation of Payment Rates - Clinical Laboratory Test Fee Schedules
20.1 - Initial Development of Laboratory Fee Schedules
20.2 - Annual Fee Schedule Updates
20.3 Clinical Laboratory Fee Schedule Based on Protecting Access to Medicare
Act (PAMA) of 2014
30 - Special Payment Considerations
30.1 - Mandatory Assignment for Laboratory Tests
30.1.1 - Rural Health Clinics
30.2 - Deductible and Coinsurance Application for Laboratory Tests
30.3 - Method of Payment for Clinical Laboratory Tests - Place of Service Variation
30.4 - Payment for Review of Laboratory Test Results by Physician
40 - Billing for Clinical Laboratory Tests
40.1 - Laboratories Billing for Referred Tests
40.1.1 - Claims Information and Claims Forms and Formats
40.1.1.1 - Paper Claim Submission to A/B MACs (B)
40.1.1.2 - Electronic Claim Submission to A/B MACs (B)
40.2 - Payment Limit for Purchased Services
40.3 - Hospital Billing Under Part B
40.3.1 - Critical Access Hospital (CAH) Outpatient Laboratory Service
40.4 - Special Skilled Nursing Facility (SNF) Billing Exceptions for Laboratory Tests
40.4.1 - Which A/B MAC (A) or (B) to Bill for Laboratory Services Furnished to a Medicare
Beneficiary in a Skilled Nursing Facility (SNF)
40.5 - Rural Health Clinic (RHC) Billing
40.6 - Billing for End Stage Renal Disease (ESRD) Related Laboratory Tests
40.6.1 - Automated Multi-Channel Chemistry (AMCC) Tests for ESRD Beneficiaries
40.6.2 - Claims Processing for Separately Billable Tests for ESRD Beneficiaries
40.6.2.1 - Separately Billable ESRD Laboratory Tests Furnished by Hospital-Based
Facilities
40.6.2.2 - Reserved
40.6.2.3 - Skilled Nursing Facility (SNF) Consolidated Billing (CB) Editing and
Separately Billed ESRD Laboratory Test Furnished to Patients of Renal Dialysis
Facilities
40.7 - Billing for Noncovered Clinical Laboratory Tests
40.8 - Date of Service (DOS) for Clinical Laboratory and Pathology Specimens
50 - A/B MAC (B) Claims Processing

50.1 - Referring Laboratories
50.2 - Physicians
50.2.1 - Assignment Required
50.3 - Hospitals
50.3.1 - Hospital-Leased Laboratories
50.3.2 - Hospital Laboratory Services Furnished to Nonhospital Patients
50.4 - Reporting of Pricing Localities for Clinical Laboratory Services
50.5 - Jurisdiction of Laboratory Claims
50.5.1 - Jurisdiction of Referral Laboratory Services
50.5.2 - Examples of Independent Laboratory Jurisdiction
60 - Specimen Collection Fee and Travel Allowance
60.1 - Specimen Collection Fee
60.1.1- Independent Laboratory Specimen Drawing
60.1.2 Coding Requirements For Specimen Collection
60.1.3 - Specimen Drawing for Dialysis Patients
60.1.4 - Coding Requirements for Specimen Collection
60.2 - Travel Allowance
70 - Clinical Laboratory Improvement Amendments (CLIA) Requirements
70.1 - Background
70.2 - Billing
70.3 - Verifying CLIA Certification
70.4 - CLIA Numbers
70.5 - CLIA Categories and Subcategories
70.6 - Certificate for Provider-Performed Microscopy Procedures
70.7 - Deleted - Held for Expansion
70.8 - Certificate of Waiver
70.9 - HCPCS Subject To and Excluded From CLIA Edits
70.10 - CLIA Number Submitted on Claims from Independent Labs
70.10.1 - Physician Notification of Denials
70.11 - Reasons for Denial - Physician Office Laboratories Out-of-Compliance
80 - Issues Related to Specific Tests
80.1 - Screening Services
80.2 - Anatomic Pathology Services
80.2.1 - Technical Component (TC) of Physician Pathology Services to Hospital Patients
80.3 - National Minimum Payment Amounts for Cervical or Vaginal Smear Clinical Laboratory Tests
80.4 - Oximetry
90 - Automated Profile Tests and Organ/Disease Oriented Panels
90.1 - Laboratory Tests Utilizing Automated Equipment
90.1.1 - Automated Test Listing
90.2 - Organ or Disease Oriented Panels
90.3 - Claims Processing Requirements for Panel and Profile Tests
90.3.1 - History Display
90.3.2 - Medicare Secondary Payer
90.4 - Evaluating the Medical Necessity for Laboratory Panel CPT Codes

90.5 - Special Processing Considerations
100 - CPT Codes Subject to and Not Subject to the Clinical Laboratory Fee Schedule
100.1 - Deleted - Held for Expansion
100.2 - Laboratory Tests Never Subject to the Fee Schedule
100.3 - Procedures Not Subject to Fee Schedule When Billed With Blood Products
100.4 - Not Otherwise Classified Clinical Laboratory Tests
100.5 - Other Coding Issues
100.5.1 - Tests Performed More Than Once on the Same Day
100.6 - Pricing Modifiers
110 - Coordination Between A/B MACs (B) and Other Entities
110.1 - Coordination Between A/B MACs (B) and A/B MACs (A)/RRB
110.2 - Coordination With Medicaid
110.3 - Coordination With A/B MACs (A) and Providers
110.4 - A/B MAC (B) Contacts With Independent Clinical Laboratories
120- Clinical Laboratory Services Based on the Negotiated Rulemaking
120.1 - Negotiated Rulemaking Implementation
120.2 - Implementation and Updates of Negotiated National Coverage Determinations
(NCDs) or Clinical Diagnostic Laboratory Services
Exhibit 1- List of Diagnostic Tests that are Considered End Stage Renal Disease (ESRD)

10 - Background
(Rev. 1, 10-01-03)
B3-2070, B3-2070.1, B3-4110.3, B3-5114
Diagnostic X-ray, laboratory, and other diagnostic tests, including materials and the services of technicians,
are covered under the Medicare program. Some clinical laboratory procedures or tests require Food and Drug
Administration (FDA) approval before coverage is provided.
A diagnostic laboratory test is considered a laboratory service for billing purposes, regardless of whether it is
performed in:
• 	A physician’s office, by an independent laboratory;
• 	By a hospital laboratory for its outpatients or nonpatients;
• 	In a rural health clinic; or
• 	In an HMO or Health Care Prepayment Plan (HCPP) for a patient who is not a member.
When a hospital laboratory performs laboratory tests for nonhospital patients, the laboratory is functioning as
an independent laboratory, and still bills the A/B MAC (A). Also, when physicians and laboratories perform
the same test, whether manually or with automated equipment, the services are deemed similar.
Laboratory services furnished by an independent laboratory are covered under SMI if the laboratory is an
approved Independent Clinical Laboratory. However, as is the case of all diagnostic services, in order to be
covered these services must be related to a patient’s illness or injury (or symptom or complaint) and ordered
by a physician. A small number of laboratory tests can be covered as a preventive screening service.
See the Medicare Benefit Policy Manual, Chapter 15, for detailed coverage requirements.
See the Medicare Program Integrity Manual, Chapter 10, for laboratory/supplier enrollment guidelines.
See the Medicare State Operations Manual for laboratory/supplier certification requirements.
10.1 - Definitions
(Rev. 85, 02-06-04)
B3-2070.1, B3-2070.1.B, RHC-406.4
“Independent Laboratory” - An independent laboratory is one that is independent both of an attending or
consulting physician’s office and of a hospital that meets at least the requirements to qualify as an emergency
hospital as defined in §1861(e) of the Social Security Act (the Act.) (See the Medicare Benefits Policy
Manual, Chapter 15, for detailed discussion.)
“Physician Office Laboratory” - A physician office laboratory is a laboratory maintained by a physician or
group of physicians for performing diagnostic tests in connection with the physician practice.
“Clinical Laboratory” - See the Medicare Benefits Policy Manual, Chapter 15.
“Qualified Hospital Laboratory” - A qualified hospital laboratory is one that provides some clinical
laboratory tests 24 hours a day, 7 days a week, to serve a hospital’s emergency room that is also available to
provide services 24 hours a day, 7 days a week. For the qualified hospital laboratory to meet this requirement,
the hospital must have physicians physically present or available within 30 minutes through a medical staff
call roster to handle emergencies 24 hours a day, 7 days a week; and hospital laboratory technologists must be
on duty or on call at all times to provide testing for the emergency room.

"Hospital Outpatient” - See the Medicare Benefit Policy Manual, Chapter 2.
“Referring laboratory” - A Medicare-approved laboratory that receives a specimen to be tested and that
refers the specimen to another laboratory for performance of the laboratory test.
“Reference laboratory” - A Medicare-enrolled laboratory that receives a specimen from another, referring
laboratory for testing and that actually performs the test.
“Billing laboratory” - The laboratory that submits a bill or claim to Medicare.
“Service” - A clinical diagnostic laboratory test. Service and test are synonymous.
“Test” - A clinical diagnostic laboratory service. Service and test are synonymous.
“CLIA” - The Clinical Laboratory Improvement Act and CMS implementing regulations and processes.
“Certification” - A laboratory that has met the standards specified in the CLIA.
“Draw Station’ - A place where a specimen is collected but no Medicare-covered clinical laboratory testing is
performed on the drawn specimen.
“Medicare-approved laboratory - A laboratory that meets all of the enrollment standards as a Medicare
provider including the certification by a CLIA certifying authority.
10.2 - General Explanation of Payment
(Rev. 3510, Issued: 04-29-16, Effective: 10-01-16, Implementation; 10-03-16)
Outpatient laboratory services can be paid in different ways:
• 	Physician Fee Schedule;
• 	101 percent of reasonable cost (critical access hospitals (CAH) only);
NOTE: When the CAH bills a 14X bill type for a non-patient laboratory specimen, the CAH is paid under
the fee schedule.
• 	Laboratory Fee Schedule;
• 	Outpatient Prospective Payment System, (OPPS) except for most hospitals in the State of Maryland
that are subject to a waiver; or
• 	Reasonable Charge
Annually, CMS distributes a list of codes and indicates the payment method. Carriers, FIs, and A/B MACs pay
as directed by this list. Neither deductible nor coinsurance applies to HCPCS codes paid under the laboratory
fee schedule. The majority of outpatient laboratory services are paid under the laboratory fee schedule or the
OPPS.
Carriers, FIs and A/B MACs are responsible for applying the correct fee schedule for payment of clinical
laboratory tests. FIs/AB MACs must determine which hospitals meet the criteria for payment at the 62 percent
fee schedule. Only sole community hospitals with qualified hospital laboratories are eligible for payment
under the 62 percent fee schedule. Generally, payment for diagnostic laboratory tests that are not subject to the

clinical laboratory fee schedule is made in accordance with the reasonable charge or physician fee schedule
methodologies (or at 101 percent of reasonable cost for CAHs).
For Clinical Diagnostic Laboratory services denied due to frequency edits, the contractor shall use the
following remittance advice messages and associated codes when rejecting/denying claims under this
policy. 	This CARC/RARC combination is compliant with CAQH CORE Business Scenario Three.
Group Code: CO or PR
CARC: 151
RARC: N/A
MSN: N/A
20 - Calculation of Payment Rates - Clinical Laboratory Test Fee Schedules
(Rev. 4479; Issued: 12-20-19 Effective: 01-23-20, Implementation: 01-23-20)
Section 216 of Public Law 113-93, the “Protecting Access to Medicare Act of 2014,” added section 1834A to
the Social Security Act (the Act). This provision requires extensive revisions to the payment and coverage
methodologies for clinical laboratory tests paid under the clinical laboratory fee schedule (CLFS). The Centers
for Medicare & Medicaid Services (CMS) published CMS-1621-F Medicare Clinical Diagnostic Laboratory
Tests Payment System, on June 23, 2016, which implemented the provisions of the new legislation.
The final rule set forth new policies for how CMS sets rates for tests on the CLFS and is effective for dates
of service on and after January 1, 2018. Beginning on January 1, 2017, applicable laboratories will be
required to submit data to CMS which describes negotiated payment rates with private payers for and
corresponding volumes of tests on the CLFS. In general, with certain designated exceptions, the payment
amount for a test on the CLFS furnished on or after January 1, 2018, will be equal to the weighted median of
private payer rates determined for the test, based on data collected from laboratories during a specified data
collection period. In addition, a subset of tests on the CLFS, advanced diagnostic laboratory tests (ADLTs),
will have different data, reporting, and payment policies associated with them. In particular, the final rule
discusses CMS’ proposals regarding:
• 	Definition of “applicable laboratory” (who must report data under section 1834A of the Act)
• 	Definition of “applicable information” (what data will be reported)
• 	Data collection period
• 	Schedule for reporting data to CMS
• 	Definition of ADLT
• 	Data Integrity
• 	Confidentiality and public release of limited data
• 	Coding for new tests on the CLFS
• 	Phased in payment reduction
Prior to January 1, 2018
Under Part B, for services rendered on or after July 1, 1984, clinical laboratory tests performed in a
physician’s office, by an independent laboratory, or by a hospital laboratory for its outpatients are reimbursed

on the basis of fee schedules. Current exceptions to this rule are CAH laboratory services as described in §10,
and services provided by hospitals in the State of Maryland.
Medicare pays the lesser of:
• Actual charges;
• The fee schedule amount for the State or a local geographic area; or
• A national limitation amount (NLA) for the HCPCS code as provided by §1834(h) of the Act.
Annually, CMS furnishes to A/B MACs (A) and (B) the proper amount to pay for each HCPCS code for each
local geographic area.
This includes a calculation of whether a national limitation amount or the local fee schedule amount is to be
used. This information is available to the public on the CMS Web site in public use files.
20.1 - Initial Development of Laboratory Fee Schedules
(Rev. 4479; Issued: 12-20-19 Effective: 01-23-20, Implementation: 01-23-20)
Initially, each A/B MAC (B) established the fee schedules on an A/B MAC (B)-wide basis (not to exceed a
statewide basis). If an A/B MAC (B)’s area includes more than one State, the A/B MAC (B) established a
separate fee schedule for each State. The A/B MAC (B) determined the fee schedule amount based on
prevailing charges for laboratory billings by physicians and independent laboratories billing the A/B MAC
(B). A/B MACs (B) set the fees at 60 percent of prevailing charges. A/B MACs (A) used the same fee
schedules to pay outpatient hospital laboratory services. They set the fee at 62 percent of A/B MAC (B)
prevailing charges. Subsequently, except for sole community hospitals, which continue to be paid at the 62
percent rate, A/B MACs (A) changed payments to hospital laboratories to the “60 percent fee schedule.”
In 1994, CMS took over the annual update and distribution of clinical laboratory fee schedules. The CMS
updates the fee schedule amounts annually to reflect changes in the Consumer Price Index (CPI) for all Urban
Consumers (U.S. city average), or as otherwise specified by legislation.
Effective for hospital outpatient tests furnished by a hospital on or after April 1, 1988, to receive the 62
percent fee the hospital must be a sole community hospital. Otherwise, the fee is the “60 percent fee schedule.”
If a hospital is uncertain whether it meets the qualifications of a sole community hospital it can seek assistance
from the A/B MAC (A) or the RO.
For tests to hospital non-patients, the fee is 60 percent of the A/B MAC (B) prevailing charge. If a hospital
laboratory acts as an independent laboratory, i.e., performs tests for persons who are nonhospital patients; or if
the hospital laboratory is not a qualified hospital laboratory, the services are reimbursed using the 60 percent
fee schedule or the adjusted fee schedule, as appropriate.
See §10.1 for the definition of a hospital outpatient.
See §20.3 for CLFS effective January 1, 2018.
20.2 - Annual Fee Schedule Updates
(Rev. 4479; Issued: 12-20-19 Effective: 01-23-20, Implementation: 01-23-20)
The CMS adjusts the fee schedule amounts annually to reflect changes in the Consumer Price Index for all
urban consumers (CPI-U) (U.S. city average) and the 10-year moving average of changes in annual economy-
wide private nonfarm business multi-factor productivity, unless alternative updates are specified by legislation.
The CMS communicates this information via an annual recurring update notification (RUN). The CMS also
determines, publishes for A/B MAC (A) or (B) use, and places on its web site, coding and pricing changes.
This information is updated on an annual basis.

See §20.3 for CLFS effective January 1, 2018.
20.3 – Clinical Laboratory Fee Schedule Based on Protecting Access to Medicare Act
(PAMA) of 2014
(Rev. 4479; Issued: 12-20-19 Effective: 01-23-20, Implementation: 01-23-20)
Effective January 1, 2018, CLFS rates were based on weighted median private payer rates as required by the
Protecting Access to Medicare Act (PAMA) of 2014.
Fee Schedule Through December 31, 2017
Outpatient clinical laboratory services are paid based on a fee schedule in accordance with Section 1833 (h) of
the Social Security Act. Payment is lesser of the amount billed, the local fee for a geographic area, or a
national limit. In accordance with the statute, the national limits are set at a percent of the median of all local
fee schedule amounts for each laboratory test code. Each year, fees are updated for inflation based on the
percentage change in the Consumer Price Index. However, legislation by Congress can modify the update to
the fees. Co-payments and deductibles do not apply to services paid under the Medicare clinical laboratory fee
schedule.
Each year, new laboratory test codes are added to the clinical laboratory fee schedule and corresponding fees
are developed in response to a public comment process. Also, for a cervical or vaginal smear test (pap smear),
the fee cannot be less than a national minimum payment amount, initially established at $14.60 and updated
each year for inflation.
Sole Community Hospitals
Effective for hospital outpatient tests furnished by a hospital on or after April 1, 1988 through December 31,
2017, to receive the 62 percent fee the hospital must be a sole community hospital. Effective for hospital
outpatient tests furnished by a Sole community possessive hospital’s payment is based on a fee schedule in
accordance with Section 1833(h) of the Social Security Act. Payment is the lesser of the amount billed, the
local fee for a geographic area, or a national limit.
Critical Access Hospitals
Critical access hospitals are generally paid for outpatient laboratory tests on a reasonable cost basis, instead of
by the fee schedule, as long as the lab service is provided to a CAH outpatient .
30 - Special Payment Considerations
(Rev. 1, 10-01-03)
30.1 - Mandatory Assignment for Laboratory Tests
(Rev. 1, 10-01-03)
B3-5114.1
Unless a laboratory, physician, or medical group accepts assignment, the A/B MAC (B) makes no Part B
payment for laboratory tests paid on the laboratory fee schedule. Laboratories, physicians, or medical groups
that have entered into a participation agreement must accept assignment. Sanctions of double the violation

charges, civil money penalties (up to $2,000 per violation), and/or exclusion from the program for a period of
up to five years may be imposed on physicians and laboratories, with the exception of rural health clinic
laboratories, that knowingly, willfully, and repeatedly bill patients on an unassigned basis. However, sole
community physicians and physicians who are the sole source of an essential specialty in a community are not
excluded from the program. Whenever a A/B MAC (B) is notified of a sanction action for this reason, the A/B
MAC (B) does not pay for any laboratory services unless the services were furnished within 15 days after the
date on the exclusion or suspension notice to the practitioner, and:
• 	It is the first claim filed for services rendered to that beneficiary after the date on the notice of
suspension or exclusion; or
• 	It is filed with respect to services furnished within 15 days of the date on the first notice of denial of
claims to the beneficiary. (Fifteen days are allowed for the notice to reach the beneficiary.)
A/B MACs (B) refer questions on payment procedures to the Sanctions Coordinator in the RO.
A/B MACs (B) process laboratory claims inadvertently submitted as unassigned as if they were assigned.
(See §50.)
For purposes of this section, the term assignment includes assignment in the strict sense of the term as well as
the procedure under which payment is made, after the death of the beneficiary, to the person or entity that
furnished the service, on the basis of that person’s or entity’s agreement to accept the Medicare payment as the
full charge or fee for the service.
30.1.1 - Rural Health Clinics
(Rev. 1, 10-01-03)
PM A-99-8, Rev. 810, CR 1133, PM A-00-30
Rural Health Clinics (RHCs) must furnish the following laboratory services to be approved as an RHC.
However, these and other laboratory services that may be furnished are not included in the encounter rate and
must be billed separately:
• 	Chemical examinations of urine by stick or tablet method or both;
• 	Hemoglobin or hematocrit;
• 	Blood sugar;
• 	Examination of stool specimens for occult blood;
• 	Pregnancy tests; and
• 	Primary culturing for transmittal to a certified laboratory (No CPT code available).
Effective January 1, 2001, freestanding RHCs/Federally Qualified Health Centers (FQHCs) bill all laboratory
services to the A/B MAC (B), and provider based RHCs/FQHCS bill all laboratory tests to the A/B MAC (A)
under the host provider’s bill type. In either case payment is made under the fee schedule. HCPCS codes are
required for laboratory services. (See §40.4 for details on RHC billing.)
30.2 - Deductible and Coinsurance Application for Laboratory Tests
(Rev. 2581, Issued: 11-02-12, Effective: 04-01-13, Implementation: 04-01-13)
Neither the annual cash deductible nor the 20 percent coinsurance apply to:
• 	Clinical laboratory tests performed by a physician, laboratory, or other entity paid on an assigned basis;
• 	Specimen collection fees; or
• 	Travel allowance related to laboratory tests (e.g., collecting specimen).

Codes on the physician fee schedule are generally subject to the Part B deductible and coinsurance, although
exceptions may be noted for a given code in the MPFS or through formal Medicare instructions such as
temporary instructions and requirements for specific services noted in this manual.
Any laboratory code paid at reasonable charge is subject to the Part B deductible and coinsurance, unless
otherwise specified in the description of coverage and payment rules.
30.3 - Method of Payment for Clinical Laboratory Tests - Place of Service Variation
(Rev. 3685, Issued: 12-22-16, Effective: 01-01-17, Implementation: 01-03-17)
The following apply in determining the amount of Part B payment for clinical laboratory tests:
Laboratory tests not payable on the Clinical Diagnostic Laboratory Fee Schedule (CLFS) will be based on
OPPS (for hospitals subject to OPPS) and current methodology for hospitals not subject to OPPS.
Independent laboratory or a physician or medical group - Payment to an independent laboratory or a physician
or medical group is the lesser of the actual charge, the fee schedule amount or the national limitation amount.
Part B deductible and coinsurance do not apply.
Reference laboratory - For tests performed by a reference laboratory, the payment is the lesser of the actual
charge by the billing laboratory, the fee schedule amount, or the national limitation amount (NLA). (See
§50.5 for A/B MAC (B) jurisdiction details.) Part B deductible and coinsurance do not apply.
Outpatient of OPPS hospital - For hospitals paid under the OPPS, beginning January 1, 2014 outpatient
laboratory tests are generally packaged as ancillary services and do not receive separate payment. Only in the
following circumstance are lab tests eligible for separate payment under the CLFS.
(1) Outpatient lab tests only - If the hospital only provides outpatient laboratory tests to the patient (directly or
under arrangement) and the patient does not also receive other hospital outpatient services on that day.
Payment to a hospital for laboratory tests payable on the Clinical Diagnostic Laboratory Fee Schedule,
furnished to an outpatient of the hospital, is the lesser of the actual charge, fee schedule amount, or the NLA.
Part B deductible and coinsurance do not apply. Laboratory tests not payable on the Clinical Diagnostic
Laboratory Fee Schedule will be based on OPPS (for hospitals subject to OPPS) and current methodology for
hospitals not subject to OPPS.
Exception: Reasonable cost reimbursement has been provided for outpatient clinical laboratory tests furnished
by hospitals with fewer than 50 beds in qualified rural areas for cost reporting periods beginning on July 1,
2004 through 2008 (per the following legislation: Section 416 of the Medicare Modernization Act (MMA) of
2003, Section 105 of the Tax Relief and Health Care Act (TRHCA) of 2006, and Section 107 of the Medicare,
Medicaid and State Children’s Health Insurance Program (SCHIP) Extension Act of 2007). Section 3122 of
the Patient Protection and Affordable Care Act re-institutes the above reasonable cost provisions for cost
reporting periods beginning on or after July 1, 2010, through June 30, 2011. Section 109 of the Medicare and
Medicaid Extenders Act extends the above reasonable cost provisions for cost reporting periods beginning on
or after July 1, 2011, through June 30, 2012.
Non-Patient (Referred) Laboratory Specimen- A non-patient is defined as a beneficiary that is neither an
inpatient nor an outpatient of a hospital, but that has a specimen that is submitted for analysis to a hospital and
the beneficiary is not physically present at the hospital. All hospitals (including Maryland waiver hospitals
and CAHs) bill non-patient lab tests on TOB 14X. They are paid under the clinical laboratory fee schedule at
the lesser of the actual charge, the fee schedule amount, or the NLA (including CAH and MD Waiver
hospitals). Part B deductible and coinsurance do not apply.

Inpatient without Part A – Payment to a hospital for laboratory tests payable on the Clinical Diagnostic
Laboratory Fee Schedule, is the lesser of the actual charge, fee schedule amount, or the NLA. Part B
deductible and coinsurance do not apply. Laboratory tests not payable on the Clinical Diagnostic Laboratory
Fee Schedule will be based on OPPS (for hospitals subject to OPPS) and current methodology for hospitals
not subject to OPPS. For hospitals subject to the OPPS, beginning January 1, 2014 Part B inpatient laboratory
tests are packaged as ancillary services and do not receive separate payment unless the service with which the
labs would otherwise be packaged is not a payable Part B inpatient service (see Chapter 6, Section 10 of the
Medicare Benefit Policy Manual, Pub. 100-02). Payment to a SNF inpatient without Part A coverage is made
under the laboratory fee schedule.
Inpatient or SNF patient with Part A - Payment to a hospital for laboratory tests furnished to an inpatient,
whose stay is covered under Part A, is included in the PPS rate for PPS facilities or is made on a reasonable
cost basis for non-PPS hospitals and is made at 101 percent of reasonable cost for CAHs. Payments for lab
services for beneficiaries in a Part A stay in a SNF, other than a swing bed in a CAH are included in the SNF
PPS rate. For such services provided in a swing bed of a CAH, payment is made at 101 percent of reasonable
cost.
Sole community hospital – Sole community hospitals are subject to the OPPS, therefore OPPS packaging rules
apply. When the OPPS exception for separate payment of outpatient laboratory tests under the CLFS applies,
a sole community hospital with a qualified hospital laboratory identified on the hospital’s certification in the
Provider Specific File is paid the least of the actual charge, the 62 percent fee schedule amount, or the 62
percent NLA. The Part B deductible and coinsurance do not apply.
Waived Hospitals - Payment for outpatient (bill type13X), to a hospital which has been granted a waiver of
Medicare payment principles for outpatient services is subject to Part B deductible and coinsurance unless
otherwise waived as part of an approved waiver. Specifically, laboratory fee schedules do not apply to
laboratory tests furnished by hospitals in States or areas that have been granted waivers of Medicare
reimbursement principles for outpatient services. The State of Maryland has been granted such a waiver.
Payment for non-patient laboratory specimens (bill type14X) is based on the fee schedule. Laboratory tests
not payable on the Clinical Diagnostic Laboratory Fee Schedule will be paid based on current methodology.
Critical Access Hospital - When the CAH bills a 14X bill type as a non-patient laboratory specimen, it is paid
on the laboratory fee schedule. If the beneficiary is an outpatient of the CAH, the CAH bills using an 85x bill
type and is paid based on 101 percent of reasonable cost.
Beneficiaries are not liable for any coinsurance, deductible, co-payment, or other cost sharing amount with
respect to CAH clinical laboratory services.
Section 148 of the Medicare Improvements for Patients and Providers Act (MIPPA)
Effective for services furnished on or after July 1, 2009, the beneficiary is no longer required to be physically
present in a CAH at the time the specimen is collected in order for the CAH to be paid based on 101 percent of
reasonable cost. However, the beneficiary must be an outpatient of the CAH, as defined at 42 CFR §410.2 and
be receiving services directly from the CAH. In order for the beneficiary to be receiving services directly from
the CAH if he/she is not present in the CAH when the specimen is collected, the beneficiary must either be
receiving outpatient services in the CAH on the same day the specimen is collected, or the specimen must be
collected by an employee of the CAH or of a facility provider-based to the CAH.
Dialysis facility - Effective for items and services furnished on or after January 1, 2011 Section 153b of the
Medicare Improvements for Patients and Providers Act (MIPPA) requires that all ESRD-related laboratory
tests be reported by the ESRD facility whether provided directly or under arrangements with an independent
laboratory. When laboratory services are billed by a laboratory other than the ESRD facility and the
laboratory service furnished is designated as a laboratory test that is included in the ESRD PPS (i.e., ESRD-
related), the claim will be rejected or denied. The list of items and services subject to consolidated billing

located at http://www.cms.gov/ESRDPayment/50_Consolidated_Billing.asp#TopOfPage includes the list of
ESRD-related laboratory tests that are routinely performed for the treatment of ESRD. In the event that an
ESRD-related laboratory service was furnished to an ESRD beneficiary for reasons other than for the
treatment of ESRD, the supplier may submit a claim for separate payment using modifier “AY”. See Pub.100-
04, Chapter 8 for more information regarding Outpatient ESRD Hospital, Independent Facility, and
Physician/Supplier Claims.
Rural Health Clinic (RHC)/Federally Qualified Health Center (FQHC) - Payment to a RHC/FQHC for
laboratory tests performed for a patient of that clinic/center is not included in the all-inclusive rate and may be
billed separately by either the base provider for a provider-based RHC/FQHC, or by the physician for an
independent or free-standing RHC/FQHC. Payment for the laboratory service is not subject to Part B
deductible and coinsurance. If the RHC/FQHC is provider-based, payment for lab tests is to the base provider
(i.e., hospital). If the RHC/FQHC is independent or freestanding, payment for lab tests is made to the
practitioner (physician) via the clinical lab fee schedule. (See Sections 30.1.1 and 40.5 for details on
RHC/FQHC billing.)
Enrolled in Managed Care - Payment to a participating health maintenance organization (HMO) or health care
prepayment plan (HCPP) for laboratory tests provided to a Medicare beneficiary who is an enrolled member is
included in the monthly capitation amount.
Non-enrolled Managed Care - Payment to a participating HMO or HCPP for laboratory tests performed for a
patient who is not a member is the lesser of the actual charge, or the fee schedule, or the NLA. The Part B
deductible and coinsurance do not apply.
Hospice - Payment to a hospice for laboratory tests performed by the hospice is included in the hospice rate.
30.4 - Payment for Review of Laboratory Test Results by Physician
(Rev. 1, 10-01-03)
B3-5114.2
Reviewing results of laboratory tests, phoning results to patients, filing such results, etc., are Medicare covered
services. Payment is included in the physician fee schedule payment for the evaluation and management (E
and M) services to the patient. Visit services entail a wide range of components and activities that may vary
somewhat from patient to patient. The CPT lists different levels of E and M services for both new and
established patients and describes services that are included as E and M services. Such activities include
obtaining, reviewing, and analyzing appropriate diagnostic tests.
40 - Billing for Clinical Laboratory Tests
(Rev. 1, 10-01-03)
40.1 - Laboratories Billing for Referred Tests
(Rev. 85, 02-06-04)
B3-5114.1.E,
Section 1833(h)(5)(A) of the Act provides that a referring laboratory may bill for clinical laboratory diagnostic
tests on the clinical laboratory fee schedule for Medicare beneficiaries performed by a reference laboratory
only if the referring laboratory meets certain conditions. Payment may be made to the referring laboratory but
only if one of the following conditions is met:
• 	the referring laboratory is located in, or is part of, a rural hospital;
• 	the referring laboratory is wholly owned by the entity performing such test, the referring laboratory
wholly owns the entity performing such test, or both the referring laboratory and the entity performing
such test are wholly-owned by a third entity; or

• 	the referring laboratory does not refer more than 30 percent of the clinical laboratory tests for which it
receives requests for testing during the year (not counting referrals made under the wholly-owned
condition described above).
In the case of a clinical laboratory test provided under an arrangement (as defined in §1861(w)(1)) made by a
hospital, CAH or SNF, payment is made to the hospital or SNF.
Examples of 30 Percent Exception:
(1) - A laboratory receives requests for 200 tests, performs 139 tests, and refers 61 tests to a non-
related laboratory. All tests referred to a non-related laboratory are counted. Thus, 30.5 percent
(61/200) of the tests are considered tests referred to a non-related laboratory and, since this exceeds
the 30 percent standard, the referring laboratory may not bill for any Medicare beneficiary
laboratory tests referred to a non-related laboratory.
(2) - A laboratory receives requests for 200 tests, performs 139 tests and refers 15 to a related
laboratory and 46 to a non-related laboratory. Only 23 percent of the tests were referred to non-
related laboratories. Since this is less than 30 percent, the referring laboratory may bill for all tests.
If it is later found that a referring laboratory does not, in fact, meet an exception criterion, the A/B MAC (B)
should recoup payment for the referred tests improperly billed. The RO shall take whatever action is
necessary to correct the problem.
NOTE: This provision of §6111(b) of OBRA of 1989 has no effect on hospitals that are paid under
§1833(h)(5)(A)(iii).
NOTE: Laboratory services provided to a SNF inpatient under Part A are billed by the SNF, not the
laboratory, due to consolidated billing for SNFs.
Only one laboratory may bill for a referred laboratory service. It is the responsibility of the referring
laboratory to ensure that the reference laboratory does not bill Medicare for the referred service when the
referring laboratory does so (or intends to do so). In the event the reference laboratory bills or intends to bill
Medicare, the referring laboratory may not do so.
40.1.1 - Claims Information and Claims Forms and Formats
(Rev. 85, 02-06-04)
Claims for referred laboratory services may be made only by suppliers having specialty code 69, i.e.,
independent clinical laboratories. Claims for referred laboratory services made by other entities will be
returned as unprocessable.
Independent laboratories shall use modifier 90 to identify all referred laboratory services. A claim for a
referred laboratory service that does not contain the modifier 90 is returned as unprocessable if the claim can
otherwise be identified as being for a referred service.
The name, address, and CLIA number of both the referring laboratory and the reference laboratory shall be
reported on the claim.
40.1.1.1 - Paper Claim Submission to A/B MACs (B)
(Rev. 3255, Issued: 05-08-15, Effective: 10-01-15, Implementation: 10-05-15)

An independent clinical laboratory may file a paper claim form shall file Form CMS-1500 for a referred
laboratory service (as it would any laboratory service). The line item services must be submitted with a
modifier 90.
An independent clinical laboratory that submits claims in paper format) may not combine non-referred (i.e.,
self-performed) and referred services on the same CMS 1500 claim form. When the referring laboratory bills
for both non-referred and referred tests, it shall submit two separate claims, one claim for non-referred tests,
the other for referred tests. If billing for services that have been referred to more than one laboratory, the
referring laboratory shall submit a separate claim for each laboratory to which services were referred (unless
one or more of the reference laboratories are separately billing Medicare). A paper claim that contains both
non-referred and referred tests is returned as unprocessable. When the referring laboratory is the billing
laboratory, the reference laboratory’s name, address, and ZIP Code shall be reported in item 32 on the CMS-
1500 claim form to show where the service (test) was actually performed. The NPI shall be reported in item
32a. Also, the CLIA number of the reference laboratory shall be reported in item 23 on the CMS-1500 claim
form. A paper claim that does not have the name, address, and ZIP Code of the reference laboratory in item
32 and NPI in 32a or the CLIA number of the reference laboratory in item 23 is returned as unprocessable.
EXAMPLE: A physician has ordered the ABC Laboratory to perform carcinoembryonic antigen (CEA) and
hemoglobin testing for a patient. Since the ABC Laboratory is approved to perform tests only within the
hematology LC level (which includes the hemoglobin test), it refers the CEA testing (which is a routine
chemistry LC) to the XYZ laboratory.
Result: The ABC laboratory submits a claim for the hemoglobin test and reports its CLIA number in item 23
on the CMS-1500 form. Since the ABC laboratory referred the CEA test to the XYZ laboratory to perform,
the ABC laboratory (billing laboratory) submits a second claim for the CEA testing, reporting XYZ’s CLIA
number in item 23 on the CMS-1500 form. The XYZ laboratory’s name, address, and ZIP Code are also
reported in item 32 and the NPI is reported in item 32a on Form CMS-1500 to show where the service (test)
was actually rendered.
NOTE: Effective for claims submitted with a receipt date on and after October 1, 2015, the billing physician
or supplier must report the name, address, and NPI of the performing physician or supplier in Item 32a on anti-
markup and reference laboratory claims, even if the performing physician or supplier is enrolled in a different
A/B MAC (B) jurisdiction. See Pub. 100-04, Chapter 1, §10.1.1 for more information regarding claims filing
jurisdiction.
40.1.1.2 - Electronic Claim Submission to A/B MACs (B)
(Rev. 3255, Issued: 05-08-15, Effective: 10-01-15, Implementation: 10-05-15)
Electronic Claim Submission
ASC X12 837 professional claim format (HIPAA compliant version):
CLIA number:
An electronic claim for laboratory testing will require the presence of the performing (and billing) laboratory’s
CLIA number; if tests are referred to another laboratory, the CLIA number of the laboratory where the testing
is rendered must also be on the claim. An electronic claim for laboratory testing must be submitted using the
following rules:
Electronic claim: the billing laboratory performs all laboratory testing:
The independent laboratory submits a single claim for CLIA-covered laboratory tests and reports the billing
laboratory’s number in:

loop 2300, REF02. REF01 = X4
Electronic claim: billing laboratory performs some laboratory testing; some testing is referred to
another laboratory:
The claim will not be split; CLIA numbers from both the billing and reference laboratories must be submitted
on the same claim. The presence of the ‘90’ modifier at the line item service identifies the referral tests.
Referral laboratory claims are only permitted for independently billing clinical laboratories, specialty code 69.
The billing laboratory submits, on the same claim, tests referred to another (referral/rendered) laboratory, with
modifier 90 reported on the line item and reports the referral laboratory’s CLIA number in:
loop 2400, REF02. REF01 = F4
EXAMPLE: A physician has ordered the DEF independent laboratory to perform glucose testing and tissue
typing for a patient. Since the DEF Laboratory is approved to perform only at the routine chemistry LC level
(which includes glucose testing), it refers the tissue-typing test to the GHI laboratory.
The DEF laboratory submits a single claim for the glucose and tissue typing tests; the line item service for the
glucose test is submitted without a ‘90’ modifier since the DEF laboratory performed this test. The CLIA
number for the DEF laboratory is entered in the electronic claim in:
loop 2300, REF02. REF01 = X4
On the same claim, the line item service for the tissue typing test is submitted with a ‘90’ modifier and the
referral/rendering GHI laboratory’s CLIA number is entered on the electronic claim in:
loop 2400, REF02. REF01 = F4
Reference Laboratory’s Address:
An electronic claim for laboratory testing requires the presence of the performing and billing laboratory’s,
name and address. The performing laboratory for a service with a line item CPT 90 modifier requires provider
information for the appropriate 837 loop.
NOTE: Effective for claims submitted with a receipt date on and after October 1, 2015, the billing physician
or supplier must report the name, address, and NPI of the performing physician or supplier on the claim on
reference laboratory claims, even if the performing physician or supplier is enrolled in a different A/B
MAC(B) jurisdiction. See Pub. 100-04, Chapter 1, §10.1.1 for more information regarding claims filing
jurisdiction.
40.2 - Payment Limit for Purchased Services
(Rev. 16, 10-31-03)
For payment instructions for Physician purchased diagnostic tests refer to the Claims Processing Manual 100-
04, Chapter 1, §30.2.9, Chapter 13 §20.2.4ff.
When an Independent Laboratory (IL) bills for the technical component (TC) of a physician pathology service
purchased from a separate physician or supplier, the payment amount for the TC is based on the lower of the
billed charge or the Medicare Physician Fee Schedule. The purchase diagnostic test payment provision does
not apply, thus, the purchase service information shall not be entered on the claim.
All purchased diagnostic services are based on the Medicare Physician Fee Schedule and are subject to the
jurisdiction rules for that fee schedule.

The IL must perform at least one of the component services. If they purchase both the PC and the TC
services, only the physician or supplier that performed those services may bill.
40.3 - Hospital Billing Under Part B
(Rev. 3014, Issued: 08-06-14, Effective: ICD- 10: Upon Implementation of ICD-10 ASC-X12: 01-01-12,
Implementation: ICD-10: Upon Implementation of ICD-10 ASC X12: 09-08-14)
Hospital laboratories, billing for either outpatient or non-patient claims, bill the A/B MAC (A).
Neither deductible nor coinsurance applies to laboratory tests paid under the fee schedule.
Hospitals must follow requirements for submission of the ASC X12 837 institutional claim or the hardcopy
Form CMS-1450. (See Chapter 25 for a description of the data set, and for requirements for the paper form.
See the ASC X12 837 implementation guide for billing requirements for the electronic claim,).
When the hospital obtains laboratory tests for outpatients under arrangements with clinical laboratories or
other hospital laboratories, only the hospital can bill for the arranged services.
As discussed in section 30.3 (“Place of Service Variation, Critical Access Hospitals”) of this chapter, when the
CAH bills a 14X bill type as a non-patient laboratory specimen, it is paid on the clinical laboratory fee
schedule. For CAHs, payment for clinical diagnostic laboratory tests is made at 101 percent of reasonable cost
only if the beneficiary is an outpatient of the CAH (85X TOB), as defined in 42 CFR 410.2, and is physically
present in the CAH at the time the specimen is collected, for dates of service prior to July 1, 2009. However,
for dates of service on or after July 1, 2009, the beneficiary does not have to be physically present in the CAH
at the time the specimen is collected as long as certain criteria are met, per Section 148 of the MIPPA (i.e.
other outpatient services are received by the beneficiary in the CAH on the same day the specimen is collected,
or the specimen is collected by an employee of the CAH or of a facility provider-based to the CAH) (see
Section 30.3 above, Critical Access Hospital). Clinical diagnostic laboratory tests performed for a beneficiary
who is not physically present at the CAH when the specimen is collected, by a non-CAH employee or who are
not receiving other outpatient services in the CAH on the same day the specimen is collected, are paid are paid
for under the clinical lab fee schedule. Similarly, for Maryland waiver hospitals, the waiver is limited to
services to inpatients and registered outpatients as defined in 42 CFR 410.2. Therefore payment for non-
patients (specimen only, TOB 14X) who are not registered outpatients at the time of specimen collection will
be made on the clinical diagnostic laboratory fee schedule.
Section 416 of the Medicare Prescription, Drug, Improvement, and Modernization Act (MMA) of 2003 also
eliminates the application of the clinical laboratory fee schedule for hospital outpatient laboratory testing by a
hospital laboratory with fewer than 50 beds in a qualified rural area for cost reporting periods beginning
during the 2-year period beginning on July 1, 2004. Payment for these hospital outpatient laboratory tests will
be reasonable costs without coinsurance and deductibles during the applicable time period. A qualified rural
area is one with a population density in the lowest quartile of all rural county populations.
The reasonable costs are determined using the ratio of costs to charges for the laboratory cost center multiplied
by the PS&R’s billed charges for outpatient laboratory services for cost reporting periods beginning on or after
July 1, 2004 but before July 1, 2006.
In determining whether clinical laboratory services are furnished as part of outpatient services of a hospital,
the same rules that are used to determine whether clinical laboratory services are furnished as an outpatient
critical access hospital service will apply.
40.3.1 - Critical Access Hospital (CAH) Outpatient Laboratory Service
(Rev. 2971, Issued: 05-23-14, Effective: 07-01-14, Implementation: 07-07-14)

Effective for services furnished on or after the enactment of the Balanced Budget Refinement Act of 1999
(BBRA), Medicare beneficiaries are not liable for any coinsurance, deductible, co-payment, or other cost
sharing amount with respect to clinical laboratory services furnished as a CAH outpatient service. This
change is effective for claims with dates of service on or after November 29, 1999.
For CAH bill type 85X, the laboratory fees are paid at 101 percent of reasonable cost. When the CAH bills a
14X bill type as a non-patient laboratory specimen, it is paid on the clinical laboratory fee schedule.
40.4 - Special Skilled Nursing Facility (SNF) Billing Exceptions for Laboratory Tests
(Rev. 1, 10-01-03)
SNF 541, A3-3137.1, HO-437, B3-5114.1
When a SNF furnishes laboratory services directly, it must have a Clinical Laboratory Improvement Act
(CLIA) number or a CLIA certificate of waiver, and the laboratory itself must be in the portion of the facility
so certified. Normally the A/B MAC (A) makes payment under Part B for clinical laboratory tests only to the
entity that performed the test. However, the law permits SNFs to submit a Part B claim to the A/B MAC (A)
for laboratory tests that it makes arrangements for another entity to perform on the SNF’s behalf. Section
1833(h)(5) of the Act (as enacted by The Deficit Reduction Act of 1984, P.L. 98-369) requires the
establishment of a fee schedule for clinical laboratory tests paid under Part B and also requires that, with
certain exceptions, only the entity that performed the test may be paid.
The fee schedule applies to all SNF clinical laboratory services.
Where a SNF operates a laboratory that provides laboratory services to patients other than its own patients, it
is functioning as a clinical laboratory. The billing for these laboratory services depends upon the HCPCS code
as defined in the CMS annual fee schedule releases (laboratory and MPFS), and the arrangements made for
payment with the referring entity (e.g., does the SNF or the referring entity bill under the agreement between
the two). The SNF is responsible for ascertaining the necessary information for billing the A/B MAC (A).
Any questions must be referred to the A/B MAC (A).
40.4.1 - Which A/B MAC (A) or (B) to Bill for Laboratory Services Furnished to a
Medicare Beneficiary in a Skilled Nursing Facility (SNF)
(Rev. 1, 10-01-03)
Inpatient Part A beneficiary - SNF bills the A/B MAC (A) under Part A. The service is included in SNF
PPS payment.
Inpatient Part B beneficiary (benefits exhausted or no Part A entitlement) - SNFs may provide the service
and bill the A/B MAC (A), may obtain the service under arrangement and bill the A/B MAC (A) under Part B,
or may have agreement with a reference laboratory for the reference laboratory to provide the service and have
the reference laboratory bill the A/B MAC (B) under Part B. Regardless of who bills, CMS policy requires
that the service be paid under the fee schedule, whether or not the beneficiary is in a Medicare certified bed.
Outpatient Part B - See inpatient Part B beneficiary (benefits exhausted or no Part A entitlement),
immediately above.
40.5 - Rural Health Clinic (RHC) Billing
(Rev. 1, 10-01-03)
B3-3628
For independent RHCs, laboratory services provided in the RHC’s laboratory are not included in the all-
inclusive rate payment to the RHC and may be billed separately to the A/B MAC (B). This includes the six
basic laboratory tests required for certification as well as any other laboratory tests provided in the RHC
laboratory.

Note: If the RHC sends laboratory services to an outside laboratory, the outside laboratory bills the A/B MAC
(B) for the tests.
If the RHC laboratory becomes certified as a clinical laboratory, it bills all laboratory tests performed in its
laboratory to the laboratory’s A/B MAC (B). Laboratory tests are not included as RHC costs nor as part of the
RHC all-inclusive rate payment.
For provider based RHCs the rules in the preceding paragraph apply with the following exception. The
provider bills tests provided in its laboratory to the A/B MAC (A).
40.6 - Billing for End Stage Renal Disease (ESRD) Related Laboratory Tests
(Rev. 2487, Issued: 06-08-12, Effective: 01-01-11, Implementation: 06-19-12)
With the implementation of the ESRD PPS, effective for claims with dates of service on or after January 1,
2011, all ESRD-related laboratory services are included in the ESRD PPS base rate and must be reported by
the ESRD facility and are not separately paid. For instructions on ESRD facility billing under ESRD PPS, see
Publication 100-04, Chapter 8. The list of items and services subject to consolidated billing located at
http://www.cms.gov/ESRDPayment/50_Consolidated_Billing.asp#TopOfPage includes the list of ESRD-
related laboratory tests that are routinely performed for the treatment of ESRD.
Laboratory services that are not related to the treatment of ESRD are separately billable under the ESRD PPS
and may be billed by either the ESRD facility or the independent laboratory. If the ESRD facility or
independent laboratory bills a laboratory service that was not related to the treatment of ESRD, the bill must
include the modifier AY. The AY modifier serves as an attestation that the item or service is medically
necessary for the dialysis patient but is not being used for the treatment of ESRD.
40.6.1 - Automated Multi-Channel Chemistry (AMCC) Tests for ESRD Beneficiaries
Rev. 3116, Issued: 11-06-14, Effective: 04-01-15, Implementation: 04-06-15)
Instructions for Services Provided on and After January 1, 2011
Section 153b of the MIPPA requires that all ESRD-related laboratory tests must be reported by the ESRD
facility whether provided directly or under arrangements with an independent laboratory. When laboratory
services are billed by providers other than the ESRD facility and the laboratory test furnished is designated as
a laboratory test that is included in the ESRD PPS (ESRD-related), the claim will be rejected or denied. In the
event that an ESRD-related laboratory test was furnished to an ESRD beneficiary for reasons other than for the
treatment of ESRD, the provider may submit a claim for separate payment using modifier AY. The AY
modifier serves as an attestation that the item or service is medically necessary for the dialysis patient but is
not being used for the treatment of ESRD. The items and services subject to consolidated billing located on
the CMS website includes the list of ESRD-related laboratory tests that are routinely performed for the
treatment of ESRD.
For services provided on or after January 1, 2011, the 50/50 rule no longer applies to independent laboratory
claims for AMCC tests furnished to ESRD beneficiaries. The 50/50 rule modifiers (CD, CE, and CF) are no
longer required for independent laboratories effective for dates of service on and after January 1, 2011.
However, for services provided between January 1, 2011 and March 31, 2015, the 50/50 rule modifiers are
still required for use by ESRD facilities that are receiving the transitional blended payment amount (the
transition ends in CY 2014). For services provided on or after April 1, 2015, the 50/50 rule modifiers are no
longer required for use by ESRD facilities.
Effective for dates of service on and after January 1, 2012, A/B MACs (B) shall allow organ disease panel
codes (i.e., HCPCS codes 80047, 80048, 80051, 80053, 80061, 80069, and 80076) to be billed by independent
laboratories for AMCC panel tests furnished to ESRD eligible beneficiaries if:

• 	The beneficiary is not receiving dialysis treatment for any reason (e.g., post-transplant beneficiaries),
or
• 	The test is not related to the treatment of ESRD, in which case the supplier would append modifier
“AY”.
A/B MACs (B) shall make payment for organ disease panels according to the Clinical Laboratory Fee
Schedule and shall apply the normal ESRD PPS editing rules for independent laboratory claims. The
aforementioned organ disease panel codes were added to the list of bundled ESRD PPS laboratory tests in
January 2012.
Effective for dates of service on and after April 1, 2015, A/B MACs (A) shall allow organ disease panel codes
(i.e., HCPCS codes 80047, 80048, 80051, 80053, 80061, 80069, and 80076) to be billed by ESRD facilities for
AMCC panel tests furnished to ESRD eligible beneficiaries if:
• 	These codes best describe the laboratory services provided to the beneficiary, which are paid under the
ESRD PPS, or
• 	The test is not related to the treatment of ESRD, in which case the ESRD facility would append
modifier “AY” and the service may be paid separately from the ESRD PPS.
Instructions for Services Provided Prior to January 1, 2011
For claims with dates of service prior to January 1, 2011, Medicare will apply the following rules to
Automated Multi-Channel Chemistry (AMCC) tests for ESRD beneficiaries:
• 	Payment is at the lowest rate for tests performed by the same provider, for the same beneficiary, for the
same date of service.
• 	The facility/laboratory must identify, for a particular date of service, the AMCC tests ordered that are
included in the composite rate and those that are not included. See Publication 100-02, Chapter 11,
Section 30.2.2 for the chart detailing the composite rate tests for Hemodialysis, Intermittent Peritoneal
Dialysis (IPD), Continuous Cycling Peritoneal Dialysis (CCPD), and Hemofiltration as well as a
second chart detailing the composite rate tests for Continuous Ambulatory Peritoneal Dialysis (CAPD).
• 	If 50 percent or more of the covered tests are included under the composite rate payment, then all
submitted tests are included within the composite payment. In this case, no separate payment in
addition to the composite rate is made for any of the separately billable tests.
• 	If less than 50 percent of the covered tests are composite rate tests, all AMCC tests submitted for that
Date of Service (DOS) for that beneficiary are separately payable.
• 	A noncomposite rate test is defined as any test separately payable outside of the composite rate or
beyond the normal frequency covered under the composite rate that is reasonable and necessary.
• 	For A/B MAC (B) processed claims, all chemistries ordered for beneficiaries with chronic dialysis for
ESRD must be billed individually and must be rejected when billed as a panel.
(See §100.6 UH for details regarding pricing modifiers.)
Implementation of this Policy:

ESRD facilities when ordering an ESRD-related AMCC must specify for each test within the AMCC whether
the test:
a. 	Is part of the composite rate and not separately payable;
b. 	Is a composite rate test but is, on the date of the order, beyond the frequency covered under the
composite rate and thus separately payable; or
c. 	Is not part of the ESRD composite rate and thus separately payable.
Laboratories must:
a. 	Identify which tests, if any, are not included within the ESRD facility composite rate payment
b. 	Identify which tests ordered for chronic dialysis for ESRD as follows:
1) 	Modifier CD: AMCC Test has been ordered by an ESRD facility or MCP physician that is part
of the composite rate and is not separately billable.
2) 	Modifier CE: AMCC Test has been ordered by an ESRD facility or MCP physician that is a
composite rate test but is beyond the normal frequency covered under the rate and is separately
reimbursable based on medical necessity.
3) 	Modifier CF: AMCC Test has been ordered by an ESRD facility or MCP physician that is not
part of the composite rate and is separately billable.
c. 	Bill all tests ordered for a chronic dialysis ESRD beneficiary individually and not as a panel.
The shared system must calculate the number of AMCC tests provided for any given date of service. Sum all
AMCC tests with a CD modifier and divide the sum of all tests with a CD, CE, and CF modifier for the same
beneficiary and provider for any given date of service.
If the result of the calculation for a date of service is 50 percent or greater, do not pay for the tests.
If the result of the calculation for a date of service is less than 50 percent, pay for all of the tests.
For A/B MAC (A) processed claims, all tests for a date of service must be billed on the monthly ESRD bill.
Providers that submit claims to an A/B MAC (A) must send in an adjustment if they identify additional tests
that have not been billed.
A/B MAC (B) shared systems shall adjust the previous claim when the incoming claim for a date of service is
compared to a claim on history and the action is adjust payment. A/B MAC (B) shared systems shall spread
the payment amount over each line item on both claims (the claim on history and the incoming claim).
The organ and disease oriented panels (80048, 80051, 80053, and 80076) are subject to the 50 percent rule.
However, clinical diagnostic laboratories shall not bill these services as panels, they must be billed
individually. Laboratory tests that are not covered under the composite rate and that are furnished to CAPD
end stage renal disease (ESRD) patients dialyzing at home are billed in the same way as any other test
furnished home patients.
A/B MAC (A) Business Requirements for ESRD Reimbursement of AMCC Tests:

Requirement
Number 	Requirement 	Responsibility
1.1 	The A/B MAC (A) shared system must RTP a claim for AMCC
tests when a claim for that date of service has already been
submitted.
Shared system
1.2 	Based upon the presence of the CD, CE and CF payment
modifiers, identify the AMCC tests ordered that are included and
not included in the composite rate payment.
Shared System
1.3 	Based upon the determination of requirement 1.2, if 50 percent or
more of the covered tests are included under the composite rate, no
separate payment is made.
Shared System
1.4 	Based upon the determination of requirement 1.2, if less than 50
percent are covered tests included under the composite rate, all
AMCC tests for that date of service are payable.
Shared System
1.5 	Effective for claims with dates of service on or after January 1,
2006, include any line items with a modifier 91 used in
conjunction with the “CD,” “CE,” or “CF” modifier in the
calculation of the 50/50 rule.
Shared System
1.6 	A/B MACs (A) must return any claims for additional tests for any
date of service within the billing period when the provider has
already submitted a claim. Instruct the provider to adjust the first
claim.
A/B MAC (A) or
Shared System
1.7 	After the calculation of the 50/50 rule, services used to determine
the payment amount may never exceed 22. Effective for claims
with dates of service on or after January 1, 2006, accept all valid
line items submitted for the date of service and pay a maximum of
the ATP 22 rate.
Shared System
A/B MAC (B) Business Requirements for ESRD Reimbursement of AMCC Tests:
Requirement
Number 	Requirement 	Responsibility
1 	The shared systems shall calculate payment at
the lowest rate for these automated tests even if
reported on separate claims for services
performed by the same provider, for the same
beneficiary, for the same date of service.
Shared Systems
2 	Shared Systems shall identify the AMCC tests
ordered that are included and are not included
in the composite rate payment based upon the
presence of the “CD,” “CE” and “CF”
modifiers.
Shared Systems
3 	Based upon the determination of requirement 2
if 50 percent or more of the covered services
are included under the composite rate payment,
Shared Systems shall indicate that no separate
payment is provided for the services submitted
for that date of service.
Shared Systems
4 	Based upon the determination of requirement 2
if less than 50 percent are covered services
included under the composite rate, Shared
Systems shall indicate that all AMCC tests for
that date of service are payable under the 50/50
rule.
Shared Systems

Requirement
Number 	Requirement 	Responsibility
5 	Effective for claims with dates of service on or
after January 1, 2006, include any line items
with a modifier 91 used in conjunction with the
“CD,” “CE,” or “CF” modifier in the
calculation of the 50/50 rule.
Shared Systems
6 	Shared Systems shall adjust the previous claim
when the incoming claim is compared to the
claim on history and the action is to deny the
previous claim. Spread the payment amount
over each line item on both claims (the adjusted
claim and the incoming claim).
Shared Systems
7 	Shared Systems shall spread the adjustment
across the incoming claim unless the adjusted
amount would exceed the submitted amount of
the services on the claim.
Shared System
8 	After the calculation of the 50/50 rule, services
used to determine the payment amount may
never exceed 22. Accept all valid line items for
the date of service and pay a maximum of the
ATP 22 rate.
Shared Systems
Examples of the Application of the 50/50 Rule
The following examples are to illustrate how claims should be paid. The percentages in the action section
represent the number of composite rate tests over the total tests. If this percentage is 50 percent or greater, no
payment should be made for the claim.
Example 1: Provider Name: Jones Hospital
DOS 2/1/02, Claim/Services:
CPT Code- 	Modifier
82040 	Mod CD
82310 	Mod CD
82374 	Mod CD
82435 	Mod CD
82947 	Mod CF
84295 	Mod CF
82040 	Mod CD (Returned as duplicate)
84075 	Mod CE
82310 	Mod CE
84155 	Mod CE
ACTION: 9 services total, 2 non-composite rate tests, 3 composite rate tests beyond the frequency, 4
composite rate tests; 4/9 = 44.4%<50% pay at ATP 09
Example 2: Provider Name: Bon Secours Renal Facility
DOS 2/15/02, Claim/Services:
CPT Code 	Modifier
82040 	Mod CE and Mod 91
84450 	Mod CE
82310 	Mod CE
82247 	Mod CF
82465 	No modifier present

CPT Code 	Modifier
82565 	Mod CE
84550 	Mod CF
82040 	Mod CD
84075 	Mod CE
82435 	Mod CE
82550 	Mod CF
82947 	Mod CF
82977 	Mod CF
ACTION: 12 services total, 5 non-composite rate tests, 6 composite rate tests beyond the frequency, 1
composite rate test; 1/12 = 8.3%<50% pay at ATP 12
Example 3: Provider Name: Sinai Hospital Renal Facility
DOS 4/02/02, Claim/Services:
CPT Code 	Modifier
82565 	Mod CD
83615 	Mod CD
82247 	Mod CF
82248 	Mod CF
82040 	Mod CD
84450 	Mod CD
82565 	Mod CE
84550 	Mod CF
82248 	Mod CF (Duplicate
ACTION: 8 services total, 3 non-composite rate tests, 4 composite rate tests, 1 composite rate test beyond the
frequency; 4/8 = 50%, therefore no payment is made.
Example 4: Provider Name: Dr. Andrew Ross
DOS 6/01/02, Claim/Services:
CPT Code 	Modifier
84460 	Mod CF
82247 	Mod CF
82248 	Mod CF
82040 	Mod CD
84075 	Mod CD
84450 	Mod CD
ACTION: 6 services total, 3 non-composite rate tests and 3 composite rate tests; 3/6 = 50%, therefore no
payment.
Example 5: (A/B MAC (B) Processing Example Only)
Payment for first claim, second claim creates a no payment status for either claim.
Provider Name: Dr. Andrew Ross
DOS 6/01/06, Claim/Services - First claim
CPT Code 	Modifier
84460 	Mod CF
82247 	Mod CF
82248 	Mod CF
ACTION: 3 services total, 3 non-composite rate tests, 0 composite rate tests beyond the frequency, and 0
composite rate tests, 0/3 = 0%, therefore ATP 03
Example 5: continued (A/B MAC (B) Processing Example Only)
Provider Name: Dr. Andrew Ross

DOS 6/01/06, Claim/Services - Second claim
CPT Code 	Modifier
82040 	Mod CD
84075 	Mod CD
84450 	Mod CD
ACTION: An additional 3 services are billed, 0 non-composite rate tests, 8 composite rate tests beyond the
frequency, 3 composite rate tests. For both claims there are 6 services total, 3 non-composite rate tests and 3
composite rate tests; 3/6 = 50% U >U 50%, therefore no payment. An overpayment should be recovered for the
ATP 03 payment on the first claim.
40.6.2 - Claims Processing for Separately Billable Tests for ESRD Beneficiaries
(Rev. 1655, Issued: 12-31-08, Effective: 01-01-09, Implementation: 02-02-09)
Clinical laboratory tests can be performed individually or in predetermined groups on automated profile
equipment. If a test profile is performed see §40.6.1. If a clinical laboratory test is performed individually,
see §40.6.2.1. However the tests are performed in the laboratory setting, the services must be billed
individually, and must not be billed in a group as an organ or disease panel.
40.6.2.1 - Separately Billable ESRD Laboratory Tests Furnished by Hospital-Based
Facilities
(Rev. 3425, Issued: 12-18-15, Effective: 01-01-16, Implementation: 01-04-16)
Independent laboratories and independent dialysis facilities with the appropriate clinical laboratory
certification in accordance with CLIA may be paid for ESRD clinical laboratory tests that are separately
billable. The laboratories and independent dialysis facilities are paid for separately billable clinical laboratory
tests according to the Medicare laboratory fee schedule for independent laboratories. (See §40.3 for details on
Part B hospital billing rules for laboratory services.)
Hospital-based laboratories providing separately billable laboratory services to dialysis patients of the
hospital’s dialysis facility or any other dialysis facility bill and are paid in accordance with the hospital
outpatient laboratory provisions in Chapter 16, section 40.3.
40.6.2.2 - Reserved
(Rev. 1655, Issued: 12-31-08, Effective: 01-01-09, Implementation: 02-02-09)
40.6.2.3 - Skilled Nursing Facility (SNF) Consolidated Billing (CB) Editing and
Separately Billed ESRD Laboratory Test Furnished to Patients of Renal Dialysis
Facilities
(Rev. 4227, Issued: 02-01-2019, Effective: 07-01-19, Implementation: 07-01-19 )
Effective April 1, 2003, for dates of service (DOS) on or after April 1, 2001 and ending June 30, 2019:
Effective April 1, 2003, for DOS on or after April 1, 2001, CWF will not apply the SNF CB edits to line items
that contain the CB modifier. A provider or supplier may use the “CB” modifier only when it has determined
that: (a) the beneficiary has ESRD entitlement, (b) the test is related to the dialysis treatment for ESRD, (c)
the test is ordered by a doctor providing care to patients in the dialysis facility, and (d) the test is not included
in the dialysis facility’s composite rate payment.
Those diagnostic tests that are presumptively considered to be dialysis-related and, therefore, appropriate for
submission with the “CB” modifier are identified in Exhibit 1. This list was not designed as an all- inclusive
list of Medicare covered diagnostic services. Additional diagnostic services related to the beneficiary’s ESRD
treatment/care may be considered dialysis-related. However, if these services are not included in our listing,
the A/B MAC (A) may require supporting medical documentation.

When a hospital laboratory is billing for laboratory services ordered by an ESRD facility and the patient
(beneficiary) is a SNF resident under a Part A stay, the hospital laboratory must use the “CB” modifier for
those services excluded from consolidated billing.
Beneficiaries in a SNF Part A stay are eligible for a broad range of diagnostic services as part of the SNF Part
A benefit. Physicians ordering medically necessary diagnostic test that are not directly related to the
beneficiary’s ESRD are subject to the SNF consolidated billing requirements. Physicians may bill the A/B
MAC (B) for the professional component of these diagnostic tests. In most cases, however, the technical
component of diagnostic tests is included in the SNF PPS rate and is not separately billable to the A/B MAC
(B). Physicians should coordinate with the SNF in ordering such tests since the SNF will be responsible for
bearing the cost of the technical component.
Effective for DOS on or after July 1, 2019:
Effective for claims with DOS on or after July 1, 2019, the CB modifier, previously used by Independent
Labs when billing for separate payment outside the SNF Consolidated Billing for ESRD dialysis-related
lab services, is no longer applicable.
With the January 1, 2011 implementation of the ESRD PPS and effective for DOS on or after July 1,
2019, Exhibit 1 is no longer recognized as the list of separately billable ESRD dialysis-related services.
Instead, a list of the recognized renal dialysis laboratory tests that are subject to Part B ESRD PPS
consolidated billing requirements, are considered routinely performed for the treatment of ESRD, and
are not separately paid when provided to ESRD beneficiaries by providers or suppliers other than the
ESRD facility, is located on the CMS Website: https://www.cms.gov/Medicare/Medicare-Fee-for-
Service-Payment/ESRDpayment/Consolidated_Billing.html.
The list of renal dialysis laboratory tests provided in the Part B ESRD PPS consolidated billing
requirements is not an all-inclusive list. For laboratory tests not included in this list, the distinction of
what is considered to be a renal dialysis laboratory test is a clinical decision determined by the ESRD
beneficiary’s ordering practitioner. If any laboratory test is ordered for the treatment of ESRD, then
the laboratory test is considered to be included in the ESRD PPS, is the responsibility of the ESRD
facility and is excluded from the SNF PPS. More information regarding renal dialysis services payable
under the ESRD PPS is available in Pub. 100-02, chapter 11.
Beneficiaries in a SNF Part A stay are eligible for a broad range of diagnostic services as part of the
SNF Part A benefit. Physicians ordering medically necessary diagnostic tests that are not directly
related to the beneficiary’s ESRD are subject to the SNF consolidated billing requirements. Physicians
may bill the A/B MAC (B) for the professional component of these diagnostic tests. In most cases,
however, the technical component of diagnostic tests is included in the SNF PPS rate and is not
separately billable to the A/B MAC (B). Physicians should coordinate with the SNF in ordering such
tests since the SNF will be responsible for bearing the cost of the technical component.
A patient’s physician or practitioner may order a laboratory test that is included on the list of items and
services subject to consolidated billing edits for reasons other than for the treatment of ESRD. When
this occurs, the SNF CB applies.
40.7 - Billing for Noncovered Clinical Laboratory Tests
(Rev. 1, 10-01-03)
B3-5114.1
Ordinarily, neither a physician nor a laboratory bills the Medicare Program for noncovered tests. However, if
the beneficiary (or his/her representative) contends that a clinical laboratory test which a physician or
laboratory believes is noncovered may be covered, the physician or laboratory must file a claim that includes

the test to effectuate the beneficiary’s right to a Medicare determination. The physician or laboratory
annotates the claim that he/she believes that the test is noncovered and is submitting it at the beneficiary’s
insistence. Before furnishing a beneficiary a test which the physician or laboratory believes is excluded from
coverage as not reasonable and necessary (rather than excluded from coverage as part of a routine physical
check-up), the physician or laboratory must obtain a signed Advanced Beneficiary Notice (ABN) from the
beneficiary (or representative) that the physician or laboratory has informed him/her of the noncoverage of the
test and that there will be a charge for the test. This protects the physician or laboratory against possible
liability for the test under the limitation of liability provision.
See Chapter 30, regarding Advance Beneficiary Notices (ABN) and demand bills.
40.8 - Date of Service (DOS) for Clinical Laboratory and Pathology Specimens
(Rev. 4481; Issued: 12-20-19, Effective: 01-01-20, Implementation: 01-23-20)
The DOS policy for either a clinical laboratory test or the technical component of physician pathology
service is as follows:
General Rule: The DOS of the test/service must be the date the specimen was collected.
Variation: If a specimen is collected over a period that spans two calendar days, then the DOS must be the
date the collection ended.
Exceptions: The following three exceptions apply to the DOS policy for either a clinical laboratory test or
the technical component of physician pathology service:
A. DOS for Tests/Services Performed on Stored Specimens:
In the case of a test/service performed on a stored specimen, if a specimen was stored for less than or equal
to 30 calendar days from the date it was collected, the DOS of the test/service must be the date the
test/service was performed only if:
• 	The test/service is ordered by the patient’s physician at least 14 days following the date of the
patient’s discharge from the hospital;
• 	The specimen was collected while the patient was undergoing a hospital surgical procedure;
• 	It would be medically inappropriate to have collected the sample other than during the hospital
procedure for which the patient was admitted;
• 	The results of the test/service do not guide treatment provided during the hospital stay; and
• 	The test/service was reasonable and medically necessary for treatment of an illness.
If the specimen was stored for more than 30 calendar days before testing, the specimen is considered to have
been archived and the DOS of the test/service must be the date the specimen was obtained from storage.
B. DOS for Chemotherapy Sensitivity Tests/Services Performed on Live Tissue:
In the case of a chemotherapy sensitivity test/service performed on live tissue, the DOS of the test/service
must be the date the test/service was performed only if:
• 	The decision regarding the specific chemotherapeutic agents to test is made at least 14 days after
discharge;

• 	The specimen was collected while the patient was undergoing a hospital surgical procedure;
• 	It would be medically inappropriate to have collected the sample other than during the hospital
procedure for which the patient was admitted;
• 	The results of the test/service do not guide treatment provided during the hospital stay; and
• 	The test/service was reasonable and medically necessary for treatment of an illness.
For purposes of applying the above exception, a “chemotherapy sensitivity test” is defined as a test that
requires a fresh tissue sample to test the sensitivity of tumor cells to various chemotherapeutic agents. CMS
identifies such tests through program instructions issued to the Medicare Administrative Contractors
(MACs).
C. 	DOS for Advanced Diagnostic Laboratory Tests and Molecular Pathology Tests:
In the case of a molecular pathology test performed by a laboratory other than a blood bank or center, or a
test designated by CMS as an ADLT under paragraph (1) of the definition of advanced diagnostic
laboratory test in 42 CFR 414.502, the DOS must be the date the test was performed only if:
● The test was performed following a hospital outpatient’s discharge from the
hospital outpatient department;
● The specimen was collected from a hospital outpatient during an encounter
(as both are defined in 42 CFR 410.2);
● It was medically appropriate to have collected the sample from the hospital outpatient during the
hospital outpatient encounter;
● The results of the test do not guide treatment provided during the hospital outpatient encounter; and
● The test was reasonable and medically necessary for the treatment of an illness.
For the purpose of section 40.8.C, a “blood bank or center” means an entity whose primary function
is the performance or responsibility for the performance of, the collection, processing, testing,
storage and/or distribution of blood or blood components intended for transfusion and
transplantation.
50 - A/B MAC (B) Claims Processing
(Rev. 1, 10-01-03)

50.1 - Referring Laboratories
(Rev. 85, 02-06-04)
B3-5114.1
Medicare recognizes that specimens drawn or collected by one laboratory are sometimes
referred to another laboratory for testing. Payment for a Medicare-covered, referred
laboratory service may be made under the rules established in Chapter 15 §40.1.
The rules specified Chapter 15 §40.1 do not apply to services performed in a physician
office laboratory or a qualified hospital laboratory. Both circumstances are entirely
outside the scope of all sections concerning referral laboratory services.
Every A/B MAC (B) shall process a claim for a referred laboratory service if submitted
by an independent clinical laboratory with a physical presence within the A/B MAC (B)’s
jurisdiction, notwithstanding that the referred laboratory service may have been
performed outside of its jurisdiction.
Every A/B MAC (B) shall maintain the clinical laboratory fee schedules for each A/B
MAC (B) jurisdiction and be able to process claims using those fee schedules.
Every A/B MAC (B) shall base payment for a referred service on the fee schedule for the
jurisdiction in which the service was performed, i.e., where the test was performed. An
exception to this rule allows a payment for a service that is A/B MAC (B)-priced to be
based upon the price developed by the A/B MAC (B) processing the claim.
Every A/B MAC (B) that has previously assigned “reference use only” PINs to out-of-
jurisdiction laboratories for the purpose of their billing referred services shall cancel such
“reference-use-only” PINs.
A/B MACs (B) must use the numerical locality codes specified in 50.4 to identify the
appropriate clinical diagnostic laboratory fee schedule for use in pricing a referred
laboratory service.
50.2 - Physicians
(Rev. 1, 10-01-03)
B3-4110.2
If a physician or medical group furnishes laboratory tests in an office setting and it is
appropriate for them to be performed in the physician’s office, no further development of
the source of the laboratory tests is required.
If a claim or physician’s bill raises a question as to the source of a laboratory test and it
cannot be resolved from available information, A/B MACs (B) must request the source of
the laboratory service from the physician.
If the clinical laboratory test is subject to the laboratory fee schedule, A/B MACs (B)
must pay only the person or entity that performed or supervised the performance of the

test. However, A/B MACs (B) may also pay one physician for tests performed or
supervised by another physician with whom he/she shares a practice, i.e., the two
physicians are members of a medical group whose physicians submit claims in their own
names rather than in the name of the group. Where the medical group submits claims in
the name of the group for the services of the physician who performed or supervised the
performance of these tests, A/B MACs (B) must pay the group. Regardless of who
submits the claim, assignment is required for payment. See §50.2.1 below.
50.2.1 - Assignment Required
(Rev. 3510, Issued: 04-29-16, Effective: 10-01-16, Implementation; 10-03-16)
Carriers must:
• 	Pay for clinical laboratory services provided in the physician’s office only on an
assignment basis.
• 	Treat as assigned any claims for clinical laboratory services provided in the
physician’s office even if the claimant submits the claim on a non-assigned basis
or if the assignment option is not designated.
• 	Deny claims where it is apparent from the claims form or from other evidence that
the beneficiary or provider refuses to assign.
The contractor shall use the following remittance advice message and associated codes
when rejecting/denying claims under this policy. This CARC/RARC combination is
compliant with CAQH CORE Business Scenario Three.
Group Code: CO or PR
CARC: 111
RARC: N/A
MSN: 16.41 OR 16.6
50.3 - Hospitals
(Rev. 1, 10-01-03)
50.3.1 - Hospital-Leased Laboratories
(Rev. 1, 10-01-03)
B3-4110.1
A/B MACs (B) process claims from hospital laboratories that are leased by physicians
and independent laboratories.
Before processing claims for services furnished by a hospital laboratory department
operated on a lease or concession basis by a pathologist or by a nonphysician specialist
such as a biochemist (with a visiting pathologist or outside independent laboratory doing
the hospital’s tissue work), A/B MACs (B) must ascertain if the laboratory has been
approved by the RO.

Services furnished by a laboratory that does not meet the hospital laboratory conditions
of participation and is operated under a lease arrangement in a domestic emergency
hospital are covered only if they are emergency inpatient services payable under Part A.
Additional information concerning nonparticipating emergency hospital services is found
in Chapter 3.
50.3.2 - Hospital Laboratory Services Furnished to Nonhospital Patients
(Rev. 3014, Issued: 08-06-14, Effective: ICD- 10: Upon Implementation of ICD-10
ASC-X12: 01-01-12, Implementation: ICD-10: Upon Implementation of ICD-10
ASC X12: 09-08-14)
When a hospital laboratory performs a laboratory service for a non-hospital patient, (i.e.,
for neither an inpatient nor an outpatient), the hospital bills its A/B MAC (A) on the ASC
X12 837 institutional claim format or on the hard copy Form CMS-1450. If an A/B
MAC (B) receives such claims, the A/B MAC (B) should deny them. When the lab
services are provided in Maryland, services to a hospital’s own outpatients are paid under
the State cost containment system. A Maryland hospital cannot seek payment based on a
percent of charges for tests provided to individuals in locations such as a rural health
clinic (RHC), a provider-based HHA, the individual’s home or a physician’s office).
Individuals in these locations are non-patients of the Maryland hospital and their lab tests
would be categorized as “non-patient specimen only lab tests” (TOB 14x), and are paid
under the lab fee schedule.
When a hospital-leased laboratory performs a service for a non-hospital patient, it must
bill the A/B MAC (B).
50.4 - Reporting of Pricing Localities for Clinical Laboratory Services
(Rev. 3875, Issued: 10-06-17, Effective: 01-08-18, Implementation: 01-08-18)
PM-B-97-12
A/B MACs (B) shall report to the common working file (CWF) new State pricing
localities (positions 58 and 59 on the A/B MAC (B) record) indicated on the Clinical
Diagnostic Laboratory fee schedule for any reference laboratory service billed with a
HCPCS 90 modifier. If the laboratory test billed is not a reference laboratory service, the
A/B MAC (B) Locality (location 11-12) on the Clinical Diagnostic Laboratory fee
schedule should be forwarded to the CWF. For dates of service on or after April 1, 2004,
CWF will not edit clinical laboratory pricing locality.
The A/B MAC (A) and (B) record layouts, plus the State pricing locations are as follows:
A/B MAC (B) RECORD LAYOUT FOR DATA FILE
CLINICAL LABORATORY FEE SCHEDULE
Data
Element
Name
Picture 	Location 	Comment
HCPCS Code 	X(05) 	1-5

Data
Element
Name
Picture 	Location 	Comment
A/B MAC (B)
Number
X(05) 	6-10
A/B MAC (B) Lo X(02) 	11-12 	00--Single State A/B MAC (B)
01--North Dakota
02--South Dakota
02--South Dakota
20--Puerto Rico
60% Local
Fee
9(05)V99 	13-19
62% Local
Fee
9(05)V99 	20-26
60% Natl
Limit Amt
9(05)V99 	27-33
62% Natl
Limit Amt
9(05)V99 	34-40
60% Pricing
Amt
9(05)V99 	41-47
62% Pricing
Amt
9(05)V99 	48-54
Gap-Fill
Indicator
X(01) 	55-55 	0 No Gap-fill Required
1-- A/B MAC (B) Gap-fill
2--Special Instructions Apply
Modifier 	X(02) 	56-57 Where modifier is shown, QW denotes
a CLIA waiver test
State Locality 	X(02) 	58-59 	See attached
FILLER 	X(01) 	60
A/B MAC (A) RECORD LAYOUT FOR DATA FILE
CLINICAL LABORATORY FEE SCHEDULE
Data
Element
Name
Picture 	Location 	Comment
HCPCS 	X(05) 	1-5
Filler 	X(04) 	6-9
60% Pricing
Amt
9(05)V99 	10-16
62% Pricing
Amt
9(05)V99 	17-23
Filler 	X(07) 	24-30
A/B MAC (B)
Number
X(05) 	31-35

Data
Element
Name
Picture 	Location 	Comment
A/B MAC (B)
Locality
X(02) 	36-37 	00--Single State A/B MAC (B)
01--North Dakota
02--South Dakota
20 Puerto Rico
State Locality 	X(02) 	38-39 	See Attached
FILLER 	X(21) 	40-60
On or after January 1, 2018, the record layouts of the CLFS are as follows:
Data
Element
Name
Picture 	Location 	Comment
Year 	PIC X(04) 	1-4 Calendar year (YYYY) associated with
the Clinical Lab Fee Schedule.
Filler 	PIC X(01) 	5 	Value ' '
HCPCS
Code PIC X(05) 	6-10 All current year active CPT and alpha-
numeric codes subject to CLFS.
Filler 	PIC X(01) 	11 	Value ' '
Modifier 	PIC X(02) 	12-13 Where modifier is shown, QW denotes
a CLIA waiver test.
Filler 	PIC X(01) 	14 	Value ' '
Effective
Date PIC X(08) 	15-22 Date the Clinical Lab Fee Schedule
became effective (YYYYMMDD).
Filler 	PIC X(01) 	23 	Value ' '
Indicator 	PIC X(01) 	24 National (N) or Local (L) payment
indicator.
Filler 	PIC X(01) 	25 	Value ' '
Payment
Rate
PIC
Z9(05)V99 26-32
The payment amount associated with
each test on the Clinical Lab Fee
Schedule.
Filler 	PIC X(01) 	33 	Value ' '
Description 	PIC X(40) 	34-73 Short description of the applicable
HCPCS code.
CarrierLocality/StateLocality Map
Carrier/Loc 1010200 =State Loc 01 (ALABAMA)
Carrier/Loc 0210201 =State Loc 02 (ALASKA)

Carrier/Loc 0310200 =State Loc 04 (ARIZONA)
Carrier/Loc 0710213 =State Loc 05 (ARKANSAS)
Carrier/Loc 0118218 =State Loc 06 (CALIFORNIA)
Carrier/Loc 0118226 =State Loc 06 (CALIFORNIA)
Carrier/Loc 0111252 =State Loc 06 (CALIFORNIA)
Carrier/Loc 0111207 =State Loc 06 (CALIFORNIA)
Carrier/Loc 0111205 =State Loc 06 (CALIFORNIA)
Carrier/Loc 0111206 =State Loc 06 (CALIFORNIA)
Carrier/Loc 0111209 =State Loc 06 (CALIFORNIA)
Carrier/Loc 0111251 =State Loc 06 (CALIFORNIA)
Carrier/Loc 0111253 =State Loc 06 (CALIFORNIA)
Carrier/Loc 0111254 =State Loc 06 (CALIFORNIA)
Carrier/Loc 0111255 =State Loc 06 (CALIFORNIA)
Carrier/Loc 0111256 =State Loc 06 (CALIFORNIA)
Carrier/Loc 0111257 =State Loc 06 (CALIFORNIA)
Carrier/Loc 0111258 =State Loc 06 (CALIFORNIA)
Carrier/Loc 0111259 =State Loc 06 (CALIFORNIA)
Carrier/Loc 0111260 =State Loc 06 (CALIFORNIA)
Carrier/Loc 0111261 =State Loc 06 (CALIFORNIA)
Carrier/Loc 0111262 =State Loc 06 (CALIFORNIA)
Carrier/Loc 0111263 =State Loc 06 (CALIFORNIA)
Carrier/Loc 0111264 =State Loc 06 (CALIFORNIA)
Carrier/Loc 0111265 =State Loc 06 (CALIFORNIA)
Carrier/Loc 0111266 =State Loc 06 (CALIFORNIA)
Carrier/Loc 0111267 =State Loc 06 (CALIFORNIA)
Carrier/Loc 0111268 =State Loc 06 (CALIFORNIA)
Carrier/Loc 0111269 =State Loc 06 (CALIFORNIA)
Carrier/Loc 0111270 =State Loc 06 (CALIFORNIA)
Carrier/Loc 0118271 =State Loc 06 (CALIFORNIA)
Carrier/Loc 0118272 =State Loc 06 (CALIFORNIA)
Carrier/Loc 0118273 =State Loc 06 (CALIFORNIA)
Carrier/Loc 0118274 =State Loc 06 (CALIFORNIA)
Carrier/Loc 0118217 =State Loc 06 (CALIFORNIA)
Carrier/Loc 0111275 =State Loc 06 (CALIFORNIA)
Carrier/Loc 0411201 =State Loc 08 (COLORADO)
Carrier/Loc 1310200 =State Loc 09 (CONNECTICUT)
Carrier/Loc 1210201 =State Loc 10 (DELAWARE)
Carrier/Loc 1220201 =State Loc 11 (DISTRICT OF COLUMBIA)
Carrier/Loc 0910203 =State Loc 12 (FLORIDA)
Carrier/Loc 0910204 =State Loc 12 (FLORIDA)
Carrier/Loc 0910299 =State Loc 12 (FLORIDA)
Carrier/Loc 1020201 =State Loc 13 (GEORGIA)
Carrier/Loc 1020299 =State Loc 13 (GEORGIA)
Carrier/Loc 0121201 =State Loc 15 (HAWAII/GUAM)
Carrier/Loc 0220200 =State Loc 16 (IDAHO)
Carrier/Loc 0610216 =State Loc 17 (ILLINOIS)
Carrier/Loc 0610212 =State Loc 17 (ILLINOIS)
Carrier/Loc 0610215 =State Loc 17 (ILLINOIS)
Carrier/Loc 0610299 =State Loc 17 (ILLINOIS)

Carrier/Loc 0810200 =State Loc 18 (INDIANA)
Carrier/Loc 0510200 =State Loc 19 (IOWA)
Carrier/Loc 0520200 =State Loc 20 (KANSAS)
Carrier/Loc 1510200 =State Loc 21 (KENTUCKY)
Carrier/Loc 0720201 =State Loc 22 (LOUISIANA)
Carrier/Loc 0720299 =State Loc 22 (LOUISIANA)
Carrier/Loc 1411203 =State Loc 23 (MAINE)
Carrier/Loc 1411299 =State Loc 23 (MAINE)
Carrier/Loc 1230201 =State Loc 24 (MARYLAND)
Carrier/Loc 1230299 =State Loc 24 (MARYLAND)
Carrier/Loc 1421201 =State Loc 25 (MASSACHUSETTS)
Carrier/Loc 1421299 =State Loc 25 (MASSACHUSETTS)
Carrier/Loc 0820201 =State Loc 26 (MICHIGAN)
Carrier/Loc 0820299 =State Loc 26 (MICHIGAN)
Carrier/Loc 0620200 =State Loc 27 (MINNESOTA)
Carrier/Loc 0730200 =State Loc 28 (MISSISSIPPI)
Carrier/Loc 0530202 =State Loc 29 (MISSOURI)
Carrier/Loc 0530201 =State Loc 29 (MISSOURI)
Carrier/Loc 0530299 =State Loc 29 (MISSOURI)
Carrier/Loc 0320201 =State Loc 30 (MONTANA)
Carrier/Loc 0540200 =State Loc 31 (NEBRASKA)
Carrier/Loc 0131200 =State Loc 32 (NEVADA)
Carrier/Loc 1431240 =State Loc 33 (NEW HAMPSHIRE)
Carrier/Loc 1240201 =State Loc 34 (NEW JERSEY)
Carrier/Loc 1240299 =State Loc 34 (NEW JERSEY)
Carrier/Loc 0421205 =State Loc 35 (NEW MEXICO)
Carrier/Loc 1320201 =State Loc 36 (NEW YORK)
Carrier/Loc 1320202 =State Loc 36 (NEW YORK)
Carrier/Loc 1320203 =State Loc 36 (NEW YORK)
Carrier/Loc 1329204 =State Loc 36 (NEW YORK)
Carrier/Loc 1328299 =State Loc 36 (NEW YORK)
Carrier/Loc 1150200 =State Loc 37 (NORTH CAROLINA)
Carrier/Loc 0330201 =State Loc 38 (NORTH DAKOTA)
Carrier/Loc 1520200 =State Loc 39 (OHIO)
Carrier/Loc 0431200 =State Loc 40 (OKLAHOMA)
Carrier/Loc 0230201 =State Loc 41 (OREGON)
Carrier/Loc 0230299 =State Loc 41 (OREGON)
Carrier/Loc 1250201 =State Loc 42 (PENNSYLVANIA)
Carrier/Loc 1250299 =State Loc 42 (PENNSYLVANIA)
Carrier/Loc 0920220 =State Loc 72 (PUERTO RICO)
Carrier/Loc 1441201 =State Loc 44 (RHODE ISLAND)
Carrier/Loc 1120201 =State Loc 45 (SOUTH CAROLINA)
Carrier/Loc 0340202 =State Loc 46 (SOUTH DAKOTA)
Carrier/Loc 1030235 =State Loc 47 (TENNESSEE)
Carrier/Loc 0441231 =State Loc 48 (TEXAS)
Carrier/Loc 0441220 =State Loc 48 (TEXAS)
Carrier/Loc 0441209 =State Loc 48 (TEXAS)
Carrier/Loc 0441211 =State Loc 48 (TEXAS)
Carrier/Loc 0441228 =State Loc 48 (TEXAS)

Carrier/Loc 0441215 =State Loc 48 (TEXAS)
Carrier/Loc 0441218 =State Loc 48 (TEXAS)
Carrier/Loc 0441299 =State Loc 48 (TEXAS)
Carrier/Loc 0350209 =State Loc 49 (UTAH)
Carrier/Loc 1451250 =State Loc 50 (VERMONT)
Carrier/Loc 0920250 =State Loc 78 (VIRGIN ISLANDS)
Carrier/Loc 1130200 =State Loc 51 (VIRGINIA)
Carrier/Loc 0240202 =State Loc 53 (WASHINGTON)
Carrier/Loc 0240299 =State Loc 53 (WASHINGTON)
Carrier/Loc 1140216 =State Loc 54 (WEST VIRGINIA)
Carrier/Loc 0630200 =State Loc 55 (WISCONSIN)
Carrier/Loc 0360221 =State Loc 56 (WYOMING)
50.5 - Jurisdiction of Laboratory Claims
(Rev. 3071, Issued: 09-19-14, Effective: 12-22-14, Implementation: 12-22-14)
Jurisdiction of payment requests for laboratory services furnished by an independent
laboratory, except where indicated in §50.5.1 and §50.5.2, lies with the A/B MAC (B)
serving the area in which the laboratory test is performed. Jurisdiction is not affected by
whether or not the independent laboratory uses a central billing office and whether or not
the laboratory provides services to customers outside its A/B MAC (B)’s service area.
The location where the independent laboratory performed the test determines the
50.appropriate billing jurisdiction. Therefore, even if the sample originates in a different
jurisdiction from where the sample is being tested, the claim would still be filed in the
jurisdiction where the test was performed.
Claims filing jurisdiction for the specimen collection fee and travel allowance is also
determined by the location where the test was performed. When billed by an independent
lab, the specimen collection fee and travel allowance must be billed in conjunction with a
covered lab test. For more information about the specimen collection fee and travel
allowance, see §60.1 and §60.2, respectively.
50.5.1 - Jurisdiction Of Referral Laboratory Services
(Rev. 85, 02-06-04)
Regardless of whether the laboratory that bills Medicare is the referring or reference
laboratory, the laboratory that does the billing may bill only the A/B MAC (B) that
services the jurisdiction in which the billing laboratory is physically located. The
location of the draw station, when a separate draw station is employed, never determines
claims filing jurisdiction.
50.5.2 - Examples of Reference Laboratory Jurisdiction Rules
(Rev. 85, 02-06-04)
B3-3102
EXAMPLE 1:
Scenario 1:

An independent laboratory located in Oregon performs laboratory services for physicians
whose offices are located in several neighboring States. A physician from Nevada sends
specimens to the Oregon laboratory.
Jurisdiction: The A/B MAC (B) in Oregon has jurisdiction.
EXAMPLE 2:
Scenario 2: American Laboratories, Inc., is an independent laboratory company with
branch laboratories located in Philadelphia, PA and Wilmington, DE, as well as regional
laboratories located in Millville, NJ and Boston, MA.
The Philadelphia laboratory receives a blood sample from a patient whose physician
ordered a complete blood count, a basic metabolic panel and a B12 and folate. The
Philadelphia laboratory performs the complete blood count, but the basic metabolic panel
is performed at the Millville laboratory, while the B12 and folate is performed at the
Boston Laboratory.
Jurisdiction: The Pennsylvania A/B MAC (B) may retain jurisdiction for processing the
claim for all of the services. The A/B MAC (B) servicing Boston and/or Millville may
have jurisdiction for processing their claims if those laboratories bill for the services they
perform, but the Philadelphia laboratory is barred from billing for the services that
Boston and Millville submit for payment.
EXAMPLE 3:
Scenario 3: Same relationships as in Example 2. American Laboratories, Inc., is an
independent laboratory company with branch laboratories located in Philadelphia, PA
and Wilmington, DE, as well as regional laboratories located in Millville, NJ and Boston,
MA.
This time the Wilmington laboratory draws a blood specimen from a patient whose
physician has ordered a blood culture. The Wilmington laboratory then sends the
specimen to the Boston laboratory, which performs the required test.
Jurisdiction: The A/B MAC (B) processing claims for providers/suppliers located in
Delaware may retain jurisdiction for processing the claim. If the laboratory in Boston
chooses to bill for the service to the Massachusetts A/B MAC (B), then the Wilmington
laboratory may not bill for the service.
60 - Specimen Collection Fee and Travel Allowance
(Rev. 1, 10-01-03)
B3-5114.1
60.1 - Specimen Collection Fee
(Rev. 13576; Issued: 01-08-26, Effective: 01-01-2026: Implementation: 01-05-2026)
Section 1833(h)(3) of the Act specifies that the Secretary shall
provide for and establish a nominal fee in addition to the payment

amounts for CDLTs on the
CLFS to cover the appropriate costs of collecting the sample on
which a clinical diagnostic laboratory test (CDLT) was performed and
for which payment is made with respect to samples collected in the
same encounter. The nominal fee is intended to cover the appropriate
costs in collecting the sample, which could include the costs related
to drawing, collecting, or handling a specimen.
Specimen Collection Fee Eligibility
To be eligible for a specimen collection fee, the specimen must be:
• 	used to perform a CDLT paid under the CLFS regulations
at 42 CFR part 414, subpart G, § 414.523;
• 	collected by a trained technician from a Medicare
beneficiary who is homebound, as described in § 424.22(a)(1)(ii),
or is a non-hospital inpatient, but only when no qualified
personnel are available at the facility to collect the specimen;
and,
• 	of the following type—a blood specimen collected
through venipuncture or a urine sample collected by
catheterization.
Trained Technician
The phrase “trained technician” refers to those staff providing specimen
collection services. However, “trained technician” does not mandate certain
educational requirements and for the purposes of the specimen collection
provisions, the term includes a phlebotomist.
Specimen Collection Type
A specimen collection fee is allowed in two circumstances:
(1) 	drawing a blood sample through venipuncture (i.e.,
inserting into a vein a needle with syringe or vacutainer to draw the
specimen) or
(2) 	collecting a urine sample by catheterization.
A specimen collection fee is not payable for any other specimen
types, including blood samples where the cost of collecting the
specimen is minimal (such as a throat culture or a routine capillary
puncture for clotting or bleeding time). This fee will not be paid to
anyone who has not extracted the specimen. Only one collection fee
is allowed for each type of specimen for each patient encounter,
regardless of the number of specimens drawn. This means that, if
different types or multiple specimens are drawn from one patient,
only one specimen collection fee would be allowed. Additionally,

when a series of specimens is required to complete a single test (e.g.,
glucose tolerance test), the series is treated as a single encounter.
Specimen Collection Fee Rate
Effective January 1, 2026, CMS pays a general specimen collection fee of $9.34 for all
specimens collected in one patient encounter. This fee is increased by $2 ($11.34) for
specimen collection from a Medicare beneficiary in a skilled nursing facility (SNF) or on
behalf of a home health agency (HHA) for all specimens collected in one patient
encounter.
Specimen Collection Fee Annual Update
Beginning January 1, 2024, the specimen collection fee amount will
update for each calendar year (CY) by the percent change in the
Consumer Price Index for All Urban Consumers (CPI-U) (U.S city
average) for the 12-month period ending June 30th of the year
preceding the update year. CMS issues these updates to the specimen
collection fee amounts through subregulatory guidance, specifically
the existing CMS change request process, on an annual basis.
60.1.1 - Independent Laboratory Specimen Drawing
(Rev. 11778, Issued:01-06-23; Effective:01-01-23; Implementation:01-23-23)
Medicare allows separate charges made by laboratories for drawing or collecting
specimens whether or not the specimens are referred to hospitals or independent
laboratories. The laboratory does not bill for routine handling charges where a specimen
is referred by one laboratory to another.
Payment for the specimen collection fee is made based on the clinical laboratory fee
schedule.
Medicare allows payment for a specimen collection fee when it is medically necessary
for a trained technician to draw a specimen from either a nursing home patient, a non-
hospital inpatient or homebound patient.
The trained technician must personally draw the specimen, i.e., venipuncture or urine
sample by catheterization. Medicare does not allow a specimen collection fee to the
visiting technician if a patient in a facility is (a) not confined to the facility, or (b) the
facility has personnel on duty qualified to perform the specimen collection. Medical
necessity for such services exists, for example, where a trained technician draws a blood
specimen from a homebound or an institutionalized patient. A patient need not be
bedridden to be homebound.
However, where the specimen is a type that would require only the services of a
messenger and would not require the skills of a trained technician, e.g., urine or sputum, a
specimen pickup service would not be considered medically necessary. (See Chapters 7
and 15 of Pub. 100-02, the Medicare Benefit Policy Manual for a discussion of

“homebound” and a more complete definition of a medically necessary laboratory service
to a homebound or an institutional patient.)
Claims Annotation
In addition to the usual information required on claim forms (including the name of the
prescribing physician), all independent laboratory claims for such specimen drawing
prescribed by a physician should be appropriately annotated, e.g., “patient confined to
home,” “patient homebound,” or “patient in nursing home, no qualified person on duty to
draw specimen.” A/B MACs (B) must assure the validity of the annotation through
scientific claims samples as well as through regular bill review techniques. (This could
be done by use of the information in A/B MAC (B) files, and where necessary, contact
with the prescribing physician.)
Medical Necessity Requirement
If a physician requests an independent laboratory to obtain specimens in situations which
do not meet, or without regard to whether they meet, the medical necessity criteria in
Chapter 15 of the Medicare Benefit Policy Manual, an educational contact with the
prescribing physician is warranted and, where necessary, corroborating documentation
should be obtained on claims until the A/B MAC (B) is assured that the physician
prescribes such services only when the criteria are met.
The specimen collection fee is paid based on the location of the independent laboratory
where the test is performed and is billed in conjunction with a covered laboratory test.
60.1.2 - Coding Requirements for Specimen Collection
(Rev. 11778, Issued:01-06-23; Effective:01-01-23, Implementation:01-23-23)
The following HCPCS codes and terminology must be used:
• 	36415 - Collection of venous blood by venipuncture.
• 	G0471 - Collection of venous blood by venipuncture or urine sample by
catheterization from an individual in a skilled nursing facility (SNF) or by a
laboratory on behalf of a home health agency (HHA)
• 	P9612 - Catheterization for collection of specimen(s), (single patient), all places
of services
• 	P96l5 - Catheterization for collection of specimen(s), (multiple patients)
The allowed amount for specimen collection in each of the above circumstances is
included in the laboratory fee schedule distributed annually by CMS via a Recurring
Update Notification (RUN) change request. Neither the annual deductible nor the 20
percent coinsurance for Medicare apply to the specimen collection fees.
60.1.3 - Specimen Drawing for Dialysis Patients
(Rev. 3056, Issued: 08-29-14, Effective: 04-01-14, Implementation: 12-01-14)

See the Medicare Benefit Policy Manual, Chapter 11, for a description of laboratory
services included in the composite rate. With the implementation of the ESRD PPS,
effective for claims with dates of service on or after January 1, 2011, all ESRD-related
laboratory services are included in the ESRD PPS base rate.
Clinical laboratory tests can be performed individually or in predetermined groups on
automated profile equipment. A specimen collection fee determined by CMS will be
allowed only in the following circumstances:
• 	Drawing a blood sample through venipuncture (i.e., inserting into a vein a needle
with a syringe or vacutainer to draw the specimen).
• 	Collecting a urine sample by catheterization.
Special rules apply when such services are furnished to dialysis patients. The specimen
collection fee is not separately payable for patients dialyzed in the facility or for patients
dialyzed at home under reimbursement Method I. A specimen collection fee is also not
separately payable when an ESRD facility is collecting a specimen for transplant
eligibility or other transplant requirements. Payment for specimen collection is included
under the ESRD PPS, regardless of whether the laboratory test itself is included in the
ESRD PPS or is separately billable with the AY modifier (see §40.6 of this chapter).
Fees for taking specimens in the hospital setting, but outside of the dialysis unit, for use
in performing laboratory tests not included in the ESRD composite rate may be paid
separately.
60.1.4 - Coding Requirements for Specimen Collection
(Rev. 3056, Issued: 08-29-14, Effective: 04-01-14, Implementation: 12-01-14)
The following HCPCS codes and terminology must be used:
• 	36415 - Collection of venous blood by venipuncture.
• 	G0471 - Collection of venous blood by venipuncture or urine sample by
catheterization from an individual in a skilled nursing facility (SNF) or by a
laboratory on behalf of a home health agency (HHA)
• 	P96l5 - Catheterization for collection of specimen(s).
The allowed amount for specimen collection in each of the above circumstances is
included in the laboratory fee schedule distributed annually by CMS.
60.2 - Travel Allowance
(Rev. 13746, Issued: 04-17-26; Effective:04-01-26; Implementation:04-06-26)
Section 1833(h)(3)(B) of the Act states that the Secretary shall provide for and
establish a fee in addition to the payment amounts for CDLTs on the CLFS to
cover the transportation and personnel expenses for trained personnel to travel to

the location of an individual to collect the sample.
Travel Allowance Eligibility
CMS pays a travel allowance when the specimen collection fee is paid.
Requirements regarding payment for specimen collection are described in Section
60.1 above and CFR § 414.523(a)(1). These requirements must be met for the
travel allowance to be payable.
Travel for simple pickup of specimens or for specimen collection that does not
require the services of trained technicians should not be considered in the
calculation of the travel allowance. This means that the travel allowance amount
may be paid only if a specimen collection fee is also payable; for example, no
travel allowance would be paid if a trained technician merely performs a
messenger service to pick up a specimen drawn by other technicians.
The travel allowance may be provided only with respect to an individual who is
homebound or an inpatient in an inpatient facility (other than a hospital), such that
travel allowance may only be paid when a trained technician draws a specimen
from a patient who either is in an inpatient facility that is not a hospital or is a
homebound patient.
Only one travel allowance payment may be made for specimen collection for a
Medicare beneficiary based on the beneficiary’s location, and only when a
Medicare beneficiary requires the collection of a specimen necessary for
performance of CDLTs.
Only Medicare patients should be considered in the calculation and payment of the
travel allowance, as the statutory language states “the location of an individual,”
that is, the location of a Medicare beneficiary receiving specimen collection
services. Non-Medicare patients should not be included in any portion of the
calculation of the travel allowance.
Travel Allowance Eligible Miles
For the purposes of travel allowance for specimen collection, eligible miles are
those miles traveled that may be included in the calculation to determine the travel
allowance amount. Eligible miles begin at the laboratory or the starting point of the
trained technician’s travel for specimen collection and end at the laboratory or the
ending point of the trained technician’s travel for specimen collection. A trained
technician’s travel for specimen collection from Medicare beneficiaries may begin
at a laboratory or at a location other than the laboratory. Therefore, eligible miles
begin at the laboratory or the starting point of the trained technician’s travel for
specimen collection. Additionally, a trained technician’s travel for specimen
collection from Medicare beneficiaries may end at a laboratory or at a location
other than the laboratory. Therefore, eligible miles end at the laboratory or the
ending point of the trained technician’s travel for specimen collection.
Eligible miles do not include miles traveled for any purpose unrelated to specimen

collection, such as collecting specimens from non-Medicare beneficiaries or for
personal reasons. Therefore, any miles traveled to a location where no specimens
are collected, such as to the location of a non-Medicare beneficiary for specimen
collection, to a Medicare beneficiary where no specimen collection occurs, or for
personal purposes, are excluded from the calculation of eligible miles.
Effective January 1, 2022, CMS has made permanent the option for laboratories to
maintain electronic documentation of miles traveled for the purposes of covering
the transportation and personnel expenses for trained technicians to travel to the
location of an individual to collect a specimen sample. This option for laboratories
to maintain electronic documentation applies to specimen collection for any
CDLT. Laboratories may utilize electronic and/or other documentation in order to
demonstrate miles traveled for the purposes of specimen collection. Laboratories
need to be able to produce electronic documentation in a form and manner that can
be shared with MACs and should continue to consult with their local MACs
regarding the format and process for submission of this information if necessary.
Travel Allowance Mileage Rate
The Act requires the travel allowance to cover both the “transportation” and
“personnel expenses” for trained personnel to travel to the location of an individual
to collect a sample. The travel allowance mileage rate reflects both of these
components.
The “transportation” component of the travel allowance mileage rate equals the
IRS standard mileage rate. The IRS updates and issues standard mileage rates on a
periodic basis, generally annually and are used to calculate the deductible costs of
operating an automobile for business, charitable, medical, or moving for the
purpose of calculating Federal taxes.
The “personnel expenses” component of the travel allowance mileage rate where
the trained technician’s personnel expenses is based on a wages-per-mile amount.
Effective January 1, 2023, CMS uses wage data in the Bureau of Labor Statistics
BLS-defined category of phlebotomist to establish the personnel expense
component of the travel allowance mileage rate.
Specifically, CMS uses the latest available published figure for the median hourly
wage amount for phlebotomists, which is published by the BLS, for the purposes of
annually updating the travel allowance amount for specimen collection.
CMS calculates a per-mile amount to derive the approximate number of miles
traveled by the trained technician each hour by using an average driving speed.
The average miles-per-hour driving speed is multiplied by the trained technician’s
estimated wages, as described above, and the result would be an amount that
represents wages per mile, which is the personnel expenses associated with travel
for specimen collection. CMS uses an average driving speed of 40 miles per hour,
as most of the travel related to specimen collection would be performed in local
and residential areas.
To establish the personnel expenses component of the travel allowance mileage rate,

which is a per-mile amount, CMS divides the most recent median hourly wage for
phlebotomists, as published by the BLS, by 40, to represent an average miles-per-
hour.
The total travel allowance mileage rate, which includes both the “transportation”
and “personnel expenses” for trained personnel to travel to the location of an
individual to collect a sample, is equal to the IRS standard mileage rate plus an
amount to cover expenses for a trained technician which is equal to the most recent
median hourly wage for phlebotomists, as published by the BLS, divided by 40 to
represent an average miles-per-hour driving speed.
Updates to the Travel Allowance Mileage Rate
Updates to the travel allowance mileage rate are issued through subregulatory
guidance, specifically the existing CMS change request process, on an annual
basis. Updates will be made to the travel allowance mileage rate based upon the
most recently published IRS standard mileage rate, as well as the most recently
published wage rate for phlebotomist as published by the BLS. The revised travel
allowance mileage rate will be effective for the January update of the clinical
laboratory fee schedule file.
The travel allowance mileage rate for CY2024 is $1.13:
• 	The IRS standard mileage rate, which is $0.67; plus,
• 	The most recent median hourly wage for phlebotomists, as published
by the BLS, which is $18.53, divided by 40 to represent an average
miles-per-hour driving speed, which is $0.46.
• 	Yielding a total travel allowance mileage rate for CY2024 of $1.133,
rounded up to $1.13.
Travel Allowance Bases: Flat-Rate and Per-Mile
CMS pays a travel allowance on the following bases:
(1) 	flat-rate travel allowance; and
(2) 	per-mile travel allowance.
Flat-Rate Travel Allowance
The flat-rate travel allowance basis applies when the trained technician travels 20
eligible miles or less to and from one location for specimen collection from one or
more Medicare beneficiaries.
Laboratories bill Medicare using HCPCS code P9604 to receive payment for the
flat-rate travel allowance amount, prorated by the number of beneficiaries for
whom a specimen collection fee is paid.
Per-Mile Travel Allowance

The per-mile travel allowance basis applies in two circumstances:
1) 	When the round-trip travel to one location is greater than 20 eligible miles
for specimen collection from one or more beneficiaries; or,
2) 	When travel is to more than one location, regardless of the number of
miles traveled.
Laboratories bill Medicare using HCPCS code P9603 to receive payment for the
per-mile travel allowance amount, prorated by the number of beneficiaries for
whom a specimen collection fee is paid.
Effective for claims with Date of Service on or after April 1, 2026, the billing of
HCPCS code P9603 is acceptable when calculated to the tenth of a mile (ex., 13.7
miles) when units billed are less than 100 eligible miles. Standard rounding rules
apply in order to calculate to the nearest tenth of a mile. 	When calculated to
100+ eligible miles, only units equal to whole numbers are allowable for HCPCS
code P9603.
For trips totaling up to 100 eligible miles, the mileage must be rounded up to the nearest
tenth of a mile. The decimal must be used in the appropriate place (e.g., 99.9).
For trips totaling 100 eligible miles and greater, the mileage must be rounded to the
nearest whole number without the use of a decimal (e.g., 998.5 miles should be reported
as 999).
For trips totaling less than 1 eligible mile, enter a “0” before the decimal (e.g., 0.9).
Travel Allowance Amount Calculation: Flat-rate Travel Allowance Basis
For flat-rate travel allowance basis, the travel allowance amount calculation is the
travel allowance mileage rate multiplied by ten (10) and divided by the number of
beneficiaries for whom a specimen collection fee is paid.
Dividing by the number of beneficiaries for whom a specimen collection fee is paid
ensures that the flat-rate travel allowance amount is apportioned to each
beneficiary receiving specimen collection services and that payment is calculated
in an operationally feasible manner, as a laboratory must submit a claim for each
beneficiary to receive payment for travel allowance. This method allows for a
fixed payment amount to be straightforwardly apportioned to the number of
beneficiaries for whom a specimen collection fee is paid in a single location.
Example: Flat-rate Travel Allowance Calculation
For an example of the flat-rate travel allowance calculation, consider a situation in
which a trained technician travels 7 miles from the laboratory to a nursing home to
collect blood specimens collected through venipuncture from five patients, four of
whom are Medicare beneficiaries.

The trained technician collects three specimens from Medicare beneficiaries,
collects one specimen from the non-Medicare patient, and simply picks up a
previously collected specimen from one Medicare beneficiary. The trained
technician then drives 7 miles back to the laboratory to deliver the specimens
without making any other stops.
The trained technician has provided specimen collection services to three Medicare
beneficiaries. One Medicare beneficiary did not require specimen collection
services, and therefore, a specimen collection fee would not be payable.
In this example, the laboratory would use the flat-rate travel allowance basis
because the trained technician traveled a total of 14 miles. To calculate the travel
allowance mileage rate, the laboratory would divide flat-rate travel allowance
amount of $11.30 by the number of beneficiaries for whom a specimen collection
fee is paid (three beneficiaries), which equals $3.77. To bill for the travel
allowance, the laboratory would submit one claim for each beneficiary for whom a
specimen collection fee is paid by billing HCPCS code P9604.
Calculation: Per-mile Travel Allowance Basis
The calculation for the per-mile travel allowance amount is equal the number of
eligible miles multiplied by the travel allowance mileage rate, divided by the
number of beneficiaries for whom a specimen collection fee is paid.
To calculate the per-mile travel allowance amount, the laboratory would first
calculate the total number of eligible miles that the trained technician traveled –
this would be the total number of miles traveled by the trained technician to
locations where one or more Medicare beneficiaries received specimen collection
services and back to the laboratory where the technician returns the specimen(s)
for testing.
The eligible miles would be multiplied by the travel allowance mileage rate as
described above, then divided by the number of beneficiaries for whom a specimen
collection fee is paid. This quotient yields a prorated travel allowance amount for
each beneficiary. The laboratory receives payment for the total number of eligible
miles traveled for specimen collection, apportioned equally to each Medicare
beneficiary for whom a specimen collection fee is paid. The laboratory then
submits a claim billing HCPCS code P9603 for payment of the per-mile travel
allowance amount for each beneficiary for whom a specimen collection fee is paid.
Examples: Per-mile Travel Allowance Amount Calculation Example 1:
For an example of the per-mile travel allowance amount calculation, consider a
trained technician traveling 45 miles from a laboratory in a city to a rural SNF,
collecting blood specimens through venipuncture from 6 Medicare beneficiaries,
and then driving 45 miles to return to the laboratory.
In this example, the laboratory would use the per-mile travel allowance basis
because the trained technician traveled more than 20 eligible miles to one location
for specimen collection.

To calculate the per-mile travel allowance amount, the laboratory would sum the
eligible miles traveled to the location of Medicare beneficiaries receiving specimen
collection services, which, in this case is 45 miles from the laboratory to the SNF
and 45 miles from the SNF returning to the laboratory, for a total of 90 eligible
miles.
The eligible miles would then be multiplied by the travel allowance mileage rate of
$1.13, yielding a total of $101.70. This total amount would then be prorated by
dividing by the number of Medicare beneficiaries for whom a specimen collection
fee is paid (6), yielding a per-beneficiary amount of $16.95 ($101.70/6 = $16.95).
To bill for the travel allowance, the laboratory would submit one claim for each
beneficiary in the amount of $16.95 HCPCS code P9603.
Example 2:
In another example, a trained technician travels 40 miles from a laboratory to the
location of a Medicare beneficiary to collect a blood specimen through
venipuncture, then travels 10 miles to the location of a non- Medicare patient to
collect a blood specimen through venipuncture, then travels 20 miles to the
location of two Medicare beneficiaries to collect urine specimens by
catheterization, and then travels 20 miles to return to the laboratory.
In this example, the laboratory would use the per-mile travel allowance basis
because the trained technician traveled to more than one location for specimen
collection.
To calculate the per-mile travel allowance amount, the laboratory would sum the
eligible miles, which would include the miles traveled from the laboratory to the
locations of Medicare beneficiaries to collect specimens plus the miles back to the
laboratory for specimen drop-off. Eligible miles would not include the 10 miles
traveled to the location of the non-Medicare patient to collect a specimen, but
would include the 40 miles traveled from the laboratory to the location of the first
Medicare beneficiary, the 20 miles to the location of the two Medicare
beneficiaries, and the return trip to the laboratory of 20 miles, for a total of 80
eligible miles.
The eligible miles would then be multiplied by the travel allowance mileage rate of
$1.13, yielding a total of $90.40. This total would then be prorated by dividing by
three (3) Medicare beneficiaries for whom a specimen collection fee is paid,
yielding an amount of $30.13. The laboratory would then submit a claim using
HCPCS code P9603 for travel allowance for each of the Medicare beneficiaries in
the amount of $30.13. The laboratory would receive payment for the eligible miles
traveled by the trained technician, apportioned equally to each Medicare
beneficiary for whom a specimen collection fee is paid.
Neither the annual deductible nor the 20 percent coinsurance for Medicare apply to
the travel allowance amount for CDLTs.

70 - Clinical Laboratory Improvement Amendments (CLIA)
Requirements
(Rev. 1, 10-01-03)
A3-3628.2, RHC-640, ESRD 322, HO-306, HHA-465, SNF 541, HO-437.2,
PM B-97-3
70.1 - Background
(Rev. 3014, Issued: 08-06-14, Effective: ICD- 10: Upon Implementation of ICD-10
ASC-X12: 01-01-12, Implementation: ICD-10: Upon Implementation of ICD-10
ASC X12: 09-08-14)
The Clinical Laboratory Improvements Amendments of 1988 (CLIA), Public Law 100-
578, amended §353 of the Public Health Service Act (PHSA) to extend jurisdiction of the
Department of Health and Human Services to regulate all laboratories that examine
human specimens to provide information to assess, diagnose, prevent, or treat any disease
or impairment. The purpose of the CLIA program is to assure that laboratories testing
specimens in interstate commerce consistently provide accurate procedures and services.
As a result of CLIA, any laboratory soliciting or accepting specimens in interstate
commerce for laboratory testing is required to hold a valid license or letter of exemption
from licensure issued by the Secretary of HHS. The term “interstate commerce” means
trade, traffic, commerce, transportation, or communication between any state, possession
of the United States, the Commonwealth of Puerto Rico, or the District of Columbia, and
any place outside thereof, or within the District of Columbia.
The CLIA mandates that virtually all laboratories, including physician office laboratories
(POLs), meet applicable Federal requirements and have a CLIA certificate in order to
receive reimbursement from Federal programs. CLIA also lists requirements for
laboratories performing only certain tests to be eligible for a certificate of waiver or a
certificate for Physician Performed Microscopy Procedures (PPMP). Since 1992, A/B
MACs (B) have been instructed to deny clinical laboratory services billed by independent
laboratories which did not meet the CLIA requirements. POLs were excluded from the
1992 instruction but included in 1997.
The CLIA number must be included on each claim billed on the ASC X12 837
professional format or Form CMS-1500 claim for laboratory services by any laboratory
performing tests covered by CLIA. See §70.2 and 70.10 for more information.
70.2 - Billing
(Rev. 3014, Issued: 08-06-14, Effective: ICD- 10: Upon Implementation of ICD-10
ASC-X12: 01-01-12, Implementation: ICD-10: Upon Implementation of ICD-10
ASC X12: 09-08-14)
See §70.10 for instructions for reporting the CLIA number.
70.3 - Verifying CLIA Certification
(Rev. 865, Issued: 02-17-06; Effective: 01-01-06; Implementation: 07-03-06)

CWF edits A/B MAC (B) claims to ascertain that the laboratory identified by the CLIA
number is certified to perform the test. (CWF uses data supplied from the certification
process.) See Chapter 27 for related specifications.
Providers that bill A/B MACs (A) are responsible for verifying CLIA certification prior
to ordering laboratory services under arrangement. The survey process validates that
these providers have procedures in place to insure that laboratory services are provided
by CLIA approved laboratories.
Refer to the Medicare State Operations Manual for information about CLIA license or the
CLIA licensure exemptions.
70.4 - CLIA Numbers
(Rev. 1, 10-01-03)
A3-3628.2.D
The structure of the CLIA number follows:
Positions 1 and 2 contain the State code (based on the laboratory’s physical
location at time of registration);
Position 3 contains the letter “D"; and
Positions 4-10 contain the unique CLIA system assigned number that identifies
the laboratory. (No other laboratory in the country has this number.)
Initially, providers are issued a CLIA number when they apply to the CLIA program.
Independent dialysis facilities must obtain a CLIA certificate in order to perform clotting
time tests.
70.5 - CLIA Categories and Subcategories
(Rev. 11463; Issued: 06-23-22; Effective: 07-25-22; Implementation: 07-25-22)
A laboratory may be licensed or exempted from licensure in several major categories of
procedures. These major categories are:
Category
Number
Category/Subcategory Name
010 	Histocompatibility
100 	Microbiology
110 	Bacteriology
115 	Mycobacteriology
120 	Mycology
130 	Parasitology
140 	Virology
150 	Other Microbiology
200 	Diagnostic Immunology
210 	Syphilis Serology

Category
Number
Category/Subcategory Name
220 	General Immunology
300 	Chemistry
310 	Routine
320 	Urinalysis
330 	Endocrinology
340 	Toxicology
350 	Other
400 	Hematology
500 	Immuno-hematology
510 	ABO Group and RH Type
520 	Antibody Detection (Transfusion)
530 	Antibody Detection (Non
Transfusion)
540 	Antibody Identification
550 	Compatability Testing
560 	Other
600 	Pathology
610 	Histopathology
620 	Oral Pathology
630 	Cytology
800 	Radioassay
900 	Clinical Cytogenics
Information regarding CLIA test complexity categorization can be found by searching the
U.S. Food and Drug Administration website (www.fda.gov).
70.6 - Certificate for Provider-Performed Microscopy Procedures
(Rev. 865, Issued: 02-17-06; Effective: 01-01-06; Implementation: 07-03-06)
Effective January 19, 1993, a laboratory that holds a certificate for provider-performed
microscopy procedures may perform only those tests specified as provider-performed
microscopy procedures and waived tests, as described below, and no others.
HCPCS
Code
Test
Q0111 	Wet mounts, including preparations of vaginal, cervical or skin specimens
Q0112 	All potassium hydroxide (KOH) preparations
Q0113 	Pinworm examinations
Q0114 	Fern test
Q0115 	Post-coital direct, qualitative examinations of vaginal or cervical mucous

81015 	Urinalysis; microscopic only
81000 	Urinalysis, by dipstick or tablet reagent for bilirubin, glucose, hemoglobin,
ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any
number of these constituents; non-automated, with microscopy
81001 	Urinalysis, by dipstick or tablet reagent for bilirubin, glucose, hemoglobin,
ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any
number of these constituents; automated, with microscopy (NOTE: May
only be used when the lab is using an automated dipstick urinalysis
instrument approved as waived.)
81020 	Urinalysis; two or three glass test
89055 	Fecal leukocyte examination
89190 	Nasal smears for eosinophils
G0027 	Semen analysis; presence and/or motility of sperm excluding Huhner
70.7 - Deleted - Held for Expansion
(Rev. 1, 10-01-03)
70.8 - Certificate of Waiver
(Rev. 11463; Issued: 06-23-22; Effective: 07-25-22; Implementation: 07-25-22)
Effective September 1, 1992, all laboratory testing sites (except as provided in 42 CFR
493.3(b)) must have either a CLIA certificate of waiver, certificate for provider-
performed microscopy procedures, certificate of registration, certificate of compliance, or
certificate of accreditation to legally perform clinical laboratory testing on specimens
from individuals in the United States.
The Food and Drug Administration approves CLIA waived tests on a flow basis. The
CMS identifies CLIA waived tests by providing an updated list of waived tests to the A/B
MACs (A) and (B) on a quarterly basis via a Recurring Update Notification. To be
recognized as a waived test, some CLIA waived tests have unique HCPCS procedure
codes and some must have a QW modifier included with the HCPCS code.
Information regarding CLIA test complexity categorization can be found by searching the
U.S. Food and Drug Administration website (www.fda.gov).
70.9 - HCPCS Subject To and Excluded From CLIA Edits
(Rev. 11463; Issued: 06-23-22; Effective: 07-25-22; Implementation: 07-25-22)
At this time, all claims submitted for laboratory tests subject to CLIA are edited at the
CLIA certificate level. However, the HCPCS codes that are considered a laboratory test
under CLIA change each year. The CMS identifies the new HCPCS (non-waived, non-
provider-performed procedure) codes, including any modifiers that are subject to CLIA

edits by providing an updated listing of these tests to the A/B MACs (A) and (B) on an
annual basis via a Recurring Update Notification. A facility that submits a claim for any
test mentioned in the HCPCS codes that are subject to CLIA edits list must have either a
valid, current CLIA certificate of registration (certificate type 9), a CLIA certificate of
compliance (certificate type 1), or a CLIA certificate of accreditation (certificate type 3).
Information regarding CLIA test complexity categorization can be found by searching the
U.S. Food and Drug Administration website (www.fda.gov).
In addition, the CMS identifies the new HCPCS codes in the 80000 series that are
excluded from CLIA edits by providing an updated listing of these tests to the A/B
MACs (A) and (B) on an annual basis via a Recurring Update Notification. No CLIA
certificate is required for a claim submitted for any test mentioned in the HCPCS codes in
the 80000 series that are excluded from CLIA edits list.
70.10 - CLIA Number Submitted on Claims from Independent Labs
(Rev. 3014, Issued: 08-06-14, Effective: ICD- 10: Upon Implementation of ICD-10
ASC-X12: 01-01-12, Implementation: ICD-10: Upon Implementation of ICD-10
ASC X12: 09-08-14)
Effective with services provided October 1, 1997, any independent laboratory performing
tests covered by CLIA must submit the CLIA number on the claim as provided below.
The CLIA number is reported in:
• 	ASC X12 837 professional claim format REF segment as REF02, with qualifier
of “X4” in REF01, or
• 	Field 23 of the paper CMS-1500.
The CLIA number is not required on the ASC X12 institutional claim data set or its
related paper Form CMS-1450.
See Chapter 26 for detailed format instructions for the paper claim CMS-1500.
Laboratory claims submitted without the required CLIA number are returned as
unprocessable. If the CLIA number is submitted on the claim, but is inconsistent with the
CLIA format, the A/B MAC (B) returns the claim as unprocessable. If more than one
CLIA number is submitted on the claim, except when a reference laboratory is on the
same claim, the A/B MAC (B) returns the claim as unprocessable.
If the tests on one claim have been performed in more than one Physician Office
Laboratory (POL) by the same physician, the appropriate CLIA number should be
associated with the test that was performed in each laboratory. In such a case, the
physician must submit a separate claim for each location (CLIA number) where a test
was performed.
70.10.1 - Physician Notification of Denials
(Rev. 3510, Issued: 04-29-16, Effective: 10-01-16, Implementation; 10-03-16)

If there is no CLIA number on the claim, the contractor shall use the following
remittance advice message and associated codes when rejecting/denying claims under
this policy. This CARC/RARC combination is compliant with CAQH CORE Business
Scenario Two
Group Code: CO or PR
CARC: 16
RARC: MA120
MSN: N/A
70.11 - Reasons for Denial - Physician Office Laboratories Out-of-
Compliance
(Rev. 3510, Issued: 04-29-16, Effective: 10-01-16, Implementation; 10-03-16)
The contractor shall use the following remittance advice message and associated codes
when rejecting/denying claims under this policy. This CARC/RARC combination is
compliant with CAQH CORE Business Scenario Three.
Group Code: CO
CARC: B7
RARC: N/A
MSN: 14.1
80 - Issues Related to Specific Tests
(Rev. 1, 10-01-03)
80.1 - Screening Services
(Rev. 1, 10-01-03)
See chapter 18 for payment, edit and MSN requirements for the following screening
services.
• 	Screening Pap Smear and Pelvic Examination
• 	Screening Prostate Tests
• 	Colorectal Cancer Screening
80.2 - Anatomic Pathology Services
(Rev. 1, 10-01-03)
A3-3628.1, SNF 541.1, HO-437.1, RHC-437, CIM 50.20.1, PM AB-98-7, AB-98-22,
B-98-16, A-98-6, R103.CIM, A3-4603.1
Clinical laboratory tests include some services described as anatomic pathology services
in CPT (i.e., certain cervical, vaginal, or peripheral blood smears). The CPT code 85060
is used only when a physician interprets an abnormal peripheral blood smear for a
hospital inpatient or a hospital outpatient, and the hospital is responsible for the technical
component. When an independent laboratory bills a physician interpretation of an
abnormal peripheral blood smear, the service is considered a complete or global service,
and is not billed under the CPT code 85060. A physician interpretation of an abnormal

peripheral blood smear performed by an independent laboratory is considered a routine
part of the ordered hematology service (i.e., those tests that include a different white
blood count).
The HCPCS code 88150 (cervical or vaginal smears) included both screening and
interpretation in CPT 1986 terminology while the CPT 1987 terminology includes only
screening. A new code, 88151, was added for those smears that require physician
interpretation. Code 88151 is treated and priced in the same manner as code 88150 was
previously treated and priced. Code 88151 with a “-26” modifier is paid when a
physician performs an interpretation of an abnormal smear for a hospital inpatient or
outpatient, and the hospital is responsible for the technical component. The “-26”
modifier for code 88150 is no longer recognized. Code 88151(26) is priced as code
88150(26) would have been priced if the coding terminology had not been revised.
Independent laboratories bill under code 88150 for normal smears and under code 88151
for abnormal smears. However, the fee schedule amount is equivalent.
80.2.1 - Technical Component (TC) of Physician Pathology Services to
Hospital Patients
(Rev. 2714, Issued: 05-24-13, Effective: 07-01-12 Implementation: 06-25, 13)
Section 542 of the Benefits Improvement and Protection Act of 2000 (BIPA) provides
that the A/B MAC(B) can continue to pay for the TC of physician pathology services
when an independent laboratory furnishes this service to an inpatient or outpatient of a
covered hospital. This provision applies to TC services furnished during the 2-year
period beginning on January 1, 2001. Administrative extensions of this provision, and
new provisions established under Section 732 of the Medicare Modernization Act
(MMA); Section 104 of the Tax Relief and Health Care Act (TRHCA) of 2006; Section
104 of the Medicare, Medicaid and SCHIP Extension Act of 2007 (MMSEA); Section
136 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA);
Section 3104 of the Patient Protection and Affordable Care Act (PPACA); Section 105 of
the Medicare & Medicaid Extenders Act of 2010 (MMEA); and Section 3006 of the
Middle Class Tax Relief and Job Creation Act of 2012 (MCTRJCA) allow the A/B MAC
(B) to continue to pay for this service through June 30, 2012.
For this provision, covered hospital means a hospital that had an arrangement with an
independent laboratory or other entity that was in effect as of July 22, 1999, under which
the laboratory or other entity furnished the TC of physician pathology services to fee-for-
service Medicare beneficiaries who were hospital inpatients or outpatients and submitted
claims for payment for the TC to an A/B MAC (B). The TC could have been submitted
separately or combined with the professional component and reported as a combined
service.
The term “fee-for-service Medicare beneficiary” means an individual who:
1. Is entitled to benefits under Part A or enrolled under Part B of title XVIII or both;
and
2. Is not enrolled in any of the following:

a. A Medicare + Choice plan under Part C of such title;
b. A plan offered by an eligible organization under §1876 of the Act;
c. A program of all-inclusive care for the elderly under §1894 of the Act; or
d. A social health maintenance organization demonstration project established
under §4108(b) of the Omnibus Budget Reconciliation Act of 1987.
The following examples illustrate the application of the statutory provision to
arrangements between hospitals and independent laboratories and/or other entities.
In implementing BIPA §542; MMA §732; TRHCA §104; MMSEA §104; MIPPA §136;
and PPACA § 3104; MMEA § 105; and MCTRJCA § 3006, the A/B MAC (B) should
consider as independent laboratories any entity that it has previously recognized and paid
as an independent laboratory as of July 22, 1999.
An independent laboratory that has acquired another independent laboratory that had an
arrangement on July 22, 1999, with a covered hospital, can bill the TC of physician
pathology services for that hospital’s inpatients and outpatients under the physician fee
schedule through June 30, 2012.
EXAMPLE 1:
Prior to July 22, 1999, independent laboratory A had an arrangement with a hospital in
which this laboratory billed the A/B MAC (B) for the TC of physician pathology
services. In July 2000, independent laboratory B acquires independent laboratory A.
Independent laboratory B bills the A/B MAC (B) for the TC of physician pathology
services for this hospital’s patients in 2001 and forward.
If a hospital is a covered hospital, any independent laboratory that furnishes the TC of
physician pathology services to that hospital’s inpatients or outpatients can bill the A/B
MAC (B) for these services furnished in 2001 and forward up to June 30, 2012 (see note
below on last paragraph).
EXAMPLE 2:
As of July 22, 1999, the hospital had an arrangement with an independent laboratory,
laboratory A, under which that laboratory billed the A/B MAC (B) for the TC of
physician pathology service to hospital inpatients or outpatients. In 2001, the hospital
enters into an arrangement with a different independent laboratory, laboratory B, under
which laboratory B wishes to bill its A/B MAC (B) for the TC of physician pathology
services to hospital inpatients or outpatients. Because the hospital is a “covered
hospital,” independent laboratory B can bill its A/B MAC (B) for the TC of physician
pathology services to hospital inpatients or outpatients.
If the arrangement between the independent laboratory and the covered hospital limited
the provision of TC physician pathology services to certain situations or at particular

times, then the independent laboratory can bill the A/B MAC (B) only for these limited
services.
An independent laboratory that furnishes the TC of physician pathology services to
inpatients or outpatients of a hospital that is not a covered hospital may not bill the A/B
MAC (B) for TC of physician pathology services furnished to patients of that hospital.
An independent laboratory or other entity that has an arrangement with a covered hospital
should forward a copy of this agreement or other documentation to its A/B MAC (B) to
confirm that an arrangement was in effect between the hospital and the independent
laboratory as of July 22, 1999. This documentation should be furnished for each covered
hospital the independent laboratory or other entity services. If the laboratory or other
entity did not have an arrangement with the covered hospital as of July 22, 1999, but has
subsequently entered into an arrangement, then it should obtain a copy of the
arrangement between the predecessor laboratory or other entity and the covered hospital
and furnish this to the A/B MAC (B). The A/B MAC (B) maintains a hard copy of this
documentation for postpayment reviews.
Please Note: Effective on or after July 1, 2012, only the hospital may bill for the TC of a
physician pathology service provided to an inpatient or outpatient. Neither example 1 nor
example 2 above will apply for claims with dates of service on or after July 1, 2012.
80.3 - National Minimum Payment Amounts for Cervical or Vaginal
Smear Clinical Laboratory Tests
(Rev. 1, 10-01-03)
PM AB-99-84, AB-99-99
For cervical or vaginal smear clinical laboratory tests, payment is the lesser of the local
fee or the national limitation amount, but not less than the national minimum payment
amount (NMPA). However, in no case may payment for these tests exceed actual
charges. The Part B deductible and coinsurance do not apply.
For tests performed on or after January 1, 2000, a NMPA of $14.60 is established and
applies for cervical or vaginal smear clinical laboratory tests in accordance with §224 of
the Balanced Budget Refinement Act (Public Law 106-113). The affected CPT
laboratory test codes for the NMPA are 88142, 88143, 88144, 88145, 88147, 88148,
88150, 88152, 88153, 88154, 88164, 88165, 88166, 88167, G0123, G0143, G 0144,
G0145, G0147, G0148, and P3000.
The NMPA will be reviewed and updated in conjunction with the clinical laboratory fee
schedule, as required. Instructions for such updates will be sent to A/B MACs (A) and
(B) through periodic temporary instructions.
80.4 - Oximetry
(Rev. 1, 10-01-03)
B3-5114.1
Certain blood gas levels are determined either by invasive means through use of a blood
specimen for a clinical laboratory test or by noninvasive means through ear or pulse

oximetry, which is not considered a clinical laboratory test. CPT code 82792 is used for
invasive oximetry. HCPCS code M0592 is used for ear and pulse oximetry. Code
M0592 is not subject to fee schedules.
90 - Automated Profile Tests and Organ/Disease Oriented Panels
(Rev. 1, 10-01-03)
The term “profile” or “panel” means a grouping of laboratory tests, which is usually
performed automatically on a single piece of testing equipment.
90.1 - Laboratory Tests Utilizing Automated Equipment
(Rev. 4299; Issued: 05-03-19; Effective: 01-01-19; Implementation: 10-07-19)
B3-5114, HO-437, A3-3628
Clinical laboratory tests are covered under Medicare if they are reasonable and necessary
for the diagnosis or treatment of an illness or injury. Because of the numerous
technological advances and innovations in the clinical laboratory field and the increased
availability of automated testing equipment, no distinction is generally made in
determining payment for individual tests because of either (1) the sites where the service
is performed, or (2) the method of the testing process used, whether manual or
automated. Whether the test is actually performed manually or with automated
equipment, the services are considered similar and the payment is the same.
90.1.1 - Automated Test Listing
(Rev. 4299, Issued: 05-03-19, Effective: 01-01-19, Implementation: 10-07-19)
B3-5114, HO-437, A3-3628, PMs AB-97-5, AB-97-7, AB-97-17
Profiles are specific groupings of blood chemistries that enable physicians to more
accurately diagnose their patients’ medical problems. While the component tests in
automated profiles may vary somewhat from one laboratory to another, or from one
physician’s office or clinic to another, in order to develop appropriate payment amounts,
A/B MACs (A) and (B) group together those profile tests that can be performed at the
same time on the same equipment. The A/B MAC (A) or (B) must group together the
individual tests in the profile when billed separately and consider the price of the related
automated profile test. Payment cannot exceed the lower of the profile price or the totals
of the prices of all the individual tests. (This rule is applicable also if the tests are done
manually.) The profile HCPCS code and each individual test is priced at the lower of the
billed charge or the fee amount; and payment is made at the lower of the profile/panel
price or the total of the prices for all covered components.
Payment is made only for those tests in an automated profile that meet Medicare
coverage rules. Where only some of the tests in a profile of tests are covered, payment
cannot exceed the amount that would have been paid if only the covered tests had been
ordered. For example, the use of the 12-channel serum chemistry test to determine the
blood sugar level in a proven case of diabetes is unreasonable because the results of a
blood sugar test performed separately provide the essential information. Normally, the
payment allowance for a blood sugar test is lower than the payment allowance for the
automated profile of tests. In no event, however, may payment for the covered tests
exceed the payment allowance for the profile.

However, the A/B MAC (B) prices and pays the 1-22 automated multi-channel chemistry
tests tested in §90.2 at the lowest possible amount in accordance with §90.3.
As of January 1, 2018, the profiles referenced in the above section are no longer
recognized by Medicare. The Protecting Access to Medicare Act of 2014 requires
Medicare to pay a weighted median collected from private payor rates for each
HCPCS code on the CLFS. Therefore the automated profiles described above are
no longer used to pay for the automated profiles of tests.
90.2 - Organ or Disease Oriented Panels
(Rev. 4299, Issued: 05-03-19, Effective: 01-01-19, Implementation: 10-07-19)
Prior to January 1, 2018, organ or disease panels must be paid at the lower of the billed
charge, the fee amount for the panel, or the sum of the fee amounts for all components.
Payment for the total panel may not exceed the sum total of the fee amounts for
individual covered tests. All Medicare coverage rules apply.
The Medicare shared systems must calculate the correct payment amount. The CMS
furnishes fee prices for each code but the A/B MAC (A) or (B) system must compare
individual codes billed with codes and prices for related individual tests. (With each
HCPCS update, HCPCS codes are reviewed and the system is updated). Once the codes
are identified, A/B MACs (A) and (B) publish panel codes to providers.
The only acceptable Medicare definition for the component tests included in the CPT
codes for organ or disease oriented panels is the American Medical Association (AMA)
definition of component tests. The CMS will not pay for the panel code unless all of the
tests in the definition are performed. If the laboratory has a custom panel that includes
other tests, in addition to those in the defined CPT or HCPCS panels, the additional tests,
are billed separately in addition to the CPT or HCPCS panel code.
NOTE: If a laboratory chooses, it can bill each of the component tests of these panels
individually, but payment will be based upon the above rules.
Effective for claims with dates of service on or after January 1, 2019, laboratories shall
bill the HCPCS panel test code and not unbundle the individual components if all
components of the HCPCS panel are performed. Claims will be returned as
unprocessable/rejected if the HCPCS panel test code is not billed. Providers and suppliers
are required to submit all AMCC laboratory test HCPCS for the same beneficiary,
performed on the same date of service on the same claim. This billing policy applies
when:
a). Submitting a complete organ disease panel; or
b). Submitting individual component tests of an organ disease panel when all components
of the panel were not performed.
TABLE OF CHEMISTRY PANELS

Hepatic
Function
Panel
80076
Basic
Metabolic
Panel
(Calcium,
ionized)
80047
Basic
Metabolic
Panel
(Calcium,
total)
80048
Comprehensive
Metabolic
Panel
80053
Renal
Function
Panel
80069
Lipid0F
1
Panel
80061
Electrolyte
Panel
80051
Chemistry 	CPT
Albumin 	82040 	X 	X 	X
Alkaline
phosphatase
84075 	X 	X
ALT (SGPT) 	84460 	X 	X
AST (SGOT) 	84450 	X 	X
Bilirubin, total 	82247 	X 	X
Bilirubin, direct 	82248 	X
Calcium 	82310 	X 	X 	X
Calcium ionized 	82330 	X
Chloride 	82435 	X 	X 	X 	X 	X
Cholesterol 	82465 	X
CK, CPK 	82550
CO2
(bicarbonate)
82374 	X 	X 	X 	X 	X
Creatinine 	82565 	X 	X 	X 	X
GGT 	82977
Glucose 	82947 	X 	X 	X 	X
LDH 	83615
Phosphorus 	84100 	X
Potassium 	84132 	X 	X 	X 	X 	X
Protein 	84155 	X 	X
Sodium 	84295 	X 	X 	X 	X 	X
Triglycerides 	84478 	X
Urea nitrogen
(BUN)
84520 	X 	X 	X 	X
Uric Acid 	84550
90.3 - Claims Processing Requirements for Panel and Profile Tests
(Rev. 4299, Issued: 05-03-19, Effective: 01-01-19, Implementation: 10-07-19)
All test codes should be processed and stored in history as they are submitted. That is, if
tests are submitted as individual CPT codes together and paid as a panel (see §90), the
claim history data will reflect the individual codes and the panel used in pricing. All tests
must maintain their identity as billed.
Prior to January 1, 1998, automated panel codes were adjudicated only on a line-by-line
basis with application of the correct coding initiative (CCI) edits for duplicate detection.
As of January 1, 1998, when individual automated test codes are received, A/B MACs
(A) and (B) did not combine them into panels for processing. The only instance in which
they should be panel codes is when they were coded as such on the claim.
1 CPT code 83718 is billed with Organ/Disease Panel 80061 but is not included in the AMCC bundling.

Beginning January 1, 2018, Medicare does not recognize automated test panels, unless a
panel has its own CPT code, as described in section 90.2.
A/B MACs (A) and (B)
1. Deny Duplicates. Deny duplicate services detected within the same processing cycle
or stored in an automated history file. Consider claims that match on the following items
as duplicates
a. 	The service was performed by the same provider,
b. 	For the same beneficiary, and
c. 	For the same date of service.
2. Medical Necessity. Determine medical necessity. This process permits the
identification of CPT codes subject to local medical review policies.
3. Process Claims. For claims with dates of service prior to January 1, 2019, the
processes shown below (A-K) should be followed to price and pay claims for automated
panels (as defined in HCPCS) and individual tests. This does not replace or abridge any
current procedures in place concerning the adjudication of claim. This is a general
procedure for combining these services to attain the lowest pricing outcome. This display
is an example only. System maintainers have the flexibility to vary these procedures as
long as they attain the same result.
A. Unbundle all panels to single lines representing individual automated multi-channel
chemistry (AMCC) tests, and identify duplicate tests within the claim. On
concurrently processed claims, determine the total amount payable based on the
combination of all AMCC tests billed by the same laboratory, for the same
beneficiary, and for the same date of service.
B. Check history for laboratory AMCC services provided by the same provider, to the
same beneficiary, on the same day. Unbundle any panels. Identify duplicate
services. Aggregate all nonduplicate services for pricing (include the submitted
charge and paid amounts for both individually or paneled billed claims). If a single
organ disease panel or a single chemistry panel contains the only AMCC test claims
for that date of service, adjudicate as billed.
C. Compare each line’s submitted charge to the fee schedule for that code (including
automated tests retrieved from history).
D. Sum the comparisons of the line by line.
E. Obtain the fee for all AMCC tests as a panel including all services in history. If organ
disease (OD) panels are involved, this amount will include fees for nonautomated
tests included in the OD panel.
F. 	Carry forward the lesser of items D or E.

G. For steps A-C above, include the following calculations to price the claim by locality,
using the fee schedule amount for each locality, when one or more test has been
referred to another laboratory for processing:
Use the total number of allowable AMCC tests (both referred and nonreferred) to
calculate the amount payable for each test. For example, if three tests are performed
within the A/B MAC (A)’s or (B)’s jurisdiction, and two are referred to another
laboratory for processing, first determine the amount payable for the five tests in each
payment jurisdiction. Divide the total fee schedule amount for all tests being priced by
the total number of allowable AMCC tests (in this example, five tests). The result is the
unit price for each test. Multiply this result by the total number of AMCC tests
performed within each pricing jurisdiction. (In this example, three tests were performed
in jurisdiction 1 and two tests were performed in jurisdiction 2). Repeat this process for
each pricing jurisdiction. In this example, there are two pricing jurisdictions. In
jurisdiction 1, the amount payable is calculated by dividing the total fee schedule amount
for jurisdiction 1 by five, and multiplying the result by three. Similarly, the amount
payable for jurisdiction 2 is calculated by dividing the total fee schedule amount for
jurisdiction 2 by five, and multiplying the result by two. Sum the two results (i.e.,
jurisdiction 1 amount + jurisdiction 2 amount). Compare this calculated amount to the
submitted charges for the AMCC tests to determine the amount payable. (The amount
payable is the lower of the fee schedule amount versus the submitted charges.)
H. Carry forward the lesser of the fee schedule amount versus the submitted charges, as
determined in item G.
I. 	Subtract from item H any previous laboratory AMCC test (individual or paneled) or
organ disease panel containing automated test payments. If nothing is payable on the
claim, allow it with no payment.
J. 	The amount payable is the total payable based on the combination of current and
previously processed claims, less the total amount paid on the previous claim(s).
K. If a claim is a CLIA reject from the CWF, recycle that claim through the payment
process to recalculate payment.
(NOTE: These calculations are provided as an example only. A/B MACs (A) and (B)
and shared system maintainers have the flexibility to vary these procedures as long as
they attain the same result.)
If none of the AMCC tests have been referred to another laboratory for processing, A/B
MACs (A) and (B) should exclude item G in calculating the amounts payable for
individual AMCC tests and AMCC panels.
90.3.1 - History Display
(Rev. 4299, Issued: 05-03-19, Effective: 01-01-19, Implementation: 10-07-19)
Prior to January 1, 2018, when displaying claims payment for each CPT code in history,
A/B MACs (A) and (B) apply the following rules:

1. 	If all component tests of any panel are allowed because the individual line item
comparison is less than the fee (as determined in item C above), record the panel codes as
determined on the line-by-line comparison.
2. 	If all component tests are paid based on the panel price, allocate the current
payment proportionate to the amount submitted for each CPT code.
3. 	If any panel tests will be denied or there are previously paid automated laboratory
tests (as indicated by a check of beneficiary history), allocate the current payment amount
by allowed line proportionate to what was submitted for the current claim being
processed.
For administration of pricing requirements and/or invalid coding policies, A/B MACs (A)
and (B) must establish a processing sequence for concurrently processed claims based on
ascending order of internal control number (ICN). In the case of pricing, they must
process the “first claim” (i.e., lower CN) based solely on the billed codes on that claim,
process the “second” claim based on a combination of the billed codes on both claims
and pay the balance due after subtracting the amount paid on the “first” claim. In the
case of unacceptable code combinations, A/B MACs (A) and (B) must deny the “second”
claim.
90.3.2 - Medicare Secondary Payer
(Rev. 1, 10-01-03)
When processing claims involving Medicare secondary payer (MSP), A/B MACs (B)
should use the MSP payment formula as follows:
When Medicare is secondary, Medicare pays the lowest of:
• 	The actual charge less the primary payment;
• 	The amount Medicare would pay if primary; or
• 	The higher of the Medicare or primary allowable less the primary payment.
The two-step pricing comparison described above is required for calculating MSP
amounts.
90.4 - Evaluating the Medical Necessity for Laboratory Panel CPT
Codes
(Rev. 1, 10-01-03)
PM-B-98-1
The American Medical Association’s (AMA) 1998 edition of the Current Procedural
Terminology (CPT) establishes three new and one revised Organ or Disease Oriented
laboratory panels. Since these panels are composed of clinically relevant groupings of
automated multi-channel tests there is a general presumption of medical necessity. If
A/B MACs (B) suspect abuse of the new panel codes, they should review such claims.
Should an A/B MAC (B) determine the need to develop a LMRP for laboratory panel
codes, the A/B MAC (B) should develop such a policy at the panel code level. As

appropriate, an A/B MAC (B) may review the panel and deny component tests on a case-
by-case basis or evaluate the need for the component level test.
90.5 - Special Processing Considerations
(Rev. 4299, Issued: 05-03-19, Effective: 01-01-19, Implementation: 10-07-19)
PM AB-97-17
To order any of the 23 automated tests, a physician may select individual tests or the
panel. A physician may order a mix of panels and individual tests. The physician should
review what tests are in each panel and not order individual tests that might duplicate
tests in the panel. Medicare denies duplicate tests.
Specialists are not, based on their specialty, restricted to ordering certain panels or
individual tests. The physician (general practitioner or specialist) should identify which
tests he/she requires; and, if the tests match a grouping, order the appropriate panel.
Claimants should use the QP modifier with the single ordering of tests or when a single
code is available for groupings of tests. This modifier indicates that the claimant has
documentation on file showing that the laboratory test(s) was ordered individually or
ordered as a CPT-recognized panel
100 - CPT Codes Subject to and Not Subject to the Clinical Laboratory
Fee Schedule
(Rev. 1, 10-01-03)
HO-437, A3-3628, B3-5114.1
For fee schedule purposes, clinical laboratory services include most laboratory tests listed
in codes 80048-89399 of CPT-1996. The CMS issues an update to the laboratory fee
schedule each year, with information about whether prices have been determined by
CMS or whether the individual A/B MAC (B) must determine the allowable charge.
Codes not included are not paid under the laboratory fee schedule but may be paid under
the MPFS if covered for Medicare.
100.1 - Deleted - Held for Expansion
(Rev. 1, 10-01-03)
100.2 - Laboratory Tests Never Subject to the Fee Schedule
(Rev. 1, 10-01-03)
Some CPT codes in the 80000 series are not clinical laboratory tests and are therefore
never subject to fee schedule limitations. Some of these codes are exempted because
they are not clinical laboratory services. They include codes for procedures, services,
blood products and auto-transfusions. They include codes such as whole blood, various
red blood cell products, platelets, plasma, and cryoprecipitate. Other codes for tests
primarily associated with the provision of blood products are also not considered to be
clinical tests. Such tests identify various characteristics of blood products, but are not
diagnostic in nature. These include various blood cross matching techniques. If they are

covered, Medicare pays exclusion codes under the MPFS, reasonable charges, reasonable
costs, or OPPS as applicable.
100.3 - Procedures Not Subject to Fee Schedule When Billed With Blood
Products
(Rev. 1, 10-01-03)
The following codes are not subject to fee schedule limitations when submitted for
payment on the same bill with charges for blood products. Rather, assume they are to be
used for blood matching and not for diagnostic purposes.
Codes: 86901, 86905, 86930-86932, 86920-86922, 86890, 86870, 86891, 86880-86886,
86971, and 86930.
If no blood product is provided and billed for on the same claim, assume the codes are
diagnostic and subject to the clinical laboratory fee schedule.
The shared system provides for this processing.
100.4 - Not Otherwise Classified Clinical Laboratory Tests
(Rev. 1, 10-01-03)
The following codes for unlisted or not otherwise classified (NOC) clinical laboratory
tests are not subject to the NLA:
81099 87999
84999 88299
85999 89399
86999
The NOC codes shall suspend for review and the A/B MAC (B) shall determine a price
for them.
100.5 - Other Coding Issues
(Rev. 1, 10-01-03)
100.5.1 - Tests Performed More Than Once on the Same Day
(Rev. 1, 10-01-03)
PM AB-98-7
When it is necessary to obtain multiple results in the course of treatment, the modifiers 59
or 91 are used to indicate that a test was performed more than once on the same day for
the same patient. The 91 modifier is used for laboratory tests paid under the clinical
laboratory fee schedule.
These modifiers may be used to indicate that a test was performed more than once on the
same day for the same patient, only when it is necessary to obtain multiple results in the
course of treatment. These modifiers may not be used when tests are rerun to confirm

initial results; due to testing problems with specimens and equipment; or for any other
reason when a normal, one-time, reportable result is all that is required. These modifiers
may not be used when there are standard HCPCS codes available that describe the series
of results (e.g., glucose tolerance tests, evocative/suppression testing, etc.). These
modifiers may be used only for laboratory tests paid under the clinical laboratory fee
schedule.
Improper use of modifiers is likely to indicate a fraudulent or abusive circumstance.
When informing laboratories of the availability of modifiers, A/B MACs (B) are to
emphasize that these modifiers have very narrow application and that any evidence of
excessive use will be referred to A/B MAC (A) or (B) Program Integrity Unit for further
review.
100.6 - Pricing Modifiers
(Rev. 2487, Issued: 06-08-12, Effective: 01-01-11, Implementation: 06-19-12)
PM A-03-033
Prior to January 1, 2011
Three pricing modifiers discretely identify the different payment situations for ESRD
Automated Multi-Channel Chemistry (AMCC) tests. The physician that orders the tests
is responsible for identifying the appropriate modifier when ordering the tests. The
modifiers are in the following listing:
• 	CD - AMCC test has been ordered by an ESRD facility or MCP physician that is
part of the composite rate and is not separately billable
• 	CE - AMCC test has been ordered by an ESRD facility or MCP physician that is a
composite rate test but is beyond the normal frequency covered under the rate and
is separately reimbursable based on medical necessity
• 	CF - AMCC test has been ordered by an ESRD facility or MCP physician that is
not part of the composite rate and is separately billable
The ESRD clinical laboratory tests identified with modifiers “CD,” “CE,” or “CF” may
not be billed as organ or disease panels. Effective October 1, 2003, all ESRD clinical
laboratory tests must be billed individually.
Effective January 1, 2011
With the implementation of the ESRD PPS, effective for claims with dates of service on
or after January 1, 2011, all ESRD-related laboratory services are included in the ESRD
PPS base rate. If the ESRD facility needs to report a lab service that was not related to
the treatment of ESRD, they must include the modifier AY to indicate the item or service
is not for the treatment of ESRD. Modifiers CD, CE, and CF (also known as the 50/50
rule modifiers) are no longer valid for use on independent laboratory claims.

Effective January 1, 2012, A/B MACs (B) shall allow organ disease panel codes (i.e.,
HCPCS codes 80047, 80048, 80051, 80053, 80061, 80069, and 80076) to be billed by
independent laboratories for AMCC panel tests furnished to ESRD eligible beneficiaries.
For more information regarding billing of AMCC tests for ESRD beneficiaries, see
Section 40.6.1 of this manual.
110 - Coordination Between A/B MACs (B) and Other Entities
(Rev. 1, 10-01-03)
B3-5114.1
110.1 - Coordination Between A/B MACs (B) and A/B MACs (A)/RRB
(Rev. 1, 10-01-03)
The A/B MAC (B) furnishes copies of fees that are locally established under the fee
schedules (price code = 22) to A/B MACs (A) and to the RRB Specialty MAC (S MAC).
The A/B MAC (B) must provide updates at least 30 days prior to the A/B MAC (B)’s
scheduled implementation of the update. The A/B MACs (A) add these fees to system
fee schedule tables to use in paying for hospital laboratory tests performed for both
outpatients of the hospital and persons who are not patients of the hospital. The RRB S
MAC uses the fee schedules in paying for outpatient clinical laboratory tests.
A/B MACs (A) and the RRB may consult with A/B MACs (B) on filling gaps in fee
schedules for tests where the A/B MAC (B) may not have established an amount. If an
A/B MAC (A) or the RRB S MAC has bills for payment on laboratory tests for which the
A/B MAC (B) has not furnished amounts, it consults with the A/B MAC (B). If
necessary the A/B MAC (B) consults with other nearby A/B MACs (B).
110.2 - Coordination With Medicaid
(Rev. 1, 10-01-03)
A/B MACs (B) furnish copies of the fee schedules and the annual update (including
NLAs where applicable) to State agencies (SAs). A/B MACs (B) provide updates to SAs
at least 30 days prior to the scheduled implementation. To obtain Federal matching funds
for clinical laboratory services, State Medicaid agencies may not pay more than Medicare
pays for the services and specimen collections.
Since the fee schedule provisions were implemented on a carrier wide basis, a State may
have had more than one carrier servicing Medicare beneficiaries residing in the State. A
Medicaid agency for such a State may, if it deems necessary, use the fee schedules of
either one or both of the A/B MACs (B) to meet the Federal fund-matching requirement.
State Medicaid agencies may consult with ROs concerning the fee schedule, the NLAs,
and specimen collection provisions.
110.3 - Coordination With A/B MACs (A) and Providers
(Rev. 1, 10-01-03)
HO-437, A3-3628

There may be procedures hospitals bill for outpatients that are not included in the fee
schedule. Where gaps occur, hospitals should work out procedures with the A/B MAC
(A) so that the hospital can secure the missing information promptly. Price Codes
established by the A/B MAC (B) to fill gaps are valid until replaced by the earlier of
permanent codes or the next annual update.
110.4 - A/B MAC (B) Contacts With Independent Clinical Laboratories
(Rev. 1, 10-01-03)
B3-2070.1.F
An important role of the A/B MAC (B) is as a communicant of necessary information to
independent clinical laboratories. Failure to inform independent laboratories of Medicare
regulations and claims processing procedures may have an adverse effect on prosecution
of laboratories suspected of fraudulent activities with respect to tests performed by, or
billed on behalf of, independent laboratories. United States Attorneys often must
prosecute under a handicap or may refuse to prosecute cases where there is no evidence
that a laboratory has been specifically informed of Medicare regulations and claims
processing procedures.
To assure that laboratories are aware of Medicare regulations and A/B MAC (B)’s policy,
notification must be sent to independent laboratories when any changes are made in
coverage policy or claims processing procedures. Additionally, to completely document
efforts to fully inform independent laboratories of Medicare policy and the laboratory’s
responsibilities, previously issued newsletters should be periodically re-issued to remind
laboratories of existing requirements.
Some items which should be discussed are the requirements to have the same charges for
Medicare and private patients, to document fully the medical necessity for collection of
specimens from a skilled nursing facility or a beneficiary’s home, and, in cases when a
laboratory service is referred from one independent laboratory to another independent
laboratory, to identify the laboratory actually performing the test.
Additionally, when A/B MAC (B) professional relations representatives make personal
contacts with particular laboratories, they should prepare and retain reports of contact
indicating dates, persons present, and issues discussed.
120 - Clinical Laboratory Services Based on the Negotiated Rulemaking
(Rev. 1, 10-01-03)
PM AB-02-129
Section 4554(b)(1) of the Balanced Budget Act (BBA), Public Law 105-33 mandated the
use of a negotiated rulemaking committee to develop national coverage and
administrative policies for clinical laboratory services payable under Part B of Medicare.
The BBA required that these national policies be designed to promote program integrity
and national uniformity; and to simplify administrative requirements with respect to
clinical diagnostic laboratory services payable under Part B.
These changes apply to every diagnostic clinical laboratory service that is payable under
Medicare Part B. Neither the place where the service was performed, nor the type of A/B

MAC (A) or (B) that will process the request for payment, has any effect on the
applicability of these policies. A clinical laboratory service done in a hospital laboratory,
independent laboratory, physician/practitioner office laboratory or other type of CLIA
approved laboratory service is subject to these administrative policies.
The final rule did not affect the requirement that all physician claims must have a
diagnosis. If a physician submits a claim for a service performed in a physician office
laboratory, that claim is considered a physician claim and must meet the requirements for
physician claims.
120.1 - Negotiated Rulemaking Implementation
(Rev. 1769, Issued: 07-10-09, Effective/Implementation: 07-31-09)
The following requirements apply to service providers:
• 	The date of service should be reported as the date of specimen collection.
• 	The person obtaining the specimen must furnish the date of collection for the
specimen to the entity billing Medicare.
• 	For specimen collections that span more than a 24-hour period, the date of service
should be reported as the date the collection began.
• 	For laboratory tests that require a specimen from stored collections, the date of
service should be defined as the date the specimen was obtained from the
archives.
• 	If a situation occurs that does not correspond to the two situations described, the
A/B MAC (A) or (B) will submit the question to the RO with the appropriate
documentation. The RO will contact the Division of Supplier Claims Processing
in CMS, which will serve as the point of contact.
Matching of Diagnosis to Procedure
During claims processing and adjudication, the A/B MAC (A) or (B) adheres to the
following:
• 	If there is a LMRP or NCD for one or more of the services included on the claim,
the A/B MAC (A) or (B) reviews all of the diagnosis codes in making a
determination regarding medical necessity of the service.
• 	Even though a claim matches diagnosis to procedure in accordance with an NCD,
other rules of adjudication may apply, which could result in denial.
• 	Diagnoses are required on all claims.
Physicians Reporting Diagnosis Codes When A Diagnostic Test Is Ordered

Section 4317 of the Balanced Budget Act of 1997 provides, with respect to diagnostic
laboratory and certain other services, that “if the Secretary (or A/B MAC (A) or (B) of
the Secretary) requires the entity furnishing the services to provide diagnostic or other
medical information to the entity, the physician or practitioner ordering the service shall
provide that information to the entity at the time the service is ordered by the physician or
practitioner.” A laboratory or other provider must report on a claim for Medicare
payment the diagnostic code(s) furnished by the ordering physician. In the absence of
such coding information, the laboratory or other provider may determine the appropriate
diagnostic code based on the ordering physician’s narrative diagnostic statement or seek
diagnostic information from the ordering physician/practitioner. However, a laboratory
or other provider may not report on a claim for Medicare payment a diagnosis code in the
absence of physician-supplied diagnostic information supporting such code.
Clarification of the Use of the Term “Screening” or “Screen"
The final rule clarifies that effective February 21, 2002, the use of the term “screening”
or “screen” in CPT code descriptor does not necessarily describe a test performed in the
absence of signs and symptoms of illness, disease or condition. A/B MACs (A) and (B)
do not deny a service based solely on the presence of the term “screening” or “screen” in
the descriptor.
Tests that are performed in the absence of signs, symptoms, complaints, personal history
of disease, or injury are not covered except when there is a statutory provision that
explicitly covers tests for screening as described.
If a person is tested to rule out or to confirm a suspected diagnosis because the patient has
a sign and/or symptoms, this is considered a diagnostic test, not a screening test. A/B
MACs (A) and (B) have discretionary authority to make reasonable and necessary scope
of benefit determinations.
120.2 - Implementation and Updates of Negotiated National Coverage
Determinations (NCDs) for Clinical Diagnostic Laboratory Services
(Rev. 3014, Issued: 08-06-14, Effective: ICD-10: Upon Implementation of ICD-10
ASC-X12: 01-01-12, Implementation: ICD-10: Upon Implementation of ICD-10
ASC X12: 09-08-14)
Under a negotiated rulemaking process, the Center for Medicare & Medicaid Services
(CMS) developed 23 NCDs for clinical diagnostic laboratory services. The NCDs are
applicable to services billed under Part B regardless of the entity providing the services.
Thus, they are binding on A/B MACs (A and B) in processing clinical diagnostic
laboratory services on an outpatient basis.
In order to ensure uniformity in the implementation of the NCDs, CMS developed the
NCDs utilizing three lists of diagnosis codes. Every diagnosis code will fall into one the
three lists. The lists included: Codes Covered by Medicare, Codes Denied, and Codes
That Do Not Support Medical Necessity.

Related software, called the laboratory edit module, is incorporated in the shared systems
so that laboratory claims subject to one of the 23 NCDs are processed uniformly
throughout the nation.
In addition, the NCDs are maintained through the NCD process that was announced in
the "Federal Register" on September 26, 2003 (68 FR 55634). This process provides for
public participation through a comment period at the beginning of the evaluation of the
issue and includes a detailed decision document that outlines the rationale for the
decision. These documents may be viewed on the Medicare coverage homepage at
cms.hhs.gov/coverage.
On a quarterly basis, CMS will update the NCD edit module as necessary for ministerial
coding changes and to implement the NCD decisions described above. CMS assures the
updated software is communicated to the shared system maintainers. The shared system
maintainers install the revised edit module after testing and distribute it to the A/B MACs
(A and B) as part of their routine release. A/B MACs (A and B) will conduct provider
education to advise the laboratories of changes to the laboratory edit module quarterly.
Exhibit 1 - List of Diagnostic Tests that are Considered End Stage Renal
Disease (ESRD)
(Rev. 1769, Issued: 07-10-09, Effective/Implementation: 07-31-09)
Refer to section 40.6.2.3 for guidance on the usage of this list.
71010 Chest x-ray
71015 Chest x-ray
71020 Chest x-ray
71021 Chest x-ray
71022 Chest x-ray
71030 Chest x-ray
71035 Chest x-ray
73120 X-ray hand
75710 Artery x-rays, arm/leg
75716 Artery x-rays, arm/leg
75774 Artery x-rays, arms/legs
75790 Artery x-ray, each vessel
75820 Visualize A-V shunt
75822 Vein x-ray, arm/leg
75893 Vein x-ray, arms/legs
75894 Transcath therapy, embolization
75896 X-rays, transcath therapy
75898 X-rays, transcath therapy
75901 Mechanical removal of pericath obstructive material
75902 Mechanical removal of intraluminal obstructive material
75961 Transcath retrieval of intravascular foreign body
75962 Transcath balloon angioplasty
75964 Transcath balloon angioplasty, each additional
76070 Computed tomography, bone mineral density study, axial
76075 Dual energy DEXA, bone density study, axial

76080 Radiologic exam, abscess, fistual or sinus tract study
76092 Screening mammography bilateral
76778 Ultrasound, transplanted kidney
78070 Parathyroid nuclear imaging
78351 Bone density, dual photon absorptionmetry
80048 Basic metabolic panel
80051 Electrolyte panel
80053 Comprehensive Metabolic Panel
? 80061 Lipid panel
80069 Renal function panel
80074 Acute hepatitis panel
80076 Hepatic function panel
80197 Tacrolimus
80410 Calcitonin stim panel
81000 Urinalysis with microscopy
81001 Urinalysis, auto w/scope
81002 Urinalysis nonauto w/o scope
81003 Urinalysis, auto, w/o scope
81005 Urinalysis, qual or semi-quant
81007 Urine screen for bacteria, except by culture or dipstick
81015 Microscopic exam of urine
82009 Test for acetone/ketones,qual
82010 Acetone assay, quant
82017 Acylcarnitines, quant
82040 serum albumin
82042 albumin, urine quant or other source
82108 Assay of aluminum
82232 Beta2microglobulin (monitor large molecular weigh solute clearance by dial
82247 Bilirubin, total
82248 Bilirubin, direct
82306 Assay of vitamin D-3 (calcifediol)
82307 Assay of vitamin D (calciferol)
82308 Assay of calcitonin
82310 Assay of calcium
82330 Assay of calcium, ionized
82374 Bicarbonate (CO2)
82379 Assay of carnitine
82435 Chloride blood (needed to determine acid/base status)
82465 cholesterol, total serum
82550 CPK, total
82565 Assay of creatinine
82570 Assay of urine creatinine
82575 urine creatinine clearance test
82607 Vit B12
82728 ferritin
82746 serum folate
82747 RBC folate
82800 Blood Ggases, ppH onlyy
82803 Blood gases: pH, pO2 & pCO2

82805 Blood gases W/02 saturation
82810 Blood gases, O2 sat only
82945 Glucose other fluid
82947 Assay, glucose, blood quant
82948 Reagent strip/blood glucose
83540 Assay of iron
83550 Iron binding test
83735 magnesium (monitored to avoid hypermagnesium)
83937 Osteocalcin
83970 parathormone (PTH)
83986 Assay of body fluid acidity
84075 alkaline phosphatase
84100 Assay of phosphorus, inorganic
84105 urine phosphorus
84132 Assay of serum potassium
84133 urine potassium
84134 Assay of prealbumin
84155 Assay of protein
84160 serum protein by refractometry
84295 Assay of serum sodium
84315 Body fluid specific gravity
84450 Transferase (AST) (SGOT)
84460 Alanine amino (ALT) (SGPT)
84466 transferrin
84520 Urea nitrogen, quantitative
84540 Assay of urine/urea-n
84545 Urea-N clearance test
84630 zinc
85002 Bleeding time test
85004 Automated diff wbc count
85007 Bl smear w/diff wbc count
85008 Bl smear w/o diff wbc count
85009 Manual diff wbc count b-coat
85013 Spun microhematocrit
85014 Hematocrit
85018 Hemoglobin
85025 Complete CBC w/auto diff wbc
85027 Complete CBC, automated
85032 Manual cell count, each
85041 Automated RBC count
85044 Manual reticulocyte count
85045 Automated reticulocyte count
85046 Reticyte/hgb concentrate
85048 Automated leukocyte count
85049 Automated platelet count
85345 Coagulation time, Lee-White
85347 Coagulation time, activated
85348 Coagulation time, other methods
85520 Heparin assay

85610 Prothrombin time
85611 Prothrombin test,substitution
85651 sed rate
85652 automates sed rate
85730 thromboplastin time, partial (PTT)
85732 Thromboplastin time, partial, substitution
86590 Streptokinase, antibody
86644 CMV screen
86645 Cytomegalovirus antibody dfa (IgM)
86687 HTLV-I antibody
86688 HTLV-II antibody
86689 HTLV/HIV confirmatory test
86692 Hepatitis, delta agent
86701 HIV-1
86702 HIV-2
86703 HIV-1/HIV2, ,singgle assayy
86704 Hep B core antibody, total
86705 Hep b core antibody, IgM
86706 Hep B surface antibody
86707 Hep Be antibody
86709 Hep A, IgM antibody
86803 Hepatitis C ab test
86804 Hep C ab test, confirm
86812 HLA typing, A, B, or C
86813 HLA typing, A, B, or C, multiple antigens
86816 HLA typing, DR/DQ
86817 HLAy tpypigng, DR/DQ, multiple antigens
86900 Blood typing, ABO
86901 Rh typing
86903 Blood typing, antigen screen
86904 Blood typing, patient serum
86905 Blood typing, RBC antigens
86906 Blood typing, Rh phenotype
87040 culture, blood
87070 Culture, bacteria, other
87071 Culture bacteri aerobic other, quant
87073 Culture bacteria anaerobic, quant
87075 Culture bacteria anaerobic, any source w/ID
87076 Culture anaerobe ident, each
87077 Culture aerobic identify
87081 Culture screen only
87084 Culture w/ colony estimation
87086 Urine culture/quant colony count
87088 Urine bacteria culture, isolation & ID
87181 Microbe susceptible, diffuse
87184 Microbe susceptible, disk
87185 Microbe susceptible, enzyme
87186 Microbe susceptible, mic
87187 Microbe susceptible, mlc

87188 Microbe suscept, macrobroth
87190 Microbe suscept, mycobacteri
87197 Bactericidal level, serum
87205 Smear, gram stain
87271 CMV, DFA
87340 HepB surface antigen
87341 HepatitisB surface, ag, eia, neutralization
87350 HepatitisBe ag, eia
87380 Hepatitis delta ag, eia
87390 HIV-1 ag, eia
87391 HIV-2 ag, eia
87515 Hepatitis B, DNA, dir probe
87516 Hepatitis B, DNA, amp probe
87517 Hepatitis B, DNA, quant
87520 Hepatitis C, RNA, dir probe
87521 Hepatitis C, RNA, amp probe
87522 Hepatitis C, RN A, quant
87525 Hepatitis G, DNA, dir probe
87526 Hepatitis G, DNA, amp probe
87527 Hepatitis G, DNA, quant
89050 cell count, peritoneal fluid (no diff)
89051 cell count, peritoneal fluid with diff
93000 Echo exam of heart
93005 Electrocardiogram, tracing
93010 Electrocardiogram report
93040 Rhythm ECG with report
93041 Rhythm ECG, tracing
93042 Rhythm ECG with report
93307 Echo exam of heart
93308 Echo exam of heart, follow-up
93922 Extremity study
93923 Extremity study, multiple levels
93925 Lower extremity study - arterial
93926 Lower extremity study, limited- arterial
93930 Upper extremity study- arterial
93931 Upper extremity study, limited-arterial
93965 Extremity study-venous
93970 Extremity study-venous
93971 Extremity study, limited-venous
G0001 Routine venipuncture
G0202 Screening mammography, digital

Transmittals Issued for this Chapter
Rev # 	Issue Date Subject 	Impl Date CR#
R13746CP 04/17/2026 Laboratory Specimen Collection Travel
Allowance Billing to the Tenth of a Mile 04/06/2026 14130
R13576CP 01/08/2026 Clinical Laboratory Fee Schedule –
Medicare Travel Allowance Fees for
Collection of Specimens and New Updates
for 2026
01/05/2026 14345
R13412CP 09/11/2025 Laboratory Specimen Collection Travel
Allowance Billing to the Tenth of a Mile-
Rescinded and replaced by Transmittal
13746
04/06/2026 14130
R13320CP 07/24/2025 Laboratory Specimen Collection Travel
Allowance Billing to the Tenth of a Mile-
Rescinded and replaced by Transmittal
13412
04/06/2026 14130
R12443CP 01/04/2024 Clinical Laboratory Fee Schedule –
Medicare Travel Allowance Fees for
Collection of Specimens and New Updates
for 2024
02/07/2024 13503
R11778CP 01/06/2023 Clinical Laboratory Fee Schedule –
Medicare Travel Allowance Fees for
Collection of Specimens and New Updates
for 2023
01/23/2023 13071
R11463CP 06/23/2022 Internet Only Manual Update to Publication
100-04, Chapter 16, Sections 70.5, 70.8, and
70.9 to Remove References to the Clinical
Laboratory Improvement Amendments
(CLIA) Files
07/25/2022 12766
R11184CP 01/14/2022 Clinical Laboratory Fee Schedule –
Medicare Travel Allowance Fees for
Collection of Specimens
02/02/2022 12593
R10615CP 03/09/2021 Clinical Laboratory Fee Schedule –
Medicare Travel Allowance Fees for
Collection of Specimens
03/19/2021 12140
R10341CP 09/04/2020 Internet Only Manual Update to Pub. 100-04,
Chapter 16, Section 60.1.2 and Pub. 100-04,
Chapter 26, Section 10.4, Item 19
10/06/2020 11935

Rev # 	Issue Date Subject 	Impl Date CR#
R4495CP 	01/17/2020 Clinical Laboratory Fee Schedule – Medicare
Travel Allowance Fees for Collection of
Specimens
02/18/2020 11641
12/20/2019 Internet Only Manual Update to Pub 100-
04, Chapter 16, Section 40.8 – Laboratory
Date of Service Policy
01/23/2020 11574
12/20/2019 Internet Only Manual Update to Add New
and Revise Sections of Publication 100-04,
Chapter 16
01/23/2020 11553
R4299CP 	05/03/2019 Re-implementation of the AMCC Lab Panel
Claims Payment System Logic
10/07/2019 11248
R4227CP 	02/01/2019 Independent Laboratory Billing of
Laboratory Tests for End-Stage Renal
Disease (ESRD) Beneficiaries and the
Sunset of the CB Modifier
07/01/2019 11061
R4199CP 	01/11/2019 Clinical Laboratory Fee Schedule –
Medicare Travel Allowance Fees for
Collection of Specimens
02/12/2019 11146
R4112CP 	11/01/2018 Temporary Transitional Payment for Home
Infusion Therapy Services for CYs 2019
and 2020
01/07/2019 10836
R4000CP 	03/16/2018 Internet Only Manual Update to Pub 100-
04, Chapter 16, Section 40.8 - Date of
Service Policy
07/02/2018 10419
R3942CP 	12/22/2017 Clinical Laboratory Fee Schedule –
Medicare Travel Allowance Fees for
Collection of Specimens
01/22/2018 10448
R3875CP 	10/06/2017 Internet Only Manual Update to Pub. 100-
04, Chapter 16, to update Clinical Lab Fee
Schedule Layout
01/08/2018 10195
R3717CP 	02/10/2017 Clinical Laboratory Fee Schedule –
Medicare Travel Allowance Fees for
Collection of Specimens
05/12/2017 9960

Rev # 	Issue Date Subject 	Impl Date CR#
R3685CP 	12/22/2016 January 2017 Update of the Hospital
Outpatient Prospective Payment System
(OPPS)
01/03/2017 9930
R3619CP 	10/07/2016 Table of Chemistry Panels 	01/10/2017 9790
R3510CP 	04/29/2016 Updates to Pub. 100-04, Chapters 1 and 16
to Correct Remittance Advice Messages
10/03/2016 9578
R3433CP 	12/31/2015 Clinical Laboratory Fee Schedule –
Medicare Travel Allowance Fees for
Collection of Specimens
02/01/2016 9485
R3425CP 	12/18/2015 January 2016 Update of the Hospital
Outpatient Prospective Payment System
(OPPS)
01/04/2016 9486
R3255CP 	05/08/2015 Correction to the Multi-Carrier System
(MCS) Editing on the Service Location
National Provider Identifier (NPI) Reported
for Anti-Markup and Reference Laboratory
Claims
10/05/2015 9150
R3189CP 	02/05/2015 Clinical Laboratory Fee Schedule –
Medicare Travel Allowance Fees for
Collection of Specimens
04/24/2015 9066
R3169CP 	01/23/2015 Clinical Laboratory Fee Schedule –
Medicare Travel Allowance Fees for
Collection of Specimens – Rescinded and
replaced by Transmittal 3189
04/24/2015 9066
R3116CP 	11/06/2014 Elimination of the 50/50 Payment Rule for
Laboratory Services on End Stage Renal
Disease (ESRD) Claims
04/06/2015 8957
R3103CP 	11/03/2014 Reporting the Service Location National
Provider Identifier (NPI) on Anti-Markup
and Reference Laboratory Claims
04/06/2015 8806
R3098CP 	10/21/2014 Reporting the Service Location National
Provider Identifier (NPI) on Anti-Markup
and Reference Laboratory Claims –
04/05/2014 8806

Rev # 	Issue Date Subject 	Impl Date CR#
Rescinded and replaced by Transmittal
3103
R3071CP 	09/19/2014 Manual Update to Clarify Claims
Processing for Laboratory Services
12/22/2014 8883
R3056CP 	08/29/2014 Sample Collection Fee Adjustment for
Clinical Laboratory Fee Schedule and
Laboratory Services
12/01/2014 8837
R3047CP 	08/22/2014 Reporting the Service Location National
Provider Identifier (NPI) on Anti-Markup
and Reference Laboratory Claims –
Rescinded and replaced by Transmittal
3098
01/05/2014 8806
R3014CP 	08/06/2014 Update to Pub. 100-04, Chapter 16 to
Provide Language-Only Changes for
Updating ICD-10 and ASC X12
09/08/2014 8613
R2971CP 	05/23/2014 July 2014 Update of the Hospital Outpatient
Prospective Payment System (OPPS)
07/07/2014 8776
R2907CP 	03/14/2014 Clinical Laboratory Fee Schedule –
Medicare Travel Allowance Fees for
Collection of Specimens
06/16/2014 8641
R2904CP 	03/14/2014 Update to Pub. 100-04, Chapter 16 to
Provide Language-Only Changes for
Updating ICD-10 and ASC X12 –
Rescinded and replaced by Transmittal
3014
10/01/2014 8613
R2730CP 	06/20/2013 Coding Requirements for Laboratory
Specimen Collection Update
07/16/2013 8339
R2726CP 	06/14/2013 Coding Requirements for Laboratory
Specimen Collection Update – Rescinded
and replaced by Transmittal 2730
07/16/2013 8339
R2714CP 	05/24/2013 Updates to Chapter 12 and Chapter 16 of
the Medicare Claims Processing Manual to
Revise Instructions Regarding the Technical
06/25/2013 8013

Rev # 	Issue Date Subject 	Impl Date CR#
Component (TC) of Pathology Services
Furnished to Hospital Patients
R2581CP 	11/02/2012 Outpatient Laboratory Services Rendered in
a Critical Access Hospital (CAH)
04/01/2013 8025
R2487CP 	06/08/2012 Internet Only Manual (IOM) Update for
Laboratory Services and Durable Medical
Equipment, Prosthetics, Orthotics, and
Supplies (DMEPOS) Claims Processed
under the End Stage Renal Disease
Prospective Payment System (ESRD PPS)
06/19/2012 7749
R2475CP 	05/18/2012 Internet Only Manual (IOM) Update for
Laboratory Services and Durable Medical
Equipment, Prosthetics, Orthotics, and
Supplies (DMEPOS) Claims Processed
under the End Stage Renal Disease
Prospective Payment System (ESRD PPS)
06/19/2012 7749
R2136CP 	01/21/2011 Medicare and Medicaid Extenders Act of
2010 (MMEA) Extension of Reasonable
Cost Payment for Clinical Lab Tests
Furnished to Hospitals with Fewer Than 50
Beds in Qualified Rural Areas
07/05/2011 7294
R2106CP 	11/24/2010 Calendar Year (CY) 2011 Annual Update
for Clinical Laboratory Fee Schedule and
Laboratory Services Subject to Reasonable
Charge Payment
01/03/2011 6991
R1945CP 	04/09/2010 New Legislation to Allow Independent
Laboratory Billing for the Technical
Component of Physician Pathology Services
for Hospital Inpatients and Outpatients
07/09/2010 6813
R1940CP 	04/02/2010 Extension of Reasonable cost Payment for
Clinical lab Tests Furnished by Hospitals
With Fewer Than 50 Beds in Qualified
Rural Areas
07/06/2010 6873
R1884CP 	12/23/2009 Calendar Year (CY) 2010 Annual Update
for Clinical Laboratory Fee Schedule and
01/04/2010 6657

Rev # 	Issue Date Subject 	Impl Date CR#
Laboratory Services Subject to Reasonable
Charge Payment
R1782CP 	07/30/2009 Section 148 of the Medicare Improvements
for Patients and Providers Act (MIPPA)
07/06/2009 6395
R1769CP 	07/10/2009 ESRD: Placement of a List of Diagnostic
Tests that are Considered End Stage Renal
Disease (ESRD)
07/31/2009 6515
R1763CP 	07/02/2009 ESRD: Placement of a List of Diagnostic
Tests that are Considered End Stage Renal
Disease (ESRD) – Rescinded and replaced
by Transmittal 1769
07/02/2009 6515
R1729CP 	05/08/2009 Section 148 of the Medicare Improvements
for Patients and Providers Act (MIPPA) -
Rescinded and replaced by Transmittal
1782
07/06/2009 6395
R1712CP 	04/17/2009 Section 148 of the Medicare Improvements
for Patients and Providers Act (MIPPA) -
Rescinded and replaced by Transmittal
1729
07/06/2009 6395
R1690CP 	02/27/2009 Reporting the National Provider Identifier
(NPI) on Claims for Reference Laboratory
and Purchased Diagnostic Services
Performed Outside the Billing Jurisdiction
03/27/2009 6362
R1655CP 	12/31/2008 End Stage Renal Disease (ESRD) Medicare
Claims Processing Manual Clarification
02/02/2009 6245
R1652CP 	12/19/2008 New Waived Tests 	01/05/2009 6287
R1584CP 	09/05/2008 Clinical Laboratory Fee Schedule –
Medicare Travel Allowance Fees for
Collection of Specimens
10/06/2008 6195
R1561CP 	07/25/2008 Medicare Improvements for Patients and
Providers Act of 2008- Legislative Change
Concerning Independent Laboratory Billing
for the Technical Component of Physician
Pathology Services
08/25/2008 6042

Rev # 	Issue Date Subject 	Impl Date CR#
R1524CP 	05/30/2008 Clinical Laboratory Fee Schedule-Medicare
Travel Allowance Fees for Collection of
Specimens
06/30/2008 5996
R1515CP 	05/23/2008 Date of Service (DOS) for Clinical
Laboratory and Pathology Specimens
01/05/2009 6018
R1472CP 	03/06/2008 Update of Institutional Claims References 	04/07/2008 5893
R1451CP 	02/15/2008 Clinical Lab: New Automated Test for the
AMCC Panel Payment Algorithm
07/07/2008 5874
R1445CP 	02/08/2008 January 2008 Update of the Hospital
Outpatient Prospective Payment System
(OPPS)-Manualization
03/10/2008 5946
R1440CP 	02/07/2008 Medicare, Medicaid, and SCHIP Extension
Act of 2007 Changes to Independent
Laboratory Billing for the Technical
Component of Physician Pathology Services
03/07/2008 5943
R1421CP 	01/25/2008 Update of Institutional Claims References -
Rescinded and Replaced by Transmittal
1472
04/07/2008 5893
R1319CP 	08/17/2007 Date of Service for Laboratory Specimens 	01/01/2008 5573
R1221CP 	04/18/2007 Common Working File (CWF) Duplicate
Claim Edit for the Technical Component
(TC) of Radiology and Pathology
Laboratory Services Provided to Hospital
Patients
04/02/2007 5347
R1098CP 	11/03/2006 Common Working File (CWF) Duplicate
Claim Edit for the Technical Component
(TC) of Radiology and Pathology
Laboratory Services Provided to Hospital
Patients Replace by Transmittal 1221
04/02/2007 5347
R865CP 	02/17/2006 Health Common Procedure Coding System
(HCPCS) Codes Subject to and Excluded
from Clinical Laboratory Improvement
Amendments (CLIA) Edits
07/03/2006 4321

Rev # 	Issue Date Subject 	Impl Date CR#
R852CP 	02/10/2006 Ambulance Fee Schedule – CY 2006
Update: Correction to CR 4061
02/24/2006 4362
R800CP 	12/30/2005 Clinical Diagnostic Laboratory Date of
Service (DOS) for Archived Specimens
04/03/2006 4156
R795CP 	12/30/2005 Redefined Type of Bill (TOB) 14X for
Non-Patient Laboratory Specimens-CR
3835 Manualization
04/03/2006 4208
R744CP 	11/04/2005 File Descriptions and Instructions for
Retrieving the 2006 Fee Schedules and
HCPCS through CMS's Mainframe
Telecommunications System
01/03/2006 4084
R734CP 	10/28/2005 Redefined Type of Bill (TOB), 14x, for
Non-Patient Laboratory Specimens
04/03/2006 3835
R733CP 	10/28/2005 Repeat Tests for Automated Multi-Channel
Chemistries for End Stage Renal Disease
Beneficiaries
04/03/2006 4101
R598CP 	06/27/2005 Implementation of Carrier Guidelines for
End Stage Renal Disease (ESRD)
Reimbursement for Automated Multi-
Channel Chemistry (AMCC) Tests
01/01/2006 3890
R595CP 	06/24/2005 Implementation of Carrier Guidelines for
End Stage Renal Disease (ESRD)
Reimbursement for Automated Multi-
Channel Chemistry (AMCC) Tests
07/25/2005 3890
R372CP 	11/19/2004 Payment for Referred Laboratory
Automated Multi-Channel Chemistry
(AMCC) Tests
04/04/2005 3483
R289CP 	08/27/2004 File Descriptions and Instructions for
Retrieving 2004 Pricing Files
01/03/2005 3428
R198CP 	06/04/2004 AMCC tests for ESRD-related lab services 	01/03/2005 2813
R164CP 	04/30/2004 Replaced by Rev 198CP 	06/04/2004 2813

Rev # 	Issue Date Subject 	Impl Date CR#
R102CP 	02/20/2004 New waived tests approved by the Food and
Drug Administration under Clinical
Laboratory Improvement Amendments of
1988
04/05/2004 3061
R100CP 	02/13/2004 Outpatient Clinical Laboratory Tests
Furnished by Hospitals with Fewer than 50
beds in Qualified Rural Areas for cost
reporting periods beginning during the 2-
year period beginning on July 1, 2004.
07/06/2004 3130
R085CP 	02/06/2004 Pricing payment for referred services based
upon zip code of where the service was
performed
07/06/2004 3090
R079CP 	02/06/2004 ESRD Reimbursement for AMCC Tests 	07/06/2004 2813
R071CP 	01/23/2004 Quarterly updates for NCD edit module for
clinical diagnostic lab services
04/05/2004 3032
&
3072
R069CP 	01/23/2004 Deletion of requirement to validate that the
ESRD beneficiary is in a SNF Part A stay
02/23/2004 2906
R023CP 	10/31/2003 Pricing payment for referred services based
upon zip code of where the service was
performed
4/5/2004 	2193
R016CP 	10/31/2003 Fee schedule payment for independent
laboratories for the technical component of
a purchased diagnostic service
04/05/2004 2919
R012CP 	10/24/2003 Claims for fecal leukocyte examinations 	01/01/2004 2924
R001CP 	10/01/2003 Initial Publication of Manual 	NA 	NA
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