I 
118TH CONGRESS 
1ST SESSION H. R. 4882 
To amend title XVIII of the Social Security Act to promote laboratory 
price transparency under the Medicare program. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 25, 2023 
Mrs. MILLER of West Virginia introduced the following bill; which was re-
ferred to the Committee on Ways and Means, and in addition to the 
Committee on Energy and Commerce, for a period to be subsequently de-
termined by the Speaker, in each case for consideration of such provisions 
as fall within the jurisdiction of the committee concerned 
A BILL 
To amend title XVIII of the Social Security Act to promote 
laboratory price transparency under the Medicare program. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Clinical Laboratory 
Price Transparency Act of 2023’’. 
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SEC. 2. PROMOTING LABORATORY PRICE TRANSPARENCY 
UNDER THE MEDICARE PROGRAM. 
Part E of title XVIII of the Social Security Act (42 
U.S.C. 1395x et seq.) is amended by adding at the end 
the following new section: 
‘‘SEC. 1899C. LABORATORY PRICE TRANSPARENCY RE-
QUIREMENT. 
‘‘(a) IN GENERAL.—Beginning January 1, 2025, 
each applicable laboratory that receives payment under 
this title for furnishing a specified clinical diagnostic lab-
oratory test shall— 
‘‘(1) make publicly available (in a manner and 
form specified by the Secretary) on an Internet 
website the information described in subsection (b) 
with respect to each such specified clinical diagnostic 
laboratory test that such laboratory is so available to 
furnish; and 
‘‘(2) ensure that such information is updated 
not less frequently than annually. 
‘‘(b) INFORMATION DESCRIBED.—For purposes of 
subsection (a), the information described in this sub-
section is, with respect to an applicable laboratory and a 
specified clinical diagnostic laboratory test, the following: 
‘‘(1) The discounted cash price for such test 
(or, if no such price exists, the gross charge for such 
test). 
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‘‘(2) 
If 
required 
by 
the 
Secretary, 
the 
deidentified minimum negotiated rate in effect be-
tween such laboratory and any group health plan or 
group or individual health insurance coverage for 
such test and the deidentified maximum negotiated 
rate in effect between such laboratory and any such 
plan or coverage for such test. 
‘‘(c) METHOD AND FORMAT.—Not later than Janu-
ary 1, 2028, the Secretary shall establish one or more 
methods and formats for each provider of services and 
supplier to use in compiling and making public standard 
charges and prices (as applicable) pursuant to subsection 
(a). Any such method and format— 
‘‘(1) may be similar to any template made 
available by the Centers for Medicare & Medicaid 
Services as of the date of the enactment of this sub-
section; 
‘‘(2) shall meet such standards as determined 
appropriate by the Secretary in order to ensure the 
accessibility and usability of such charges and 
prices; and 
‘‘(3) shall be updated as determined appro-
priate by the Secretary, in consultation with stake-
holders. 
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‘‘(d) MONITORING
COMPLIANCE.—The Secretary 
shall, through notice and comment rulemaking and in con-
sultation with the Inspector General of the Department 
of Health and Human Services, establish a process to 
monitor compliance with this section. 
‘‘(e) ENFORCEMENT.— 
‘‘(1) IN GENERAL.—In the case that the Sec-
retary determines that an applicable laboratory is 
not in compliance with subsection (a)— 
‘‘(A) not later than 30 days after such de-
termination, the Secretary shall notify such lab-
oratory of such determination; 
‘‘(B) upon request of the Secretary, such 
laboratory shall submit to the Secretary, not 
later than 45 days after such request is sent, a 
corrective action plan to comply with such sub-
section; and 
‘‘(C) if such laboratory continues to fail to 
comply with such paragraph after the date that 
is 90 days after such notification is sent (or, in 
the case of such a laboratory that has sub-
mitted a corrective action plan described in sub-
paragraph (B) in response to a request so de-
scribed, after the date that is 90 days after 
such submission), the Secretary may impose a 
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civil monetary penalty in an amount not to ex-
ceed $300 for each subsequent day during 
which such failure to comply is ongoing. 
‘‘(2) INCREASE AUTHORITY.—In applying this 
paragraph with respect to violations occurring in 
2027 or a subsequent year, the Secretary may 
through notice and comment rulemaking increase 
the amount of the civil monetary penalty under 
paragraph (1)(C). 
‘‘(3) APPLICATION OF CERTAIN PROVISIONS.— 
The provisions of section 1128A (other than sub-
sections (a) and (b) of such section) shall apply to 
a civil monetary penalty imposed under this sub-
section in the same manner as such provisions apply 
to a civil monetary penalty imposed under subsection 
(a) of such section. 
‘‘(4) AUTHORITY TO WAIVE OR REDUCE PEN-
ALTY.—The Secretary may waive or reduce any pen-
alty otherwise applicable with respect to an applica-
ble laboratory under this paragraph if the Secretary 
determines that imposition of such penalty would re-
sult in a significant hardship for such laboratory 
(such as in the case of an applicable laboratory lo-
cated in a rural or underserved area where imposi-
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tion of such penalty may result in, or contribute to, 
a lack of access to care for individuals in such area). 
‘‘(5) CLARIFICATION OF NONAPPLICABILITY OF 
OTHER
ENFORCEMENT
PROVISIONS.—Notwith-
standing any other provision of this title, this sub-
section shall be the sole means of enforcing the pro-
visions of this section. 
‘‘(f) DEFINITIONS.—In this section: 
‘‘(1) APPLICABLE
LABORATORY.—The term 
‘applicable laboratory’ has the meaning given such 
term in section 414.502, of title 42, Code of Federal 
Regulations (or any successor regulation). 
‘‘(2) GROUP HEALTH PLAN; GROUP HEALTH IN-
SURANCE
COVERAGE; INDIVIDUAL
HEALTH
INSUR-
ANCE COVERAGE.—The terms ‘group health plan’, 
‘group health insurance coverage’, and ‘individual 
health insurance coverage’ have the meaning given 
such terms in section 2791 of the Public Health 
Service Act. 
‘‘(3) SPECIFIED CLINICAL DIAGNOSTIC LABORA-
TORY TEST.—The term ‘specified clinical diagnostic 
laboratory test’ means a clinical diagnostic labora-
tory test that is included on the list of shoppable 
services specified by the Centers for Medicare & 
Medicaid Services pursuant to section 180.60 of title 
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45, Code of Federal Regulations (or a successor reg-
ulation), other than such a test that is an advanced 
diagnostic laboratory test (as defined in section 
1834A(d)(5)).’’. 
Æ 
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