[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4882 Introduced in House (IH)]
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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
referred to the Committee on Ways and Means, and in addition to the
Committee on Energy and Commerce, for a period to be subsequently
determined 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 Representatives 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''.
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 REQUIREMENT.
``(a) In General.--Beginning January 1, 2025, each applicable
laboratory that receives payment under this title for furnishing a
specified clinical diagnostic laboratory 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 subsection 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).
``(2) If required by the Secretary, the deidentified
minimum negotiated rate in effect between 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 January 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 subsection;
``(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 appropriate by the
Secretary, in consultation with stakeholders.
``(d) Monitoring Compliance.--The Secretary shall, through notice
and comment rulemaking and in consultation 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 Secretary
determines that an applicable laboratory is not in compliance
with subsection (a)--
``(A) not later than 30 days after such
determination, the Secretary shall notify such
laboratory 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 subsection; 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 submitted a corrective
action plan described in subparagraph (B) in response
to a request so described, after the date that is 90
days after such submission), the Secretary may impose a
civil monetary penalty in an amount not to exceed $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 subsections (a) and (b) of such
section) shall apply to a civil monetary penalty imposed under
this subsection 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 penalty.--The Secretary
may waive or reduce any penalty otherwise applicable with
respect to an applicable laboratory under this paragraph if the
Secretary determines that imposition of such penalty would
result in a significant hardship for such laboratory (such as
in the case of an applicable laboratory located in a rural or
underserved area where imposition 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.--Notwithstanding any other provision of
this title, this subsection shall be the sole means of
enforcing the provisions 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 insurance coverage;
individual health insurance 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 laboratory test.--The
term `specified clinical diagnostic laboratory test' means a
clinical diagnostic laboratory 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 45, Code of Federal Regulations (or a successor
regulation), other than such a test that is an advanced
diagnostic laboratory test (as defined in section
1834A(d)(5)).''.
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