What This Bill Does
This bill changes how Medicare decides whether to cover individual drugs and biological products. The bill requires Medicare to review each drug or biological product separately rather than reviewing entire groups of similar drugs at the same time.
Who It Affects
Medicare beneficiaries (people covered by Medicare) and drug manufacturers whose products Medicare reviews for coverage.
Key Provisions
• Medicare must evaluate each drug or biological product individually to determine if it is reasonable and necessary for Medicare to cover, rather than evaluating groups or classes of drugs together (Sec. 2)
What Changes
Starting from when this bill becomes law, Medicare's coverage decisions about whether to pay for drugs or biological products must be made one drug at a time instead of reviewing multiple drugs in the same drug class together.
Important Definitions
The bill does not explicitly define "reasonable and necessary," "drug," "biological," or "drug class," though it uses these terms.
Effective Date
Not specified in bill text
IB
Union Calendar No. 779
118TH CONGRESS
2D SESSION
H. R. 133
[Report No. 118–764, Part I]
To amend title XVIII of the Social Security Act to clarify the use of the
national coverage determination process under the Medicare program.
IN THE HOUSE OF REPRESENTATIVES
JANUARY 9, 2023
Mr. BUCHANAN (for himself, Ms. BARRAGA´N, and Ms. SALAZAR) introduced
the following bill; which was referred to the Committee on Energy and
Commerce, and in addition to the Committee on Ways and Means, 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 com-
mittee concerned
NOVEMBER 22, 2024
Reported from the Committee on Energy and Commerce with an amendment
[Strike out all after the enacting clause and insert the part printed in italic]
NOVEMBER 22, 2024
Referral to the Committee on Ways and Means extended for a period ending
not later than December 19, 2024
DECEMBER 19, 2024
Additional sponsors: Mr. FITZPATRICK, Mr. FERGUSON, Mr. CAREY and Mrs.
MILLER of West Virginia
DECEMBER 19, 2024
Committee on Ways and Means discharged; committed to the Committee of
the Whole House on the State of the Union and ordered to be printed
[For text of introduced bill, see copy of bill as introduced on January 9, 2023]
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•HR 133 RH
A BILL
To amend title XVIII of the Social Security Act to clarify
the use of the national coverage determination process
under the Medicare program.
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•HR 133 RH
Be it enacted by the Senate and House of Representa-
1
tives of the United States of America in Congress assembled,
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SECTION 1. SHORT TITLE.
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This Act may be cited as the ‘‘Mandating Exclusive
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Review of Individual Treatments Act’’ or the ‘‘MERIT
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Act’’.
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SEC. 2. CLARIFICATION ON MEDICARE NATIONAL COV-
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ERAGE DETERMINATION PROCESS.
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Section 1862(a) of the Social Security Act (42 U.S.C.
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1395y(a)) is amended by adding at the end the following
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new sentence: ‘‘For purposes of paragraph (1)(E), with re-
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spect to a determination made on or after the date of the
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enactment of this sentence of whether a drug or biological
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is reasonable and necessary to carry out the purposes of
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such section, such determination shall be made with respect
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to each drug or biological involved and not with respect to
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a class of drugs or biologicals.’’.
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Union Calendar No. 779
118TH CONGRESS
2D SESSION
H. R. 133
[Report No. 118–764, Part I]
A BILL
To amend title XVIII of the Social Security Act to
clarify the use of the national coverage deter-
mination process under the Medicare program.
DECEMBER 19, 2024
Committee on Ways and Means discharged; committed to
the Committee of the Whole House on the State of the
Union and ordered to be printed
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01:24 Dec 24, 2024
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PO 00000
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