[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 4510 Introduced in Senate (IS)]
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118th CONGRESS
2d Session
S. 4510
To amend the American Taxpayer Relief Act of 2012 to delay
implementation of the inclusion of oral-only ESRD-related drugs in the
Medicare ESRD prospective payment system.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
June 11, 2024
Mrs. Blackburn (for herself and Mr. Lujan) introduced the following
bill; which was read twice and referred to the Committee on Finance
_______________________________________________________________________
A BILL
To amend the American Taxpayer Relief Act of 2012 to delay
implementation of the inclusion of oral-only ESRD-related drugs in the
Medicare ESRD prospective payment system.
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 ``Kidney Patient Access to
Technologically Innovative and Essential Nephrology Treatments Act of
2024'' or the ``Kidney PATIENT Act of 2024''.
SEC. 2. PROHIBITION OF IMPLEMENTATION OF ORAL-ONLY POLICY FOR CERTAIN
DRUGS UNDER MEDICARE ESRD PROSPECTIVE PAYMENT SYSTEM.
(a) In General.--Section 632(b) of the American Taxpayer Relief Act
of 2012 (42 U.S.C. 1395rr note) is amended--
(1) in the heading, by striking ``Two-year delay'' and
inserting ``Delay''; and
(2) in the first sentence of paragraph (1), by striking
``may not implement'' and all that follows through ``January 1,
2025.'' and inserting ``may not implement the policy under
section 413.174(f)(6) of title 42, Code of Federal Regulations
(relating to oral-only ESRD-related drugs in the ESRD
prospective payment system) with respect to such drugs
indicated for the reduction, management, or control of the
serum phosphate of an individual before January 1, 2027.''.
(b) Study.--Not later than 1 year after the date of the enactment
of this Act, the Secretary of Health and Human Services shall submit to
Congress and make available on the public website of the Centers for
Medicare & Medicaid Services a report containing data from 2022 through
2024 on--
(1) the number of individuals entitled to benefits under
part A of title XVIII of the Social Security Act (42 U.S.C.
1395c et seq.) or enrolled under part B of such title (42
U.S.C. 1395j et seq.) with end-stage renal disease who are
enrolled under a prescription drug plan under part D of such
title (42 U.S.C. 1395w-101 et seq.) or under an MA-PD plan
under part C of such title (42 U.S.C. 1395w-21 et seq.), along
with a specification of any gaps in coverage under such
prescription drug plans or MA-PD plans;
(2) the amount of expenditures under such part D
attributable to oral-only drugs related to the treatment of
end-stage renal disease and the amount of cost sharing incurred
by such individuals for such drugs;
(3) such individuals' adherence to prescriptions for such
drugs, including as measured by serum phosphate levels,
reported through the end-stage renal disease quality reporting
system;
(4) adverse events of such individuals related to
hyperphosphatemia and estimated costs attributable to such
adverse events under such title; and
(5) any recommended strategies or standards of practice to
increase adherence to prescribed phosphate binders or lowering
agents or other strategies to reduce costs to such individuals
and expenditures under such program for such agents.
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