[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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