[House Report 118-548]
[From the U.S. Government Publishing Office]
118th Congress } { Rept. 118-548
HOUSE OF REPRESENTATIVES
2d Session } { Part 1
======================================================================
KIDNEY PATIENT ACCESS TO TECHNOLOGICALLY INNOVATIVE AND ESSENTIAL
NEPHROLOGY TREATMENTS ACT OF 2024
_______
June 11, 2024.--Ordered to be printed
_______
Mr. Smith of Missouri, from the Committee on Ways and Means, submitted
the following
R E P O R T
[To accompany H.R. 5074]
The Committee on Ways and Means, to whom was referred the
bill (H.R. 5074) 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, having considered the same, reports favorably thereon
with an amendment and recommends that the bill as amended do
pass.
CONTENTS
Page
I. SUMMARY AND BACKGROUND...........................................2
A. Purpose and Summary................................. 2
B. Background and Need for Legislation................. 2
C. Legislative History................................. 3
Background........................................... 3
Committee Hearings................................... 3
Committee Action..................................... 3
D. Designated Hearing.................................. 3
II. EXPLANATION OF THE BILL..........................................3
A. Reasons for Change.................................. 3
B. Explanation of Provisions........................... 4
C. Effective Date...................................... 4
III. VOTES OF THE COMMITTEE...........................................4
IV. BUDGET EFFECTS OF THE BILL.......................................5
A. Committee Estimate of Budgetary Effects............. 5
B. Statement Regarding New Budget Authority and Tax
Expenditures Budget Authority...................... 5
V. COST ESTIMATE PREPARED BY THE CONGRESSIONAL BUDGET OFFICE........5
VI. OTHER MATTERS TO BE DISCUSSED UNDER THE RULES OF THE HOUSE.......5
A. Committee Oversight Findings and Recommendations.... 5
B. Statement of General Performance Goals and
Objectives......................................... 5
C. Information Relating to Unfunded Mandates........... 5
D. Congressional Earmarks, Limited Tax Benefits, and
Limited Tariff Benefits............................ 6
E. Duplication of Federal Programs..................... 6
VII. CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED............6
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
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.
I. SUMMARY AND BACKGROUND
A. Purpose and Summary
The policy would allow patients to continue to access
kidney disease therapies through their Medicare Part D benefit
until 2027 and require the Department of Health and Human
Services (HHS) to submit a report on the effects of providing
these drugs through Medicare Part D.
B. Background and Need for Legislation
Certain noninjectable oral drugs (``oral-only'') for
patients with end-stage renal disease (ESRD) are included in a
patient's traditional Medicare Part D drug coverage, allowing
patients to access these drugs at their local pharmacy. This
includes drugs such as ``phosphate binders'' which help ESRD
patients maintain healthy levels of phosphate in the blood. The
Centers for Medicare and Medicaid Services (CMS) plan to move
these drugs from Medicare Part D coverage to the ESRD payment
``bundle'' in 2025. The ESRD bundle is an all-inclusive payment
to dialysis providers under Medicare Part B; the base payment
for 2024 is $271.02 per dialysis session; intended to cover
dialysis treatments, but not extra costs such as noninjectable
drugs. When new ESRD drugs are eligible for treatment, an
additional time-limited add-on payment is added to the ESRD
bundle to encourage adoption, known as Transitional Drug Add-on
Payment Adjustment (TDAPA).
C. Legislative History
Background
H.R. 5074 was introduced on July 28, 2023, and was referred
to the Committee on Energy and Commerce and the Committee on
Ways and Means.
Committee Hearings
The Committee on Ways and Means held the following
hearing(s) concerning the policy in H.R. 5074:
On Wednesday, May 10, 2023, the Committee on Ways and Means
Health Subcommittee held a hearing titled, ``Examining Policies
that Inhibit Innovation and Patient Access'' to explore
regulatory and legislative barriers to patient access to
innovative treatments.
Committee Action
The Committee on Ways and Means marked up H.R. 5074, the
Kidney PATIENT Act of 2023, on March 6, 2024, and favorably
reported the bill, as amended, to the House of Representatives
(with quorum being present).
D. Designated Hearing
Pursuant to clause 3(c)(6) of rule XIII, the following
hearing was used to develop and consider H.R. 5074:
On Wednesday, May 10, 2023, the Committee on Ways and Means
Health Subcommittee held a hearing titled, ``Examining Policies
that Inhibit Innovation and Patient Access'' to explore
regulatory and legislative barriers to patient access to
innovative treatments.
II. EXPLANATION OF THE BILL
A. Reasons for Change
CMS plans to move oral-only ESRD drugs from Medicare Part D
coverage to the ESRD bundle.
The ESRD bundle is a limited, all-inclusive payment, so
dialysis providers may not be able to invest in and provide
innovative oral-only drugs to patients. Dialysis providers
would need to expand their infrastructure to dispense oral-only
drugs. Phosphate-lowering therapies, which are oral-only drugs,
must be taken with a meal and therefore cannot be administered
by a provider while patients dialyze and the common starting
dose for phosphate therapies is more than 100 pills/month.
Allowing oral-only drugs to move to the bundle would result
in higher costs for patients. The TDAPA add-on payment for new
drug adoption is anticipated resulting in higher cost sharing
for patients. Keeping these drugs in Medicare Part D will allow
patients to utilize certain cost sharing protections and
provide patients with better access to the full-range of drugs
that may be necessary to manage their hyperphosphatemia.
B. Explanation of Provisions
This policy delays drugs that treat high levels of
phosphate in the blood and do not have an injectable
alternative from entering the ESRD payment bundle until 2027.
The policy also requires the Secretary of HHS to report
information based on data from 2022 through 2024 on the
prescription drug coverage of patients with ESRD, Medicare
spending and patient cost sharing under Part D for oral-only
ESRD related drugs, patient adherence, patient adverse events
related to hyperphosphatemia and estimated costs to the
Medicare program, and any recommended strategies to increase
patient adherence.
C. Effective Date
The bill would become effective upon enactment.
III. VOTES OF THE COMMITTEE
In compliance with the Rules of the House of
Representatives, the following statement is made concerning the
vote of the Committee on Ways and Means during the markup
consideration of H.R. 5074, the ``Kidney PATIENT Act of 2023,''
on March 6, 2024.
H.R. 5074 was ordered favorably reported to the House of
Representatives as amended by a roll call vote of 41 yeas to 1
nay (with a quorum being present). The vote was as follows:
----------------------------------------------------------------------------------------------------------------
Representative Yea Nay Present Representative Yea Nay Present
----------------------------------------------------------------------------------------------------------------
Mr. Smith (MO)..................... X ...... ......... Mr. Neal............. X ...... .........
Mr. Buchanan....................... X ...... ......... Mr. Doggett.......... ...... X .........
Mr. Smith (NE)..................... X ...... ......... Mr. Thompson......... X ...... .........
Mr. Kelly.......................... X ...... ......... Mr. Larson........... X ...... .........
Mr. Schweikert..................... X ...... ......... Mr. Blumenauer....... X ...... .........
Mr. LaHood......................... X ...... ......... Mr. Pascrell......... X ...... .........
Dr. Wenstrup....................... X ...... ......... Mr. Davis............ X ...... .........
Mr. Arrington...................... X ...... ......... Ms. Sanchez.......... X ...... .........
Dr. Ferguson....................... X ...... ......... Ms. Sewell........... X ...... .........
Mr. Estes.......................... X ...... ......... Ms. DelBene.......... X ...... .........
Mr. Smucker........................ X ...... ......... Ms. Chu.............. X ...... .........
Mr. Hern........................... X ...... ......... Ms. Moore............ ...... ...... .........
Ms. Miller......................... X ...... ......... Mr. Kildee........... X ...... .........
Dr. Murphy......................... X ...... ......... Mr. Beyer............ X ...... .........
Mr. Kustoff........................ X ...... ......... Mr. Evans............ X ...... .........
Mr. Fitzpatrick.................... X ...... ......... Mr. Schneider........ X ...... .........
Mr. Steube......................... X ...... ......... Mr. Panetta.......... X ...... .........
Ms. Tenney......................... X ...... ......... Mr. Gomez............ X ...... .........
Mrs. Fischbach..................... X ...... .........
Mr. Moore.......................... X ...... .........
Mrs. Steel......................... X ...... .........
Ms. Van Duyne...................... X ...... .........
Mr. Feenstra....................... X ...... .........
Ms. Malliotakis.................... X ...... .........
Mr. Carey.......................... X ...... .........
----------------------------------------------------------------------------------------------------------------
IV. BUDGET EFFECTS OF THE BILL
A. Committee Estimate of Budgetary Effects
With respect to clause 3(d) of rule XIII of the Rules of
the House of Representatives, a cost estimate provided by the
Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974 was not made available to the
Committee in time for the filing of this report.
B. Statement Regarding New Budget Authority and Tax Expenditures Budget
Authority
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee states that the
bill involved no new or increased budget authority. The
Committee states further that the bill involves no new or
increased tax expenditures.
V. COST ESTIMATE PREPARED BY THE CONGRESSIONAL BUDGET OFFICE
With respect to the requirements of clause 3(c)(2) of rule
XIII of the Rules of the House of Representatives and section
308(a) of the Congressional Budget Act of 1974 and with respect
to requirements of clause (3)(c)(3) of rule XIII of the Rules
of the House of Representatives and section 402 of the
Congressional Budget Act of 1974, the Committee has requested
but not received a cost estimate for this bill from the
Director of Congressional Budget Office. The Chairman of the
Committee shall cause such estimate and statement to be printed
in the Congressional Record upon its receipt by the Committee.
VI. OTHER MATTERS TO BE DISCUSSED UNDER THE RULES OF THE HOUSE
A. Committee Oversight Findings and Recommendations
With respect to clause 3(c)(1) of rule XIII of the Rules of
the House of Representatives, the Committee made findings and
recommendations that are reflected in this report.
B. Statement of General Performance Goals and Objectives
With respect to clause 3(c)(4) of rule XIII of the Rules of
the House of Representatives, the Committee advises that the
bill does not authority funding, so no statement of general
performance goals and objectives is required.
C. Information Relating to Unfunded Mandates
This information is provided in accordance with section 423
of the Unfunded Mandates Reform Act of 1995 (Pub. L. No. 104-
4).
The Committee has determined that the bill does not contain
Federal mandates on the private sector. The Committee has
determined that the bill does not impose a Federal
intergovernmental mandate on State, local, or tribal
governments.
D. Congressional Earmarks, Limited Tax Benefits, and Limited Tariff
Benefits
With respect to clause 9 of rule XXI of the Rules of the
House of Representatives, the Committee has carefully reviewed
the provisions of the bill, and states that the provisions of
the bill do not contain any congressional earmarks, limited tax
benefits, or limited tariff benefits within the meaning of the
rule.
E. Duplication of Federal Programs
In compliance with clause 3(c)(5) of rule XIII of the Rules
of the House of Representatives, the Committee states that no
provision of the bill establishes or reauthorizes: (1) a
program of the Federal Government known to be duplicative of
another Federal program; (2) a program included in any report
from the Government Accountability Office to Congress pursuant
to section 21 of Public Law 111-139; or (3) a program related
to a program identified in the most recent Catalog of Federal
Domestic Assistance, published pursuant to the Federal Program
Information Act (Pub. L. No. 95-220, as amended by Pub. L. No.
98-169).
VII. CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italics, and existing law in which no
change is proposed is shown in roman):
AMERICAN TAXPAYER RELIEF ACT OF 2012
* * * * * * *
TITLE VI--MEDICARE AND OTHER HEALTH EXTENSIONS
* * * * * * *
Subtitle C--Other Health Provisions
* * * * * * *
SEC. 632. REVISIONS TO THE MEDICARE ESRD BUNDLED PAYMENT SYSTEM TO
REFLECT FINDINGS IN THE GAO REPORT.
(a) Adjustment to ESRD Bundled Payment Rate To Account for
Changes in the Utilization of Certain Drugs and Biologicals.--
Section 1881(b)(14) of the Social Security Act (42 U.S.C.
1395rr(b)(14)) is amended by adding at the end the following
new subparagraph:
``(I) For services furnished on or after January 1, 2014, the
Secretary shall, by comparing per patient utilization data from
2007 with such data from 2012, make reductions to the single
payment that would otherwise apply under this paragraph for
renal dialysis services to reflect the Secretary's estimate of
the change in the utilization of drugs and biologicals
described in clauses (ii), (iii), and (iv) of subparagraph (B)
(other than oral-only ESRD-related drugs, as such term is used
in the final rule promulgated by the Secretary in the Federal
Register on August 12, 2010 (75 Fed. Reg. 49030)). In making
reductions under the preceding sentence, the Secretary shall
take into account the most recently available data on average
sales prices and changes in prices for drugs and biological
reflected in the ESRD market basket percentage increase factor
under subparagraph (F).''.
(b) [Two-year Delay] Delay of Implementation of Oral-Only
ESRD-Related Drugs in the ESRD Prospective Payment System;
Monitoring.--
(1) Delay.--The Secretary of Health and Human
Services [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), prior to January 1, 2025.]
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. Notwithstanding section 1881(b)(14)(A)(ii) of the
Social Security Act (42 U.S.C. 1395rr(b)(14)(A)(ii)),
implementation of the policy described in the previous
sentence shall be based on data from the most recent
year available.
(2) Monitoring.--With respect to the implementation
of oral-only ESRD-related drugs in the ESRD prospective
payment system under subsection (b)(14) of section 1881
of the Social Security Act (42 U.S.C. 1395rr(b)(14)),
the Secretary of Health and Human Services shall
monitor the bone and mineral metabolism of individuals
with end stage renal disease.
(c) Analysis of Case Mix Payment Adjustments.--By not later
than January 1, 2016, the Secretary of Health and Human
Services shall--
(1) conduct an analysis of the case mix payment
adjustments being used under section 1881(b)(14)(D)(i)
of the Social Security Act (42 U.S.C.
1395rr(b)(14)(D)(i)); and
(2) make appropriate revisions to such case mix
payment adjustments.
(d) Updated GAO Report.--Not later than December 31, 2023,
the Comptroller General of the United States shall submit to
Congress a report that updates the report submitted to Congress
under section 10336 of the Patient Protection and Affordable
Care Act (Public Law 111-148; 124 Stat. 974). The updated
report shall include an analysis of how the Secretary of Health
and Human Services has addressed points raised in the report
submitted under such section 10336 with respect to the
Secretary's preparations to implement payment for oral-only
ESRD-related drugs in the bundled prospective payment system
under section 1881(b)(14) of the Social Security Act (42 U.S.C.
1395rr(b)(14)).
* * * * * * *