[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5027 Introduced in House (IH)]
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118th CONGRESS
1st Session
H. R. 5027
To improve the understanding of, and promote access to treatment for,
chronic kidney disease, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
July 27, 2023
Mrs. Miller of West Virginia (for herself and Ms. Sewell) 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 improve the understanding of, and promote access to treatment for,
chronic kidney disease, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
This Act may be cited as the ``Chronic Kidney Disease Improvement
in Research and Treatment Act of 2023''.
TITLE I--PREVENTING KIDNEY DISEASE AND EXPANDING AWARENESS AND
EDUCATION
SEC. 101. EXPANDING MEDICARE ANNUAL WELLNESS BENEFIT TO INCLUDE KIDNEY
DISEASE SCREENING.
(a) In General.--Section 1861(ww)(2) of the Social Security Act (42
U.S.C. 1395x(ww)(2)) is amended--
(1) by redesignating subparagraph (O) as subparagraph (P);
and
(2) by inserting after subparagraph (N) the following new
subparagraph:
``(O) Chronic kidney disease screening as defined
by the Secretary.''.
(b) Effective Date.--The amendments made by this section apply to
items and services furnished on or after January 1, 2022.
SEC. 102. INCREASING ACCESS TO MEDICARE KIDNEY DISEASE EDUCATION
BENEFIT.
(a) In General.--Section 1861(ggg) of the Social Security Act (42
U.S.C. 1395x(ggg)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A), by inserting ``or stage
V'' after ``stage IV''; and
(B) in subparagraph (B), by inserting ``or of a
physician assistant, nurse practitioner, or clinical
nurse specialist (as defined in section 1861(aa)(5))
assisting in the treatment of the individual's kidney
condition'' after ``kidney condition''; and
(2) in paragraph (2)--
(A) by striking subparagraph (B); and
(B) in subparagraph (A)--
(i) by striking ``(A)'' after ``(2)'';
(ii) by striking ``and'' at the end of
clause (i);
(iii) by striking the period at the end of
clause (ii) and inserting ``; and'';
(iv) by redesignating clauses (i) and (ii)
as subparagraphs (A) and (B), respectively; and
(v) by adding at the end the following:
``(C) a renal dialysis facility subject to the
requirements of section 1881(b)(1) with personnel who--
``(i) provide the services described in
paragraph (1); and
``(ii) is a physician (as defined in
subsection (r)(1)) or a physician assistant,
nurse practitioner, or clinical nurse
specialist (as defined in subsection
(aa)(5)).''.
(b) Payment to Renal Dialysis Facilities.--Section 1881(b) of the
Social Security Act (42 U.S.C. 1395rr(b)) is amended by adding at the
end the following new paragraph:
``(15) For purposes of paragraph (14), the single payment
for renal dialysis services under such paragraph shall not take
into account the amount of payment for kidney disease education
services (as defined in section 1861(ggg)). Instead, payment
for such services shall be made to the renal dialysis facility
on an assignment-related basis under section 1848.''.
(c) Effective Date.--The amendments made by this section apply to
kidney disease education services furnished on or after January 1,
2022.
TITLE II--INCENTIVIZING KIDNEY CARE INNOVATION
SEC. 201. REFINING THE END-STAGE RENAL DISEASE PAYMENT SYSTEM TO
IMPROVE ACCURACY IN PAYMENT AND SUPPORT THERAPIES.
(a) In General.--Section 1881(b)(14) of the Social Security Act (42
U.S.C. 1395ww(b)(14)) is amended by adding the following new
subparagraph:
``(J) Payment for new and innovative drugs,
biologicals, and devices that are renal dialysis
services.--
``(i) In general.--For drugs or biologicals
defined as within a functional category and
furnished on or after January 1, 2024, the
Secretary shall implement an add-on adjustment
for claims that include such drugs or
biologicals that, among other things, shall--
``(I) calculate a per-treatment
cost using the most recent cost and
utilization data collected during a
transitional payment period of not less
than 3 years by dividing the total
spending for such drug or biological
during such transitional period by the
total number of treatments for which
such drug or biological was listed on
such claim during such period of time;
``(II) offset the amount of the
add-on adjustment by an amount that
corresponds with the reduction in
expenditures for other formerly
separately billed renal dialysis drugs
that were directly the result of the
inclusion of the new product;
``(III) update the add-on
adjustment annually to account for
inflationary changes; and
``(IV) be applied immediately upon
the expiration of the TDAPA period for
a product to avoid a gap between the
TDAPA and availability of the post-
TDAPA add-on adjustment.
``(ii) Implementation.--This policy shall
not be implemented in a budget neutral
manner.''.
(b) New Devices and Other Technologies.--As part of the
promulgation of the annual rule for the Medicare end-stage renal
disease prospective payment system under section 1881(b)(14) of the
Social Security Act (42 U.S.C. 1395rr(b)(14)) for calendar year 2022,
and in consultation with stakeholders, the Secretary of Health and
Human Services (in this section referred to as the ``Secretary'') shall
ensure that the single payment amount is adequate to cover the cost of
the new innovative device or other technology with substantial clinical
improvement and increase the single payment amount if the Secretary
determines such payment amount is not adequate to cover such cost. In
carrying out the preceding sentence, the Secretary shall use the cost
and utilization data collected during a 3-year transitional payment
period, as otherwise described in the final regulation published on
November 9, 2020 (85 Fed. Reg. 71398 et seq.).
SEC. 202. ENSURING MEDICARE ADVANTAGE SUPPORTS KIDNEY CARE INNOVATIVE
THERAPIES.
Section 1853(c) of the Social Security Act (42 U.S.C. 1395ww-23(c))
is amended by adding the following new paragraph:
``(8) Adjustment for innovative products for enrolles with
end stage renal disease.--If the Secretary makes a
determination with respect to the application of the End Stage
Renal Disease Transitional Drug Add-On Payment Adjustment or
the Transitional Add-on Payment Adjustment for New and
Innovative Equipment and Supplies to a product under this title
that will result in an increase in the costs to Medicare+Choice
of providing benefits under contracts under this part for the
period of the Transitional Drug Add-On Payment Adjustment or
the Transitional Add-on Payment Adjustment for New and
Innovative Equipment and Supplies, the Secretary shall directly
make the payments adjustments to providers of services or
independent dialysis facilities consistent with the application
of such adjustments under the ESRD prospective payment system
outlined in section 1881(b)(14) of this title for the complete
duration that the adjustment applies under such section. After
the duration of such adjustment, the Secretary shall adjust
appropriately the payments to such organizations under this
part.
``(9) Post-TDAPA payment add-on adjustment.--The Secretary
shall require providers of services or independent dialysis
facilities to apply the adjustment required under subparagraph
(J) of section 1881(b)(14) to payments made under this part.''.
SEC. 203. IMPROVING PATIENT LIVES AND QUALITY OF CARE THROUGH RESEARCH
AND INNOVATION.
(a) Study.--The Secretary of Health and Human Services (in this
section referred to as the ``Secretary'') shall conduct a study on
increasing kidney transplantation rates. Such study shall include an
analysis of each of the following:
(1) Any disincentives in the payment systems under the
Medicare program under title XVIII of the Social Security Act
(42 U.S.C. 1395 et seq.) that create barriers to kidney
transplants and post-transplant care for beneficiaries with
end-stage renal disease.
(2) The practices used by States with higher than average
donation rates and whether those practices and policies could
be successfully utilized in other States.
(3) Practices and policies that could increase deceased
donation rates of minority populations.
(4) Whether cultural and policy barriers exist to
increasing living donation rates, including an examination of
how to better facilitate chained donations.
(5) Other areas determined appropriate by the Secretary.
(b) Report.--Not later than 18 months after the date of the
enactment of this Act, the Secretary shall submit to Congress a report
on the study conducted under subsection (a), together with such
recommendations as the Secretary determines to be appropriate.
TITLE III--ADDRESSING THE KIDNEY CARE WORKFORCE CRISIS
SEC. 301. ENSURING ACCURACY AND STABILITY IN KIDNEY CARE PAYMENT.
Section 1881(b)(14) of the Social Security Act (42 U.S.C.
1395ww(b)(14)) is amended by adding the following new subparagraph:
``(K) Beginning with calendar year 2024, the
Secretary shall compute an adjustment to the annual
update of the previous calendar year's rate to account
for forecast error. The initial adjustment (in calendar
year 2024) to the update of the previous calendar
year's rate will take into account the cumulative
forecast error between calendar years 2021 and 2022.
Subsequent adjustments in succeeding fiscal years will
take into account the forecast error from the most
recently available calendar year for which there is
final data. The forecast error adjustment shall apply
whenever the difference between the forecasted and
actual percentage change in the ESRD market basket
index exceeds the threshold of 0.5 percentage
points.''.
SEC. 302. ENCOURAGING KIDNEY CARE WORKFORCE IN UNDER SERVED AREAS.
(a) Definition of Primary Care Services.--Section 331(a)(3)(D) of
the Public Health Service Act (42 U.S.C. 254d(a)(3)(D)) is amended by
inserting ``renal dialysis,'' after ``dentistry,''.
(b) National Health Service Corps Scholarship Program.--Section
338A(a)(2) of the Public Health Service Act (42 U.S.C. 254l(a)(2)) is
amended by inserting ``, which may include nephrology health
professionals'' before the period at the end.
(c) National Health Service Corps Loan Repayment Program.--Section
338B(a)(2) of the Public Health Service Act (42 U.S.C. 254l-1(a)(2)) is
amended by inserting ``, which may include nephrology health
professionals'' before the period at the end.
TITLE IV--EXPANDING PATIENT CHOICE OF COVERAGE
SEC. 401. MEDIGAP COVERAGE FOR BENEFICIARIES WITH END-STAGE RENAL
DISEASE.
(a) Guaranteed Availability of Medigap Policies to All ESRD
Medicare Beneficiaries.--
(1) In general.--Section 1882(s) of the Social Security Act
(42 U.S.C. 1395ss(s)) is amended--
(A) in paragraph (2)--
(i) in subparagraph (A), by striking ``is
65'' and all that follows through the period
and inserting the following: ``is--
``(i) 65 years of age or older and is
enrolled for benefits under part B; or
``(ii) entitled to benefits under 226A(b)
and is enrolled for benefits under part B.'';
and
(ii) in subparagraph (D), in the matter
preceding clause (i), by inserting ``(or is
entitled to benefits under 226A(b))'' after
``is 65 years of age or older''; and
(B) in paragraph (3)(B)--
(i) in clause (ii), by inserting ``(or is
entitled to benefits under 226A(b))'' after
``is 65 years of age or older''; and
(ii) in clause (vi), by inserting ``(or
under 226A(b))'' after ``at age 65''.
(2) Effective date.--The amendments made by paragraph (1)
shall apply to Medicare supplemental policies effective on or
after January 1, 2022.
(b) Additional Enrollment Period for Certain Individuals.--
(1) One-time enrollment period.--
(A) In general.--In the case of an individual
described in subparagraph (B), the Secretary of Health
and Human Services shall establish a one-time
enrollment period during which such an individual may
enroll in any Medicare supplemental policy under
section 1882 of the Social Security Act (42 U.S.C.
1395ss) of the individual's choosing.
(B) Enrollment period.--The enrollment period
established under subparagraph (A) shall begin on
January 1, 2023, and shall end June 30, 2023.
(2) Individual described.--An individual described in this
paragraph is an individual who--
(A) is entitled to hospital insurance benefits
under part A of title XVIII of the Social Security Act
under section 226A(b) of such Act (42 U.S.C. 426-1);
(B) is enrolled for benefits under part B of such
title XVIII; and
(C) would not, but for the provisions of, and
amendments made by, subsection (a) be eligible for the
guaranteed issue of a Medicare supplemental policy
under paragraph (2) or (3) of section 1882(s) of such
Act (42 U.S.C. 1395ss(s)).
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