[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4065 Introduced in House (IH)]
<DOC>
117th CONGRESS
1st Session
H. R. 4065
To improve the understanding of, and promote access to treatment for,
chronic kidney disease, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 22, 2021
Ms. Sewell (for herself and Mr. Buchanan) 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 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.
(a) Short Title.--This Act may be cited as the ``Chronic Kidney
Disease Improvement in Research and Treatment Act of 2021''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--INCREASING AWARENESS, EXPANDING PREVENTIVE SERVICES, AND
IMPROVING CARE COORDINATION
Sec. 101. Expanding Medicare annual wellness benefit to include kidney
disease screening.
Sec. 102. Increasing access to Medicare kidney disease education
benefit.
Sec. 103. Improving patient lives and quality of care through research
and innovation.
Sec. 104. Understanding the progression of kidney disease and treatment
of kidney failure in minority populations.
TITLE II--CREATING AN ECONOMICALLY STABLE DIALYSIS INFRASTRUCTURE AND
INCENTIVIZING INNOVATION
Sec. 201. Refining the end-stage renal disease payment system to
improve accuracy in payment and support
therapies.
TITLE III--INCREASING PATIENT ACCESS TO QUALITY PERFORMANCE BY
IMPROVING THE ACCURACY AND TRANSPARENCY OF END-STAGE RENAL DISEASE
QUALITY PROGRAMS
Sec. 301. Improving patient decision making and transparency by
consolidating and modernizing quality
programs.
TITLE IV--EMPOWERING PATIENTS
Sec. 401. Medigap coverage for beneficiaries with end-stage renal
disease.
Sec. 402. Network adequacy requirements for dialysis services.
Sec. 403. Allowing individuals with kidney failure to retain access to
private insurance.
TITLE I--INCREASING AWARENESS, EXPANDING PREVENTIVE SERVICES, AND
IMPROVING CARE COORDINATION
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.
SEC. 103. 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
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.
SEC. 104. UNDERSTANDING THE PROGRESSION OF KIDNEY DISEASE AND TREATMENT
OF KIDNEY FAILURE IN MINORITY POPULATIONS.
(a) Study.--The Secretary of Health and Human Services (in this
section referred to as the ``Secretary'') shall conduct a study on--
(1) the social, behavioral, and biological factors leading
to kidney disease;
(2) efforts to slow the progression of kidney disease in
minority populations that are disproportionately affected by
such disease; and
(3) treatment patterns associated with providing care,
under the Medicare program under title XVIII of the Social
Security Act, the Medicaid program under title XIX of such Act,
and through private health insurance, to minority populations
that are disproportionately affected by kidney failure.
(b) Report.--Not later than 1 year 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 II--CREATING AN ECONOMICALLY STABLE DIALYSIS INFRASTRUCTURE AND
INCENTIVIZING 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. 1395rr(b)(14)) is amended--
(1) in subparagraph (D), in the matter preceding clause
(i), by striking ``Such system'' and inserting ``Subject to
subparagraph (J), such system''; and
(2) by adding at the end the following new subparagraph:
``(J) For payment for renal dialysis services
furnished on or after January 1, 2024, under the system
under this paragraph--
``(i) the payment adjustment described in
clause (i) of subparagraph (D)--
``(I) shall not take into account
comorbidities; and
``(II) shall take into account age
for purposes of distinguishing between
individuals who are under 18 years of
age and those who are 18 years of age
and older but shall not include any
other adjustment for age for patients
18 years of age and older;
``(ii) the Secretary shall reassess any
adjustments related to patient weight under
such clause;
``(iii) the payment adjustment described in
clause (ii) of such subparagraph shall not be
included; and
``(iv) take into account reasonable costs
for determining the payment rate consistent
with paragraph (2)(B).''.
(b) Inclusion of Network Fee as an Allowable Cost.--Section
1881(b)(14) of the Social Security Act (42 U.S.C. 1395rr(b)(14)), as
amended by subsection (a), is amended by adding at the end the
following new subparagraph:
``(K) Not later than January 1, 2022, the Secretary
shall amend the ESRD facility cost report to include
the per treatment network fee (as described in
paragraph (7)) as an allowable cost or offset to
revenue.''.
(c) Determination of Productivity Adjustment.--Section
1886(b)(3)(B)(xi) of the Social Security Act (42 U.S.C.
1395ww(b)(3)(B)(xi)) is amended--
(1) in subclause (I), by striking ``For 2012'' and
inserting ``Subject to subclause (IV), for 2012''; and
(2) by adding at the end, the following new subclause:
``(IV) For each of 2022 through
2025, the productivity adjustment
described in subclause (II) shall be
zero for a payment system in any year
in which the Medicare Payment Advisory
Commission estimates that payments
under this title pursuant to such
payment system, on an aggregate
national basis, exceed costs, on an
aggregate national basis, by 3.0
percent or less.''.
(d) Payment for New and Innovative Drugs and Biologicals That Are
Renal Dialysis Services.--Section 1881(b)(14) of the Social Security
Act (42 U.S.C. 1395ww(b)(14)), as amended by subsections (a) and (b),
is amended by adding the following new subparagraph--
``(L) Payment for new and innovative drugs,
biologicals, and devices that are renal dialysis
services.--
``(i) In general.--For drugs or biologicals
determined to be within a functional category,
the Secretary, in consultation with
stakeholders, shall ensure that the single
payment amount is adequate to cover the cost of
new innovative drugs or biologicals 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
the three-year transitional payment period, as
otherwise described in the final regulation
published on November 14, 2018 (83 Fed. Reg.
56922 et seq.).
``(ii) Money to follow the patient.--The
Secretary, through notice and comment
rulemaking, shall implement a policy for any
drug or biological that is not provided to the
`average' patient that results in the amount by
which the single payment amount is increased
pursuant to this subparagraph shall be paid
only when a provider or renal dialysis facility
has demonstrated that it has administered the
drug or biological to a patient.''.
(e) 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 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 three-year transitional payment
period, as otherwise described in the final regulation published on
November 9, 2020 (85 Fed. Reg. 71398 et seq.).
TITLE III--INCREASING PATIENT ACCESS TO QUALITY PERFORMANCE BY
IMPROVING THE ACCURACY AND TRANSPARENCY OF END-STAGE RENAL DISEASE
QUALITY PROGRAMS
SEC. 301. IMPROVING PATIENT DECISION MAKING AND TRANSPARENCY BY
CONSOLIDATING AND MODERNIZING QUALITY PROGRAMS.
(a) Measures.--Section 1881(h)(2) of the Social Security Act (42
U.S.C. 1395rr(h)(2)) is amended--
(1) by striking subparagraph (A) and inserting the
following:
``(A) The measures specified under this paragraph
with respect to the year involved shall be selected by
the Secretary in consultation with stakeholders to
promote improvement in beneficiary outcomes and shared
decision-making with beneficiaries and their
caregivers. When selecting measures specified under
this paragraph, the Secretary shall take into account
clinical gaps in care, underutilization that may lead
to beneficiary harm, patient safety, and outcomes.'';
(2) in subparagraph (B)(i), by striking ``subparagraph
(A)(iv)'' and inserting ``subparagraph (A)'';
(3) by striking subparagraph (E); and
(4) by adding at the end the following new subparagraphs:
``(E) Weighting limitation.--No single measure
specified by the Secretary or individual measure within
a composite measure so specified may be weighted less
than 10 percent of the total performance score.
``(F) Statistically valid and reliable.--In
specifying measures under subparagraph (A), the
Secretary shall only specify measures that have been
shown to be statistically valid and reliable through
testing.''.
(b) Endorsement.--Section 1881(h)(2)(B) of the Social Security Act
(42 U.S.C. 1395rr(h)(2)(B)) is amended--
(1) in clause (ii), by adding at the end the following new
sentence: ``The exception under the preceding sentence shall
not apply to a measure that the entity with a contract under
section 1890(a) (or a similar entity) considered but failed to
endorse.''; and
(2) by adding at the end the following new clause:
``(iii) Composite measures.--Clauses (i)
and (ii) shall apply to composite measures in
the same manner as such clauses apply to
individual measures.''.
(c) Requirements for Dialysis Facility Compare Star Rating
Program.--Section 1881(h)(6) of the Social Security Act (42 U.S.C.
1395rr(h)(6)) is amended by adding at the end the following new
subparagraph:
``(E) Requirements for any dialysis facility
compare star rating program.--To the extent that the
Secretary maintains a dialysis facility compare star
rating program, under such a program the Secretary--
``(i) shall assign stars using the same
methodology and total performance score results
from the quality incentive program under this
subsection;
``(ii) shall determine the stars using the
same methodology used under such quality
incentive program; and
``(iii) shall not use a forced bell curve
when determining the stars or rebaselining the
stars.''.
(d) Incentive Payments.--Section 1881(h)(1) of the Social Security
Act (42 U.S.C. 1395rr(h)(1)) is amended by adding at the end the
following new subparagraph:
``(D) Incentive payments.--
``(i) In general.--In the case of a
provider of services or a renal dialysis
facility that the Secretary determines exceeds
the attainment performance standards under
paragraph (4) with respect to a year, the
Secretary may make a bonus payment to the
provider or facility (pursuant to a process
established by the Secretary).
``(ii) Funding.--The total amount of bonus
payments under clause (i) in a year shall be
equal to the total amount of reduced payments
in a year under subparagraph (A).
``(iii) No effect in subsequent years.--The
provisions of subparagraph (C) shall apply to a
bonus payment under this subparagraph in the
same manner subparagraph (C) applies to a
reduction under such subparagraph.''.
(e) Effective Date.--The amendments made by this section shall
apply to items and services furnished on or after January 1, 2022.
TITLE IV--EMPOWERING PATIENTS
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)).
SEC. 402. NETWORK ADEQUACY STANDARDS FOR DIALYSIS SERVICES.
Section 1852(d) of the Social Security Act (42 U.S.C. 1395w-22(d))
is amended by adding at the end the following new paragraph:
``(7) Network adequacy requirements for dialysis
services.--For plan year 2022 and subsequent plan years, the
Secretary shall apply the network adequacy standards under this
subsection with respect to access to dialysis services--
``(A) using the time and distance standards in
effect for plan year 2020; and
``(B) without regard to the final rule titled
`Medicare Program; Contract Year 2021 Policy and
Technical Changes to the Medicare Advantage Program,
Medicare Prescription Drug Benefit Program, and
Medicare Cost Plan Program' (85 Fed. Reg. 33796).''.
SEC. 403. ALLOWING INDIVIDUALS WITH KIDNEY FAILURE TO RETAIN ACCESS TO
PRIVATE INSURANCE.
(a) In General.--Section 1862(b)(1)(C) of the Social Security Act
(42 U.S.C. 1395y(b)(1)(C)) is amended--
(1) in the last sentence, by inserting ``and before January
1, 2022'' after ``prior to such date''; and
(2) by adding at the end the following new sentence:
``Effective for items and services furnished on or after
January 1, 2022 (with respect to periods beginning on or after
the date that is 42 months prior to such date), clauses (i) and
(ii) shall be applied by substituting `42-month' for `12-month'
each place it appears.''.
(b) Effective Date.--The amendments made by this subsection shall
take effect on the date of enactment of this Act. For purposes of
determining an individual's status under section 1862(b)(1)(C) of the
Social Security Act (42 U.S.C. 1395y(b)(1)(C)), as amended by
subsection (a), an individual who is within the coordinating period as
of the date of enactment of this Act shall have that period extended to
the full 42 months described in the last sentence of such section, as
added by the amendment made by subsection (a)(2).
<all>