[Congressional Record Volume 161, Number 33 (Thursday, February 26, 2015)]
[Senate]
[Pages S1166-S1168]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
By Mr. CARDIN (for himself, Mr. Crapo, and Mr. Nelson):
S. 598. A bill to improve the understanding of, and promote access to
treatment for, chronic kidney disease, and for other purposes; to the
Committee on Finance.
Mr. CARDIN. Mr. President, I rise in support of the bipartisan
Chronic Kidney Disease Improvement in Research and Treatment Act of
2015, which I am introducing with Senators Crapo and Nelson today. This
legislation seeks to make a real difference in the lives of Americans
suffering from kidney disease and end-stage renal disease.
Kidney disease is the 9th leading cause of death in the United
States, and unfortunately, more than one in ten Americans today suffer
from some form of kidney disease. More than 615,000 Americans are
living with kidney failure or end-stage renal disease, which is an
irreversible condition that can be fatal without a kidney transplant or
life-sustaining dialysis. 430,000 patients in our country rely on life-
sustaining dialysis care to survive.
This legislation seeks to promote research, expand patient choice,
and improve care coordination for these hundreds of thousands of
patients. Specifically, it would identify the gaps in research and
improve the coordination of Federal research efforts. The bill would
require the Government Accountability Office to submit a comprehensive
report analyzing current federally funded research projects regarding
chronic kidney disease and identifying knowledge gaps that are not
being addressed through those research efforts. It would also direct
the Department of Health and Human Services to evaluate and report on
the biological, social, and behavioral factors related to kidney
disease and efforts to slow the progression of disease in minority
populations disproportionately affected by this disease.
This legislation would improve access to pre-dialysis kidney
education programs to better manage patients' kidney disease and even
prevent kidney failure in some cases. Nephrologists and other health
professionals would be incentivized to work in underserved rural and
urban areas, and current payment policies would be modified to
encourage home dialysis, which is not incentivized under the current
Medicare payment structure. Patients with acute kidney injury would
also be allowed to receive treatments through dialysis providers,
therefore reducing costs associated with care provided in the more
expensive hospital outpatient setting. Perhaps most importantly, our
legislation would establish a voluntary coordinated care program that
would incentivize doctors and dialysis facilities to work together to
improve the coordination of care and reduce costly hospitalization.
Lastly, the bill would expand the options for patients by allowing
individuals diagnosed with kidney failure to enroll in the Medicare
Advantage program and reauthorizing on a permanent basis the Medicare
Advantage Special Needs Plan for patients with kidney failure.
I urge my colleagues to join me, Senator Crapo and Senator Nelson in
supporting the Chronic Kidney Disease Improvement in Research and
Treatment Act of 2015, which will improve the care of patients who
suffer from kidney disease and end-stage renal disease.
Mr. President, I ask unanimous consent that the text of the bill be
printed in the Record.
There being no objection the text of the bill was ordered to be
printed in the Record, as follows:
S. 598
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 ``Chronic Kidney Disease
Improvement in Research and Treatment Act of 2015''.
SEC. 2. TABLE OF CONTENTS.
The table of contents of this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
TITLE I--IMPROVING UNDERSTANDING OF CHRONIC KIDNEY DISEASE THROUGH
EXPANDED RESEARCH AND COORDINATION
Sec. 101. Identifying gaps in chronic kidney disease research.
Sec. 102. Coordinating research on chronic kidney disease.
Sec. 103. Understanding the progression of kidney disease and treatment
of kidney failure in minority populations.
Sec. 104. Identifying Medicare payment disincentives for transplant and
post-transplant care.
TITLE II--PROMOTING ACCESS TO CHRONIC KIDNEY DISEASE TREATMENTS
Sec. 201. Increasing access to Medicare kidney disease education
benefit.
Sec. 202. Improving access to chronic kidney disease treatment in
underserved rural and urban areas.
Sec. 203. Promoting access to home dialysis treatments.
Sec. 204. Expanding access for patients with acute kidney injury.
TITLE III--CREATING ECONOMIC STABILITY FOR PROVIDERS CARING FOR
INDIVIDUALS WITH CHRONIC KIDNEY DISEASE
Sec. 301. Stabilizing Medicare payments for services provided to
beneficiaries with stage V chronic kidney disease
receiving dialysis services.
Sec. 302. Providing individuals with kidney failure access to managed
care and coordinated care programs.
TITLE I--IMPROVING UNDERSTANDING OF CHRONIC KIDNEY DISEASE THROUGH
EXPANDED RESEARCH AND COORDINATION
SEC. 101. IDENTIFYING GAPS IN CHRONIC KIDNEY DISEASE
RESEARCH.
(a) Report.--Not later than one year after the date of
enactment of this Act, the Comptroller General of the United
States shall develop and submit to Congress a comprehensive
report assessing the adequacy of Federal expenditures in
chronic kidney disease research relative to Federal
expenditures for chronic kidney disease care.
(b) Contents.--The report required by this section shall--
(1) analyze the current chronic kidney disease research
projects being funded by Federal agencies;
[[Page S1167]]
(2) identify, including by surveying the kidney care
community, areas of chronic kidney disease knowledge gaps
that are not part of current Federal research efforts;
(3) report on the level of Federal expenditures on kidney
research as compared to the amount of Federal expenditures on
treating individuals with chronic kidney disease; and
(4) identify areas of kidney failure knowledge gaps in
research to assess treatment patterns associated with
providing care to minority populations that are
disproportionately affected by kidney failure.
SEC. 102. COORDINATING RESEARCH ON CHRONIC KIDNEY DISEASE.
(a) Interagency Committee.--The Secretary of Health and
Human Services shall establish and maintain an interagency
committee for the purpose of improving the coordination of
chronic kidney disease research.
(b) Reports.--For the purpose described in subsection (a),
the interagency committee established under such subsection
shall issue public reports that--
(1) include a strategic plan, including recommendations
for--
(A) improving communication and coordination among Federal
agencies;
(B) procedures for monitoring Federal chronic kidney
disease research activities; and
(C) ways to maximize the efficiency of the Federal chronic
kidney disease research investment and minimize the potential
for unnecessary duplication;
(2) include a portfolio analysis that provides information
on chronic kidney disease research projects, organized by the
strategic plan objectives; and
(3) address such other topics as the interagency committee
determines appropriate.
(c) Meetings.--The interagency committee established under
subsection (a) shall meet not less frequently than semi-
annually.
SEC. 103. UNDERSTANDING THE PROGRESSION OF KIDNEY DISEASE AND
TREATMENT OF KIDNEY FAILURE IN MINORITY
POPULATIONS.
Not later than one year after the date of enactment of this
Act, the Secretary of Health and Human Services shall--
(1) complete a study on--
(A) the social, behavioral, and biological factors leading
to kidney disease;
(B) efforts to slow the progression of kidney disease in
minority populations that are disproportionately affected by
such disease; and
(C) 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; and
(2) submit to Congress a report on the results of such
study.
SEC. 104. IDENTIFYING MEDICARE PAYMENT DISINCENTIVES FOR
TRANSPLANT AND POST-TRANSPLANT CARE.
Not later than 2 years after the date of enactment of this
Act, the Secretary of Health and Human Services shall submit
to Congress a report on 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.
TITLE II--PROMOTING ACCESS TO CHRONIC KIDNEY DISEASE TREATMENTS
SEC. 201. 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'';
(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 such 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, 2016.
SEC. 202. IMPROVING ACCESS TO CHRONIC KIDNEY DISEASE
TREATMENT IN UNDERSERVED RURAL AND URBAN 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 ``and includes renal
dialysis services'' before the period at the end.
(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 ``, including
nephrologists and non-physician practitioners providing renal
dialysis services'' 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 ``, including
nephrologists and non-physician practitioners providing renal
dialysis services'' before the period at the end.
SEC. 203. PROMOTING ACCESS TO HOME DIALYSIS TREATMENTS.
Section 1834(m)(4)(C)(ii) of the Social Security Act (42
U.S.C. 1395m(m)(4)(C)(ii)) is amended by adding at the end
the following new subclause:
``(IX) A renal dialysis facility (as defined in section
1881).''.
SEC. 204. EXPANDING ACCESS FOR PATIENTS WITH ACUTE KIDNEY
INJURY.
Section 1881(b) of the Social Security Act (42 U.S.C.
1395rr(b)) is amended--
(1) in paragraph (1), by inserting ``or acute kidney
injury'' after ``individuals who have been determined to have
end stage renal disease'';
(2) in paragraph (2)(A), by inserting ``or acute kidney
injury'' after ``end stage renal disease'';
(3) in paragraph (2)(B), by inserting ``or acute kidney
injury'' after ``end stage renal disease'';
(4) in paragraph (3), in the matter preceding subparagraph
(A), by inserting ``or acute kidney injury'' after ``end
stage renal disease'';
(5) in paragraph (11)(A), by inserting ``or acute kidney
injury'' after ``end stage renal disease'';
(6) in paragraph (11)(B), by inserting ``or acute kidney
injury'' after ``end stage renal disease'';
(7) in paragraph (14)(B)--
(A) in clause (ii), by inserting ``or acute kidney injury''
after ``end stage renal disease'';
(B) in clause (iii), by inserting ``or acute kidney
injury'' after ``end stage renal disease''; and
(C) in clause (iv), by inserting ``or acute kidney injury''
after ``end stage renal disease''; and
(8) in paragraph (14)(H)(i), by inserting ``or acute kidney
injury'' after ``end stage renal disease''.
TITLE III--CREATING ECONOMIC STABILITY FOR PROVIDERS CARING FOR
INDIVIDUALS WITH CHRONIC KIDNEY DISEASE
SEC. 301. STABILIZING MEDICARE PAYMENTS FOR SERVICES PROVIDED
TO BENEFICIARIES WITH STAGE V CHRONIC KIDNEY
DISEASE RECEIVING DIALYSIS SERVICES.
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)(i) For payment for renal dialysis services furnished
on or after January 1, 2016, under the system under this
paragraph--
``(I) the payment adjustment described in clause (i) of
subparagraph (D) shall not take into account comorbidities;
``(II) the payment adjustment described in clause (ii) of
such subparagraph shall not be included;
``(III) the standardization factor described in the final
rule published in the Federal Register on November 8, 2012
(77 Fed. Reg. 67470), shall be established using the most
currently available data (and not historical data) and
adjusted on an annual basis, based on such available data, to
account for any change in utilization of drugs and any
modification in adjustors applied under this paragraph; and
``(IV) the Secretary shall take into account reasonable
costs consistent with paragraph (2)(B) when calculating such
payments.
``(ii) Not later than January 1, 2016, the Secretary shall
amend the ESRD facility cost report to--
``(I) include the per treatment network fee (as described
in paragraph (7)) as an allowable cost; and
``(II) eliminate the limitation for reporting medical
director fees on such reports in order to take into account
the wages of a board-certified nephrologist.''.
SEC. 302. PROVIDING INDIVIDUALS WITH KIDNEY FAILURE ACCESS TO
MANAGED CARE AND COORDINATED CARE PROGRAMS.
(a) Expanding Access to Medicare Advantage.--
(1) Eligibility under medicare advantage.--
(A) In general.--Section 1851(a)(3) of the Social Security
Act (42 U.S.C. 1395w-21(a)(3)) is amended--
(i) by striking subparagraph (B); and
(ii) by striking ``eligible individual.--'' and all that
follows through ``In this title''
[[Page S1168]]
and inserting ``eligible individual.--In this title''.
(B) Conforming amendment.--Section 1852(b)(1) of the Social
Security Act (42 U.S.C. 1395w-22(b)(1)) is amended--
(i) by striking subparagraph (B); and
(ii) by striking ``Beneficiaries.--'' and all that follows
through ``A Medicare+Choice organization'' and inserting
``Beneficiaries.--A Medicare Advantage organization''.
(C) Effective date.--The amendments made by this paragraph
shall apply with respect to plan years beginning on or after
January 1, 2016.
(2) Education.--Section 1851(d)(2)(A)(iii) of the Social
Security Act (42 U.S.C. 1395w-21(d)(2)(A)(iii)) is amended by
inserting before the period at the end the following ``,
including any additional information that individuals
determined to have end stage renal disease may need to make
informed decisions with respect to such an election''.
(3) Quality metrics.--Section 1852(e)(3)(A) of the Social
Security Act (42 U.S.C. 1395w-22(e)(3)(A)) is amended by
adding at the end the following new clause:
``(v) Requirements with respect to individuals with esrd.--
In addition to the data required to be collected, analyzed,
and reported under clause (i) and notwithstanding the
limitations under subparagraph (B), as part of the quality
improvement program under paragraph (1), each MA organization
shall provide for the collection, analysis, and reporting of
data, determined in consultation with the kidney care
community, that permits the measurement of health outcomes
and other indices of quality with respect to individuals
determined to have end stage renal disease.''.
(b) Permanent Extension of Medicare Advantage ESRD Special
Needs Plans Authority.--Section 1859(f)(1) of the Social
Security Act (42 U.S.C. 1395w-28(f)(1)) is amended by
inserting ``, in the case of a specialized MA plan for
special needs individuals who have not been determined to
have end stage renal disease,'' before ``for periods before
January 1, 2017''.
(c) Voluntary ESRD Coordinated Care Gainsharing Program.--
(1) In general.--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)(A) Not later than January 1, 2017, the Secretary
shall, in accordance with this paragraph, establish an ESRD
Care Coordination gainsharing program for nephrologists,
renal dialysis facilities, and providers of services that
develop coordinated care organizations to provide a full
range of clinical and supportive services (as described in
subparagraph (D)) to individuals determined to have end stage
renal disease.
``(B) Under such program, subject to subparagraph (C), the
payment amounts renal dialysis facilities and providers of
services described in subparagraph (A) would otherwise
receive under paragraph (14) and nephrologists described in
subparagraph (A) would otherwise receive under section 1848
with respect to dialysis services furnished by such a
facility, provider, or nephrologist during a year, shall be
increased by a portion of the amount (as determined by the
Secretary) of actual reductions in expenditures under this
title attributable to the coordinated care organization
developed by such facility, provider, or nephrologist
involved, taking into account non-dialysis expenditures under
parts A and B, during the preceding calendar year. The
payment amount under this subparagraph shall be provided to a
nephrologist, renal dialysis facility, and provider of
services that developed the coordinated care organization not
later than March 31 of the year after the year during which
such services are provided by such nephrologist, facility, or
provider.
``(C) The aggregate incentive payment amounts provided
under such program for a year may not exceed the amount equal
to 2 percent less than the estimated total amount of non-
dialysis expenditures under parts A and B for 2017 for items
and services that are not related to dialysis or transplant
services.
``(D) For purposes of subparagraph (A), the full range of
clinical and supportive services includes at least the
following:
``(i) Primary care and other preventative services.
``(ii) Specialty care for co-morbidities or non-renal acute
conditions, including at least podiatry, cardiology, and
orthopedics.
``(iii) Vascular access.
``(iv) Laboratory testing and diagnostic imaging.
``(v) Pharmacy care management.
``(vi) Patient, family, and caregiver education.
``(vii) Psychiatric, behavioral therapy, and counseling
services.
``(E) In providing payment incentive amounts under such
program, the Secretary shall apply a risk adjustment
methodology that--
``(i) uses risk adjuster factors applied under part C; and
``(ii) adjusts such payments to exclude the top 2 percent
of outliers.
``(F) In establishing such program, the Secretary shall
ensure that each of the following is satisfied:
``(i) The program allows for all types and sizes of renal
dialysis facilities and providers of services described in
subparagraph (A), including profit and not-for-profit, urban
and rural, as well as all other types and sizes of such
facilities and providers, to participate.
``(ii) The program rewards high quality, efficient
facilities and providers through gain-sharing.
``(iii) For purposes of determining the actual reductions
in expenditures under this title attributable to a
coordinated care organization described in subparagraph (A),
the program includes a market-based benchmark system that
will not be rebased against which such expenditures shall be
compared.
``(iv) The program results in reductions of expenditures
under parts A and B for services that are not dialysis-
related services.
``(v) The program allows new applicants to participate in
the program after the initial implementation period.
``(vi) The program establishes clear quality metrics in
consultation with the kidney care community.
``(vii) The program provides for waivers of Federal laws or
requirements, in consultation with interested stakeholders.
``(viii) Under such program the Secretary attributes
individuals described in subparagraph (A) who receive
treatment through a care coordination organization described
in such subparagraph to such organization rather than to any
other payment model that requires beneficiary attribution.
``(ix) Under such program the Secretary provides quarterly
Medicare parts A and B claims data to facilities and
providers described in subparagraph (A) participating in such
program.
``(G) Not later than 3 years after the date of the
implementation of the ESRD Care Coordination gainsharing
program, the Secretary shall submit to Congress a report on
the waivers granted under subparagraph (F)(vii) and the
effectiveness of such waivers in allowing the coordination of
care.''.
(2) Conforming amendments.--
(A) Section 1881.--Section 1881(b) of the Social Security
Act (42 U.S.C. 1395rr(b)) is amended--
(i) in each of paragraphs (12)(A) and (13)(A), by striking
``paragraph (14)'' and inserting ``paragraphs (14) and
(15)''; and
(ii) in paragraph (14)(A)(i), by inserting ``and paragraph
(15)'' after ``Subject to subparagraph (E)''.
(B) Section 1848.--Section 1848 of the Social Security Act
(42 U.S.C. 1395w-4) is amended by adding at the end the
following new subsection:
``(q) Voluntary ESRD Coordinated Care Program.--For
provisions related to incentive payment amounts to
nephrologists under the ESRD Care Coordination gainsharing
program, see section 1881(b)(15).''.
(d) Patient Information Requirement.--The Secretary of
Health and Human Services shall require hospitals that
furnish items and services to individuals entitled to
benefits under part A of title XVIII of the Social Security
Act or eligible for benefits under part B of such title and
who subsequently receive dialysis services at a renal
dialysis facility (as defined in section 1881 of such Act (42
U.S.C. 1395rr)) to provide to such facility health
information with respect to such individual, including a
discharge summary and co-morbidity information, upon request
of the facility, not later than 7 days after notification by
the hospital of the provision of such services to such
individual or of the determination that such individual has
end stage renal disease, as applicable.
Mr. CRAPO. Mr. President, I rise to speak on the importance of the
Chronic Kidney Disease Improvement in Research and Treatment Act being
introduced today. This legislation will not only pave the way for
enhanced research opportunities and allow physicians greater
flexibility in how and where they treat patients, but, importantly,
will provide increased access to care for those with chronic and end-
stage kidney disease, particularly in rural and underserved areas. As
our Nation continues to face dangerously high levels of debt, it is
imperative we prioritize initiatives such as this while simultaneously
ensuring we do not worsen our already fragile fiscal picture. Prior to
passage, as with any piece of legislation, a responsible offset that is
budget neutral must be included.
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