Bill Summary
This legislation aims to improve access to care for chronic kidney disease patients, particularly in underserved areas. It includes provisions to expand the definition of primary care services to include renal dialysis, and to include nephrology health professionals in scholarship and loan repayment programs. It also addresses economic stability for dialysis facilities, payment for new technologies, and transparency in quality programs. Lastly, it promotes shared decision-making between patients and caregivers and ensures availability of Medigap policies for ESRD Medicare beneficiaries.
Possible Impacts
1. Under the new legislation, patients in underserved areas will have improved access to care as renal dialysis will be included as a primary care service and nephrology health professionals will be eligible for scholarship and loan repayment programs.
2. Hospitals will be required to provide health and treatment information to renal dialysis facilities for recently discharged patients, ensuring a smoother transition and continuity of care for those with chronic kidney disease.
3. Patients with end-stage renal disease will have more transparency and control over their treatment decisions thanks to amendments promoting shared decision-making and the establishment of a Medigap enrollment period.
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 1676 Introduced in Senate (IS)]
<DOC>
116th CONGRESS
1st Session
S. 1676
To improve the understanding of, and promote access to treatment for,
chronic kidney disease, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
May 23 (legislative day, May 22), 2019
Mr. Cardin (for himself and Mr. Blunt) introduced the following bill;
which was read twice and referred to the Committee on Finance
_______________________________________________________________________
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 2019''.
(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. Increasing access to Medicare kidney disease education
benefit.
Sec. 102. Improving patient lives and quality of care through research
and innovation.
Sec. 103. Understanding current utilization of palliative care
services.
Sec. 104. Understanding the progression of kidney disease and treatment
of kidney failure in minority populations.
Sec. 105. Improving access in underserved areas.
Sec. 106. Improving care coordination for dialysis patients by
requiring hospitals to provide information.
TITLE II--INCENTIVIZING INNOVATION FOR TRULY INNOVATIVE NEW DRUGS,
BIOLOGICALS, DEVICES, AND OTHER TECHNOLOGIES
Sec. 201. Maintaining an economically stable dialysis infrastructure.
TITLE III--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.
TITLE I--INCREASING AWARENESS, EXPANDING PREVENTIVE SERVICES, AND
IMPROVING CARE COORDINATION
SEC. 101. 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,
2020.
SEC. 102. 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. 103. UNDERSTANDING CURRENT UTILIZATION OF PALLIATIVE CARE
SERVICES.
(a) Study.--
(1) In general.--The Comptroller General of the United
States (in this section referred to as the ``Comptroller
General'') shall conduct a study on the utilization of
palliative care in treating individuals with advanced kidney
disease, from stage IV through stage V, including individuals
with kidney failure on dialysis through any progression of the
disease. Such study shall include an analysis of--
(A) how palliative care can be utilized to improve
the quality of life of those with kidney disease and
facilitate care tailored to their individual goals and
values;
(B) the successful use of palliative care in the
care of patients with other chronic diseases and
serious illnesses;
(C) the utilization of palliative care at any point
in an illness, including when used at the same time as
curative treatment; and
(D) other areas determined appropriate by the
Comptroller General.
(2) Definition of palliative care.--In this section, the
term ``palliative care'' means patient and family centered care
that optimizes quality of life by anticipating, preventing, and
treating suffering. Such term includes care that is furnished
throughout the continuum of the illness that addresses
physical, intellectual, emotional, social, and spiritual needs
and that facilitates patient autonomy, access to information
and choice.
(b) Report.--Not later than 1 year after the date of the enactment
of this Act, the Comptroller General shall submit to the Congress a
report on the study conducted under subsection (a), together with such
recommendations as the Comptroller General 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.
SEC. 105. IMPROVING ACCESS IN UNDERSERVED 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.
SEC. 106. IMPROVING CARE COORDINATION FOR DIALYSIS PATIENTS BY
REQUIRING HOSPITALS TO PROVIDE INFORMATION.
Section 1881 of the Social Security Act (42 U.S.C. 1395rr) is
amended by adding at the end the following new subsection:
``(i) Hospitals Required To Provide Information.--
``(1) In general.--The Secretary shall establish a process
under which a hospital or a critical access hospital shall
provide a renal dialysis facility with health and treatment
information with respect to an individual who is discharged
from the hospital or critical access hospital and who
subsequently receives treatment at the facility.
``(2) Elements.--Under the process established under
paragraph (1)--
``(A) the request for health and treatment
information may be initiated by the individual prior to
discharge or upon request by the renal dialysis
facility after the individual is discharged; and
``(B) the information requested must be provided to
the facility within 7 days of the request being
made.''.
TITLE II--INCENTIVIZING INNOVATION FOR TRULY INNOVATIVE NEW DRUGS,
BIOLOGICALS, DEVICES, AND OTHER TECHNOLOGIES
SEC. 201. MAINTAINING AN ECONOMICALLY STABLE DIALYSIS INFRASTRUCTURE.
(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, 2020, 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 only 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;
``(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;
``(iv) 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
``(v) 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, 2020, 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 2020 through
2024, 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 two-year transitional payment period, as
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 2021,
and in consultation with stakeholders, the Secretary shall establish a
process for identifying and determining appropriate payment amounts for
incorporating new devices and technologies into the bundled payment
under such system.
TITLE III--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, 2020.
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, 2021.
(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, 2021, and shall end June 30, 2021.
(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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