[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.
                                 ______