II 117th CONGRESS 1st Session S. 1971 IN THE SENATE OF THE UNITED STATES June 8, 2021 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.

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. I Increasing awareness, expanding preventive services, and improving care coordination 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. 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. 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. 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. II Creating an economically stable dialysis infrastructure and incentivizing innovation 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.). III Increasing patient access to quality performance by improving the accuracy and transparency of end-stage renal disease quality programs 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. IV Empowering patients 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) ). 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). .