II 118th CONGRESS 2d Session S. 4469 IN THE SENATE OF THE UNITED STATES June 5, 2024 Mr. Cardin (for himself and Mrs. Blackburn ) 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 2024 . (b) Table of contents The table of contents for this Act is as follows: Sec. 1. Short title; table of contents. TITLE I—Preventing kidney disease by expanding education and awareness Sec. 101. Expanding Medicare annual wellness benefit to include kidney disease screening. Sec. 102. Increasing access to Medicare kidney disease education benefit. Sec. 103. Understanding the progression of kidney disease and treatment of kidney failure in minority populations. TITLE II—Incentivizing kidney care innovation Sec. 201. Refining the end-stage renal disease payment system to improve accuracy in payment and support therapies. Sec. 202. Ensuring Medicare Advantage supports kidney care innovative therapies. Sec. 203. Improving patient lives and quality of care through research and innovation. TITLE III—Addressing the kidney care workforce crisis. Sec. 301. Improving patient decision making and transparency by consolidating and modernizing quality programs. Sec. 302. Ensuring accuracy and stability in kidney care payment. TITLE IV—Expanding patient choice of coverage Sec. 401. Medigap coverage for beneficiaries with end-stage renal disease. I Preventing kidney disease by expanding education and awareness 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 moving subparagraph (N) 2 ems to the left; (2) by redesignating subparagraph (O) as subparagraph (P); and (3) 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, 2025. 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 indenting appropriately; 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, 2025. 103. 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 associated with kidney disease onset and progression; (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 disease. (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 Incentivizing kidney care 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 by adding at the end the following new subparagraph: (J) Payment for new and innovative drugs, biologicals, and devices that are renal dialysis services (i) In general For any new renal dialysis drug or biological product that is used to treat or manage a condition for which there is a functional category as defined in section 413.234(a) of title 42, Code of Federal Regulations that received a transitional drug add-on adjustment (referred to in this subparagraph as TDAPA ) under section 413.234(c)(2) of such title, and was furnished on or after January 1, 2024, the Secretary shall establish a permanent add-on adjustment to the base rate for claims submitted on or after January 1, 2025, that includes the administration of such drugs or biologicals. (ii) Calculation of the Post-TDAPA Add-on adjustment In calculating the add-on adjustment described in clause (i), the Secretary shall— (I) base the calculation on— (aa) except as provided in items (bb) and (cc), the most recent 12-month period of utilization for the new renal dialysis drug or biological product and the most recent available full calendar quarter of average sales price data for such drug or product; (bb) if the most recent available full calendar quarter of average sales price data reflects 0 or negative sales, 100 percent of the wholesale acquisition cost (as defined in section 1847A(c)(6)) of such drug or product; or (cc) if the wholesale acquisition cost is not available, the drug manufacturer's invoice; (II) calculate the post-TDAPA add-on payment adjustment as the expenditures for the new renal dialysis drug or biological product divided by the total number of renal dialysis services during which such drug or biological was administered during the same period; (III) set the amount of the add-on adjustment as an amount equal to 65 percent of the amount calculated under subclause (II); (IV) update the add-on adjustment annually to account for inflationary changes; and (V) apply the add-on adjustment amount immediately upon the expiration of the TDAPA period and availability of the post-TDAPA add-on adjustment. (iii) Implementation This subparagraph shall not be implemented in a budget neutral manner and shall not be adjusted by any applicable patient-level case-mix adjustments described in section 413.235 of title 42, Code of Federal Regulations (or any successor regulation). . (b) Extension of transitional drug add-On adjustment under the drug designation policy The Secretary shall pay the transitional drug add-on adjustment under paragraph (c) of section 413.234 of title 42, Code of Federal Regulations (or a successor regulation) for a total of 3 years for any new renal dialysis drug or biological product that— (1) is used to treat or manage a condition for which there is a functional category as defined in paragraph (a) of such section; (2) qualifies for such adjustment under paragraph (c)(2) of such section; and (3) is furnished on or after January 1, 2024. (c) New devices and other technologies (1) In general 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 2026, and in consultation with stakeholders, the Secretary of Health and Human Services (referred to in this subsection as the Secretary ) shall— (A) ensure that the single payment amount is adequate to cover the cost of any new innovative device or other technology with substantial clinical improvement; and (B) increase the single payment amount if the Secretary determines such payment amount is not adequate to cover such cost. (2) Cost and utilization data In carrying out paragraph (1), the Secretary shall use the cost and utilization data collected during a 3-year transitional payment period, as described in the final regulation published on November 9, 2020 (85 Fed. Reg. 71398). 202. Ensuring Medicare Advantage supports kidney care innovative therapies Section 1853(c) of the Social Security Act ( 42 U.S.C. 1395w–23(c) ) is amended by adding at the end the following new paragraph: (8) Treatment of innovative products for enrollees with end stage renal disease (A) In general The Secretary shall make direct payment adjustments to providers of services or renal dialysis facilities for— (i) any new renal dialysis drug or biological product that receives a transitional drug add-on adjustment under section 413.234(c) of title 42, Code of Federal Regulations; or (ii) an item or service that receives a transitional add-on payment adjustment for new and innovative equipment and supplies under section 413.236 of such title. (B) Amount of direct payment The amount of the adjustment shall equal the amount determined under the end stage renal disease prospective payment system described in section 1881(b)(14). (C) Duration of direct payment The Secretary shall make payments under subparagraph (A) for the duration of the transitional payment under the end stage renal disease prospective payment system described in such section. . 203. Improving patient lives and quality of care through research and innovation (a) Study The Secretary of Health and Human Services (referred to in this section 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 ( 42 U.S.C. 1395 et seq. ) that create barriers to kidney transplants and post-transplant care for beneficiaries with end-stage renal disease. (2) The practices used by donation service areas with higher than average donation rates and whether those practices and policies could be successfully utilized in other donation service areas. (3) Practices and policies that could increase donation rates among minority populations. (4) Whether cultural and policy barriers exist to increasing living donation rates, including an examination of how to better facilitate kidney paired donations. (5) Criteria for transplant recipients for referral and for getting on the waitlist to receive a kidney. (6) Other areas determined appropriate by the Secretary. (b) Report Not later than 18 months after the date of enactment of this Act, the Secretary shall submit to Congress a report on the study conducted pursuant to subsection (a), together with such recommendations as the Secretary determines to be appropriate. 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)(ii) of the Social Security Act ( 42 U.S.C. 1395rr(h)(2)(B)(ii) ) is amended 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. . (e) Effective date The amendments made by this section shall apply to items and services furnished on or after January 1, 2025. 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, 2026. (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, 2026, and shall end June 30, 2026. (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) ).