Chronic Kidney Disease Improvement in Research and Treatment Act of 2019

II 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 Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 3 (a) SHORT TITLE.—This Act may be cited as the 4 ‘‘Chronic Kidney Disease Improvement in Research and 5 Treatment Act of 2019’’. 6 (b) TABLE OF CONTENTS.—The table of contents for 7 this Act is as follows: 8 Sec. 1. Short title; table of contents. TITLE I—INCREASING AWARENESS, EXPANDING PREVENTIVE SERVICES, AND IMPROVING CARE COORDINATION VerDate Sep 11 2014 05:27 Jun 04, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6211 E:\BILLS\S1676.IS S1676 kjohnson on DSK79L0C42 with BILLS 2 •S 1676 IS Sec. 101. Increasing access to Medicare kidney disease education benefit. Sec. 102. Improving patient lives and quality of care through research and in- novation. 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 hos- pitals to provide information. TITLE II—INCENTIVIZING INNOVATION FOR TRULY INNOVATIVE NEW DRUGS, BIOLOGICALS, DEVICES, AND OTHER TECH- NOLOGIES 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 AWARE- 1 NESS, EXPANDING PREVEN- 2 TIVE SERVICES, AND IMPROV- 3 ING CARE COORDINATION 4 SEC. 101. INCREASING ACCESS TO MEDICARE KIDNEY DIS- 5 EASE EDUCATION BENEFIT. 6 (a) IN GENERAL.—Section 1861(ggg) of the Social 7 Security Act (42 U.S.C. 1395x(ggg)) is amended— 8 (1) in paragraph (1)— 9 (A) in subparagraph (A), by inserting ‘‘or 10 stage V’’ after ‘‘stage IV’’; and 11 (B) in subparagraph (B), by inserting ‘‘or 12 of a physician assistant, nurse practitioner, or 13 clinical nurse specialist (as defined in section 14 VerDate Sep 11 2014 05:27 Jun 04, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1676.IS S1676 kjohnson on DSK79L0C42 with BILLS 3 •S 1676 IS 1861(aa)(5)) assisting in the treatment of the 1 individual’s kidney condition’’ after ‘‘kidney 2 condition’’; and 3 (2) in paragraph (2)— 4 (A) by striking subparagraph (B); and 5 (B) in subparagraph (A)— 6 (i) by striking ‘‘(A)’’ after ‘‘(2)’’; 7 (ii) by striking ‘‘and’’ at the end of 8 clause (i); 9 (iii) by striking the period at the end 10 of clause (ii) and inserting ‘‘; and’’; 11 (iv) by redesignating clauses (i) and 12 (ii) as subparagraphs (A) and (B), respec- 13 tively; and 14 (v) by adding at the end the following: 15 ‘‘(C) a renal dialysis facility subject to the 16 requirements of section 1881(b)(1) with per- 17 sonnel who— 18 ‘‘(i) provide the services described in 19 paragraph (1); and 20 ‘‘(ii) is a physician (as defined in sub- 21 section (r)(1)) or a physician assistant, 22 nurse practitioner, or clinical nurse spe- 23 cialist (as defined in subsection (aa)(5)).’’. 24 VerDate Sep 11 2014 05:27 Jun 04, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1676.IS S1676 kjohnson on DSK79L0C42 with BILLS 4 •S 1676 IS (b) PAYMENT TO RENAL DIALYSIS FACILITIES.— 1 Section 1881(b) of the Social Security Act (42 U.S.C. 2 1395rr(b)) is amended by adding at the end the following 3 new paragraph: 4 ‘‘(15) For purposes of paragraph (14), the sin- 5 gle payment for renal dialysis services under such 6 paragraph shall not take into account the amount of 7 payment for kidney disease education services (as 8 defined in section 1861(ggg)). Instead, payment for 9 such services shall be made to the renal dialysis fa- 10 cility on an assignment-related basis under section 11 1848.’’. 12 (c) EFFECTIVE DATE.—The amendments made by 13 this section apply to kidney disease education services fur- 14 nished on or after January 1, 2020. 15 SEC. 102. IMPROVING PATIENT LIVES AND QUALITY OF 16 CARE THROUGH RESEARCH AND INNOVA- 17 TION. 18 (a) STUDY.—The Secretary of Health and Human 19 Services (in this section referred to as the ‘‘Secretary’’) 20 shall conduct a study on increasing kidney transplantation 21 rates. Such study shall include an analysis of each of the 22 following: 23 (1) Any disincentives in the payment systems 24 under the Medicare program under title XVIII of 25 VerDate Sep 11 2014 05:27 Jun 04, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1676.IS S1676 kjohnson on DSK79L0C42 with BILLS 5 •S 1676 IS the Social Security Act that create barriers to kid- 1 ney transplants and post-transplant care for bene- 2 ficiaries with end-stage renal disease. 3 (2) The practices used by States with higher 4 than average donation rates and whether those prac- 5 tices and policies could be successfully utilized in 6 other States. 7 (3) Practices and policies that could increase 8 deceased donation rates of minority populations. 9 (4) Whether cultural and policy barriers exist to 10 increasing living donation rates, including an exam- 11 ination of how to better facilitate chained donations. 12 (5) Other areas determined appropriate by the 13 Secretary. 14 (b) REPORT.—Not later than 18 months after the 15 date of the enactment of this Act, the Secretary shall sub- 16 mit to Congress a report on the study conducted under 17 subsection (a), together with such recommendations as the 18 Secretary determines to be appropriate. 19 SEC. 103. UNDERSTANDING CURRENT UTILIZATION OF PAL- 20 LIATIVE CARE SERVICES. 21 (a) STUDY.— 22 (1) IN GENERAL.—The Comptroller General of 23 the United States (in this section referred to as the 24 ‘‘Comptroller General’’) shall conduct a study on the 25 VerDate Sep 11 2014 05:27 Jun 04, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1676.IS S1676 kjohnson on DSK79L0C42 with BILLS 6 •S 1676 IS utilization of palliative care in treating individuals 1 with advanced kidney disease, from stage IV through 2 stage V, including individuals with kidney failure on 3 dialysis through any progression of the disease. Such 4 study shall include an analysis of— 5 (A) how palliative care can be utilized to 6 improve the quality of life of those with kidney 7 disease and facilitate care tailored to their indi- 8 vidual goals and values; 9 (B) the successful use of palliative care in 10 the care of patients with other chronic diseases 11 and serious illnesses; 12 (C) the utilization of palliative care at any 13 point in an illness, including when used at the 14 same time as curative treatment; and 15 (D) other areas determined appropriate by 16 the Comptroller General. 17 (2) DEFINITION OF PALLIATIVE CARE.—In this 18 section, the term ‘‘palliative care’’ means patient 19 and family centered care that optimizes quality of 20 life by anticipating, preventing, and treating suf- 21 fering. Such term includes care that is furnished 22 throughout the continuum of the illness that ad- 23 dresses physical, intellectual, emotional, social, and 24 VerDate Sep 11 2014 05:27 Jun 04, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1676.IS S1676 kjohnson on DSK79L0C42 with BILLS 7 •S 1676 IS spiritual needs and that facilitates patient autonomy, 1 access to information and choice. 2 (b) REPORT.—Not later than 1 year after the date 3 of the enactment of this Act, the Comptroller General shall 4 submit to the Congress a report on the study conducted 5 under subsection (a), together with such recommendations 6 as the Comptroller General determines to be appropriate. 7 SEC. 104. UNDERSTANDING THE PROGRESSION OF KIDNEY 8 DISEASE AND TREATMENT OF KIDNEY FAIL- 9 URE IN MINORITY POPULATIONS. 10 (a) STUDY.—The Secretary of Health and Human 11 Services (in this section referred to as the ‘‘Secretary’’) 12 shall conduct a study on— 13 (1) the social, behavioral, and biological factors 14 leading to kidney disease; 15 (2) efforts to slow the progression of kidney dis- 16 ease in minority populations that are disproportion- 17 ately affected by such disease; and 18 (3) treatment patterns associated with pro- 19 viding care, under the Medicare program under title 20 XVIII of the Social Security Act, the Medicaid pro- 21 gram under title XIX of such Act, and through pri- 22 vate health insurance, to minority populations that 23 are disproportionately affected by kidney failure. 24 VerDate Sep 11 2014 05:27 Jun 04, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1676.IS S1676 kjohnson on DSK79L0C42 with BILLS 8 •S 1676 IS (b) REPORT.—Not later than 1 year after the date 1 of the enactment of this Act, the Secretary shall submit 2 to Congress a report on the study conducted under sub- 3 section (a), together with such recommendations as the 4 Secretary determines to be appropriate. 5 SEC. 105. IMPROVING ACCESS IN UNDERSERVED AREAS. 6 (a) DEFINITION OF PRIMARY CARE SERVICES.—Sec- 7 tion 331(a)(3)(D) of the Public Health Service Act (42 8 U.S.C. 254d(a)(3)(D)) is amended by inserting ‘‘renal di- 9 alysis,’’ after ‘‘dentistry,’’. 10 (b) NATIONAL HEALTH SERVICE CORPS SCHOLAR- 11 SHIP PROGRAM.—Section 338A(a)(2) of the Public Health 12 Service Act (42 U.S.C. 254l(a)(2)) is amended by insert- 13 ing ‘‘, which may include nephrology health professionals’’ 14 before the period at the end. 15 (c) NATIONAL HEALTH SERVICE CORPS LOAN RE- 16 PAYMENT PROGRAM.—Section 338B(a)(2) of the Public 17 Health Service Act (42 U.S.C. 254l–1(a)(2)) is amended 18 by inserting ‘‘, which may include nephrology health pro- 19 fessionals’’ before the period at the end. 20 VerDate Sep 11 2014 05:27 Jun 04, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S1676.IS S1676 kjohnson on DSK79L0C42 with BILLS 9 •S 1676 IS SEC. 106. IMPROVING CARE COORDINATION FOR DIALYSIS 1 PATIENTS BY REQUIRING HOSPITALS TO 2 PROVIDE INFORMATION. 3 Section 1881 of the Social Security Act (42 U.S.C. 4 1395rr) is amended by adding at the end the following 5 new subsection: 6 ‘‘(i) HOSPITALS REQUIRED TO PROVIDE INFORMA- 7 TION.— 8 ‘‘(1) IN GENERAL.—The Secretary shall estab- 9 lish a process under which a hospital or a critical ac- 10 cess hospital shall provide a renal dialysis facility 11 with health and treatment information with respect 12 to an individual who is discharged from the hospital 13 or critical access hospital and who subsequently re- 14 ceives treatment at the facility. 15 ‘‘(2) ELEMENTS.—Under the process estab- 16 lished under paragraph (1)— 17 ‘‘(A) the request for health and treatment 18 information may be initiated by the individual 19 prior to discharge or upon request by the renal 20 dialysis facility after the individual is dis- 21 charged; and 22 ‘‘(B) the information requested must be 23 provided to the facility within 7 days of the re- 24 quest being made.’’. 25 VerDate Sep 11 2014 05:27 Jun 04, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S1676.IS S1676 kjohnson on DSK79L0C42 with BILLS 10 •S 1676 IS TITLE II—INCENTIVIZING INNO- 1 VATION FOR TRULY INNOVA- 2 TIVE NEW DRUGS, BIOLOGI- 3 CALS, DEVICES, AND OTHER 4 TECHNOLOGIES 5 SEC. 201. MAINTAINING AN ECONOMICALLY STABLE DIALY- 6 SIS INFRASTRUCTURE. 7 (a) IN GENERAL.—Section 1881(b)(14) of the Social 8 Security Act (42 U.S.C. 1395rr(b)(14)) is amended— 9 (1) in subparagraph (D), in the matter pre- 10 ceding clause (i), by striking ‘‘Such system’’ and in- 11 serting ‘‘Subject to subparagraph (J), such system’’; 12 and 13 (2) by adding at the end the following new sub- 14 paragraph: 15 ‘‘(J) For payment for renal dialysis serv- 16 ices furnished on or after January 1, 2020, 17 under the system under this paragraph— 18 ‘‘(i) the payment adjustment de- 19 scribed in clause (i) of subparagraph (D)— 20 ‘‘(I) shall not take into account 21 comorbidities; and 22 ‘‘(II) shall only take into account 23 age for purposes of distinguishing be- 24 tween individuals who are under 18 25 VerDate Sep 11 2014 05:27 Jun 04, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S1676.IS S1676 kjohnson on DSK79L0C42 with BILLS 11 •S 1676 IS years of age and those who are 18 1 years of age and older but shall not 2 include any other adjustment for age; 3 ‘‘(ii) the Secretary shall reassess any 4 adjustments related to patient weight 5 under such clause; 6 ‘‘(iii) the payment adjustment de- 7 scribed in clause (ii) of such subparagraph 8 shall not be included; 9 ‘‘(iv) the standardization factor de- 10 scribed in the final rule published in the 11 Federal Register on November 8, 2012 (77 12 Fed. Reg. 67470), shall be established 13 using the most currently available data 14 (and not historical data) and adjusted on 15 an annual basis, based on such available 16 data, to account for any change in utiliza- 17 tion of drugs and any modification in ad- 18 justors applied under this paragraph; and 19 ‘‘(v) take into account reasonable 20 costs for determining the payment rate 21 consistent with paragraph (2)(B).’’. 22 (b) INCLUSION OF NETWORK FEE AS AN ALLOW- 23 ABLE COST.—Section 1881(b)(14) of the Social Security 24 Act (42 U.S.C. 1395rr(b)(14)), as amended by subsection 25 VerDate Sep 11 2014 05:27 Jun 04, 2019 Jkt 089200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S1676.IS S1676 kjohnson on DSK79L0C42 with BILLS 12 •S 1676 IS (a), is amended by adding at the end the following new 1 subparagraph: 2 ‘‘(K) Not later than January 1, 2020, the 3 Secretary shall amend the ESRD facility cost 4 report to include the per treatment network fee 5 (as described in paragraph (7)) as an allowable 6 cost or offset to revenue.’’. 7 (c) DETERMINATION OF PRODUCTIVITY ADJUST- 8 MENT.—Section 1886(b)(3)(B)(xi) of the Social Security 9 Act (42 U.S.C. 1395ww(b)(3)(B)(xi)) is amended— 10 (1) in subclause (I), by striking ‘‘For 2012’’ 11 and inserting ‘‘Subject to subclause (IV), for 2012’’; 12 and 13 (2) by adding at the end, the following new sub- 14 clause: 15 ‘‘(IV) For each of 2020 through 16 2024, the productivity adjustment de- 17 scribed in subclause (II) shall be zero 18 for a payment system in any ye [Text truncated for display. 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