Chronic Kidney Disease Improvement in Research and Treatment Act

I 116TH CONGRESS 1ST SESSION H. R. 3912 To amend title XVIII of the Social Security Act to increase awareness, expand preventative services, and improve care for individuals with end- stage renal disease, and for other purposes. IN THE HOUSE OF REPRESENTATIVES JULY 23, 2019 Mr. LEWIS (for himself and Mr. BUCHANAN) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subse- quently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To amend title XVIII of the Social Security Act to increase awareness, expand preventative services, and improve care for individuals with end-stage renal 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. 3 This Act may be cited as the ‘‘Chronic Kidney Dis- 4 ease Improvement in Research and Treatment Act’’. 5 VerDate Sep 11 2014 21:09 Aug 13, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3912.IH H3912 tkelley on DSKBCP9HB2PROD with BILLS 2 •HR 3912 IH TITLE I—INCREASING AWARE- 1 NESS, EXPANDING PREVENT- 2 ATIVE SERVICES, AND IM- 3 PROVING CARE COORDINA- 4 TION 5 SEC. 101. INCREASING ACCESS TO MEDICARE KIDNEY DIS- 6 EASE EDUCATION BENEFIT. 7 (a) IN GENERAL.—Section 1861(ggg) of the Social 8 Security Act (42 U.S.C. 1395x(ggg)) is amended— 9 (1) in paragraph (1)— 10 (A) in subparagraph (A), by inserting ‘‘or 11 stage V’’ after ‘‘stage IV’’; and 12 (B) in subparagraph (B), by inserting ‘‘or 13 of a physician assistant, nurse practitioner, or 14 clinical nurse specialist (as defined in section 15 1861(aa)(5)) assisting in the treatment of the 16 individual’s kidney condition’’ after ‘‘kidney 17 condition’’; and 18 (2) in paragraph (2)— 19 (A) by striking subparagraph (B); and 20 (B) in subparagraph (A)— 21 (i) by striking ‘‘(A)’’ after ‘‘(2)’’; 22 (ii) by striking ‘‘and’’ at the end of 23 clause (i); 24 VerDate Sep 11 2014 02:56 Aug 07, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3912.IH H3912 tkelley on DSKBCP9HB2PROD with BILLS 3 •HR 3912 IH (iii) by striking the period at the end 1 of clause (ii) and inserting ‘‘; and’’; 2 (iv) by redesignating clauses (i) and 3 (ii) as subparagraphs (A) and (B), respec- 4 tively; and 5 (v) by adding at the end the following: 6 ‘‘(C) a renal dialysis facility subject to the 7 requirements of section 1881(b)(1) with per- 8 sonnel who— 9 ‘‘(i) provide the services described in 10 paragraph (1); and 11 ‘‘(ii) is a physician (as defined in sub- 12 section (r)(1)) or a physician assistant, 13 nurse practitioner, or clinical nurse spe- 14 cialist (as defined in subsection (aa)(5)).’’. 15 (b) PAYMENT TO RENAL DIALYSIS FACILITIES.— 16 Section 1881(b) of the Social Security Act (42 U.S.C. 17 1395rr(b)) is amended by adding at the end the following 18 new paragraph: 19 ‘‘(15) For purposes of paragraph (14), the sin- 20 gle payment for renal dialysis services under such 21 paragraph shall not take into account the amount of 22 payment for kidney disease education services (as 23 defined in section 1861(ggg)). Instead, payment for 24 such services shall be made to the renal dialysis fa- 25 VerDate Sep 11 2014 02:56 Aug 07, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3912.IH H3912 tkelley on DSKBCP9HB2PROD with BILLS 4 •HR 3912 IH cility on an assignment-related basis under section 1 1848.’’. 2 (c) EFFECTIVE DATE.—The amendments made by 3 this section apply to kidney disease education services fur- 4 nished on or after January 1, 2020. 5 SEC. 102. UNDERSTANDING CURRENT UTILIZATION OF PAL- 6 LIATIVE CARE SERVICES. 7 (a) STUDY.— 8 (1) IN GENERAL.—The Comptroller General of 9 the United States (in this section referred to as the 10 ‘‘Comptroller General’’) shall conduct a study on the 11 utilization of palliative care in treating individuals 12 with advanced kidney disease, from stage 4 through 13 stage 5, including individuals with kidney failure on 14 dialysis through any progression of the disease. Such 15 study shall include an analysis of— 16 (A) how palliative care can be utilized to 17 improve the quality of life of those with kidney 18 disease and facilitate care tailored to their indi- 19 vidual goals and values; 20 (B) the successful use of palliative care in 21 the care of patients with other chronic diseases 22 and serious illnesses; 23 VerDate Sep 11 2014 02:56 Aug 07, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3912.IH H3912 tkelley on DSKBCP9HB2PROD with BILLS 5 •HR 3912 IH (C) the utilization of palliative care at any 1 point in an illness, including when used at the 2 same time as curative treatment; and 3 (D) other areas determined appropriate by 4 the Comptroller General. 5 (2) DEFINITION OF PALLIATIVE CARE.—In this 6 section, the term ‘‘palliative care’’ means patient 7 and family centered care that optimizes quality of 8 life by anticipating, preventing, and treating suf- 9 fering. Such term includes care that is furnished 10 throughout the continuum of the illness that ad- 11 dresses physical, intellectual, emotional, social, and 12 spiritual needs and that facilitates patient autonomy, 13 access to information and choice. 14 (b) REPORT.—Not later than 1 year after the date 15 of the enactment of this Act, the Comptroller General shall 16 submit to the Congress a report on the study conducted 17 under subsection (a), together with such recommendations 18 as the Comptroller General determines to be appropriate. 19 SEC. 103. IMPROVING ACCESS IN UNDERSERVED AREAS. 20 (a) DEFINITION OF PRIMARY CARE SERVICES.—Sec- 21 tion 331(a)(3)(D) of the Public Health Service Act (42 22 U.S.C. 254d(a)(3)(D)) is amended by inserting ‘‘and in- 23 cludes renal dialysis services’’ before the period at the end. 24 VerDate Sep 11 2014 02:56 Aug 07, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H3912.IH H3912 tkelley on DSKBCP9HB2PROD with BILLS 6 •HR 3912 IH (b) NATIONAL HEALTH SERVICE CORPS SCHOLAR- 1 SHIP PROGRAM.—Section 338A(a)(2) of the Public Health 2 Service Act (42 U.S.C. 254l(a)(2)) is amended by insert- 3 ing ‘‘, including nephrology health professionals’’ before 4 the period at the end. 5 (c) NATIONAL HEALTH SERVICE CORPS LOAN RE- 6 PAYMENT PROGRAM.—Section 338B(a)(2) of the Public 7 Health Service Act (42 U.S.C. 254l–1(a)(2)) is amended 8 by inserting ‘‘, including nephrology health professionals’’ 9 before the period at the end. 10 SEC. 104. IMPROVING CARE COORDINATION FOR DIALYSIS 11 PATIENTS. 12 (a) HOSPITALS REQUIRED TO PROVIDE INFORMA- 13 TION.—Section 1881 of the Social Security Act (42 U.S.C. 14 1395rr) is amended by adding at the end the following 15 new subsection: 16 ‘‘(i) HOSPITALS REQUIRED TO PROVIDE INFORMA- 17 TION.— 18 ‘‘(1) IN GENERAL.—The Secretary shall estab- 19 lish a process under which a hospital or a critical ac- 20 cess hospital shall provide a renal dialysis facility 21 with health and treatment information with respect 22 to an individual who is discharged from the hospital 23 or critical access hospital and who subsequently re- 24 ceives treatment at facility. 25 VerDate Sep 11 2014 21:09 Aug 13, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H3912.IH H3912 tkelley on DSKBCP9HB2PROD with BILLS 7 •HR 3912 IH ‘‘(2) ELEMENTS.—Under the process estab- 1 lished under paragraph (1)— 2 ‘‘(A) the request for the health information 3 may be initiated by the individual prior to dis- 4 charge or upon request by the renal dialysis fa- 5 cility after the patient is discharged; and 6 ‘‘(B) the information must be provided to 7 the facility within 7 days of the request being 8 made.’’. 9 TITLE II—INCENTIVIZING INNO- 10 VATION FOR TRULY INNOVA- 11 TIVE NEW DRUGS, 12 BIOLOGICALS, DEVICES, AND 13 OTHER TECHNOLOGIES. 14 SEC. 201. MAINTAIN AN ECONOMICALLY STABLE DIALYSIS 15 INFRASTRUCTURE. 16 (a) IN GENERAL.—Section 1881(b)(14) of the Social 17 Security Act (42 U.S.C. 1395rr(b)(14)) is amended— 18 (1) in subparagraph (D), in the matter pre- 19 ceding clause (i), by striking ‘‘Such system’’ and in- 20 serting ‘‘Subject to subparagraph (J), such system’’; 21 and 22 (2) by adding at the end the following new sub- 23 paragraph: 24 VerDate Sep 11 2014 21:09 Aug 13, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H3912.IH H3912 tkelley on DSKBCP9HB2PROD with BILLS 8 •HR 3912 IH ‘‘(J) For payment for renal dialysis services 1 furnished on or after January 1, 2020, under the 2 system under this paragraph— 3 ‘‘(i) the payment adjustment described in 4 clause (i) of subparagraph (D)— 5 ‘‘(I) shall not take into account 6 comorbidities; and 7 ‘‘(II) shall only take into account age 8 for purposes of distinguishing between in- 9 dividuals who are under 18 years of age 10 and those who are 18 years of age and 11 older but shall not include any other ad- 12 justment for age; 13 ‘‘(ii) the Secretary shall reassess any ad- 14 justments related to patient weight under such 15 clause; 16 ‘‘(iii) the payment adjustment described in 17 clause (ii) of such subparagraph shall not be in- 18 cluded; 19 ‘‘(iv) the standardization factor described 20 in the final rule published in the Federal Reg- 21 ister on November 8, 2012 (77 Fed. Reg. 22 67470), shall be established using the most cur- 23 rently available data (and not historical data) 24 and adjusted on an annual basis, based on such 25 VerDate Sep 11 2014 02:56 Aug 07, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H3912.IH H3912 tkelley on DSKBCP9HB2PROD with BILLS 9 •HR 3912 IH available data, to account for any change in uti- 1 lization of drugs and any modification in adjus- 2 tors applied under this paragraph; and 3 ‘‘(v) take into account reasonable costs for 4 determining the payment rate consistent with 5 paragraph (2)(B).’’. 6 (b) INCLUSION OF NETWORK FEE AS AN ALLOW- 7 ABLE COST.—Section 1881(b)(14) of the Social Security 8 Act (42 U.S.C. 1395rr(b)(14)), as amended by subsection 9 (a), is amended by adding at the end the following new 10 subparagraph: 11 ‘‘(K) Not later than January 1, 2020, the Sec- 12 retary shall amend the ESRD facility cost report to 13 include the per treatment network fee (as described 14 in paragraph (7)) as an allowable cost or offset to 15 revenue.’’. 16 (c) AFFIRMATION OF AVAILABILITY OF BAD DEBT 17 REIMBURSEMENT FOR NON-COMPOSITE RATE SERV- 18 ICES.— 19 (1) REPEAL OF MIPPA BAD DEBT RULE OF 20 CONTRUCTION.—Section 153(b)(4) of the Medicare 21 Improvements for Patients and Providers Act (42 22 U.S.C. 1395rr note) is repealed. 23 (2) BAD DEBT PAYMENTS.—Section 24 1881(b)(14) of the Social Security Act (42 U.S.C. 25 VerDate Sep 11 2014 02:56 Aug 07, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H3912.IH H3912 tkelley on DSKBCP9HB2PROD with BILLS 10 •HR 3912 IH 1395rr(b)), as amended by subsections (a) and (b), 1 is further amended by adding at the end the fol- 2 lowing new subparagraphs: 3 ‘‘(L) Notwithstanding any other provision of 4 this title, the Secretary shall provide payments for 5 any unrecovered amount for any bad debt attrib- 6 utable to deductible and coinsurance for any item or 7 service reimbursed under the system under this 8 paragraph or bad debt described in section 9 153(b)(4) of the Medicare Improvements for Pa- 10 tients and Providers Act of 2008. Such payments for 11 any unrecovered amount shall be made in addition 12 to payments made under such system and such drug 13 designation process. 14 ‘‘(M) The additional payments made under sub- 15 paragraph (L)— 16 ‘‘(i) shall not be considered an adjustment 17 under subparagraph (D); and 18 ‘‘(ii) shall not be implemented in a budget 19 neutral manner.’’. 20 (3) EFFECTIVE DATE.—Paragraph (1) and the 21 amendments made by paragraph (2) shall apply to 22 payments beginning on January 1, 2020. 23 VerDate Sep 11 2014 02:56 Aug 07, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H3912.IH H3912 tkelley on DSKBCP9HB2PROD with BILLS 11 •HR 3912 IH (d) PRODUCTIVITY ADJUSTMENT.—Section 1 1886(b)(3)(B)(xi) of the Social Security Act (42 U.S.C. 2 1395ww(b)(3)(B)(xi)) is amended— 3 (1) in subclause (I), by striking ‘‘For 2012’’ 4 and inserting ‘‘Subject to subclause (IV), for 2012’’; 5 and 6 (2) by adding at the end, the following new sub- 7 clause: 8 ‘‘(IV) For 2020 through 2024, 9 the productivity adjustment described 10 in subclause (II) shall be zero for a 11 payment system for any year in which 12 the Medicare Payment Advisory Com- 13 mission established under section 14 1805 estimates that payments pro- 15 vided under such payment system, on 16 an aggregate national basis, exceed 17 costs, on an aggregate national basis, 18 by 3.0 percent or less.’’. 19 (e) PAYMENT FOR NEW AND INNOVATIVE DRUGS 20 AND BIOLOGICALS THAT ARE RENAL DIALYSIS SERV- 21 ICES.—Section 1881(b)(14) of the Social Security Act (42 22 U.S.C. 1395ww(b)(14)), as amended by subsections (a), 23 (b), and (c), is further amended by adding the following 24 new subparagraph: 25 VerDate Sep 11 2014 02:56 Aug 07, 2019 Jkt 089200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H3912.IH H3912 tkelley on DSKBCP9HB2PROD with BILLS 12 •HR 3912 IH ‘‘(N) PAYMENT FOR NEW AND INNOVATIVE 1 DRUGS, BIOLOGICALS, AND DEVICES THAT ARE 2 RENAL DIALYSIS SERVICES.— 3 ‘‘(i) IN GENERAL.—For drugs or 4 biologicals determined to be within a func- 5 tional category, the Secretary, in consulta- 6 tion with stakeholders, shall ensure that 7 the single payment amount is adequate to 8 cover the cost of new innovative drugs or 9 biologicals and increase the single payment 10 amount if it is not. The Secretary shall use 11 the cost and utilization data collected dur- 12 ing the two-year transitional period, as set 13 forth in the final regulation entitled ‘Medi- 14 care Program; End-Stage Renal Disease 15 Prospective Payment System, Payment for 16 Renal Dialysis Services Furnished to Indi- 17 viduals With Acute Kidney Injury, End- 18 Stage Renal Disease Quality Incentive Pro- 19 gram, Durable Medical Equipment, Pros- 20 thetics, Orthotics and Supplies (DMEPOS) 21 Competitive Bidding Program (CBP) and 22 Fee Schedule Amounts, and Technical 23 Amendments To Correct Existing Regula- 24 tions Related to the CBP for Certain 25 VerDate Sep 11 2014 02:56 Aug 07, 2019 Jkt 089200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H3912.IH H3912 tkelley on DSKBCP9HB2PROD with BILLS 13 •HR 3912 IH DMEPOS’ published on November 14, 1 2018 (83 Fed. Reg. 56922 et seq.). 2 ‘‘(ii) MONEY TO FOLLOW THE PA- 3 TIENT.—The Secretary through notice and 4 comment rulemaking [Text truncated for display. Full text available on Congress.gov.]