Patient Access to ESRD New Innovative Devices Act

II 117TH CONGRESS 1ST SESSION S. 2025 To amend title XVIII of the Social Security Act to improve access to innova- tive new medical devices furnished to individuals with end stage renal disease under part B of the Medicare program by establishing a new device add-on payment adjustment under such part. IN THE SENATE OF THE UNITED STATES JUNE 10, 2021 Mr. CORNYN (for himself, Ms. SINEMA, Mrs. HYDE-SMITH, and Mr. CARPER) introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To amend title XVIII of the Social Security Act to improve access to innovative new medical devices furnished to individuals with end stage renal disease under part B of the Medicare program by establishing a new device add-on payment adjustment under such part. 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 ‘‘Patient Access to 4 ESRD New Innovative Devices Act’’. 5 SEC. 2. FINDINGS. 6 Congress finds the following: 7 VerDate Sep 11 2014 07:02 Jun 23, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S2025.IS S2025 kjohnson on DSK79L0C42PROD with BILLS 2 •S 2025 IS (1) There are approximately 400,000 Medicare 1 beneficiaries with end-stage renal disease, making up 2 1 percent of the Medicare population but accounting 3 for approximately 7 percent of all Medicare spend- 4 ing. 5 (2) Expected remaining lifetime for dialysis pa- 6 tients under 80 years old is one-third as long as 7 their counterparts without ESRD, and for dialysis 8 patients over 80 years old, it is one-half as long as 9 that of their counterparts without ESRD. 10 (3) On average, hemodialysis patients are hos- 11 pitalized nearly twice per year and about 30 percent 12 have an unplanned rehospitalization within the 30 13 days following discharge, contributing to high costs 14 for treating ESRD Medicare beneficiaries. 15 (4) There is a lack of innovative new devices for 16 ESRD Medicare beneficiaries, in part because of the 17 lack of reimbursement incentives for novel devices. 18 SEC. 3. INCREASING PATIENT ACCESS TO INNOVATIVE DE- 19 VICES FOR THE TREATMENT OF ESRD. 20 The Secretary of Health and Human Services shall 21 provide, and may implement by program instruction or 22 otherwise— 23 (1) a 3-year temporary add-on payment adjust- 24 ment under section 1881(b)(14) of the Social Secu- 25 VerDate Sep 11 2014 07:02 Jun 23, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2025.IS S2025 kjohnson on DSK79L0C42PROD with BILLS 3 •S 2025 IS rity Act (42 U.S. 1395rr(b)(14)) for a new medical 1 device approved by the Food and Drug Administra- 2 tion under section 513(f)(2) of the Federal Food, 3 Drug, and Cosmetic Act (21 U.S.C. 360c) on or 4 after January 1, 2020, that is furnished to a bene- 5 ficiary for the diagnosis, treatment, or management 6 of end stage renal disease; and 7 (2) for such adjustment to be implemented in 8 a nonbudget neutral manner under such section 9 1881(b)(14). 10 Æ VerDate Sep 11 2014 07:02 Jun 23, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6301 E:\BILLS\S2025.IS S2025 kjohnson on DSK79L0C42PROD with BILLS