Patient Access to ESRD New Innovative Devices Act

There are approximately 400,000 Medicare beneficiaries with end-stage renal disease, making up 1 percent of the Medicare population but accounting for approximately 7 percent of all Medicare spending.

Expected remaining lifetime for dialysis patients under 80 years old is one-third as long as their counterparts without ESRD, and for dialysis patients over 80 years old, it is one-half as long as that of their counterparts without ESRD.

On average, hemodialysis patients are hospitalized nearly twice per year and about 30 percent have an unplanned rehospitalization within the 30 days following discharge, contributing to high costs for treating ESRD Medicare beneficiaries.

There is a lack of innovative new devices for ESRD Medicare beneficiaries, in part because of the lack of reimbursement incentives for novel devices.

a three-year temporary add-on payment adjustment (as described in section 413.236(d) of title 42, Code of Federal Regulations) for a new medical device approved by the Food and Drug Administration under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c) on or after January 1, 2020, and furnished to an individual entitled to benefits under part B of title XVIII of the Social Security Act for the diagnosis, treatment, or management of end stage renal disease; and

for the adjustment under paragraph (1) to be implemented in a nonbudget neutral manner under subparagraph (D)(iv) of section 1881(b)(14) of the Social Security Act (42 U.S.C. 1395rr(b)(14)(D)(iv)).