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H.R. 5331: Patient Access to ESRD New Innovative Devices Act

The text of the bill below is as of Sep 22, 2021 (Introduced).



1st Session

H. R. 5331


September 22, 2021

(for himself, Mr. Rush, Mr. Wenstrup, and Mr. Hollingsworth) 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 subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned


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.


Short title

This Act may be cited as the Patient Access to ESRD New Innovative Devices Act.



Congress finds the following:


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.


Temporary add-on payment for new medical devices to diagnose, treat, or manage end stage renal disease

The Secretary of Health and Human Services shall provide—


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)).