I 
117TH CONGRESS 
1ST SESSION H. R. 5331 
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 HOUSE OF REPRESENTATIVES 
SEPTEMBER 22, 2021 
Mr. DANNY K. DAVIS of Illinois (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 Com-
mittee 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 
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-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Patient Access to 
ESRD New Innovative Devices Act’’. 
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SEC. 2. FINDINGS. 
Congress finds the following: 
(1) 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 spend-
ing. 
(2) Expected remaining lifetime for dialysis pa-
tients 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. 
(3) On average, hemodialysis patients are hos-
pitalized 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. 
(4) There is a lack of innovative new devices for 
ESRD Medicare beneficiaries, in part because of the 
lack of reimbursement incentives for novel devices. 
SEC. 3. 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— 
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(1) a three-year temporary add-on payment ad-
justment (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 Administra-
tion 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 indi-
vidual entitled to benefits under part B of title 
XVIII of the Social Security Act for the diagnosis, 
treatment, or management of end stage renal dis-
ease; and 
(2) 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)). 
Æ 
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