I 
116TH CONGRESS 
1ST SESSION H. R. 2710 
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 
MAY 14, 2019 
Mr. DANNY K. DAVIS of Illinois (for himself and Mr. HOLLINGSWORTH) intro-
duced 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 
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. INCREASING PATIENT ACCESS TO INNOVATIVE DE-
VICES FOR THE TREATMENT OF ESRD. 
As part of the promulgation of the annual rule for 
the Medicare end stage renal disease prospective payment 
system under section 1881(b)(14) of the Social Security 
Act (42 U.S.C. 1395rr(b)(14)) for calendar year 2020, the 
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Secretary of Health and Human Services (in this section 
referred to as the ‘‘Secretary’’) shall establish a process 
to provide— 
(1) an add-on payment adjustment for a new 
medical device reviewed by the Food and Drug Ad-
ministration under section 513(f)(2) or section 515 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360c, 360e) on or after January 1, 2020, 
and furnished to a beneficiary for the diagnosis, 
treatment, or management of end stage renal dis-
ease; and 
(2) for such adjustment to be implemented in 
a nonbudget neutral manner under subparagraph 
(D)(iv) of such section 1881(b)(14). 
Æ 
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