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II
116TH CONGRESS
1ST SESSION
S. 2751
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
OCTOBER 30, 2019
Mr. CORNYN (for himself, Ms. SINEMA, Mrs. HYDE-SMITH, and Mr. JONES)
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,
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SECTION 1. SHORT TITLE.
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This Act may be cited as the ‘‘Patient Access to
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ESRD New Innovative Devices Act’’.
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SEC. 2. FINDINGS.
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Congress finds the following:
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•S 2751 IS
(1) There are approximately 400,000 Medicare
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beneficiaries with end-stage renal disease, making up
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1 percent of the Medicare population but accounting
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for approximately 7 percent of all Medicare spend-
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ing.
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(2) Expected remaining lifetime for dialysis pa-
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tients under 80 years old is one-third as long as
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their counterparts without ESRD, and for dialysis
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patients over 80 years old, it is one-half as long as
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that of their counterparts without ESRD.
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(3) On average, hemodialysis patients are hos-
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pitalized nearly twice per year and about 30 percent
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have an unplanned rehospitalization within the 30
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days following discharge, contributing to high costs
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for treating ESRD Medicare beneficiaries.
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(4) There is a lack of innovative new devices for
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ESRD Medicare beneficiaries, in part because of the
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lack of reimbursement incentives for novel devices.
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SEC. 3. INCREASING PATIENT ACCESS TO INNOVATIVE DE-
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VICES FOR THE TREATMENT OF ESRD.
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As part of the promulgation of the annual rule for
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the Medicare end stage renal disease prospective payment
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system under section 1881(b)(14) of the Social Security
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Act (42 U.S.C. 1395rr(b)(14)) for calendar year 2021, the
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Secretary of Health and Human Services (in this section
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•S 2751 IS
referred to as the ‘‘Secretary’’) shall establish a process
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to provide—
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(1) a 3-year temporary add-on payment adjust-
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ment for a new medical device approved by the Food
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and Drug Administration under section 513(f)(2) or
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section 515 of the Federal Food, Drug, and Cos-
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metic Act (21 U.S.C. 360c, 360e) on or after Janu-
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ary 1, 2020, that provides meaningful clinical im-
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provement and is furnished to a beneficiary for the
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diagnosis, treatment, or management of end stage
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renal disease; and
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(2) for such adjustment to be implemented in
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a
nonbudget
neutral
manner
under
section
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1881(b)(14).
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Æ
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