Title: Patient Access to ESRD New Innovative Devices Act
Policy area: Health

Summary:
Patient Access to ESRD New Innovative Devices Act
This bill requires the Centers for Medicare & Medicaid Services (CMS) to establish a process to provide a certain payment adjustment under the Medicare end-stage renal disease (ESRD) prospective payment system. Specifically, the CMS must establish a process to provide for a temporary add-on payment adjustment for new medical devices used to diagnose, treat, or manage ESRD.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 2751 Introduced in Senate (IS)]

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116th CONGRESS
  1st Session
                                S. 2751

 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.


_______________________________________________________________________


                   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 Representatives 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''.

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 spending.
            (2) 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.
            (3) 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.
            (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 DEVICES 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 2021, the Secretary of Health and Human Services (in this 
section referred to as the ``Secretary'') shall establish a process to 
provide--
            (1) a 3-year temporary add-on payment adjustment for a new 
        medical device approved by the Food and Drug Administration 
        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, that provides meaningful clinical improvement 
        and is furnished to a beneficiary for the diagnosis, treatment, 
        or management of end stage renal disease; and
            (2) for such adjustment to be implemented in a nonbudget 
        neutral manner under section 1881(b)(14).
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