Patient Access to ESRD New Innovative Devices Act

Patient Access to ESRD New Innovative Devices Act

This bill requires the Centers for Medicare & Medicaid Services (CMS) to provide a certain payment adjustment under the Medicare end-stage renal disease (ESRD) prospective payment system. Specifically, the CMS must provide for a three-year temporary add-on payment adjustment for new medical devices used to diagnose, treat, or manage ESRD. (CMS regulations currently provide a two-year temporary add-on payment adjustment.)

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5331 Introduced in House (IH)]

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117th CONGRESS
  1st Session
                                H. R. 5331

 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 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 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 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. 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--
            (1) 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
            (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)).
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