Patient Access to ESRD New Innovative Devices Act

Bill: 117-s-2025
Sponsor: full_name: Sen. Cornyn, John [R-TX]
Introduced: 2021-06-10
Policy area: Health
Subjects: Administrative law and regulatory procedures

Department of Health and Human Services

Digestive and metabolic diseases

Drug safety, medical device, and laboratory regulation

Health care coverage and access

Health technology, devices, supplies

Medical tests and diagnostic methods

Medicare
Latest action: action_date: 2021-06-10
text: Read twice and referred to the Committee on Finance.

Summaries:
action_date: 2021-06-10
action_desc: Introduced in Senate
text: <p><b>Patient Access to ESRD New Innovative Devices Act</b></p> <p>This bill requires the Centers for Medicare &amp; 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.)</p>

tv_txt: II 117th CONGRESS 1st Session S. 2025 IN THE SENATE OF THE UNITED STATES June 10, 2021 Mr. Cornyn (for himself, Ms. Sinema , Mrs. Hyde-Smith , and Mr. Carper ) 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.

1. Short title This Act may be cited as the Patient Access to ESRD New Innovative Devices Act . 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. 3. Increasing patient access to innovative devices for the treatment of ESRD The Secretary of Health and Human Services shall provide, and may implement by program instruction or otherwise— (1) a 3-year temporary add-on payment adjustment under section 1881(b)(14) of the Social Security Act (42 U.S. 1395rr(b)(14)) 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, that 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 such section 1881(b)(14).