117 S2025 IS: Patient Access to ESRD New Innovative Devices Act U.S. Senate 2021-06-10 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

II117th CONGRESS1st SessionS. 2025IN THE SENATE OF THE UNITED STATESJune 10, 2021Mr. 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 FinanceA BILLTo 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).