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Neutral Bill Mar 16, 2026

Ensuring Patient Access to Critical Breakthrough Products Act

[Congressional Bills 119th Congress] [From the U.S. Government Publishing Office] [H.R. 5343 Introduced in House (IH)] <DOC> 119th CONGRESS 1st Session H. R. 5343 To amend title XVIII of the Social Security Act to ensure prompt coverage of breakthrough devices under the Medicare program. _______________________________________________________________________ IN THE HOUSE OF REPRESENTATIVES September 15, 2025 Mr. Moore of Utah (for himself, Ms. DelBene, Mr. Yakym, Ms. Sewell, Mr. Bilirakis, and Mrs. Trahan) introduced the following bill; which was referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, 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 ensure prompt coverage of breakthrough devices under the Medicare program. 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 ``Ensuring Patient Access to Critical Breakthrough Products Act''. SEC. 2. ENSURING PROMPT COVERAGE OF BREAKTHROUGH DEVICES UNDER THE MEDICARE PROGRAM. (a) Ensuring Coverage Through a Transitional Coverage Period.-- (1) In general.--Section 1862(a)(1) of the Social Security Act (42 U.S.C. 1395y(a)(1)) is amended-- (A) in subparagraph (O), by striking ``and'' at the end; (B) in subparagraph (P), by adding ``and'' at the end; and (C) by inserting after subparagraph (P) the following new subparagraph: ``(Q) in the case of a breakthrough device (as defined in section 1861(nnn)) furnished during the transitional coverage period (as so defined) with respect to such device, which is not furnished for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member

https://www.congress.gov/bill/119th-congress/house-bill/5343
Cliff Bentz U.S. Representative John Joyce U.S. Representative Cosponsor Blake Moore U.S. Representative Sponsor George Whitesides U.S. Representative Cosponsor David Valadao U.S. Representative Cosponsor Kevin Mullin U.S. Representative Cosponsor Gregory Murphy U.S. Representative Cosponsor Sharice Davids U.S. Representative Cosponsor David Kustoff U.S. Representative Cosponsor Sam Liccardo U.S. Representative Cosponsor John Rutherford U.S. Representative Cosponsor Nanette Barragán U.S. Representative Cosponsor Kevin Hern U.S. Representative Cosponsor Mike Kelly U.S. Representative Cosponsor Frank J Mrvan U.S. Representative Cosponsor Maria Salazar U.S. Representative Cosponsor Young Kim U.S. Representative Cosponsor Rich McCormick U.S. Representative Cosponsor Scott Peters U.S. Representative Cosponsor Mary Scanlon U.S. Representative Cosponsor Neal Dunn U.S. Representative Cosponsor Haley Stevens U.S. Representative Cosponsor Madeleine Dean U.S. Representative Cosponsor Thomas Kean U.S. Representative Cosponsor
Health Health programs administration and funding Congressional oversight Drug safety, medical device, and laboratory regulation Health technology, devices, supplies Health care coverage and access Health care costs and insurance Medicare
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