119-s1717

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 1717 Introduced in Senate

    (IS) ]

<DOC>

119th CONGRESS
 1st Session
 S. 1717

 To amend title XVIII of the Social Security Act to ensure prompt 
 coverage of breakthrough devices under the Medicare program, and for 
 other purposes.

_______________________________________________________________________

 IN THE SENATE OF THE UNITED STATES

 May 12, 2025

Mr. Young (for himself and Mr. Padilla) 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 ensure prompt 
 coverage of breakthrough devices under the Medicare program, and for 
 other purposes.

 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 of 2025''.

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 striking the semicolon 
 at the end and inserting ``, and''; 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 in accordance with the Food and Drug 
 Administration-approved labeling for such device or that the 
 Secretary determines, based on a review of clinical data, 
 presents an undue risk of harm that outweighs the potential 
 clinical benefits for individuals entitled to benefits under 
 part A or enrolled under part B;''.

    (2) === Definitions. ===
-

Section 1861 of the Social Security Act 
 (42 U.S.C. 1395x) is amended by adding at the end the following 
 new subsection:
 ``

    (nnn) Breakthrough Device.--
 ``

    (1) In general.--The term `breakthrough device' means a 
 device so designated by the Secretary under 

section 1899C.
 ``

    (2) Transitional coverage period.--The term `transitional 
 coverage period' means, with respect to a breakthrough device, 
 the 4-year period that begins on the date that such device is 
 so designated by the Secretary under 

section 1899C.''.

    (3) Breakthrough device determinations.--Part E of title 
 XVIII of the Social Security Act (42 U.S.C. 1395x et seq.) is 
 amended by adding at the end the following new section:

``

SEC. 1899C. DESIGNATION OF BREAKTHROUGH DEVICES.

 ``

    (a) In General.--Beginning 18 months after the date of the 
enactment of this section, upon application of a manufacturer of a 
device (as defined in 

section 201 of the Federal Food, Drug, and 
Cosmetic Act) that is cleared, classified, or approved under 

section 510

    (k) , 513

    (f)

    (2) , or 515 of such Act on or after the date of the 
enactment of this section, the Secretary shall designate such device as 
a breakthrough device if the Secretary determines that such device 
meets the criteria specified in subsection

    (b) .
 ``

    (b) Criteria.--For purposes of subsection

    (a) , the criteria 
specified in this subsection is, with respect to a device, that the 
device is provided with priority review pursuant to 

section 515B of the 
Federal Food, Drug, and Cosmetic Act.
 ``
            (c) Determination Process.--
 ``

    (1) In general.--The Secretary shall make a determination 
 with respect to a device that is the subject of an application 
 described in subsection

    (a) not later than 6 months after such 
 application is submitted to the Secretary.
 ``

    (2) Explanation required in case of determination that 
 device does not meet criteria for designation.--In the case 
 that the Secretary determines that a device that is the subject 
 of an application described in subsection

    (a) does not meet the 
 criteria specified in subsection

    (b) , the Secretary shall 
 notify the manufacturer of such device of such determination 
 and include in such notification an explanation identifying the 
 specific criterion or criteria that such device failed to meet.
 ``
            (d) Reports.--The Secretary shall submit to Congress on an annual 
basis a report specifying--
 ``

    (1) the number of applications received under this 
 section during such year;
 ``

    (2) the number of devices designated as breakthrough 
 devices under this section during such year; and
 ``

    (3) the number of applications for a designation for a 
 device under this section with respect to which the Secretary 
 determined that such device did not meet the criteria specified 
 in subsection

    (b) during such year.''.

    (b) Ensuring Issuance of National Coverage Determination During 
Transition Period.--

Section 1862
            (l) (2) of the Social Security Act (42 
U.S.C. 1395y
            (l) (2) ) is amended by adding at the end the following new 
flush sentence:
 ``In the case of a request for a national coverage 
 determination with respect to a breakthrough device (as defined 
 in 

section 1861

    (nnn) ), the Secretary shall ensure that a final 
 decision is made on such request prior to the end of the 
 transitional coverage period (as so defined) for such device if 
 such request was submitted to the Secretary before the date 
 that is 9 months (or 12 months, in the case such request is a 
 request to which subparagraph
        (B) applies) before the last day 
 of such period.''.
            (c) Funding.--In addition to amounts otherwise available, there are 
appropriated to the Centers for Medicare & Medicaid Services Program 
Management Account, out of any monies in the Treasury not otherwise 
appropriated, $10,000,000 for each of fiscal years 2026 through 2031, 
to remain available until expended, to carry out the amendments made by 
this section.
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