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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 5349 Introduced in Senate (IS)]

<DOC>

118th CONGRESS
  2d Session
                                S. 5349

   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

                           November 20, 2024

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 2024''.

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 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 2025 through 2030, 
to remain available until expended, to carry out the amendments made by 
this section.
                                 <all>
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