119-hr5343

[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 
 in accordance with the Food and Drug Administration-approved 
 labeling for such device and for the indication for which such 
 device was provided priority review under 

section 515B of the 
 Federal Food, Drug, and Cosmetic Act, or that the Secretary 
 finds, 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 that--
 ``
        (A) is so designated by the Secretary under 
 

section 1899D; and
 ``
        (B) is furnished at such frequency as specified 
 in the Food and Drug Administration-approved labeling 
 for such device (or, in the case such device has no 
 frequency so specified, at such frequency as determined 
 appropriate by the Secretary).
 ``

    (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 1899D.''.

    (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. 1899D. 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 are, with respect to a device, the 
following:
 ``

    (1) The device is provided with priority review pursuant 
 to 

section 515B of the Federal Food, Drug, and Cosmetic Act.
 ``

    (2) In the case such device is cleared under 

section 510

    (k) of such Act, such device is so cleared based on clinical 
 data, which may include clinical trial information from an 
 applicable device clinical trial (as such terms are defined in 
 

section 402

    (j) of such Act), that included individuals entitled 
 to benefits under part A or enrolled under part B.
 ``

    (3) The device would, without application of 

section 1862

    (a) , otherwise be covered under part A or B.
 ``

    (4) The device does not, based on a review of clinical 
 data, present an undue risk of harm that outweighs the 
 potential clinical benefits for individuals entitled to 
 benefits under part A or enrolled under part B, as determined 
 by the Secretary.
 ``
            (c) Determination Process.--
 ``

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

    (a) , in the case that the Secretary 
 determines that such device 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 identification of the specific 
 criterion or criteria that such device failed to meet and an 
 explanation of why such device failed to meet such criterion or 
 criteria.
 ``
            (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.
 ``

    (e) Review of Aberrant Billing.--The Secretary may conduct a 
review of the medical necessity and reasonableness of a breakthrough 
device furnished by a provider of service or supplier that the 
Secretary determines has an aberrant billing pattern with respect to 
such a device or otherwise is an outlier with respect to the furnishing 
of such device compared to similarly situated providers of services and 
suppliers.''.

    (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 (or determine that such device 
 is otherwise covered under this title) 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.
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