[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5343 Introduced in House (IH)]
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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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