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