[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1691 Reported in House (RH)]
<DOC>
Union Calendar No. 801
118th CONGRESS
2d Session
H. R. 1691
[Report No. 118-952, Part I]
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 HOUSE OF REPRESENTATIVES
March 22, 2023
Mr. Wenstrup (for himself, Ms. DelBene, Mr. Bilirakis, Mr. Cardenas,
Mr. Moore of Utah, Ms. Sewell, Mr. Guthrie, and Ms. Eshoo) 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
December 24, 2024
Additional sponsors: Mr. Joyce of Pennsylvania, Ms. Kuster, Mr.
Crenshaw, Mr. Kilmer, Mrs. Miller of West Virginia, Ms. Craig, Mrs.
Steel, Ms. Dean of Pennsylvania, Mr. Bacon, Mr. Peters, Mr. Balderson,
Mr. Auchincloss, Mr. Curtis, Ms. Houlahan, Mr. Bucshon, Mr.
Fitzpatrick, Mr. Yakym, Ms. Lofgren, Ms. Schrier, Mrs. Trahan, Mr.
Lieu, Mr. McGovern, Mr. Boyle of Pennsylvania, Ms. Wild, Mr. Bera, Mr.
Correa, Ms. Porter, Mr. Swalwell, Mr. Ciscomani, Mr. Ferguson, Mr.
Carey, Mr. Simpson, Mrs. Kim of California, Mr. Pappas, Mr. Burgess,
Mrs. Miller-Meeks, Ms. Scanlon, Mr. Panetta, Mr. Dunn of Florida, Mr.
Mullin, Ms. Ross, Mr. Kelly of Pennsylvania, Ms. DeGette, Ms. Lee of
Florida, Mr. Gottheimer, Mr. Phillips, Ms. Tenney, Mr. Barr, Mr. Kean
of New Jersey, Mr. Neguse, Mr. Pence, Mrs. Fischbach, Mr. Mast, Mr.
Johnson of Ohio, Mr. Langworthy, Ms. Van Duyne, Ms. Pettersen, Mr.
Finstad, Mr. LaHood, Mr. Schneider, Mr. Owens, Mr. Smucker, Mr.
Thompson of Pennsylvania, Ms. Caraveo, Mr. Rutherford, Mr. Crow, Mr.
Westerman, Mr. Armstrong, Mr. Cohen, Mr. Soto, Mr. Carter of Georgia,
Mr. Nickel, Mr. Obernolte, Mr. Smith of Nebraska, Mr. James, Ms. Maloy,
Ms. Barragan, Mr. Davis of North Carolina, Ms. Slotkin, Mr. Davis of
Illinois, Ms. Strickland, and Ms. Stevens
December 24, 2024
Reported from the Committee on Ways and Means with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
December 24, 2024
Committee on Energy and Commerce discharged; committed to the Committee
of the Whole House on the State of the Union and ordered to be printed
[For text of introduced bill, see copy of bill as introduced on March
22, 2023]
_______________________________________________________________________
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 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
trial information from an applicable device clinical trial (as
such terms are defined in section 402(j) of such Act) that
enrolled individuals entitled to benefits under part A or
enrolled under part B.
``(3) The device is not a clinical diagnostic laboratory
test.
``(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.
Union Calendar No. 801
118th CONGRESS
2d Session
H. R. 1691
[Report No. 118-952, Part I]
_______________________________________________________________________
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.
_______________________________________________________________________
December 24, 2024
Reported from the Committee on Ways and Means with an amendment
December 24, 2024
Committee on Energy and Commerce discharged; committed to the Committee
of the Whole House on the State of the Union and ordered to be printed