What This Bill Does
This bill changes how Medicare covers certain medical devices called breakthrough devices. It creates a four-year period during which Medicare must cover these newly approved devices while the government reviews whether they should be permanently covered.
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Who It Affects
- Medicare patients (people entitled to benefits under part A or enrolled under part B)
- Medical device manufacturers who apply for breakthrough device status
- The Centers for Medicare & Medicaid Services (the agency that runs Medicare)
##
Key Provisions
- Medicare must cover breakthrough devices during a four-year transitional coverage period starting when a device receives breakthrough designation, unless the device is not used according to FDA (Food and Drug Administration) labeling or poses an undue risk of harm that outweighs potential benefits (Sec. 2(a)(1))
- A device qualifies as a breakthrough device if it receives priority review from the FDA and meets other specified criteria, as determined by the Secretary of Health and Human Services (Sec. 2(a)(3))
- The Secretary must decide whether to grant breakthrough device designation within six months of a manufacturer's application (Sec. 2(a)(3))
- If the Secretary denies breakthrough device designation, the manufacturer must receive a written explanation identifying which specific criteria the device failed to meet (Sec. 2(a)(3))
- The Secretary must issue a final coverage decision for breakthrough devices before the four-year transitional period ends, if the coverage request was submitted at least nine months before the period ends (Sec. 2(b))
##
What Changes
Medicare coverage rules change to allow automatic coverage of certain newly approved medical devices for four years while the government completes its review process. Previously, devices might not have been covered during this waiting period.
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Important Definitions
- **Breakthrough device**: A medical device designated by the Secretary that meets specific FDA review and approval criteria (Sec. 2(a)(2))
- **Transitional coverage period**: The four-year period that begins when a device receives breakthrough device designation (Sec. 2(a)(2))
- **Clinical diagnostic laboratory test**: Not specified in bill text, but excluded from breakthrough device status
##
Effective Date
The process for designating breakthrough devices begins 18 months after this bill becomes law. Not specified in bill text when other provisions take effect.
IB
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. CA´RDENAS,
Mr. MOORE of Utah, Ms. SEWELL, Mr. GUTHRIE, and Ms. ESHOO) intro-
duced 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. CREN-
SHAW, 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 Cali-
fornia, 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.
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•HR 1691 RH
BARRAGA´N, 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 Medi-
care program, and for other purposes.
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•HR 1691 RH
Be it enacted by the Senate and House of Representa-
1
tives of the United States of America in Congress assembled,
2
SECTION 1. SHORT TITLE.
3
This Act may be cited as the ‘‘Ensuring Patient Access
4
to Critical Breakthrough Products Act of 2024’’.
5
SEC. 2. ENSURING PROMPT COVERAGE OF BREAKTHROUGH
6
DEVICES UNDER THE MEDICARE PROGRAM.
7
(a) ENSURING COVERAGE THROUGH A TRANSITIONAL
8
COVERAGE PERIOD.—
9
(1) IN GENERAL.—Section 1862(a)(1) of the So-
10
cial Security Act (42 U.S.C. 1395y(a)(1)) is amend-
11
ed—
12
(A) in subparagraph (O), by striking ‘‘and’’
13
at the end;
14
(B) in subparagraph (P), by adding ‘‘and’’
15
at the end; and
16
(C) by inserting after subparagraph (P) the
17
following new subparagraph:
18
‘‘(Q) in the case of a breakthrough device (as de-
19
fined in section 1861(nnn)) furnished during the
20
transitional coverage period (as so defined) with re-
21
spect to such device, which is not furnished in accord-
22
ance with the Food and Drug Administration-ap-
23
proved labeling for such device or that the Secretary
24
determines, based on a review of clinical data, pre-
25
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•HR 1691 RH
sents an undue risk of harm that outweighs the poten-
1
tial clinical benefits for individuals entitled to bene-
2
fits under part A or enrolled under part B;’’.
3
(2) DEFINITIONS.—Section 1861 of the Social
4
Security Act (42 U.S.C. 1395x) is amended by adding
5
at the end the following new subsection:
6
‘‘(nnn) BREAKTHROUGH DEVICE.—
7
‘‘(1) IN GENERAL.—The term ‘breakthrough de-
8
vice’ means a device so designated by the Secretary
9
under section 1899C.
10
‘‘(2) TRANSITIONAL
COVERAGE
PERIOD.—The
11
term ‘transitional coverage period’ means, with re-
12
spect to a breakthrough device, the 4-year period that
13
begins on the date that such device is so designated
14
by the Secretary under section 1899C.’’.
15
(3)
BREAKTHROUGH
DEVICE
DETERMINA-
16
TIONS.—Part E of title XVIII of the Social Security
17
Act (42 U.S.C. 1395x et seq.) is amended by adding
18
at the end the following new section:
19
‘‘SEC. 1899C. DESIGNATION OF BREAKTHROUGH DEVICES.
20
‘‘(a) IN GENERAL.—Beginning 18 months after the
21
date of the enactment of this section, upon application of
22
a manufacturer of a device (as defined in section 201 of
23
the Federal Food, Drug, and Cosmetic Act) that is cleared,
24
classified, or approved under section 510(k), 513(f)(2), or
25
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•HR 1691 RH
515 of such Act on or after the date of the enactment of
1
this section, the Secretary shall designate such device as a
2
breakthrough device if the Secretary determines that such
3
device meets the criteria specified in subsection (b).
4
‘‘(b) CRITERIA.—For purposes of subsection (a), the
5
criteria specified in this subsection are, with respect to a
6
device, the following:
7
‘‘(1) The device is provided with priority review
8
pursuant to section 515B of the Federal Food, Drug,
9
and Cosmetic Act.
10
‘‘(2) In the case such device is cleared under sec-
11
tion 510(k) of such Act, such device is so cleared based
12
on clinical trial information from an applicable de-
13
vice clinical trial (as such terms are defined in sec-
14
tion 402(j) of such Act) that enrolled individuals enti-
15
tled to benefits under part A or enrolled under part
16
B.
17
‘‘(3) The device is not a clinical diagnostic lab-
18
oratory test.
19
‘‘(c) DETERMINATION PROCESS.—
20
‘‘(1) IN GENERAL.—The Secretary shall make a
21
determination with respect to a device that is the sub-
22
ject of an application described in subsection (a) not
23
later than 6 months after such application is sub-
24
mitted to the Secretary.
25
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•HR 1691 RH
‘‘(2) EXPLANATION REQUIRED IN CASE OF DE-
1
TERMINATION
THAT
DEVICE
DOES
NOT
MEET
CRI-
2
TERIA FOR DESIGNATION.—In the case that the Sec-
3
retary determines that a device that is the subject of
4
an application described in subsection (a) does not
5
meet the criteria specified in subsection (b), the Sec-
6
retary shall notify the manufacturer of such device of
7
such determination and include in such notification
8
an explanation identifying the specific criterion or
9
criteria that such device failed to meet.
10
‘‘(d) REPORTS.—The Secretary shall submit to Con-
11
gress on an annual basis a report specifying—
12
‘‘(1) the number of applications received under
13
this section during such year;
14
‘‘(2) the number of devices designated as break-
15
through devices under this section during such year;
16
and
17
‘‘(3) the number of applications for a designa-
18
tion for a device under this section with respect to
19
which the Secretary determined that such device did
20
not meet the criteria specified in subsection (b) dur-
21
ing such year.’’.
22
(b) ENSURING ISSUANCE OF NATIONAL COVERAGE DE-
23
TERMINATION
DURING
TRANSITION
PERIOD.—Section
24
1862(l)(2) of the Social Security Act (42 U.S.C.
25
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•HR 1691 RH
1395y(l)(2)) is amended by adding at the end the following
1
new flush sentence:
2
‘‘In the case of a request for a national coverage de-
3
termination with respect to a breakthrough device (as
4
defined in section 1861(nnn)), the Secretary shall en-
5
sure that a final decision is made on such request
6
prior to the end of the transitional coverage period
7
(as so defined) for such device if such request was sub-
8
mitted to the Secretary before the date that is 9
9
months (or 12 months, in the case such request is a
10
request to which subparagraph (B) applies) before the
11
last day of such period.’’.
12
(c) FUNDING.—In addition to amounts otherwise
13
available, there are appropriated to the Centers for Medi-
14
care & Medicaid Services Program Management Account,
15
out of any monies in the Treasury not otherwise appro-
16
priated, $10,000,000 for each of fiscal years 2025 through
17
2030, to remain available until expended, to carry out the
18
amendments made by this section.
19
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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 pur-
poses.
DECEMBER 24, 2024
Reported from the Committee on Ways and Means with
an amendment
DECEMBER 24, 2024
Committee on Energy and Commerce discharged; com-
mitted to the Committee of the Whole House on the
State of the Union and ordered to be printed
VerDate Sep 11 2014
00:09 Dec 27, 2024
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PO 00000
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