SEC. 
2. 
ENSURING 
PROMPT 
COVERAGE 
OF 
BREAK-
THROUGH DEVICES UNDER THE MEDICARE 
PROGRAM. 
(a) ENSURING COVERAGE THROUGH
A TRANSI-
TIONAL 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 re-
spect to such device, which is not furnished for the 
diagnosis or treatment of illness or injury or to im-
prove the functioning of a malformed body member 
in accordance with the Food and Drug Administra-
tion-approved labeling for such device and for the in-
dication 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 
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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 add-
ing 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 re-
spect to a breakthrough device, the 4-year period 
that begins on the date that such device is so des-
ignated by the Secretary under section 1899D.’’. 
(3) 
BREAKTHROUGH
DEVICE
DETERMINA-
TIONS.—Part E of title XVIII of the Social Security 
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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 de-
termines 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 
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such Act), that included individuals entitled to bene-
fits 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 individ-
uals 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 manu-
facturer of such device of such determination and in-
clude in such notification an identification of the 
specific criterion or criteria that such device failed to 
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meet and an explanation of why such device failed 
to meet such criterion or criteria. 
‘‘(d) REPORTS.—The Secretary shall submit to Con-
gress 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 break-
through devices under this section during such year; 
and 
‘‘(3) the number of applications for a designa-
tion 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) dur-
ing such year. 
‘‘(e) REVIEW
OF ABERRANT BILLING.—The Sec-
retary 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 deter-
mines has an aberrant billing pattern with respect to such 
a device or otherwise is an outlier with respect to the fur-
nishing of such device compared to similarly situated pro-
viders 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. 
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1395y(l)(2)) is amended by adding at the end the fol-
lowing new flush sentence: 
‘‘In the case of a request for a national coverage de-
termination with respect to a breakthrough device 
(as defined in section 1861(nnn)), the Secretary 
shall ensure that a final decision is made on such re-
quest (or determine that such device is otherwise 
covered under this title) prior to the end of the tran-
sitional coverage period (as so defined) for such de-
vice 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 subpara-
graph (B) applies) before the last day of such pe-
riod.’’. 
(c) FUNDING.—In addition to amounts otherwise 
available, there are appropriated to the Centers for Medi-
care & Medicaid Services Program Management Account, 
out of any monies in the Treasury not otherwise appro-
priated, $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. 
Æ 
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