system established in section 1834A may be in 
the form of an increase to the amount deter-
mined for the breakthrough device using cross- 
walking under section 1834A(c)(1)(A), an ex-
tension of the initial period of payment applica-
ble to advance diagnostic laboratory tests under 
section 1834A(d)(1)(A), and in such other form 
or manner as the Secretary determines reflects 
the costs for such breakthrough device under 
the relevant provisions of section 1834A. 
‘‘(4) PAYMENT FOR BREAKTHROUGH DEVICES 
AFTER
THE
TRANSITIONAL
COVERAGE
PERIOD.— 
Payment for a breakthrough device that is furnished 
after the conclusion of the transitional coverage pe-
riod under subsection (b)(1) for such device shall be 
made pursuant to the applicable payment system in-
volved, taking into account the additional evidence 
and data collected under subsection (b)(2). 
‘‘(e) SPECIAL RULES FOR CERTAIN BREAKTHROUGH 
DEVICES.— 
‘‘(1) COVERAGE OF SPECIFIED BREAKTHROUGH 
DEVICES.— 
‘‘(A) IN
GENERAL.—Subject to the suc-
ceeding provisions of this subsection and not-
withstanding any other provision of law, the 
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Secretary shall provide for coverage and pay-
ment pursuant to this section of a specified 
breakthrough device (as defined in subpara-
graph (B)). 
‘‘(B) SPECIFIED BREAKTHROUGH DEVICE 
DEFINED.—In this section, the term ‘specified 
breakthrough device’ means a breakthrough de-
vice with respect to which no Medicare benefit 
category exists. 
‘‘(2) PERIOD OF TRANSITIONAL COVERAGE.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (C), the provisions of subsection (b)(1) 
(relating to the transitional coverage period and 
payment for breakthrough devices, including the 
use of the most recently available data and in-
formation on costs) shall apply to a specified 
breakthrough device in the same manner as 
such provisions apply to a breakthrough device. 
The Secretary may use methodologies under ex-
isting payment systems established under this 
title, may provide for appropriate adjustments 
to such methodologies, or may establish a new 
payment methodology under this title, to pro-
vide for payment for a specified breakthrough 
device to ensure the payment basis for such 
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payment covers costs of the specified break-
through device are covered by such payment. 
‘‘(B) REPORT.— 
‘‘(i) IN
GENERAL.—With respect to 
each specified breakthrough device, the 
Secretary shall submit to Congress a re-
port on the coverage of and payment for 
such specified breakthrough device under 
this section that includes the following in-
formation: 
‘‘(I) The manner in which cov-
erage is provided and payment is 
made for the specified breakthrough 
device, including how such device was 
classified (such as an item of durable 
medical equipment or otherwise) and 
the payment methodology the Sec-
retary applied with respect to such de-
vice. 
‘‘(II) The impact of the avail-
ability of the specified breakthrough 
device to Medicare beneficiaries, in-
cluding impacts on the quality of pa-
tient care, patient outcomes, and pa-
tient experience. 
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‘‘(III) The impact of the avail-
ability of the specified breakthrough 
device to Medicare beneficiaries on 
program expenditures under this title. 
‘‘(IV) Such other information as 
the Secretary determines to be appro-
priate. 
‘‘(ii) DEADLINE.— 
‘‘(I) IN
GENERAL.—Except as 
provided in subclause (II), the Sec-
retary shall submit a report required 
under this subparagraph no later than 
the end of the transitional period of 
coverage and payment applicable to 
such specified breakthrough device. 
‘‘(II) EXTENSION TO GENERATE 
ADDITIONAL DATA.—If the Secretary 
determines that additional data or evi-
dence is required to complete a report 
required under this subparagraph 
with respect to a specified break-
through device, the deadline under 
this clause may be extended for an 
additional two years. 
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‘‘(C) ADDITIONAL
PERIOD
OF
TRANSI-
TIONAL
COVERAGE
TO
DEVELOP
ADDITIONAL 
DATA.—Insofar as the Secretary determines 
that additional data or evidence is required to 
complete a report required under subparagraph 
(B) with respect to a specified breakthrough de-
vice, the transitional coverage period of cov-
erage and payment for such device shall be ex-
tended by the lesser of— 
‘‘(i) two years; or 
‘‘(ii) the amount of additional time re-
quired for the submission of the report 
with respect to such device. 
‘‘(3) COVERAGE
AND
PAYMENT
AFTER
THE 
TRANSITIONAL
PERIOD.—The Secretary may con-
tinue to provide for coverage of and payment for a 
specified breakthrough device after the end of the 
transitional period of coverage and payment for 
breakthrough devices through the national coverage 
determination process if the Secretary determines 
that the specified breakthrough device— 
‘‘(A) improves the quality of care and pa-
tient outcomes; 
‘‘(B) improves the delivery of care; or 
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‘‘(C) reduces spending under this title 
without reducing the quality of care.’’. 
(b) STUDY OF LIMIT ON 510(k) BREAKTHROUGH 
DEVICES.— 
(1) STUDY.—The Secretary of Health and 
Human Services shall conduct a study on the effect 
of the limit under section 1899C(a)(2) of the Social 
Security Act, as added by subsection (a), on the 
number of devices cleared under section 510(k) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360(k)) that are breakthrough devices for 
purposes of such section 1899C. 
(2) MATTERS
EXAMINED.—In conducting the 
study described in paragraph (1), the Secretary 
shall— 
(A) determine the number of medical de-
vices cleared under such section 510(k) during 
the 5-year period beginning on the date of the 
enactment of this Act; 
(B) determine the number of such devices 
that were not included as breakthrough devices 
for purposes of such section 1899C by reason 
of the limitation under subsection (a)(2) of such 
section; and 
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(C) examine the impact of such limitation 
on access to such devices for individuals entitled 
to benefits under part A or enrolled in part B 
of title XVIII of the Social Security Act (42 
U.S.C. 1395 et seq.) or both. 
(3) REPORT.—Not later than 6 years after the 
date of the enactment of this Act, the Secretary 
shall submit to Congress a report on the study con-
ducted under this subsection and shall include such 
recommendations for legislative or administrative 
changes as the Secretary determines to be appro-
priate. 
(c) CONFORMING AMENDMENTS.— 
(1) INPATIENT
PROSPECTIVE
PAYMENT
SYS-
TEM.—Section 1886(d)(5)(K) of the Social Security 
Act (42 U.S.C. 1395ww(d)(5)(K)) is amended by 
adding at the end the following new clause: 
‘‘(x) Effective for discharges occurring on 
or after October 1, 2019, in the case of a new 
medical service or technology that is a break-
through 
device 
(as 
defined 
in 
section 
1899C(a)), the additional payment established 
for such breakthrough device under this sub-
paragraph shall be made for the 3-year period 
applicable to such breakthrough device under 
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section 
1899C(d)(1). 
In 
determining 
the 
amount of the additional payment for a break-
through device under this subparagraph during 
such 3-year period, the Secretary shall apply 
section 412.88(b) of title 42, Code of Federal 
Regulations (or any successor regulation), as if 
the reference to ‘50 percent’ in such section 
were a reference to ‘80 percent’.’’. 
(2) OUTPATIENT PROSPECTIVE PAYMENT SYS-
TEM.—Section 1833(t)(6)(C) of such Act (42 U.S.C. 
1395l(t)(6)(C)) is amended by adding at the end the 
following new clause: 
‘‘(iii) SPECIAL
RULE
FOR
BREAK-
THROUGH
DEVICES.—Notwithstanding 
clause (i) or (ii), or any other provision of 
this paragraph to the contrary, in the case 
of a breakthrough device (as defined in 
section 1899C(a)) that is furnished on or 
after January 1, 2020, payment under this 
paragraph for such breakthrough device 
shall be made for the 3-year period appli-
cable to such breakthrough device under 
section 1899C(d)(2). The provisions of this 
clause shall also apply for purposes of 
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transitional pass-through payment under 
section 1833(i)(2)(D).’’. 
(3) COMPETITIVE BIDDING PROGRAM.—Section 
1847(a) of such Act (42 U.S.C. 1395w-3(a)) is 
amended— 
(A) in paragraph (2)(A)— 
(i) by striking ‘‘and excluding drugs’’ 
and inserting ‘‘excluding drugs’’; and 
(ii) by inserting before the period at 
the end the following: ‘‘and excluding 
breakthrough devices (as defined in section 
1899C(a))’’; and 
(B) in paragraph (7), by adding at the end 
the following new subparagraph: 
‘‘(C) BREAKTHROUGH DEVICES.—A break-
through device described in paragraph (2)(A) 
that is furnished during the transitional cov-
erage 
period 
(as 
defined 
in 
section 
1899C(b)(1)(B)) applicable to such device 
under section 1899C.’’. 
(d) EFFECTIVE DATE.—This section, and the amend-
ments made by this section, shall take effect on the date 
of the enactment of this Act and, unless otherwise speci-
fied in this section (or in an amendment made by this sec-
tion), shall apply to breakthrough devices (as defined in 
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section 1899C(a) of the Social Security Act, as added by 
subsection (a)), approved or cleared on or after July 1, 
2019, or, in the case of a specified breakthrough device 
(as defined in such section as so added), approved or 
cleared on or after December 1, 2018. 
Æ 
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