for an additional payment under section 
1886(d)(5)(K) or for pass-through payment 
under section 1833(t)(6) or section 1833(i), the 
Secretary shall use the most recently available 
data and information on the costs of such 
breakthrough device, which may include list 
prices and invoice prices charged for such 
breakthrough device. 
‘‘(2) PROCESS FOR REGULAR COVERAGE.—For 
purposes of the application of section 1862(a)(1)(A) 
to a breakthrough device furnished after the transi-
tional coverage period (as defined in paragraph 
(1)(B)) for such device, the Secretary shall establish 
a process for the coverage of such breakthrough de-
vices under this title after such period as follows: 
‘‘(A) IDENTIFICATION OF ADDITIONAL EVI-
DENCE.— 
‘‘(i) IN GENERAL.—With respect to a 
breakthrough device, not later than 1 year 
after the date of the approval of such de-
vice under section 515 of the Federal 
Food, Drug, and Cosmetic Act or of the 
clearance of such device under section 
510(k) of such Act, as applicable, the Sec-
retary shall identify whether any additional 
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data or evidence is required with respect to 
any indications for such device for pur-
poses of the application of such section 
1862(a)(1)(A) to such device for such indi-
cations. 
‘‘(ii) NON-DUPLICATION OF DATA RE-
QUESTS.—In carrying out clause (i) with 
respect to a breakthrough device, the Sec-
retary shall ensure that data or evidence 
identified— 
‘‘(I) does not duplicate data re-
quired to be collected by the Food and 
Drug Administration with respect to 
such breakthrough device; 
‘‘(II) minimizes the administra-
tive burdens of data collection and re-
porting on providers of services, sup-
pliers, and manufacturers of break-
through devices; and 
‘‘(III) is not otherwise unneces-
sary or redundant. 
‘‘(B) PROPOSAL
FOR
COVERAGE
AFTER 
THE
TRANSITIONAL
COVERAGE
PERIOD.—Not 
later than 2 years after the date of the approval 
or clearance of a breakthrough device by the 
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Food and Drug Administration, the Secretary 
shall develop a proposal for coverage under this 
title of such breakthrough device for such indi-
cations as the Secretary determines to be ap-
propriate, based on the data and evidence col-
lected under subparagraph (A), for such devices 
furnished after the transitional coverage period 
under paragraph (1) for such device. If the Sec-
retary does not, on a date that is before the end 
of such two-year period, take action to modify 
the indications for which coverage of a break-
through device may be provided under this title 
after such period, for purposes of section 
1862(a)(1)(A) coverage under this title of such 
breakthrough device shall be made for all indi-
cations for which such device is approved under 
section 515 of the Federal Food, Drug, and 
Cosmetic Act or cleared under section 510(k) of 
such Act. 
‘‘(3) RULES
OF
CONSTRUCTION.—Nothing in 
this section shall be construed to— 
‘‘(A) affect the ability of the manufacturer 
of a breakthrough device to seek approval for 
pass-through payment status under section 
1833(t)(6) or to seek approval for an additional 
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payment under section 1886(d)(5)(K) insofar 
as such breakthrough device does not qualify 
for transitional coverage under paragraph (1); 
‘‘(B) affect the application and approval 
process for pass-through payment status under 
section 1833(t)(6) or for an additional payment 
under section 1886(d)(5)(K) in the case of a 
medical device that is not approved by the Food 
and Drug Administration as a breakthrough de-
vice; or 
‘‘(C) prohibit the Secretary from using ex-
isting authority under this title to suspend or 
terminate coverage of a breakthrough device if 
the Secretary, based on clinical evidence, deter-
mines that— 
‘‘(i) such breakthrough device offers 
no clinical benefit to Medicare bene-
ficiaries; or 
‘‘(ii) furnishing such breakthrough de-
vice to Medicare beneficiaries causes, or 
may cause, serious harm to Medicare bene-
ficiaries. 
‘‘(c) CODING.— 
‘‘(1) PROMPT
ASSIGNMENT.—Not later than 
three months after the date of approval or clearance 
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of a breakthrough device by the Food and Drug Ad-
ministration, the Secretary shall assign a unique 
temporary or permanent code or codes for purposes 
of coverage and payment for such breakthrough de-
vice under the applicable payment systems (de-
scribed in paragraph (4)). 
‘‘(2) UPDATES.— 
‘‘(A) IPPS.—The Secretary shall provide 
for semiannual updates under the applicable 
payment system described in paragraph (4)(A) 
(relating to the inpatient hospital prospective 
payment system) to recognize the code or codes 
assigned under paragraph (1). 
‘‘(B) OPPS.—The Secretary shall provide 
for quarterly updates under the applicable pay-
ment system described in paragraph (4)(B) (re-
lating to the outpatient hospital prospective 
payment system) to recognize the code or codes 
assigned under paragraph (1). 
‘‘(C) OTHER
PAYMENT
SYSTEMS.—The 
Secretary shall provide for semiannual or quar-
terly updates, as the case may be, under the ap-
plicable payment systems described in subpara-
graphs (C) through (L) of paragraph (4) to rec-
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ognize the code or codes assigned under para-
graph (1). 
‘‘(3) TRANSPARENCY.—The process for the as-
signment of a code or codes under this subsection 
shall provide for public notice and a meaningful op-
portunity for public comment from affected parties. 
‘‘(4) APPLICABLE
PAYMENT
SYSTEMS
DE-
SCRIBED.—For purposes of this subsection, the term 
‘applicable payment systems’ means— 
‘‘(A) with respect to inpatient hospital 
services, the prospective payment system for in-
patient hospital services established under sec-
tion 1886(d); 
‘‘(B) with respect to outpatient hospital 
services, the prospective payment system for 
covered OPD services established under section 
1833(t); 
‘‘(C) with respect to ambulatory surgical 
center services, the fee schedule for such serv-
ices established under 1833(i); 
‘‘(D) with respect to physicians’ services, 
the physician fee schedules established under 
section 1848; 
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‘‘(E) with respect to covered items of dura-
ble medical equipment, the applicable fee sched-
ules established under section 1834; 
‘‘(F) with respect to diagnostic laboratory 
tests, the payment amounts under section 
1834A and the fee schedules establish under 
section 1848, as the case may be; 
‘‘(G) with respect to inpatient hospital 
services furnished by rehabilitation facilities, 
the prospective payment system established 
under section 1886(j); 
‘‘(H) with respect to inpatient hospital 
services furnished by long-term care hospitals, 
the prospective payment system under section 
1886(m); 
‘‘(I) with respect to inpatient hospital serv-
ices furnished by psychiatric hospitals and psy-
chiatric units, the prospective payment system 
under section 1886(s); 
‘‘(J) with respect to home health services, 
the prospective payment system under section 
1895; and 
‘‘(K) with respect to items and services, or 
a provider of services or supplier, not described 
in subparagraphs (A) through (I), the payment 
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Nothing in this paragraph shall be construed to af-
fect the authority of the Secretary to use claims 
data to establish new diagnosis or procedure codes 
for breakthrough devices or to identify appropriate 
diagnosis-related groups for the assignment of 
breakthrough devices under annual rulemaking to 
carry out section 1886(d)(5)(K). 
‘‘(2) OUTPATIENT PROSPECTIVE PAYMENT SYS-
TEM: DEEMED
ELIGIBILITY
FOR
PASS-THROUGH 
PAYMENT.—The Secretary shall deem each break-
through device as approved for pass-through pay-
ment under section 1833(t)(6) (including for pur-
poses of section 1833(i)(2)(D)) during the 4-year pe-
riod that begins— 
‘‘(A) except as provided in subparagraph 
(B), on the date that the Secretary, pursuant to 
subsection (c)(2)(B), updates the payment sys-
tem under section 1833(t) to recognize the 
unique temporary or permanent code or codes 
assigned under subsection (c)(1) to such break-
through device; or 
‘‘(B) in the case of a device that has not 
received approval or clearance as a break-
through device by the Food and Drug Adminis-
tration before such payment system is updated 
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100 
under subsection (c)(2)(B) to recognize the 
unique temporary or permanent code or codes 
assigned under subsection (c)(1) to such device, 
on the date of such approval or clearance. 
Nothing in this paragraph shall be construed to af-
fect the authority of the Secretary to use claims 
data to establish new ambulatory payment classifica-
tion groups for breakthrough devices or to revise 
such groups to take into account breakthrough de-
vices under annual rulemaking to carry out section 
1833(t). 
‘‘(3) OTHER PAYMENT SYSTEMS.— 
‘‘(A) IN
GENERAL.—In the case of a 
breakthrough device that is furnished and for 
which payment may be made under the pay-
ment system established under section 1834, 
1834A, 1848, 1886(j), 1886(m), 1886(s), or 
1895 or any other provision of this title (other 
than sections 1833(i), 1833(t), and 1886(d)), 
the Secretary shall provide for an additional 
payment for such breakthrough device under 
such applicable payment system or an adjust-
ment to such applicable payment system, as the 
case may be. The payment basis for such addi-
tional payment or adjustment, as the case may 
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101 
be, shall equal an amount that the Secretary 
determines covers the costs of such break-
through device. 
‘‘(B) COST INFORMATION.—In determining 
the costs of a breakthrough device for purposes 
of determining an additional payment or pay-
ment adjustment under subparagraph (A), the 
Secretary shall use the most recently available 
data and information on the costs of such 
breakthrough device, which may include list 
prices and invoice prices charged for such 
breakthrough device. 
‘‘(C) RULE OF CONSTRUCTION.—Nothing 
in this paragraph shall be construed to affect 
the authority of the Secretary to use claims 
data to establish new or modify existing ambu-
latory payment classification groups, diagnosis- 
related groups, level II HCPCS codes or such 
other groups or codes as the Secretary may es-
tablish under the annual rulemaking authority 
under the provisions referred to in subpara-
graph (A). 
‘‘(D) CLINICAL DIAGNOSTIC LABORATORY 
TESTS.—An additional payment or payment ad-
justment under subparagraph (A) for a break-
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102 
through device under the applicable payment 
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-
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103 
withstanding any other provision of law, the 
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 
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