I 
117TH CONGRESS 
1ST SESSION H. R. 4043 
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 
JUNE 22, 2021 
Ms. DELBENE (for herself, Mrs. WALORSKI, Mr. CA´RDENAS, Mr. BILIRAKIS, 
Ms. SEWELL, and Mr. UPTON) 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 de-
termined by the Speaker, in each case for consideration of such provisions 
as fall within the jurisdiction of the committee concerned 
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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Ensuring Patient Ac-
cess to Critical Breakthrough Products Act of 2021’’. 
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SEC. 2. COVERAGE AND PAYMENT FOR BREAKTHROUGH 
DEVICES UNDER THE MEDICARE PROGRAM. 
(a) IN GENERAL.—Part E of title XVIII of the Social 
Security Act (42 U.S.C. 1395x et seq.) is amended by add-
ing at the end the following new section: 
‘‘SEC. 1899C. COVERAGE OF BREAKTHROUGH DEVICES. 
‘‘(a) BREAKTHROUGH DEVICES.—For purposes of 
this section, the term ‘breakthrough device’ means a med-
ical device that is a device (as defined in section 201 of 
the Federal Food, Drug, and Cosmetic Act) and that is— 
‘‘(1) provided with review priority by the Sec-
retary under subsection (d)(5) of section 515 of such 
Act; and 
‘‘(2) approved or cleared pursuant to section 
510(k), 513(f), or 515 of such Act for use in treat-
ing an indication on or after March 15, 2019. 
Such term also includes a breakthrough device that is a 
specified breakthrough device (as defined in subsection 
(e)(1)(B)) approved or cleared pursuant to section 510(k), 
513(f), or 515 of such Act for use in treating an indication 
on or after March 15, 2019. 
‘‘(b) COVERAGE.— 
‘‘(1) TRANSITIONAL COVERAGE.— 
‘‘(A) IN
GENERAL.—During the transi-
tional coverage period (as defined in subpara-
graph (B)) a breakthrough device shall be— 
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‘‘(i) deemed to be reasonable and nec-
essary 
for 
purposes 
of 
section 
1862(a)(1)(A); 
‘‘(ii) deemed to be approved for an ad-
ditional 
payment 
under 
section 
1886(d)(5)(K) (other than with respect to 
the cost criterion under clause (ii)(I) of 
such section); 
‘‘(iii) deemed to be approved for pass- 
through payment under section 1833(t)(6) 
and section 1833(i) (other than with re-
spect to the cost criterion under section 
1833(t)(6)(A)(iv)); and 
‘‘(iv) insofar as such breakthrough de-
vice may be furnished in a setting for 
which payment is made under an applica-
ble payment system described in subpara-
graphs (D) through (I) of subsection 
(c)(4), deemed eligible for an additional 
payment or payment adjustment, as the 
case may be, pursuant to subsection (d)(3) 
when furnished in a setting for which pay-
ment is made under such an applicable 
payment system during such transitional 
coverage period. 
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‘‘(B) TRANSITIONAL
COVERAGE
PERIOD 
DEFINED.—As used in this section, the term 
‘transitional coverage period’ means, with re-
spect to a breakthrough device, the period 
that— 
‘‘(i) begins on the date of the approval 
under section 515 of the Federal Food, 
Drug, and Cosmetic Act or of the clear-
ance under section 510(k) of such Act, as 
applicable, of such device by the Secretary 
for the indication described in subsection 
(a)(1); and 
‘‘(ii) ends on the last day of the 4- 
year period that begins on the date that 
the Secretary, pursuant to subsection 
(c)(2), updates the relevant applicable pay-
ment system (as defined in subsection 
(c)(4)) to recognize the unique temporary 
or permanent code or codes assigned under 
subsection (c)(1) to such breakthrough de-
vice, except as provided in subsections 
(d)(1)(B) and (d)(2)(B). 
‘‘(C) DATA USED TO MEET THE NTAP AND 
PASS-THROUGH
COST
CRITERIA.—In 
deter-
mining whether a breakthrough device qualifies 
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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); 
or 
‘‘(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. 
‘‘(c) CODING.— 
‘‘(1) PROMPT
ASSIGNMENT.—Not later than 
three months after the date of approval or clearance 
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 
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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 (K) of paragraph (4) to 
recognize the code or codes assigned under 
paragraph (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-
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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; 
‘‘(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, 
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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 (K), the payment 
system established under this title for such 
items and services when furnished by such pro-
vider of services or supplier. 
‘‘(d) PAYMENT.— 
‘‘(1) INPATIENT HOSPITAL PROSPECTIVE PAY-
MENT SYSTEM: DEEMED ELIGIBILITY FOR BREAK-
THROUGH
PAYMENT.—The Secretary shall deem 
each breakthrough device as approved for an addi-
tional payment under section 1886(d)(5)(K) for the 
4-year period that begins— 
‘‘(A) except as provided in subparagraph 
(B), on the date that the Secretary, pursuant to 
subsection (c)(2)(A), updates the payment sys-
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tem under section 1886(d) 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 
under subsection (c)(2)(A) 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 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-
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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 
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.— 
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‘‘(A) IN GENERAL.—In the case of break-
through device that is furnished and for which 
payment may be made under the payment sys-
tem established under section 1834, 1834A, 
1848, 1886(j), 1886(m), 1886(s), or 1895 or 
any other provision of this title (other than sec-
tions 1833(i), 1833(t), and 1886(d)), the Sec-
retary shall provide for an additional payment 
for such breakthrough device under such appli-
cable payment system or an adjustment to such 
applicable payment system, as the case may be. 
The payment basis for such additional payment 
or adjustment, as the case may be, shall equal 
an amount that the Secretary determines covers 
the costs of such breakthrough 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. 
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‘‘(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-
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. 
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‘‘(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 
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.— 
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‘‘(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 
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: 
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‘‘(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. 
‘‘(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-
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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. 
‘‘(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 
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‘‘(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 
‘‘(C) reduces spending under this title 
without reducing the quality of care.’’. 
(b) 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 
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1899C(a)), the additional payment established 
for such breakthrough device under this sub-
paragraph shall be made for the 4-year period 
applicable to such breakthrough device under 
section 
1899C(d)(1). 
In 
determining 
the 
amount of the additional payment for a break-
through device under this subparagraph during 
such 4-year period, the Secretary shall apply 
section 412.88(b) of title 42, Code of Federal 
Regulations, as in effect on the date of the en-
actment of this clause, except as if the ref-
erence in such section to ‘65 percent’ were a 
reference to ‘65 percent (or such greater per-
cent specified by the Secretary)’.’’. 
(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 
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paragraph for such breakthrough device 
shall be made for the 4-year period appli-
cable to such breakthrough device under 
section 1899C(d)(2). The provisions of this 
clause shall also apply for purposes of 
transitional pass-through payment under 
section 1833(i)(2)(D).’’. 
(c) 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 
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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