I 
115TH CONGRESS 
2D SESSION 
H. R. 5997 
To amend titles XVIII and XIX of the Social Security Act to ensure prompt 
coverage of breakthrough devices under the Medicare and Medicaid pro-
grams, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 5, 2018 
Ms. DELBENE (for herself, Mrs. WALORSKI, Ms. SEWELL of Alabama, Mr. 
BILIRAKIS, and Mr. CA´RDENAS) 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 titles XVIII and XIX of the Social Security Act 
to ensure prompt coverage of breakthrough devices under 
the Medicare and Medicaid programs, and for other pur-
poses. 
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 2018’’. 
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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.— 
‘‘(1) IN GENERAL.—For purposes of this sec-
tion, 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— 
‘‘(A) provided with review priority by the 
Secretary under subsection (d)(5) of section 
515 of such Act; and 
‘‘(B) approved or cleared pursuant to sec-
tion 510(k), 513(f), or 515 of such Act for use 
in treating an indication. 
‘‘(2) LIMITATION ON NUMBER OF 510(k) DE-
VICES.—With respect to a 5-year period, in no case 
may more than five medical devices described in 
paragraph (1) that are classified under section 
510(k) of the Federal Food, Drug, and Cosmetic 
Act be covered and paid for under this title by rea-
son of this section during each such 5-year period. 
‘‘(b) COVERAGE.— 
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‘‘(1) TRANSITIONAL COVERAGE.— 
‘‘(A) IN
GENERAL.—During the transi-
tional coverage period (as defined in subpara-
graph (B)) a breakthrough device shall be— 
‘‘(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); 
‘‘(iii) deemed to be approved for pass- 
through payment under section 1833(t)(6) 
and section 1833(i); 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 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 subpara-
graph (A)(ii) or (B) of subsection (a)(1), 
respectively; and 
‘‘(ii) ends on the last day of the 3- 
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). 
‘‘(2) PROCESS FOR REGULAR COVERAGE.—For 
purposes of the application of section 1862(a)(1)(A) 
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to a breakthrough device furnished after the transi-
tional coverage period (as defined in paragraph 
(1)(B)) for such device, the Secretary, acting 
through the Council for Technology and Innovation 
(established under section 1868(b)) in conjunction 
with the Coverage and Analysis Group of the Cen-
ters for Medicare & Medicaid Services, shall estab-
lish a process for the coverage of such breakthrough 
devices 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 
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. 
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‘‘(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 
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-
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‘‘(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, subject to subparagraph (B), the Sec-
retary shall assign a unique temporary or permanent 
code or codes for purposes of coverage and payment 
for such breakthrough device under the applicable 
payment systems (described 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-
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tional payment under section 1886(d)(5)(K) for the 
3-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-
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). 
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‘‘(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 3-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-
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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 break-
through device that is furnished and for which 
payment may be made under the payment sys-
tem established under section 1819(a), 1834, 
1834A, 1848, 1886(j), 1886(m), 1886(s), or 
1895 or any other relevant provision of this 
title (other than sections 1833(i), 1833(t), and 
1886(d)), the Secretary shall provide for an ad-
ditional payment for such breakthrough device 
under such payment system in an amount equal 
to 80 percent of the costs of such breakthrough 
device. 
‘‘(B) 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 
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under the provisions referred to in subpara-
graph (A). 
‘‘(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) TREATMENT
OF
BREAKTHROUGH
DEVICES 
UNDER ALTERNATIVE PAYMENT MODELS.— 
‘‘(1) ALTERNATIVE
PAYMENT
MODEL
DE-
FINED.—In this subsection, the term ‘alternative 
payment model’ means, with respect to items and 
services for which payment is made under the appli-
cable payment systems under this title, payment ini-
tiatives designed to improve the quality, efficiency, 
and overall value of health care furnished to individ-
uals entitled to benefits under part A or enrolled 
under part B through financial incentives to pro-
viders of services and suppliers for meeting or ex-
ceeding certain quality or performance measures or 
through financial penalties on providers that fail to 
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achieve specified goals or cost savings, or both. Such 
term includes— 
‘‘(A) the Medicare shared savings program 
under established section 1899; 
‘‘(B) shared savings programs tested by 
the Center for Medicare and Medicaid Innova-
tion under section 1115A; 
‘‘(C) the National Pilot Program on Pay-
ment Bundling under section 1866D; 
‘‘(D) bundled payment programs tested by 
the Center for Medicare and Medicaid Innova-
tion under section 1115A; and 
‘‘(E) any other similar program conducted 
under this title or under applicable authorities 
under title XI. 
‘‘(2) EXCLUSION
OF
ADDITIONAL
COSTS
OF 
BREAKTHROUGH DEVICES.—Insofar as the amount 
of payment for a breakthrough device exceeds the 
amount of payment that the item or service would 
otherwise receive under an alternative payment 
model for which shared savings or shared losses are 
calculated, the Secretary shall exclude from the cal-
culation of such shared savings or losses under such 
program for such period the amount by which the 
payment for the breakthrough device involved ex-
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ceeds the payment amount for such other item or 
service that would have been made but for the use 
of the breakthrough device. 
‘‘(3) ADJUSTMENT TO QUALITY PROCESS MEAS-
URES FOR BREAKTHROUGH DEVICES.— 
‘‘(A) IN GENERAL.—In the case that the 
furnishing by a provider of services or supplier 
participating in an alternative payment model 
of a breakthrough device to an individual enti-
tled to benefits under part A or enrolled under 
part B and participating in such program would 
result in such provider or supplier, with respect 
to the condition and episode of care for which 
such device is furnished, receiving a poor or 
failing score for a quality measure under such 
program that measures whether such provider 
or supplier gave the treatment known to give 
the best results for most patients with a par-
ticular condition (commonly known as a ‘clinical 
process of care’ measure), the Secretary shall 
exclude such quality measure from any deter-
mination of whether such provider or supplier 
met applicable quality performance thresholds 
under such program with respect to such condi-
tion and episode of care of such individual. 
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‘‘(B) INAPPLICABILITY TO CLINICAL OUT-
COMES MEASURES.—Nothing in subparagraph 
(A) may be construed to allow for the exclusion, 
with respect to a breakthrough device furnished 
to an individual by a provider or supplier under 
an alternative payment model, of any quality 
measure designed to reflect the results of care 
furnished to such individual by such provider or 
supplier (commonly known as a ‘clinical out-
come’ measure) from a determination described 
in such subparagraph.’’. 
(b) STUDY ON LIMIT OF 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— 
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(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 breakthrough devices for pur-
poses of such section 1899C by reason of the 
limitation under subsection (a)(2) of such sec-
tion; and 
(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.). 
(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) MODIFICATIONS TO THE COUNCIL FOR TECH-
NOLOGY AND INNOVATION.— 
(1) EXPANSION OF DUTIES.—Paragraph (3) of 
section 1868(b) of the Social Security Act (42 
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U.S.C. 1395ee(b)) is amended by adding at the end 
the following: ‘‘The Council shall also coordinate ac-
tivities of the Secretary for the implementation of 
section 1899C (relating to breakthrough devices), es-
pecially with respect to timely coverage, coding, evi-
dence-gathering, and payment for such devices.’’. 
(2) REORGANIZATION
WITHIN
THE
CMMI.— 
Such section is further amended— 
(A) in paragraph (1), by striking ‘‘within 
the Centers’’ and all that follows through the 
end and inserting ‘‘within the Center for Medi-
care and Medicaid Innovation established under 
section 1115A (in this subsection referred to as 
‘CMMI’).’’; and 
(B) in paragraph (4), by striking ‘‘the Ad-
ministrator of CMS’’ and inserting ‘‘the Direc-
tor of the CMMI’’. 
(d) IMPROVEMENTS TO NTAP PAYMENT ADJUST-
MENT UNDER THE INPATIENT PROSPECTIVE PAYMENT 
SYSTEM.— 
(1) PAYMENT
FOR
COSTS
OF
NEW
TECH-
NOLOGIES.—With respect to hospital discharges for 
which payment is made under section 1886(d) of the 
Social Security Act (42 U.S.C. 1395ww(d)) occur-
ring on or after October 1, 2016, in calculating the 
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amount of the additional payment for a new medical 
service or technology under paragraph (5)(K) of 
such section with respect to such a discharge, the 
Secretary of Health and Human Services shall apply 
section 412.88 of title 42, Code of Federal Regula-
tions, as if the reference to ‘‘50 percent’’ each place 
it appears in such section were a reference to ‘‘80 
percent’’. 
(2) CLARIFICATION REGARDING PAYMENTS FOR 
NEW TECHNOLOGIES.— 
(A) IPPS NEW TECHNOLOGY PAYMENT.— 
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) During the period with respect to 
which a new medical service or technology 
is eligible for an additional payment under 
this subsection by reason of this subpara-
graph, any local coverage determination 
(as defined in section 1869(f)(2)(B)) that 
would affect the coverage of, or the addi-
tional payment under this subsection for, 
such new medical service or technology 
shall have no force or effect in law or regu-
lation.’’. 
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(B) CONFORMING AMENDMENT FOR OPPS 
PASS-THROUGH PAYMENT.—Section 1833(t)(6) 
of 
the 
Social 
Security 
Act 
(42 
U.S.C. 
1395l(t)(6)) is amended by adding at the end 
the following new subparagraph: 
‘‘(G) PROHIBITION ON USE OF LOCAL COV-
ERAGE
DETERMINATIONS
TO
AFFECT
COV-
ERAGE OF AND PAYMENT FOR PASS-THROUGH 
DEVICES.—During the period with respect to 
which a drug, biological, or medical device is eli-
gible for an additional payment under this 
paragraph, any local coverage determination (as 
defined in section 1869(f)(2)(B)) that would af-
fect the coverage of, or the additional payment 
under this paragraph for, such drug, biological, 
or medical device shall have no force or effect 
in law or regulation.’’. 
(C) EFFECTIVE
DATE.—This paragraph, 
and the amendments made by this paragraph, 
shall apply with respect to items and services 
furnished on or after the date of the enactment 
of this Act, including any such item or service 
that is eligible on such date for an additional 
payment under section 1833(t)(6) of the Social 
Security Act (42 U.S.C. 1395l(t)(6)) or under 
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