I 
114TH CONGRESS 
2D SESSION 
H. R. 5009 
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 
APRIL 20, 2016 
Mr. BOUSTANY (for himself, Mr. NEAL, 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 Com-
merce, for a period to be subsequently determined by the Speaker, in 
each case for consideration of such provisions as fall within the jurisdic-
tion 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 2016’’. 
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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 either— 
‘‘(A) is— 
‘‘(i) provided with review priority by 
the Secretary under subsection (d)(5) of 
section 515 of such Act; and 
‘‘(ii) approved under such section for 
use in treating an indication; or 
‘‘(B) subject to paragraph (2), is cleared 
under section 510(k) 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)(B) be covered and paid for under this 
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title by reason of this section during each such 5- 
year period. 
‘‘(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— 
‘‘(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 
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payment system during such transitional 
coverage period. 
‘‘(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). 
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‘‘(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, 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 
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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 
Food and Drug Administration, the Secretary 
shall develop a proposal for coverage under this 
title of such breakthrough device for such indi-
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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 
payment under section 1886(d)(5)(K) insofar 
as such breakthrough device does not qualify 
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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, 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). 
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‘‘(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). 
‘‘(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); 
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‘‘(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 fee schedule established under section 
1834(h), 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); and 
‘‘(I) with respect to inpatient hospital serv-
ices furnished by psychiatric hospitals and psy-
chiatric units, the prospective payment system 
under section 1886(s). 
‘‘(d) PAYMENT.— 
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‘‘(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 
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 
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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 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. 
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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 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 break-
through device that is furnished and for which 
payment may be made under the payment sys-
tem established under sections 1834, 1834A, 
1848, 1886(j), 1886(m), 1886(s), or any other 
relevant 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 pay-
ment systems 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 
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other groups or codes as the Secretary may es-
tablish under the annual rulemaking authority 
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 PAY-FOR-PERFORMANCE PROGRAMS.— 
‘‘(1) PAY-FOR-PERFORMANCE
PROGRAMS
DE-
FINED.—In this subsection, the term ‘pay-for-per-
formance programs’ means, with respect to items 
and services for which payment is made under the 
applicable payment systems under this title, pay-
ment initiatives designed to improve the quality, effi-
ciency, and overall value of health care furnished to 
individuals entitled to benefits under part A or en-
rolled under part B through financial incentives to 
providers of services and suppliers for meeting or ex-
ceeding certain quality or performance measures or 
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through financial penalties on providers that fail to 
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, including the Pioneer 
ACO program; 
‘‘(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 a pay-for-performance pro-
gram 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 
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program for such period the amount by which the 
payment for the breakthrough device involved ex-
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 a pay-for-performance program 
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 
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under such program with respect to such condi-
tion and episode of care of such individual. 
‘‘(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 
a pay-for-performance program, 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. 
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(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 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. 
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(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 
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.— 
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(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 
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 
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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.’’. 
(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 
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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 
section 1886(d) of such Act (42 U.S.C. 
1395ww(d)) by reason of paragraph (5)(K) of 
such section, or that would have been so eligible 
on such date but for a local coverage deter-
mination that limits or denies coverage of and 
such additional payment for the item or service. 
(3) REVISION TO THE COST THRESHOLD.— 
(A) 
IN
GENERAL.—Section 
1886(d)(5)(K)(ii)(I) of the Social Security Act 
(42 U.S.C. 1395ww(d)(5)(K)(ii)(I)) is amended 
by striking ‘‘75 percent’’ each place it appears 
and inserting ‘‘50 percent’’. 
(B) EFFECTIVE
DATE.—The amendment 
made by subparagraph (A) shall take effect on 
the date of the enactment of this Act. 
(4) USE OF BEST AVAILABLE COST DATA FOR 
MS–DRG CLASSIFICATION.— 
(A) IN GENERAL.—Section 1886(d)(5)(K) 
of 
the 
Social 
Security 
Act 
(42 
U.S.C. 
1395ww(d)(5)(K)), as amended by paragraph 
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(2)(A)), is further amended by adding at the 
end the following new clause: 
‘‘(xi) In carrying out the requirement 
under clause (ii)(IV) for classification of a 
new medical service or technology to a new 
or existing diagnosis-related group after 
the close of the period under clause (ii)(II), 
the Secretary shall use the most recently 
available data and information on the costs 
of such service or technology in making 
such a classification for the service or tech-
nology, including data and information 
from surveys of providers of services and 
suppliers conducted by the Secretary, pri-
vate payers, health plans, physician spe-
cialty societies, or manufacturers as well as 
commercial price data and data from man-
ufacturer invoices.’’. 
(B) EFFECTIVE
DATE.—The amendment 
made by subparagraph (A) shall take effect on 
the date of the enactment of this Act. 
(5) CRITERIA APPLIED IN MAKING SUBSTAN-
TIAL IMPROVEMENT DETERMINATIONS.— 
(A) IN GENERAL.—Section 1886(d)(5)(K) 
of 
the 
Social 
Security 
Act 
(42 
U.S.C. 
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1395ww(d)(5)(K)), as amended by paragraphs 
(2)(A) and (4)(A), is further amended by add-
ing at the end the following new clause: 
‘‘(xii)(I) In making a determination 
under this subparagraph whether a new 
medical service or technology represents an 
advance in medical technology that sub-
stantially improves the diagnosis or treat-
ment of Medicare beneficiaries relative to a 
medical service or technology that was pre-
viously available, the Secretary shall also 
consider whether such new medical service 
or technology meets one or more of the fol-
lowing criteria: 
‘‘(aa) The use of the new medical 
service or technology can result in a 
reduction of the length of a hospital 
stay. 
‘‘(bb) The use of the new medical 
service or technology can improve pa-
tient quality of life. 
‘‘(cc) The use of the new medical 
service or technology can create long- 
term clinical efficiencies in treatment. 
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‘‘(dd) The use of the new medical 
service or technology can address pa-
tient-centered objectives (as defined 
by the Secretary). 
‘‘(ee) The use of the new medical 
service or technology can meet such 
other criteria as the Secretary may 
specify. 
‘‘(II) In considering whether a new 
medical service or technology potentially 
meets the criteria under subclause (I), the 
Secretary shall consider the following 
forms of evidence: 
‘‘(aa) Evidence described in well- 
documented case histories, including 
registry data. 
‘‘(bb) Studies published in peer- 
reviewed journals. 
‘‘(cc) Data collected in countries 
other than the United States so long 
as such data otherwise meet the cri-
teria specified in this clause.’’. 
(B) EFFECTIVE
DATE.—The amendment 
made by subparagraph (A) shall take effect on 
the date of the enactment of this Act. 
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(6) REVISION TO THE NEWNESS CRITERION.— 
(A) 
IN
GENERAL.—Section 
1886(d)(5)(K)(vi) of the Social Security Act 
(42 U.S.C. 1395ww(d)(5)(K)(vi)) is amended— 
(i) by inserting ‘‘(I)’’ after ‘‘(vi)’’; and 
(ii) by adding at the end the following 
new subclauses: 
‘‘(II) Under the criteria estab-
lished under this clause with respect 
to the determination of whether a 
medical service or technology is con-
sidered new for purposes of this sub-
paragraph and subparagraph (L), the 
Secretary shall include devices that in-
volve 
a 
significant 
technological 
change that do not raise different 
questions of safety and effectiveness 
(in a comparison to the predicate de-
vice) and result in enhanced clinical 
advantages or reduced cost, even 
though they use the same or similar 
mechanism of action or are assigned 
to the same diagnosis-related group. 
‘‘(III) Under the criteria estab-
lished under this clause with respect 
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to the determination of whether a 
medical service or technology is con-
sidered new for purposes of this sub-
paragraph and subparagraph (L), the 
Secretary shall not disqualify a new 
medical service or technology as not 
meeting the newness criterion solely 
on the basis of a finding of a de mini-
mis number of claims for such med-
ical service or technology in Medicare 
claims data. For purposes of this sub-
clause, the term ‘de minimis’ means, 
with respect to claims, an amount 
that is fewer than 50.’’. 
(B) EFFECTIVE
DATE.—The amendment 
made by subparagraph (A) shall take effect on 
the date of the enactment of this Act. 
(7) REVISION TO THE COMMENCEMENT OF THE 
PERIOD FOR COLLECTION OF COST DATA FOR NEW 
TECHNOLOGIES.— 
(A) 
IN
GENERAL.—Section 
1886(d)(5)(K)(ii)(II) of the Social Security Act 
(42 U.S.C. 1395ww(d)(5)(K)(ii)(II)) is amend-
ed by inserting ‘‘the later of the date that is the 
date of the clearance or approval by the Com-
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missioner of Food and Drugs of the service or 
technology or’’ after ‘‘beginning on’’. 
(B) EFFECTIVE
DATE.—The amendment 
made by subparagraph (A) shall take effect on 
the date of the enactment of this Act, and shall 
apply with respect to hospital discharges for in-
patient hospital services for which payment is 
made under section 1886(d) of the Social Secu-
rity Act (42 U.S.C. 1395ww) occurring on or 
after October 1, 2016. 
(8) PERMITTING
APPEALS
OF
NTAP
DETER-
MINATIONS.— 
(A) IN GENERAL.—Section 1886(d)(5)(K) 
of 
the 
Social 
Security 
Act 
(42 
U.S.C. 
1395ww(d)(5)(K)), as amended by paragraphs 
(2)(A), (4)(A), and (5)(A), is further amended 
by adding at the end the following new clause: 
‘‘(xiii)(I) An individual or entity that 
submits an application for additional pay-
ment under this subparagraph for a new 
technology shall be entitled to administra-
tive review of an adverse determination by 
the Secretary with respect to such applica-
tion. 
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‘‘(II) The Secretary shall establish a 
process for administrative review for pur-
poses of subclause (I). Under such process, 
administrative review shall be conducted by 
an official of the Department of Health 
and Human Services (other than an offi-
cial of the Centers for Medicare & Med-
icaid Services). Under such process, the 
Department official involved shall complete 
administrative review within 90 days of re-
ceipt of a request for such review. 
‘‘(III) In the case of an application 
for additional payment under this subpara-
graph for a new technology that is ap-
proved under administrative review, the 
Secretary shall provide for such additional 
payment for such new technology during 
the period that— 
‘‘(aa) begins on the date that is 
the first day of the first calendar 
quarter that begins after the date of 
the completion of such administrative 
review; and 
‘‘(bb) ends on the date that is 
not less than 2 years and not more 
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than 3 years after the date referred to 
in item (aa).’’. 
(B) CONFORMING
AMENDMENT.—Section 
1886(d)(7)(B) 
of 
such 
Act 
(42 
U.S.C. 
1395ww(d)(7)(B)) is amended by inserting ‘‘but 
not including a denial by the Secretary of an 
application for additional payment under para-
graph (5)(K) with respect to a discharge occur-
ring on or after the date of the date of the en-
actment of the Ensuring Patient Access to Crit-
ical Breakthrough Products Act of 2016’’ after 
‘‘paragraph (4)(D)’’. 
(C) EFFECTIVE DATE.—The amendments 
made by this paragraph shall take effect on the 
date of the enactment of this Act, and shall 
apply with respect to hospital discharges for in-
patient hospital services for which payment is 
made under section 1886(d) of the Social Secu-
rity Act (42 U.S.C. 1395ww) occurring on or 
after October 1, 2016. 
(e) CONFORMING AMENDMENTS.— 
(1) INPATIENT
PROSPECTIVE
PAYMENT
SYS-
TEM.—Section 1886(d)(5)(K)(i) of the Social Secu-
rity Act (42 U.S.C. 1395ww(d)(5)(K)(i)) is amended 
by adding at the end the following new sentence: 
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‘‘Effective for discharges occurring on or after Octo-
ber 1, 2016, in the case of a new medical service or 
technology that is a breakthrough device (as defined 
in section 1899C(a)) payment for such breakthrough 
device shall be made for the 3-year period applicable 
to 
such 
breakthrough 
device 
under 
section 
1899C(d)(1).’’. 
(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, 2017, 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 
transitional pass-through payment under 
section 1833(i)(2)(D).’’. 
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(f) 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), as added by subsection (a)) approved 
on or after January 1, 2017. 
Æ 
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