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-
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 
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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. 
‘‘(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-
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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 
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 
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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 2018’’ 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: 
‘‘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 
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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, 2019, 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).’’. 
(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 
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section 1899C(a), as added by subsection (a)) approved 
on or after January 1, 2019. 
Æ 
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