I 
116TH CONGRESS 
2D SESSION 
H. R. 8624 
To amend title XVIII of the Social Security Act to authorize the extension 
of pass-through status under the Medicare program for certain drugs 
and devices impacted by COVID–19. 
IN THE HOUSE OF REPRESENTATIVES 
OCTOBER 16, 2020 
Mr. WENSTRUP (for himself and Mr. BISHOP of Georgia) introduced the fol-
lowing bill; which was referred to the Committee on Energy and Com-
merce, and in addition to the Committee on Ways and Means, for a pe-
riod to be subsequently determined by the Speaker, in each case for con-
sideration of such provisions as fall within the jurisdiction of the com-
mittee concerned 
A BILL 
To amend title XVIII of the Social Security Act to authorize 
the extension of pass-through status under the Medicare 
program for certain drugs and devices impacted by 
COVID–19. 
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 ‘‘Protecting Access to 
Innovation During COVID–19 Act’’. 
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SEC. 2. AUTHORIZING THE EXTENSION OF PASS-THROUGH 
STATUS UNDER THE MEDICARE PROGRAM 
FOR CERTAIN DRUGS AND DEVICES IM-
PACTED BY COVID–19. 
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: 
‘‘(K) 
AUTHORITY
TO
EXTEND
PASS- 
THROUGH
STATUS
FOR
CERTAIN
DRUGS
AND 
DEVICES IMPACTED BY COVID–19.— 
‘‘(i) IN
GENERAL.—Notwithstanding 
the preceding provisions of this paragraph, 
in the case of an eligible drug or device (as 
defined in clause (iv)), if the Secretary de-
termines, prior to or on the date of the ex-
piration of pass-through status for such 
drug or device (or, in the case of such a 
drug or device whose pass-through status 
expired before the date of the enactment of 
this subparagraph, not later than 30 days 
after such date), that the cost of such drug 
or device is unable to be accurately cal-
culated due to the effects of COVID–19, 
the Secretary may extend the pass-through 
status of such eligible drug or device in ac-
cordance with clause (ii). 
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‘‘(ii) 
EXTENSION.—The 
Secretary 
may extend the pass-through status of an 
eligible drug or device described in clause 
(i) with respect to which a determination 
has been made under such clause— 
‘‘(I) in the case of a drug or de-
vice whose period of pass-through sta-
tus expired during the emergency pe-
riod 
described 
in 
section 
1135(g)(1)(B) before the date of the 
enactment of this subparagraph, for a 
period beginning on the first day after 
such period of up to the number of 
days occurring during such period 
during which such drug or device had 
pass-through status; 
‘‘(II) in the case of a drug or de-
vice whose period of pass-through sta-
tus would otherwise expire during 
such emergency period on or after 
such date of enactment— 
‘‘(aa) for the remainder of 
such period; and 
‘‘(bb) for a period beginning 
on the first day after such period 
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of up to the number of days oc-
curring during such period dur-
ing which such drug or device 
had pass-through status (not tak-
ing into account any extension of 
such status pursuant to this sub-
clause); and 
‘‘(III) in the case of a drug or 
device not described in subclause (I) 
or (II), by the number of days occur-
ring during such emergency period 
during which such drug or device had 
pass-through status. 
‘‘(iii) SPECIAL RULES FOR ALREADY- 
EXPIRED
DRUGS
AND
DEVICES.—In the 
case of an eligible drug or device described 
in clause (ii)(I) for which payment under 
this subsection was packaged into a pay-
ment for a covered OPD service (or group 
of services) and whose period of pass- 
through status is extended in accordance 
with such clause, the Secretary— 
‘‘(I) shall, for the period during 
which such extension is in effect for 
such drug or device— 
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‘‘(aa) remove, during such 
period, the packaged costs of 
such drug or device (as deter-
mined by the Secretary) from the 
payment amount under this sub-
section for the covered OPD serv-
ice (or group of services) with 
which it is packaged; and 
‘‘(bb) not make any adjust-
ments to payment amounts under 
this subsection for a covered 
OPD service (or group of serv-
ices) for which no costs were re-
moved under subclause (I); and 
‘‘(II) may not, when calculating 
the cost of such drug or device at the 
end of such extension, take into ac-
count claims for such drug or device 
made while such drug or device was 
so packaged. 
‘‘(iv) ELIGIBLE DRUG OR DEVICE DE-
FINED.—For purposes of this subpara-
graph, the term ‘eligible drug or device’ 
means a drug or device with pass-through 
status in effect during any portion of the 
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emergency period described in section 
1135(g)(1)(B).’’. 
Æ 
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