Protecting Access to Innovation During COVID-19 Act
This bill allows the Centers for Medicare & Medicaid Services (CMS) to extend the duration of pass-through status (i.e., additional payment) for certain drugs and devices under the Medicare prospective payment system for hospital outpatient department services.
Specifically, the CMS may extend the pass-through status of drugs and devices that received such status during the public health emergency relating to COVID-19 (i.e., coronavirus disease 2019) if their cost cannot be accurately calculated due to the effects of COVID-19. The bill's provisions apply to drugs and devices that had pass-through status during any portion of the public health emergency period, including those for which such status has already expired.
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8624 Introduced in House (IH)]
<DOC>
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
following bill; which was referred to the Committee on Energy and
Commerce, and in addition to the Committee on Ways and Means, for a
period to be subsequently determined 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 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 Representatives 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''.
SEC. 2. AUTHORIZING THE EXTENSION OF PASS-THROUGH STATUS UNDER THE
MEDICARE PROGRAM FOR CERTAIN DRUGS AND DEVICES IMPACTED
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 determines,
prior to or on the date of the expiration 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
calculated due to the effects of COVID-19, the
Secretary may extend the pass-through status of
such eligible drug or device in accordance with
clause (ii).
``(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
device whose period of pass-through
status expired during the emergency
period 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
device whose period of pass-through
status 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 of up to the
number of days occurring during
such period during which such
drug or device had pass-through
status (not taking into account
any extension of such status
pursuant to this subclause);
and
``(III) in the case of a drug or
device not described in subclause (I)
or (II), by the number of days
occurring 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 payment 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--
``(aa) remove, during such
period, the packaged costs of
such drug or device (as
determined by the Secretary)
from the payment amount under
this subsection for the covered
OPD service (or group of
services) with which it is
packaged; and
``(bb) not make any
adjustments to payment amounts
under this subsection for a
covered OPD service (or group
of services) for which no costs
were removed under subclause
(I); and
``(II) may not, when calculating
the cost of such drug or device at the
end of such extension, take into
account claims for such drug or device
made while such drug or device was so
packaged.
``(iv) Eligible drug or device defined.--
For purposes of this subparagraph, the term
`eligible drug or device' means a drug or
device with pass-through status in effect
during any portion of the emergency period
described in section 1135(g)(1)(B).''.
<all>
Introduced in House
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
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