Title: Protecting Access to Innovation During COVID–19 Act
Policy area: Health

Summary:
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>