Protecting Access to Innovation During COVID-19 Act

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. 1. Short title This Act may be cited as the Protecting Access to Innovation During COVID–19 Act 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) (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 .

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.