Protecting Access to Innovation During COVID–19 Act

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- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Protecting Access to 4 Innovation During COVID–19 Act’’. 5 VerDate Sep 11 2014 18:55 Nov 03, 2020 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H8624.IH H8624 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 8624 IH SEC. 2. AUTHORIZING THE EXTENSION OF PASS-THROUGH 1 STATUS UNDER THE MEDICARE PROGRAM 2 FOR CERTAIN DRUGS AND DEVICES IM- 3 PACTED BY COVID–19. 4 Section 1833(t)(6) of the Social Security Act (42 5 U.S.C. 1395l(t)(6)) is amended by adding at the end the 6 following new subparagraph: 7 ‘‘(K) AUTHORITY TO EXTEND PASS- 8 THROUGH STATUS FOR CERTAIN DRUGS AND 9 DEVICES IMPACTED BY COVID–19.— 10 ‘‘(i) IN GENERAL.—Notwithstanding 11 the preceding provisions of this paragraph, 12 in the case of an eligible drug or device (as 13 defined in clause (iv)), if the Secretary de- 14 termines, prior to or on the date of the ex- 15 piration of pass-through status for such 16 drug or device (or, in the case of such a 17 drug or device whose pass-through status 18 expired before the date of the enactment of 19 this subparagraph, not later than 30 days 20 after such date), that the cost of such drug 21 or device is unable to be accurately cal- 22 culated due to the effects of COVID–19, 23 the Secretary may extend the pass-through 24 status of such eligible drug or device in ac- 25 cordance with clause (ii). 26 VerDate Sep 11 2014 18:55 Nov 03, 2020 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H8624.IH H8624 pamtmann on DSKBC07HB2PROD with BILLS 3 •HR 8624 IH ‘‘(ii) EXTENSION.—The Secretary 1 may extend the pass-through status of an 2 eligible drug or device described in clause 3 (i) with respect to which a determination 4 has been made under such clause— 5 ‘‘(I) in the case of a drug or de- 6 vice whose period of pass-through sta- 7 tus expired during the emergency pe- 8 riod described in section 9 1135(g)(1)(B) before the date of the 10 enactment of this subparagraph, for a 11 period beginning on the first day after 12 such period of up to the number of 13 days occurring during such period 14 during which such drug or device had 15 pass-through status; 16 ‘‘(II) in the case of a drug or de- 17 vice whose period of pass-through sta- 18 tus would otherwise expire during 19 such emergency period on or after 20 such date of enactment— 21 ‘‘(aa) for the remainder of 22 such period; and 23 ‘‘(bb) for a period beginning 24 on the first day after such period 25 VerDate Sep 11 2014 18:55 Nov 03, 2020 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H8624.IH H8624 pamtmann on DSKBC07HB2PROD with BILLS 4 •HR 8624 IH of up to the number of days oc- 1 curring during such period dur- 2 ing which such drug or device 3 had pass-through status (not tak- 4 ing into account any extension of 5 such status pursuant to this sub- 6 clause); and 7 ‘‘(III) in the case of a drug or 8 device not described in subclause (I) 9 or (II), by the number of days occur- 10 ring during such emergency period 11 during which such drug or device had 12 pass-through status. 13 ‘‘(iii) SPECIAL RULES FOR ALREADY- 14 EXPIRED DRUGS AND DEVICES.—In the 15 case of an eligible drug or device described 16 in clause (ii)(I) for which payment under 17 this subsection was packaged into a pay- 18 ment for a covered OPD service (or group 19 of services) and whose period of pass- 20 through status is extended in accordance 21 with such clause, the Secretary— 22 ‘‘(I) shall, for the period during 23 which such extension is in effect for 24 such drug or device— 25 VerDate Sep 11 2014 18:55 Nov 03, 2020 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H8624.IH H8624 pamtmann on DSKBC07HB2PROD with BILLS 5 •HR 8624 IH ‘‘(aa) remove, during such 1 period, the packaged costs of 2 such drug or device (as deter- 3 mined by the Secretary) from the 4 payment amount under this sub- 5 section for the covered OPD serv- 6 ice (or group of services) with 7 which it is packaged; and 8 ‘‘(bb) not make any adjust- 9 ments to payment amounts under 10 this subsection for a covered 11 OPD service (or group of serv- 12 ices) for which no costs were re- 13 moved under subclause (I); and 14 ‘‘(II) may not, when calculating 15 the cost of such drug or device at the 16 end of such extension, take into ac- 17 count claims for such drug or device 18 made while such drug or device was 19 so packaged. 20 ‘‘(iv) ELIGIBLE DRUG OR DEVICE DE- 21 FINED.—For purposes of this subpara- 22 graph, the term ‘eligible drug or device’ 23 means a drug or device with pass-through 24 status in effect during any portion of the 25 VerDate Sep 11 2014 18:55 Nov 03, 2020 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H8624.IH H8624 pamtmann on DSKBC07HB2PROD with BILLS 6 •HR 8624 IH emergency period described in section 1 1135(g)(1)(B).’’. 2 Æ VerDate Sep 11 2014 18:55 Nov 03, 2020 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\H8624.IH H8624 pamtmann on DSKBC07HB2PROD with BILLS