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 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Protecting Access to 

5 Innovation During COVID–19 Act’’. 


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1 SEC. 2. AUTHORIZING THE EXTENSION OF PASS-THROUGH 

2 STATUS UNDER THE MEDICARE PROGRAM 

3 FOR CERTAIN DRUGS AND DEVICES IM4 PACTED BY COVID–19. 

5 Section 1833(t)(6) of the Social Security Act (42 

6 U.S.C. 1395l(t)(6)) is amended by adding at the end the 

7 following new subparagraph: 

8 ‘‘(K) AUTHORITY TO EXTEND PASS9 THROUGH STATUS FOR CERTAIN DRUGS AND

10 DEVICES IMPACTED BY COVID–19.— 

11 ‘‘(i) IN GENERAL.—Notwithstanding 

12 the preceding provisions of this paragraph, 

13 in the case of an eligible drug or device (as 

14 defined in clause (iv)), if the Secretary de15 termines, prior to or on the date of the ex16 piration of pass-through status for such 

17 drug or device (or, in the case of such a 

18 drug or device whose pass-through status 

19 expired before the date of the enactment of 

20 this subparagraph, not later than 30 days 

21 after such date), that the cost of such drug 

22 or device is unable to be accurately cal23 culated due to the effects of COVID–19, 

24 the Secretary may extend the pass-through 

25 status of such eligible drug or device in ac26 cordance with clause (ii). 


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1 ‘‘(ii) EXTENSION.—The Secretary 

2 may extend the pass-through status of an 

3 eligible drug or device described in clause 

4 (i) with respect to which a determination 

5 has been made under such clause— 

6 ‘‘(I) in the case of a drug or de7 vice whose period of pass-through sta8 tus expired during the emergency pe9 riod described in section 

10 1135(g)(1)(B) before the date of the 

11 enactment of this subparagraph, for a 

12 period beginning on the first day after 

13 such period of up to the number of 

14 days occurring during such period 

15 during which such drug or device had 

16 pass-through status; 

17 ‘‘(II) in the case of a drug or de18 vice whose period of pass-through sta19 tus would otherwise expire during 

20 such emergency period on or after 

21 such date of enactment— 

22 ‘‘(aa) for the remainder of 

23 such period; and 

24 ‘‘(bb) for a period beginning 

25 on the first day after such period 


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1 of up to the number of days oc2 curring during such period dur3 ing which such drug or device 

4 had pass-through status (not tak5 ing into account any extension of 

6 such status pursuant to this sub7 clause); and 

8 ‘‘(III) in the case of a drug or 

9 device not described in subclause (I) 

10 or (II), by the number of days occur11 ring during such emergency period 

12 during which such drug or device had 

13 pass-through status. 

14 ‘‘(iii) SPECIAL RULES FOR ALREADY15 EXPIRED DRUGS AND DEVICES.—In the 

16 case of an eligible drug or device described 

17 in clause (ii)(I) for which payment under 

18 this subsection was packaged into a pay19 ment for a covered OPD service (or group 

20 of services) and whose period of pass21 through status is extended in accordance 

22 with such clause, the Secretary— 

23 ‘‘(I) shall, for the period during 

24 which such extension is in effect for 

25 such drug or device— 


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1 ‘‘(aa) remove, during such 

2 period, the packaged costs of 

3 such drug or device (as deter4 mined by the Secretary) from the 

5 payment amount under this sub6 section for the covered OPD serv7 ice (or group of services) with 

8 which it is packaged; and 

9 ‘‘(bb) not make any adjust10 ments to payment amounts under 

11 this subsection for a covered 

12 OPD service (or group of serv13 ices) for which no costs were re14 moved under subclause (I); and 

15 ‘‘(II) may not, when calculating 

16 the cost of such drug or device at the 

17 end of such extension, take into ac18 count claims for such drug or device 

19 made while such drug or device was 

20 so packaged. 

21 ‘‘(iv) ELIGIBLE DRUG OR DEVICE DE22 FINED.—For purposes of this subpara23 graph, the term ‘eligible drug or device’ 

24 means a drug or device with pass-through 

25 status in effect during any portion of the 


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1 emergency period described in section 

2 1135(g)(1)(B).’’. 

Æ 


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