I 

116TH CONGRESS 

1ST SESSION H. R. 4178 

To amend title XVIII of the Social Security Act to require manufacturers 

of certain single-dose vial drugs payable under part B of the Medicare 

program to provide rebates with respect to amounts of such drugs discarded, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

AUGUST 9, 2019 

Mr. ENGEL 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 require 

manufacturers of certain single-dose vial drugs payable 

under part B of the Medicare program to provide rebates 

with respect to amounts of such drugs discarded, and 

for other purposes. 

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 ‘‘Recovering Excessive 

5 Funds for Unused and Needless Drugs Act of 2019’’ or 

6 the ‘‘REFUND Act of 2019’’. 


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1 SEC. 2. REQUIRING MANUFACTURERS OF CERTAIN SINGLE2 DOSE VIAL DRUGS PAYABLE UNDER PART B 

3 OF THE MEDICARE PROGRAM TO PROVIDE 

4 REBATES WITH RESPECT TO DISCARDED 

5 AMOUNTS OF SUCH DRUGS. 

6 (a) IN GENERAL.—Section 1834 of the Social Secu7 rity Act (42 U.S.C. 1395m) is amended by adding at the 

8 end the following new subsection: 

9 ‘‘(x) REBATE FOR CERTAIN DISCARDED SINGLE10 DOSE VIAL DRUGS.— 

11 ‘‘(1) IN GENERAL.—The manufacturer (as de12 fined in section 1847A(c)(6)(A)) of a rebatable sin13 gle-dose vial drug furnished in a calendar quarter 

14 shall, not later than 30 days after the date of receipt 

15 of information described in paragraph (2)(A)(iii) 

16 with respect to such quarter, provide to the Sec17 retary a rebate that is equal to the amount specified 

18 in paragraph (3) for such drug for such quarter. 

19 ‘‘(2) SECRETARIAL DUTIES.— 

20 ‘‘(A) IN GENERAL.—For each calendar 

21 quarter, the Secretary shall, with respect to a 

22 rebatable single-dose vial drug of a manufac23 turer furnished during such quarter— 

24 ‘‘(i) require, through use of a modifier 

25 such as the JW modifier used as of the 

26 date of enactment of this subsection (or 


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1 any such successor code that includes such 

2 data as determined appropriate by the Sec3 retary), an indication on a claim for such 

4 drug of the amount of such drug that was 

5 discarded after such drug was furnished, if 

6 any; 

7 ‘‘(ii) determine the rebatable amount 

8 (as defined in subparagraph (B)) with re9 spect to such drug; and 

10 ‘‘(iii) not later than 60 days after the 

11 end of such quarter, provide to such manu12 facturer notice of— 

13 ‘‘(I) the total number of units of 

14 such drug discarded during such 

15 quarter (as determined by the Sec16 retary based on the aggregate rebata17 ble amount (as so defined) with re18 spect to such drug for such quarter), 

19 if any; and 

20 ‘‘(II) the rebate amount specified 

21 in paragraph (3) for such drug and 

22 such quarter. 

23 ‘‘(B) REBATABLE AMOUNT.—The term 

24 ‘rebatable amount’ means, with respect to a 

25 rebatable single-dose vial drug of a manufacVerDate Sep 11 2014 03:40 Aug 16, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4178.IH H4178

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1 turer furnished during a quarter, 90 percent of 

2 the amount (if any) of such drug that was dis3 carded as indicated pursuant to subparagraph 

4 (A)(i). 

5 ‘‘(3) REBATE AMOUNT.—The amount of the re6 bate specified in this paragraph is, with respect to 

7 a rebatable single-dose vial drug of a manufacturer 

8 furnished in a calendar quarter, an amount equal to 

9 the product of— 

10 ‘‘(A) the total number of units of such 

11 drug discarded during such quarter as deter12 mined under paragraph (2)(A)(iii)(I); and 

13 ‘‘(B) the lesser of— 

14 ‘‘(i) the average sales price (as de15 fined in section 1847A(c)(1)) for a unit of 

16 such drug for such quarter (or, in the case 

17 of a drug subject to an agreement with 

18 such manufacturer under section 340B of 

19 the Public Health Service Act, the price 

20 for a unit of such drug for such quarter 

21 under such agreement); or 

22 ‘‘(ii) the wholesale acquisition cost (as 

23 defined in section 1847A(c)(6)(B)) for a 

24 unit of such drug. 


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1 ‘‘(4) REBATE DEPOSITS.—Amounts paid as re2 bates pursuant to paragraph (1) shall be deposited 

3 into the Federal Supplementary Medical Insurance 

4 Trust Fund established under section 1841. 

5 ‘‘(5) ENFORCEMENT.— 

6 ‘‘(A) AUDITS.—Each manufacturer of a 

7 rebatable single dose-vial drug that is required 

8 to provide a rebate under this subsection shall 

9 be subject to periodic audit with respect to such 

10 drug and such rebates by the Secretary. 

11 ‘‘(B) CIVIL MONEY PENALTY.— 

12 ‘‘(i) IN GENERAL.—The Secretary 

13 shall impose a civil money penalty on a 

14 manufacturer of a rebatable single dose15 vial drug who has failed to comply with the 

16 requirement under paragraph (1) for such 

17 drug for a calendar quarter in an amount 

18 the Secretary determines is commensurate 

19 with the sum of— 

20 ‘‘(I) the amount that the manu21 facturer would have paid under such 

22 paragraph with respect to such drug 

23 for such quarter; and 

24 ‘‘(II) 25 percent of such amount. 


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1 ‘‘(ii) APPLICATION.—The provisions 

2 of section 1128A (other than subsections 

3 (a) and (b)) shall apply to a civil money 

4 penalty under this subparagraph in the 

5 same manner as such provisions apply to a 

6 penalty or proceeding under section 

7 1128A(a). 

8 ‘‘(6) DEFINITIONS.—In this subsection: 

9 ‘‘(A) REBATABLE SINGLE-DOSE VIAL

10 DRUG.—The term ‘rebatable single-dose vial 

11 drug’ means a single source drug or biological 

12 (as defined in section 1847A(c)(6)(D)) paid for 

13 under this part and furnished on or after Janu14 ary 1, 2020, from a single-dose vial. 

15 ‘‘(B) UNIT.—The term ‘unit’ has the 

16 meaning given such term in section 

17 1847A(b)(2)(B).’’. 

18 (b) COLLECTION OF COINSURANCE ONLY FOR POR19 TION OF REBATABLE SINGLE-DOSE VIAL DRUG ADMINIS20 TERED.—Section 1833 of the Social Security Act (42 

21 U.S.C. 1395l) is amended— 

22 (1) in subsection (a)(1)(S), by inserting ‘‘sub23 ject to subsection (cc),’’ before ‘‘with respect to’’; 

24 and 


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1 (2) by adding at the end the following new sub2 section: 

3 ‘‘(cc) COLLECTION OF COINSURANCE ONLY FOR

4 PORTION OF REBATABLE SINGLE-DOSE VIAL DRUG AD5 MINISTERED.—When processing a claim for a rebatable 

6 single-dose vial drug (as defined in section 1834(w)(6)), 

7 the Secretary, acting through the relevant Medicare ad8 ministrative contractor with respect to such claim, shall 

9 only collect coinsurance from a beneficiary, taking into ac10 count any coverage under a Medicare supplemental policy 

11 certified under section 1882 or any other supplemental in12 surance coverage of the beneficiary, with respect to the 

13 portion of the drug administered (as indicated by the J14 portion of the claim for the drug used as of the date of 

15 enactment of this subsection, or any successor code that 

16 includes such data as determined appropriate by the Sec17 retary), in an amount equal to 20 percent of the amount 

18 of payment that would be made if payment for the claim 

19 was based only on the portion of the drug administered 

20 (as so indicated). Nothing in the preceding sentence shall 

21 affect the amount paid to the provider of services or sup22 plier with respect to the drug under this part (as deter23 mined based on the total amount of the drug for which 

24 the claim was submitted, including the portion of the drug 

25 administered and the portion discarded, as indicated by 


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1 the J-portion of the claim and the JW modifier, respec2 tively, used as of such date of enactment or any successor 

3 codes that include such data as determined appropriate 

4 by the Secretary).’’. 

Æ 


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