II 

116TH CONGRESS 

1ST SESSION S. 2051 

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

to report drug pricing information with respect to drugs under the 

Medicare program. 

IN THE SENATE OF THE UNITED STATES 

JUNE 28 (legislative day, JUNE 27), 2019 

Mr. MENENDEZ (for himself and Mr. YOUNG) introduced the following bill; 

which was read twice and referred to the Committee on Finance 

A BILL 

To amend XVIII of the Social Security Act to require certain 

manufacturers to report drug pricing information with 

respect to drugs under the Medicare program. 

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 ‘‘Strengthening Average 

5 Sales Price Reporting Act of 2019’’. 


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1 SEC. 2. REQUIRING CERTAIN MANUFACTURERS TO REPORT 

2 DRUG PRICING INFORMATION WITH RE3 SPECT TO DRUGS UNDER THE MEDICARE 

4 PROGRAM. 

5 (a) IN GENERAL.—Section 1847A of the Social Secu6 rity Act (42 U.S.C. 1395w–3a) is amended— 

7 (1) in subsection (b)— 

8 (A) in paragraph (2)(A), by inserting ‘‘or 

9 subsection (f)(2), as applicable’’ before the pe10 riod at the end; 

11 (B) in paragraph (3), in the matter pre12 ceding subparagraph (A), by inserting ‘‘or sub13 section (f)(2), as applicable,’’ before ‘‘deter14 mined by’’; and 

15 (C) in paragraph (6)(A), in the matter 

16 preceding clause (i), by inserting ‘‘or subsection 

17 (f)(2), as applicable,’’ before ‘‘determined by’’; 

18 and 

19 (2) in subsection (f)— 

20 (A) by striking ‘‘For requirements’’ and 

21 inserting the following: 

22 ‘‘(1) IN GENERAL.—For requirements’’; and 

23 (B) by adding at the end the following new 

24 paragraph: 

25 ‘‘(2) MANUFACTURERS WITHOUT A REBATE

26 AGREEMENT UNDER TITLE XIX.— 


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1 ‘‘(A) IN GENERAL.—In the case of a man2 ufacturer of an applicable drug or biological 

3 that does not have a rebate agreement in effect 

4 under section 1927, for calendar quarters be5 ginning on or after January 1, 2020, such man6 ufacturer shall report to the Secretary the in7 formation described in subsection (b)(3)(A)(iii) 

8 of such section 1927 with respect to such appli9 cable drug or biological in a time and manner 

10 specified by the Secretary. 

11 ‘‘(B) DEFINITION OF APPLICABLE DRUG

12 OR BIOLOGICAL.—In this paragraph, the term 

13 ‘applicable drug or biological’ means— 

14 ‘‘(i) a drug or biological described 

15 in— 

16 ‘‘(I) subparagraph (C), (E), or 

17 (G) of section 1842(o)(1); or 

18 ‘‘(II) clause (ii) or (iii) of section 

19 1881(b)(14)(B); and 

20 ‘‘(ii) an item for which payment is es21 tablished under this section. 

22 ‘‘(C) AUDIT.—Information reported under 

23 subparagraph (A) is subject to audit by the In24 spector General of the Department of Health 

25 and Human Services. 


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1 ‘‘(D) VERIFICATION.—The Secretary may 

2 survey wholesalers and manufacturers that di3 rectly distribute an applicable drug or biologi4 cal, when necessary, to verify manufacturer 

5 prices and manufacturer’s average sales prices 

6 (including wholesale acquisition cost) if required 

7 to make payment reported under subparagraph 

8 (A). The Secretary may impose a civil monetary 

9 penalty in an amount not to exceed $100,000 

10 on a wholesaler, manufacturer, or direct seller, 

11 if the wholesaler, manufacturer, or direct seller 

12 of such a drug refuses a request for information 

13 about charges or prices by the Secretary in con14 nection with a survey under this subparagraph 

15 or knowingly provides false information. The 

16 provisions of section 1128A (other than sub17 sections (a) (with respect to amounts of pen18 alties or additional assessments) and (b)) shall 

19 apply to a civil money penalty under this sub20 paragraph in the same manner as such provi21 sions apply to a penalty or proceeding under 

22 section 1128A(a). 

23 ‘‘(E) CONFIDENTIALITY.—Notwith24 standing any other provision of law, information 

25 disclosed by manufacturers or wholesalers 


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1 under this paragraph (other than the wholesale 

2 acquisition cost for purposes of carrying out 

3 this section) is confidential and shall not be dis4 closed by the Secretary in a form which dis5 closes the identity of a specific manufacturer or 

6 wholesaler or prices charged for an applicable 

7 drug or biological by such manufacturer or 

8 wholesaler, except— 

9 ‘‘(i) as the Secretary determines to be 

10 necessary to carry out this section (includ11 ing the determination and implementation 

12 of the payment amount), or to carry out 

13 section 1847B; 

14 ‘‘(ii) to permit the Comptroller Gen15 eral to review the information provided; 

16 and 

17 ‘‘(iii) to permit the Director of the 

18 Congressional Budget Office to review the 

19 information provided.’’. 

20 (b) ENFORCEMENT.—Section 1847A such Act (42 

21 U.S.C. 1395w–3a) is further amended— 

22 (1) in subsection (d)(4)— 

23 (A) in subparagraph (A), by striking ‘‘IN

24 GENERAL’’ and inserting ‘‘MISREPRESENTA25 TION’’; 


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1 (B) in subparagraph (B), by striking ‘‘sub2 paragraph (B)’’ and inserting ‘‘subparagraph 

3 (A), (B), or (C)’’; 

4 (C) by redesignating subparagraph (B) as 

5 subparagraph (D); and 

6 (D) by inserting after subparagraph (A) 

7 the following new subparagraphs: 

8 ‘‘(B) FAILURE TO PROVIDE TIMELY INFOR9 MATION.—If the Secretary determines that a 

10 manufacturer described in subsection (f)(2) has 

11 failed to report on information described in sec12 tion 1927(b)(3)(A)(iii) with respect to an appli13 cable drug or biological in accordance with such 

14 subsection, the Secretary shall apply a civil 

15 money penalty in an amount of $10,000 for 

16 each day the manufacturer has failed to report 

17 such information and such amount shall be paid 

18 to the Treasury. 

19 ‘‘(C) FALSE INFORMATION.—Any manu20 facturer required to submit information under 

21 subsection (f)(2) that knowingly provides false 

22 information is subject to a civil money penalty 

23 in an amount not to exceed $100,000 for each 

24 item of false information. Such civil money penVerDate Sep 11 2014 03:25 Jul 04, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S2051.IS S2051

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1 alties are in addition to other penalties as may 

2 be prescribed by law.’’; and 

3 (2) in subsection (c)(6)(A), by striking the pe4 riod at the end and inserting ‘‘, except that, for pur5 poses of subsection (f)(2), the Secretary may, if the 

6 Secretary determines appropriate, exclude repack7 agers of an applicable drug or biological from such 

8 term.’’. 

9 (c) REPORT.—Not later than January 1, 2021, the 

10 Inspector General of the Department of Health and 

11 Human Services shall assess and submit to Congress a 

12 report on the accuracy of average sales price information 

13 submitted by manufacturers under section 1847A of the 

14 Social Security Act (42 U.S.C. 1395w–3a). Such report 

15 shall include any recommendations on how to improve the 

16 accuracy of such information. 

Æ 


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