I 

116TH CONGRESS 

1ST SESSION H. R. 2087 

To amend title XVIII of the Social Security Act to require certain manufacturers to report drug pricing information with respect to drugs under 

the Medicare program, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 4, 2019 

Mr. DOGGETT (for himself and Mr. BUCHANAN) 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 

certain manufacturers to report drug pricing information 

with respect to drugs under the Medicare program, 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 ‘‘Drug Price Trans5 parency Act’’. 


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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 a drug or biological described in 

3 subparagraph (C), (E), or (G) of section 

4 1842(o)(1) or in clause (ii) or (iii) of section 

5 1881(b)(14)(B) that does not have a rebate 

6 agreement in effect under section 1927, for cal7 endar quarters beginning on or after January 

8 1, 2020, such manufacturer shall report to the 

9 Secretary the information described in sub10 section (b)(3)(A)(iii) of such section 1927 with 

11 respect to such drug or biological in a time and 

12 manner specified by the Secretary. 

13 ‘‘(B) AUDIT.—Information reported under 

14 subparagraph (A) is subject to audit by the In15 spector General of the Department of Health 

16 and Human Services. 

17 ‘‘(C) VERIFICATION.—The Secretary may 

18 survey wholesalers and manufacturers that di19 rectly distribute drugs described in subpara20 graph (A), when necessary, to verify manufac21 turer prices and manufacturer’s average sales 

22 prices (including wholesale acquisition cost) if 

23 required to make payment reported under sub24 paragraph (A). The Secretary may impose a 

25 civil monetary penalty in an amount not to exVerDate Sep 11 2014 03:17 Apr 16, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2087.IH H2087

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1 ceed $100,000 on a wholesaler, manufacturer, 

2 or direct seller, if the wholesaler, manufacturer, 

3 or direct seller of such a drug refuses a request 

4 for information about charges or prices by the 

5 Secretary in connection with a survey under 

6 this subparagraph or knowingly provides false 

7 information. The provisions of section 1128A 

8 (other than subsections (a) (with respect to 

9 amounts of penalties or additional assessments) 

10 and (b)) shall apply to a civil money penalty 

11 under this subparagraph in the same manner as 

12 such provisions apply to a penalty or proceeding 

13 under section 1128A(a). 

14 ‘‘(D) CONFIDENTIALITY.—Notwithstand15 ing any other provision of law, information dis16 closed by manufacturers or wholesalers under 

17 this paragraph (other than the wholesale acqui18 sition cost for purposes of carrying out this sec19 tion) is confidential and shall not be disclosed 

20 by the Secretary in a form which discloses the 

21 identity of a specific manufacturer or whole22 saler or prices charged for drugs by such manu23 facturer or wholesaler, except— 

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

25 necessary to carry out this section (includVerDate Sep 11 2014 03:17 Apr 16, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2087.IH H2087

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1 ing the determination and implementation 

2 of the payment amount), or to carry out 

3 section 1847B; 

4 ‘‘(ii) to permit the Comptroller Gen5 eral to review the information provided; 

6 and 

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

8 Congressional Budget Office to review the 

9 information provided.’’. 

10 (b) ENFORCEMENT.— 

11 (1) IN GENERAL.—Section 1847A such Act (42 

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

13 (A) in subsection (d)(4)— 

14 (i) in subparagraph (A), by striking 

15 ‘‘IN GENERAL’’ and inserting ‘‘MISREPRE16 SENTATION’’; 

17 (ii) in subparagraph (B), by striking 

18 ‘‘subparagraph (B)’’ and inserting ‘‘sub19 paragraph (A), (B), or (C)’’; 

20 (iii) by redesignating subparagraph 

21 (B) as subparagraph (D); and 

22 (iv) by inserting after subparagraph 

23 (A) the following new subparagraphs: 

24 ‘‘(B) FAILURE TO PROVIDE TIMELY INFOR25 MATION.—If the Secretary determines that a 


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

2 failed to report on information described in sec3 tion 1927(b)(3)(A)(iii) with respect to a drug or 

4 biological in accordance with such subsection, 

5 the Secretary shall apply a civil money penalty 

6 in an amount of $25,000 for each day the man7 ufacturer has failed to report such information 

8 and such amount shall be paid to the Treasury. 

9 ‘‘(C) FALSE INFORMATION.—Any manu10 facturer required to submit information under 

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

12 information is subject to a civil money penalty 

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

14 item of false information. Such civil money pen15 alties are in addition to other penalties as may 

16 be prescribed by law.’’; and 

17 (B) in subsection (c)(6)(A), by striking the 

18 period at the end and inserting ‘‘, except that, 

19 for purposes of subsection (f)(2), the Secretary 

20 may, if the Secretary determines appropriate, 

21 exclude repackagers of a drug or biological from 

22 such term.’’. 

23 (2) CONFORMING EXISTING MANUFACTURER

24 REPORTING PENALTIES.—Section 1927(b)(3)(C)(i) 

25 of such Act (42 U.S.C. 1396r–8(b)(3)(C)(i)) is 


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1 amended by inserting ‘‘(or, for such failures occur2 ring on or after January 1, 2020, $25,000)’’ after 

3 ‘‘$10,000’’. 

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

5 Inspector General of the Department of Health and 

6 Human Services shall assess and submit to Congress a 

7 report on the accuracy of average sales price information 

8 submitted by manufacturers under section 1847A of the 

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

10 shall include any recommendations on how to improve the 

11 accuracy of such information. 

Æ 


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