I 

116TH CONGRESS 

1ST SESSION H. R. 2064 

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

of certain drugs, devices, biologicals, and medical supplies to report 

on product samples provided to certain health care providers, and for 

other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 3, 2019 

Ms. JUDY CHU of California (for herself and Mr. NUNES) 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 XI of the Social Security Act to require 

manufacturers of certain drugs, devices, biologicals, and 

medical supplies to report on product samples provided 

to certain health care providers, 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, 


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1 SECTION 1. REQUIREMENT FOR MANUFACTURERS OF CER2 TAIN DRUGS, DEVICES, BIOLOGICALS, AND 

3 MEDICAL SUPPLIES TO REPORT ON PROD4 UCT SAMPLES PROVIDED TO CERTAIN 

5 HEALTH CARE PROVIDERS. 

6 (a) IN GENERAL.—Section 1128G(a) of the Social 

7 Security Act (42 U.S.C. 1320a–7h(a)) is amended by add8 ing at the end the following new paragraph: 

9 ‘‘(3) CERTAIN PRODUCT SAMPLES.— 

10 ‘‘(A) IN GENERAL.—In addition to the re11 quirements under paragraphs (1)(A) and (2), 

12 on the 90th day of each calendar year (begin13 ning with 2023), any applicable manufacturer 

14 that provides a payment or other transfer of 

15 value that is a product sample described in sub16 paragraph (B) to any covered recipient (or to 

17 an entity or individual at the request of, or des18 ignated on behalf of, such a covered recipient) 

19 shall submit to the Secretary, in such electronic 

20 form as the Secretary shall require, the fol21 lowing information with respect to the pre22 ceding calendar year: 

23 ‘‘(i) The total quantity of all such 

24 payments or other transfers of value pro25 vided to covered recipients. 


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1 ‘‘(ii) The total value of all such pay2 ments or other transfers of value provided 

3 to covered recipients. 

4 ‘‘(iii) If applicable, information de5 scribed in clauses (vii) and (viii) of para6 graph (1)(A) with respect to such a pay7 ment or other transfer of value. 

8 ‘‘(B) PRODUCT SAMPLE DESCRIBED.—For 

9 purposes of subparagraph (A), a product sam10 ple described in this subparagraph is a product 

11 sample that is not intended to be sold and is in12 tended for patient use.’’. 

13 (b) PUBLIC AVAILABILITY OF INFORMATION.—Sec14 tion 1128G(c)(1)(C) of the Social Security Act (42 U.S.C. 

15 1320a–7h(c)(1)(C)) is amended— 

16 (1) in clause (ii)— 

17 (A) by striking ‘‘(ii) contains’’ and insert18 ing ‘‘(ii)(I) with respect to information that is 

19 not information submitted under paragraph (3) 

20 of subsection (a), contains’’; 

21 (B) by striking ‘‘, as applicable;’’ and in22 serting ‘‘, as applicable; and’’; and 

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

24 subclause: 


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1 ‘‘(II) with respect to information sub2 mitted under paragraph (3) of subsection 

3 (a), contains information that is presented 

4 by the name of the applicable manufac5 turer, the total amount of all payments or 

6 other transfers of value described in such 

7 paragraph provided to covered recipients, 

8 the total value of all such payments or 

9 other transfers of value provided to covered 

10 recipients, and the name of the covered 

11 drug, device, biological, or medical supply, 

12 as applicable;’’; 

13 (2) in clause (viii), by striking ‘‘, and’’ at the 

14 end and inserting a semicolon; 

15 (3) in clause (ix), by striking the period at the 

16 end and inserting ‘‘; and’’; and 

17 (4) by adding at the end the following new 

18 clause: 

19 ‘‘(x) in the case of information sub20 mitted under paragraph (3) of subsection 

21 (a), lists such information separately from 

22 the other information submitted under 

23 subsection (a) and presents such informa24 tion by the name of the applicable manu25 facturer, the total quantity of all payments 


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1 or other transfers of value described in 

2 such paragraph provided to covered recipi3 ents, the total value of all such payments 

4 or other transfers of value provided to cov5 ered recipients, and the name of the cov6 ered drug, device, biological, or medical 

7 supply, as applicable.’’. 

8 (c) CONFORMING AMENDMENT.—Section 

9 1128G(e)(10)(B)(ii) of the Social Security Act (42 U.S.C. 

10 1320a–7h(e)(10)(B)(ii)) is amended by striking ‘‘Product 

11 samples’’ and inserting ‘‘Except for purposes of paragraph 

12 (3) of subsection (a), product samples’’. 

Æ 


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