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.

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 fol- lowing bill; which was referred to the Committee on Energy and Com- merce, and in addition to the Committee on Ways and Means, for a pe- riod to be subsequently determined by the Speaker, in each case for con- sideration of such provisions as fall within the jurisdiction of the com- mittee 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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 VerDate Sep 11 2014 20:42 Apr 15, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2064.IH H2064 pamtmann on DSKBFK8HB2PROD with BILLS 2 •HR 2064 IH SECTION 1. REQUIREMENT FOR MANUFACTURERS OF CER- 1 TAIN DRUGS, DEVICES, BIOLOGICALS, AND 2 MEDICAL SUPPLIES TO REPORT ON PROD- 3 UCT SAMPLES PROVIDED TO CERTAIN 4 HEALTH CARE PROVIDERS. 5 (a) IN GENERAL.—Section 1128G(a) of the Social 6 Security Act (42 U.S.C. 1320a–7h(a)) is amended by add- 7 ing at the end the following new paragraph: 8 ‘‘(3) CERTAIN PRODUCT SAMPLES.— 9 ‘‘(A) IN GENERAL.—In addition to the re- 10 quirements under paragraphs (1)(A) and (2), 11 on the 90th day of each calendar year (begin- 12 ning with 2023), any applicable manufacturer 13 that provides a payment or other transfer of 14 value that is a product sample described in sub- 15 paragraph (B) to any covered recipient (or to 16 an entity or individual at the request of, or des- 17 ignated on behalf of, such a covered recipient) 18 shall submit to the Secretary, in such electronic 19 form as the Secretary shall require, the fol- 20 lowing information with respect to the pre- 21 ceding calendar year: 22 ‘‘(i) The total quantity of all such 23 payments or other transfers of value pro- 24 vided to covered recipients. 25 VerDate Sep 11 2014 20:42 Apr 15, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2064.IH H2064 pamtmann on DSKBFK8HB2PROD with BILLS 3 •HR 2064 IH ‘‘(ii) The total value of all such pay- 1 ments or other transfers of value provided 2 to covered recipients. 3 ‘‘(iii) If applicable, information de- 4 scribed in clauses (vii) and (viii) of para- 5 graph (1)(A) with respect to such a pay- 6 ment or other transfer of value. 7 ‘‘(B) PRODUCT SAMPLE DESCRIBED.—For 8 purposes of subparagraph (A), a product sam- 9 ple described in this subparagraph is a product 10 sample that is not intended to be sold and is in- 11 tended for patient use.’’. 12 (b) PUBLIC AVAILABILITY OF INFORMATION.—Sec- 13 tion 1128G(c)(1)(C) of the Social Security Act (42 U.S.C. 14 1320a–7h(c)(1)(C)) is amended— 15 (1) in clause (ii)— 16 (A) by striking ‘‘(ii) contains’’ and insert- 17 ing ‘‘(ii)(I) with respect to information that is 18 not information submitted under paragraph (3) 19 of subsection (a), contains’’; 20 (B) by striking ‘‘, as applicable;’’ and in- 21 serting ‘‘, as applicable; and’’; and 22 (C) by adding at the end the following new 23 subclause: 24 VerDate Sep 11 2014 20:42 Apr 15, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2064.IH H2064 pamtmann on DSKBFK8HB2PROD with BILLS 4 •HR 2064 IH ‘‘(II) with respect to information sub- 1 mitted under paragraph (3) of subsection 2 (a), contains information that is presented 3 by the name of the applicable manufac- 4 turer, the total amount of all payments or 5 other transfers of value described in such 6 paragraph provided to covered recipients, 7 the total value of all such payments or 8 other transfers of value provided to covered 9 recipients, and the name of the covered 10 drug, device, biological, or medical supply, 11 as applicable;’’; 12 (2) in clause (viii), by striking ‘‘, and’’ at the 13 end and inserting a semicolon; 14 (3) in clause (ix), by striking the period at the 15 end and inserting ‘‘; and’’; and 16 (4) by adding at the end the following new 17 clause: 18 ‘‘(x) in the case of information sub- 19 mitted under paragraph (3) of subsection 20 (a), lists such information separately from 21 the other information submitted under 22 subsection (a) and presents such informa- 23 tion by the name of the applicable manu- 24 facturer, the total quantity of all payments 25 VerDate Sep 11 2014 20:42 Apr 15, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2064.IH H2064 pamtmann on DSKBFK8HB2PROD with BILLS 5 •HR 2064 IH or other transfers of value described in 1 such paragraph provided to covered recipi- 2 ents, the total value of all such payments 3 or other transfers of value provided to cov- 4 ered recipients, and the name of the cov- 5 ered drug, device, biological, or medical 6 supply, as applicable.’’. 7 (c) CONFORMING AMENDMENT.—Section 8 1128G(e)(10)(B)(ii) of the Social Security Act (42 U.S.C. 9 1320a–7h(e)(10)(B)(ii)) is amended by striking ‘‘Product 10 samples’’ and inserting ‘‘Except for purposes of paragraph 11 (3) of subsection (a), product samples’’. 12 Æ VerDate Sep 11 2014 20:42 Apr 15, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\H2064.IH H2064 pamtmann on DSKBFK8HB2PROD with BILLS