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-
tives of the United States of America in Congress assembled, 
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SECTION 1. REQUIREMENT FOR MANUFACTURERS OF CER-
TAIN DRUGS, DEVICES, BIOLOGICALS, AND 
MEDICAL SUPPLIES TO REPORT ON PROD-
UCT 
SAMPLES 
PROVIDED 
TO 
CERTAIN 
HEALTH CARE PROVIDERS. 
(a) IN GENERAL.—Section 1128G(a) of the Social 
Security Act (42 U.S.C. 1320a–7h(a)) is amended by add-
ing at the end the following new paragraph: 
‘‘(3) CERTAIN PRODUCT SAMPLES.— 
‘‘(A) IN GENERAL.—In addition to the re-
quirements under paragraphs (1)(A) and (2), 
on the 90th day of each calendar year (begin-
ning with 2023), any applicable manufacturer 
that provides a payment or other transfer of 
value that is a product sample described in sub-
paragraph (B) to any covered recipient (or to 
an entity or individual at the request of, or des-
ignated on behalf of, such a covered recipient) 
shall submit to the Secretary, in such electronic 
form as the Secretary shall require, the fol-
lowing information with respect to the pre-
ceding calendar year: 
‘‘(i) The total quantity of all such 
payments or other transfers of value pro-
vided to covered recipients. 
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‘‘(ii) The total value of all such pay-
ments or other transfers of value provided 
to covered recipients. 
‘‘(iii) If applicable, information de-
scribed in clauses (vii) and (viii) of para-
graph (1)(A) with respect to such a pay-
ment or other transfer of value. 
‘‘(B) PRODUCT SAMPLE DESCRIBED.—For 
purposes of subparagraph (A), a product sam-
ple described in this subparagraph is a product 
sample that is not intended to be sold and is in-
tended for patient use.’’. 
(b) PUBLIC AVAILABILITY OF INFORMATION.—Sec-
tion 1128G(c)(1)(C) of the Social Security Act (42 U.S.C. 
1320a–7h(c)(1)(C)) is amended— 
(1) in clause (ii)— 
(A) by striking ‘‘(ii) contains’’ and insert-
ing ‘‘(ii)(I) with respect to information that is 
not information submitted under paragraph (3) 
of subsection (a), contains’’; 
(B) by striking ‘‘, as applicable;’’ and in-
serting ‘‘, as applicable; and’’; and 
(C) by adding at the end the following new 
subclause: 
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‘‘(II) with respect to information sub-
mitted under paragraph (3) of subsection 
(a), contains information that is presented 
by the name of the applicable manufac-
turer, the total amount of all payments or 
other transfers of value described in such 
paragraph provided to covered recipients, 
the total value of all such payments or 
other transfers of value provided to covered 
recipients, and the name of the covered 
drug, device, biological, or medical supply, 
as applicable;’’; 
(2) in clause (viii), by striking ‘‘, and’’ at the 
end and inserting a semicolon; 
(3) in clause (ix), by striking the period at the 
end and inserting ‘‘; and’’; and 
(4) by adding at the end the following new 
clause: 
‘‘(x) in the case of information sub-
mitted under paragraph (3) of subsection 
(a), lists such information separately from 
the other information submitted under 
subsection (a) and presents such informa-
tion by the name of the applicable manu-
facturer, the total quantity of all payments 
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