[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2064 Introduced in House (IH)]
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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.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. REQUIREMENT FOR MANUFACTURERS OF CERTAIN DRUGS, DEVICES,
BIOLOGICALS, AND MEDICAL SUPPLIES TO REPORT ON PRODUCT
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 adding at the end the following new
paragraph:
``(3) Certain product samples.--
``(A) In general.--In addition to the requirements
under paragraphs (1)(A) and (2), on the 90th day of
each calendar year (beginning with 2023), any
applicable manufacturer that provides a payment or
other transfer of value that is a product sample
described in subparagraph (B) to any covered recipient
(or to an entity or individual at the request of, or
designated on behalf of, such a covered recipient)
shall submit to the Secretary, in such electronic form
as the Secretary shall require, the following
information with respect to the preceding calendar
year:
``(i) The total quantity of all such
payments or other transfers of value provided
to covered recipients.
``(ii) The total value of all such payments
or other transfers of value provided to covered
recipients.
``(iii) If applicable, information
described in clauses (vii) and (viii) of
paragraph (1)(A) with respect to such a payment
or other transfer of value.
``(B) Product sample described.--For purposes of
subparagraph (A), a product sample described in this
subparagraph is a product sample that is not intended
to be sold and is intended for patient use.''.
(b) Public Availability of Information.--Section 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 inserting
``(ii)(I) with respect to information that is not
information submitted under paragraph (3) of subsection
(a), contains'';
(B) by striking ``, as applicable;'' and inserting
``, as applicable; and''; and
(C) by adding at the end the following new
subclause:
``(II) with respect to information
submitted under paragraph (3) of subsection
(a), contains information that is presented by
the name of the applicable manufacturer, 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 submitted
under paragraph (3) of subsection (a), lists
such information separately from the other
information submitted under subsection (a) and
presents such information by the name of the
applicable manufacturer, the total quantity 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.''.
(c) Conforming Amendment.--Section 1128G(e)(10)(B)(ii) of the
Social Security Act (42 U.S.C. 1320a-7h(e)(10)(B)(ii)) is amended by
striking ``Product samples'' and inserting ``Except for purposes of
paragraph (3) of subsection (a), product samples''.
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