Title: 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.
Policy area: Health

Summary:
This bill requires drug manufacturers to provide the Department of Health and Human Services with aggregate data related to product samples of drugs, devices, biologic products, and medical supplies given to hospitals, physicians, or other medical professionals during the previous calendar year, beginning in 2023.

[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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