Title: Opioid Advocacy Transparency Act of 2018
Policy area: Health

Summary:
Opioid Advocacy Transparency Act of 2018
This bill expands reporting requirements related to the ownership and investment interests of certain patient-advocacy organizations.
Under current law, a manufacturer of drugs, devices, or medical supplies that are covered under Medicaid or Medicare must regularly report on any payment or transfer of value by the manufacturer to a "covered recipient," defined as either a physician who is not an employee of the manufacturer or a teaching hospital. The bill expands the definition of "covered recipient," for purposes of this requirement, to also include patient-advocacy organizations that advocate on issues related to opioids. Furthermore, with respect to transfers of value to such organizations, the bill subjects not only manufacturers but also pharmaceutical trade associations to the reporting requirement.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 3565 Introduced in Senate (IS)]

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115th CONGRESS
  2d Session
                                S. 3565

  To amend title XI of the Social Security Act to include additional 
 covered recipients for transparency reports required of manufacturers 
                              of opioids.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            October 10, 2018

 Mrs. McCaskill (for herself and Mr. Cassidy) introduced the following 
  bill; which was read twice and referred to the Committee on Finance

_______________________________________________________________________

                                 A BILL


 
  To amend title XI of the Social Security Act to include additional 
 covered recipients for transparency reports required of manufacturers 
                              of opioids.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Opioid Advocacy Transparency Act of 
2018''.

SEC. 2. ADDITIONAL COVERED RECIPIENTS FOR TRANSPARENCY REPORTS REQUIRED 
              OF MANUFACTURERS OF OPIOIDS.

    (a) In General.--Section 1128G(e) of the Social Security Act (42 
U.S.C. 1320a-7h(e)) is amended--
            (1) in paragraph (6)--
                    (A) in subparagraph (A)--
                            (i) in the matter preceding clause (i), by 
                        inserting ``and subject to subparagraph (C)'' 
                        after ``subparagraph (B)''; and
                            (ii) by adding at the end the following new 
                        clause:
                            ``(vi) A relevant patient advocacy 
                        organization (as defined in subparagraph (D)) 
                        or a foundation established by such an 
                        organization.''; and
                    (B) by adding at the end the following new 
                subparagraphs:
                    ``(C) Limitation.--Clause (vi) of subparagraph (A) 
                shall only apply with respect to information required 
                to be submitted under this section by an applicable 
                manufacturer that is the manufacturer of a covered 
                drug, device, biological, or medical supply that is an 
                opioid (as defined in section 102 of the Controlled 
                Substances Act (21 U.S.C. 802)).
                    ``(D) Relevant patient advocacy organization.--For 
                purposes of subparagraph (A)(vi), the term `relevant 
                patient advocacy organization' means an organization 
                engaged in advocacy on issues related to opioids (as so 
                defined), including patient use of and access to 
                opioids, the use of opioids for the treatment of pain, 
                and opioid addiction treatment.''; and
            (2) in paragraph (10)(B)--
                    (A) in clause (i), by striking ``A transfer'' and 
                inserting ``Subject to clause (xiii), a transfer''; and
                    (B) by adding at the end the following new clause:
                            ``(xiii) In the case of a covered recipient 
                        described in paragraph (6)(A)(vi), a transfer 
                        of anything of value to the covered recipient 
                        by an applicable manufacturer described in 
                        paragraph (6)(C), unless the aggregate amount 
                        transferred to, requested by, or designated on 
                        behalf of the covered recipient by the 
                        applicable manufacturer during the calendar 
                        year exceeds $4,000. For calendar years after 
                        2024, the dollar amount specified in the 
                        preceding sentence shall be increased by the 
                        same percentage as the percentage increase in 
                        the consumer price index for all urban 
                        consumers (all items; U.S. city average) for 
                        the 12-month period ending with June of the 
                        previous year.''.
    (b) Treatment of Certain Payments or Other Transfers of Value Made 
by Pharmaceutical Trade Associations.--Section 1128G(a)(1) of the 
Social Security Act (42 U.S.C. 1320a-7h(a)(1)) is amended by adding at 
the end the following new subparagraph:
                    ``(C) Treatment of certain payments or other 
                transfers of value by pharmaceutical trade 
                associations.--For purposes of this section, the 
                provisions that apply to an applicable manufacturer 
                with respect to a payment or other transfer of value 
                described in subparagraph (A) shall also apply to a 
                pharmaceutical trade organization (as defined by the 
                Secretary) but only with respect to a payment or other 
                transfer of value described in such subparagraph 
                provided to a covered recipient described in subsection 
                (e)(6)(A)(vi) (or to an entity or individual at the 
                request of or designated on behalf of a covered 
                recipient described in such subsection).''.
    (c) Effective Date.--The amendments made by this section shall 
apply with respect to information required to be submitted under 
section 1128G of the Social Security Act (42 U.S.C. 1320a-7h) on or 
after January 1, 2024.
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