II 115th CONGRESS 2d Session S. 3565 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.

1. Short title This Act may be cited as the Opioid Advocacy Transparency Act of 2018 . 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.