S2710-119

1. Short title This Act may be cited as the Open Payments Expansion Act.

2. Disclosure of pharmaceutical and device manufacturer covered payments to patient advocacy organizations Section 1128G of the Social Security Act (42 U.S.C. 1320a–7h) is amended— in subsection (a), by adding at the end the following new paragraph: In addition to the requirements under paragraphs (1) and (2), on March 31, 2027, and on the 90th day of each calendar year beginning thereafter, any applicable manufacturer or applicable group purchasing organization shall submit to the Secretary, in such electronic form as the Secretary shall require, details regarding any covered payment made by such manufacturer or organization to any patient advocacy organization, including— the name of the patient advocacy organization; and the amount of the covered payment. In this paragraph: The term covered payment means any— payment or other transfer of value; or indirect payment or other transfer of value. The term indirect payment or other transfer of value means a payment or other transfer of value made by an applicable manufacturer or applicable group purchasing organization to a patient advocacy organization through a third party, where the applicable manufacturer or applicable group purchasing organization requires, instructs, directs, or otherwise causes the third party to provide the payment or transfer of value, in whole or in part, to a patient advocacy organization. The term patient advocacy organization means an organization described in section 501(c)(3) of the Internal Revenue Code of 1986 that is exempt from taxation under section 501(a) of such Code that— provides education, advocacy, and support services oriented towards patients and caregivers; is concerned with a medical condition diagnosed by a licensed medical practitioner who is in good standing with a State licensing body; or has a mission that seeks to help vulnerable individuals affected by medical conditions or to help the families of such vulnerable individuals and takes actions consistent with such mission. in subsection (c)(1)(C)(ix), by striking or covered recipient each place it appears and inserting covered recipient, or patient advocacy organization. Chapter 35 of title 44, United States Code, shall not apply to this section or the amendments made by this section. (3) Donations to patient advocacy organizations (A) In general In addition to the requirements under paragraphs (1) and (2), on March 31, 2027, and on the 90th day of each calendar year beginning thereafter, any applicable manufacturer or applicable group purchasing organization shall submit to the Secretary, in such electronic form as the Secretary shall require, details regarding any covered payment made by such manufacturer or organization to any patient advocacy organization, including— (i) the name of the patient advocacy organization; and (ii) the amount of the covered payment. (B) Definitions In this paragraph: (i) Covered payment The term covered payment means any— (I) payment or other transfer of value; or (II) indirect payment or other transfer of value. (ii) Indirect payment or other transfer of value The term indirect payment or other transfer of value means a payment or other transfer of value made by an applicable manufacturer or applicable group purchasing organization to a patient advocacy organization through a third party, where the applicable manufacturer or applicable group purchasing organization requires, instructs, directs, or otherwise causes the third party to provide the payment or transfer of value, in whole or in part, to a patient advocacy organization. (iii) Patient advocacy organization The term patient advocacy organization means an organization described in section 501(c)(3) of the Internal Revenue Code of 1986 that is exempt from taxation under section 501(a) of such Code that— (I) provides education, advocacy, and support services oriented towards patients and caregivers; (II) is concerned with a medical condition diagnosed by a licensed medical practitioner who is in good standing with a State licensing body; or (III) has a mission that seeks to help vulnerable individuals affected by medical conditions or to help the families of such vulnerable individuals and takes actions consistent with such mission. ; and