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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 5510 Introduced in Senate (IS)]

<DOC>

118th CONGRESS
  2d Session
                                S. 5510

To amend title XI of the Social Security Act to require pharmaceutical 
and device manufacturers to publicly disclose covered payments made to 
                    patient advocacy organizations.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                           December 12, 2024

  Mr. Grassley (for himself and Ms. Hassan) 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 require pharmaceutical 
and device manufacturers to publicly disclose covered payments made to 
                    patient advocacy organizations.

    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 ``Open Payments Expansion Act''.

SEC. 2. DISCLOSURE OF PHARMACEUTICAL AND DEVICE MANUFACTURER COVERED 
              PAYMENTS TO PATIENT ADVOCACY ORGANIZATIONS.

    (a) In General.--Section 1128G of the Social Security Act (42 
U.S.C.1320a-7h) is amended--
            (1) in subsection (a), by adding at the end the following 
        new paragraph:
            ``(3) Donations to patient advocacy organizations.--
                    ``(A) In general.--In addition to the requirements 
                under paragraphs (1) and (2), on March 31, 2026, 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
            (2) in subsection (c)(1)(C)(ix), by striking ``or covered 
        recipient'' each place it appears and inserting ``covered 
        recipient, or patient advocacy organization''.
    (b) Administration.--Chapter 35 of title 44, United States Code, 
shall not apply to this section or the amendments made by this section.
                                 <all>
```