On September 4, 2025, US Senators Charles Grassley and Maggie Hassan, members of the Senate Finance Committee, reintroduced the Open Payments Expansion Act in a continued effort to require pharmaceutical and medical device manufacturers to publicly report their financial relationships with tax-exempt patient advocacy organizations.
The bipartisan bill would expand the existing Physician Payments Sunshine Act (also known as the Sunshine Act) by adding “patient advocacy organizations” to the list of entities that manufacturers are required to include in their “open payments” reporting. The bill would also require disclosure of indirect payments or other transfers of value to patient advocacy organizations made by manufacturers through third parties.
This expansion targets the advocacy ecosystem, requiring companies to evaluate a new category of relationships and potentially redesign compliance infrastructure to capture non-traditional payment flows
Unlike traditional Sunshine Act reporting focused on healthcare providers, this expansion targets the advocacy ecosystem, requiring companies to evaluate a new category of relationships and potentially redesign compliance infrastructure to capture non-traditional payment flows.
Senator Grassley has long led efforts for increased disclosures of financial data and relationships between manufacturers and third parties. Senator Grassley (along with Senator Herb Kohl) introduced the original, independent legislation in 2007, but it was not enacted until 2010, when it was included in the Patient Protection and Affordable Care Act. In 2015, Senator Grassley led the legislative effort to expand the Sunshine Act disclosure requirements to include an array of healthcare professionals, and in 2020 he issued an investigative report (along with Senator Ron Wyden) examining the relationship between pharmaceutical manufacturers and certain tax-exempt patient advocacy organizations. Senators Grassley and Hassan first introduced the Open Payments Expansion Act (using identical bill text) in December 2024, but it was not passed during that legislative session.
The bill would require “applicable manufacturers” and “applicable group purchasing organizations” that make payments or transfers of value to patient advocacy organizations to annually disclose the name of the patient advocacy organization and the amount of any “covered payment” (defined to include direct and indirect payments or transfers of value made via third parties) in accordance with existing Sunshine Act requirements.
“Patient advocacy organizations” are defined as tax-exempt 501(c)(3) organizations that: (1) provide education, advocacy, and support services for patients and caregivers; (2) focus on a medical condition diagnosed by a licensed practitioner in good standing with a state licensing body; or (3) have a mission that seeks to help vulnerable individuals and families affected by medical conditions and act consistently with this mission.
Manufacturers often collaborate with patient advocacy organizations and may provide financial support for educational programs and research initiatives, lobbying efforts and public awareness campaigns, patient support programs, and other cooperative endeavors. The Senators indicated through press releases that the impetus for the reintroduced bill is concern that manufacturers’ payments to patient advocacy organizations may influence the advocacy groups’ actions and marketing.
The expanded disclosure requirements could cast aspersions on relationships between manufacturers and patient advocacy organizations without additional context or understanding. As an example, the impact of manufacturer payments on patient advocacy groups submitting comment letters to prescription drug affordability boards (PDABs) is already a topic of media attention and industry debate.
Manufacturers should be aware of the potential changes to their disclosure requirements. If passed, the bill’s reporting requirement would take effect on March 31, 2027.