S. 2710: Open Payments Expansion Act

The proposed legislation, known as the Open Payments Expansion Act, aims to enhance transparency regarding financial relationships between pharmaceutical and medical device manufacturers and patient advocacy organizations. The bill seeks to amend the Social Security Act by requiring manufacturers and group purchasing organizations to publicly disclose certain payments made to these advocacy groups.

Key Provisions

• Disclosure Requirements: Starting March 31, 2027, manufacturers and purchasing organizations will need to report details about any covered payments made to patient advocacy organizations. These disclosures must be submitted annually, specifically every 90 days within the calendar year.
• Details of Payments: The required disclosures must include the name of the patient advocacy organization and the exact amount of the payment made.
• Definition of Covered Payments: The term 'covered payment' encompasses all forms of payments or transfers of value. This includes direct payments as well as indirect payments made through third parties when the manufacturer or organization plays a role in facilitating those payments to the advocacy organizations.
• Indirect Payments Explained: An indirect payment is one made via a third party where the manufacturer has control over directing how that payment is distributed to a patient advocacy organization.
• Definition of Patient Advocacy Organizations: These organizations are defined as non-profit entities that provide education, advocacy, and support to patients and their caregivers. They must be classified under section 501(c)(3) of the Internal Revenue Code, and their mission should focus on addressing medical conditions or aiding vulnerable individuals affected by such conditions.

Exclusions from Other Regulations

The bill states that certain administrative regulations, as defined in Chapter 35 of Title 44 of the United States Code, do not apply to the provisions laid out in this act or to its amendments.

Objective

The overall goal of the Open Payments Expansion Act is to improve transparency in the financial interactions between manufacturers of pharmaceuticals and medical devices and organizations that advocate for patients. By mandating these disclosures, the legislation aims to foster accountability and inform patients and the public about the financial contributions that may influence patient advocacy efforts.

Relevant Companies

• PFE (Pfizer Inc.): As a major pharmaceutical company, Pfizer could be significantly impacted by the need to disclose payments made to patient advocacy organizations.
• NVS (Novartis AG): This global healthcare company may also need to adjust its reporting and transparency policies to comply with the disclosure mandates outlined in the bill.
• MDT (Medtronic plc): As a device manufacturer, Medtronic would be subject to the same transparency requirements as pharmaceutical companies regarding payments made to advocacy organizations.