In June 2018, Senator Claire McCaskill (D-Mo.) introduced the Patient Advocacy Transparency Act of 2018 (the “Act”), which, if adopted, would amend the Physician Payment Sunshine Act (the “Sunshine Law”). The Sunshine Law requires reporting to the government about certain transfers of value from manufacturers of drugs and medical devices to physicians and teaching hospitals. The Centers for Medicare & Medicaid Services (CMS), makes this information public in a database called Open Payments ( https://www.cms.gov/openpayments/).
If it becomes law, the Act would expand the reporting requirements under the Sunshine Law, including the types of payments that are required to be reported and the types of recipients to which payments or transfers are required to be reported. The following is a summary of the changes that would result if the Act is adopted:
- Payments or transfers of value to the following recipients would be required to be reported: professional societies of health care providers or pharmacists; patient advocacy organizations, consumer advocacy organizations, voluntary health agencies, or a coalition of such organizations, including a disease-specific advocacy organization; patient education organizations; providers of continuing education, including a medical education or communications company; a clinical trial organization; an education accreditation or organization; a co-pay assistance organization or other organization providing financial assistance to patients; and a foundation established by one of the foregoing entities. This is a much more expansive list than is currently in the Sunshine Law; under the Sunshine Law as it currently stands, only payments or transfers of value to physicians or teaching hospitals must be reported.
- The Act would expand the payments required to be reported to include: fundraising event sponsorships; meeting or conference expenses that are not otherwise already required to be reported; and funding of marketing, public relations activities, placement on television programs or internet websites, or social medical support.
- The Act would expand the definitions of grants required to be reported to include education grants and capacity building grants.
If the Act becomes law, the changes would go into effect in 2023.