As a follow-up to Senator Claire McCaskill’s long running opioid investigation and report titled: Fueling an Epidemic: Exposing the Financial Ties Between Opioid Manufacturers and Third Party Advocacy Groups, the senator released the Patient Advocacy Transparency Act of 2018. The proposed legislation, if adopted, would expand Open Payment reporting to include television programs, websites, and payments to patient advocacy organizations, professional societies, clinical trial organizations, and Continuing Medica Education (CME) providers.
This legislation amends the Physician Payment Sunshine Act to:
- Broaden the reporting definition of “grants” to include various types of educational grants and “capacity building grants”;
- Also expands reporting for:
- fundraising event sponsorship;
- meeting or conference expenses not currently covered in Open Payments;
- funding of marketing and public relations activities; and
- placement on television programs or internet websites, or social media support.
The bill also amends the definition of “covered recipient” to include:
- Professional societies of health care providers or pharmacists;
- Patient advocacy organizations, consumer advocacy organizations, voluntary health agencies, or a coalition of such organizations, including disease-specific advocacy organizations;
- Patient education organizations;
- Providers of continuing education, including medical education or communications companies;
- Clinical trial organizations;
- Education accreditation organizations;
- Co-pay assistance organizations or other organizations providing financial assistance to patients; and
- Foundations established by an entity described in any of clauses (iii) 20 through (ix)
As currently drafted, the amendments would go into effect in 2023. Tracking payments to those entities by manufacturers would begin on January 1, 2022, and the first reports would be due to Centers for Medicare and Medicaid Services (CMS) by March 31, 2023.
Analysis
This bill targets almost every type of organization that may receive funding from industry even for attendance at their fundraising events. Interesting enough, the bill gives a free pass to Missouri based PBM’s (pharmacy benefit managers) who receive large rebates from manufacturers with no current disclosure requirements.
The proposed bill may have trade secret and privacy constitutional implications as most of the additional covered recipients listed in the proposed legislation do not receive reimbursement for patient care and do not receive direct funding from Medicare or Medicaid. The US Supreme Court has been clear on not requiring reporting nonprofit revenue. For instance, forcing the disclosure of nonprofit supporters was ruled unconstitutional by the Supreme Court in its 1958 Alabama v. NAACP decision.