Posted on January 28, 2015
Source: Annals of Internal Medicine
The Physician Payment Sunshine Act (PPSA) intends to bring greater transparency to physician–industry relationships. A reference to Justice Brandeis' observation that “sunlight is said to be the best of disinfectants,” the PPSA aims to shed light on financial relationships that may compromise patient care and research integrity.
Public reporting of financial relationships is already required in 4 states plus the District of Columbia, and at least 13 pharmaceutical companies now disclose information through quasi-voluntary agreements reached through settlements with the U.S. Department of Justice (1). Nevertheless, the PPSA dramatically expanded transparency, extending the scope of disclosure and the degree of public accessibility. Under the new program, now known as “Open Payments,” manufacturers of drugs, devices, biologics, and medical supplies must report nearly all transfers of value made to physicians or teaching hospitals (2). This information will be posted to a public Web site, scheduled to launch 30 September 2014 (3).
Among the PPSA's most notable disclosure expansions are for payments for research, including clinical trials (4). Unlike earlier disclosure requirements, which generally focused on marketing, speakers' fees, and gifts, the PPSA creates a separate disclosure stream for research. These payments will be distinguished from “general payments,” including speaking or consulting fees, gifts, royalties, and investment interests.
Establishing 2 tracks to differentiate research payments from other activities reflects recognition of the “special status” of research, including its social value in advancing health. Nevertheless, 1 part of the PPSA's requirements for disclosing research payments risks conveying a distorted image of certain physician–industry relationships. Specifically, the Centers for Medicare & Medicaid Services (CMS), which issued the final regulations for the PPSA's implementation, requires not only that investigators report industry funding of research projects but also, importantly, that manufacturers report the value of pharmaceuticals provided for research, including those donated for federally funded clinical trials. Consequently, for physicians doing research involving donated drugs—a common practice in large networks funded by the National Institutes of Health (NIH), such as the cooperative oncology groups and the AIDS Clinical Trials Group—the monetary value of those drugs will be listed as “research payments” in public databases. Reports will include the recipient physician's name, total payment amount, study name, and study drug (5). For research involving multiple investigators, the donation will be reported as a payment to the principal investigator or, for multicenter trials, to each site's investigator of record.