In December 2011, the Centers for Medicare and Medicaid Services (CMS) issued a notice of proposed rulemaking announcing the publication of draft regulations that would implement the “Transparency Reports and Reporting of Physician Ownership or Investment Interests” section of the Patient Protection and Affordable Care Act, commonly referred to as the Sunshine Act. Under the Sunshine Act, drug, device, biological product, and medical supply manufacturers are required to report annually certain information regarding payments and other transfers of value to physicians and teaching hospitals. An additional provision requires manufacturers and group purchasing organizations (GPOs) to report all ownership or investment interests held by physicians or members of their family. Since releasing the draft regulations, CMS has accepted comments from interested parties and has engaged stakeholders regarding the implementation of the regulations. CMS has not yet released the final regulations.
Recently, the American Medical Association (AMA) published an editorial voicing its disapproval of CMS’ intention to have the Center for Program Integrity, CMS’ anti-fraud unit, implement the Sunshine Act. According to the editorial, putting the Center for Program Integrity (CPI) in charge of the collection and distribution of public reports on physician-industry interactions “creates the impression that any physician who appears on the list, no matter how limited financially or legitimate the nature of the interaction, is somehow engaged in behavior that could be seen as ethically or legally suspect.” As a result, CPI’s implementation of the Sunshine Act “could have a chilling effect on beneficial interactions between doctors and researchers that help advance medicine.” The AMA proposes that CMS leave “data collection, reporting and appeals to another part of the agency and reserve CPI only for matters involving compliance with the law.”
The AMA previously voiced its objection to CPI’s implementation of the Sunshine Act in an October 2012 letter to CMS. In this letter, AMA’s Executive Vice President and CEO, James L. Madara, MD, noted that the purpose of the Sunshine Act “is not to supplant the role of the profession in regulating ethical conduct or to create new fraud and abuse laws.” Dr. Madara further noted that having CPI implement the Sunshine Act “could lead to a public perception that most, if not all, transparency reports are prima facie evidence of unethical or illegal behavior.” In sum, Dr. Madara urged CMS to “reconsider tasking [CPI] with implementation of the final Sunshine Act regulation because it will cause significant confusion about the purpose of the transparency reports and create a strong perception that anything contained in a transparency report presumptively raises ethical, fraud, abuse, and program integrity concerns.”