The Physician Payments Sunshine Act (“Sunshine Act”) is a U.S. federal law enacted as part of the Affordable Care Act (“ACA”), for the purpose of creating transparency regarding relationships between physicians and teaching hospitals and the manufacturers of drugs, medical devices and biologicals. The Sunshine Act, since its implementation in 2010, requires annual reporting to the Centers for Medicare and Medicaid Services (“CMS”) by certain manufacturers of covered drugs, medical supplies, biologicals and devices, of certain payments or other transfers of value made to physicians and teaching hospitals. The annual release is known as the CMS “Open Payments” program and publicizes information pertaining to doctors’ financial interactions with industry including consulting fees for providing expertise in clinical research studies or evaluating treatments, honoraria sourced compensation for speaking engagements at various academic or professional meetings and other compensation or items of value. Although Sunshine Act reporting is the legal obligation of drug and device manufacturers, physicians are notified of potential reporting and have 45 days to review their Open Payments data and dispute errors before public release. Once the information is released, it is publicly available on CMS’ Open Payments website. (openpaymentsdata.cms.gov)
In addition to industry’s obligations to report information pursuant to the Sunshine Act, almost all hospitals, academic medical centers, and health system require physicians – both those with employment relationships and those with voluntary hospital medical staff privileges – to regularly report their financial relationships with these same manufacturers. Health systems do so to ensure that decision-making regarding their research, product development, and purchasing is performed with the full knowledge of its physicians’ relationships with industry to avoid potential conflicts of interest that may arise in the decision-making process. A physician’s failure to properly disclose relationships may lead to consequences with respect to their relationships with these facilities.
Of course, a physician’s engagement with industry does not in and of itself create a conflict of interest. There are a host of legitimate reasons for physicians to be listed in the Open Payments report due to their relationships with industry. Monetary support for clinical trials, research and development of new interventions and technologies that improve patient care, and industry-funded medical educations, are all crucial components to the advancement of medicine and do not necessarily equate to conflicts of interest that impede on a physician’s ability to remain impartial and not be inappropriately influenced in ways that affect their decisions and recommendations as providers. However, there is an increasing emphasis on ensuring that these relationships are fully disclosed.
We recommend that physicians (1) actively review planned disclosures of financial interest under the Open Payments program to confirm their accuracy; (2) make sure that they are accurately making self-disclosures regarding relationships with industry when requested, knowing that this self-reported information is often being compared to public Open Payments information.
Frier Levitt has extensive experience guiding physicians through their relationships with both industry and with large hospitals and health systems. This knowledge enables us to assist providers in ensuring that any industry financial interests are protected and reported appropriately. Please feel free to contact us if you have any questions regarding these issues.
