On November 10, 2016, the U.S. Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) issued its 2017 Work Plan. The OIG’s annual Work Plan outlines the agency’s priority areas for review associated with its oversight of the Centers for Medicare & Medicaid Services (CMS) and other HHS agencies. As OIG has broad investigative authority over allegations of fraud, waste, and abuse related to government healthcare spending — and the power to seek substantial penalties — companies are well-served to look to OIG’s Work Plan as a guide to their own risk management process, and in the development of compliance priorities for the year.
For life sciences companies, one of the most noteworthy Work Plan items in 2017 will be OIG’s stated intention to focus on the federal Open Payments program. Implemented as part of the Affordable Care Act, Open Payments (also known as the Sunshine Act) requires pharmaceutical and medical device manufacturers to collect and report to the government most transfers of value made to physicians and teaching hospitals. Since August 1, 2013, manufacturers have been responsible for capturing detailed spend information at the recipient level and submitting annual reports to CMS. These payments are posted in a publicly accessible database where users may search by the name of the doctor or teaching hospital receiving payments, or by the company making payments. Currently, CMS’s Open Payments website contains more than 28 million records that total almost $17 billion in transactions.