What is in this article?:
The Sunshine Act provisions of the Affordable Care Act are here to stay. A compliance expert opened the 2013 Pharma Forum in Orlando with a detailed look at what meeting professionals at pharmaceutical and other life sciences and medical device manufacturers need to know to keep their programs complaint.
Daniel Garen, senior vice president and chief compliance office, Wright Medical Technology, Inc.
Determine How Information Will Flow
The Centers for Medicare and Medicaid require companies to report data for August 1, 2013, through December 2013 by March 31, 2014. The data goes public by September 30, 2014. CMS will give HCPs 45 days to review their data, and dispute any discrepancies. “If you find a mistake, report it right away,” said Garen. “If you make a mistake, it’s $10,000. If you don’t report it [and it’s discovered], it’s $100,000.”
"Everyone needs to have someone who's responsible for the aggregate spend data," he said. And you need to be able to get your hands on the evidence that proves your data's validity quickly as well, since you'll only have 15 calendar days to find evidence to support your data if it's challenged. This means having a systematic way to store receipts, sign-in sheets, lists, and other tracking documentation.
It's vital to understand your company's or your clients’ policies, said Garen, and to have communication channels set up to let everyone involved know when those policies change. Companies will be monitoring to ensure policies are being adhered to, and management will review the aggregate spend reports to certify that everything is correct.