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.
The Costs of Errors
The ostensible goal of Sunshine, he said, is to enable patients to see their healthcare providers’ financial relationships with industry. “But we’re not there yet,” he said. The government, however, is finding ways to use the data that’s already out there. The feds are mining it to find outliers, such as disproportionate payments, to back up qui tam (whistleblower) lawsuits, and to uncover potential kickbacks and inducements to prescribers. One of the biggest miners of available data? The Internal Revenue Service.
The Sunshine Act also is intended to make the idea of receiving something of value on the physician side, or providing something of value on the manufacturer side, less attractive. “Both physicians and manufacturers are now thinking twice” about their financial relationships, Garen said, though the ultimate responsibility—and penalties—belong to the manufacturers.
If found out of compliance, medical device, biotech, and pharma manufacturers, along with group purchasing organizations, will have to pay $10,000 for each mistake they make in their data reporting, with a cap of $150,000. “If you knowingly make a mistake, it’ll cost up to $100,000 for each incident, with a cap of $1 million. The higher fines only come into play if the error is intentional.
“Manufacturers are ultimately responsible for the accuracy of the data,” Garen said. “We get information from a number of sources, but manufacturers are the ones on the hook. We are the ones who need to make sure we have the right procedures, policies, training, and education for physicians, and our executives have to certify that the information is accurate.”
All this is costly to implement, monitor, and comply with, and it requires a number of departments to work together. And, while it may all start with compliance, implementation is really a financial and IT issue, he added.