Daniel Garen senior vice president and chief compliance office Wright Medical Technology Inc

Daniel Garen, senior vice president and chief compliance office, Wright Medical Technology, Inc.

Pharma Planners and the Sunshine Act: Be Prepared to Back Up Your Numbers

The Sunshine Act allows docs to dispute what’s reported about them—and you’ll have only 15 days to prove otherwise.

While medical meeting professionals have been preparing for the Sunshine Act [4] for years, there is one provision that took some by surprise when it was brought up by keynote speaker Daniel Garen, senior vice president and chief compliance officer at Wright Medical Technology, Arlington, Tenn., at the 9th Annual Pharma Forum [5] March 20—dispute resolution.

Dispute resolution is a process outlined within the Physician Payment Sunshine Act that allows physicians to challenge the expenditures that pharmaceutical companies and device manufacturers have attributed to them.

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.

Get Your System In Place

"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 have only 15 calendar days to find evidence to support your data if it's challenged.

What that means is that companies will need a systematic way to store tracking documentation so they can be readyto present the evidence, explained Garen. “Let me tell you, you will need a really great filing system for the receipts, sign-in sheets, and lists,” he said to the audience of more than 600 at the Marriott Orlando World Center. “This cannot be in the ‘Raiders of the Lost Ark’ warehouse—you’re going to need to get your hands on this quickly. This dispute-resolution process will be huge. You’re going to have to have communications people who are dealing with these issues.”

Dispute-Related Planner Challenges

For meeting professionals, this raises a lot of concerns. Who will store the data—the compliance department? Finance? Meetings? What if the company uses a third-party meeting planning company? Will the third party have to collect the data on site, store it, and produce the documentation if audited? With such a short timeframe to produce the documentation, will companies have enough time to follow the proper paper trail, and will third parties and corporations need to hire more people to produce the evidence? What if a receipt or some form of documentation is missing?

In a session for third-party meeting planning companies, participants discussed the additional resources required to do this work. “This is another thing we’re going to have to think about,” said one of the audience members. It’s going to require more time, resources, and investment not only to collect and archive the data, but also to retrieve it and resolve any discrepancies in short order.

This also was a hot topic in the senior-level think tank. Some corporations believe companies cannot outsource “compliance” to a third-party company, meaning that all data collection and entering into an internal system needs to be done by in-house personnel. That puts additional burden on the in-house meetings team, and, in fact, some corporate planners recommend charging internally for additional hours.

Those life sciences companies that do outsource meeting management and leave data entry up to them can expect to be handed some additional billings.

In the third-party session, some suggested charging by the hour. Most agreed such on-site collection of data and data entry would be above and beyond the usual scope of duties and should require additional fees. According to Garen, the ultimate responsibility for the data, at least from the government’s perspective, is the manufacturer.

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.

In the closing session of the conference, panelist Angie Duncan, an independent meeting consultant based in Indianapolis, said it’s hard to know how time- and resource-intensive the dispute-resolution process will be without knowing how many physicians will want to dispute the charges. “We don’t know the cost of preparing for that,” she said. But when it does happen, it’s going to be labor-intensive.