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.
Know What Transactions Are Reportable
Companies have to integrate their vendors' data, and identify multiple sources of HCP spend, he said. These include all direct or indirect transfers of value, from cash and marketing materials to non-patient educational materials, in addition to gifts, honoraria, and food and travel expenses.
And the details to be tracked are many, including HCP name/address/specialty, payment dates, the drug or device that the payment or transfer of value (POTV) relates to, and the form of payment rendered. One issue that will be thorny is vendor data integration, especially the form of what physician identification you use to track each healthcare provider. Most, but not all, HCPs have a national provider identification, or NPI, number. The government says you have to make a “good faith effort” to find that number, which means you “have to go through all the John Smiths to make sure you’re reporting for the right person—and by the way, he doesn’t have an NPI.” While he didn’t have a solution for this issue, he did warn that planners should know that it’s in play.
Addressing a persistent rumor that companies are going to start holding their HCP meetings in Canada to get around Sunshine requirements, Garen said it would do no good “because it doesn’t matter where the meeting is held—it’s where [the HCPs] are licensed.”