Drug and Device companies that constitute “applicable manufacturers” under the Sunshine Act and its enabling regulations will need to submit detailed information on “payments” to physicians or teaching hospitals on March 31, 2014 to the federal Center for Medicare and Medicaid Services (“CMS”). As of August 1, 2013, firms were required to track payments – and other ways in which value is conferred on physicians and teaching hospitals – in order to include them in the filings due with CMS on March 31, 2014.
The Sunshine Act’s regulations, issued in February 2013, are complex and, in some cases, not clear. We discussed key general aspects of the rule in our Client Alert of February 25, 2013 (click here) and followed that with a more in-depth discussion of research-related payments in a second Client Alert on March 6, 2013 (click here).
Because many questions remained after CMS promulgated its final regulations last February, the agency has published a number of follow-up “Questions & Answers” on its website dedicated to the Sunshine Act, which CMS dubs “Open Payments.” While these Q&A’s clarify many issues regarding the Sunshine Act, now is the time to resolve any remaining concerns that drug and device firms may have about the law’s applicability to their operations.