The Centers for Medicare and Medicaid Services (CMS) issued the final regulations on the U.S. Sunshine Act on February 8, 2013. Transparency Reports and Reporting of Physician Ownership or Investment Interests, 78 Fed. Reg. 9458 (Feb 8, 2013) (to be codified at 42 C.F.R. pts. 402, 403). While there remain implementation questions and challenges, CMS has addressed and clarified many difficult and impractical aspects of the transparency statute. Although the final rule is not long, the public comments and agency responses are lengthy and helpful in understanding some provisions. Notably, CMS appears to have committed to a frequently asked questions (FAQ) process.

Applicable manufacturers and applicable group purchasing organizations (GPOs) must begin to collect the required data on August 1, 2013, and report the data to CMS by March 31, 2014. Failure to timely, accurately, or completely report may result in significant monetary penalties (up to $10,000 per violation or $100,000 for knowing violations).