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), available here. 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).
To aid the review and understanding of the final regulations, Morgan Lewis has updated its U.S. Sunshine chart to capture the statute, the proposed rule, and the final rule with appropriate citations to the statute, Code of Federal Regulations, and relevant Federal Register preamble. View the chart here.