CMS Delays Data Collection by Manufacturers under the Physician Payments Sunshine Act Until January 1, 2013

May 16, 2012   

On May 3, 2012, Marilyn Travenner, Acting Administrator of the Centers for Medicare and Medicaid Services (“CMS”), sent a letter to Senator Charles Grassley (R-IA) formally responding to a letter sent to her on April 4, 2012 by Senator Grassley and Senator Herb Kohl (D-WI) urging CMS to issue its final rule implementing the Physician Payments Sunshine Act (“the Sunshine Act”) (see our previous post here). The CMS letter states, among other things, that drug and medical device manufacturers do not need to begin collecting data required under the Sunshine Act before January 1, 2013.

As we previously reported, the Sunshine Act, section 6002 of the Patient Protection and Affordable Care Act (“PPACA”), requires drug and medical device manufacturers to annually report to CMS payments made to physicians, and also requires that CMS, in turn, provide these required payment disclosure reports to the public through a searchable website. CMS published a proposed rule on December 19, 2011 with a 60-day comment period. As of the close of the comment period on February 17, 2012, CMS had received over 300 comments from a variety of stakeholders.

In their April 4 letter, Senators Grassley and Kohl urged CMS to release a final rule implementing the Sunshine Act by June of 2012 so that drug and device manufacturers could do a partial reporting to CMS for 2012. However, in its response letter, CMS stated that in order for a sufficient amount of data to be collected in 2012, the final rule would have to be issued in early 2012 to allow applicable manufactures an appropriate time period to collect and prepare the data submissions. The letter states,  “[g]iven the volume of the public comments received, and the numerous important issues to be clarified and refined in the final rule, CMS does not believe it is feasible to address all of the remaining issues in such a short time period.” CMS does intend to release a final rule later this year, but it will not require data collection by manufacturers before January 1, 2013.

In CMSs May 3 response to the Senators, Administrator Tavenner states that CMS has identified an internal work group for implementation, which is composed of both technical and policy staff. Currently, the work group is assessing the staffing and resources that will be required for full implementation of the Sunshine Act. The letter also states that CMS plans to issue a request for proposal this year to further aid with implementation.

Fuerst Ittleman will continue to monitor CMSs progress on issuing the final rule implementing the Sunshine Act. For more information, please contact us at contact@fuerstittleman.com or (305) 350-5690.