Proposed Changes to the Sunshine Act Will Be Expensive for Medtech Companies
Sunday, October 19, 2014
In July 2014, the Centers for Medicare and Medicaid Services (“CMS”) issued proposed revisions to the rules governing the reporting requirements under the federal Physician Payments Sunshine Act (which CMS refers to as the Open Payments requirements). Two of the proposed changes – if adopted – could have a significant impact on medical device manufacturers’ obligations to track and report to CMS payments and transfers of value they provide to U.S. physicians and teaching hospitals.
Moreover, if adopted, the time permitted to incorporate the changes into systems, processes, and operations could be short (possibly little more than 30 days). Device manufacturers would be wise to consider now the potential impact CMS’ proposals might have on them, and understand what process and system changes might be needed so that they are prepared to quickly execute on any changes to the reporting requirements that may come later this year.