On August 14, 2012, several industry organizations, including the Advanced Medical Technology Association (AdvaMed) and the Pharmaceutical Research and Manufacturers of America (PhRMA), sent a joint letter to Marilyn Travenner, Acting Administrator at the Centers for Medicare and Medicaid Services (CMS), encouraging CMS to “promptly publish” the final rule implementing the Sunshine Act provisions of the Patient Protection and Affordable Care Act. In addition, the organizations request that CMS provide applicable manufacturers 180 days after the final rule is published before requiring data collection. The organizations believe that its member companies will need this additional time to “properly implement the data collection and reporting required by the Sunshine provisions,” as well as time for “system development, implementation, testing, and training.”
In December 2011, CMS issued a notice of proposed rulemaking announcing the publication of draft regulations to implement the Sunshine Act, which requires applicable drug, device, biological product, and medical supply manufacturers to annually disclose certain information regarding payments and other transfers of value to physicians and teaching hospitals. An additional provision requires manufacturers and group purchasing organizations (GPOs) to disclose all ownership or investment interests held by physicians or members of their family. Although the Sunshine Act requires manufacturers and GPOs to begin collecting data starting January 1, 2012, CMS has indicated that it will not require data collection by applicable manufacturers and applicable GPOs before January 1, 2013.
Click Here to view a copy of the industry organizations’ letter to CMS.