In a blog entry on May 3, 2012, CMS announced it was delaying the Sunshine Act requirement for data collection until January 1, 2013. CMS’s stated rationale was:
In order to provide time for organizations to prepare for data submission and to sufficiently address the important input we received during the rulemaking process, CMS will not require data collection by applicable manufacturers and applicable group purchasing organizations before January 1, 2013.
A related May 3 letter to Senator Grassley from CMS’s Acting Administrator, Marilyn Tavenner explained that CMS has set up an internal work group and will solicit additional input from stakeholders as it moves toward issuing a final rule by the end of the year. The work group includes both technical and policy staff and “is currently assessing the staff and resource requirements for full implementation of the program. CMS also plans to issue a request for proposal this year to further aid with implementation.”
Senator Grassley was not pleased by this development, stating, “It’s disappointing that CMS won’t even collect data at all this year. The process has dragged on long past the statutory deadline for implementation. Consumers need to know more about the financial relationships between their doctors and drug companies sooner rather than later. It’s important that CMS get this right in every way, including the usefulness and accuracy of the information. Given all of the extra time, CMS will have no further excuses for not accomplishing these goals.”
The tone of the CMS notices suggests we will not have final regulations until the fall. If you were prepared to begin collecting data, this further delay does provide an opportunity to test your systems and utilize the data you collect for review of the return on investment for such payment and other strategic issues.