As we noted last week, the Centers for Medicare and Medicaid Services (CMS) announced that it was delaying the reporting of payments under the Physician Payment Sunshine Act, which was enacted as Section 6002 of the Physician Payment Sunshine Act.
The Sunshine Act requires manufacturers of pharmaceuticals and medical devices to report certain types of payments over $10 made to physicians.
As a result of the delay, CMS has set up an internal work group and will also solicit stakeholders’ help as it grapples with how to meet it latest plan to issue a final rule by the end of the year and require manufacturers to start collecting data on financial relationships between doctors and physicians on Jan. 1, 2013. The work group, which includes both technical and policy staff, will assess the staff and resource requirements needed to fully implement the program, and CMS will also issue a request for proposals later this year soliciting outside help, CMS chief Marilyn Tavenner told Sen. Chuck Grassley (R-IA) in a May 3 letter.
Tavenner told Grassley that a staff briefing on progress to date in implementing the Sunshine law has been scheduled. She also wrote that CMS recognizes it is important for reporting to begin as soon as possible but does not believe it is possible to begin collecting data in 2012. The agency still needs to address issues brought up in the more than 300 comments received on proposed rule, she said.
“Given the volume of the 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, Tavenner said. “As a result, while we intend to release a final rule later this year, we will not require data collection by application manufacturers and applicable group purchase before Jan. 1, 2013,” she said.
Grassley and Sen. Herb Kohl (D-WI), who coauthored the Sunshine Act, expressed disappointment in CMS’ May 3 announcement that it will delay enforcing the data collection requirement. The two lawmakers have closely watched the implementation process, which has been repeatedly delayed, and wrote to CMS in April asking for information on the agency’s plans. Under the reform law, data collection was supposed to start Jan. 1, 2012.
Responding to Tavenner’s statement that a final regulation would be out later this year, Grassley says in a statement, “It’s disappointing that CMS won’t even collect data at all this year.”
He adds: “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.”
“While I am disappointed by this delay and the timeline, I do look forward to working with CMS to finalize the rules so that data collection can begin in January 2013, “ Kohl added.