Federal requirements for collecting information on gifts and payments to physicians from drug and device manufacturers will not begin until 2013, said a top Centers for Medicare & Medicaid Services official.
Data collection was expected to begin in 2012, and the first public transparency reports on relationships between manufacturers and doctors were expected to be released in September 2013. But citing a number of operational issues, acting CMS Administrator Marilyn Tavenner has told Sen. Charles Grassley (R, Iowa) that it would not be possible to begin the information-gathering process this year.
The agency instead will issue a final rule this year that implements provisions of the Physician Payments Sunshine Act, which was championed by Grassley and included in the health system reform law, and start collecting data in 2013.
A December 2011 proposed rule had generated more than 300 comments from organized medicine, health industry and patient advocacy groups, Tavenner said in a May 3 letter to Grassley. CMS is addressing all stakeholder concerns.
“In order to collect a sufficient amount of data in 2012 and provide applicable manufacturers with an appropriate time period to prepare for data submission, CMS would have to publish a final rule early in 2012,” Tavenner said. “Given 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.”
The regulations would require industry firms to track any transfers of value to physicians of more than $10, as well as smaller payments to doctors whose total transfers from a firm exceed $100. The data would be made public through searchable online databases.
The American Medical Association had urged CMS to postpone the Sunshine Act’s data collection process. A delay was necessary to ensure thoughtful implementation of accurate transparency reports, said AMA President Peter W. Carmel, MD.
“The delay will provide needed time to help prepare and inform physicians so they know what information will be reported and how to revise incorrect information,” Dr. Carmel said. “CMS should use the delay to fully consider AMA’s concerns regarding the scope and application of the proposed regulations. We urge CMS to resolve these issues in the final rule.”
Grassley and Sen. Herb Kohl (D, Wis.) expressed disappointment over the delay, but they urged the Medicare agency to move ahead with regulations that ensure the accuracy and usefulness of the disclosure mandate.
“Consumers need to know more about the financial relationships between their doctors and drug companies sooner rather than later,” Grassley said.
The full and original article can be found at: http://www.ama-assn.org/amednews/2012/05/07/gvsc0510.htm