amednews | By Charles Fiegl
Proposed transparency rules need further revision and clarification to
ensure accuracy of the reporting process, according to the Centers for Medicare
& Medicaid Services.
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.