Consumer groups appear to have won the latest round of the regulatory tussle over whether manufacturers' indirect payments to doctors for continuing medical education activities must be reported to the Open Payments database.
The CMS said in new guidance last week that some payments made by medical-device and drug manufacturers to physicians for participating in continuing medical education activities will have to be reported starting in 2016. Consumer groups have argued for disclosure of these payments, while industry groups have sought to exclude them, saying that accredited CME programs have standards that prevent conflicts of interest.
In the Dec. 15 guidance, the CMS clarified that payments must be reported by the second quarter of the following reporting year if the manufacturer finds out the name of a physician paid to speak at a CME event the company funded. That includes cases where the manufacturer did not pay the physician directly or select the speaker.
This is a change from a 2013 final rule that excluded certain CME payments from the database. Another rule and the guidance, both of which came out in 2014, are expected to streamline the reporting process, in part by no longer distinguishing between accredited CME and non-accredited education activities. “The accreditation aspect is no longer relevant… That is really the driving force behind the rule change,” said Dr. Shantanu Agrawal, director of the CMS' Center for Program Integrity. “We didn't implement the change to expand or contract reporting.”
But the new guidance is expected to increase reporting. Accredited CME providers usually promote the events and the names of doctors hired to speak, said Dr. Daniel Carlat, former director of the Prescription Project at Pew Charitable Trusts. “It would almost be unimaginable for the company not to learn the identity of the physicians speaking.”
The CME Coalition, which represents companies providing accredited CME programs, said the new guidance is inconsistent with the final rule from October. “We believe this creates the need for further clarification,” Andrew Rosenberg, the CME Coalition's senior adviser, said in a written statement.
The purpose of the Open Payments database is to make financial relationships between manufacturers and healthcare providers more transparent and discourage conflicts of interest.
