According to a new article published in Medical Marketing & Media, the updated '21st Century Cures' discussion draft released by the House Energy and Commerce Committee would "exempt physicians from reporting requirements relating to some continuing medical education activities." The provision in the 'Cures' draft is based on legislation (H.R. 293) introduced by Reps. Michael Burgess (R-TX) and Peter DeFazio (D-OR), which would appropriately exempt CME and certain educational materials from the reporting requirements of the Sunshine Act. The article goes on to note that "a spokesman for the CME Coalition applauded the decision to 'exclude independent CME-related payments from the Sunshine Act's reporting requirements.'"
House lawmakers introduced a new discussion draft on Wednesday, making dozens of proposed legislative changes to the drug development and delivery process.
The 199-page draft is part of 21st Century Cures, a broad legislative effort initiated by Reps. Fred Upton (R-Mich.) and Diana DeGette (D-Colo.).
It makes dozens of proposals, including boosting funding for the NIH, modernizing search capabilities on ClinicalTrials.gov, requiring the FDA to establish a framework to assess patient experience data in regulatory decision making and establishing a priority review program for certain breakthrough medical devices and technologies.
The draft would also exempt physicians from reporting requirements relating to some continuing medical education activities. The Centers for Medicare and Medicaid Services last year changed the rules for what CME payments have to be reported to the Open Payments database, which collects data about financial relationships between manufacturers and healthcare providers. A spokesman for the CME Coalition applauded the decision to “exclude independent CME-related payments from the Sunshine Act's reporting requirements.”
House lawmakers revealed the first discussion draft in January. Those proposals were pared down before the release of the new draft.