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The final provisions for the The Sunshine Act, which requires pharmaceutical and medical device manufacturers to track and publicly report what they spend on physicians at their meetings, were released February 1. Here’s a rundown of how the rule will affect—and why some continuing education providers are breathing a qualified sigh of relief.
CME Providers Breath Sigh of Relief—for Now
Those on the continuing medical education side, however, had been in limbo, waiting to see if they would have to slice and dice the unrestricted grants they receive from industry for the CME activities to account for what is spent on chilling effect on speakers and on participants, who may not want to have their honoraria or the cost of their lunch publicly posted.and participants at their events. The concern was that this process would be onerous and expensive for providers, and that it could have a
At an early morning session on February 2 at the Alliance for Continuing Education in the Health Professions’ annual conference in San Francisco, Thomas Sullivan, president of the medical education company Rockpointe Corp. and author of the Policy and Medicine blog, gave a preliminary overview of the final rule. It includes a new section, 42 CFR §403.904(g), which outlines the conditions under which CME is exempt from reporting:
• The activity must meet the accreditation or certification requirements and standards for continuing education of the Accreditation Council for CME, the American Academy of Family Physicians, the American Dental Association's Continuing Education Recognition Program, the American Medical Association, or the American Osteopathic Association.
• The pharma or device company does not pay the speaker directly.
• The pharma or device company does not choose the speaker, or give the CME provider a group of speakers to consider for the activity.
The upshot: The final rule, according to CMS, “will greatly reduce the number of payments to speakers of accredited or certified CME that must be reported,” something that was applauded by those attending the Sunshine update session at ACEHP.
After a preliminary analysis, it appears that non-accredited and non-certified CME providers will still have to disclose and report honoraria, meal and travel costs, and other activity-related data to their grantors, which in turn will disclose and report those to CMS along with physician-related financial relationships involved in their promotional meetings, advisory boards, clinical research, and other interactions with healthcare professionals. Activities relating to risk evaluation and mitigation strategies, or REMS, also likely will be reportable if they are not accredited, said Sullivan.
However, the rule does exempt buffet meals, snacks, soft drinks, coffee, or other refreshments available to everyone at an activity, though individually plated meals would have to be reported. Companies also are not required to track and report giveaways valued at less than $10 at large conferences, since “it will be extremely difficult for applicable manufacturers to identify physician-covered recipients,” according to the final rule.
The rule gets very specific about some other allowable exclusions, which generally are things that directly benefit patients or are designed to be used by patients. So the costs of medical textbooks and journal reprints provided to docs for their own edification do have to be reported, while posters, anatomical models, and flash drives designed for docs to use with patients do not have to be reported. “Basically, they took educational materials off the table,” said Sullivan. “As long as it benefits patients in some way, it should be excluded.”