According to an article in Policy and Medicine, over 100 medical societies including the American Medical Assocation (AMA) -- 49 state medical societies and 64 medical specality societies -- sent a letter to the Centers for Medicare and Medicaid Services (CMS) to request the the expansion of reporting requirements for educational activities under the Physician payment Sunshine Act. As the article notes, CMS is proposing to replace the CME exemption with the “indirect payment” provision; CME grants would now only be exempt where an industry donor is unaware of the physician recipients before and 18 months after the funds are transferred. The medical associations express that this is a tenuous exemption because “industry could learn the identities of speakers/faculty and potentially participants after the funds have been transferred through brochures, programs, and other publications. "
Medial associations and specialty societies have been understandably frustrated with the way the Physician Payments Sunshine Act has rolled out so far.
Yesterday, over 100 medical societies including the American Medical Assocation--49 state medical societies and 64 medical specality societies--sent a letter to Marilyn Tavenner, Administrator of the Centers for Medicare and Medicaid Services (CMS) asking for redress over three problematic issues: (1) the expansion of reporting requirements for educational activities, (2) Open Payments’ condensed timeframe for physician registration, and (3) the complicated registration process for dispute, including manufacturer discretion to dismiss disputes.
Expansion of Reporting for Educational Activities: CME Exemption
We have been keeping close tabs on CMS’ proposal to remove the existing continuing medical education (CME) exemption from the Sunshine Act. The American Medical Association (AMA) and the co-signing associations are concerned that revoking the existing reporting exclusion for CME would have a “significant chilling effect” on continuing education (CE).
As we have reported, CMS is proposing to replace the CME exemption with the “indirect payment” provision. CME grants would now only be exempt where an industry donor is unaware of the physician recipients before and 18 months after the funds are transferred. The medical associations believes this is a tenuous exemption because “industry could learn the identities of speakers/faculty and potentially participants after the funds have been transferred through brochures, programs, and other publications, or through their physician-employees’ participation in CE activities (either as speakers/faculty or attendees).”
The associations recommend that CMS modifies their proposal to state that the indirect payment exemption applies “when an applicable manufacturer provides funding to a CE provider, but does not select or pay the covered recipient speaker/faculty directly, or provide the CE provider with a distinct, identifiable set of covered recipients to be considered as speakers/faculty for the CE program.” The letter notes that “[t]he agency can include the guidance in the regulation or preamble that the foregoing is achieved where the industry donor is unaware of the speakers/faculty and other participants before committing to fund the activity under [the indirect payments section].”
“This accomplishes CMS’ goal while eliminating the potential for negatively impacting CE. To allow CE providers time to ensure that their processes comply with the modified exemption, we urge CMS to make this change effective six months after the final rule is issued.”
The associations also takes issue with CMS’ interpretation of medical textbooks and journal reprints. The Sunshine Act lists as one of its exclusions "educational materials that directly benefit patients or are intended for patient use," which do not have to be reported. However, CMS has stated that they do not believe medical textbooks and journal articles fall within this educational carve out. CMS stated these items only have "downstream benefits" for patients as compared to "wall models and anatomical models," which are intended to be used with the patient and are excluded from reporting requirements. The letter notes: “The Agency’s decision to not cover these materials under the educational materials exclusion is inconsistent with the statutory language on its face, congressional intent, and the reality of clinical practice where patients benefit directly from improved physician medical knowledge.”
While CMS’ proposal to get rid of the CME exemption is very recent, doctors, pharmaceutical companies, patient-groups, and members of Congress have urged CMS to clarify the textbook aspect of the law for close to a year.
