Jaimy Lee, New York based reporter for Modern Healthcare, helped to clarify the recent Sunshine Act notice from the Centers for Medicare and Medicaid Services (CMS). The notice of the final rule originally confused some stakeholders and industry watchers as its language first eliminated the so-called CME exclusion and then did some linguistical gymnastics to finally allow drug and device manufactures to support continuing medical education events without reporting the payments in the Open Payments Database.
One doctor who participated in the regulatory comment process had his commented quoted in the article. “As a physician in a field which is rapidly changing, oncology, I use CME accredited programs daily to keep up to date for my patients,” Dr. Parvin Peddi of California wrote in a comment letter to the CMS. “The proposed CMS rule … would make producing these programs as well as using them very hard by requiring companies to assign a monetary value to every time I read an e-mail or listen to an audio CD.”
One doctor who participated in the regulatory comment process had his commented quoted in the article. “As a physician in a field which is rapidly changing, oncology, I use CME accredited programs daily to keep up to date for my patients,” Dr. Parvin Peddi of California wrote in a comment letter to the CMS. “The proposed CMS rule … would make producing these programs as well as using them very hard by requiring companies to assign a monetary value to every time I read an e-mail or listen to an audio CD.”
The federal Open Payments database will still exclude most payments made by medical manufacturers to physicians participating in continuing medical education programs even though the CMS eliminated an explicit exclusion in new regulations.
A final rule the agency issued late Friday deleted the CME exclusion in its entirety. But the CMS says in the regulation that another section of the law that calls for the disclosures makes most CME payments exempt from public reporting under the exclusion for what are called indirect payments. The disclosure requirement stems from the Physician Payments Sunshine Act provision of the Patient Protection and Affordable Care Act.
Although the CMS proposed eliminating the CME exclusion in a draft rule issued in July, experts believe the agency was merely intending to create more consistent reporting requirements rather than capture CME payments in the database.
But the move created confusion in the industry. The CME coalition, a trade group for CME providers and others, believed that the rule would make industry support for CME reportable just like payments to physicians for promotion and marketing. “If it is allowed to stand, this policy change will be massively disruptive to every stakeholder in the CME ecosystem—doctors, educators and commercial supporters—who have spent over a year preparing for the implementation of the current rules,” Andrew Rosenberg, the coalition's senior adviser, said this summer.
The agency is expected to issue guidance clarifying the policy.
Some experts say the new rule could actually exclude even more CME payments from the reporting requirement than would have fallen under the explicit exemption. That's because previous exclusion, included in a February 2013 regulation, applied only to education activities accredited or certified by the Accreditation Council for Continuing Medical Education and four other accrediting bodies. The new interpretation removes that requirement. The new rule, however, still prohibits manufacturers from directing CME payments to particular physicians or selecting physicians who will speak at educational events.
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“As a physician in a field which is rapidly changing, oncology, I use CME accredited programs daily to keep up to date for my patients,” Dr. Parvin Peddi of California wrote in a comment letter to the CMS. “The proposed CMS rule … would make producing these programs as well as using them very hard by requiring companies to assign a monetary value to every time I read an e-mail or listen to an audio CD.”
