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.
“What isn't clear is the exact implications,” said Dr. Daniel Carlat, former director of the Prescription Project at Pew Charitable Trusts. “The language seems to allow wiggle room in how companies can interpret” the rule.
Medical device and pharmaceutical companies are required to collect data about the research and promotional payments and other transfers of value, such as food, travel expenses, or gifts that they make to physicians and teaching hospitals. That data are published annually in the Open Payments database. The first round of data went public in September.
The law is intended to improve transparency of financial relationships between industry and healthcare providers and prevent conflicts of interest that can affect a doctor's prescribing patterns or care choices. The first round of data went public in September.
Manufacturers pay hundreds of millions of dollars each year to companies and not-for-profit organizations that develop educational programs to teach physicians about new treatments or techniques. The third-party companies and organizations hire physicians to teach the CME activities.
Some experts worry that CME funding influences physicians. Dr. Brad Tanner, a physician in North Carolina, told the CMS in a comment letter that publicly disclosing CME payments “will clean up CME and return it to being continuing medical education … It's time to get pharma back in the business of making drugs and CME educators fully in the business or providing education to health professionals.”
Others say that voluntary CME standards do enough to protect physicians from industry influence and industry support is necessary to keep educational programs in operation.
“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.”
Follow Jaimy Lee on Twitter: @MHjlee