Earlier this month the Centers for Medicaid and Medicare Services issued answers to the many questions continuing medical education providers have been asking about how the Sunshine Act’s physician payment provisions will affect their ability to pay for physician lodging, travel, and meals, among other issues. The Sunshine Act, also called Open Payments, requires pharmaceutical and medical device manufacturers to track and publicly report what they spend on physicians at their meetings.
The CME Coalition, a Washington, D.C.–based lobbying group that represents the interests of accredited CME providers, is among those who had asked for exemptions from the Act’s mandatory reporting requirements for accredited CME speaker travel, meals, and lodging; buffet or box-lunch meals served at accredited CME activities; and most educational materials. And now the CMS has confirmed in its FAQs that these are among the items that will be considered “Sunshine exempt.”
According to Andrew Rosenberg, senior adviser to the CME Coalition, “CMS has been very open to our input throughout the process, and we feel confident that we have built a constructive relationship with CMS. There are very thoughtful people over there who are working hard to get it right.” In particular, he says that CMS was very interested in learning why it is important to provide reporting exemptions for accredited continuing medical educational programming, since that will encourage physicians to participate and learn how to better treat their patients rather than create an environment in which physicians will be tempted to skip an event because their names will be recorded in a database as receiving payments from pharma.
While the answers given by the CMS were overall greeted as positive by accredited CME advocates, one response could prove to be chilling for physician speaker participation in industry-grant-supported activities that are accredited by pharmacist, nursing, optometrist, podiatrist, chiropractor, and other organizations not given the CMS stamp of approval in 42 CFR § 403.904(g)(1)(i). CMS has recognized that CME run by organizations that are accredited by the Accreditation Council for Continuing Medical Education, the American Academy of Family Physicians, the American Dental Association's Continuing Education Recognition Program, the American Medical Association, and the American Osteopathic Association, are eligible for exemptions from Sunshine reporting requirements. According to the CME Coalition, there are 11 more, including some international accreditors that either have formally adopted’s Standards for Commercial Support or have developed near-identical standards of their own.
But the CMS didn’t buy that CME providers who use physician speakers also could fall under the potential exemption umbrella, saying, “The list of accrediting or certifying bodies in the final rule at 42 CFR § 403.904(g)(1)(i) is exhaustive; in order to qualify for the exclusion in § 403.904(g)(1), CME events must be run by CME providers that are accredited or certified by one of the accreditation or certification entities in § 403.904(g)(1)(i) and, accordingly, meet the accreditation or certification requirements and standards of any of those specific entities. Payments to speakers at CME events that are not run by CME providers accredited or certified by one of the entities in § 403.904(g)(1)—or that don't meet either or both of the other two requirements for exclusion in § 403.904(g)(1)—are reportable payments or other transfers of value for Open Payments.” But CMS did leave some hope for those who are accredited under these other bodies when it added, “We will consider modifications to this provision in possible future rulemaking.”
The CME Coalition now will focus its attention on creating a campaign to educate pharmaceutical companies and physicians about the Sunshine Act rules. They also hope to work with academic and research institutions to develop an understanding of how these rules create a new litmus test for CME activities that meet the criteria for Sunshine exemption so that they may be persuaded to allow their physicians to participate in accredited activities that receive commercial support, something that several currently do not allow.
Here’s the full list of FAQs on the CMS Web site; and here’s a rundown of the CME-pertinent FAQs, with commentary from Thomas Sullivan, president and founder of medical education company Rockpointe Corporation, on the Policy and Medicine blog. The CME Coalition also offers numerous Sunshine-related resources on its Web site.