According to an article in Medscape, a leading web resource for physicians and health professionals, "many physicians feel that removal of the [Sunshine Act] exemption somehow taints CME and, by extension, its participants." In an article that directs readers to submit comments on the proposal through the CME Coalition's Action Center, the author notes concerns that the ambiguity will deter not just the speakers at CME activities, but also the attendees. The article, included in its entirety below, goes on to note that many groups including the CME Coalition, ACCME, AMA, MGMA, AAFP and others are preparing to submit statements in opposition to the change.
More Scope for the Sunshine Act?
The Centers for Medicare & Medicaid Services (CMS) Open Payments program (aka the Sunshine Act) just got much cloudier.
When CMS issued its Final Rule in 2013, it stated that the compensation physicians received for teaching continuing medical education (CME) activities did not have to be disclosed as payment from a drug or medical device company.
But in July, CMS proposed entirely eliminating the CME exemption as one of several changes to the 2015 Physician Fee Schedule. It explained that some accrediting organizations that weren't named last year were requesting exemptions for their speakers, and other stakeholders found inconsistencies in the continuing education reporting requirements. Eliminating the CME exemption was intended to address these inconsistencies while removing what CMS said was a redundancy in another section of the Act.
But many physicians feel that removal of the exemption somehow taints CME and, by extension, its participants.
What's more, some are concerned that the ambiguity will deter not just the speakers at CME activities, but also the attendees. Could you wind up getting publicly listed for a dinner or handouts you received while receiving an update on the latest developments in treating hypertension? And if that's the case, should you proactively register with the CMS portal so you can check to see that the information submitted about you is accurate? And do you care?
Tell CMS to expand the Sunshine Act exemption for CME
And this is happening at a time when industry-supported CME activities continue to decrease. According to the Accreditation Council for Continuing Medical Education (ACCME) 2013 Annual Report, only 17% of 138,000 activities produced by ACCME- and state-accredited providers received commercial support last year.
Physicians Are Perplexed and Outraged
"We're confused and concerned," said Reid B. Blackwelder, MD, a family physician in Kingsport, Tennessee, and President of the American Academy of Family Physicians (AAFP). "We very much support transparency, but we have followed extremely strict guidelines, and there's no influence at all from industry in our CME." Nevertheless, if this change is accepted, he said, "the value of AAFP CME will have to be reported -- not just for speakers, but also for attendees."
As Gregory A. Hood, MD, an internist in Lexington, Kentucky, and member of the Medscape Editorial Board, sees it, "The bureaucrats are making everything as complicated as possible to justify their existence. It's impossible for physicians to know what's right or wrong in this situation. How can they figure out what the value of the CME is? They'll just have to go by what the people registering them at the CME activities tell them."
Doris Greenberg, MD, a developmental-behavioral pediatrician in Savannah, Georgia, has been a CME speaker in the past. "I don't think this exclusion should happen," she said. "I want to be transparent and ethical, and do the right thing. If I'm going to speak, it must be consistent with my belief system. When I've done unrestricted talks, the quality was as good as any that are not corporate sponsored. Never was I fed things to talk about." To Greenberg, the change would mean she won't accept any more CME speaking engagements at industry-supported events. "Anyone would be stupid to do anything to get on that list. I don't want to have my name besmirched in that way."
What impact will the proposed change have on physicians who rely on industry-supported activities for their CME credits? "This is going to take a lot of CME programs away," Greenberg said. "The fact is, many doctors don't have a lot of money, and these CME activities are very helpful. When people realize they're going to have to pay $5000 for a meeting, they won't go," she added. "They'll go online, but they won't learn what they could. Doctors learn a lot from sitting around with other doctors; that's going to disappear."
Greenberg was emphatic: "CME programs should be nonreportable, and the meals shouldn't be reportable either. If I attend a 7:30 AM meeting on depression, I don't think I should be denied my breakfast."
The Brouhaha About the Public Reporting
To Greenberg and others, being tagged with accepting payments (Open Payments) data in the CMS Website is tantamount to having a black mark in the National Practitioners Data Bank. Sunjay R. Devarajan, MD, a third-year resident in internal medicine and pediatrics at Georgetown University Hospital in Washington, DC, sees things differently. "I'm shielded from the process now because I don't yet take CME, but I think transparency is always a good thing -- especially in healthcare, which is too opaque. I personally don't have a problem with what would appear about me online. We should be fighting for more transparency."
Physician groups, such as the AAFP, are encouraging their members to register with the CMS's Open Payments system -- preferably by August 27, 2014, which is the end of the current Review and Dispute Period.[3,4]
Registration is voluntary, but if you don't register, you can't review data that industry may have submitted about you. "If you don't report, you run the risk of erroneous information being out there," said Blackwelder, calling the possibility that CME compensation may be included in the new system "a big mess with no benefit. They're adding additional hurdles with no relationship to CME."
Many Groups Show Their Concern
Concerns about the registration process led the Medical Group Management Association (MGMA) and 25 other organizations to send a letter to CMS that identified "certain pressing issues related to implementation" of the Sunshine Act. Foremost was a request for CMS to describe how they plan to provide the public with context for understanding the information that will soon be released. Congress had mandated CMS to provide such context, the letter noted, specifically to avoid potential public confusion and misinterpretation of the data.
The letter also asked for greater outreach and education to physicians about "what will be reported, when it will be reported, what the reporting will look like, and how they can see what will be reported about them." Finally, the letter urged CMS to try to simplify the registration process, which physicians have complained is cumbersome and overly personal and poses the risk of discouraging some from completing the registration.
How Much Do Patients Care About Public Payment Reports?
Seeing as the point of greater transparency is to ultimately educate the public, do physicians feel their patients could be affected by information about them in the new database? "A patient comes in and makes a judgment about the physician -- is he or she interested, caring, competent, engaged?" said Hood. "They're not going to say, 'How many CME talks have you given recommending the blood pressure med you just prescribed?' or 'Did you ever attend a meeting of the manufacturer?' Give me a break!" He added: "Maybe when the patient comes in who's been on the same outdated medication regimen for 24 years, he'll realize it would have been better if his doctor had gone to a CME meeting and received an update on current treatments."
But some patients clearly welcome transparency. Martin Greenberg, MD, Doris Greenberg's husband, is a neonatologist who became a medical ethicist several years ago and now serves as Professor of Bioethics and Professionalism for Mercer University School of Medicine in Savannah. He observed that an acquaintance facing orthopedic surgery was told by his surgeon, "In the interest of full disclosure, I must tell you that I helped develop the device I'm giving you, and I get royalties from its use." How did the patient react? "He said, 'It made me feel better about this doctor, whose reputation I knew was excellent. It was reassuring that he was so open with me." Of course, in this instance, the patient had the context that many are concerned will be lacking in the CMS's public release of data.
Devarajan, the resident physician, believes certain patients will be affected by this reporting: "They'll look at the data and draw their own conclusions." Some doctors fear that when patients are given such information out of context, they may get negative reviews, "and they can't defend themselves."
What's to Come?
CMS has requested comments on the proposed changes, and it specifically asks for feedback on two alternatives: expanding the list of accrediting organizations by name, or specifying standards for accreditation or certification that would permit the CME exclusion. Comments must be received by September 2, 2014. The ACCME, American Medical Association (AMA), AAFP, MGMA, CME Coalition, and many other groups are preparing to submit statements in opposition to the change.
Ethicist Martin Greenberg said, "There have been improprieties and excesses in the past, but the situation in CME now fairly well covers everything. The AMA guidelines are very well delineated." Describing the proposal to remove the CME exemption as "a tempest in a teapot," he added, "I'm a very liberal person, but this is just too much regulation."
Hood, the Lexington, Kentucky, internist, isn't optimistic that the effort to reverse the CME exemption will succeed. "I don't think there will be enough political heat to make CMS change their position."
Click here to let CMS know how you feel about the Sunshine Act CME exemption.
A decision is expected in November.
- Proposed rules. Medicare program; revisions to payment policies under the Physician Fee Schedule, Clinical Laboratory Fee Schedule, Access to Identifiable Data for the Center for Medicare and Medicaid Innovation Models & other revisions to Part B for CY 2015. Fed Regist. 2014;79:40383-40384. https://www.federalregister.gov/articles/2014/07/11 Accessed July 16, 2014.
- Accreditation Council for CME publishes 2013 annual report. Accreditation Council for Continuing Medical Education. July 15, 2014. http://www.accme.org/print/news-publications/news/accreditation-council-cme-publishes-2013-annual-report Accessed July 27, 2014.
- Open Payments/Physician Sunshine Act. American Academy of Family Physicians. http://www.aafp.org/advocacy/informed/legal/sunshine.html Accessed July 28, 2104.
- Centers for Medicare & Medicaid Services. Physicians. Review and dispute period: July 14-August 27, 2014. http://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment-Transparency-Program/Physicians.html Accessed August 2, 2014.
- MGMA. CMA open payments program sign on letter. http://www.mgma.com/government-affairs/issues-overview/compliance/sunshine/cms-open-payments-program-sign-on-letter Accessed August 4, 2014.