Perspective - UCSF Division of Geriatrics

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Mar 22, 2012 - to industry support of continuing medical education (CME). The Ac creditation Council for Continu ing Medical Education (ACCME),.
The

NEW ENGLA ND JOURNAL

of

MEDICINE

Perspective march 22, 2012

Industry Support of CME — Are We at the Tipping Point? Michael A. Steinman, M.D., C. Seth Landefeld, M.D., and Robert B. Baron, M.D.

I

n the 1970s and 1980s, industry-sponsored junkets for physicians, thinly disguised as educational events, were common. Increasing public scrutiny and the threat of government regulation and legal

action led physicians’ organiza­ tions and the pharmaceutical in­ dustry to adopt increasingly re­ strictive codes of conduct related to industry support of continuing medical education (CME). The Ac­ creditation Council for Continu­ ing Medical Education (ACCME), which accredits CME providers, progressively developed an aggres­ sive system of identifying, disclos­ ing, and resolving conflicts of interest. Despite these increasing restric­ tions, industry support for CME grew substantially between 1998 and 2007, from $301 million to $1.2 billion per year (see graph).1 By 2007, industry support account­ ed for 48% of the revenue of ac­ credited CME providers (not in­ cluding advertising and exhibit payments, which accounted for an additional 11% of total reve­ nue). In the past few years, how­

ever, the tides have started to shift. Commercial support for CME started to decline in 2008, and by 2010 it was down 31% from its peak 3 years earlier. Over a similar period, a series of influential reports and policy pa­ pers have recommended major new restrictions on industry fund­ ing, with some proposing the complete elimination of industry support for CME.2-4 Several aca­ demic medical centers have adopt­ ed stringent restrictions on con­ flicts of interest for speakers and in some cases required that in­ dustry funds be directed to a cen­ tral funding pool divorced from individual programs. Other insti­ tutions have gone further and completely prohibited industry support of their CME programs. Twenty percent of accredited CME providers and 80% of accredited CME activities (including grand

n engl j med 366;12  nejm.org  march 22, 2012

rounds programs) did not receive any commercial support in 2010.5 New rules under “sunshine” pro­ visions of the 2010 health care reform legislation may require ex­ tensive disclosure reporting for speakers and learners in commer­ cially supported CME activities, creating an additional roadblock for industry support. Perhaps most strikingly of all, the House of Delegates of the American Medical Association (AMA) recently approved an opin­ ion from the AMA Council on Ethical and Judicial Affairs that “when possible,” CME activities should be developed without in­ dustry support and without the participation of teachers or pro­ gram planners who have financial interests in the subject matter. The new policy defines circum­ stances that allow continued in­ dustry support and the involve­ ment of conflicted experts. It was passed only after more restrictive language that was present in four previous, unsuccessful proposals had been watered down. None­ theless, this policy is important 1069

PERSPE C T I V E

Industry Support of CME — A Tipping Point?

3,000

Other revenue Commercial support

Millions of U.S. Dollars

2,500 2,000 1,500 1,000 500

10 20

09

08

20

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07

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20

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01

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99

02 20

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Commercial Support for Accredited CME, 1998–2010. “Other revenue” includes advertising and exhibit fees, which accounted for 10 to 14% of total revenue in each year.

because the AMA represents a mainstream voice in U.S. medi­ cine. The passage of the policy signals broader acceptance of a restrictive approach to CME fund­ ing that has historically been at the margins. We may thus have reached a tipping point: the slow, uphill progress in limiting industry in­ volvement appears to be acceler­ ating, and further restrictions are likely to become more widespread. These changes did not arise from one or two events. Rather, they resulted from shifting norms in the culture of medicine. It is doubtful that all industry involve­ ment with CME will cease in the near future, and the recent de­ cline in industry support may also reflect difficult economic times. However, we appear to be entering a new era in which ear­ lier norms of acceptability no longer apply. What effects will changes in CME funding have on continuing education for physicians? Those who endorse ongoing industry support argue that more stringent regulation will have negative ef­ fects on the availability, quality, and cost of CME. Although reduc­ ing reliance on industry funds will 1070

not be painless, it remains highly feasible to do so in a manner that preserves (and in some ways en­ hances) access and quality. Costs can be substantially reduced by avoiding high­priced venues such as the hotel conference spaces where CME events are often held. When Memorial Sloan­Kettering decided to forgo all industry sup­ port for its CME programs, it started holding its events in medi­ cal center facilities. Moreover, CME providers are de­emphasiz­ ing traditional lecture­hall–based teaching in favor of more interac­ tive, interprofessional, and com­ petency­based learning strategies. Such strategies include online teaching tools, point­of­care CME, and performance­improvement CME, which not only offer peda­ gogical value but in many cases can also be provided at relatively low cost. This trend is likely to continue as CME is increasingly linked to practice­improvement and maintenance­of­certification processes that require explicit practice­based learning. Another source of concern for some observers is losing the con­ tributions of experts whose par­ ticipation in CME would be re­ stricted because of their financial n engl j med 366;12

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conflicts of interest. It is worth remembering, however, the exam­ ples of some journals and profes­ sional medical organizations that have successfully solicited edito­ rials and developed clinical­prac­ tice guidelines despite having strong policies limiting the par­ ticipation of people with conflicts of interest. In addition, removing the financial conflicts of interest of CME providers will probably yield a more balanced mix of con­ tent, since the existing system provides incentives for develop­ ing symposia focused on drug therapy so as to attract industry sponsors. Although increased restrictions on industry support are likely to have beneficial effects for accred­ ited CME, unintended conse­ quences are also likely. To the extent that industry funding for CME is squeezed, industry is like­ ly to channel its energy and money into other venues, as it did when gifts from pharmaceutical sales representatives were restricted. The effect may be like that of squeezing a balloon: if you clamp down on one side, another side will pop out. Reducing industry funding of CME may also result in increases in nonaccredited med­ ical education, such as dinner lec­ tures at restaurants and satellite symposia at professional society meetings. Such events are often sponsored directly by drug man­ ufacturers and need not abide by the ACCME’s and CME providers’ regulations governing conflicts of interest and balance of content. If changes in the CME land­ scape drive physicians away from accredited events toward these nonaccredited activities, the over­ all state of medical education will not have improved. Industry may also be driven to redouble its ef­ forts to influence professional so­ cieties, policymakers, and opinion

PERSPECTIVE

leaders, all of whom can have major downstream effects on the practice of individual physicians. Thus, efforts to regulate CME should not be made in isolation from the myriad other ways in which industry interacts with and influences physicians and insti­ tutions. Careful attempts to reach across the silos of education, re­ search, and clinical practice could lead to a more coherent set of pol­ icies and help to avert unintend­ ed adverse consequences. Although industry support for accredited CME is unlikely to dis­ appear entirely in the near future, a sea change toward greater re­ striction is beginning to happen as a result of cultural, regulatory, and economic changes — and a few courageous acts. CME and health care will be better for it.

Industry Support of CME — A Tipping Point?

The question for both supporters and opponents of greater restric­ tion is not whether we should in­ stitute these changes — that train has already left the station — but how to maximize the benefits of these changes and avoid unintend­ ed consequences in other aspects of physician–industry relations. The views expressed in this article are those of the authors and do not necessarily reflect those of the ACCME or the Depart­ ment of Veterans Affairs. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. From the Division of Geriatrics (M.A.S., C.S.L.), the Department of Medicine (M.A.S., C.S.L., R.B.B.), and the Office of the Associate Dean for Graduate and Continuing Medical Education (R.B.B.), University of California, San Francisco; and the San Francisco VA Medical Center (M.A.S., C.S.L.) — both in San Francisco; and the Accreditation Review Committee of the Accreditation Council for Continuing Medical Education (R.B.B.).

1. Accreditation Council for Continuing Medical Education. ACCME 2010 annual report data. 2010 (http://www.accme.org/dir_docs/ doc_upload/e7520312-92c3-4969-acf0bdf4c5b8d289_uploaddocument.pdf). 2. Committee on Conflict of Interest in Medical Research Education and Practice, Institute of Medicine. Conflict of interest in medical research, education, and practice. Washington, DC: National Academies Press, 2009. 3. Brennan TA, Rothman DJ, Blank L, et al. Health industry practices that create conflicts of interest: a policy proposal for academic medical centers. JAMA 2006;295:429-33. 4. Fletcher SW. Chairman’s summary of the conference. In: Hager M, Russell S, Fletcher SW, eds. Continuing education in the health professions: improving healthcare through lifelong learning. New York: Josiah Macy, Jr. Foundation, 2008:13-23. 5. Accreditation Council for Continuing Medical Education. ACCME 2010 annual report data addendum: analysis of commercial support distribution and long-term cme trends. 2011 (http://www.accme.org/sites/default/ files/null/606_2010_Annual_Report_ Addendum_20110915.pdf). Copyright © 2012 Massachusetts Medical Society.

Directions for Bipartisan Medicare Reform Gail R. Wilensky, Ph.D.

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efore Senator Ron Wyden (D-OR) and Representative Paul Ryan (R-WI) introduced their “Bipartisan Options for the Future” on December 15, 2011, the notion that Democrats and Republicans agreed about cer­ tain aspects of Medicare might have seemed unthinkable.1 But the pairing of a liberal Democrat who has long worked on health care reforms and a fiscally conserva­ tive Republican primarily known for work on budget issues sug­ gests that it might be possible for the parties to reach a com­ promise on Medicare reform. Of course, meaningful reform is not likely to occur in 2012: any signifi­ cant reform probably won’t hap­ pen until the public sends a clearer signal about the kinds of change it will tolerate, which won’t be possible until after the fall elec­

tions. Yet some Republicans and Democrats appear to be in sub­ stantial agreement about some changes that might make Medi­ care more efficient, effective, and fiscally sustainable — even if none of these changes are universally accepted by either party as desir­ able or even tolerable. First, there has long been dis­ cussion about raising Medicare’s eligibility age from 65 to 67, as is happening with Social Security. Though still controversial among some Democrats, this policy change was put on the table by President Barack Obama as part of a compromise package. With 78 million baby boomers becom­ ing Medicare-eligible over the next 18 years, eventually doubling the number of beneficiaries, increased spending due to population ag­ ing and greater longevity is mak­ n engl j med 366;12  nejm.org  march 22, 2012

ing such a change seem more compelling. As opponents note, however, the savings from increasing the eligibility age by 2 years probably wouldn’t be large, since the young­ est seniors tend to be the health­ iest. Moreover, if Medicare doesn’t cover them, 65- and 66-year-olds will need to continue working to get coverage from employers (which, it could be argued, would be better for them and for the economy, assuming that the econ­ omy improves enough to generate the jobs needed) or they will get subsidized coverage from the health insurance exchanges being created by the Affordable Care Act (ACA). The effect of such a change on overall spending has been de­ bated, but the effect on federal spending is likely to be favorable. Second, despite past controver­ 1071