of revenue, including industry advertising and sponsorship (which is on the rise), fees, governmental grants and non-traditional sources of funding, such as grants from third-party payers. Planners are also re-examining CME settings, with an eye on both funders and future learners. The Endocrine Society, for example, is looking at more regional education and e-learning opportunities. “I think there will still be a role for the face-to-face interactions,” Johnson said, “but I am very cognizant that the generation coming into the field today has learned in a completely different manner.”
In fact, the days of the “anonymous learner” are gone, Doyle-Scharff said, referring to the large annual conferences and congresses that have been a stronghold of CME programming. With Pfizer’s restructuring and new two-track system, only 10 percent of its CME grants would go toward those types of meetings.
Shifting funding away from those events will enhance the impact of Pfizer’s dollars, Doyle-Scharff said, because while there will always be value in face-to-face interaction at a large, annual meeting, that’s not the best setting for quality education. And it’s not where funders are going to be spending their dollars. “I grew up in CME and I believe in the power of education, but you have to recognize that it’s got to be more than education for education’s sake,” she said. “Everyone has to roll up their sleeves and think about who the learner is and what their true needs are. You can’t rely on the perceived need of the learners anymore; that’s not going to cut it.”
Indeed, CME providers that are too complacent in today’s evolving marketplace will soon find themselves left behind, Johnson said. “The entire CME paradigm is shifting,” she said. “I think we’re all going to have to be collaborative and creative, and we’re going to have to rethink the type of education we’re delivering.”
Timeline: The Rise and Fall of Industry-Backed CME A chronology of the regulations, standards, and guidelines that govern, guide, and restrict industry provider relations.
2002 The Pharmaceutical Research and Manufacturers of America (PhRMA)
, the leading trade association for pharmaceutical and biotech companies, releases its Code on Interaction with Health Care Professionals. The Code is designed to govern relations between industry representatives and health-care providers, and to ensure there is no undue influence to prescribe or recommend certain medications.
2003 The Advanced Medical Technology Association (Adva- Med)
, the chief trade group for the medical-device industry, follows suit with its own Code of Ethics on Interactions with Health Care Professionals. The U.S. Department of Health & Human Services (HHS) Office of Inspector General (OIG)
issues “Compliance Program Guidance for Pharmaceutical Manufacturers, ”which recommends that drug and device makers adopt corporate policies to prevent kickbacks to CME providers, and that the companies separate their education-grant activity from their product-marketing activity.
2004 The Accreditation Council for Continuing Medical Education (ACCME)
releases updated Standards for Commercial Support, addressing conflicts of interest, transparency, and independence. All CME providers must comply with the standards in order to obtain accreditation.
2006 ACCME releases Accreditation Criteria,
which incorporate the 2004 Standards for Commercial Support and shift focus to CME effectiveness. The criteria state that CME programs should be designed to change physicians’ competence or performance, or patient outcomes, and that all accredited providers must evaluate their programs’ effectiveness in achieving those goals.
2007 The U.S. Senate Finance Committee
releases a staff report, the culmination of a two-year investigation, claiming that there is evidence that drug and medical-device companies use educational grants as a way to increase market share, and that some CME programs are improperly influenced by commercial sponsors.
Pharmaceutical giant Pfizer announces that it will no longer award grants to medical education/communication companies (MECCs). GlaxoSmithKline follows suit in 2009.
PhRMA and AdvaMed adopt new, more restrictive codes (effective 2009) to govern the pharmaceutical industry’s relationships with physicians and other health-care professionals. Under the new codes, companies can’t provide health-care professionals with pens, pads, mugs, or other non-educational gifts, and can’t directly provide meals or receptions at CME events.
U.S. Sen. Charles Grassley, R-IA, ranking member of the U.S. Senate Finance Committee, contacts leading U.S. medical associations and societies requesting details about industry funding the groups have received since 2003.
2009 Federal regulators
reach a $2.3-billion settlement with Pfizer for off-label drug promotion - the largest settlement to date with a single defendant in the Justice Department. The Justice Department had charged Pfizer with making illegal payments and providing entertainment and travel gifts to doctors to induce them to promote and prescribe the company’s drugs.
The nonprofit Institute of Medicine(bold) releases Conflict of Interest in Medical Research, Education, and Practice, a report that calls for an end to educational grants from pharmaceutical and medical-device manufacturers and for a new funding mechanism “free of industry influence.”
, as part of the 2009 settlement, begins posting payments made to health-care professionals - for meals, compensation, payments, and “transfers of value” of $25 or more— to its website. In 2011, the value is lowered to $10 or more. The Physician Payment Sunshine Act
is written into the Patient Protection and Affordable Care Act of 2010, requiring industry to report to HHS all payments and transfers of value to physicians and other health-care providers on an annual basis. If passed, the Act will require disclosure of both direct payments, such as speaking and consulting fees, and indirect payments, such as travel, lodging, and participation in CME programs - even if the program is administered by a third-party organization, such as a medical society. The gathering and reporting of the data, therefore, will fall to CME providers.
2011 The American Medical Association’s Council on Judicial and Ethical Affairs
releases a report stating that industry funding of CME should be avoided altogether, if possible. GlaxoSmithKline agrees to pay $3 billion
to the U.S. Justice Department for settlement of ongoing criminal and civil investigations into the company’s sales and marketing practices, including funding of CME activities.
2012 The Sunshine Act
Drug and medical-device companies must begin recording all transfers of value to physicians and other providers for 2013 reporting.
Sidebar: ‘The Balance of Revenue Has Shifted’
The bad news for continuing medical education is that financial support from drug and device makers is down for the third consecutive year, and it’s not likely to recover any time soon &emdash or ever. “The bottom line is, budgets have decreased, and they’re not going to increase,” said Maureen Doyle-Scharff, senior director of Pfizer’s Medical Education Group. “I don’t see that happening.”
The good news is it might not matter. Total CME revenue is up, according to the Accreditation Council for Continuing Medical Education (ACCME), and it seems medical meeting organizers are finding other ways to foot the bill for CME. As ACCME stated in its 2010 annual report: “The balance of revenue has shifted.”
In 2010, total income for organizations that offer CME programming increased 3