The Future of CME

The ACCME’s redefinition of the term “commercial interest” has both near and longer term implications for MECCs.  The impacts will come in waves over the next few years.  First, some grantors will limit their grant activity to organizations that are in compliance now, despite the August 2009 effective date.  Next, MECCS will have to make a decision to comply with the new definition by modifying their structure, policies, relationships, etc. or change their focus to regulated or non-CME education by August 2009.  At that time, accredited MECCs will be in compliance as determined by ACCME or lose their accreditation.  Non-accredited MECCs that continue as joint sponsors in CME will face separate clearance procedures by each of their accredited partners.  As there has been no indication of timely oversight by ACCME in this area and since few accredited providers have the resources to validate the claims made by their non-accredited joint sponsoring MECCs, we can expect wide disparities and significant confusion within the joint sponsorship arena.  Action is needed soon to provide clarity and consistency to prevent this from damaging the image and value of CME.

Predicting the future of MedEd funding requires a better crystal ball than mine!  Here are some “for what it’s worth” guesses.  Near term industry support will surely decline.  It will decline because; fewer new products are being approved, industry is conserving resources because the direction of the new administration in Washington is unclear, there is price pressure from all sides impacting profits, more academics and public figures say industry should not fund CME, the regulations require costly new procedures and management structures which use up a portion of the CME money, and maybe, but only maybe, because the industry is a little tired of being punished for trying to do a good thing.  What happens longer term is very unclear.  Will medical societies build the cost of the CME they require into their dues?  Will physicians decide to pay for their own CME, because all other choices are gone?  Will provider organizations fund CME for their physicians?  Will the pendulum swing back as the value of industry support is recognized?  And finally will the rapid advance of technology allow reduced funding to provide adequate education options at a much reduced cost?  What is the future? Who knows, not me.  

“The role of CME in Quality Improvement (QI) is expanding but there is a serious problem.  MECCs often lack access to data, which is available to hospitals, medical schools and insurance companies, that is required to draw definitive conclusions concerning the impact of their educational interventions on physician performance and patient outcomes.  As a result MECCs are often using surrogate measures to assure themselves that the activities they implement are contributing to the greater good.  What is needed is a low cost, HIPAA compliant, longitudinal data base linking physicians and patients.  MECCs could access this information to both document unmet needs and treatment gaps and to measure the improvement in patient outcomes directly related to their CME offerings.”

This is a bit outside my area of expertise, but my understanding is that MECCs who have affiliations with commercial interests will have to document they have a fire wall in place and operate completely independently. 

I think it remains to be seen what the pharmaceutical industry will do regarding support of CME. They are in the process of evaluating whether the increased regulation and scrutiny is worth their efforts. As we evolve away from traditional CME to more practice-based, competency-based performance improvement, funding of those activities will change too. Although there has been a long-standing expectation that physicians’ professional development will be subsidized, they will be willing to pay for activities that truly benefit them. If pharmaceutical funding goes away, there will be increased efforts for developing CME that is relevant and important to physicians in improving their individual practices.

My organization is positioned to assist with the integration of CME and Quality Improvement. CME should be considered one of many “interventions” for performance improvement. Often education isn’t what is needed to improve performance. CME that is developed with specific performance measures in mind; offers quality improvement tools; and opportunity for measuring change and improvement in practice will contribute to the overall improvement of patient care. One-off CME activities that are not linked to quality management will not be in step with where we are headed.

The goal for all groups involved in the CME enterprise should be to identify and resolve both individual and organizational conflicts of interest.  From a commercial supporter’s perspective, it is important that there is separation between a medical education company in CME and its related companies, such as a parent company or sister companies that engage in promotional marketing activities.  AstraZeneca asks that MECCs disclose specific information regarding structure and relationship in order for us to understand and document the “firewalls” in place.   

 

The ACCME has gone one step further by redefining “commercial interest” in an effort, in essence, to remove potential conflicts of interest related to affiliations with organizations involved in some way with aspects of the commercial supporters’ business interests.  This new definition will impact some MECCs.  The educational providers impacted may have to decide whether or not to change their business model in order to meet the ACCME’s new rules.  

 

How will medical education continue to be funded in the future? 

AstraZeneca is strongly committed to enhancing the health and well being of people everywhere.  One dimension of our commitment is supporting independent medical education because we believe that it can enhance patient care by providing health care professionals with the most current information on disease states, treatment options and effective doctor-patient interaction.

 

Educational activities certified for credit are an important element of life-long learning and the continuing professional development of health care professionals.  CME activities are designed to address identified educational needs and provide valuable information to assist health care professionals in their efforts to enhance patient care.  Since enhancing patient care is important to all of us, there should be a shared responsibility for funding continuing medical education across medical schools, hospitals, specialty societies, professional associations, healthcare systems, insurance companies, industry, employers and health care professionals.   

 

The current ACCME Accreditation Criteria will help in raising the bar in CME because it focuses on the important connection between the educational provider developing and evaluating quality educational programs and the adoption by health care professionals of best practices based on best evidence and available data.  Educational providers are beginning to collaborate with each other to develop the partnerships needed in building a new framework for CME to address the needs of the learners and demands for practice improvement.  What that looks like will continue to evolve.  When reviewing grant requests, commercial supporters will need to understand these more complex quality improvement (QI) initiatives that are different than traditional programming requests and the complicated educational provider partnerships involved.  The challenges we face are identifying specific review and decision criteria and stretching grants budgets in order to support long-term quality improvement initiatives.  Although we face opportunities and challenges in the QI arena, the prospects are exciting and the end results will be worth it.

 

Related to your question about MECCs, MECCs with strong capabilities and skills to address identified gaps and to reach across the disciplines have an advantage. They have an opportunity to form partnerships with hospitals and healthcare systems and to put together what is needed for quality improvement educational activities. 

The ACCME defines “commercial interests” as “…any entity producing, marketing re-selling, or distributing health care goods or services consumed by, or used on, patients.”  (reference: ACCME Policies, August 2007) 

The ACCME has given accredited providers a deadline of August 2009 to modify their corporate structures so that the CME component of their organization can be made into a separate entity.

MECCs will need to establish strong firewalls between their promotional/branded educational division and their accredited medical education division.  New corporate entities will need to be formed with separate officers, staff and possibly separate locations.  This will place a burden on many MECCs who currently share staff and facilities resulting in some companies deciding to focus their business on either promotion or accredited education.   It will cause MECCs to think strategically about the future of both sides of the equation and determine where their strengths reside. 

The separation may result in a stronger and more impactful MECC able to rise to even greater heights in educational planning, implementation and outcomes.  Or, the separation may dilute the efforts of the company resulting in fewer CME activities, or CME of lesser quality.   

However, I believe if the end result of the CME activity is unbiased, quality education with impactful outcomes, what difference does it make if it was planned and implemented by a commercial or non-commercial interest? 

It will be a few years before we can draw any conclusions as to the impact of the new rules for commercial interests on MECCs.  

 

The existing paradigm of pharmaceutical support for accredited education will be altered, perhaps significantly, over the next 2-5 years. The increased public and regulatory scrutiny of CME and the resulting inquiries into grant funding and practices will, in my opinion, alter the existing balance of risks vs. benefits of pharmaceutical grant support.  

In order to supplement decreased or non-existent pharmaceutical grant funding for accredited education, other sources of support will need to emerge. These sources will include the attendees themselves and perhaps managed care and government agencies. Other entities such as trade unions or commercial consumer companies may also become involved in educational support.  

If a universal healthcare system is instituted with the new president, the government will have a greater role and responsibility for educating health care providers, similar to the UK and Canada. And, if a new system is established it may also play a role in decreasing pharmaceutical grant support for CME.    

I don’t believe accredited education will cease to exist because of the inevitable shift in funding. The value proposition of CME must continue to be measured and the results must be made transparent and available to the public and the press. We should be proud of our accomplishments and eager to demonstrate  the value of our work and the contributions we make toward increasing clinicians’ knowledge and improving skills and impacting quality patient care. 

I recently left the pharmaceutical industry and established a company specializing in instructional design.  I started the company because of the need to link CME with quality improvement (QI)  initiatives through the use of valid and reliable adult learning theory and data-driven, learner-centric education which result in changes in  behavior and practice patterns of physicians. CME and quality improvement are firmly linked and we should endeavor to align them more closely than in the past.  

The new ACCME criteria reflect a shift to align CME with quality improvement through the link with maintenance of certification and the emphasis on outcomes in terms of improved behavior and better patient care. The new criteria also require CME professionals to identify practice gaps and design educational activities  to close the gaps. These new criteria linking CME with quality improvement become effective in November 2008.  

Departments of CME within hospitals and academic medical centers would do well by aligning more closely with their QI departments. The CME department might reside within QI, or be represented on the QI Committees.  There should be QI representatives on the CME Education Committees, as well. 

MECCs should pay close attention to the quality improvement processes within their organization and ensure that all their staff understand and implement QI and that the resulting CME activities reflect a systematic  approach to designing and measuring specific learning competencies.  

If I could take out a crystal ball, I predict the CME landscape will change dramatically over the next 2-5 years.  It will be a place with perhaps fewer players and less dependence on pharmaceutical support for survival, but the challenge, as with all challenges, will make us stronger, more nimble and better able to respond to market forces to deliver high quality, evidence-based educational interventions which impart knowledge and skills and  improve patient care.  

The future of CME, in my opinion, depends upon how well we articulate the difference between “Independent CME” – which is not an oxymoron – and “promotional CME”, which simply doesn’t exist.  Our challenge is how to educate the media, our legislators and the public about the difference between the two – and the unintended consequences of withdrawing commercial support from CME that provides necessary physician education and ultimately helps patients.

At the heart of the matter from the legislative perspective is the simple fact that commercial support of various activities may influence physicians’ prescribing practices.  Senate and House Committees are rightly concerned about the rising cost of drugs and are looking for ways to reduce this drain on government funding.  But while pharma money currently flows to many different segments of the medical community, CME draws the most fire from well-meaning but uninformed critics.

Research studies and focus groups dedicated to investigating the persuasive powers of “drug money” have the potential for categorizing all industry contributions to the medical community as inherently suspect, without paying attention to what differentiates “certified CME activities” from “promotional activities” and “research activities”.  Recent attempts by the media to sensationalize CME attest to this misunderstanding.

Promotional activities are regulated  by the FDA , which expressly defines how messages about approved products may be directed toward physicians, and prohibits discussion of off-label uses.  Drug developers and manufacturers write the scripts and create the slide decks, and the education provided is very real and necessary:  it just isn’t independent of industry influence. It’s not the venue of these activities, but rather the character of “designed for pharma” versus “designed to fill gaps in patient care”.   Ethical codes published by the AMA, PhRMA, AdvaMed and other organizations limit expenditures to roughly $100 per physician, per activity. These activities include:

• Exhibits at major professional society meetings 

• Promotional lectures, dinners 

• Journal advertising 

• Pharmaceutical detailing

• Distributing free drug samples

• Small gifts to individual physicians in clinical settings [pens, pizza…] 

Research activities, also regulated by the FDA, provide substantial sources of revenue for academic medical centers and equally substantial financial opportunities for clinical investigators. Aside from conducting the research and publishing their data, prominent “key opinion leaders” (KOLs) with faculty appointments have traditionally earned consulting fees by speaking at CME activities AND promotional functions – clearly a conflict of interest, now under scrutiny by policy makers.  The grayest area of CME involves so-called “satellite” programs that are commercially supported, certified CME activities “revolving around” major meetings organized by specialty societies but potentially driven by industry agendas.  

Independent CME activities take place in hospitals; at grand rounds, around specialty society and state association meetings; in peer-reviewed journals; and online.  The topics are based on what physicians need to know to address identified gaps in their knowledge, skills, attitudes and competencies, not what drug companies have to sell.  The content is derived from evidence-based research, and alternative treatments are compared and discussed. The activities are evaluated and outcomes are measured to document the effect on physician learning and behavior and/or patient care. The collegial atmosphere allows physicians to share their patient experiences and ask questions of each other. 

THIS is the CME that deserves a fair shake in the press and generous unrestricted contributions from pharmaceutical and medical device companies.  When 60-80% of drugs prescribed in pediatrics, oncology, and HIV are for off-label uses – and certified CME is the only environment where off-label uses can be discussed – it’s plain to see that patients will be the losers if commercially supported independent CME is lost. 

What can we do, as CME professionals who develop, evaluate, and fund independent CME activities?  We can back the ACCME in its efforts to keep CME a self-regulated enterprise.  We can continue our own education and stay on top of new voluntary policies that bring out the best in us and in our educational services and assessments.  We can communicate the ways that CME benefits patients and remind the world that “independent CME” is not an oxymoron.