Life Science Compliance Update

November 16, 2015

ACCME: Accreditation Rules Safeguard Continuing Medical Education from Commercial Influence

Continuing medical education courses have been under attack lately, with skeptical writers making unsubstantiated claims that CME courses have "become a key marketing tool for increasing clinician receptivity to new products." Those writers make bold claims, but are unable to back their claims up with concrete evidence.

Graham T. McMahon, a physician and the president of the Accreditation Council for Continuing Medical Education (ACCME), has been working diligently to set some of these unsupported claims straight, reminding medical professionals and others that organizations such as the ACCME exist to "set and monitor the standards that, among other goals, ensure that educational programs offered by organizations that we accredit are independent and free of commercial bias."

Dr. McMahon continues to reiterate that promotion and marketing do not have a place in accredited CME courses. Accredited education is designed to offer physicians and health care teams a space to learn, teach, discuss emerging science, and debate ethical or controversial issues without any commercial influence. Non-accredited CME does exist, however, and Dr. McMahon cannot speak to the rigorous standards that might be applied to those courses, but states that if the authors making allegations against CME courses are referring to non-accredited CME being infiltrated with marketing tactics, then they should specify that and not apply such a broad brush against all CME courses.

The authors of the most recent article, including Adriane Fugh-Bermann, a known CME critic and director of PharmedOut, suggest that providers of CME activities have allowed commercial support to include marketing messages to increase awareness and understanding of hypoactive sexual desire disorder, and implies that the ACCME Standards for Commercial Support are either inadequate or ignored by accredited organizations. The authors, however, do not provide any support or evidence of actual courses that have been given accreditation with such "marketing messages."

As we have previously written, the standards that accredited CME courses must follow cover a wide range of topics including "independence from commercial interests; resolution of any personal conflicts of interest; appropriate use of commercial support; and content and format without commercial bias." A course will not be accredited if it does not follow the standards required by the ACCME.

Dr. McMahon reviewed the ten key points the critical authors presented as being "marketing messages," and concluded that all ten points appeared to be "appropriate elements to describe the epidemiology, diagnosis, and impact of an established disorder on affected patients," not "marketing messages" as were alleged.

Dr. McMahon reminds readers that two important functions of accredited CME courses are to both "creat[e] awareness of newly identified diseases and facilitat[e] the translation of new research into practice." He continues on to state that physicians and health care teams need evidence-based disease-awareness education so they can learn how to efficiently and quickly respond to public health priorities, and know how to diagnose and treat their patients appropriately.

In addition to the strict rules the ACCME has in place regarding the management of funds and conflicts of interests for CME providers, the activities of CME providers are subject to routine audit by the ACCME. These audits are performed on a randomized basis and Dr. McMahon also highlighted the fact that only 11% of accredited CME providers receive commercial support.

Dr. McMahon ended his written response by reminding everyone that accredited CME is part of the solution to the health needs of our country, "there is considerable evidence to show that accredited CME has a positive impact on physicians' ability to deliver high-quality care, and is one of the key resources that enables physicians and teams to deliver safe, ethical, effective, cost-efficient, and compassionate care that is based on best practice and evidence – and not on promotion."

Confirming Dr. McMahon's position is a synthesis of systematic reviews, done earlier in 2015 and focused on the impact of CME on physician performance and patient health outcomes. That synthesis identified eight systematic reviews of CME effectiveness published beginning in 2003. Five of the eight reviews directly addressed the question of "Is CME Effective?" by using primary studies that employed randomized controlled trials or experimental design methods, and concluded that CME courses and requirements do improve both physician performance and patient health outcomes.

August 14, 2015

ABIM and ACCME Announce Collaboration in Support of Physician Lifelong Learning

  Accme logoAccme logo

On August 12, the American Board of Internal Medicine (ABIM) and the Accreditation Council for Continuing Medical Education (ACCME) announced a collaboration to support physicians who are engaged in lifelong learning by enabling them to use those activities to satisfy requirements for ABIM’s Maintenance of Certification (MOC) program.

“This collaboration will expand the options available to physicians to receive MOC credit and will enable continuing medical education (CME) providers to offer more lifelong learning options with MOC credit to internists and subspecialists,” according to a new press release from ACCME and ABIM.  This also means a more streamlined process for accredited CME providers—ABIM will no longer require them to submit applications for activity approval and peer review to ABIM. Instead, accredited CME providers will be able to use one unified shared system to record information about CME and ABIM MOC activities. Importantly, this system will help lower the burden on CME providers who wish to register activities for MOC credit. 

View ABIM's medical knowledge assessment recognition program here

“All accredited CME providers in the ACCME system already use the ACCME Program and Activity Reporting System (PARS) to enter data about each of their CME activities,” ACCME states. “With this collaboration, CME providers will also be able to use PARS to register activities for ABIM MOC. As part of this registration process, providers can attest to compliance with ABIM-specific requirements for the Medical Knowledge Assessment Recognition Program and submit learner data.”

ABIM and ACCME will begin testing the technology later this month, and they expect to have the process open for accredited CME providers that meet standards set by ABIM by the end of 2015. The ACCME will maintain a list of activities that have met ABIM requirements and are registered for MOC credit. ACCME states that this list will be publicly available on their website, “providing a one-stop resource for ABIM diplomates seeking to earn ABIM MOC credits by participating in accredited CME.” Data verifying that diplomates have completed the activity will be communicated through PARS to ABIM.

This collaboration offers additional choices for CME providers and internists without adding any new ACCME requirements. “While ABIM already offers more than 300 medical knowledge options to physicians engaged in MOC, our diplomates have asked for a more streamlined process to enable them to more seamlessly combine their ongoing educational activities with MOC requirements,” said Richard J. Baron MD, President and CEO of ABIM. “By collaborating with ACCME, ABIM will open the door to even more options for physicians engaged in MOC and will allow them to get MOC credit for high-quality CME activities they are already doing.”

Under the new system, diplomates will have the option to pursue CME activities that have been registered for MOC credit, while ACCME providers have the option—but are not required—to offer accredited CME that meets ABIM MOC requirements and to submit activity and learner data through PARS to ABIM, states the announcement. 

Graham McMahon, MD, MMSc, President and CEO of the ACCME stated:

“The ACCME has long supported the goals of MOC and the alignment of accredited CME and MOC. We share a common mission to facilitate the continuing professional development of physicians. We celebrate this collaboration because it will make a real and meaningful difference to physicians and educators who are working every day to improve healthcare in their communities. This collaboration will generate many more opportunities for accredited CME providers to serve as a strategic resource by delivering relevant, effective, independent, practice-based education that counts for MOC. I look forward to working together with ABIM, our community of accredited CME providers, and our community of diplomates to leverage the power of education to drive quality in our medical profession and improve care for the patients we serve."

MOC Update

In another big change, ABIM is reversing its policy requiring physicians who have passed their initial Certification exam in 2014 or later to have enrolled in the MOC process in order to be listed as board certified. Effective immediately, physicians who are meeting all other programmatic requirements will not lose certification simply for failure to enroll in MOC.

The American College of Cardiology wrote that earlier this year, ACC leadership was made aware that ABIM had sent emails to early career cardiologists who had passed the Cardiovascular Disease Certification Exam in 2014. The email informed them of the need to enroll in MOC by March 31, 2015, in order to be publicly reported as certified in Cardiovascular Disease, and also that their certification would remain valid only as long as they were participating in MOC. “Concerned about the implications of this new process, ACC leadership engaged ABIM leaders immediately, encouraging them to level the playing field for all diplomats,” the College wrote. “The current policy reversal that affects all recent ABIM diplomats, not only cardiologists, is a direct result of ACC intervention.”

"By tying together board certification and enrollment in Maintenance of Certification, the American Board of Internal Medicine appeared to devalue the secure examination passed by recently certified physicians, by setting different standards for them compared to those certified in previous years. The ABIM should be commended for recognizing the negative impact of this policy on current and future employment opportunities, particularly for those in the early stages of their careers, and taking the steps necessary to reverse it," said ACC President Kim Allan Williams, Sr., MD, FACC.

July 29, 2015

ACCME Annual Report Data 2014

The Accreditation Council for Continuing Medical Education (ACCME) recently published its 2014 Annual Report Data which includes data on the size and scope of the continuing medical education (CME) enterprise nationwide.

In looking at the trends from 2007-2014, the report shows:

*In the last year, the CME Economy grew by 4.9%, by $124,945,126, to $2,668,123,727. However, in seven years since the market crash, CME is still 1.7% below the peak revenue from 2007.

*Commercial support for CME increased by 2.4%, by $15,959,275, to $675,912,838 ending seven years of decline. This is a 45.9% total drop in commercial support since 2007. Commercial support now represents 25.3% of the total CME funding, down from 46.5% of total funding in 2007, and slightly down from 25.8% last year. Thus, while funding slightly increased, the percentage went down in the last year.      

*Physician attendance decreased -1.2%, by -165,209 attendees, to 13,599,687. Non-Physician attendance, on the other hand, increased 6%, by 658,301 attendees, to 11,587,518.

*The majority of CME did not receive commercial support, including 89% of activities and 59% of providers.

*33.7% of physicians attended regularly scheduled events such as grand rounds, followed by 31.9% who received credit for internet enduring materials, 14.8% for courses, and 8.5% for Journal CME.

*The cost per learner in CME programs varied widely, from $37 for hospital physicians to $236 for physician membership organizations.

*Physicians' attendance in CME provided by publishing and education companies represented 27% of all participants, followed by Hospitals at 22.9%, Universities at 22.6%, and Associations with 22% of the attendees.

*The data shows that there are more than 1,900 accredited CME providers across the country that offered more than 147,000 activities in 2014, a 6.4% increase from 2013. Accredited CME providers report that their 2014 activities educated more than 25 million participants including nearly 14 million physicians and nearly 12 million non-physician health care professionals.

In addition, the 2014 Annual Report Data features separate data sets about the CME delivered by ACCME-accredited providers and by state-accredited providers, offering an overview of the CME system at both the national and state levels.

The ACCME directly accredits providers that offer CME primarily to national or international audiences of physicians and other healthcare professionals. The ACCME also recognizes state and territory medical societies as accreditors for providers that offer CME primarily to learners from their state or contiguous states. All accredited providers within the ACCME accreditation system are held to the same high standards and are required to report information about their programs that the ACCME collects and analyzes in order to produce annual report data.

Physician v. Non-Physician attendees:

This chart shows the trend that while less physicians are attending CME activities, the last few years have seen a noticeable increase in non-physician attendees. Physician attendance decreased by 165,209 attendees to 13,599,687 in 2014. Physician participants still occupy a greater percentage of attendees, but the gap is narrowing.

Total CME Income by Source and Year 2007-2014:

The 2014 Annual Report Data includes an overview of commercial support received by ACCME-accredited providers. The data shows commercial support distribution by numbers and types of activities, hours of instruction, and participants. The ACCME is able to publish this commercial support overview because of the Program and Activity Reporting System (PARS). Launched in 2010, PARS is a Web-based portal designed to centralize and streamline the collection, management, and analysis of program and activity data from accredited CME providers. The structure of PARS and the CME community's adoption of PARS enable the ACCME to produce new information.

The 2014 Annual Report Data marks the 16th year the ACCME has been collecting, analyzing, and publishing information about accredited providers, and offers more than a decade-long perspective on the evolution of the ACCME accreditation system. 

The total income of the CME industry increased by $124,945,126, or 4.9%, to $2,668,123,727 between 2013 and 2014. The total income has decreased by -$16,998,570, or -0.6% since 2007.

Commercial support of CME increased in terms of dollar value, but decreased in terms of percentage of the total industry. Commercial support increased from $659,953,563 in 2013 to $675,912,838 in 2014, falling for 25.9% of the total to 25.3% of the total. The amount of commercial support in 2014 is a 45.9% reduction since 2007, from $1,248,924,872 down to $675,912,838.

Making up for some of this lost income over time, however, were increases in Advertising/Exhibits (4.2% in 2014 and 24.7% since 2007) and "Other Income," (6.1% in 2014 and 42.2% since 2007). Other income accounts for 62% or $1,637,853,145 of the total. According to the ACCME, "Other income" represents income other than commercial support and advertising and exhibits income; for instance, participant registration fees, government funding, and allocations from a provider's parent organization or other internal departments.   

CME Income Sources Since 2007

Commercial support now represents only 25% of the total CME enterprise, a 2.4% increase since 2013, a -47% decline since 2007.  The rate of decline has fallen, but that may be due to the economy finally getting better. "Other Income" now represents 62% of the total revenue for accredited CME providers. Advertising and exhibits share has increased over time but not by very much.  

CME Income By Type of Organization:

There are wide variations in the changes to CME income by provider type.  Publishing and education companies saw their revenue increase by 13.6%, Government had a 15.2% increase.

 Publishing and Medical Education Companies

Total income increased 13.6% for publishing and medical education companies. However, total income since 2007 has decreased -9.9%. For publishers, commercial support increased 8.8% in 2014, which is up from 2013's increase of 5.3%. However, as a percentage of the total, commercial support is down to its lowest percentage, 41.6%--down 1.8% from last year and down from 71.5% in 2007.  The overall decline of commercial support going to publishers is -47.6% since 2007. The income has increased dramatically in advertising and exhibits (22.8% in 2014) and seen a significant increase in "other income" (16.9% in 2014). 

27.3% of CME activities taken by physicians were provided by Publisher/MEC's. 

Medical Schools:

For schools of medicine (universities), total income decreased -1.2%.

Commercial support decreased by -4.6%, a difference from the year before which saw growth of 2.4% in 2013 and a -36.1% decline since 2007.

In the category of "other income" medical schools saw a decrease of -1.6% in 2014.  Exhibits increased 23.4%.

Schools of Medicine delivered most of their programming via courses, regularly scheduled series, and internet enduring materials. The vast majority of the physicians participating in CME associated with schools of medicine did so in regularly scheduled series.

Associations and Nonprofits:

For Nonprofits (physician membership organizations and other nonprofits), total increased 4% vs 2013, which saw a -0.3% decrease, and has increased 12.3% since 2007. Commercial support increased 6.9% in 2014, and has declined -46.2% since 2007.

The main physician participants in CME activities offered by associations includes internet enduring, journal CME and live courses.

Physician Participation by Activity Type:

The grand total types of activities supported directly by accredited CME providers are broken down below:

  • Courses: 71,047 activities, with 406,740 hours of instruction and 2,017,323 physician participants
  • Regularly scheduled series: 23,427 activities, with 488,230 hours of instruction and 4,592,819 physician participants
  • Internet (enduring materials): 34,006 activities, with 65,178 hours of instruction, and 4,338,342 physician participants
  • Enduring materials (other): 8,452 activities, with 46,027 hours of instruction and 1,129,995 total physician participants
  • Journal CME: 6,996 activities and 1,162,319 physician participants

Activities by Organization

The total numbers of directly sponsored activities based on type of CME provider and the top three formats of CME offered are as follows:

  • Hospital/health care delivery system: 48,514 activities. Courses (27,851); Regularly scheduled series (14,361); internet (enduring materials) (3,227)
  • School of medicine: 28,672 activities. Courses (10,996); Regularly scheduled series (7,809); internet (enduring materials) (8,582)
  • Publishing/education company: 24,070 activities. Courses (4,780); internet (enduring materials) (13,757); enduring materials other (4,204). journal CME (664)
  • Nonprofit (physician membership organization): 26,673 activities. Courses (15,376); internet (enduring materials) (5,529); journal CME 3,313; enduring materials (other) (1,287)
  • Government or Military: 8,481 activities. Courses (5,549).

 Total Hours of Instruction 2007-2014:

Overall there were over 1,033,615 hours of CME content delivered. Regularly scheduled series offered the most total hours of instruction for directly supported CME (488,230); followed by courses (406,740); and internet, enduring materials (65,178); and enduring other (46,027).

CME Provider Breakdown by Hours:

  • Hospital/health care delivery system: 360,445 hours; most hours are Regularly scheduled series (236,906)
  • School of medicine: 339,196 hours; most hours Regularly scheduled series (225,317)
  • Nonprofit (physician membership organization): 142,983 hours; and the most hours were for courses (95,044)
  • Publishing/education company: 84,383 hours; most hours courses (34,473); internet (enduring materials) (22,312); enduring materials (other) (21,737)
  • Government or Military: 57,530 hours; most hours courses (43,151)
  • Non-profit (other) 29,238 – most hours courses (19,053)

Total CME Physician Participants by Provider Types:

Below is the number of total physician participants attending CME programs based on the provider of the CME.  

Overall, publishing/education companies have the most physician participants (3,717,507) followed by:

  • School of medicine: 3,084,294
  • Hospital/health care delivery system: 3,125,707
  • Nonprofit (physician membership organization): 3,002,062
  • Non-profit (other): 261,724
  • Insurance company/managed care company: 111,929
  • Government or Military: 172,600
  • Other: 261,724
  • Publishing/education company3,717,507 participants; most participants: internet (enduring materials) (2,399,891); enduring materials (other) 754,613; courses (182,031).
  • Hospital/health care delivery system: 3,125,707 participants; most participants: Regularly scheduled series (2,247,159); courses (519,230); internet (enduring materials) (193,234).
  • School of medicine: 3,084,294 participants; most participants Regularly scheduled series (2,132,865); internet (enduring materials) (524,326); courses (360,556)
  • Nonprofit (physician membership organization): 3,002,062 participants; most participants internet (enduring materials) 958,910 followed by journal CME (891,084); live courses (791,265).

Cost Per Learner:

In 2014, the cost per learner in CME programs varied widely, from $37 for hospital physicians to $236 for Nonprofit physician membership participants. 


The CME Economy is slowly coming back from the big drop with the stock market crash. New innovations and a stronger focus on outcomes are driving important CME programs.  Unfortunately, accounting for inflation, the data should actually be considered a larger drop than the numbers reflect.

There are bright spots with some sectors growing, but at this point the CME enterprise is growing at the same rate, roughly 4%, as the overall economy.


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