Life Science Compliance Update

August 08, 2016

AAFP Revises CME Requirement

AAFP-News

The American Academy of Family Physicians recently approved measures that will simplify CME requirements for Academy members. Previously, AAFP physicians could claim a maximum number of credits for self-directed individual activities (i.e., published research, clinical research, paper presentations, exhibit presentations, medical writing, peer review, and writing test questions).

However, effective immediately, these activities may be reported as “scholarly activities” and will quality for AAFP Prescribed credit. A maximum of 100 credits in this area can be claimed by members in each three-year re-election cycle.

Members can earn CME credit in formal and informal categories. Formal CME includes activities that have been certified by the AAFP for Prescribed or Elective Credit, while Informal CME includes self-directed learning activities that are not certified for credit.

Amy Smith, MBA, AAFP senior manager of CME credit systems and compliance, notes that “We didn’t take away members’ ability to claim credit for the scholarly pursuit of knowledge; we reduced the complexity of how members report this information.” Director of the AAFP’s membership division, Elaine Conrad, stated “This effort is intended simply to make things easier for members by streamlining requirements.”

AAFP CME Requirement

As a condition of continued membership in AAFP, active members and supporting FP members are mandated to report a minimum of 150 credits of approved CME every three calendar years, also known as a “re-election cycle.” CME credits must be reported in the year in which they were earned. Of the 150 credits, at least 75 of them must be AAFP Prescribed credits.

Current AAFP CME requirements call for members to obtain a minimum of 25 credits from live learning activities every three years. A live activity must be held in real time, include two or more people and offer either Prescribed or Elective credit. Some examples of live activities include medical seminars or conferences (i.e., AAFP clinical courses, lecture series, live webinars, or life support activities – advanced cardiovascular life support, advanced trauma life support, basic life support, pediatric advanced life support).

An exemption of 25 credits from live activities is allowed for members who submit evidence that they are providing medical care outside of the United States in a missionary/charitable practice setting for a period of longer than twelve months.

Teaching also counts as a live activity, and members are permitted to report a maximum of sixty AAFP Prescribed credits every three years for teaching health professionals.

There are maximum credit allowances for certain CME activities during the three-year re-election cycle, including:

  • Professional Enrichment: limited to 25 AAFP Elective credits
  • Published research: limited to 45 AAFP Prescribed credits (15 AAFP Prescribed credits per paper)
  • Presentation or publication of a paper: limited to 30 AAFP Elective credits (10 AAFP Elective credits per paper)
  • Preparation and presentation of a scientific medical exhibit: limited to 15 AAFP Elective credits
  • Clinical research studies: limited to 30 AAFP Prescribed credits
  • Teaching health professions: limited to 60 AAFP Prescribed credits
  • Peer review of journal manuscripts: limited to 45 AAFP Prescribed credits (3 credits per manuscript)
  • Writing test questions: limited to 30 AAFP Prescribed credits
  • Advanced training: limited to 25 AAFP Prescribed credits
  • ABFM or AOA Certification: limited to 25 AAFP Elective credits
  • Medical writing: limited to 30 AAFP Elective credits
  • Scholarly Activities: limited to 100 AAFP Prescribed credits

July 20, 2016

ACCME 2015 Annual Report Released

The Accreditation Council for Continuing Medical Education (ACCME) released their 2015 Annual Report, which includes data from a community of nearly 1900 accredited continuing medical education (CME) providers from around the country that offer physicians and healthcare teams a wide array of resources to "promote quality, safety, and the evolution of healthcare."

According to the report, CME providers in the ACCME system offered over 148,000 educational activities in 2015, totaling over one million hours of instruction. These activities included almost 26 million interactions with physicians and other healthcare professionals. In comparison to past years, the numbers of activities, hours of instruction, and participants have increased since 2014 and the number of CME activities has increased an average of 3% each year since 2010.

As for income total income for CME programs is reported down by $200 million but this can largely be accounted by a change at the ACCME which no longer requires institutions to report internal funds spend on CME courses. The ACCME also changed the reporting so there is no longer a category for "other income" but rather divides it up by registration, government grants, private donatations and exhibits.

ACCME acknowledges that accredited CME providers are routinely achieving ACCME expectations. The ACCME's Accreditation Criteria require providers to produce educational activities that are designed to create change and to analyze the changes that were achieved as a result of the activities and many providers are now measuring for these outcomes. The report shows that over 90% of CME activities are designed for changes in competence (teaching healthcare professionals strategies for translating new knowledge into action); nearly 60% are designed to change performance (changing and improving what healthcare professionals actually do in practice); and roughly 30% are designed to change patient outcomes.

The 2015 Annual Report features aggregated statistics for all providers accredited in the ACCME system, including organizations accredited by ACCME Recognized Accreditors, those accredited directly by ACCME, as well as organizations that have received Joint Accreditation for Interprofessional Continuing Education™.

According to Graham McMahon, MD, MMSc, President and CEO of ACCME,

This report shows that accredited CME is evolving constantly to meet the needs of new generations of learners and to address emerging healthcare challenges. The numbers in this report represent our CME providers' ongoing work and commitment to improving the quality and safety of healthcare in their communities. I am hopeful that review of this Annual Report can help healthcare leaders recognize the strategic power of education to drive change and create collaborative communities, and the returns that can be derived from support for and investment in skill development training for healthcare professionals.

New in 2015

According to the ACCME report, the functionality of the ACCME Program and Activity Reporting System (PARS) has allowed the ACCME to produce more comprehensive annual reports in recent years. Starting in 2015, the reports can include additional detail regarding registration fees (including registration, subscription, or publication fees received from CME activity participants), government grants, and private donations.

This year, providers reported over $2.4 billion in investment in education, from a variety of sources. The data this year showed that the majority of income (53%) came from participant registration fees, commercial support accounted for 28%, advertising and exhibits for 13%, and private donations and government grants less than 2% each.

There is also a video explaining the CME System including an overview of the 2015 Annual Report.

 

Links

For a link to the 2014 Annual Report for comparison purposes, click here.

The 2015 Annual Report can be found here.

The 2015 Annual Report Addendum can be found here.

July 14, 2016

AMA, AAFP and Medical Societies Support Senate Bill Promoting CME Exemption in Open Payments

Cme_full

A long list of over one hundred specialty groups and state medical societies penned a joint letter to Senator John Barrasso expressing their “strong support” for S. 2978, the Senate bill that would exempt certain continuing medical education (CME) from Sunshine Act reporting requirements. Among the lengthy list of groups signing the letter were groups such as the: American Medical Association, American College of Cardiology, American Academy of Family Physicians, and Medical Society of the District of Columbia.

The groups note that the enactment of the senate bill would “protect the dissemination of peer and independent third-party reviewed services and products that improve patient care.” Such legislation is important because evidence-based medicine is facilitated by a practicing physician's ability to look at independent peer-reviewed journals, medical textbooks, and independent continuing medical education.

In the letter, the groups urge Congress to pass the bill because CMS has already "chilled the dissemination of medical textbooks and peer-reviewed medical reprints and journals" and appears ready to also stifle access to independent certified and/or accredited CME. The letter also mentions the fact that the bill attempts to clarify that CME which meets the standard for independence must be exempt from Sunshine Act reporting. Such a requirement has become necessary due to contradictory guidance from CMS that required several revisions to subregulatory guidance.

The letter continues on, stating, "[a]dding to the concern, a recent New England Journal of Medicine article, which was co-authored by current and former CMS staff, says that 'payments related to all accredited CME activities must be reported beginning in 2017.' This statement only adds to the confusion surrounding the status of independent CME as it relates to Open Payments reporting.” 

The groups believe that when Congress first enacted the Physician Payments Sunshine Act, it specifically intended to exclude independent sources of clinical information from sunshine reporting requirements. Congress wrote into the law twelve exclusions from the reporting requirements, including an exclusion for "[e]ducational materials that directly benefit patients or are intended for patient use."

However, CMS has decided to interpret the statute to mean that medical textbooks, reprints of peer-reviewed scientific clinical journal articles, and abstracts of these articles are not directly beneficial to patients, nor are they meant to be used by patients. According to the letter, "[t]his conclusion is inconsistent with the reality of clinical practice where patients benefit directly from improved physician medical knowledge and is not supported by the statutory language on its face or congressional intent.”

The letter continues, stating, "[s]cientific peer-reviewed journal reprints, supplements, and medical text books have long been considered essential tools for physicians to remain informed about the latest in medical practice and patient care. Independent, peer-reviewed medical textbooks and journal article supplements and reprints represent the gold standard in evidence-based medical knowledge and provide a direct benefit to patients because better informed clinicians render better care to their patients."

The groups also make mention of the 2009 FDA guidance, "Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices," stating that the guidance shows that the FDA understands the "important public health and policy justification supporting dissemination of truthful and non-misleading medical journal articles and medical or scientific reference publications."

As one of the participating organizations, the American Academy of Family Physicians issued a statement on the letter, noting that the Academy “seeks to safeguard physicians’ unfettered access to high-quality educational resources and independent certified and/or accredited CME.

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