Life Science Compliance Update

September 26, 2017

Report Examines CME Preferences and Habits of Medical Education Teams


Life science teams employ several different types of independent medical education providers. These providers include dedicated third parties, hospitals, professional medical societies and academic institutions. Several factors such as corporate goals, public perception, drug program type and cost influence the CME provider decision.

Over three-fourths of surveyed global medical affairs teams consider dedicated continuing medical education (CME) providers as their first choice when funding CME programs, according to a recent survey done by Cutting Edge Information. The data found that apart from dedicated CME providers, life science teams may dedicate the majority of their CME funding to hospitals or professional medical societies instead.

Equal percentages of surveyed teams consider hospitals, medical institutions, or universities (nine percent each) as their second-most funded CME provider. Roughly one-third of surveyed teams will fund a university CME program as their third choice. Fifteen percent of surveyed teams use medical societies as the most common choice to provide with CME funding.

Despite the popularity of CME providers, other surveyed medical affairs teams are reluctant to work with dedicated CME providers because of cost concerns.

For example, one Top 10 pharmaceutical company's team does not directly work with or fund commercial medical education providers, but it may work indirectly with such groups if they are part of a larger CME initiative.

The type of product may strongly affect the CME provider decision. When a drug has a large patient population, teams often have more non-dedicated CME options than companies with rare disease products. Due to the scarcity of data and smaller potential audience size, fewer medical organizations or professional groups may be willing to undertake CME programs for rare disease. This forces teams with drug programs or limited patient populations to rely on dedicated CME vendors.

"Medical education programs are a vital part of any life science team's activities," said Natalie DeMasi, research team leader at Cutting Edge Information. "These activities disseminate new medical information across the medical community to help increase disease awareness and expand knowledge about existing treatment options."

The full report can be purchased here, and provides insight on discovering and implementing innovative methods for measuring medical education value and understanding key trends in internal v. external speaking staff.  

The below image highlights the different organizations to which teams most frequently provide CME funding.


August 24, 2017

15th Annual Independent Medical Education and Grants Breakthrough Summit


The Fifteenth Annual Independent Medical Education and Grants Breakthrough Summit will be held September 12 through 13, 2017 at the Sonesta Hotel in Philadelphia, Pennsylvania. The event promises to bring together supporting organizations, medical education providers, and other key stakeholders to address some of the industry-leading issues.

Attendees will gain the latest insights on how to: assess the opportunities for medical education in a value-based healthcare landscape; evaluate and weigh the benefits versus costs to incorporate innovative learning formats and the latest technologies into CME; partner with patient advocacy groups to improve the value and effectiveness of IME programs; and communicate the value of CME to internal stakeholders.

On Tuesday, September 12, 2017, the day opens with a continental breakfast, followed by a welcome and opening remarks by Mike LoPresti of the Global Academy for Medical Education. Andrew Rosenberg with the CME Coalition will then present a Washington Healthcare Update. After a few other presentations and a networking rbeak, the first panel will form, “Patient Advocacy Groups 101 – Understanding How Patient Advocacy Groups Function and their Role in the Healthcare Industry,” with panelists including Stephen Chavez of Health Advocacy Partners, Jennifer Mefford of the Pulmonary Fibrosis Foundation, and Gina Ross Murdoch with the Multiple Sclerosis Association of America. The afternoon will have several workshop offerings, including “Creating More Impactful Reports and Communications,” “Telemedicine – The Next Big Thing in CME and QIE,” and “Innovating in Traditional CME Offerings.” The day ends with a networking, wine and cheese reception.

On Wednesday, the day starts again with a panel on “Shared Risk, Reduced Costs and Improved Outcomes – What’s the Role of CME in Value-based Healthcare,” with panelists Molly Mooney with the Cleveland Clinic, Michael Reilly of Regeneron Pharmaceuticals, and Karyn Ruiz-Cordell of RealCME. Several other panels and a networking lunch will preclude the final panel, “Grants Review – The Art of Crafting Quality Grant Applications.” The final panel will include thoughts from Ann Marie DeMatteo of Regeneron Pharmaceuticals, Samantha Koth of Sunovion Pharmaceuticals, Derek Warnick of Pfizer Inc., and Greselda Butler of Otsuka Pharmaceutical Development and Commercialization, Inc.

Policy and Medicine readers can save $300 on registration by using the code IMEPM3. The discount applies to standard rates only and may not be combined with other offers, category rates, promotions or applied to an existing registration. Offer not valid on academic or non-profit registrations.

August 23, 2017

AMA and ACCME Announce Simplification of Credit and Accreditation Systems


On August 1, 2017, the American Medical Association (AMA) and the Accreditation Council for Continuing Medical Education (ACCME) announced that they have adopted a final proposal to simplify and align their expectations for accredited continuing medical education (CME) activities certified for AMA PRA Category 1 Credit.

The final proposal follows a call for comment on the proposed simplification in April 2017, when the vast majority of those who responded endorsed the proposal and agreed that it would give them sufficient opportunity to innovate and evolve their CME programs. The proposal was then adopted by both the AMA and the ACCME and the organizations are now working together to develop a list of frequently asked questions and other resources to assist members with implementation.

This simplification is expected to encourage both innovation and flexibility in CME while ensuring that activities meet education standards and are free from commercial influence. The simplification aims to permit accredited CME providers to introduce and blend new instructional practices and learning formats that are appropriate to the learners and the setting – as long as they follow the AMA’s seven core requirements.

The core requirements are aligned with ACCME accreditation requirements—and do not represent any new rules for accredited providers. In addition, the AMA has simplified and reduced its learning format requirements to provide more flexibility for CME providers. To further encourage innovation in educational design and delivery, CME providers may design and deliver an activity that uses blended or new approaches to driving meaningful learning and change. For these activities, the provider can designate credits on an hour-per-credit basis using their best reasonable estimate of the time required to complete the activity.

“The simplification and alignment will encourage innovation and experimentation in CME, so that educators are free to respond nimbly to their learners’ changing needs while staying true to core principles for educational excellence and independence. We celebrate this collaborative effort with our AMA colleagues and thank our community of accredited CME providers for their high level of engagement in this process. We look forward to our continued work together to drive quality in clinicians’ lifelong learning and improve care for the patients we all serve,” said Graham McMahon, MD, MMSc, President and CEO, ACCME.

“Recognizing the need to better align the AMA and ACCME’s requirements for CME accreditation and reaccreditation, we believe that our newly adopted proposal will support the evolution of CME to better meet the needs of educators, physicians, and the patients they serve,” said Susan Skochelak, MD, AMA Group Vice President for Medical Education. “We look forward to continuing our work with ACCME on a more streamlined system that benefits providers and patients alike.”

In addition to collaborating on the simplification and alignment, the AMA and ACCME produced a shared glossary of terms and definitions to help clarify terminology for accredited CME providers and learners, developed as part of their alignment efforts and in response to requests from CME providers.


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