Life Science Compliance Update

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.

July 24, 2017

AAFP and ABFM Collaborate to Create Unified Credit Reporting Process


Earlier this month, the American Academy of Family Physicians (AAFP) announced a collaboration with the American Board of Family Medicine (ABFM) to create a more seamless credit-reporting experience for family physicians. The new process will allow AAFP members to use the AAFP as a one-stop shop for all of their Continuing Medical Education (CME) credit reporting needs.

It is hoped that this new process will make it easier for providers to claim their credit for performance improvement CME activities with both the AAFP and the ABFM.

The AAFP – as one of the nation’s three CME accrediting bodies – will work with CME provider organizations that wish to have their CME activities (including performance improvement activities) certified for AAFP Prescribed and/or Elective credit. CME providers can seek approval for those activities through the AAFP Credit System.

The AAFP and ABFM are currently working together to allow CME providers to apply for AAFP Performance Improvement CME Credit and ABFM Certification Activity credit for their performance improvement activities through the AAFP Credit System using a single application process. Starting in October, CME providers who apply for dual credit using the new unified process will no longer have to pay an additional fee for ABFM Certification Activity credit approval.

In addition to meeting AAFP performance improvement activity requirements, to be eligible to receive Certification Activity credit from the ABFM, each performance improvement activity must comply with the ABFM's Industry Support Policy and meet the ABFM Requirements for Performance Improvement activities, and the provider must agree to periodic audits by the ABFM.

From the physician-learner's perspective, the unified process means that ABFM diplomates will have more performance improvement activities to choose from. In addition, when the physician reports CME credit for a dually approved performance improvement activity to the AAFP, the ABFM will automatically be notified that the performance improvement certification activity has been completed.

The AAFP was created as a national professional association to protect the rights of general practitioners, and is the oldest national CME accreditor. Each year, the AAFP produces over 100 CME activities, including the Family Medicine Experience, live events, as well as journal and online CME sessions that are designed for family physicians with input from members. AAFP also reviews more than 3,000 activities from about 1,300 different organizations for accreditation annually to ensure they meet the needs of family physicians.


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