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June 6

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IN THIS ISSUE / JUNE 6, 2018


Feedback requested: Primary cutaneous melanoma treatment draft guidelines

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The American Academy of Dermatology (AAD) is requesting feedback from AAD members about its draft Guidelines of Care for Management of Primary Cutaneous Melanoma. AAD members are encouraged to provide comments on the draft guidelines before the comment period closes June 18.

Guidelines serve as decision-making and educational aids for clinical practice to support and improve quality dermatologic care, and are used as the framework for quality measurement, reimbursement decisions, advocacy efforts, public messaging, and the identification of research gaps. When finalized, these evidence-based guidelines will be submitted for publication in the Journal of the American Academy of Dermatology and will be considered current for five years from the date of publication.

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Integrating the human touch at the AAD Annual Meeting 

chu-dww.jpgAt the 2017 AAD Annual Meeting in Orlando, the Patient Advocate Task Force piloted a patient participation program that was aimed at integrating the patient perspective in educational sessions. The program received very positive results from patients, participants, and session directors. As a result, the Task Force brought the program back to the 2018 Annual Meeting in San Diego and both patients and session directors found it very valuable. Here is what they had to say about the sessions:

“I loved this experience! I found it really humbling ― so many people were interested in my perspective of my disease and really hope to participate again.” Educational session patient

“The patient was great. The audience asked a ton of questions and stayed an extra 15 minutes for a very interactive Q&A. It was great and I would HIGHLY recommend it again.” Session director

“Provided a humanistic side to patient care that is often lost in the old-fashioned lecture style sessions.” Session director

One patient story in particular made its mark on attendees. Denise Albert shared her experience about the dermatologic side effects of anticancer drugs. In response to Ms. Albert’s talk, session attendee Mario E. Lacouture, MD, FAAD, stated, “I would like to thank the AAD Patient Advocate Task Force for this wonderful opportunity. It was the best experience I have had at a lecture, it was so moving, there were doctors in the audience with tears in their eyes after hearing her story. Amazingly, she took off her wig in front of everyone, unexpectedly, showing her courage. The audience gave her a standing ovation. I was speechless after her lecture.” 

These comments underscore the value of integrating the patient perspective in educational sessions. If you would like to incorporate the patient perspective into your 2019 Annual Meeting education session, either in person or by video recording, the Patient Advocate Task Force has resources to bring patients to Washington, D.C. Please contact me if you are interested at emily.chu@uphs.upenn.edu.

Emily Y. Chu, MD, PhD, serves as the chair of the Academy’s Patient Advocate Task Force. She also serves as assistant professor of dermatology at the Hospital of the University of Pennsylvania.


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Insurer reverses onerous isotretinoin policy

The insurance company Highmark has reversed a new policy that would have required Pennsylvania physicians to obtain prior authorizations for prescriptions for isotretinoin generics. The Pennsylvania Academy of Dermatology and its members advocated against this policy.

As prior authorizations continue to take hold in practices across the country, physicians and their staff may be looking for some relief. Read more about how to use evidence-based medicine when managing prior authorizations in Dermatology World.

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FDA issues REMS draft guidance for manufacturers

The U.S. Food and Drug Administration (FDA) has issued two draft guidance documents in an effort to help applicant manufacturers of generic drugs with safety restrictions get onto the market faster. According to a statement issued by FDA Commissioner Scott Gottlieb, MD, these policies attempt to reduce the ability of brand drug manufacturers to use Risk Evaluation and Mitigation Strategy (REMS) programs to block generic drugs from entering the market. 

The first draft guidance document, Development of a Shared System REMS, provides proposed general guidelines and recommendations intended to help REMS program sponsors develop shared REMS systems. A shared REMS system includes multiple prescription drug products and is developed and implemented by two or more applicants. “The goal is to improve the clarity and efficiency for developing shared system REMS, which will enable timelier market entry for products that are part of these REMS,” said Dr. Gottlieb. 

The other draft guidance document, Waivers of the Single, Shared System REMS Requirement, outlines the proposed circumstances by which the FDA would consider waiving the shared system requirement, and the process for requesting a waiver. If a waiver is granted, then that drug will have its own REMS. Read more about these guidance documents, and check out Dermatology World for a closer look at the FDA’s REMS program.

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CMS releases QPP participation results

According to the Centers for Medicare and Medicaid Services (CMS), the Quality Payment Program (QPP) exceeded its participation goals in 2017. In a blog post, CMS Administrator Seema Verma indicated that in the first year of the QPP program 91% of physicians participated in the Merit-based Incentive Payment System. Physicians in ACOs and rural practices participated at higher rates at 98% and 94% respectively. CMS also reiterated its recent efforts to “reduce burden, add flexibility, and help clinicians spend less time on unnecessary requirements and more time with patients.” CMS has indicated that it will provide more information on QPP performance in the near future.

The AADA continues to advocate for fixes that would make QPP reporting less burdensome for dermatologists. Read more about MIPS reporting in 2018 in Dermatology World and check out the Academy’s 2018 MIPS Reporting Module ― now available for purchase.

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​​EB treatment receives rare pediatric disease designation from FDA

The U.S. FDA has granted ‘rare pediatric disease designation’ for CCP-020 ointment (diacerein 1%) for the treatment of epidermolysis bullosa (EB). This designation indicates that the FDA may give the drug a priority review if the drug is approved for the rare pediatric indication. According to a press release issued by Castle Creek Pharmaceuticals, “Diacerein is a slow-acting, small molecular weight compound of the class anthraquinone with potent anti-inflammatory properties. Diacerein and its active metabolite rhein have been shown to inhibit the in vitro and in vivo production and activity of IL-1β and other pro-inflammatory cytokines.”

As technology evolves and more is learned about genetic disorders, the therapeutic options for these conditions are starting to expand. Read more about treatments for dermatologic genetic conditions in Dermatology World.

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​​2019 committee appointment application now open

 

Every year, hundreds of dermatologists serve the Academy through its organizational governance structure and through other service opportunities. The Appointment Selection Committee, chaired by George J. Hruza, MD, MBA, has begun accepting applications to fill 2019 open appointments. Applications must be submitted by June 30, 2018. Members who are selected to serve will be contacted in the winter. Letters of recommendation are highly suggested but are not required. 

Access the 2019 online appointment application at www.aad.org/applications/cctf. Learn more about the specific committees and task forces, committee member responsibilities, and other opportunities, in the CCTF Resources-Governance Handbook.