July 3


IN THIS ISSUE / July 3, 2019

Academy comments on FDA sunscreen proposal


On June 27, the Academy submitted a comment letter to the Food and Drug Administration (FDA) regarding the use of over-the-counter (OTC) sunscreen drug products. In the letter, the Academy advocates for patients and the public to have access to sunscreen products that have been proven effective against skin cancer, skin aging, and sunburn.

In addition to emphasizing that unprotected exposure to the sun's ultraviolet (UV) rays is a known risk factor for skin cancer, the Academy also encourages the public to continue to use sunscreen products to limit exposure to ultraviolet (UV) light as a part of comprehensive photoprotection. Of particular concern to the Academy has been the public confusion and misconceptions about the safety of sunscreen products. The Academy asks that the FDA be more proactive in explaining the importance of continuing to use sunscreen products and the logistics of safety data generation and evaluation moving forward.

While the Academy has not taken a specific position on specific safety testing methodology now required for both currently marketed and pending sunscreen ingredients, the Academy encourages FDA and industry to come together to facilitate access given the importance of skin cancer prevention. To that end, the Ad Hoc Task Force on Sunscreens, chaired by Henry W. Lim, MD, has been in communication with industry as well as the FDA. In addition the Academy hosted a webinar June 25 on the absorption testing that FDA is asking industry to perform, which is called the maximal usage trial (MUsT). Listen to the webinar here.

The FDA is proposing to have a maximum labeled SPF value of SPF 60+ citing (1) variability in SPF values and (2) additional clinical benefits associated with SPF 60 sunscreens. While AADA appreciates FDA raising the maximum labeled SPF value from the previous SPF 50+, sunscreens labeled with SPF 100+ have additional clinical benefits that have been published in a peer-reviewed scientific journal and are significantly more effective in protecting against sunburn than SPF 50+ sunscreen in actual use conditions.

Read the Academy's letter to view all comments and recommendations. In the Sunscreen Innovation Act, Congress required the FDA to issue the final rule by Nov. 26 of this year. DW Weekly will have updates as they become available. In addition, please visit www.aad.org/sunscreen for additional resources, including FAQs, on how to answer patient questions about sunscreen safety. 

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DW Insights and Inquiries: Oy, another “Oid” to worry about — cryptococcoid lesions 

heymann-warren-95px.jpgThe suffix “oid” means “resembling.” There is a plethora of “oids” in dermatology — lichenoid, Pagetoid, rupioid, targetoid, to name a few. (My favorite is “oid-oid” disease, aka Sulzberger-Garbe disease, or exudative discoid and lichenoid chronic dermatosis; a likely variant of severe nummular dermatitis, originally described in Jewish men. Until I wrote this introduction, I had assumed “oid-oid” was really meant to be “oy-oy” disease!) 

Clinical and histologic mimicry challenge even the most seasoned dermatologists. The latest “oid” that may compel clinicians to say “oy” is the cryptococcoid histologic appearance of neutrophilic dermatoses (ND). The clinical variability of ND runs the spectrum from urticarial lesions to Sweet syndrome, pyoderma gangrenosum, to resembling necrotizing fasciitis (so-called “necrotizing neutrophilic dermatoses”). Keep reading!

VA launches Community Care Network to provide better access to care

In June, the Veterans Affairs (VA) Department began to roll out its new Community Care Network (CCN), giving veterans enhanced access to care at non-VA facilities. The limited workforce of VA dermatologists and Mohs surgeons creates barriers and challenges for veterans seeking timely access to skin cancer care. 

Under the new CCN, veterans needing private dermatologic care, including Mohs surgery, would need to meet the following criteria:

  • Average drive time to a specific VA medical facility: 60-minute average drive time for specialty care; or
  • Appointment wait time at a specific VA medical facility: 28 days for specialty care from the date of request, unless the Veteran agrees to a later date in consultation with their VA health care provider

If a veteran is unable to see a VA dermatologist within 28 days, or the VA clinic is more than an hour’s drive, then the veteran can obtain a referral from the VA to see a dermatologist in private practice.  Under the CCN, the VA would reimburse at the prevailing Medicare rates. Learn more about the CCN on the VA website.

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CMS has begun MIPS data validation, audits for 2017 and 2018 performance years

In June, the Centers for Medicare & Medicaid Services (CMS) began its data validation and audit process for the MIPS 2017 and 2018 performance years. If you are selected for data validation and/or audit, you will receive either an email or certified mail notice with a request for information from Guidehouse — the third-party company conducting the data validation and audit. Upon notification, you will have 45 days to provide the requested information. Be sure to comply with this request in a timely manner, otherwise CMS may take further action, including the possibility that you will be selected for future audits. If you are selected and reported via DataDerm™, contact DataDerm@aad.org with questions.

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What happened at the AMA House of Delegates meeting? Private equity, compounding, and more.

The American Medical Association (AMA) held its Annual meeting of the House of Delegates (HOD) June 8-12, in Chicago. During that meeting, the Dermatology Section Council (DSC) met, deliberated, contributed to policy discussions, and voted on numerous critical health policy and AMA governance matters, many of which pertain to dermatology. 

This year, the DSC authored one resolution, cosponsored one resolution, and supported two Board of Trustees reports that resulted from previous DSC resolutions. The resolution and reports were adopted or referred for decision by the HOD. Learn more about the resolutions below.

  • Compounding: The DSC introduced a resolution that called on the AMA to preserve a physician’s ability to prepare medications in physicians’ offices. The resolution was referred for decision and will be discussed at an upcoming AMA Board of Trustees meeting.
  • Shade structures in public planning and zoning matters: The DSC cosponsored a resolution, adopted by the HOD, that recommends the AMA support sun shade structures (such as trees, awnings, gazebos, and other structures providing shade) in the planning of public and private spaces, as well as in zoning matters and variances, in recognition of the critical importance of sun protection as a public health measure.
  • Private equity firms: In 2018, the DSC authored a resolution advocating for the AMA to study the positive and negative effects of private equity firms acquiring physician practices. In response, the AMA Board of Trustees produced a policy report that was adopted by the House of Delegates at the 2019 Annual Meeting. In addition to highlighting that more data is needed to determine the impact, the AMA will encourage physicians who are contemplating corporate investor partnerships to consider specific guidelines.
  • Vector-borne diseases: In 2018, the Academy authored a resolution with 24 state and national medical specialty society co-sponsors that asked the AMA to study the emerging epidemic of vector-borne diseases. In response, the AMA Council on Science and Public Health authored a comprehensive report that was adopted as policy by the AMA HOD. The report called on the AMA to advocate for improved surveillance, increased funding for prevention programs, and research for new vaccines, diagnostics, and treatments. 

Also from the AMA Annual Meeting ...

The AMA passed its first policy on AI, adopting language directly from the Academy position statement on augmented intelligence (AuI) that reinforces the role human intelligence plays when AI is used to enhance physician care, rather than replace it. The new policy and inclusion of language from Academy's AuI position statement is a result of the DSC's advocacy efforts. Read more about the AMA policy on AI

CMS proposes Medicare Part D electronic prior authorization standards

CMS released a proposed rule to update e-prescribing standards to reduce provider burden and expedite access to needed medications. It would implement new prior authorization transaction standards for the Part D e-Prescribing program as required by the SUPPORT for Patients and Communities Act and would begin in January 2021. Read the proposed rule.

Check out the Academy's prior authorization resources, including a letter generator to quickly create appeals to help overturn denials.