Recent Developments

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Special Report: Navigating the Ins and Outs of Your Insurance Coverage During COVID-19

Expert tips for assessing your current insurance coverage and using this time proactively.

Jason O’Dell, a financial consultant and insurance specialist at OJM Group, spoke with New Jersey-based dermatologist Jeanine Downie, MD and Chicagoland facial plastic surgeon Steve Dayan, MD about what to expect from insurance coverage during the pandemic and how to beef up your policies in the future during a recent edition of Coping with COVID-19. Watch the Practical Dermatology® and Modern Aesthetics® program in its entirety online.

Here are six take-home messages to help navigate the ins and outs of your coverage during the COVID-19 pandemic.

1. Don’t expect to be paid out on a “business interruption” claim.

Most commercial casualty insurance plans have a well-defined exclusion for pandemics. In the future, riders may be available to add such coverage to your plan for a price.

2. Do know that your family will receive death benefits from your life insurance policy if you die prematurely due to COVID-19.

That said, most payers are temporarily postponing the sale of new life insurance policies to individuals of a certain age and/or pre-existing conditions.

3. Do review your policies.

Use this time to review your existing insurance policies, paying close attention to any known business interruption exclusions such as flooding. Consider adding riders for known exceptions, including sexual harassment and cybersecurity breaches.

4. Do take stock of your possessions.

Take photo inventory of any devices in your office and send these images to your insurer for a more accurate assessment of your practice’s value.

5. Do ask for pro-rated malpractice insurance.

Many malpractice insurers are offering retroactive pro-rating of policies during COVID-19. The same may also be true for auto insurance, as fewer people are driving. It never hurts to ask.

6. Do choose your insurance agent wisely.

Select someone who regularly works with physicians and has been referred to you by trusted colleagues.

Get more. Watch the Practice Insurance Protections and Pitfalls episode of our Coping with COVID-19 series at ModernAesthetics.com/series/coping-with-covid-19


AAD: Most Americans Know Sun Protection is Important, Still Don’t Protect Themselves

While three-quarters of Americans agree that sun protection is an important habit, only 41 percent report regularly protecting themselves outdoors—increasing their risk for skin cancer, according to a new survey from the American Academy of Dermatology (AAD).

What’s more, 28 percent of Americans admit they rarely or never use sun protection, and 65 percent of Americans don’t know that shade protects them from the sun’s harmful UV rays, the survey showed.

In recognition of Skin Cancer Awareness Month in May and Melanoma Monday on May 4, the AAD launched its annual national public awareness campaign encouraging Americans to #PracticeSafeSun to protect themselves and their families from skin cancer.

The AAD recommends that everyone #PracticeSafeSun and reduce their risk of skin cancer by seeking shade when appropriate, wearing sun-protective clothing, a wide-brimmed hat, and sunglasses with UV protection, and applying a broad-spectrum, water-resistant sunscreen with an SPF of 30 or higher to all skin not covered by clothing.

Bruce H. Thiers, MD, FAAD, president of the AAD, recommends that patients perform regular skin self-exams and look out for the ABCDE signs of melanoma.

“When detected early, skin cancer, including melanoma, is highly treatable, making it imperative to check your skin regularly,” says Dr. Thiers. “To reduce your risk of developing skin cancer, practice safe sun. It only takes a few simple steps to protect your skin from UV, and it could save your life.”

Cutera Unveils Free Digital Resources to Help Practices Thrive Through COVID-19 and Beyond

Cutera, Inc., is launching the Cutera University e-learning series to support medical professionals through the COVID-19 crisis and beyond.

The Cutera University e-learning series offers complimentary solutions that practices can leverage to expand their knowledge base, help their business endure while keeping patients engaged and informed. Visit cutera.com for more.

“At Cutera we work aggressively alongside our physician partners to push the boundaries of innovation forward from the technology we create, to the education and practice management resources we deliver,” states Dave Mowry, CEO of Cutera, Inc., in a news release.

“During these unprecedented times we are working to bridge the gaps of uncertainty, delivering tangible answers for our customers. This multi-channel series gives on-going insights from Cutera thought leaders to our customers with meaningful digital events, activities, guidance and a high level of interaction and care.”

As part of the program, Cutera is also launching an e-book, “Survive, Thrive, Grow: Proactive Strategies for Practice Success,” that delves deeper into topics that matter to practices like harnessing digital technologies to keep patients engaged, business and financial best practices, modern social media strategy and more.

Regulations Needed to Reduce Rates of Nickel Allergic Contact Dermatitis

The US government must start regulating nickel in clothing and jewelry to reduce nickel allergic contact dermatitis reactions, according to a new American Academy of Pediatrics policy statement.

Nickel is now the number one allergen nationwide in all age groups, and the number of children who test positive for it has quadrupled over the past three decades, to 1.1 million children, the policy authors point out.

Since Denmark and the European Union passed laws to reduce nickel in items like earrings and clothing, there has been a global reduction in incidence of nickel reactions.

The policy recommends more research to better understand the relationship between nickel exposure and health.

“Nickel is the leading allergen in children and adults with contact allergy and has tripled in incidence in the past three decades,” says Nanette Silverberg, MD, Chief of Pediatric Dermatology for the Mount Sinai Health System in New York City. “Legislation in Europe to limit the release of nickel from items in prolonged contact with the skin has been successful in controlling and reducing Nickel allergy in children. It is supported that the United States adopt the same legislation for the benefit of our children.”

JAK Inhibition EYED to Halt COVID-19-Associated Cytokine Storm

Incyte’s JAK inhibitor may play a role in stopping COVID-19-associated cytokine storms.

Incyte is starting RUXCOVID, a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating the efficacy and safety of ruxolitinib (Jakafi) plus standard-of-care (SoC) in patients aged ≥12 years with COVID-19-associated cytokine storm. The collaborative study is sponsored by Incyte in the US and Novartis outside of the US.

Additionally, given the urgent nature of the COVID-19 pandemic, Incyte is also initiating a separate emergency Expanded Access Program (EAP) in the US. The protocol will allow eligible patients with severe COVID-19-associated cytokine storm to receive ruxolitinib while it is being investigated for this indication.

Emerging evidence suggests that regulating overactive signaling through the JAK-STAT pathway during a cytokine storm associated with COVID-19 could be a potential treatment approach, and it is hypothesized that ruxolitinib, a JAK1/JAK2 inhibitor, may be able to play a role in treating these patients.

Currently, there is limited clinical evidence on the safety and efficacy of ruxolitinib for the treatment of COVID-19-associated cytokine storm, and ruxolitinib is not FDA-approved for this use.

Incyte is increasing manufacturing efforts to respond to anticipated supply needs related to studies and working with distribution partners to monitor the supply of ruxolitinib.

CLOSE UP with Dr. Sebastiano Recalcati

Dr. Sebastiano Recalcati, a dermatologist in Lombardy, Italy, was one of many doctors called to the frontlines in that country when COVID-19 ravaged the region. He published his observations in the Journal of the European Academy of Dermatology and Venereology. Dr. Recalcati spoke to DermWire and Practical Dermatology® magazine about skin manifestations seen in COVID-19 patients. He also spoke of ongoing observations of skin manifestations in younger COVID-19 patients. These findings will help shed light on the pathogenesis of this novel respiratory virus and may guide dermatologists from other countries that are behind Italy in terms of managing the outbreak.

WHY IS THIS TOPIC IMPORTANT TO STUDY?

Dr. Recalcati: There are no data in the literature so far about skin manifestations in COVID-19. I live in Lombardy, Italy, and this is one of the most involved regions in the world. Despite extraordinary restriction measures, many health workers were affected and due to this condition a strong effort was asked [of all] physicians and nurses. Dermatologists were involved in front line as well, especially in the triage stations and in the medical wards with positive cases because of the lack of medical doctors. As dermatologists we tried to analyze the cutaneous involvement in COVID-19 patients hospitalized in Lecco, Lombardy. Our observations could help physicians to consider and suspect a COVID-19-related exanthem in the differential diagnosis of a rash, particularly if associated with fever and dyspnea, to make a proper diagnosis and to perform suitable restrictions measures.

DESCRIBE THE RESEARCH AND YOUR FINDINGS.

Dr. Recalcati: We looked at what was going on with the skin in 148 inpatients with COVID-19. We excluded 60 who had started new drugs within 15 days to rule out acute drug reactions. Of the 88 COVID-19 patients, 20.4 percent developed skin manifestations. Eight of the 18 (44 percent) had skin eruptions at symptom onset, and the rest after hospitalization. Fourteen (78 percent) had erythematous rashes, three had widespread urticaria, and one had chickenpox-like vesicles. The most commonly affected area was the trunk. Itching was mild or absent, and lesions usually healed up in a few days. Apparently, skin manifestations did not correlate with disease severity. These skin manifestations were similar to cutaneous involvement occurring during common viral infections.

WHAT IS THE NEXT STEP?

Dr. Recalcati: We are focusing now on the pediatric and young adult population. From the end of March we started observing several acral frostbite-like lesions, mainly in children, and we are trying to understand and interpret them. A paper is already under review. Moreover, recently the scientific community is focusing on the pathogenetic role of coagulation cascade and vascular involvement in COVID-19, so we are concentrating now on cutaneous vascular lesions. We found interesting histological findings and maybe we could add something to the disease’s pathogenesis. Lastly I will say that I appreciate a lot the global efforts of the physician community to share data and to try to better understand COVID-19 features. This is the way hopefully we will win this “war.”

Amgen’s Otezla Adds Scalp Data

With FDA approval of a supplemental New Drug Application (sNDA), the label for Amgen’s Otezla will now be updated to include scalp psoriasis data from the Phase 3 STYLE trial. The label expansion makes Otezla the only oral treatment option to have data specific to moderate to severe scalp psoriasis in the label.

Estimates suggest that up to 80 percent of patients with plaque psoriasis have scalp involvement. “The scalp is a particularly difficult location to treat as the patient’s hair may act as a barrier to effective treatment with topical or phototherapy options. This label update reinforces the use of Otezla as an oral, non-biologic option that may reduce the severity and itch of scalp psoriasis, in appropriate patients,” says Linda Stein Gold, MD, director of Dermatology Clinical Research at Henry Ford Health System in Detroit and STYLE investigator.

Kubota Vision, LEO Pharma to Screen VAP-1 Inhibitors for Inflammatory Skin Diseases

Kubota Vision Inc. signed an Open Innovation Agreement with LEO Pharma A/S to screen novel Vascular Adhesion Protein-1 (VAP-1) inhibitor compounds for potential therapeutic use in inflammatory skin diseases, such as psoriasis and atopic dermatitis.

During R&D activities to develop novel therapeutics for uveitis, diabetic macular edema, dry eye, and post-operative eye inflammation, Kubota Vision discovered several novel VAP-1 inhibitors that are very potent and highly selective. VAP-1 inhibitors, also known as Semicarbazide-Sensitive Amine Oxidase (SSAO) inhibitors, are a promising new class of drugs to treat inflammation-driven diseases.

VAP-1 inhibitors can potentially be used for multiple inflammatory conditions, including acute respiratory distress syndrome induced by viral infections, such as COVID-19, psoriasis, atopic dermatitis, diabetic kidney disease, osteoarthritis, nonalcoholic steatohepatitis (NASH), certain cancers, and several other diseases.

LEO Pharma established its Open Innovation screening program to collaborate with external partners to identify promising new therapies for inflammatory skin diseases.

New Melanoma Test May Reduce Unnecessary Lymph Node Biopsies

A new skin cancer test may reduce up to 42 percent of sentinel lymph node biopsies used in the diagnosis of patients with melanoma, researchers at SkylineDx and Mayo Clinic report. The study appears in JCO Precision Oncology.

The test, which is under development, calculates a patient’s risk of nodal metastasis on an individual basis through a combination analysis of eight genes from the patient’s primary tumor, the tumor thickness and the patient’s age. Design of the test’s underlying algorithm, a biological assertion of the genes involved and the performance of the diagnostic test, have been published in JCO Precision Oncology. It has already been validated in an independent European dataset presented at the European Society of Medical Oncology conference in 2019.

Prescriber’s Choice Launches “PC Direct” and “PC Delivers”

Two new options from Prescriber’s Choice enable physicians to prescribe and ship medicines directly to patients for the treatment of dozens of dermatologic conditions. The ability to ship Prescriber’s Choice medicines to patients is an alternative to existing in-office dispensing to support the current needs of physicians and patients.

PC Direct for in-office use and PC Delivers for remote prescribing enable prescribers to access the medicines they are seeking for their patients while minimizing the exposure of patients who are currently following shelter-at-home policies. All Prescriber’s Choice products are sourced from its affiliated FDA-Registered 503B-Outsourcing Facility.

Prescriber’s Choice says that PC Direct leverages groundbreaking patent-pending technology and an in-office point of sale terminal to enable prescriptions submitted via the physician’s electronic medical records (EMR) to be shipped to the patient following their visit. PC Direct enables office management, tracking of patient records and financial reconciliation through the new technology, FRED (Financial Reconciliation E-prescription Data). Medicines are shipped free by UPS to patients’ homes.

Created out of necessity during COVID-19, PC Delivers is a more basic offering of PC Direct, supporting fundamental prescribing and delivery needs for those using telemedicine, Prescriber’s Choice says. Through PC Delivers, prescriptions are submitted via the physician’s EMR, selecting Sincerus Florida as the pharmacy, and medicines are shipped free by UPS to patients’ homes.

Clarification:

Please note the following, regarding inevstigational ruxolitinib cream, discussed in the April edition of Practical Dermatology® magazine in the article, “Phase 2 and 3 Trials of JAK Inhibitors for Atopic Dermatitis: A Review.”

Ruxolitinib cream is not marketed and does not have a branded name; Jakafi/Jakavi are trademarked names of the oral formulation, marketed by Incyte and Novartis (not Pfizer). The editors apoligize for introducing this error.

Clinical trial number NCT03575871 is not associated with ruxolitinib cream.

Primary phase 2 results have been published in The Journal of Allergy and Clinical Immunology (145(2):572-582). Key Findings from TRuE-AD1 and TRuE-AD2:

Almost 1,250 patients (age ≥ 12 years) diagnosed with AD for at least two years and who are candidates for topical therapy were enrolled in the identically-designed TRuE-AD1 and TRuE-AD2 trials. Patients with an Investigator’s Global Assessment (IGA) score of 2 to 3, and with AD on 3% to 20% of their Body Surface Area (BSA) (excluding scalp) were randomized 2:2:1 into one of three treatment arms for eight weeks, including: ruxolitinib cream 0.75% administered twice daily (BID); ruxolitinib cream 1.5% BID; and vehicle (non-medicated cream).

The primary endpoint of both TRuE-AD1 and TRuE-AD2 was IGA-TS at week 8. Secondary endpoints in both trials included the proportion of participants who achieved a ≥75% improvement in Eczema Area and Severity Index (EASI75) score at week 8 and the proportion of participants with a ≥ 4-point improvement in Itch Numerical Rating Scale (NRS4) score at week 8. Key efficacy results include:

TRuE-AD1: 50.0% of patients treated with ruxolitinib cream 0.75% BID and 53.8% of patients treated with ruxolitinib cream 1.5% BID achieved IGA-TS, compared to 15.1% treated with vehicle control (p < 0.0001 and p < 0.0001, respectively).

56.0% of patients treated with ruxolitinib cream 0.75% BID and 62.1% of patients treated with ruxolitinib cream 1.5% BID achieved at least a 75% improvement in their EASI score from baseline, compared to 24.6% treated with vehicle control (p < 0.0001 and p < 0.0001, respectively).

TRuE-AD2: 39% of patients treated with ruxolitinib cream 0.75% BID and 51.3% of patients treated with ruxolitinib cream 1.5% BID achieved IGA-TS, compared to 7.6% treated with vehicle control (p < 0.0001 and p < 0.0001, respectively).

51.5% of patients treated with ruxolitinib cream 0.75% BID and 61.8% of patients treated with ruxolitinib cream 1.5% BID achieved at least a 75% improvement in their EASI score from baseline, compared to 14.4% treated with vehicle control (p < 0.0001 and p < 0.0001, respectively).

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