FDA approves first vitiligo treatment for skin repigmentation
The FDA has approved topical ruxolitinib (Opzelura) for the treatment of nonsegmental vitiligo in patients aged 12 years or older. The cream formulation of ruxolitinib — a Janus kinase (JAK) 1/JAK 2 inhibitor — was first approved in September 2021 for the treatment of mild-to-moderate atopic dermatitis. Previously, no treatment was approved to repigment patients with vitiligo.
[FDA approves first topical JAK inhibitor for atopic dermatitis. Read more in DermWorld Weekly.]
Approval was based on the results of two phase 3 trials of patients with nonsegmental vitiligo covering 10% or less of their total body surface area. At 24 weeks, 30% of the patients receiving twice daily treatment achieved at least a 75% improvement in the facial Vitiligo Area Scoring Index (F-VASI75) compared with 8% and 13% among those in the vehicle groups. At 52 weeks, about 50% of the patients treated with topical ruxolitinib achieved F-VASI75.
The most common side effects during the vehicle-controlled part of the trials were development of acne and pruritus at the application site, headache, urinary tract infections, erythema at the application site, and pyrexia.
Read about how the potential FDA approval of multiple JAK inhibitors could offer new treatment options for dermatology patients inDermWorld.
DermWorld Insights and Inquiries: A single case report has the potential to change the world — Could JAK inhibition alter the trajectory of multicentric reticulohistiocytosis?
Multicentric reticulohistiocytosis (MR) is a rare, non-Langerhans cell histiocytosis, characterized by red-brown papulonodular cutaneous lesions and destructive arthritis. It is more likely to affect women and is usually diagnosed between the patient’s fourth and fifth decade of life. The papulonodules can be scattered or grouped and are usually distributed on the face, hands, and juxta‐articular areas. MR can also present with mucosal lesions in up to half of all cases. The papules are classically found periungually (so-called “coral beads”) and in the nasolabial folds. There have been multiple reports of MR mimicking dermatomyositis, however, skin biopsies demonstrate reticulohistiocytomas. Interestingly, approximately 15% of cases of MR have a coexisting autoimmune or connective tissue disease such as systemic lupus erythematosus, Sjögren’s syndrome, or scleroderma.Keep reading!
OIG initiates audit of dermatologist claims using modifier 25
The Office of the Inspector General (OIG) confirmed it has initiated an audit of dermatologists’ use of modifier 25 when reporting an E/M and minor procedure. The OIG audit is intended to verify CMS’s procedures and provide a report back to the agency. It is not an audit of individual practices. However, after the report is complete there is potential that CMS may seek repayment for any claims deemed erroneous.
The OIG audit team have begun contacting dermatology practices; however, while the AADA has requested additional details, the OIG would not provide a timeline as to when the audits will be completed, nor provide details as to the number of claims being reviewed or number of dermatologists contacted. The OIG stated it will notify the AADA when the report is completed and would contact the AADA if any additional information is needed.
When the OIG workplan was announced in early 2021, the AADA immediately took a number of steps to educate the OIG on the appropriate use of modifier 25 and build understanding that dermatologists routinely see patients with multiple diagnoses, necessitating the appropriate use of the modifier 25. A Modifier 25 Advisory Workgroup was formed to educate decision makers on appropriate use.
The AADA facilitated a call with the OIG audit team to discuss its workplan. While the OIG could not share details on the planned audit, workgroup members detailed the nuances involved in the appropriate use of modifier 25 in dermatology.
The workgroup shared how the AAD/A promotes appropriate use of modifier 25 as essential to efficient, patient-centered dermatologic practice.
At the AADA’s invitation, the OIG audit team participated in a 2.5-hour virtual meeting with a dermatologist practice to demonstrate the many scenarios that result in appropriate use of modifier 25. The OIG audit team was very appreciative of the information provided during the virtual visit.
Next steps: The AADA will continue to monitor and check with the OIG as the audit continues and as it nears completion. When OIG reports its findings, the Modifier 25 Workgroup will prepare the AADA response.
Dermatology practices contacted by the OIG should comply with the request, as it is likely that any non-responses will be considered by the OIG as not meeting modifier 25 criteria. If you do receive a request from the OIG or have any questions, contact privatepayer@aad.org.
DermWorld Young Physician Focus: Counseling patients on cosmetic concerns
Our patients’ consumption of various types of electronic and social media was already skyrocketing prior to COVID. During the pandemic, that utilization increased significantly. Whether patients are using video chat platforms, looking at photos, others’ social media posts, or advertisements, they are constantly bombarded by images of people who are altered, filtered, air-brushed, and unrealistic. Look in your settings — even Zoom offers you the option to “touch up” your appearance. Online, patients are constantly presented with a ‘new and improved’ reality. Is it any wonder they are increasingly concerned with what they see in the unretouched mirror? Read more from DermWorld Young Physician Advisor Bridget McIlwee, DO, FAAD.
June AMA House of Delegates has implications for dermatology
Last month, the House of Delegates of the American Medical Association met to pass resolutions and discuss a variety of medical- and health-related topics doctors face today. Dermatologists were represented by delegates of several dermatology societies, including the Academy, at a meeting that also saw Jack Resneck Jr., MD, FAAD, sworn in as the first dermatologist president of the AMA since 1925.
Many of the resolutions that passed have implications for dermatology. In particular, two adopted resolutions concerned scope of practice and scope creep. Resolution 222 urges the AMA to take action to push back against the unsupervised practice of non-physician clinicians (NPCs), and Resolution 228 proposes that the AMA support various state-level pieces of legislation requiring board oversight of NPCs who are practicing without physician supervision.
To show support for practicing physicians still reeling financially from the pandemic, Resolution 238 requires the AMA to advocate for COVID-19 loan forgiveness at a federal level for practices with five or fewer physicians.
Two resolutions deal with common drug-related issues. Resolution 223 asks the AMA to urge the FDA to take direct and swift actions to address the national shortage of lidocaine and saline preparations, and Resolution 108 requests the AMA to advocate that health payment plans include reimbursement for a variety of high-cost, in-office purchased medications, including aminolevulinic acid hydrochloride gel (Ameluz).
Finally, a handful of resolutions, 701, 710, 727, and 731, all concern easing the burden of administrative costs on physicians, especially when it comes to obtaining prior authorization. In addition, the Board of Trustees Report 2 recommended that the American Contact Dermatitis Society, among others, be granted representation in the House of Delegates.
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