HORSHAM, PA — STRATA Skin Sciences, Inc. (NASDAQ: SSKN) announced it is collaborating with the Centers for Medicare & Medicaid Services (CMS) to expedite reimbursement access for its XTRAC® excimer laser system following a major code expansion by the American Medical Association.
The company is pursuing temporary CMS codes that would accelerate the timeline for reimbursement eligibility from 2027 to as early as 2026. This follows the AMA’s recent decision to broaden CPT codes 96920–96922 to include autoimmune and inflammatory skin conditions like vitiligo, atopic dermatitis, and alopecia areata, in addition to the treatment of psoriasis.
If successful, the move would significantly expand XTRAC’s eligible patient population—potentially tripling its market reach—and create new financial incentives for providers. According to STRATA CEO Dr. Dolev Rafaeli, this effort is about both enhancing patient access and improving economics for physicians, many of whom currently rely on non-reimbursable or high-cost pharmaceutical options.
Backing this initiative is growing clinical evidence supporting XTRAC’s efficacy. Two peer-reviewed studies published last month bolster its use in treating vitiligo when combined with Janus kinase (JAK) inhibitors, a new class of immunomodulating drugs.
A 52-week, multicenter randomized trial published in the International Journal of Dermatology showed that patients receiving combined excimer laser and oral baricitinib therapy achieved a 100% response rate and 96% pigment stability, with no serious adverse events. Another case study in Human Vaccines and Immunotherapeutics reported that a patient achieved 70% repigmentation over 13 months using a similar regimen involving excimer laser and tofacitinib.
Meanwhile, STRATA is pressing forward in litigation it filed last year in federal court against LaserOptek America, alleging false advertising related to Pallas lasers. The U.S. District Court for the Eastern District of Pennsylvania has now added LaserOptek Co. Ltd., the South Korean parent company, and its U.S. representative, C. Dalton, LLC, as co-defendants. STRATA contends that the defendants made misleading claims about reimbursement eligibility for treatments using Pallas devices, exposing providers to regulatory risk.
The company believes this legal development strengthens its position in the market and underscores the need for clear, compliant marketing practices. With a patent portfolio that includes intellectual property covering the integration of excimer laser therapy with JAK inhibitors and other systemic treatments, STRATA appears well-positioned to capitalize on emerging dermatological trends.
As regulatory, clinical, and legal developments converge, STRATA is aiming to secure its place at the forefront of non-pharmaceutical therapies for chronic skin conditions—offering providers and patients alike an alternative path in the evolving treatment landscape.
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