SciBase Holding AB says Highmark Blue Cross Blue Shield has adopted a limited medical policy for its Nevisense skin-assessment device, marking the Swedish company’s first positive policy from a private U.S. insurer.
According to SciBase, the policy applies when a dermatologist is weighing a biopsy for a suspicious pigmented lesion assessed as atypical, with melanoma among the possible diagnoses. The lesion must measure 2 mm to 20 mm and be on the trunk or an extremity; patients must be at least 18. The policy excludes lesions on mucosal surfaces, palms, soles or nails, along with lesions that are ulcerated, bleeding or recently traumatized. SciBase says CPT code 0658T is used to report the procedure, which requires an FDA-approved device and a dermatologist trained to assess pigmented lesions clinically and with dermoscopy.
SciBase says the policy applies to Highmark’s commercial insured plans and self-funded employer groups that opt in. The company says Highmark and its Blue-branded affiliates serve more than 7 million members across multiple states, but did not say how many could meet the clinical criteria. It also disclosed no payment rates, patient cost-sharing terms or claims figures, and did not say whether any claims had been paid.
A public Highmark commercial policy page for Pennsylvania continues to classify code 0658T as experimental or investigational and noncovered. The page lists an effective date of April 1, 2024, and a last revision date of March 2024. It does not establish how that listing relates to the policy SciBase announced.
SciBase said the Highmark policy is its first from a private insurer. In 2023, the company reported that Medicare contractors First Coast Service Options and Novitas Solutions had updated fee schedules for code 0658T, retroactive to Jan. 1, 2023. SciBase said the contractors’ regions together cover about one-third of the U.S. Medicare population.
Nevisense received FDA approval in 2017. FDA labeling describes the device as an aid to a dermatologist’s biopsy assessment and says it should not be used when melanoma is clinically obvious.
SciBase CEO Pia Renaudin called the policy “a defining milestone for SciBase.” In an Oct. 15 update, the company said it wants a significant share of the roughly $1 billion combined market it estimates for skin cancer detection and skin-barrier assessment, and set a 75% gross-margin target. SciBase said it will continue discussions with other U.S. insurers but gave no timetable for another payer decision.
