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Commenters also stated that they believe the level of clinical staff work required for irreversible electroporation is extensive and therefore suggested CMS to accept the standard 90-day global pre-service clinical labor times in the facility setting for CPT code 47384

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A licensed 503A compounding pharmacy manufactures under pharmaceutical-grade conditions with sterility testing, potency verification, and third-party documentation

So far, research trials havent prompted regulatory agencies to approve these substances or convinced companies to invest in further development