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no approved human use TGA Australia: approved as a compounded preparation (pharmacy compounding) Approximately 15+ peer-reviewed publications in PubMed Reference sources (PubMed) Ng FM

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We anticipate that if any non-opioid treatments for pain relief qualify during CY 2026, any potential CMS review process would be similar to the other existing quarterly approval processes, such as OPPS New Technology APC process or the CMS HCPCS application process, where CMS evaluates and approves products on a more frequent basis than annual rulemaking