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Regulatory and safety status: TA-1 is pending FDA review and not currently approved for use in humans

Watch for these: Missing or incorrect ICD-10 diagnosis code Drug classified as self-administered under Medicare policy Missing NDC on the drug J-code line Injection billed in a facility setting where the physician can't separately bill the administration code MUE limit exceeded without documented medical necessity for additional units Per CMS Medicare Part B drug benefit policy , coverage determinations for specific drugs are governed by Local Coverage Determinations issued by each Medicare Administrative Contractor

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Explor Endocr Metab Dis2025 Jun 24;2:101433