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Self-Administered Drug Exclusion List:
A52571
First Coast Service Options, Inc. (J09)
Effective: September 18, 2025
Updated: December 31, 2025
Policy Summary
Medicare Part B excludes drugs that are usually self‑administered (oral, topical, suppository, and subcutaneous when >50% of beneficiaries self‑administer) while generally covering injectable drugs (IV/IM) that are not usually self‑administered and meet medical necessity/FDA/incident‑to criteria. Contractors must apply a structured evidentiary process (including utilization %, literature, FDA labeling and claims data), require JA/JB modifiers for multi‑route HCPCS codes, and provide a 45‑day notice plus appeal rights before removing coverage for a previously covered drug.
Coverage Criteria Preview
Key requirements from the full policy
"Medicare covers drugs and biologicals that are not usually self‑administered (i."
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