Off Label Medication Requests
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Governs review and prior-authorization of off-label (unlabeled) medication uses for CareSource Georgia members, describing required evidence and documentation for initial approvals and reauthorizations; applies to providers submitting requests to CareSource Georgia.
Added reauthorization criteria requiring documentation of positive response and compliance with therapy.
Clarified that member must try and fail available FDA-approved on-label drugs first unless contraindicated or not tolerated.
Amended acceptable compendia to include Lexicomp and specified evidence levels/classes (e.g., Lexicomp Evidence level A; Micromedex Recommendation class I/IIa/IIb).
Off-Label Coverage Criteria
Off-label coverage criteria
Criteria for approval of off-label medication requests.
ALL of the following
- Documentation that the member has tried and failed existing FDA-approved and/or clinical guideline-recommended therapies unless contraindicated or not tolerated.
ANY of the following
- Narrative information from American Hospital Formulary Service (AHFS) Drug Information or Clinical Pharmacology.
- Lexicomp: Evidence level A.
- Micromedex: Recommendation class I, IIa, or IIb.
- At least two published studies from major peer-reviewed scientific or medical journals demonstrating safety and efficacy for the specified condition in a comparable population (e.g., similar age group or disease severity).
- Interim supportive clinical trial results may be considered by the clinician reviewer when applicable (if applicable clinical trial is yet to be published).
Initial Therapy Requirements
Initial therapy requirements
Initial approval prerequisites for off-label use.
ALL of the following
- Documentation that the member has trialed and failed available on-label FDA-approved and/or guideline-recommended therapies unless those therapies are contraindicated or not tolerated.
ANY of the following
- Narrative information from AHFS Drug Information or Clinical Pharmacology.
- Lexicomp: Evidence level A.
- Micromedex: Recommendation class I, IIa, or IIb.
- At least two published peer-reviewed studies demonstrating safety and efficacy in a comparable population.
- Interim supportive clinical trial results may be considered by the clinician reviewer when applicable.
Continuation / Reauthorization
Continuation/reauthorization
Rules for continued treatment after initial approval.
ALL of the following
- Documentation demonstrating the member has had a positive clinical response to the therapy.
- Documentation demonstrating the member is compliant with the prescribed therapy.
- Approved authorizations are designated for an appropriate authorization period; continued treatment may be authorized when the member has shown tolerability and a positive clinical response.
Prior Authorization and Evidence Submission
Prior authorization and reauthorization requirements
Submit a prior authorization request that includes documentation the member has tried and failed existing FDA‑approved and/or clinical guideline–recommended therapies unless those therapies are contraindicated or not tolerated. For reauthorization, include documentation showing a positive clinical response and member compliance with therapy. Approved authorizations are issued for an appropriate authorization period; continued treatment may be considered when the member demonstrates tolerability and a positive clinical response.
- Initial PA must document trial and failure of available FDA‑approved and/or guideline‑recommended therapies unless contraindicated or not tolerated.
- Reauthorization must include documentation of positive response to therapy and documentation of member compliance.
- Approved authorizations are for an appropriate authorization period; continued treatment considered upon tolerability and positive response.
Evidence requirements for off‑label requests
Off‑label requests must be supported by one or more accepted evidence sources: AHFS narrative or Clinical Pharmacology; Lexicomp with Evidence level A; Micromedex with Recommendation class I, IIa, or IIb; or at least two published peer‑reviewed studies demonstrating safety and efficacy in a comparable population. Interim supportive clinical trial results may be considered by the clinician reviewer if applicable.
- AHFS narrative information or Clinical Pharmacology
- Lexicomp: Evidence level A
- Micromedex: Recommendation class I, IIa, or IIb
- At least two published studies from major peer‑reviewed journals showing safety and efficacy in a comparable population
- Interim supportive clinical trial results may be considered by the clinician reviewer
Key Definitions
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