Compounded Medications — Highmark
any FDA-approved indication(s) meeting all criteria A–E
Initial criteria
- The compounded medication does not contain any items precluded from coverage unless a covered benefit (for example, items for a cosmetic purpose or erectile dysfunction).
- The identical product is not commercially available.
- The compounded product contains at least one FDA approved ingredient and is being used for an FDA-approved indication.
- The compounded product does not contain any 'experimental' or 'investigational' ingredients.
- The member has tried and failed all commercially available formulary products that are FDA approved for the diagnosis being treated.
- Exclusion: Compounded medications made from bulk chemicals will not be covered.
- Exclusion: The use of Makena (hydroxyprogesterone caproate) or hydroxyprogesterone caproate to reduce the risk of preterm birth will not be covered.
Reauthorization criteria
- The prescriber attests that the member has experienced positive clinical response to therapy.
Approval duration
initial up to 3 months; reauthorization up to 6 months