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Off-Label Medication Use

Provider Type

  • Physicians
  • Participating Physician Groups (PPG)
  • Ancillary

A medication prescribed for a use that is not stated in the indications and usage information published by the manufacturer is covered only if the medication is:

  • Approved by the Food and Drug Administration (FDA).
  • On the Recommended Drug List (RDL) and prescribed or administered by a participating licensed health care professional for the treatment of:
    • A life-threatening condition
    • A chronic and seriously debilitating condition for which the medication is determined to be medically necessary to treat such condition
  • Recognized for treatment of the life-threatening or chronic and seriously debilitating condition by one of the following:
    • The American Hospital Formulary Service (AHFS) Drug Information.
    • One of the following compendia, if recognized by the federal Centers for Medicare & Medicaid Services (CMS) as part of an anticancer therapeutic regimen:
      • Elsevier Gold Standard's Clinical Pharmacology..
      • National Comprehensive Cancer Network Drug and Biologics Compendium.
      • Thomson Micromedex DrugDex.
  • Two articles from major peer-reviewed medical journals that present data supporting the proposed off-label use as generally safe and effective unless there is clear and convincing contradictory evidence presented in a major peer-reviewed medical journal.

The following definitions apply to the terms mentioned in this provision only.

Life-threatening means either or both of the following:

  • Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted.
  • Diseases or conditions with potentially fatal outcomes, where the end-point of clinical intervention is survival.

Chronic and seriously debilitating refers to:

  • Diseases or conditions that require ongoing treatment to maintain remission or prevent deterioration and cause significant long-term morbidity
Last Updated: 07/01/2024