Off-Label Medication Use
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