OFF-LABEL MEDICATIONS

What is an off-label medication?

A drug is used off-label when the doctor prescribes that drug for a medical use other than the one that received Food and Drug Administration (FDA) approval.  Off-label prescribing is a commonly used and accepted medical practice.  These drugs do have FDA approval – but for a different use.  For example, doctors frequently prescribe FDA-approved anticonvulsant medications for persons who do not have seizures, but who need a mood stabilizer.  When an anticonvulsant medication is prescribed for use as a mood stabilizer, that is considered an off-label use.

How do the PDPs respond to prescriptions for medications that are off-label?

Every PDP is permitted to develop its own procedures for off-label medications.  Some PDPs may allow the pharmacists in their network to fill these prescriptions just as they would for any other prescription drug.  But other PDPs may require prior authorization or other procedures that may greatly delay the consumer’s receipt of the medication and may be time-consuming and burdensome for the physicians.  You can research each PDP’s formulary and procedures on the CMS website at www.medicare.gov.