How to Get to Yes When Off-Label Drug Use is DeniedPosted by Medicare Made Clear
If your doctor hands you a drug prescription and your Medicare Part D plan won’t cover it, the drug may be considered “off-label.”
Doctors may prescribe drugs to treat conditions other than those the FDA has approved the drugs for. This is called “off-label” drug use.
It is legal for a doctor to prescribe an FDA-approved drug for off-label use. But your Medicare plan may not pay for it.
If your plan denies coverage for a drug your doctor prescribes off-label, you have a few options,
- Ask your doctor if there is another medication that may help treat your condition and that Medicare will pay for.
- Request an exception, which means to ask your Medicare Part D plan in writing to pay for your medication. Your doctor will need to write a letter indicating why the drug is medically necessary and why other drugs on the formulary will not work for you. If your plan won’t give you an exception and you decide to keep taking the drug, but you’ll have to pay for it yourself, you can ask that the price of the drug be lowered if you have trouble paying for it.
- If the drug coverage is still denied, you make an appeal. Your appeal process will be the same whether you have a stand-alone Part D prescription drug plan or a Medicare Advantage plan that includes drug coverage. If you need your drug right away, you can file an expedited appeal.
Learn about the appeal process and what steps you need to take.
For more information, explore MedicareMadeClear.com or contact the Medicare helpline 24 hours a day, seven days a week at 1-800-MEDICARE (1-800-633-4227), TTY 1-877-486-2048.
Words With Peter: Tiered Formulary: MedicareMadeClear.com
Part D Appeals: Medicare Interactive Org
Medicare & You: Get the official U.S. government Medicare handbook.