Dear Marci,
I have been taking Lidocaine patches for years to help my back pain. There has never been a problem getting my Part D plan to cover the patches, and nothing has changed this year in terms of my condition or coverage. Earlier this year, I got a notice from my plan saying that the patches have been denied because of off-label use. What exactly does off-label mean, and can I do anything to get the medication covered?
– Jill (Houston, TX)
Dear Jill,
Off-label drug use means that a prescription drug is prescribed for a reason other than the use that is approved by the U.S. Food and Drug Administration (FDA). Medicare does not cover drugs that are prescribed for reasons other than the FDA-approved use. You can appeal this decision, but these appeal requests are not always granted.
In general, there can be several reasons for Part D drug denials. For example, a drug can be denied based onquantity limits (amount you need exceeds the authorized limit), step therapy (you must try a less expensive drug before the more expensive one is covered), or not on theformulary (a plan’s list of covered drugs).
Off-label drug denials are more complex. You may think that because your doctor writes you a prescription to treat a particular condition, you must be using the drug for an approved purpose. However, this is not necessarily the case. In some cases, your doctor may prescribe a drug for off-label drug use, meaning that the reason you use the drug is not an approved use by the Food and Drug Administration (FDA). Medicare Part D plans only cover drugs that are prescribed for medically indicated use, meaning that it is FDA approved or is listed in one of three Medicare-approved drug compendia. A drug compendia is a medical encyclopedia of approved drug uses.
Off-label means that the reason that you are using the drug for has not been approved by the FDA and is not mentioned in a Medicare drug compendia. So, although off-label drugs are still legal for a doctor to prescribe and can be helpful in treating your medical condition, Medicare does not cover them.
In terms of your denial, Jill, the Lidocaine patches were denied due to off-label use because Lidocaine patches are only approved by the FDA to treat post-herpetic neuralgia, a complication of shingles. This means that the only way Medicare covers Lidocaine patches is if you have post-herpetic neuralgia. It does not make a difference what Part D plan you have; Lidocaine patches are not covered by Medicare unless you have this diagnosis. Although the Lidocaine patches may significantly improve your back pain, Medicare Part D does not cover it since this is not an FDA approved use.
You can request an exception for your plan to cover the patches, but these requests are rarely granted for off-label drugs. Before starting the appeal process, have a conversation with your doctor regarding the denial. You may want to explore other Medicare-covered prescription drugs.
If you appeal the denial, your first step is requesting an exception to ask your plan formally to cover the Lidocaine patches. Your doctor should write a letter of support, indicating why Lidocaine patches are medically necessary for you, and why other drugs on the formulary would be less effective or even harmful for you. If the plan denies the exception request, you can move on to the appeals process.
-Marci