Medically Accepted Indications: How "Off-Label" Drug Use Can Lead to a Part D Denial

You have just been to the doctor, and they have prescribed a new medication that you need. You feel relieved, but that relief turns into confusion when you go to the pharmacy and find out your Medicare Part D plan will not cover it. The reason? It was prescribed for "off-label" use.

This can be incredibly frustrating and even a little scary. You trust your doctor, and you know the medication is important for your health. So, what does "off-label" even mean, and what can you do about it?

The good news is that you have a path forward. Understanding the rules is the first step toward getting the coverage you need. This article will help you understand why this denial happened and give you the tools to fight it.

What is a "Medically Accepted Indication"?

When a drug is approved by the Food and Drug Administration (FDA), it is approved to treat a specific condition or a set of conditions. These approved uses are called "medically accepted indications."

However, doctors are legally allowed to prescribe a drug for a different use than what the FDA approved. This is known as "off-label" use. For example, a drug approved to treat depression might also be effective in treating chronic pain, so a doctor might prescribe it for that purpose. This is a common and legitimate practice.

The challenge comes with Medicare Part D. While off-label prescribing is legal, your Part D plan is generally only required to cover drugs for their FDA-approved uses. If a drug is prescribed for an off-label use, your plan can deny coverage.

Why Off-Label Prescribing Can Be Covered

The good news is that Medicare does make an exception. A Part D plan is required to cover an off-label use if it is supported by a compendium.

A compendium is a trusted medical encyclopedia that lists different drugs and the conditions they are used to treat. Think of it as an official reference guide for doctors and pharmacists. These compendia often include both FDA-approved uses and scientifically-supported off-label uses.

Medicare recognizes a specific list of these compendia. If your doctor's off-label prescription is listed as a supported use in one of these publications, your plan is required to cover the drug.

What to Do if You Get a Denial

If your plan denies a claim for an off-label prescription, here is what you should do:

1. Call and Write Your Plan: The first step is to call and write your Part D plan and ask for a "coverage redetermination." This is a formal request for them to reconsider their denial decision. You or your doctor must make this request.

2. Ask Your Doctor for Help: This is the most important step. Your doctor knows why they prescribed the drug and can provide a letter of support for your case. They should check to see if the drug's off-label use is listed in one of the Medicare-approved compendia and, if so, provide a copy of the applicable compendium entry for the drug and reference that in their letter.

3. File a Formal Appeal: If your plan still denies coverage or authorization, you can appeal further to an impartial reviewer. The denial notice from your plan will include instructions on how to appeal, as well as the deadline. Your doctor's letter and any other supporting documentation are key to a successful appeal.

Remember, the appeals process can feel intimidating, but you have the right to challenge a denial. By working with your doctor and using the official resources available, you can build a strong case for the coverage you need.