Does Medicare Cover Non-FDA Approved Drugs?

The United States Food and Drug Administration (FDA) is a federal agency within the Department of Health and Human Services.

The FDA is responsible for protecting and promoting public health by regulating and supervising the safety of food, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, and more.

The FDA does not approve every type of medication, yet many of them are still used and available on the market.

Medicare will generally provide coverage for drugs that are FDA-approved. But what about those that aren’t? What if you want to take an experimental drug or one that otherwise has not gotten FDA approval.

This leads to a fairly common question people have which is “Does Medicare cover Non-FDA drugs?”

In this article, we answer the question in clear, plain English.

Does Medicare Cover Non-FDA Drugs?

The short answer in most cases is no. Medicare will not cover the cost of drugs that have not gotten approval from the FDA. However, there may be some situations where you can get these costs covered.

Below we’ll take a closer look at this to see when you might be able to get Medicare to pay for your non-FDA-approved drugs.

Original Medicare Coverage of Non-FDA Drugs

Original Medicare (Medicare Part A and Part B) does not provide coverage for non-FDA drugs. So that means you will have to pay 100 percent for medications that fall under this category.

That said, there are some instances in which FDA-approved medications are prescribed for non-FDA-approved treatments. For example, let’s take the example of a cold medicine that is prescribed to treat something like shortness of breath due to severe asthma.

This drug may be approved to treat colds by the FDA but not asthma. However, your physician prescribes it as a way to treat your asthma. In this case, Medicare may cover the cost of the drug.

Medicare Advantage Coverage of Non-FDA Drugs

Like Original Medicare, Medicare Advantage plans (Medicare Part C) do not cover non-FDA drugs. Medicare Advantage plans generally cover everything Original Medicare does, plus some additional benefits. However, coverage and out-of-pocket costs will vary depending on the providers’ plan.

Medicare Part D plans also do not provide coverage for non-FDA-approved drugs. Medicare Part D is a prescription drug plan. Like Medicare Part C, Medicare Part D plans are provided by private insurance companies.

Your plan may also deny coverage for drugs that do not meet the FDA’s Drug Efficacy Study Implementation (DESI) standards. The DESI evaluates the effectiveness of the drugs that had been previously approved on safety grounds alone.

Note: Medicare coverage changes all the time. And your specific coverage may vary from plan to plan for Medicare Advantage. Always double-check with your health care provider and/or Medicare insurance provider about what your plan covers and what it does not.