Over the past few months, we have been hearing from Medicare beneficiaries who are using certain “off- label” prescription medications and asking about how to get Part D coverage for these drugs.  The term “off–label” refers to drugs that are being used to treat conditions other than those approved by the Federal Drug Administration (FDA).   For instance, some pain relief medication is approved by the FDA for cancer-related pain, but is not approved by the FDA for Medicare beneficiaries who have non-cancer related pain.  Therefore, such a medication would be considered “off-label” if it was used to treat non-cancer related pain.

Why is this topic so important?
As noted by the Medicare Rights Center, a Medicare advocacy group that is responsible for much of the attention on this subject, if a medication is used for a treatment that is not approved by the FDA, the drugs falls outside the coverage of the Medicare Part D prescription drug program – and, therefore, “off-label” medications are not part of your prescription drug plan coverage.

How widespread is the use of “off-label” medications?
In a recent article from the Baltimore Sun, it was suggested that more than 20% of the 725 million prescriptions written for the 500 most common medications prescribed in the United States are being used as off-label medications.  That is, these medications are being used to treat conditions outside of their FDA approved use.

So what to do if you are using an “off-label” Medication?
If indeed your Medicare Part D prescription drug plan considers an off-label medication as a "non-formulary" drug, your first step is to work with your physician to find an effective alternative that is covered under your Part D plan formulary.

If an alternative drug is not available, the next step is for you to submit your off-label medication to your prescription drug plan’s formulary-exception process for inclusion under your Part D coverage.  In other words, you will ask that your Part D plan include your medication into your personal covered drug list.  When in doubt as to the procedure, contact your Part D plan’s Member Services department.

In general, the formulary exception process will take a bit of time and effort, but the possibility exists to get otherwise excluded medications under the coverage of a Part D plan.  Be sure to ask for assistance from your attending doctor(s).  As many physicians know, there is a ”medically accepted indication" exclusion that the Medicare law provides stating that if any published evidence can be shown that the medication helps a particular condition, it should be considered during the formulary exception process.  Usually, this means that there is some information on the "off-label" use of a medication in the major drug compendia (or major drug encyclopedias).

Unfortunately, the reality is that, although covering a vast number of uses, the compendia do not list all off-label drug uses and many people only find satisfaction by seeking an exception to the formulary, appealing any Part D plan denials, and finally fighting the denials in an administrative court - which could take months.

The Medicare Rights Center has recorded many cases were Medicare beneficiaries went through the complete formulary exception/appeal process; and still were denied covered of their "off-label" medications.  In the end, some Medicare beneficiaries sought relief from previous employer health plans, State Pharmacy Assistance Programs or SPAPs (were available), or drug manufacturer Patient Assistance Programs (PAPs).  However, some of these programs are only available to the low-income Medicare beneficiary.

Still not sure where to begin or you have a question?  Click here to let us know.