What’s in a name? Medicare coverage of off-label prescriptions

When you get a prescription from your doctor for a medication, it is natural to assume that the medication is approved for treating the condition you are suffering from. However, very often this is not the case and your doctor has prescribed the drug for an off-label use.

Off-label prescribing is when a doctor prescribes you a medication that the U.S. Food and Drug Administration (FDA) has approved to treat a condition different from your condition. Examples of medications that are frequently prescribed off-label include drugs that treat gastrointestinal conditions, antidepressants, antibiotics, respiratory treatments and pain management.

Drug makers seek FDA approval for specific uses of their medications and conduct trials to test the medication’s safety and effectiveness in patients with specific conditions. If the FDA approves the drug for those conditions, the drug manufacturer has to sell the medication with a label that lists the FDA approved uses for that drug. Any use outside of that use is off-label.

“Many people may be surprised to know that the FDA regulates drug approval, not drug prescribing and … doctors are free to prescribe a drug for any [reason they think is medically appropriate],” says G. Caleb Alexander, MD, MS, a medical ethics advocate and assistant professor of medicine at the University of Chicago Medical Center. “Off-label use is so common, that virtually every drug is used off-label in some circumstances.”

Off-label prescribing is widespread in the medical community as an essential means of providing patients with optimal medical care. In fact, a former FDA deputy commissioner for policy stated as long ago as 1996, that “under certain circumstances, off-label uses of approved products are appropriate, rational and accepted medical practice.” Doctors routinely prescribe drugs for off-label purposes to treat medical conditions that are not listed on the label based on their professional medical judgment. Some 20 percent of prescriptions written are for off-label uses. In addition, the FDA does not update its labels in a timely manner.

An example of a medication often prescribed for off-label use is Gabapentin. Gabapentin (Neurontin) is a medication that was originally approved to treat seizures. Since then, it has been also been approved to treat nerve pain that occurs after shingles. However, it is frequently used off-label for a growing list of conditions, including but not limited to, complex regional pain syndrome, which is chronic pain in the arm or leg after an injury.

While the Medicare prescription drug benefit provides assistance for many people with their drug costs, the requirement for coverage of the off-label use of a drug are onerous and often result in beneficiaries not being able to get the drug coverage they need. Many doctors are unaware that the drugs they are prescribing have not been approved by the FDA for the condition they prescribed it for, and they lack up-to-date information on off-label usage.

Under federal law, Medicare must only cover FDA approved drugs that are prescribed for medically accepted indications. The Centers for Medicare & Medicaid (CMS) has interpreted this to mean a use that is either FDA approved or supported by at least one of the approved medical compendia. Compendia are encyclopedias of drug chemicals, with information on dosage and usage. Congress has given Medicare the authority to revise the list of approved compendia as appropriate. Unfortunately, the burden of proving if a particular drug has been included in the compendia falls to the patient. MSA Meds has access to the compendia and can assist your doctor to document support for any off-label prescription of the medication.

Further complicating this process is opposition from insurance carriers for the approval of off-label prescriptions and their inclusion as costs covered under the Medicare set-aside allocations. Why such opposition, when the insurance carrier is paying for these drugs while the claim is pending? It is because CMS calculates a lifetime supply of the current dose and frequency of the medication. Common and some of the costliest off-label prescriptions include Lidoderm patches, Neurontin, Lyrica, Seroquel and Abilify and fentanyl-based medications.

So as an injured worker being treated with an off-label prescription you are faced with a possible denial of coverage for a medication your doctor has prescribed, if the medication does not meet with CMS’ approval. Moreover, even if the insurance carrier is paying for the medication while the claim is pending, they may very well seek to exclude the medication from inclusion in the Medicare set-aside allocation.

As such, it is imperative that should your doctor prescribe medication for an off-label use, that there be support in the medical compendia for such a use, and that you ask the doctor if in fact such a use is supported. Otherwise, you may find your self relying on a medication that Medicare will not cover. Even if your attorney is able to negotiate with the carrier for the inclusion of additional funds to cover the off-label prescriptions, once those funds are exhausted there will be no coverage by Medicare.

Accordingly, it is important that you work closely with your doctor to understand if any of the medications that you are taking for your work-related injury have been prescribed for an off-label use and if so, inform your attorney so that any potential issues regarding coverage under Medicare can be addressed.

MSAMeds and its affiliated pharmacy, AllianceMeds, will work with your doctors to ensure that the medications you are taking for your work-related injury are either FDA approved for that use or that the off-label use is supported by the recognized medical compendia. Your doctor’s primary concern must be your medical treatment, however, the prescribing of medication for off-label uses may complicate the administration of your set-aside funds. MSAMeds and AllianceMeds will research the off-label usage for your doctor so as to ensure that future Medicare coverage for the medication is not jeopardized.

MSAMeds stands ready to assist you, your doctors and your attorney in resolving your workers’ compensation claim so you can focus on treating your injuries.