We review how FDA approval and insurance coverage aren’t directly related.
The difference
It can be easy to conflate FDA approval and insurance coverage. You might assume that if a medication has FDA approval, and has been cleared by the Food and Drug Administration, that it will then be covered by insurance. However, these two things are actually very separate.
FDA approval means that a medication has been found to be safe and effective (such that benefits outweigh potential risks) for a specific indication. FDA approved medications may then be used by physicians for their approved indication or for other indications (called “off-label” prescribing).
Insurance coverage simply means that an insurance company has decided that they are willing to pay for the use of a medication.
FDA approved, but not covered
Many medications have FDA approval but may not be covered by insurance.
Your insurance company may say the medication is not ‘on formulary’, meaning it is not included on the list of covered medications. Alternatively they may say that only some versions of a drug are covered – for instance, only a generic version of the drug may be covered. They may also say that they will not cover a medication because its use is considered experimental.
Sometimes insurance companies will say that the condition itself is not covered. We have seen many patients with chronic Lyme disease, which is not a covered condition by many insurance carriers. Therefore, they won’t approve therapies to treat chronic Lyme.
There are many reasons that an insurance company may give for refusing to cover a medication or treatment.
Covered, but not FDA indicated
Many medications are used off-label — meaning they are FDA approved for an indication, but they are used in practice for other indications. Some of these non-indicated, or off-label uses, are still covered by insurance, while others are not.
Zofran (ondansetron) is an example of a drug that is often covered for off-label use. It was FDA indicated and received approval for chemotherapy-induced nausea. It is frequently used, and covered, for use for all kinds of nausea.
Limitations and Variations – Check with your Insurer
Even when an insurance company covers a medication or procedure, they may not cover the full cost of providing it. The insurance companies also often delay or deny claims after the fact, or simply refuse to pay them, resulting in a lower effective reimbursement rate.
Different insurance companies operate in different ways. What is covered by one company may not be by another, or the requirements to seek coverage may vary.
IV ketamine infusions for depression are typically not covered by insurance companies, although some insurers may cover some part of the cost. TMS treatments may be covered, although it is much more likely that rTMS protocols are covered while newer and more advanced accelerated protocols are less likely to be covered.
If you are pursuing coverage for a procedure or medication that is not clearly covered, we encourage you to discuss the details with your insurance company.
About Us
Wells Medicine is a Houston-based practice designed to provide meaningful care for mental health. Providing targeted interventional treatments for Depression, Anxiety, OCD, PTSD and other conditions, with Ketamine Treatments, Stellate Ganglion Blocks, TMS, and Nitrous-Oxide Treatments. Focused on comprehensive care and integration with Psychiatry, Psychology, and Support Services. We are evidence-based, patient-focused and mission-driven.
The content here is for informational purposes and should not be relied upon for medical decisions. For the details of your specific medical conditions and treatments consult your doctors or other qualified healthcare professionals.
