NeuroStar is a form of transcranial magnetic stimulation (TMS) therapy that is growing in popularity and as the treatment of several mental health conditions. One of those conditions is major depressive disorder, which does not always respond to traditional prescription medications.
When this happens, the diagnosis changes to treatment-resistant depression. This can feel overwhelming, but we want you to know there is hope. Although NeuroStar TMS therapy has become more popular, the central question some people still have is: Is NeuroStar experimental?
The initial 2008 FDA clearance of NeuroStar TMS therapy was for individuals with major depressive disorder who had not experienced satisfactory improvement using at least one antidepressant. Since then, it has also received FDA clearance for use in other populations, including, under certain conditions, adolescents aged 15 to 21 as an adjunctive therapy for major depressive disorder.
Unlike medications, which can receive FDA approval, devices can be “cleared,” meaning the FDA found them safe and substantially equivalent to existing treatments. As a result, NeuroStar is not considered experimental when it is used for approved indications.
Thus far, NeuroStar TMS has received FDA clearance for the treatment of major depressive disorder in adults and as an adjunct treatment in adolescents (15-21). In 2022, it received clearance as an adjunct therapy for adults with obsessive-compulsive disorder (OCD) and for comorbid anxiety with major depressive disorder when traditional treatments and medications are not satisfactory.
TMS has received recognition within the medical community because it is an effective treatment for certain mental health conditions. The American Psychiatric Association acknowledges that TMS provides effective treatment for several conditions, is not experimental for those conditions, and provides consensus recommendations for its clinical application in depression.
Many insurance companies offer coverage for TMS therapy when you meet specific criteria, known as medical necessity. Those criteria typically include having treatment-resistant depression. Insurance coverage is another indication that NeuroStar TMS is recognized as a legitimate and non-experimental treatment option in FDA-cleared conditions.
NeuroStar TMS’s designation as investigational or experimental is crucial to insurance coverage. Most major insurance companies cover TMS therapy for conditions that the FDA has cleared.
There is such variability in insurance policies that you must consult directly with your provider to get up-to-date information regarding the eligibility and potential out-of-pocket expenses of using NeuroStar TMS therapy .
Some insurers will offer coverage if you can demonstrate that other traditional therapies have been unsuccessful and current research indicates that TMS therapy can prove useful. Insurance companies want to pay for treatments that effectively reduce or eliminate symptoms.
When used for the treatment of conditions the FDA has cleared, such as treatment-resistant depression or as an adjunctive therapy for OCD, NeuroStar is not experimental. Call us today to schedule a consultation if your depression or OCD has not responded well to traditional treatments, and learn more about how NeuroStar TMS therapy can help.
