Drug therapy has not helped me - could this device work in my case?
Yes. The device can work for patients who have not found success with medication.
Can I use the device at the same time I am taking medication?
Yes. The device does not have any contraindications with medication.
Are there any side effects?
When used cranially to treat insomnia, depression and anxiety, 1 in 500 patients report a mild headache upon using the device.
Approximately 1 in 250 patients may experience an increase in wakefulness immediately after using the device. If this occurs, the device should not be used within three hours of bedtime.
What is the difference between FDA-Cleared and FDA-Approved?
Pharmaceutical drugs must be FDA-Approved to enter the market; medical devices must be FDA-Cleared. The Fisher Wallace Stimulator® is FDA-Cleared to treat depression, anxiety and insomnia and the FDA regularly inspects our facilities.
How does the device work?
The device works by generating a gentle electrical pulse at a patented frequency that stimulates the brain to produce serotonin and other neurochemicals required for healthy mood and sleep.
How long must I use the device and are there any long term negative effects?
Ideally, you should use the device twice a day for 20 minutes until your symptoms go into remission. If you no longer experience symptoms, you may stop using the device and renew treatment if the symptoms return.
The device has been on the market for 24 years and there is no evidence of it causing any long-term negative effects.
What does the electrical stimulation feel like?
The electrical current is so gentle that many patients do not feel it at all, while some may feel tingling at the sponge contact sites. Mild optic nerve stimulation may also occur, which may produce the sensation of flashing light in the corner of the eyes - this is normal and harmless.
How soon do patients experience benefits?
Many people report positive changes during or shortly after the first 5-10 treatment sessions. Results in treating insomnia are typically experienced faster than in treating depression and anxiety. The device should be used daily for 30-45 days before making a decision regarding effectiveness. While level 2 is the recommended starting dosage level, the device may be used safely at level 3 and 4, should level 2 not produce positive results after two weeks.
Is there anyone who should not use the Fisher Wallace Stimulator?
The only patients who are not qualified to use our device are those with implanted medical devices, such as an implanted nerve stimulator or pacemaker, as the Fisher Wallace Stimulator® may interfere with the functioning of such devices.
Is this device covered by my insurance?
Many private insurance companies, such as Aetna, United Healthcare and Blue Cross often reimburse patients for the purchase of a Fisher Wallace Stimulator® when it is prescribed for the treatment of pain using the procedure code E0720.
When the device is authorized only for the treatment of depression, anxiety or insomnia, the reimbursement rate decreases significantly. When the device is authorized for depression / anxiety / insomnia AND pain, patients will be able to have the device reimbursed more easily.
Fisher Wallace Laboratories is not in network with any insurance. Fisher Wallace Laboratories does not process reimbursement paperwork on behalf of its customers, but will assist customers throughout the process.
After purchasing your device, call your insurance company, provide them with the device reimbursement code (procedure HSPCS code) E0720 and the diagnosis code which should be supplied by your healthcare professional on the written authorization form. The insurance company will typically mail you a DME (Durable Medical Equipment) claim form that needs to be filled out and attached to the proof of payment. Your emailed receipt from Fisher Wallace contains all the information you will need, with the exception of the diagnosis code. The following information is often required by insurance companies to process a reimbursement (or payment) request:
Federal Tax ID # for Fisher Wallace Laboratories, LLC: 20-8131183
NPI #: 1497045215
Device Reimbursement Code (Procedure HSPCS Code): E0720
Patients who encounter difficulty receiving insurance approval may enhance their claim by submitting a letter from their doctor that describes the necessity of the device. You may download a template of this letter by clicking here . Your doctor will need to edit the template to reflect your particular situation.
The letter should be signed by your doctor and printed on the doctor's professional stationary.
MEDICARE & MEDICAID
Medicare & Medicaid will not reimburse patients for the purchase of our device at this time. To help deflect the cost, we offer a $100 discount to Medicaid recipients or members of military families. If you have a secondary insurance plan that covers the device, you will first need to receive a denial from Medicare for coverage in order to apply for reimbursement from the secondary insurance. To do so please call Medicare and ask for the 1490S Medicare form that you will need to fill out, attach your prescription, proof of payment and a cover letter stating that you are requesting a denial. All information needs to be sent to the Medicare Durable Medical Equipment address in your state (please call Medicare to obtain that address).
Office Visit Codes for receiving treatment by a doctor in the office:
G0283 Electrical Stimulation (unattended), to one or more areas for indications other than wound care, as part of a therapy plan of care.