Humana Cranial Electrical Stimulation - Medicare Advantage Form

Please refer to CMS website for the most current applicable CMS Online Manual System (IOMs)/National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/ Transmittals. There are NCDs or LCDs for cranial electrostimulation therapy. Cranial Electrical Stimulation Page: 2 of 4 Description Cranial electrostimulation (CES) (cranial electrotherapy stimulation, transcranial electrotherapy) applies a low energy pulsed alternating current to stimulate cranial nerves in the forehead. The treatment usually lasts for 20 minutes per session and occurs either daily or every other day. CES is marketed for anxiety, depression and insomnia and is being studied for other uses, such as addiction and improving mental focus. Examples of CES devices include, but may not be limited to, Alpha-Stim AID, Cervella, CES Ultra and the Fisher Wallace stimulator. Coverage Determination Humana follows the CMS requirements that only allows coverage and payment for services that are reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare. Coverage Limitations US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage Cranial electrostimulation therapy will not be considered medically reasonable and necessary: A review of the current medical literature shows that the evidence is insufficient to determine that this service is standard medical treatment. There remains an absence of randomized, blinded clinical studies examining benefit and long-term clinical outcomes establishing the value of this service in clinical management. Summary of Evidence Reduction of Pain/Fibromyalgia There is insufficient evidence to allow conclusions regarding the safety and efficacy of this treatment. There is substantial uncertainty in the determination of patient selection criteria, whether the treatment effects are maintained and for the optimal treatment parameters. Clinically important benefits cannot be determined.3,6 Migraines/Headaches The evidence is insufficient to determine the safety and efficacy and the impacts on health outcomes/patient management.4,6 Depression It is not known whether cranial electrical stimulation is an effective adjunctive treatment for bipolar major depression. A small 2-week randomized trial compared active cranial electrical stimulation with sham stimulation as an add-on treatment in individuals with bipolar depression, with study participants receiving Cranial Electrical Stimulation Page: 3 of 4 20 minutes of treatment per day. The scores in the cranial stimulation group were comparable to the sham group and adverse events were also equivalent.7 There are no high-quality studies that have demonstrated that cranial electrical stimulation is efficacious in the treatment of unipolar major depression. A review of 3 randomized trials lasting 2-3 weeks found that none of the studies found that active treatment was beneficial.8