Two new developments for cranial electrotherapy stimulation (CES) devices should make it easier for patients to get Alpha-Stim®, a handheld, prescription medical device that is FDA cleared for treatment of anxiety, insomnia, depression, and pain using a mild, painless and patented microcurrent.
The FDA published in the Federal Register on December 20, 2019 its decision to downclassify CES from Class III into Class II for the indications of anxiety and insomnia. Class II medical devices are a lower risk category than Class III; the FDA determined that “special and general controls under the classification will provide a reasonable assurance of safety and effectiveness for CES devices intended to treat anxiety and/or insomnia.”¹
Although CES has been proven effective at the treatment of depression as well, the FDA is requiring a Premarket Approval application for that indication. Electromedical Products International, Inc. (EPI), manufacturer of Alpha-Stim, is working diligently to complete the requirements of the application, having proven with over 100 independent clinical research studies that the device is safe and effective.
Additionally, EPI’s application for a Healthcare Common Procedure Coding System (HCPCS) code with the Centers for Medicare & Medicaid Services (CMS) was approved for its CES devices. Effective January 1, 2020, the HCPCS code for CES is K1002: Cranial electrotherapy stimulator with accessories.
The designation of a HCPCS code represents a major step forward for the accessibility of CES devices to consumers. Private insurance carriers can now be billed for CES devices such as Alpha-Stim. Though the payment schedule for the code will be determined by individual carriers, the door is now open for patients to receive insurance coverage for Alpha-Stim rather than paying out of pocket. A prescription from a licensed healthcare practitioner will continue to be required for CES devices in the United States.
The FDA’s downclassification of CES devices, in conjunction with the granting of a HCPCS code by CMS, shows regulatory acknowledgment and support for what EPI has known for decades: cranial electrotherapy stimulation is not a danger to consumers but rather a safe and effective treatment that can dramatically improve the health and the lives of those who use it.
For assistance submitting a claim for Alpha-Stim to your insurance carrier, or to see additional clinical research on Alpha-Stim, visit www.alpha-stim.com.
Alpha-Stim® is a non-invasive prescription medical device (prescription not required outside the U.S.) that is FDA cleared to provide fast, safe and effective treatment of anxiety, insomnia, depression, and pain. The brain functions electrochemically and can be readily modified by electrical intervention. The Alpha-Stim AID utilizes cranial electrotherapy stimulation (CES) to deliver the only patented waveform which is clinically proven to significantly decrease anxiety and comorbid depression. The Alpha-Stim M uses CES to treat mood and sleep, plus microcurrent electrical therapy (MET) to also treat pain. Alpha-Stim can be used alone, along with other therapies, or as an adjunct to medication (without the risk of drug interactions). There are no serious adverse effects, no risk of addiction, and more than 100 research studies over 35 years that prove the effectiveness of this low level electrical prescription brain therapy. To learn more, call 1-800-FOR-PAIN or visit www.alpha-stim.com.