NeuroSigma Announces Receipt of Permanent HCPCS Codes from CMS for Monarch eTNS System








LOS ANGELES, Sept. 27, 2022 (GLOBE NEWSWIRE) -- NeuroSigma, Inc., a Los Angeles-based bioelectronics company, announced that the Centers for Medicare & Medicaid Services ("CMS") has confirmed the durable medical equipment (DME) benefit category determination and two permanent Level II Healthcare Common Procedure Coding System ("HCPCS") codes for the Monarch eTNS® System, effective October 1, 2022, as part of the final coding decisions of its biannual update. The permanent codes are K1016 (Transcutaneous electrical nerve stimulator for electrical stimulation of the trigeminal nerve) and K1017 (Monthly supplies for use of device coded at K1016).

The Monarch eTNS System is a bioelectronic medical device that uses external trigeminal nerve stimulation (eTNS) to treat neurological and neuropsychiatric disorders. NeuroSigma is currently commercializing the system to treat pediatric attention deficit hyperactivity disorder (ADHD), and the Monarch is the first non-drug treatment for pediatric ADHD cleared by the U.S. Food and Drug Administration (FDA).


"We are extremely pleased that CMS has confirmed the DME benefit category determination and permanent Level II HCPCS codes for the Monarch eTNS System and the single-use NS-2 Electric Patch,” said Colin Kealey, M.D., President of NeuroSigma. “Finalizing this status and establishing Medicare’s reimbursement policy is a key component of our market access strategy and should facilitate insurance coverage during the upcoming launch of our Monarch Pediatric Care Program, a new co-pay program for patients interested in using the Monarch eTNS System to treat pediatric ADHD.”


Level II of the HCPCS is a standardized coding system used primarily to identify products, supplies, services, and durable medical equipment. The coding system is maintained by CMS. Commercial payers use the database to classify products and typically follow CMS’ lead on coding and benefit category decisions, but can set their own reimbursement rates.


About NeuroSigma

NeuroSigma is a Los Angeles, California-based bioelectronic medical device company developing technologies to transform medical practice and patients' lives. The company is currently commercializing the Monarch eTNS System to treat pediatric ADHD. Pipeline indications for the system and NeuroSigma’s eTNS platform include a wide spectrum of neurological and neuropsychiatric disorders, such as adult ADHD, drug-resistant epilepsy, and depression. For more information about NeuroSigma, please visit www.neurosigma.com. For more information on the Monarch eTNS System, please visit www.monarch-etns.com.


CONTACT: Colin Kealey, M.D., President of NeuroSigma at CKealey@neurosigma.com

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