MONTCLAIR, N.J., Aug. 16, 2021 /PRNewswire/ -- Theranica, a prescribed digital therapeutics company developing advanced electroceuticals for migraine and other pain conditions, today announced that the Centers for Medicare and Medicaid Services (CMS) published its most recent Level II Healthcare Common Procedure Coding System (HCPCS), assigning a new HCPCS Level II code K1023 "Distal Transcutaneous Electrical Nerve Stimulator, Stimulates Peripheral Nerves of the Upper Arm." The coding decision covers Theranica's product Nerivio. The code will become effective on October 1, 2021.
Nerivio, a drug-free remote electrical neuromodulation (REN) device for the acute treatment of migraine in patients 12 years and older, delivers electrical waveform to nerve fibers at the upper arm, to trigger the conditioned pain modulation in the central nervous system, activating the body's endogenous analgesic mechanism. Nerivio was recently included in the 2021 American Headache Society Consensus Statement for treating migraine.
Level II of the HCPCS is a standardized coding system used primarily to identify products, supplies, and services such as medical devices used outside a physician's office.
"The creation of this new HCPCS code covering Nerivio acknowledges the unique aspects of our technology and helps distinguish our device from other modalities such as TENS. It is an important milestone towards gaining favorable coverage for patients with migraine who are prescribed this therapy," said Alon Ironi, co-founder and CEO of Theranica. "We are pleased with this CMS decision. We are dedicated to delivering safe, effective, first-line, non-pharmaceutical treatments to people living with migraine, and this new unique code is a significant step in making this therapy affordable for them."
Theranica is a prescribed digital therapeutics company dedicated to creating effective, safe, affordable, low-side effect, therapies for idiopathic pain conditions. The company's award-winning flagship product, Nerivio®, is the first FDA-cleared smartphone-controlled prescribed wearable device for acute treatment of migraine, and already serves close to 25,000 people with migraine in the USA, including adolescents and veterans. Theranica is expanding its proprietary technology to offer additional solutions for other pain conditions. Nerivio has received FDA authorization and CE mark for use in acute treatment of episodic and chronic migraine in adult and adolescent patients.