CareFirst BCBS Designates Nalu Neurostimulation System as ‘Medically Necessary’

CareFirst BCBS has issued an updated medical coverage policy designating the Nalu Neurostimulation System from Nalu Medical Inc. as medically necessary to treat chronic peripheral nerve pain. Effective Aug. 4, the change resulted from a review by CareFirst of Nalu clinical data, inclusive of the recently published COMFORT 2 confirmatory randomized control trial, and marks an important milestone in Nalu’s mission to expand patient and physician access to safe, innovative, drug-free alternatives for chronic pain relief.

This policy shift moves Nalu from its prior classification of “Investigational/Experimental” to “Medically Necessary” for eligible patients—opening access to more than 3.5 million additional patients in the District of Columbia, Maryland, and Northern Virginia area.

“CareFirst BCBS recognition of Nalu as a medically necessary therapy is a powerful validation of our technology, clinical evidence, and commitment to patient outcomes,” Nalu Medical President/CEO Tom West said. “We’ve built a robust body of published clinical data demonstrating that Nalu PNS provides safe, effective, and durable relief for patients living with chronic, intractable pain. These clinical results are further supported by health economic data demonstrating that use of Nalu PNS results in significant cost savings. We’re proud to see a payer like CareFirst acknowledge that value, and we look forward to engaging with other health plans to expand access to this therapy.”

Chronic peripheral nerve pain is often debilitating and unresponsive to conventional therapies, including long-term medication and surgery. The Nalu Neurostimulation System offers a minimally invasive, drug-free alternative that delivers precise electrical stimulation to targeted peripheral nerves, providing long-lasting relief while reducing the risks of opioid dependency and avoiding systemic side effects.

The Nalu System consists of a fully featured, battery-free, miniaturized implantable pulse generator (IPG)¹ that is powered wirelessly by an externally worn Therapy Disc and controlled through a smartphone-based remote control app. Despite its small size, the Nalu micro-IPG delivers treatment capabilities similar to larger IPGs as well as advantages associated with advanced waveforms, extensive programming options, software upgradability, and an expected 18-year service life. The Nalu Neurostimulation System has been repeatedly recognized for its technology, including being named as one of the world’s top 100 new products by R&D Magazine in 2021 and ranking number 19 in the 2023 Deloitte Technology Fast 500. It is cleared by the U.S. Food and Drug Administration for spinal cord stimulation and peripheral nerve stimulation.

Nalu is a Carlsbad, Calif.-based medical technology company developing and commercializing minimally invasive solutions for patients with chronic neuropathic pain. The Nalu Neurostimulation System delivers gentle electrical pulses to the nervous system to modulate pain signals before they get to the brain. The Nalu Neurostimulation System is designed to address major unmet needs in treating chronic neuropathic pain.

Reference
¹ Data on file, Nalu Medical, Inc. 2025.