Anthem Blue Cross and Blue Shield has established favorable coverage for Mainstay Medical's ReActiv8 Restorative Neurostimulation therapy for the treatment of intractable chronic low back pain. The coverage policy, which went into effect on April 16, 2025, designates ReActiv8 as the only therapy considered medically necessary when specific clinical conditions are met.
Under the new policy, patients with a diagnosis of lumbar multifidus muscle dysfunction who meet selection criteria consistent with FDA approval guidelines and Mainstay's clinical trial protocols will have access to this treatment option. This decision significantly expands treatment accessibility for Anthem policyholders suffering from chronic low back pain who have not responded to conventional therapies.
Clinical Significance and Patient Selection
ReActiv8 is designed specifically for adults with intractable chronic low back pain associated with multifidus muscle dysfunction, which can be confirmed through imaging or physiological testing. The therapy targets patients who have failed other treatment modalities, including pain medications and physical therapy, and who are not candidates for spine surgery.
The International Society for the Advancement of Spine Surgery (ISASS) advocated for restorative neurostimulation as a medically necessary treatment for mechanical chronic lower back pain in a 2023 statement. Additionally, ISASS was instrumental in establishing a new ICD-10-CM code for lumbar multifidus dysfunction that took effect in October 2024.
"This coverage decision is a testament to what happens when rigorous science, thoughtful advocacy, and patient need align," said Dr. Morgan Lorio, ISASS Past Co-President. "ISASS is proud to have helped advance the recognition of restorative neurostimulation as a medically necessary treatment for mechanical chronic low back pain. We believe therapies like ReActiv8 offer new hope for restoring function and improving lives."
Mainstay Medical's Research Journey
Jason Hannon, CEO of Mainstay Medical, emphasized the company's long-term commitment to developing clinical evidence supporting ReActiv8's efficacy and safety.
"We have been on a 17-year mission to prove the value of ReActiv8 through careful and thorough research," Hannon stated. "We have made a commitment to developing a large body of robust clinical and real-world evidence proving the efficacy and safety of the therapy in an indication where patients are desperately seeking durable solutions."
Hannon expressed gratitude to the clinical investigators worldwide who have contributed to the research and indicated plans to pursue coverage from other major health plans based on their accumulated evidence.
Treatment Landscape for Chronic Low Back Pain
Chronic low back pain represents a significant healthcare challenge, with conventional treatments often providing limited relief for many patients. The multifidus muscle, a key stabilizer of the spine, has been increasingly recognized as a critical factor in many cases of persistent back pain.
ReActiv8 works by delivering targeted electrical stimulation to restore control and stability to the multifidus muscle, addressing a root cause of mechanical back pain rather than simply masking symptoms. This approach offers a potential solution for patients who have exhausted other non-surgical options.
The therapy has already received regulatory approval in multiple regions, including the European Economic Area, Australia, the United Kingdom, and the United States, where it is commercially available.
Impact on Patient Access
Anthem's decision represents a significant milestone in expanding access to innovative treatments for chronic pain. For eligible patients, this coverage determination removes a substantial financial barrier to receiving ReActiv8 therapy.
The coverage policy's specificity regarding patient selection criteria helps ensure that the therapy is directed toward those most likely to benefit, potentially improving outcomes while managing healthcare resources effectively.
As one of the largest health insurers in the United States, Anthem's coverage decision may influence other payers to evaluate their policies regarding restorative neurostimulation, potentially leading to broader access for patients suffering from chronic low back pain associated with multifidus dysfunction.
