Mainstay Medical Achieves Coverage Milestone with Highmark
Mainstay Medical Holdings plc has announced a significant reimbursement milestone for its ReActiv8 Restorative Neurostimulation™ therapy, following a favorable coverage decision from Highmark Inc. The new medical policy, which became effective on July 27, 2026, recognizes ReActiv8 as a medically necessary treatment for eligible members with chronic low back pain when specific clinical criteria are met. The decision marks another important step toward expanding patient access to an innovative therapy designed to address the underlying cause of certain types of chronic back pain rather than simply managing symptoms.
The coverage policy applies to Highmark members whose treatment is deemed clinically appropriate and medically necessary according to their individual health plan benefits and established medical guidelines. Notably, the policy specifies that ReActiv8 is the only therapy considered medically necessary within its category when all coverage requirements are satisfied, underscoring the insurer’s confidence in the therapy’s clinical evidence and therapeutic value.
A Major Milestone in Patient Access
Highmark Inc., together with its Blue-branded affiliates, is one of the largest Blue Cross Blue Shield organizations in the United States, serving nearly eight million members across Pennsylvania, Delaware, New York, West Virginia, Missouri, and Kansas. As one of the nation’s largest commercial health insurers, Highmark’s coverage decisions often influence broader payer adoption and improve access to innovative medical technologies.
For Mainstay Medical, the policy represents more than a reimbursement achievement—it significantly broadens the availability of ReActiv8 for patients living with chronic low back pain associated with dysfunction of the lumbar multifidus muscles. With Highmark joining other Blue Cross Blue Shield organizations that have adopted favorable reimbursement policies, ReActiv8 is now accessible to more than 50 million Blue Cross Blue Shield-affiliated members nationwide.
The expanded coverage is expected to increase treatment options for physicians managing patients who have exhausted conventional therapies without achieving meaningful, long-lasting relief.
Recognizing the Clinical Value of ReActiv8
According to Dr. Matt Fickie, Senior Medical Director for Medical Policy at Highmark Inc., the insurer’s decision reflects its commitment to supporting therapies backed by strong clinical evidence that improve patient outcomes.
He noted that ReActiv8 has demonstrated both safety and effectiveness for patients suffering from chronic low back pain linked to multifidus muscle dysfunction. Clinical studies have also shown that treatment with ReActiv8 may contribute to reduced opioid use, an important consideration as healthcare systems continue efforts to minimize long-term dependence on prescription pain medications.
Highmark’s evaluation considered available clinical evidence supporting the therapy’s ability to improve pain, restore function, and provide durable outcomes for carefully selected patients.
Addressing the Root Cause Rather Than Symptoms
Unlike many existing neuromodulation therapies designed primarily to mask pain signals, ReActiv8 utilizes a restorative neurostimulation approach intended to treat an underlying functional impairment contributing to chronic low back pain.
The therapy specifically targets dysfunction of the lumbar multifidus muscles, which play a critical role in stabilizing the spine during movement. In some patients, these muscles become inhibited or weakened, leading to impaired spinal stability and persistent mechanical low back pain.
Rather than providing temporary pain relief through continuous stimulation, ReActiv8 delivers programmed electrical stimulation to nerves that activate the multifidus muscles. Over time, this repeated stimulation is intended to restore normal muscle control and improve spinal stability, helping address the underlying cause of pain instead of simply suppressing symptoms.
This restorative mechanism differentiates ReActiv8 from conventional peripheral nerve stimulators and other neuromodulation devices used primarily for palliative pain management.
Evidence Supporting Long-Term Benefits
Mainstay Medical has invested extensively in clinical research evaluating ReActiv8 across multiple patient populations. According to the company, evidence from randomized clinical trials and real-world studies consistently demonstrates durable improvements in pain relief, physical function, and quality of life.
Importantly, these benefits have been observed over extended follow-up periods, suggesting that patients may continue to experience improvements well beyond the initial treatment phase.
The company also highlights evidence indicating reductions in opioid consumption among treated patients, reflecting growing interest in therapies that help decrease reliance on long-term pharmacologic pain management.
Jason Hannon, Chief Executive Officer of Mainstay Medical, emphasized that years of clinical development and evidence generation have positioned ReActiv8 as a unique therapeutic option for patients whose treatment alternatives remain limited.
He explained that the therapy differs fundamentally from standard peripheral nerve stimulation technologies because it aims to restore neuromuscular function rather than temporarily interrupt pain signaling. Clinical findings from both controlled studies and real-world patient experiences continue to support its long-term effectiveness and favorable safety profile.
Coverage Criteria Focus on Appropriate Patient Selection
Highmark’s policy establishes clear clinical requirements to ensure that ReActiv8 is used in patients most likely to benefit from treatment.
Coverage applies to individuals diagnosed with chronic low back pain associated with lumbar multifidus muscle dysfunction, provided they also meet patient selection criteria consistent with both the therapy’s FDA approval and the protocols used during Mainstay Medical’s pivotal clinical trials.
These requirements help ensure that treatment is directed toward patients whose condition closely matches the populations evaluated during clinical development.
Careful patient selection has been an important component of ReActiv8’s clinical success, as mechanical low back pain caused by multifidus dysfunction represents a distinct medical condition requiring specialized evaluation and diagnosis.
Understanding Mechanical Chronic Low Back Pain
Chronic low back pain remains one of the leading causes of disability worldwide and affects millions of adults every year. However, not all forms of back pain share the same underlying causes.
Mechanical chronic low back pain associated with multifidus dysfunction represents a specific subset of patients in whom impaired spinal stabilization contributes significantly to persistent pain.
These individuals often experience ongoing symptoms despite undergoing multiple conservative treatments, including:
- Physical therapy
- Exercise programs
- Anti-inflammatory medications
- Prescription pain medications
- Lifestyle modifications
Many patients continue to experience disabling pain even after months or years of treatment.
Compounding the challenge, a considerable number of these individuals are not appropriate candidates for spinal surgery because structural abnormalities requiring surgical correction may be absent.
As a result, physicians frequently have limited treatment options capable of delivering durable symptom improvement.
Filling an Important Treatment Gap
The availability of ReActiv8 under Highmark’s medical policy provides physicians with an evidence-based therapeutic option for patients who previously had few alternatives beyond continued conservative management.
Without access to restorative treatments, many patients cycle repeatedly through temporary interventions—including medications, injections, and rehabilitation programs—that may provide only short-term relief while failing to address the underlying neuromuscular dysfunction.
By targeting impaired multifidus muscle activation, ReActiv8 offers a different therapeutic strategy focused on restoring function rather than repeatedly managing symptoms.
Healthcare providers specializing in pain management, physical medicine, rehabilitation, and spine care may now have greater confidence recommending the therapy for eligible patients whose clinical presentation aligns with established treatment criteria.
Growing Momentum Among U.S. Health Plans
Mainstay Medical views Highmark’s favorable policy as part of a broader trend toward increased reimbursement support for restorative neurostimulation.
As more insurers evaluate the growing body of published clinical evidence, coverage decisions may continue to expand, allowing additional patients to access therapies that address chronic low back pain through innovative mechanisms.
The company indicated that it will continue engaging with other commercial health plans to present clinical and economic evidence supporting ReActiv8’s effectiveness, safety, and long-term value.
Broader reimbursement adoption could help reduce disparities in treatment access while supporting earlier intervention for appropriate patients before prolonged disability develops.
The Highmark coverage decision represents a significant advancement for patients living with chronic low back pain caused by lumbar multifidus dysfunction. By recognizing ReActiv8 as medically necessary for eligible members, Highmark has expanded access to a therapy supported by robust clinical evidence and designed to address the underlying neuromuscular causes of persistent back pain.
For Mainstay Medical, the policy reinforces years of investment in clinical research and positions ReActiv8 for broader adoption across the U.S. healthcare system. With coverage now extending to more than 50 million Blue Cross Blue Shield-affiliated members, the company is well positioned to continue expanding reimbursement while offering physicians an evidence-based, restorative treatment option for a patient population that has historically faced limited long-term solutions.
About ReActiv8®
ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction, which may be evidenced by imaging or physiological testing. Candidates for ReActiv8 are patients with multifidus muscle dysfunction who have failed other forms of therapy (including pain medication and physical therapy) and are not candidates for spine surgery. ReActiv8 has received regulatory approval in several geographic areas, and is commercially available in the European Economic Area, Australia, the UK, and the US.
About Mainstay Medical
Mainstay Medical is a medical device company focused on commercializing its innovative implantable Restorative NeurostimulationTM system, ReActiv8®, for people with disabling mechanical CLBP. Mainstay Medical is headquartered in Dublin, Ireland and has subsidiaries operating in Ireland, the United States, Australia, Germany, and the Netherlands.