Policy title: Restorative Neurostimulation Therapy

Policy number: MA 1.034

Effective date: 8/1/2026

Policy

Restorative neurostimulation therapy (ReActiv8) is considered investigational as there is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

This medical policy applies to Medicare Advantage plans offered by Capital Blue Cross and its subsidiaries.

Description/Background

Restorative neurostimulation for chronic lower back pain attributed to multifidus dysfunction

Restorative neuromodulation therapy (ReActiv8) uses an implanted device to deliver electrical stimulation to the nerves controlling the multifidus muscles of the lumbar spine. It is proposed that restorative neuromodulation reduces pain by triggering contractions of the multifidus muscles to restore neuromuscular control and help stabilize the spine. It is intended for individuals with intractable chronic low back pain associated with multifidus dysfunction for whom available low back pain treatments do not provide sufficient or durable symptom relief.

Regulatory status for restorative neurostimulation devices

In 2020, the ReActiv8 (Mainstay Medical) was FDA approved through the Premarket Approval (PMA) process (PMA P190021) for individuals with intractable chronic low back pain associated with multifidus dysfunction for whom available low back pain treatments do not provide sufficient or durable symptom relief. FDA Product Code: QLK

Rationale

Summary of Evidence

For individuals who have chronic pain conditions including low back pain who receive restorative neurostimulation therapy (ReActiv8), the evidence includes 1 sham-controlled RCT (N = 204), 1 open-label RCT (N=203), 1 prospective single-arm trial (N = 53), and a case series (N = 44). Relevant outcomes are symptoms, functional outcomes, quality of life, and medication use. In the sham-controlled RCT, there was no difference between groups on the primary endpoint of treatment response at 120 days, defined as the composite of 30% or greater reduction in VAS and no increase in pain medications (57.1% intervention vs 46.6% sham; p =.1377). Prespecified secondary analyses of primary outcome data favored the intervention group, but clinical significance is unclear. An uncontrolled follow-up phase of the RCT reported continued improvement in pain scores through 3 years but results are at high risk of bias due to lack of a control group and high attrition. The open-label RCT showed statistically significant improvements in the treatment arm compared to the control arm in the primary and secondary outcomes. However, limitations included lack of blinding, imbalance in baseline depression between treatment and control arms, and greater clinical contact than standard management protocols in the treatment arm. Nonrandomized studies are limited by lack of blinding, no sham control, high attrition. and small sample sizes. Additional evidence from longer-term sham controlled RCTs is needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Definitions

N/A

Disclaimer

Capital Blue Cross’ medical policies are used to determine coverage for specific medical technologies, procedures, equipment, and services. These medical policies do not constitute medical advice and are subject to change as permitted by law or applicable clinical evidence from independent treatment guidelines. Treating providers are solely responsible for medical advice and treatment of members. These policies are not a guarantee of coverage or payment. Payment of claims is subject to a determination regarding the member’s benefit program and eligibility on the date of service, and a determination that the services are medically necessary and appropriate. Final processing of a claim is based upon the terms of contract that applies to the members’ benefit program, including benefit limitations and exclusions. If a provider or a member has a question concerning this medical policy, please contact Capital Blue Cross’ Provider Services or Member Services.

Coding Information

Note: This list of codes is not exhaustive and may change from time to time as permitted by law or applicable clinical guidelines. The inclusion of a code in this section is not a guarantee of coverage or payment. In addition, not all covered services are eligible for separate reimbursement.

Considered investigational for lymphatic physiologic microsurgery and therefore not covered.

References

1. Gilligan C, Volschenk W, Russo M, et al. Long-Term Outcomes of Restorative Neurostimulation in Patients With Refractory Chronic Low Back Pain Secondary to Multifidus Dysfunction: Two-Year Results of the ReActiv8-B Pivotal Trial. Neuromodulation. Jan 2023; 26(1): 87-97. PMID 35088722
2. Gilligan C, Volschenk W, Russo M, et al. Three-Year Durability of Restorative Neurostimulation Effectiveness in Patients With Chronic Low Back Pain and Multifidus Muscle Dysfunction. Neuromodulation. Jan 2023; 26(1): 98-108. PMID 36175320
3. Gilligan C, Volschenk W, Russo M, et al. Five-Year Longitudinal Follow-Up of Restorative Neurostimulation Shows Durability of Effectiveness in Patients With Refractory Chronic Low Back Pain Associated With Multifidus Muscle Dysfunction. Neuromodulation. 2024;27(5):930-943. doi:10.1016/j.neurom.2024.01.006
4. Schwab F, Mekhail N, Patel KV, et al. Restorative Neurostimulation Therapy Compared to Optimal Medical Management: A Randomized Evaluation (RESTORE) for the Treatment of Chronic Mechanical Low Back Pain due to Multifidus Dysfunction. Pain Ther. Feb 2025; 14(1): 401-423. PMID 39812968
5. Deckers K, De Smedt K, Mitchell B, et al. New Therapy for Refractory Chronic Mechanical Low Back Pain-Restorative Neurostimulation to Activate the Lumbar Multifidus: One Year Results of a Prospective Multicenter Clinical Trial. Neuromodulation. Jan 2018; 21(1): 48-55. PMID 29244235
6. Thomson S, Chawla R, Love-Jones S, et al. Restorative Neurostimulation for Chronic Mechanical Low Back Pain: Results from a Prospective Multi-centre Longitudinal Cohort. Pain Ther. Dec 2021; 10(2): 1451-1465. PMID 34478115
7. Mitchell B, Deckers K, De Smedt K, et al. Durability of the Therapeutic Effect of Restorative Neurostimulation for Refractory Chronic Low Back Pain. Neuromodulation. Aug 2021; 24(6): 1024-1032. PMID 34242440
8. Ardeshiri A, Shaffrey C, Stein KP, et al. Real-World Evidence for Restorative Neurostimulation in Chronic Low Back Pain-a Consecutive Cohort Study. World Neurosurg. Dec 2022; 168: e253-e259. PMID 36184040
9. National Institute for Health and Care Excellence. 2022 Neurostimulation of lumbar muscles for refractory nonspecific chronic low back pain: Interventional Procedures Guidance. https://www.nice.org.uk/guidance/ipg739.
10. Lorio M, Lewandrowski KU, Coric D, Phillips F, Shaffrey CI. International Society for the Advancement of Spine Surgery Statement: Restorative Neurostimulation for Chronic Mechanical Low Back Pain Resulting From Neuromuscular Instability. Int J Spine Surg. 2023;17(5):728-750. doi:10.14444/8525
11. Sayed D, Grider J, Strand N, et al. The American Society of Pain and Neuroscience (ASPN) Evidence-Based Clinical Guideline of Interventional Treatments for Low Back Pain [published correction appears in J Pain Res. 2022 Dec 24;15:4075-4076. doi: 10.2147/JPR.S402370]. J Pain Res. 2022;15:3729-3832. Published 2022 Dec 6. doi:10.2147/JPR.S386879

Policy History

• MA 1.161
• 03/02/2026 New policy to address Reactiv8 device as investigational.

Plans issued by Capital Blue Cross and it’s subsidiaries are independent licensees of the Blue Cross Blue Shield Association. Communications issued by Capital Blue Cross in its capacity as administrator of programs and provider relations for all companies.

Health care benefit programs issued or administered by Capital Blue Cross and/or its subsidiaries, Capital Advantage Insurance Company^®, Capital Advantage Assurance Company^® and Keystone Health Plan^® Central. Independent licensees of the Blue Cross BlueShield Association. Communications issued by Capital Blue Cross in its capacity as administrator of programs and provider relations for all companies.