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Medical Policy Percutaneous Electrical Nerve Stimulation and Percutaneous Neuromodulation Therapy and Restorative Neurostimulation Therapy Table of Contents • Policy: Commercial • Coding Information
• Information Pertaining to All Policies
• Policy: Medicare • Description
• References
• Authorization Information • Policy History

Policy Number: 172 BCBSA Reference Number: 7.01.29 (For Plan internal use only) Related Policies
• Transcutaneous Electrical Nerve Stimulation, #003 • Interferential Stimulation for Treatment of Pain, #509
• Temporomandibular Joint Dysfunction, #035 • Peripheral Subcutaneous Field Stimulation, #513 • Surgical and Non-surgical Treatment of Gynecomastia, #661 • Cranial Electrotherapy Stimulation and Auricular Electrostimulation, #362 Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity

Percutaneous electrical neurostimulation is considered INVESTIGATIONAL.

Percutaneous neuromodulation therapy is considered INVESTIGATIONAL.

Restorative neurostimulation therapy (ReActiv8) is considered INVESTIGATIONAL. Prior Authorization Information Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

Outpatient Commercial Managed Care (HMO and POS) This is not a covered service. Commercial PPO and Indemnity This is not a covered service.

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CPT Codes / HCPCS Codes / ICD Codes
The following codes are included below for informational purposes. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

Note: Percutaneous Electronic Nerve Stimulator (PENS), when covered, are a DME benefit and are subject to any applicable DME co-insurance and benefit maximum CPT Codes There is no specific CPT code for this service.

Description Chronic Pain A variety of chronic musculoskeletal or neuropathic pain conditions, including low back pain, neck pain, diabetic neuropathy, chronic headache, and surface hyperalgesia, present a substantial burden to patients, adversely affecting function and quality of life.

Treatment These chronic pain conditions have typically failed other treatments, and percutaneous electrical nerve stimulation (PENS) and percutaneous neuromodulation therapy (PNT) have been evaluated as treatments to relieve unremitting pain.

Percutaneous electrical nerve stimulation is similar in concept to transcutaneous electrical nerve stimulation (TENS) (see evidence review 1.01.09) but differs in that needles are inserted either around or immediately adjacent to the nerves serving the painful area and are then stimulated. Percutaneous electrical nerve stimulation is generally reserved for patients who fail to get pain relief from TENS. Percutaneous electrical nerve stimulation is also distinguished from acupuncture with electrical stimulation. In electrical acupuncture, needles are also inserted just below the skin, but the placement of needles is based on specific theories regarding energy flow throughout the human body. In PENS, the location of stimulation is determined by proximity to the pain.

Percutaneous neuromodulation therapy is a variant of PENS in which fine filament electrode arrays are placed near the area causing pain. Some use the terms PENS and PNT interchangeably. It is proposed that PNT inhibits pain transmission by creating an electrical field that hyperpolarizes C fibers, thus preventing action potential propagation along the pain pathway.

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.

Summary
Description Percutaneous electrical nerve stimulation (PENS), percutaneous neuromodulation therapy (PNT), and restorative neurostimulation therapy (ReActiv8) combine the features of electroacupuncture and transcutaneous electrical nerve stimulation. Percutaneous electrical nerve stimulation is performed with needle electrodes while PNT uses very fine needle-like electrode arrays placed near the painful area to stimulate peripheral sensory nerves in the soft tissue. ReActiv8 is an implantable electrical neurostimulation system that stimulates the nerves that innervate the lumbar multifidus muscles.

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Summary of Evidence For individuals who have chronic pain conditions (eg, back, neck, neuropathy, headache, hyperalgesia) who receive PENS, the evidence includes primarily small, controlled trials and 2 systematic reviews. Relevant outcomes are symptoms, functional outcomes, quality of life, and medication use. Two systematic reviews have not revealed consistent benefit from PENS in musculoskeletal pain disorders. One review concluded that PENS could decrease pain intensity but not related disability, while the other found no significant differences between PENS and TENS in mitigation of pain. These conclusions are uncertain due to important methodological limitations in individual trials included in these reviews, such as high heterogeneity with regard to application methods. In the highest quality trial of PENS conducted to date in chronic low back pain, no difference in outcomes was found between the active (30 minutes of stimulation with 10 needles) and the sham (5 minutes of stimulation with 2 needles) treatments. Smaller trials, which have reported positive results, are limited by unclear blinding and short-term follow-up. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have chronic pain conditions (eg, knee osteoarthritis) who receive PNT, the evidence consists of a randomized controlled trial (RCT). Relevant outcomes are symptoms, functional outcomes, quality of life, and medication use. The single trial is limited by lack of investigator blinding, unclear participant blinding, and short-term follow-up. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have chronic pain conditions including low back pain who receive restorative neurostimulation therapy (ReActiv8), the evidence includes a systematic review, 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. A post-hoc reanalysis of the sham-controlled RCT using common clinically relevant thresholds reported statistically significant differences favoring treatment for disability, quality of life, and patient satisfaction, but not for categorical pain responder rates. The outcome thresholds evaluated were not included in the original trial's prespecified analysis plan. 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.

Policy History Date Action 5/2026 Annual policy review. Policy updated with literature review through January 22, 2026; references added. Policy statements unchanged. 8/2025 Annual policy review. Policy updated with literature review through April 23, 2025; reference added. Policy statements unchanged. 8/2024 Annual policy review. References updated. Policy statements unchanged. 12/2023 Annual policy review. References added. Policy revised. New indication and investigational policy statement added for restorative neurostimulation therapy (Reactiv8). Policy statements for percutaneous electrical nerve stimulation and percutaneous neuromodulation therapy separated out for clarity; intent unchanged. Title changed to reflect new indication. Effective 12/1/2023.

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8/2022 Annual policy review. Description, summary, and references updated. Policy statement unchanged. 1/2021 Medicare information removed. See MP #132 Medicare Advantage Management for local coverage determination and national coverage determination reference.
8/2020 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 8/2019 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 5/2017 Annual policy review. Policy statement clarified. 5/1/2017 10/2013 New references from Annual policy review. 11/2011- 4/2012 Medical policy ICD 10 remediation: Formatting, editing, and coding updates. No changes to policy statements.
1/2012 Annual policy review. No changes to policy statements. 6/2011 Reviewed - Medical Policy Group - Orthopedics, Rehabilitation Medicine, and Rheumatology. No changes to policy statements. 1/2011 Reviewed - Medical Policy Group - Neurology and Neurosurgery. No changes to policy statements. 7/2010 Reviewed - Medical Policy Group - Orthopedics, Rehabilitation Medicine, and Rheumatology. No changes to policy statements. 5/2010 Annual policy review. No changes to policy statements. 3/2010 New medical policy describing covered and non-covered indication. Effective 3/1/2010. Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

References

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59. Centers for Medicare & Medicaid. National Coverage Determination (NCD) for Assessing Patient's Suitability for ELECTRICAL NERVE STIMULATION Therapy (160.7.1). 2006; https://www.cms.gov/medicare-coverage- database/details/ncd- details.aspx?NCDId=63&ncdver=2&CoverageSelection=National&KeyWord=Electrical+Nerve+Stimul ation&Key WordLookUp=Title&KeyWordSearchType=And&list_type=ncd&bc=gAAAABAAAAAA&. Accessed January 20, 2026.