Stimulation and Percutaneous Neuromodulation

Coverage Summary & Determination

This policy assesses two minimally invasive electrical stimulation technologies — Percutaneous Electrical Nerve Stimulation (PENS) and Percutaneous Neuromodulation Therapy (PNT) — for chronic musculoskeletal and neuropathic pain and concludes that both are investigational / not covered because the evidence is insufficient to demonstrate an improvement in net health outcome. Effective date: 2010-10-01; Last review: 2025-08-01; Next review: 2026-08-01.

Policy Coverage Statement

Percutaneous electrical neurostimulation and percutaneous neuromodulation therapy coverage determination:

PENS investigational: Percutaneous electrical nerve stimulation (PENS) is considered investigational because the evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
PNT investigational: Percutaneous neuromodulation therapy (PNT) is considered investigational because the evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Policy metadata

Effective DateOctober 2010

Last ReviewAugust 2025

Next ReviewAugust 2026

Coverage StancePercutaneous electrical neurostimulation (PENS) and percutaneous neuromodulation therapy (PNT) are considered investigational (not covered).

Scope SummaryWellmark medical policy reviewing PENS and PNT for chronic musculoskeletal and neuropathic pain; summarizes trials, guidelines, FDA device clearances, coding, and investigational coverage determination.

Medical-Necessity / Investigational Rationale

High-level rationale for the investigational determination is that randomized controlled trials and systematic reviews provide only low- to very-low–quality and inconsistent evidence of benefit. Systematic reviews have reported short-term reductions in pain intensity in some pooled analyses but not consistent improvements in disability or durable outcomes, and results across trials are heterogeneous.

Key limitations include heterogeneity of application methods, small trial sizes, short follow-up, and risk-of-bias concerns (notably blinding and allocation concealment). Guideline conclusions (NICE NG59) recommend do not offer PENS for low back pain, reinforcing the policy's cautious stance despite some earlier NICE guidance (IPG450) noting short-term efficacy for refractory neuropathic pain.

Evidence Summary & Definitions

Percutaneous electrical nerve stimulation (PENS) uses needle electrodes inserted around or adjacent to sensory nerves supplying the painful area to deliver electrical stimulation; percutaneous neuromodulation therapy (PNT) is a variant using very fine filament electrode arrays placed near the painful area. FDA 510(k)–cleared devices include the Vertis Neuromodulation (Percutaneous Neuromodulation Therapy™, cleared 2002) and the Biowave Deepwave® Percutaneous Neuromodulation Pain Therapy System (cleared 2006). These therapies are proposed as alternatives for patients who have not obtained relief from other treatments such as TENS.

Citation	Design / N	Key Findings / Limitations
Plaza-Manzano et al (2020)	Systematic review and meta-analysis of 19 RCTs; total N≈1617 (range 24–242)	Found low/poor quality evidence suggesting PENS may decrease short-term pain intensity (large effect vs sham; moderate vs other interventions) but no clear effect on related disability; results limited by high heterogeneity, methodological limitations (allocation concealment, participant blinding), and imprecision.
Beltran-Alacreu et al (2022)	Systematic review and meta-analysis of 9 RCTs (quantitative N=527; study sizes 20–131)	Reported low-quality evidence of greater short-term pain reduction with PENS vs TENS but not clinically significant; when restricted to low risk-of-bias trials, no difference between PENS and TENS. Limitations include high risk of bias for participant and personnel blinding and heterogenous PENS/TENS protocols.
Weiner et al (2008) RCT	Largest sham-controlled RCT in chronic low back pain, N=200; 4-arm design (PENS, sham PENS, ± physical conditioning), twice weekly for 6 weeks	No significant differences between active PENS and sham at 1 week or 6 months for pain, disability, or gait velocity; sham included brief stimulation (5 min with 2 needles) vs active (30 min with 10 needles). Strengths: NIH-funded, blinded outcome assessor; limitation: sham produced similar improvement, raising concerns about specific efficacy of PENS.
Kang et al (2007) (PNT)	Single-blinded RCT in knee osteoarthritis, N=70; single treatment with follow-up to 1 week	Immediate post-treatment VAS pain improved with active neuromodulation but not sham; no significant difference at 48 hours; stiffness improved but pain/function did not at 48 hours. Limitations: lack of investigator blinding, short-term follow-up, differential dropout (20% sham), and questions about blinding effectiveness.
NICE guideline NG59 (2016; updated 2020)	Clinical practice guideline on low back pain and sciatica (adults)	Recommendation: Do not offer percutaneous electrical nerve stimulation (PENS) for managing low back pain with or without sciatica (NICE NG59, last updated Dec 2020).
NICE Interventional Procedure Guidance IPG450 (2013)	Interventional procedures guidance on PENS for refractory neuropathic pain	Concluded evidence raised no major safety concerns and found evidence of short-term efficacy for PENS in refractory neuropathic pain; supplemental guidance contrasted with later NG59 recommendation for low back pain.

Glossary: • PENS — Percutaneous electrical nerve stimulation: stimulation performed with needle electrodes placed around or adjacent to nerves serving the painful area. • PNT — Percutaneous neuromodulation therapy: a PENS variant using fine filament electrode arrays placed near the painful area. (Note: the term Percutaneous Electrical Nerve Stimulation is used interchangeably with PENS in the policy.)

Coding

Unlisted procedure code (nervous system)CPT

64999

Unlisted procedure code, nervous system

Durable medical equipment, miscellaneousHCPCS

E1399

Durable medical equipment, miscellaneous

Type of Service - Durable Medical Equipmentmixed

Durable Medical Equipment

Type of Service

Place of Service - Physician Office, Outpatientmixed

Physician Office, Outpatient

Place of Service

Provider Actions & Billing Impact

Documentation Required

Prior approval not applicable

Policy states prior approval is Not applicable; however investigational determination means services are not considered medically necessary per policy.

Denial Risk

Investigational — likely noncoverage

Claims for PENS or PNT may be denied as investigational since the evidence is insufficient to demonstrate improvement in net health outcome.

Guidelines, Regulatory Status, and Evidence Notes

Regulatory context includes FDA 510(k) clearances for the Vertis Percutaneous Neuromodulation Therapy system (2002) and Biowave’s Deepwave® Percutaneous Neuromodulation Pain Therapy System (2006); PENS/PNT devices are regulated as class II devices under applicable product codes. Medicare/coverage determinations listed in the policy’s medicare_determinations section do not provide a substantive national coverage approval. NICE guidance influenced the policy: NICE IPG450 (2013) noted short-term efficacy for refractory neuropathic pain, but the later NICE guideline NG59 (last updated December 2020) advised do not offer PENS for low back pain, a recommendation the policy cites in support of its investigational determination.

Evidence limitations: small sample sizes and many trials underpowered to detect durable effects.

Short-term benefits reported in some trials and meta-analyses, but little or no evidence of sustained improvement in disability or long-term outcomes.

Heterogeneity across trials in application protocols and stimulation parameters limits pooling and interpretation of results.

Risk-of-bias concerns in many studies (frequent lack of adequate blinding and allocation concealment) weaken confidence in positive findings.

Revision History

August 2025revisedLatest

Review Date: August 2025; Policy revised August 2025 with literature update through August 2025.

August 2025revised

August 2025: Annual Review and Policy Revised.

October 2023revised

October 2023: Policy Revised - content moved from retired policy 'Electrical Stimulation for Treatment of Muscle Rehabilitation, Pain and Miscellaneous Conditions'.