CurrentUnitedHealthcarePolicy CS036PA.W

Electrical Stimulation for the Treatment of Pain and Muscle Rehabilitation (for Pennsylvania Only)

Pennsylvania-only UnitedHealthcare medical policy specifying covered electrical stimulation indications with clinical criteria, unproven/not medically necessary modalities, applicable procedure and supply codes, documentation expectations, and device examples.

Policy Summary

PayerUnitedHealthcare

PolicyElectrical Stimulation for the Treatment of Pain and Muscle Rehabilitation (for Pennsylvania Only)

Policy CodePolicy CS036PA.W

Change TypeAdded/removed CPT; updated documentation and unproven indications

Effective DateMay 1, 2026

Next Review Date

Key ActionEnsure patient medical records contain legible history, physical exam, and diagnostic test results supporting that clinical criteria are met and make documentation available upon request.

SourceLink

POLICY UPDATE CHANGES

Revised list of unproven and not medically necessary indications; replaced 'pulsed electrical stimulation (PES)' with 'pulsed electromagnetic field stimulation (PEMF) [also known as pulsed electrical stimulation (PES)]'.

Added CPT code 64567 to Applicable Codes.

Removed CPT code 0720T from Applicable Codes.

Updated Description of Services, Clinical Evidence, FDA, and References sections to reflect the most current information.

3Therapies explicitly covered (with criteria)

11Modalities unproven/not medically necessary

~40Procedure & supply codes listed

low-to-moderateOverall evidence quality (reported)

Coverage Summary

This Pennsylvania-only UnitedHealthcare coverage policy addresses electrical stimulation therapies (including TENS, FES, NMES, and other modalities) for pain and muscle rehabilitation. The policy specifies covered indications with clinical criteria, lists modalities deemed unproven / not medically necessary, provides applicable procedure and supply codes (including updates), and details documentation expectations for medical record review. The policy is effective 05/01/2026 and the policy status is CURRENT.

Quick facts and thresholds

Therapies explicitly covered3 (TENS, FES, NMES)

Modalities not medically necessary (count)11

Applicable codes (count)~40 (procedure and supply codes listed)

Overall evidence qualitylow-to-moderate

Latest revision date05/01/2026

Independent standing tolerance (threshold)>= 3 minutes

Post recovery from SCI (threshold)>= 6 months

Responder definitions (thresholds)>= 50% pain reduction; >= 30% reported in some studies

Medical-Necessity Criteria

Transcutaneous Electrical Nerve Stimulation (TENS)

Covered when criteria in the referenced InterQual CP are met. Transcutaneous electrical nerve stimulation (TENS) is proven and medically necessary in certain circumstances. For medical necessity clinical coverage criteria, refer to the InterQual CP noted below.

Criteria met per InterQual CP for Durable Medical Equipment, Transcutaneous Electrical Nerve Stimulation (TENS).
Refer to InterQual CP: Durable Medical Equipment, Transcutaneous Electrical Nerve Stimulation (TENS) for full clinical criteria and documentation requirements.

Functional Electrical Stimulation (FES) for ambulation rehabilitation in lower limb paralysis due to spinal cord injury (SCI)

Functional electrical stimulation (FES) is proven and medically necessary as a component of a comprehensive ambulation rehabilitation program in individuals with lower limb paralysis due to spinal cord injury (SCI) when ALL of the following are met:

FES for ambulation rehabilitation in lower limb paralysis due to spinal cord injury (SCI)

Not Medically Necessary / Unproven Modalities

Unproven / Not Medically Necessary Modalities

The following modalities are unproven and not medically necessary due to insufficient evidence of efficacy:

Interferential therapy (IFT) for treating musculoskeletal disorders/injuries or to facilitate healing of nonsurgical soft tissue injuries or bone fractures.

Microcurrent electrical nerve stimulation (MENS).

Percutaneous electrical nerve stimulation (PENS) or percutaneous neuromodulation therapy (PNT).

Percutaneous electrical nerve field stimulation (PENFS).

Percutaneous peripheral nerve stimulation (PNS).

Evidence Summaries

Evidence summaries by condition (narrative, not prescriptive criteria)

Summaries of randomized trials, systematic reviews, and guideline statements addressing FES/NMES effectiveness across conditions:

Circulatory system / Heart failure: Multiple RCTs and meta-analyses report FES of legs improved peak VO2, 6MWT, and QOL; study quality fair to good; limitations include heterogeneity and bias.

(Wang et al. 2022a; Kadoglou et al. 2017)

NICE guideline for SCI rehab: For rehabilitation after SCI, consider additional techniques and specialized equipment such as FES to promote mobility and walking (NICE 2022).

NMES evidence: Limited but supportive evidence for disuse atrophy when nerve supply intact; some evidence for swallowing disorders and prevention of ICU-acquired weakness-related atrophy; controlled trials needed.

Definitions

Term	Definition
{"text":"FES","status":""},{"text":"Functional electrical stimulation: direct application of electric current to intact nerve fibers to cause purposeful contraction, enabling therapeutic or functional outcomes such as standing or ambulation.","status":""}
{"text":"NMES","status":""},{"text":"Neuromuscular electrical stimulation: transcutaneous application of electrical currents to cause muscle contractions to promote reinnervation, prevent disuse atrophy, relax spasms, and promote voluntary control.","status":""}
{"text":"TENS","status":""},{"text":"Transcutaneous electrical nerve stimulation: electric current delivered through skin electrodes to decrease perception of pain via peripheral nerve activation and/or endorphin release.","status":""}
{"text":"PENS","status":""},{"text":"Percutaneous electrical nerve stimulation: minimally invasive electrical stimulation with needle electrodes placed percutaneously to modulate pain via inserted electrodes connected to an external power source.","status":""}
{"text":"IFT","status":""},{"text":"Interferential therapy: mid-frequency current therapy intended for pain relief via crisscrossing medium-frequency pulsed currents to produce a low-frequency effect in tissues.","status":""}
{"text":"MENS / MCT / FSM / MET","status":""},{"text":"Microcurrent electrical nerve stimulation / microcurrent therapy / frequency-specific microcurrent / microelectrical therapy: low-amplitude (microampere) current stimulation modalities intended for pain relief and to facilitate healing.","status":""}
{"text":"PENFS","status":""},{"text":"Percutaneous electrical nerve field stimulation: percutaneous auricular or field-based neuromodulation approaches targeting cranial nerve branches for pain and GI disorders (auricular neuromodulation).","status":""}
{"text":"PNS","status":""},{"text":"Percutaneous peripheral nerve stimulation: temporary or implantable leads placed near peripheral nerves to deliver electrical impulses to disrupt transmission of pain signals.","status":""}
{"text":"PNFS","status":""},{"text":"Peripheral nerve field stimulation (peripheral subcutaneous field stimulation): subcutaneous lead stimulation of a painful region when the field is not confined to a single peripheral nerve.","status":""}
{"text":"PEMF","status":""},{"text":"Pulsed electromagnetic field stimulation: noninvasive electromagnetic therapy applied externally with variable frequency/intensity/duration, also referred to as pulsed electrical stimulation (PES); hypothesized to affect bone and cartilage healing and inflammation.","status":""}
{"text":"ReActiv8","status":""},{"text":"ReActiv8: implantable restorative neurostimulation system targeting multifidus activation (bilateral L2 medial branch stimulation) intended for rehabilitative treatment of mechanical chronic low back pain associated with multifidus dysfunction.","status":""}
{"text":"PoNS","status":""},{"text":"PoNS (Portable Neuromodulation Stimulator): portable nonimplantable device delivering surface electrical stimulation to the dorsal tongue combined with physical therapy to improve balance/gait (translingual stimulation).","status":""}
{"text":"Scrambler","status":""},{"text":"Scrambler therapy (Calmare): noninvasive transdermal treatment delivering variable nonlinear waveforms via surface electrodes to present nonpain information to painful areas for symptomatic relief of chronic pain.","status":""}
{"text":"AFO","status":""},{"text":"Ankle-foot orthosis.","status":""}
{"text":"6MWT","status":""},{"text":"6-Minute Walk Test.","status":""}
{"text":"CCFES","status":""},{"text":"Contralaterally controlled functional electrical stimulation: patient-driven stimulation controlled by movement of the contralateral limb to assist rehabilitation.","status":""}
{"text":"cNMES","status":""},{"text":"Conventional neuromuscular electrical stimulation.","status":""}
{"text":"Restorative neurostimulation","status":""},{"text":"Implantable stimulation (e.g., ReActiv8) targeting multifidus muscle activation to treat mechanical chronic low back pain associated with multifidus dysfunction.","status":""}

Coding (Applicable codes and device/product codes)

Procedure / CPT codes listed for referenceCPT

0278T	Transcutaneous electrical modulation pain reprocessing (e.g., scrambler therapy), each treatment session (includes placement of electrodes).
0783T	Transcutaneous auricular neurostimulation, set-up, calibration, and patient education on use of equipment
63650	Percutaneous implantation of neurostimulator electrode array, epidural.
63655	Laminectomy for implantation of neurostimulator electrodes, plate/paddle, epidural.
63663	Revision including replacement, when performed, of spinal neurostimulator electrode percutaneous array(s), including fluoroscopy, when performed.
63664	Revision including replacement, when performed, of spinal neurostimulator electrode plate/paddle(s) placed via laminotomy or laminectomy, including fluoroscopy, when performed.
63685	Insertion or replacement of spinal neurostimulator pulse generator or receiver, requiring pocket creation and connection between electrode array and pulse generator or receiver.
64555	Percutaneous implantation of neurostimulator electrode array; peripheral nerve (excludes sacral nerve).
64567	Percutaneous electrical nerve field stimulation, cranial nerves, without implantation.
64596	Insertion or replacement of percutaneous electrode array, peripheral nerve, with integrated neurostimulator, including imaging guidance, when performed; initial electrode array.

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HCPCS / Supply and device codes listed for referenceHCPCS

A4438	Adhesive clip applied to the skin to secure external electrical nerve stimulator controller, each.
A4543	Supplies for transcutaneous electrical nerve stimulator, for nerves in the auricular region, per month.
A4544	Electrode for external lower extremity nerve stimulator for restless legs syndrome.
A4556	Electrodes (e.g., apnea monitor), per pair.
A4557	Lead wires (e.g., apnea monitor), per pair.
A4593	Neuromodulation stimulator system, adjunct to rehabilitation therapy regime, controller.
A4594	Neuromodulation stimulator system, adjunct to rehabilitation therapy regime, mouthpiece, each.
A4595	Electrical stimulator supplies, 2 lead, per month, (e.g., TENS, NMES).
E0720	Transcutaneous electrical nerve stimulation (TENS) device, two-lead, localized stimulation.
E0721	Transcutaneous electrical nerve stimulator, stimulates nerves in the auricular region.

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Devices verified by CMS PDAC to be reported with HCPCS code E0770HCPCS

E0770	Deluxe Digital Electronic Muscle Stimulator (Drive Medical) - E0770 verified device example
E0770	NESS L300 and H200 devices (Bioness) - E0770 verified device example
E0770	Odstock ODFS Pace FES System (Odstock Medical/Boston Brace) - E0770 verified device example
E0770	WalkAide (Innovative Neurotronics) - E0770 verified device example

FDA product codes referenced for device lookupmixed

GZI	Functional electrical stimulation product code (FDA lookup)
IPF	Neuromuscular electrical stimulation for muscle rehabilitation product code (FDA lookup)
LIH	Interferential therapy devices product code (FDA lookup)
ILX	Pulsed electromagnetic field stimulation product code (FDA lookup)
NHI	Percutaneous/peripheral nerve stimulation product code (FDA lookup)
GZB	Percutaneous/peripheral nerve stimulation product code (FDA lookup)
GZF	Percutaneous/peripheral nerve stimulation product code (FDA lookup)
LGW	Peripheral subcutaneous/nerve field stimulation device product code (FDA lookup, PMA)
GZJ	Microcurrent/TENS/Scrambler device product code (FDA lookup)
NUH	TENS product code (FDA lookup)

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FDA-cleared/approved devices mentionedmixed

PoNS/Portable Neuromodulation Stimulator	De Novo approval March 25, 2021 for short-term treatment of gait deficit due to mild-moderate MS as adjunct to supervised exercise program (age >=22)
ReActiv8 Implantable Neurostimulation System	PMA approval June 16, 2020 for bilateral L2 medial branch stimulation for intractable chronic low back pain associated with multifidus dysfunction (adults failing therapy and not candidates for spine surgery)
Calmare/ST MC-5A (Scrambler) then ST-5A	Initial 510(k) Feb 20, 2009; subsequent clearance May 22, 2015; replaced Dec 23, 2020 (product code GZJ)
IB-Stim	FDA approved June 7, 2019 for functional abdominal pain associated with IBS in patients 11-18 years (denovo ID DEN180057)
Deepwave Percutaneous Neuromodulation Pain Therapy System	510(k) approval April 27, 2006 for treatment of pain

Added/Removed CPT codes in Applicable CodesCPT

64567	Added to policy's Applicable Codes (exact description not provided in this excerpt)
0720T	Removed from policy's Applicable Codes (exact description not provided in this excerpt)

Provider Actions & Documentation Requirements

Documentation Required

Support medical necessity with medical record documentation

Medical records documentation may be required to support the medical necessity of electrical stimulation devices and associated services. Provide a concise 1-3 sentence summary that justifies the request in the chart and be prepared to make records available for review.

Relevant history including onset, severity, prior therapies and response
Focused physical examination documenting neurologic and musculoskeletal findings (motor, sensory, reflexes, range of motion, stability)
Pertinent diagnostic tests or procedures (imaging, nerve conduction studies, electromyography) supporting the diagnosis and intact lower motor unit when applicable
Baseline and serial outcome measures (functional status, gait metrics, pain scores, validated scales) to support initial need and ongoing benefit
Device details (manufacturer, model, HCPCS/CPT code if known) and stimulation parameters used during trials and after implantation or fitting
Documentation of informed consent discussing risks, benefits, alternatives, and expected outcomes
Follow-up monitoring notes including complications, device-related adverse events, and rationale for explant or revision if performed

Medicare Determinations

Effective Date	Name	Type	Number/Notes
{"text":"2019-09-05","status":""},{"text":"Functional Electrical Stimulation (FES) - Coverage and HCPCS Coding - Revised","status":""},{"text":"NCD","status":""},{"text":"","status":""}

Evidence Items & Key Findings

Key evidence highlights orient readers to the most-cited trials and findings: the multicenter RESTORE/ReActiv8 trial (ReActiv8 restorative neurostimulation; N=203) reported significant improvements in ODI, pain (NRS), and QOL at 1 year; PNFS/PNFS RCTs (van Gorp, SubQStim/Eldabe) showed benefit as an add-on in selected failed-back-surgery populations but were limited by small size and early termination in some trials; PEMF systematic reviews and RCTs produced mixed results with heterogeneity in parameters and short follow-up; and PENFS (auricular) studies and registries—along with professional guidance—report favorable short-term results in pediatric DGBIs but are limited by small trials and short-term follow-up.

Key numeric evidence metrics

RESTORE participants203

Eldabe SubQStim randomized participants116

ReActiv8 combined follow-up participants261

Participants in PEMF reviews (Kull 2025)9 RCTs

Participants in PEMF reviews (Yang 2020)

Revision History

2026-05-01policy_revisionLatest

Revised list of unproven and not medically necessary indications — replaced 'pulsed electrical stimulation (PES)' with 'pulsed electromagnetic field stimulation (PEMF) [also known as pulsed electrical stimulation (PES)]'.

2026-05-01policy_additionLatest

Added language to 'Medical Records Documentation Used for Reviews' specifying that benefit coverage is determined by federal, state, or contractual requirements and detailing documentation expectations (relevant history, physical exam, diagnostic tests; must be legible and available upon request).

Policy Summary

PayerUnitedHealthcare

PolicyElectrical Stimulation for the Treatment of Pain and Muscle Rehabilitation (for Pennsylvania Only)

Policy CodePolicy CS036PA.W

Change TypeAdded/removed CPT; updated documentation and unproven indications

Effective DateMay 1, 2026

Next Review Date

Key ActionEnsure patient medical records contain legible history, physical exam, and diagnostic test results supporting that clinical criteria are met and make documentation available upon request.

SourceLink

On This Page

Demonstration of intact lower motor units (L1 and below) (both muscle and peripheral nerves).

Muscle and joint stability for weight-bearing at upper and lower extremities that can demonstrate balance and control to maintain an upright support posture independently.

Demonstration of brisk muscle contraction.

Demonstration of sensory perception sufficient for muscle contraction.

Demonstration of a high level of motivation, commitment, and cognitive ability for device use.

Ability to transfer independently.

Demonstration of hand and finger function to manipulate controls.

Absence of hip and knee degenerative disease.

Absence of history of long bone fracture secondary to osteoporosis.

Post recovery from spinal cord injury and restorative surgery of at least 6 months.>= 6 months

Demonstration of independent standing tolerance for at least 3 minutes.>= 3 minutes

FES - Other indications

FES is unproven and not medically necessary for any other indication not explicitly listed above.

Any other use of FES not meeting the criteria listed for SCI ambulation rehabilitation is considered unproven and not medically necessary due to insufficient evidence of efficacy.

Neuromuscular Electrical Stimulation (NMES)

Neuromuscular electrical stimulation (NMES) is proven and medically necessary for the following indications. Use requires that the nerve supply to the target muscle is intact when specified, and NMES is used as part of a comprehensive rehabilitation program where noted.

ONE of

Disuse muscle atrophy when ALL of the following are met: - The nerve supply to the muscle is intact; and - The disuse muscle atrophy is not of neurological origin but results from other conditions (e.g., casting, splinting, or contractures).
When used as part of a comprehensive lower limb rehabilitation program following total knee arthroplasty (TKA).
To improve upper extremity function in persons with partial paralysis following stroke when used as part of a comprehensive rehabilitation program.

NMES - Other indications

NMES is unproven and not medically necessary for any indication not meeting the criteria above.

Any other use of NMES not meeting the specified indications (disuse atrophy with intact nerve supply, post-TKA rehabilitation, or post-stroke upper extremity rehabilitation as part of a comprehensive program) is considered unproven and not medically necessary due to insufficient evidence of efficacy.

Peripheral subcutaneous field stimulation (PSFS) or peripheral nerve field stimulation (PNFS).

Pulsed electromagnetic field stimulation (PEMF) [also known as pulsed electrical stimulation (PES)].

Restorative neurostimulation.

Translingual stimulation for gait rehabilitation.

The policy lists multiple modalities as unproven / not medically necessary primarily because the evidence is limited and inconsistent: key concerns include substantial heterogeneity in devices, stimulation parameters and protocols, predominance of small single-center trials, short follow-up durations, and methodologic limitations (lack of blinding, attrition, and potential sponsor bias). These evidence limitations underpin the recommendation that many modalities remain unproven.

Musculoskeletal / Joint replacement and ACL: Meta-analyses and RCTs report NMES plus rehab can reduce pain and improve functional recovery and quadriceps strength after joint replacement and ACL reconstruction; heterogeneity and small samples limit conclusions.

THR: Small RCTs suggest NMES may reduce early postoperative pain during mobilization, decrease calf swelling, increase femoral venous peak velocity, and reduce edema vs compression; limited by size and short follow-up.

Amputation rehabilitation: Pilot RCT suggests home-based NMES plus traditional program may accelerate residual limb strength recovery pre-prosthesis; limited evidence.

Cerebral palsy: RCTs and reviews indicate NMES can improve muscle strength, biomechanics, gait, and functional mobility in spastic CP; dosing/protocols heterogeneous.

Stroke: Systematic reviews and RCTs report NMES (alone or combined with other therapies) can improve walking speed, gait, swallowing, ADLs (especially when applied in subacute stage and to upper extremity); evidence quality ranges very low to moderate.

General limitations: Common limitations: small sample sizes, heterogeneity of devices/protocols, variable blinding, single-center studies, limited long-term follow-up, variable adverse event reporting.

Evidence summaries by modality

Summaries of evidence by modality:

PENFS (auricular) in pediatric DGBIs and FAPDs: multiple small RCTs, registries, and observational studies report reductions in abdominal pain, nausea, and disability with short-term follow-up; evidence favorable but limited.

(ECRI, Chogle, Krasaelap)

PNS (percutaneous): Percutaneous peripheral nerve stimulation for chronic peripheral neuropathic and postsurgical pain: mixed evidence from small RCTs and observational studies; some trials and HTAs report clinically meaningful pain reduction but overall low-moderate quality and heterogeneity.

PNFS: Peripheral nerve field/subcutaneous stimulation evidence limited to small trials and case series; not recommended as standard pending robust RCTs.

Hayes / ECRI / ASIPP: Hayes and ECRI reviews often conclude limited support and call for larger blinded RCTs; ASIPP supports implantable PNS leads for refractory chronic pain (level III/fair; moderate recommendation).

Evidence-based conclusions (narrative summaries)

Findings from randomized controlled trials and systematic reviews summarized; conclusions about sufficiency of evidence:

PNFS (selected RCTs): Multiple RCTs report PNFS as effective add-on to SCS or optimized management for reducing low back pain in select populations (FBSS, localized chronic back pain) but limitations include small sizes, lack of blinding, and early terminations.

(van Gorp 2016/2019; McRoberts 2013; Eldabe SubQStim 2019)

PEMF: Systematic reviews and RCTs show mixed results: some trials show short-term pain/function benefits in OA and certain post-op contexts; others show no benefit. Heterogeneous protocols and short follow-up limit conclusions; overall insufficient evidence for routine use.

(Yang 2020; Chen 2019; Kull 2025; Picelli 2024; Newberry 2017)

Restorative neurostimulation (ReActiv8): Multiple RCTs and follow-ups report clinically meaningful improvements in pain, ODI, and QOL in refractory mechanical CLBP associated with multifidus dysfunction; limitations include open-label designs, manufacturer funding, conflicts of interest, attrition, and explants.

(RESTORE 2025; ReActiv8 pivotal and follow-ups)

A detailed evidence inventory is summarized in the policy (randomized trials, systematic reviews, HTAs, and guideline statements). Overall evidence quality is described as low-to-moderate with mixed consistency of outcomes across modalities and indications, reflecting the heterogeneous and often small or biased studies cited in the evidence table.

Prior Authorization

Prior authorization implications and affected modalities

Coverage for TENS and other modalities may require meeting InterQual CP or other clinical criteria and could have prior authorization implications. Providers should confirm plan-specific prior authorization requirements and be prepared to document prior therapy trials or failures when required.

TENS: Coverage requires meeting InterQual CP: Durable Medical Equipment, Transcutaneous Electrical Nerve Stimulation (TENS)
ReActiv8 and restorative neurostimulation: Potential prior authorization implication (informational) — documentation of indication and prior conservative therapies may be required
PNS/PNFS (percutaneous peripheral nerve stimulation / peripheral nerve field stimulation): Potential requirement for demonstration of prior therapy failure and detailed documentation of target nerve/field and treatment rationale

Documentation Required

Patient selection, informed consent, monitoring, and informational guidance

Selection of patients and informed consent must be documented, including evidence-based rationale and acknowledgement of evidence limitations for certain devices or indications. Monitor for device-related adverse events and document any explant, revision, or complications in the medical record; FDA approval status is informational and not determinative of coverage.

Evidence-based rationale for FES use: document indication (e.g., ambulation rehab for SCI), objective findings (intact lower motor units, muscle contraction, standing tolerance), and rehabilitation program participation
Evidence limitations and patient selection: document when an indication is considered unproven or not medically necessary (e.g., indications outside listed criteria) and justify patient selection when evidence is limited
Informed consent and selection for PNS/PNFS and other implantable/percutaneous therapies: document discussion of risks, benefits, alternatives, unknowns, and realistic expectations
PENFS in pediatrics: evidence-based indication documentation required; note pediatric use may have limited supporting evidence
Patient selection considerations: document comorbidities, cognitive and motivational capacity, ability to operate device controls, transfer and standing abilities when relevant
Monitor for device-related adverse events and explants: document any adverse event, timing, interventions, decision to explant/revise, and follow-up care
Device lookup and verification: record manufacturer, model, and any PDAC/CMS verification (e.g., FES devices reported with HCPCS E0770) when applicable
Informational: FDA approval or clearance alone is not a sole basis for coverage — include clinical documentation demonstrating medical necessity
Check federal, state, and contractual requirements (including Pennsylvania-specific rules) prior to device use; document compliance with applicable mandates

16 RCTs (systematic review counted 16 trials)

SubQStim planned vs enrolledplanned 314; enrolled 116 (early termination)

2026-05-01code_updateLatest

Added CPT code 64567 to Applicable Codes.

2026-05-01code_updateLatest

Removed CPT code 0720T from Applicable Codes.

archived_prior_policy

Archived prior policy version CS036PA.V (supporting information sections updated).