CurrentUnitedHealthcarePolicy CS036IN.13

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

State-specific UnitedHealthcare medical policy (Indiana) describing coverage rationale, medical necessity criteria, and noncoverage determinations for various electrical stimulation modalities including TENS, FES, NMES, and other modalities, with applicable CPT/HCPCS/other billing codes listed for reference.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS036IN.13

Change TypeRevisions and additions to indications, codes, and documentation language

Effective DateMay 1, 2026

Next Review Date

Key ActionEnsure the patient's medical record contains legible documentation (medical history, physical exam, and diagnostic test results) that supports medical necessity and make records available upon request.

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.

Added notation that HCPCS codes E0721 and E0743 are not managed for medical necessity review for Indiana at this time.

Removed notation that CPT code 64555 is not managed for medical necessity review for Indiana at this time.

3Proven/Medically Necessary Modalities

11Unproven/Not Medically Necessary Modalities

~60Procedure/supply codes referenced

heterogeneousOverall evidence quality

203Notable RCT size (ReActiv8 RESTORE)

conditionalPENFS pediatric guideline support

Coverage Summary & Scope

Policy scope: This is the UnitedHealthcare (Indiana) state-specific medical policy (#CS036IN.13) for electrical stimulation modalities used for pain and muscle rehabilitation. It takes a mixed coverage stance: some modalities are designated proven/medically necessary in defined, narrow clinical situations (for example, TENS per InterQual criteria; FES for ambulatory rehabilitation after SCI meeting specific criteria; NMES for selected indications), while a larger set of modalities are listed as unproven or not medically necessary due to insufficient or low-quality evidence. The policy provides condition- and device-specific medical necessity criteria, applicable CPT/HCPCS/L codes and coding notes, and documentation expectations for Indiana-specific coverage determinations. It also summarizes the overall evidence base as heterogeneous and often limited in quality. (See stats summary for counts of proven vs unproven modalities.)

Operational thresholds & quick-reference items

Independent standing tolerance>= 3 minutes

Post-recovery from SCI / restorative surgery>= 6 months

Responder definition (PNS trials)>= 50% reduction in pain

PENFS pediatric pain-reduction threshold>= 30% reduction in worst abdominal pain

Medical Necessity Criteria (by modality)

Transcutaneous electrical nerve stimulation (TENS)

Refer to InterQual CP: Durable Medical Equipment, Transcutaneous Electrical Nerve Stimulation (TENS). TENS is considered medically necessary in certain circumstances per InterQual criteria; determinations should be deferred to that InterQual CP for specific clinical coverage criteria.

All determinations of medical necessity for Transcutaneous Electrical Nerve Stimulation (TENS) should follow the InterQual CP referenced above; TENS is medically necessary in certain circumstances when the InterQual criteria are met.

Functional electrical stimulation (FES) — Covered Indication (ambulatory rehabilitation after 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:

ALL of the following

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

Evidence Summary & Clinical Rationale

Evidence summary: systematic reviews, RCTs, and cohort studies are synthesized by condition and device. For FES and NMES the policy cites multiple systematic reviews and randomized trials across spinal cord injury, cerebral palsy, stroke, multiple sclerosis, and heart failure showing variable benefits (improvements in muscle strength, gait parameters, aerobic capacity, or dysphagia when combined with therapy) but with many small trials, heterogeneity in protocols, and low-to-moderate certainty overall. Contralaterally controlled FES (CCFES) RCTs/meta-analyses suggest some upper-extremity gains after stroke versus cyclic NMES but inconsistent effects on broader functional measures. For pediatric PENFS there are RCTs and registry data suggesting short-term abdominal pain and functional improvements in IBS/FAPDs but limited long-term data. Percutaneous and implantable PNS/PNFS trials include RCTs showing responder rates in select postoperative or neuropathic pain populations, but the evidence is often small, industry-sponsored, and heterogeneous. Restorative neurostimulation (ReActiv8) has RCT and follow-up data reporting clinically meaningful ODI and pain improvements in carefully selected refractory mechanical CLBP patients, yet concerns about open-label design, sponsorship, attrition, and generalizability are noted. Overall the body of evidence is heterogeneous and frequently low to very low in quality; guideline panels (NICE, ACP, AHA/ASA) generally call for more research or recommend against certain modalities.

Evidence-based conclusions presented in this policy section

Summarized conclusions from trials and systematic reviews in this part:

Restorative Neurostimulation (ReActiv8): ReActiv8 trials (Gilligan et al. 2021 RCT, RESTORE 2025) and follow-ups report clinically significant improvements in ODI, NRS, and QOL in selected patients with mechanical CLBP associated with multifidus dysfunction; limitations include open-label designs, manufacturer funding, attrition, and explant rates.

Not Medically Necessary / Experimental Modalities

Modalities considered unproven or not medically necessary: based on evidence review and guideline guidance, the policy lists several modalities as unproven/not medically necessary (IFT, MENS/MCT/MET, PENS/PNT, PENFS in many adult indications, PNS in many indications, PNFS/PSFS, PEMF/PES for routine use, restorative neurostimulation outside defined criteria, scrambler therapy, and translingual stimulation for gait). The rationale is consistent: small, heterogeneous trials; low or very low certainty evidence; inconsistent or transient benefits; and guideline recommendations that either discourage routine use or call for research/clinical governance. For many of these modalities, limited positive signals exist in select studies, but overall evidence strength and guideline support are insufficient to justify broad medical necessity.

Applicable Procedure, HCPCS, and Supply Codes

Reference CPT codes (neurostimulation and related procedures)CPT

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 of spinal neurostimulator electrode percutaneous array(s), including fluoroscopy, when performed
63664	Revision including replacement 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
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; initial electrode array

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HCPCS / DME / supply codesHCPCS

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, for nerves in the auricular region

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Implantable neurostimulator / implant supplies (L codes) and miscellaneous S codesHCPCS|Other

L8678	Electrical stimulator supplies (external) for use with implantable neurostimulator, per month
L8679	Implantable neurostimulator, pulse generator, any type
L8680	Implantable neurostimulator electrode, each
L8682	Implantable neurostimulator radiofrequency receiver
L8685	Implantable neurostimulator pulse generator, single array, rechargeable, includes extension
L8686	Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension
L8687	Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension
L8688	Implantable neurostimulator pulse generator, dual array, nonrechargeable, includes extension
S8130	Interferential current stimulator, 2 channel
S8131	Interferential current stimulator, 4 channel

E0770 verified devices (CMS PDAC)mixed

E0770

Functional electrical stimulator, any type; verified devices: Deluxe Digital Electronic Muscle Stimulator (Drive Medical), NESS L300 and H200 (Bioness), Odstock ODFS Pace FES System (Odstock Medical/Boston Brace), WalkAide (Innovative Neurotronics)

FDA product codes referenced (informational)mixed

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

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Added CPT codesCPT

64567

Added to Applicable Codes (no description in this part)

Removed CPT codesCPT

0720T

Removed from Applicable Codes (no description in this part)

HCPCS management notesHCPCS

E0721	Not managed for medical necessity review for the state of Indiana at this time; refer to Prior Authorization and Notification List for UnitedHealthcare Community Plan of Indiana
E0743	Not managed for medical necessity review for the state of Indiana at this time; refer to Prior Authorization and Notification List for UnitedHealthcare Community Plan of Indiana

Provider Actions & Documentation Requirements

Documentation Required

Document medical necessity in medical record

Document medical necessity in medical record: The patient's medical record must contain documentation that fully supports the medical necessity for the requested services. Records should include relevant medical history, physical examination findings, and results of pertinent diagnostic tests or procedures. Documentation should also describe the indication, therapeutic goals, prior conservative therapies attempted (with dates and outcomes), and objective baseline measures where applicable. Documentation must be legible, maintained in the patient's medical record, and must be made available upon request.

Prior Authorization

Refer to the Prior Authorization and Notification List for Indiana

Indiana prior authorization / managed codes: Some HCPCS/CPT codes related to electrical stimulation and neuromodulation are subject to prior authorization or are not managed for Indiana. Providers must refer to the Prior Authorization and Notification List for UnitedHealthcare Community Plan of Indiana for the current managed-code list and prior authorization requirements.

Definitions and Terms

Key definitions (compact list): FES — direct coordinated stimulation to produce purposeful muscle contractions; NMES — transcutaneous stimulation to elicit muscle contractions for reinnervation/strengthening; TENS — cutaneous stimulation to reduce pain perception; IFT — interferential medium-frequency crossed currents for deeper tissue stimulation; MENS/MCT/MET — microcurrent/low‑amplitude therapies for pain/healing; PENS — needle‑based percutaneous electrical stimulation; PENFS — auricular/peripheral field percutaneous nerve field stimulation; PNS — electrodes placed near peripheral nerves (temporary or implantable) to modulate pain signals; PNFS/PSFS — subcutaneous field electrode arrays for localized pain; PEMF (PES) — pulsed electromagnetic field therapy applying time-varying magnetic fields to tissues; ReActiv8 — implantable restorative neurostimulation targeting multifidus for mechanical CLBP; PoNS/TLS — translingual neuromodulation device used adjunctively with PT for gait/balance; Scrambler therapy — noninvasive variable-pattern cutaneous electrostimulation intended to replace pain signaling; common outcome measures referenced include 6MWT (6-minute walk test), ODI (Oswestry Disability Index), and NRS/VAS (numeric pain rating scales).

Guidelines & Regulatory Guidance (selected)

Guidelines and regulatory highlights: NICE positions generally call for research or recommend against routine use of IFT and caution about NMES/IFT for knee OA and chronic primary pain; NICE regards transcutaneous NMES for dysphagia as limited and to be used with special arrangements. AHA/ASA notes NMES with therapy may reduce spasticity but lacks clear evidence for improved gait/hand use. ACP states evidence is insufficient for IFT in low back pain. FDA regulatory notes: PoNS received De Novo clearance for short-term adjunctive treatment of gait deficit in mild-to-moderate MS; ReActiv8 received PMA approval for implantable restorative neurostimulation for multifidus dysfunction–associated CLBP; IB‑Stim (auricular PENFS) has De Novo authorization for adolescent functional abdominal pain. Medicare/CMS and PDAC device verifications and specific HCPCS/CPT coding are referenced but FDA approval alone is not a basis for coverage; state‑specific prior authorization rules apply in Indiana. Providers should document guideline‑recommended selection criteria and prior therapy failures when requesting coverage.

Revision History

2026-05-01material_revisionLatest

2026-05-01material_additionLatest

Added language clarifying that benefit coverage is determined by federal, state, or contractual requirements and that medical records documentation may be required to assess clinical criteria and does not guarantee coverage; specified required documentation elements (medical history, physical exam, diagnostic test results) and that documentation must be legible and available upon request.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS036IN.13

Change TypeRevisions and additions to indications, codes, and documentation language

Effective DateMay 1, 2026

Next Review Date

On This Page

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

Demonstration of hand and finger function to manipulate controls.

Post-recovery from SCI and restorative surgery of at least 6 months.>= 6 months

Absence of hip and knee degenerative disease.

Absence of history of long bone fracture secondary to osteoporosis.

Functional electrical stimulation (FES) — Not Covered Indications

FES is unproven and not medically necessary for indications other than the covered indication stated above.

ANY of the following

Any other indication for FES not explicitly listed in the covered indication above is considered unproven and not medically necessary due to insufficient evidence of efficacy.

Neuromuscular electrical stimulation (NMES) — Covered Indications

Neuromuscular electrical stimulation (NMES) is proven and medically necessary for the following indications when used as specified:

ANY of the following

Disuse muscle atrophy
- The nerve supply to the muscle is intact.
- 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.
To improve upper extremity function in persons with partial paralysis following stroke when used as part of a comprehensive rehabilitation program.

Neuromuscular electrical stimulation (NMES) — Not Covered Indications

NMES is unproven and not medically necessary for conditions that do not meet the NMES covered criteria above.

ANY of the following

Any condition or indication not meeting the NMES covered criteria listed above is considered unproven and not medically necessary due to insufficient evidence of efficacy.

Other electrical stimulation modalities — Not medically necessary / Unproven

The following electrical stimulation modalities are considered unproven and not medically necessary due to insufficient evidence of efficacy for the listed indications:

ANY of the following

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).
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.
Scrambler therapy.
Translingual stimulation for gait rehabilitation.

Evidence-based efficacy statements

Evidence-based efficacy statements:

Electrotherapies have variable evidence by modality; FES and NMES have evidence supporting specific functional rehabilitation uses described above, while many other modalities lack sufficient high-quality evidence demonstrating consistent clinical benefit.

Randomized controlled trials, systematic reviews, and guideline statements support FES for ambulation-related rehabilitation after SCI under strict candidate-selection criteria and NMES for disuse atrophy and adjunctive post-arthroplasty and post-stroke rehabilitation when used in comprehensive programs.

Evidence for IFT, MENS, PENS/PNT, PENFS, PNS/PSFS/PNFS, PEMF, restorative neurostimulation, scrambler therapy, and translingual stimulation is inconsistent, limited, or of low quality and does not establish efficacy for routine clinical use in the listed indications.

Guideline and regulatory recommendations

Guideline and regulatory recommendations:

Follow applicable FDA clearances/approvals and device labeling for indications and use. CMS PDAC verification applies for select FES devices reported with HCPCS code E0770; only CMS-verified devices should be billed with that code.

Clinical practice guideline recommendations and specialty society guidance support use of FES and NMES in the specific, evidence-backed indications listed above; other modalities lack endorsement for general use in these conditions.

For TENS, InterQual CP criteria are the operational standard for clinical coverage determinations per this policy.

Summary of Clinical Conclusions in This Section

Summary of clinical conclusions in this section:

FES: Proven and medically necessary for ambulatory rehabilitation after SCI when strict candidate criteria are met (see covered FES criteria).

NMES: Proven and medically necessary for disuse muscle atrophy (non-neurological), as part of rehabilitation after total knee arthroplasty, and to improve upper extremity function post-stroke when used within comprehensive rehabilitation programs.

TENS: Clinical coverage determinations are governed by the InterQual CP; TENS can be medically necessary in specified circumstances per InterQual.

All other listed modalities: Considered unproven and not medically necessary due to insufficient evidence.

Evidence-based recommendations & strength summaries

Evidence-based recommendations and strength summaries:

Recommendation: Use FES for ambulatory rehabilitation after SCI only when all candidate-selection criteria are met. Strength: Supported by moderate-quality evidence and guideline consensus for selected patients.

Recommendation: Use NMES for disuse atrophy (non-neurological), post-total knee arthroplasty rehabilitation, and adjunctive post-stroke upper extremity rehabilitation within comprehensive programs. Strength: Supported by low-to-moderate quality evidence showing functional benefit when combined with rehab.

Recommendation: Do not use IFT, MENS, PENS/PNT, PENFS, PNS/PSFS/PNFS, PEMF, restorative neurostimulation, scrambler therapy, or translingual stimulation for the listed indications outside of research settings. Strength: Insufficient evidence; recommendation against routine use.

PNS / PNFS adult evidence

Percutaneous Peripheral Nerve Stimulation (PNS) / Peripheral Nerve Field Stimulation (PNFS) — adult evidence summary:

The evidence for percutaneous peripheral nerve stimulation (PNS) and peripheral nerve field stimulation (PNFS) in adults is limited and heterogeneous. High-quality randomized controlled trials demonstrating durable, clinically meaningful outcomes across diagnostic groups are lacking for the indications listed in this policy.

When available, studies are often small, single-center, or uncontrolled and show mixed results for pain reduction and functional improvement. Long-term effectiveness, optimal patient selection, and comparative effectiveness versus standard therapies remain uncertain.

Specific indications such as occipital neuralgia and select headache disorders may be addressed under other targeted UnitedHealthcare policies; refer to specialized policies for those conditions.

Evidence summary / Coverage-relevant conclusions

Evidence summary / Coverage-relevant conclusions:

Coverage decisions should be aligned with the modality-specific evidence: approve FES and NMES for the defined, evidence-based indications and consider other modalities not medically necessary for routine coverage.

Documentation requirements: medical records must demonstrate how the patient meets the specific clinical criteria listed for covered modalities (e.g., intact lower motor units, standing tolerance, timing after SCI for FES; nerve intactness and non-neurological etiology for NMES in disuse atrophy).

Devices billed under specific HCPCS/CPT codes must meet regulatory verification where applicable (e.g., CMS PDAC verification for certain FES devices billed with E0770).

When evidence is insufficient, coverage is not supported; consider enrollment in clinical trials or referral to specialty programs when appropriate.

ReActiv8 evidence summary

Scrambler therapy conclusions: Scrambler therapy evidence is mixed and generally low/very low quality; small RCTs and observational studies suggest possible short-term benefits in select neuropathic pain conditions but guidelines (ASCO/ESMO) do not recommend routine use for CIPN.

Scrambler therapy evidence summary

Translingual stimulation (PoNS): PoNS/TLS evidence for gait/balance rehabilitation is inconclusive: some RCTs and pilots report improvements when combined with PT for mmTBI and MS; ECRI concluded evidence inconclusive and called for independent studies.

PoNS evidence summary

PENFS pediatric evidence

Summarized study-level findings for pediatric DGBIs, IBS, CVS and FAPDs:

PENFS pediatric registry and trials: Chogle et al. (2024) registry (n=292) showed improvements in API, NSS, and FDI up to 12 weeks; Krasaelap et al. (2020) RCT subanalysis (n=50) showed 59% PENFS achieved >=30% reduction in worst abdominal pain vs 26% sham; Kovacic et al. (2017) RCT showed greater reduction in worst pain after 3 weeks in PENFS vs sham. Limitations: small samples, short follow-up, heterogeneous populations.

PENFS pediatric evidence summaries

Device categories and definitions (concise): the policy defines key device types to orient clinical readers: FES (coordinated stimulation to elicit purposeful muscle contractions for function), NMES (transcutaneous stimulation to elicit muscle contraction for strengthening/rehabilitation), TENS (cutaneous stimulation to reduce pain perception), IFT (interferential therapy using medium-frequency crossed currents), MENS/MCT/MET (microcurrent/very low‑amplitude microcurrent therapies), PENS (percutaneous electrical nerve stimulation with needle electrodes), PENFS (percutaneous electrical nerve field/auricular stimulation), PNS (peripheral nerve stimulation, temporary or implantable), PNFS/PSFS (peripheral nerve field/subcutaneous field stimulation), PEMF (PES) (pulsed electromagnetic field stimulation), Restorative neurostimulation (ReActiv8) (implantable multifidus stimulation), PoNS/TLS (translingual stimulation device), and Scrambler therapy (transcutaneous electrostimulation presenting non-pain signals). See the policy definitions section for full operational definitions and device examples.

Affected example codes (verify current PA list): E0721, E0743, (and other codes listed in the Applicable Codes section).
Codes marked with an asterisk in the policy text are not managed for medical necessity at the time the policy became effective — always confirm current status on the Indiana PA list.

Documentation Required

Transcutaneous NMES for dysphagia — governance/research use recommended

Transcutaneous NMES for dysphagia — use with governance or research: Transcutaneous neuromuscular electrical stimulation (NMES) for oropharyngeal dysphagia should be used within approved clinical governance, research protocols, or formal quality improvement programs. The evidence base is limited, heterogeneous, and of low quality; therefore coverage of transcutaneous NMES for dysphagia requires an evidence-based justification in the record when requested outside defined research or governance frameworks.

Document the study or governance protocol under which therapy is being delivered.
Describe patient selection criteria and the specific device and stimulation parameters used.

Documentation Required

Evidence-based justification required for investigational or limited modalities

Investigational/limited modalities — evidence-based justification required: For modalities classified as investigational or limited (for example, PEMF, restorative neurostimulation, scrambler therapy, translingual stimulation, PoNS when outside studied protocols), an evidence-based justification must be included in the medical record to support coverage decisions. This should summarize pertinent literature, rationale for use in the individual patient, and expected measurable outcomes.

List the specific investigational or limited modality and cite key supporting or limiting literature in the record when available.
State how the patient differs from populations in negative or low-quality studies and why clinical benefit is anticipated.

Documentation Required

Clinical population definitions and required outcome measures

Clinical population definitions and outcome measures to document: When requesting review for restorative or neuromodulation therapies, document the clinical population definition (diagnosis, duration of symptoms, prior treatments) and baseline objective outcome measures. Relevant outcome measures may include, but are not limited to, Oswestry Disability Index (ODI), Numeric Rating Scale (NRS) or Visual Analogue Scale (VAS) for pain, 6-minute walk test (6MWT), standardized swallowing assessments for dysphagia, and device-specific functional scales.

Include baseline scores (ODI, NRS/VAS), functional test results (6MWT), and standardized swallowing evaluation results when applicable.
Document symptom duration and prior conservative therapies with dates and responses.

Documentation Required

Implantable restorative neurostimulation — candidate selection and conservative therapy documentation

Implantable restorative neurostimulation candidate selection and prior conservative therapy: For implantable restorative neurostimulation (e.g., ReActiv8-like devices), document that the patient meets candidate selection criteria on an operational level: clear diagnosis (e.g., chronic mechanically induced low back pain with multifidus dysfunction), failure of adequate conservative therapy (physical therapy, medications, injections as appropriate), documented baseline pain and disability thresholds (e.g., ODI and NRS), and that the patient has tried and not responded to specified noninvasive therapies for a defined duration.

Document conservative therapies attempted (type, dates, duration, response).
Document baseline disability/pain thresholds (e.g., ODI score, NRS/VAS) and functional limitations.
Note any device-specific candidacy criteria such as diagnostic blocks or electrophysiologic testing if applicable.

Documentation Required

Document PEMF device and stimulation parameters

PEMF therapy parameter heterogeneity: Pulsed electromagnetic field (PEMF) therapy studies demonstrate wide heterogeneity in device parameters (frequency, intensity, treatment duration, and waveform). When PEMF is considered, document the exact device, parameter settings, treatment schedule, and rationale linking those parameters to any supporting evidence or expected clinical effect.

Specify PEMF device make/model and program settings (frequency, intensity, waveform, duration, number of sessions).
Provide evidence or rationale for the chosen parameter set if relying on extrapolated literature.

Documentation Required

ReActiv8 / restorative neurostimulation — patient selection documentation

Patient selection considerations for ReActiv8 (implantable restorative neurostimulation): Document that the patient meets specific clinical features consistent with the device indication and published selection criteria: chronicity of symptoms, predominant low back pain related to multifidus dysfunction, failure of conservative care, and objective measures of disability/pain. If device-specific pre-implant testing (e.g., temporary stimulation or diagnostic testing) is used, document methods and results.

Record symptom duration and prior conservative treatment details.
Document any pre-implant test stimulation results and patient-reported responses.

Documentation Required

PoNS / translingual stimulation — combined with PT and study limitations

PoNS / Translingual stimulation — study limitations and combined-with-PT documentation: Translingual neurostimulation devices (e.g., PoNS) have been studied primarily as an adjunct to structured physical therapy. When used, document that therapy is delivered in conjunction with an appropriate, supervised rehabilitation program, include details of the PT program, and note study limitations relevant to the patient (small sample sizes, short follow-up, heterogeneity of protocols).

Document PT frequency, duration, and goals alongside device use.
Summarize key study limitations pertinent to expected outcomes (sample size, follow-up length, heterogeneity).

Documentation Required

Scrambler therapy — document trial protocol and response

Scrambler therapy — trial documentation expectations: For scrambler therapy (transcutaneous electrical modulation pain reprocessing), document the specific treatment protocol used (number of sessions, frequency, electrode placement), baseline pain scores, prior therapies tried, and clinical response during the trial. Include objective pain/function measures and duration of any benefit.

Document CPT/HCPCS code used (e.g., 0278T if applicable) and session-level details.
Include baseline and interval pain scores (NRS/VAS) and functional measures.

Billing Rule

Indiana billing/coding note — verify PA status for listed HCPCS codes

State-specific HCPCS non-managed codes (billing rule): In Indiana, certain codes are not managed for medical necessity review at policy effective date but billing and PA status may change. Verify current billing requirements on the Indiana Prior Authorization and Notification List prior to submission.

Example non-managed codes at effective date: E0721 (auricular TENS), E0743 (external lower extremity nerve stimulator for RLS).
Codes marked with an asterisk in the policy text were not managed for Indiana at the policy effective date — confirm current status.

Note

FDA approval does not alone guarantee coverage — document regulatory status and rationale

FDA approvals and device-specific regulatory status: FDA clearance or approval for a device or indication does not by itself guarantee coverage. When device use is requested, document the device regulatory status and label indication in the record, and explain how the requested use aligns with or differs from the labeled indication.

2026-05-01material_additionLatest

Added CPT code 64567 to Applicable Codes.

2026-05-01material_removalLatest

Removed CPT code 0720T from Applicable Codes.

2026-05-01non_material_revisionLatest

Noted that HCPCS codes E0721 and E0743 are not managed for medical necessity review for Indiana and referred to the Prior Authorization and Notification List for UnitedHealthcare Community Plan of Indiana.

2026-05-01non_material_removalLatest

Removed previous notation that CPT code 64555 is not managed for medical necessity review for Indiana.