Electrical Stimulation Devices
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Defines medical necessity, coverage, and exclusions for electrical stimulation devices (TENS, NMES, FES, PENS, implanted peripheral stimulators, and other modalities) for Moda Health members. Applies to ordering providers, DME suppliers, and clinical reviewers requesting prior authorization or claims adjudication for these devices.
Added an additional 9-month rental if approved for NMES and clarified rental-to-purchase conversion after 1 year of rental.
Restorative Therapies RT300 (and similar exercise FES equipment) are considered not medically necessary and not covered.
Revised terminology replacing 'percutaneous' with 'peripheral' in sections addressing nerve stimulation.
Coverage and Medical Necessity Criteria
NMES and associated supplies (covered criteria)
Covered when ALL of the following are met
NMES for prevention/treatment of disuse atrophy
- Device approval: Device must be FDA approved.
- Intact nerve supply: The nerve supply to the muscle is intact, including brain, spinal cord and peripheral nerves.
- Clinical context: Patient had previous casting or splinting of a limb, contractures due to burn scarring, prolonged immobilization, or major hip or knee surgery (until physical therapy begins).
- Conservative therapy tried: Patient was unresponsive to conservative treatment such as physical therapy, pharmacotherapy, etc.
- Age: Patient is at least 2 years of age.>=2 years
- Exclusions for NMES uses: NMES is considered experimental/investigational for: general muscle strengthening in healthy individuals; treatment of scoliosis; treatment of denervated muscles; cardiac conditioning; facilitating voluntary motor control.
- Specific device exclusion: CyMedica QB1 System (form-fitted conductive knee brace) is not covered (considered experimental/investigational).
Form-fitting conductive garments with NMES
- FDA marketing approval: Conductive garment is approved for marketing by the FDA.
- Physician prescription: A physician has prescribed the conductive garment for use in delivering covered NMES.
- Patient inability without garment: Patient cannot manage without the conductive garment due to one or more of the following: area too large or too many sites to stimulate with conventional electrodes; frequent stimulation required that precludes conventional electrodes; chronic intractable pain inaccessible with conventional electrodes; skin problems precluding application of electrodes; need for stimulation beneath a cast.
See subitems for specifics.
FES, PENS, and implanted peripheral stimulators (covered criteria)
Covered when ALL of the following are met
FES for ambulation assistance (e.g., Parastep I)
- Motor units intact: Intact L1 and below motor units.
- Timing after injury: Six months post spinal cord injury and restorative surgery.>=6 months
- Weight-bearing ability: Ability to bear weight with both upper and lower extremities.
- Postural control: Ability to independently maintain upright posture and transfer and maintain standing for at least three minutes.>=3 minutes
- Manual control: Presence of hand and finger function to operate controls.
- Positive contraction response: Positive brisk muscle contraction response to neuromuscular electrical stimulation.
- Sufficient sensory perception: Sensory perception of electrical stimulation sufficient for muscle contraction.
- Absence of structural disease: Absence of hip/knee degenerative disease and long bone fracture secondary to osteoporosis.
- Patient factors: Patient is highly motivated, cognitively able to operate device, and has completed at least 32 physical therapy sessions over three months using the device.>=32 sessions
- Contraindications: Patient does NOT have pacemaker; severe scoliosis (>40°); severe osteoporosis (T score < -2.5 SD with fragility fractures); skin disease or cancer at stimulation area; irreversible contractures; or autonomic dysreflexia.
Experimental / Investigational (not covered)
Not covered / Experimental and investigational
Includes interferential stimulators; H-wave stimulators; microcurrent/MENS (e.g., Alpha-Stim); galvanic stimulators (e.g., SportTX); sympathetic stimulators; BioniCare Knee Device; peripheral subcutaneous field stimulation (PSFS) / peripheral nerve field stimulation (PNFS); peroneal nerve stimulators (e.g., WalkAide, NESS L300, ODFS) for gait disorders due to CNS disorders; Reactiv8; auricular stimulation (P-stim, E-pulse) for multiple indications; cranial electrical stimulation devices (Fisher Wallace, CES Ultra); and TENS for listed mental and sleep disorder diagnoses.
Specific devices and indications listed as experimental and investigational are excluded from coverage because available evidence is insufficient to establish effectiveness. Examples called out in the policy include interferential stimulators, H-wave stimulators, microcurrent (MENS) stimulators (e.g., Alpha-Stim), galvanic stimulators, sympathetic stimulators, BioniCare® Knee Device, peripheral subcutaneous field stimulation (PSFS) / peripheral nerve field stimulation (PNFS), peroneal nerve stimulators for CNS gait disorders (e.g., WalkAide, NESS L300, ODFS), Reactiv8, auricular stimulation devices (e.g., P‑stim, E‑pulse) for multiple indications, and cranial electrical stimulation devices (e.g., Fisher Wallace, CES Ultra).
Where applicable, coverage must comply with existing Medicare National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs). Submitters should follow those CMS policies and include required documentation when claims or prior authorization requests fall within Medicare determinations; additional indications may be considered at the plan’s discretion.
Restorative Therapies RT300 and similar exercise FES equipment are explicitly stated as not medically necessary and not covered by the plan.
Medical Necessity Details
NMES medical necessity
Medical necessity criteria for NMES rental, purchase, and device use
Initial approval limited to a 2-month rental; further authorization may allow an additional 9-month rental; device deemed purchase after 1 year of rental.
FES (Parastep) medical necessity
Medical necessity criteria for FES (Parastep) use and training
Training program requirement: ≥32 PT sessions over 3 months; restorative exercise FES equipment (e.g., RT300) is NOT medically necessary.
Rental, Extension, and Deemed-Purchase Rules
| Equipment | Rule / Action | Details |
|---|---|---|
| NMES devices (neuromuscular electrostimulation) | ||
| rental then deemed purchase | ||
| Initial approval limited to a 2-month rental; further authorization may allow an additional 9-month rental if approved; device is deemed purchased after 1 year of rental; NMES allowed when all medical necessity criteria are met (device FDA approved; intact nerve supply; prior casting/splinting or prolonged immobilization/contracture/major surgery until PT begins; failed conservative therapy; age ≥2 years). |
| Equipment | Rule / Action | Details |
|---|---|---|
| TENS and other electrical nerve stimulators (transcutaneous electrical nerve stimulators and related devices) | ||
| rental | purchase | ||
| Follow Medicare Part B rules and applicable NCDs/LCDs for rental versus purchase determinations; documentation and billing must comply with applicable Medicare coverage rules where they apply and additional indications may be considered at plan discretion. Prior authorization required when indicated per medical necessity criteria. |
CPT / HCPCS / Diagnosis Codes and Jurisdiction Notes
| A4595 | ELECTRICAL STIMULATOR SUPPLIES, 2 LEAD, PER MONTH, (E.G., TENS, NMES). |
| E0744 | Neuromuscular stimulator for scoliosis. |
| E0745 | Neuromuscular stimulator, electronic shock unit. |
| E0764 | Functional neuromuscular stimulator, transcutaneous stimulation of sequential muscle groups of ambulation with computer control, used for walking by spinal cord injured, entire system, after completion of training program. |
| E0770 | Function electrical stimulator, transcutaneous stimulation of nerve and/or muscle groups, any type, complete system, not otherwise specified. |
| 64555 | Peripheral nerve (excludes sacral nerve). |
| 64561 | Sacral nerve (transforaminal placement), including image guidance, if performed. |
| 64590 | Insertion or replacement of peripheral or gastric neurostimulator pulse generator or receiver, direct or inductive coupling. |
| G56.00-G59 | Mononeuropathies |
| G89.18 | Other acute postprocedural pain |
| G89.21-G89.29 | Chronic pain |
| G89.4 | Chronic pain syndrome |
| G90.50-G90.59 | Complex regional pain syndrome I (CRPS I) |
| M51.04-M51.06 | Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with myelopathy |
| M54.10-M54.18 | Radiculopathy |
| M54.30-M54.32 | Sciatica |
| M54.40-M54.42 | Lumbago with sciatica |
| M54.5 | Low back pain [lumbago] |
| NCD 280.13 | Transcutaneous Electrical Nerve Stimulators (TENS) |
| NCD 160.7 | Electrical Nerve Stimulators |
| LCD L33802 | Transcutaneous Electrical Nerve Stimulators (TENS) - Noridian |
| LCA A52520 | TENS Policy Article - Noridian |
Prior Authorization, Trials, and Submission Guidance
Obtain prior authorization and cite supported codes
Prior authorization is required for devices and services listed in this policy; requests must reference the specific HCPCS/CPT codes for the device (e.g., A4595, E0744, E0745, E0764, E0770, 64555, 64561, 64590) and include documentation that demonstrates medical necessity for that device and code.
- Submit prior authorization using the specific HCPCS/CPT code(s) for the device or procedure.
- Include evidence in the request that the member meets the policy medical necessity criteria for the requested code.
Comply with applicable Medicare NCDs/LCDs
When a Medicare NCD or LCD applies to the requested device or service, follow the applicable NCD/LCD coverage rules and submit the documentation required by those determinations with the authorization or claim.
- NCDs/LCDs referenced include NCD 280.13, NCD 160.7, LCD L33802 and LCA A52520; follow these where applicable.
- Use the Medicare Coverage Database for current NCD/LCD details and required supporting documentation.
Require and document successful transcutaneous trial before implantation
Before implantation of a peripheral implanted nerve stimulator, submit documentation of a successful transcutaneous stimulation trial demonstrating at least 50% pain reduction for a minimum of 3 days.
- Document the trial result (≥50% pain reduction) and duration (minimum 3 days) in the prior authorization request.
- Ensure psychological evaluation and other listed pre-implantation criteria are also met for peripherally implanted stimulators.
Submit complete required documentation with requests
Include all required materials listed by the policy when submitting prior authorization or claims to avoid delays or denials.
- Ordering physician's chart notes
- Appropriate imaging studies or other diagnostic test results
- Documentation of conservative treatments trialed
Provide ordering physician notes, imaging, and conservative treatment history
Prior authorization requests must include the ordering physician's chart notes, appropriate imaging or diagnostic test results, and documentation of prior conservative treatment trials as specified in the policy.
- Chart notes from the ordering physician showing clinical indications and response to prior treatments.
- Relevant imaging or diagnostic test results (e.g., EMG, MRI) when objective evidence of pathology is required.
Align documentation with Medicare NCD/LCD requirements and appendix codes
When Medicare NCDs/LCDs are applicable, ensure submitted documentation aligns with those determinations and reference the applicable diagnosis codes from Appendix 1 when indicated.
- List applicable diagnosis codes from Appendix 1 on the request when following Medicare NCD/LCD guidance.
- Supply any additional documentation required by the referenced NCD/LCD.
Omitting required documentation may trigger denial
Failure to include the ordering physician's chart notes, appropriate imaging/diagnostic test results, and documentation of conservative treatments tried may result in denial of the prior authorization request.
- Omitting any of the required items listed in the policy is a trigger for denial.
- Provide clear documentation of conservative therapy trials to demonstrate medical necessity.
Risk of denial for noncompliance with NCDs/LCDs
Noncompliance with applicable Medicare NCDs/LCDs may lead to denial; coverage may be limited to indications specified in CMS policies or at the plan's discretion.
- If an NCD/LCD applies, failure to follow its rules and required documentation can result in denial.
- Additional indications outside NCD/LCDs may be considered only at plan discretion.
Device and Policy Definitions
Background and Context
Electrical stimulators encompass both external devices applied via skin electrodes and implanted peripheral stimulators. They are used for purposes including pain relief, muscle strengthening, prevention of disuse atrophy, reduction of spasticity, and functional assistance (for example, ambulation after spinal cord injury). Device categories described in the policy include TENS, NMES, FES, H‑wave, interferential, microcurrent/MENS, galvanic, sympathetic therapy, auricular stimulation, peroneal nerve stimulators, and implanted peripheral stimulators.
Submission and Documentation Requirements
Include physician notes, imaging, and conservative treatment documentation with prior auth
Prior authorization submissions must include ordering physician notes, appropriate imaging/diagnostic studies, and documentation of conservative treatment trials as required by the policy.
- Ensure chart notes document the clinical indication and prior therapies attempted.
- Attach imaging or test results and records of conservative treatment attempts.
Submit documentation per NCD/LCD requirements when applicable
When Medicare NCDs/LCDs apply, submit the documentation required by those determinations; the plan may cover additional indications at its discretion but requires alignment with the NCD/LCD when applicable.
- Follow the NCD/LCD documentation requirements for Medicare Part B covered indications.
- Reference the applicable NCD/LCD documents (e.g., NCD 280.13, NCD 160.7, LCD L33802) on submissions.
Excluded and Not Medically Necessary Devices
Devices and indications that are explicitly not covered include: Restorative Therapies RT300 and similar exercise FES equipment; and a list of devices considered experimental and investigational such as interferential stimulators, H‑wave stimulators, microcurrent (MENS) stimulators, galvanic stimulators, sympathetic stimulators, BioniCare® Knee Device, peripheral subcutaneous field stimulation (PSFS/PNFS), peroneal nerve stimulators for gait disorders due to central nervous system conditions, Reactiv8, auricular stimulation for multiple indications, and cranial electrical stimulation devices. The policy also lists specific CPT/HCPCS codes that are not covered (e.g., S8930 and E1399).
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