CurrentUnitedHealthcarePolicy CSO36TNX

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

State-specific UnitedHealthcare medical policy for Tennessee Medicaid/CoverKids addressing coverage, medical necessity, and exclusions for multiple electrical stimulation modalities (TENS, NMES, FES, PENS, PNS, IFT, MENS, scrambler therapy, restorative neurostimulation, etc.), with applicable HCPCS/CPT/L-codes and clinical evidence summaries.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CSO36TNX

Change TypeAdministrative / reference updates

Effective DateMar 1, 2025

Next Review Date

Key ActionProviders must refer to InterQual CP: Durable Medical Equipment; Transcutaneous Electrical Nerve Stimulation (TENS) and TennCare Medicaid Chapter 1200-13-13-.10 for specific medical necessity criteria and exclusions.

POLICY UPDATE CHANGES

03/01/2025 Summary of Changes: Coverage Rationale updated and reference link to the TennCare Medicaid exclusions was updated; supporting information sections (Description of Services, Clinical Evidence, FDA, and References) updated and previous policy version CSO36TN.W archived.

1State-specific policy (Tennessee)

3Proven/Covered modalities (examples listed)

10Modalities considered unproven/not medically necessary (listed)

mixed

Overall Evidence Strength

insufficientLong-term Evidence

1Policy revision in this part (2025-03-01)

Coverage Summary

This state-specific UnitedHealthcare policy (Tennessee Medicaid/CoverKids) addresses coverage, medical necessity, and exclusions for multiple electrical stimulation modalities used for muscle rehabilitation, pain relief, and neuromodulation. The policy takes a mixed coverage stance: NMES is deemed proven and medically necessary for specific indications (disuse muscle atrophy not of neurological origin; as part of comprehensive lower-limb rehabilitation after total knee arthroplasty; and to improve upper extremity function in persons with partial paralysis after stroke when used within a comprehensive rehabilitation program). Selected device categories and uses such as certain TENS/FES applications are covered under referenced medical necessity criteria (InterQual and TennCare rules).

The policy also lists multiple modalities as unproven/not medically necessary due to insufficient evidence, including MENS, IFT, PENS/PNT, PENFS, PNS, PES, PSFS/PNFS, restorative neurostimulation, scrambler therapy, and translingual stimulation. Applicable HCPCS/CPT and L-codes for FES/NMES, TENS, implantable neurostimulators, and related supplies are provided for billing and verification purposes. The document emphasizes heterogeneous and limited evidence across many modalities and notes that regulatory status varies by device (e.g., certain devices have PMA or De Novo approvals while many have 510(k) clearance).

Key facts

Effective Date2025-03-01

Policy NumberCSO36TNX

Scope SummaryState-specific UnitedHealthcare medical policy for Tennessee Medicaid/CoverKids addressing coverage, medical necessity, and exclusions for multiple electrical stimulation modalities (TENS, NMES, FES, PENS, PNS, IFT, MENS, scrambler therapy, restorative neurostimulation, etc.), with applicable HCPCS/CPT/L-codes and clinical evidence summaries.

Overall Evidence Strengthmixed

Long-term Evidenceinsufficient long-term data

Clinical Effect Summarysome positive short-term effects

Medical-Necessity Criteria

Coverage Rationale - NMES

NMES is proven and medically necessary when ALL of the following apply for the listed indications:

Indications (any of the following)

Any indication: Disuse muscle atrophy when the disuse muscle atrophy is not of neurological origin but results from other conditions (e.g., casting, splinting, or contractures)
Any indication: When used as part of a comprehensive lower limb rehabilitation program following total knee arthroplasty
Any indication: To improve upper extremity function in persons with partial paralysis following stroke when used as part of a comprehensive rehabilitation program

Evidence Summary & Coverage Implications

Evidence-based conclusions in this document section

Summarized evidence statements and conclusions from HTAs, systematic reviews, RCTs, and observational studies in this section:

Evidence statements

PNS: Percutaneous Peripheral Nerve Stimulation (PNS): Evidence is low to very low quality; some studies suggest pain reduction, QOL and medication use improvement but insufficient to draw definitive conclusions or define patient selection.
Implantable PNS systems (e.g., SPRINT, Nalu): Minimal or no robust evidence supporting routine use; HTAs found minimal support or no relevant peer-reviewed studies for certain systems.
PEMF/PES: Pulsed Electromagnetic Field (PEMF)/Pulsed Electrical Stimulation (PES): Evidence is mixed; some small RCTs and systematic reviews suggest short-term pain and function benefit in OA and select postoperative contexts, but overall evidence is insufficient and heterogeneous; further well-designed RCTs needed.

Coding

Procedure / CPT / HCPCS / Unlisted codes referencedmixed

0278T	Transcutaneous electrical modulation reprocessing (eg , scrambler therapy), each treatment session (includes placement of electrodes) - pain
0720T	Percutaneous electrical nerve field stimulation, cranial nerves, without implantation
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)
64596	Insertion or replacement of percutaneous electrode array, peripheral nerve, with integrated neurostimulator, including imaging guidance, when performed; initial electrode array

1–10 of 41

1/5

HCPCS E0770 Verified FES devices (PDAC verified devices)HCPCS

E0770*

Functional electrical stimulator; devices verified by CMS PDAC: Odstock ODFS Pace FES System; NESS L300 and L200 devices (Bioness); WalkAide (Innovative Neurotronics); Deluxe Digital Electronic Muscle Stimulator (Drive Medical).

FDA product/device codes referencedmixed

GZJ	TENS / MENS / Scrambler Therapy product code referenced
IPF	NMES for muscle rehabilitation product code
LIH	Interferential Therapy product code
PZR	Peripheral Subcutaneous Field Stimulation / PNFS product code
NHI	PENS device product code
QHH	IB-Stim PENFS system product code
QLK	ReActiv8 restorative neurostimulation product code

FDA-cleared/approved devices mentionedmixed

Calmare/ST MC-SA; Model ST-5A	Scrambler Therapy device — 510(k) clearances (2009, 2015) and replacement ST-5A (2020)
PoNS (Portable Neuromodulation Stimulator)	De Novo approval March 25, 2021 — indicated as adjunct to supervised therapeutic exercise for short-term treatment of deficits due to mild-to-moderate MS in patients >=22 years
ReActiv8 Implantable Neurostimulation System	PMA June 16, 2020 — indicated for bilateral stimulation of L2 medial branch for intractable CLBP associated with multifidus dysfunction
IB-Stim	PENFS system for functional abdominal pain in IBS ages 11-18 — FDA approval June 7, 2019
Deepwave Percutaneous Neuromodulation Pain Therapy System	PENS device — 510(k) April 27, 2006
Freedom Peripheral Nerve Stimulator (Curonix)	PSFS/PNFS device — FDA 510(k)

Provider Actions & Prior Authorization

Documentation Required

Refer to external medical necessity criteria

Consult the InterQual CP for Durable Medical Equipment: Transcutaneous Electrical Nerve Stimulation (TENS) and the TennCare regulations (Chapter 1200-13-13-.10) for state-specific medical necessity and coverage rules prior to ordering or billing.

InterQual CP: Durable Medical Equipment; Transcutaneous Electrical Nerve Stimulation (TENS)
TennCare Medicaid Chapter 1200-13-13-.10

Prior Authorization

Potential requirement for careful pre-authorization (informational)

Prior authorization may be required. Provide thorough documentation of prior conservative management and device-specific indications when requesting authorization to support medical necessity.

Definitions

Term	Definition
{"text":"NMES","status":""},{"text":"Neuromuscular electrical stimulation — transcutaneous electrical currents to cause muscle contractions to promote reinnervation, prevent atrophy, relax spasms, and promote voluntary control.","status":""}
{"text":"TENS","status":""},{"text":"Transcutaneous electrical nerve stimulation — surface electrodes delivering currents to decrease pain perception by inhibiting afferent pain impulses and/or stimulating endorphin release.","status":""}
{"text":"PENS/PNT","status":""},{"text":"Percutaneous electrical nerve stimulation / percutaneous neuromodulation therapy — needles inserted percutaneously connected to an external stimulator; not permanently implanted.","status":""}
{"text":"IFT","status":""},{"text":"Interferential therapy — two medium-frequency pulsed currents delivered via skin electrodes producing a low-frequency current proposed for deeper muscle penetration.","status":""}
{"text":"MENS","status":""},{"text":"Microcurrent electrical nerve stimulation / microcurrent electrical therapy / frequency-specific microcurrent — very low amplitude electrical currents applied for pain or healing.","status":""}
{"text":"TEAS","status":""},{"text":"Transcutaneous electrical acupoint stimulation — noninvasive electrical stimulation applied to acupoints, often perioperative.","status":""}
{"text":"PENFS","status":""},{"text":"Percutaneous electrical nerve field stimulation — auricular or percutaneous field stimulation that stimulates skin and underlying tissues in a general area to modulate central pathways.","status":""}
{"text":"PNS","status":""},{"text":"Percutaneous peripheral nerve stimulation — temporary or implanted stimulation of peripheral nerves delivering impulses to disrupt transmission of pain signals.","status":""}
{"text":"MME","status":""},{"text":"Morphine Milligram Equivalents.","status":""}
{"text":"CLBP","status":""},{"text":"Chronic Low Back Pain.","status":""}
{"text":"PEMF","status":""},{"text":"Pulsed Electromagnetic Field therapy — pulsed electromagnetic fields applied for hypothesized effects on bone, cartilage, inflammation and pain.","status":""}
{"text":"Scrambler Therapy","status":""},{"text":"A noninvasive transcutaneous electrical stimulation approach (also called Calmare) intended to present non-pain information to painful areas using variable nonlinear waveforms for symptomatic relief of chronic pain.","status":""}
{"text":"PoNS","status":""},{"text":"Translingual Stimulation (Portable Neuromodulation Stimulator) — neuromuscular electrical stimulation delivered to the dorsal surface of the tongue to augment rehabilitation (e.g., gait/balance); De Novo cleared for adjunct use in mild-to-moderate MS in adults >=22.","status":""}
{"text":"ReActiv8","status":""},{"text":"An implanted restorative neurostimulation system targeting the L2 medial branch to treat multifidus-related chronic low back pain (ReActiv8 Implantable Neurostimulation System).","status":""}

Medicare Determinations

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

Revision History

2025-03-01policy_revisionLatest

Summary of Changes: Coverage Rationale updated; reference link to the TennCare Medicaid exclusions updated; supporting information sections (Description of Services, Clinical Evidence, FDA, and References) updated; previous policy version CSO36TN.W archived. (is_material: false)

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CSO36TNX

Change TypeAdministrative / reference updates

Effective DateMar 1, 2025

Next Review Date

On This Page

TENS is proven and medically necessary in certain circumstances; specific medical necessity criteria are referenced to InterQual CP and TennCare regulations:

Refer to external criteria: For medical necessity clinical coverage criteria, refer to the InterQual CP: Durable Medical Equipment; Transcutaneous Electrical Nerve Stimulation (TENS)

External document

Refer to exclusions/guidance: Refer to TennCare Medicaid Chapter 1200-13-13-.10 for exclusions and specific FES/TENS guidelines

External regulation

Not Medically Necessary / Unproven

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

Unproven / Not Medically Necessary modalities

MENS: Microcurrent electrical nerve stimulation (MENS)
IFT: Interferential therapy (IFT) for treating musculoskeletal disorders/injuries, or to facilitate healing of nonsurgical soft tissue injuries or bone fractures
PENS/PNT: Percutaneous electrical nerve stimulation (PENS) or percutaneous neuromodulation therapy (PNT)
PENFS: Percutaneous electrical nerve field stimulation (PENFS)
PNS: Percutaneous peripheral nerve stimulation (PNS)
PES: Pulsed electrical stimulation (PES)
PSFS/PNFS: Peripheral subcutaneous field stimulation (PSFS) or peripheral nerve field stimulation (PNFS)
Restorative neurostimulation
Scrambler Therapy: Scrambler therapy (ST)
Translingual stimulation (TS) for rehabilitation gait

ReActiv8: Restorative Neurostimulation (ReActiv8): Mixed evidence; some RCT and longer-term follow-ups report clinically meaningful and durable improvements for selected refractory mechanical CLBP patients, but HTAs characterize evidence as limited, with risk-of-bias and need for more independent trials.

Scrambler Therapy / TEMPR: Evidence insufficient; pilot and small single-arm studies exist but RCTs vs sham or conventional therapy lacking.

Evidence-based coverage implication

Policy conclusions derived from evidence summaries and guideline recommendations in this section:

Policy conclusions

ST conclusion: Scrambler Therapy (ST) — evidence insufficient to support efficacy for chronic pain and CIPN; studies are small, heterogeneous, and often single-arm or low quality (multiple RCTs and systematic reviews show marginal or inconsistent benefit).
ASCO guideline (Loprinzi et al. 2020) — no recommendation for ST outside clinical trials for CIPN due to low strength of evidence and low benefits.
ESMO guideline: ESMO/EONS/EANO guideline (Jordan et al. 2020) — ST not recommended for CIPN (graded D: moderate evidence against efficacy or for adverse outcome).
PoNS/TLS: Translingual Stimulation (TLS/PoNS) — insufficient evidence for many indications; some RCTs and trials suggest potential benefit for balance/gait in mmTBI and MS when combined with physical therapy, but overall evidence is inconclusive and additional studies are needed.
ReActiv8 PMA implication: Restorative neurostimulation (ReActiv8) — FDA premarket approval (PMA) for ReActiv8 for intractable CLBP associated with multifidus dysfunction in adults who have failed therapy and are not surgical candidates; implies stronger evidence for that specific implant indication.
Variable regulatory status: Multiple device categories (FES, NMES, IFT, PES, PENS, PNS, PSFS, MENS, TENS) — numerous products exist; regulatory status varies (510(k), De Novo, PMA); evidence and indications vary by device and condition.

This policy defines coverage rationale and applicable criteria for Tennessee Medicaid and CoverKids for electrical stimulation therapies and related devices; it applies specifically to Medicaid and CoverKids in Tennessee and references TennCare Chapter 1200-13-13-.10 and InterQual criteria for detailed TENS/FES medical necessity determinations. The purpose is to distinguish indications considered medically necessary (for example, NMES for specified muscle rehabilitation scenarios) from modalities judged unproven due to insufficient or low-quality evidence.

The evidence base summarized in this policy is heterogeneous—consisting of RCTs, systematic reviews, HTAs, and observational studies—with many trials being small, short-term, and variable in protocol. The policy notes the need for additional well-designed, adequately powered randomized controlled trials to address evidence gaps and better define patient selection, long-term outcomes, and optimal stimulation protocols before broader coverage recommendations can be made.

Selected evidence metrics and device approvals

Evidence items summarized (quantity)multiple systematic reviews and RCTs (many small trials)

Number of RCTs in major NMES dysphagia meta-analysis46 RCTs (n=3,346) — Wang et al., 2023

Examples of high-quality device regulatory decisionsPoNS De Novo approval (March 25, 2021); ReActiv8 PMA (June 16, 2020); IB‑Stim FDA approval (June 7, 2019)

PDAC‑verified FES devices (examples)Odstock ODFS Pace, NESS L300/L200, WalkAide, Drive Medical Deluxe Digital EMS (reported PDAC verified for E0770)

Evidence items typeRandomized controlled trials, systematic reviews, meta-analyses, HTAs, guideline assessments (NICE, ASCO, ESMO), and ECRIs/Hayes reviews

Payer may require prior authorization for device-based electrical stimulation therapies
Document prior conservative therapy (e.g., medications, physical therapy) and device-specific indications

Billing Rule

Device/product verification

Verify the device regulatory status and appropriate product or billing code before submitting claims. Confirm whether the device has PMA, De Novo, or 510(k) clearance and select the correct code(s).

Check FDA status: PMA / De Novo / 510(k)
Confirm product codes and match to the policy code groups or FDA device listing prior to billing

Documentation Required

Evidence limitations and patient selection

Evidence for many electrical stimulation modalities is heterogeneous and limited, with some studies reporting only short-term or immediate outcomes. Use caution when extrapolating benefits beyond the study durations and document the rationale for patient selection, expected timeframe for benefit, and relevant guideline/evidence considerations when ordering or authorizing therapy.

Heterogeneity of study designs, devices, and outcomes limits generalizability
Many trials report short-term or immediate outcomes—exercise caution interpreting long-term benefit
Document selection criteria and set realistic short-term versus long-term expectations in the medical record
When considering Scrambler Therapy (ST) or Translingual Stimulation (TLS), explicitly reference available guideline recommendations and the evidence rationale supporting use

Documentation Required

Reference federal/state/contractual requirements

Verify federal, state, and contract-specific benefit differences prior to rendering services; contractual or statutory requirements may supersede this policy.

Check member's benefit plan for federal, state, or contractual mandates
State Medicaid rules (TennCare) and federal requirements may govern coverage determinations

Policy content is informational only and does not substitute for individualized clinical decision-making.