ModifiedUnitedHealthcarePolicy CS061KS.02

Implanted Electrical Stimulator for the Spinal Cord (Kansas-only)

This Kansas-only UnitedHealthcare medical policy governs coverage and medical necessity criteria for implanted electrical spinal cord stimulators and dorsal root ganglion stimulation, specifying covered and not medically necessary indications and referencing InterQual criteria for clinical details.

Policy Summary

PayerUnitedHealthcare

PolicyImplanted Electrical Stimulator for the Spinal Cord (Kansas-only)

Policy CodePolicy CS061KS.02

Change TypeRevised indications and DRG languagedocumentation clarifications

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionDocument trial stimulation results, validated psychosocial screening, and pertinent medical records to support medical necessity for prior authorization.

SourceLink

POLICY UPDATE CHANGES

Revised list of proven and medically necessary conditions; replaced 'painful lower limb diabetic neuropathy' with 'painful diabetic neuropathy'.

Replaced DRG stimulation language to state it is proven and medically necessary for CRPS I and CRPS II when performed according to FDA labeled indications, contraindications, warnings, and precautions.

Added detailed Medical Records Documentation language describing required elements (history, physical, diagnostic tests) and that documentation may be required to assess clinical criteria but does not guarantee coverage.

Updated Clinical Evidence and References sections to reflect the most current information.

3Proven indications

2Unproven indications

10+

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152Subjects in ACCURATE trial

Coverage and Medical Necessity Criteria

Medically necessary indications for SCS

Covered when performed according to FDA labeled indications and InterQual clinical criteria:

Medically necessary SCS indications: SCS is considered proven and medically necessary for Complex Regional Pain Syndrome (CRPS), Painful Diabetic Neuropathy, and Failed Back Surgery Syndrome when performed according to U.S. Food and Drug Administration (FDA) labeled indications, contraindications, warnings, and precautions and to InterQual CP: Procedures, Spinal Cord Stimulator (SCS) Insertion.

Refer to InterQual for specific clinical criteria and patient selection.

Unproven / Not Medically Necessary for SCS

Not medically necessary / unproven for SCS when evidence is insufficient:

Unproven SCS indications: Chronic intractable back pain without prior spine surgery; Refractory angina pectoris.

Policy states insufficient evidence of efficacy for these indications.

Dorsal Root Ganglion (DRG) stimulation

DRG stimulation coverage stance:

DRG proven indication: DRG stimulation is proven and medically necessary for Complex Regional Pain Syndrome (CRPS I and CRPS II) when performed according to U.S. Food and Drug Administration (FDA) labeled indications, contraindications, warnings, and precautions and to InterQual criteria.

Refer to InterQual for specific clinical criteria and patient selection.

DRG unproven indications: DRG stimulation is unproven and not medically necessary for all other conditions due to insufficient evidence of efficacy (effectiveness and safety for other neuropathic pain etiologies are unknown).

Hayes and systematic reviews note limited/very low quality evidence beyond CRPS; additional well-designed studies are needed.

Replacement generator/battery

Replacement devices:

Replacement battery/generator: Coverage of a replacement battery/generator for a previously implanted electrical stimulator is appropriate when the existing device is malfunctioning, cannot be repaired, and is no longer under warranty.

Document device malfunction, repair attempts, and warranty status in the medical record.

Guideline-informed coverage considerations

Policy revisions and external guideline recommendations referenced in this section inform coverage; specific clinical criteria are in other parts of the policy.

Guideline and evidence considerations: Consider SCS/HF10 per NICE recommendations: for residual chronic neuropathic back or leg pain at least 50 mm on a 0–100 mm VAS and at least 6 months after back surgery despite conventional medical management, and after a successful stimulation trial as part of a multidisciplinary assessment.VAS >= 50 mm; >=6 months post-surgery

NICE guidance referenced (Senza HF10); clinicians should follow InterQual and FDA labeling for individual eligibility.

Conflicting guidance: Some guideline positions differ: VA/DoD (2022) recommended against SCS for primary low back pain and NASS found insufficient studies addressing electrical stimulation for low back pain; weigh these conflicts when determining appropriateness.

Providers should consider guideline conflicts and plan-specific requirements when evaluating indications.

Dorsal root ganglion (DRG) stimulation and spinal cord stimulation (SCS) coverage decisions reference detailed clinical criteria in InterQual. This policy defers to InterQual CP: Procedures, Spinal Cord Stimulator (SCS) Insertion for the specific medical necessity requirements and patient selection used to determine coverage for SCS/DRG procedures.

The evidence base for DRG stimulation outside of its established indication(s) is limited. Systematic reviews and pooled analyses report promising responder rates in selected cohorts but note most data derive from nonrandomized or industry-sponsored studies and that infections and other complications occur with implantation. Consequently, DRG stimulation is considered proven and medically necessary only for Complex Regional Pain Syndrome (CRPS I and II) when performed according to FDA labeling and InterQual criteria; use for other neuropathic pain etiologies is unproven and not medically necessary because effectiveness and safety have not been established.

Clinical guideline statements differ on use of electrical stimulation for low back pain. The North American Spine Society (NASS, 2020) evidence review found no studies adequate to address electrical stimulation for low back pain, while the VA/DoD (2022) clinical practice guideline recommended against SCS for patients with low back pain. These guideline positions should be considered alongside InterQual criteria when assessing appropriateness.

Implanted electrical spinal cord stimulators are not medically necessary for chronic intractable back pain without prior spine surgery. The policy states evidence is insufficient to support SCS for this primary low back pain population, consistent with the absence of adequate trials identified by guideline reviews.

The VA/DoD 2022 Clinical Practice Guideline explicitly recommended against spinal cord stimulation for patients with low back pain, citing insufficient evidence to support its use in that population.

Overall, evidence and guideline statements do not support using SCS for primary low back pain without other qualifying features (for example, prior spine surgery or neuropathic pain conditions covered by InterQual). Providers should rely on InterQual clinical criteria and consider guideline conflicts when determining medical necessity.

Procedure, Supply, and Product Codes

Covered CPT Codes (reference)CPT

63650	Percutaneous implantation of neurostimulator electrode array, epidural.
63655	Laminectomy for implantation of neurostimulator electrodes, plate/paddle, epidural.
63685	Insertion or replacement of spinal neurostimulator pulse generator or receiver, requiring pocket creation and connection between electrode array and pulse generator or receiver.
63688	Revision or removal of implanted spinal neurostimulator pulse generator or receiver, with detachable connection to electrode array.

Relevant HCPCS / Supply CodesHCPCS

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, non-rechargeable, includes extension.
L8687	Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension.
L8688	Implantable neurostimulator pulse generator, dual array, non-rechargeable, includes extension.
L8695	External recharging system for battery (external) for use with implantable neurostimulator, replacement only

FDA product codes mentionedmixed

LGW	FDA product code referenced for PMA devices
GZB	FDA product code referenced for PMA devices
GZF	FDA product code referenced for 510(k) devices
PMP	FDA product code referenced for DRG stimulation devices

inv-15: Responder rate — ≥ 50% pain reduction on NRS or VAS

Responder threshold≥ 50% reduction in pain on the Numerical Rating Scale (NRS) or Visual Analog Scale (VAS)

Usage in trialsResponder rate (≥50% pain reduction) was the primary/secondary endpoint in multiple RCTs (DISTINCT, Patel 2023, Kapural 2022)

Timepoints reportedResponder rates reported at 3, 6, 12 and 24 months across studies (examples: 80.9% at 3 months; 78–82% at 6–24 months)

inv-38: Frequency limits — No explicit frequency limits stated; procedural and replacement coding listed for reference

Frequency limits statedNo explicit frequency limits are stated in this policy section

What Providers Must Do (Authorization, Documentation, Trials)

Prior Authorization

Prior Authorization and Code Reference

Prior authorization is required. Coverage is governed by medical necessity criteria and InterQual® CP: Procedures, Spinal Cord Stimulator (SCS) Insertion. Submit prior authorization requests with appropriate procedure and diagnosis codes referenced in the policy (e.g., CPT 63650, 63655, 63685, 63688; HCPCS L8679, L8680, L8682, L8685–L8688, L8695).

Prior authorization required and determined by InterQual clinical criteria
Include applicable CPT/HCPCS codes on the request

Step Therapy

Trial Stimulation Recommendation

A percutaneous or paddle SCS trial stimulation is recommended before permanent implantation except where contraindicated (for example anginal pain per ASRAPM guidance). Document the trial method, duration, objective pain scores, percent pain relief, functional improvements, and device settings. For DRG or HF10 therapies, document reason for selection and trial outcomes.

Record trial type (percutaneous/paddle/DRG/HF10), start/end dates, and results

Conservative Management and InterQual Reference

See InterQual criteria

For detailed clinical inclusion, exclusion, and trial requirements, see InterQual CP: Procedures, Spinal Cord Stimulator (SCS) Insertion.

InterQual referral: UnitedHealthcare uses InterQual clinical criteria for medical necessity determinations for SCS/DRG; refer to InterQual CP: Procedures, Spinal Cord Stimulator (SCS) Insertion for specific conservative therapy, trial stimulation, and psychosocial screening requirements.

InterQual contains the operative decision logic and stepwise conservative treatment requirements.

Conservative treatment and patient selection requirements

Conservative treatment requirements and patient selection considerations:

Conservative therapy prior to neuromodulation: Patients considered for SCS or DRG stimulation should have failed appropriate conventional medical management (pharmacologic and nonpharmacologic interventions) consistent with InterQual and the literature.

DRG studies and reviews commonly enrolled patients who failed prior therapies; document prior treatments and responses.

Assessment, Imaging, and Preimplant Evaluation

Note

Refractory angina SCS discussed in evidence but not mandated here

SCS for refractory angina is discussed in the evidence section but this policy section does not mandate specific coverage or trial requirements for that indication.

Clinical studies (e.g., Vervaat et al.) are described, but benefit coverage must still follow plan and policy criteria.

Documentation Required

Perform psychosocial screening and ensure appropriate patient selection prior to implant

Guidelines recommend objective psychosocial screening and appropriate patient selection prior to SCS/DRG implantation; the policy does not specify particular imaging requirements in this section.

Perform validated psychosocial screening; document results in the medical record.

Background and Definitions

Spinal cord stimulation (SCS) and dorsal root ganglion (DRG) stimulation are implantable neuromodulation therapies intended to modulate pain signaling for certain chronic neuropathic and postsurgical pain conditions. The policy references randomized trials, meta-analyses, and systematic reviews demonstrating benefit for select indications (for example, DRG for CRPS and SCS for some postsurgical neuropathic pain syndromes), while also noting limitations in the literature, risk of device-related complications with implantation, and the need to follow FDA labeling and InterQual clinical criteria for patient selection.

inv-29: Proven / medically necessary — definitions of proven indications

Definition — Proven / medically necessaryIndications with sufficient evidence when performed per FDA labeled indications and InterQual criteria: Complex Regional Pain Syndrome (CRPS), Painful Diabetic Neuropathy, and Failed Back Surgery Syndrome.

Context for coverageCoverage requires procedures be performed according to FDA labeled indications, contraindications, warnings, precautions, and InterQual CP: Procedures, Spinal Cord Stimulator (SCS) Insertion.

Replacement devicesReplacement battery/generator coverage is appropriate when existing device is malfunctioning, not repairable, and no longer under warranty.

Services Not Covered / Experimental

Not covered indications include: chronic intractable back pain without prior spine surgery and refractory angina pectoris for SCS, and DRG stimulation for indications other than Complex Regional Pain Syndrome (CRPS I or II). These exclusions reflect the policy determination that evidence is insufficient to establish efficacy and safety for those uses and align with guideline findings noting lack of adequate trials or recommendations against SCS for primary low back pain.

Policy Summary

PayerUnitedHealthcare

PolicyImplanted Electrical Stimulator for the Spinal Cord (Kansas-only)

Policy CodePolicy CS061KS.02

Change TypeRevised indications and DRG languagedocumentation clarifications

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionDocument trial stimulation results, validated psychosocial screening, and pertinent medical records to support medical necessity for prior authorization.

SourceLink

On This Page

Procedural coding referenced

CPT codes listed for reference: 63650, 63655, 63685, 63688

HCPCS / supply codes referencedHCPCS codes listed for reference: L8679, L8680, L8682, L8685, L8686, L8687, L8688, L8695

Document >=50% pain relief when applicable (per trial success definitions)

Note

Check Benefit Requirements and Submit Documentation

Before requesting implantation, check benefit plan requirements and submit complete documentation. Reference federal, state, or contractual benefit terms as they may govern coverage. UnitedHealthcare uses InterQual for primary clinical criteria; if InterQual is not applicable, other UnitedHealthcare policies approved by the Kansas Department of Health and Environment may apply.

Verify member benefits and prior authorization/medical necessity requirements
Attach InterQual decision support output or equivalent clinical rationale with request

Step Therapy

Step Therapy / Conservative Treatment

Conservative therapy and stepwise treatment are expected prior to permanent implant or advanced modalities like DRG stimulation. DRG and other neuromodulation therapies were generally studied in patients who failed other pharmacologic and nonpharmacologic interventions.

Document prior conservative treatments (e.g., medications, physical therapy, injections) and durations
Indicate failure or contraindication to those therapies before proceeding

Step Therapy

Conservative Therapy Prior to DRG

For Dorsal Root Ganglion (DRG) stimulation, conservative therapy prior to DRG is expected as most DRG studies enrolled patients who failed other interventions. Document prior interventions and reasons for selecting DRG over conventional SCS.

List prior failed treatments and clinical rationale for DRG selection
Include trial stimulation results and comparative considerations versus SCS

Documentation Required

Trial Stimulation / Multidisciplinary Assessment

Multidisciplinary assessment and objective psychosocial screening are expected prior to implantation and as part of the stimulation trial process. A successful trial combined with a comprehensive assessment supports proceeding to permanent implant (per ASRAPM and NICE recommendations).

Document multidisciplinary team assessment and validated psychosocial screening tool results
Document that trial success was assessed within the context of the multidisciplinary evaluation

Denial Risk

Documentation Insufficiency

Incomplete or insufficient documentation may result in denial or inability to determine coverage. Medical records must be legible and include relevant history, physical exam, diagnostic test results, trial stimulation documentation, and psychosocial screening.

Failure to provide requested records (history, exam, diagnostics, trial results) may lead to denial
Maintain and make available complete medical records upon request

NICE timing criterion for post‑surgical pain: For residual chronic neuropathic back or leg pain after spine surgery, consider neuromodulation only after at least 6 months post‑surgery and after failure of conventional medical management.>= 6 months post-surgery

NICE recommendation cited for HF10 therapy; InterQual may specify comparable timing and trial criteria.

Trial stimulation and multidisciplinary assessment: A successful temporary stimulation trial and multidisciplinary assessment (including psychosocial screening) should be documented prior to permanent implantation unless InterQual or FDA labeling provides an exception.

ASRAPM and NICE guidance highlight trial stimulation and psychosocial screening as part of selection; document trial outcome (e.g., >=50% pain reduction) and screening results.

Failure of conventional medical management prior to consideration

Failure of conventional medical management prior to consideration:

Minimum duration post-surgery for consideration: For residual chronic neuropathic back or leg pain following back surgery, neuromodulation should be considered only after at least 6 months have elapsed since surgery and after failure of conventional medical management.>= 6 months post-surgery

This timing aligns with NICE recommendations cited in the policy; InterQual criteria should also be consulted for allowable variations.

Documentation Required

Include full SCS/DRG evaluation and implantation documentation when relevant

When relevant to medical necessity determinations, include documentation of the SCS/DRG evaluation and implantation in the medical record (history, exam, diagnostic test results, trial outcomes).

Provide operative reports and implantation details when requested for review.

inv-30: Unproven / not medically necessary — definitions of unproven indications

Definition — Unproven / not medically necessaryIndications with insufficient evidence of efficacy: chronic intractable back pain without prior spine surgery; refractory angina pectoris.

DRG-specific limitationDRG stimulation is unproven and not medically necessary for treating all conditions other than CRPS.

Evidence implicationPolicy states insufficient evidence of efficacy for these listed indications; see InterQual for medical necessity clinical criteria.

inv-31: Trial stimulation — definition

Definition — Trial stimulationA temporary stimulation period used to assess pain relief and patient response prior to consideration of permanent implantation; trial outcomes and documentation (including validated psychosocial screening) should be recorded.

Guideline recommendationA trial stimulation is recommended before permanent implant for SCS/DRG systems (except when anginal pain per ASRAPM guidance).

Documentation requirementDocument trial stimulation results in the medical record; results may be requested to assess medical necessity.

inv-32: Treatment success (ACCURATE) — ≥50% decrease in pain score definition

ACCURATE trial definition of successTreatment success = ≥ 50% decrease in VAS pain score from pre‑implant baseline AND no stimulation-related neurological deficits.

Trial contextACCURATE defined the primary composite end point at three months and assessed subjects through 12 months for long-term outcomes and adverse events.

Comparative resultIn ACCURATE, treatment success (≥50% decrease without deficits) was higher in the DRG arm (81.2%) than the SCS arm (55.7%).

inv-33: FDA Class III implantable spinal cord stimulation systems — device class definition

Definition — FDA Class III deviceImplantable spinal cord stimulation systems for pain relief are regulated by the FDA as Class III devices and are approved via PMA or 510(k) pathways.

Product code referenceFDA product codes referenced for PMA/510(k) devices include LGW, GZB, GZF; DRG devices searchable by product code PMP.

Regulatory noteFDA approval is informational only and not alone a basis for coverage per the policy statement.

inv-34: Temporary trial of SCS demonstrating adequate pain relief prior to permanent implantation — successful stimulation trial definition

Successful stimulation trial — definitionA temporary trial of SCS/DRG that demonstrates adequate pain relief (commonly defined as ≥50% pain reduction) and acceptable tolerability prior to permanent implantation.

Policy expectationPolicy and guidelines (e.g., NICE, ASRAPM) expect a successful stimulation trial as part of multidisciplinary assessment prior to permanent implant.

Documentation implicationTrial results and multidisciplinary assessment should be documented; lack of trial documentation may lead to denial or inability to assess medical necessity.