ModifiedUnitedHealthcarePolicy CSNCT0567.09

Implanted Electrical Stimulator for the Spinal Cord (DRG stimulation) — North Carolina

North Carolina–specific medical policy governing coverage and medical necessity of dorsal root ganglion (DRG) stimulation and related implanted spinal cord stimulators for members covered under the referenced payer program.

Policy Summary

PayerUnitedHealthcare

PolicyImplanted Electrical Stimulator for the Spinal Cord (DRG stimulation) — North Carolina

Policy CodePolicy CSNCT0567.09

Change TypeLanguage clarifieddocumentation expectations added

Effective DateFebruary 1, 2026

Next Review DateN/A

Key ActionProvide complete medical records (history, physical exam, diagnostic test results) to support medical necessity when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

Replaced language indicating DRG stimulation is "proven and medically necessary for treating refractory complex regional pain syndrome..." with wording that removes the term 'refractory' and states DRG stimulation is proven and medically necessary for treating complex regional pain syndrome when performed according to FDA labeled indications.

Added more explicit Medical Records Documentation language describing that records may be required to assess whether member meets clinical criteria and listing required elements (history, exam, diagnostic test results), and noting that documentation does not guarantee coverage.

Removed reference link to the Medical Policy titled Bariatric Surgery (for North Carolina Only) and Gastrointestinal Motility Disorders, Diagnosis and Treatment (for North Carolina Only).

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

CRPSCovered indication

AllowedReplacement batteries

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Coverage and Medical Necessity Criteria

Covered Indications (short policy-level)

Covered when ALL of the following are met (policy-level statements and references):

Primary covered 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 per referenced clinical criteria (North Carolina Medicaid Physician: 1A-25 and InterQual Procedures, Spinal Cord Stimulator (SCS) Insertion).

Refer to NC Medicaid 1A-25 and InterQual for detailed element-level criteria (trial success, prior conservative care, trial period, etc.).

Unproven / Not Medically Necessary Indications

Not covered / not medically necessary when:

Other indications: DRG stimulation is unproven and not medically necessary for treating all other conditions not specified as covered due to insufficient evidence of efficacy.

Replacement battery/generator coverage is addressed separately: replacement is appropriate when the existing unit is malfunctioning, cannot be repaired, and is no longer under warranty.

Coverage rationale / Evidence

Coverage rationale and evidence summary

Coverage stance: DRG stimulation is proven and medically necessary for treating complex regional pain syndrome (CRPS I and CRPS II) in certain circumstances when performed according to FDA labeled indications, contraindications, warnings, and precautions.

Policy language was revised to remove the term 'refractory' in describing the covered CRPS indication.

Supporting clinical evidence: Randomized comparative trial (ACCURATE) in CRPS/causalgia demonstrated higher treatment success for DRG versus dorsal column SCS (81.2% vs 55.7% achieving ≥50% pain relief at 3 months) with greater improvements in quality of life; pooled analyses and systematic reviews report responder rates and mean pain reductions across multiple focal pain etiologies (pooled responder ~63% at 12 months) but note most studies are small, of limited quality, and frequently industry‑sponsored, indicating the need for additional randomized trials with longer follow-up.

Device-related and serious adverse events were similar between groups in the ACCURATE trial; common complications in pooled studies included IPG pocket pain, lead fracture/migration, and infection.

DRG stimulation is unproven and not medically necessary for treating any conditions other than complex regional pain syndrome (CRPS) due to insufficient evidence of efficacy. The policy explicitly states that indications not identified as covered lack sufficient evidence to support medical necessity.

FDA clearance or approval of an implantable spinal cord or DRG stimulation device is provided for informational purposes only and is not by itself a basis for coverage. Coverage decisions must follow applicable federal, state, or contractual requirements, and in the event of any conflict those requirements govern.

Use of DRG stimulation for indications other than CRPS is considered not medically necessary (unproven). The policy identifies CRPS as the condition supported for coverage and treats other indications as lacking sufficient evidence to meet medical necessity criteria.

The evidence base for many non‑CRPS indications is limited: available studies are often small, of poor or variable quality, and drawn from highly selected or industry‑linked populations. Although many authors report positive outcomes, systematic reviews and pooled analyses conclude the results are inconclusive and call for additional randomized controlled trials with longer follow‑up to validate effectiveness and safety.

Procedure and Device Codes

Covered CPT Codes (listed for 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.

Device HCPCS codes (some not on NC Medicaid fee schedule)HCPCS

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 referencedmixed

LGW	FDA product code for implantable spinal cord stimulation systems (PMA).
GZB	FDA product code for implantable spinal cord stimulation systems (PMA).
GZF	FDA product code for implantable spinal cord stimulation systems approved via 510(k).
PMP	FDA product code for devices used for DRG stimulation (searchable).

Primary outcome threshold in reviews — ≥50% pain relief

Primary outcome threshold in systematic reviews>= 50% pain relief (used as the primary outcome in pooled reviews)

Secondary outcomes reportedPhysical function, mood, quality of life, opioid use, and complications (per Nagpal et al. 2021)

Range of cohort success ratesCohort data success rates reported 43%–83% at ≤6 months and 27%–100% at >6 months (Nagpal et al.)

Pain reduction threshold (study-defined) — ≥50% decrease in VAS

Study-defined pain reduction threshold≥ 50% decrease in VAS pain score (ACCURATE trial and used as treatment-success threshold)

Provider Responsibilities and Authorization

Billing Rule

Codes and Replacement Device Coverage

The following procedure (CPT) and device (HCPCS) codes are provided for reference only. Inclusion does not guarantee coverage, does not imply reimbursement, and state-specific fee schedules or contractual requirements may differ. Codes marked with an asterisk (*) are not on the State of North Carolina Medicaid Fee Schedule and therefore may not be covered by North Carolina Medicaid.

CPT codes (examples): 63650, 63655, 63685, 63688 — implantation, revision, replacement, or removal of spinal neurostimulator components.
HCPCS codes (examples): L8679, L8680, L8682, L8685, L8686, L8687, L8688, L8695 — implantable neurostimulator generators, electrodes, receivers, recharging systems. (Codes with * may not be covered by NC Medicaid.)

Documentation Required

Medical Records Requirements

Prior Conservative Care and Trial Requirements

Diagnostic and Imaging Documentation

Documentation Required

Include pertinent diagnostic test/imaging results in the record

Medical records must include results of pertinent diagnostic tests or procedures to support medical necessity; specific imaging requirements are not specified in this excerpt but relevant test results should be documented.

Attach imaging or diagnostic test reports pertinent to the pain condition
Ensure test results are legible and filed in the medical record for review

Note

DRG stimulation — include procedure-relevant imaging/diagnostics

DRG stimulation is the procedure addressed by this policy; ensure imaging and diagnostic information pertinent to DRG candidacy and target pain region are included in documentation supporting the request.

Document anatomical localization and diagnostic confirmation for DRG-targeted pain
Refer to NC Medicaid and InterQual for any procedure-specific imaging prerequisites

Key Terms and Definitions

Dorsal root ganglion (DRG) stimulation

DefinitionImplanted neuromodulation therapy targeting dorsal root ganglia to modulate pain signals

Typical indicationsUsed for focal neuropathic pain such as complex regional pain syndrome (CRPS I and II) and other localized neuropathic pain syndromes

Clinical rationaleProvides more focal paresthesia and reduced extraneous/postural variation compared with dorsal column SCS in some studies

Replacement battery/generator

DefinitionReplacement of an implanted stimulator's pulse generator or battery when the existing unit is malfunctioning, cannot be repaired, and is no longer under warranty

Associated CPT/HCPCS context

Frequency and Replacement Limits

DRG stimulation — Frequency limits and related language

Frequency limits statementNo specific numeric frequency limits specified in this policy excerpt for DRG stimulation; coverage should follow federal, state, or contractual requirements

Procedural frequency contextPolicy lists DRG stimulation under procedures but delegates detailed utilization/frequency criteria to NC Medicaid 1A-25 and InterQual tools

Operational instructionWhen applying frequency or utilization limits, reference applicable state/federal/contractual terms and InterQual criteria as directed in the policy

Not Covered / Not Medically Necessary

Not covered: DRG stimulation for indications other than CRPS is categorized as unproven / not medically necessary. Requests for DRG therapy outside the covered CRPS indication do not meet the policy's medical necessity standards.

Not covered: Several pain syndromes evaluated in the literature (for example, groin, pelvic, neuropathic, and various regional pain conditions) are supported only by small case series and observational reports. Study limitations include very small sample sizes, low methodological quality, and potential conflict of interest; device‑related harms such as overstimulation, lead migration/fracture, pocket pain, and infection have been reported.

Background and Clinical Context

Dorsal root ganglion (DRG) stimulation is an implanted neuromodulation therapy that targets the dorsal root ganglia to modulate pain signaling. It is used primarily to treat focal neuropathic pain conditions, most notably complex regional pain syndrome (CRPS), and may produce more focal paresthesia and less postural variation compared with traditional dorsal column spinal cord stimulation.