Implanted Electrical Stimulator for Spinal Cord (for Kansas Only)

Coverage Summary

Scope: This policy applies only to Kansas and covers implanted electrical spinal cord stimulators (SCS) and dorsal root ganglion (DRG) stimulation for specified indications. It references the InterQual Clinical Practice (InterQual CP: Procedures, Spinal Cord Stimulator (SCS) Insertion) as the primary source for detailed medical necessity criteria. Effective date: 2025-06-01. Coverage stance: mixed.

Overview: Implanted electrical spinal cord stimulators and DRG stimulation are described with medically necessary indications (e.g., painful lower limb diabetic neuropathy, complex regional pain syndrome, failed back surgery syndrome for SCS; refractory CRPS I/II for DRG) and not medically necessary / unproven indications (e.g., refractory angina, chronic intractable back pain without prior spine surgery for SCS; all other conditions for DRG). Replacement internal pulse generators/batteries are covered when the existing device is malfunctioning, cannot be repaired, and is no longer under warranty. InterQual criteria and FDA labeled indications/precautions must be followed when determining medical necessity.

Key policy facts

policy_numberCSO61KS.01

effective_dateJune 1, 2025

geographic_scopeApplies only to Kansas members

referenced_clinical_criteriaInterQual CP: Procedures, Spinal Cord Stimulator (SCS) Insertion

coverage_stanceMixed — SCS/DRG medically necessary for specified indications; unproven/not medically necessary for others; InterQual used for medical necessity determinations

listed_medically_necessary_SCS_indications_count3 (painful lower limb diabetic neuropathy; CRPS; failed back surgery syndrome)

listed_unproven_SCS_indications_count2 (refractory angina pectoris; chronic intractable back pain without prior spine surgery)

Medical Necessity Criteria

Medically Necessary Indications (Implanted electrical spinal cord stimulators)

Implanted electrical spinal cord stimulators are proven and medically necessary for treating the following conditions, in certain circumstances, when performed according to FDA labeled indications, contraindications, warnings, and precautions:

Painful lower limb diabetic neuropathy

Complex regional pain syndrome (CRPS)

Failed back surgery syndrome

Operational coverage note

Not Medically Necessary / Unproven Indications (Implanted electrical spinal cord stimulators)

Implanted electrical spinal cord stimulators are unproven and not medically necessary for the following conditions due to insufficient evidence of efficacy:

Coding

Relevant CPT codes (procedures 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

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

FDA product code referenced for 510(k) searchmixed

GZF	FDA product code referenced for 510(k) Premarket Notification search (DRG/spinal cord stimulation devices)

Provider Actions & Requirements

Documentation Required

Use InterQual criteria for medical necessity

For medical necessity clinical coverage criteria, refer to and apply the InterQual CP: Procedures, Spinal Cord Stimulator (SCS) Insertion prior to making a coverage determination.

Documentation Required

Follow FDA labeling

Procedures must be performed according to U.S. Food and Drug Administration (FDA) labeled indications, contraindications, warnings, and precautions for the device being implanted.

Background & Evidence Summary

Background: Implantable spinal cord stimulation systems and DRG devices are regulated by the U.S. Food and Drug Administration as Class III devices and are approved via the PMA or 510(k) processes; the policy references the FDA 510(k) product code GZF for DRG/spinal cord stimulation device searches.

Scope and guidance: This medical policy is applicable to Kansas members only and uses InterQual as the referenced clinical criteria set for determining medical necessity. DRG stimulation is presented in the context of SCS neuromodulation therapies, with specific evidence summaries and guideline context provided in the full policy.

Evidence / Source	Key Findings
DISTINCT RCT (Deer et al., 2023)	SCS (passive recharge burst) showed 73.1% responder rate (>=50% pain relief) in ITT vs 6.2% for CMM at 6 months; improvements in ODI and function; three serious and 14 non-serious device- or procedure-related events reported; short-term follow-up and manufacturer involvement noted.
ACCURATE trial (Deer et al., 2017)	DRG stimulation had 81.2% treatment success vs 55.7% for SCS at 3 months for CRPS/causalgia; greater improvements in QoL and less postural variation in paresthesia; device-related and serious AEs were not different between groups; additional longer-term studies needed.
Systematic reviews / assessments	Multiple systematic reviews and HTAs (ECRI, Hayes, pooled analyses, and other SRs) report benefits of SCS/DRG for select indications but note low-to-moderate quality evidence, small sample sizes, risk of bias, heterogeneity, and need for larger long-term RCTs.
Key guideline citations	Multiple professional guidance documents and assessments cited (NICE, NASS, AHA/ACC/HRS, ASRAPM, VA/DoD) that discuss use, evidence gaps, patient selection, and recommendations (e.g., NICE evaluations of Senza/Evoke; ASRAPM recommends trial stimulation; VA/DoD recommends against SCS for low back pain).

Definitions: InterQual CP: Procedures, Spinal Cord Stimulator (SCS) Insertion — referenced clinical criteria set used to determine medical necessity for SCS/DRG procedures (criteria not reproduced in this document).

CRPS — Complex regional pain syndrome (types I and II).

GZF — FDA product code recommended for searching 510(k) Premarket Notifications for DRG/spinal cord stimulation devices.

Operational notes: Procedures must be performed according to FDA labeled indications, contraindications, warnings, and precautions, and providers should follow InterQual criteria prior to coverage determination. The policy effective date and revision history note a New Medical Policy summary of changes dated 06/01/2025.

Revision History

2025-06-01material_changeLatest

New Medical Policy summary of changes dated 06/01/2025 indicates policy creation.