CurrentUnitedHealthcarePolicy CS061KY.12

Implanted Electrical Stimulator for the Spinal Cord (for Kentucky Only)

Clinical policy governing medical necessity and coverage of implanted spinal cord stimulators (SCS) and dorsal root ganglion (DRG) stimulation for UnitedHealthcare members in Kentucky.

Policy Summary

PayerUnitedHealthcare

PolicyImplanted Electrical Stimulator for the Spinal Cord (for Kentucky Only)

Policy CodePolicy CS061KY.12

Change TypeRevisions and operational updates

Effective DateMar 1, 2026

Next Review Date

Key ActionEnsure patient medical records fully document relevant history, physical exam, and diagnostic test results to support medical necessity and make documentation available upon request.

SourceLink

POLICY UPDATE CHANGES

Revised list of proven and medically necessary conditions for implanted electrical spinal cord stimulators and replaced 'painful lower limb diabetic neuropathy' with 'painful diabetic neuropathy'.

Revised DRG stimulation language to state DRG stimulation is proven and medically necessary for treating complex regional pain syndrome (CRPS I, CRPS II) when performed according to FDA labeled indications, contraindications, warnings, and precautions.

Added detailed Medical Records Documentation requirements emphasizing that documentation may be required to assess clinical criteria and must support medical necessity.

Updated Clinical Evidence and References sections to reflect most current information and archived previous policy version CS061KY.11.

3Conditions listed as proven/medically necessary for SCS

2Conditions listed as unproven/not medically necessary for SCS

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11CPT/HCPCS codes listed (sample)

1 RCTKey study designs cited for DRG evidence

63-81%Reported responder rates (≥50% pain relief) in pooled/ACCURATE DRG data

Common AEsSafety signals reported

Medically Necessary and Not Medically Necessary Indications

Covered (Proven and Medically Necessary) — Spinal Cord Stimulation (SCS)

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

ALL of the following

ONE of the following diagnoses
- Complex regional pain syndrome (CRPS)
- Painful diabetic neuropathy
- Failed back surgery syndrome
Procedure performed according to FDA labeled indications, contraindications, warnings, and precautions
Refer to InterQual CP: Procedures, Spinal Cord Stimulator (SCS) Insertion for medical necessity clinical coverage criteria.

Not Medically Necessary / Unproven — Spinal Cord Stimulation (SCS)

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

ANY of the following

Chronic intractable back pain without prior spine surgery
Refractory angina pectoris

Covered (Proven and Medically Necessary) — Dorsal Root Ganglion (DRG) Stimulation

Dorsal root ganglion stimulation is proven and medically necessary for the following condition when performed according to FDA labeled indications, contraindications, warnings, and precautions:

ALL of the following

ANY of the following
- Complex regional pain syndrome (CRPS I, CRPS II)
Procedure performed according to FDA labeled indications, contraindications, warnings, and precautions
Refer to InterQual CP: Procedures, Spinal Cord Stimulator (SCS) Insertion for medical necessity clinical coverage criteria.

Not Medically Necessary / Unproven — Dorsal Root Ganglion (DRG) Stimulation

DRG stimulation is unproven and not medically necessary for all other conditions due to insufficient evidence of efficacy.

ANY of the following

Any indication other than CRPS (e.g., cancer-related neuropathic pain, postherpetic neuralgia, DPN outside FDA indication, central neuropathic pain due to MS/stroke/ischemia/amputation, chronic pelvic pain)

Replacement Battery/Generator Coverage

Replacement of implantable device battery/generator

ALL of the following

Replacement battery/generator is appropriate when the existing battery/generator is malfunctioning
Replacement is appropriate when device cannot be repaired
Replacement is appropriate when the device is no longer under warranty

Clinical Evidence Summary, Guidelines, and Limitations

DRG stimulation — evidence summary and coverage linkage

Clinical evidence summarized in this section supports DRG stimulation for specific indications when performed per FDA labeling; conclusions and limitations from cited studies are captured below.

ALL of the following

DRG stimulation demonstrated meaningful pain reduction and responder rates in pooled analyses and randomized trials (e.g., ACCURATE trial showed 81.2% ≥50% pain relief for DRG vs 55.7% for SCS at 3 months)
Safety profile includes IPG pocket pain, lead fracture, lead migration, infection, and overstimulation as reported adverse events
Most studies are small, include industry-sponsored data, and additional randomized controlled trials with longer follow-up are needed
UnitedHealthcare revised coverage language to state DRG stimulation is medically necessary for CRPS I and CRPS II in certain circumstances when performed according to FDA labeled indications, contraindications, warnings, and precautions

Applicable Codes and Product References

CPT codes (procedures)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

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 referenced (informational)mixed

LGW	PMA product code for implantable spinal cord stimulation systems
GZB	PMA product code for implantable spinal cord stimulation systems
GZF	510(k) product code reference for spinal cord stimulation products
PMP	Product code reference for DRG stimulation devices

Documentation, Prior Authorization, and Denial Risks

Documentation Required

Medical record documentation required

The patient's medical record must contain documentation that fully supports medical necessity for the requested services and be made available upon request for review.

Include relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.
Documentation supporting medical necessity should be legible, maintained in the patient's medical record, and must be made available upon request.

Documentation Required

Medical record documentation requirement (legibility and availability)

Medical records must fully support medical necessity for requested services and may be required for review; documentation should include relevant history, physical examination, and diagnostic test/procedure results, be legible, and available upon request.

Documentation may be required to assess whether the member meets clinical criteria for coverage but does not guarantee coverage.
Records must be maintained in the patient's medical record and be made available upon request.

Numeric / Clinical Thresholds

Thresholds (NICE HF10 guidance)

NICE HF10 therapy candidate VAS threshold≥ 50 mm on 0-100 mm VAS for residual chronic neuropathic back or leg pain

NICE post-surgery timing for HF10At least 6 months after back surgery despite conventional medical management

Defined Terms

Definitions

InterQual CP: Procedures, Spinal Cord Stimulator (SCS) InsertionA proprietary set of clinical criteria referenced by UnitedHealthcare for determining medical necessity for SCS and DRG procedures.

Responder rateProportion of participants achieving a predefined threshold of pain reduction, commonly ≥50% decrease in pain intensity.

IPGImplantable pulse generator — the implanted battery and control unit for neurostimulation devices.

Policy Changes and Updates

2026-03-01Revision — Coverage Rationale updatedLatest

Revised the list of proven and medically necessary conditions for implanted electrical spinal cord stimulators, replacing 'painful lower limb diabetic neuropathy' with 'painful diabetic neuropathy', and clarified DRG coverage language to tie DRG stimulation to FDA labeled indications, contraindications, warnings, and precautions.

2026-03-01Operational — Medical records documentation added

Added detailed medical records documentation requirements specifying that records must fully support medical necessity (history, physical exam, diagnostic tests), be legible, maintained in the patient's chart, and made available upon request.

Policy Summary

PayerUnitedHealthcare

PolicyImplanted Electrical Stimulator for the Spinal Cord (for Kentucky Only)

Policy CodePolicy CS061KY.12

Change TypeRevisions and operational updates

Effective DateMar 1, 2026

Next Review Date

Key ActionEnsure patient medical records fully document relevant history, physical exam, and diagnostic test results to support medical necessity and make documentation available upon request.

SourceLink

On This Page

Coverage linkage — therapy must conform to FDA labeling

Spinal cord stimulation (SCS) — guideline positions and evidence limitations

Guideline and evidence statements inform the use of SCS across indications and recommended pre-implant assessments.

ANY of the following

ASRAPM (2023) recommends an SCS trial before permanent implant for chronic non-cancer pain (except anginal pain) and psychosocial screening with validated instruments
VA/DoD (2022) recommended against SCS for patients with low back pain
NICE recommendations support HF10 therapy (Senza) for chronic neuropathic back/leg pain after failed back surgery (≥50 mm VAS, ≥6 months post-surgery) and require a successful stimulation trial and multidisciplinary assessment
ACC/AHA and related cardiovascular guideline documents note insufficient evidence to recommend SCS/vagal stimulation for prevention of ventricular arrhythmias or in acute ischemic settings

Evidence quality and limitations

Summarized limitations that affect coverage certainty

ALL of the following

Many DRG and SCS studies are small, single-arm, observational, or industry-sponsored
Meta-analyses sometimes limited by heterogeneity and small numbers of randomized trials
Further randomized trials with longer follow-up are needed to validate findings

This policy summarizes UnitedHealthcare’s assessment of the clinical evidence and programmatic requirements for implanted spinal cord stimulation (SCS) systems and dorsal root ganglion (DRG) stimulation for members in Kentucky. It reflects evidence reviews (Hayes, ECRI, systematic reviews, randomized trials) and guideline positions that inform when these neuromodulation therapies are considered proven and medically necessary versus not medically necessary/unproven, and clarifies documentation and device-labeling expectations for coverage decisions (see policy number CS061KY.12). [[1]][[3]][[48]]

Prior Authorization

Reference InterQual clinical criteria for medical necessity

Use the InterQual CP: Procedures, Spinal Cord Stimulator (SCS) Insertion clinical coverage criteria when submitting requests for medical necessity determinations for SCS or DRG procedures.

UnitedHealthcare uses InterQual for primary medical/surgical criteria and refers to InterQual CP: Procedures, Spinal Cord Stimulator (SCS) Insertion for medical necessity.

Prior Authorization

DRG coverage conditioned on FDA-labeled indications

Coverage for dorsal root ganglion (DRG) stimulation is conditioned on the procedure being performed according to U.S. FDA labeled indications, contraindications, warnings, and precautions; reviewers may require documentation demonstrating adherence to labeling.

DRG stimulation is proven and medically necessary for CRPS I and CRPS II only when performed according to FDA labeled indications, contraindications, warnings, and precautions.
Reviewers may request documentation showing the procedure conforms to FDA labeling.

Documentation Required

Stimulation trial recommended prior to permanent implant

A stimulation trial is recommended and evidence of a successful trial may be required prior to permanent implant; ASRAPM recommends a trial before definitive implantation except for anginal pain, and NICE requires a successful stimulation trial as part of assessment.

ASRAPM (2023) recommends an SCS trial before permanent implant for chronic non-cancer pain except when there is anginal pain.
NICE guidance requires a successful stimulation trial and multidisciplinary assessment for HF10 therapy candidates.

Denial Risk

Denial risk when evidence is limited or use outside FDA labeling

Requests may be denied or require further justification when evidence is limited (small, nonrandomized studies) or when device use is outside FDA labeling.

Many DRG and SCS studies are small, single-arm, observational, or industry-sponsored and additional randomized trials are needed.
Coverage determinations may require stronger evidence or rationale when indications fall outside FDA-labeled uses.

2026-03-01Updated — Supporting information

Updated Clinical Evidence and References sections to reflect current information and archived previous policy version CS061KY.11.