UnitedHealthcare SCS DRG Coverage Update

Coverage Criteria for SCS and DRG Stimulation

Covered Indications (SCS)

Covered when ALL of the following are met

Proven/covered indications for SCS: Implanted electrical spinal cord stimulators are 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.

Refer to InterQual CP: Procedures, Spinal Cord Stimulator (SCS) Insertion for specific medical necessity criteria

Unproven / Not Medically Necessary Indications

Not covered / Not medically necessary

Unproven for SCS: Implanted electrical spinal cord stimulators are unproven and not medically necessary for chronic intractable back pain without prior spine surgery and for refractory angina pectoris due to insufficient evidence of efficacy.

DRG Stimulation Coverage

Covered when ALL of the following are met

DRG stimulation for CRPS: Dorsal root ganglion (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 InterQual CP criteria.

DRG stimulation is unproven and not medically necessary for other conditions.

Suggested candidate criteria (evidence-informed)

Evidence indicates DRG stimulation may be effective in select focal neuropathic pain conditions when prior therapies have failed; higher-quality trials are limited.

Suggested candidate profile: Patient has focal neuropathic pain (for example CRPS or causalgia) refractory to conservative management (medication, rehabilitation, TENS) and is being considered for DRG stimulation; an appropriate trial stimulation has been attempted unless contraindicated; baseline pain scores and validated psychosocial screening are documented.

Based on systematic reviews, meta-analyses, and randomized or comparative trials (e.g., ACCURATE) showing benefit in select populations; evidence for other etiologies is limited or very low quality.

High-level coverage positions represented in document portion

Coverage stance and guideline-aligned criteria summarized from cited guidance and policy changes in this document portion:

SCS trial recommendation: An SCS trial should be performed before a permanent implant (except when the indication is anginal pain).

Recommendation from ASRAPM and supported by FDA advisory statements; see ASRAPM guidance.

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

Policy revision clarifies alignment with FDA labeling.

Low back pain guidance: VA/DoD clinical practice guideline (2022) recommends against SCS for patients with low back pain, which may limit consideration of coverage for non-focal low back pain.

See VA/DoD guideline statement.

Dorsal root ganglion (DRG) stimulation is described in this policy as proven and medically necessary for complex regional pain syndrome (CRPS I and II) when performed according to FDA labeled indications, contraindications, warnings, and precautions and when InterQual CP criteria are met. The policy explicitly states that DRG stimulation is unproven and not medically necessary for all other conditions due to insufficient evidence of efficacy; replacement battery/generator coverage is permitted only when the existing unit is malfunctioning, not repairable, and no longer under warranty.

The policy references guideline and evidence summaries that do not support routine use of SCS or DRG for general low back pain. A 2022 VA/DoD Clinical Practice Guideline recommends against SCS for patients with low back pain, and systematic reviews cited in the policy identify important evidence gaps for non‑focal low back pain and for other indications (for example, some DRG studies are small, uncontrolled, and of low quality). These guideline positions and low‑quality evidence are cited as relevant when evaluating coverage for chronic coronary disease/refractory angina and other nonfocal back pain indications.

The VA/DoD 2022 Clinical Practice Guideline explicitly recommends against using spinal cord stimulation (SCS) for patients with low back pain. The policy notes this guidance and indicates it may be considered when evaluating coverage decisions for low back pain indications, consistent with the guideline’s recommendation and the policy’s finding of insufficient evidence for nonfocal low back pain.

The policy states that implanted electrical spinal cord stimulators are unproven and not medically necessary for chronic intractable back pain without prior spine surgery and for refractory angina pectoris because evidence of efficacy is insufficient. For medical necessity determinations, providers are directed to the InterQual CP: Procedures, Spinal Cord Stimulator (SCS) Insertion criteria for specific clinical requirements.

Use of SCS or DRG stimulation for non‑focal low back pain is not supported by the cited VA/DoD guideline and by systematic reviews summarized in the policy. The policy highlights that available trials for low back pain are limited, often of short duration, and do not demonstrate consistent long‑term benefit; therefore routine use for nonfocal low back pain is not supported by current evidence.

The policy reiterates that the VA/DoD 2022 guideline does not support SCS for low back pain and that, in the absence of stronger evidence, SCS for that indication may be considered not medically necessary depending on benefit terms. Providers should refer to InterQual criteria and benefit language when assessing coverage for low back pain cases.

Procedure, HCPCS, and Product Codes

Referenced procedure and HCPCS codesmixed

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.
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.

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FDA product codes referencedmixed

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

Responder definition used in studies

Responder definition (study endpoint)Defined in trials and analyses as ≥ 50% reduction in pain on the Numerical Rating Scale (NRS) or Visual Analog Scale (VAS).

Use in DISTINCT and pooled analysesResponder thresholds (≥50% reduction) were applied to report responder rates at primary and follow-up endpoints in randomized and observational studies.

Interpretation for clinical documentationBaseline and follow-up pain scores should be recorded using NRS or VAS to assess responder status (≥50% reduction).

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required: Trial and Plan Requirements

Prior authorization decisions for implanted spinal cord stimulators and dorsal root ganglion (DRG) stimulation must include documentation of a trial stimulation attempt when clinically appropriate, except for anginal pain where a trial may be omitted. The prior authorization request should reference applicable federal, state, or contractual benefit requirements and include evidence that the member meets clinical criteria (see InterQual CP: Procedures, Spinal Cord Stimulator (SCS) Insertion).

Prior authorization must document trial stimulation results or a clinical reason why a trial was contraindicated (e.g., angina).
Include baseline and post-trial pain scores (e.g., VAS), functional assessments, and duration of benefit from the trial.
Reference InterQual CP: Procedures, Spinal Cord Stimulator (SCS) Insertion when submitting requests.

Documentation Required

Required Medical Record Documentation and Denial Risk

Conservative Therapy and Trial Requirements

Failure of conservative therapies and documented trial stimulation (except angina) prior to permanent implant is recommended.

Recommended prerequisite: Failure of conservative therapies and documentation of a trial stimulation (unless contraindicated, e.g., angina) prior to permanent implant is recommended.

Document baseline pain measures and psychosocial screening; see InterQual criteria and ASRAPM guidance.

Failure of conventional medical management (CMM) and a successful stimulation trial are suggested prerequisites before permanent implantation per NICE guidance.

NICE-informed prerequisite: Failure of conventional medical management (CMM) typically for at least 6 months (for post-surgical neuropathic back/leg pain per NICE) and a successful stimulation trial are suggested prerequisites before permanent implantation.>= 6 months

Recommendation based on NICE guidance for HF10/Senza SCS; consider multidisciplinary assessment and documented successful trial.

Replacement and Device Frequency Limits

Replacement battery/generator — frequency limits / replacement guidance

Replacement guidanceReplacement of a battery/generator is appropriate when the individual's existing battery/generator is malfunctioning, cannot be repaired, and is no longer under warranty.

Coverage contextCoverage of replacement battery/generator applies to previously implanted electrical stimulators when criteria above are met.

Documentation implicationMedical record should document device malfunction, repair attempts (if any), and warranty status to support replacement coverage request.

Imaging, Testing, and Assessment Requirements

Note

Include ischemia imaging (MIBI‑SPECT) when available for angina cases

Some refractory angina studies documented proof of ischemia by MIBI‑SPECT in participants, but the policy does not mandate specific imaging for coverage; include imaging if relevant to the clinical case.

If ischemia testing (e.g., MIBI‑SPECT) was performed, include results in the record.
Policy does not require specific imaging for coverage but imaging may support clinical rationale.

Note

No specific imaging mandated; follow guideline patient‑selection and trialing

Guideline recommendations emphasize proper patient selection and trialing for DRG/SCS; the policy section does not specify particular imaging requirements for trial or implantation.

Follow guideline-recommended patient selection and trial procedures.
No specific imaging modality is mandated by the policy for DRG/SCS coverage.

Key Definitions

DRG stimulation

DefinitionDorsal root ganglion (DRG) stimulation: targeted electrical stimulation of the dorsal root ganglion for focal neuropathic pain conditions such as CRPS.

Policy coverage statementDRG stimulation is stated as proven and medically necessary for complex regional pain syndrome (CRPS I and II) when performed according to FDA labeled indications, contraindications, warnings, and precautions and InterQual criteria.

Supporting evidenceRandomized and observational trials (e.g., ACCURATE) and systematic reviews report clinically meaningful responder rates and pain reductions for DRG stimulation in CRPS and select focal neuropathic conditions.

SCS (spinal cord stimulation)

DefinitionSpinal cord stimulation (SCS): implanted electrical spinal cord stimulators that deliver epidural stimulation for chronic neuropathic or postsurgical pain.

Medical necessity reference

Background and Evidence Summary

Spinal cord stimulation (SCS) and dorsal root ganglion (DRG) stimulation are implantable neuromodulation therapies used to manage chronic neuropathic and postsurgical pain. The policy identifies SCS as proven and medically necessary for select indications (for example, CRPS, painful diabetic neuropathy, and failed back surgery syndrome when performed per FDA labeling and InterQual criteria) while noting that evidence is insufficient and SCS/DRG are unproven or not medically necessary for other conditions such as chronic intractable back pain without prior surgery and refractory angina. The document emphasizes using InterQual CP criteria and FDA labeling to determine medical necessity and appropriate patient selection.

Not Covered / Not Medically Necessary Indications

Consistent with the policy statements, DRG stimulation is not covered for indications other than CRPS, and SCS is identified as not medically necessary for chronic intractable back pain without prior spine surgery. The policy references the VA/DoD guideline (2022) recommendation against SCS for low back pain as part of the rationale for excluding nonfocal low back pain from covered indications.

OpenPayer

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