UnitedHealthcare SCS/DRG Coverage Policy Update

Coverage and Medical Necessity Criteria

Medically necessary indications for SCS

Covered when performed according to FDA-labeled indications, contraindications, warnings, and precautions and when InterQual CP criteria are met.

Medically necessary SCS indications: SCS is proven and medically necessary for: Complex regional pain syndrome (CRPS); Painful lower limb diabetic neuropathy; Failed back surgery syndrome.

Clinical coverage criteria per InterQual CP: Procedures, Spinal Cord Stimulator (SCS) Insertion

DRG stimulation — medically necessary indication

DRG stimulation — coverage statement for medically necessary use.

Medically necessary DRG indication: DRG stimulation is proven and medically necessary for refractory complex regional pain syndrome (CRPS I and II) when performed according to FDA-labeled indications, contraindications, warnings, and precautions and InterQual criteria.

DRG stimulation is unproven for other conditions.

Evidence and guideline-based coverage considerations

Evidence- and guideline-informed considerations extracted from included sections:

Refractory Angina: Systematic reviews and meta-analyses report that SCS can reduce angina frequency, nitroglycerin consumption, and pain scores and may increase exercise time for patients with refractory angina not candidates for revascularization; further larger long-term studies are needed.

Pan et al.; Imran et al.

DRG for CRPS/Peripheral Neuropathic Pain: Randomized and comparative trials (e.g., ACCURATE) and multiple reviews report higher short-term responder rates for DRG stimulation versus traditional SCS for CRPS/causalgia and other focal neuropathic conditions, but long-term and higher-quality evidence is limited and many studies have short follow-up and industry involvement.

Deer et al.; Nagpal et al.; systematic reviews

Safety and complications: Reported complications include infections (trial and implant stages), lead fracture or migration, lead dislocation, pocket pain, and isolated reports of permanent nerve injury during revision; pooled DRG implant infection ~4.8% reported in reviews.

See systematic reviews and trial safety reports.

Clinical prerequisites and guidance

Coverage-related clinical considerations and recommended prerequisites noted in referenced guidance:

Trial stimulation: A stimulation trial should be performed before a definitive implant (except when the indication is anginal pain).trial performed

ASRAPM recommends trial stimulation prior to permanent implant (except anginal pain); FDA advisory supports trial due to reports of inadequate pain control.

Psychosocial assessment: Patients should be screened with objective validated instruments for psychosocial factors including depression prior to selection for SCS.validated instrument used

ASRAPM consensus guideline recommends validated psychosocial screening.

Device-specific considerations: For HF10 (Senza) therapy: consider use for residual chronic neuropathic back or leg pain >=50 mm on a 0–100 mm VAS at least 6 months after back surgery despite conventional medical management, and only after a successful stimulation trial and multidisciplinary assessment.

Implanted electrical spinal cord stimulators (SCS) are listed in this policy as unproven and not medically necessary for certain indications when evidence is insufficient to demonstrate efficacy. Specifically, the policy identifies chronic intractable back pain without prior spine surgery and refractory angina pectoris as conditions for which SCS is considered not medically necessary. The policy also notes that Dorsal Root Ganglion (DRG) stimulation is proven and medically necessary only for refractory complex regional pain syndrome (CRPS I and II) in specified circumstances, and that DRG stimulation is unproven and not medically necessary for other conditions. Replacement batteries or generators for previously implanted devices may be covered when the existing unit is malfunctioning, irreparable, and no longer under warranty.

The 2022 Department of Veterans Affairs/Department of Defense (VA/DoD) Clinical Practice Guideline for low back pain contains a recommendation against the use of spinal cord stimulation (SCS) for patients with low back pain. This guideline position is explicitly cited in the policy and should be considered when evaluating requests for SCS for low back pain.

The VA/DoD guideline issues an explicit recommendation against SCS for patients with low back pain. When applying this policy, the guideline’s negative recommendation for this indication may inform determinations of medical necessity under applicable benefit terms.

SCS is specifically identified as unproven and not medically necessary for chronic intractable back pain in patients without prior spine surgery. The policy separately lists refractory angina pectoris as another indication for which SCS is considered not medically necessary due to insufficient evidence of benefit.

The policy notes that guideline recommendations — including the 2022 VA/DoD guidance that recommends against SCS for low back pain — may affect medical necessity determinations. Where such external guideline positions conflict with other guidance or with plan benefit terms, reviewers should consider the VA/DoD recommendation alongside the policy’s stated exclusions (for example, SCS for chronic intractable back pain without prior spine surgery) when making coverage decisions.

Procedure, Device, and Regulatory Codes

Referenced CPT procedure codesCPT

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.

Referenced HCPCS device 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 codes (informational)mixed

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

Responder rate threshold used in trials

Responder definition used in clinical trialsResponders commonly defined as ≥50% reduction in pain on NRS or VAS

Examples from pivotal trialsDISTINCT and other SCS trials reported responder rates based on ≥50% pain reduction (NRS/VAS) at primary endpoints

ACCURATE trial thresholdPrimary composite end point included subjects reporting ≥50% decrease in VAS from baseline

Long-term reporting consistency12–24 month follow-ups in several studies continue to report outcomes using the ≥50% pain reduction responder threshold

Provider Requirements and Operational Notes

Prior Authorization

Prior Authorization / Membership Verification

Prior authorization is required before implantation of a spinal cord stimulator (SCS) or dorsal root ganglion (DRG) neurostimulator. Verify member eligibility and plan benefits prior to scheduling. Benefit coverage is governed by the member's federal, state, or contractual plan terms; in case of conflict, those terms supersede this policy.

Verify member eligibility and benefits prior to preauthorization request.
Submit clinical documentation and medical records as indicated by the Medical Records Documentation Used for Reviews protocol.

Prior Authorization

Trial Stimulation Requirement

A trial stimulation should generally be performed prior to permanent implant except in limited indications (e.g., anginal pain) per guideline recommendations. Lack of a documented trial when indicated may lead to denial of coverage. Multidisciplinary assessment and a successful trial are recommended for some indications (for example HF10 therapy per NICE guidance).

Document trial parameters and outcomes in the medical record (duration, pain scores, percent pain relief, functional change).

Conservative Care and Prior Treatment Requirements

Failure of conventional management prior to considering DRG-S/SCS

Failure of conventional management prior to consideration of DRG stimulation or SCS:

Failure of conventional management: Documented failure of appropriate conventional management (pharmacologic and nonpharmacologic therapies) for the target pain condition prior to considering DRG stimulation or SCS.

Many studies and reviews enroll patients who have failed prior treatments; candidate selection should follow InterQual criteria and guideline-based practice.

Failed conventional medical management prior to considering HF10/Senza (>= 6 months when applicable)

Device-specific conventional management requirement for HF10 (Senza):

Failed conventional medical management for HF10: Residual chronic neuropathic back or leg pain of at least 50 mm on a 0–100 mm VAS that persists at least 6 months after back surgery despite conventional medical management.>= 6 months since surgery when applicable

Replacement and Frequency Guidance

Replacement battery/generator coverage conditions

Coverage condition for replacementReplacement battery/generator is appropriate when the existing device is malfunctioning, cannot be repaired, and is no longer under warranty

Prior device statusApplies to previously implanted electrical stimulators (replacement, not initial implant)

Documentation expectationClinical documentation should support malfunction, inability to repair, and warranty expiration

Imaging and Assessment Requirements

Note

Refractory angina evaluations in studies used MIBI‑SPECT

For refractory angina evaluation in studies, ischemia was commonly documented by MIBI-SPECT; consider this imaging modality when documenting study-context diagnostic workup.

Vervaat et al. (2020) reported ischemia proven by MIBI-SPECT in 69% of patients in the refractory angina cohort.

Note

Imaging requirements not specified in guideline excerpts

The policy excerpts and referenced guidelines (ASRAPM, NICE) address patient selection and trial protocols but do not prescribe specific imaging requirements in these sections.

ASRAPM addresses patient selection and trial stimulation but does not specify imaging requirements in the provided excerpts.
NICE discusses assessment and trial adaptation needs but not specific imaging mandates.

Background and Scope

Spinal cord stimulation (SCS) and dorsal root ganglion (DRG) stimulation are implantable neuromodulation therapies used to treat certain refractory neuropathic and regional pain conditions. This policy distinguishes between therapies supported by sufficient evidence and those considered unproven: DRG stimulation is described as proven and medically necessary for refractory CRPS I and II in specified circumstances, while SCS is not medically necessary for selected indications such as chronic intractable back pain without prior spine surgery and for refractory angina pectoris. The policy also notes that replacement batteries/generators may be covered when the existing device is malfunctioning, cannot be repaired, and is out of warranty.

Definitions and Key Terms

DRG stimulation definition and scope

DefinitionDorsal root ganglion (DRG) stimulation is an implantable neuromodulation therapy targeted to the dorsal root ganglia for focal neuropathic pain (eg, CRPS I/II)

Indication scopeDescribed as proven and medically necessary for refractory complex regional pain syndrome (CRPS I and II) in certain circumstances

Evidence basisRandomized comparative trials (eg, ACCURATE) and systematic reviews report higher short-term responder rates versus traditional SCS for focal neuropathic conditions

Spinal cord stimulation (SCS) definition

DefinitionSpinal cord stimulation (SCS) refers to implanted epidural or paddle electrode systems that deliver electrical stimulation to the dorsal columns to manage chronic neuropathic or regionally refractory pain

Typical indications

Services Not Covered / Unproven Indications

The policy’s Not Covered statements identify specific unproven uses of SCS: most prominently, SCS for chronic intractable back pain without prior spine surgery and SCS for refractory angina pectoris are listed as not medically necessary. It also specifies that DRG stimulation is not medically necessary for conditions other than refractory CRPS. Additionally, the 2022 VA/DoD guideline recommendation against SCS for low back pain is cited and may be considered in benefit determinations.

OpenPayer

Implanted electrical spinal cord stimulators (SCS) and dorsal root ganglion (DRG) stimulation