ModifiedUnitedHealthcarePolicy CS061NM.C

Implanted Electrical Stimulator for the Spinal Cord (for New Mexico Only)

Defines UnitedHealthcare medical policy for implanted spinal cord stimulators (SCS) and dorsal root ganglion (DRG) stimulators as applied to New Mexico members, including covered and not medically necessary indications and reference to InterQual criteria for clinical detail.

Policy Summary

PayerUnitedHealthcare

PolicyImplanted Electrical Stimulator for the Spinal Cord (for New Mexico Only)

Policy CodePolicy CS061NM.C

Change TypeRevised indications and clarified DRG CRPS wordingdocumentation and evidence sections updated.

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionConfirm trial stimulation (when applicable), documentation of failed conservative therapies, and supporting medical records when requesting authorization.

SourceLink

POLICY UPDATE CHANGES

Removed reference link to Bariatric Surgery and Gastrointestinal Motility Disorders (for New Mexico Only) from Related Policies.

Revised list of proven and medically necessary conditions; replaced 'painful lower limb diabetic neuropathy' with 'painful diabetic neuropathy'.

Reworded DRG stimulation coverage statement removing the word 'refractory' when describing CRPS indications relative to FDA labeling.

Added language specifying that medical records documentation may be required to assess clinical criteria for coverage and listed the types of documentation expected.

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

3Proven indications

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Coverage Criteria for Implanted SCS and DRG Stimulators

Medically Necessary Indications for SCS

Covered when ALL of the following are met:

Proven SCS indications: SCS is proven and medically necessary for Complex regional pain syndrome (CRPS); Painful diabetic neuropathy; Failed back surgery syndrome when performed according to U.S. Food and Drug Administration (FDA) labeled indications, contraindications, warnings, and precautions and InterQual CP: Procedures, Spinal Cord Stimulator (SCS) Insertion.

See InterQual for detailed clinical entry and continuation criteria.

Unproven / Not Medically Necessary Indications for SCS

Not medically necessary for the following conditions:

Unproven SCS indications: Chronic intractable back pain without prior spine surgery; Refractory angina pectoris.

These indications are listed as unproven/not medically necessary due to insufficient evidence of efficacy.

DRG Stimulation

DRG stimulation coverage statements:

DRG proven indication: DRG stimulation is proven and medically necessary for Complex regional pain syndrome (CRPS I, CRPS II) when performed according to U.S. Food and Drug Administration (FDA) labeled indications, contraindications, warnings, and precautions and InterQual CP: Procedures, Spinal Cord Stimulator (SCS) Insertion.

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

Evidence summary

Evidence highlights and populations studied

Refractory angina evidence: Meta-analyses of randomized trials of SCS for refractory angina reported reduced angina frequency and nitroglycerin use, increased exercise time and decreased VAS pain scores; however, some outcomes (physical limitation, angina stability) were not significant and larger long-term trials are needed.

Pan et al. 2017; Imran et al. 2017

DRG stimulation evidence (CRPS and neuropathic pain): Systematic reviews, RCTs (including the ACCURATE trial), and observational studies indicate DRG stimulation can provide ≥50% pain relief in many patients with CRPS, causalgia, and focal neuropathic pain and may offer advantages over conventional SCS for lower-extremity CRPS; overall evidence quality is generally low to moderate and larger definitive trials are needed.

Hayes reports; ACCURATE trial; multiple systematic reviews

Safety signals: Reported complications across studies include lead dislocation/fracture, infections (pooled trial infection ~1.03%, implant infections ~4.80%, overall pooled ~2.82%), IPG pocket pain, and device/revision–related adverse events; maintenance and revision issues have been substantial in some series.

Documentation of prior conservative therapies and failed noninvasive management before implant

Documentation of prior conservative therapies and failed noninvasive management is appropriate before implant:

Document prior conservative care: Clinical record documents trial(s) of conservative, noninvasive therapies (for example: medication optimization, transcutaneous electrical nerve stimulation [TENS], and rehabilitation) with inadequate pain relief prior to consideration of neuromodulation.

Supported by guideline statements and randomized trials comparing DRG to conventional medical management; see InterQual for specific expected therapies and durations.

Documentation elements: Medical record includes indication (e.g., CRPS, causalgia, focal neuropathic pain), chronology of therapies tried, objective assessments of response, and results of any trial stimulation where performed.

Records must be legible and available upon request.

Failure of conventional medical management

Failure of conventional medical management before SCS implant is defined as:

Timing after surgery: For post–failed back surgery indications, failure of conventional medical management is generally documented at least 6 months after back surgery before considering SCS (consistent with NICE recommendations for HF10/Senza SCS).>= 6 months post-surgery

See InterQual for specific timing and treatment trials.

Guideline-based considerations

Guideline and evaluative statements relevant to coverage decisions:

Guideline positions: ASRAPM recommends performing an SCS trial before definitive implant (except for anginal pain) and screening patients with validated psychosocial instruments; VA/DoD recommends against SCS for low back pain; NICE endorses HF10/Senza for chronic neuropathic back or leg pain ≥50 mm VAS at least six months after back surgery with a successful trial as part of multidisciplinary assessment.VAS >= 50 mm; >=6 months after surgery

These guideline statements inform clinical expectations and prior-authorization review but do not replace InterQual clinical criteria.

Dorsal root ganglion (DRG) stimulation is considered proven and medically necessary only for complex regional pain syndrome (CRPS I, CRPS II) when performed per FDA-labeled indications and InterQual clinical criteria. The policy explicitly states that DRG stimulation is unproven and not medically necessary for all other conditions because current evidence is insufficient to establish efficacy for non–FDA indicated uses. Providers should refer to the InterQual CP: Procedures, Spinal Cord Stimulator (SCS) Insertion for detailed clinical coverage criteria when assessing DRG stimulation requests.

Systematic reviews, randomized trials, and observational studies report that DRG stimulation can produce clinically meaningful pain relief and improved patient-reported outcomes in select neuropathic pain populations—most notably CRPS, causalgia, and certain focal neuropathic syndromes. However, the evidence base is generally limited by small sample sizes, short follow-up, potential industry sponsorship, and variable study designs; pooled analyses report responder rates in many series but also document device-related complications (lead fracture/migration, pocket pain, and infections). Because of these limitations, the policy concludes that effectiveness and safety for many other neuropathic pain etiologies remain unknown or insufficiently supported, and use outside FDA-labeled CRPS indications is considered unproven.

The policy designates implanted spinal cord stimulators as unproven and not medically necessary for chronic intractable back pain without prior spine surgery. This stance reflects an assessment of the available evidence and is consistent with guideline guidance cited in the document (for example, the VA/DoD recommendation against SCS for low back pain). When considering SCS for low back pain, reviewers should note the policy’s noncoverage position and that supporting clinical criteria are available via InterQual for other indications.

Applicable Codes and Product Identifiers

Covered CPT Codes (reference list)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/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, 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 (informational)mixed

LGW	FDA product code referenced for PMA-regulated implantable SCS systems
GZB	FDA product code referenced for PMA-regulated implantable SCS systems
GZF	FDA product code referenced for 510(k)-cleared devices
PMP	FDA product code referenced for DRG stimulation devices

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization — confirm trial, conservative therapy, and indication

Prior authorization may be required. Verify that any authorization workflow confirms: a pre-implant trial was performed (except anginal pain where trial may be exempt), indication aligns with InterQual clinical criteria (or equivalent third-party criteria used by UnitedHealthcare), and documented failures of conservative/stepwise therapies are present. UnitedHealthcare may use InterQual or similar tools to administer benefits; always confirm plan-specific prior authorization rules and processes.

Confirm SCS/DRG indication per InterQual and FDA-labeled indications
Confirm documented trial stimulation prior to permanent implant (angina exception noted)
Confirm documented prior conservative/step therapy attempts and failures
Check payer-specific prior authorization portal/process

Step Therapy

Pre-implant trial and assessment

A pre-implant trial stimulation is recommended prior to permanent spinal cord stimulator implantation except for anginal pain per guideline recommendations. Trial stimulation should demonstrate adequate pain relief (commonly ≥ 50% reduction in pain) and improvement in function prior to proceeding to a permanent implant. Patients should undergo psychosocial screening with validated instruments prior to implant as part of selection.

Conservative Treatment and Prior Therapy Requirements

Requirement to document prior conservative therapies and failed noninvasive management before implant (supporting guideline/trial contexts)

Prior to implant, providers should document prior conservative therapies and failed noninvasive management in the medical record consistent with guideline and trial contexts:

Record indication and prior care: Document indication (e.g., CRPS, causalgia, refractory focal neuropathic pain), prior conservative therapies attempted, and objective evidence of inadequate response.

Suggested documentation elements include results of trial stimulation when performed and psychosocial screening per ASRAPM.

Trial stimulation documentation: If a trial stimulation is performed, document trial parameters, duration, patient-reported pain reduction, and whether the trial met success criteria prior to permanent implant.

ASRAPM recommends a trial prior to permanent implant except for angina; absence of a trial may depart from guideline expectations.

Imaging and Diagnostic Requirements

Documentation Required

Use imaging (e.g., MIBI‑SPECT) to document ischemia for refractory angina when indicated

In refractory angina evaluations, objective evidence of ischemia (for example, MIBI‑SPECT) was used in trials; imaging may be appropriate to document ischemia when clinically indicated.

Vervaat et al. reported ischemia proven by MIBI‑SPECT in 69% of participants

Prior Authorization

Use multidisciplinary assessment and adapt trials for disabilities

Multidisciplinary assessment and appropriately adapted trial stimulation/testing are recommended; testing should account for physical, sensory, linguistic, or communication disabilities.

Ensure trial testing and assessments are adapted to the patient's disabilities

Not Medically Necessary / Not Covered Indications

Not covered: Chronic intractable back pain without prior spine surgery is listed as unproven and not medically necessary for implanted spinal cord stimulators. The policy also states that DRG stimulation is not covered for indications other than FDA-labeled CRPS. Replacement devices (battery/generator) remain appropriate only when the existing device is malfunctioning, irreparable, and out of warranty, consistent with the policy note on replacements.

Archived item: previous policy versions (for example, CS061NM.B) and prior revisions are retained in the policy history. These archival entries document updates to the Clinical Evidence and References sections and changes in documentation expectations (such as specifying that supporting medical records must be legible and available upon request).

Archived item: the policy history includes multiple archived entries noting that Clinical Evidence and References were updated and that a prior version (CS061NM.B) was archived; these entries are retained for auditability and historical context.

The policy highlights that use of DRG stimulation for many chronic pain etiologies beyond CRPS—such as postherpetic neuralgia, cancer-related neuropathic pain, central neuropathic pain from stroke or multiple sclerosis, or other nonstudied conditions—remains unsupported by high-quality evidence. Systematic reviews and pooled analyses report promising responder rates in selected cohorts but also note methodological limitations and safety events; therefore, DRG stimulation for these nonstudied etiologies is considered not covered.

Archived item: additional not-covered listings and explanatory notes were recorded in prior policy revisions and are maintained in the revision history. These archival notes document prior rationale and administrative updates related to evidence and references.

Definitions and Key Terms

Dorsal root ganglion (DRG) stimulation — definition and coverage stance

DefinitionAn implanted neuromodulation therapy that delivers targeted electrical stimulation to the dorsal root ganglion (DRG).

Proven/Medically Necessary StatementDRG stimulation is proven and medically necessary for Complex Regional Pain Syndrome (CRPS I, CRPS II) when performed according to FDA-labeled indications, contraindications, warnings, precautions and InterQual criteria.

LimitationsDRG stimulation is unproven and not medically necessary for all other conditions not listed as FDA‑indicated CRPS due to insufficient evidence of efficacy.

SCS trial — temporary stimulation period prior to permanent implant

DefinitionA temporary stimulation period performed prior to permanent spinal cord stimulator implantation to evaluate efficacy and tolerability of SCS therapy.

Background

Background: Spinal cord stimulation (SCS) and dorsal root ganglion (DRG) stimulation are implanted neuromodulation therapies intended to reduce chronic neuropathic and postsurgical pain. Clinical evidence cited in the policy includes randomized controlled trials (including comparative trials such as ACCURATE), systematic reviews, meta-analyses, and observational cohorts that evaluate efficacy (for example, responder rates defined as ≥50% pain reduction) and safety (lead complications, infections, device-related adverse events). The policy uses these clinical summaries to define coverage: SCS has specified proven indications when performed per FDA labeling and InterQual clinical criteria, while DRG stimulation is proven for CRPS under the same conditions but is unproven for other indications.

Clinical Evidence and References

Evidence summary

Pooled studies, randomized trials, and systematic review highlights:

Refractory angina trials: Meta-analyses of RCTs (Pan et al. 2017; Imran et al. 2017) including up to 12 trials and ~476–518 participants showed SCS reduced angina frequency, nitroglycerin use, and increased exercise time, with some outcomes not reaching significance and a need for larger long-term studies.

Pan et al. 2017; Imran et al. 2017

DRG trial and comparative evidence: The ACCURATE trial (Deer et al. 2017) found higher treatment success for DRG versus SCS at three months (81.2% vs 55.7%) in subjects with CRPS or causalgia; multiple systematic reviews and observational studies report responder rates often ≥50% but overall evidence quality is low to moderate.

ACCURATE trial; Hayes 2021/2024; multiple systematic reviews

Safety and complications in studies: Systematic reviews and pooled analyses report device-related complications including lead migration/fracture, IPG pocket pain, and infections with pooled implant infection rates around 4.8% and overall pooled infection ~2.82%; maintenance and revision burdens reported in observational series.

Revision History and Policy Changes

2026-02-01policy_revisionLatest

Revised list of proven and medically necessary conditions (replaced 'painful lower limb diabetic neuropathy' with 'painful diabetic neuropathy'); clarified DRG stimulation coverage statement by removing the word 'refractory' for CRPS indications; updated medical records documentation language; updated Clinical Evidence and References sections; removed two related-policy reference links specific to New Mexico.

Note

Archived note: no PA requirements specified in these chunks

This archived note indicates no prior‑authorization requirements are specified in the archived chunks.

Update summary: the Clinical Evidence and References sections were updated to reflect the most current information and prior policy versions (for example, CS061NM.B) were archived. The revision history documents these updates and clarifies changes to the list of proven indications and documentation expectations; providers should review the current references when preparing authorization requests or clinical documentation.

Policy Summary

PayerUnitedHealthcare

PolicyImplanted Electrical Stimulator for the Spinal Cord (for New Mexico Only)

Policy CodePolicy CS061NM.C

Change TypeRevised indications and clarified DRG CRPS wordingdocumentation and evidence sections updated.

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionConfirm trial stimulation (when applicable), documentation of failed conservative therapies, and supporting medical records when requesting authorization.

SourceLink

On This Page

Note

No prior authorization requirements are stated in this policy — verify plan terms

No blanket statement of "no prior authorization required" is made in this policy. Always confirm with the member's federal, state, or contractual benefit terms and the payer's authorization requirements before scheduling services.

Check member's plan and contractual documents for prior authorization requirements
In case of conflict, federal/state/contractual requirements govern coverage

Step Therapy

Trial stimulation recommended before SCS implant

Trial stimulation is recommended before a permanent SCS implant except where guidelines note an anginal pain exception. Absence of a documented trial (when indicated) may depart from guideline-based expectations and can affect medical necessity determinations.

Document rationale if proceeding without a trial (e.g., documented anginal pain indication)
Include trial outcome measures (pain scores, functional status) in the record

Denial Risk

No denial triggers are stated in this section — watch for documentation/criteria failures

This section does not list specific denial triggers; however, lack of required documentation (see documentation callouts) or failure to meet medical necessity criteria (e.g., inadequate conservative therapy, no trial when indicated, unsupported indication) are common reasons services may be denied.

No explicit denial triggers are enumerated here — denials are based on medical necessity and documentation
Inadequate records or failure to meet InterQual criteria can lead to denial

Documentation Required

Required medical record documentation

Required medical record documentation must fully support medical necessity and be made available upon request. Documentation should be legible and include relevant history, physical exam findings, diagnostic test results, and therapy response.

Relevant medical history and physical examination
Pertinent diagnostic tests or procedure results
Documentation of prior conservative treatments and outcomes
Trial stimulation records (parameters, duration, pain scores, functional outcomes)
Psychosocial screening results

Denial Risk

No documentation or prior authorization information provided may lead to denial or delay

If no documentation or prior authorization information is provided when requested, the request may be delayed or denied. Ensure timely submission of all required records and authorization forms.

Submit complete medical records with authorization requests
Respond promptly to requests for additional information to avoid denials or delays

Step Therapy

Conservative/step therapy reference — document stepwise therapy before implant

Conservative or stepwise therapy should be documented prior to implant. InterQual criteria and guideline recommendations imply and require consideration of less invasive therapies before proceeding to permanent neuromodulation.

Document trials of conservative therapies (medications, physical therapy, injections, behavioral therapy) and reasons for failure
Stepwise approach should be evident in the record prior to permanent implantation

Psychosocial screening — validated instruments for predictors of poor response

DefinitionUse of objective, validated instruments to assess psychosocial factors (including depression) that may predict poor response to SCS.

Guideline recommendationASRAPM recommends that all patients be screened with an objective, validated psychosocial instrument prior to SCS and that patient selection consider predictors of poor response.

Purpose for screeningIdentify depression and other psychosocial determinants to inform selection, optimize outcomes, and document suitability for neuromodulation therapy.

Guideline-based considerations: the policy references multiple guideline sources to inform coverage decisions. ASRAPM (2023) recommends performing an SCS trial before permanent implantation (except for anginal pain) and screening patients with validated psychosocial instruments. NICE supports HF10 therapy for certain post–failed back surgery patients with a VAS pain score of at least 50 mm and a successful trial as part of multidisciplinary assessment. The 2022 VA/DoD guideline recommends against SCS for low back pain, a position the policy cites when designating that indication as not medically necessary.