ModifiedBlue Cross Blue Shield - IowaPolicy 07.01.61

Spinal Cord and Dorsal Root Ganglion Stimulation

Medical policy governing use of spinal cord stimulation (SCS) and dorsal root ganglion stimulation (DRGS) for treatment‑refractory chronic pain and specified other indications; applies to Blue Cross Blue Shield - Iowa (Wellmark) benefit determinations and providers seeking coverage decisions.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicySpinal Cord and Dorsal Root Ganglion Stimulation

Policy CodePolicy 07.01.61

Change TypePolicy Revised (June 2025)

Effective DateNov 1, 2000

Next Review Date

Key ActionDocument failure of 6 months of conservative therapy and a successful temporary trial (≥50% pain reduction for 3–7 days) before proceeding to permanent SCS implantation.

SourceLink

POLICY UPDATE CHANGES

Policy was revised during the June 2025 annual review.

6 monthsprior conservative therapy duration

>50%trial pain reduction threshold

3-7 daystypical trial duration

critical limb ischemia/angina/etc.insufficient evidence for

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Coverage Criteria for Spinal Cord & Dorsal Root Ganglion Stimulation

Indication‑Specific Coverage Considerations

Indication-specific coverage considerations — evidence summaries and coverage implications for certain nonstandard or less‑studied indications. The evidence below is consolidated by indication and reflects whether SCS and/or DRGS are considered supported, insufficient, or investigational for the listed conditions.

ALL of the following

Critical limb ischemia: Multiple small RCTs and pooled systematic reviews_REPORT inconsistent results for amputation prevention; some pooled analyses show lower amputation risk but findings are not consistently statistically significant. Overall evidence is insufficient to conclude improved net health outcomes; SCS for critical limb ischemia remains investigational for broad use.
See systematic reviews (Ubbink & Vermeulen 2013; Klomp 2009) and Section Summary.
Refractory angina pectoris: Numerous small RCTs with mixed findings; two recent RCTs showed no significant benefit for primary outcomes. Evidence is insufficient to support routine use of SCS for refractory angina.
See trials Zipes et al (2012), Lanza et al (2011) and systematic reviews (Pan 2017; Tsigaridas 2015).
Heart failure: Limited evidence from small studies (including 2 RCTs) with inconsistent effects on functional measures and biomarkers. Additional high-quality trials are needed; SCS for heart failure is investigational.
See systematic review summary.
Cancer‑related pain: No randomized controlled trials identified; evidence limited to case series. Insufficient evidence to support SCS or DRGS for cancer‑related pain; considered investigational.
See Cochrane updates and narrative reviews.
Post‑herpetic neuralgia (PHN): Case series and small-scale studies (including a systematic review reporting ~69% achieving pain relief) show promising results, but RCT evidence is lacking. SCS/DRGS for PHN remains investigational pending randomized trials.
See Isagulyan et al (2023).
Multiple sclerosis (MS) neuropathic pain and spasticity: Systematic review evidence is heterogeneous with signals of benefit in some symptoms (urinary dysfunction, neuropathic pain) but unclear patient selection and high adverse event rates in some reports. Insufficient evidence to define appropriate indications; considered investigational until prospective RCTs clarify benefit and timing.
See Rapisarda et al (2021).
Fibromyalgia: Observational data (retrospective matched cohort) show no clear superiority of outcomes versus controls; RCTs are lacking. SCS for fibromyalgia is investigational.
See D'Souza et al (2023).
Combined SCS and DRGS: Current evidence consists primarily of small case series and one small RCT (BOOST‑DRG) that was underpowered and terminated early; no consistent benefit demonstrated. Combined use of SCS and DRGS is considered investigational and not supported by current evidence.
See Rigoard et al (2025) and case series (Goebel 2018; Yang 2017).
Use of DRGS: DRGS has RCT evidence (ACCURATE) demonstrating benefit versus standard SCS in selected CRPS/lower limb neuropathic pain populations. DRGS may be considered medically necessary for indications aligned with trial populations (e.g., refractory lower‑limb neuropathic pain/CRPS meeting device trial and response criteria).
See ACCURATE trial (Deer et al 2017) and Section Summary for DRGS.
High‑frequency and alternative stimulation modes (burst, 10‑kHz HFSCS): Evidence from RCTs supports high‑frequency (10‑kHz) SCS in certain populations (e.g., nonsurgical refractory back pain, painful diabetic neuropathy) with notable RCTs (Kapural et al, Petersen et al, Kapural 2022). Burst stimulation trials are generally small with short follow‑up; SUNBURST showed noninferiority and preference for burst in some patients but limitations exist. Alternate waveforms may be considered when evidence aligns with studied populations and when standard trial/response criteria are met.
See SUNBURST, DISTINCT, Kapural trials, Petersen et al (2021).

Procedure and Supply Codes

See Codes tablemixed

No codes listed

No explicit CPT/ICD codes in this sectionmixed

No codes listed

SCS/Neurostimulator procedure CPT codesCPT

63650	Percutaneous implantation of neurostimulator electrode array, epidural.
63655	Laminectomy for implantation of neurostimulator electrodes, plate/paddle, epidural.
63661	Removal of spinal neurostimulator electrode percutaneous array(s), including fluoroscopy, when performed.
63662	Removal of spinal neurostimulator electrode plate/paddle(s) placed via laminotomy or laminectomy, including fluoroscopy, when performed.

Covered CPT/HCPCS/L-codes for neurostimulator procedures and devicesmixedCovered

63650	Percutaneous implantation of neurostimulator electrode array, epidural
63655	Laminectomy for implantation of neurostimulator electrodes, plate/paddle, epidural
63661	Removal of spinal neurostimulator electrode percutaneous array(s), including fluoroscopy, when performed
63662	Removal of spinal neurostimulator electrode plate/paddle(s) placed via laminotomy or laminectomy, including fluoroscopy, when performed
63663	Revision including replacement, when performed, of spinal neurostimulator electrode percutaneous array(s), including fluoroscopy, when performed
63664	Revision including replacement, when performed, of spinal neurostimulator electrode plate/paddle(s) placed via laminotomy or laminectomy, including fluoroscopy, when performed
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
95970	Electronic analysis of implanted neurostimulator pulse generator/transmitter without programming
95971	Electronic analysis with simple spinal cord or peripheral nerve neurostimulator programming

1–10 of 35

1/4

inv-39: Trial pain reduction threshold — required trial response (>50% reduction)

Required trial response>50% reduction in pain during temporary SCS trial

Documentation standardPain reduction of >50% must be documented in the medical record

Role in decisionSuccessful >50% pain reduction during trial is required before permanent implantation

inv-40: Trial duration — typical trial 3 to 7 days

Typical trial duration3 to 7 days (commonly performed)

Policy requirement

Prior Authorization, Documentation, and Billing Requirements

Prior Authorization

Prior authorization/medical necessity summary for SCS trial and permanent implant

Prior authorization is required for spinal cord stimulation (SCS) trials and permanent implants. Requests must document multidisciplinary screening, diagnosis, and that conservative therapies have failed for at least 6 months unless contraindicated. Prior authorization should include psychological clearance and absence of untreated substance use disorder. Temporary (trial) SCS implantation is considered medically necessary only when these criteria are met and no further surgical intervention is indicated.

Prior authorization must document: diagnosis, multidisciplinary evaluation, 6 months of failed conservative therapy (pharmacologic, surgical, psychological, or physical) unless unsuitable/contraindicated, psychological evaluation/clearance, and no untreated substance use disorder.
For permanent implant authorization, include documentation of a successful trial (see trial-required items) and objective evidence of pain relief (e.g., decreased opioid use, improved function, VAS/NRS improvement).

Prior Authorization

Trial required before permanent implant

A temporary trial of SCS (standard or high-frequency) is required and must be documented prior to permanent implantation except in specific clinical circumstances (e.g., select anginal pain per guideline exceptions). The trial should be performed according to device labeling and candidate evaluation by the treating team.

Required Conservative Treatments Before Neurostimulation

Must document failure of 6 months of conservative therapy

Conservative treatment requirements for SCS/DRGS

Minimum conservative therapy duration: Documentation of failure of conservative treatments (pharmacologic, surgical, psychological, or physical therapies) for at least 6 months is required prior to trial SCS or DRGS unless such therapies are unsuitable or contraindicated.6 months

Consistent with guideline and trial eligibility recommendations.

Documentation of prior therapies: Medical record must document prior conventional medical management and prior conservative or interventional therapies attempted and considered (e.g., revascularization for limb ischemia when relevant).

For DRGS, failure of ≥2 pharmacologic classes is expected per ACCURATE trial eligibility.

Trial stimulation expectation:

Trial and Implant Frequency Expectations

inv-125: Trial typically performed once as part of evaluation; permanent implantation follows successful trial

Typical trial frequencyTrial typically performed once as part of evaluation; permanent implantation follows a successful trial

Two-step processInitial temporary epidural electrode implantation for trial, followed by permanent implant if trial successful

Trial purposeTrial performed to confirm satisfactory pain relief before definitive implantation per FDA recommendations

inv-126: Temporary epidural lead trial followed by permanent implantation if trial success demonstrated

Temporary epidural lead trialTemporary epidural electrode implanted for trial stimulation prior to permanent implantation

Follow-up action

Imaging & Diagnostic Confirmation

Documentation Required

Obtain and document imaging as indicated for diagnostic confirmation (e.g., arachnoiditis)

When documenting candidacy for trial or implant, include diagnostic confirmation imaging as indicated (for example, myelography or MRI when documenting lumbosacral arachnoiditis), per the policy's diagnostic notes.

Arachnoiditis usually documented by high CSF protein and/or myelography or MRI
Include imaging results when relevant to diagnosis and lead placement planning

Documentation Required

Use myelography or MRI to document arachnoiditis when relevant to SCS trial/implant

When documenting an SCS trial or implant for arachnoiditis, include myelography or MRI findings as appropriate, since the policy specifically cites these modalities for arachnoiditis documentation.

Include myelography or MRI reports when arachnoiditis is the diagnosis under consideration

Not Medically Necessary / Investigational Uses

SCS has not been shown to have sufficient evidence to support routine coverage for critical limb ischemia, refractory angina, heart failure, or cancer‑related pain. Clinicians and coverage reviewers should consider these indications unsupported by high‑quality RCT evidence when evaluating requests for therapy.

Reiterating the policy stance: SCS is not established as effective for critical limb ischemia, refractory angina, heart failure, or cancer‑related pain based on current evidence; these uses remain investigational or unsupported for routine coverage.

Requests for SCS for the above indications should be evaluated in light of inconsistent trial results and lack of definitive RCT evidence demonstrating improved patient‑level outcomes such as survival, limb salvage, or meaningful functional benefit.

If a patient does not demonstrate clinical improvement during the documented temporary SCS trial period, proceeding to permanent implantation is not supported by the trial‑to‑implant pathways used in RCTs and is considered not covered.

Combined or dual SCS+DRGS systems lack sufficient evidence of safety and efficacy; combined implantation for CRPS or other indications should be considered investigational and generally not covered under routine benefit rules.

Because no randomized trials were identified for SCS in cancer‑related pain, coverage for that indication cannot be supported by high‑quality comparative evidence and is not established.

Background and Definitions

Spinal cord stimulation delivers low‑voltage epidural electrical stimulation to the dorsal columns of the spinal cord to modulate pain signals. Devices comprise a lead (typically with 4–8 electrodes), an extension, and a power source (implantable generator or external). The FDA recommends a temporary trial implantation of an epidural electrode to assess symptomatic response before permanent implantation. Standard SCS frequencies typically range from 100–1000 Hz, while high‑frequency systems (e.g., HF10) use substantially higher frequencies (commonly ~10,000 Hz).

inv-90: Definition — Spinal cord stimulation (SCS)

DefinitionSpinal cord stimulation (SCS): delivery of low‑voltage electrical stimulation to the dorsal columns of the spinal cord via an implanted neurostimulator to modulate pain signals

ComponentsSCS systems include leads, extension wires, and a power source (implantable or external receiver)

PurposeUsed to reduce pain sensation in treatment‑refractory chronic trunk or limb pain

inv-91: Definition — Dorsal root ganglion stimulation (DRGS)

Policy Revision History

2025-06Policy revisedLatest

Policy was revised during the June 2025 annual review.

2024-06Policy revised

Policy was revised during the June 2024 annual review.

2023-06Policy revised

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicySpinal Cord and Dorsal Root Ganglion Stimulation

Policy CodePolicy 07.01.61

Change TypePolicy Revised (June 2025)

Effective DateNov 1, 2000

Next Review Date

Key ActionDocument failure of 6 months of conservative therapy and a successful temporary trial (≥50% pain reduction for 3–7 days) before proceeding to permanent SCS implantation.

SourceLink

On This Page

Trial of at least 3 to 7 days documented in the medical record for permanent implant consideration

Study protocolsSome trial protocols reported up to 14 days in trials (site-dependent)

inv-41: Conservative treatment duration — 6 months prior conservative therapy requirement

Minimum conservative therapy duration6 months of conservative treatment failure documented

Scope of therapiesIncludes pharmacological, surgical, psychological, or physical therapies unless unsuitable/contraindicated

Documentation requirementFailure of 6 months must be recorded in medical records prior to trial SCS

inv-42: Responder threshold — ≥50% pain relief

Responder definitionResponder typically defined as ≥50% reduction in pain (e.g., VAS/NRS)

Trial and follow-up use≥50% threshold used in trials to define successful trial stimulation and longer-term responders

Implication for coverageDocumentation of ≥50% pain relief during trial expected for permanent implantation

inv-43: Trial response MCID (VAS) — decrease of at least 3 points on VAS considered important improvement

MCID on VAS for trial responseDecrease of at least 3 points on the VAS considered an important (MCID) improvement

Use in studiesSome stSCS observational studies used ≥3-point VAS decrease to define clinically important improvement

DocumentationRecord pre- and post-trial VAS to demonstrate MCID when applicable

inv-44: Programming parameter count — CPT 0788T (1-3 params simple), 0789T (4+ params complex)

0788T (simple programming)Electronic analysis with simple programming of implanted integrated neurostimulation system: 1–3 parameters

0789T (complex programming)Electronic analysis with complex programming of implanted integrated neurostimulation system: 4 or more parameters

Programming contextCodes apply to integrated neurostimulation systems (spinal cord or sacral nerve) when performed by qualified professionals

Trial period is typically 3 to 7 days (some devices/sites allow up to 14 days or site-specific protocols).
Permanent implantation should only be performed in patients who have undergone and passed a stimulation trial.

Prior Authorization

Trial stimulation required before permanent implant

Successful trial stimulation is a prerequisite for permanent SCS implantation. The trial must document clinically meaningful pain reduction and improvement in function or medication use.

Success threshold is typically ≥50% pain reduction during a trial of at least 3 to 7 days (some protocols use up to 14 days).
Document objective indicators of response: reduced opioid consumption, improved range of motion/ activity, and validated pain scores (VAS/NRS).

Prior Authorization

Trial stimulation and prior authorization

Prior authorization submissions for permanent SCS must include trial stimulation details and trial outcomes. The trial documentation should establish that the patient was treatment-refractory prior to the trial and that the trial produced the requisite pain relief.

Include trial start/end dates, stimulation parameters, percent pain reduction, and objective functional measures.
If prior authorization is requested without a documented successful trial, provide strong justification and documentation of contraindications to trial stimulation or applicable guideline exceptions.

Billing Rule

Procedure coding for implantable neurostimulator electrodes

Report appropriate procedure and supply codes for implantation, removal, and programming of implantable neurostimulator electrodes. Use the specific CPT, HCPCS, and L-codes that match the service and device.

CPT codes commonly used: 63650 (percutaneous implantation of neurostimulator electrode, epidural), 63655 (laminectomy for implantation of neurostimulator electrodes, plate/paddle), 63661 (removal percutaneous array), 63662 (removal plate/paddle).
Include HCPCS/C-codes and L-codes for implanted generators, leads, and programmers on claims as applicable.

Billing Rule

Codes requiring review

Several specific CPT/HCPCS/L-codes and test/programming codes require review and appropriate documentation when billed. Verify that coding aligns with the service rendered and the documentation in the medical record.

Add-on and proprietary codes: 0788T (electronic analysis with simple programming), 0789T (electronic analysis with complex programming) when applicable.
HCPCS/C-codes: C1767, C1778 (lead), C1787 (patient programmer), C1816, C1820, C1822, C1826, C1827, C1883, C1897; L-codes: L8679, L8680, L8681, L8682, L8683, L8685–L8688, L8989. Ensure device descriptions match items billed.

Denial Risk

Failure to respond during SCS trial

Patients who do not demonstrate improvement during the SCS trial should not proceed to permanent implantation. Authorization for permanent implantation will be denied if trial documentation shows inadequate response.

Documented lack of ≥50% pain reduction (or site-specific success criterion) during the trial is a contraindication for permanent implant per policy.
If a permanent implant is performed despite inadequate trial response, provide documentation explaining medical necessity and rationale; absence of such justification may result in denial.

Denial Risk

Denial risk if submitted evidence does not meet policy criteria

Coverage decisions may be denied if submitted evidence and documentation do not meet policy criteria or trial eligibility consistent with pivotal studies. Ensure submitted clinical evidence aligns with study eligibility where relevant.

Denial risk increases when documentation lacks 6 months of failed conservative therapy, absence of psychological clearance, missing trial results, or inappropriate/unsupported indications.
Requests for indications with mixed or insufficient evidence (e.g., refractory angina, combined SCS+DRGS without clear rationale) may be denied unless strong supporting clinical rationale and evidence are provided.

Note

Eligibility alignment with ACCURATE trial

When referencing clinical trial eligibility (e.g., the ACCURATE trial), ensure member clinical status aligns with those criteria for relevance to coverage considerations.

ACCURATE trial alignment: chronic pain ≥6 months, failed ≥2 drugs from different classes, neuropathic lower-limb pain associated with CRPS or causalgia, no prior neurostimulation, and successful temporary trial (≥50% pain reduction) before permanent implant.
If the patient does not meet these types of eligibility features, include justification why the case is clinically comparable and merits consideration.

Denial Risk

Refractory angina — potential denial risk

Refractory angina is a condition with mixed and generally insufficient evidence for routine SCS coverage. Requests for SCS for refractory angina require robust supporting documentation and may be denied if evidence is inadequate.

Small RCTs and observational series offer mixed results; two recent RCTs showed no significant benefit for primary outcomes.
Provide clear clinical rationale, prior medical therapy details, and evidence that revascularization is not an option when requesting SCS for refractory angina.

Billing Rule

Coding requirement

Claims must be reported with appropriate CPT, HCPCS, Revenue, and ICD-10 diagnosis codes that accurately reflect the procedures and diagnoses. Incorrect or missing codes may result in denial or misprocessing.

Ensure procedural CPT codes, device HCPCS/C-codes, and implantable device L-codes are consistent with the operative report and device details.
Include correct diagnosis ICD-10 codes that support the medical necessity for SCS on each claim.

Documentation Required

Required documentation for trial and permanent implantation

Prior authorization and medical records must include detailed documentation for both the trial and any permanent implantation to establish medical necessity and support claims.

Required documentation: diagnosis, duration of pain (≥6 months typically), prior therapies attempted and failed (including at least 6 months of conservative care unless contraindicated), psychosocial evaluation and clearance, absence of untreated substance use disorder, and documented contraindications to other interventions.
For permanent implants include trial stimulation records (dates, parameters), percent pain reduction, objective measures of benefit (reduced medications, improved function), and device details (manufacturer, model, UDI).

Documentation Required

Adverse event and explant documentation

Adverse events, complications, and explantation reasons must be documented in the medical record and submitted when relevant to authorization or coverage decisions.

Document device-related complications (lead migration, lead fracture, high lead impedance), infections, neurologic deficits, and any serious adverse events.
If explantation is performed, document the reason (e.g., inadequate pain relief, infection, device failure) and supporting clinical details.

Documentation Required

Required documentation for implant consideration

When considering implantation, document baseline pain and functional measures, prior management attempts, and evidence of stepwise progression in care leading to SCS consideration.

Include baseline validated pain scores, functional status measures, and records of conservative treatments and their durations.
Provide rehabilitation/therapy documentation and rationale for SCS compared with alternative therapies attempted.

Documentation Required

Document indication (e.g., refractory chronic neuropathic pain)

Document the clinical indication clearly (e.g., refractory chronic neuropathic pain such as FBSS, CRPS, radiculopathy, diabetic neuropathy) and align with policy-specified eligible conditions.

Indications generally must be neuropathic in nature and treatment-refractory after appropriate conservative measures.
SCS is generally not indicated for purely nociceptive pain or central deafferentation pain without supporting evidence.

Documentation Required

Device complications — documentation

Device complications must be recorded and submitted with claims and prior authorization documentation when relevant. Documentation supports medical necessity for revisions, replacements, or removals.

Common device complications: lead dislodgement/migration, lead fracture/connection failure, generator failure, implant-site infection, high lead impedance.
Revisions or replacements are medically necessary when the device has failed and repair or warranty coverage is unavailable; replacements for upgrade/technology when original device functioning are not covered.

Billing Rule

Coding and claim documentation

Ensure coding and claim documentation reflect the specific services, devices, and clinical findings. Use the full set of applicable codes and include device identifiers when available.

Attach operative reports, device model/UDI, and trial documentation to prior authorization requests and retain these in the medical record for claims support.
Incorrect/missing codes or lack of supporting documentation may result in claim processing delays or denials.

Billing Rule

Coding documentation

Use appropriate coding systems and supply all necessary code detail on claims. Coding entries should be consistent across CPT, HCPCS/C-codes, and L-codes to avoid denials.

Verify that CPT procedure codes correspond to the documented surgical approach (percutaneous vs plate/paddle vs removal) and that HCPCS/C-codes and L-codes reflect the implanted component types (rechargeable vs nonrechargeable, high-frequency capable, closed-loop).
Include diagnosis ICD-10 codes that justify the SCS procedure and match clinical documentation.

Step Therapy

Conservative therapy prerequisite and expectation

SCS is considered appropriate only after adequate conservative therapy has failed. Prior authorization and medical records must reflect a stepwise progression of care.

Conservative therapy prerequisite: documentation of failure of pharmacologic, surgical, psychological, or physical therapies for at least 6 months prior to trial (unless unsuitable/contraindicated).
Policy expectation: SCS is a treatment for refractory chronic trunk or limb neuropathic pain after conventional therapies have been exhausted.

Step Therapy

Conservative pharmacologic therapy before DRGS and trial stimulation progression

For dorsal root ganglion stimulation (DRGS) considerations, document prior conservative pharmacologic therapy trials and that DRGS is being considered based on prior treatment history; SCS is typically considered before DRGS or combined systems unless justified.

Conservative pharmacologic therapy before DRGS: documentation of failed trials of at least 2 different drug classes for neuropathic pain is expected (consistent with trials like ACCURATE).
Stepwise progression: consider standard SCS prior to DRGS or combined/dual systems unless clinical rationale supports DRGS as preferred or salvage therapy; combined systems have limited evidence and may require stronger justification.

Note

Evidence references (no mandated step-therapy beyond conservative failure and trial)

Evidence references were evaluated but the policy does not impose an explicit step-therapy sequence beyond the expectation that conservative therapies are attempted first and that trial stimulation precedes permanent implantation in typical cases.

Guidelines (e.g., ASRA, NICE) recommend trial stimulation prior to permanent implantation except in specific exceptions such as some angina cases.
While literature supports SCS effectiveness for selected refractory neuropathic conditions, combined or newer approaches (e.g., dual SCS+DRGS) have limited evidence and may need additional justification.

Short‑term trial stimulation is commonly used (typical trial durations reported 3–14 days); documentation of clinically meaningful improvement during the trial (e.g., ≥50% pain reduction or ≥3‑point VAS decrease per study MCID) is required before permanent implantation.

trial duration 3–14 days; response ≥50% or VAS decrease ≥3 points

Failure documented in medical record — 6 months

Failure documented in medical record

Record of failed conservative therapies: Medical records must document failure of conservative medical and/or surgical therapies and that the patient is treatment‑refractory prior to trial SCS/DRGS consideration.6 months typical

Failure of multidisciplinary conservative therapy should be explicit in documentation.

Document prior use of conservative medical/surgical therapies and treatment-refractory status before SCS trial

Document prior use of conservative medical/surgical therapies and treatment‑refractory status before SCS trial

Prior conservative/interventional therapies: Documentation of prior use of conservative medical therapies and any relevant surgical or interventional procedures attempted and of continued refractory symptoms despite these therapies.

Comparators in trials included conventional medical management and surgical options.

Failure of conservative therapy prior to SCS

Expectation of failed conservative therapy: Patients considered for SCS should have exhausted noninvasive therapies (medical management, physical therapy, rehabilitation) with inadequate response prior to SCS consideration.

Documentation of prior CMM required; specifics depend on clinical context.

Conventional medical management documented: Documentation that conventional medical management (CMM) was attempted and found inadequate; specifics of prior CMM should be provided relative to the clinical indication.

Pharmacologic therapy trials and chronicity documented

Pharmacologic trial requirement (DRGS): For DRGS consideration (evidence aligned with ACCURATE), document chronicity ≥6 months and failure of at least 2 pharmacologic treatments from different drug classes.>=6 months pain duration; failed >=2 drug classes

Prior conservative or standard therapy trial recommended/expected

Prior standard therapies considered: Prior use of or consideration of standard medical or surgical therapies relevant to the indication (e.g., revascularization for limb ischemia, medical therapy for angina) should be documented before SCS is pursued.

Evidence supports use of a short-term trial and documentation of clinically meaningful VAS improvement before permanent implantation

Evidence supports use of a short-term trial and documentation of clinically meaningful VAS improvement before permanent implantation in study protocols.

Trial response and MCID: Document trial stimulation response using clinically meaningful thresholds (e.g., ≥50% pain reduction commonly used; study MCID often a ≥3‑point decrease on VAS) before proceeding to permanent implantation.≥50% or VAS decrease ≥3 points

Trial durations in studies varied (3–14 days).

Exhaustion of appropriate conservative and interventional modalities prior to SCS/DRGS consideration

Guideline‑consistent conservative management: Guidelines and RCT eligibility support persistent pain ≥6 months despite appropriate conventional medical management and exhaustion of conservative/interventional modalities prior to considering SCS or DRGS.≥6 months

Permanent implantation performed if trial demonstrates clinically meaningful improvement

Procedure contextFDA and policy guidance recommend trial prior to permanent SCS implantation

inv-127: SCS implantation and related procedures — frequency not specified in excerpt

SCS implantation proceduresIncludes implantation, revision, removal, and related procedures (codes such as CPT 63650–63662 listed in policy)

Frequency limits in policySpecific numeric frequency limits for implantation/revision not specified in this excerpt

Registry dataLong-term registries report explantation and complication rates relevant to subsequent procedures

inv-128: Trial stimulation prior to permanent implant — trial period up to 14 days reported

Reported trial period lengthTrial stimulation periods up to 14 days have been reported in trial protocols

Common practiceProviders typically perform stimulation trials for 3–7 days, but some studies allowed longer site-dependent durations

Documentation expectationTrial duration and outcomes should be documented in the medical record to support permanent implantation decisions

inv-129: DRG trial and implantation — temporary trial followed by permanent implant if successful

DRG trial approachDRG uses a temporary trial period with epidural lead placement; permanent implant follows if trial is successful

ACCURATE trial specificsACCURATE allowed temporary trial lasting 3 to 30 days depending on site protocol with ≥50% pain reduction required for permanent implant

No explicit numeric frequency limitsPolicy does not state explicit numeric frequency limits for repeated DRG trials in this section

inv-130: Frequency limits not specified in this section (placeholder)

Frequency limits absentFrequency limits for SCS/DRGS procedures are not specified in this section of the policy

Clinical implicationPolicy emphasizes a single trial-to-permanent pathway rather than repeated trials; numeric limits not provided

RecommendationDocument clinical rationale and trial outcomes when multiple procedures are requested due to complications or revisions

inv-131: Fluoroscopy referenced 'including fluoroscopy, when performed' for procedures

Fluoroscopy referencedProcedure codes (e.g., CPT 63661, 63662) include wording 'including fluoroscopy, when performed' indicating fluoroscopic use is referenced for these procedures

Imaging guidanceSome implantation and integrated electrode insertion codes state 'including imaging guidance' when performed

Coding implicationWhen fluoroscopy/imaging is performed, ensure documentation aligns with code descriptions for claims

Dorsal root ganglion stimulation is not covered for indications that were not studied in randomized trials or systematic reviews; DRGS coverage should be limited to populations consistent with the ACCURATE trial and other supporting evidence.

Given mixed and sometimes negative RCT results in refractory angina, routine coverage of SCS for refractory angina is not supported without stronger evidence or compelling patient‑specific rationale.

For several conditions with limited or observational evidence (e.g., post‑herpetic neuralgia, multiple sclerosis, fibromyalgia), routine coverage should not be assumed because high‑quality RCT evidence is lacking and results are heterogeneous.

DefinitionDorsal root ganglion stimulation (DRGS): targeted neurostimulation that places leads to stimulate the dorsal root ganglion to modulate sensory signal transmission

Indication nuanceDRGS allows more precise targeting for focal neuropathic pain (e.g., CRPS, post-amputation pain)

ApproachUses an epidural approach similar to SCS but targets DRG anatomical structures

inv-92: Definition — Trial (temporary) SCS

DefinitionTrial (temporary) SCS: temporary placement of a standard or high-frequency SCS system (temporary epidural electrode) to assess benefit before permanent implantation

Typical processTemporary electrode implanted in epidural space for a short stimulation period (commonly 3–7 days) to evaluate pain relief

Decision linkPermanent implantation recommended only after a successful trial showing clinically meaningful improvement

inv-93: Definition — SCS general description

General descriptionSCS (dorsal column stimulation) uses epidural electrical stimulation via implanted leads and power source to modulate pain signals

Device componentsLeads (4–8 electrodes), extension wire, and power source (implantable or external) are typical components

Two-step implantationTypically involves temporary lead trial followed by permanent implantation if response confirmed

inv-94: Definition — DRGS general description

General descriptionDRGS targets dorsal root ganglia to modulate sensory neuron signaling; useful for localized neuropathic pain with potentially less paresthesia

Clinical advantageAllows precise targeting of specific nerves and pain areas compared with conventional SCS

RecoveryRecovery from DRGS implantation typically spans about 6–8 weeks

inv-95: Definition — Treatment-refractory chronic pain example conditions

Examples of treatment-refractory conditionsFailed back surgery syndrome (FBSS), complex regional pain syndrome (CRPS), arachnoiditis, radiculopathies, phantom limb/stump pain, peripheral neuropathy, painful diabetic neuropathy

Population relevancePolicy focuses on chronic trunk or limb neuropathic pain refractory to prior therapies

Clinical contextCandidates are typically those who have failed conservative medical/surgical management

inv-96: Definition — Standard SCS

Standard SCSEpidural electrical stimulation of dorsal columns using leads (4–8 electrodes) and power source operating typically at 100–1000 Hz

IndicationsUsed for treatment‑refractory chronic trunk or limb pain; trial period recommended prior to permanent implant

Device selectionLead electrode count (4–8) may be chosen based on complexity of pain pattern

inv-97: Definition — CMM (conventional medical management)

CMMConventional medical management (CMM): noninvasive medical therapies used as comparators before considering SCS/DRGS

ComponentsMay include medications, physical therapy, psychological interventions, and interventional procedures prior to neuromodulation

DocumentationPrior attempt and failure of CMM should be documented before trial stimulation per policy and trials

inv-98: Definition — FBSS (failed back surgery syndrome)

FBSSFailed back surgery syndrome: chronic back pain persisting or recurring after spinal surgery; listed as an example qualifying diagnosis

RelevanceFBSS patients are commonly included in SCS trial and RCT populations

ConsiderationDevice selection and lead placement guided by pain distribution in FBSS

inv-99: Definition — SCS (abbreviation entry)

AbbreviationSCS = Spinal Cord Stimulation

UsageCommonly used throughout policy to refer to epidural dorsal column neurostimulation

ContextMay be modified by frequency descriptors (e.g., high-frequency SCS) or waveform (burst)

inv-100: Definition — SAE (serious adverse event)

SAESerious adverse event (SAE): significant device- or procedure-related harms such as infection, neurological deficit, or life-threatening complications

Registry reportsRELIEF registry and trials report device- and procedure-related SAEs (infections, neurological deficits) requiring documentation

ImplicationSAEs may necessitate explantation or termination of therapy and should be recorded in medical records

inv-101: Definition — High-frequency SCS (HFSCS)

High-frequency SCS (HFSCS)Implanted SCS delivering high-frequency pulses (commonly 10,000 Hz; HF10 therapy) intended to treat chronic trunk or limb pain and potentially reduce paresthesia

Evidence baseMultiple RCTs (e.g., SENZA/Kapural series) evaluate HFSCS at 10 kHz vs traditional SCS or CMM

Clinical notePolicies require prior conservative management and a successful trial before permanent HFSCS implantation

inv-102: Definition — Responder (≥50% pain reduction)

Responder (trial outcome)Typically defined in trials as ≥50% reduction in pain (VAS/NRS) during trial or follow-up periods

Use in coverageResponder status (≥50%) commonly required to proceed to permanent implantation

DocumentationResponder definition should be documented in the medical record when used for coverage decisions

inv-103: Definition — DRG Neurostimulation technical note

DRG technical noteDRG neurostimulation targets dorsal root ganglia via epidural lead placement; anatomy and lead positioning differ from standard SCS

IndicationUseful for focal neuropathic pain e.g., CRPS and causalgia as evaluated in ACCURATE trial

Safety/efficacyRCT evidence demonstrates DRG noninferior or superior in some outcomes to standard SCS in selected populations

inv-104: Definition — Treatment‑refractory chronic pain (alternate entry)

Alternate entry — treatment‑refractory painChronic trunk or limb pain that has not responded adequately to conventional therapies (examples include FBSS, CRPS, arachnoiditis, radiculopathies, phantom limb pain)

Policy thresholdTypically requires ≥6 months duration and failure of conservative therapies prior to neuromodulation consideration

Clinical implicationCandidates should be evaluated by multidisciplinary team with psychosocial clearance

inv-106: Definition — Spinal cord stimulation (alternate entry)

Alternate SCS entrySpinal cord stimulation (alternate entry): epidural electrical stimulation of dorsal columns delivered via leads and power source to modulate pain

Component reminderDevices may be totally implantable or use external power with implanted receiver

Trial recommendationTrial stimulation prior to permanent implantation is recommended by FDA and policy guidance

inv-107: Definition — DRGS (alternate entry)

DRGS (alternate entry)Dorsal root ganglion stimulation: targeted neuromodulation focused at DRG to modulate neuropathic pain signals; allows precise targeting

Clinical trialsACCURATE RCT provides comparative evidence versus standard SCS in selected lower-limb neuropathic pain populations

Recovery and riskRecovery typically 6–8 weeks; device- and procedure-related complications reported in observational studies

inv-108: Definition — DUAL stimulation (combined SCS+DRGS)

DUAL stimulationCombined SCS and DRGS stimulation approach evaluated in crossover trials (DUAL) for refractory spinal pain; current evidence insufficient for routine combined use

Evidence statusOne small RCT (BOOST-DRG) was terminated early and provided limited evidence; combined use considered investigational/not covered

Clinical implicationPrioritize single-target SCS or DRGS per evidence; combined systems may be considered only in research or exceptional cases

inv-109: Definition — stSCS (short-term SCS trial)

stSCS definitionShort-term SCS trial (stSCS): brief trial of stimulation (commonly 7–14 days) to assess responsiveness prior to permanent implantation

Outcome measuresStudies using stSCS often assess VAS changes and MCID (e.g., ≥3-point VAS decrease) as indicators of clinically meaningful improvement

Use casestSCS used to select candidates and guide decision for permanent implant when conservative measures failed

inv-110: Definition — Trial stimulation (general)

Trial stimulation (general)A temporary stimulation period performed before definitive SCS implant to assess patient response and guide implantation decisions

Guideline supportGuidelines (e.g., ASRA) recommend trial stimulation before definitive implant except in select indications

DocumentationTrial results (duration, pain reduction) should be recorded to support coverage and clinical decision-making

inv-111: Definition — DRG stimulation targeted neuromodulation

DRG stimulation purposeTargeted neuromodulation of the dorsal root ganglion for focal neuropathic pain (e.g., CRPS, post-amputation) with precise nerve targeting

MechanismModulates sensory neuron cell bodies in DRG to intercept or diminish pain signals before they enter the spinal cord

Clinical outcomeDRGS trials report favorable paresthesia localization and responder rates in selected populations

inv-112: Definition — HF10 therapy (10-kHz)

HF10 therapy10-kHz high-frequency SCS waveform modality (HF10) delivering 10,000 Hz stimulation

Clinical evidenceHF10 therapy evaluated in RCTs (e.g., SENZA) demonstrating efficacy vs traditional low-frequency SCS

Device implicationHF10 devices are coded and referenced in policy under high-frequency SCS modalities

inv-113: Definition — CPT 63650 percutaneous implantation

63650Percutaneous implantation of neurostimulator electrode array, epidural

Typical useUsed to report percutaneous implantation procedures for SCS leads in claims/documentation

Coding noteDocumentation should support procedure coding including imaging/guidance when performed

inv-114: Definition — CPT 63655 laminectomy for implantation

63655Laminectomy for implantation of neurostimulator electrodes, plate/paddle, epidural

Typical useUsed to report plate/paddle electrode implantation requiring laminotomy/laminectomy

Coding noteInclude imaging guidance/fluoroscopy documentation when performed as described in code descriptor

Policy was revised during the June 2023 annual review.

2022-08Policy renewed

Policy was renewed following the August 2022 annual review.

2021-08Policy renewed

Policy was renewed following the August 2021 annual review.

2020-08Policy revised

Policy was revised during the August 2020 annual review.

2019-08Policy revised

Policy was revised during the August 2019 annual review.

2018-08Policy revised

Policy was revised during the August 2018 annual review.

2017-08Policy revised

Policy was revised during the August 2017 annual review.

2016-08Policy renewed

Policy was renewed following the August 2016 annual review.

2015-09Policy revised

Policy was revised during the September 2015 annual review and had an interim revision in February 2015.

2014-10Policy revised

Policy was revised during the October 2014 annual review (with interim revisions in May 2014).

2014-01Policy created

New policy created with a policy revision in January 2014 following the annual review.

2013-01Policy renewed

Policy was renewed following the January 2013 annual review.

2012-01Policy renewed

Policy was renewed following the January 2012 annual review.

2011-02Policy revised

Policy was revised during the February 2011 annual review.

2010-10Policy renewed

Policy was renewed following the October 2010 annual review.