RetiredCareSourcePolicy N/A

Implantable Spinal Cord Stimulator (SCS)

Policy governing medical necessity, trial and permanent implantation, contraindications, exclusions, and related coverage conditions for spinal cord stimulators for members covered under CareSource Arkansas PASSE.

Policy Summary

PayerCareSource

PolicyImplantable Spinal Cord Stimulator (SCS)

Policy CodePolicy N/A

Change TypeRetired / Archived

Effective Date08/01/2023

Next Review DateN/A

Key ActionObtain and submit prior authorization with device interrogation reports (performed within 3 months) for replacement requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3-14dtrial duration

>=50%trial success threshold

6 moactive conservative therapy

6 moinactive conservative therapy

08/01/23-05/31/24active period

Coverage Criteria for Spinal Cord Stimulation

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inv-01: Preliminary Trial (Chronic Pain)

Covered when ALL of the following are met

Preliminary Trial Criteria: 1. Patient has one of the following diagnoses: (a) Failed back surgery syndrome (FBSS); (b) Complex regional pain syndrome (CRPS) or reflex sympathetic dystrophy (RSD); (c) Neuropathic pain that is moderate to severe (Visual Analog Scale >= 5); or (d) Limb ischemia.VAS >= 5 for neuropathic pain

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Pain Documentation: 2. Pain pathology is documented in the medical record.

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Surgical Candidacy: 3. Surgical intervention is not indicated.

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Multidisciplinary Evaluation: 4. The patient has undergone careful screening, evaluation, and diagnosis by a multidisciplinary team prior to implantation.

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Psychological Evaluation: 5. The patient has undergone a psychological evaluation by a licensed mental health provider that reveals no evidence of inadequately controlled mental or behavioral health problems (including alcohol abuse, drug abuse, depression, or psychosis) that would negatively impact SCS success or contraindicate placement.

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Conservative Therapy Failure: 6. Failure of conservative therapy, evidenced by BOTH: (a) documentation of at least 6 months of active conservative therapy within the past 12 months OR documentation of inability to complete active conservative therapy due to contraindication, increased pain, or intolerance; AND (b) documentation of at least 6 months of inactive conservative therapy within the past 12 months.6 months

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inv-02: Permanent SCS Placement (Chronic Pain)

Covered when ALL of the following are met

Prerequisite - Trial Criteria Met: Patient has met all preliminary trial criteria (A.1-6) prior to consideration of permanent implantation.

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Demonstrated Trial Benefit: At least a 50% reduction in pain was achieved during the trial period and is documented in the medical record.>=50% pain reduction

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inv-03: SCS for Chronic Stable Angina Pectoris (Trial and Permanent)

Trial and permanent placement considered medically necessary when ALL criteria are met

Angina Trial Criteria: 1. Chronic stable angina pectoris classified as NYHA/CCS Class III or IV; 2. Failure to obtain satisfactory improvement with optimal pharmacologic therapy including long-acting nitrates, beta-adrenergic blockers, and calcium-channel antagonists; 3. Patient is not a candidate for revascularization procedures (CABG or PTCA); 4. Psychological evaluation by a licensed mental health provider reveals no evidence of inadequately controlled mental or behavioral health problems (including alcohol/drug abuse, depression, psychosis).NYHA/CCS Class III or IV

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Angina Permanent Criteria: Permanent SCS placement for chronic stable angina is medically necessary when the above angina trial criteria are met and at least a 50% reduction in symptoms was achieved during the trial and documented in the medical record.>=50% symptom reduction

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inv-04: Replacement and Removal

Covered when criteria met

Replacement of a lumbar or thoracic spinal cord stimulator and/or battery/generator is medically necessary when the existing stimulator and/or battery/generator are no longer under warranty and cannot be repaired. Lead and electrode replacement are not generally required at the time of generator replacement due to end of battery life.

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Removal of an SCS is considered medically necessary, including in situations where initial installation would not have been indicated.

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Documentation for Replacement Requests: Device interrogation reports with interpretation must be acquired within a minimum of 3 months of a prior authorization request and submitted with each prior authorization request for replacement.device interrogation within 3 months

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CareSource excludes the intra-operative use of motor evoked potentials (MEP) and somatosensory evoked potentials (SSEP) in association with spinal cord stimulator procedures. Additionally, cervical placement of a spinal cord stimulator is excluded for any indication. These exclusions are listed as experimental/investigational and are not covered under this policy.

While CareSource recognizes high-frequency spinal cord stimulators as an equal and effective alternative to standard SCS for medically necessary indications, the policy explicitly states that replacement of a functioning standard SCS with a high-frequency SCS is not considered medically necessary and therefore is not covered.

Provider Requirements and Authorization

Prior Authorization

Prior authorization required for replacements; archival date

Prior authorization is required for replacement requests. The prior authorization submission must include device interrogation reports with interpretation obtained within the minimum 3 months prior to the request. Note: this policy was archived effective 05/31/2024.

Step Therapy

Conservative therapy prerequisite: 6 months active + 6 months inactive

Failure of conservative therapy must be documented prior to SCS: at least 6 months of active conservative therapy within the past 12 months (or documented inability to complete active therapy due to contraindication, increased pain, or intolerance) AND at least 6 months of inactive conservative therapy within the past 12 months.

Documentation Required

Device interrogation reports required with replacement PA

For replacement prior authorization requests, submit device interrogation reports with interpretation that were acquired within a minimum of 3 months of the prior authorization request; these reports must be included in the medical record and prior authorization submission.

Documentation Required

Required clinical documentation for trial and permanent implantation

Medical records must document the pain pathology, multidisciplinary team screening/evaluation, a psychological evaluation by a licensed mental health provider showing no inadequately controlled mental/behavioral health problems, and trial results (including at least 50% pain reduction) to support permanent implantation.

Denial Risk

Contraindications that may trigger denial

Presence of certain conditions is a contraindication and may trigger denial: active infection or sepsis; coagulopathy; major psychiatric disorders (including somatization); active and untreated substance abuse; or presence of other implanted programmable devices that may interfere.

Conservative Treatment and Documentation Requirements

inv-16: Documentation of conservative therapy durations

Active Conservative Therapy Duration: Documentation in the medical record of at least 6 months of active conservative therapy within the past 12 months OR documentation of inability to complete active therapy due to contraindication, increased pain, or intolerance.>= 6 months within past 12 months

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Inactive Conservative Therapy Duration: Documentation in the medical record of at least 6 months of inactive conservative therapy within the past 12 months.>= 6 months within past 12 months

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Definitions

Conservative Therapy — definition and requirements

DefinitionA multimodality plan of care including both active (e.g., physical therapy, occupational therapy, physician-supervised home exercise program) and inactive therapies (e.g., rest, ice, heat, medical devices, TENS, pharmacotherapy).

Active therapies examplePhysical therapy, occupational therapy, supervised home exercise program (HEP) with a 6-week prescription and documented follow-up or documented inability to complete due to physical reasons.

Inactive therapies exampleRest, ice, heat, medical devices, TENS use, and pharmacotherapy; use/frequency/duration/start dates must be documented in the medical record to count toward conservative therapy.

Documentation requirementDocument durations and details of active and inactive conservative therapies in the medical record as part of prior authorization requests.

Trial — preliminary percutaneous implantation

DefinitionA preliminary 3-14 day percutaneous implantation of temporary neurostimulator electrode(s) with an external generator to assess suitability for permanent implantation.

Typical trial durationShort trial of approximately 3-14 days using temporary percutaneous leads and external generator.

Trial procedure settingCan be performed under light sedation in an office setting if sterility, equipment, training, and support personnel are available; leads placed via epidural needle under x-ray guidance.

Success thresholdIf at least 50% pain relief is achieved during the trial, the temporary system may be transitioned to a permanent system; trial documentation is a prerequisite for permanent implantation.

High Frequency SCS — definition and policy note

DefinitionSpinal cord stimulation operating at higher frequencies (example: 10,000 Hz) compared with traditional SCS (40-60 Hz).

Clinical positionHigh-frequency SCS is described as providing a higher frequency (10,000 Hz) versus traditional 40-60 Hz systems and is referenced in definitions of SCS modalities.

Replacement noteReplacement of a functioning standard SCS with a high-frequency SCS is identified elsewhere in the policy as not considered medically necessary.

Imaging Guidance for Lead Placement

Note

X-ray (fluoroscopic) guidance required for lead placement

Lead placement (trial and permanent) must be performed under x-ray (fluoroscopic) guidance.

Frequency Limits and Procedural Staging

Two-stage process and frequency limits

ProcessTwo-stage implantation process: an initial short trial with temporary leads followed, if successful, by permanent implantation with percutaneous or paddle leads and implanted neurostimulator.

No explicit frequency limitsPolicy describes the trial-then-permanent two-stage process but does not specify numeric frequency limits for how often trials or replacements may be performed.

Imaging and settingIn both stages leads are placed under x-ray guidance; permanent implantation must occur in an Ambulatory Surgical Center (ASC) or hospital.

Procedures and Uses Not Covered

The following are considered not covered under this policy: cervical placement of a spinal cord stimulator for any indication; the intra-operative use of MEP and SSEP; and all other indications not specified as medically necessary because their effectiveness has not been established (examples include chronic vegetative/minimally conscious state, chronic cancer-related pain, chronic pelvic pain, gait disorders, IBS, Parkinson’s disease, sleep disorders, Sphincter of Oddi dysfunction, certain non-neuropathic chronic pain types, and ventricular arrhythmias).

Background on Spinal Cord Stimulation

Spinal cord stimulation (SCS) delivers electrical current to the dorsal columns of the spinal cord to modulate pain signaling and is used primarily for neuropathic pain syndromes such as failed back surgery syndrome, complex regional pain syndrome, radiculopathies, phantom limb pain, and peripheral neuropathy. A short percutaneous trial is performed to assess response, and permanent systems (percutaneous or paddle leads with an implantable pulse generator) are used in appropriate candidates. This policy outlines the clinical indications, trial requirements, conservative therapy prerequisites, and device replacement/removal considerations for SCS.

Policy Summary

PayerCareSource

PolicyImplantable Spinal Cord Stimulator (SCS)

Policy CodePolicy N/A

Change TypeRetired / Archived

Effective Date08/01/2023

Next Review DateN/A

Key ActionObtain and submit prior authorization with device interrogation reports (performed within 3 months) for replacement requests.

SourceLink

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