Defines UnitedHealthcare coverage criteria and supporting evidence for spinal cord stimulator (SCS) trials and permanent implantation for chronic intractable pain, and references applicable CMS NCDs/LCDs; intended for providers performing or requesting authorization for SCS procedures.
Policy Summary
PayerUnitedHealthcare
PolicySpinal Cord Stimulators for Chronic Pain
Policy CodePolicy MMP368.12
Change TypeCode list and reference updates
Effective DateJul 1, 2025
Next Review DateN/A
Key ActionObtain prior authorization with documentation of an adequate SCS trial demonstrating ≥50% pain reduction (or ≥50% reduction in analgesic medications) plus evidence of functional improvement before permanent implantation.
Applicable diagnosis code lists were updated — multiple ICD-10 codes were removed from coverage lists for CPT codes 63650, 63655, and 63685.
Supporting clinical evidence and references were updated to reflect the most current information.
≥50%trial pain reduction threshold
50%trial response threshold
10 kHzhigh-frequency modality
90.1%SENZA-PDN trial success
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4.8%DRGS pooled infection rate
24 momaximum follow-up
Coverage Criteria for Spinal Cord Stimulation
inv-01: Permanent Implantation after Trial
Covered when ALL of the following are met:
Permanent implantation criteria: 1) Trial achieved at least a 50% reduction of target pain or 50% reduction of analgesic medications; 2) Some element of functional improvement was achieved; 3) Adequate documentation of the trial is in the chart to support proceeding to permanent implant; 4) Patient selection included multidisciplinary screening (including psychological evaluation) and conservative therapies were attempted prior to SCS trialsee node text
Patients with reflex sympathetic dystrophy (CRPS) may require longer trials; replacement for battery/malfunction does not require a new trial if prior SCS was effective
inv-02: Requirement for Trial Prior to Permanent Implantation
Policy requires a trial prior to permanent implantation except in certain replacement situations:
Trial requirement: A temporary implanted electrode trial and demonstration of effectiveness is a prerequisite for permanent implantation; however, when replacing a functioning SCS (battery change, malfunction, or end of stimulator life) a new trial is not neededtrial required unless replacement of functioning system
If an initial trial fails, a repeat trial is not appropriate unless extenuating circumstances are documented
inv-03: Coverage-relevant study criteria and thresholds
Common clinical criteria and outcome thresholds used in reviewed studies
Typical criteria for offering SCS/DRG trial: Patient with chronic intractable pain (eg, failed back surgery syndrome, nonsurgical refractory back pain, neuropathic pain, complex regional pain syndrome, painful diabetic peripheral neuropathy) refractory to conventional medical management and conservative therapiesduration and specific prior therapies vary by study
Multiple randomized trials required prior CMM before randomization or implant
Trial success for permanent implant: Demonstrated trial-phase analgesic benefit, commonly ≥50% pain reduction; some protocols additionally require adequate overlap of stimulation with the painful distribution (eg, ~80% overlap)>= 50% pain reduction
Scalone et al used 50% reduction and 80% overlap as trial criteria
Expected outcomes reported:
inv-04: General coverage considerations
Coverage is informed by clinical evidence and society guidance; many studies and guidelines recommend a trial stimulation and selection by multidisciplinary assessment.
Trial and selection: A trial stimulation should be performed and be successful (commonly defined as ≥50% pain reduction and adequate overlap of stimulation with the painful area) before permanent implantation>=50% pain reduction
ASRAPM recommends trial prior to implant except for angina; FDA advisory supports conducting a trial prior to implant
Evidence of effectiveness: Randomized and prospective studies demonstrate benefit of SCS and DRG stimulation in select populations (FBSS, PDPN, CRPS) with improvements in pain and health‑related quality of life up to 24 months
DRG stimulation showed higher treatment success vs traditional SCS in the ACCURATE trial for CRPS/causalgia
This coverage policy applies to spinal cord stimulation (SCS) and related procedures when used for chronic intractable pain. UnitedHealthcare follows CMS LCD/NCD guidance and supplements those criteria to define when permanent implantation is reasonable and necessary. In general, SCS is intended for patients who have undergone multidisciplinary evaluation, attempted conservative therapies (medications, physical therapy, psychological therapies, and other modalities), and completed a temporary percutaneous trial stimulation to demonstrate benefit prior to consideration of a permanent implant. Replacement of a functioning system for battery change, malfunction, or end of stimulator life does not require a new trial if the prior SCS was effective.
The evidence for dorsal root ganglion (DRG) stimulation is strongest for focal neuropathic syndromes such as complex regional pain syndrome (CRPS) and causalgia; systematic reviews and health-technology assessments describe only limited or very low-quality evidence for DRG stimulation in many other neuropathic pain etiologies. As noted in the Hayes assessment, the effectiveness and safety of DRG stimulation for neuropathic pain associated with other chronic conditions (for example, cancer-related neuropathy, postherpetic neuralgia, central neuropathic pain due to multiple sclerosis, stroke, ischemia, or amputation) remain unknown.
Coverage decisions are informed by randomized trials, prospective studies, systematic reviews, and society guidance. Many clinical studies require documentation of prior conservative care and a successful trial (commonly defined as ≥ 50% pain reduction) before permanent implantation. Society and guideline input is also considered: ASRAPM and FDA advisory commentary support the use of a trial stimulation and multidisciplinary selection processes, whereas the 2022 VA/DoD guideline recommends against SCS for primary low back pain and the 2020 NASS review found no adequate studies addressing electrical stimulation for low back pain.
The policy is intended to reduce inappropriate permanent implantation. Performance and documentation of an effective temporary trial stimulation is emphasized as a key decision point; if trial criteria and documentation requirements are not met, permanent implantation may be considered not reasonable and necessary. Providers should document trial outcomes, prior conservative treatments, multidisciplinary screening (including psychological evaluation), and any extenuating circumstances if a repeat trial is attempted after an initial failed trial.
DRG stimulation has demonstrated benefit in select, focal neuropathic conditions—most notably CRPS—in randomized and cohort studies. However, broader indications for DRG stimulation (for example, pelvic pain, phantom limb pain, trunk neuropathic pain, diabetic neuropathy, or other non-CRPS etiologies) are supported primarily by small, low-quality studies, case series, or limited cohort data. As a result, DRG stimulation for these broader indications should be considered investigational or not medically necessary unless stronger comparative evidence and adequate documentation are provided.
Caution is advised when considering SCS for primary low back pain without a clear neuropathic mechanism or evidence of likely benefit. The 2022 VA/DoD guideline recommends against SCS for low back pain, and the 2020 NASS evidence review found no adequate studies addressing electrical stimulation for low back pain; therefore, SCS for primary low back pain may be considered not medically necessary in the absence of supportive evidence or when neuropathic features are not documented.
Coding and Diagnostic Codes
Applicable CPT CodesCPT
63650
Percutaneous implantation of neurostimulator electrode array, epidural.
63655
Laminectomy for implantation of neurostimulator electrodes, plate/paddle, epidural
63685
CPT Code 63685
Diagnosis Codes (external list)ICD-10
Diagnosis code list is provided in an external PDF (link).
Affected CPT Codes referenced in updatesCPT
63650
Insertion or replacement of spinal neurostimulator pulse generator or receiver, direct or inductive coupling
63655
Revision or removal of spinal neurostimulator pulse generator or receiver
63685
Placement of spinal neurostimulator leads, percutaneous
Example ICD-10 codes listed in policy history (removed from certain CPT code lists)ICD-10
T85.01XA
Complication of internal orthopedic device, initial encounter
T85.810A
Complication of nervous system device, initial encounter
inv-15: Trial pain reduction threshold
Trial pain reduction threshold>= 50% reduction in target pain
Analgesic medication reduction threshold>= 50% reduction in analgesic medications
Functional improvement requirementSome element of functional improvement must be achieved during the trial
inv-16: Trial response threshold
Trial response threshold (general)>= 50% reduction in pain intensity from baseline (eg, VAS or NRS)
Trial duration exampleSome trials used a 7-day trial (de Vos et al.) to assess >=50% improvement
Provider Actions, Prior Authorization, and Documentation
Prior Authorization
Prior Authorization Required
Prior authorization is required for spinal cord stimulator (SCS) implantation. Requests must follow UnitedHealthcare (or delegated entity) prior authorization processes and include relevant CPT codes for trial and permanent implantation. Providers should obtain authorization before proceeding with trial stimulation or permanent implantation to avoid potential claim denials.
Applicable CPT codes should be included with requests (e.g., 63650, 63655, 63685).
If a delegate manages prior authorization for the member's plan, follow the delegate's submission process and timelines.
Prior Authorization
Demonstrate Prior Conservative Care and Successful Trial
Prior authorization must demonstrate that conservative therapies were attempted and that a successful trial stimulation supports progression to permanent implantation. Documentation should show failure or inadequate response to conventional medical management (CMM) and completion of recommended conservative care prior to SCS trial.
Document prior conservative therapies such as medications, physical therapy, psychological evaluation/therapy, interventional procedures, and other modalities.
Conservative Treatment Requirements Before SCS
inv-36: Conservative therapies attempted before considering SCS trial
Conservative therapies that should be attempted prior to consideration of an SCS trial include all of the following:
Required conservative therapies: 1) Appropriate trials of medications (eg, guideline-directed neuropathic agents, analgesics, optimization of opioid therapy where applicable); 2) Noninvasive physical rehabilitation or supervised physical therapy; 3) Psychological assessment and, when indicated, psychological therapy addressing mood/behavioral contributors to pain; 4) Other noninvasive modalities (eg, TENS, activity modification, bracing) as clinically appropriateduration and exact therapies tailored per patient and studies
SCS is considered a late option after these conservative attempts have been tried
inv-37: Document prior conservative care attempts and CMM before considering trial/implant
Prior to proceeding with a trial or permanent implant, documentation must record attempts at conventional medical management and multidisciplinary evaluation:
Imaging and Procedural Guidance
Billing Rule
Use fluoroscopy for percutaneous electrode insertion and lead advancement
Fluoroscopic guidance is required for percutaneous insertion of the electrode and advancement to the dorsal column during permanent implantation.
Use fluoroscopy for lead placement and electrode advancement to target dorsal column levels
Document fluoroscopic guidance in operative records
Documentation Required
Document pain–stimulation overlap during trial when required (eg, 80%)
During trial assessment, some studies required demonstration of adequate overlap between stimulation and the painful area (eg, 80% paresthesia overlap) though imaging requirements for overlap are not specified in all studies; document trial overlap when applicable.
Frequency Limits and Implant Frequency
inv-39: Permanent implantation requires percutaneous insertion of an electrode into the epidural space under fluoroscopy.
Implantation approachPercutaneous insertion of an electrode into the epidural space under fluoroscopy
Lead advancementTip of the electrode advanced to appropriate level behind the dorsal column
Connection to IPGElectrode tunneled subcutaneously and connected to an implanted pulse generator in abdominal wall or low back
inv-40: SCS trial leading to permanent implant — relation between trial and single permanent implant after successful trial.
Relation of trial to permanent implantPermanent implantation is contingent on a successful trial demonstrating adequate pain relief (commonly >=50%)
Single permanent implant after trial
Definitions
inv-30: Trial stimulation — temporary percutaneous implantation of neurostimulator electrode(s) connected to external pulse generator to assess suitability.
Definition of trial stimulationTemporary percutaneous implantation of neurostimulator electrode(s) connected to an external pulse generator to assess suitability prior to permanent implant
PurposeAssess analgesic benefit and paresthesia overlap before committing to permanent implantation
Typical procedure stepsPercutaneous lead placement with externalized connection to an external pulse generator for a brief trial period
inv-31: Permanent implantation — placement of a permanent electrode in the epidural space connected to an implanted pulse generator.
Definition of permanent implantationPlacement of a permanent electrode in the epidural space connected via subcutaneous tunneling to an implanted pulse generator
Background
Spinal cord stimulation (also called dorsal column stimulation) involves placement of electrodes in the epidural space connected to a pulse generator to deliver electrical stimulation that modulates pain signaling. Treatment is typically performed in two phases: a temporary percutaneous trial stimulation using externalized leads to assess patient suitability, followed by permanent implantation of leads and an implanted pulse generator when the trial demonstrates adequate pain relief and functional improvement. Patient selection, multidisciplinary evaluation, and fluoroscopic guidance for lead placement are important elements of safe and effective SCS therapy.
Not Covered / Experimental Indications
This policy does not attempt to list every specific procedure that may be not covered. Instead, coverage determinations are driven by whether the required trial and documentation criteria are met and by applicable NCDs/LCDs. Providers should ensure documentation of an adequate trial, prior conservative care, multidisciplinary evaluation, and clinical outcome measures to support a request for permanent implantation.
DRG stimulation for neuropathic pain etiologies lacking supportive evidence—such as certain cancer-related neuropathies, postherpetic neuralgia, or central neuropathic pain syndromes—has only limited or very low-quality evidence per systematic reviews and the Hayes assessment. Use of DRG stimulation for these indications should be considered unsupported unless robust, comparative evidence and appropriate documentation demonstrating likely benefit are provided.
As with other statements in this policy, DRG stimulation for unsupported neuropathic etiologies is not broadly endorsed; the available literature is small, often observational, and frequently limited by study quality, small sample sizes, and short follow-up. Therefore, such uses are generally not considered standard of care and require strong documentation and justification when submitted for coverage review.
Policy Summary
PayerUnitedHealthcare
PolicySpinal Cord Stimulators for Chronic Pain
Policy CodePolicy MMP368.12
Change TypeCode list and reference updates
Effective DateJul 1, 2025
Next Review DateN/A
Key ActionObtain prior authorization with documentation of an adequate SCS trial demonstrating ≥50% pain reduction (or ≥50% reduction in analgesic medications) plus evidence of functional improvement before permanent implantation.
Responder rates and functional/QoL improvement reported in RCTs and observational studies at 3–12 months and up to 24 months (examples: high responder rates in 10-kHz trials and improvements in ODI/QoL)
eg, responder rates 50–90% depending on modality and study
Kapural et al reported 80.9% responder rate at 3 months for 10-kHz SCS; Amirdelfan et al reported 69.6% improved ODI at 12 months
Study-defined responderResponder commonly defined as >=50% reduction in pain in cited trials
Include timing and duration of conservative care and reason for escalation to trial stimulation (e.g., persistent neuropathic pain despite multimodal CMM).
Denial Risk
Denial Risk for Insufficient Documentation or Criteria Not Met
Insufficient or missing documentation supporting trial success, conservative care, or selection criteria may lead to denial of coverage. Prior authorization criteria supplement Medicare NCDs and LCDs; failure to meet these supplemental criteria increases risk of inappropriate approval or denial.
Denials commonly result from inadequate chart documentation of trial outcomes or lack of evidence of prior conservative management.
Providers should ensure records explicitly support medical necessity for permanent implantation to reduce denial risk.
Denial Risk
Infection and Complication-Related Denial Risk
Infection and other device- or procedure-related complications are recognized risks and may influence coverage decisions. Higher infection rates occur at implant and revision stages compared with trial stages; these risks should be considered in patient selection and documented informed consent.
Document infection prevention measures, informed consent discussion of risks (infection, hemorrhage, lead migration/fracture, device failure), and rationale for proceeding with implant.
Documentation Required
Required Clinical Outcome Documentation
Clinical outcome documentation is required pre- and post-trial/implant to support medical necessity. Objective measures should be recorded to demonstrate trial success and ongoing benefit after permanent implantation.
Record baseline and post-intervention pain scores (e.g., NRS or VAS) and report responder status (≥50% pain reduction for trial).
Document functional status using validated instruments (e.g., Oswestry Disability Index [ODI]) and quality-of-life measures (e.g., EQ-5D).
Document changes in analgesic medication use (≥50% reduction in analgesics supports success) and any functional improvement observed.
Documentation Required
Record Retention and Evidence
Maintain complete records to support medical necessity, prior authorization, and billing. UnitedHealthcare (or its delegate) may request chart documentation; providers must retain access to the member-specific records used to justify SCS trial and implantation.
Retain trial and implant procedure notes, pain and functional assessments, psychosocial screening results, informed consent, and documentation of conservative care attempts.
Lack of available documentation when requested may result in claim denial or recoupment. Coverage is ultimately governed by the member-specific benefit plan.
Step Therapy
Conservative Therapy Before SCS
SCS should be considered only after appropriate conservative therapies have been tried and failed. Clinical trials and guidelines support SCS as a later-line option after exhaustion of CMM and documented multidisciplinary evaluation.
Conservative interventions include optimized medications, physical therapy, psychological therapy, and other noninvasive treatments.
Ensure multidisciplinary evaluation (including psychological screening) and documentation that conservative measures were inadequate prior to SCS trial.
Step Therapy
Step from CMM to SCS
Progression from conventional medical management (CMM) to SCS requires clear documentation that CMM was attempted and failed, and that trial stimulation demonstrates adequate pain relief and functional benefit prior to permanent implant.
Randomized trials comparing SCS + CMM vs CMM alone show superior pain and functional outcomes for SCS in selected patients; document prior CMM strategies and timelines.
Trial stimulation should achieve ≥50% pain relief (or ≥50% reduction in analgesics) and some functional improvement before permanent implantation is authorized.
Documentation expectations:
1) Record of prior conservative care attempts and failure of conventional medical management (eg, medications, TENS, rehabilitation, other noninvasive treatments); 2) Baseline pain intensity and functional measures (eg, NRS/VAS, ODI) documented prior to trial; 3) Trial results with post‑trial pain and function assessments documented (eg, ≥50% pain reduction during trial) and clinician rationale for proceeding to implant; 4) Evidence of multidisciplinary screening including psychological evaluation and informed consent including whether trialing clinician will perform permanent implant
see node text
Prior authorization should include these records to demonstrate prior CMM and successful trial when applicable
inv-38: Failure of conventional medical management prior to consideration of SCS
Failure of conventional medical management must be demonstrated before considering SCS:
Failure of CMM: Patient has exhausted or failed appropriate conventional medical management and conservative therapies for the pain condition (eg, persistent significant pain despite prior treatments) and remains a candidate for SCS trialfailure of CMM as defined by lack of adequate pain relief or functional improvement despite prior therapies
Randomized trials required prior CMM; documentation in the chart should support that conventional measures were attempted and were inadequate
If study/protocol requires, document paresthesia overlap (eg, 80%) during trial
Record method used to confirm overlap and patient-reported mapping
Billing Rule
Document fluoroscopic guidance for lead placement and permanent implant
Lead placement and permanent implant procedures are performed with fluoroscopic imaging guidance implied as standard practice; document imaging guidance used during lead placement and generator implantation.
Document fluoroscopic guidance during lead placement and generator pocket creation
Record lead location and confirmation of appropriate paresthesia overlap
Patients with a positive trial proceed to permanent device implantation; trials that meet success criteria lead to implant
Repeat trial guidanceIf a trial fails, a repeat trial is not appropriate unless extenuating circumstances are documented
inv-41: No explicit frequency limits provided in this document segment; trials include single implant after successful trial.
Frequency limits providedNo explicit frequency limits provided in this document segment
Trial-to-implant patternTrials described generally proceed to a single permanent implant after a successful trial
Trial duration examplesCited studies reported trial periods commonly ~7–15 days (eg, 7-day in de Vos; 15-day in Scalone)
Surgical elements
Requires pocket creation for pulse generator and connection between electrode array and pulse generator
Imaging guidanceTypically performed under fluoroscopy to advance electrode tip to dorsal column level
inv-32: Responder — typically defined as ≥ 50% reduction in pain from baseline (eg, VAS or NRS).
Responder definitionTypically defined as >= 50% reduction in pain from baseline (eg, VAS or NRS)
Use in trialsResponder/rate used as primary or composite endpoints in multiple RCTs and prospective studies
Reporting timeframeResponder rates reported at follow-ups up to 12–24 months in cited studies
inv-33: Successful trial — commonly defined as at least 50% pain reduction and in some studies 80% overlap of pain with induced stimulation prior to permanent implant.
Successful trial (core definition)At least 50% pain reduction during the trial prior to permanent implant
Additional overlap criterion used in some studiesSome protocols (eg, Scalone) also required ~80% overlap of pain distribution with induced stimulation
Documentation requirementAdequate chart documentation of the effective trial is required to support proceeding to permanent implantation
inv-34: Trial stimulation — temporary percutaneous lead stimulation period (~7–15 days in cited studies) used to assess response prior to permanent implantation.
Trial stimulation periodCommonly approximately 7–15 days in cited studies (eg, 7 days in de Vos; 15 days in Scalone)
Purpose of durationShort-term percutaneous stimulation used to assess pain reduction and paresthesia overlap before implant
Proceeding to implantPatients with successful trial periods (meeting >=50% pain reduction) proceeded to permanent implantation in trials
inv-35: DRG stimulation — neurostimulation targeting the dorsal root ganglion with demonstrated higher success for CRPS/causalgia in some studies.
DRG stimulation descriptionNeurostimulation targeting the dorsal root ganglion
Clinical advantage evidenceDRG stimulation demonstrated higher treatment success for CRPS/causalgia versus traditional dorsal column SCS in the ACCURATE randomized trial
Outcomes reportedDRG arm achieved higher percentage of subjects with >=50% pain relief and treatment success at 3 months (81.2% vs 55.7%)