ModifiedPremera BluecrossPolicy 7.01.25

Spinal cord stimulation (SCS) and dorsal root ganglion (DRG) neurostimulation

Policy defines medical necessity criteria, site-of-service guidance, indications (trial and permanent implantation), replacement rules, investigational exclusions, coding lists, regulatory status, and supporting evidence/guidelines for SCS and DRG neurostimulation. This brief covers the content present in Part 1 of 2 of the policy.

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Policy Summary

PayerPremera Bluecross

PolicySpinal cord stimulation (SCS) and dorsal root ganglion (DRG) neurostimulation

Policy CodePolicy 7.01.25

Change TypeRevised coverage and site-of-service criteria

Effective DateNov 7, 2025

Next Review DateN/A

Key ActionDocument failure or unsuitability of other treatments, obtain psychosocial clearance, conduct and document a ≥50% pain-reduction trial (≥3 days) before permanent implant, and follow updated ASC site-of-service requirements for dates of service on/after 2025-11-07.

SourceLink

POLICY UPDATE CHANGES

Policy has been revised (header indicates '*This policy has been revised').

Added explicit criteria for ASC availability and clinical risk factors for site-of-service determination.

Removed Related Policy 11.01.524 Site of Service: Select Surgical Procedures and added related policy 11.01.525 Site of Service Ambulatory Service Center (ASC) Select Surgical Procedures; effective 2025-11-07 after 90-day provider notification.

Policy statements unchanged after annual review approved June 23, 2025; literature review updated through March 12, 2025.

>=50%Pain reduction threshold for permanent implant

30ASC geographic availability threshold (miles)

>8MELD liver risk cutoff

<50%COPD pulmonary risk cutoff (FEV1)

107,728FDA MAUDE reports (2016-2020)

497Reports associated with patient death

Coverage Summary

This policy (Policy No. 7.01.25; effective 2025-11-07; last revised 2025-07-08) defines medical necessity criteria and related requirements for spinal cord stimulation (SCS) and dorsal root ganglion (DRG) neurostimulation. It covers: site-of-service guidance (preferred Ambulatory Surgical Center with an ASC 30-mile access rule and specified clinical risk exceptions), indications and stepwise criteria for trial and permanent implantation (including psychosocial clearance and requirement to document failure or unsuitability of other therapies), replacement rules (limited replacement allowed; replacement of a functioning standard SCS with high-frequency SCS is not medically necessary), investigational exclusions (e.g., central deafferentation, nociceptive pain, critical limb ischemia for amputation prevention, refractory angina, cancer-related pain, heart failure), the lists of applicable CPT and HCPCS/L-codes for procedures and device components, FDA/regulatory considerations (device approvals and FDA recommendations about conducting a trial), and an evidence summary (RCTs, systematic reviews, and guideline support).

Key thresholds and quick facts

Trial pain reduction threshold>= 50% reduction in pain with at least a 3-day trial of temporary stimulation

Trial stimulation durationTypically 3 to 7 days (per FDA and policy)

ASC geographic availability thresholdNo qualifying ASC within 30 miles

Liver risk cutoff (MELD)> 8 (advanced liver disease)

COPD pulmonary risk cutoff (FEV1)FEV1 < 50%

Asthma pulmonary function cutoff (FEV1)FEV1 < 80% despite treatment

FDA MAUDE reports (Jul 27, 2016–Jul 27, 2020)107,728 total reports; 497 deaths; 77,937 patient injuries; 29,924 device malfunctions

Medical Necessity Criteria

Site of Service for Elective Surgical Procedures

Certain elective surgical procedures will be covered in the most appropriate, safe, and cost-effective site of service; inpatient site considered not medically necessary when criteria not met.

Ambulatory Surgical Center (ASC) is preferred medically necessary site of service for certain elective surgical procedures

Off-campus outpatient hospital/medical center

On-campus outpatient hospital/medical center

ASC unavailable or inpatient required when ANY of the following are met

No qualifying ASC within 30 miles that can provide the necessary care because: no geographically accessible ASC with necessary equipment

Codes for Procedures, Devices, and Historical Notes

Covered/Used CPT codes for SCS/DRG proceduresCPTCovered

0784T	Insertion or replacement of percutaneous electrode array, spinal, with integrated neurostimulator; including imaging guidance; when performed.
0785T	Revision or removal of neurostimulator electrode array, spinal, with integrated neurostimulator.
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, direct or inductive coupling.
63688	Revision or removal of implanted spinal neurostimulator pulse generator or receiver.

Covered/Used HCPCS and L-codes for implants and componentsHCPCSCovered

C1767	Generator; neurostimulator (implantable), nonrechargeable.
C1778	Lead, neurostimulator (implantable).
C1787	Patient programmer; neurostimulator.
C1820	Generator; neurostimulator (implantable), with rechargeable battery and charging system.
C1822	Generator; neurostimulator (implantable), high frequency, with rechargeable battery and charging system.
C1826	Generator; neurostimulator (implantable); includes closed feedback loop leads and all implantable components, with rechargeable battery and charging system.
C1827	Generator; neurostimulator (implantable), nonrechargeable; with implantable stimulation lead and external paired stimulation controller.
C1883	Adaptor/extension, pacing lead or neurostimulator lead (implantable).
C1897	Lead, neurostimulator test kit (implantable).
L8679	Implantable neurostimulator; generator; any type pulse.

1–10 of 19

1/2

HCPCS / Device Codes mentioned historically/addedHCPCS

L8679	Historically added HCPCS (policy history).
L8683	Historically added HCPCS (policy history).
L8684	Previously removed HCPCS (policy history).
C1767	Added HCPCS (policy history).
C1778	Added HCPCS (policy history).
C1787	Added HCPCS (policy history).
C1820	Added HCPCS (policy history).
C1822	Added HCPCS (policy history); later removed noted 02/06/18.
C1826	Added HCPCS 01/01/23.
C1827	Added HCPCS 01/01/23.

1–10 of 12

1/2

CPT codes (recently added)CPT

0784T	Added CPT code 01/01/24 (policy history).
0785T	Added CPT code 01/01/24 (policy history).

Other Procedure/ICD-10/PCS historical codesmixed

86.96	ICD-9 procedure code added historically (policy history).
86.94	Referenced literature/policy mapping (policy history).

Provider Actions & Billing/Authorization Requirements

Documentation Required

Prior conservative treatments documented

Document failure or unsuitability/contraindication of other treatments (pharmacologic, surgical, psychological, or physical) must be recorded prior to performing a trial of SCS or DRG neurostimulation.

Document which conservative modalities were tried and why they failed or are contraindicated.

Documentation Required

Psychosocial clearance required

Obtain and document psychosocial clearance from a licensed mental health professional (licensed psychologist, psychiatrist, or other licensed mental health professional) prior to trial stimulation and before permanent implant.

Prior Authorization

Background, Evidence, and Definitions

SCS and DRG therapies modulate pain pathways by delivering electrical stimulation to spinal cord dorsal columns or dorsal root ganglia. Devices typically include leads, extension wires, and an implanted or rechargeable pulse generator/receiver. Implantation is commonly a two-step workflow: a temporary epidural lead placement for a stimulation trial (usually 3–7 days), and, if the trial demonstrates satisfactory pain relief (commonly defined as at least 50% reduction), permanent implantation of leads and the generator. DRG stimulation uses similar epidural techniques but targets the dorsal root ganglion for more focal targeting; device programming (including burst or high-frequency modes) and manufacturer labeling guide trial conduct and implantation.

Evidence includes randomized controlled trials and multiple systematic reviews demonstrating clinically meaningful benefit of SCS and DRG neurostimulation for treatment-refractory neuropathic pain of the trunk or limbs; these data have been judged sufficient to improve net health outcomes for appropriate neuropathic indications. Key trials and bodies of evidence cited include high-quality RCTs and meta-analyses (examples referenced include the SENZA-RCT and trials of 10-kHz/high-frequency SCS such as EVOKE and other randomized studies). NICE guidance supports SCS for chronic neuropathic pain measuring at least 50 mm on a 0–100 mm VAS persisting for at least 6 months with a successful trial. Evidence is insufficient or inconsistent for other indications (critical limb ischemia, refractory angina, heart failure, and cancer-related pain), and gaps remain for some investigational uses and long-term comparative effectiveness across device types and specific patient subgroups.

Term	Definition
ASA score
American Society of Anesthesiologists physical status classification (1-5) describing perioperative risk.
CRPS
Complex Regional Pain Syndrome; chronic pain condition often following trauma with sensory and autonomic changes; types I and II described.
Neuropathic pain
Pain caused by damage to the somatosensory nervous system, often chronic, shooting or burning in character.
Nociceptive pain
Pain resulting from tissue damage or inflammation, typically resolving when tissue heals.
DDD
Degenerative disk disease.
FBSS
Failed back surgery syndrome.
PMA
Premarket Approval (FDA regulatory pathway for certain devices).
RSD
Reflex sympathetic dystrophy (an older term related to complex regional pain syndrome).
SCS
Spinal Cord Stimulation — delivery of low-voltage electrical stimulation to dorsal columns via implanted device to block pain; includes leads, extensions, and implanted or rechargeable generators; typically involves a temporary trial followed by permanent implantation upon satisfactory response.

Medicare National Coverage Determinations

Effective Date	Name	Number/Section	Type
1995-08-07
CNS stimulator implantation for chronic intractable pain
Manual Section 160.7
NCD
1995
Electrical Nerve Stimulators
160.7
NCD

Revision History

2025-11-07site-of-service policy change (effective)Latest

Removed Related Policy 11.01.524 and added Related Policy 11.01.525 'Site of Service Ambulatory Service Center (ASC) Select Surgical Procedures'; site-of-service ASC criteria (including the 30-mile ASC availability rule and enumerated clinical risk factors) apply for dates of service on or after this effective date following 90-day provider notification.

2025-07-08interim review / header revision noted

Policy marked '*This policy has been revised' in the header and an interim review approved; documentation notes removal of Related Policy 11.01.524 and preparatory administrative changes for the upcoming ASC criteria update.

Policy Summary

PayerPremera Bluecross

PolicySpinal cord stimulation (SCS) and dorsal root ganglion (DRG) neurostimulation

Policy CodePolicy 7.01.25

Change TypeRevised coverage and site-of-service criteria

Effective DateNov 7, 2025

Next Review DateN/A

SourceLink

On This Page

No geographically accessible ASC where the individual's physician has privileges

An ASC's specific guideline prohibits use of the ASC related to the individual's health condition or weight

Individual is aged 18 or younger

Service is performed in conjunction with an additional service that requires hospital outpatient department and procedures are performed in same operative session

Individual has a clinical condition that increases risk for complications (examples listed below)

Examples of clinical conditions that increase risk for complications

Anesthesia risk: ASA classification III or higher
See ASA score definition
Anesthesia risk: Personal history of complication of anesthesia
Anesthesia risk: Documentation of alcohol dependence or history of cocaine use
Anesthesia risk: Prolonged surgery (> 3 hours)
Cardiovascular risk: Uncompensated chronic heart failure (NYHA class III or IV)
Cardiovascular risk: Recent myocardial infarction (< 3 months)
Cardiovascular risk: Poorly controlled, resistant hypertension (>=3 drugs to control BP)
Cardiovascular risk: Recent cerebrovascular accident (< 3 months)
Cardiovascular risk: Increased risk for cardiac ischemia (drug eluting stent < 1 year or angioplasty < 90 days)
Cardiovascular risk: Symptomatic cardiac arrhythmia despite medication
Cardiovascular risk: Significant valvular heart disease
Liver risk: Advanced liver disease (MELD score > 8)
Pulmonary risk: COPD (FEV1 < 50%)
Pulmonary risk: Poorly controlled asthma (FEV1 < 80% despite treatment)
Pulmonary risk: Moderate to severe OSA (AHI >=15)
Renal risk: End stage renal disease on dialysis
Other: Morbid obesity (BMI >= 50)
Other: Pregnancy
Other: Bleeding disorder requiring replacement factor, blood products, or special infusion product (DDAVP does not meet this criterion)

Spinal Cord Stimulation (SCS) Trial and Permanent Placement

A trial with standard or high-frequency SCS using a temporary stimulator may be considered medically necessary when ALL of the following criteria are met:

ALL of the following

Other treatment modalities (pharmacological, surgical, psychological, or physical, if applicable) have failed or are judged unsuitable or contraindicated
Examples of qualifying neuropathic diagnoses
- Failed lumbar back surgery syndrome
- Complex regional pain syndrome (CRPS)
- Arachnoiditis
- Phantom limb/stump pain
- Peripheral neuropathy
- Painful diabetic neuropathy
Member has obtained clearance by a licensed psychologist, psychiatrist, or other licensed mental health professional
No untreated drug habituation exists

Permanent SCS placement: Above medical necessity criteria for a trial SCS are met and demonstration of at least a 50% reduction in pain with at least a 3-day trial of temporary spinal cord stimulation>=50% pain reduction; trial >=3 days

High-frequency SCS

High-frequency SCS (10 kHz) coverage criteria mirror standard SCS trial logic

Used as last resort after other therapies failed or are unsuitable; individual has severe and chronic neuropathic pain of the trunk or limbs from peripheral nerve damage (examples: FBSS, CRPS, arachnoiditis, phantom limb/stump pain, peripheral neuropathy, painful diabetic neuropathy); licensed mental health clearance obtained; no untreated drug habituation exists

Permanent placement requires demonstration of at least a 50% reduction in pain with at least a 3-day trial of temporary stimulation>=50% pain reduction; trial >=3 days

Dorsal Root Ganglion (DRG) Stimulation Trial and Permanent Placement

A DRG neurostimulation trial is considered medically necessary when ALL of the following criteria are met:

Other treatment modalities have failed or are judged unsuitable or contraindicated; individual has severe and chronic neuropathic pain of the trunk or limbs resulting from actual damage to peripheral nerves (examples: failed back surgery syndrome, complex regional pain syndrome, arachnoiditis, phantom limb/stump pain, peripheral neuropathy, painful diabetic neuropathy); member has obtained clearance by a licensed mental health professional; no untreated drug habituation exists

Permanent DRG placement: Above trial medical necessity criteria are met and demonstration of at least a 50% reduction in pain with at least a 3-day trial of temporary DRG neurostimulation>=50% pain reduction; trial >=3 days

Replacement of SCS or DRG Neurostimulators

Replacement may be medically necessary only in a small subset of individuals when specific conditions are met:

Replacement is medically necessary when: the stimulator is not working or is broken; OR replacement is needed because the individual's condition has changed such that the current processor is inadequate or no longer meets functional needs and improvement is expected with a replacement device

Not covered: Replacement of a functioning standard SCS with a high-frequency SCS is considered not medically necessary

Investigational / Not Medically Necessary Indications

SCS is considered investigational for all other situations not outlined above, including but not limited to:

Central deafferentation pain (CNS damage from stroke or spinal cord injury)

Nociceptive pain (pain from irritation rather than nerve damage)

Critical limb ischemia as a technique to forestall amputation

Refractory angina pectoris

Chronic pelvic (abdominal or visceral) pain

Treatment of cancer-related pain

Treatment of heart failure

Medically Necessary - General Requirements (as referenced)

Covered when ALL of the following are met:

Chronic intractable pain of the trunk and/or limbs resulting from indications such as failed back surgery syndrome, intractable low back pain, radicular pain/radiculopathies, herniated disk, postlaminectomy pain, multiple back operations, unsuccessful disk surgery, degenerative disk disease/herniated disk refractory to conservative and surgical interventions, peripheral causalgia, epidural fibrosis, arachnoiditis or lumbar adhesive arachnoiditis, CRPS/RSD/causalgia

Trial requirement: Demonstration of satisfactory pain relief during a stimulation trial prior to permanent implantation; trial typically performed for 3 to 7 days and success usually defined by at least 50% reduction in pain symptoms>=50% pain reduction; trial 3-7 days

Permanent implantation only after individual has undergone and passed a stimulation trial

Pre-implant counseling: Pre-implantation counseling and provision of manufacturer's patient labeling and education materials; discussion of benefits, risks, MRI compatibility, and individualized programming/treatment/follow-up plan; provide device manufacturer name, model, and unique device identifier to the individual

Dorsal Root Ganglion (DRG) Neurostimulation

Covered when ALL of the following are met (policy statement changed from investigational to medically necessary as of prior history):

Severe and chronic pain of the trunk or limbs meeting general medically necessary SCS criteria and having demonstrated benefit from a trial stimulation

High-Frequency (10 kHz) SCS Indications

Covered when ALL of the following are met (per device indications/labeling):

Chronic intractable pain of the trunk and/or limbs including failed back surgery syndrome, intractable low back pain and leg pain

When programmed to include a frequency of 10 kHz, indications may include chronic intractable pain of the lower limbs associated with diabetic neuropathy and non-surgical refractory back pain (intractable back pain without prior surgery and not a candidate for back surgery), per device labeling (Senza example)

FDA Recommendations / Safety Requirements

FDA recommends the following before permanent implantation:

Conduct a trial stimulation as described in device labeling to identify and confirm satisfactory relief before permanent implantation

Inform patients about risks of serious side effects and what to expect during the trial stimulation

Develop individualized programming, treatment, and follow-up plan for therapy delivery

Demonstrate trial response prior to permanent implant

For permanent SCS or DRG implantation, document that the trial stimulation produced at least a 50% reduction in pain and that the trial lasted a minimum of 3 days (trial typically 3–7 days).

Record baseline and post-trial pain scores demonstrating ≥50% pain reduction.
Document trial start and end dates to confirm minimum 3‑day duration.

Prior Authorization

Trial stimulation required before permanent implant / FDA reminder

A trial stimulation must be conducted as described in device labeling to identify and confirm satisfactory relief before permanent implantation. FDA recommends performing a stimulation trial (typically 3–7 days) and informing patients about risks, expected experience during the trial, and providing individualized programming, treatment, and follow-up plans prior to permanent implant.

Billing Rule

Use specified CPT/HCPCS codes for procedures and devices

Bill procedures and device components using the specified CPT and HCPCS/L-codes as listed below.

0784T
0785T
63650
63655
63661
63662
63663
63664
63685
63688
C1767
C1778
C1787
C1820
C1822
L8679
L8680

Denial Risk

Replacement denial for functionally adequate device

Replacement of a functioning standard spinal cord stimulator with a high‑frequency SCS is considered not medically necessary and may be denied.

Documentation Required

Pre-implant counseling and device documentation

Before implantation, provide and document pre‑implant counseling and education including discussion of benefits and risks, MRI compatibility, individualized programming/treatment/follow‑up plan, and give the device manufacturer's patient labeling. Also document the device manufacturer, model, and unique device identifier (UDI).

Document that patient received manufacturer patient labeling and education materials.
Record device manufacturer, model, and unique device identifier provided to the individual.
Document counseling on MRI compatibility, risks/benefits, and individualized follow-up/programming plan.

Billing Rule

Site of Service / ASC criteria change effective 2025-11-07

Related policy 11.01.525 (Site of Service Ambulatory Service Center (ASC) Select Surgical Procedures) and updated ASC criteria become effective 2025-11-07. Providers were given a 90‑day notification and must follow the updated site‑of‑service requirements for dates of service on/after the effective date.

Effective date: 2025-11-07
90-day provider notification prior to the effective date

2025-07-01annual review

Annual review approved June 23, 2025 with literature review updated through March 12, 2025; core coverage policy statements remained unchanged (no substantive changes to coverage criteria on this date).

2024-01-01coding update

CPT codes 0784T and 0785T were added to the coding section (policy history entry noting CPT additions effective 01/01/24).

2018-06-01site-of-service criteria originally effective

Site of service criteria for elective surgical procedures (preferring ASC and listing conditions when hospital outpatient or inpatient site is required) became effective, including the ASC availability threshold of 'no qualifying ASC within 30 miles' and enumerated clinical risk examples.