ModifiedPremera BluecrossPolicy 7.01.25

Spinal cord stimulation and dorsal root ganglion neurostimulation coverage

Defines medical necessity criteria, investigational exclusions, site-of-service rules, coding, regulatory status, and evidence summary for spinal cord stimulation (SCS) and dorsal root ganglion (DRG) neurostimulation including trials, permanent implantation, and replacement devices. Covers indications, required prior evaluations, psychosocial clearance, trial success thresholds, and situations considered investigational.

Policy Summary

PayerPremera Bluecross

PolicySpinal cord stimulation and dorsal root ganglion neurostimulation coverage

Policy CodePolicy 7.01.25

Change TypeRevised; replaces prior policy 7.01.25; site-of-service ASC criteria added

Effective DateNov 7, 2025

Next Review Date

Key ActionDocument that other treatments have failed or are unsuitable, obtain psychosocial clearance, perform and document a temporary trial demonstrating >=50% pain reduction for at least 3 days before permanent implantation.

SourceLink

POLICY UPDATE CHANGES

Policy has been revised and replaces prior policy 7.01.25.

07/01/25 Annual Review approved June 23, 2025; updated literature through March 12, 2025; policy statements unchanged

08/01/25 Interim Review approved July 8, 2025; Removed Related Policy 11.01.524 and added Related Policy 11.01.525 Site of Service ASC criteria effective Nov 7, 2025 following 90-day notification

2Device types addressed (SCS, DRG)

>=50%Required trial pain reduction threshold

ASC geographic access threshold (miles)

SeveralCPT/HCPCS codes listed

4Devices with cleared indications listed

497MAUDE reports (Jul2016-Jul2020) - deaths

Coverage Summary

Policy 7.01.25 (status: MODIFIED; last review: 2025-07-08; effective date: 2025-11-07) defines medical necessity, investigational exclusions, site-of-service rules, coding, regulatory status, and evidence summary for spinal cord stimulation (SCS) and dorsal root ganglion (DRG) neurostimulation. The policy addresses both trial (temporary) and permanent implantation pathways, requires psychosocial clearance and conservative-therapy failure documentation, and lists covered CPT/HCPCS codes and FDA-cleared devices. Headline trial threshold: a temporary trial demonstrating ≥50% reduction in pain with at least a 3‑day trial is required before permanent implantation.

Key thresholds and quick facts

Trial pain reduction threshold>= 50% reduction in pain (trial success)

Trial durationTypically 3-7 days (minimum 3 days required)

ASC geographic access thresholdHospital outpatient allowed if no qualifying ASC within 30 miles

Device types addressedSpinal cord stimulation (SCS) and dorsal root ganglion (DRG) neurostimulation

MAUDE reports (Jul 27, 2016–Jul 27, 2020)107,728 device reports

Reports associated with patient death497 deaths reported

Reports associated with patient injury77,937 patient injuries reported

Medical-Necessity Criteria

Site of Service for Elective Surgical Procedures - Medical Necessity

Certain elective surgical procedures will be covered in the most appropriate, safe, and cost-effective site when ALL of the following apply:

ALL of the following

ALL of the following
- Examples of clinical conditions increasing risk (ANY of the following): Anesthesia risk: ASA classification III or higher
- Examples of clinical conditions increasing risk (ANY of the following): Personal history of complication of anesthesia
- Examples of clinical conditions increasing risk (ANY of the following): Documentation of alcohol dependence or history of cocaine use

Not Medically Necessary / Investigational Indications

Investigational / Not Medically Necessary Indications

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

Excluded indications (ANY of the following): Central deafferentation pain (CNS damage from stroke or spinal cord injury)

Excluded indications (ANY of the following): Nociceptive pain (pain resulting from irritation rather than nerve damage)

Excluded indications (ANY of the following): Critical limb ischemia as a technique to forestall amputation

Excluded indications (ANY of the following): Refractory angina pectoris

FDA Recommendations and Cleared Device Indications

FDA recommendations regarding trial stimulation and implantation

FDA letter recommendations (Sept 2020) regarding SCS trial and implantation

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

Permanent spinal cord stimulation should only be implanted in individuals who have undergone and passed a stimulation trial

Providers typically perform a stimulation trial on an individual for 3 to 7 days3-7 days

Success of trial stimulation is usually defined by a 50% reduction in pain symptoms50% reduction

Coding

Covered CPT / SCS and DRG procedure codes listedCPTCovered

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 HCPCS / Implantable neurostimulator equipment and suppliesHCPCSCovered

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

FDA device product codes and 510(k)/PMA references mentionedmixed

LGW	Product code for multiple SCS systems (Evoke, Senza, Prospera)
GZB	Product code for Nalu Neurostimulation System
P190002	Evoke SCS System 510(k)/PMA number
P130022	Senza SCS System 510(k)/PMA number
K183047	Nalu Neurostimulation System 510(k) number
P210037	Prospera SCS System 510(k)/PMA number

Provider Actions

Prior Authorization

Trial requirement prior to permanent implant

A temporary trial demonstrating ≥50% pain reduction for at least 3 days is required before permanent implantation of SCS or DRG devices. Document the trial duration and the measured pain reduction before approving a permanent implant.

Trial duration: typically 3–7 days; minimum documented duration ≥3 days
Success threshold: ≥50% reduction in pain during the trial

Documentation Required

Conservative therapy failure documentation

Document that other treatment modalities (pharmacologic, surgical, psychological, or physical) have failed, or are unsuitable or contraindicated, before proceeding with an SCS or DRG trial or implantation.

Evidence Summary & Definitions

Systematic reviews and randomized controlled trials provide sufficient evidence that SCS improves net health outcomes for refractory neuropathic trunk or limb pain, and high‑frequency SCS has shown clinically significant benefits in some RCTs. DRG neurostimulation RCT(s) and reviews have shown higher rates of treatment success and noninferiority to SCS on several measures. Evidence is insufficient for many non‑neuropathic indications (eg, critical limb ischemia, angina, cancer pain, heart failure). FDA MAUDE data (Jul 27, 2016–Jul 27, 2020) reported 107,728 device reports including 497 deaths, 77,937 injuries, and 29,924 device malfunctions, with common patient complaints (inadequate pain relief, infection, pain) and device problems (charging issues, impedance, migration, battery problems).

Term	Definition
Neuropathic pain	Pain caused by problems with or damage to the somatosensory nervous system; often shooting or burning and chronic; placement of a spinal cord stimulator is only appropriate for treatment of neuropathic pain.
Nociceptive pain	Pain resulting from tissue damage or inflammation; not a primary indication for SCS per this policy.
ASA classification	American Society of Anesthesiologists physical status classification; ASA III or higher indicates severe systemic disease and increased anesthesia risk.
CRPS	Complex Regional Pain Syndrome; chronic pain condition often affecting a limb; includes types based on confirmed nerve injury (CRPS Type I previously RSD; CRPS Type II previously causalgia).
DDD	Degenerative disk disease.
FDS/FBS	Failed back syndrome (also referenced as failed back surgery syndrome).
PMA	Premarket approval (regulatory term used for certain FDA device approvals).
RSD	Reflex sympathetic dystrophy (older term for CRPS Type I).
SCS	Spinal cord stimulation: delivers low-voltage electrical stimulation to the dorsal columns via an implanted device to block the sensation of pain; typically involves a temporary trial followed by permanent implantation if trial is successful (≥50% pain reduction).

Medicare Determinations

Name	Effective Date	Number/Type
Implantation of central nervous system stimulators for chronic intractable pain	1995-08-07	NCD
Electrical Nerve Stimulators	1995	NCD 160.7

Revision History

2025-08-01revised

Interim Review approved July 8, 2025; Removed Related Policy 11.01.524 and added Related Policy 11.01.525 Site of Service ASC criteria effective Nov 7, 2025 following 90-day notification

2025-07-01non-material_revision

07/01/25 Annual Review approved June 23, 2025; updated literature through March 12, 2025; policy statements unchanged

2025-11-07revisedLatest

Policy has been revised and replaces prior policy 7.01.25.

Policy Summary

PayerPremera Bluecross

PolicySpinal cord stimulation and dorsal root ganglion neurostimulation coverage

Policy CodePolicy 7.01.25

Change TypeRevised; replaces prior policy 7.01.25; site-of-service ASC criteria added

Effective DateNov 7, 2025

Next Review Date

SourceLink

On This Page

Examples of clinical conditions increasing risk (ANY of the following): Prolonged surgery (> 3 hours)

Examples of clinical conditions increasing risk (ANY of the following): Cardiovascular risk: uncompensated chronic heart failure (NYHA class III or IV)

Examples of clinical conditions increasing risk (ANY of the following): Recent MI (< 3 months)

Examples of clinical conditions increasing risk (ANY of the following): Poorly controlled, resistant hypertension (3 or more drugs)

Examples of clinical conditions increasing risk (ANY of the following): Recent CVA (< 3 months)

Examples of clinical conditions increasing risk (ANY of the following): Increased risk for cardiac ischemia (DES < 1 year or angioplasty < 90 days)

Examples of clinical conditions increasing risk (ANY of the following): Symptomatic cardiac arrhythmia despite medication

Examples of clinical conditions increasing risk (ANY of the following): Significant valvular heart disease

Examples of clinical conditions increasing risk (ANY of the following): Liver risk: advanced liver disease (MELD score > 8)

Examples of clinical conditions increasing risk (ANY of the following): Pulmonary risk: COPD (FEV1 < 50%)

Examples of clinical conditions increasing risk (ANY of the following): Poorly controlled asthma (FEV1 < 80% despite treatment)

Examples of clinical conditions increasing risk (ANY of the following): Moderate to severe OSA (AHI >=15 to <=30 moderate; >=30 severe)

Examples of clinical conditions increasing risk (ANY of the following): Renal risk: end stage renal disease (on dialysis)

Examples of clinical conditions increasing risk (ANY of the following): Other: morbid obesity (BMI >= 50)

Examples of clinical conditions increasing risk (ANY of the following): Pregnancy

Examples of clinical conditions increasing risk (ANY of the following): Bleeding disorder requiring replacement factor, blood products, or special infusion product (DDAVP does not meet criterion)

Site is an Ambulatory Surgical Center (preferred) or Off campus-/On campus-outpatient hospital/medical center; If performed in hospital outpatient department, there is no qualifying ASC within 30 miles that can provide necessary care OR no geographically accessible ASC with necessary equipment OR no ASC where the physician has privileges OR ASC guideline prohibits use for individual's health condition or weight OR individual is aged 18 or younger OR service is in conjunction with additional service requiring hospital outpatient department performed in same operative session OR individual has a clinical condition increasing risk for complications (see list)

SCS Trial (standard or high-frequency) - Medical Necessity

A trial with temporary stimulator may be considered medically necessary when ALL of the following are met:

ALL of the following

Other treatment modalities (pharmacological, surgical, psychological, or physical, if applicable) have failed, or are judged to be unsuitable or contraindicated
Individual has severe and chronic neuropathic pain of the trunk or limbs resulting from actual damage to peripheral nerves (examples: failed lumbar back surgery syndrome; complex regional pain syndrome; 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

SCS Permanent Implantation - Medical Necessity

Placement of a permanent spinal cord stimulator may be considered medically necessary when ALL of the trial criteria are met AND:

ALL of the following

The above medical necessity criteria for a trial spinal cord stimulator are met
There is demonstration of at least a 50% reduction in pain with at least a 3-day trial of temporary spinal cord stimulation>=50% reduction; trial >=3 days

DRG Stimulation Trial - Medical Necessity

A dorsal root ganglion neurostimulation trial is considered medically necessary when ALL of the following are met:

ALL of the following

Other treatment modalities (pharmacological, surgical, psychological, or physical, if applicable) have failed, or are judged to be unsuitable or contraindicated
Individual has severe and chronic neuropathic pain of the trunk or limbs resulting from actual damage to peripheral nerves (examples: failed lumbar back surgery syndrome; complex regional pain syndrome; 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

DRG Permanent Implantation - Medical Necessity

Placement of a permanent dorsal root ganglion neurostimulator may be considered medically necessary when ALL of the following are met:

ALL of the following

The above medical necessity criteria for a trial DRG neurostimulator are met
There is demonstration of at least a 50% reduction in pain with at least a 3-day trial of temporary DRG neurostimulation>=50% reduction; trial >=3 days

Replacement of SCS or DRG Neurostimulators - Medical Necessity

Replacement may be considered medically necessary in a small subset when ALL of the following apply:

Reasons permitting replacement (ANY of the following)

Stimulator is not working or is broken
Replacement 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

Exclusion: Replacement of a functioning standard spinal cord stimulator with a high-frequency spinal cord stimulator is considered not medically necessary

explicit exclusion

Excluded indications (ANY of the following): Chronic pelvic (abdominal or visceral) pain

Excluded indications (ANY of the following): Treatment of cancer-related pain

Excluded indications (ANY of the following): Treatment of heart failure

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

Discuss benefits and risks of different types of implants and other treatment options, including MRI compatibility

Provide manufacturer's patient labeling and education materials for the device that will be implanted

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

Provide each individual with the name of the device manufacturer, model, and the unique device identifier of the implant received

Device cleared indications (device-level summaries)

Devices cleared by FDA with their stated indications

Evoke SCS System (Saluda Medical Pty Ltd; product code LGW; 510(k) P190002; original clearance/approval date Feb 2022): Indication - Chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral associated with failed back surgery syndrome; intractable low back pain and leg pain

Senza SCS System (Nevro Corporation; product code LGW; 510(k) P130022; original clearance May 2015): Indication - Chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain, and leg pain. When programmed to include a frequency of 10 kHz: indication includes chronic intractable pain of the lower limbs associated with diabetic neuropathy and non-surgical refractory back pain

Nalu Neurostimulation System (Nalu Medical, Inc.; product code GZB; 510(k) K183047; original clearance Mar 2019): Indication - Chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain

Prospera SCS System (Biotronik NRO, Inc.; product code LGW; 510(k) P210037; original clearance Mar 2023): Indication - Chronic, intractable pain in the trunk and/or limbs, which may include unilateral or bilateral pain resulting from: failed back syndrome/low back syndrome, radicular pain syndromes, herniated disk, postlaminectomy pain, multiple back operations, unsuccessful disk surgery, degenerative disk disease/herniated disk pain refractory to conservative and surgical interventions, peripheral causalgia, epidural fibrosis, arachnoiditis or lumbar adhesive arachnoiditis, CRPS/RSD/causalgia

SCS and DRG neurostimulation deliver targeted electrical stimulation to modulate pain signals; SCS targets the dorsal columns of the spinal cord while DRG stimulation targets dorsal root ganglia for more focal nerve territory control. Implantation is typically a two‑step workflow where an initial temporary electrode trial (commonly 3–7 days) is performed and, if successful, followed by permanent implantation. Multiple devices and systems have been cleared or approved by the FDA for chronic intractable trunk and/or limb pain (examples include Evoke, Senza, Nalu, and Prospera among others).

Documentation Required

Psychosocial clearance

Obtain and document clearance from a licensed psychologist, psychiatrist, or other licensed mental health professional prior to performing a stimulation trial.

Billing Rule

Use appropriate CPT/HCPCS codes

Report the applicable CPT and HCPCS codes for SCS and DRG insertion, revision, removal, generators, leads, and related device components as listed below.

CPT: 0784T, 0785T, 63650, 63655, 63661, 63662, 63663, 63664, 63685, 63688
HCPCS/C-codes and L-codes: C1767, C1778, C1787, C1820, C1822, C1826, C1827, C1883, C1897, L8679, L8680, L8681, L8682, L8683, L8685, L8686, L8687, L8688, L8689

Denial Risk

Replacement limitations

Replacement of a functioning standard spinal cord stimulator with a high-frequency spinal cord stimulator is considered not medically necessary and may be denied; document clinical justification if a replacement is proposed for other reasons (nonfunctioning device or changed clinical needs).

Documentation Required

Document trial stimulation and outcome

Document conduct of the stimulation trial, including trial start and end dates, that the trial lasted the documented period (typically 3–7 days), and objective documentation that trial success was achieved (usually defined as ≥50% reduction in pain) prior to permanent implantation.

Trial duration to document: typically 3–7 days (minimum ≥3 days)
Documented outcome: achievement of ≥50% pain reduction

Documentation Required

Provide device information and education

Provide and document the device manufacturer name, model, and unique device identifier (UDI), and provide the manufacturer's patient labeling and education materials to the individual prior to implantation.

Documentation Required

Develop individualized therapy plan

Develop and document an individualized programming, treatment, and follow-up plan for SCS/DRG therapy delivery tailored to the individual before implantation.