Spinal Cord and Dorsal Root Ganglion Stimulation

POLICY NUMBER

A.7.01.25

DESCRIPTION

Spinal cord stimulation delivers low-voltage electrical stimulation to the dorsal columns of the spinal cord to block the sensation of pain; this is achieved through a surgically implanted spinal cord stimulation device, which comes equipped with a radiofrequency receiver. The neurostimulator device is also issued with a standard power source (battery) that can be implanted or worn externally. Other neurostimulators target the dorsal root ganglion.

Chronic Pain

Spinal cord stimulation has been used in a wide variety of chronic refractory pain conditions, including pain associated with cancer, failed back pain syndromes, arachnoiditis, and complex regional pain syndrome (CRPS; ie, chronic reflex sympathetic dystrophy). There has also been interest in spinal cord stimulation as a treatment of critical limb ischemia, primarily in patients who are poor candidates for revascularization and in patients with refractory chest pain.

Spinal Cord StimulationSpinal cord stimulation (also called dorsal column stimulation) involves the use of low-level epidural electrical stimulation of the spinal cord dorsal columns. The neurophysiology of pain relief after spinal cord stimulation is uncertain, but may be related to either activation of an inhibitory system or blockage of facilitative circuits.

Spinal cord stimulation devices consist of several components: 1) the lead that delivers the electrical stimulation to the spinal cord; 2) an extension wire that conducts the electrical stimulation from the power source to the lead; and 3) a power source that generates the electricity. The lead may incorporate from 4 to 8 electrodes, with 8 electrodes more commonly used for complex pain patterns. There are two basic types of power source: one type, the power source (battery), can be surgically implanted or worn externally with an antenna over the receiver; the other, a radiofrequency receiver, is implanted. Totally implantable systems are most commonly used.

The patient’s pain distribution pattern dictates at what level of the spinal cord the stimulation lead is placed. The pain pattern may influence the type of device used. For example, a lead with 8 electrodes may be selected for those with complex pain patterns or bilateral pain. Implantation of the spinal cord stimulator is typically a 2-step process. Initially, the electrode is temporarily implanted in the epidural space, allowing a trial period of stimulation. Once treatment effectiveness is confirmed (defined as at least 50% reduction in pain), the electrodes and radio-receiver/transducer are permanently implanted. Successful spinal cord stimulation may require extensive programming of the neurostimulators to identify the optimal electrode combinations and stimulation channels.

Dorsal Root Ganglion Neurostimulation

Dorsal root ganglion neurostimulation (or dorsal root ganglion stimulation, DRGS) uses the same epidural approach technique as spinal cord stimulation but targets a different anatomical target, the dorsal root ganglion. Dorsal root ganglia, situated within the spine as clusters of nerve cell bodies, serve as the "sensory gate" for pain signals entering the spinal cord. DRGS seeks to modulate the activity of these nerve cell bodies, potentially intercepting or diminishing pain signals before they reach the spinal cord. DRGS proves particularly efficacious for localized or chronic nerve pain conditions, such as complex regional pain syndrome, post-amputation pain, and pain following specific surgical procedures. It allows for more precise targeting of specific nerves and pain areas compared to SCS, potentially leading to better pain relief with fewer side effects. Moreover, DRGS may induce less paresthesia (tingling or numbness) than SCS, owing to its focused and precise stimulation. Recovery from DRGS implantation typically spans 6-8 weeks, during which patients are advised to refrain from strenuous activities.

Traditional spinal cord stimulation devices use electrical stimulation with a frequency of 100 to 1000 Hz. High frequency devices use electrical stimulation with a frequency of 10,000 Hz. In 2016, the U.S. Food and Drug Administration (FDA) approved a clinician programmer application that allows a spinal cord stimulation device to provide stimulation in bursts rather than at a constant rate. Burst stimulation is proposed to relieve pain with fewer paresthesias. The burst stimulation device works in conjunction with standard spinal cord stimulation devices. With the newly approved app, stimulation is provided in five, 500-Hz burst spikes at a rate of 40 Hz, with a pulse width of 1 ms. Other neurostimulators target the dorsal root ganglion.

A large number of neurostimulator devices have been approved by the FDA through the premarket approval process under FDA product code: LGW (stimulator, spinal-cord, totally implanted for pain relief), PMP (Dorsal Root Ganglion Stimulator for Pain Relief), and GZB (Stimulator, Spinal-Cord, Implanted [Pain Relief]). In October 2016, the FDA approved BurstDR™ stimulation (St. Jude Medical), a clinician programmer application that provides intermittent "burst" stimulation for patients with certain St. Jude spinal cord stimulation devices.

FDA Cleared or Approved Devices for Spinal Cord and Dorsal Root Ganglion Stimulation

CRPS: Complex regional pain syndrome; DDD: degenerative disk disease; FBS: failed back syndrome; PMA: premarket approval; RSD: reflex sympathetic dystrophy; SCS: spinal cord stimulation.ª Withdrawn in 2016

The FDA made the following recommendations for clinicians to consider:

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

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

• Providers typically perform a stimulation trial on a patient for 3 to 7 days, and success is usually defined by a 50% reduction in pain symptoms. Inform patients about the risks of serious side effects and what to expect during the trial stimulation.

• Before implantation of any spinal cord stimulation, discuss the benefits and risks of the different types of implants and other treatment options, including magnetic resonance imaging (MRI) compatibility of the devices.

• Before implantation, provide patients with the manufacturer's patient labeling and any other education materials for the device that will be implanted.

• Develop an individualized programming, treatment, and follow-up plan for spinal cord stimulation therapy delivery with each patient.

• Provide each patient with the name of the device manufacturer, model, and the unique device identifier of the implant received.

POLICY

Spinal cord stimulation with standard or high-frequency stimulation may be considered medically necessary for the treatment of severe and chronic pain of the trunk or limbs that is refractory to all other pain therapies, when performed according to policy guidelines.

Dorsal root ganglion neurostimulation is considered medically necessary for the treatment of severe and chronic pain of the trunk or limbs that is refractory to all other pain therapies when performed according to policy guidelines.

Spinal cord stimulation is considered investigational in all other situations including, but not limited to, treatment of critical limb ischemia to forestall amputation and treatment of refractory angina pectoris, heart failure, and cancer-related pain.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity. 

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Candidate selection focuses on determining whether the individual is refractory to other types of treatment. The following considerations may apply.

• The treatment is used only as a last resort; other treatment modalities (pharmacologic, surgical, psychological, or physical, if applicable) have failed or are judged to be unsuitable or contraindicated;

• Pain is neuropathic in nature (i.e., resulting from actual damage to the peripheral nerves). Common indications include, but are not limited to, failed back surgery syndrome, complex regional pain syndrome (i.e., reflex sympathetic dystrophy), arachnoiditis, radiculopathies, phantom limb/stump pain, peripheral neuropathy, and painful diabetic neuropathy. Spinal cord stimulation is generally not effective in treating nociceptive pain (resulting from irritation, not damage to the nerves) and central deafferentation pain (related to central nervous system damage from a stroke or spinal cord injury).

• No serious untreated drug habituation exists;

• Demonstration of at least 50% pain relief with a temporarily implanted electrode precedes permanent implantation;

• All the facilities, equipment, and professional and support personnel required for the proper diagnosis, treatment, and follow-up of the patient are available.

"Burst" neurostimulation is an alternate programming of a standard spinal cord stimulation device. A clinician programmer application is used to configure a standard spinal cord stimulation device to provide stimulation in "bursts" rather than at a constant ("tonic") rate.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

6/1993: Approved by Medical Policy Advisory Committee (MPAC).

3/2001: Policy reviewed; Hyperlinks inserted under Policy, Managed Care Requirements deleted, Sources updated.

2/15/2002: Investigational definition added.

3/6/2002: Individual consideration requirement deleted

5/7/2002: Type of Service and Place of Service deleted

2/21/2005:CPT63685,95970,95971,95972,95973description revised, CPT 63690-63691 deleted 1999, ICD-9 procedure codes 02.93, 03.93 description revised, HCPCS E0751 deleted 2001, HCPCS E0753 deleted 2002

10/26/2005: Code Reference section updated; CPT-4: 63660 added; ICD-9 Procedure: 02.93 deleted; 03.94, 86.94, 86.95, 86.96 added; HCPCS: E0752, E0754 added.

11/15/2005: ICD9 procedure codes 86.97, 86.98 added

3/14/2006: Coding updated. HCPCS 2005 & 2006 revisions added to policy

4/1/2008: Policy reviewed, no changes

12/31/2008: Code reference section updated per 2009 CPT/HCPCS revisions

1/8/2009: Policy reviewed, no changes

12/16/2009: Coding Section revised for 2010 CPT4 and HCPCS revisions

04/27/2010: Policy description re-written extensively to provide information on various conditions spinal cord stimulation is used for, FDA status of devices, and techniques for device placement. Policy statement updated to add “and as a treatment for refractory angina pectoris” to the investigational statement. Patient selection criteria added to the policy guidelines. FEP verbiage added to the Policy Exceptions section. Deleted outdated references in the Sources section.

04/18/2011: Policy description and statement unchanged. Removed deleted CPT code 63660 from the Code Reference section.

03/02/2012: Policy reviewed; no changes.

04/04/2013: Policy reviewed; no changes to policy statement. Added ICD-9 procedure code 86.05 to the Code Reference section.

04/22/2014: Policy statement updated to add "in all other situations including but not limited to" and "cancer-related pain" to the investigational policy statement.

12/31/2014: Code Reference section updated to revise the description of the following CPT code: 95972.

02/09/2015: Policy reviewed; description updated. Policy statement updated to add heart failure as investigational.

08/27/2015: Code Reference section updated for ICD-10. Removed deleted HCPCS codes E0752, E0754, E0756, E0757, and E0758.

12/31/2015: Policy guidelines updated to add medically necessary and investigative definitions. Code Reference section updated to revise the description for CPT code 95972.

05/31/2016: Policy number A.7.01.25 added.

07/20/2016: Policy description updated regarding devices. Policy statement updated to add "with standard (non-high-frequency) stimulation" to the medically necessary statement. Added statement that high-frequency spinal cord stimulation is investigational for the treatment of severe and chronic pain of the trunk or limbs.

09/30/2016: Code Reference section updated to add new ICD-10 procedure code 05P002Z.

06/21/2017: Policy description updated regarding devices. Medically necessary policy statement updated to add high-frequency spinal cord stimulation. Removed policy statement that high-frequency spinal cord stimulation is investigational for the treatment of severe and chronic pain of the trunk or limbs. Added statement that wireless injectable dorsal root ganglion neurostimulation is investigational for treatment of severe and chronic pain of the trunk or limbs.

08/16/2017: Policy title changed from "Spinal Cord Stimulation" to "Spinal Cord and Dorsal Root Ganglion Stimulation." Policy description updated regarding devices. Investigational policy statement regarding dorsal root ganglion neurostimulation updated to remove "Wireless injectable."

05/03/2018: Policy description updated to add health outcome measures. Policy statements unchanged. Policy Guidelines updated regarding burst neurostimulation.

12/21/2018: Code Reference section updated to revise code descriptions for CPT codes 95970, 95971, and 95972, effective 01/01/2019.

02/11/2020: Policy description updated regarding devices and adverse events related to spinal cord stimulation. Policy statement regarding dorsal root ganglion neurostimulation changed from investigational to medically necessary for the treatment of severe and chronic pain of the trunk or limbs that is refractory to all other pain therapies when performed according to policy guidelines.

05/20/2020: Policy description updated regarding devices. Medically necessary policy statement regarding dorsal root ganglion updated to change "refractory to all other therapies" to "refractory to all other pain therapies."

07/16/2021: Policy description updated regarding FDA recommendations. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

05/31/2022: Policy description updated regarding devices. Policy statements unchanged.

03/31/2023: Code Reference section updated to add new HCPCS code L8678 as investigational, effective 04/01/2023.

05/12/2023: Policy description updated regarding devices. Policy statements unchanged. Policy Guidelines updated with minor wording changes.

12/21/2023: Code Reference section updated to revise the code description for CPT code 63685, effective 01/01/2024.

05/20/2024: Policy description updated regarding devices. Policy statements unchanged. Policy Guidelines updated.

05/13/2025: Policy description updated regarding dorsal root ganglion neurostimulation. Policy statements unchanged.

SOURCE(S)

Blue Cross & Blue Shield Association policy # 7.01.25

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

I

nvestigational Codes

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