Spinal Cord And Dorsal Root Ganglion Stimulation Form

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Spinal Cord and Dorsal Root Ganglion Stimulation - Medical Policy
Updated Revision Effective: January 1, 2024 Policy Number:

UM300POL

Approval Date: 12/05/2023

Line(s) of Business:

FF
SF
Medicare
MedSupp-G
MedSupp-I
Medicaid

Description

Spinal cord stimulation (SCS), also called dorsal column stimulation, involves the use of low level epidural electrical stimulation of the spinal cord dorsal columns to block the sensation of pain. The neurophysiology of pain relief after SCS is uncertain but may be related to either activation of an inhibitory system or to blockage of facilitative circuits. SCS 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 (i.e., chronic reflex sympathetic dystrophy). There has also been interest in SCS as a treatment of critical limb ischemia, primarily in individuals who are poor candidates for revascularization and in individuals with refractory chest pain.

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 electrical stimulation. The lead may incorporate from four to eight electrodes, with eight electrodes more commonly used for complex pain patterns. There are two basic types of power source. In one type, the power source (battery) can be surgically implanted or worn externally with an antenna over the receiver. In the other, a radiofrequency receiver is implanted. Totally implantable systems are most commonly used.

The procedure initially involves a short-term trial (i.e., greater than 48 hours) of percutaneous (temporary) spinal cord stimulation, prior to the subcutaneous (permanent) implantation of the spinal cord stimulation device, to determine whether the spinal cord stimulator device will induce sufficient pain relief to render it medically necessary. Although it may vary depending on the specific device, a traditional dorsal column stimulator (i.e., non-high-frequency) generally produces a pulse width between 20-1000 µs and frequencies between 2 and 1200 Hz. Some devices allow adjustment of the settings, including burst- and/or continuous- mode stimulation.

Other neurostimulators target the dorsal root ganglion, which consists of sensory cell bodies that transmit input from the peripheral nervous system to the central nervous system, and play a role in neuropathic pain

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perception. Dorsal root ganglia are located in the epidural space between spinal nerves and the spinal cord on the posterior root in a minimal amount of cerebrospinal fluid, amenable to epidural access.

Dorsal root ganglion (DRG) stimulation is an emerging method of treatment for neuropathic pain. With DRG, stimulation leads are placed percutaneously into the epidural space under fluoroscopic guidance directly over the targeted dorsal root ganglion within the lumbar or sacral region of the spine. Similar to spinal cord stimulation, a short-term trial (i.e., greater than 48 hours) is recommended using an external pulse generator; upon success of the trial a permanent pulse generator may then be implanted.

Policy

I. (A) Standard or high-frequency spinal cord stimulation (SCS) or dorsal root ganglion stimulation (DRGS) trial treatment using a temporary stimulator in the epidural space may be considered MEDICALLY NECESSARY for all lines of business (except for Medicare, see NCD below) when ALL of the following criteria are met:

1. The individual has severe and chronic neuropathic pain of the trunk or limbs resulting from actual damage to peripheral nerves, such as (but not limited to):  Failed back syndrome, or  Complex regional pain syndrome (i.e., reflex sympathetic dystrophy), or  Lumbosacral arachnoiditis, or  Radiculopathies, or  Phantom limb/stump pain, or  Peripheral neuropathy, or  Inoperable chronic ischemic limb pain secondary to peripheral vascular disease, or  Post-herpetic neuralgia, or  Intercostal neuralgia, or  Cauda equina injury, or
    Incomplete spinal cord injury, or
    Plexopathy;

   AND

2. Other pain management modalities (pharmacologic, surgical, psychological, and physical therapies) have been tried and failed for at last 12 months, or are judged to be unsuitable or contraindicated; AND

3. The individual has undergone careful screening, evaluation and diagnosis by a multidisciplinary pain management team (including psychological as well as physical evaluation) and is deemed to be an appropriate candidate with no contraindication to SCS and DRGS trial ; AND

4. No untreated drug habituation exists per assessment from a licensed mental health provider.

   (B) There are no MassHealth guidelines for Spinal Cord and Dorsal Root Ganglion Stimulation. The above criteria applies.

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(C) Standard or high-frequency spinal cord stimulation (SCS) may be considered MEDICALLY NECESSARY for Medicare members when National Coverage Determination (NCD) 160.7 Electrical Nerve Stimulators criteria are met: MCD Search (cms.gov)

II. Permanent placement of a spinal cord stimulator or dorsal root ganglion stimulator may be considered MEDICALLY NECESSARY (for all lines of business) when the above medical necessity criteria for a trial treatment are met, the trial has been performed, and the individual has demonstrated pain relief of at least 50% for a minimum of 48 hours with the temporarily implanted electrode and with clear documentation of such in the medical records.

III. Replacement of an existing cervical, lumbar or thoracic SCS or DRGS’s battery or generator is MEDICAL NECESSARY (for all lines of business) for individuals who meet the medical necessity criteria for dorsal column stimulation, have had a positive pain relief response and when the existing stimulator, battery or generator is malfunctioning, cannot be repaired, and is no longer under warranty. (Lead and electrode replacement will not be approved as are generally not required at the time of generator replacement due to end of battery life).

IV. Spinal cord stimulation or dorsal root ganglion stimulation is considered EXPERIMENTAL and INVESTIGATIONAL for all other indications that do not meet the criteria above, including but not limited to the following:

1. The use of cervical dorsal column stimulation for the treatment of members with cervical trauma, disc herniation, essential tremor, failed cervical spine surgery syndrome presenting with arm pain, neck pain, cervicogenic headache, gliomas, migraine, radiation-induced brain injury, stroke, trigeminal neuropathy, or any other indication (other than CRPS).
2. Treatment of critical limb ischemia as a technique to forestall amputation.
3. Treatment of refractory angina pectoris.
4. Treatment of nociceptive pain (pain resulting from irritation rather than damage to the nerves, i.e., inflammation, chemicals or physical events).
5. Treatment of visceral pain (abdominal or pelvic).
6. Treatment of cancer-related pain.
7. Treatment of central deafferentation pain (pain related to central nervous system damage from stroke or spinal cord surgery).
8. Treatment of heart failure.
9. Dysesthesias involving the lower extremities secondary to spinal cord injury.
10. Dorsal root ganglion stimulators for treatment of chronic pelvic pain syndrome.
11. The concurrent use of two dorsal column stimulators for the treatment of complex regional pain syndrome or any other indications.

12. The combined use of dorsal column stimulation and dorsal root ganglion stimulation for the treatment of complex regional pain syndrome or any other indications.

    V. Spinal cord stimulation or dorsal root ganglion stimulation is NOT COVERED under following circumstances due to relative or absolute contraindications:

13. Inability to control the device.
14. Uncontrolled bleeding disorder
15. Local or systemic sepsis.
16. An unresolved major psychiatric comorbidity.
17. An active and untreated substance abuse disorder.
18. Pregnancy.

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7. Immunosuppression.

   Policy Guidelines and Definitions

   Policy Guidelines:

   Medical documentation must include:
   • All other treatment modalities used, including pharmacologic agents, surgeries, physical, or psychological, transcutaneous and percutaneous electrical nerve stimulation, if appropriate) and the results of these treatments.
   • Supporting documentation of the screening, evaluation, and diagnosis by a multidisciplinary team.

   Definitions:

   Complex Regional Pain Syndrome (CRPS) is defined by the International Association for the Study of Pain (IASP) as a variety of painful conditions following injury which appear regionally having a distal predominance of abnormal findings, exceeding in both magnitude and duration the expected clinical course of the inciting event and often resulting in significant impairment of motor function, and showing variable progression over time. In addition to injury, CRPS can also occur as a result of various medical disorders or illnesses.

   Failed back surgery syndrome (FBSS) is a lumbar spinal pain of unknown origin despite surgical intervention or appearing after surgical intervention for spinal pain originally in the same spinal region. Procedures/surgery that do not encroach into the spinal canal e.g. interspinous/interlaminar/facet distraction, kyphoplasty/vertebroplasty surgery, etc.

   Nociceptive pain arises from stimulation of pain receptors within tissue that has been damaged or involved in an inflammatory process.

   Neuropathic pain results from damage to or dysfunction of the peripheral or central nervous system, rather than stimulation of pain receptors. Diagnosis is suggested by pain out of proportion to tissue injury, dysesthesia (e.g., burning, tingling), and signs of nerve injury detected during neurologic examination.

   Coding Guidance

   Code Description Prior Auth CPT Codes

   63650 Percutaneous implantation of neurostimulator electrode array, epidural YES 63655 Laminectomy for implantation of neurostimulator electrodes, plate/paddle, epidural YES 63663 Revision including replacement, when performed, of spinal neurostimulator electrode percutaneous array(s), including fluoroscopy, when performed YES 63664 Revision including replacement, when performed, of spinal neurostimulator electrode plate/paddle(s) placed via laminotomy or laminectomy, including fluoroscopy, when performed YES

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Code Description Prior Auth 63685 Insertion or replacement of spinal neurostimulator pulse generator or receiver, requiring pocket creation and connection between electrode array and pulse generator or receiver YES 63688 Revision or removal of implanted spinal neurostimulator pulse generator or receiver, with detachable connection to electrode array YES 64553 Percutaneous implantation of neurostimulator electrode array; cranial nerve (For trial) YES HCPCS codes

Code Description Prior Auth L8680 Implantable neurostimulator electrode, each YES L8681 Patient programmer (external) for use with implantable programmable neurostimulator pulse generator NO L8682 Implantable neurostimulator radiofrequency receiver YES L8683 Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver YES L8685 Implantable neurostimulator pulse generator, single array, rechargeable, includes extension YES L8686 Implantable neurostimulator pulse generator, single array, non- rechargeable, includes extension YES L8687 Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension YES CPT® Copyright 2024 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Note: CPT/HCPCS codes are included for informational purposes and may not be all-inclusive. Inclusion or exclusion of a CPT/HCPCS code(s) does not signify or imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member’s specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee of payment. Other policies and coverage determination guidelines may apply.

References

Practice Parameters for the Use of Spinal Cord Stimulation in the Treatment of Chronic Neuropathic Pain. The Neuromodulation Foundation (neuromodfound.org)

Mehta, N., MD. (2016, September 23). Advantages of Spinal Cord Stimulation.
https://www.spine-health.com/treatment/pain-management/advantages-spinal-cord-stimulation

DerSarkissian, C. (2020, February 5). Spinal Cord Stimulation for Back Pain.
https://www.webmd.com/back-pain/guide/spinal-cord-stimulation

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National Coverage Determination (NCD) for Electrical Nerve Stimulators (160.7). (1995, August).
https://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?NCDId=240&ncdver=1&DocID=160.7&bc=gAAAABAAAAAA&&smau_=iVV98q2HDrpDDRWw

CMS.gov, Centers for Medicare and Medicaid Services

Verrills, P., Sinclair, C., & Barnard, A. (2016, July). A review of spinal cord stimulation systems for chronic pain.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4938148/

Song, J. J., Popescu, A., & Bell, R. L. (2014). Present and potential use of spinal cord stimulation to control chronic pain.

https://www.ncbi.nlm.nih.gov/pubmed/24850105.

Fishman, M. A., Antony, A., Esposito, M., Deer, T., & Levy, R. (2019, June 1). The Evolution of Neuromodulation in the Treatment of Chronic Pain: Forward-Looking Perspectives.

https://www.ncbi.nlm.nih.gov/pubmed/31152176.

Deer, T. R., Jain, S., Hunter, C., & Chakravarthy, K. (2019, January 24). Neurostimulation for Intractable Chronic Pain.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6406470/

Policy Implementation

Approved by the Medical and Pharmacy Policy Committee

Kate McIntosh MD MBA

Chief Medical Officer

Saad Usmani MD MBA

Medical Director

Date Update 5/8/2007 Initial policy created 11/2023 Policy name changed, updated code descriptions for 63685, added 63688 and 64553 to policy. Criteria re-written with no significant change.

Medical Criteria Disclaimer

Property of Health New England. All rights reserved. The treating physician or primary care provider must submit to Health New England the clinical evidence that the patient meets the criteria for the treatment, testing or surgical procedure. Without this documentation and information, Health New England will not be able to properly review the request for prior authorization. The clinical review criteria reflect how Health New England determines whether certain services or supplies are medically necessary. Health New England established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors).
Health New England expressly reserves the right to revise these conclusions as clinical information changes, and

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welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by Health New England, as some programs exclude coverage for services or supplies that Health New England considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at time of publication. Health New England has adopted the herein policy in providing management, administrative and other services to its Health Plan.