E-Mail Us Close
Please note that this email should only be used for feedback and comments specifically related to this particular medical policy.
  
Horizon BCBSNJ
Uniform Medical Policy ManualSection:Surgery
Policy Number:067
Effective Date: 02/14/2020
Original Policy Date:06/23/2006
Last Review Date:01/14/2020
Date Published to Web: 09/04/2019
Subject:
Spinal Cord and Implantable Peripheral Nerve Stimulators

Description:
_______________________________________________________________________________________

IMPORTANT NOTE:

The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.

Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.

__________________________________________________________________________________________________________________________

CMM-211: Spinal Cord Stimulators

CMM-211.1: Definitions
CMM-211.2: Indications
CMM 211.3: Replacement
CMM 211.4: Non-Indications
CMM-211.5: Procedure (CPT®) Codes
CMM 211.6: References

CMM-211.1 Definitions


Spinal cord stimulation, also known as dorsal column stimulation or neuromodulation, is a reversible therapy applied for neuropathic pain with techniques that include multi-output implanted pulse generators and a choice of electrodes, some of which can be placed percutaneously. The technical goal of this therapy is to achieve stimulation of paresthesia of the dorsal horn of the spinal cord at a subjectively comfortable level, overlapping an individual’s topography of pain. The procedure initially involves a short-term trial (e. g., 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.

High frequency spinal cord stimulation, also referred to as kilohertz frequency spinal cord stimulation or HF10, is a type of spinal cord stimulation (SCS) providing a higher frequency than traditional spinal cord stimulator systems. The HF10 SCS uses low amplitude, high frequency, and short duration pulses. HF10 SCS does not generate paresthesia and operates at a frequency of 10,000 Hz to provide pain relief in comparison to traditional spinal cord stimulation systems, which operate at a frequency in the range of 40-60 Hz and do generate paresthesia. As an alternative to traditional dorsal spinal column stimulation, HF10 SCS is proven safe and effective for treatment of chronic, intractable low back and leg pain in members with failed back surgery syndrome.

In contrast to spinal cord stimulation, peripheral nerve stimulation involves implantation of electrodes near or on a peripheral nerve to reduce pain. Peripheral nerve field stimulation is a technology that involves placement of electrodes subcutaneously within an area of maximal pain, with the objective of stimulating a region of affected nerves to reduce pain. Depending on the targeted nerve, leads may be placed percutaneously just under the skin or via an open approach for larger deeper peripheral nerves. Similar to spinal cord stimulation, a short term trial is required prior to permanent implantation of a generator. The use of these technologies, used alone or in combination with spinal cord stimulation for treatment of pain conditions is under investigation.

Please note: this policy does not apply to the cranial nerve (i.e., vagus nerve, trigeminal nerve), gastric, sacral nerve, and/or posterior tibial nerve stimulation.

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. At this time, the evidence in the peer-reviewed scientific literature is insufficient to support long-term safety and efficacy. The use of this technology for treatment of pain conditions remains under investigation.

Failed back surgery syndrome (FBSS) is lumbar spinal pain of unknown origin despite surgical intervention or appearing after surgical intervention for spinal pain originally in the same spinal region.


Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)

CMM-211.2 Indications

The determination of medical necessity for implantation of a dorsal spinal cord stimulator is always made on a case-by-case basis.

Chronic Intractable Pain Secondary to Failed Back Surgery Syndrome
A short-term trial (e.g., greater than 48 hours) spinal cord stimulation [i.e., non high-frequency, high-frequency (HF 10 SCS)] is considered medically necessary for the treatment of chronic, intractable pain secondary to failed back surgery syndrome (FBSS) with intractable neuropathic leg pain when ALL of the following criteria are met:

    ® Failure of at least six consecutive months of provider-supervised conservative medical management (e.g., pharmacotherapy, physical therapy, cognitive therapy, and activity lifestyle modification)
    ® Surgical intervention is not indicated or for members who do not wish to proceed with spinal surgery
    ® An evaluation by a mental health provider (e.g., a face-to-face assessment with or without psychological questionnaires and/or psychological testing) reveals no evidence of an inadequately controlled mental health problem (e.g., alcohol or drug dependence, depression, psychosis) that would impact perception of pain and/or negatively impact the success of a SCS or contraindicate placement of the device.

Permanent implantation of a spinal cord stimulator (i.e., non high-frequency, HF 10 SCS) is considered medically necessary for the treatment of chronic, intractable pain secondary to failed back surgery syndrome (FBSS) with intractable neuropathic leg pain when at least a 50% reduction in pain has been demonstrated during a short-term trial of SCS.

Complex Regional Pain Syndrome (CRPS)/Reflex Sympathetic Dystrophy (RSD)
A short-term trial (i.e., greater than 48 hours) of a non high-frequency dorsal column spinal cord stimulator (SCS) is considered medically necessary for the treatment of chronic, intractable pain secondary to complex regional pain syndrome (CRPS)/reflex sympathetic dystrophy (RSD) when ALL of the following criteria are met:

    ® Diagnosis of complex regional pain syndrome (CRPS)/reflex sympathetic dystrophy (RSD) as evidenced by ALL of the following:
      • Continuing pain that is disproportionate to any inciting event
      • Must report at least one (1) of the symptoms in the following categories:
        •  Sensory: reports of hyperesthesia
        • Vasomotor: reports of temperature asymmetry, skin color changes, and/or skin color asymmetry
        • Sudomotor/edema: reports of edema, sweating changes, and/or sweating asymmetry
        • Motor/trophic: reports of decreased range of motion, motor dysfunction (weakness, tremor, dystonia), and/or trophic changes (hair, nail, skin).
      • Must display at least one (1) of the signs on physical examination in TWO or MORE the following categories:
        •  Sensory: evidence of hyperalgesia (to pinprick) and/or allodynia (to light touch)
        • Vasomotor: evidence of temperature asymmetry, skin color changes, and/or asymmetry
        • Sudomotor/edema: evidence of edema, sweating changes, and/or sweating asymmetry
        • Motor/trophic: evidence of decreased range of motion, motor dysfunction (weakness, tremor, dystonia), and/or trophic changes (hair, nail, skin).
    ® Failure of at least six consecutive months of provider-supervised conservative medical management (e.g., pharmacotherapy, physical therapy, cognitive therapy, and activity lifestyle modification)
    ® Surgical intervention is not indicated
    ® An evaluation by a mental health provider (e.g., a face-to-face assessment with or without psychological questionnaires and/or psychological testing reveals no evidence of an inadequately controlled mental health problem (e.g., alcohol or drug dependence, depression, psychosis) that would impact perception of pain and/or negatively impact the success of SCS or contraindicate placement of the device.

Permanent implantation of non high-frequency dorsal column spinal cord stimulator is considered medically necessary for the treatment of chronic, intractable pain secondary to complex regional pain syndrome (CRPS)/reflex sympathetic dystrophy (RSD) when at least a 50% reduction in pain has been demonstrated during a short-term trial of SCS.

Chronic Critical Limb Ischemia (CLI)

A short-term trial (e.g., greater than 48 hours) of a low frequency dorsal column spinal cord stimulator (SCS) is considered medically necessary for the treatment of chronic, intractable pain secondary to chronic critical limb ischemia (CLI) when BOTH of the following criteria are met:

    ® Failure of available conventional multidisciplinary medical (e.g., pharmacological, physical therapy) and surgical management (e.g., revascularization)
    ® An evaluation by a mental health provider (e.g., a face-to-face assessment with or without psychological questionnaires and/or psychological testing) reveals no evidence of an inadequately controlled mental health problem (e.g., alcohol or drug dependence, depression, psychosis) that would impact perception of pain and/or negatively impact the success of a SCS or contraindicate placement of the device.

Permanent implantation of non high-frequency dorsal column spinal cord stimulator (SCS) is considered medically necessary for the treatment of chronic, intractable pain secondary to chronic critical limb ischemia (CLI) when a beneficial clinical response from a temporarily implanted electrode has been demonstrated prior to consideration of permanent implantation.

Chronic Stable Angina Pectoris
A short-term trial (e.g., greater than 48 hours) of a non high-frequency dorsal column spinal cord stimulator (SCS) is considered medically necessary for the treatment of chronic, intractable pain secondary to chronic stable angina pectoris/myocardial ischemia when all of the following criteria are met:

    ® Angina pectoris is Canadian Cardiovascular Society (CCS) functional class III or class IV (see Appendix A)
    ® Attestation that the individual’s treating cardiologist confirms coronary artery disease (CAD) and the individual is not a suitable candidate for a revascularization procedure
    ® Optimal pharmacological treatment using anti-anginal medications (e.g., long-acting nitrates, beta-adrenergic blockers, or calcium-channel antagonists) has failed to adequately improve anginal symptoms
    ® An evaluation by a mental health provider (e.g., a face-to-face assessment with or without psychological questionnaires and/or psychological testing) reveals no evidence of an inadequately controlled mental health problem (e.g., alcohol or drug dependence, depression, psychosis) that would impact perception of pain and/or negatively impact the success of a SCS or contraindicate placement of the device.

Permanent implantation of a non high-frequency dorsal column spinal cord stimulator (SCS) is considered medically necessary for the treatment of chronic, intractable pain secondary to chronic stable angina pectoris for myocardial ischemia when a beneficial clinical response from a temporarily implanted electrode has been demonstrated prior to consideration of permanent implantation.

CMM-211.3 Replacement

The replacement of an existing high frequency or non high-frequency dorsal column spinal cord stimulator (SCS) and/or battery/generator is considered medically necessary for an individual when the existing stimulator and/or battery/generator is malfunctioning, cannot be repaired, and is no longer under warranty.

Replacement of a functioning non high-frequency dorsal column spinal cord stimulator with a high frequency spinal cord stimulator is considered not medically necessary.

CMM-211.4 Non-Indications
A high frequency spinal cord stimulator is considered investigational for ANY other indication, including CRPS/RSD.

A non high-frequency dorsal column spinal cord stimulator (SCS) is considered investigational for any other indication including but not limited to:

    ® Post-amputation pain (phantom limb pain)
    ® Post-herpetic neuralgia
    ® Peripheral neuropathy
    ® Dysesthesias involving the lower extremities secondary to spinal cord injury.

Dorsal root ganglion stimulation is considered investigational for ALL indications.

Generator modes other than tonic low and high frequency (e.g., burst stimulation) is considered investigational.

Peripheral nerve stimulation, including peripheral nerve field stimulation, is considered investigational for treatment of acute or chronic pain conditions, including ANY of the following:

    ® Failed back surgery syndrome (FBSS) with intractable neuropathic leg pain
    ® Complex regional pain syndrome (CRPS)/reflex sympathetic dystrophy (RSD)
    ® Chronic Critical Limb Ischemia (CLI)
    ® Chronic Stable Angina Pectoris
    ® Post-amputation pain (phantom limb pain)
    ® Post-herpetic neuralgia
    ® Peripheral neuropathy
    ® Dysesthesias involving the lower extremities secondary to spinal cord injury.

    Appendix A

    New York Heart Association and Canadian Cardiovascular Society Functional Classifications
Class
New York Heart Association Functional Classification
Canadian Cardiovascular Society Functional Classification
I
Members with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.Ordinary physical activity does not cause angina, such as walking and climbing stairs. Angina occurs with strenuous or rapid or prolonged exertion at work or recreation.
II
Members with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.Slight limitation of ordinary activity. Walking or climbing stairs rapidly, walking uphill, walking or stair climbing after meals, in cold, in wind, or under emotional stress, or only during the few hours after awakening. Walking more than two blocks on the level and climbing more than one flight of ordinary stairs at a normal pace and in normal conditions.
III
Members with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain.Marked limitation of ordinary physical activity. Walking one to two blocks on the level and climbing one flight in normal conditions and at a normal pace.
IV
Member with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.Inability to carry on any physical activity without discomfort—anginal syndrome may be present at rest.
(Heart Failure Society of America [HFSA], 2006; Gibbons, et al., 2002; American Heart Association [AHA], 1994; Canadian Cardiovascular Society [CCS], 1976).

CMM-211.5 Procedure (CPT®) Codes

This guideline relates to the CPT® code set below. Codes are displayed for informational purposes only. Any given code’s inclusion on this list does not necessarily indicate prior authorization is required.
CPT®
Code Description/Definition
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) place via 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
95970
Electronic analysis of implanted neurostimulator pulse generator system (e.g., rate, pulse, amplitude and duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and member compliance measurements); simple or complex brain, spinal cord, or peripheral (i.e., cranial nerve, peripheral nerve, autonomic nerve, neuromuscular) neurostimulator pulse generator/transmitter, without reprogramming
95971
Electronic analysis of implanted neurostimulator pulse generator system (e.g., rate, amplitude and duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and member compliance measurement(s); simple spinal cord, or peripheral (i.e., peripheral nerve, automatic nerve, neuromuscular) neurostimulator pulse generation/transmitter, with intraoperative or subsequent programming
95972
Electrode analysis of implanted neurostimulator pulse generator system (e.g., rate, pulse amplitude and duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and member compliance measurement(s); complex spinal cord, or peripheral (except cranial nerve) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming
This list may not be all inclusive and is not intended to be used for coding/billing purposes. The final determination of reimbursement for services is the decision of the health plan and is based on the individual’s policy or benefit entitlement structure as well as claims processing rules.

    Medicare Coverage:
    CMS has issued a National Coverage Determination (NCD) which speaks to coverage of Implanted Peripheral Nerve Stimulators and Central Nervous System Stimulators (Dorsal Column and Depth Brain Stimulators). Per NCD for Electrical Nerve Stimulators 160.7, the implantation of central nervous system stimulators may be covered as therapies for the relief of chronic intractable pain under limited circumstances. For additional information and eligibility, refer to NCD for Electrical Nerve Stimulators 160.7. NCD available to be accessed at CMS National Coverage Determinations (NCDs) Alphabetical Index search page: https://www.cms.gov/medicare-coverage-database/indexes/ncd-alphabetical-index.aspx.

    Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has also issued a determination that dorsal column stimulators are covered when LCD Spinal Cord Stimulation (Dorsal Column Stimulation) L35450 criteria, Article A5702 criteria, and NCD 160.7 criteria are met. For additional information and eligibility, refer to Local Coverage Determination (LCD): Spinal Cord Stimulation (Dorsal Column Stimulation) (L35450) and Local Coverage Article: Billing and Coding: Spinal Cord Stimulation (Dorsal Column Stimulation) (A57023). Available to be accessed at Novitas Solutions, Inc., Medical Policy Search page: https://www.novitas-solutions.com/webcenter/portal/MedicareJL/pagebyid?contentId=00024370.

    Medicaid Coverage:

    For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.

    FIDE SNP:

    For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.

    ________________________________________________________________________________________

    Horizon BCBSNJ Medical Policy Development Process:

    This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

    ___________________________________________________________________________________________________________________________

    Index:
    Spinal Cord and Implantable Peripheral Nerve Stimulators
    Spinal Cord Stimulation
    Dorsal Column Stimulation
    Dorsal Root Ganglion Stimulation
    Implantable Peripheral Nerve Stimulators

    References:
    1. Al-Kaisy A, Van Buyten JP, Smet I, et al. Sustained effectiveness of 10 kHz high-frequency spinal cord stimulation for patients with chronic, low back pain: 24-month results of a prospective multicenter study. Pain Med. 2014;15(3):347-354.

    2. Amann W, Berg P, Gersbach P, et al; European Peripheral Vascular Disease Outcome Study SCS- EPOS. Spinal cord stimulation in the treatment of non-reconstructable stable critical leg ischaemia: results of the European Peripheral Vascular Disease Outcome Study (SCS-EPOS). Eur J Vasc Endovasc Surg. 2003;26(3):280-286.

    3. American College of Occupational and Environmental Medicine. Occupational Medicine Practice Guideline, 2nd Ed. 2008.

    4. American Medical Association. Current Procedural Terminology – 2014 Professional Edition.

    5. Baber, Z and Erdeck. Failed back surgery syndrome: current perspectives. J Pain Res 2016; 9: 979 – 987.

    6. Bicket MC, Dunn RY, Ahmed SU. High-frequency spinal cord stimulation for chronic pain: Pre-clinical overview and systematic review of controlled trials. Pain Med 2016; 17(12): 2326-36.

    7. Burns B, Watkins L, Goadsby PJ. Treatment of intractable chronic cluster headache by occipital nerve stimulation in 14 patients. Neurology 2009; 72: 341–345.

    8. Burns B, Watkins L, Goadsby PJ. Treatment of hemicrania continua by occipital nerve stimulation with a bion device: long­term follow­up of a crossover study. Lancet Neurol 2008;7:1001–12.

    9. Claeys L, Berg W, Jonas S. Spinal cord stimulation in the treatment of chronic critical limb ischemia. Acta Neurochir Suppl. 2007;97(Pt 1):259-265.

    10. Cruccu G, Aziz T, Garcia-Larrea L, et al. EFNS guidelines on neurostimulation therapy for neuropathic pain. Eur J Neurol. 2007;14(9):952-970.

    11. Daousi C, Benbow SJ, MacFarlane IA. Electrical spinal cord stimulation in the long-term treatment of chronic painful diabetic neuropathy. Diabet Med 2005;22:393–398.

    12. Deer T, Pope J, Hayek S, et al. Neurostimulation for the treatment of axial back pain: A review of mechanisms, techniques, outcomes, and future advances. Neuromodulation 2014; 17(suppl 2): 52-68.

    13. Deer T, Pope J, Hunter C, et al. Safety Analysis of Dorsal Root Ganglion Stimulation in the Treatment of Chronic Pain. Neuromodulation: Technology at the Neural Interface. 2019. doi:10.1111/ner.12941.

    14. Deer TR, Levy RM, Kramer J, et al. Dorsal root ganglion stimulation yielded higher treatment success rate for complex regional pain syndrome and causalgia at 3 and 12 months. Pain. 2017;158(4):669-681. doi:10.1097/j.pain.0000000000000814.

    15. Deer TR, Pope JE, Lamer TJ, et al. The Neuromodulation Appropriateness Consensus Committee on Best Practices for Dorsal Root Ganglion Stimulation. Neuromodulation: Technology at the Neural Interface. 2018;22(1):1-35. doi:10.1111/ner.12845.

    16. de Vos CC, Meier K, Zaalberg PB, et al. Spinal cord stimulation in patients with painful diabetic neuropathy: a multicenter randomized clinical trial. Pain 2014;155:2426–2431.

    17. Fontaine D, Christophe Sol J, Raoul S, Fabre N, Geraud G, Magne C et al. Treatment of refractory chronic cluster headache by chronic occipital nerve stimulation. Cephalalgia 2011;31:1101–5.

    18. Forouzanfar T, Kemler M, Weber W, et al. Spinal cord stimulation in complex regional pain syndrome: cervical and lumbar devices are comparably effective. Br J Anaesth. 2004;92(3):348-53.

    19. Gersbach P, Argitis V, Gardaz Jpet al. Late outcome of spinal cord stimulation for unreconstructable and limb-threatening lower limb ischemia. Eur J Vasc Endovasc Surg. 2007;33(6):717-724.

    20. Grider JS, Manchikanti L, Carayannopoulos A, et al. Effectiveness of spinal cord stimulation in chronic spinal pain: A systemic review. Pain Physician 2016; 19(1):E33-54.

    21. Harden R, Bruehl S, Perez R, et al. Validation of proposed diagnostic criteria (the “Budapest criteria”) for complex regional pain syndrome. PAIN 2010:150:268 – 74.

    22. Harden RN, Bruehl S, Stanton-Hicks M, Wilson PR. Proposed new diagnostic criteria for complex regional pain syndrome. Pain Med 2007;8:326–31.

    23. Harke H, Gretenkort P, Ladleif H, Rahman S. Spinal cord stimulation in sympathetically maintained complex regional pain syndrome type I with severe disability. A prospective clinical study. Eur J Pain. 2005;9(4):363-373.

    24. Harvey AM. Classification of chronic pain – descriptions of chronic pain syndromes and definitions of pain terms. Clin J Pain 1995; 11(2); 179.

    25. Huang KT, Martin J, Marky A, et al. A national survey of spinal cord stimulation trail-to-permanent conversion rates. Neuro-modulation 2015; 18:133-9.

    26. Jose De Andres, MD, PhD, FIPP, EDRA, Vicente Monsalve-Dolz, PhD, Gustavo Fabregat-Cid, MD, PhD, Vicente Villanueva-Perez, MD, PhD, Anushik Harutyunyan, Juan Marcos Asensio-Samper, M.D, Nerea Sanchis-Lopex, MD. Prospective, Randomized Blind Effect-on-Outcome Study of Conventional vs High-Frequency Spinal Cord Stimulation in Patients with Pain and Disability Due to Failed Back Surgery Syndrome. Pain Medicine 2017; 18: 2401-2421.

    27. Jivegård L, Augustinsson L, Holm J, et al. Effects of spinal cord stimulation (SCS) in patients with inoperable severe lower limb ischaemia: a prospective randomised controlled study. Eur J Vasc Endovasc Surg. 1995;9(4):421-425.

    28. Kapural L, Narouze S, Janicki TI, Mekhail N. Spinal cord stimulation is an effective treatment for the chronic intractable visceral pelvic pain. Pain Med. 2006;;7(5):440-443.

    29. Kapural L, Yu C, Doust MW, et al. Novel 10-kHz high-frequency therapy (HF10 Therapy) is superior to traditional low-frequency spinal cord stimulation for the treatment of chronic back and leg pain: The SENZA-RCT Randomized Controlled Trial. Anesthesiology. 2015;123(4):851-860.

    30. Kapural L, Yu C, Doust MW, et al. Comparison of 10-kHz High-Frequency and Traditional Low-Frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: 24-Month Results From a Multicenter, Randomized, Controlled Pivotal Trial. Neurosurgery. 2016 Sep 6.

    31. Kemler M, Barendse GA van Kleef M, et al. Spinal cord stimulation in patients with chronic reflex sympathetic dystrophy. N Engl J Med. 2000;343(9):618-624.

    32. Kemler M, de Vet H, Barendse G, et al. Effect of spinal cord stimulation for chronic complex regional pain syndrome Type I: five-year final follow-up of patients in a randomized controlled trial. J Neurosurg. 2008;108(2):292-298.

    33. Kemler M, de Vet H, Barendse G, et al. Spinal cord stimulation for chronic reflex sympathetic dystrophy – five year follow-up. N Engl J Med. 2006;354(22):2394-2396.

    34. Kemler M, de Vet H, Barendse G, et al. The effect of spinal cord stimulation in patients with chronic reflex sympathetic dystrophy: two years’ follow-up of the randomized controlled trial. Ann Neurol. 2004;55:13-18.

    35. Kemler M, Furnee C. Economic evaluation of spinal cord stimulation for chronic reflex sympathetic dystrophy. Neurology. 2002;59(8):1203-1209.

    36. Klomp H, Spincemaille G, Steyerberg E, et al. Spinal-cord stimulation in critical limb ischaemia: a randomised trial. ESES Study Group. Lancet. 1999;353(9158):1040-1044.

    37. Kumar K, Hunter G, Demeria D. Spinal cord stimulation in treatment of chronic benign pain: challenges in treatment planning and present status, a 22-year experience. Neurosurgery. 2006;58(3):481-496; discussion 481-96.

    38. Kumar K, Taylor RS, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: A multicenter randomized controlled trial in patients with failed back surgery syndrome. Pain 2007; 132(1-2): 179-88.

    39. Latif O, Nedeljkovic S, Stevenson L. Spinal cord stimulation for chronic intractable angina pectoris: a unified theory on its mechanism. Clin Cardiol. 2001;24:533-541.

    40. Lipton R, Goadsby P, Cady R, Aurora SK, Grosberg B, Freitag F et al. PRISM study: occipital nerve stimulation for treatment-­‐refractory migraine. Cephalalgia 2009;29:30.

    41. Magis D, Allena M, Bolla M, De Pasqua V, Remacle JM, Schoenen J. Occipital nerve stimulation for drug-resistant chronic cluster headache: a prospective pilot study. Lancet Neurol 2007; 6: 314–321.

    42. Magis D, Gerardy PY, Remacle JM, Schoenen J. Sustained effectiveness of occipital nerve stimulation in drug-resistant chronic cluster headache. Headache 2011;51:1191–201.

    43. Magis D, Schoenen J. Advances and challenges in neurostimulation for headaches. Lancet Neurol 2012;11:708–19.

    44. Mailis-Gagnon A, Furlan A, Sandoval J, Taylor R, Spinal cord stimulation for chronic pain, Cochrane Database Syst Rev. 2004;3:CD003783.

    45. Mannheimer C, Eliasson T, Augustinsson LE, et al. Electrical stimulation versus coronary artery bypass surgery in severe angina pectoris: the ESBY study. Circulation. 1998;97:1157-1163.

    46. Marin JC, Goadsby P. Response of SUNCT (short-lasting unilateral neuralgiform headaches with conjunctival injection and tearing), SUNA (short-lasting unilateral neuralgifom headaches with autonomic symptoms) and primary stabbing headaches to occipital nerve stimulation (ONS). Neurology 2010;74:P04.006, abstract.

    47. McGreevy K, Williams K. Contemporary insights into painful diabetic neuropathy and treatment with spinal cord stimulation. Curr Pain Headache Rep 2012;16:43-­49.

    48. Mekhail NA, Mathews M, Nageeb F, et al. Retrospective review of 707 cases of spinal cord stimulation: indications and complications. Pain Pract 2011; 11:148-53.

    49. National Institute for Health and Care Excellence (NICE). Pain (chronic neuropathic or ischaemic) - spinal cord stimulation: final appraisal determination. September 2008.

    50. North R, Calkins S, Campbell D, et al. Automated, patient-interactive, spinal cord stimulator adjustment: a randomized controlled trial. Neurosurgery. 2003;52(3):572-580.

    51. North RB, Campbell JN, James CS, et al. Failed back surgery syndrome: Five year followup in 102 patients undergoing repeated operation. Neurosurgery 1991; 28; 28: 685-91.

    52. North R, Kidd D, Farrokhi F, Piantadosi S. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial. Neurosurgery. 2005;56(1):98-106..

    53. North R, Kidd D, Lee M, et al. A prospective, randomized study of spinal cord stimulation versus reoperation for failed back surgery syndrome: initial results. Stereotact Funct Neurosurg. 1994;62:267-272.

    54. North R, Kidd H, Piantadosi S. Spinal cord stimulation versus reoperation for failed back surgery syndrome: a prospective, randomized study design. Acta Neurochir. 1995;64(Suppl):106-8.

    55. North R, Kidd D, Shipley J, Taylor R. Spinal cord stimulation versus reoperation for failed back surgery syndrome: a cost effectiveness and cost utility analysis based on a randomized, controlled trial. Neurosurgery. 2007;61(2):361-368.

    56. Pedrini L, Magnoni F. Spinal cord stimulation for lower limb ischemic pain treatment. Interact Cardiovasc Thorac Surg. 2007;6(4):495-500.

    57. Perruchoud C, Eldabe S, Batterham AM, et al. Analgesic efficacy of high-frequency spinal cord stimulation: A randomized double-blind placebo controlled study. Neuromodulation 2013; 16(4): 363-9.

    58. Rapcan R, Mlaka J, Venglarcik M, et al. High-frequency - spinal cord stimulation. Bratisl Lek Listy. 2015;116(6):354-356.

    59. Reed K. Peripheral neuromodulation and headaches: history, clinical approach, and considerations on underlying mechanisms. Curr pain Headache Rep 2013;17:305.

    60. Reed KL, Black SB, Banta CJ 2nd, Will KR. Combined occipital and supraorbital neurostimulation for the treatment of chronic migraine headaches: initial experience. Cephalalgia 2010;30:260–71.

    61. Russo M, Van Buyten JP. 10-kHz high-frequency SCS therapy: A clinical summary. Pain Med. 2015;16(5):934-942.

    62. Saper JR, Dodick DW, Silberstein SD, McCarville S, Sun M, Goadsby PJ. Occipital nerve stimulation for the treatment of intractable chronic migraine headache: ONSTIM feasibility study. Cephalalgia 2011; 31:271–85.

    63. Schwedt TJ, Dodick DW, Trentman TL, Zimmerman RS. Response to occipital nerve block is not useful in predicting efficacy of occipital nerve stimulation. Cephalalgia 2007; 27: 271–274.

    64. Shanahan P, Watkins L, Matharu M. Treatment of medically intractable short-lasting unilateral neuralgiform headache attacks with conjunctival injection and tearing (SUNCT) and short-lasting unilateral neuralgiform headache attacks with autonomic symptoms (SUNA) with occipital nerve stimulation (ONS) in 6 patients. Cephalalgia 2009;29:150.

    65. Silberstein S, Dodick D, Saper J, Huh B, Slavin KV, Sharan A et al. Safety and efficacy of peripheral nerve stimulation of the occipital nerves for the management of chronic migraine: Results from a randomized, multicenter, double-­blinded, controlled study. Cephalalgia 2012;32(16):1165–79.

    66. Sitzman B, Provenzano D. Best Practices in Spinal Cord Stimulation. SPINE 2017: 42; 14S, S67–S71.

    67. Skaribas I, Calvillo O, Delikanaki-Skaribas E. Occipital peripheral nerve stimulation in the management of chronic intractable occipital neuralgia in a patient with neurofibromatosis type 1: a case report. Journal of Medical Case Reports 2011;5:174.Lambru G, Matharu M. Occipital nerve stimulation in primary headache syndromes. Ther Adv Neurol Disord 2012;5(1):57-­67.

    68. Slangen R, Pluijms WA, Faber CG, Dirksen CD, Kessels AG, van Kleef M. Sustained effect of spinal cord stimulation on pain and quality of life in painful diabetic peripheral neuropathy. Br J Anaesth 2013;111:1030– 1031.

    69. Slangen R, Schaper NC, Faber CG, et al. Spinal cord stimulation and pain relief in painful diabetic peripheral neuropathy: a prospective two-center randomized controlled trial. Diabetes Care 2014;37:3016–3024.

    70. Stancák A, Kozák J, Vrba I, et al. Functional magnetic resonance imaging of cerebral activation during spinal cord stimulation in failed back surgery syndrome patients. Eur J Pain. 2008;12(2):137-48.

    71. Stanton-Hicks M, Burton A, Bruehl S, et al. An updated interdisciplinary clinical pathway for CRPS: report of an expert panel. Pain Pract. 2005; 84(3):S4-S16.

    72. Sundaraj S, Johnstone C, Noore F, et al. Spinal cord stimulation: a seven-year audit. J Clin Neurosci. 2005 Apr;12(3):264-270.

    73. Taylor R, Buyten J, Buchser E. Spinal cord stimulation for complex regional pain syndrome: A systematic review of the clinical and cost-effectiveness literature and assessment of prognostic factors. Eur J Pain. 2006;10(2):91-101.

    74. Taylor RS, Desai MJ, Rigoard P, Taylor RJ. Predictors of pain relief following spinal cord stimulation in chronic back and leg pain and failed back surgery syndrome: A systemic review and meta-regression analysis. Pain Pract 2014; 14(6): 489-505.

    75. Taylor R, Taylor R. Spinal cord stimulation for failed back surgery syndrome: a decision-analytic model and cost-effectiveness analysis. Int J Technol Assess Health Care. 2005;21(3):351-358.

    76. TenVaarwerk I, Jessurun G, DeJongste M, et al. Clinical outcome of patients treated with spinal cord stimulation for therapeutically refractory angina pectoris. The Working Group on Neurocardiology. Heart. 1999;82(1):82-88.

    77. Tesfaye S, Watt J, Benbow S, et al. Electrical spinal-cord stimulation for painful diabetic peripheral neuropathy. Lancet. 1996;348:1698-1701.

    78. Tiede J, Brown L, Gekht G, et al. Novel spinal cord stimulation parameters in patients with predominant back pain. Neuromodulation. 2013;16(4):370-375.

    79. Ubbink D, Vermeulen H. Spinal cord stimulation for critical leg ischemia: a review of effectiveness and optimal patient selection. J Pain Symptom Manage. 2006;31:S30-S35.

    80. Ubbink D, Vermeulen H. Spinal cord stimulation for non-reconstructable chronic critical leg ischaemia. Cochrane Database Syst Rev. 2005;CD004001.

    81. van Beek M, Slangen R, Schaper N, Faber C, Joosten E, Dirksen C, van Dongen R, Kessels A, van Kleef M. Sustained treatment effect of spinal cord stimulation in painful diabetic peripheral neuropathy: 24-month follow-up of a prospective two-center randomized controlled trial. Diabetes Care 2015;38:e132-e134.

    82. VanBuyten JP, Al-Kaisy A, Smet I, Palmisani S, Smith T. High-frequency spinal cord stimulation for the treatment of chronic back pain patients: Results of a prospective multicenter European clinical study. Neuromodulation 2013; 16(1): 59-65.

    83. Weiner RL, Reed KL (1999) Peripheral neurostimulation for control of intractable occipital neuralgia. Neuromodulation 2:217–22.

    84. Workloss Data Institute. Official Disability Guidelines 2008

    Codes:
    (The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

    CPT*

      63650
      63655
      63661
      63662
      63663
      63664
      63685
      63688
      95970
      95971
      95972
    HCPCS

    * CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
    _________________________________________________________________________________________

    Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.

    The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy

    ____________________________________________________________________________________________________________________________