SPINAL CORD STIMULATOR

Transcription

1 SPINAL CORD STIMULATOR Policy Number: 2016M0002B Effective Date: February 1, 2016 Table of Contents: Page: Cross Reference Policy: POLICY DESCRIPTION 2 Deep Brain Stimulator, 2012M0005A COVERAGE RATIONALE/CLINICAL CONSIDERATION 2 Transcranial Magnetic Stimulation, BACKGROUND M0007A REGULATORY STATUS 6 CLINICAL EVIDENCE 7 Extracorporeal Magnetic Stimulation For APPLICABLE CODES 8 Urinary Incontinence, 2013M0012A REFERENCES 10 Gastric Electrical Stimulation For POLICY HISTORY/REVISION INFORMATION 13 Gastroparesis, 2013M0012A INSTRUCTIONS: Medical Policy assists in administering UCare benefits when making coverage determinations for members under our health benefit plans. When deciding coverage, all reviewers must first identify enrollee eligibility, federal and state legislation or regulatory guidance regarding benefit mandates, and the member specific Evidence of Coverage (EOC) document must be referenced prior to using the medical policies. In the event of a conflict, the enrollee's specific benefit document and federal and state legislation and regulatory guidance supersede this Medical Policy. In the absence of benefit mandates or regulatory guidance that govern the service, procedure or treatment, or when the member s EOC document is silent or not specific, medical policies help to clarify which healthcare services may or may not be covered. This Medical Policy is provided for informational purposes and does not constitute medical advice. In addition to medical policies, UCare also uses tools developed by third parties, such as the InterQual Guidelines, to assist us in administering health benefits. The InterQual Guidelines are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice. Other Policies and Coverage Determination Guidelines may also apply. UCare reserves the right, in its sole discretion, to modify its Policies and Guidelines as necessary and to provide benefits otherwise excluded by medical policies when necessitated by operational considerations. Page 1 of 14

2 POLICY DESCRIPTION: This medical policy provides information on the spinal cord stimulator devices which are used to produce electrical stimulation of the spinal nerves to block the sensation of pain. This therapy, also called dorsal column stimulation or neurostimulation, delivers low-voltage, electrical signals to the spinal cord through electrodes surgically placed in the epidural space of the spinal column, and a pulse generator (which contains a battery) implanted into a pocket in the abdomen. The generator and the electrodes are connected by a cable that is tunneled under the skin. The goal of this treatment is to relieve or control a variety of chronic, refractory pain of neurologic origin. COVERAGE RATIONALE / CLINICAL CONSIDERATIONS: A temporary trial of spinal cord stimulation may be CONSIDERED MEDICALLY NECESSARY for the relief of intractable, chronic, neuropathic pain when ALL of the following are present: A. At least ONE of the following conditions: 1. Lumbosacral radiculopathy or radiculitis, or 2. Failed back surgery syndrome (FBSS), post-surgical or posttraumatic, including that of postlaminectomy syndrome, or 3. Chronic pain caused by incomplete spinal cord injury/cauda equina injury, or 4. Chronic pain caused by complex regional pain syndrome I (also known as reflex sympathetic dystrophy), and complex regional pain syndrome II (also known as causalgia), or 5. Chronic pain caused by end-stage peripheral vascular disease (limb ischemia), when the patient cannot undergo revascularization or when revascularization has failed to relieve painful symptoms and the pain has not responded to medical management, or 6. Chronic pain caused by plexopathy, or 7. Chronic pain caused by intercostal neuralgia that did not respond to medical management and nerve blocks, or 8. Phantom limb syndrome/postamputation syndrome, or 9. Chronic pain due to chronic peripheral neuropathy, or 10. Chronic refractory angina pectoris, functional class III or class IV (New York Heart Association) in patients who are not considered candidates for a revascularization procedure, AND B. The patient has failed to achieve satisfactory pain control with treatment modalities over a period of at least 6 months which must include all of the following: 1. Medication management and 2. Conservative treatment which may include alternative treatments, such as acupuncture and chiropractic care, AND must include at least 8 weeks of intensive physical therapy in which the member actively and regularly participates AND C. The patient does not have a condition for which there is a surgical treatment, AND Page 2 of 14

3 D. The patient has undergone a psychological evaluation that has determined that unaddressed psychosocial factors or substance abuse factors do not contribute to the patient s intractable, chronic, neuropathic pain. Note: All facilities, equipment and personnel required for the proper diagnosis, treatment, training and follow-up of the patient must be available. Permanent implantation of a lumbar or thoracic spinal cord stimulator may be CONSIDERED MEDICALLY NECESSARY when the patient has met the above criteria for a temporary trial and has undergone a temporary trial of spinal cord stimulation for a minimum of 2 weeks, and this has resulted in significant improvement in symptoms of intractable, chronic, neuropathic pain. Generally, electronic analysis services (CPT codes ) are not CONSIDERED MEDICALLY NECESSARY when provided at a frequency more often than once every 30 days. More frequent analysis may be necessary in the first month after implantation. Treatment of all other diseases and disorders by an implanted epidural spinal cord stimulator (both temporary and permanent) IS CONSIDERED INVESTIGATIONAL AND NOT MEDICALLY NECESSARY, including, but not limited, to treatment of the following: 1. Central deafferentation pain (related to CNS damage from a stroke or complete spinal cord injury). 2. Chronic pelvic pain. 3. Critical limb ischemia as a technique to forestall amputation. 4. Headache, including but not limited to chronic cluster headaches. 5. Nociceptive pain (resulting from irritation, not damage to the nerves). 6. Postherpetic neuralgia. 7. Visceral pain. 8. Vulvodynia; vulvar vestibulitis. IMPLANTABLE SUBCUTANEOUS TARGET STIMULATOR DEVICES (both temporary and permanent) are CONSIDERED EXPERIMENTAL AND/OR INVESTIGATIONAL AND NOT MEDICALLY NECESSARY for all indications. Clinical Considerations: A. The goals of spinal cord stimulation (SCS) are to create a maximal overlap of SCS-induced paresthesia over the patient's painful area without undesired motor responses or paresthesia beyond the painful site. The devices work best when used on an intact nervous system and are the least effective for patients with damage to the nervous system. Clinical evidence supports the use of spinal cord stimulation for the treatment of intractable chronic pain of the trunk and limbs that has not responded to surgical, pharmacological, and conservative treatment modalities. Documentation in the medical record that medical management has been tried for at least six months and did not provide satisfactory pain control, or are judged unsuitable or contraindicated for the given patient. No medical contraindications to the implantation/spinal surgery (e.g., drug allergies, sepsis, coagulopathy, inability to cope with the technology). Page 3 of 14

4 Documentation from the patient s primary care physician or a mental health professional (i.e., psychiatrist or Ph.D psychologist) that identified any mental health or chemical dependency disorder, that would negatively impact the success of a SCS, is being or has been addressed. Demonstration of at least 50% pain relief with a temporarily implanted electrode precedes permanent implantation. Adverse Effects/Complications: In the evaluation of the risks for implantable devices, observational studies can provide data on the likelihood of potential complications. The following complications for spinal cord stimulation have been reported: o Lead migration, connection failure, and/ lead breakage o Superficial and deep infection with or without abscess o Hematoma o Nerve injury and paralysis o Lack of appropriate paresthesia coverage Medical contraindications to the use of SCS include: o Uncontrolled bleeding disorder o Ongoing anticoagulant therapy o Local or systemic sepsis o Presence of a demand pacemaker or implanted defibrillator o Immunosuppression o Pregnancy o Active or untreated abuse of alcohol, drugs, or medication BACKGROUND: Neuropathic pain refers to pain that is generated and perpetuated by the nervous system itself, without any ongoing stimuli from injury. Examples of neuropathic pain include diabetic neuropathy, post herpetic neuralgia, phantom limb pain, and trigeminal neuralgia. Neuropathic pain can also occur after spinal surgery; this condition is generally known as failed back surgery syndrome (FBSS). Another disorder that appears to be neuropathic in nature is complex regional pain syndrome (CRPS), which can develop spontaneously or after stroke, spinal cord injury, surgery, or peripheral trauma. CRPS is differentiated by type I and type II. Both types have the same basic symptoms, but type I, also known as reflex sympathetic dystrophy (RSD), describes cases with no nerve injury. CRPS type II, also called causalgia, refers to cases with a distinct nerve injury. Neuropathic pain responds poorly to standard pain therapies, can last indefinitely, increasing over time, and often results in severe disability. Therapies used for neuropathic pain include topical agents (capsaicin or topical anesthetics), local or regional nerve blocks, acupuncture or transcutaneous electrical nerve stimulation, physical therapy, behavioral therapy; and drugs, such as antiepileptic drugs, tricyclic antidepressants, and N-methyl-Daspartate (NMDA) receptor antagonists. Narcotic analgesics may be effective initially, but over time increasing doses may be required to control pain and dependency can result. Surgical procedures may be used to relieve nerves that are being compressed by tumors or other tissue masses. If chronic neuropathic pain fails to respond adequately to medical and/or surgical therapies, spinal cord Page 4 of 14

5 stimulation (SCS) may be attempted to provide pain relief. 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 four to eight electrodes, with eight electrodes more commonly used for complex pain patterns, such as bilateral pain or pain extending from the limbs to the trunk. Two basic types of power sources may be used. In one type, the power source (i.e., battery) can be surgically implanted. In the second type, a radiofrequency receiver is implanted and the power source is worn externally with an antenna over the receiver. Totally implantable systems are most commonly used. The patient's pain distribution pattern dictates the placement level of the stimulation lead in the spinal cord. The pain pattern may influence the type of device used (e.g., a lead with eight electrodes may be selected for those with complex pain patterns or bilateral pain). Implantation of the spinal cord stimulator is typically a two-step process. Initially, the electrode is temporarily implanted percutaneously in the epidural space through a special needle, allowing a trial period of stimulation. Some patients may need an open procedure requiring laminectomy to place the electrodes. After placement of the electrodes, the patient is provided with an external neurostimulator, initially on a trial basis. The trial period may be extended up to four weeks. If during the trial period it is determined that the modality is not effective, or it is not acceptable to the patient, the electrodes may be removed. 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 of channels. Computer-controlled programs are often used to assist the physician in studying the various programming options when complex systems are used. The first reports of pain relief by direct spinal cord stimulation were published in The first multiprogrammable stimulator was introduced in 1980, and the totally implantable neurostimulator was introduced in In 1988 a noninvasive programmable, implantable pulse generator with radiofrequency capabilities was introduced. Early spinal cord stimulator electrodes required a surgical laminectomy, two to four spinal segments superior to the patient's highest painful dermatome. Today the electrode is introduced through a Touhy needle into the epidural space at the appropriate spinal level for stimulation. Current systems use four or eight electrodes with a power source. This allows reversing the placement without altering the spinal architecture. Implantable Subcutaneous Target Stimulation. A new technique for treating chronic pain is the use of subcutaneous target stimulation (also referred to as peripheral subcutaneous field stimulation). This method involves the use of electrodes implanted directly at the painful area in the subcutaneous space, bypassing the spinal column and nerves. The electrodes are attached to a pulse generator which delivers permanent electrical stimulation. Like the implanted spinal cord stimulators, subcutaneous target stimulators are done in a two-phase process. The first phase involves a temporary trial with the second phase as a permanent implantation following at least a 50% reduction in pain following the temporary trial. Page 5 of 14

6 REGULATORY STATUS: 1. U.S. FOOD AND DRUG ADMINISTRATION (FDA): SCS devices are approved for use as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain and leg pain (FDA, 2004). They are not specifically approved for the treatment of chronic stable angina. Totally implantable SCS systems are regulated by the FDA as Class III premarket-approval (PMA) devices. Examples of these devices include the PRECISION Plus SCS (Spinal Cord Stimulator) System (Boston Scientific, MA) and the Genesis IPG System (St. Jude Medical, Inc. previously Advanced Neuromodulation Systems, Inc.; Plano, TX). Systems with external transmitters (e.g., X-trel Neurostimulation Systems [Medtronic, Inc., Minneapolis MN]) are regulated by the FDA as Class II 510(k) devices. 2. CENTERS FOR MEDICARE AND MEDICAID SERVICES (CMS): Neuromuscular Electrical Stimulation (NMES) for Spinal Cord Injury (NCD #: 160.7). Two general classifications of electrical nerve stimulators are employed to treat chronic intractable pain: peripheral nerve stimulators and central nervous system stimulators. Relevant to this policy is the Central Nervous System Stimulators (Dorsal Column and Depth Brain Stimulators). The implantation of central nervous system stimulators may be covered as therapies for the relief of chronic intractable pain, subject to the following conditions: Types of Implantations. There are two types of implantations covered by this instruction: Dorsal Column (Spinal Cord) Neurostimulation - The surgical implantation of neurostimulator electrodes within the dura mater (endodural) or the percutaneous insertion of electrodes in the epidural space is covered. Depth Brain Neurostimulation - The stereotactic implantation of electrodes in the deep brain (e.g., thalamus and periaqueductal gray matter) is covered. Conditions for Coverage. No payment may be made for the implantation of dorsal column or depth brain stimulators or services and supplies related to such implantation, unless all of the conditions listed below have been met: The implantation of the stimulator is used only as a late resort (if not a last resort) for patients with chronic intractable pain; Other treatment modalities (pharmacological, surgical, physical, or psychological therapies) have been tried and did not prove satisfactory, or are judged to be unsuitable or contraindicated for the given patient; Patients have undergone careful screening, evaluation and diagnosis by a multidisciplinary team prior to implantation. (Such screening must include psychological, as well as physical evaluation); All the facilities, equipment, professional and support personnel required for the proper diagnosis, treatment, training, and follow up of the patient must be available; and Demonstration of pain relief with a temporarily implanted electrode precedes permanent implantation. Contractors may find it helpful to work with QIOs to obtain the information needed to apply these conditions to claims. Notice: CMS Local Coverage Determination for spinal cord stimulator imposes diagnosis limitations Page 6 of 14

7 that support diagnosis to procedure code automated denials. However, services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules. 3. MINNESOTA DEPARTMENT OF HUMAN SERVICES (DHS): Minnesota DHS does not have a policy statement regarding spinal cord stimulators in its Provider Manual or other specific provider references. CLINICAL EVIDENCE SUMMARY: Neuropathic Pain: The available evidence for SCS as a treatment of neuropathic trunk and limb pain is mixed and limited by heterogeneity. However, systematic reviews, randomized controlled trials, numerous nonrandomized studies, and most clinical practice guidelines have found support for the use of SCS when all other treatment modalities have failed to adequately reduce symptoms in this patient population for whom there are limited options. There is some evidence that spinal cord stimulation (SCS) can reduce chronic, refractory, neuropathic pain and may improve quality of life (QOL) in patients who have failed back surgery syndrome (FBSS) or complex regional pain syndrome (CRPS). The available literature contained 3 randomized controlled trials (RCTs) or comparative controlled trials evaluating the efficacy of SCS in patients with FBSS, and significant pain reduction compared with reoperation and conventional medical management was evident for 2 years. In the only RCT in patients with CRPS, SCS was more efficacious than physical therapy for 2 years, but not at 3-, 4-, or 5-year follow-up times. Complications arising from SCS implantation required reoperation in 24% to 42% of patients. Overall, the evidence was limited by the small number of studies, small sample sizes and single-site studies, making it difficult to evaluate the generalizability of the results. In addition, none of the trials included a placebo control, which makes it difficult to evaluate the magnitude of the treatment effect. There is insufficient evidence to determine whether position-adaptive or high-frequency SCS improves outcomes or whether methods or factors other than a trial of SCS with temporary electrodes can improve the prognosis of SCS for neuropathic pain. Definitive patient selection criteria for SCS as a treatment for neuropathic pain could not be established due to the limited amount of evidence of low quality. Intractable Angina Pectoris: Evidence from a small number of randomized controlled or comparative trials and a limited number of nonrandomized or uncontrolled studies suggests that SCS can reduce the frequency and severity of anginal pain in some patients with chronic, medically refractory angina, and that some also experience an increase in exercise tolerance and improvement in quality-of-life measures. However, most of the available studies were limited by lack of adequate controls or blinding, small sample size, short duration of follow-up, and use of subjective outcome measures. SCS appeared to be a relatively safe therapy, with few serious adverse effects reported. There was no evidence that the analgesic effect of SCS masks the warning pain of myocardial infarction, and patients who have been treated with SCS have not been shown to be at increased risk for morbidity or mortality compared with their peers. Although there are some promising results from a small number of studies, data from larger, well-designed, randomized controlled trials are required to confirm that SCS is an effective pain management strategy for patients with refractory angina and to establish appropriate patient selection criteria. Implantable Subcutaneous Target Stimulation: Subcutaneous target stimulation appears to be a Page 7 of 14

8 promising alternative to implanted spinal cord stimulators for the treatment of chronic pain, however current literature is limited to small group sizes, case series, and retrospective reviews. Further long-term follow-up evaluations and controlled trials are necessary to determine safety and efficacy. APPLICABLE CODES: The Current Procedural Terminology (CPT ) codes and HCPCS codes listed in this policy are for reference purposes only. Listing of a service or device code in this policy does not imply that the service described by this code is a covered or non-covered health service. The inclusion of a code does not imply any right to reimbursement or guarantee claims payment. Other medical policies and coverage determination guidelines may apply. HCPCS Codes C1767 C1778 C1787 C1816 C1820 C1883 C1897 L8679 L8680 L8681 L8682 L8683 L8685 L8686 L8687 L8688 L8689 L8695 CPT Codes Description Generator, neurostimulator (implantable), nonrechargeable Lead, neurostimulator (implantable) Patient programmer, neurostimulator Receiver and/or transmitter, neurostimulator (implantable) Generator, neurostimulator (implantable), with rechargeable battery and charging system Adaptor/extension, pacing lead or neurostimulator lead (implantable) Lead, neurostimulator test kit (implantable) Implantable neurostimulator, pulse generator, any type Implantable neurostimulator electrode (with any number of contact points), each Patient programmer (external) for use with implantable programmable neurostimulator pulse generator Implantable neurostimulator radiofrequency receiver Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver Implantable neurostimulator pulse generator, single array, rechargeable, includes extension Implantable neurostimulator pulse generator, single, array, nonrechargeable, includes extension Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension Implantable neurostimulator pulse generator, dual array, onrechargeable, includes extension External recharging system for battery (internal) for use with implantable neurostimulator External recharging system for battery (external) for use with implantable neurostimulator, replacement only Description Percutaneous implantation of neurostimulator electrode array, epidural Laminectomy for implantation of neurostimulator electrodes, plate/paddle, epidural Removal of spinal neurostimulator electrode percutaneous array(s), including fluoroscopy, when performed Removal of spinal neurostimulator electrode plate/paddle(s) placed via laminotomy or laminectomy, including fluoroscopy, when performed Revision including replacement, when performed, of spinal neurostimulator electrode percutaneous array(s), including fluoroscopy, when performed Revision including replacement, when performed, of spinal neurostimulator electrode plate/paddle(s) placed via laminotomy or laminectomy, including fluoroscopy, when performed Page 8 of 14

9 63685 Insertion or replacement of spinal neurostimulator pulse generator or receiver, direct or inductive coupling Revision or removal of implanted spinal neurostimulator pulse generator or receiver 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 patient 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 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 patient compliance measurement(s); simple spinal cord, or peripheral (i.e., peripheral nerve, autonomic nerve, neuromuscular) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming 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 patient compliance measurement(s); complex spinal cord, or peripheral (except cranial nerve) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, first hour 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 patient compliance measurement(s); complex spinal cord, or peripheral (except cranial nerve) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, each additional 30 minutes after first hour 0282T Percutaneous or open implantation of neurostimulator electrode array(s), subcutaneous (peripheral subcutaneous field stimulation), including imaging guidance, when performed, cervical, thoracic or lumbar; for trial, including removal at the conclusion of trial period 0283T Percutaneous or open implantation of neurostimulator electrode array(s), subcutaneous (peripheral subcutaneous field stimulation), including imaging guidance, when performed, cervical, thoracic or lumbar; permanent, with implantation of a pulse generator 0284T Revision or removal of pulse generator or electrodes, including imaging guidance, when performed, including addition of new electrodes, when performed 0285T Electronic analysis of implanted peripheral subcutaneous field stimulation pulse generator, with reprogramming when performed ICD-9 Codes Description Implantation or replacement of spinal neurostimulator lead(s) Removal of spinal neurostimulator lead(s) Incision with removal of foreign body or device from skin and subcutaneous tissue Insertion or replacement of single array neurostimulator pulse generator, not specified as rechargeable Insertion or replacement of dual array neurostimulator pulse generator, not specified as rechargeable Insertion or replacement of other neurostimulator pulse generator Insertion or replacement of single array rechargeable neurostimulator pulse generator Insertion or replacement of dual array rechargeable neurostimulator pulse generator ICD-10 Codes 00HU0MZ- 00HU4MZ 00HV0MZ- Description Insertion of neurostimulator lead into spinal canal [by approach; includes codes 00HU0MZ, 00HU3MZ, 00HU4MZ] Insertion of neurostimulator lead into spinal cord [by approach; includes codes 00HV0MZ, Page 9 of 14

10 00HV4MZ 00HV3MZ, 00HV4MZ] G03.0-G03.9 Meningitis due to other and unspecified causes (arachnoiditis) G54.0-G54.9 Nerve root and plexus disorders G55 Nerve root and plexus compressions in diseases classified elsewhere G56.00-G56.92 Mononeuropathies of upper limb G57.00-G57.92 Mononeuropathies of lower limb G58.0-G58.9 Other mononeuropathies G59 Mononeuropathy in diseases classified elsewhere G89.11 Acute pain due to trauma G89.21 Chronic pain due to trauma G89.4 Chronic pain syndrome G90.50-G90.59 Complex regional pain syndrome I (CRPS I) M50.00-M50.93 Cervical disc disorders M51.04-M51.9 Thoracic, thoracolumbar, and lumbosacral intervertebral disc disorders M53.0-M53.9 Other and unspecified dorsopathies, not elsewhere classified M54.00-M54.9 Dorsalgia CPT is a registered trademark of the American Medical Association. REFERENCES: 1. American Society of Anesthesiologists (ASA) Website. Statement on anesthetic care during interventional pain procedures for adults. October 20, Available at: Accessed November 17, American Society of Anesthesiologists, Inc. Practice guidelines for chronic pain management: an updated report by the American Society of Anesthesiologists task force on chronic pain management and the American Society of Regional Anesthesia and Pain Medicine. Anesthesiology. 2010; 112(4): Andréll P, Yu W, Gersbach P, Gillberg L, Pehrsson K, Hardy I, Ståhle A, Andersen C, Mannheimer C. Long-term effects of spinal cord stimulation on angina symptoms and quality of life in patients with refractory angina pectoris--results from the European Angina Registry Link Study (EARL). Heart Jul;96(14): Bell GK, Kidd D, North RB. Cost-effectiveness analysis of spinal cord stimulation in treatment of failed back surgery syndrome. J Pain Symptom Manage. 1997;13(5): Bondesson S, Pettersson T, Erdling A, Hallberg IR, Wackenfors A, Edvinsson L. Comparison of patients undergoing enhanced external counterpulsation and spinal cord stimulation for refractory angina pectoris. Coron Artery Dis Dec;19(8): Börjesson M, Andrell P, Lundberg D, Mannheimer C. Spinal cord stimulation in severe angina pectoris--a systematic review based on the Swedish Council on Technology assessment in health care report on long-standing pain. Pain Dec;140(3): Burgher AH, Huntoon MA, Turley TW, et al. Subcutaneous Peripheral Nerve Stimulation with Inter-lead Stimulation for Axial Neck and Low Back Pain: Case Series and Review of the Literature. Neuromodulation Aug Cameron T. Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: a 20 year literature review. J Neurosurg (spine3). 2004; 100 (3 Suppl Spine): Centers for Medicare & Medicaid Services (CMS). National coverage determination (NCD) for electrical nerve stimulators (160.7). August 7, Available at: Accessed November 17, Chou R, Loeser J, Owens D, et al. Interventional therapies, surgery, and interdisciplinary rehabilitation for low back pain an evidence based clinical practice guideline from the American Pain Society. Spine. 2009;34: Page 10 of 14

11 11. de Jongste, MJ, Hautvast, RW, Hillege, HL, Lie, KI. Efficacy of spinal cord stimulation as adjuvant therapy for intractable angina pectoris: a prospective, randomized clinical study. Working Group on Neurocardiology. J Am Coll Cardiol Jun;23(7): de Vries J, Dejongste MJ, Durenkamp A, Zijlstra F, Staal MJ. The sustained benefits of long-term neurostimulation in patients with refractory chest pain and normal coronary arteries. Eur J Pain Apr;11(3): Deer TR, Raso LJ. Spinal cord stimulation for refractory angina pectoris and peripheral vascular disease. Pain Physician Oct;9(4): Diedrichs H, Zobel C, Theissen P, et al. Symptomatic relief precedes improvement of myocardial blood flow in patients under spinal cord stimulation. Curr Control Trials Cardiovasc Med. 2005; 6(1): Dyer MT, Goldsmith K, Khan S, Sharples L, Freeman C, Hardy I, Buxton M, Schofield P. Clinical and costeffectiveness analysis of an open label, single-centre, randomised trial of spinal cord stimulation (SCS) versus percutaneous myocardial laser revascularisation (PMR) in patients with refractory angina pectoris: The SPiRiT trial. Trials Jun 30;9: Eddicks S, Maier-Hauff K, Schenk M, Muller A, Baumann G, Theres H.Thoracic spinal cord stimulation improves functional status and relieves symptoms in patients with refractory angina pectoris: the first placebo-controlled randomised study. Heart May;93(5): Foletti A, Durrer A, Buchser E. Neurostimulation technology for the treatment of chronic pain: a focus on spinal cord stimulation. Expert Rev Med Devices Mar;4(2): Frey, ME, Manchikanti, L, Benyamin, RM, Schultz, DM, Smith, HS, Cohen, SP. Spinal cord stimulation for patients with failed back surgery syndrome: a systematic review. Pain Physician Mar-Apr;12(2): PMID: Hautvast, RW, DeJongste, MJ, Staal, MJ, van Gilst, WH, Lie, KI. Spinal cord stimulation in chronic intractable angina pectoris: a randomized, controlled efficacy study. Am Heart J Dec;136(6): Hayes, Winifred S. Medical Technology Directory. Spinal Cord Stimulation for Relief of Neuropathic Pain. October 8, Available at: Accessed November 17, Hayes, Winifred S. Medical Technology Directory. Electrical Spinal Cord Stimulation for the Treatment of Intractable Angina Pectoris. October 23, Reviewed: October 26, Available at: Accessed November 17, Institute for Clinical Systems Improvement (ICSI) Website. Health care guideline: assessment and management of chronic pain. Sixth edition. December Available at: Accessed November 17, Kemler MA, Barendse GA, van Kleef M, et al. Spinal cord stimulation in patients with chronic reflex sympathetic dystrophy. N Engl J Med. 2000; 343(9): Kemler MA, de Vet HC, Barendse GA et al. Spinal cord stimulation for chronic reflex sympathetic dystrophy--fiveyear follow-up. N Engl J Med. 2006; 354(22): Kemler MA, Furnee CA. Economic evaluation of spinal cord stimulation for chronic reflex sympathetic dystrophy. Neurology. 2002;59(8): Klomp HM, Spinc le GH, Steyerberg EW, et al. Spinal cord stimulation in critical limb ischemia: a randomized trial. Lancet.1999; 353(9158): Klomp HM, Steyerberg EW, Habbema JD, van Urk H; ESES study group. What is the evidence on efficacy of spinal cord stimulation in (subgroups of) patients with critical limb ischemia? Ann Vasc Surg. 2009; 23(3): Kumar K, Taylor RS, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomized controlled trial in patients with failed back surgery syndrome Pain. 2007; 132(1-2): Lapenna E, Rapati D, Cardano P, De Bonis M, Lullo F, Zangrillo A, Alfieri O. Spinal cord stimulation for patients with refractory angina and previous coronary surgery. Ann Thorac Surg Nov;82(5): Mailis-Gagnon A, Furlan AD, Sandoval JA, Taylor R. Spinal cord stimulation for chronic pain. Cochrane Database Page 11 of 14

12 Syst Rev. 2004; (3):CD Manchikanti L, Boswell MV, Singh V, et al. Comprehensive evidence based guidelines for interventional techniques in the management of chronic spinal pain. Pain Physician. 2009;12(4): Mannheimer C, Camici P, Chester MR, Collins A, DeJongste M, Eliasson T, Follath F, Hellemans I, Herlitz J, Luscher T, Pasic M, Thelle D. The problem of chronic refractory angina; report from the ESC Joint Study Group on the Treatment of Refractory Angina. Eur Heart J Mar;23(5): Mannheimer, C, Eliasson, T, Augustinsson, LE, et al. Electrical stimulation versus coronary artery bypass surgery in severe angina pectoris: the ESBY study. Circulation Mar 31;97(12): McNab D, Khan SN, Sharples LD, Ryan JY, Freeman C, Caine N, Tait S, Hardy I, Schofield PM. An open label, singlecentre, randomized trial of spinal cord stimulation vs. percutaneous myocardial laser revascularization in patients with refractory angina pectoris: the SPiRiT trial. Eur Heart J May;27(9): Mekhail, NA, Mathews, M, Nageeb, F, Guirguis, M, Mekhail, MN, Cheng, J. Retrospective review of 707 cases of spinal cord stimulation: indications and complications. Pain Pract Mar;11(2): PMID: National Guideline Clearinghouse Website. Unstable angina and NSTEMI: the early management of unstable angina and non-st-segment-elevation myocardial infarction. Available at: Accessed November 17, National Guideline Clearinghouse Website. American College of Occupational and Environmental Medicine (ACOEM). Low back disorders. Occupational medicine practice guidelines: evaluation and management of common health problems and functional recovery in workers. Second edition; National Guideline Clearinghouse Website. American College of Occupational and Environmental Medicine (ACOEM). Chronic pain. Occupational medicine practice guidelines: evaluation and management of common health problems and functional recovery in workers National Guideline Clearinghouse Website. Work Loss Data Institute (WLDI). Low back lumbar & thoracic (acute & chronic) National Guideline Clearinghouse Website. Work Loss Data Institute (WLDI). Pain (chronic) National Institute for Health and Clinical Excellence (NICE) Website. Spinal cord stimulation for chronic pain of neuropathic or ischaemic origin. November North RB, Kidd DH, Lee MS, et al. A prospective, randomized study of spinal cord stimulation versus reoperation for failed back surgery syndrome: initial results. Stereotact Funct Neurosurg. 1994; 62(1-4): North, RB, Kidd, D, Shipley, J, Taylor, RS. Spinal cord stimulation versus reoperation for failed back surgery syndrome: a cost effectiveness and cost utility analysis based on a randomized, controlled trial. Neurosurgery Aug;61(2):361-8; discussion 8-9. PMID: North, RB, Kidd, DH, Farrokhi, F, Piantadosi, SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial. Neurosurgery. 2005;56(1):98-106; discussion -7. PMID: Sator-Katzenschlager S, Fiala K, Kress HG, et al. Subcutaneous target stimulation (STS) in chronic noncancer pain: a nationwide retrospective study. Pain Pract. 2010; 10(4): Simpson EL, Duenas A, Holmes MW, Papaioannou D, Chilcott J. Spinal cord stimulation for chronic pain of neuropathic or ischaemic origin: systematic review and economic evaluation. Health Technol Assess Mar;13(17):iii, ix-x, Stanton-Hicks MD, Burton AW, Bruehl SP, Carr DB, Harden N, Hassenbusch SJ, et al. An Updated Interdisciplinary Clinical Pathway for CRPS: Report of an Expert Panel. Pain practice Nov (2): Taylor RS, De Vries J, Buchser E, Dejongste MJ. Spinal cord stimulation in the treatment of refractory angina: systematic review and meta-analysis of randomised controlled trials. BMC Cardiovasc Disord Mar 25;9: Taylor RS. Spinal cord stimulation in complex regional pain syndrome and refractory neuropathic back and leg pain/failed back surgery syndrome: results of a systematic review and meta-analysis. J Pain Symptom Manage. Page 12 of 14

13 2006; 31(4 Suppl):S UpToDate Website. Cancer pain management: interventional therapies. October Available at: Accessed November 17, UpToDate Website. Lower extremity peripheral arterial disease in end stage renal disease. April Available at: Accessed November 17, UpToDate Website. New therapies for angina pectoris. August Available at: Accessed November 17, UpToDate Website. Overview of the treatment of chronic pain. August Available at: Accessed November 17, UpToDate Website. Prevention and management of complex regional pain syndrome in adults. August Available at: Accessed November 17, UpToDate Website. Subacute and chronic low back pain: surgical treatment. March Available at: Accessed November 17, UpToDate Website. Treatment of lower extremity critical limb ischemia. July Available at: Accessed November 17, POLICY HISTORY: DATE ACTION/DESCRIPTION 09/25/2012 New policy 2012M0002A. Approved by the Interim Medical Policy Committee. 02/28/2013 Reviewed and approved by the Quality Improvement Advisory and Credentialing Council (QIACC). 11/15/2013 Published to UCare.org 03/01/2014 Policy Revision : Policy Number has changed to 2014M0002B Revised Coverage Rationale: Added implantable subcutaneous target stimulator devices to Investigational and Not Medically Necessary statement. Clarified medically necessary criteria for Chronic Refractory Angina Pectoris. Updated Background, Clinical Evidence, and References sections. Updated Coding section to include 01/01/2014 HCPCS changes and ICD-10 codes. 03/12/2014 New Policy. Reviewed by the Medical Policy Committee. 03/27/2014 Reviewed and approved by the Quality Improvement Advisory and Credentialing Committee (QIACC). 12/7/2015 Revised Policy reviewed by the Medical Policy Committee. Coverage rationale unchanged but rewritten for clarity. 12/17/2015 Reviewed and approved by the Quality Improvement Advisory and Credentialing Committee (QIACC). 01/01/2016 Published to UCare.org Page 13 of 14

14 QUESTIONS AND ANSWERS: Q1: A1: ATTACHMENTS: A- New York Heart Association and Canadian Cardiovascular Society Functional Classifications Class I II III IV New York Heart Association Functional Classification Patients with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain. Patients 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. Patients 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. Patient 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. Canadian Cardiovascular Society Functional Classification 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. 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. 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. 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). Page 14 of 14