Cigna Medical Coverage Policy Subject

Minimally Invasive Treatment of Back and Neck Pain

Table of Contents Coverage Policy .................................................. 1 General Background ........................................... 5 Coding/Billing Information ................................. 30 References ........................................................ 42

Effective Date ............................ 7/15/2014 Next Review Date ...................... 7/15/2015 Coverage Policy Number ................. 0139 Hyperlink to Related Coverage Policies Acupuncture Bone Graft Substitutes for Use in Bone Repair Botulinum Therapy Discography Intervertebral Disc (IVD) Prostheses Lumbar Fusion for Spinal Instability and Degenerative Disc Conditions, Including Sacroiliac Fusion Mechanical Devices for the Treatment of Back Pain Percutaneous Vertebroplasty, Kyphoplasty, and Sacroplasty Spinal Orthoses

INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna companies. Coverage Policies are intended to provide guidance in interpreting certain standard Cigna benefit plans. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations. Proprietary information of Cigna. Copyright ©2014 Cigna

Coverage Policy TRIGGER POINT INJECTION Diagnostic/Stabilization Phase Cigna covers trigger-point injection(s) of anesthetic and/or corticosteroid (CPT codes 20552, 20553) for diagnosis/stabilization of subacute or chronic back, or neck pain, or subacute or chronic myofascial pain syndrome as medically necessary when pain has persisted despite appropriate conservative treatment, including pharmacological therapy, physical therapy, and/or a home exercise program. A maximum of four injection sessions for diagnosis and stabilization will be covered at minimum intervals of one week when provided to determine whether injections provide therapeutic benefit. Therapeutic Phase Cigna covers therapeutic trigger-point injections of anesthetic and/or corticosteroid (CPT codes 20552, 20553) as medically necessary when prior diagnostic/stabilization injections resulted in a beneficial

Page 1 of 50 Coverage Policy Number: 0139

clinical response (e.g., improvement in pain, functioning, activity tolerance) and BOTH of the following criteria are met: • •

subacute or chronic back pain, neck pain, or myofascial pain syndrome persists injections are provided in conjunction with an active treatment program, which may include pain management, physical therapy, and/or a home exercise program

A maximum of six treatment sessions for injection of the same muscle may be covered at a minimum interval of two months, if the preceding therapeutic injection resulted in more than 50% relief for at least six weeks. Cigna does not cover long-term repeated or maintenance therapeutic trigger point injections for any indication because it is considered experimental, investigational or unproven. Repeat therapeutic trigger point injections provided for 12 months or longer may result in medical necessity review. Cigna does not cover dry needling of trigger points for any indication because it is considered experimental, investigational, or unproven. Cigna does not cover ultrasound guidance (76942) for trigger point injections for any indication because it is considered not medically necessary. EPIDURAL STEROID INJECTION / SELECTIVE NERVE ROOT BLOCK Diagnostic Phase: Cigna covers diagnostic epidural steroid injection/selective nerve root block (CPT codes 62310, 62311, 64479-64484) as medically necessary when BOTH of the following criteria are met: • •

acute or recurrent cervical, thoracic or lumbar radicular pain (e.g. sciatica) failure to improve following at least six weeks of conservative management, including pharmacological therapy, physical therapy, and/or a home exercise program, OR worsening (e.g., incapacitating pain, advancing neurological symptoms) following at least two weeks of conservative management

A maximum of two diagnostic injection treatment sessions may be covered at a minimum interval of two weeks Therapeutic Phase Cigna covers subsequent epidural steroid injections/selective nerve root blocks as medically necessary when prior diagnostic/stabilization injections resulted in a beneficial clinical response (e.g., improvement in pain, functioning, activity tolerance) and BOTH of the following criteria are met: • •

cervical, thoracic or lumbar radicular pain (e.g., sciatica) has persisted or worsened minimum interval of two months between injection sessions

A maximum of four therapeutic injection treatment sessions may be covered for the same diagnosis/condition within a twelve month period, if preceding therapeutic injection resulted in more than 50% relief for at least two months. Cigna does not cover long-term repeated or maintenance epidural steroid injection/selective nerve root block for any indication because it is considered experimental, investigational or unproven. Repeat epidural steroid injection/selective nerve root block provided for 12 months or longer may result in medical necessity review. Cigna does not cover EITHER of the following because each is considered experimental, investigational or unproven: •

Epidural steroid injection/selective nerve root block for acute, subacute, or chronic back pain without radiculopathy (e.g., sciatica)

Page 2 of 50 Coverage Policy Number: 0139

•

Epidural steroid injection with ultrasound guidance (0228T-0231T) for any indication

INTRADISCAL STEROID INJECTION Cigna does not cover intradiscal steroid injection for the treatment of acute, subacute, or chronic back or neck pain because it is considered experimental, investigational, or unproven. FACET JOINT INJECTION Diagnostic Cigna covers a diagnostic* facet joint injection (CPT codes 64490-64495) as medically necessary when used to determine whether chronic neck or back pain is of facet joint origin when ALL of the following criteria are met: • • •

Pain is exacerbated by extension and rotation, or is associated with lumbar rigidity Pain has persisted despite appropriate conservative treatment (e.g., nonsteroidal anti-inflammatory drugs (NSAIDs, exercise) Clinical findings and imaging studies suggest no other obvious cause of the pain (e.g., spinal stenosis, disc degeneration or herniation, infection, tumor, fracture)

*Note: A facet joint injection performed on the same side at the same level subsequent to a diagnostic injection is considered to be therapeutic; see policy statement below on coverage of therapeutic facet joint injection. Therapeutic Cigna does not cover therapeutic facet joint injection (CPT codes 64490-64495) for the treatment of acute, subacute, or chronic neck or back pain or radicular syndromes because it is considered experimental, investigational, or unproven. Cigna does not cover diagnostic or therapeutic facet joint injection with ultrasound guidance (CPT codes 0213T-0218T) for any indication because it is considered experimental, investigational, or unproven. SACROILIAC (SI) JOINT INJECTION Cigna covers SI joint injection (CPT code 27096, HCPCS code G0260) for the treatment of back pain associated with localized SI joint pathology (e.g., inflammatory arthritis) confirmed on imaging studies. Cigna does not cover SI joint injection (CPT code 27096) for the diagnosis or treatment of acute, subacute, or chronic back pain or radicular syndromes not associated with localized SI joint pathology confirmed on imaging studies because it is considered experimental, investigational, or unproven. Cigna does not cover ultrasound guidance (76942) for SI joint injection for any indication because it is considered experimental, investigational, or unproven ABLATIVE TREATMENT Cigna covers initial percutaneous radiofrequency denervation of paravertebral facet joint nerves (also referred to as radiofrequency neurolysis, neurotomy, facet rhizotomy) (CPT codes 64633-64636) for the treatment of chronic back or neck pain as medically necessary when ALL of the following criteria are met: • • •

Pain is exacerbated by extension and rotation, or is associated with lumbar rigidity There is severe pain unresponsive to at least six months of conservative medical management. (e.g., pharmacological therapy, physical therapy, exercise) Facet joint origin of pain is suspected and medial branch block/injection of facet joint with local anesthetic results in elimination or marked decrease in intensity of pain

Page 3 of 50 Coverage Policy Number: 0139

•

Clinical findings and imaging studies suggest no other obvious cause of the pain (e.g., spinal stenosis, disc degeneration or herniation, infection, tumor, fracture)

Cigna covers repeat percutaneous radiofrequency denervation of paravertebral facet joint nerves at the same level for the treatment of chronic back or neck pain as medically necessary when BOTH of the following criteria are met: • •

At least six months have elapsed since the previous radiofrequency ablation/neurolysis of paravertebral facet joint nerves More than 50% relief is obtained, with associated functional improvement, for at least ten weeks following the previous treatment

Cigna does not cover ANY of the following ablative procedures for the treatment of back, or neck pain because each is considered experimental, investigational or unproven (this list may not be allinclusive);       

Pulsed radiofrequency (CPT code 64999) Endoscopic radiofrequency denervation/endoscopic dorsal ramus rhizotomy (CPT code 64999) Cryoablation/cryoneurolysis/cryodenervation (CPT code 64999) Chemical ablation (e.g., alcohol, phenol, glycerol) (CPT codes 64633-64636) Laser ablation (CPT code 64999) Ablation by any method for sacroiliac (SI) joint pain Cooled radiofrequency ablation

Percutaneous and Endoscopic Laminectomy and Disc Decompression Procedures Cigna does not cover a percutaneous or endoscopic laminectomy or disc decompression procedure, including but not limited to the following, because it is considered experimental, investigational or unproven (this list may not be all-inclusive): • • • • •

automated percutaneous lumbar discectomy (APLD)/automated percutaneous nucleotomy (CPT code 62287, HCPS codes C2614) endoscopic anterior spinal surgery/Yeung endoscopic spinal system (YESS)/percutaneous endoscopic diskectomy (PELD)/arthroscopic microdiscectomy, selective endoscopic discectomy (SED) (CPT code 62287) ™ endoscopic disc decompression, ablation, or annular modulation using the DiscFX System (CPT code 62287) ® percutaneous laminotomy/laminectomy, percutaneous spinal decompression (e.g., mild procedure) (CPT codes 22899, 64999, 0274T, 0275T) percutaneous laser discectomy /decompression, laser-assisted disc decompression (LADD) (CPT code 62287)

THERMAL INTRADISCAL PROCEDURES Cigna does not cover ANY of the following procedures because each is considered experimental, investigational or unproven (this list may not be all-inclusive): • • • •

intervertebral disc biacuplasty (CPT code 22899) ™ intradiscal electrothermal annuloplasty (e.g., intradiscal electrothermal therapy [IDET ]) (CPT codes 22526, 22527) percutaneous intradiscal radiofrequency thermocoagulation (PIRFT), intradiscal radiofrequency thermomodulation or percutaneous radiofrequency thermomodulation (CPT code 22899, HCPCS code S2348) ® ™ Coblation Nucleoplasty , disc nucleoplasty, decompression nucleoplasty plasma disc decompression (CPT code 62287)

OTHER PROCEDURES

Page 4 of 50 Coverage Policy Number: 0139

Cigna does not cover ANY of the following procedures because each is considered experimental, investigational or unproven (this list may not be all-inclusive): • • • • •

devices for annular repair (e.g., Inclose™ Surgical Mesh System, Xclose™ Tissue Repair System (Anulex Technologies, Inc., Minnetonka, MN) endoscopic epidural adhesiolysis (CPT code 64999) epiduroscopy, epidural myeloscopy, epidural spinal endoscopy (CPT code 64999) intradiscal and/or paravertebral oxygen/ozone injection percutaneous epidural adhesiolysis, percutaneous epidural lysis of adhesions, Racz procedure (CPT codes 62263, 62264)

General Background Back pain is a frequent cause of chronic pain and disability, affecting approximately 15% of the U.S. population during their lifetime. Most episodes of low back pain improve substantially within a month without formal medical intervention. In a small minority of patients, back pain may be persistent and disabling. Conservative treatment may include pharmacological therapy (e.g., analgesics, anti-inflammatory drugs, muscle relaxants), exercise, spinal manipulation, acupuncture, cognitive-behavioral therapy, and physical therapy. If these measures are unsuccessful, a number of interventional techniques and procedures may be considered that attempt to target specific structures or spinal abnormalities considered to be potential sources of pain, including back muscles and soft tissues, degenerated facet or sacroiliac joints, spinal canal stenosis, and degenerated or herniated intervertebral discs (Chou et al., 2009). Surgery may be appropriate for medical conditions with remediable underlying pathology (e.g. herniated disc) when confirmed and correlated with imaging findings. There is evidence that surgical discectomy provides significant pain relief in selected patients with lumbar disc prolapse with sciatica that fails to improve with conservative treatment. Discectomy was originally performed in an open operation over the spine called hemilaminectomy, in which the muscles are dissected away from the spine and access to the intervertebral disc is obtained by cutting away a piece of spinal bone (i.e., lamina). This technique remains the treatment of choice in some patients, including those with severe pain or weakness and complicated herniation. Microsurgical discectomy (i.e., microdiscectomy) is a less invasive technique that evolved in an effort to decrease postoperative morbidity and recovery time. Microdiscectomy employs direct visualization but is performed through a smaller (15–25 mm) central incision with the use of an operating microscope. Microdiscectomy outcomes are similar to outcomes seen with open discectomy, and microdiscectomy is considered the standard treatment by which to compare other minimally invasive therapies. Management of back pain that is persistent and disabling despite the use of recommended conservative treatment is challenging. Numerous diagnostic and therapeutic injections and other interventional and surgical treatments have therefore been proposed for the treatment back pain. Choosing Wisely: The following statement is included in the North American Spine Society (NASS) Choosing Wisely recommendations: Don’t recommend bed rest for more than 48 hours when treating low back pain. In patients with low back pain, bed rest exceeding 48 hours in duration has not been shown to be of benefit. Literature Review Injection Therapies Trigger point injections, epidural steroid injections, intradiscal steroid injections, and facet joint injections and blocks have been employed in the treatment of acute, subacute, and chronic back pain. Although the evidence for the efficacy of these diagnostic and therapeutic injections discussed below is not strong, several have gained widespread use as alternatives to more invasive interventions. Trigger point injections involve injection of anesthetic or corticosteroids into distinct, focal hyper-irritable spots (i.e., trigger points) located in a tight band of skeletal muscle. Myofascial pain syndrome is a chronic form of muscle pain centered around trigger points. Pain may be perceived at the site of the trigger point or can be referred to other parts of the body, including the back and neck. Trigger point injections involve injection of local anesthetic, saline, dextrose, and/or cortisone into the trigger point. Fluoroscopic or computed tomography guidance is used with other types of injections used to diagnose and treat back and neck pain (e.g., epidural

Page 5 of 50 Coverage Policy Number: 0139

steroid injections) to identify the surrounding structures and ensure accurate needle placement to the target area. Guidance is not needed for trigger point injections, however, since the injection is made into skeletal muscle tissue. A Cochrane systematic review was conducted to determine if injection therapy is more effective than placebo or other treatments for patients with subacute or chronic low back pain (Staal et al., 2008). This updated review evaluated 18 randomized controlled trials (n=1179) of injection therapy involving epidural, facet or local sites (i.e., tender or trigger points) in patients with non-radicular pain. The injected drugs included corticosteroids, local anesthetics, and a variety of other drugs. Overall, the results indicated that there was no strong evidence for or against the use of any type of injection therapy. The authors concluded that there is insufficient evidence to support the use of injection therapy in subacute and chronic low back pain, but it cannot be ruled out that specific subgroups of patients may respond to a specific type of injection therapy. Peloso et al. (2007) conducted a Cochrane systematic review to determine the effects of medication and injections on primary outcomes (e.g., pain) for adults with mechanical neck disorders and whiplash. The review evaluated 36 trials that examined the effects of steroid injections, anesthetic agents, psychotropic agents, and NSAIDs. The authors stated that lidocaine injection into myofascial trigger points appeared effective in two trials. Guidelines on injection therapies, low-back pain, and lumbar fusion published by the American Association of Neurological Surgeons (AANS)/Congress of Neurological Surgeons (Resnick et al., 2005), based on a systematic review of studies evaluating trigger point injections, facet joint injections, and epidural steroid injections, concluded that there is conflicting evidence suggesting that the use of local trigger point injections can be effective for the short-term relief of low-back pain. There are no data to suggest that trigger point injections with either steroids or anesthetics alone provide lasting benefit for patients suffering from chronic lowback pain. American College of Occupational and Environmental Medicine (ACOEM) evidence-based practice guidelines on low back disorders, updated in 2011, state that trigger and/or tender point injections are not recommended for treatment of acute low back pain because there are other more efficacious treatment strategies available. These injections may be reasonable as second or tertiary options for subacute or chronic low back pain that is not resolving with conservative treatment (e.g., NSAID, progressive aerobic exercises, and other exercises). The guideline states that injections should consist solely of topical anesthetic (e.g., bupivacaine), and that there is no evidence that steroid is required for efficacy of these injections. Repeat injections should be linked to subjective and objective improvements and be a component of an active therapy program. The ACOEM guideline recommends an interval of at least three to four weeks between injections. If the results are unsatisfactory after the first set, the injections may be repeated. If subjective and objective improvements are not seen, further injections are not recommended. An American Society of Interventional Pain Physicians (ASIPP) Practice Guideline, Interventional Techniques in the Management of Chronic Pain, Part 2.0 (Manchikanti et al., 2001) includes the following recommendations for trigger point injections: • • • • •

In the diagnostic or stabilization phase, a patient may receive trigger point injections at intervals of no sooner than one week and preferably two weeks. In the treatment or therapeutic phase (after the stabilization is completed), the frequency should be two months or longer between each injection provided that at least >50% relief is obtained for six weeks. In the diagnostic or stabilization phase, the number of trigger point injections should be limited to no more than four times per year. In the treatment or therapeutic phase, the trigger point injections should be repeated only as necessary judging by the medical necessity criteria and these should be limited to a maximum of six times for local anesthetic and steroid injections. Under unusual circumstances with a recurrent injury or cervicogenic headache trigger point injections may be repeated at intervals of six weeks after stabilization in the treatment phase.

Dry Needling of trigger points has been proposed as a treatment of myofascial pain in various parts of the body, including low back pain. Dry-needling involves the insertion of a needle (acupuncture needle or other type

Page 6 of 50 Coverage Policy Number: 0139

of needle) into a trigger point without injecting any medication in an effort to deactivate the trigger point. The needle is not left in place; it is removed and is often followed by stretching exercises. A Cochrane systematic review of acupuncture and dry needling (Furlan, et al., 2003, updated 2011) concluded that there is insufficient evidence to make any recommendation regarding acupuncture or dry needling for acute low back pain. For chronic low back pain, acupuncture and dry needling may be useful adjuncts to other therapies. Because most studies were of poor methodological quality, however, there is a need for higher quality trials in this area. There is insufficient evidence to demonstrate the efficacy of dry needling for the treatment of acute or chronic back pain. Epidural steroid injections/selective nerve root blocks: Epidural injection of corticosteroids has been a widespread practice for many decades used in an effort to reduce inflammation and associated pressure for treatment of back pain with radicular features. Epidural injections may be performed using caudal, interlaminar or transforaminal approaches. Injectable corticosteroids include methylprednisolone, hydrocortisone, triamcinolone, betamethasone, and dexamethasone. On April 23, 2014, a U.S. Food and Drug Administration (FDA) Drug Safety Communication was issued, warning that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death. The communication stated that the effectiveness and safety of epidural administration of corticosteroids have not been established, and the FDA has not approved corticosteroids for this use. FDA is requiring the addition of a warning to the drug labels of injectable corticosteroids to describe these risks. Patients are advised to discuss the benefits and risks of epidural corticosteroid injections with their health care professional along with the benefits and risks associated with other possible treatment. The results of the Cochrane systematic review of injection therapy discussed above (Staal, et al. 2008) indicated that there was no strong evidence for or against the use of any type of injection therapy. The authors concluded that there is insufficient evidence to support the use of injection therapy in subacute and chronic low back pain, but it cannot be ruled out that specific subgroups of patients may respond to a specific type of injection therapy. Novak et al. (2008) conducted a systematic review to evaluate the evidence in support of guidelines on frequency and timing of epidural steroid injections in order to help determine what sort of response should occur to repeat an injection. The review included 11 randomized controlled trials, one prospective controlled trial, and two prospective cohort studies. The authors stated that many of the problems with this type of research stem from a lack of understanding of the underlying mechanisms of radicular pain and a lack of understanding of how epidural steroid injections provide an effect. The underlying mechanism of glucocorticoid activity is not clearly understood, and there is no indication for repeat injection based solely on the characteristics of the medication itself. The authors concluded that there is limited evidence to suggest guidelines for frequency and timing of epidural steroid injections or to help define an appropriate partial response that would trigger a repeat injection. Research suggests that repeat injections may improve outcomes, but conclusions cannot be made due to methodological limitations of the available evidence. The authors concluded that there does not appear to be any evidence to support the common practice of a series of injections. The American Society of Interventional Pain Physicians (ASIPP) Update of Comprehensive Evidence-Based Guidelines for Interventional Techniques in Chronic Spinal Pain were published in 2013, based on a systematic review of the literature utilizing Institute of Medicine criteria (Manchikanti et al.). The quality of each article was assessed by Cochrane review criteria for randomized trials, Newcastle-Ottawa Scale for observational studies, and Quality Appraisal of Reliability studies checklist for diagnostic accuracy studies. Meta-analysis was performed when the predetermined minimum number of studies was available, and finally, analysis of evidence was based on U.S. Preventive Services Task Force criteria. The analysis was conducted using three levels of evidence, good, fair, and limited or poor, in all systematic reviews. The guideline states that because substantial differences are described in the literature regarding the technique and outcomes among the three approaches to epidural injections, caudal, Interlaminar, and transforaminal injections are considered separately. In addition, because the response to epidural injections for various conditions (disc herniation and/or radiculitis, discogenic pain without disc herniation, spinal stenosis, and post surgery syndrome) is variable, outcomes are assessed based on pathology for each approach.

Page 7 of 50 Coverage Policy Number: 0139

The guideline includes the following recommendations: Low back pain: • The evidence for caudal epidural, interlaminar epidural, and transforaminal epidural injections is good in managing disc herniation or radiculitis; fair for axial or discogenic pain without disc herniation, radiculitis or facet joint pain with caudal and lumbar interlaminar epidural injections, and limited with transforaminal epidural injections; fair for spinal stenosis with caudal, interlaminar, and transforaminal epidural injections; and fair for post surgery syndrome with caudal epidural injections and limited with transforaminal epidural injections. • The recommendation for epidural injections for disc herniation is that one of the three approaches may be used; for spinal stenosis any of the three approaches are recommended; whereas for axial or discogenic pain, either lumbar interlaminar or caudal epidural injections are recommended. However for transforaminal the evidence is limited for axial or discogenic pain and post surgery syndrome. Neck pain • The evidence is good for therapeutic cervical interlaminar epidural injections for cervical disc herniation or radiculitis; whereas, it is fair for axial or discogenic pain, pain of spinal stenosis, and pain of post cervical surgery syndrome. • Cervical interlaminar epidural injections are recommended for patients with chronic neck and upper extremity pain secondary to disc herniation, spinal stenosis, and post cervical surgery syndrome. Thoracic pain • The evidence for thoracic epidural injection in treating chronic thoracic pain is fair. • Thoracic epidural injections are recommended for thoracic discogenic, disc-related, post surgery syndrome, or spinal stenosis pain. The ASIPP guideline includes the following recommendations for frequency of caudal, interlaminar and transforaminal epidural injections: • Diagnostic phase: patient may receive two procedures at intervals of no sooner than two weeks or preferably four weeks • Therapeutic phase (after the diagnostic phase is completed), suggested frequency should be two months or longer between each injection, provided that > 50% relief is obtained for two months • If neural blockade is applied for different regions, they may be performed at intervals of no sooner than one week and preferably two weeks for most types of procedures. • The therapeutic frequency may remain at intervals of at least two months for each region. It is further suggested that all regions be treated at the same time, provided all procedures can be performed safely. • In the treatment or therapeutic phase, the epidural injections should be repeated only as necessary according to medical necessity criteria, and it is suggested that these be limited to a maximum of four times per year. • Cervical and thoracic regions are considered as one region and lumbar and sacral are considered as one region. The ACOEM evidence-based practice guidelines on low back disorders 2011) state that epidural glucocorticosteroid injections are an option for acute or subacute radicular pain syndromes. The injection may provide short-term improvement to allow time to determine whether conservative care will succeed. Epidural steroid injections may be appropriate for radicular pain syndromes lasting at least three weeks, when there is no evidence of trending towards spontaneous resolution following treatment with NSAIDs. A second epidural steroid injection is not recommended if following the first injection there has been resolution of the symptoms of the acute radicular pain syndrome, particularly resolution of leg symptoms, or a decrease in symptoms to a tolerable level. If there has been no response to a first epidural injection, there would be no recommendation for a second injection. In patients who respond with three to six weeks of temporary, partial relief of leg pain, but who then have a worsening of leg pain and function, and who are not yet interested in surgical discectomy; a repeat epidural steroid injection is an option. Generally, there are not benefits beyond three injections for a given episode of radicular pain. The guideline also states that epidural steroid injections may be considered as a second-line treatment for acute flare-ups of spinal stenosis, when symptoms have persisted for one to two months despite treatment with NSAIDs and exercise. Epidural steroid injections are not recommended for acute, subacute or chronic low back pain in the absence of significant radicular symptoms.

Page 8 of 50 Coverage Policy Number: 0139

The ACOEM evidence-based guideline on cervical and thoracic spine disorders (2011) states that an epidural glucocorticosteroid injection is an option for acute or subacute radicular pain syndromes. This is a consensusbased recommendation; although the evidence was considered insufficient. Epidural glucocorticosteroid injections are not recommended for acute, subacute or chronic cervical pain in the absence of significant radicular symptoms, or for chronic cervicothoracic pain with radicular symptoms, due to insufficient evidence. ` The AANS guideline on injection therapies, low-back pain, and lumbar fusion (referenced above) concluded that there is no meaningful evidence in the medical literature that the use of epidural injections is of any long-term value in the treatment of patients with chronic low-back pain. The literature does indicate that the use of lumbar epidural injections can provide short-term relief in selected patients with chronic low-back pain. The American Society of Anesthesiologists has not published guidelines specific to the treatment of back or neck pain, but a practice guideline for chronic pain management was published by the ASA Task Force on Chronic Pain Management and the American Society of Regional Anesthesia (ASRA) and Pain Medicine in 2010. The guideline was based on scientific evidence, opinion-based evidence (i.e., expert opinion, membership opinion, and informed opinion). The level of evidence for individual recommendations is not specified. This guideline states that epidural steroid injections with or without local anesthetics may be used as part of a multimodal treatment regimen to provide pain relief in selected patients with radicular pain or radiculopathy. An assessment of the use of epidural steroid injections to treat radicular lumbosacral pain was published by the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology (Arnon et al., 2007) Recommendations and evidence were classified as follows: • • • • • • • •

A. Established as effective, ineffective, or harmful for the given condition in the specified population. (Level A rating requires at least two consistent Class I studies.) B Probably effective, ineffective, or harmful for the given condition in the specified population. (Level B rating requires at least one Class I study or at least two consistent Class II studies.) C: Possibly effective, ineffective, or harmful for the given condition in the specified population. (Level C rating requires at least one Class II study or two consistent Class III studies.) U: Data inadequate or conflicting; given current knowledge, treatment is unproven. Class I. Prospective, randomized, controlled clinical trial (RCT) with masked outcome assessment, in a representative population Class II. Prospective matched group cohort study in a representative population with masked outcome assessment that meets A–D above OR a RCT in a representative population that lacks one criterion A– D. Class III. All other controlled trials (including well-defined natural history controls or patients serving as own controls) in a representative population, where outcome is independently assessed, or independently derived by objective outcome measurement. Class IV. Evidence from uncontrolled studies, case series, case reports, or expert opinion.

The report included the following conclusions and recommendations. •

• •

Epidural steroid injections may result in some improvement in radicular lumbosacral pain when determined between 2 and 6 weeks following the injection, compared to control treatment (Level C, Class I–III evidence). The average magnitude of effect is small, and the generalizability of the observation is limited by the small number of studies, limited to highly selected patient populations, the few techniques and doses studied, and variable comparison treatments. In general, epidural steroid injections for radicular lumbosacral pain have shown no impact on average impairment of function, on need for surgery, or on long-term pain relief beyond 3 months. Their routine use for these indications is not recommended (Level B, Class I–III evidence). Data on use of epidural steroid injections to treat cervical radicular pain are inadequate to make any recommendation (Level U).

A North American Spine Society (NASS) Clinical Guideline for Multidisciplinary Spine Care, Diagnosis and Treatment of Degenerative Lumbar Spinal Stenosis, updated in 2011, includes recommendations for epidural steroid injections. Recommendations are rated as follows:

Page 9 of 50 Coverage Policy Number: 0139

• • • •

A: Good evidence (Level I studies with consistent findings) for or against recommending intervention. B: Fair evidence (Level II or III studies with consistent findings) for or against recommending intervention. C: Poor quality evidence (Level IV or V studies) for or against recommending intervention. I: Insufficient or conflicting evidence not allowing a recommendation for or against intervention.

The guideline includes the following recommendations: • Contrast-enhanced fluoroscopy is recommended to guide epidural steroid injections to improve the accuracy of medication delivery. Grade of recommendation: A • Interlaminar epidural steroid injections are suggested to provide short-term (two weeks to six months) symptom relief in patients with neurogenic claudication or radiculopathy. There is, however, conflicting evidence concerning long-term (21.5-24 months) efficacy. Grade of recommendation: B • A multiple injection regimen of radiographically-guided transforaminal epidural steroid injection or caudal injections is suggested to produce medium-term (3-36 months) relief of pain in patients with radiculopathy or neurogenic intermittent claudication (NIC) from lumbar spinal stenosis. Grade of recommendation: C The authors noted that the “multiple-injection” regimen utilized in newer studies should be distinguished from a “series” of injections used in older studies. In a multiple-injection protocol, a patient is a candidate for a repeat injection when pain recurs or becomes severe again. The purpose of this protocol is to control pain over a longer period of time to maximize the chance that the patient will respond to medical/interventional therapy. A series of injections generally consists of three injections performed at 24-hour or one week intervals regardless of symptoms. A North American Spine Society (NASS) Clinical Guideline for Multidisciplinary Spine Care, Diagnosis and Treatment of Cervical Radiculopathy (2010) includes the following recommendation for epidural steroid injections: •

Transforaminal epidural steroid injections using fluoroscopic or CT guidance may be considered when developing a medical-interventional treatment plan for patients with cervical radiculopathy from degenerative disorders. Due consideration should be given to potential complications. Grade of recommendation: C

Intradiscal steroid injections, in which glucocorticoids are injected directly into the intervertebral disc under fluoroscopy, has been proposed as a method to reduce the degree of disc herniation and/or produce an inflammatory response. According to The ACOEM evidence-based practice guidelines on low back disorders (2011) intradiscal steroid injections are not recommended for the management of acute low back pain. The available evidence indicates that intradiscal steroid injections are not effective. There is no quality evidence that these injections improve on the natural history of the condition, or that they provide a treatment benefit compared to no treatment or treatment with epidural steroids. In addition, these injections may cause discitis, progression of disc degeneration, and calcification of the intervertebral disc. The guideline also states that intradiscal steroids are moderately not recommended for subacute or chronic low back pain. There is insufficient evidence in the published medical literature to determine the safety and efficacy of Intradiscal steroid injection for the treatment of back pain. Facet joint injections/facet blocks (e.g., medial branch blocks) have been used to treat back pain and/or to help determine whether the facet joint is a source of pain. Facet joints (i.e., zygapophysial joints) are located in the posterior compartment of the spinal column, and provide stability and allow the spine to bend and twist. Facet joints are well innervated by the medial branches of the dorsal rami, and can be subjected to significant strain during spine loading. Facet joints are thought to be a common source of chronic back pain. A diagnostic facet joint injection involves fluoroscopy-guided injection of local anesthetic with or without a steroid into the facet joint or around the nerve supply to the joint (i.e., medial branch nerve). A diagnostic facet joint

Page 10 of 50 Coverage Policy Number: 0139

injection may be used to identify the source of spinal pain. If pain is relieved following the injection, the pain is presumed to be of facet joint origin, although the accuracy of this diagnostic method has not been definitely determined. Therapeutic facet joint injections of an anesthetic and corticosteroid have been proposed as treatment of pain considered to be of facet joint origin (i.e., significant relief following a diagnostic injection). The Canadian Agency for Drugs and Technology in Health (CADTH) rapid response report, Facet Joint Injection as Diagnostic and Therapeutic Tools for Pain of the Cervical and Lumbar Spine: A Review of Clinical and CostEffectiveness, was published in 2011. The report was based on evaluation of six systematic reviews, one randomized controlled trial, and five non-randomized studies. The clinical efficacy of diagnostic cervical and lumbar diagnostic facet joint injections was unclear. Some evidence suggests that false positive rates are approximately 30-60%, which could limit the clinical utility of diagnostic injections. There was some evidence of short-term benefit of therapeutic lumbar facet joint injections for relief of low back pain, but evidence of longerterm benefit was unclear. The majority of evidence was based on patients who failed to respond to conventional treatment, and generalizability to the broader population with lumbar facet joint pain is unknown. The literature does not support the use of therapeutic cervical facet joint injections for neck pain. The report concluded that overall, evidence of the diagnostic accuracy and clinical effectiveness of lumbar and cervical facet joint injections is conflicting and subject to a number of limitations. Therefore, the diagnostic accuracy and clinical effectiveness of lumber and cervical facet joint injections remains largely unknown. The results of the Cochrane systematic review of the effects of injection therapy involving epidural, facet or local sites, discussed above (Staal, et al. 2008), indicated that there was no strong evidence for or against the use of any type of injection therapy. The authors concluded that there is insufficient evidence to support the use of injection therapy in subacute and chronic low back pain, but it cannot be ruled out that specific subgroups of patients may respond to a specific type of injection therapy. The ASIPP guideline referenced above (Manchicanti, et al., 2013) includes the following recommendations: Low back pain • Diagnostic:  The evidence for diagnostic lumbar facet joint nerve blocks is good with 75% to 100% pain relief as the criterion standard with controlled local anesthetic or placebo blocks.  Diagnostic lumbar facet joint nerve blocks are recommended in patients with suspected facet joint pain. • Therapeutic  The evidence is fair to good for lumbar facet joint nerve blocks, and limited for intraarticular injections.  Among the therapeutic facet joint interventions either conventional radiofrequency neurotomy or therapeutic facet joint nerve blocks are recommended after the appropriate diagnosis with controlled diagnostic lumbar facet joint blocks. Neck pain • Diagnostic  The evidence for diagnostic cervical facet joint nerve blocks is good with a criterion standard of 75% or greater relief with placebo or local anesthetic controlled diagnostic blocks.  Diagnostic cervical facet joint nerve blocks are recommended for the diagnosis of cervical facet joint pain. • Therapeutic  The evidence is fair for cervical medial branch blocks, and limited for cervical intraarticular injections  Therapeutic facet joint nerve blocks are recommended in managing chronic neck pain after the appropriate diagnosis from controlled diagnostic blocks. Thoracic pain • Diagnostic  The evidence for diagnostic accuracy of thoracic facet joint nerve blocks is good with a criterion standard of at least 75% pain relief with placebo or local anesthetic controlled diagnostic blocks.

Page 11 of 50 Coverage Policy Number: 0139



•

The diagnostic thoracic facet or zygapophysial joint nerve blocks are recommended in the diagnosis of chronic thoracic pain. Therapeutic  The evidence is fair for therapeutic thoracic facet or zygapophysial joint nerve blocks, limited for radiofrequency neurotomy, and none for thoracic intraarticular injections  Therapeutic thoracic facet or zygapophysial joint nerve blocks are recommended. However, radiofrequency neurotomy and conventional radiofrequency neurotomy may be performed based on emerging evidence.

The ASA Task Force on Chronic Pain Management/ASRA and Pain Medicine guideline on chronic pain management states that diagnostic medial branch blocks or facet joint injections may be considered for patients with suspected facet-mediated pain to screen for subsequent therapeutic procedures, and that intra-articular facet joint injections may be used for the symptomatic relief of facet mediated pain. The guideline also states that Intra-articular facet injections may be used for the symptomatic relief off facet-mediated pain. As stated above, the guideline was based on scientific evidence, opinion-based evidence (i.e., expert opinion, membership opinion, and informed opinion). The level of evidence for individual recommendations is not specified. The ACOEM evidence-based practice guidelines on low back disorders (2011) states that one diagnostic facet joint injection may be recommended for patients with chronic low back pain that is significantly exacerbated by extension and rotation or associated with lumbar rigidity, and is not alleviated with other conservative treatments e.g., NSAID, progressive aerobic exercises, other exercises, and manipulation). This diagnostic injection may determine whether specific interventions targeting the facet joint are recommended. Repeated diagnostic injections in the same location are not recommended. The guideline states that therapeutic facet joint injections are not recommended for acute, subacute, or chronic low back pain or for any radicular pain syndrome. The guideline also states that there is no recommendation for or against the use of therapeutic facet joint injections for treatment of flare ups of chronic low back pain, and that therapeutic facet joint injections are moderately not recommended for routine treatment of chronic non-specific axial pain. Repeat use of intraarticular therapeutic facet joint injections are moderately not recommended for patients who have failed to achieve lasting functional improvements with a prior injection. The AANS guideline on injection therapies, low-back pain, and lumbar fusion (referenced above) concluded that there is evidence that suggests that facet joint injections can be used to predict outcome of radiofrequency ablation of a facet joint. No evidence exists, however, to support the effectiveness of facet injections in the treatment of patients with chronic low-back pain. SI joint injection of anesthetic and steroid, performed under fluoroscopic guidance, has been proposed as a method to confirm that pain originates from the SI joint. The SI joint lies between the sacrum and the ileum, and functions more for stability than for movement. The joint’s stability is maintained in part by several large ligaments and muscle groups. Pain may arise in this highly innervated joint or in the related muscles and ligaments. Pain may be felt in the lower back or may radiate to one or both hips and/or one or both legs. If the injection does not alleviate the pain, alternative diagnoses may be considered (ECRI, 2008). The ASIPP guidelines referenced above (Manchicanti, et al., 2013, include the following conclusions: Diagnostic: • The evidence for diagnostic intraarticular sacroiliac joint injections is good with 75% to 100% pain relief as the criterion standard with controlled local anesthetic or placebo blocks, and fair due to the limitation of the number of studies with 50% to 74% relief with a dual block. • Controlled sacroiliac joint blocks with placebo or controlled comparative local anesthetic blocks are recommended when indications are satisfied with suspicion of sacroiliac joint pain Therapeutic • The evidence is limited for sacroiliac intraarticular steroid injections; and limited for periarticular injections with steroids or botulinum toxin • Due to emerging evidence for intraarticular injections, they are recommended in select cases with or without periarticular injections. Cooled radiofrequency neurotomy is recommended after appropriate diagnosis confirmed by diagnostic sacroiliac joint injections.

Page 12 of 50 Coverage Policy Number: 0139

The ACOEM evidence-based practice guidelines on low back disorders (2011) state that SI joint injections are not recommended for acute low back pain, including low back pain thought to be SI joint related, or for subacute or chronic non-specific low back pain, including pain attributed to the SI joint, but without evidence of inflammatory sacroiliitis. The guideline also states that SI joint injections are not recommended for treatment of any radicular pain syndromes, and recommends SI joint injections as a treatment option only for patients with a specific known cause of sacroiliitis (i.e., proven rheumatologic inflammatory arthritis involving the SI joint). The ASA Task Force on Chronic Pain Management /ASRA and Pain Medicine guideline on chronic pain management states that diagnostic SI joint injections or lateral branch blocks may be considered for the evaluation of patients with suspected SI joint pain, and that SI joint injection may be considered for the symptomatic relief of sacroiliac joint pain. American Pain Society: The following recommendations are included in an evidence-based clinical practice guideline from the American Pain Society, Interventional Therapies, Surgery, and Interdisciplinary Rehabilitation for Low Back Pain (Chou et al., 2009): • • • •

•

There is insufficient evidence to evaluate the validity or utility of diagnostic selective nerve root block, intra-articular facet joint block, medial branch block, or sacroiliac joint block as diagnostic procedures for low back pain with or without radiculopathy. In patients with persistent nonradicular low back pain, facet joint corticosteroid injection, and intradiscal corticosteroid injection are not recommended There is insufficient evidence to adequately evaluate benefits of local injection, epidural steroid injection, therapeutic medial branch block, radiofrequency denervation, or sacroiliac joint steroid injection, for nonradicular low back pain. In patients with persistent radiculopathy due to herniated lumbar disc, it is recommended that clinicians discuss risks and benefits of epidural steroid injection as an option. It is recommended that shared decision-making regarding epidural steroid injection include a specific discussion about inconsistent evidence showing moderate short-term benefits, and lack of long-term benefits. There is insufficient evidence to adequately evaluate benefits and harms of epidural steroid injection for spinal stenosis.

The authors recommend consideration of interdisciplinary rehabilitation with a cognitive/behavioral emphasis as a treatment option in patients with nonradicular low back pain who do not respond to usual, non-interdisciplinary interventions. Guidance for Injections Guidance is not needed for trigger point injections, since the injection is made into skeletal muscle tissue. The use of fluoroscopy for diagnostic and therapeutic epidural injections is recommended, however, for several reasons. Injections performed without fluoroscopic guidance are not always made into the epidural space or the intended interspace. Needle misplacement has been estimated to occur in 40% of caudal and 30% of lumbar epidural injections when done without fluoroscopic guidance. Accidental intravascular injections may also occur. In addition, if anatomical anomalies, such as a midline epidural septum or multiple separate epidural compartments are present, flow of medication to the presumed pain generator is restricted and remains undetected without fluoroscopy. Finally, if an injection fails to relieve pain, it would not be possible to determine whether the failure was caused by a poor response or by improper needle placement (Canale and Beaty, 2012). Ultrasound (US) guidance has been proposed as an alternative to fluoroscopic guidance. A randomized controlled trial by Park et al (2013) compared the short-term effects and advantages of ultrasound-guided caudal epidural steroid injections with fluoroscopy guided injections for lumbar radicular pain (n=120)..There was no significant difference in treatment effects between the groups at two weeks and twelve weeks. US has also been proposed as an alternative to fluoroscopy or CT guidance for facet injections. Facet joint injections are typically performed using fluoroscopic guidance in order to identify the target facet joint and surrounding structures and to ensure accurate needle placement. A randomized controlled trial by Obernauer et al. (2012) evaluated the accuracy, time-saving, radiation doses and pain relief of ultrasound guided facet joint injections compared to CT guided injections. The accuracy of ultrasound-guided interventions was 100%.The mean time to final needle placement was significantly shorter in the US group compared to the CT group

Page 13 of 50 Coverage Policy Number: 0139

(p 50% relief is obtained for 10–12 weeks. It is suggested that all regions be treated at the same time, provided all procedures can be performed safely. ASA Task Force on Chronic Pain Management and the American Society of Regional Anesthesia (ASRA) and Pain Medicine (2010) states that other treatment modalities should be attempted before the consideration of ablative techniques, and includes the following recommendations: •

Conventional (e.g., 80°C) or thermal (e.g., 67°C) radiofrequency ablation of the medial branch nerves to the facet joint should be performed for low back (medial branch) pain when previous diagnostic or therapeutic injections of the joint or medial branch nerve have provided temporary relief.

•

Conventional radiofrequency ablation may be performed for neck pain.

•

Water-cooled radiofrequency ablation may be used for chronic sacroiliac joint pain.

•

Chemical denervation (e.g., alcohol, phenol, or high concentration local anesthetics) should not be used in the routine care of patients with chronic noncancer pain.

•

Cryoablation may be used in the care of selected patients (e.g., postthoracotomy pain syndrome, low back pain [medial branch], and peripheral nerve pain).

•

Conventional or other thermal radiofrequency ablation of the dorsal root ganglion should not be routinely used for the treatment of lumbar radicular pain.

The guideline was based on scientific evidence, opinion-based evidence (i.e., expert opinion, membership opinion, and informed opinion). The level of evidence for individual recommendations is not specified. Several alternatives to percutaneous radiofrequency denervation have been proposed, including pulsed radiofrequency (discussed below), cooled radiofrequency, cryoneurolysis, laser ablation, and chemical ablation, in which a neurolytic substance (e.g., alcohol, phenol, glycerol) is injected into the affected nerve root. An alternative method of denervation using an endoscopic approach (i.e., endoscopic dorsal ramus rhizotomy) has also been proposed. There is insufficient evidence in the published medical literature to determine the safety and efficacy of these emerging alternative modalities or approaches compared to radiofrequency denervation for the treatment of spinal pain. Sacroiliac (SI) Joint Radiofrequency Denervation/Radiofrequency Ablation (RFA)/Radiofrequency Neurotomy: As discussed above. radiofrequency denervation of facet joints has been used to treat spinal pain presumed to be of facet origin. Thermal/conventional RFA as well as cooled radiofrequency have also been explored for the treatment of SI joint pain. The sensory innervation of the SI joint has not been defined as Page 16 of 50 Coverage Policy Number: 0139

definitively as that of the lumbar facet joints, however. Most of the posterior sensory innervation is thought to be transmitted from the S1, S2, and S3 dorsal rami via the lateral branches, as well as though medial branches from the L4 and L5 dorsal rami (Ayden, 2010). Evaluation of radiofrequency neurotomy was included in systematic review of the therapeutic effectiveness of SI joint interventions (Hansen et al., 2012). The authors concluded that the evidence was fair for cooled radiofrequency neurotomy. Limitations of the review included a paucity of literature on therapeutic interventions, variations in technique, and variable diagnostic standards for SI joint pain. Aydin et al. (2010) conducted a meta-analysis to assess the effectiveness of RFA of the SI joint for pain relief at three and six months. Ten articles were included in the analysis. Different techniques and combinations of different nerve lesions were used in the included studies. The authors noted that no standards have been established for the specific nerves to ablate, the type of technique, or the type of RFA. The primary outcome measure was a reduction in pain by ≥ 50%. Analysis was conducted on seven groups from six studies. At three and six month follow-up, half or greater of the patients treated with RFA of the SI joint met the outcome measure of ≥ 50%.reduction in pain. The authors concluded that RFA of the SI joint appears to have a role in the treatment of patients with SI joint pain refractory to more conservative measures. The study is limited, however, by the available literature and lack of randomized controlled trials. Evaluation of radiofrequency neurotomy was included in a systematic review of the therapeutic effectiveness of SI joint interventions (Hansen et al., 2012). Limitations of the review included a paucity of literature on therapeutic interventions, variations in technique, and variable diagnostic standards for SI joint pain. The authors concluded that the evidence was poor for conventional and pulsed radiofrequency neurotomy. According to the ASIPP practice guidelines referenced above (Manchicanti, et al., 2013), the evidence is limited for sacroiliac conventional radiofrequency neurotomy. There is insufficient evidence in the published medical literature to demonstrate the safety and efficacy of SI joint radiofrequency ablation (RFA) or ablation of lumbar or sacral dorsal rami for the treatment of SI joint pain. Pulsed Radiofrequency Pulsed radiofrequency has been introduced as a nonablative alternative to RFA. Pulsed radiofrequency delivers short bursts of radiofrequency current rather than the continuous flow utilized in standard RFA. Pulsed radiofrequency allows the tissue to cool between bursts, resulting in lower maximum temperatures compared to continuous radiofrequency. This technique is reported to reduce the risk of destruction of neighboring tissue. It does not destroy targeted nerves and therefore requires less precise electrode placement. The mechanism of action of pulsed radiofrequency is not well understood. It has been hypothesized that electrical fields reversibly disrupt the transmission of nerve impulses across small unmyelinated fibers, but the fibers are not destroyed, and larger fibers are not affected Studies of pulsed radiofrequency consist primarily of small trials with limited follow-up. Most studies are case series in which the safety and efficacy of pulsed radiofrequency cannot be evaluated against alternative treatment methods (Vallejo et al., 2006; Lindner et al., 2006; Martin et al., 2007). Van Zundert et al. (2007) conducted a randomized sham-controlled trial evaluating pulsed radiofrequency for the treatment of chronic cervical radicular pain. Of 256 patients screened, 23 met the inclusion criteria. Patients were eligible if they reported neck pain radiating over the posterior shoulder to the arm persisting for > six months, had symptoms suggestive of cervical spinal nerve involvement, and were unresponsive to conventional therapy. The primary outcome was comprised of three measures three months after the intervention: success defined as at least 50% pain improvement of the global perceived effect (GPE); a reduction of at least 20% in the VAS pain score; and reduced pain medication intake. An improvement of the GPE of at least 50% was achieved in 9/11 (82%) patients in the radiofrequency group and 4/12 (33%) in the sham group (p=0.03). A reduction of at least 20% in the VAS pain score was seen in 9/11 patients in the radiofrequency group (82%) compared to 3/12 (25%) in the sham group (p=0.02). A reduction in pain medication intake was noted in the radiofrequency group, but no significance was reached at three months. The need for pain medication was significantly reduced in the pulsed radiofrequency group after six months, however. The authors concluded that pulsed radiofrequency treatment of the cervical dorsal root ganglion may provide pain relief for a limited number of carefully selected patients. The authors stated that, since percutaneous pulsed radiofrequency is presumed to Page 17 of 50 Coverage Policy Number: 0139

be less neurodestructive, this approach may have a better risk/benefit ratio than continuous radiofrequency lesioning, but this hypothesis needs to be confirmed in larger observational studies. Tekin et al. (2007) conducted a randomized, controlled double-blind trial to compare conventional and pulsed radiofrequency denervation for treatment of chronic facet joint pain. Patients over age 17, with symptoms of greater than six months duration, were randomized to treatment with continuous radiofrequency (n=20), treatment with pulsed radiofrequency (n=20), or to a control group (n=20). Patients in the control group received local anesthetic alone. Radiofrequency treatment was subsequently made available to patients in the control group who experienced no pain relief. Pain relief was evaluated using a VAS and Oswestry Disability Scale (ODI) prior to the procedure, at the time of the procedure, and six and twelve months post-procedure. Preprocedure VAS and ODI scores were similar in all groups. Mean pre-procedure VAS and ODI scores were higher than all post-procedure scores in all groups. Mean VAS and ODI scores were lower in both radiofrequency groups than in the control group at the post-procedure evaluation. The decrease in pain was maintained in the continuous radiofrequency group at six months and one year but was not maintained in the pulsed radiofrequency group. Analgesic usage was lower and patient satisfaction was higher in the continuous radiofrequency group. The 2013 ASIPP practice guideline, Interventional Techniques in the Management of Chronic Spinal Pain, states that the evidence is limited for lumbar pulsed radiofrequency. There is insufficient evidence in the published medical literature to demonstrate the safety and efficacy of pulsed radiofrequency in the treatment of spinal pain. Studies published to date do not allow conclusions regarding the safety, efficacy, and duration of effect of this technique. Additional well-designed trials are needed to determine how this treatment compares to other medical and surgical treatments for chronic spinal pain. Percutaneous and Endoscopic Laminectomy and Disc Decompression Procedures Automated Percutaneous Lumbar Discectomy (APLD)/Automated Percutaneous Nucleotomy: Automated percutaneous lumbar discectomy (APLD), also referred to as automated percutaneous nucleotomy, is a minimally-invasive surgical procedure used in the treatment of herniated lumbar intervertebral discs. In this procedure, a cannula is placed in the center of the disc under fluoroscopic guidance using a posterolateral approach. A probe connected to an automated cutting and aspiration device is then introduced through the cannula. The disc is then aspirated until no more nuclear material is obtained (NICE, 2004) A systematic review by Manchikanti et al. (2013) evaluated the use of automated percutaneous mechanical lumbar discectomy for treatment of contained herniated lumbar discs. The primary outcome was pain relief; secondary outcome measures were functional improvement, improvement of psychological status, opioid intake, and return to work. Nineteen observation studies were included; of the three randomized trials reviewed, none met inclusion criteria for methodological quality assessment. The authors stated that, due to the lack of randomized trials. The evidence is limited for automated percutaneous mechanical lumbar discectomy, but the procedure may provide appropriate relief in properly selected patients with contained lumbar disc herniation. Manchikanti et al. (2013) conducted a systematic review to evaluate the evidence for percutaneous disc decompression (PDD) with Dekompressor in the management of chronic low back and lower extremity pain. The primary outcome was pain relief; secondary outcome measures included functional improvement, improvement of psychological status, opioid intake, and return to work. The authors stated that the evidence of effectiveness is limited, but the procedure may be recommended for patients with persistent pain after failure of other intervention techniques when microdiscectomy is not indicated. Hirsch et al. (2009) conducted a systematic evaluation of the literature to determine the effectiveness of APLD. The primary outcome measure was pain relief; short term effectiveness was defined as significant (>50%) pain relief at six months, and long term effectiveness was defined as significant pain relief at one year. Other outcome measures included functional improvement, improvement in psychological status, and return to work. The authors concluded that this systematic review indicates Level II-2 evidence for APLD; APLD may provide appropriate relief in properly selected patients with contained lumbar disc prolapse. (Level II-2 evidence, as defined by the U.S. Preventive Services Task Force as evidence obtained from well-designed cohort or casecontrol analytic studies, preferably from more than one center or research group.). The authors acknowledged the paucity of randomized controlled trials in the literature as a limitation. Page 18 of 50 Coverage Policy Number: 0139

A Cochrane review of surgery for lumbar disc prolapse, published in 2003 and updated in 2007 (Gibson and Waddell), assessed the effects of available surgical interventions and states that trials of APLD suggest that clinical outcomes are at best fair and certainly worse than microdiscectomy, although the importance of patient selection is acknowledged. The authors stated that there is a need for high-quality randomized controlled trials on APLD and for long-term studies into the effects of surgery on the lifetime natural history of disc disease. The Cochrane review concluded that unless or until better scientific evidence is available, APLD should be regarded as a research technique. An ECRI Health Technology Assessment on automated percutaneous nucleotomy (ECRI, 2004) concluded that the available evidence does not favor the use of automated percutaneous nucleotomy over microdiscectomy for treatment of patients with symptomatic herniated lumbar discs. The procedure leads to inferior combined pain and function scores compared to microdiscectomy, and it is more likely to fail, requiring additional surgery. The strength of evidence supporting these conclusions is weak, however due to the low number of studies and small number of patients. ASIPP 2013 Practice Guidelines for the Management of Chronic Spinal Pain, state that the evidence is limited to fair for APLD, and that the procedure is recommended in select cases. American College of Occupational and Environmental Medicine (ACOEM) evidence-based practice guidelines on low back disorders, surgical considerations (2011) states that there is no quality evidence that automated percutaneous discectomy is an effective treatment for any back or radicular pain problem. There is insufficient evidence in the peer-reviewed medical literature to support the safety and efficacy of APLD. Results of published studies are inconsistent and do not demonstrate long-term improvement. There is no evidence that APLD is as effective as discectomy/microdiscectomy. Laser Discectomy (Percutaneous or Laparoscopic)/, Laser Disc Decompression/Laser Assisted Disc Decompression (LADD): Laser-assisted discectomy, also called laser-assisted disc decompression (LADD) or laser disc decompression, is a minimally-invasive procedure proposed as an alternative to discectomy/microdiscectomy. It is intended to provide symptomatic relief of pain cause by a contained herniated intervertebral disc. Laser light energy is used to vaporize part of the nucleus pulposus, resulting in a reduction in intradiscal pressure. Several approaches may be used, depending on the location of the disc and type of laser being used. With one method, a needle is inserted percutaneously into the disc approximately one centimeter (cm) posterior to the disc center, and a flexible optical quartz fiber is threaded through the needle into the disc, delivering laser energy to vaporize and coagulate the nucleus pulposus. In the laparoscopic approach, a trocar is inserted periumbilically and the abdomen is inflated with carbon dioxide. Additional trocars are placed above the pelvic brim. The large and small bowels are retracted, and the iliac bifurcation is identified. The posterior peritoneum is opened and retracted. The L5-S1 interspace is identified and its margins confirmed by x-ray. The annulus of the disc is opened and excised with the neodymium: yttrium-aluminum-garnet (Nd: YAG) laser. A review of the literature published by Schenck et al. (2006) evaluated 16 clinical trials representing a total of 1579 patients. Most were case series with small sample sizes, making interpretation of success rates difficult. Generalization of the results into general clinical practice remains difficult due to different inclusion and exclusion criteria, laser types, and outcome measures as well as the variation in duration of follow-up. These shortcomings prevent a valid comparison to studies evaluating the outcome of conventional surgical treatment for lumbar disc herniation. The authors concluded that well-designed research of sufficient scientific strength comparing percutaneous laser disc decompression to both conventional surgery and conservative management is needed to determine whether this procedure has a role in the treatment of lumbar disc herniation. An ECRI Health Technology Assessment (2004) evaluating laser discectomy for the treatment of herniated lumbar discs noted a lack of controlled trials comparing this procedure to either continued conservative care or other operative procedures such as open discectomy or microdiscectomy. Since laser discectomy is considered an alternative to open discectomy, the absence of a trial comparing these procedures is noteworthy. The authors stated that controlled trials are important when evaluating pain-relieving treatments to determine the influence of nonspecific effects and regression to the mean on pain-related outcome measures. Considering the natural history of herniated lumbar discs, pain relief may be as likely without invasive treatment as with invasive

Page 19 of 50 Coverage Policy Number: 0139

treatment. A controlled trial is needed to determine the actual extent to which laser discectomy achieves pain relief beyond the natural course of the disorder. An ECRI Health Technology Assessment (2009) evaluating percutaneous disc decompression for cervical disc herniation focused on techniques that remove or ablate the nucleus pulposus, including APLD, percutaneous laser discectomy, and plasma disc decompression (PDD), also referred to as nucleoplasty. The report states that one low-quality small study and one moderate-quality randomized controlled trial suggest that percutaneous decompression reduces pain more than conservative medical or physical therapy. Differences in reporting between the two studies and the poor reporting of one study prevent conclusive determination of whether this effect is statistically significant or clinically meaningful. The randomized trial suggested significantly improved quality of life and reduced disability with percutaneous discectomy, but results of a single study cannot be used to draw firm evidence-based conclusions. The authors noted that no evidence addressed the questions of how the efficacy of percutaneous cervical disc decompression compares with other surgical procedures or how efficacy outcomes compare among different methods of percutaneous disc decompression. A Cochrane systematic review of surgery for lumbar disc prolapse, published in 2003 and updated in 2007 (Gibson and Waddell), assessed the effects of available surgical interventions and states that trials of laser discectomy suggest that clinical outcomes are at best fair and certainly worse than microdiscectomy, although the importance of patient selection is acknowledged. The authors stated that there is a need for high-quality, randomized controlled trials on laser discectomy and for long-term studies into the effects of surgery on the lifetime natural history of disc disease. The Cochrane Review further concluded that unless or until further scientific evidence is available, laser discectomy should be regarded as a research technique. Updated ASIPP Practice Guidelines for the Management of Chronic Spinal Pain (2013) state that the evidence for percutaneous lumbar laser disc decompression is limited. ACOEM evidence-based practice guidelines on low back disorders, surgical considerations (2011) states that there is no quality evidence that laser discectomy is an effective treatment for any back or radicular pain problem. There is insufficient evidence in the published medical literature to demonstrate the safety, efficacy and longterm outcome of laser discectomy. There are no randomized controlled trials that evaluate laser discectomy and compare this procedure to established treatment methods. Endoscopic Anterior Spinal Surgery / Yeung Endoscopic Spinal Surgery (YESS) / Selective Endoscopic Discectomy: The Yeung Endoscopic Spinal System (Richard Wolf Surgical Instrument Corporation) is a specialized endoscope developed for percutaneous spinal endoscopy and discectomy. This endoscope has multi-channel inflow and outflow ports, allowing visualization through one port and suction or other therapeutic services through the working port. The YESS is also used for other spinal procedures, including arthroscopic microdiscectomy, radiofrequency ablation, injection of intraoperative steroids, and laser disc decompression and ™ ablation. Selective Endoscopic Discectomy (SED), performed with the YESS endoscope, is used to shrink and remove herniated discs. ™

™

Disc-FX System (Elliquence LLC, Baldwin, NY): The Disc-FX system is a single-use disposable kit used to perform minimally invasive lumbar disc procedures, including endoscopic disc decompression, nucleus ablation and annulus modulation.) There is a steep learning curve for procedures used to access and treat lesions with endoscopic guidance. The purported advantages of endoscopic discectomy or its superiority over microsurgical discectomy have not been demonstrated in the medical literature. There are no prospective controlled clinical trials of the YESS or the Disc FX system, nor are there any prospective studies with long-term follow-up. The efficacy of endoscopic spinal surgery and surgery with the YESS or Disc FX System has not been established in the peer-reviewed medical literature. ®

®

The mild Procedure: The mild Device Kit (Vertos Medical, Inc., Aliso Viejo, CA) received U.S. Food and Drug Administration (FDA) approval on February 4, 2010. The device kit is set of specialized arthroscopic surgical instruments intended to be used to perform lumbar decompressive procedures for the treatment of various spinal conditions. The mild device is used for image-guided minimally invasive lumbar decompression, referred Page 20 of 50 Coverage Policy Number: 0139

to as the mild (minimally invasive lumbar decompression) procedure. The procedure is performed under fluoroscopic guidance through a dorsal approach to the spine. The instruments are inserted and positioned on the posterior spinal lamina, to the left or right of the spinous process. The tools are used to cut and remove tissue and bone from the posterior side of the lumbar spine to create a space inside the spine that can help ® decompress some of the spinal nerves. The mild procedure has been proposed as a minimally invasive alternative to conservative treatment or surgical decompression for the treatment of lumbar spinal stenosis. Chopko (2013) reported two-year outcomes of mild lumbar decompression in the treatment of patients with neurogenic claudication associated lumbar spinal stenosis. The study included 45 of 58 patients included in an earlier analysis of one-year results Of the 13 patients unavailable at two years and not included in the two-year cohort, 3 underwent lumbar spine surgery, one died of unrelated causes, and nine did not respond or withdrew from the study. Outcome measures included the Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and Zurich Claudication Questionnaire (ZCQ). At two years, VAS improved from an average of 7.2 at baseline to a mean of 4.8 (p