Spinal Orthoses. Medical Coverage Policy. Table of Contents. Related Coverage Resources. Coverage Policy

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1 Medical Coverage Policy Effective Date...11/15/2017 Next Review Date...11/15/2018 Coverage Policy Number Spinal Orthoses Table of Contents Coverage Policy... 1 Overview... 2 General Background... 2 Coding/Billing Information... 8 References Related Coverage Resources Lumbar Fusion for Spinal Instability and Degenerative Disc Conditions, including Sacroiliac Fusion Mechanical Devices for the Treatment of Back Pain Minimally Invasive Intradiscal/ Annular Procedures and Trigger Point Injections Percutaneous Vertebroplasty, Kyphoplasty and Sacroplasty Physical Therapy INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. 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. Coverage Policy Coverage for spinal orthoses is subject to the terms, conditions and limitations of the applicable benefit plan s External Prosthetic Appliances and Devices (EPA) or Durable Medical Equipment (DME) benefit and schedule of copayments. Please refer to the applicable benefit plan document to determine benefit availability and the terms, conditions and limitations of coverage. Under many benefit plans, coverage for EPA and DME is limited to the lowest-cost alternative. A spinal orthosis (e.g., cervical orthosis, cervical-thoracic orthosis, thoracic orthosis, thoracic-lumbarsacral orthosis, lumbar-sacral orthosis, lumbar orthosis) is considered medically necessary for ANY of the following indications: when mobility restriction is necessary to alleviate pain of spinal origin postoperatively or post-injury to facilitate healing of the spine or related soft tissues as support for weak spinal musculature or a spinal deformity that significantly impacts the ability to perform activities of daily living Repair and Replacement Repair and/or replacement of a spinal orthosis is considered medically necessary under the following circumstances: Page 1 of 18

2 when anatomical change or reasonable wear and tear renders the item nonfunctional and the repair will make the equipment usable. when anatomical change or reasonable wear and tear renders the item nonfunctional and nonrepairable. Repair or replacement is considered not medically necessary when a spinal orthosis becomes unusable or non-functioning because of misuse, abuse or neglect. Not Covered A spinal orthosis for ANY other indication, including the following is considered not medically necessary: when used primarily for improved athletic performance or sports participation to prevent injury in an otherwise uninjured body part as a preoperative diagnostic tool prior to lumbar fusion surgery duplicate orthoses for use as spare devices The following do not address an underlying physical condition, are considered convenience/comfort items and not medically necessary: prophylactic elastic lumbar supports (e.g., tool belts, lumbar belt) inflatable lumbar support pillows/cushions back rest supports protective body socks SpineCor brace for the treatment of any condition is considered experimental, investigational or unproven. Overview This Coverage Policy addresses orthotic devices related to the spine. General Background Back pain is a common ailment that affects individuals of all ages and may result from conditions including, but not limited to, injury, obesity, age, disc disease, spinal stenosis, spinal sprains and strains. Back pain treatments include short-term rest, nonsteroidal anti-inflammatory drugs, muscle relaxants, back braces/spinal orthotics and passive modalities such as heat, cold, massage, ultrasound, electrical stimulation, acupuncture, traction, and spinal manipulation. More invasive treatments may involve anesthetic injections and surgery. All spinal orthoses are categorized as class I devices by the US Food and Drug Administration (FDA). Biomechanics Orthotic devices are orthopedic appliances or apparatuses used to support, align, prevent or correct deformities. A brace is an orthosis or orthopedic appliance that supports or holds in correct position any movable part of the body and that allows for motion of that body part. A spinal orthosis can be designed to control gross movement of the trunk and intersegmental motion of the vertebrae in one or more planes of motion: lateral/flexion (side bending) in the coronal/frontal plane flexion (forward bending) or extension (backward bending) in the sagittal plane axial rotation (twisting) in the transverse plane If the device does not provide control of motion in one or more planes, or if it does not provide intracavitary pressure, then the item should not be considered a spinal orthosis. Sagittal control is achieved by a rigid Page 2 of 18

3 posterior panel. Coronal control is achieved by a rigid panel in the mid-axillary line (which may be either an integral part of a posterior or anterior panel or a separate panel). Transverse control is achieved by one of the following structural features: a rigid panel in the upper sternal area which is an integral part of an anterior shell a rigid panel in the upper sternal area which is rigidly attached to a rigid abdominal or posterior panel rigid extensions form a rigid posterior panel to the upper anterior chest bilaterally Usage of orthotics depends on the amount of stabilization or support required. Spinal orthoses may be flexible, rigid or semi-rigid. Conditions for which spinal orthoses have been recommended for relieving pain, reducing progression of disease/injury, and improving function include but are not limited to spinal stenosis, vertebral fractures, scoliosis, spondylosis, spondylolisthesis, Scheuermann s disease (kyphotic deformity), and sprains. Spinal orthoses include cervical orthoses (CO), cervical-thoracic orthoses, (CTO), thoracic orthoses (TO), thoracic-lumbar-sacral orthoses, (TLSO), lumbar-sacral orthoses (LSO), and lumbar orthoses (LO). Prefabricated, Pre-fitted, Custom-fabricated Spinal orthoses may be prefabricated, pre-fitted, or custom-fabricated. A prefabricated orthosis is one that is manufactured in quantity without a specific patient in mind. A prefabricated orthosis can be modified (e.g., trimmed, bent or molded) for use by a specific patient and is then considered a custom-fitted orthosis. An orthosis that is made from prefabricated components is considered a prefabricated orthosis. Any orthosis that does not meet the standard definition of custom-fabricated is considered to be a prefabricated device. A custom-fabricated orthosis is one that is specifically made for an individual patient, starting with the most basic materials that may include plastic, metals, leather or various cloths. The construction of these devices requires substantial labor such as cutting, bending, molding and sewing, and may even involve the use of some prefabricated components. A molded-to-patient model orthosis is a type of custom-fabricated device for which an impression of the specific body part is made (e.g., by means of a plaster cast, or CAD-CAM [computer-aided design] technology). The impression is then used to make a specific patient model. The actual orthosis is molded from the patient-specific model. Unmodified, prefabricated orthoses are generally used in treating conditions prior to a custom-fitted orthosis (prefabricated orthoses that are modified by bending or molding for a specific patient). Custom-fitted orthoses are generally attempted prior to the use of custom-fabricated orthoses (individually constructed from materials). A custom-fitted orthosis may be required initially for conditions including, but not limited to: scoliosis management, following surgical stabilization of the spine following trauma, and for unstable spinal fractures that are treated nonoperatively (e.g., burst fractures). An orthotic device used solely to prevent injury in an otherwise uninjured body part is considered preventive or a prophylactic treatment modality. Identical, spare orthoses are considered convenience items. Cervical and Thoracic Orthoses Spinal orthoses include cervical orthoses (CO), cervical-thoracic orthoses, (CTO), thoracic orthoses (TO), thoracic-lumbar-sacral orthoses, (TLSO), lumbar-sacral orthoses (LSO), and lumbar orthoses (LO). Cervical orthoses (HCPCS codes L0120 L0200) and thoracic orthoses (HCPCS code L0220) may be used as non-operative management for cervical and/or thoracic trauma. There are various types of orthoses, including soft and rigid devices. Soft collars that are made of lightweight material are very flexible and can be easily removed. However, they offer minimal immobilization and primarily act as reminders to limit neck motion. Soft collars are typically indicated for mild cervical sprains and neck pain without unstable bony or ligamentous injury. This collar is contraindicated for injuries with the potential for instability. Examples of rigid collars include the Philadelphia (Philadelphia Cervical Collar, Thorofare, NJ), Miami J (Össur, Paulsboro, NJ), and Aspen (Aspen Medical Products, Irvine, CA). L0220 falls under the category of thoracic and is described as a thoracic, rib belt, custom fabricated. Other orthoses that can be used to immobilize the cervical spine include poster braces, variations of cervicothoracic orthoses (CTOs), and the halo vest. A CTO (e.g., Minerva brace, sternal-occipital- Page 3 of 18

4 mandibular immobilizer [SOMI] brace) extends farther down the trunk than does a poster brace. The halo vest immobilizes the spine in all three planes. It provides end-point control of the cervical spine and is best for immobilizing the upper and lower cervical spine. Halo gravity traction is a well -accepted gradual distraction technique either preoperatively or postoperatively with staged severe scoliosis correction following soft tissue release and prior to the second stage fusion. Thoracolumbar Orthoses Thoracolumbar orthoses can be either soft or rigid. Common types include the thoracolumbosacral orthosis (TLSO), thoracolumbar hyperextension orthosis (ie, Jewett brace [L0472], cruciform anterior spinal hyperextension [CASH] brace, Knight-Taylor [i.e., chairback] brace), lumbosacral orthosis (LSO), and various types of soft lumbar and thoracolumbar corsets. The TLSO and LSO may be prefabricated or custom-molded. TLSO (HCPCS codes L0450 L0492); lumbar orthoses (HCPCS codes L0625 L0627, L0641 L0642); and LSO (HCPCS codes L0628 L0640, L0643 L0651) have the following characteristics: They are used to immobilize a specified area of the spine. They have an intimate fit and are generally worn under clothing. They are not specifically designed for patients in wheelchairs (some braces may be worn by a patient in a wheelchair, e.g., neuromuscular scoliosis, post-spinal cord injury). In addition to the immobilization and intimate fit, the body-jacket type orthoses (HCPCS L0639, L0640, L0458 L0464, and L0480 L0492, L0651) are characterized by a rigid shell that encircles the trunk with overlapping edges and stabilizing closures. It provides a high degree of immobility. The entire circumference of the shell must be the same rigid material. They are often used post-fracture to reduce risk of further injury, postoperatively for complex spinal surgeries when increased support is required for spinal immobilization and for nonoperative management of unstable fractures (e.g., burst fractures). Rigid devices are also recommended for the treatment of scoliosis. Semi-rigid devices combine the support of rigid materials and the comfort of flexible fabrics. A TLSO brace extends from the sacrococcygeal junction to just inferior to the scapular spine, excluding elastic or equal shoulder straps or other strapping. The anterior must, at a minimum, extend from the symphysis pubis to the xiphoid. Some extend up to the sternal notch. Flexible orthoses (LSOs, LOs) consist of cloth belts and elastic corsets with adjustable fasteners. Lumbosacral supports or back braces/corsets are used for the treatment of acute and chronic back pain. Combined with education and training on back mechanics and lifting, elastic rib belts and lumbar supports have been proposed for the prevention of injury in the workplace. A protective body sock, HCPCS code L0984, is a garment made of cloth or similar material that is worn under a spinal orthosis and is not primarily medical in nature. Other items that are not primarily medical in nature and considered convenience items include, but are not limited to, prophylactic elastic lumbar supports (e.g., tool belts, lumbar belt), inflatable lumbar support pillows/cushions and back rest supports. Literature Review Studies addressing the use of spinal orthotic devices such as lumbar supports and belts for the prevention of injury report that despite their use, efficacy is debatable (van Poppel, et al., 1998), and individual workers presenting with no prior history of low-back pain are unlikely to benefit from back belt use (Ammendolia, et al., 2005). In general, research has not demonstrated these devices are effective when used for the prevention of injury (Erdil, 2016; Bigos, et al., 2009; van Duijvenbode, et al., 2009; van Poppel, 2004; Lahad, et al., 1994). A randomized controlled trial (Urquhart, et al., 2017) was conducted to determine whether there was a difference in long-term clinical and radiographic outcomes between the thoracolumbar burst fracture patients treated with and those treated without a TLSO. Results showed both patient groups maintain similar pain relief and improvement in function for 5-10 years. Skoch et al. (2016) performed a systematic literature review of orthotic braces after surgical thoracolumbar fracture stabilization. Postoperative bracing (POB) was adopted in 62 studies for a median wear time of 13.3 Page 4 of 18

5 weeks. Between braced and nonbraced groups, there were no significant differences between pain, screw breakage, infection, or return to work in this comprehensive multistudy review. Small but significant increases in overall complication rates and loss of kyphotic correction were observed in the POB groups, and a higher rate of pseudoarthrosis was seen in the non-pob groups. A systematic review with meta-analysis (Takasaki, et al., 2017) was performed to determine if continuous use of an LSO for a prolonged period in patients with low back pain reduces mechanical loading to the trunk muscle in daily living and results in impairments of the trunk muscle. The meta-analyses demonstrated no negative effect by the continuous use of an LSO for 1-6 months. However, the quality of evidence ranged from low to very low, and the authors noted that more high-quality trials are required to draw a definitive conclusion on the impact of the continuous use of an LSO on trunk motor performances. Newman et al. (2016) systematically reviewed the evidence of effectiveness of spinal orthoses for adults with vertebral osteoporosis. The researchers concluded that the limited evidence about orthoses after acute osteoporotic vertebral fracture is inconclusive; better evidence of efficacy is needed, particularly when considering complications. A Cochrane review on braces for idiopathic scoliosis in adolescents (Negrini, et al., 2016) considered elastic, rigid (polyethylene), and very rigid (polycarbonate) braces. The authors found quality of life was not affected during brace treatment (very low quality evidence); and quality of life, back pain, and psychological and cosmetic issues did not change in the long term (very low quality evidence). They noted additional studies are needed. In a review of the literature, Agabegi et al. (2010) noted the following: The most common indication for a spinal orthosis is in the setting of spinal trauma to manage fractures deemed sufficiently stable to undergo nonsurgical management but that lack the intrinsic stability to withstand normal physiologic loads. External support may provide pain relief for patients with osteoporotic compression fractures in the thoracolumbar spine. There is no evidence that the use of a cervical orthosis, either soft or rigid, is beneficial in the management of axial neck pain. The literature on low back pain is conflicting. When orthoses are used for this purpose, physical therapy consisting of abdominal strengthening and trunk stabilization exercises should be prescribed, as well, to avoid deconditioning of the trunk musculature. Spinal braces are commonly used in the management of adolescent patients with symptomatic spondylolysis and spondylolisthesis. Controversy exists regarding the need for bracing. The main benefit of bracing in these patients may be as a means of restricting activity (ie, kinesthetic reminder) rather than as a means of biomechanically stabilizing the pars defect. The use of modern spinal instrumentation has led to reduced use of bracing postoperatively. Bracing is used more commonly in the cervical spine. Braces are used to provide three-point forces to prevent progression of spinal deformity (i.e., scoliosis, kyphosis) in skeletally immature patients. A randomized controlled trial and cohort study (Weinstein, et al., 2013) demonstrated bracing significantly decreased the progression of high-risk curves to the threshold for surgery in patients with adolescent idiopathic scoliosis. Improper use of spinal orthoses can lead to treatment failure and potential complications. The generalized inactivity following bracing can lead to trunk muscular weakness, with the potential for pain and disability. When the clinical situation allows, an exercise regimen should be maintained, and orthosis use should be discontinued as soon as possible. A Cochrane review on lumbar supports for prevention and treatment of low back pain (van Duijvenbode, et al., 2008) concluded with moderate evidence that lumbar supports are not more effective than no intervention or training in preventing low-back pain, and conflicting evidence whether they are effective supplements to other preventive interventions. It remains unclear whether lumbar supports are more effective than no or other interventions for treating low-back pain. There is still a need for high quality randomized trials on the effectiveness of lumbar supports. A randomized trial was performed in which patients who wore a postoperative lumbar corset for eight weeks fulltime after a posterior lumbar arthrodesis for a degenerative spinal condition were compared with those who did not use a corset after such an operation (Yee, et al., 2008). With a follow up of two years, pain questionnaires, Page 5 of 18

6 spine function, complications, and reoperation rates were studied. The authors noted results did not indicate a significant advantage or disadvantage to the use of a postoperative lumbar corset. SpineCor: According to their website, the Spine Corporation Limited has two braces, the Spinecor Dynamic Corrective brace and the SpineCor Pain Relief Back brace. The SpineCor is a non-rigid brace composed of a thermoplastic pelvic base with stabilizing and corrective bands across the upper body. In a small randomized controlled trial, Guo et al. (2014) evaluated adolescent females with idiopathic scoliosis, comparing the SpineCor brace to a rigid underarm TLSO brace in a randomized controlled trial. Results demonstrated a significantly higher curve progression rate in the SpineCor group when compared with the rigid brace group. Changing to rigid bracing could control further curve progression for majority of patients who previously failed with SpineCor bracing. There is a lack of large, randomized controlled trials comparing the SpineCor corrective brace and the SpineCor pain relief brace with established treatments. Professional Societies/Organizations American College of Physicians (ACP): The ACP Clinical Practice Guideline on Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain (Qaseem, et al 2017) provides treatment guidance based on the efficacy, comparative effectiveness, and safety of noninvasive pharmacologic and non-pharmacologic treatments for acute (<4 weeks), subacute (4 to 12 weeks), and chronic (>12 weeks) low back pain in primary care. Non-pharmacologic interventions evaluated were numerous and included interdisciplinary or multicomponent rehabilitation (physical therapy plus psychological therapy with some coordination), psychological therapies, exercise and related interventions (such as yoga or tai chi), complementary and alternative medicine therapies (spinal manipulation, acupuncture, and massage), passive physical modalities (such as heat, cold, ultrasound, TENS, electrical muscle stimulation, interferential therapy, short-wave diathermy, traction, LLLT, and lumbar supports/braces), and taping. Acute or Subacute Low Back Pain: Low-quality evidence showed no difference in pain or function between lumbar supports added to an educational program compared with an educational program alone or other active interventions in patients with acute or subacute low back pain. Chronic Low Back Pain: Evidence was insufficient to compare lumbar support versus no lumbar support. Lowquality evidence showed no difference between a lumbar support plus exercise (muscle strengthening) versus exercise alone for pain or function at 8 weeks or 6 months. Low quality evidence showed no clear differences between lumbar supports and other active treatments (traction, spinal manipulation, exercise, physiotherapy, or TENS) for pain or function. Radicular Low Back Pain: Evidence was insufficient for lumbar support. American Chiropractic Association (ACA): In March 2017, the ACA adopted the ACP s Clinical Practice Guideline on Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain The 2016 ACA Clinical Practice Guideline Chiropractic Care for Low Back Pain (Globe, et al., 2016) states Because of the scarcity of definitive evidence, lumbar supports (bracing/taping/orthoses) are not recommended for routine use, but there may be some utility in both acute and chronic conditions based upon clinician judgment, patient presentation, and preferences. Caution should be exercised as these orthopedic devices may interfere with conditioning and return to regular activities of daily living (ADLs). American Association of Neurological Surgeons (AANS) and Congress of Neurological Surgeons: The AANS Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine: (Dailey, et al., 2014) Part 14 Brace therapy as an adjunct to or substitute for lumbar fusion makes the following statements: Grade* B The prescription of a lumbar brace is useful for the secondary prevention of low-back pain by reducing the number of days of self-reported low-back pain and days lost to work in laborers with a history of lowback pain. Page 6 of 18

7 For primary prevention, the use of a lumbar corset does not prevent the development of low-back pain in the general working population. For patients presenting with low-back pain, the prescription of a lumbar support in the setting of subacute pain (< 6 months duration) reduced the visual analog scale (VAS) pain score and medication usage and improved functional disability at days. Grade C The use of a brace following instrumented posterolateral lumbar fusion (PLF) for lumbar spondylosis is not supported due to equivalent outcomes with and without bracing. Finally, a trial of preoperative bracing is not predictive of outcome for lumbar fusion in the setting of low back pain (Dailey, et al., 2014). *AANS Grading: A - Good evidence 2 or more Level I studies w/ consistent findings B - Fair evidence single Level I study or multiple Level II or III studies w/ consistent findings C - Poor evidence single Level II study or multiple Level IV or V studies I - Insufficient evidence for recommendation single Level III, IV, or V study; studies of equivalent strength w/ conflicting findings/conclusions North American Spine Society (NASS) (2014) Diagnosis and Treatment of Adult Isthmic Spondylolisthesis: What is the role of ancillary treatments such as bracing, traction, electrical stimulation and transcutaneous electrical stimulation (TENS) in the treatment of isthmic spondylolisthesis? There was no evidence to address this clinical question. Due to the paucity of literature addressing this question, the work group was unable to generate a recommendation. NASS 2014 Diagnosis and Treatment of Degenerative Lumbar Spondylolisthesis (2 nd ed, 1 st ed was 2008): What is the role of ancillary treatments such as bracing, traction, electrical stimulation and transcutaneous electrical stimulation (TENS) in the treatment of degenerative lumbar spondylolisthesis? An updated systematic review of the literature yielded no studies to adequately address any of the medical/interventional treatment questions posed (except for injections). NASS 2012 Diagnosis and Treatment of Lumbar Disc Herniation with Radiculopathy: What is the role of ancillary treatments such as bracing, electrical stimulation, acupuncture and transcutaneous electrical stimulation (TENS) in the treatment of lumbar disc herniation with radiculopathy? An RCT with long term follow-up and validated outcome measures would assist in providing evidence to assess the efficacy of ancillary treatments in the management of lumbar disc herniation with radiculopathy. When ethically possible, this would be compared to an untreated control group. Other active treatment groups could be substituted as a comparative group. NASS 2011 Diagnosis and Treatment of Degenerative Lumbar Spinal Stenosis: What is the role of ancillary treatments such as bracing, traction, electrical stimulation and transcutaneous electrical stimulation (TENS) in the treatment of lumbar spinal stenosis? The use of a lumbosacral corset is suggested to increase walking distance and decrease pain in patients with lumbar spinal stenosis. There is no evidence that results are sustained once the brace is removed (Grade of Recommendation: B). American Physical Therapy Association (APTA): The APTA guideline on Low back pain (Delitto, et al., 2012) does not address spine orthotics (support/bracing) as an intervention. American Pain Society (APS): Interventional therapies, surgery, and interdisciplinary rehabilitation for low back pain: an evidence-based clinical practice guideline from the American Pain Society (Chou, et al., 2009) defines lumbar support as a back brace, corset, or orthotic device worn to passively support the back. In the Summary of Evidence the APS noted: For acute low back pain, one lower-quality trial found a lumbar support superior to advice on lifestyle and bed rest for pain relief, return to work, and overall improvement (level of evidence: poor). For low back pain of unspecified duration, there is insufficient evidence from one lower-quality trial to determine whether lumbar supports are effective compared to no intervention (level of evidence: poor). Page 7 of 18

8 For low back pain of varying or unspecified duration, three trials (one higher-quality) found no clear differences between lumbar supports and other interventions (minimal massage, spinal manipulation, physiotherapy with any intervention other than manipulation, acetaminophen, TENS, or usual care). Most comparisons were evaluated in only one lower-quality trial (level of evidence: poor to fair). For chronic low back pain, one higher-quality trial found a lumbar support with a rigid insert associated with superior global improvement compared to a support without a rigid insert (level of evidence: fair). The American Board of Internal Medicine s (ABIM) Foundation Choosing Wisely Initiative (2017): The Choosing Wisely initiative includes the following recommendation: ACA (August 15, 2017): Do not prescribe lumbar supports or braces for the long-term treatment or prevention of low-back pain. Use Outside of the US National Institute for Health and Clinical Excellence (NICE): NICE guideline Low back pain and sciatica in over 16s: assessment and management (November 2016) states Do not offer belts or corsets for managing low back pain with or without sciatica. Coding/Billing Information Note: 1) This list of codes may not be all-inclusive. 2) Deleted codes and codes which are not effective at the time the service is rendered may not be eligible for reimbursement. Considered Medically Necessary when criteria in the applicable policy statements listed above are met: HCPCS Codes L0120 L0130 L0140 L0150 L0160 L0170 L0172 L0174 L0180 L0190 L0200 L0220 L0450 L0452 L0454 Description Cervical, flexible, nonadjustable, prefabricated, off-the-shelf (foam collar) Cervical, flexible, thermoplastic collar, molded to patient Cervical, semi-rigid, adjustable (plastic collar) Cervical, semi-rigid, adjustable molded chin cup (plastic collar with mandibular/occipital piece) Cervical, semi-rigid, wire frame occipital/mandibular support, prefabricated, offthe-shelf Cervical collar, molded to patient model Cervical collar, semi-rigid thermoplastic foam, two piece, prefabricated, off-theshelf Cervical collar, semi-rigid, thermoplastic foam, two piece with thoracic extension, prefabricated, off-the-shelf Cervical, multiple post collar, occipital/mandibular supports, adjustable Cervical, multiple post collar, occipital/mandibular supports, adjustable cervical bars (SOMI, Guilford, Taylor types) Cervical, multiple post collar, occipital/mandibular supports, adjustable cervical bars, and thoracic extension Thoracic, rib belt, custom fabricated TLSO, flexible, provides trunk support, upper thoracic region, produces intracavitary pressure to reduce load on the intervertebral disks with rigid stays or panel(s), includes shoulder straps and closures, prefabricated, off-the-shelf TLSO, flexible, provides trunk support, upper thoracic region, produces intracavitary pressure to reduce load on the intervertebral disks with rigid stays or panel(s), includes shoulder straps and closures, custom fabricated TLSO flexible, provides trunk support, extends from sacrococcygeal junction to above T-9 vertebra, restricts gross trunk motion in the sagittal plane, produces intracavitary pressure to reduce load on the intervertebral disks with rigid stays Page 8 of 18

9 L0455 L0456 L0457 L0458 L0460 L0462 L0464 L0466 L0467 or panel(s), includes shoulder straps and closures, prefabricated item that has been trimmed, bent, molded, assembled, or otherwise customized to fit a specific patient by an individual with expertise TLSO, flexible, provides trunk support, extends from sacrococcygeal junction to above T-9 vertebra, restricts gross trunk motion in the sagittal plane, produces intracavitary pressure to reduce load on the intervertebral disks with rigid stays or panel(s), includes shoulder straps and closures, prefabricated, off-the-shelf TLSO, flexible, provides trunk support, thoracic region, rigid posterior panel and soft anterior apron, extends from the sacrococcygeal junction and terminates just inferior to the scapular spine, restricts gross trunk motion in the sagittal plane, produces intracavitary pressure to reduce load on the intervertebral disks, includes straps and closures, prefabricated item that has been trimmed, bent, molded, assembled, or otherwise customized to fit a specific patient by an individual with expertise TLSO, flexible, provides trunk support, thoracic region, rigid posterior panel and soft anterior apron, extends from sacrococcygeal junction and terminates just inferior to the scapular spine, restricts gross trunk motion in the sagittal plane, produces intracavitary pressure to reduce load on the intervertebral disks, includes straps and closures, prefabricated, off-the-shelf TLSO, triplanar control, modular segmented spinal system, two rigid plastic shells, posterior extends from the sacrococcygeal junction and terminates just inferior to the scapular spine, anterior extends from the symphysis pubis to the xiphoid, soft liner, restricts gross trunk motion in the sagittal, coronal, and transverse planes, lateral strength is provided by overlapping plastic and stabilizing closures, includes straps and closures, prefabricated, includes fitting and adjustment TLSO, triplanar control, modular segmented spinal system, two rigid plastic shells, posterior extends from the sacrococcygeal junction and terminates just inferior to the scapular spine, anterior extends from the symphysis pubis to the sternal notch, soft liner, restricts gross trunk motion in the sagittal, coronal, and transverse planes, lateral strength is provided by overlapping plastic and stabilizing closures, includes straps and closures, prefabricated item that has been trimmed, bent, molded, assembled, or otherwise customized to fit a specific patient by an individual with expertise TLSO, triplanar control, modular segmented spinal system, three rigid plastic shells, posterior extends from the sacrococcygeal junction and terminates just inferior to the scapular spine, anterior extends from the symphysis pubis to the sternal notch, soft liner, restricts gross trunk motion in the sagittal, coronal, and transverse planes, lateral strength is provided by overlapping plastic and stabilizing closures, includes straps and closures, prefabricated, includes fitting and adjustment TLSO, triplanar control, modular segmented spinal system, four rigid plastic shells, posterior extends from sacrococcygeal junction and terminates just inferior to scapular spine, anterior extends from symphysis pubis to the sternal notch, soft liner, restricts gross trunk motion in sagittal, coronal, and transverse planes, lateral strength is provided by overlapping plastic and stabilizing closures, includes straps and closures, prefabricated, includes fitting and adjustment TLSO, sagittal control, rigid posterior frame and flexible soft anterior apron with straps, closures and padding, restricts gross trunk motion in sagittal plane, produces intracavitary pressure to reduce load on intervertebral disks, prefabricated item that has been trimmed, bent, molded, assembled, or otherwise customized to fit a specific patient by an individual with expertise TLSO, sagittal control, rigid posterior frame and flexible soft anterior apron with straps, closures and padding, restricts gross trunk motion in sagittal plane, Page 9 of 18

10 L0468 L0469 L0470 L0472 L0480 L0482 L0484 L0486 L0488 produces intracavitary pressure to reduce load on intervertebral disks, prefabricated, off-the-shelf TLSO, sagittal-coronal control, rigid posterior frame and flexible soft anterior apron with straps, closures and padding, extends from sacrococcygeal junction over scapulae, lateral strength provided by pelvic, thoracic, and lateral frame pieces, restricts gross trunk motion in sagittal, and coronal planes, produces intracavitary pressure to reduce load on intervertebral disks, prefabricated item that has been trimmed, bent, molded, assembled, or otherwise customized to fit a specific patient by an individual with expertise TLSO, sagittal-coronal control, rigid posterior frame and flexible soft anterior apron with straps, closures and padding, extends from sacrococcygeal junction over scapulae, lateral strength provided by pelvic, thoracic, and lateral frame pieces, restricts gross trunk motion in sagittal and coronal planes, produces intracavitary pressure to reduce load on intervertebral disks, prefabricated, offthe-shelf TLSO, triplanar control, rigid posterior frame and flexible soft anterior apron with straps, closures and padding, extends from sacrococcygeal junction to scapula, lateral strength provided by pelvic, thoracic, and lateral frame pieces, rotational strength provided by subclavicular extensions, restricts gross trunk motion in sagittal, coronal, and transverse planes, produces intracavitary pressure to reduce load on the intervertebral disks, includes fitting and shaping the frame, prefabricated, includes fitting and adjustment TLSO, triplanar control, hyperextension, rigid anterior and lateral frame extends from symphysis pubis to sternal notch with two anterior components (one pubic and one sternal), posterior and lateral pads with straps and closures, limits spinal flexion, restricts gross trunk motion in sagittal, coronal, and transverse planes, includes fitting and shaping the frame, prefabricated, includes fitting and adjustment TLSO, triplanar control, one piece rigid plastic shell without interface liner, with multiple straps and closures, posterior extends from sacrococcygeal junction and terminates just inferior to scapular spine, anterior extends from symphysis pubis to sternal notch, anterior or posterior opening, restricts gross trunk motion in sagittal, coronal, and transverse planes, includes a carved plaster or cad-cam model, custom fabricated TLSO, triplanar control, one piece rigid plastic shell with interface liner, multiple straps and closures, posterior extends from sacrococcygeal junction and terminates just inferior to scapular spine, anterior extends from symphysis pubis to sternal notch, anterior or posterior opening, restricts gross trunk motion in sagittal, coronal, and transverse planes, includes a carved plaster or cad-cam model, custom fabricated TLSO, triplanar control, two piece rigid plastic shell without interface liner, with multiple straps and closures, posterior extends from sacrococcygeal junction and terminates just inferior to scapular spine, anterior extends from symphysis pubis to sternal notch, lateral strength is enhanced by overlapping plastic, restricts gross trunk motion in the sagittal, coronal, and transverse planes, includes a carved plaster or cad-cam model, custom fabricated TLSO, triplanar control, two piece rigid plastic shell with interface liner, multiple straps and closures, posterior extends from sacrococcygeal junction and terminates just inferior to scapular spine, anterior extends from symphysis pubis to sternal notch, lateral strength is enhanced by overlapping plastic, restricts gross trunk motion in the sagittal, coronal, and transverse planes, includes a carved plaster or cad-cam model, custom fabricated TLSO, triplanar control, one piece rigid plastic shell with interface liner, multiple straps and closures, posterior extends from sacrococcygeal junction and terminates just inferior to scapular spine, anterior extends from symphysis pubis Page 10 of 18

11 L0490 L0491 L0492 L0621 L0622 L0623 L0624 L0625 L0626 L0627 L0628 to sternal notch, anterior or posterior opening, restricts gross trunk motion in sagittal, coronal, and transverse planes, prefabricated, includes fitting and adjustment TLSO, sagittal-coronal control, one piece rigid plastic shell, with overlapping reinforced anterior, with multiple straps and closures, posterior extends from sacrococcygeal junction and terminates at or before the T-9 vertebra, anterior extends from symphysis pubis to xiphoid, anterior opening, restricts gross trunk motion in sagittal and coronal planes, prefabricated, includes fitting and adjustment TLSO, sagittal-coronal control, modular segmented spinal system, two rigid plastic shells, posterior extends from the sacrococcygeal junction and terminates just inferior to the scapular spine, anterior extends from the symphysis pubis to the xiphoid, soft liner, restricts gross trunk motion in the sagittal and coronal planes, lateral strength is provided by overlapping plastic and stabilizing closures, includes straps and closures, prefabricated, includes fitting and adjustment TLSO, sagittal-coronal control, modular segmented spinal system, three rigid plastic shells, posterior extends from the sacrococcygeal junction and terminates just inferior to the scapular spine, anterior extends from the symphysis pubis to the xiphoid, soft liner, restricts gross trunk motion in the sagittal and coronal planes, lateral strength is provided by overlapping plastic and stabilizing closures, includes straps and closures, prefabricated, includes fitting and adjustment Sacroiliac orthosis, flexible, provides pelvic-sacral support, reduces motion about the sacroiliac joint, includes straps, closures, may include pendulous abdomen design, prefabricated, off-the-shelf Sacroiliac orthosis, flexible, provides pelvic-sacral support, reduces motion about the sacroiliac joint, includes straps, closures, may include pendulous abdomen design, custom fabricated Sacroiliac orthosis, provides pelvic-sacral support, with rigid or semi-rigid panels over the sacrum and abdomen, reduces motion about the sacroiliac joint, includes straps, closures, may include pendulous abdomen design, prefabricated, off-the-shelf Sacroiliac orthosis, provides pelvic-sacral support, with rigid or semi-rigid panels placed over the sacrum and abdomen, reduces motion about the sacroiliac joint, includes straps, closures, may include pendulous abdomen design, custom fabricated Lumbar orthosis, flexible, provides lumbar support, posterior extends from L-1 to below L-5 vertebra, produces intracavitary pressure to reduce load on the intervertebral discs, includes straps, closures, may include pendulous abdomen design, shoulder straps, stays, prefabricated, off-the-shelf Lumbar orthosis, sagittal control, with rigid posterior panel(s), posterior extends from L-1 to below L-5 vertebra, produces intracavitary pressure to reduce load on the intervertebral discs, includes straps, closures, may include padding, stays, shoulder straps, pendulous abdomen design, prefabricated item that has been trimmed, bent, molded, assembled, or otherwise customized to fit a specific patient by an individual with expertise Lumbar orthosis, sagittal control, with rigid anterior and posterior panels, posterior extends from L-1 to below L-5 vertebra, produces intracavitary pressure to reduce load on the intervertebral discs, includes straps, closures, may include padding, shoulder straps, pendulous abdomen design, prefabricated item that has been trimmed, bent, molded, assembled, or otherwise customized to fit a specific patient by an individual with expertise Lumbar-sacral orthosis, flexible, provides lumbo-sacral support, posterior extends from sacrococcygeal junction to T-9 vertebra, produces intracavitary Page 11 of 18

12 L0629 L0630 L0631 L0632 L0633 L0634 L0635 L0636 L0637 pressure to reduce load on the intervertebral discs, includes straps, closures, may include stays, shoulder straps, pendulous abdomen design, prefabricated, off-the-shelf Lumbar-sacral orthosis, flexible, provides lumbo-sacral support, posterior extends from sacrococcygeal junction to T-9 vertebra, produces intracavitary pressure to reduce load on the intervertebral discs, includes straps, closures, may include stays, shoulder straps, pendulous abdomen design, custom fabricated Lumbar-sacral orthosis, sagittal control, with rigid posterior panel(s), posterior extends from sacrococcygeal junction to T-9 vertebra, produces intracavitary pressure to reduce load on the intervertebral discs, includes straps, closures, may include padding, stays, shoulder straps, pendulous abdomen design, prefabricated item that has been trimmed, bent, molded, assembled, or otherwise customized to fit a specific patient by an individual with expertise Lumbar-sacral orthosis, sagittal control, with rigid anterior and posterior panels, posterior extends from sacrococcygeal junction to T-9 vertebra, produces intracavitary pressure to reduce load on the intervertebral discs, includes straps, closures, may include padding, shoulder straps, pendulous abdomen design, prefabricated item that has been trimmed, bent, molded, assembled, or otherwise customized to fit a specific patient by an individual with expertise Lumbar-sacral orthosis, sagittal control, with rigid anterior and posterior panels, posterior extends from sacrococcygeal junction to T-9 vertebra, produces intracavitary pressure to reduce load on the intervertebral discs, includes straps, closures, may include padding, shoulder straps, pendulous abdomen design, custom fabricated Lumbar-sacral orthosis, sagittal-coronal control, with rigid posterior frame/panel(s), posterior extends from sacrococcygeal junction to T-9 vertebra, lateral strength provided by rigid lateral frame/panels, produces intracavitary pressure to reduce load on intervertebral discs, includes straps, closures, may include padding, stays, shoulder straps, pendulous abdomen design, prefabricated item that has been trimmed, bent, molded, assembled, or otherwise customized to fit a specific patient by an individual with expertise Lumbar-sacral orthosis, sagittal-coronal control, with rigid posterior frame/panel(s), posterior extends from sacrococcygeal junction to T-9 vertebra, lateral strength provided by rigid lateral frame/panel(s), produces intracavitary pressure to reduce load on intervertebral discs, includes straps, closures, may include padding, stays, shoulder straps, pendulous abdomen design, custom fabricated Lumbar-sacral orthosis, sagittal-coronal control, lumbar flexion, rigid posterior frame/panel(s), lateral articulating design to flex the lumbar spine, posterior extends from sacrococcygeal junction to T-9 vertebra, lateral strength provided by rigid lateral frame/panel(s), produces intracavitary pressure to reduce load on intervertebral discs, includes straps, closures, may include padding, anterior panel, pendulous abdomen design, prefabricated, includes fitting and adjustment Lumbar-sacral orthosis, sagittal-coronal control, lumbar flexion, rigid posterior frame/panels, lateral articulating design to flex the lumbar spine, posterior extends from sacrococcygeal junction to T-9 vertebra, lateral strength provided by rigid lateral frame/panels, produces intracavitary pressure to reduce load on intervertebral discs, includes straps, closures, may include padding, anterior panel, pendulous abdomen design, custom fabricated Lumbar-sacral orthosis, sagittal-coronal control, with rigid anterior and posterior frame/panels, posterior extends from sacrococcygeal junction to T-9 vertebra, lateral strength provided by rigid lateral frame/panels, produces intracavitary pressure to reduce load on intervertebral discs, includes straps, closures, may include padding, shoulder straps, pendulous abdomen design, prefabricated item Page 12 of 18

13 L0638 L0639 L0640 L0641 L0642 L0643 L0648 L0649 L0650 L0651 that has been trimmed, bent, molded, assembled, or otherwise customized to fit a specific patient by an individual with expertise Lumbar-sacral orthosis, sagittal-coronal control, with rigid anterior and posterior frame/panels, posterior extends from sacrococcygeal junction to T-9 vertebra, lateral strength provided by rigid lateral frame/panels, produces intracavitary pressure to reduce load on intervertebral discs, includes straps, closures, may include padding, shoulder straps, pendulous abdomen design, custom fabricated Lumbar-sacral orthosis, sagittal-coronal control, rigid shell(s)/panel(s), posterior extends from sacrococcygeal junction to T-9 vertebra, anterior extends from symphysis pubis to xyphoid, produces intracavitary pressure to reduce load on the intervertebral discs, overall strength is provided by overlapping rigid material and stabilizing closures, includes straps, closures, may include soft interface, pendulous abdomen design, prefabricated item that has been trimmed, bent, molded, assembled, or otherwise customized to fit a specific patient by an individual with expertise Lumbar-sacral orthosis, sagittal-coronal control, rigid shell(s)/panel(s), posterior extends from sacrococcygeal junction to T-9 vertebra, anterior extends from symphysis pubis to xyphoid, produces intracavitary pressure to reduce load on the intervertebral discs, overall strength is provided by overlapping rigid material and stabilizing closures, includes straps, closures, may include soft interface, pendulous abdomen design, custom fabricated Lumbar orthosis, sagittal control, with rigid posterior panel(s), posterior extends from L-1 to below L-5 vertebra, produces intracavitary pressure to reduce load on the intervertebral discs, includes straps, closures, may include padding, stays, shoulder straps, pendulous abdomen design, prefabricated, off-the-shelf Lumbar orthosis, sagittal control, with rigid anterior and posterior panels, posterior extends from L-1 to below L-5 vertebra, produces intracavitary pressure to reduce load on the intervertebral discs, includes straps, closures, may include padding, shoulder straps, pendulous abdomen design, prefabricated, off-the-shelf Lumbar-sacral orthosis, sagittal control, with rigid posterior panel(s), posterior extends from sacrococcygeal junction to T-9 vertebra, produces intracavitary pressure to reduce load on the intervertebral discs, includes straps, closures, may include padding, stays, shoulder straps, pendulous abdomen design, prefabricated, off-the-shelf Lumbar-sacral orthosis, sagittal control, with rigid anterior and posterior panels, posterior extends from sacrococcygeal junction to T-9 vertebra, produces intracavitary pressure to reduce load on the intervertebral discs, includes straps, closures, may include padding, shoulder straps, pendulous abdomen design, prefabricated, off-the-shelf Lumbar-sacral orthosis, sagittal-coronal control, with rigid posterior frame/panel(s), posterior extends from sacrococcygeal junction to T-9 vertebra, lateral strength provided by rigid lateral frame/panels, produces intracavitary pressure to reduce load on intervertebral discs, includes straps, closures, may include padding, stays, shoulder straps, pendulous abdomen design, prefabricated, off-the-shelf Lumbar-sacral orthosis, sagittal-coronal control, with rigid anterior and posterior frame/panel(s), posterior extends from sacrococcygeal junction to T-9 vertebra, lateral strength provided by rigid lateral frame/panel(s), produces intracavitary pressure to reduce load on intervertebral discs, includes straps, closures, may include padding, shoulder straps, pendulous abdomen design, prefabricated, offthe-shelf Lumbar-sacral orthosis, sagittal-coronal control, rigid shell(s)/panel(s), posterior extends from sacrococcygeal junction to T-9 vertebra, anterior extends from symphysis pubis to xyphoid, produces intracavitary pressure to reduce load on Page 13 of 18