Cigna Orthotic Devices and Shoes - (0543) Form

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. Each coverage request should be reviewed on its own merits. Medical directors are expected to exercise clinical judgment where appropriate and have discretion in making individual coverage determinations. Where coverage for care or services does not depend on specific circumstances, reimbursement will only Medical Coverage Policy:0543 be provided if a requested service(s) is submitted in accordance with the relevant criteria outlined in the applicable Coverage Policy, including covered diagnosis and/or procedure code(s). Reimbursement is not allowed for services when billed for conditions or diagnoses that are not covered under this Coverage Policy (see “Coding Information” below). When billing, providers must use the most appropriate codes as of the effective date of the submission. Claims submitted for services that are not accompanied by covered code(s) under the applicable Coverage Policy will be denied as not covered. 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.. This Coverage Policy addresses orthotic devices. Orthotic devices are defined as orthopedic appliances used to support, align, prevent or correct deformities. Static orthoses are rigid and are used to support weakened or paralyzed body parts in a particular position. Dynamic orthoses are used to facilitate body motion to allow optimal function. Myoelectric orthotic devices use neurologic sensors, microprocessor units, and electric motors to provide self-initiated movement. The policy statements below provide medical necessity criteria for the following: General Criteria for an Orthotic Device • Non Foot Orthosis  Cranial Orthotic Devices for Positional or Deformational Plagiocephaly  Upper Limb  Lower Limb  Knee Braces  Shoes  Spinal Orthotic Devices Custom Foot Orthosis • Not Medically Necessary Orthoses • Experimental, Investigational, or Unproven Orthoses • Orthosis Repair and Replacement Coverage Policy Coverage for orthotic devices varies across benefit plans. Please refer to the customers’ benefit plan document to determine benefit availability and the terms and conditions of coverage. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations. For the intent of this policy, microprocessor-controlled/computer-controlled devices are considered a type of power enhanced/controlled device. ______________________________________________________________________ GENERAL CRITERIA FOR AN ORTHOTIC DEVICE An orthotic device is considered medically necessary when BOTH of the following criteria are met: Medical Coverage Policy:0543 The orthosis is prescribed to support, align, prevent or correct a deformity • Evidence of a physical examination within the prior six months, for a condition that supports the use of the item prescribed, is documented in the individual’s medical record. An orthotic device is not covered or reimbursable when the above criteria is not met. When coverage is available for the specific orthotic device, the following orthoses are considered eligible for coverage: Non Foot Orthosis  Cranial Orthotic Devices for Positional or Deformational Plagiocephaly  Upper Limb  Lower Limb  Knee Braces  Shoes  Spinal Orthotic Devices Custom Foot Orthosis An addition or component to an orthotic device is considered medically necessary when it is required for the effective use of the orthosis. A custom-foot orthosis for the treatment of plantar fasciitis is considered clinically equivalent but not superior to a conventional orthosis, is significantly more expensive than a conventional device, and is therefore considered not medically necessary under many benefit plans. _________________________________________________________________________________________ NON FOOT ORTHOSIS I. Cranial Orthosis Coding for Cranial Orthoses A custom molded/fitted cranial orthotic device (HCPCS code S1040) is considered medically necessary for the treatment of synostotic plagiocephaly (i.e., craniosynostosis) following surgical correction when the benefit plan includes coverage for this indication. A custom molded/fitted cranial orthotic device (HCPCS code S1040) is considered medically necessary for the treatment of moderate to severe nonsynostotic positional plagiocephaly when the benefit plan includes coverage for this indication and ALL of the following conditions are met:  Child is EITHER ONE of the following: o between three and five months of age and has failed to respond to a two- month trial of repositioning therapy o age six months to 18 months  Cranial asymmetry as evidenced by EITHER of the following: o cephalic index ± at least two standard deviations from the mean for the appropriate gender/age (see Table 1) o asymmetry of 12 mm or more in ONE of the following measures:   cranial vault skull base Medical Coverage Policy:0543  orbitotragial depth (see Table 2)  A subsequent custom molded/fitted cranial orthotic device to accommodate growth changes is considered medically necessary when significant cranial asymmetry persists and further meaningful improvement in the asymmetry is expected with continued use of a cranial orthotic device. Please note: A protective helmet (HCPCS code A8000–A8004) is not a cranial remolding device. A protective helmet (HCPCS code A8000-A8004) is considered a safety device worn to prevent injury to the head rather than a device needed for active treatment. See “Not Covered or Reimbursable” section below. __________________________________________________________________________________ II. Upper Limb Orthosis Coding for Upper Limb Orthoses  An upper extremity orthotic device (HCPCS codes L3650-L3999) (i.e., non- myoelectric, non-power enhanced, non custom fitted or custom fabricated hand) is considered medically necessary for an individual requiring stabilization or support to the upper limb and who is expected to have improved function with the use of the device:  to substitute for weak muscles (e.g., following cervical spine injury, brachial plexus injury, peripheral nerve injury [e.g., median, ulnar or radial nerves], sprain, strain)  to support or immobilize a structure (e.g., rheumatoid arthritis, osteoarthritis, overuse syndromes [e.g., lateral epicondylitis, cubital tunnel syndrome, carpal tunnel syndrome, de Quervain tenosynovitis, trigger finger], trauma, following surgical repairs, fractures [e.g, acromioclavicular dislocation, clavicle fracture])  prevent contracture or deformity from neurological injury (e.g., brain injury, stroke [i.e., spasticity], spinal cord injury, brachial plexus injury, peripheral nerve injury)  correct joint contractures resulting from disease or immobilization (e.g., post fracture, burns)  when necessary to carry out activities of daily living (ADLs) (e.g., spinal cord injured individuals) A custom fitted (HCPCS codes L3807, L3915, L3917, L3923, L3929, L3931) or custom fabricated (L3763-L3766, L3806, L3808, L3891, L3900, L3901, L3905, L3906, L3913, L3919, L3921, L3933, L3935, L3956, L4205) hand orthotic is medically necessary when the patient’s clinical findings are severe and dysfunctional such that an off-the-shelf orthotic is insufficient for the patient’s needs when the above medical necessity criteria has been met for an upper limb orthotic and BOTH of the following criteria are met :  One or more of the following additional criteria are met: o post-surgical intervention o orthotic requires unique components (e.g., pulleys, rubber bands) o neurologic co-morbidities (e.g., sensory deficit, spasticity) o swelling/lymphedema comorbidity o multiple-joint involvement o plan of care for serial splinting o orthotic will need frequent modification o skin impairment co-morbidity Medical Coverage Policy:0543  The clinical documentation supports the medical necessity of a custom fitted or custom fabricated orthotic beyond what is necessary for an off-the-shelf orthotic. __________________________________________________________________________________ III. Lower Limb Orthosis Coding for Lower Limb Orthoses An ankle orthosis is considered medically necessary for treatment of ankle fracture, sprain, or injury requiring immobilization and/or stabilization. A nonambulatory ankle-foot orthosis (AFO)/night splint (HCPCS L4396, L4397, L4398) is considered medically necessary for the following indications:  Achilles tendonitis  plantar fasciitis  plantar flexion contracture of the ankle with dorsiflexion on passive range of motion testing of at least 10 degrees (i.e., a non-fixed contracture) when ALL of the following criteria are met: o o contracture interferes or is expected to interfere significantly with the person’s reasonable expectation of the ability to correct the contracture functional abilities o ankle contracture splint is used as a component of a therapy program that includes active stretching of the involved muscles and/or tendons A nonambulatory AFO/night splint (HCPCS L4396, L4397, L4398) for ANY other indication, including the following, is not covered or reimbursable:    the plantar flexion contracture is fixed foot drop in the absence of ankle flexion contracture for the prevention or treatment of heel pressure ulcer Each of the following is not covered or reimbursable:   any orthosis used to treat pressure ulcers (HCPCS A9283) foot drop splints used as recumbent positioning devices (HCPCS L4394, L4398) The following prefabricated ankle-foot (AFO) or knee-ankle-foot orthoses (KAFO) are each considered medically necessary:  an AFO for an AMBULATORY individual with a weakness or deformity of the foot and ankle requiring stabilization who is expected to have improved function with the use of the device; HCPCS codes used to represent an ankle-foot device include: L1902, L1906, L1910, L1930, L1932, L1951, L1971, L2112-L2116, L2132, L2134, L2136, L4350, L4360, L4361, L4386, and L4387.  a KAFO for an AMBULATORY individual who meets criteria for an ankle-foot orthosis and who requires additional knee stability; HCPCS codes used to represent a knee- ankle-foot device include: L2035, L2132-L2136, L2000–L2034, L2036-L2038, L2126, L2128 and L4370. A custom-fabricated AFO or KAFO (HCPCS code L1900, L1904, L1907, L1920, L1940–L1950, L1960–L1970, L1980–L2034, L2036–L2108 and L2126–L2128, L4631) in an AMBULATORY individual who meets the above medical necessity Medical Coverage Policy:0543 criteria for an AFO or KAFO is considered medically necessary when ANY of the following criteria applies:  The individual cannot be fitted with a prefabricated (off-the-shelf) AFO or has a documented neurological, circulatory or orthopedic status that necessitates custom fabrication to prevent tissue injury.  The condition necessitating the orthosis is expected to be permanent or of long- standing duration (> 6 months).  There is a need to control movement about the knee, ankle or foot in more than one plane.  The individual has a healing fracture that lacks normal anatomical integrity or anthropometric proportions. __________________________________________________________________________________ IV. Knee Brace Coding for Knee Brace A fracture knee brace or a rehabilitative knee brace is considered medically necessary when applied at the time of initial stabilization (e.g., post-surgery, post-injury, post- fracture). A patellofemoral knee brace is considered medically necessary for the treatment of patellofemoral dislocations or chronic patellar symptomatic subluxation for EITHER of the following indications:   recurrent dislocation/subluxation of the patella following failure of a three-month following reduction for an acute (initial) patellar dislocation trial of exercise and strengthening A prefabricated (i.e., off-the-shelf, custom-fitted) functional knee brace is considered medically necessary when there is documented knee instability and the individual is not considered a surgical candidate for ligament reconstruction. A custom-fabricated functional knee brace is considered medically necessary when the criteria for a prefabricated functional knee brace have been met and the individual is unable to be fitted with a prefabricated device as a result of ANY of the following (this list may not be all-inclusive):  abnormal limb contour (e.g., disproportionate size/shape)  knee deformity (e.g., valgus, varus deformity)  minimal muscle mass upon which to suspend the orthosis A prefabricated unloading/offloading knee brace is considered medically necessary for the treatment of moderate to severe osteoarthritis of the knee when ALL of the following criteria are met:  unicompartmental disease that requires load reduction to an affected compartment  documented failure of prior medical treatment modalities (e.g., nonsteroidal anti- inflammatory medications, steroid injections, viscoelastic supplementation)  radiographic documentation of single-compartment osteoarthritis with or without varus/valgus deformity  persistent knee pain limiting activities of daily living Medical Coverage Policy:0543 A custom-fabricated unloading/offloading knee brace is considered medically necessary when criteria for a prefabricated unloading/offloading brace have been met and the individual is unable to be fitted with a prefabricated device as a result of ANY of the following (this list may not be all-inclusive):  abnormal limb contour (e.g., disproportionate size/shape)  knee deformity (e.g., valgus, varus deformity)  minimal muscle mass upon which to suspend the orthosis Accessories to a Knee Brace: a heavy duty knee joint (HCPCS L2385, L2395) is considered medically necessary when medical necessity criteria for the knee brace has been met and the individual weighs greater than 300 pounds. Accessories to a Knee Brace: high-strength, lightweight material (HCPCS code L2755) is considered medically necessary for an individual who meets medical necessity criteria for a custom-fabricated knee brace with EITHER of the following indications:  daily activity level (e.g., employment) requires a brace designed for high- impact/high-stress activities  weight greater than 250 lbs __________________________________________________________________________________ V. Shoes Coding for Shoes Depth shoes (including inlays provided with the shoe) are considered medically necessary (HCPCS A5500) for an individual with ANY of the following systemic conditions, that are significant enough to result in severe circulatory insufficiency and/or areas of decreased peripheral sensation in the lower extremity:  diabetes mellitus  peripheral vascular disease  peripheral neuropathy Custom molded shoes (including inlays provided with the shoe) are considered medically necessary (HCPCS A5501) when criteria have been met for a depth shoe, and the type and/or severity of foot deformity results in failure, contraindication or intolerance to a depth shoe. The following modifications to depth or custom-molded shoes may be considered medically necessary:  rigid rocker bottoms (HCPCS A5503)  roller bottoms (HCPCS A5503)  wedges (HCPCS A5504)  metatarsal bars (HCPCS A5505)  offset heels (HCPCS A5506) A depth shoe, custom molded shoe or shoe modification, (including the above and deluxe features, compression molded inlays/inserts) for any other indication is not covered or reimbursable. __________________________________________________________________________________ Medical Coverage Policy:0543 VI. Spinal Orthosis Coding for Spinal Orthoses A spinal orthosis (e.g., cervical orthosis, cervical-thoracic orthosis, thoracic orthosis, thoracic-lumbar-sacral 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 (e.g., joint instability, hypermobility)  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  scoliosis bracing for children or adolescents (e.g., Milwaukee, Charleston, Boston or Wilmington Brace) CUSTOM FOOT ORTHOSIS Coding for Custom Foot Orthoses A custom-fabricated foot orthosis (HCPCS L3000-L3031) is considered medically necessary when there is failure, contraindication, or intolerance to a prefabricated foot orthosis for ANY of the following conditions:  impaired peripheral sensation and/or altered peripheral circulation (e.g., diabetic neuropathy and peripheral vascular disease)  the foot orthosis is an integral part of a leg brace and is necessary for the proper functioning of the brace  the foot orthosis is used to compensate for a missing portion of the foot (e.g., amputation) and is necessary for the alleviation or correction of illness, injury or congenital defect  neurologic or neuromuscular condition (e.g., cerebral palsy, hemiplegia, spina bifida) producing spasticity, malalignment or pathological positioning of the foot where there is reasonable expectation of improvement  acquired or congenital foot deformity when ALL of the following criteria are met: o The deformity is the result of ONE of the following:   posterior tibial tendon dysfunction  mid- or hind-foot arthritis symptomatic rigid flatfoot o The deformity is associated with significant pain that interferes with activities of daily living and there is impaired gait, balance or mobility as a result of the condition. o Conservative medical management has failed. o There is a reasonable expectation that the condition will improve through the use of the orthotic device. A custom-fabricated foot orthosis (HCPCS L3000-L3031) for any other indication is not covered or reimbursable. _____________________________________________________________________ Medical Coverage Policy:0543 NOT COVERED OR REIMBURSABLE The following orthoses are each not covered or reimbursable: custom molded/fitted cranial orthotic device for indications other than those specifically listed above protective helmet (HCPCS code A8000-A8004) • upper limb orthosis (non-powered) for indications other than those specifically listed above • any orthosis used to treat edema • any orthosis used primarily for improved athletic performance or sports participation • any orthosis used on uninjured body parts or to prevent injury • prophylactic knee braces • patellofemoral knee braces/sleeves for the treatment of postoperative knee effusion or patellofemoral syndrome without subluxation or dislocation prefabricated knee brace with inflatable air bladder (HCPCS L1847, L1848) • a spinal orthosis for indications other than listed above, including as a preoperative diagnostic tool prior to lumbar fusion surgery prefabricated foot orthoses • • • an additional removable or nonremovable interface (HCPCS L2820, L2830, K0672) separate orthotic devices for an additional pair of shoes socks and brace sleeves used in conjunction with an orthotic device dispensed with the initial device any of the following items that are considered convenience items and do not treat an underlying physical condition:  prophylactic elastic lumbar supports (e.g., tool belts, lumbar belt)   back rest supports inflatable lumbar support pillows/cushions _________________________________________________________ EXPERIMENTAL, INVESTIGATIONAL OR UNPROVEN (EIU) The following orthoses are each considered experimental, investigational or unproven:  myoelectric and/or power enhanced upper extremity orthotic device (e.g., MyoPro® 2)  custom-fabricated foot orthosis for the treatment of hallux valgus or hallux rigidus foot  deformity foot adductus positioning device (e.g., UNFO foot brace) for the treatment of metatarsus adductus  AposTherapy® biomechanical device (Apos US Management Inc., New York, NY)  magnetic insole (i.e., orthosis with magnetic foil)  electronic/electromagnetic activated stance control KAFO devices (e.g., E-Mag Active, Sensor Walk™, C-Brace®)  Copes spinal scoliosis brace  SpineCor® spinal orthosis REPAIR / REPLACEMENT Repair and/or replacement of an orthotic device is considered medically necessary under the following circumstances: Medical Coverage Policy:0543  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 an orthosis becomes unusable or non-functioning because of misuse, abuse or neglect. General Background Orthotic Device An orthotic device is a rigid or semi-rigid device used to support, align, prevent or correct a deformity. Orthotics may also redirect, eliminate or restrict motion of an impaired body part. Medical necessity for any orthotic device must be documented in the individual’s medical record. Supportive documentation includes a prescription for the specific device, recent physical examination for the condition being treated, (i.e., < six months) with assessment of functional capabilities/limitations and any other comorbidities. Orthoses may be prefabricated or custom fabricated. A prefabricated orthosis is any orthoses 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 computer-aided design/computer-aided manufacturing [CAD-CAM] technology). The impression is then used to make a specific patient model. The actual orthosis is molded from the patient-specific model. CAD-Cam and other technologies, such as those that determine alignment of the device, are considered integral to the fitting and manufacturing of the base device. An unmodified, prefabricated orthosis is generally used in treating a condition prior to a custom- fitted orthosis (prefabricated orthosis that is modified by bending or molding for a specific patient). A custom-fitted orthosis is generally attempted prior to the use of a custom-fabricated orthosis (individually constructed from materials). Custom fabricated devices are considered medically necessary only when the established medical necessity criteria is met for the device and the individual cannot be fitted with a prefabricated (off-the-shelf) device or one is not available. Examples of conditions precluding the use of a prefabricated device typically include abnormal limb contour (e.g., disproportionate size/shape) or deformity (e.g., valgus, varus deformity) or when there is minimal muscle mass upon which to suspend the orthosis. Orthoses and accessories that are used for participation in sports, to improve athletic performance, that are used to prevent injury in an otherwise uninjured body part, and that are used in conjunction with the device (e.g., socks) are considered not medically necessary. Medical Coverage Policy:0543 Identical, spare orthoses used only for the patient’s convenience are considered not medically necessary. Additionally, one orthotic per foot is considered appropriate; separate orthotic devices for additional pairs of shoes are not considered medically necessary. U.S. Food and Drug Administration A majority of orthotic devices are regulated by the FDA as Class 1 devices, including the MyoPro® (Myomo) upper limb myoelectric device. Class I devices are subject to the least regulatory control. Cranial orthoses are regulated by the FDA as Class II medical devices and require 510(k) approval. According to the FDA, cranial orthoses are intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly. Cranial Orthotic Devices for Positional or Deformational Plagiocephaly Cranial orthotic devices, also referred to as cranial remolding helmets, are used for treating cranial asymmetry, a condition caused by mechanical factors in-utero or after birth that lead to misshaping of the skull. Cranial orthotic devices are indicated to promote corrective shaping as a treatment of synostotic (i.e., resulting from premature closure of an infant’s sutures) or nonsynostotic plagiocephaly (e.g., positional or deformational plagiocephaly), as well as to prevent recurrence of the deformity. Evaluation of Plagiocephaly Cephalic Index: Evaluation of cranial asymmetry may be based on the cephalic index, a ratio between the width (side to side) and length (front to back) of the head. Head width is calculated by subtracting the distance from the euryon on the right side of the head (eur) to the euryon on the left side of head (eul) and multiplying by 100. Head length is generally calculated by measuring the distance from the glabella midpoint (g) (midpoint of the flat area of bone just above the nose between the eyebrows) to the opisthocranion point (op), the most projecting point at the back of the head (posterior most point in the midsagittal plane of the occiput) (Figure A). (Cranial Technologies, 2014) Figure A The cephalic index is then calculated as: Head width (eu – eu) x 100 Head length (g – op) The cephalic index is considered abnormal if it is two standard deviations (SD) above or below the mean measurements (American Academy of Orthotists and Prosthetists [AAOP], 2004; Farkas and Munro, 1987). The indices for infants up to 12 months may be found on the following table: Table 1 Cephalic Index Gender Age 2 SD 1SD Mean + 1SD + 2SD Medical Coverage Policy:0543 Male 16 days–6 months 63.7 68.7 73.7 78.7 83.7 6–12 months 64.8 71.4 78.0 84.6 91.2 Female 16 days–6 months 63.9 68.6 73.3 78.0 82.7 6–12 months 69.5 74.0 78.5 83.0 87.5 Anthropometric Measurements: The evaluation of cranial asymmetry may also be made based on one or more of three anthropometric measures: cranial vault, skull base or orbitotragial depth measurements (AAOP, 2004; Littlefield, et al., 1998). A physician or technician skilled in anthropometry should perform all anthropometric measurements. Cranial orthoses have been indicated for moderate to severe plagiocephaly defined as asymmetry of 12 mm or more (Moss, 1997). Table 2 below defines how these measurements are taken and Figure 1 below illustrates some of the anthropometric landmarks. Table 2 Specifications for Taking Anthropometric Measurements Anthropometric Measure Measurement Cranial Vault [left frontozygomatic point (fz) to right euryon (eu)] minus [right frontozygomatic point (fz) to left euryon (eu)] Skull Base [subnasal point (sn) to left tragus (t)] minus [subnasal point (sn) to right tragus (t)] Orbitotragial Depth [left exocanthion point (ex) to left tragus (t)] minus [right exocanthion point (ex) to right tragus (t)] (Hayes, Inc. 2017) Upper Limb Orthotic Devices Upper Limb (Non Powered): Non powered upper limb orthotic devices are most commonly used to treat injuries and disorders of the finger, hand, wrist, elbow and infrequently, the shoulder. The devices may be classified according to the anatomic region (e.g., wrist, hand), by purpose (e.g., correction, restricting motion) or by function (e.g., compensating for deformity, weakness). Various types of upper limb orthotic devices are available including but not limited to shoulder orthoses, elbow orthoses, finger orthoses, and elbow-wrist-hand orthoses, to name a few. These devices can also be classified as either static (e.g., used to prevent deformity, reduce tone, provide stretch), dynamic (e.g., allow restricted motion) or adaptive/functional (e.g., used to compensate for absent function). Static devices do not allow motion, provide rigid support and are Medical Coverage Policy:0543 typically used to treat fractures, inflammatory conditions, or nerve injuries. Dynamic devices do allow motion and are most often used to treat weakened muscles and joint contractures. Adaptive/functional devices are used to assist with restoring function, such as for performance of activities of daily living. Published evidence indicates a number of devices are available for a variety of uses and generally supports upper extremity orthoses are clinically effective for the following indications: to substitute for weak or absent muscles (e.g., following cervical spine injury, brachial plexus injury, peripheral nerve injury [e.g., median, ulnar or radial nerves], sprain, strain, • protect damaged or diseased muscles/joints by limiting motion (e.g., rheumatoid arthritis, osteoarthrtitis, overuse syndromes [e.g., lateral epicondylitis, cubital tunnel syndrome, carpal tunnel syndrome, de Quervain tenosynovitis, trigger finger], trauma, following surgical repairs, fractures [e.g, acromioclavicular dislocation, clavicle fracture]) prevent risk of contracture or deformity from neurological injury (e.g., brain injury, stroke [i.e., spasticity], spinal cord injury, brachial plexus injury, peripheral nerve injury) correct joint contractures resulting from disease or immobilization (e.g., post fracture, burns) when necessary to carry out ADLs (e.g., spinal cord injured individuals) Upper Limb Myoelectric: Myoelectric powered upper-extremity orthotic devices use neurologic sensors, microprocessor units, and electric motors to provide self-initiated movement of the affected upper extremity. One device, the MyoPro® (Myomo, Inc., Boston, MA), is a myoelectric arm orthosis designed to support a weak or deformed arm. It is purported the MyoPro can enable individuals to self-initiate and control movements of a partially paralyzed or weakened arm using their own muscle signals. The device may be used as exercise equipment during rehabilitatio or as a personal assistive device. Individuals with traumatic brain injury, spinal cord injury, brachial plexus injury, amyotrophic lateral sclerosis, stroke, multiple sclerosis and other upper limb neuromuscular deficits may be considered candidates for use of the device. According to the manufacture there are three MyoPro 2 models available, all models are myoelectrically controlled by the wearer's own muscle signal. The Motion E features a powered elbow with static rigid wrist support; Motion W has a powered elbow and a multi-articulating wrist, with flexion/extension and supination/pronation; and Motion G offers a powered elbow, a multi-articulating wrist and a powered elbow. According to the United States Food and Drug Administration (FDA), Myomo Inc. received 510(k) approval for the Myomo e100 in 2007 as a Class 2 device, described further as exercise equipment, powered, EMG-triggered. The device is indicated for use by stroke patients undergoing rehabilitation to facilitate stroke rehabilitation by muscle re-education, and/or maintaining or increasing range of motion. Evidence in the peer-reviewed published scientific literature evaluating an upper limb myoelectric orthotic device consists of review articles, mainly retrospective observational studies, and few randomized controlled trials with small patient populations reporting short term outcomes. Much of the evidence evaluates use of robotic movement training in a rehabilitation setting as an adjunct to conventional therapies or for exercise training, with limited evidence evaluating use of the myoelectric device in the home setting (Pundik, et al., 2022; McCabe, et al., 2019; Page, et al., 2013; Willigenburg, et al., 2013; Stein, et al., 2007). One randomized controlled trial published by Page and colleagues (2020) involved 34 subjects with chronic, moderate post-stroke upper extremity hemiparesis. Subjects were divided into one of three groups: use of Myomo with repetitive task specific practice, task specific practice only, or Myomo only. The Fugl–Meyer score was the primary outcome used to determine success with a secondary outcome measure being the Arm Motor Activity Test. A total of 31 subjects completed the analysis, for the primary outcome measure, all three groups demonstrated near-identical score increases of approximately +2 Medical Coverage Policy:0543 points, with no difference in the amount of change. For secondary scores both Myomo groups demonstrated near-identical score increases of +1 point; the repetitive task group had a 2.6 point increase. The authors noted they rejected their initial study hypothesis that Myomo would result in significantly greater reductions in in upper extremity impairment, and concluded that changes using the Myomo device were comparable to those of manual-based therapies. Limitations of the trial include small sample population, use of devices that worked improperly, and limited activities and tasks that could be performed. Although myoelectric powered upper extremity orthotic devices are an evolving technology, more recently including those manufactured using 3D technology, additional well-designed, large-scale clinical studies evaluating benefits and harms of this technology after stroke and other neurological injuries are needed to firmly establish safety and clinical efficacy. Lower Limb Orthotic Devices Lower limb orthoses are classified by anatomic location (e.g., ankle orthoses, ankle-foot orthoses [AFO], knee-ankle-foot orthoses [KAFO]). Ankle orthoses are supportive devices used to provide immobilization to the ankle. AFOs have a shoe insert component as well as an ankle component. KAFOs contain a knee component, ankle component and shoe insert. Ankle Orthoses: An ankle orthosis is a type of orthotic device used to treat acute ankle injuries such as a sprain, for rehabilitation after the initial injury and to prevent re-injury of the ankle. They are also used to treat chronically unstable ankles. Ankle orthotic device options include lightweight sports plastics/Velcro models, hinged devices, lace-up devices, neoprene sleeves, ankle wraps and taping, braces, various types of casts, stabilizing shoes and air stirrups. Ankle-Foot Orthoses (AFO): An AFO extends well above the ankle to the top of the calf. It requires fastening at the lower leg, just above the ankle. This device may be considered medically necessary for ambulatory patients with weakness or deformity of the foot and ankle, which also require stabilization for medical reasons and when the patient has the potential to benefit functionally from use of the device. Commonly, AFOs are used to treat disorders including but not limited to ankle dorsiflexion (upward motion), plantar flexion (downward motion), inversion and eversion (turning inward or outward), spastic displegia due to cerebral palsy, lower motor neuron weakness due to poliomyelitis and spastic hemiplegia associated with cerebral infarction. Knee-Ankle-Foot Orthoses (KAFO): A KAFO is an AFO with metal uprights, a mechanical knee joint and two thigh bands. KAFOs may be medically necessary for ambulatory patients who meet criteria for an ankle-foot orthosis, and who also require additional support to the knee for stability. HCPCS codes representing KAFOs are L2000–L2038, L2126–L2136, and L4370. AFOs and KAFOs may be used by individuals for the treatment of edema and/or for the prevention or treatment of pressure ulcers. When the individual is ambulatory these devices are considered not medically necessary because when used for prevention/treatment of edema or pressure ulcers the devices are not being used to treat a weakness or deformity that requires stabilization and do not meet the definition of a brace. Similarly, walking boots (L4360 and L4386) are AFOs that may be used to relieve pressure on the sole of the foot or that may be used for patients with foot ulcers, when used for these indications these devices are also considered not medically necessary. A walking boot may be considered medically necessary when it is used to provide stabilization for treatment of orthopedic conditions or when used postoperatively for orthopedic surgery. Additions to AFO/KAFO Devices: Additions to AFOs or KAFOs (L2180–L2550, L2750–L2830) are considered not medically necessary if either the base orthosis is not medically necessary or the specific addition is not medically necessary. Medical Coverage Policy:0543 Nonambulatory AFO/Splints: A splint is defined as an appliance for preventing movement of joints or for the fixation of a displaced or movable body part. Nonambulatory AFO devices, often referred to as splints, include the ankle contracture splint, a night splint and/or a foot drop splint/recumbent positioning device. A static or dynamic positioning AFO (HCPCS L4396, L4397), also referred to as an ankle contracture splint, is a prefabricated AFO that has all of the following characteristics: designed to accommodate an ankle with a plantar flexion contracture of up to 45˚ • applies dorsiflexion force to the ankle • • has a soft interface for use by a patient who is minimally ambulatory or nonambulatory These devices may be used to treat plantar flexion contracture of the ankle, Achilles tendonitis, and plantar fasciitis. Ankle flexion contracture is a condition where the muscles and/or tendons that plantarflex the ankle are shortened, resulting in an inability to bring the ankle to 0˚ by passive range of motion. At 0˚ flexion, the ankle is perpendicular to the lower leg. Plantar fasciitis is an inflammation of the heel of the foot. Achilles tendonitis is a condition where there is painful inflammation of the Achilles tendon, most often the result of overuse. Conservative treatment for these conditions includes physical therapy, NSAIDS, non-weight-bearing, and strengthening and stretching of the tendons. Nonambulatory AFO/splint devices maintain elongation/stretching of the tendons and reduce tension when worn, typically at bedtime. When used to treat a fixed contracture and/or in patients who demonstrate foot drop without an ankle-flexion contracture these devices are considered not medically necessary. Furthermore when used to correct positioning of the knee or hip, the effectiveness of these splints is not well- established in the peer-reviewed literature. A foot drop splint/recumbent positioning device (HCPCS L4398) is a prefabricated AFO and has all of the following characteristics: designed to maintain the foot at a fixed position of 0˚ (i.e., perpendicular to the lower leg) • not designed to accommodate an ankle with a plantar flexion contracture • • has a soft interface for use by a patient who is nonambulatory Foot drop is a condition where there is a weakness and/or lack of use of the muscles that dorsiflex the ankle, but the ability to bring the ankle to 0˚ by passive range of motion remains. A foot drop splint/recumbent positioning device is not considered medically necessary for the treatment of foot drop when the individual is non-ambulatory because there are other more appropriate treatment modalities. Stance Control Orthoses: A stance control orthosis is an orthotic knee joint or custom- fabricated KAFO that allows swing-phase knee flexion. The knee joint locks when weight-bearing to provide stance phase stability and, when not weighted, it unlocks to allow a swinging motion of the knee. It is proposed that the stance control components allow the patient to swing their impaired limb with sufficient ground clearance to provide a more normal gait. While there are no specific patient criteria, it is intended for use in patients with lower extremity weakness and who demonstrate some control of hip muscles. Candidates who may benefit from this type of device typically have conditions such as polio, post-polio syndrome, spinal cord injuries, multiple sclerosis, stroke or trauma. Medical Coverage Policy:0543 These devices can be activated by a mechanical mechanism controlled by activated movement (e.g., ankle range of motion, limb inclination), or mechanical and controlled electronically (e.g., microprocessor-controlled, electromagnetic). Classifications of the devices include the ankle driven device that requires ankle motion to lock and unlock the knee joint; a gait driven device which requires the individual have the ability to reach full hip extension in stance and full knee extension in swing phase in order to unlock and lock the knee joint; or weight driven which locks the knee joint when weight is transferred onto foot plates. Electronic activated devices generally add resistance to knee flexion when the limb is loaded in less than a fully extended position, potentially improving function when the individual is ascending stairs or walking on uneven surfaces. Evidence in the published, peer-reviewed scientific literature evaluating stance control orthotic devices is limited. Most of the evidence that support some improvement of gait pattern are in the form of literature reviews (Rafiaei, et, al. 2015), small case reports (Kim, et al., 2016; Yakamovich et al., 2006; Herbert and Liggins, 2005) and small case series (Probsting, et al., 2015; Bernhardt, et al., 2011; Irby, et al., 2007; Irby, et al., 2005) and lack high statistical power. The types of devices in these trials vary making comparisons across studies difficult. Furthermore much of the information available for these devices is from the manufacturers. As a result, drawing strong conclusions that support improved clinical outcomes with the use of these devices is difficult. Stance control devices have not been clearly established as superior to conventional devices and there is limited evidence to suggest it is considered equivalent. Published scientific evidence evaluating enhanced features such as electronic controls (i.e., microprocessor, electromagnetic activation) is inadequate to support clinical utility. University of California Berkeley Laboratory (UCBL) Orthosis (HCPCS L3000): This orthosis is a variant of the traditional prefabricated arch support and was originally designed to maintain a flexible, paralytic valgus foot deformity in the corrected position. This orthosis is cast in a semi-weight-bearing position. Some authors recommend the device to treat flatfoot, plantar fasciitis, calcaneal spurs, posterior tibial tendon dysfunction and rheumatoid arthritis. __________________________________________________________ Knee Braces A brace is defined as 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 part. It must be a rigid or semirigid device used for the purpose of supporting a weak or deformed body member or restricting or eliminating motion in a diseased or injured part of the body. It must provide support and counterforce on the limb on which it is being used. For individuals who weigh more than 300 pounds heavy duty knee joints may be medically necessary. Types of Knee Braces There are four basic kinds of knee braces referenced in the published literature: prophylactic braces, which are designed to prevent or reduce the severity of knee injury • functional braces, which are designed to (a) provide stability for the anterior-cruciate ligament (ACL) or other ligament deficiency of the knee and (b) provide protection for the ACL or other ligaments after repairs or reconstructions rehabilitative braces, which are designed to allow protected motion of injured knees or knees that have been treated operatively unloader/offloader braces, which are designed to provide pain relief in arthritic knees Prophylactic Knee Braces: The objective of using a prophylactic knee brace is to prevent or reduce the severity of injury to a healthy knee. The prophylactic knee brace is generally indicated Medical Coverage Policy:0543 for protection of the medial-collateral ligament (MCL) against valgus knee stresses and ACL protection from rotational stress in similar situations and are available off-the-shelf. There is insufficient evidence to provide strong conclusions that use of prophylactic knee braces significantly reduces knee injuries (AAOS, 2014; AAOS, 2003; AAP, 2001). Functional Knee Braces: Functional knee braces, also referred to as derotational braces (e.g., HCPCS code L1840), provide stability to an unstable knee when rotational and anterior-posterior forces are applied to the ligaments. Their main function is to reduce risk of injuries without significantly impairing function (AAP, 2003) and can either be purchased off-the-shelf or are custom fabricated. The brace is designed to be worn during activities and to allow protected motion, as well as to prevent excessive loading. The published, peer-reviewed scientific literature reveals few clinical studies to support improvement in subjective responses with use of the functional brace, such as increased stability, decreased pain, improved performance or increased patient confidence. However, there is some evidence to indicate that functional braces are beneficial when the patient has demonstrated knee instability and is not a candidate for ACL reconstruction. Rehabilitative Knee Braces: Rehabilitative knee braces (e.g., HCPCS codes L1832, L1844) are intended to control the knee flexion-extension angle during the initial healing period after cruciate ligament or meniscal fracture management or reconstructive surgery. Rehabilitative braces are typically used short term for the early postoperative period to protect the fracture site or surgical repair while range-of-motion, weight-bearing and muscle activity are initiated. There is little published evidence and data supporting the use of rehabilitative braces, although they appear to be well accepted clinically and avoid the risks to the knee associated with cast immobilization. Unloading/Offloading Knee Braces: Unloading braces are recommended for the treatment of pain and disability that may result from moderate to severe osteoarthritis of the knee. Osteoarthritis of the knee is associated with an overload of a focal area of cartilage. This focal overload leads to failure of the load-bearing capacity of the affected cartilage and subchondral bone. Grading of osteoarthritis is often determined by the Kellgren-Lawrence scale which describes the severity of articular cartilage changes associated with osteoarthritis; grade 3 or 4 on the grading scale is considered moderate to severe osteoarthritis. In most cases, unicompartmental osteoarthritis and varus and valgus deformities can be treated by unloading braces, although joint disease that is present in both medial and lateral compartments and patellofemoral joint disease has not been successfully treated with braces (Pruitt, 2005). Varus deformities cause overload to the medial compartment, while valgus deformities cause overload to the lateral compartment. Knee braces with varus or valgus adjustments (e.g., HCPCS code L1843, L1844, L1845) may be medically necessary for patients who are ambulatory and require bracing to alleviate pressure on the medial or lateral compartment of the knee. Evidence in the published, peer-reviewed scientific literature evaluating the use of knee bracing for osteoarthritis (Matsuno, et al., 1997; Kirkley, et al., 1999; Richards, et al., 2005; Richmond, et al., 2009; Rannou, et al., 2010; Duivenvoorden, et al., 2015) tends to support some effectiveness and demonstrate reduction in pain, improved functionality, and reduced loading to the damaged compartment. Fracture brace: Another less commonly utilized knee brace is a fracture brace (e.g., HCPCS code L1832). This type of brace has been employed for the treatment of tibial-femoral fractures and may be custom-made or prefabricated. It is a functional brace that is applied after initial stabilization. It allows protected weightbearing and motion of the joints above and below the fracture. Published literature indicates this brace promotes early joint movement, prevention of contractures, and early weightbearing, which results in earlier healing. Patellofemoral knee brace: Knee sleeves, also known as patellofemoral knee braces (e.g., HCPCS code L1810), are elastic sleeves used to provide a feeling of support to the knee. These Medical Coverage Policy:0543 devices are intended to resist lateral displacement of the patella and thereby decrease knee pain. Generally, these devices function as a counterforce brace and have little efficacy for improving pain and function in the treatment of patellar subluxation, dislocation, or patellar hypermobility. The sleeve may be modified to include an opening for the patella, movable straps or a buttress (e.g., felt, inflatable air pocket) and is used to stabilize the patella. Plain knee sleeves may be used to treat postoperative knee effusions and patellofemoral pain syndrome in the absence of subluxation, although clinical efficacy has not been firmly established when used for these conditions (France and Paulos, 1994; Paluska and McKeag, 2000; LaBella, 2004; Lun, te al., 2005; Chew, et al., 2007). __________________________________________________________ Shoes (Therapeutic) In contrast to standard shoes (basic shoe), therapeutic shoes have additional depth and may be used to accommodate foot deformities. In general, therapeutic shoes may be considered medically necessary for the treatment of some foot conditions, are accommodative or functional, and are fitted and furnished by a specially trained health professional (e.g., podiatrist, orthotist, prosthetist) or certified pedorthotist. Shoe selection is based primarily on the foot condition or related disease, the shape of the foot, and the individual’s daily activities (Janisse and Janisse, 2008). Standard shoes (basic shoes) purchased over-the-counter are not considered therapeutic shoes. According to the American Diabetic Association (ADA), diabetic Individuals with neuropathy or evidence of plantar pressure may be adequately managed with a well-fitted walking shoe or athletic shoe; those with bony deformities (e.g., hammertoes, prominent metatarsal heads, bunions) may require extra-wide shoes or depth shoes; those with extreme bony deformities (e.g., Charcot foot) who cannot be accommodated with commercial therapeutic footwear may require custom-molded shoes (ADA, 2007). Early management is important for prevention or delay of ulceration and/or amputation. Shoes Types and Accessories: Therapeutic shoes that may be considered medically necessary for a person with systemic conditions that involve impaired circulation and/or loss of protective sensation, including diabetes mellitus, include a depth shoe (HCPCS code A5500) or a custom- molded shoe (HCPCS code A5501), and may or may not have an internally seamless toe. A depth shoe is defined as follows: has a full length, heel-to toe filler that when removed provides a minimum of 3/16" of additional depth used to accommodate custom-molded or customized inserts is made from leather or other suitable material of equal quality • has some form of closure (e.g., velcro, lace or zipper) • is available in full and half sizes with a minimum of three widths so that the sole is graded to the size and width of the upper portions of the shoe according to the American standard last sizing schedule or its equivalent. (The American last sizing schedule is the numerical shoe sizing system used for shoes in the United States.) A custom-molded shoe is defined as follows: • • has removable inserts which can be altered or replaced as the individual’s condition warrants is constructed over a positive model or mold of an individual’s foot is made of leather or other suitable material of equal quality has some form of shoe closure (lace, velcro, zipper). Medical Coverage Policy:0543 Therapeutic shoe inserts (HCPCS A5512, A5513, A5514) and/or modifications (HCPCS codes A5503, A5504, A5505, A5506, and A5507) may be considered medically necessary and are often required for correct fitting of the shoe. Inserts are total contact (continuous physical contact with weight-bearing portion of the foot) multiple density removable inlays that are directly molded to the plantar surface of the individual’s foot or a model of the foot. Modifications of depth or custom-molded shoes include but are not limited to: • • wedges • metatarsal bars • offset heels • flared heels rigid rocker bottoms roller bottoms Deluxe features (HCPCS codes A5508) such as special colors, special leathers, and styles do not contribute to the accommodative or therapeutic function of the shoe and are not considered medically necessary. Inlays (i.e., inserts) that reflect compression molding to the individual’s foot over time through heat and pressure generated by wearing a shoe with the insert present (HCPCS code A5510), without external heat sources, do not offer total contact and are not considered medically necessary. Soft, open toe post-operative shoes (i.e., Sroufe “toe shoe”) do not meet the definition of durable medical equipment, are not considered orthotics, and are considered convenience items. A foot adductus positioning device (e.g., UNFO foot brace, UNOS Medical ltd., Holon Israel) is a device intended for the treatment of metatarsus adductus in newborns. Metatarsus adductus is a condition resulting in medial deviation of the forefoot on the hindfoot, also referred to as “in- toeing”. Management of metatarsus adductus depends on degree of flexibility, treatment often involves only observation with spontaneous resolution in a majority of cases. In some cases, passive stretching or serial casting may be recommended (i.e., if no improvement by six months of age). Long term functional problems are rare even if in-toing does not completely resolve (Rosenfeld, et al. 2020). According to the manufacturer, components of the UNFO foot brace include a rigid plastic insert to support the foot. The insert is covered by a soft thermoplastic material to prevent pressure sores. The medial wall is curved as “anti-adductus shape” to allow more space at the mid-foot for adequate correction. The cushion is molded over the first metatarsus and the big toe for better consistent fixation of the foot in the brace. A circular adjustable strap immobilizes the foot in the brace. Fixed over the medial wall of the brace, ta Velcro strap (which features a wide and soft pillow for comfort) can be adjusted by the treating physician as the treatment progresses. The strap has two major functions: to stabilize the heel in the heel cage and the whole foot in the brace, which ensures that the foot remains securely fixed in the brace and to apply corrective pressures on the mid foot for adequate realignment of the foot. According to the FDA approval for this device, it is a Class I device, classified as a corrective orthotic shoe. Evidence in the peer- reviewed scientific literature evaluating the foot adductus positioning device is lacking therefore conclusions regarding safety, efficacy, and improved net health outcomes cannot be made. AposTherapy® is a customized shoe-like device claimed by the manufacturer to be a noninvasive biomechanical treatment for osteoarthritis (OA) of the knee and lower back pain (Apos US Management Inc., New York, NY). It is purported adjustable external spacers (i.e., pods) placed in the sole of the custom shoe aim to correct gait patterns. AposTherapy is initiated by a physical Medical Coverage Policy:0543 therapist using computerized gait analysis software to analyze the walking pattern. The physical therapist then calibrates the pods which provide perturbation on the bottom of the AposTherapy shoes based on the analysis. It is claimed the biomechanical device works to retrain muscles around the knee by adjusting the center of pressure, thereby changing the way one’s foot interacts with the ground. In theory, the pod causes an imbalance requiring one to realign the weight placed on joints and correct abnormal walking patterns, thereby correcting back, hip and knee alignment during ambulation. The device is proposed as an addition to or alternative to non- surgical standard care. Other nonsurgical comparators for treatment of OA include but are not limited to physical therapy, splints, supports, braces, and intra-articular joint injections. The evidence base to date consists mainly of retrospective case series, prospective trials, and non-randomized trials (Elbaz, et al., 2010; Drexler, et al., 2012; Segal, et al., 2013; Bar-Ziv, et al., 2013; Yaari, et al., 2015; Barzilay, et al., 2016; Yaari, et al., 2015; Tenenbaum, et al., 2017; Solomonow-Avnon, et al., 2017, Debbi, et al., 2019; Reichenbach et al., 2020; Drew, et al., 2022;Shema-Shiratzky, et al., 2023; Greene, et al., 2023). There is a growing body of evidence evaluating the incidence rate of TKR following initiation of treatment, which is mainly retrospective and lacks comparators, (Shema-Shiratzky, et al., 2023; Greene, et al., 2023; Drew, et al., 2022). Results of these trials extend two to five years, Drew and associates (2022) reported that 86% of particpiants who utilized AposTherapy (204/237 subjects) avoided TKR at two years, Greene, et. al., (2023) reported that 84% of subjects (305/365) who met criteria for TKR did not progress to having a TKR upon use of AposTherapy at two years follow-up, and Shema-Shiratzky et al. (2023) reported a low incidence of TKR in their study at five year followup (18%, n=414). Shema- Shiratzky and colleagues compared their results to prior reports that 50% of patients who sustain knee pain caused by OA will ultimately have a total knee replacement (TKR) after exhausting non- surgical treatment solutions. The trial was a retrospective study, with self-reported outcomes and lacked a control group. Limitations of this study include retrospective design, lack of confirmational imaging of OA (clinical diagnosis determined by physiotherapist), and lack of data surrounding treatment plans, adjustments, and use of the device, therefore strong conclusions cannot be made at this time. Furthermore, these outcomes suggest that surgery was delayed, whether AposTherapy results in complete avoidance of surgery has yet to be proven, long-term data is insufficient. In 202 Reichenbach and colleagues published the results of a randomized controlled trial evaluating the effect of biomechanical footwear therapy (n=111) versus control footwear (n=109) for treatment of pain related to knee osteoarthritis at 24 weeks followup. The experimental group wore two shoes with two convex adjustable rubber pods screwed to the outsole at the heel while the control group wore footwear which had a device that had visible outsole pods that were not adjustable and did not create a convex walking surface. Followup occurred at 24 weeks with outcomes measured using WOMAC pain subscores standardized to range from 0 (no symptoms) to 10 (extreme symptoms) and secondary outcomes which included WOMAC physical function and stiffness subscores and the WOMAC global score, all ranging from 0 (no symptoms) to 10 (extreme symptoms). A total of 213 subjects completed follow-up. All scores improved in all groups at 24 weeks, the authors reported the experimental group scores demonstrated a larger decrease in scores compared to the control group and that results were statistically significant, but of uncertain clinical importance. In addition to lack of long term outcomes, some limitations of the trial noted by the authors include differences in appearance of the shoes, lack of blinding, longer daily shoe wear in the experimental group, and allowance of supplemental analgesic use (Reichenbach, et al., 2020). The device has been investigated as a treatment for a number of conditions including OA of the knee and hip, pre- and post- total arthroplasty, as well as chronic back pain and other miscellaneous musculoskeletal conditions (e.g., osteonecrosis, ankle instability). However studies have primarily been in the form of case series and cohort studies with small patient populations, Medical Coverage Policy:0543 short-term follow-up and lack controls and there is a lack of comparative evidence with other commonly accepted non-surgical treatments. There is some evidence supporting significant improvement in short and mid-term outcomes using WOMAC scores and SF-36 questionnaires as well as improvement in gait velocity, cadence and stride length. Additionally, some evidence supports use of Apos Therapy results in reduction of pain medication, physical therapy, and other non-pharmacological interventions, while improving pain and function in some subjects. Although the available data suggest that the device may improve pain and function short-term for some individuals, larger, well designed studies with long-term follow-up are needed to establish the role of AposTherapy in the management of musculoskeletal conditions. Clinical trials in the form of RCTs evaluating the effectiveness of AposTherapy for knee pain due to OA are in progress. At present, there is insufficient evidence in the published peer-reviewed medical literature to support clinical efficacy of AposTherapy as a treatment for musculoskeletal conditions, including but not limited to knee osteoarthritis and/or chronic low back pain. __________________________________________________________ Spinal Orthotic Devices 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). These devices are used to relieve pain, reduce progression of disease/injury, and to improve function related to various spine conditions such as spinal stenosis, vertebral fractures, scoliosis, spondylosis, spondylolisthesis, Scheuermann’s disease (kyphotic deformity), and sprains. 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. 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. 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 (Bataller Cervero, et al., 2019; Erdil, 2016; Bigos, et al., 2009; van Duijvenbode, et al., 2009; van Poppel, 2004; Lahad, et al., 1994). Evidence evaluating use of these devices for treatment of various clinical conditions, including non specific back pain, is mixed, although some evidence supports improved clinical outcomes with use of these devices a majority of the evidence suggests there is little to no difference in outcomes (Gignoux, et al , 2022; Urquhart, et al., 2017; Takasaki, et al., 2017; Skoch, et al., 2016; Newman, et al., 2016; Negrini, et al., 2016; Agabegi, et al., 2010; van Duijvenbode, et al., 2008; Yee, et al., 2008). The results of one prospective RCT (Annaswamy, et al., 2021) designed to evaluate the effect of semi-rigid back bracing for treatment of low back pain was halted early due to worse Pain Disability Questionanaire, Patient Reported Outcome Measurement Information System and EQ-5D scores in the treatment group when compared to the control group. All subjects underwent back school instruction, the treatment group also underwent use of a semi- rigid lumbar orthosis, worn as needed, for symptom relief. Outcomes were measured at baseline, six weeks, 12 weeks and six months. An interim analysis at the half way point were 61 of the planned 120 subjects were enrolled, demonstrated there was no relief of pain when compared with exercise and instruction alone. Evidence evaluating spinal orthoses for treatment of Adolescent Idiopathic Scoliosis (AIS) has been published. The goal of treatment for AIS is a curve with a Cobb angle of <40° at skeletal maturity. Natural history studies indicate that curves <40° do not progress after skeletal maturity. In skeletally immature patients with AIS, bracing reduces the risk of curve progression to ≥50° Medical Coverage Policy:0543 (the usual threshold for surgery) at skeletal maturity. The efficacy of bracing is directly related to the number of hours per day that the brace is worn. Most curves can be managed with an underarm brace (a TLSO, also known as the Boston brace). The TLSO is relatively easy to hide under clothing and fairly well accepted by most patients. Other types of underarm braces include the Charleston brace and the Providence brace, which are designed to be worn only at night. A small percentage of curves require a brace with an under-chin extension (a CTLSO, also known as the Milwaukee brace). The CTLSO is more difficult to hide under clothes and less well-tolerated by patients. Data regarding the efficacy of other brace types such as flexible braces (e.g., SpineCor, Copes) is lacking (Scherl/UpToDate, 2022; Guo, et al., 2014). _________________________________________________________ Custom Foot Orthosis A foot orthosis is a type of shoe insert that does not extend beyond the ankle and may include items such as heel wedges and/or arch supports. The goal of treating conditions with foot orthoses is to decrease pain and increase function. They may also be indicated to correct foot deformities and provide shock absorption to the foot. Evidence in the published, scientific, peer-reviewed literature and clinical practice guidelines tend to suggest custom-fitted and custom-fabricated foot orthoses are at least as effective as prefabricated orthoses for the treatment of heel-pain syndromes and other conditions; the evidence does not indicate custom fabricated devices are clinically more effective when compared to prefabricated devices. Conditions for which shoe orthoses may be indicated include the following when there is failure, contraindication, or intolerance to a prefabricated device: treatment of impaired peripheral circulation and sensation (i.e., diabetic peripheral neuropathy, altered biomechanics, peripheral vascular disease, skin pathology, ulcers) when the orthosis is an integral part of a leg brace and is necessary for the proper functioning of the brace treatment of neurologic or neuromuscular conditions (i.e., stroke, neoplasms, hemiplegia, cerebral palsy, myelomeningocele, lower extremity spasticity, hypotonicity of certain muscles, neuromuscular imbalances) and there is reasonable expectation of improvement for congenital or acquired foot deformities (i.e., symptomatic rigid flatfoot, posterior tibial tendon dysfunction, mid- or hind-foot arthritis) when there is associated significant pain, impaired gait and prior conservative management has failed.