Humana Orthotics - Medicare Advantage Form

Please refer to CMS website for the most current applicable National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/CMS Online Manual System/Transmittals. Type Title ID Number Internet- Only Manuals (IOMs) Internet- Only Manuals (IOMs) Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15 Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15 NCD NCD NCD Corset Used as Hernia Support Durable Medical Equipment Reference List Sykes Hernia Control §130 Leg, Arm, Back and Neck Braces, Trusses, and Artificial Legs, Arms, and Eyes §140 Therapeutic Shoes for Individuals with Diabetes 280.11 280.1 280.12 LCA Standard Documentation Requirements for all Claims Submitted to DME MACs A55426 Orthotics Page: 2 of 41 Jurisdiction Medicare Administrative Contractors (MACs) Applicable States/Territories DME A - Noridian Healthcare Solutions, LLC (DME MAC) DME B - CGS Administrators, LLC (DME MAC) DME C - CGS Administrators, LLC (DME MAC) DME D - Noridian Healthcare Solutions, LLC (DME MAC) CT, DE, DC, ME, MD, MA, NH, NJ, NY, PA, RI, VT IL, IN, KY, MI, MN, OH, WI AL, AR, CO, FL, GA, LA, MS, NM, NC, OK, SC, TN, TX, VA, WV, PR, U.S. VI AK, AZ, CA, HI, ID, IA, KS, MO, MT, NE, NV, ND, OR, SD, UT, WA, LCA LCA Non-Payment for Prefabricated Splints A56112 Non-Payment for Prefabricated Splints A52754 Ankle-Foot/Knee-Ankle-Foot Orthosis Knee Orthoses Orthopedic Footwear LCD LCA Spinal Orthoses: TLSO and LSO Therapeutic Shoes for Persons with Diabetes L33686 A52457 L33318 A52465 L33641 A52481 L33790 A52500 L33369 A52501 Orthotics Page: 3 of 41 JE - Noridian Healthcare Solutions, LLC JF - Noridian Healthcare Solutions, LLC DME A - Noridian Healthcare Solutions, LLC (DME MAC) DME B - CGS Administrators, LLC (DME MAC) DME C - CGS Administrators, LLC (DME MAC) DME D - Noridian Healthcare Solutions, LLC (DME MAC) CA, HI, NV, American Samoa, Guam, Northern Mariana Islands AK, AZ, ID, MT, ND, OR, SD, UT, WA, WY CT, DE, DC, ME, MD, MA, NH, NJ, NY, PA, RI, VT IL, IN, KY, MI, MN, OH, WI AL, AR, CO, FL, GA, LA, MS, NM, NC, OK, SC, TN, TX, VA, WV, PR, U.S. VI AK, AZ, CA, HI, ID, IA, KS, MO, MT, NE, NV, ND, OR, SD, UT, WA, Description Orthotics are devices that may be utilized to support, align, prevent or correct deformities or to improve the function of movable parts of the body. Orthotics include, but may not be limited to, braces (devices that support a weak joint or joints), splints (rigid devices used to immobilize an injury), casts (devices used to immobilize fractured body parts) and supports. Orthotics may be classified as: Over-the-counter (OTC) – off-the-shelf – Devices that are not modified or changed from the original product. These items are generally available without a prescription and typically not covered under the Plan. Prefabricated – Devices that are generally premade; however, may require a fitting or adjustment to fit the individual. Custom fabricated – Devices that involve substantial work such as cutting, bending, molding or sewing. An impression of the body part may also be made to form a model from which the orthotic is molded. Orthotics Page: 4 of 41 Examples of orthotics include, but may not be limited to: • Air splints • Cervical collars (eg, postsurgical) • Clavicle splints (eg, figure eight splint) • Finger splints (eg, volar plate or tendon avulsions) • Knee immobilizers (eg, internal derangement, ligament sprains, postsurgical) • Lumbar braces • Orthopedic shoes • Serial casting/plaster splinting • Torsion bar braces • Unloader braces, such as for the knee or back • Wrist splints (eg, carpal tunnel syndrome) Alternative types of orthotics include, but may not be limited to: A scoliosis brace is utilized to help the individual’s scoliosis curve from getting worse in hopes of avoiding surgical treatment. Scoliosis braces are typically rigid and cover the front and back of the upper body. Generally, thoracolumbrosacral/lumbosacral (TLSO/LSO) braces are utilized. Other braces that have been introduced include tension-based braces (eg, SpineCor) and thermoplastic braces that purportedly have pressure and expansion areas built in to provide correction from three different anatomical planes (eg, Wood Cheneau Rigor brace). Intrepid Dynamic Exoskeleton Orthosis (IDEO) is a custom molded device that was reportedly developed for individuals who have suffered massive tissue, nerve and bone damage to supposedly return capabilities to the injured ankle. Purportedly, the individual can return to a high level of activity, such as running. The IDEO device is molded out of lightweight black carbon that includes a foot plate and a strut that runs up the back of the calf to a cuff that is situated just below the knee. Reportedly, when force is applied to the foot plate, the strut bends. As the individual steps down, it bends the foot plate, transferring energy forward. The ExoSym brace resembles the IDEO orthosis; however, it is purportedly lighter and stronger than the original version. Microprocessor activated mobility devices combine electronic components with specialized orthotic braces to reportedly aid in walking to individuals with back injuries or leg muscle weakness. Examples of microprocessor activated devices include, but may not be limited to, the C-Brace Orthotronic Mobility System or the Sensor Walk Stance Control knee brace. Myoelectric orthotic devices were reportedly designed for upper limb deficiencies. They purportedly enable individuals who have been afflicted by a stroke or other neuromuscular conditions to self-initiate movement of a partially paralyzed arm using their own muscle signals. Supposedly, when the user tries to bend the affected limb, sensors in the brace detect the muscle signal, which activates the motor to move Orthotics Page: 5 of 41 the arm in the desired direction. Examples of this brace include, but may not be limited to, the MyoPro myoelectric limb orthosis and the Myomo e100. Orthotic full body garments (eg, TheraTogs) are elasticized undergarments that include straps that are reportedly used for individuals with sensorimotor impairments. The garment along with the strapping purportedly improves stability, movement as well as postural alignment. Wearable robotic exoskeletons have been developed to reportedly help individuals ambulate despite partial or complete paraplegia. The devices include fitted braces for the legs and upper body with motorized hip and knee joints, a backpack containing a computer and rechargeable batteries, an array of upper body motion sensors and a computer based wireless control system worn on the individual’s wrist. Crutches are also used to provide the user with additional stability when walking, standing or rising from a chair. Typically, these devices are indicated for use by people with paraplegia due to spinal cord injuries at levels T7 to L5 when accompanied by a specially trained caregiver and for individuals with spinal cord injuries at levels T4 to T6 where the device is limited to use in rehabilitation institutions.45,47,52 Examples of these types of devices include, but may not be limited to, the following: • Alalante • EksoGT and EksoNR systems (for use only in rehabilitation institutions) • Indego powered exoskeleton • Keeogo Dermoskeleton system • ReWalk Personal System • ReWalk Restore Generally, the use of these devices requires that individuals are able to stand using an assistive device (eg, standing frame) and their hands and shoulders are able to support crutches or a walker.45,47,52 Coverage Determination Humana follows the CMS requirements that only allows coverage and payment for services that are reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare. In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the following criteria: Fitting/application of a pre-packaged or “off the shelf” splint will be considered medically reasonable and necessary. (29105, 29125, 29126, 29130, 29131, 97760, 97799) Please refer to the following CMS guidance: Orthotic Type Associated CMS Guidance Orthotics Page: 6 of 41 Arm Orthosis Cervical Orthosis Fabric Supports Hernia Orthosis Knee Orthosis Leg Orthosis Orthopedic Footwear Spinal/Back Orthoses Therapeutic Shoes for Persons with Diabetes Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15-§130 Leg, Arm, Back and Neck Braces, Trusses, and Artificial Legs, Arms, and Eyes Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15-§130 Leg, Arm, Back and Neck Braces, Trusses, and Artificial Legs, Arms, and Eyes 280.1 - Durable Medical Equipment Reference List 280.11- Corset Used as Hernia Support 280.12- Sykes Hernia Control L33318 – Knee Orthoses A52465 – Knee Orthoses Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15-§130 Leg, Arm, Back and Neck Braces, Trusses, and Artificial Legs, Arms, and Eyes Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15-§130 Leg, Arm, Back and Neck Braces, Trusses, and Artificial Legs, Arms, and Eyes L33686 - Ankle-Foot/Knee-Ankle-Foot Orthosis A52457 - Ankle-Foot/Knee-Ankle-Foot Orthoses - Policy Article L33641 – Orthopedic Footwear A52481 – Orthopedic Footwear – Policy Article L33790 – Spinal Orthoses: TLSO and LSO A52500 Spinal Orthoses: TLSO and LSO – Policy Article Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15-§130 Leg, Arm, Back and Neck Braces, Trusses, and Artificial Legs, Arms, and Eyes Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15-§140 Therapeutic Shoes for Individuals with Diabetes L33369 – Therapeutic Shoes for Persons with Diabetes A52501 – Therapeutic Shoes for Persons with Diabetes – Policy Article The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy. Orthotics Page: 7 of 41 Coverage Limitations US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage The following services/items will not be considered medically reasonable and necessary: • C-Brace Orthotronic Mobility System (L2006) • Myoelectric upper extremity orthotic devices (L8701, L8702) • Wearable robotic exoskeletons (eg, Atalante, EksoGT system, EksoNR system, Indego powered exoskeleton, Keeogo Dermoskeleton system, ReWalk Personal System, ReWalk ReStore) (E1399, K1007) A review of the current medical literature shows that the evidence is insufficient to determine that these services/items are standard medical treatment. There remains an absence of randomized, blinded clinical studies examining benefit and long-term clinical outcomes establishing the value of these services in clinical management. Summary of Evidence C-Brace Orthotronic Mobility System A clinical literature search was performed in health technology assessment that resulted in the evidence finding to be inconclusive for use of the C-Brace. One before and after study was located and found to have a high risk of bias. 21 Myoelectric upper extremity orthotic devices Current medical evidence is too limited in quantity and quality to determine how myoelectric prosthetic devices compare with other therapies intended to improve arm and hand impairment in individuals with upper extremity weakness or paralysis from conditions such as stroke, nerve injury, traumatic brain injury and neuromuscular diseases.19,24,27,35 Studies did show that clinical important and statistically significant gains were made on a measure of upper limb control however, further studies with a larger cohort are warranted. 28 Wearable robotic exoskeletons Results of a clinical evidence assessment literature search resulted in two English-speaking before and after published studies for the use of an exoskeleton in individuals with multiple sclerosis in neurorehabilitation. Both studies reported improvement in gait efficiency and speed. Each study separately reported improved neuromotor coordination and lower limb strength in some participants. Conclusions reached included the positive effects of the exoskeletons were not long lasting and further investigation is warranted.18 The following services/items will not be considered medically reasonable and necessary: Orthotics Page: 8 of 41 • DDS 500 Lumbar Traction LSO belt • E- Mag Active Knee Joint System • ExoSym brace • IDEO device • Sensor Walk Stance Control knee brace • Tension based scoliosis orthotic (eg, SpineCor System Dynamic Corrective Brace) (L1005) • Wood Cheneau Rigo scoliosis brace (L0999) A review of the current medical literature shows that there is no evidence to determine that these services/ items are standard medical treatments. There is an absence of randomized, blinded clinical studies examining benefit and long-term clinical outcomes establishing the value of these services/items in clinical management.