Humana Prosthetics - 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 Jurisdiction Medicare Applicable States/Territories Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15 §120 Prosthetics Administrative Contractors (MACs) Prosthetics Page: 2 of 31 Internet- Only Manuals (IOMs) 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 16 §130 Leg, Arm, Back and Neck Braces, Trusses, and Artificial Legs, Arms, and Eyes §20 Services Not Reasonable and Necessary 50.2 NCD Electronic Speech Aids NCD Prosthetic Shoe NCD Scleral Shell 280.10 80.5 LCD LCA Cosmetic and Reconstructive Surgery L33428 A56658 LCD LCA Standard Documentation Requirements for All Claims Submitted to DME MACs A55426 JJ - Palmetto GBA (Part A/B MAC) AL, GA, TN JM - Palmetto GBA (Part A/B MAC) DME A - Noridian Healthcare Solutions, LLC (DME MAC) DME B - CGS Administrators, LLC (DME MAC) NC, SC, VA, WV CT, DE, DC, ME, MD, MA, NH, NJ, NY, PA, RI, VT IL, IN, KY, MI, MN, OH, WI Prosthetics Page: 3 of 31 DME C - CGS Administrators, LLC (DME MAC) DME D - Noridian Healthcare Solutions, LLC (DME MAC) 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) 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, WY, American Samoa, Guam, Northern Mariana Islands 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, WY, American Samoa, Guam, Northern Mariana Islands Lower Limb Prosthesis Eye Prostheses External Breast Prostheses LCD LCA Facial Prostheses Orthopedic Footwear L33787 A52496 L33737 A52462 L33317 A52478 L33738 A52463 L33641 A52481 Description A prosthesis or prosthetic is an artificial device that replaces a missing body part. Examples of prostheses include arms, breasts, ears, feet, hands, legs and maxillofacial (jaw and face). Upper limb prostheses are classified into the following categories: Prosthetics Page: 4 of 31 • Body powered utilizes a body harness and cable system to provide functional manipulation. Voluntary movement of the shoulder and/or limb stump extends the cable system and transmits force to the device to control hand, forearm and elbow movement. • Hybrid is a combination of body powered and myoelectric components and may be used for high-level amputations (at or above the elbow). Hybrid systems allow control of 2 joints at once. • Myoelectric utilizes muscle activity from the residual limb for control of joint movement. Electromyographic signals from the limb stump are detected by surface electrodes, amplified and then processed by a controller to drive battery powered motors that move the hand, wrist and elbow. These devices operate on rechargeable batteries and require no external cables or harnesses. • Passive is the lightest and serves mostly a cosmetic purpose as it does not restore any function and must be repositioned manually, typically by moving it with the opposite arm. A multiarticulating, myoelectric hand prosthetic (eg, bebionic, iLimb, Michelangelo, Vincent) functions by individually powering all 5 digits to grasp by conforming to the objects shape and fluctuating the grip strength. Devices vary in function and options including, but not limited to, the ability to be controlled by a mobile device app, conductive tips for mobile device use, multiple wrist options and skin colored silicone glove covers (eg, Livingskin). The prosthetic is described as anthropomorphic (human like) in its appearance and shape. A partial hand myoelectric prosthetic (eg, ProDigits) replaces the function of one or more missing fingers as a result of a partial hand amputation. It is intended for use for an amputation at a transmetacarpal level or higher. An enhanced-dexterity prosthetic arm (eg, Life Under Kinetic Evolution [LUKE] Arm) is an upper limb prosthesis that was developed to restore function in those individuals who have lost all or part of their upper limb. It is primarily controlled by a micro-electromechanical system that is operated through an inertial measurement unit (IMU), which is located in a sensor that is attached to or embedded in the individual’s shoe. By lifting the foot in various directions, it purportedly commands the motion of the prosthesis. An osseointegrated prosthesis for the rehabilitation of amputees (OPRA), is an osseointegration device, also referred to as osseoanchored device (bone anchored) intended for skeletally mature individuals (bone growth is complete) who have transfemoral amputation due to trauma or cancer. Coverage Determination Humana follows the CMS requirement that only allows coverage and payment for services that reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare. Prosthetics Page: 5 of 31 In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the following criteria: ARTIFICIAL LARYNX Please refer to the following CMS sources for guidance regarding artificial larynx (electrolarynx, Ultravoice): • CMS National Coverage Determination 50.2 – Electronic Speech Aids • Medicare Benefit Policy Manual Chapter 15 – §120 Prosthetics BREAST Please refer to the following CMS sources for guidance regarding external breast prostheses and mastectomy bras: • CMS Local Coverage Article A52478 – External Breast Prosthesis • CMS Local Coverage Determination L33317 – External Breast Prosthesis • Medicare Benefit Policy Manual Chapter 15 – §120 Prosthetics EYE Please refer to the following CMS sources for guidance regarding eye prostheses: • CMS Local Coverage Article A52462 – Eye Prostheses • CMS Local Coverage Determination L33737 – Eye Prostheses • CMS National Coverage Determination 80.5 – Scleral Shell • Medicare Benefit Policy Manual Chapter 15 – §120 Prosthetics • Medicare Benefit Policy Manual Chapter 15 – §130 Leg, Arm, Back and Neck Braces, Trusses, and Artificial Legs, Arms, and Eyes FACIAL (including ears) Please refer to the following CMS sources for guidance regarding facial prostheses: • CMS Local Coverage Article A52463 – Facial Prostheses • CMS Local Coverage Determination L33738 – Facial Prostheses • Medicare Benefit Policy Manual Chapter 15 – §120 Prosthetics • Medicare Benefit Policy Manual Chapter 15 – §130 Leg, Arm, Back and Neck Braces, Trusses, and Artificial Legs, Arms, and Eyes LOWER LIMB Please refer to the following CMS sources for guidance regarding lower limb prostheses: • CMS Local Coverage Article A52496 – Lower Limb Prostheses Prosthetics Page: 6 of 31 • CMS Local Coverage Determination L33787 – Lower Limb Prostheses • CMS National Coverage Determination 280.10 – Prosthetic Shoe • Medicare Benefit Policy Manual Chapter 15 – §120 Prosthetics • Medicare Benefit Policy Manual Chapter 15 – §130 Leg, Arm, Back and Neck Braces, Trusses, and Artificial Legs, Arms, and Eyes Osseointegrated prosthesis for the rehabilitation of amputees (OPRA Implant System) will be considered medically reasonable and necessary when the following requirements are met: • 22 to 65 years of age; AND • Transfemoral amputation due to trauma or cancer with rehabilitation problems with or cannot use, a conventional socket prosthesis with one or more of the following: o Extensive area of skin grafting o Pain o Recurrent skin infections and ulcerations in the socket contact area o Restricted mobility o Short stump preventing the use of socket prosthesis o Socket retention problems due to excessive perspiration o Soft tissue scarring o Volume fluctuation in the stump 19,26,40 UPPER EXTREMITY Body Powered Body powered upper extremity prosthesis will be considered medically reasonable and necessary when this type of prosthesis meets the functional needs to perform normal ADLs. Myoelectric including Hybrid Myoelectric upper extremity prosthesis will be considered medically reasonable and necessary when all the following requirements are met: • Absence of a comorbidity that could interfere with maintaining function of the prosthesis (eg, neuromuscular disease); AND • Amputation or missing limb at the wrist or above (eg, forearm, elbow); AND • Remaining musculature of the arm contains the minimum microvolt threshold to allow operation of the prosthesis; AND • Standard body powered prosthesis is insufficient to meet the functional needs to perform normal ADLs; AND Prosthetics Page: 7 of 31 • Sufficient cognitive and neurological function to operate the prosthesis effectively 34 REPAIR AND REPLACEMENT Please refer to the following CMS sources for guidance regarding repair and replacement of a prostheses: • Please refer to the specific CMS Local and National Coverage Determinations noted above for guidance regarding repair and replacement. In the absence of LCD or NCD guidance, refer to the Medicare Benefit Policy Manual Chapter 15 – §120 Prosthetics OTHER DEVICES Please refer to the member’s Evidence of Coverage for the guidance regarding medical necessity and limitations of coverage: • Wigs (A9282) 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. Coverage Limitations US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage LOWER LIMB Osseointegrated prosthesis for the rehabilitation of amputees will be considered not medically reasonable and necessary when any the following requirements are met: • Atypical skeletal anatomy with the following: o Conditions which are not amenable to device insertion such as deformities, fracture, infection. o Development anomalies o Skeletal dimensions outside defined interval; OR • Body weight is higher than 220 pounds including the prosthesis; OR • Individual is pregnant; OR • Individual is unable to comply with treatment and follow up requirements; OR • Individual one of the following concurrent conditions: Prosthetics Page: 8 of 31 o Active infection or dormant bacteria o Diabetic mellitus with complications o Neuropathy or neuropathic disease and severe phantom pain o Severe peripheral vascular disease o Skin disorders involving the residual extremity; OR • Less than 2 mm of remaining cortex bone available around the implant, if implanted; OR • Osteoporosis 19, 26, 40 UPPER LIMB The following service/item will not be considered medically reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member: • Enhanced dexterity prosthetic arm (Life Under Kinetic Evolution [LUKE] Arm) (L7499); OR • Myoelectric partial hand prosthesis (eg, ProDigits) (L6026); OR • Myoelectric upper extremity orthotic brace/device (MyoPro) for muscle weakness/paralysis (eg, nerve injury, neuromuscular disorders, stroke) (L8701, L8702) A review of the current medical literature shows that the evidence is insufficient to determine that this service is standard medical treatment for these indications. There remains an absence of randomized, blinded clinical studies examining benefit and long-term clinical outcomes establishing the value of this service in clinical management for these indications. Summary of Evidence Enhanced dexterity prosthetic arm (Life Under Kinetic Evolution [LUKE] Arm An overall very low-quality body of evidence evaluated use of the LUKE arm (also known as the DEKA arm) in adults with upper extremity amputation. The evidence is insufficient to draw conclusions regarding the efficacy and safety of the DEKA arm due to an evidence base consisting only of 2 poor quality studies (9 publications), in which the results did not suggest consistent improvement on measures of function or performance with the DEKA arm compared with existing prosthesis. Along these lines, analyses evaluating the efficacy of the 2 DEKA arm control systems were too premature to draw sufficient conclusions related to performance and functionality. Like the findings for function and performance, the results did not suggest consistent improvement in overall QOL and community reintegration. In addition, lack of adequate follow-up further limits the conclusions that can be drawn since the patient learning curve would likely be a factor in improved function and patient satisfaction. The patient population in the studies evaluated in this report is limited to patients within the Military Health System (MHS).28 Myoelectric partial hand prosthesis (eg, ProDigits) Prosthetics Page: 9 of 31 A current medical literature search resulted in studies looking into the challenges of maintaining wrist control while using the myoelectric partial-hand prosthesis noting electromyogram (EMG) pattern recognition from wrist motion can obscure myoelectric finger control signals. Participants in the studies were in non- amputee and amputee groups. Wrist motion and EMG patterns were observed to determine the best method to enable signaling to the digits. A major limitation was that experiments were not performed while using the prosthesis. The purpose of the studies appears to focus on improvement to the prosthesis rather than its efficacy or medical necessity. 1,16 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. 18,32,36 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. 32