An upper limb prosthesis is a device designed to replace the function of a missing upper limb or body part due to congenital absence or amputation. Upper limb prostheses can be controlled using body-powered system, externally powered system, or a combination of both systems. Prosthetic terminal devices replace lost hand function and include passive, body-powered, and externally powered hooks, and hands.

The Plan uses guidance from the Centers for Medicare and Medicaid Services (CMS) and MassHealth for coverage determinations for its Dual Product Eligible plan members. CMS National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), Local Coverage Articles (LCAs) and documentation included in the Medicare manuals and MassHealth Medical Necessity Determinations are the basis for coverage determinations. When CMS and MassHealth do not provide guidance, the Plan's internally developed medical necessity guidelines are used. CMS and MassHealth coverage guidelines are not established for this service.

For the service Upper Limb Prostheses, evidence is sufficient for coverage. This criteria is used to assist in the appropriate Member selection and the appropriate protheses device to optimize best possible outcomes. The use of an upper limb protheses allows for Member's to have improved independent living, improved mobility, and reduce disability.

The use of this criteria in the utilization management process will ensure access to evidence based clinically appropriate care. See References section below for all evidence accessed in the development of these criteria.

Point32Health companies

1. 2105790Upper Limb Prostheses

Clinical Guideline Coverage Criteria

The Plan may authorize coverage of initial and replacement upper limb prosthesis when the requested prosthesis or component(s) is the most appropriate medically necessary device that adequately meets the functional needs of the member. When possible, The Plan may cover a trial of upper limb prosthesis, with supporting documentation.

Initial Upper Limb Prostheses Authorization

The Plan may authorize the coverage of initial upper limb prosthesis, including body powered prosthesis, when ALL the following criteria are met:

1. Documentation confirms a comprehensive evaluation has been performed by a board certified [American Board of Certification (ABC) or Board of Certification (BOCP)] prosthetist and prescribed prosthesis/component(s) is based on prosthetist recommendation; and
2. Functional evaluation indicates requested device does not exceed that which is medically necessary to adequately meet the functional needs of the member; and
3. Member has sufficient cognitive function, neurological function, cardiovascular reserve, and musculoskeletal ability to effectively utilize requested device to complete activities of daily living (ADL’s); and
4. Member will reach or maintain a predicted improved functional state, with the use of the prescribed prosthesis within a reasonable and predictable period of time.

Myoelectric Prosthesis

The Plan may authorize coverage of myoelectric upper limb prosthesis when criteria for initial upper limb prosthesis are met and when ALL the following additional criteria are met.

1. The member has sufficient neurological, musculoskeletal, myocutaneous, and cognitive function to operate the prosthesis effectively; and
2. The member has sustained a minimum of a trans metacarpal or above partial limb amputation; and
3. The member has sufficient microvolt threshold in the residual limb to allow proper function of myoelectric prosthesis;and
4. A standard body powered prosthetic device cannot be used or is insufficient to meet the functional needs of the member in performing activities of daily living; and

The member functions in an environment that would not inhibit the function of the prosthesis (i.e., a wet environment or situations involving electrical discharges)

Electric Hand

The Plan may authorize coverage of electric hand (L6880) or partial hand (L6026) prosthetic component when criteria for initial upper limb prosthesis and myoelectric prosthesis are met and documentation from a board-certified prosthetist ALL of the following criteria are met:

1. Member requires use of device for independence in activities of daily living (ADL’s) including:
   • Dressing
   • Personal hygiene, oral hygiene, and grooming
   • Toileting
   • Feeding; and
2. Member is willing and able to complete necessary training with Occupational Therapist or Physical Therapist who is trained and who specializes in terminal upper limb myoelectric prosthetic components, including partial hand/electric hand; and
3. Documented Occupational or Physical Therapy evaluation supports ALL of the following:
   • Member has the potential to function independently with requested terminal device in a reasonable and predictable period of time; and
   • ALL functions of the requested device (e.g., wrist rotation, number of articulating digits, thumb opposition, number of grip patterns) do not exceed that which is medically necessary to adequately meet the functional needs to the member; and
   • Device will allow member the grip prehension and joint movement required to sustain a minimum level of independent daily living; and
   • Member has sufficient cognitive, musculoskeletal, and neurological ability to utilize device to complete ADL’s

Prostheses and Prosthetic Components for Recreational Purposes

2 Upper Limb Prostheses

2Applicable to Harvard Pilgrim Health Care members Residing in Maine or with Maine Plans. Please refer to the Member’s plan documents for details.

The Plan may authorize coverage of one additional prosthesis and/or prosthetic component for Members under 18 years of age for recreational purposes when the following criteria are met:

1. Documentation of a complete multidisciplinary assessment (e.g., medical record notes, Physical Therapy assessment, detailed written order completed by certified prosthetist and signed by the attending physician) including an evaluation by a certified prosthetic clinician with expertise in the evaluation and fitting for the requested device is required and includes ALL of the following:
   • Requested prosthesis/prosthetic component is the most appropriate and least intensive model that meets the medical needs of the Member to maximize the Member’s ability to perform recreational activity (e.g., swim), to maximize upper-limb function and to allow developmentally appropriate experiences; and
   • Physical therapy evaluation and assessment (e.g., musculoskeletal, endurance) supports the Member is able to tolerate the physical demands of desired recreational activity; and
   • Delivery of prosthesis by prosthetist will include education regarding any specialized maintenance and care of prosthesis/prosthetic components

Replacement Prosthesis Authorization all products

(A replacement is the removal and substitution of a component of a prosthesis that has a HCPCS definition) The Plan may authorize the replacement of upper limb prosthesis or the replacement of any part of such device, if an ordering physician determines that the replacement device, or replacement part of such a device, is necessary when ALL the following criteria are met:

1. Covered repairs must be performed by a certified prosthetist as described above, or technician working under the supervision of a certified prosthetist; and
2. Documentation by Provider that member has demonstrated continuous use of current prosthesis; and
3. There is a change in the physiological condition or functional level of the member, which justifies a new prosthesisor replacement part(s); and
4. There is an irreparable change in the condition of the device, or in a part of the device; and

The component or prosthesis in need of replacement is not covered under warrantyThe Plan may cover the replacement of sockets when there is adequate documentation of functional and/or physiological need, including but not limited to: changes in the residual limb, functional need changes, or irreparable damage or wear/tear due to excessive weight or prosthetic demands of very active amputees.

In addition to the above criteria, the following replacement criteria are applicable to Tufts Health Commercial, Tufts Freedom Plan, Tufts Health Direct, and Tufts Health RITogether Products only:

1. The condition of the device, or the part of the device, requires repairs, and the cost of such repairs would be more than 60 percent of the cost of a replacement device, or, as the case may be, of the part being replaced.
2. The component or prosthesis is not in need of replacement as a result of improper use.

Limitations

The Plan will not cover the following, as they are not considered medically necessary:

1. Swim prosthesis (Note: Unless covered per \