Lower Limb Prostheses - Policy Article

NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act §1862(a)(1)(A) provisions (i.e. “reasonable and necessary”). Lower limb prostheses are covered under the Medicare Artificial Legs, Arms and Eyes benefit (Social Security Act §1861(s)(9)). In order for a beneficiary's lower limb prosthesis to be eligible for reimbursement, the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition to meeting the benefit policy, there are specific statutory payment policy requirements, discussed below, that also must be met. GENERAL: A repair is a restoration of the prosthesis to correct problems due to wear or damage. An adjustment is any modification to the prosthesis due to a change in the beneficiary's condition or to improve the function of the prosthesis. The following items are included in the reimbursement for a prosthesis and, therefore, are not separately billable to Medicare under the prosthetic benefit: Evaluation of the residual limb and gait Fitting of the prosthesis Cost of base component parts and labor contained in HCPCS base codes Repairs due to normal wear or tear within 90 days of delivery Adjustments of the prosthesis or the prosthetic component made when fitting the prosthesis or component and for 90 days from the date of delivery when the adjustments are not necessitated by changes in the residual limb or the beneficiary's functional abilities. Payment for Prostheses Provided During a Medicare Part A Covered Hospital Stay Payment by Medicare Part A for a prosthesis provided to a beneficiary for use during a Medicare Part A covered hospital stay is eligible for inclusion in the payment for the hospital stay if the following criteria (1 and 2) are met: The prosthesis is provided to a beneficiary during the inpatient hospital stay; and, The beneficiary uses the prosthesis for reasonable and necessary inpatient treatment or rehabilitation. In this situation, a claim must not be submitted to the DME MAC. Payment by the DME MAC for a prosthesis delivered to a beneficiary, not for use during a Medicare Part A covered hospital stay, is eligible for DME MAC coverage if the following criteria (1 – 3) are met: The prosthesis is reasonable and necessary for a beneficiary after discharge from a hospital; and, The prosthesis is delivered to the beneficiary no more than two days prior to discharge to home; and, The prosthesis is not used for inpatient treatment or rehabilitation. Payment for Prostheses Provided During a Medicare Part A Covered Skilled Nursing Facility (SNF) Stay Payment by Medicare Part A for a prosthesis provided to a beneficiary, described by codes L5000, L5010, L5020, L5400, L5410, L5420, L5430, L5450, L5460, L5987, L8400, L8410, L8417, L8420, L8430, L8440, L8460, L8470, and L8480, for use during a Medicare Part A covered SNF stay is eligible for inclusion in the payment for the SNF stay if the following criteria (1 and 2) are met: The prosthesis is provided to a beneficiary during the SNF stay; and, The beneficiary uses the prosthesis for reasonable and necessary treatment or rehabilitation. In this situation, a claim must not be submitted to the DME MAC. Claims (other than for the above HCPCS codes) for a lower limb prosthesis provided to a beneficiary during a Medicare Part A covered SNF stay (see below), and claims for any lower limb prosthesis provided to a beneficiary during a non-covered Medicare Part A SNF stay, are to be submitted to the DME MAC. Payment by the DME MAC for a prosthesis delivered to a beneficiary during a Part A covered SNF stay is eligible for DME MAC coverage if: The prosthesis is reasonable and necessary for a beneficiary’s use during the Medicare Part A covered SNF stay; and, The prosthetic components are classified as major category III codes under the SNFs consolidated billing. ADJUSTMENTS, REPAIRS, AND COMPONENT REPLACEMENT: Routine periodic servicing, such as testing, cleaning, and checking of the prosthesis is noncovered. Adjustments to a prosthesis required by wear or by a change in the beneficiary's condition are covered under the initial treating practitioner's order for the prosthesis for the life of the prosthesis. Repairs to a prosthesis are covered when necessary to make the prosthesis functional. If the expense for repairs exceeds the estimated expense of purchasing another entire prosthesis, no payments can be made for the amount of the excess. Maintenance which may be necessitated by manufacturer's recommendations or the construction of the prosthesis and must be performed by the prosthetist is covered as a repair. Replacement of a prosthesis or prosthetic component is covered if the treating practitioner orders a replacement device or part because of any of the following: A change in the physiological condition of the beneficiary; or Irreparable wear of the device or a part of the device; or The condition of the device, or part of the device, requires repairs and the cost of such repairs would be more than 60% of the cost of a replacement device, or of the part being replaced. Replacement of a prosthesis or prosthetic components required because of loss or irreparable damage may be reimbursed without a practitioner's order when it is determined that the prosthesis as originally ordered still fills the beneficiary's medical needs. MISCELLANEOUS: A prosthetic donning sleeve (L7600) will be denied as noncovered. REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217) Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is available here . Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary. If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage. FUNCTIONAL LEVEL CHARACTERISTICS (based on CMS Health Technology Assessment: Lower Limb Prosthetic Workgroup Consensus Document, 2017) Note : Not all traits listed for K levels must be realized by the patient in order to receive a K level assignment, but generally, documentation should demonstrate that equivalent activities can be achieved by the prosthetic user. Level 0: Does not have the ability or potential to ambulate or transfer safely with or without assistance and a prosthesis does not enhance their quality of life or mobility. The individual does not have sufficient cognitive ability to safely use a prosthesis with or without assistance. The individual requires assistance from equipment or a caregiver in order to transfer and use of a prosthesis does not improve mobility or independence with transfers. The individual is wheelchair dependent for mobility and use of a prosthesis does not improve transfer abilities. The individual is bedridden and has no need or capacity to ambulate or transfer. Level 1: Has the ability or potential to use a prosthesis for transfers or ambulation on level surfaces at fixed cadence, typical of the limited and unlimited household ambulator. The individual has sufficient cognitive ability to safely use a prosthesis with or without an assistive device and/or the assistance/supervision of one person. The individual is capable of safe but limited ambulation within the home or on a similar flat surface like a home, with or without an assistive device and/or with or without the assistance/supervision of one person. The individual requires the use of a wheelchair for most activities outside of their residence. The individual is not capable of most of the functional activities designated in Level 2. Level 2: Has the ability or potential for ambulation with the ability to transverse low level environmental barriers such as curbs, stairs or uneven surfaces. This level is typical of the limited community ambulator. The individual can, with or without an assistive device (which may include one or two handrails) and/or with or without the assistance/supervision of one person: Perform the Level 1 tasks designated above Ambulate on a flat, smooth surface (e.g., concrete, asphalt) such as might be found outside the home. (e.g., porch, deck, patio garage, driveway) Negotiate a curb Access public or private transportation Negotiate 1-2 stairs Negotiate a ramp built to ADA specifications. The individual may require a wheelchair for distances that are beyond the perimeters of the yard/driveway, apartment building, etc. The individual is only able to increase their generally observed speed of walking for short distances or with great effort. The individual is generally not capable of accomplishing most of the tasks at Level 3 (or does so infrequently with great effort). Level 3: Has the ability or potential for ambulation with variable cadence, typical of the community ambulator who has the ability to transverse most environmental barriers and may have vocational, therapeutic, or exe