Article - Lower Limb Prostheses - Policy Article (A52496)

CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor 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 gaitFitting of the prosthesisCost of base component parts and labor contained in HCPCS base codesRepairs due to normal wear or tear within 90 days of deliveryAdjustments 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 StayPayment 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,notfor 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 isnotused for inpatient treatment or rehabilitation.Payment for Prostheses Provided During a Medicare Part A Covered Skilled Nursing Facility (SNF) StayPayment 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 beneficiarys 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 initialtreating practitioner'sorder 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 treatingpractitioner orders a replacement device or part because of any of the following:A change in the physiological condition of the beneficiary; orIrreparable wear of the device or a part of the device; orThe 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 availablehere.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.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.When submitting a prosthetic claim, the billed code for knee, foot, ankle and hip (HCPCS codes L5610, L5611, L5613, L5614, L5616, L5710, L5711, L5712, L5714, L5716, L5718, L5722, L5724, L5726, L5728, L5780, L5810, L5811, L5812, L5814, L5816, L5818, L5822, L5824, L5826, L5828, L5830, L5840, L5848, L5856, L5857, L5858, L5859, L5930, L5961, L5970, L5971, L5972, L5973, L5974, L5975, L5976, L5978, L5979, L5980, L5981, L5982, L5984, L5985, L5986, L5987) components must be submitted with modifiers K0 - K4, indicating the expected beneficiary functional level. This expectation of functional ability information must be clearly documented and retained in the prosthetist's records. The simple entry of a K modifier in those records is not sufficient. There must be information about the beneficiarys history and current condition which supports the designation of the functional level by the prosthetist.For L5859, the medical records should describe the nature and extent of the comorbidity of the spine or the sound limb which is what is limiting this beneficiary to a household ambulator, and clearly document how this feature will enable the beneficiary to function as a community ambulator.Refer to the Supplier Manual for more information on documentation requirements.REPAIR/REPLACEMENT (BPM Ch 15, 120)Adjustments and repairs of prostheses and prosthetic components are covered under the original order for the prosthetic device.Medicare payment may be made for the replacement of prosthetic devices which are artificial limbs, or for the replacement of any part of such devices, without regard to continuous use or useful lifetime restrictions if atreating practitionerdetermines that the replacement device, or replacement part of such a device, is reasonable and necessary. Claims involving the replacement of a prosthesis or major component (foot, ankle, knee, socket) must be supported by a new treating practitioner's order and documentation supporting the reason for the replacement. The reason for replacement must be documented by the treating practitioner, either on the order or in the medical record, and must fall under one of the following:A change in the physiological condition of the patient resulting in the need for a replacement. Examples include but are not limited to, changes in beneficiary weight, changes in the residual limb, beneficiary functional need changes; or,An irreparable change in the condition of the device, or in a part of the device resulting in the need for a replacement; or,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.The prosthetist must retain documentation of the prosthesis or prosthetic component replaced, the reason for replacement, and a description of the labor involved irrespective of the time since the prosthesis was provided to the beneficiary. This information must be available upon request. It is recognized that there are situations where the reason for replacement includes but is not limited to: changes in the residual limb; functional need changes; or irreparable damage or wear/tear due to excessive beneficiary weight or prosthetic demands of very active amputees.CONTINUED MEDICAL NEEDFor all DMEPOS items, the initial justification for medical need is established at the time the item(s) is first ordered, therefore, beneficiary medical records demonstrating that the item is reasonable and necessary are created just prior to, or at the time of, the creation of the initial prescription. Once initial medical need is established, unless continued coverage requirements are specified in the LCD, ongoing need for the lower limb prosthesis is assumed to be met. There is no requirement for further documentation of continued medical need as long as the beneficiary continues to meet the Artificial Legs, Arms and Eyes benefit.MODIFIERSLT and RT MODIFIERS:The right (RT) and left (LT) modifiers must be used with prosthesis codes (refer to the CODING GUIDELINES section for additional information).CODING GUIDELINESREPAIR AND LABOR CODINGCode L7510 is used to bill for any "minor" materials (i.e., those without specific HCPCS codes) used to achieve the adjustment and/or repair.Code L7520 is used to bill for labor associated with adjustments and repairs that either do not involve replacement parts or that involve replacement parts billed with code L7510. Code L7520 must not be billed for labor time involved in the replacement of parts that are billed with a specific HCPCS code. Labor is included in the allowance for those codes.One unit of service of code L7520 represents 15 minutes of labor time. Documentation must exist in the supplier's records indicating the specific adjustment and/or repair performed and the time involved. The time reported for L7520 must only be for actual repair time. Time performing the following services (not all-inclusive) must not be billed using code L7520:Evaluation to determine the need for a repair or adjustment or follow-up assessmentEvaluation of problems regarding the fit or function of the prosthesisGeneral beneficiary education or gait instructionProgramming of electronic componentrySUSPENSIONCode L5671 includes both the part of the suspension locking mechanism that is integrated into the prosthesis socket and the pin(s), lanyard, or other component which is attached to the socket insert. L5671 does not include the socket insert itself. The socket inserts used in conjunction with a suspension locking mechanism are billed with codes L5673, L5679, L5681, or L5683, as appropriate. These codes include socket inserts with or without a distal umbrella adapter for attaching the pin or lanyard of the locking mechanism.