Proposed LCD - Lower Limb Prostheses (DL33787)

Coverage is extended only if there is sufficient clinical documentation of functional need for the technologic or design feature of a given type of knee. This information must be retained in the treating practitioner's or prosthetist's files.ANKLES:An axial rotation unit (L5982, L5984, L5985, L5986) is covered for beneficiaries whose functional level is 2 or above.HIPS:A pneumatic or hydraulic polycentric hip joint (L5961) is covered for beneficiaries whose functional level is 3 or above.SOCKETS:More than 2 test (diagnostic) sockets (L5618, L5620, L5622, L5624, L5626, L5628) for an individual prosthesis are not reasonable and necessary unless there is documentation in the medical record which justifies the need. Exception: A test socket is not reasonable and necessary for an immediate prosthesis (L5400, L5410, L5420, L5430, L5450,L5460).No more than two of the same socket inserts (L5654, L5655, L5656, L5658, L5661, L5665, L5673, L5679, L5681, L5683) are allowed per individual prosthesis at the same time.Socket replacements are considered reasonable and necessary if there is adequate documentation of functional and/or physiological need. It is recognized that there are situations where the explanation 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.GENERALA Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not reasonable and necessary.For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) base items that require a Written Order Prior to Delivery (WOPD), the supplier must have received a signed SWO before the DMEPOS item is delivered to a beneficiary. If a supplier delivers a DMEPOS item without first receiving a WOPD, the claim shall be denied as not reasonable and necessary. Refer to the LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.For DMEPOS base items that require a WOPD, and also require separately billed associated options, accessories, and/or supplies, the supplier must have received a WOPD which lists the base item and which may list all the associated options, accessories, and/or supplies that are separately billed prior to the delivery of the items. In this scenario, if the supplier separately bills for associated options, accessories, and/or supplies without first receiving a completed and signed WOPD of the base item prior to delivery, the claim(s) shall be denied as not reasonable and necessary.An item/service is correctly coded when it meets all the coding guidelines listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC articles. Claims that do not meet coding guidelines shall be denied as not reasonable and necessary/incorrectly coded.Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. Proof of delivery documentation must be made available to the Medicare contractor upon request. All services that do not have appropriate proof of delivery from the supplier shall be denied as not reasonable and necessary.General InformationAssociated InformationDocumentation RequirementsSection 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider. It is expected that the beneficiary's medical records will reflect the need for the care provided. The beneficiary's medical records include the treating practitioner's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.GENERAL DOCUMENTATION REQUIREMENTSIn order to justify payment for DMEPOS items, suppliers must meet the following requirements:SWOMedical Record Information (including continued need/use if applicable)Correct CodingProof of DeliveryRefer to the LCD-related Standard Documentation Requirements article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information regarding these requirements.Refer to the Supplier Manual for additional information on documentation requirements.Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSItems covered in this LCD have additional policy-specific requirements that must be met prior to Medicare reimbursement.Refer to the LCD-related Policy article, located at the bottom of this policy under the Related Local Coverage Documents section for additional information.AppendicesUtilization GuidelinesRefer to Coverage Indications, Limitations and/or Medical Necessity.Sources of InformationReserved for future use.Bibliography