Prosthetic Replacement

What You Need to Know

CMS has unique guidelines when it comes to replacing a prosthetic limb or component. Unlike other DME and bracing devices, prosthetic replacement does not rely on the Reasonable and Useful Lifetime (RUL). According to the CMS article Standard Documentation Requirements for All Claims Submitted to DME MACs, Medicare pays for prosthetic device replacement "without regard to continuous use or useful lifetime restrictions if a treating practitioner determines that the replacement device, or replacement part of such a device, is necessary." Therefore, Medicare will provide coverage regardless of when the original prosthesis was delivered as long as a replacement is medically necessary.

To justify medical necessity, CMS provides specific coverage guidelines based on information in the medical record. The referring physician not only needs to provide an order for the new prosthetic device, but also needs to document the reason for replacement. The Policy Article for Lower Limb Prostheses states that the reason for replacement must fall within one of the following three categories:

• 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.

Along with the referring physician's medical records, Medicare requires the prosthetist to document what is being replaced, the reason for replacement, and a description of the labor involved.

What this Means for You

If your patient needs a prosthetic replacement, it is important to follow Medicare guidelines to ensure payment. Coverage for a new prosthetic device is dependent on the referring physician's recommendation and does not take into consideration when the original device was delivered. After obtaining a new order from the physician, you must verify whether the reason for replacement falls within one of the three categories listed above. This information can be documented on the order itself or in the physician’s notes. The prosthetist’s corroborating documentation also needs to include the reason for replacement, along with a description of the component(s) being replaced and the labor required to complete the replacement. 

When documenting the reason for replacement, you should also include an explanation of why a new prosthetic limb or component (i.e., foot, ankle, knee, socket, etc.) is medically necessary for your patient. 

• Change in physiological condition (i.e., weight, residual limb, functional needs, etc.): document why the change necessitates a new device and why the patient's current device is no longer appropriate. 
• Irreparable wear (i.e., breakdown due to excessive beneficiary weight, prosthetic demands of very active amputees, etc.): thoroughly explain the condition of the device, including what is broken and the warranty status, and explain any functional limitations and/or safety concerns if the patient continues to use the broken prosthesis. 
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• Repair cost is more than 60% of the Medicare allowable: document exactly what needs to be repaired, why the repair is needed, including any functional and/or safety concerns, and provide an invoice for the repair to support the cost comparison.

While this article outlines the specific coverage criteria for prosthetic replacement, don’t forget that you also need to make sure all LCD/Policy Article coverage criteria are met for the new device. Even if the replacement is identical to the original prosthesis, it is always important to document how the specific features of each component meet the medical and functional needs of the patient today. The medical records should clearly convey why the recommended device is the only device available that meets the patient’s needs and explain why the “next best thing” is not appropriate for the patient (this is especially important for prostheses with advanced features). If your patient is not a Medicare beneficiary, be sure to review their insurance medical policy and plan benefit documents to determine whether their requirements for coverage differ from those outlined above.