Updated LCD Improves Amputees' Access to Prosthetic Knees and Feet

What You Need to Know

The final version of the LCD creates a pathway for some functional level K2 transfemoral amputees to obtain prosthetic feet and knees classified as K3 components. That pathway consists of two separate sets of criteria.

The first criteria set offers K2 transfemoral patients access to K3 knees "under limited circumstances" when all of the following criteria are met:

• A clinician has determined the patient's functional level;
• The medical record outlines the rationale for selection of a K3 knee, including how it willImprove the patient's functional health outcomes; andHelp the patient accomplish their activities of daily living;
• The medical record shows that the clinician has considered K2 knees and ruled them out based on the patient's specific functional and medical needs.

The second criteria set must additionally be satisfied if a clinician wishes to provide a K2 transfemoral patient with a microprocessor-controlled knee:

• The MPK is indicated for functional level 2 patients;
• The MPK has stumble recovery functionality;
• The patient can make use of a product that requires daily charging; and
• The patient can understand and respond to error alerts and alarms if the unit isn't functioning correctly.

In addition, a K2 patient who receives a K3 knee may also be eligible for a K3 foot. In those instances, the clinician must document that the K3 foot is required for the "safe and proper use" of the prosthetic knee.

In conjunction with the LCD-specific changes, the DME MACs also have updated the accompanying Policy Article. Most notably, those changes include:

• Lists of "Functional Level Characteristics" for each of the K-levels. These lists provide additional insight into what the DME MACs consider activities commonly associated with each functional level.
• A requirement that the medical record specify which activities of daily living will improve when providing a K2 patient with a K3 knee. The Policy Article lists specific examples of ADL's that may be relevant.
• A revised "Modifiers" section, including the directive that suppliers must use the "KX" modifier for prosthetic claims, which signals that (a) the supplier has satisfied existing coverage criteria, and (b) the claim contains documentation supporting medical necessity for the billed item(s).
• An explicit statement that prosthetists' and orthotists' notes are part of the medical record.

What this Means for You

First, and most important, you now have the ability to provide some K2 transfemoral Medicare patients access to K3 knees and feet. The improved mobility and stability that many of these components offer patients increase prosthetists' ability to provide their patients solutions addressing their individual needs.

Second, if you believe that a K3 knee will help your patient in ways that K2 knees cannot, you must make sure that your clinical notes address all of the first-level criteria listed above. And if your recommendation involves a MPK, you must further ensure that your notes address each of the second-level criteria as well. We have every reason to believe that the DME MACs will scrutinize these claims closely, looking for strict compliance with the standards set forth not only in the LCD, but in the Policy Article as well. That means, for example, that it is not enough to generally say a K3 knee will help your patient accomplish their ADL's. While that appears to satisfy the ADL requirement included in the first LCD criteria set listed above, the Policy Article explicitly requires more than that: you have to list the specific ADL('s) that will improve with the proposed knee. You therefore need to read and intimately understand both the LCD and the Policy Article to ensure that you can satisfy all of the stated requirements.

Third, the DME MACs noted in their responses to submitted comments to the proposed LCD that the PDAC is not responsible for determining which MPKs are "indicated" for K2 patients. This means that the PDAC will not be engaging in some kind of specific verification process involving MPKs for K2 patients. Instead, the DME MACs noted that "[s]atisfaction of this criterion is based solely on the manufacturer’s indications for the specific knee.”

Fourth, neither the LCD nor the Policy Article specifically addresses what facts would establish that a K3 foot is required for the "safe and proper use" of a K3 knee. We expect that both clinicians and product manufacturers will develop these arguments in the coming weeks and months. 

And lastly, make sure that you are familiar with the new "Modifiers" section of the LCD and that you integrate that information into each and every prosthetic claim from September 1st -forward.

To see the final LCD, click here. To see the final Policy Article, click here.