Appeal type: Surgery
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve Computer-assisted surgical navigation MAKOplasty, 
represented by CPT code 0055T. 
 
You asked the Plan to pre-approve Computer-assisted surgical navigation MAKOplasty. You say that you are 
in pain and cannot walk. The Plan denied your request. The Plan says Computer-assisted surgical navigation 
MAKOplasty, represented by code 0055T is not medically necessary and reasonable. Medical studies have not 
shown that this computer-assisted surgical navigation technique is better than standard joint implant 
procedures. 
 
The Plan must follow Medicare rules. Medicare rules say that items and services that are not medically 
necessary are not covered.  
 
We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to 
determine if the Plan was correct in denying the request to pre-approve Computer-assisted surgical navigation 
MAKOplasty. Our reviewer says that the requested items/services are not considered medically reasonable and necessary in this case. Our physician reviewer found medical literature has found found no mid-term functional 
or radiographic differences between total knee arthroplasties (TKAs) with mechanical alignment or kinematic 
alignment. The anticipated improvements in patient-reported outcomes with kinematic alignment were not 
realized. Because kinematic alignment results in a high proportion of patients whose tibial components are 
inserted in varus, loosening remains a potential long-term concern. Given the unknown impact on long-term 
survivorship of the substantial alignment alterations with kinematic alignment, medical findings do not support 
the routine use of kinematic alignment outside of a research setting. Research shows that there is no significant 
differences in clinical or radiological outcomes between computer-navigated TKA and conventional TKA. It 
remains unclear which TKA technique yields better results in terms of mid- to long-term clinical and 
radiological outcomes. You are being treated for unilateral primary left knee osteoarthritis. You presented with 
left knee pain that is severe and rated at 10/10. You note limitation of motion with crepitation and knee 
stiffness. Your medical records reveal an antalgic gait favoring the left leg. The range of motion is 5-110. There 
is some medial and lateral laxity and positive medial and lateral joint line tenderness. There is crepitus and 
retropatellar pain with knee flexion and extension. You are planning to have a left knee replacement. However, 
no large volume, long-term/high-quality clinical studies confirm the clinical benefits (ultimate outcomes of 
functional improvement and pain reduction) of computer-assisted surgery over standard surgical approaches in 
total knee arthroplasty. There is no compelling rationale presented or extenuating circumstances noted to 
support the medical necessity of this request as an exception. Therefore, the requested computer-assisted 
surgical navigation MAKOplasty is not medically reasonable or necessary. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of Computer-assisted surgical navigation MAKOplasty have not been met. 
Therefore, we decided that the Plan does not have to pre-approve Computer-assisted surgical navigation 
MAKOplasty, represented by CPT code 0055T.