Appeal type: DME/ Orthotics
Decision: Favorable

 
We decided that the Plan has to pre-approve a Foot Drop System and a Wireless Hand Rehab System. 
 
You asked the Plan to pre-approve the services. You say that this is medically necessary and essential to 
treatment. The Plan denied your request. The Plan says that this is not medically necessary. 
 
The Plan must follow Medicare rules. Medicare rules say that if there are no specific coverage rules for an item 
or service, then that item or service will be covered when it is medically necessary.  
 
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 the services. Our reviewer says that the 
requested services are considered medically reasonable and necessary in this case. Our physician reviewer 
found that the plan's invocation of the second half of the National Coverage Determination (160.12) is 
irrelevant to this case. Neither of those devices, as applied to the enrollee, are for walking. Therefore, the fact 
that the enrollee has a traumatic brain injury as opposed to spinal cord injury, has no bearing on this case. 
 
First regarding L300, given that the enrollee has diffuse weakness and spasticity through the left leg, merely 
providing a peroneal nerve stimulator to help with ankle dorsiflexion (but not knee or hip function) would not 
be sufficient to permit walking. As the authorization packet points out, the L300 can be used to treat disuse 
atrophy, which is reasonable and necessary for this enrollee because they have long term hopes of returning to 
ambulation - something that might be possible for this Beneficiary in the future as Medicare is presently 
expanding coverage for powered orthoses. 
 
Next, regarding the H200 system, this product is first and foremost a functional wrist-hand orthosis. Coverage 
of such a product is not precluded by NCD 160.12, and there is no NCD nor LCD on upper extremity braces. 
Therefore, coverage criteria falls to general reasonable necessity criteria. This device is reasonable and 
necessary because it is cleared by the Food and Drug Administration (FDA) and vetted by the peer reviewed 
literature as safe, effective, and not experimental, clinically appropriate in duration, frequency, and setting, and 
furnished in accordance with accepted standards of medical practice to improve the function of the enrollee's 
hand. This is necessary to provide essential activity of daily living (ADL) function with an otherwise impaired 
left hand. Many medically appropriate alternatives have been tried and failed over the past 22 years of 
rehabilitation. 
 
Additionally, the plan's denial based on an out-of-network (OON) request is invalid, as the provider of these 
devices is the sole provider of its own technology. Denying an OON exception would effectively block 
coverage for this reasonable and necessary care. 
 
 We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of the services have been met. Therefore, we decided that the Plan has to pre-
approve a Foot Drop System and a Wireless Hand Rehab System.  
 
If the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again 
if we believe there was a mistake or if there is new information to review. The Plan has to show us the mistake 
and/or send us the new information. This does not happen often. If we decide to open the case again, we will 
send you a letter.