Appeal type: DME/ Orthotics
Decision: Favorable

 
We decided that the Plan has to pre-approve a MyoPro Orthosis (L8702). 
 
You asked the Plan to pre-approve the orthosis. You say that the MyoPro is supported as an appropriate 
intervention and is reasonably and medically necessary as recognized by medical communities and key opinion 
leaders in rehabilitation. The Plan denied your request. The Plan says that there is not enough medical evidence 
that shows the MyoPro is helpful. 
 
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 orthosis. Our reviewer says that the 
requested items/services are considered medically reasonable and necessary in this case. Our physician 
reviewer found the Plan erred in its denial of the MyoPro. Despite the Plans and Hayes assertions to the 
contrary, the fact is that the MyoPro and similar technology is well supported by the published, peer reviewed 
evidence, so much so that it is considered reasonable and necessary by Medicare and covered on a case-by-case 
basis. Centers for Medicare & Medicaid Services (CMS) specifically created billing codes for this technology 
several years ago in order to permit such individual coverage determinations. This technology is not 
experimental. In fact, it is generally accepted as part of the standard of care among the medical community 
specializing in the treatment of patients like this one precisely because it has been proven to be helpful for 
permitting functional restoration of chronically paretic upper extremities in a way that is usually not possible 
through other therapeutic alternatives. That reality is materially proven by the literature reviews attached to the 
August 24, 2023, appeal letter by the provider, which are more complete and credible, than the non-peer-
reviewed Hayes report. This specific enrollee's medical record (as best summarized by the primary care 
physician's clinic notes from May 2023) supports the enrollee's individual need for the requested orthosis. This 
request for this enrollee is fully compliant with the reasonable and necessary criteria. In this case, because 
Myomo is the only provider who can provide the services required, the Plan must cover their services and 
provide a gap exception. Therefore, L8702 and Myomos gap exception to provide this medically reasonable 
and necessary device are hereby approved. 
 
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 orthosis have been met. Therefore, we decided that the Plan has to pre-
approve a MyoPro Orthosis (L8702).  
 
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.