Appeal type: Surgery
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve the requested 10 units of Grafix skin substitute with 
application (Q4133, 15275, 15276). 
 
You asked the Plan to pre-approve the requested 10 units of Grafix skin substitute with application (Q4133, 
15275, 15276). You say that the requested 10 units of Grafix skin substitute with application (Q4133, 15275, 
15276) are medically necessary. The Plan denied your request. The Plan says the requested 10 units of Grafix 
skin substitute with application (Q4133, 15275, 15276) are not medically necessary. 
 
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 the requested 10 units of Grafix skin 
substitute with application (Q4133, 15275, 15276). Our reviewer says that the requested 10 units of Grafix skin 
substitute with application (Q4133, 15275, 15276) are not medically necessary. Our physician reviewer found 
after careful review of the enclosed information and the pertinent guidelines for this case, the requested units of 
Grafix skin substitute with application (Q4133, 15275, 15276) are not medically reasonable or necessary for 
the enrollee in this case. It is well established that this enrollee is suffering with a diabetic ulceration to the plantar aspect of the left heel. They have been undergoing Unna boot dressing changes, oral antibiotic 
treatment, wound debridement, and offloading. The progress notes advise that the podiatrist has recommended 
that they be evaluated by vascular, however as of the last enclosed progress note they have not. The podiatry 
progress notes advise that pedal pulses are nonpalpable bilaterally. The progress notes advise that the wound 
ulceration is improving by roughly 30%. Medicare advises that they pay for items or services that are 
reasonable and necessary for the diagnosis or treatment of an illness or injury or to improve the functioning of a 
malformed body member. These services must also be furnished in a setting appropriate to the enrollees 
medical needs and condition. In this particular case the enrollee is noted to have nonpalpable pedal pulses 
which will dramatically inhibit healing. They are awaiting vascular consultation. Regardless of this, the 
podiatry progress notes advise that there is improvement of the ulceration by at least 30%. The podiatry 
progress notes advised that the ulceration is improving with Unna boot dressings, offloading, wound 
debridement, and dressings. The progress notes the medical information does not support the necessity for 
Grafix wound applications. It stands to reason that the enrollees vascular status should be assessed by vascular 
surgeon prior to applying these wound applications. Furthermore, it appears as though the ulceration is 
improving without these applications.  Therefore, the requested 10 units of Grafix skin substitute with 
application (Q4133, 15275, 15276) are not medically reasonable or necessary for the enrollee in this case. 
 
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 requested 10 units of Grafix skin substitute with application (Q4133, 15275, 
15276) have not been met. Therefore, we decided that the Plan does not have to pre-approve the requested 10 
units of Grafix skin substitute with application (Q4133, 15275, 15276).