Appeal type: DME/ Orthotics
Decision: Favorable

 
We decided that the Plan has to pre-approve Microlyte Matrix, per sq cm (A2005 x250), Axolotl Graft or 
Axolotl DualGraft, per sq cm (Q4102 x80), Celera Dual Layer or Celera Dual Membrane, per sq cm (Q4259 
x60), PalinGen or PalinGen XPlus, per sq cm (Q4173 x 80), and application of skin substitute graft to face, 
scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area 
up to 100 sq cm; first 25 sq cm or less wound surface area (15275 x10). 
 
You asked the Plan to pre-approve Microlyte Matrix, Axolotl Graft or Axolotl DualGraft, Celera Dual Layer or 
Celera Dual Membrane, PalinGen or PalinGen XPlus, and application of skin substitute graft. You say that the 
services are necessary. The Plan denied your request. The Plan says that medical necessity has not been 
established. Therefore, coverage criteria have not been met. 
 
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 Microlyte Matrix, Axolotl Graft or 
Axolotl DualGraft, Celera Dual Layer or Celera Dual Membrane, PalinGen or PalinGen XPlus, and application 
of skin substitute graft. Our reviewer says that the requested items/services are considered medically reasonable 
and necessary in this case. Our physician reviewer found based on the medical records provided and review of 
the current peer-reviewed medical literature there is support that the skin substitutes at issue in this case meet 
all Medicare criteria for medically reasonable and necessary and safe and effective for the enrollee. Provided 
records in this case document trial and failure of debridement, off-loading and usual wound care; records 
document evidence of adequate glucose control and adequate peripheral arterial circulation.  
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of Microlyte Matrix, Axolotl Graft or Axolotl DualGraft, Celera Dual Layer or 
Celera Dual Membrane, PalinGen or PalinGen XPlus, and application of skin substitute graft have been met. 
Therefore, we decided that the Plan has to pre-approve Microlyte Matrix, per sq cm (A2005 x250), Axolotl 
Graft or Axolotl DualGraft, per sq cm (Q4102 x80), Celera Dual Layer or Celera Dual Membrane, per sq cm 
(Q4259 x60), PalinGen or PalinGen XPlus, per sq cm (Q4173 x 80), and application of skin substitute graft to 
face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface 
area up to 100 sq cm; first 25 sq cm or less wound surface area (15275 x10).  
 
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.