Appeal type: Practitioner Services
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve Epifix, per square centimeter (Q4186), Epicord, per 
square centimeter (Q4187) and an 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 square centimeters; first 
25 square centimeter or less wound surface area (15275). 
 
You asked the Plan to pre-approve wound care. You say that due to the enrollee's history of treatment, you 
disagree with the denial. The enrollee was diagnosed with cellulitis and osteomyelitis in February 2023. He had 
surgery 5 days later. The Plan denied your request. The Plan says the enrollee does not have a diagnosis of 
venous stasis ulcer or diabetic ulcer. There is not enough scientific proof showing the safety and/or success for 
Epifax and Epicord when used for this reason. It falls under the class of experimental and unproven and is not 
covered by your Plan. 
 
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 wound care. Our reviewer says that the 
requested items/services are not considered medically reasonable and necessary in this case. Our physician 
reviewer found the medical documentation supports that this enrollee suffered with osteomyelitis of the left 
calcaneus. The enrollee underwent excision of infected bone and soft tissue. Status post-surgery the enrollee 
was left with an open surgical wound to the posterior left calcaneus. Epifix and Epicord are recommended for 
the use of nonhealing diabetic wounds and nonhealing venous stasis wounds. The medical documentation does 
not support that this patient is suffering with a nonhealing diabetic wound or a nonhealing venous stasis wound. 
Medicare guidelines advise that they will 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. 
Criteria that must be met include a treatment that is not experimental or investigational, appropriate, and at 
least as beneficial as existing and available medically appropriate alternatives. In this particular case, the 
medical documentation does not support that this patient is suffering with a nonhealing diabetic wound, or a 
venous stasis wound. Utilization of Epifix and Epicord would then be considered experimental and 
investigational for a surgical wound. Therefore, it is my opinion that the requested Epifix and Epicord are 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 wound care have not been met. Therefore, we decided that the Plan does not 
have to pre-approve Epifix, per square centimeter (Q4186), Epicord, per square centimeter (Q4187) and an 
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 square centimeters; first 25 square centimeter or less wound 
surface area (15275).