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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules say that the application of a skin substitute graft for lower extremity diabetic foot ulcers (DFU) and 
venous leg ulcers (VLU) will be covered when the following conditions are met and documented as appropriate 
for the individual patient: 
 Presence of neuropathic diabetic foot ulcer(s) having failed to respond to documented conservative 
wound-care measures of greater than four weeks. 
 Presence of a chronic, non-infected venous stasis ulcer with failure to respond to documented 
conservative wound-care measures (outlined below) for greater than 4-6 weeks with documented 
compliance.  
 For purposes of this LCD, conservative wound care measures include, but are not limited to: 
o Comprehensive patient assessment (history, exam, ABI (Ankle-Brachial Index) & diagnostic 
test as indicated) and implemented treatment plan.  
o For patient with DFU-assessment of type I vs. II Diabetes Mellitus and management history 
with attention to certain comorbidities (vascular disease, neuropathy, osteomyelitis); review of 
the current blood sugars/ HgbA1c, diet and nutritional status, activity level, physical exam that 
includes assessment of skin and wound, ABI (Ankle-Brachial Index), check of off-loading 
prosthetics or shoes for signs of abnormal wear. 
o For patient with VLU- assessment of history (prior ulcers, thrombosis risks), physical exam 
(edema, skin changes), ABI (Ankle-Brachial Index), and duplex scan to confirm CEAP 
classification (Clinical-Etiology-Anatomy-Pathophysiology (*CEAP) classification categorizes 
chronic venous disorders to facilitate communication between physicians, to serve as a basis for 
standardized reporting during scientific analysis of management alternatives, and to identify 
segments of venous incompetence amenable to vein ablation therapies.  
o Implemented treatment plan as indicated. 
a. debridement 
b. pressure relief [repositioning schedule, etc. for DFUs/VLUs; prior and on-going 
compression therapy (e.g., static compression includes compression hosiery (>20 mm 
HG) and compression bandages) for VLUs 
c. infection control d. management of exudate- maintenance of a moist environment (moist saline gauze, other 
classic dressings, bioactive dressing, etc.). (For indications of negative pressure wound 
therapy (NPWT) see DME MAC LCD Negative Pressure Wound Therapy Pumps 
(L5008)) 
e. Patient is a nonsmoker, or has refrained from smoking for at least 6 weeks prior to 
planned skin replacement surgery, or has received counseling on the effects of smoking 
on surgical outcomes and treatment for smoking cessation. 
 Applied to ulcers that have failed to respond to documented conservative wound-care measures. Failed 
response is defined as an ulcer that has increased in size or depth, or no change in baseline size or 
depth or no sign of improvement or indication that improvement is likely (such as granulation, 
epithelialization or progress towards closing). Documentation of response requires measurements of the 
initial ulcer, measurements at the completion of at least four weeks DFU (4-6 weeks for VLU) of 
conservative wound-care measures and measurements immediately prior to placement of the skin 
substitute graft. For VLUs, completion of conservative wound-care measures must include 4-6 weeks 
and on-going compression therapy. 
 A skin replacement surgery is considered an advanced treatment modality (not a conservative wound 
care measure). Pre-service record specifically addresses circumstances as to why the wound has failed 
to respond to standard wound care treatment of greater than 4 weeks and must reference specific 
interventions that have failed based on the prior wound evaluation. Such record should include updated 
medication history, review of pertinent medical problems that may have arisen since the previous 
wound evaluation, and explanation of the planned skin replacement surgery with choice of skin 
substitute graft product. The procedure risks and complications should also be reviewed and 
documented. 
 
You can find this rule in the Local Coverage Determination for the Application of Skin Substitute Grafts for 
Treatment of DFU and VLU of Lower Extremities, L36377.  
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.