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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 medically necessary services are those that are reasonable and necessary for the diagnosis or 
treatment of an illness or injury. Medically necessary services include services to improve the functioning of a 
malformed body member. You can find this rule in the Social Security Act, Section 1862(a)(1)(A). 
 
The rules say that services that are not medically necessary are not covered. The rules also say that 
experimental and investigational devices are not covered. You can find this rule at 42 CFR Sections 411.15 and 
411.15(o). 
 
The rules say Covered Indications 
 
Chronic Wounds are defined as wounds that do not respond to standard wound treatment for at least a 30 day 
period during organized comprehensive conservative therapy. 
 
For all wounds, documentation (as outlined in the documentation requirements of the policy) and a 
comprehensive treatment plan, before initiation of a specialized wound therapy product is required. 
 
For purposes of this LCD a Failed Response is defined as an ulcer or skin deficit that has failed to respond to 
documented appropriate wound-care measures, has increased in size or depth, or has not changed in baseline 
size or depth and has no indication that improvement is likely (such as granulation, epithelialization or progress 
towards closing). 
 
Medicare covers application of skin substitutes to Ulcers or Wounds with Failed Response that are: 
 
    Partial- or full-thickness ulcers, not involving tendon, muscle, joint capsule or exhibiting exposed bone or 
sinus tracts, with a clean granular base; 
    Skin deficit at least 1.0 square centimeter (cm) in size; 
    Clean and free of necrotic debris or exudate; 
    Have adequate circulation/oxygenation to support tissue growth/wound healing as evidenced by physical 
examination (e.g., Ankle-Brachial Index [ABI] of no less than 0.60, toe pressure greater than 30 millimeters of 
mercury [mmHg]); 
    For diabetic foot ulcers, the patients medical record reflects a diagnosis of Type 1 or Type 2 Diabetes and 
also reflects medical management for this condition. 
 Wound healing is impaired by the systemic use of tobacco. Therefore, ideally patients who have smoked will 
have ceased smoking or have refrained from systemic tobacco intake for at least 4 weeks during conservative 
wound care and prior to planned bioengineered skin replacement therapy. 
 
Documentation (in the pre-service record) specifically addressing 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. Such record should include updated medication history, review of pertinent 
medical problems that may have occurred 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. Documentation of smoking cessation counseling and cessation 
measures prescribed, if applicable, must also be documented in the patient's record. 
 
Application of a skin substitute graft for lower extremity chronic wound (DFU and VLU) will be covered when 
the following conditions are met 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, during which the patient is compliant with recommendations, and 
without evidence of underlying osteomyelitis or nidus of infection. 
    Presence of a venous stasis ulcer for at least 3 months but unresponsive to appropriate wound care for at least 
30 days with documented compliance. 
    Presence of a full thickness skin loss ulcer that is the result of abscess, injury or trauma that has failed to 
respond to appropriate control of infection, foreign body, tumor resection, or other disease process for a period 
of 4 weeks or longer. 
 
In all wound management the ulcer must be free of infection and underlying osteomyelitis with documentation 
of the conditions that have been treated and resolved prior to the institution of skin substitute therapy. For 
purposes of this LCD, appropriate therapy includes, but is not limited to: 
 
    Control of edema, venous hypertension or lymphedema 
    Control of any nidus of infection or colonization with bacterial or fungal elements 
    Elimination of underlying cellulitis, osteomyelitis, foreign body, or malignant process 
    Appropriate debridement of necrotic tissue or foreign body (exposed bone or tendon) 
    For diabetic foot ulcers, appropriate non-weight bearing or off-loading pressure 
    For venous stasis ulcers, compression therapy provided with documented diligent use of multilayer 
dressings, compression stockings of greater than 20 mmHg pressure, or pneumatic compression 
    Provision of wound environment to promote healing (protection from trauma and contaminants, elimination 
of inciting or aggravating processes) 
 
You can find this information in Medicare's Local Coverage Determination (LCD): Application of 
Bioengineered Skin Substitutes to Lower Extremity Chronic Non-Healing Wounds (L35041). 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.