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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 state that per the American Medical Association and the CPT Manual, Skin Replacement Surgery 
or Skin Substitute Grafting is a conceptual model focusing on the work and services provided regardless of 
the product used. This removes the requirement for maintenance and education on the use of supply codes that 
have little impact on the "typical patient" or the provider effort for application of the product. The application 
of CTP is distinguished according to the wound characteristics and surface area rather than by product 
description. Currently, no product has demonstrated individual superiority for the treatment of diabetic foot 
ulcers (DFU) and venous leg ulcers (VLU) of the lower extremity, and, frequently such products are utilized 
inappropriately. 
 
Non-graft wound dressings are generally included in standard wound care management; such products may 
provide value and, in fact, may preclude the need for CTP application. 
 
Standard treatment of chronic lower extremity ulcers or skin loss (e.g., DFU or VLU) primarily includes 
infection and edema control, mechanical offloading, mechanical compression or limb elevation, debridement of 
necrotic or infected tissue, and management of concomitant and inciting medical issues (blood glucose control, 
tobacco use). Maintenance of a therapeutic environment with appropriate dressings to preclude further trauma 
facilitates development of healthy granulation tissue and encourages re-epithelialization. A wound that fails to 
show evidence of healing by contraction and advancement of epithelial margins following 4 weeks of 
optimization, including all aspects of standard therapy, is considered a chronic non-healing wound and falls 
into the auspices of this LCD. The fundamental basis for non-healing of a wound is of paramount importance 
and must be corrected prior to consideration of additional therapy. 
 
The depth of skin loss is the determinant of its ability to return. Full thickness skin loss, implying the loss of all 
elements of the epidermis and dermis, will require re-epithelization of the surface once a clean granular base is 
established. Both full and partial thickness skin loss may benefit from enhanced products referred to as CTPs. 
Though no CTPs are capable of replacing the patients own skin, they have been demonstrated to allow 
scaffolding for the growth of epithelium, enzymatic cleansing and provision of growth factors beneficial to 
deficit reduction and re-epithelization. 
 
This document addresses the management of chronic non-healing wounds or skin deficits of the lower 
extremities with the goal of wound and skin closure when standard or conservative measures have failed. While 
lower extremity ulcers have numerous causes such as burns, trauma, immobility, ischemia or other neurologic 
impairment, over 90% of the lesions are related to venous stasis disease and diabetic neuropathy. Therefore, the focus of this policy is the application of bioengineered skin substitute material to diabetic foot ulcers and 
venous leg ulcers of the lower extremities and the reasonable and necessary (R&N) threshold for utilization of 
CTPs. Particular emphasis is placed on the indications for application of CTP material for DFU and VLU. 
 
Patients receiving a CTP graft must be under the care of a physician licensed by the state with full scope of 
practice for the treatment of the systemic disease process(s) etiologic for the condition (e.g., venous 
insufficiency, diabetes, neuropathy). If the provider performing the CTP graft/application is not the one 
providing the treatment for the systemic condition then a statement in the documentation that (s)he is aware of 
the systemic condition and that the patient is under the care of Doctor _____. This concurrent medical 
management and the identity of the managing medical physician shall be clearly discernable in the medical 
record and available upon request. 
 
Medicare coverage for wound care on a continuing basis, for a single wound, in an individual patient is 
contingent upon evidence documented in the patients medical record that the wound is improving in response 
to the wound care being provided. Since it is neither reasonable nor medically necessary to continue a given 
type of wound care in the absence of wound improvement, it is expected that the wounds response to treatment 
will be documented in the medical record at least once every 30 days for each episode of wound treatment and 
made available to the contractor upon request. 
 
You can find this information in the Local Coverage Determination (LCD) Wound Application of Cellular 
and/or Tissue Based Products (CTPs), Lower Extremities L36690. 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.