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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 addition of Skin Substitutes or Cellular or Tissue Based Products (CTPs) to certain 
wounds may afford a healing advantage over dressings and conservative treatments when these options appear 
insufficient to affect complete healing. 
 
There are currently a wide variety of bioengineered products available for soft tissue coverage to affect closure. 
These products may be derived from allogeneic, xenogeneic, synthetic sources or a combination of any or all of 
these types of materials. However, without the component of the recipients own distinct epithelium and 
cellular skin elements, permanent skin replacement or coverage by the graft cannot be accomplished. 
 
Autologous skin grafts, also referred to as autografts, are permanent covers that use skin from different parts of 
the individuals body. These grafts consist of the epidermis and a dermal component of variable thickness. A 
split-thickness skin graft (STSG) includes the entire epidermis and a portion of the dermis. A full thickness 
skin graft (FTSG) includes all layers of the skin. Although autografts are the optimal choice for full thickness 
wound coverage, areas for skin harvesting may be limited, particularly in cases of large burns or venous stasis 
ulceration. Harvesting procedures are painful, disfiguring and require additional wound care. 
 
Allografts which use skin from another human (e.g., cadaver) and Xenografts which use skin from another 
species (e.g., porcine or bovine) may also be employed as temporary skin replacements, but they must later be 
replaced by an autograft or the ingrowth of the patients own skin. 
 
Bioengineered Skin / Cultured Epidermal Autografts (CEA) are autografts derived from the patients own skin 
cells grown or cultured from very small amounts of skin or hair follicle. Production time is prolonged. One 
such product is grown on a layer of irradiated mouse cells, bestowing some elements of a xenograft. 
Widespread usage has not been available due to limited availability or access to the technology. 
 
Bioengineered skin substitutes or CTPs are classified into the following types: 
     Human skin allografts derived from donated human skin (cadavers) 
    Allogeneic matrices derived from human tissue (fibroblasts or membrane) 
    Composite matrices derived from human keratinocytes, fibroblasts and xenogeneic collagen 
    Acellular matrices derived from xenogeneic collagen or tissue 
 
Human Skin Allografts are bioengineered from human skin components and human tissue which have had 
intact cells removed or treated to avoid immunologic rejection. They are available in different forms promoted 
to allow scaffolding, soft tissue filling, growth factors and other bioavailable hormonal or enzymatic activity. 
 
Allogeneic Matrices are usually derived from human neonatal fibroblasts of the foreskin that may contain 
metabolically active or regenerative components primarily used for soft tissue support, though some have been 
approved for the treatment of full-thickness skin and soft tissue loss. Most are biodegradable and disappear 
after 3-4 weeks implantation. 
 
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. 
 
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 
skin substitutes. Particular emphasis is placed on the indications for application of bioengineered skin substitute 
material for DFU and VLU. 
 
Patients receiving a skin substitute 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(es) etiologic for the condition (e.g., venous 
insufficiency, diabetes, neuropathy). 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 these rules in the 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. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.