Appeal type: unknown
Decision: unknown

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 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. 
You can find these rules in the Local Coverage Determination (LCD) for Application of Bioengineered Skin 
Substitutes to Lower Extremity Chronic Non-Healing Wounds, L35041. This LCD is effective for services 
provided on or after September 26, 2019. 
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.