15273 — Application of Bioengineered Skin Substitutes / Wound Application of CTPs, Lower Extremities

Application of Bioengineered Skin Substitutes to Lower Extremity Chronic Non-Healing Wounds (L35041) and Wound Application of CTPs, Lower Extremities (L36690)

CMS: “To meet coverage criteria, the patient’s medical record must contain documentation that fully supports the medical necessity of services. Subsections 6.2.1 to 6.2.13 list the documentation requirements for example services. For detailed documentation requirements, providers who choose to submit a prior authorization request for a WISeR Select Item or Service should refer to the relevant NCDs and/or their MAC jurisdiction’s LCDs and Local Coverage Articles (LCAs), if available, for guidance. They can be found on the Medicare Coverage Database website.”

General documentation requirements for the application of a skin substitute or cellular and/or tissue product (CTP) in the treatment of diabetic foot ulcer(s) (DFU) and venous leg ulcer(s) (VLU) are as follows:

• ❑Description of the wound or ulcer at baseline (prior to beginning standard of care [SOC] treatment) relative to size, location, stage, duration, and presence of infection, as well as progression throughout treatments tried
• ❑Documentation of the following related to the wound or ulcer: a) Partial- or full-thickness ulcers, not involving tendon, muscle, or joint capsule or exhibiting exposed bone or sinus tracts, have a clean granular base unless the CTP package label indicates the CTP is approved for use involving tendon, muscle, or joint capsule or exhibiting exposed bone or sinus tracts, with a clean granular base b) Skin deficit at least 1.0 square cm in size c) Clean and free of necrotic debris or exudate d) 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 >30 mmHg) e) For DFUs, a diagnosis of Type 1 or Type 2 diabetes along with medical management for this condition
• ❑Documentation addressing the circumstances why the wound or ulcer has had a “failed response,” defined as having failed to respond to documented appropriate wound-care measures, having increased in size or depth, or having not changed in baseline size or depth with no indication that improvement is likely (such as granulation, epithelization, or progress toward closing), including but not limited to: a) Interventions that failed b) Updated medication history c) Review of pertinent medical problems that may have occurred since previous wound or ulcer evaluations d) For a neuropathic DFU, documentation of failure to respond to conservative wound- care measures of greater than 4 weeks, during which the patient is compliant with recommendations, and without evidence of underlying osteomyelitis or nidus of infection e) For a venous stasis ulcer present for at least 3 months, documentation of failure to respond to appropriate wound care for at least 30 days with documented compliance f) For a full-thickness skin loss ulcer that is the result of abscess, injury, or trauma, documentation of failure to respond to appropriate control of infection, foreign body, tumor resection, or other disease process for a period of 4 weeks or longer
• ❑Documentation that therapy has resolved any infection and/or underlying osteomyelitis with documentation of the conditions that have been treated and resolved, as applicable: a) Control of edema, venous hypertension, or lymphedema b) Control of any nidus of infection or colonization with bacterial or fungal elements c) Elimination of underlying cellulitis, osteomyelitis, foreign body, or malignant process d) Appropriate debridement of necrotic tissue or foreign body (exposed bone or tendon) e) For DFUs, appropriate non-weight-bearing or off-loading pressure f) 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 g) Provision of wound environment to promote healing (protection from trauma and contaminants, elimination of inciting or aggravating processes)
• ❑Documentation of smoking history and that the patient has received counseling on the effects of smoking on outcomes and treatment for smoking cessation (if applicable)
• ❑Documentation of choice of skin substitute graft product
• ❑Documentation of expected number of applications over a 12‐week period. Of note, simultaneous use of more than one product for the episode of wound is not covered. Product change within the episode of wound is allowed, not to exceed the 10‐application limit per wound per 12‐week period of care
• ❑Assessment and documentation of none of the following: a) Partial thickness loss with the retention of epithelial appendages is not a candidate for grafting or replacement, as epithelium will repopulate the deficit from the appendages, negating the benefit of overgrafting b) Prior utilization of skin substitute grafts when a previous full course of applications was unsuccessful within 1 year. Unsuccessful treatment is defined as: o Increase in size or depth of an ulcer or no change in baseline size or depth AND o No sign of improvement or indication that improvement is likely (such as granulation, epithelialization, or progress toward closing) for a period of 4 weeks past start of therapy c) Retreatment of healed ulcers (those showing greater than 75% size reduction and smaller than 0.5 square cm) d) Patient has inadequate control of underlying conditions or exacerbating factors (e.g., uncontrolled diabetes, active infection, active Charcot arthropathy of the ulcer extremity, vasculitis, or continued tobacco smoking without physician attempt to address smoking cessation) e) Known hypersensitivity to any component of the specific skin substitute graft (e.g., allergy to avian, bovine, porcine, equine products)

1. [21] Prior authorization and pre-payment medical review will be implemented if it meets the requirements for the codes in Appendix A and ICD-10 diagnosis code for diabetic and venous leg ulcers specified in Appendix B.
2. [22] Skin substitutes are currently not subject to prior authorization under WISeR for providers in MAC jurisdiction JF. WISeR participants must adhere to the NCDs and LCDs that are currently active in their respective state, participants in MAC jurisdiction JF (Noridian) will not proceed with prior authorization and/or prepayment review of skin substitutes as the LCD has been withdrawn. This change does not impact LCDs for skin substitutes already in effect before January 1, 2026.