15278
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Documentation Required
- Entire medical record must be maintained and available on request, with each page legible, containing complete patient identification and dates of service, and the legible signature of the responsible physician or non-physician practitioner.
- Submitted medical records must support the selected ICD-10-CM diagnosis code(s) and the CPT/HCPCS code must accurately describe the service performed.
- When a portion of a Part B drug/biological from a single-use vial/package is discarded, bill the discarded amount on a separate claim line using modifier JW and document in the medical record the date, time, amount administered, amount wasted, and reason for wastage.
- Providers are expected to use the product size that best fits the wound to minimize wastage and must document the amount applied and the amount wasted when partial discard occurs.
Key Coverage Criteria
- Application of bioengineered skin substitute grafts is covered for lower-extremity chronic non-healing wounds when dressings and conservative treatments appear insufficient to achieve complete healing.
- Skin substitute graft CPT codes (15271-15278) apply to non-autologous skin grafts (homograft/allograft), non-human/xenograft grafts, and biological sheet scaffolding products used as skin substitutes.
- Application of a cellular and/or tissue-based product (CTP) to a documented lower-extremity wound is covered when the medical record supports medical necessity for the specific wound and treatment.
- A specific CTP product may be used for the episode of care for each documented wound when use is consistent with the product's FDA labeling and submitted product-specific guidelines.
- Application of skin substitute grafts is covered for treatment of diabetic foot ulcers (DFU) and venous leg ulcers (VLU) of the lower extremities when reasonable and necessary per LCD L36377.
- Coverage applies to non-autologous skin substitute grafts including dermal or epidermal cellular and acellular grafts (homograft, allograft), non-human xenografts, and biological sheet scaffolding products when used as skin substitute grafts.
20 Active Policies
A59740 — Billing and Coding: Skin Substitutes Grafts/Cellular Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers
J05
A59739 — Billing and Coding: Skin Substitutes Grafts/Cellular Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers
J05
A59711 — Billing and Coding: Skin Substitutes Grafts/Cellular Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers
J06
A59712 — Billing and Coding: Skin Substitutes Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers
J06
Related Codes
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