A2004 — Xcellistem, 1 mg
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Documentation Required
- Medical records must be legible, include complete patient identification, dates of service, and the legible signature of the responsible physician or non-physician practitioner.
- The submitted medical record must support the selected ICD-10-CM diagnosis code(s), the CPT/HCPCS code(s) billed, that the service was performed, and the medical necessity of the services.
- Baseline wound description (prior to conservative treatment) must be documented including size, location, stage, duration, presence of infection, type of treatment given, and response, with ongoing updates during treatment.
- Pre- and post-treatment wound descriptions specific to the skin substitute graft used must be documented in the medical record.
Key Coverage Criteria
- 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.
- CTP application is covered for chronic non-healing lower extremity wounds (including diabetic foot ulcers and venous leg ulcers) that have failed to respond to documented appropriate conservative wound care for greater than 4 weeks.
- CTPs are covered for partial- or full-thickness ulcers with a clean granular base that do not involve exposed tendon, muscle, joint capsule, or bone unless the specific CTP package label explicitly permits use in such deeper wounds.
- Wound size must be at least 1.0 cm² to qualify for CTP application.
- Wound must be clean and free of necrotic debris or excessive exudate prior to CTP application.
20 Active Policies
A59739 — Billing and Coding: Skin Substitutes Grafts/Cellular Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers
J05
A59740 — 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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