Treatment of non-healing venous stasis ulcers using Grafix may be considered medically necessary when BOTH of the following criteria are met:
- Partial or full-thickness venous stasis ulcer of greater than four weeks duration for which standard wound therapy has failed
- Treated lower extremity has adequate blood supply as evidenced by either the presence of a palpable pedal pulse or an ankle-brachial index (ABI) of greater than or equal to 0.70
When the above medical necessity criteria are met, the following conditions of coverage apply:
- Treatment is limited to one (1) initial application
- Additional applications at a minimum of one (1) week intervals, for up to a maximum of four (4) in 12 weeks are considered medically necessary when evidence of wound healing is present (e.g., signs of epithelialization and reduction in ulcer size)
Additional applications beyond 12 weeks are considered not medically necessary regardless of wound status
All other HAM products for the treatment of venous stasis ulcers not listed above are considered experimental/investigational and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.