Following oral testimony at CGS' public meeting on its draft LCD and accompanying LCA on Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL366901), the Alliance submitted formal written comments to the Medicare Administrative Contractor to voice its many concerns with the draft policies. The policies are fraught with clinical inaccuracies, with   statements and limitations in the policy not supported by clinical evidence or guidelines. Issues identified in Alliance comments include:
- Lack Of A Consistent And Accurate Definition Of A Chronic Non-Healing Ulcer
- Limitation of Number of Applications of CTPs in an Episode is Not Supported by the Clinical Literature
- CTPs Are NOT Surgical Supplies
- Concerns with Requiring Clinicians to Utilize the Smallest Package Size Available For Purchase From the Manufacturer
- Concerns with Not Allowing Clinicians to Switch CTP Products During Course of Treatment
- Incorrectly Describing the Application of CTPs as an Adjunct Therapy Rather than an Advanced Therapy

Concerned about the implications these policies will have on patient care and access, the Alliance recommended that CGS pull the draft policies, then work with stakeholders and its Contractor Advisory Committee (CAC) to craft a more accurate and well-balanced policy.

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