Sample Provider Letter

Dear Medicare Administrative Contractor,

 I am a practicing clinician in (state) who routinely treats many patients with diabetic foot ulcers, venous leg ulcers and pressure wounds.  I am writing to urge you to withdraw the proposed LCD “Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers.”  The proposal is dangerous for Medicare beneficiaries, and will interfere with my medical judgment in providing appropriate treatment for my patients.  For the following reasons, I urge you not to move forward with finalizing this proposed LCD.

The proposed LCD seeks to eliminate coverage for over 200 skin substitute products, and limits treatment to only four applications of a skin substitute product per 12-week treatment episode.  These coverage limitations are inconsistent with published clinical studies which demonstrate that these products accelerate wound healing in patients with stagnant or deteriorating chronic wounds as well as in patients with diabetes.  For example, the 2021 study by Dr. Armstrong clearly demonstrated the value, both in terms of health outcomes and cost savings, of “advanced treatment,” which Dr. Armstrong defined as “cellular and acellular dermal substitutes, which are mostly coverings derived from human placental membranes and animal tissue sources.”  Ignoring that clear study, your proposed LCD recommends the opposite.

 In my experience, skin substitute products (including many products in the proposed non-covered category) are critical for effective treatment of chronic wounds that do not heal with standard of care treatment, including diabetic foot ulcers, venous leg ulcers, and pressure wounds.  I use these products regularly to treat my patients.  And the results are significant.  Of course, each patient and each wound is different, and I routinely have to exercise medical judgment to find the right treatment for a specific patient.  Your proposed LCD, however, would  eliminate my ability to treat my patients, and you would be substituting your judgment about what products I could or could not use, and how often the patient would need treatment.  That is just wrong.

The proposed LCD inappropriately restricts Medicare beneficiary access to clinically effective and medically necessary wound care treatment.  In doing so, the proposed LCD sets forth a coverage policy that is contrary to both clinical evidence and clinical practice generally, and my practice specifically.  In order for Medicare beneficiaries to benefit from the most advanced and clinically effective wound healing technologies, the MAC should not move forward with finalizing the proposed LCD.  Instead, the MAC should take steps to obtain input from wound care providers, medical researchers and scientists, treating practitioners, patients, and producers of wound care products to formulate a coverage policy that is well-reasoned and based on established data and clinical experience, and also promotes the effective care of Medicare beneficiaries suffering from chronic wounds.

Thank you for your consideration of this important matter.

 Sincerely,