Alliance Update: Comments Submitted to First Coast LCD Addressing Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers Protection Status
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By The Alliance of Wound Care Stakeholders
The Alliance of Wound Care Stakeholders submitted formal written comments in response to the First Coast Service Option (FCSO) draft local coverage determination (LCD) for Application of Skin Substitute Grafts for Treatment of Diabetic Foot Ulcers (DFU) and Venous Leg Ulcers (VLU) of Lower Extremities (DL36013 - note: this directs you to a CMS landing page where you must accept a license/disclaimer, and once accepted it connects you to the LCD).

FCSO is the Florida Medicare Administrative Contractor (MAC) – a private organization contracted by the Centers for Medicare & Medicaid Services (CMS) to carry out the administrative responsibilities of Traditional Medicare Parts A and B ("A/B MACs"). Collectively in the U.S., the MACs and the other Medicare administrative contractors process nearly 4.9 million Medicare claims each business day, and disburse more than $365 billion annually in program payments. Each Medicare contractor has the discretion to establish which treatments, procedures and services are covered as a Medicare benefit. These coverage policies are issued in a document called a Local Coverage Determination. LCDs are important to providers as they provide guidance on topics such as which services are covered and reimbursable; how to properly code the services provided and submit claims for payment; documentation requirements; and utilization guidelines.

Concerningly, clinically inaccurate, unclear and/or overly-restrictive LCDs can compromise patient care. The Alliance regularly reviews draft LCDs related to wound care, and submits comprehensive comments which reflect the inputs of clinical societies involved in wound care, in order to promote quality wound care and ensure patient and provider access to wound care technologies and procedures. The comments submitted to FCSO were written with the advice of Alliance clinical specialty societies and organizations that not only possess expert knowledge in complex chronic wounds, but also in wound care research. Many Alliance members utilize skin substitutes - or more accurately cellular and/or tissue based products for wounds (CTPs) - in their practices as an adjunctive therapy when treating a patient with a chronic non-healing wound. As such, the Alliance and its membership have a vested interest in the FCSO policy.

The Alliance focused its comments on select areas of the draft LCD, including:

  • The definition of a chronic non-healing wound provided in the draft LCD, which is inconsistent with medical literature and with other LCDs.
  • The timeframe of "only 12 weeks of treatment" and the number of applications specified in the LCD, which may be in conflict with FDA-approved labeling and clinical practice for many of the CTPs which are only applied every 2-3 weeks to allow incorporation and to monitor results.
  • Indications for use of a CTP for wounds, as the policy stated that application of a CTP on a DFU will be covered when the DFU fails to respond to conservative measures of greater than 4 weeks, yet the policy also states that the application on a VLU will be covered when the wound fails to respond after 6 weeks – it is unclear what evidence FCSO is using to support the decision to separate out the timing for recognizing failed treatment for DFU at 4 weeks and VLU at 6 weeks.
  • The lack of clarity regarding clinical evidence requirements for non-coverage decisions, following a section in the LCD noting that "specific products may be listed as non covered in the future based on clinical literature that establishes inferiority."

About the Author
The Alliance of Wound Care Stakeholders: The Alliance is a nonprofit multidisciplinary trade association of health care professional and patient organizations whose mission is to promote quality care and access to products and services for people with wounds through effective advocacy and educational outreach in the regulatory, legislative, and public arenas.

The views and opinions expressed in this blog are solely those of the author, and do not represent the views of WoundSource, Kestrel Health Information, Inc., its affiliates, or subsidiary companies.

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