The Alliance of Wound Care Stakeholders is a nonprofit association of physician and clinical organizations focused on promoting quality care and access to products and services for patients with wounds and the providers who treat them.   Through advocacy and educational outreach in the regulatory, legislative, and public arenas, the Alliance unites leading wound care experts to advocate on public policy issues that may create barriers to patient care or access to treatments. Issues of particular concern include reimbursement and wound care quality measures.

  For the Alliance and its member organizations, 2014 was a busy year of successful initiatives to protect patient and provider access to wound care treatments and services through appropriate coding, coverage, and payment.

  The Alliance created wound care quality measures where few previously existed. The Alliance worked with the United States Wound Care Registry to develop 12 new Physician Quality Reporting System wound care measures as submitted through the Qualified Clinical Data Registry process to the Center for Medicare and Medicaid Services (CMS). Physicians can use these critical reporting measures as indicators of the quality of care provided for payment purposes.

  The Alliance served as a resource to the US Food and Drug Administration (FDA) as the agency began its process of updating an important wound care research guidance document. The Alliance convened a meeting of wound care researchers and industry representatives to identify concerns with the 2006 FDA Guidance for Industry, Chronic Cutaneous Ulcer and Burn Wounds — Developing Products for Treatment. This reference document is essential for both clinicians and manufacturers conducting wound care research. Alliance members and stakeholders began the process of forming consensus recommendations, which included surrogate endpoints, trial design, and wound etiology to be used in providing comments to the FDA.

  The Alliance advocated for cellular and tissue-based products (CTPs) for wounds. The Alliance created a CTPs for Wounds guidance document for the ASTM (formerly American Society for Testing and Materials) F-04 committee on medical and surgical materials and devices; it was balloted and is currently undergoing ASTM review and update.

  The Alliance addressed coding, coverage, and reimbursement issues that could negatively impact wound care.
  Pneumatic compression devices. Alliance clinical associations advocated for and successfully delayed what they believed was a clinically inappropriate Durable Medical Equipment Medicare Administrative Carrier’s (DMEMAC) Local Coverage Determination (LCD) on pneumatic compression devices. Patients continued to have access to the devices while the CMS and DMEMACs reevaluate the LCD.

  Surgical dressings containing medical-grade honey. The Alliance worked to protect medical-grade honey as a component in surgical dressings.

  Milliman Care Guidelines (MCG) on intermittent pneumatic compression. Through the Alliance’s advocacy in addressing clinical inaccuracies in the MCG on Intermittent Pneumatic Compression, the guidelines were corrected, thus providing payers who use the MCG for their coverage policies a clinically correct version, facilitating patient access to these products.

  Wound care-related physician fee schedule. The Alliance was successful in convincing the CMS to change qualified clinical data registry requirements for outcomes measures in the final Physician Fee Schedule rule. This removed a potentially burdensome paperwork requirement.

  Local coverage determinations. To preserve access to wound therapies for Medicare patients and the providers who treat them, the Alliance submitted multiple sets of comments to Part A/Part B Medicare Administrative Contractors (A/B MACs) on local coverage determinations that were of concern to wound care:
    • The Alliance submitted comments to Novitas Solutions (a MAC) regarding concerns on its LCD policy on hyperbaric oxygen therapy. The LCD was withdrawn.
    • Following submission of Alliance comments, the National Government Services (NGS) adopted Alliance’s language and revised its LCD language regarding “failed response.”
    • Following submission of Alliance comments, Palmetto GBA (another MAC) accepted Alliance recommendations to add several additional ICD-9 codes to its debridement LCD and eliminated the quantification of the surface area, volume, or dimensions of the viable tissue removed in the debridement procedure.

  Read more about the Alliance’s ongoing activities and accomplishments at www.WoundCareStakeholders.org.

This article was not subject to the Ostomy Wound Management peer-review process.