Special to OWM: Advocating for Wound Care: Update from the Alliance of Wound Care Stakeholders

The Alliance of Wound Care Stakeholders is an 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 wound care experts to advocate on public policy issues such as coding, coverage, payment, and quality measures that may create barriers to patient access to treatment or care. The Alliance has an established reputation as a respected, effective communicator and key resource on wound care issues for government agencies and policy makers. 

In 2015, the Alliance made its collective voice heard on a range of important issues.

The Alliance championed the establishment of the first ASTM international standard on cellular and tissue-based products for wounds (CTPs). This standard defines and classifies CTPs and provides a comprehensive set of definitions related to skin wounds. ASTM (formerly known as the American Society of the International Association for Testing and Materials) standards are used for terminology purposes by clinicians, manufacturers, and scientists. The new standard gives further legitimacy to the CTP nomenclature, replacing the problematic and incorrect “skin substitute” language that is broadly used in Medicare coverage policies and thus mischaracterizes this category of products.

The Alliance submitted 12+ formal written comments to the Centers for Medicare and Medicaid Services (CMS) contractors’ local coverage determinations (LCD) across the county. This helps ensure clinically sound coverage policies for wound care products and procedures. Problematic LCDs directly impact Medicare patients’ access to services and technologies. 

Keeping Medicare contractors aware of current and evolving wound care best practices and alerting them to concerning or problematic language in the LCDs is a core focus of the Alliance. In 2015, the Alliance submitted comments on LCDs addressing pneumatic compression, hyperbaric oxygen therapy, skin substitutes to lower extremity chronic nonhealing wounds, surgical dressings, skin substitute grafts for the treatment of diabetic foot ulcers and venous leg ulcers, strapping, and various policies impacting cellular and/or tissue-based products for wounds.

The Alliance successfully ensured its concerns were addressed in the final CY2016 Outpatient Prospective Payment System and Physician Fee Schedule provisions regarding wound care. The Alliance had flagged issues such as the restructuring of the skin and debridement Ambulatory Payment Classifications, problematic new codes for total contact casting, and payment rates for disposable negative pressure wound therapy. These regulations have important implications for hospital and physician reimbursement for services and procedures.

The Alliance advocated for wound care with Congress members and staff. Various provisions of the Medicare Access and CHIP Reauthorization Act of 2015, the disposable medical technology provision in the 21st Century Cures draft bill, and the Helping Ensure Life- and Limb-Saving Access to Podiatric Physicians Act were highlighted. Throughout last year and ongoing today, the Alliance advocates on the Hill to encourage inclusion of Healthcare Common Procedure Coding System (HCPCS) coding reform in appropriate legislative vehicles.

The Alliance provided recommendation and comment to the United States Food and Drug Administration (FDA). Efforts included a meeting with key senior FDA staff to discuss recommendations on updates to the 2006 FDA guidance “Chronic Cutaneous Ulcer and Burn Wounds — Developing Products for Treatment” and comments to the agency’s guidance document, “Minimal Manipulation of Human Cell, Tissues, and Cellular and Tissue-based Products.” 

The Alliance’s work will continue into 2016 and focus not only on regulatory guidance and local coverage determinations, but also on Medicare payment reform initiatives. The Alliance is advocating to ensure appropriate wound care quality measures are incorporated as the CMS migrates toward the more quality measure-based Alternative Payment Models and Merit-based Incentive Payment System. This is anticipated to be an area of seismic shifts and changes over the years ahead. The Alliance will be advocating on behalf of wound care patients and the health providers who treat them and will keep its membership and the wound care community at large informed of relevant issues as these systems are implemented. 

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

The Alliance is an association of physician and clinical organizations focused on promoting quality care and access to procedures and technologies for patients with wounds through advocacy and educational outreach in the regulatory, legislative, and public arenas. This article was not subject to the Ostomy Wound Management peer-review process.