Special to OWM: Technology Precipitates Terminology Change for Skin Substitutes

  The Alliance of Wound Care Stakeholders, a multidisciplinary trade association of physician, clinical, and patient organizations, voted to replace the term skin substitutes with cellular and/or tissue-based products for wounds. The culmination of a yearlong effort, the choice of wording was determined to encompass present and future technology.

  Establishing new terminology has direct and specific implications for clinicians and patients. Many representatives from Alliance clinical specialty organizations who work on CPT coding issues recognized the term skin substitute was clinically inaccurate. In its draft technology assessment, the Agency for Healthcare Research and Quality (AHRQ) stated these products were not “skin substitutes.” The Centers for Medicare and Medicaid Services (CMS) abandoned the term in code descriptors for these products in 2010 when the agency determined so-named products are not skin substitutes and instead issued Q codes for individual products by brand name. As such, the Alliance believed that without accurate terminology and an appropriate classification system for these biological materials, the CMS would be unable to craft proper coverage policy. Subsequently, if policy is flawed, clinicians will not be paid for using these materials and patients will not have access to them.

  To establish a fair and inclusive process for sculpting a new term, a workgroup of scientists, clinical organizations, and business entities was culled from Alliance members to address the issue. Dr. Charles Drueck of the American Society of General Surgeons spearheaded the project, with results achieved through many conference calls. Criteria required the new term to be:
    • Based on science
    • Inclusive of all products in the current marketplace with an eye toward what may be in the pipeline
    • Neutral with regard to the US Food and Drug Administration (FDA) — ie, nothing offensive or that would not allow manufacturers to obtain approval for future products
    • Eligible for Medicare coverage as drugs and biological consistent with their United States Pharmacopeia (USP) monographs
    • Easily understood by clinicians
    • Easily linked to existing CPT codes for the application of the products.

  In October 2012, the Alliance held a decisive call that included more than 25 scientists, clinicians, and manufacturers to review the historical perspective of the 18 proposed terms. The group determined the most appropriate term was cellular and/or tissue-derived products for wounds (CTPs). A FDA representative later expressed concerns about the word derived at a November meeting. Because the FDA uses the term based in its regulations regarding human cells, tissues, and cellular and tissue-based products (HCT/Ps), the new term was changed to include based for consistency. The final term became cellular and/or tissue-based products for wounds (CTPs).

  The Alliance voted to adopt this new term in March 2013 and is now using it in all written correspondence to regulatory agencies. The Alliance has provided this term in its educational information about CTPs to the CMS and its contractors (some of whom have already adopted it as their title of their coverage policies on this subject.) The Alliance is also working with ASTM, a standards setting organization, to use this term as the title for standard guide on classification of these products. As healthcare technology continues to evolve, practitioners can expect additional terminology updates that clarify and expand treatment and reimbursement potential. In the meantime, the Alliance encourages the wound care community to consider using this new term in the preparation of educational materials, presentations, manuscripts, and clinical protocols in order for it to gain acceptance in everyday clinical language.

  For more information about the Alliance and its mission — ie, to promote quality care and patient access to wound care products and services through effective advocacy and educational outreach in regulatory, legislative, and public arenas — please visit www.woundcarestakeholders.org.

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