Alliance of Wound Care Stakeholders

In addition to the efforts taken on by the Society we have also enjoyed success through our membership in the Alliance of Wound Care Stakeholders (The Alliance). The Alliance of Wound Care Stakeholders is a nonprofit multidisciplinary trade association of physician medical specialty societies and clinical associations 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. Through the Alliance WOCN is able to comment, follow government regulations on multiple fronts, and directly affect policy decisions. Recent comments/letters include:

March 14, 2024

Letter to Acumen re Non-Pressure Ulcers Episode-Based Cost Measure

The Alliance submitted a letter informing Acumen that we cannot support the Non-Pressure Ulcers Episode-Based Cost Measure as currently written and articulating the many reasons the current version does not accurately capture the data necessary for a fair, reliable, accurate measure. The Alliance provided specific recommendations and refinements while emphasizing several key areas of concern, including:

• Costs being attributed to clinicians inappropriately: clinicians being held accountable for the work of other clinicians.
• Costs being attributed to a clinician for care provided in hospitals or facilities not associated with the clinician’s TIN.
• Tests being performed outside of a clinician TIN which they have no control over, yet which are being attributed to them.
  As the measure will be considered for potential use in the cost performance category of the Merit-based Incentive Payment System (MIPS), it is important for it to be based on fair, meaningful and correct criteria. The Alliance offered to conduct an educational session on wound care to better inform Acumen’s work on the measure.

March 8, 2024
Co-signed Letter to CMS urging update to lymphedema compression garments payment policy

In a co-signed letter with the American Physical Therapy Association, American Occupational Therapy Association, and Lymphedema Advocacy Group, the Alliance urged CMS to modify its lymphedema compression garments payment structure to ensure that clinicians are compensated for the measuring, fitting, and training services they provide. This would ensure that beneficiaries have flexibility to receive these services from either their lymphedema therapist or their DME supplier, the letter advocated, noting that the current policy doesn’t assure payment to the therapists who render these services.

March 4, 2024

Pre-Rulemaking Letter to CMS re Physician Fee Schedule

As CMS embarks on CY 2025 rulemaking, the Alliance submitted a letter urging the Agency to support patient access to CTPs (skin substitutes), level the playing field for manufacturers, and reduce Medicare Part B costs by adopting a universal average sales price (ASP) reimbursement methodology for all CTP products. The Alliance voiced concern, again, about the Agency’s past bundling proposals, which would be detrimental to patients—particularly among patients with large and/or more complex wounds.

February 27, 2024

Comments to FDA Proposed Classification of Certain Wound Dressings

In comments submitted to the FDA’s proposed rule on classification of certain wound dressings and companion amendments, the Alliance requested that the Agency withdraw the policy for further vetting. Alliance comments flagged the many “gaps and ambiguities” in the current policy, the reduced availability of wound dressing products that could result if the policy is implemented and the harm this could cause to patient care. “Though we agree with FDA that creating a classification regulation may provide added benefits regarding regulatory expectations, we believe the current proposal will create much greater confusion about requirements for wound dressings, and result in the unnecessary withdrawal of many important products from the market to the detriment of clinicians and their patients. These regulatory actions may result in clinicians using more antibiotic products, exacerbating the very resistance problems that FDA is trying to address through regulations on antiseptic-based wound dressings and washes. Therefore, the Alliance respectfully requests that FDA withdraw its current proposal, and if it desires to proceed, we ask that it publish a more detailed proposed rule, with companion guidance, addressing the points raised stakeholder comments,” the Alliance wrote.