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:
August 1, 2024
Letter to Congress on Strengthening the 21st Century Cures Act
In response to a Request for Information from Congress to collect stakeholder input, the Alliance provided a detailed collection of specific recommendations to strengthen the 21st Century Cures Act. With a unique wound care perspective, the Alliance letter focused on issues including: real world evidence, national and local coverage decision processes, local coding and billing article processes, the Coverage with Evidence Development paradigm, Contractor Advisory Committee engagement, the National Correct Coding Initiatives (NCCI), reconsideration request timelines, and more.
June 8, 2024
The Alliance submitted comments to the medical directors of each Medicare Administrative Contractor (MAC) with specific recommendations to improve the local coverage determinations/local coverage articles on “Skin Substitute Grafts/ Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers.” The Alliance provided detailed comments and substantive recommendations focused on the following key areas in need of resolution and clarity:
- Evidence, and the need for a consistent and equally applied methodology for the MACs assess and determine sufficient evidentiary support for coverage.
- Reconsideration processes, and the imperative for a predictable, consistent process under which manufacturers can submit new evidence for MACs review in a timely fashion so that there is a pathway to gain coverage as new evidence becomes available.
- Number of applications and treatment duration, with recommendations to more accurately reflect current peer-reviewed clinical evidence by increasing the number of applications allowed, and to recognize in the policy the needs of specific patient populations – like those with larger sized or deeper wounds – who will require more applications.
- Implementation timeline, with a request that MACs provide an extended implementation period to avoid interruptions to patient care.
See Alliance recommendations to the MACs to achieve better balanced, fair and clinically accurate policies, below.
May 16, 2024
Oral Testimony at MAC “Listening Sessions” on LCDs/LCAs for use of CTPs in DFU/VLU
The Alliance provided oral testimony at the open public feedback sessions that each Medicare Administrative Contractor (MAC) held to collect stakeholder input on the proposed LCD “Skin Substitute Grafts/Cellular & Tissue-Based Products for the Treatment of DFU and VLU.” The Alliance voiced support for the proposed LCD language permitting additional applications beyond the 4 application limit and the extension of the 12-week treatment period based on medical necessity with documentation provided in the patients’ medical record. The Alliance also requested more transparency and consistency regarding the evidentiary bar being applied to determine if coverage will be provided – noting that there are a number published, peer-reviewed studies supporting a range of products that for unknown reasons were not included on the MACs’ list of evidence reviewed. Finally, the Alliance encouraged the MACs to ensure they provide enough time to implement the LCD, once finalized, so not to negatively impact patient care. The comments below were delivered to: CGS Administrators (5/16/2024); First Coast Service Options (5/23/2024); National Government Services (5/16/2024); Noridian Healthcare Solutions (J-E on 5/16/2024; J-F on 5/16/2024); Novitas Solutions (5/24/2024); Palmetto GBA (5/29/2024) and WPS Insurance Corporation (5/22/2024).