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:

 

We improved CMS’ understanding of CTPs and their use in clinical practice via an “educational seminar” customized to key policymakers

As an outcome of our March meeting with CMS, the Agency invited the Alliance to lead a June educational seminar to teach key staffers about the different types of CTPs, their distinctions from surgical dressings, clinical considerations regarding use, selection & application, and the policy challenges that most impact CTP use. Six CMS Directors/Deputy Directors and 18 senior staff attended from a range of divisions that oversee HCPCS coding, the physician fee schedule, hospital outpatient and ambulatory services, coverage, home health, and more:

  • Hospital and Ambulatory Policy Groups (Division of Practitioner Services, Division of Outpatient Care, Division of Ambulatory Services);
  • Technology Coding and Pricing Group (Division of Coding and DRG; Division of Data Analysis and Market Based Pricing);
  • Chronic Care Policy Group (Division of Home Health and Hospice);
  • The Center for Clinical Standards and Quality (Coverage and Analysis Group).

 

We plan to continue our dialogue with CMS and our contacts across its many divisions as we advocate for changes to the proposed new payment structure for CTPs in the 2023 Physician Fee Schedule and HOPPS. Having policymakers at CMS who are better informed about CTPs will, we hope, enable productive conversations moving forward as part of our advocacy efforts.

 

Alliance presentation to CMS

 

We sought revisions to LCDs on CTPs for the treatment of DFU/VLU

In oral testimony (April) and written comments (June), the Alliance flagged the many provisions in the draft LCDs (DL35041 / DL36377) and accompanying billing and coding LCAs (DA54117 / DA57680) that were inaccurate, unsupported by evidence, and/or out of sync with current evidence and best practice. In comments to Novitas and to First Coast Service Options, the Alliance detailed the problematic policy language, the issues of concern underlying to those provisions, specific language changes to address the concerns, and the clinical evidence supporting our recommendations

 

We urged the NCCI contractor to fully implement recent updates

Following tenacious Alliance advocacy, in late-2021 CMS’ National Correct Coding Initiative (NCCI) contractor updated its policy manual to allow for debridement and compression to be provided on the same day. However, it failed to make changes to the accompanying edit tables, which are now confusingly inconsistent with the language in the manual. The Alliance has convened meeting and submitted letters to resolve this inconsistency. In Q2, we elevated the issue by submitting an email to CMS’ Director and Deputy Director of the Hospital & Ambulatory Policy, apprising them of the lack of CMS action and the barrier to care that results. Most recently, we reached out to CMS’ Division of Program Integrity, which has oversight of NCCI. The Director of the Division’s Audits and Vulnerabilities Group has let us know she is currently looking into this issue. The Alliance will continue to follow up to obtain resolution.

 

We supported inclusion of Global Malnutrition Composite Score in IPPS

In comments to the proposed FY 2023 Hospital Inpatient Prospective Payment System (IPPS), the Alliance noted its support of the inclusion of Global Malnutrition Composite Score (NQF #3592) in the policy and recommended that CMS move forward with implementing the Composite Score for the Hospital Inpatient Quality Reporting Program.

 

We pursued greater transparency and use of experts in development and implementation of MAC LCDs

Following submission of a January letter created by APMA and co-signed by the Alliance and 18+ aligned organizations raising concerns with the LCD/LCA development processes, the Alliance participated in ongoing follow-up activities. Alliance representatives served on the LCD-LCA Process/CAC Engagement workgroup that APMA spearheaded, cosigned follow-up letters, and participated in meetings with CMS’ Coverage and Analysis Group in February, May and June. There is optimism that changes are coming as we continue our discussions with CMS on these important issues.

 

We submitted comments and recommendations to the FDA surrounding its Wound Healing Workshop

The Alliance worked closely with the FDA as the Agency planned its April Wound Healing Scientific Workshop focused on chronic non-healing wounds. Many Alliance members not only participated in the meeting, but also served as speakers at the FDA Workshop. The Alliance submitted detailed responses to the questions posed by the FDA as it sought input heading into its April Workshop and invited FDA’s Workshop leaders to present at the Alliance’s May Wound Care Evidence Summit so that the meetings could build synergistically off each other. Our second set of comments, submitted to FDA in June, elevated consistent themes from both the Workshop and Evidence Summit, addressing topics including: real-world data/real-world evidence, primary and secondary clinical endpoints, mechanisms for modifying and expanding claims, funding of clinical trials, and new technology innovations in wound care.