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:

 

JULY 24, 2023
COMMENTS TO FDA ON DECENTRALIZED CLINICAL TRIALS
The Alliance submitted comments to the FDA on its “Decentralized Clinical Trials for Drugs, Biological Products and Devices: Draft Guidance for Industry, Investigators and Other Stakeholders.” Overall supporting the guidance and its intent to expand access to diverse locations/populations, the Alliance raised several areas of concern surrounding whether the policy would have the impact that the Agency is striving to achieve. Our comments offer a series of recommendations, as well as highlight specific provisions that would benefit from additional clarity.

 

JUNE 21, 2023
LETTER TO CONGRESS SUPPORTING THE AMPUTATION REDUCTION & COMPASSION ACT
Together with 30+ clinical organizations in cardiology, podiatry and diabetology, the Alliance co-signed a letter to Congress supporting the Amputation Reduction and Compassion Act of 2023. Each year, more than 150,000 amputations are performed in the US to remove toes, legs or feet affected by advanced peripheral artery disease (PAD). This legislation would help reduce these preventable amputations by requiring Medicare, Medicaid, and plans sold on the federal healthcare exchanges to fully cover screening tests for beneficiaries who are at-risk of PAD. Early diagnosis and intervention can restore blood flow to affected limbs and reduce the risk of amputation. Originally introduced in 2021 (see full text) and reintroduced in June 2023, this legislation includes provisions to:

  • Increase access to diagnostics aimed at identifying conditions that can lead to amputation by providing coverage for PAD screenings of at-risk beneficiaries in Medicare and Medicaid
  • Require the development of quality metrics among payers and facilities that can prevent amputations
  • Provide access to amputation prevention services through the development of a voluntary pilot program, including through patient risk medication and management approaches, early screening and detection, ongoing surveillance, testing, and more.

 

JUNE 20, 2023
ENDORSEMENT OF THE CONNECT FOR HEALTH ACT OF 2023
Together with 150+ organizations spanning health, technology, aging and more, the Alliance voiced its support for the CONNECT for Health Act of 2023. Last introduced in 2021 and re-introduced in June 2023, the Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act would expand coverage of telehealth services through Medicare, make permanent COVID-19 telehealth flexibilities, and make it easier for patients to connect with their doctors. Specifically, the legislation would:

  • Remove geographic restrictions on telehealth services and expand originating sites to include the home and other sites;
  • Allow health centers and rural health clinics to provide telehealth services
  • Allow more eligible health care professionals to utilize telehealth services
  • Remove unnecessary in-person visit requirement for telehealth services supporting mental health
  • Require more published data to learn more about how telehealth is being used, impacts of quality of care, and how it can be improved to support patients and health care providers.

 

MAY 26, 2023
CO-SIGNED LETTER TO CONGRESS SUPPORTING LEGISLATION TO MITIGATE CUTS TO MEDICARE PAYMENT RATES
Together with the Clinical Labor Coalition, the Alliance submitted a letter to Congress in support of the recently-introduced legislation, the “Providing Relief and Stability for Medicare Patients Act of 2023” (H.R. 3674). This legislation would help mitigate cuts to office-based specialists for a targeted group of services for two years, thereby helping to avoid significant disruptions in patient access to care. “As you are aware, the discrepancy between what it costs to run a physician practice and actual payment combined with the administrative and financial burden of participating in Medicare is incentivizing market consolidation. We are concerned that the ongoing severity of recent cuts, combined with additional anticipated payment adjustments, will result in a breaking point for many physicians. Absent additional Congressional intervention via passage of H.R. 3674, the result will be more providers leaving the field, more practices being closed or sold, and a significant number of patients losing access to a variety of healthcare service in their communities.”

 

MAY 26, 2023
LETTER TO CMS REGARDING RECONSIDERATION REQUEST FOR TOPICAL OXYGEN THERAPY LCD
The Alliance submitted a letter to CMS’ Coverage and Analysis Group Director inquiring why the Agency has not addressed the reconsideration request submitted in July 2021 regarding Local Coverage Determination L33797 (Oxygen and Oxygen Equipment), which had established Medicare coverage criteria for topical oxygen therapy (TOT) in the treatment of diabetic foot ulcers (DFUs). The American Diabetes Association published a clinical compendia stating that the “evidence supporting TOT’s efficacy in healing chronic DFUs can no longer be disputed” and supported the inclusion of TOT in clinical practice guidelines for chronic DFUs, the Alliance reminded CMS. “The continued [18 month] delay of not moving forward with the reconsideration request for TOT increases the risk of negative health outcomes for some of the most at-risk Medicare patients.”