Alliance Advocates for Deregulation to Enhance Wound Care Access and Efficiency
On May 12, 2025, the Alliance of Wound Care Stakeholders submitted comprehensive comments to the Office of Management and Budget (OMB), responding to a federal request for feedback on opportunities for deregulation. The Alliance’s recommendations aim to streamline regulatory processes, reduce administrative burdens, and improve patient access to essential wound care treatments. Read the full article.
Key Highlights:
- Opposition to FDA Reclassification: The Alliance urges the withdrawal of the FDA’s proposed rule to reclassify certain antimicrobial wound dressings, citing concerns over reduced product availability and potential negative impacts on patient care.
- Prior Authorization Reforms: Recommendations include simplifying prior authorization processes to alleviate delays and administrative burdens for both providers and patients.
- Medicare Therapeutic Shoe Program Adjustments: The Alliance suggests reducing complexities within this program to enhance access for diabetic patients requiring therapeutic footwear.
- Payment Provision Corrections: Calls for rectifying problematic payment structures for Cellular and/or Tissue-based Products (CTPs) within the Hospital Outpatient Prospective Payment System to ensure fair reimbursement.
- Emphasis on Real-World Evidence (RWE): Advocates for the expanded adoption of RWE in coverage determinations and updates to the Coverage with Evidence Development framework.
- Administrative Simplification: Proposes reforms to the National Correct Coding Initiative, audit procedures, and data reporting processes to eliminate duplicative or overly complex requirements.
These targeted recommendations reflect the Alliance’s commitment to fostering a regulatory environment that supports efficient, patient-centered wound care practices.
Read the full article on the Alliance of Wound Care Stakeholders website.
Keywords:
wound care regulation,
prior authorization,
therapeutic shoe program,
real-world evidence,
Medicare payment policy