Royal Biologics Withdraws From the Alliance of Wound Care Stakeholders Over Support for Restrictive LCD Policies

Royal Biologics Takes a Stand Against Policies That Limit Patient Access, Suppress Innovation, and Drive Up Healthcare Costs

HACKENSACK, NEW JERSEY / ACCESS Newswire / April 4, 2025 / Royal Biologics, a leader in regenerative biologic technologies and wound care solutions, today announced its formal decision to part ways with the Alliance of Wound Care Stakeholders. This move comes in response to the Alliance's continued support of newly adopted Local Coverage Determinations (LCDs) that Royal Biologics believes threaten fair competition, increase costs, and limit patient access to critical treatment options.

The updated LCDs pertaining to Skin Substitute Grafts and Cellular and Tissue-Based Products (CTPs) drastically reduce the number of reimbursable products available, cutting over 200 therapies from coverage consideration. Royal Biologics views this as a significant setback for innovation and a direct blow to providers seeking effective, affordable wound care options for their patients.

"At Royal Biologics, we believe patients deserve access to the full spectrum of clinically effective wound care solutions, not just a narrow, high-cost selection that benefits a few legacy manufacturers," said Royal Biologics CEO, Salvatore Leo. "These policies threaten small businesses, limit innovation, and put vulnerable patients at risk-all while driving up costs across the system. That's a direction we cannot and will not support. We also believe the National Alliance of Wound Care Stakeholders did not work in the best interest of all its members, pushing unlawful policy forward without discussing with its full list of members."

The LCD changes not only consolidate market power among a select few companies but also place a disproportionate burden on Medicare and American taxpayers. Royal Biologics contends that such policies create a breeding ground for inefficiency, waste, and abuse; consequences that run counter to the goals of value-based healthcare.

As a result, the company can no longer remain affiliated with an organization whose policy positions diverge so sharply from its mission of expanding access to biological innovation and advancing high-quality wound care for patients.

"It's time for CMS to take a step back and reconsider these flawed policies," Leo continued. "We urge CMS to engage with Congress on implementing thoughtful CTP pricing reform, reform that rewards value, curbs abuse, encourages real innovation, and most importantly, safeguards patient access."

Royal Biologics remains committed to its mission of delivering cutting-edge, accessible regenerative technologies while advocating for a marketplace that supports innovation, transparency, and choice for providers and patients alike.

About Royal Biologics: Royal Biologics is a pioneering leader in orthobiologic and wound care research and development. Royal Biologics is committed to advancing the field of wound care with innovative solutions that enhance healing and improve patient outcomes. Dedicated to a patient-first approach, Royal has developed a broad range of products designed to address diverse wound care needs and improve quality of life.

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SOURCE: Royal Biologics