CMS Skin Substitute Payment Reform: Innovation, Audit Pressure, and the Future of Mobile Wound Care

Key Takeaways 

• Audit pressure and reimbursement reform are reshaping provider behavior, with this thought leader sharing that he sees mobile and rural wound care providers feeling the greatest strain under the unified payment rate and incident-to-supply model. 
• CMS is demanding product-specific clinical evidence across regulatory pathways (361 HCT/P, 510(k), PMA/BLA), accelerating innovation but potentially increasing financial risk for manufacturers. 
• Targeted collaboration—potentially including mobile-specific reimbursement adjustments and enhanced credentialing—may be necessary to preserve patient access while supporting cost control. 

As CMS restructures reimbursement for skin substitutes and other cellular and tissue-based products (CTPs), uncertainty continues to ripple across the wound care landscape. In this interview, Rob Odell, Founder and CEO of Bobber Biotech, shares his perspective on audit risk, regulatory realignment, innovation pressures, and the growing vulnerability of mobile wound care providers. 

Audit Risk, Unified Payment, and Provider Hesitation 

CMS implemented a unified payment rate and shifted many skin substitutes into the incident-to-supply model under the Physician Fee Schedule. With updated LCDs withdrawn at the end of 2025, what are the biggest opportunities and risks for providers right now? 

One of the most immediate impacts has been heightened audit fear. For many providers, the perceived risk of scrutiny now outweighs the financial reward of offering advanced therapies. As audit activity increases, some clinicians are becoming more hesitant to treat with higher-cost CTPs. 

That hesitation carries consequences. When providers scale back, patients may be pushed back into hospital settings, particularly in rural and underserved areas. Mobile wound care providers are especially affected. These clinicians serve patients who often lack transportation, are homebound, or have limited access to brick-and-mortar wound centers. 

From an industry perspective, regulatory pathways such as 510(k), PMA, or BLA remain viable routes forward. However, the cost of pursuing those pathways is significant. While CMS has indicated that separately reimbursed products may remain an option, clarity around what reimbursement will look like—and whether it supports return on investment—remains limited. 

The result is a market that feels temporarily stalled, creating uncertainty not only for manufacturers, but for the patients who depend on consistent access to advanced therapies. 

Regulatory Realignment and the Push for Product-Specific Evidence 

As products become more tightly aligned with FDA regulatory pathways—361 HCT/P, 510(k), PMA—how should manufacturers and clinicians approach innovation and product selection while balancing clinical and economic considerations? 

One positive development is that the current environment is driving innovation. The 361 pathway has been widely used over the past decade, and some believe that overutilization limited broader regulatory exploration and product differentiation. 

Now, manufacturers have an opportunity to pursue alternative pathways and develop more differentiated technologies. However, clinical evidence will be paramount. CMS has made it clear that product-specific evidence, not just class-level data, will increasingly influence coverage and reimbursement decisions. 

In response, I'm seeing manufacturers investing more heavily in clinical trials and real-world evidence. While this increases short-term financial pressure, it may ultimately elevate the category by strengthening its scientific foundation. 

For clinicians, product selection will likely become increasingly evidence-driven. Clinical outcomes data and economic sustainability will need to align more closely than ever before. 

Mobile Wound Care and the Access Question 

What does meaningful collaboration need to look like across policymakers, clinicians, and industry to ensure cost control without sacrificing patient access? 

There is broad recognition that cost growth in the CTP category has been substantial in recent years, prompting policy intervention. However, certain care models may be disproportionately impacted—particularly mobile wound care. 

Mobile wound services have grown significantly year over year, reflecting a clear patient need. These providers treat individuals who are immobile, lack transportation, or live in geographically isolated areas. Their operational realities differ markedly from traditional clinics. A brick-and-mortar practice may see 10 to 12 patients per hour, while mobile providers inherently see fewer patients per day due to travel and care logistics. 

One potential area for policy exploration is a separate reimbursement structure for mobile wound care. Such an approach could help preserve access for vulnerable populations while maintaining broader cost-control objectives. 

In parallel, discussions are emerging around credentialing and formalized wound care training standards. Wound care has historically been under-recognized as a specialty, despite the complexity of these patients and the high stakes of delayed treatment. Strengthening credentialing standards may help ensure appropriate utilization while supporting quality care. 

A Market in Transition 

Much remains in flux. Legislative proposals are circulating, reimbursement discussions continue, and collaboration is occurring across stakeholders—though timelines remain uncertain. 

The hope is that reimbursement stabilizes at a level that is sustainable for providers while mitigating excessive spending. Ultimately, the focus must remain on ensuring that patients receive appropriate treatment from trained clinicians. 

Without thoughtful reform, the unintended consequence could be reduced access—and, in some cases, preventable limb loss. As the CTP market evolves, balancing cost control with clinical necessity will remain the central challenge. 

Mr. Odell is the Founder and CEO of Bobber Biotech.