Tap Into Resilience to Navigate Wound Care’s Current Regulatory and Reimbursement Landscape  

The regulatory landscape for wound care providers in 2025 is a lot of things, but predictable is not one of them. With major changes already in motion and the added uncertainty of a new administration, providers must navigate shifting policies, evolving reimbursement models, and the growing demands of established programs like value-based care (VBC) initiatives. What is the key to success in today’s dynamic environment? Resilience…those who can adapt to new regulations, leverage innovative care strategies, and stay ahead of compliance challenges will have the tools needed to grow.  

Unpacking the Drivers Behind Regulatory Changes 

Why has so much regulation been aimed at not just the healthcare industry but wound care providers? While that question could spark hours of discussion and debate, several issues have helped shape the current marketplace. These include: 

• Driving better outcomes: Wound care providers always look for ways to help patients improve their quality of life. Regulations in recent years have aimed to support these intrinsic goals. The shift towards VBC underscores the importance of patient outcomes in reimbursement structures, as does CMS’s Merit-based Incentive Payment System (MIPS) Value Pathways.  Both programs strive to incentivize primary and specialty care providers to coordinate effectively, thereby improving patient outcomes.  

• Fighting fraud and abuse: Recent high-profile cases of fraud in the wound care sector have prompted government and commercial payers to intensify their efforts to combat fraudulent activities. For instance, in June 2024, the U.S. Department of Justice charged nearly 200 individuals for participating in healthcare fraud schemes, including two wound care company owners from Arizona and two nurse practitioners who allegedly provided unnecessary and costly amniotic wound grafts to elderly patients, resulting in approximately $900 million in fraudulent claims to Medicare.   

• Rising costs of chronic wound care: Chronic wounds continue to impose a significant financial burden on the U.S. healthcare system. Chronic wounds affect a sizable portion of the population across all age groups. The latest data analysis indicates that about 3% of the total U.S. population is impacted by chronic wounds for an estimated 10.5 million individuals nationwide. The numbers mark an increase of more than 2.3 million over a decade and highlight its escalating impact, particularly among older Americans. As the number of people over 65 in the United States is projected to exceed 77 million by 2060, along with rising rates of diabetes and cardiovascular disease, the incidence of chronic wounds is expected to increase, driving up demand and costs. 
  
• Lack of access to quality care: There is a growing recognition of the roles that socioeconomic and cultural drivers play in health outcomes. The farmer living in a rural area of Texas has different needs, expectations, and access to services as a professional living in a major city. CMS has introduced initiatives to integrate Social Drivers of Health (SDOH) considerations into care delivery, such as lack of access to food, transportation, and housing. These programs aim to identify and mitigate social factors that adversely affect patient health, thereby promoting more equitable care.  

A Look at How Past Changes Impacted the Industry 

Regulatory changes have continually reinforced the importance of preparation, adaptability, and innovation. Providers who successfully navigated past transitions understand that staying ahead of requirements minimizes disruption and optimizes patient care. Adjustments in financial strategies (looking for new revenue streams), treatment approaches (exploring alternative therapies), and patient access (mobile wound care) may be necessary to align with evolving payment models and compliance demands. 

Beyond reimbursement, stricter oversight and new reporting requirements have made documentation more critical than ever. The focus on value-based care and SDOH has added layers of administrative responsibility, requiring adaptability as regulations evolve. In addition, according to Net Health’s Wound Care Source Report for Hospitals, 31% of wound care workers in a hospital setting said that new SDOH assessment requirements will have the greatest impact on their practice. History shows that providers who proactively adjusted to past regulatory shifts emerged stronger than before the transition. Consider these pivotal moments: 

• The introduction of “Never Events” and HAC penalties: When CMS introduced hospital-acquired conditions (HACs) and associated penalties, wound care providers quickly enhanced documentation and prevention efforts. Pressure injuries — especially Stage 3 and 4 pressure ulcers — became both a financial and reputational priority. Organizations that refined their compliance strategies and prevention protocols met new standards while improving patient outcomes. 

• The shift to value-based care: The move from fee-for-service to VBC programs forced providers to focus more on outcomes, coordination, and data tracking. Clinics that implemented digital wound management platforms and AI-driven analytics found themselves better positioned to meet performance benchmarks and maintain financial stability. Today, wound care professionals are somewhat positive about the “value” that VBC brings to the table: Net Health found that 44% say that it has potential, but that there are challenges that need to be addressed. 
   
• The adoption of specialty Electronic Health Records (EHRs): The push for EHRs in the early 1990s was a major transition for wound care providers. While the shift required investment and training, those who embraced user-friendly, interoperable systems saw gains in efficiency, documentation accuracy, and data-driven decision-making. 

Wound care respondents are positive about the potential of future regulatory change, brought about by the new administration. 

How to Ensure Resilience in 2025 and Beyond 

As the regulatory landscape shifts once again, resilience will define the success of wound care providers. But what does resilience mean in this evolving environment? 

• Adaptability in the face of change: Resilience means continuously evolving to navigate regulatory shifts, compliance demands, and technological advancements that have reshaped healthcare over the past decade. 

• Dedication to excellence despite adversity: Delivering high-quality care amid demographic shifts, resource constraints, and systemic upheavals is a testament to resilience in wound care. 

• Commitment to innovation and growth: Providers demonstrate resilience by embracing new technologies and strategies, ensuring they stay at the forefront of wound care while meeting the evolving needs of their patients. For example, Net Health found broad acceptance in the use of technology to measure wounds, because many saw it as a way to assess patients more quickly and improve image integration across systems. 

Within that context, proactive strategies leveraging technology, partnerships, and continuous education will remain crucial to surviving ongoing changes. Technology is actively transforming wound care already, and its role in compliance and workflow optimization continues to grow. Several solutions can help providers manage increasing administrative demands and documentation requirements, and trends show widespread acceptance and adoption: 

• AI-powered digital wound care platforms improve accuracy in wound assessment, streamline reporting, and enhance reimbursement compliance.   
  
• Interoperable, specialty EHRs support real-time data exchange, ensuring seamless integration across care settings and enhancing compliance.   
  
• Automated coding and documentation tools minimize errors and denials, particularly as documentation rules for skin substitutes and Cellular and Tissue Products (CTPs) become stricter than in the past.  
  
• Predictive analytics and machine learning help identify high-risk patients early, enabling proactive interventions and supporting value-based care. 

Beyond technology, optimizing workflows is crucial. Integrating wound measurement tools and AI-assisted documentation of patient visits can boost efficiency while ensuring compliance, a benefit not lost on the day-to-day workers: Net Health found that 81% of wound care professionals are positive about ambient listening for documentation, with 90% of nurses positive. 

Telehealth and remote monitoring continue to be valuable, allowing providers to track healing progress without requiring in-person visits. Due to their popularity and program success, they are expected to continue to grow and evolve (which in turn will likely lead to more regulatory oversight). 

Regulatory shifts can be complex, and no provider should navigate them alone. Partnering with legal and compliance experts, industry associations, and advocacy groups like the Alliance of Wound Care Stakeholders can offer essential support. Selecting software and medical device vendors with proven compliance records and engaging with payers and policymakers can also help providers stay ahead of changes and advocate for fair payment structures. 

Education is one of the most powerful tools for building resilience. Routine compliance training helps teams stay current with evolving requirements, reducing compliance risks, and fostering a culture of accountability. Engaging in industry webinars and conferences keep providers abreast of the latest trends and innovations; while regularly reviewing CMS updates and professional journals ensure they are prepared for regulatory changes before they take effect. 

Technology to measure wounds gain broad acceptance; many see wound measurement tech as a way to improve image integration across systems. 

Preview of 2025 Regulatory Changes 

In Chapter 2 of this series, we will dive into what lies ahead for wound care regulations. We will explore anticipated changes in reimbursement for skin substitutes and Local Coverage Determination (LCD). We’ll examine how recent changes to Cellular and Acellular Tissue Matrix (C/ATM) reimbursement by CMS highlight the complexities providers face.  

But we’ll also highlight that challenges often bring opportunities. The recent CMS decisions to cover lymphedema products and compression therapy serve as a testament to the positive shifts that can also occur.  

Again, while there’s no crystal ball, we anticipate that additional changes will reflect the growing intersection of an aging population, rising chronic wound cases, and the financial pressures on healthcare systems. In response, policymakers will continue to adjust reimbursement models, expand value-based care initiatives, and incorporate more SDOH into care planning. 

Thriving Amidst Change 

The regulatory and reimbursement landscape for wound care in 2025 is uncertain, but history has proven that providers who prepare, adapt, and innovate will thrive. 

By leveraging technology, embracing innovative solutions, forming strategic partnerships, and prioritizing education, wound care providers can not only navigate regulatory shifts but also improve patient outcomes and financial stability. 

Resilience is more than just enduring change — it’s about turning challenges into opportunities for growth, efficiency, and better care delivery. With the right strategies in place, wound care providers can navigate today’s regulatory landscape and continue delivering high-quality, efficient, and compliant care to their patients.