The 2025 Regulatory Shift: What Wound Care Providers Need to Know 

Prepare for the Regulatory Shift 

The healthcare regulatory landscape is never static, but 2025 is already shaping up to be a watershed year — especially for wound care providers. With more than a dozen regulatory updates coming into play, it can be difficult to know where to focus first. But amid the noise, six key changes stand out:  

1. Local Coverage Determinations (LCDs) for cellular and tissue-based products (CTPs) 
2. MIPS and the focus on quality 
3. SDOH and health equity  
4. Changing reimbursement practices 
5. Technology and interconnectivity 
6. Expansion of telehealth 

While each of these shifts brings its own challenges, they represent a broader trend toward accountability, outcome-driven care, and administrative precision. For wound care providers — whether in hospitals, outpatient clinics, skilled nursing facilities, or home health — this means more than just staying compliant. It also means rethinking how care is documented, how teams communicate, and how technology is used to meet expectations and maintain reimbursement. 

“From the launch of promising new therapies to the uncertainty of regulatory changes and emerging technologies, 2025 is poised to be a transformative year for wound care. With all that lies ahead, flexibility and adaptability will be key as our profession continues to change and evolve.” 

Alisha Oropallo, MD, FACS, FSVS, FAPWCA, FABWMS, Director, Department of Vascular and Endovascular Surgery Comprehensive Wound Healing Center and Hyperbarics, Northwell Health

Skin Substitute Reimbursement: A New Compliance Era  

The tightening regulatory grip is especially evident in skin substitute reimbursement. While there have been some twists and turns, CMS has finalized its Local Coverage Determinations (LCDs) for cellular and tissue-based products (CTPs), which are commonly referred to as skin substitutes. While additional revisions may yet happen, these new rules, which are now slated to go into effect in January 2026, show that CMS wants more rigorous oversight of how and when these advanced therapies are used. 

It’s a substantial change. In a survey taken at the start of the year, Net Health found that almost 45% of wound care professionals cited the management of new CMS Skin Substitute Local Coverage Determination (LCD) rules as having the greatest impact on their practice. 

Until now, providers had relative flexibility when using skin substitutes, but the updated guidance introduces specific thresholds and expectations. Applications of skin substitutes for diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) will now be capped at eight within a 16-week episode of care. After just four applications, providers must demonstrate measurable wound progress to justify continued treatment. That means documenting wound size reductions, evidence of off-loading or compression therapy, and strict adherence to a clearly defined standard of care. 

According to Mike Comer, CEO and founder of Wound Care Advantage (WCA), these new policies represent a turning point. “These changes mark a pivotal moment in our industry,” said Comer. “After 30 years in wound care, I’ve never seen a policy released with this level of coordination. It’s clear Medicare is serious about enforcing proper utilization of these products.” 

The new LCDs don’t just focus on how often products are applied — they also emphasize waste reduction. Providers must now use the smallest available product sizes to limit unused material. If wastage is not properly documented, claims may be denied. This isn’t just about money — it’s about proving that every decision made in treatment planning is medically necessary, cost-efficient, and properly recorded. 

MIPS 2025: A More Nuanced View of Quality 

The MIPS program continues to evolve in ways that deeply affect wound care providers, particularly those billing under Medicare Part B. At its core, MIPS evaluates providers based on four performance categories: quality, cost, improvement activities, and promoting interoperability. But as of 2025, the criteria are becoming far more specific when it comes to wound care. 

CMS is introducing seven new quality measures directly relevant to wound management. These include measures focused on proper nutritional assessments, compression therapy for VLUs, off-loading for DFUs, and wound healing outcomes across different ulcer types. These additions reflect a growing recognition of wound care as a specialty deserving of its own metrics, not just a subset of primary care or general surgery. 

Alongside these new measures, CMS is also revising existing quality metrics and cutting others. This suggests a move toward more specialty-specific, outcome-based assessment — a shift that could be beneficial to wound care providers if they are prepared to meet the new expectations. 

Cost measurement is also getting an overhaul. CMS plans to roll out six new episode-based cost measures, three directly tied to wound care scenarios, such as diabetic foot ulcer treatment and joint replacements that commonly involve wound management post-surgery. As a result, providers will be assessed on the quality of care they deliver and how efficiently they manage costs across an entire episode of care. 

Additionally, MIPS is eliminating the 7-point cap on “topped-out” quality measures in specialties with limited reporting options. While this offers more scoring flexibility, it also raises the stakes for performance — especially in fields like wound care, where small sample sizes and high variability in case complexity can skew results. 

This is good news for many providers. With the elimination of the 7-point cap, clinicians reporting these measures are now eligible to earn the full 10 points per measure by meeting the specified performance criteria. This adjustment gives wound care providers the ability to spotlight the quality of care delivered. According to the Net Health Source Report for Wound Care, a majority — 53% — of wound care providers felt that there was potential…and some challenges…with MIPS. Twenty-seven percent were neutral to somewhat negative.  

From a documentation perspective, it all adds up to more work — and higher stakes. Providers need to ensure their records support the new quality measures, that EHRs capture key indicators cleanly, and that workflows are designed to collect this data efficiently. Those who can align clinical practice with MIPS requirements stand to benefit. Those who can’t, may see reduced reimbursement or even penalties. 

Approved Quality Measures for 2025 Include: 

• Adequate Compression for Venous Leg Ulcers (VLUs): Ensuring compression therapy is applied appropriately at each visit. 
• Off-loading of Diabetic Foot Ulcers (DFUs): Proper off-loading techniques performed at each visit to promote healing. 
• Nutritional Assessment and Intervention: Evaluating and addressing nutritional needs in patients with wounds or ulcers. 
• Non-Invasive Arterial Assessment: Assessing arterial supply in patients with lower extremity wounds to determine healing potential. 

Source:  Quality Measures Provided by the U.S. Wound & Podiatry Registries – U.S. Wound & Podiatry Registries 

SDOH and Health Equity: From Buzzwords to Measurable Action 

For years, healthcare professionals have talked about Social Drivers of Health (SDOH) and health equity. While there are some changes in this area with the new administration, for many hospitals, health systems, and payers, these concepts are no longer aspirational — they’re being written into organizational planning and guidelines. As of this writing, CMS is introducing four new SDOH assessment items and refining an existing one (scheduled for October 2025), signaling that these factors are now essential elements of care delivery, not optional considerations. 

The new assessments require providers to evaluate patients’ living situations, food security, access to utilities, and transportation reliability. These aren’t casual questions asked during intake — they’re structured data points that must be addressed in documentation, and they’re increasingly tied to performance evaluations and future reimbursement structures. For wound care providers, this means going beyond the wound bed and looking at the broader context in which healing (or lack thereof) occurs. 

Think about the patient with a diabetic foot ulcer who misses follow-up appointments because they don’t have reliable transportation. Or the patient whose VLU isn’t healing because they can’t afford nutritious food or maintain compression due to unstable housing. In 2025, providers are being asked — and in some cases, required — to document these factors and, ideally, connect patients with resources that address them. 

This is about improving outcomes, but it’s also about accountability. Payers clearly want wound care providers to think about how and where their patients live, and about their support system (or lack thereof). Providers who embrace this more holistic model of care may see improvements not just in healing rates, but in patient satisfaction, operational efficiency, and their own MIPS scores. Integrating these assessments into workflows will require time, training, and updates to electronic health records that can flag, track, and report on these new data points. 

CMS is also looking closely at the area of pain management and encouraging the adoption of non-opioid options, particularly for chronic wound patients. This shift aligns with broader public health efforts to reduce opioid dependency. Programs that reward providers for developing individualized pain management plans may create new incentives, but they also bring a heightened need for documentation, justification, and patient follow-up. (Check out the latest on the Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act.) 

Reimbursement: Redefined by Value and Volume 

As 2025 continues to take shape, reimbursement models are arguably being reshaped to support outcomes over procedures. The push toward value-based care is continuing, and wound care providers — especially those in outpatient and hospital-affiliated settings — must adjust to the financial and operational implications. 

This year’s updates include expanded use of bundled payments in chronic wound management, where services across an entire episode of care are grouped into a single payment. While this can promote efficiency and improve care coordination, it also requires practices to monitor cost controls more closely. For smaller practices or solo providers, these models can feel burdensome, especially when margins are tight, and staffing is limited. However, those who understand how to manage costs without compromising care could find new opportunities to thrive. (And remember, technology can be a great equalizer when it comes to building efficiencies cost-effectively.) 

Value-based payment initiatives also now include wound-specific metrics. This is a major milestone. Historically, wound care outcomes haven’t always been visible in national reimbursement models. But with CMS introducing measures tied to healing rates, off-loading, compression use, and more, the spotlight is now squarely on wound healing as a quality outcome. That shift can work in your favor — if your documentation and coding support the results you’re delivering. 

One of the more significant developments for many in the wound care space was the significant reimbursement cut to Hyperbaric Oxygen Therapy (HBOT), introduced under the 2024 HOPPS rule. With a reduction of over 40%, the viability of HBOT services — especially in hospital outpatient departments — came under question. CMS did make adjustments for 2025.  

Another quiet change is the new coding and reimbursement framework for caregiver training. This includes education around wound care, pressure injury prevention, infection control, and nutritional support. For wound care providers, this adds another layer of responsibility — and another set of documentation requirements. Whether you’re training a spouse, home health aide, or skilled nursing staff, your ability to demonstrate what was taught, how it was documented, and how the training ties into patient care can influence whether you’re reimbursed and by how much. (For more information on coding – see here.)  

Lastly, updates to the Medicare Physician Fee Schedule (PFS) introduce new coding requirements and further payment reductions for some wound care services. While none of these changes are surprising, taken together, they demand tighter billing operations, more precise documentation, and stronger alignment between clinical care and back-office systems. Providers who fail to adapt may face delays in payment — or worse, claim denials that affect both cash flow and care continuity. 

Technology and Interconnectivity: Not Just Helpful — Now Required 

Technology is a regulatory requirement, especially when it comes to how data is captured, shared, and audited. One of the most important shifts is the push for responsible EHR usage. Wound care providers are increasingly expected to use platforms that support interoperability — not just within their clinic or system, but across different providers and care settings. As more patients move between hospital, home care, and outpatient wound centers, seamless data sharing becomes a necessity. And with that comes the expectation that your documentation reflects the full scope of care: what was done, why it was done, and what happened next. (See the CMS site here for additional information.) 

Advanced digital wound care tools are also coming into play. AI-powered platforms that use smartphones or tablets to capture 3D wound images, track progression, and support coding accuracy are no longer fringe innovations. They’re becoming central to how care is delivered and how reimbursement is justified. When used correctly, these tools can enhance documentation, streamline workflow, and improve reporting. 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. 

CMS has also made it clear that documentation must now demonstrate continuity of care, which means relying on technology that can integrate assessment data, photos, treatment plans, and billing codes in one accessible platform. If your EHR doesn’t support these features — or if your staff doesn’t know how to use them — you may be putting your practice at risk, not just from an efficiency standpoint but from a regulatory one as well. 

 AI-powered platforms that use smartphones or tablets to capture 3D wound images, track progression, and support coding accuracy are no longer fringe innovations. They’re becoming central to how care is delivered and how reimbursement is justified. 

Telehealth: More Than a Pandemic Legacy 

Telehealth may have skyrocketed during the COVID-19 pandemic, but today it’s evolving into a stable, regulated part of the care landscape. For wound care providers, this shift offers both opportunities and new rules to navigate. 

CMS has continued its expansion of reimbursable telehealth services, including certain wound care-related activities such as caregiver training and patient education. This allows providers to reach patients in rural or underserved areas, manage follow-ups more efficiently, and reduce unnecessary clinic visits. However, with reimbursement comes responsibility — especially in terms of documentation and HIPAA compliance. (Also see Wound Reference for additional information.) 

Telehealth services must now be coded correctly and supported by detailed records of what was provided, who was present, and how the service was delivered. Providers must also ensure that telehealth platforms meet security standards and that remote monitoring devices — such as those used for wound photography or assessment — are integrated into the patient’s health record. 

Perhaps more importantly, telehealth is being recognized as a tool for equity for historically underserved patient populations such as those in rural areas. In combination with the new SDOH requirements, virtual visits are one way CMS is encouraging providers to expand access. However, that only works if the infrastructure is accessible to providers and patients. Connectivity issues, lack of digital literacy, and concerns over remote documentation remain hurdles.  

Still, the trajectory is clear: telehealth isn’t going away. It’s becoming part of the regulatory framework, and wound care providers who incorporate it strategically will likely benefit in both outcomes and revenue. 

 What CMS Says About HIPAA-Compliant Tech 

“The HIPAA Rules establish standards to protect patients’ protected health information. All telehealth services provided by covered health care providers and health plans must comply with the HIPAA Rules. Covered health care providers and health plans must use technology vendors that comply with the HIPAA Rules.” 

A Call for Alignment, Not Just Compliance 

The regulatory shifts coming in 2025, those now in effect and pending, aren’t just about new rules — they reflect a deeper evolution in how wound care is valued, measured, and delivered. From the way we document skin substitute usage to how we incorporate social factors into care plans, wound care providers are being asked to step into a more integrated, accountable role in the healthcare system. The stakes are higher, but so is the opportunity. 

This moment calls for more than reactive compliance. It requires strategic alignment — between clinical practice, documentation, and the digital tools that support both. For providers who can adapt, these changes offer a chance to elevate the role of wound care in value-based healthcare. For those unprepared, the risks include lost revenue, compliance issues, and missed opportunities to improve patient outcomes. 

Part 3 – Reimbursement Resilience: 

In the next chapter, we’ll take a deeper dive into how these known and unknown regulatory forces intersect with Medicare Advantage, Medicaid, value-based care initiatives, and more. As payment models shift and policies evolve, understanding the full picture — both what is currently in place and what is on the horizon — is essential for wound care providers navigating this period of rapid change and uncertainty.