The recent $45 million False Claims Act (“FCA”) settlement involving a Florida wound care physician and affiliated entities underscores a hard truth for wound care providers: Medicare billing for debridement, advanced wound care services including skin substitute grafting, and related services are under sustained federal scrutiny. While the settlement includes no admission of liability, the government’s focus on medical necessity, documentation integrity, and EHR design presents clear compliance lessons for wound care practices, physician groups, and mobile wound care models nationwide.
What the Government Alleged and Why It Matters
According to the Department of Justice, the defendants allegedly billed Medicare for medically unnecessary excisional debridements, submitted claims for procedures not performed, pressured clinicians toward higher-reimbursing services, and deployed an EMR configured to restrict provider input and auto-generate documentation supporting elevated codes.
Prosecutors focused their scrutiny on the EMR system for standardizing narratives, obscuring individual clinical judgment, and purportedly facilitating auditor-resistant documentation. The bottom line is that practitioners are supposed to dictate care, not an EMR system or policy that railroads providers into a predetermined outcome.
The Compliance Fault Lines in Wound Care
Wound care is uniquely exposed to enforcement risk because high reimbursement, mobile delivery models, and documentation sensitivities converge to create multiple areas of attack for enforcement actions and claw backs from providers.
EMR and Documentation Integrity
A practice’s EMR must enable individualized, clinician-driven documentation. Systems that deploy rigid templates, require prepopulated findings, or steer coding decisions create risk when they supplant clinical judgment. Practices should validate that EMR workflows support accurate wound measurements, staging, conservative therapy documentation, comorbidity management, and clear medical necessity rationales, not the reverse.
Medical Necessity and Clinical Rationale
Excisional debridement, skin substitute application, and advanced wound modalities require patient-specific justification tied to clinical indicators, prior conservative measures, response to treatment, and documented goals. The absence of this narrative is a red flag in audits and investigations.
At Administrative Law Judge (“ALJ”) hearings, our firm has witnessed judges asking patient-specific questions and scrutinizing generic documentation, particularly concerning conservative wound care. ALJs, as well as auditors, want to be able to understand what specific modalities were attempted, what progress, if any, was made, and how that played into the decision to escalate to advanced wound care. Generic entries stating that conservative measures were attempted and failed are not enough.
Billing Precision and Internal Controls
The translation of care into claims must also be precise. Coding and documentation must faithfully reflect services performed. Furthermore, practices must implement internal controls to monitor for outlier patterns. High frequencies of advanced procedures or repetitive documentation across a patient population are triggers for data-driven audits and will draw attention from payors, auditors, and enforcement agencies.
Why Enforcement Is Intensifying
Wound care remains an enforcement priority for three reasons. First, excisional debridement and related services carry high reimbursement, creating outlier profiles that agencies monitor closely. Although, as of January 1, 2026, the reimbursement for skin grafts has been reduced significantly, there are still billions of dollars that have been paid over the past four years that are ripe for auditing and prosecution.
Second, centralized and mobile wound care models frequently rely on standardized workflows and templates that, if poorly designed, produce documentation inconsistent with individualized care. Patient specificity will always prevail over generalized documentation that is easy for investigators to attack.
Third, auditors are increasingly adept at identifying documentation gaps such as copy-forward text, incomplete wound measurements, lack of conservative care documentation, thin rationales for advanced procedures, and limited capture of comorbidity management that undercut medical necessity.
Practical Takeaways
Medical necessity must drive care, not templates, production pressures, or cloned notes. An EMR should support clinical reasoning rather than dictate it. Training and education around Medicare, NCD/LCD requirements, and payor policies should be routine and role-specific. Finally, monitor billing patterns proactively. Sustained outlier trends in high-value services are a catalyst for audits, overpayment demands, investigations and potential FCA exposure.
How Frier Levitt Helps Wound Care Providers Reduce Risk and Build Resilience
Frier Levitt represents wound care groups, mobile practices, physician organizations, and long-term care providers nationwide. Our healthcare regulatory and reimbursement team helps organizations align clinical practice, documentation, technology, and billing with evolving enforcement expectations in a practical and sustainable way.
Frier Levitt can assist, along with our trusted network of vendors, in designing and refining compliance frameworks tailored to wound care, including medical necessity protocols, documentation standards, EMR governance, and policies aligned with CMS and OIG expectations.
We regularly assist in pre- and post-payment wound care audits and can perform risk assessments focused on E/M services, debridement levels, skin substitute application, advanced wound care services, and procedure coding, which helps pinpoint trends that could trigger payor or government scrutiny.
Frier Levitt also has extensive experience in the structuring of mobile wound care arrangements, physician group models, and compensation plans that align with the Anti-Kickback Statute and the Stark Law, minimizing downstream risk while supporting operational growth.
Contact Frier Levitt
Frier Levitt stands ready to assist wound care providers to proactively strengthen compliance, mitigate risk, and build defensible clinical and billing practices. If you operate a wound care practice or provide bedside/mobile wound services, our attorneys can assess your risk profile, enhance your compliance program, and support robust responses to payor or government audits.
If your practice is the subject of a CMS or private payor audit for wound care services, contact us immediately to speak with experienced counsel regarding regulatory compliance, audit defense, your rights and responsibilities, and time-sensitive deadlines.
Frier Levitt provides strategic, industry-focused legal counsel tailored to your needs. Contact our team today to learn how we can help you.
