In the evolving landscape of Medicare audit enforcement, wound care providers must recognize that the stakes are higher than ever. Documentation that once passed scrutiny is now being dissected in unprecedented detail. At Frier Levitt, we focus on helping wound care providers navigate the full spectrum of audits and administrative appeals under the Centers for Medicare & Medicaid Services (CMS) and its contractors, utilizing integrated legal, coding, documentation, clinical, regulatory, and equitable arguments.
Heightened Coverage and Documentation Standards for Wound Care
Over the past several years, CMS has tightened the threshold for coverage of skin substitutes and cellular or tissue-based products (CTPs). Many Local Coverage Determinations (LCDs) and related policies now require that, for ongoing wound care, the medical record must clearly demonstrate that the wound is improving in response to the treatment provided. Improvement must be shown through objective clinical indicators such as drainage, inflammation, wound dimensions, granulation, and other measurable factors.
The plan of care must also address complicating factors such as unrelieved pressure, vascular insufficiency, infection, or nutritional deficiencies. In practice, this means the traditional “four weeks of conservative care before advanced therapy” notation in the medical record is no longer sufficient. Audit contractors now demand specificity. Auditors increasingly deny claims if they do not see in the notes which modalities were used, how frequently, for how long, and precisely how the wound progressed during that period, along with detailed wound measurements.
Recent updates to wound care billing guidance for 2025 further emphasize precision in wound measurement and photographic documentation. Providers must now track wound progression with measurable data at baseline, after conservative treatment, and throughout the course of advanced therapy to substantiate medical necessity and continued coverage.
A recurring denial trend in current audits involves the “lack of specific conservative care” argument. Contractors increasingly claim that the documentation fails to establish which conservative modalities were applied, whether the patient was compliant, and whether underlying conditions such as vascular disease, infection, or nutritional deficits were properly addressed. Some Administrative Law Judges (ALJs) now find these arguments persuasive, meaning that vague or generalized clinical notes that once sufficed are no longer adequate to support coverage.
Challenging Improper Audit Denials and Appeals
Another persistent challenge involves “experimental or investigational” denials. Even when a wound care product is FDA-regulated and commercially marketed, CMS contractors often label it as investigational to justify nonpayment. However, many of these denials are procedurally defective. Medicare regulations prohibit contractors from introducing new denial rationales, such as investigational status, after the Unified Program Integrity Contractor (UPIC) review level. When such arguments appear later in the appeals process, such as at the Medicare Administrative Contractor (MAC) or Qualified Independent Contractor (QIC) levels, we have successfully argued that they are legally barred and must be dismissed.
An evolution of this argument is the CMS “Q-code nomenclature” argument, where auditors contend that a product is investigational merely because of its Healthcare Common Procedure Coding System (HCPCS) Q-code assignment. We actively challenge this approach using comprehensive regulatory and scientific evidence. Our defenses include working closely with providers and manufacturers to provide documentation, including peer-reviewed clinical studies and class-wide analyses demonstrating that the product is safe, effective, and fully eligible for Medicare coverage.
How Frier Levitt Can Help
From the initial document production to UPIC auditors through the appeals process with CMS, Frier Levitt represents providers at every stage and can help guide your practice to avoid common pitfalls. Whether your practice has received a demand for records from a UPIC auditor, or you are in the redetermination, reconsideration, ALJ, or MAC stages of the appeals process, our legal team is ready to defend your practice.
Our attorneys routinely work with providers to prepare targeted response letters grounded in statutory and regulatory authority, engage forensic coding and documentation experts, develop physician declarations and testimony, and expose procedural violations when CMS contractors exceed their regulatory authority. We combine deep regulatory knowledge with practical wound care expertise to build strong, defensible cases and protect your right to reimbursement. Contact us to discuss your situation and learn how our experienced team can help you through every stage of the Medicare audit and appeals process with confidence.
