Frier Levitt achieved a major victory before the Office of Medicare Hearings and Appeals (OMHA), securing an Administrative Law Judge (ALJ) decision that reversed more than one million dollars in alleged Medicare overpayments tied to advanced wound-care products and application services. The ruling reinforces an important principle for wound-care providers nationwide: when clinical judgment, accurate coding, and Medicare policy are aligned, even substantial post-payment audit findings can be successfully overturned.
The Audit and Overpayment Allegations
The case arose from a post-payment audit in which Medicare alleged significant overpayments against an experienced wound-care provider. The disputed claims involved a Q code for a cellular and/or tissue-based product billed to CMS along with associated application services, including CPT codes 15271 and 15272. As is increasingly common in advanced wound-care audits, the contractor questioned coverage, medical necessity, and coding, placing significant reimbursement at risk.
Frier Levitt mounted a comprehensive appeal strategy focused on rebuilding the record from the ground up. Rather than relying on generalized arguments, the team addressed coverage, coding, and medical necessity on a claim-by-claim basis. Clinical documentation, operative and progress notes, and product records were carefully aligned with Medicare policy to demonstrate that the services met the agency’s “reasonable and necessary” standard.
The Administrative Law Judge Hearing
At the ALJ hearing, Frier Levitt presented a clear, patient-centered narrative and rebutted the allegations raised by the Unified Program Integrity Contractor (UPIC) auditors, which were later rubber-stamped at the Medicare Administrative Contractor (MAC) and Qualified Independent Contractor (QIC) levels.
The provider testified in detail to the medical necessity of each disputed date of service, explaining the clinical decision making that drove the use of the wound-care product and related services. A certified coding expert then translated complex billing and documentation issues into plain terms, addressing code selection, modifiers, units, documentation sufficiency, and product reporting. Together, the testimony and evidence established that the services were safe, effective, clinically appropriate, and properly billed under Medicare rules.
The ALJ Decision and Outcome
Following review of the record and testimony, the ALJ found that multiple amniotic and cellular and tissue-based product applications and related services were medically reasonable and necessary. The decision directed the Medicare contractor to process the claims consistent with the ruling, reversing more than a million dollars in alleged overpayments. The outcome reaffirmed that when the evidentiary record supports safety, effectiveness, and clinical appropriateness under the Medicare Program Integrity Manual, coverage is warranted.
This decision is particularly significant in the current audit environment, where advanced wound-care products are frequently challenged as experimental or investigational. In this case, Frier Levitt attorneys Phoebe A. Nelson, Esq. and Guillermo J. Beades, Esq. directly rebutted those assertions by tying FDA regulatory status, homologous use principles, class-level clinical support, and CMS coding decisions for Orion under HCPCS Q4276 to the facts of each claim. By pairing policy analysis with provider and coding expert testimony, the team presented a cohesive, claim-specific case for coverage.
What This Means for Wound-Care Providers
For wound-care providers facing Medicare audits and overpayment demands, this case illustrates what is possible with a disciplined, unified defense strategy. When the record demonstrates medical necessity, accurate coding, and compliance with Medicare coverage criteria on a claim-by-claim basis, meaningful reversals at the ALJ level are achievable, even in high-dollar cases.
Frier Levitt’s Medicare Audits and Appeals Team
Frier Levitt’s Medicare Audits and Appeals Team represents wound-care providers nationwide in complex audits involving advanced wound care, cellular and tissue-based products, and coding and coverage disputes. In this matter, the legal strategy leading up to and at the hearing resulted in the reversal of more than $1 million in alleged overpayments.
Need Help with a Medicare Audit?
If your practice is facing a Medicare audit or overpayment demand related to wound-care services, Frier Levitt can help evaluate your records, align documentation and coding with Medicare policy, and develop a hearing strategy that resonates with ALJs and strengthens the likelihood of a successful appeal.
