Frier Levitt secured twelve (12) fully favorable decisions from an Administrative Law Judge (ALJ) on behalf of wound care providers targeted by Medicare that sought large overpayment demands. These cases focused on the use of EpiFix and PuraPly, two advanced skin substitute products widely recognized as effective in treating chronic wounds. In each case, the ALJ reversed the overpayment findings in full, confirming that the services were medically necessary, properly documented, and reimbursable under Medicare.
At the heart of these appeals was a flawed and unfair reconsideration process conducted by the Qualified Independent Contractor (QIC). Rather than reviewing the claims based on the original denial rationale and applicable Medicare policy, the QIC imposed new, elevated standards of proof that had never been raised earlier in the audit process. Most notably, the QIC demanded “double-blind, randomized clinical trials” to validate the safety and effectiveness of the products. This level of evidence is not required under Medicare guidelines and is entirely inappropriate for products regulated under Section 361 of the Public Health Service Act.
These novel criteria that were fabricated by the QIC blindsided providers and further deprived them of the opportunity to respond at earlier stages of appeal to this made-up requirement. Medicare’s own guidance makes clear that QICs are prohibited from expanding the basis for denial during post-payment appeals. By imposing these new and unsupported requirements, the QIC overstepped its authority and violated the procedural protections that Medicare providers are entitled to during the audit and appeals process.
Our legal team responded by developing a focused evidence-driven strategy for each case. We presented clear and detailed clinical documentation showing that EpiFix and PuraPly were used appropriately for each patient’s condition. We also submitted peer-reviewed research and Medicare billing history to reinforce that these products have been widely accepted as medically necessary for years.
A key factor in our success was the direct testimony from the treating providers, which were carefully prepared and strategically structured under our firm’s guidance. We work closely with clinicians to ensure their testimony clearly communicates the medical rationale behind their treatment decisions. This includes identifying the specific failures of conservative care, explaining the clinical benefits of using EpiFix and PuraPly as advanced skin substitute therapies, and articulating why these products were the most appropriate and medically necessary choice for each patient.
As a result, the ALJ was presented not only with strong written documentation, but with credible, compelling live testimony that offered a clear window into the providers’ decision-making process, ultimately reinforcing the validity of the claims and contributing to the full reversals of the overpayment demands.
The ALJ ultimately found the QIC’s actions to be procedurally improper and inconsistent with Medicare rules, concluding that the products were not investigational or experimental, that their use was medically necessary, and that all required documentation had been submitted. The overpayment demands were dismissed in full, and the providers were fully vindicated.
These decisions send a strong message to the provider community. CMS contractors do not have the authority to rewrite standards or introduce new requirements after the fact. Providers have a right to fair review based on the actual audit findings and existing Medicare policy. When those rights are violated, there is a clear legal pathway to reversal, if the right advocacy is in place.
How Frier Levitt Can Help You
As CMS wound care audits become more frequent and more aggressive, experienced legal representation with deep knowledge of healthcare law[1] is no longer optional, it is essential. Our firm is dedicated to protecting medical providers from improper overpayment demands and ensuring that clinically sound decisions are respected and upheld throughout the Medicare appeals process.
If your practice is facing a Medicare audit or overpayment issue related to biologic wound care products, contact us today. We are ready to help you protect your practice and achieve the outcome you deserve.
Frier Levitt provides strategic, industry-focused legal counsel tailored to your needs. Contact our team today to learn how we can help you.
[1] https://www.frierlevitt.com/articles/protect-your-practice-the-importance-of-healthcare-counsel-for-medicare-audits-and-appeals/
