The U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG), has announced a nationwide audit of Medicare payments for skin substitutes. This initiative, conducted through the OIG’s Office of Audit Services, targets Medicare Part B claims submitted between May 1, 2024, and April 30, 2025.
What Providers Are Receiving
Wound care providers nationwide have started receiving audit notification letters. While these audits are framed as part of a broad, nationwide review rather than an individual investigation, the requests are serious and carry potential financial and legal consequences. Providers may be asked to provide:
- The point of contact at their office.
- Documentation covering the entire episode of care for sampled services.
- Records within a short deadline (often 10 days).
- Supporting information demonstrating compliance with Medicare coverage, local coverage determinations (LCDs) and documentation requirements.
These requests are backed by OIG’s statutory authority under the Inspector General Act of 1978 and Medicare’s right to deny claims under Section 1833(e) of the Social Security Act. HIPAA provisions also allow disclosure of records as part of “required by law” and “health oversight” activities.
Why This Matters
Even though the audit is not targeting individual providers, it is critical to take any request seriously. Failure to respond fully or on time can result in:
- Overpayment demands and recoupments.
- Denial of payments for services rendered.
- Broader enforcement actions, including civil or criminal liability.
Skin substitutes, particularly products billed under Q-codes, have been under increasing scrutiny by payers and Medicare. The OIG audit reflects a heightened focus on both clinical documentation and adherence to coverage criteria. Providers who are unprepared risk significant financial exposure and reputational harm.
How Frier Levitt Can Help
Frier Levitt’s team of specialized healthcare attorneys brings decades of experience representing wound care providers, physicians, and suppliers in OIG investigations, CMS audits, and appeals. To ensure the strongest possible defense, we frequently collaborate with certified professional coders, producing comprehensive records and addressing any inconsistencies that may arise during the audit process. Our approach begins with a careful review of audit requests to identify key compliance risks, followed by the preparation of documentation that is both thorough and strategically presented. We actively challenge any improper sampling, extrapolation, or recoupment methodologies, while also developing proactive strategies designed to minimize audit exposure and protect revenue streams.
We understand that responding to an OIG audit can be overwhelming. That’s why we work closely with providers to prepare a defensible response while minimizing disruption to day-to-day operations. Our goal is to protect your practice’s revenue, compliance, and reputation.
Immediate Steps for Providers
If your practice receives an OIG audit notification for skin substitutes, it is crucial to act quickly:
- Do not ignore the letter – deadlines are often very short.
- Gather all relevant records for the sampled claims, including progress notes, wound measurements, prior conservative treatments, and medical necessity rationale.
- Contact experienced counsel immediately before submitting records to ensure your response is accurate, compliant, and strategically positioned.
Protect Your Practice
OIG audits are part of a broader effort to enforce Medicare compliance, and skin substitutes are now a primary area of focus. Providers who act proactively and seek experienced legal guidance are far better positioned to navigate these audits successfully.
Frier Levitt is actively monitoring these audits and is ready to assist providers nationwide. With our extensive experience in healthcare law and CMS compliance, we help practices respond efficiently, protect revenue, and reduce risk of enforcement action.
If your practice has received an OIG audit notification regarding skin substitutes, contact Frier Levitt immediately. Timely action can mean the difference between a routine review and significant financial and legal consequences.
Frier Levitt provides strategic, industry-focused legal counsel tailored to your needs. Contact our team today to learn how we can help you.
