Insights & Resources

July 14, 2026 | Alerts

Skin Substitute Success Amidst National Takedown

Skin Substitute Success Amidst National Takedown

A massive national health care fraud takedown effort that charged over 455 defendants with more than $6.5 billion in alleged fraud was announced on June 23, 2026 by the U.S. Department of Justice (DOJ). Wound care providers featured prominently in DOJ’s announcement. Unlike those described in the DOJ announcement, most wound care providers likely aren’t spending money on fast cars, fancy jewelry, or luxury real estate, so it’s natural for them to think, “so what?” But, if you are a wound care provider, and particularly if you apply skin substitutes, DOJ’s announcement should be on your radar.

The DOJ announcement tracks the recent trends we see in Garfunkel Wild’s (GW) own Wound Care and Skin Substitutes Practice Group. More and more providers are being subjected to DOJ criminal indictments and civil investigations, including False Claims Act cases, as well as administrative investigations initiated by the U.S. Department of Health and Human Services, Office of Inspector General (OIG) and audit and recoupment actions by the Centers for Medicare and Medicaid Services (CMS) and their intermediaries. Significantly, the uptick in enforcement actions is happening even as CMS has drastically reduced skin substitute reimbursement rates in CY 2026, resulting in many manufacturers, distributors, and providers leaving the wound care space altogether.

The stakes for providers who continue to provide wound care services in this new environment have never been higher. DOJ’s announcement demonstrates that government enforcement activities in this space with continue for the foreseeable future, and that your practice, your reputation, and your freedom may be at risk.

GW’s Wound Care and Skin Substitutes Practice Group is uniquely positioned to help providers navigate this challenging period. “Our team of former government attorneys, medical necessity experts, and billing, coding, and documentation specialists understands the nuance and complexity of the wound care practice area,” said David Traskey, the head of the practice group and co-head of GW’s Washington, D.C. office. Importantly, the GW team has experience representing providers in criminal, civil, and administrative actions involving their use of skin substitutes.

Separately, GW’s track record of success in the Medicare hearings and appeals process is significant, with fully favorable decisions on behalf of clients in 12 of the previous 13 cases. “Our success is a direct result of having the right team in place, understanding how to refute the government’s allegations successfully, and our proprietary approach to handling appeals across all five levels of the Medicare appeals process,” David added.

Should you have any questions regarding the above or need help responding to a government audit or investigation, please contact the author, the Garfunkel Wild attorney with whom you regularly work, or contact us at [email protected].