Denise Barnes

I recently shared my perspective on President Trump’s newest executive order, which is designed to restrict federal contractors from participating in what the administration characterizes as “racially discriminatory” DEI efforts. Under this order, certain DEI‑related activities could put a contractor’s eligibility for future federal work at risk. In discussing the order, I noted that it may create additional exposure under the False Claims Act.

On September 9, the U.S. Department of Health and Human Services Office of the Inspector General (HHS-OIG) released a major report (Report) regarding the fraud risks currently associated with skin substitute products billed to Medicare. Notably, Medicare Part B expenditures for skin substitutes have surged dramatically, surpassing $10 billion annually by the end of 2024.

Effective wound care is critical for patients recovering from surgery or managing chronic or non-healing wounds. Advances in treatment have led to the development of skin substitutes—bioengineered or natural materials designed to promote healing by replacing or supporting damaged skin. While these innovations hold great promise for the future of wound care, they have also come under increased scrutiny by regulatory agencies and the Department of Justice (DOJ).