Lexology September 16, 2025
HHS-OIG Raises Red Flags Over Skin Substitutes; Heightened Enforcement Expected
The use of skin substitutes, products made from human or bioengineered tissues, is an emerging treatment for chronic, non-healing wounds. While their effectiveness remains debated, many providers report clinical benefits. However, their increasing use has drawn scrutiny from federal regulators, with enforcement actions already underway and more anticipated.
Alarming Medicare Part B Billing Trends
On September 3, 2025, the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) released a report highlighting explosive growth in Medicare Part B spending on skin substitutes provided in a non-institutional setting. Key findings include:
- Spending Surge: Medicare Part B spending on skin substitutes has skyrocketed from $400 million to nearly...
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