January 27^th 2025

President Trump’s Freeze Order Applies to Skin Substitute LCDs – LCDs will not be effective until at least April 13, 2025

The MASS Coalition applauds President Trump for his bold action ordering a freeze of all regulatory guidance not yet in effect, which includes the recent Medicare Local Coverage Determinations restricting access to skin substitute products. The “Freeze Order” specifically encompasses “guidance documents,” which include the recent Skin Substitute LCDs. We thank the Department of Health and Human Services for taking the necessary steps to withdraw the LCDs until at least April 13, 2025, so that the Department can engage in further evaluation and public comment. The Department’s action is particularly good news for Medicare beneficiaries suffering from diabetic foot ulcers and venous leg ulcers. These patients will be able to access needed treatments in order to avoid sepsis and amputations that can lead to increased costs to Medicare for lengthy in-hospital treatment, as well as premature death, for at least the next two months.

As the Coalition previously noted, the LCDs are precisely the type of Biden-era behind-closed-doors regulatory action that the Freeze Order was intended to stop. The MACs, without promised stakeholder consultation and working at the behest of a few companies, operated in secret to coordinate the LCDs. In doing so, the MACs ignored the pain and suffering of everyday Americans and threaten to create a healthcare crisis for diabetics who will face an immediate shortage of treatments and end up in the hospital – creating unnecessary delays for other Americans and increasing the cost for Medicare. The MACs do not treat patients. America’s doctors and practitioners treat patients and know what works best for them. President Trump’s Freeze Order and the upcoming actions of the Department of Health and Human Services can end the prior Administration’s misuse of the regulatory process and ensure that Americans have access to skin substitute products prescribed by their physicians. By completely rescinding the LCDs, the Trump Administration can further deliver on its promise to make America healthy again and avoid the catastrophic treatment shortage set in motion by the prior Administration that would threaten the health of millions of Americans.

Skin substitutes made from donated amniotic tissue are used in dermatology to transform chronic wounds into an acute state, improving the healing environment. These substitutes significantly enhance healing rates, reduce emergency admissions, and decrease the need for amputations when used alongside quality care practices like debridement and offloading.

Proposed Medicare changes that could limit access to these products would negatively impact patient care by reducing treatment options and potentially increasing infection risks and hospitalizations, underscoring the need for comprehensive coverage and interdisciplinary management.

Physician’s Weekly (PW) spoke with David Armstrong, MD, PhD, professor of surgery and neurological surgery at the Keck School of Medicine of the University of Southern California, to better understand the benefits of skin substitutes and how treatment could change under the proposed Medicare changes.

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