MASS COALITION WELCOMES TRUMP ORDER FREEZING SKIN SUBSTITUTE LCDs

President Trump’s Freeze Order Applies to Skin Substitute LCDs

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 urge the Department of Health and Human Services to take the necessary steps in the coming days to withdraw the LCDs for further evaluation and public comment, so that Medicare beneficiaries suffering from diabetic foot ulcers and venous leg ulcers can

access needed treatments and avoid sepsis and amputations that can lead to increased costs to Medicare for lengthy in-hospital treatment, as well as premature death.

The MASS Coalition is aware of recent statements claiming that the President has already withdrawn the LCDs, or that the Freeze Order does not encompass the LCDs. Those statements are incorrect. While the LCDs are not “rules” by statute, the Freeze Order expressly uses a different, and much broader definition of “rules”, which plainly encompasses actions by the prior Administration other than statutory rules, and

explicitly includes “guidance documents” that are not rules, such as the Skin Substitute LCDs. Thus, the President’s Order does apply to LCDs that are final but not yet in effect, including the Skin Substitute LCDs, and while further action by the Trump Administration will be needed to implement the Freeze Order across all agencies and programs, including Medicare, we urge such action to be taken swiftly.

The LCDs are precisely the type of Biden-era behind-closed-doors regulatory action that the Freeze Order was intended to stop. The MACs, witho

ut 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 threatened 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 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.