FLORHAM PARK, N.J., Jan. 27, 2025 (GLOBE NEWSWIRE) — Celularity issues the following announcement on behalf of the members of the MASS Coalition:
MASS Coalition Welcomes Trump Order Freezing Skin Substitute LCDs
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.
About MASS Coalition
The Medicare Access to Skin Substitutes Coalition (“MASS Coalition”) is comprised of wound care companies—including manufacturers, processors and distributors—that are committed to ensuring access to critical wound care products for Medicare beneficiaries and other patients suffering from diabetic foot ulcers, venous leg ulcers, pressure ulcers and other chronic wounds.
About Celularity
Celularity Inc. (Nasdaq: CELU) is a regenerative medicine company developing and commercializing advanced biomaterial products and allogeneic, cryopreserved, placental-derived cell therapies, all derived from the postpartum placenta. Its therapeutic programs target aging-related diseases, including degenerative diseases, cancer, and immune disorders, using mesenchymal-like adherent stromal cells (MLASCs), T-cells engineered with CAR (CAR T-cells), and genetically modified and unmodified natural killer (NK) cells. Celularity believes that by harnessing the placenta’s unique biology and ready availability, it can develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies. For more information, visit www.celularity.com.
Carlos Ramirez
Senior Vice President, Celularity Inc.
Carlos.ramirez@celularity.com