New Policy Restricts Access to Care and Harms Patients

March 4, 2026 – Today, a group of medical providers who provide critical, life-saving skin substitute treatments to chronic wound patients filed a class action lawsuit against the U.S. Department of Health and Human Services (HHS), the Centers for Medicare & Medicaid Services (CMS), HHS Secretary Robert F. Kennedy, Jr., and CMS Administrator Dr. Mehmet Oz. The lawsuit argues that CMS is illegally clawing back money it paid for skin substitutes, claiming they are “experimental” and “investigational” and not “safe and effective” despite the fact they are clearly covered under Local Coverage Determinations (LCDs) that have been in place since 2015.

The MASS Coalition supports these providers in their attempt to secure access to care for their patients. Skin substitutes are a vital treatment method for chronic wounds, a condition especially common among older Americans and those with diabetes. CMS’s new policy does nothing to target and combat fraud; it harms patients and jeopardizes their health rather than punishing bad actors. The MASS Coalition will continue advocating for patients and providers while demanding common-sense policies that preserve access to life-saving treatments.

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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.