HHS is at war with itself as FDA approves anti-amyloid treatment while CMS denies access

Washington, D.C. (January 11, 2022) – The Centers for Medicare and Medicaid Services (CMS) announced today that it planned on covering anti-amyloid treatments (such as Aduhelm) under what is known as a Coverage with Evidence Development (CED). The agency’s decision effectively denies access to an entire class of drugs for years to come and further exacerbates health disparities.

“This is absolutely unacceptable. If this decision stands, for the first time in history, millions of Americans will be denied coverage not just to a drug, but to a whole class of drugs—not by the agency that regulates drugs but by the federal insurance bureaucracy,” said George Vradenburg, chair and co-founder of UsAgainstAlzheimer’s. “Why are treatments for Alzheimer’s patients being held to a different standard than those treating cancer, HIV, and other illnesses? Is it because there are so many of us? Is it because we’re old? CMS should be ashamed of the way it is discriminating against this one group of patients.”

“The FDA is the only agency with the legal authority to approve drugs, it’s the only one with neurologists on staff, and for the first time ever, Medicare is second-guessing FDA—and not only on work that it has already done, but on work FDA will do in the future. 

“HHS is clearly at war with itself, with one agency approving this class of drugs and another slamming the door shut on treatment. It’s outrageous. Does CMS no longer trust the FDA’s work?” Vradenburg said.

The NCD issued today is a draft, which will now be subject to public comment for thirty days before CMS issues its final coverage determination.

###

About UsAgainstAlzheimer’s

UsAgainstAlzheimer’s exists to conquer Alzheimer’s disease. We take on the toughest problems; bring all of “Us” together to break down barriers; advocate for research that will speed treatments to market; and drive changes that matter most to people living with the disease. We will not rest until brain-span equals lifespan - for everyone.