The Freedom of Information Act (FOIA) request seeks materials regarding cost considerations, the FDA’s Accelerated Approval Program, and potential harm to millions of patients
Washington, D.C., April 15, 2022 (GLOBE NEWSWIRE) -- Today, UsAgainstAlzheimer’s announced their latest effort to demand answers from the Centers for Medicare and Medicare Services (CMS) about last week’s National Coverage Determination (NCD), which has effectively denied access to FDA-approved treatments for millions of Americans living with Alzheimer’s disease.
“The National Coverage Determination is historic – and not in a good way. CMS has covered every FDA-approved drug but now there are two classes of patients within Medicare: people with Alzheimer’s and everyone else,” said UsAgainstAlzheimer’s Chairman and Co-Founder George Vradenburg. “Patients deserve the same level of transparency from CMS that they get from the FDA, which is why we are demanding answers on how this decision was crafted and what it means for future treatments.”
UsAgainstAlzheimer’s has sent a Freedom of Information Act (FOIA) request for any materials on multiple potentially troubling issues, including:
- Whether there was any communication or consideration at CMS regarding the cost of these treatments, which CMS is legally barred from considering when making coverage decisions;
- Communications relating to the FDA’s Accelerated Approval Program, which has been used to evaluate and approve over 250 drugs to expedite patient access to lifesaving treatments;
- Any CMS documents mentioning the potential harmful impact refusing to cover these drugs would have on millions of Alzheimer’s patients.
The full text of the FOIA request is attached and below. For UsAgainstAlzheimer’s full statement on the NCD, click here