The proposed decision, which is subject to public comments that are due to CMS by February 10, 2022, does not endorse nationwide Medicare coverage for these drugs. Instead, CMS chose an alternate pathway known as Coverage with Evidence Development (“CED”). The FDA’s determination does not mandate Medicare coverage for Aduhelm. CMS would have access to all of the clinical trial data as a condition of Medicare coverage. As a result, even after a trial is completed, CMS could still determine that coverage would be approved for only a subset of Alzheimer’s patients or deny coverage.

Source: New York Times January 14, 2022 16:40 UTC