Donanemab’s Data Look Promising, But It Won’t Lead To An Imminent Change In Medicare’s Severe Restrictions On Coverage Of Alzheimer’s Disease Biologics Until lecanemab and donanemab are granted regular FDA approval it’s very unlikely there will be a change in CMS’s current severely restrictive coverage policy. Once approved CMS will be inclined to relax coverage limits. This said, upon approval unfettered access will not be a plausible scenario.