The Centers for Medicare and Medicaid Services diverged from its statutory authority and past precedents when it proposed that Medicare would only cover Alzheimer’s drugs, including Biogen, Inc./Eisai Co., Ltd.’s Aduhelm and similar treatments in development, when patients are enrolled in an approved randomized clinical trial, according to two former attorneys with the US Health and Human Services Department.
The agency’s draft national coverage determination conditioning coverage on further evidence development (CED) has drawn strong opposition from patient groups...
