On December 9, the Centers for Medicare & Medicaid Services (CMS) released a memorandum to Medicare Advantage (MA) plans regarding coverage of Qalsody, a drug granted accelerated approval by the Food and Drug Administration (FDA) in April 2023 for the treatment of amyotrophic lateral sclerosis (ALS) in adults with a specific genetic mutation. According to CMS, MA plans are inappropriately denying Medicare Part B coverage for Qalsody by classifying the physician-administered drug as "experimental and investigational" for all indications.
In the memorandum, CMS reminds MA plans of the requirement to cover all drugs and services covered under Medicare Parts A and B, and that under Medicare Part B, CMS does not make a distinction between accelerated approval drugs and drugs with traditional FDA-approval status. As such, CMS states that it is impermissible for MA plans to adopt any blanket policy that excludes Qalsody from Medicare Part B coverage by deeming it "experimental and investigational."
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