Protecting Medicare’s Discretion to Say No to Unproven Therapies

The authors discuss two legislative proposals that would restrict the Center for Medicare & Medicaid Services’ (CMS) coverage discretion for drugs and devices that lack robust evidence. A drug’s FDA approval should not be an automatic qualifier for Medicare coverage given the recognized distinctions in the FDA’s and CMS’ statutory authorities. Thus, CMS’ ability to “say no” is a critical safeguard for public health and Medicare’s financial solvency.