Final Medicare Coverage-With-Evidence-Development Guidance Delayed By CMS Staff Cuts

The CMS coverage and analysis group has had to divert its attention from finishing a CED guidance to finalizing proposed changes to the process for awarding Medicare coverage for investigational device trials, primarily due to staff cuts, says Louis Jacques, who heads the group.

Staff cuts at CMS tied to the federal budget sequester are to blame for the agency’s delay in issuing a final coverage-with-evidence-development guidance document; industry has been anticipating the final policy since a draft document was released a year ago.

A question that Louis Jacques, director of the coverage and analysis group at CMS gets a lot of lately is,...

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