Device Makers Seek Clarity On CMS' Plans For Coverage With Evidence Development
This article was originally published in The Gray Sheet
Executive Summary
Many stakeholders want CMS to restrict conditional coverage to national determinations and prevent local Medicare carriers from imposing their own CED policies.
You may also be interested in...
Medicare 'Coverage With Evidence' May Rise With FDA Postmarket Emphasis
As FDA touts plans to shift clinical data requirements when possible to the postmarket phase, a top CMS official highlights the importance of the Medicare coverage with evidence development policy.
Local Coverage With Evidence Development Is Legit, CMS Says; But It May Be Rare
CMS issued its final guidance on the coverage-with-evidence-development program, two years following a draft. It is explicit that local Medicare contractors can employ CED in setting coverage policies in their jurisdictions, but it is not clear that the language will encourage significant use at the local level. The guidance also revises its approach on ending CED policies compared to what was stated in the 2012 draft guidance.
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.