On November 29, 2012, the Centers for Medicare & Medicaid Services (CMS) issued a new draft guidance regarding its Coverage with Evidence Development (CED) policy for National Coverage Determinations (NCDs). As CMS has increasingly used CED in recent years to provide, and often limit, Medicare coverage for promising new medical treatments, revisions to this policy will be of particular interest to those manufacturing or otherwise developing new and innovative technologies for which they seek Medicare coverage. Comments on the draft guidance may be submitted to CMS until January 28, 2013.

Background on CED -

CED is an evidence-based coverage paradigm that permits CMS to develop coverage policies for certain items and services that are likely to show health benefits to Medicare beneficiaries but for which the available evidence base is not yet sufficiently developed...