On November 20, 2014, CMS released its final Medicare coverage document entitled “Guidance for the Public, Industry, and CMS Staff: Coverage with Evidence Development.”  CED policy provides the framework for Medicare coverage of items or services on the condition that they are furnished in the context of approved clinical studies or with the collection of additional clinical data. CMS notes that the CED process “can expedite earlier beneficiary access to innovative technology while ensuring that systematic patient safeguards” are in place. The final guidance describes, among other things, the history of CED, its statutory basis, governing principles, requirements for studies under the CED framework, coverage of control groups in CED studies, and transparency of such studies. CMS also responds to public comments received on a draft guidance document published on November 12, 2012. For instance, CMS notes that it has deleted a previous statement that it expects to use CED infrequently, since technology is being presented to the agency for coverage earlier in the technology lifecycle, and requesters more frequently ask CMS to consider using CED for their particular technology. CMS also agrees with commenters that CED should not be used when other forms of coverage are justified, should not duplicate efforts of other agencies or existing medical evidence, and should generally expand access to technologies. CMS also clarified that Medicare Administrative Contractors may use LCDs to determine coverage of items and services to the extent that they do not conflict with national Medicare policy.