Device Makers Seek Clarity On CMS' Plans For Coverage With Evidence Development

Device Makers Seek Clarity On CMS' Plans For Coverage With Evidence Development-thegraysheet: The agency has posted the 27 comments it received on the new CED draft guidance. The document was released on Nov. 29 and comments on it were due Jan. 28. (See "CMS Redefines Coverage-With-Evidence-Development In Draft Guidance" — "The Gray Sheet," Dec. 3, 2012.) Once finalized, the new policy will replace the 2006 policy on coverage with evidence development, explaining how and under what circumstances CMS expects to impose data-collection requirements in national coverage determinations.