Medicare Coverage of Items and Services for Coverage with Evidence Development (CMS-10697)

This collection is new. CED is a paradigm whereby Medicare covers items and services on the condition that they are furnished in the context of approved clinical studies or with the collection of additional clinical data. In making coverage decisions involving CED, CMS decides after a formal review of the medical literature to cover an item or service only in the context of an approved clinical study or when additional clinical data are collected to assess the appropriateness of an item or service for use with a particular beneficiary. The legal basis of CED comes from Section1862(a)(1)(E) of the Social Security Act (42 U.S.C. 1395y), which states that “in the case of research conducted pursuant to section 1142, which is not reasonable and necessary to carry out the purposes of that section.” CMS uses the information generated from CED for the following: • Results from studies required under CED inform medical decision-making and improve patient care. • Data from CED studies that are published in the medical literature may be used by CMS to make evidence-based changes to the NCD. • Data generated from CED required registries are used by researchers to advance the field specific to the NCD. While the intent of these CED NCDs was to monitor the appropriateness of use of these items and services, we recognized that the data could also be used to generate useful clinical evidence. More recent NCDs have tended to rely on section 1862(a)(1)(E) of the Act, in which CED is used to support clinical research.

The latest form for Medicare Coverage of Items and Services for Coverage with Evidence Development (CMS-10697) expires 2023-12-31 and can be found here.