Payment for Clinical Studies Approved Under Coverage with

10.7.3 – Payment for Clinical Studies Approved Under Coverage with Evidence Development (CED) (Rev. 120, Issued: 01-16-15, Effective: 01-01-15, Implementation: 01-01-15) In National Coverage Determinations (NCDs) requiring CED, Medicare covers items and services in CMS-approved CED studies. MAOs are responsible for payment of items and services in CMS-approved CED studies unless CMS determines that the significant cost threshold is exceeded for that item or service (see 42 CFR 422.109). Approved CED studies are posted on the CMS Coverage with Evidence Development webpage (see http://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence- Development/index.html). Billing instructions are issued for each NCD.