Are there special billing rules that apply to routine costs of an approved study under a Coverage with Evidence Development (“CED”)?
Yes. Claims for the involved routine costs of item/services require application of the special Clinical Research Billing rules (e.g. NCT#, Z00.6, Q modifiers, etc.)
For additional information concerning specific billing requirements, please visit the CMS Coverage with Evidence Development webpage under Qs & As - Mandatory Reporting of Clinical Trial Identifier Numbers on Claims.