Extract to table

" This statutory "reasonable and necessary" standard is the fundamental evidentiary threshold that any NCD request must satisfy

MEDCAC preparation, if required, would involve significant advance work, including the identification and preparation of expert witnesses, development of presentation materials, and rehearsal of testimony, all of which must be factored into NCD resource planning

External requests are submitted to the CAG using CMS's standard NCD request form and must include a description of the technology, the proposed coverage criteria, and the supporting clinical evidence

Under Section 1869(f)(1)(B) of the Social Security Act, CMS is required to issue the final NCD within 12 months of accepting the formal NCD request

CAD does not require enrollment in a formal clinical study but does impose clinical eligibility and appropriateness requirements that must be documented by the ordering physician

The technology sponsor (in this case, GDT) must propose a CMS-approved study protocol that addresses the specific evidentiary questions identified by CMS