MCS develops internal coverage criteria when coverage criteria are not fully established in applicable Medicare statute, regulation, National Coverage Determination (NCD) or Medicare Local Coverage Determination (LCD). Internal coverage criteria are based on current evidence in widely used treatment guidelines or clinical literature that is made publicly available. The clinical literature reviewed includes large, randomized controlled trials or prospective cohort studies with clear results, published in a peer-reviewed journal, and specifically designed to answer the relevant clinical question, or large systematic reviews or meta-analyses summarizing the literature of the specific question. Overseeing the work of the MCS’s Clinical Medical Policy Program is the Medical Advisory Committee, which is comprised of MCS medical directors, pharmacists, medical consultants, contracting physicians, and administrative support staff. The MCS’s Clinical Medical Policy Program produces revised and new medical policies based on the best practice of medicine and evidence-based criteria according to medical associations, LCD, NCD, and other medical and coverage criteria. Following the review and approval by the Medical Advisory Committee, the internal coverage criteria is submitted for review and approval of the MCS Utilization Management Committee. The Utilization Management Committee monitors the Clinical Medical Policy Program assessments, and the decisions of the Medical Advisory Committee for any new policies or revisions to existing policies. If revisions are made to existing policies or if new policies are developed, the MCS Utilization Management Committee evaluates the revised or new policies and decides whether to approve the policies for use. Internal coverage criteria policies are publicly available in MCS website.