Clinical Evidence to Support Reimbursement Presented to WBBA

Clinical Evidence to Support Reimbursement Presented to WBBA Reimbursement 101 “The Buck Stops Here” JUDY ROSENBLOOM APRIL 15, 2004 1/20/2022

COVERAGE l CMS and other payers (local and national) evaluate relevant clinical evidence to determine whether or not the evidence is of sufficient quality to support a finding of reasonable and necessary. The evidence may consist of: > external technology assessments > internal review of published and unpublished studies > recommendations from the Medicare Coverage Advisory Committee (CMS) > evidence-based guidelines > professional society position statements > expert opinion, and > public comments.

REIMBURSEMENT CONSIDERATIONS l Clinical Evidence > evidence of improved outcomes by patient – – > > Quality of life, mortality, morbidity as good or better than current standard evidence is applicable to payer population Meet with payers – – FDA and CMS working together Local carriers and payers

CHECKLIST FOR CLINICAL EVIDENCE l l l l 510 (k) or PMA clearance Peer reviewed literature showing clinical utility and medical necessity Technology Assessments Clinical Outcomes Guidelines from medical societies Opinions from national and local physician leaders Economic comparisons to “gold” standard