Focused on the Health Industry

Diagnostics and Laboratories

Diagnostics and Laboratories

McDermottPlus advises more diagnostics developers than any other firm of our type.   We serve some of the country’s most innovative advanced diagnostics laboratories and diagnostic kit developers. 

Representative Experience

Diagnostics and Laboratories:

  • Reimbursement consultant to leading global diagnostic manufacturers
  • Analyzes Proposed and Final Rule changes to Medicare payment policies (e.g., Medicare Physician Fee Schedule, Outpatient Prospective Payment System, Ambulatory Surgery Center) and publicly available Medicare data (including payment, cost and utilization data) to evaluate client strategies
  • Monitors national and local policies on coverage and payment for products and services and prepared issue memoranda for clients and advocacy groups
  • Prepares clinical evidence dossiers to support coverage for new products at launch including a description of the clinical need for the new product, the mechanism of action, summary of clinical evidence, summary of health economic evidence and regulatory status
  • Prepares template reimbursement assistance documents to support the launch of new products pending adoption of new billing codes, including template letters of medical necessity, claim forms, procedure reports and bibliographies
  • Formulates and implements legislative, regulatory, and oversight strategies designed to achieve client objectives
  • Obtaining a favorable Medicare clinical laboratory fee schedule rate for a diagnostic company that developed a test for a novel biomarker for heart failure