This episode breaks down the complex process of how the U.S. Centers for Medicare & Medicaid Services (CMS) decides whether to cover a new in-vitro diagnostic (IVD) test. We explore the critical "reasonable and necessary" standard, the difference between National and Local Coverage Determinations, and the vital role of clinical utility evidence in securing a positive decision. Learn about the specific frameworks CMS uses and the specialized programs in place for advanced diagnostics.
Key Questions
• What is the single most important principle Medicare uses to evaluate a new diagnostic test for coverage?
• How do National Coverage Determinations (NCDs) differ from Local Coverage Determinations (LCDs)?
• Why does CMS prioritize clinical utility over clinical validity?
• What specific evidence framework does CMS use to assess if a test improves patient outcomes?
• What is the MolDX program, and how does it impact molecular diagnostic tests?
• Why is having data generalizable to the Medicare population so critical for a successful submission?
• How does the FDA's final rule on LDTs from May 2024 affect the path to market?
• What level of evidence is needed to prove a test is "reasonable and necessary"?
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