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Reimbursement for IVD Tests

What is the procedure, for establishing reimbursement for an IVD test product?  What companies have been successful and how?  What changes will IVD makers face in the near-term.  This Kalorama Information report, Reimbursement for In Vitro Diagnostic Tests, answers these questions and provides authoritative data for IVD business planners.

One of the critical factors for the success of an IVD product is reimbursement. Reimbursement is a critical component of the health care landscape and will continue to have a major impact on the continued usage of established products as well as product innovation and the market success of new technologies since products without solid reimbursement will not achieve widespread utilization and/or will not provide the revenues for their developers to continue to introduce new products.

This report, Reimbursement for In Vitro Diagnostic (IVD) Tests examines the U.S. reimbursement system for IVD tests, focusing on key issues of current concern to industry. It covers only commercialized tests, specifically excluding those that are developmental or used primarily for research purposes.

As part of its analysis, the report has the following:

  • Explanation of the Process for Reimbursement of IVD Products Under Medicare
  • Upcoming Medicare Reimbursement Cuts
  • Recent FDA Approvals of IVD Devices
  • Oversight of LDTs, Pilot IVD Triage Program, UDI Rule and Other Regulatory Initiatives
  • Office of the General Inspector Recommendations
  • ICD Codes, Laboratory NCD Codes and CLFS Test Codes
  • Gap-Fill Rates for Molecular Diagnostics
  • The Assessment of Novel Tests
  • Case Studies of Successful IVD Products and Lessons for New Entrants
The key open issues facing IVD reimbursement may be broadly grouped into four categories that comprise budget tightening, including Medicare cost cutting; outdated CLFS; FDA initiatives encompassing both rulemaking and new regulatory pathways; and challenges assessing new tests.

Historical information for this report was gathered from a wide variety of published sources including company reports and filings, government documents, legal filings, trade journals, newspapers and business press, analysts’ reports and other sources. Interviews with company representatives and other experts were conducted to capture the perspectives from industry participants’ point of view and assess trends. Case studies of successful reimbursement strategies are included to illustrate how product developers obtain reimbursement for new IVD tests.


  • Executive Summary
    • MEDICAL DEVICE AND INVITRO DIAGNOSTICS (IVD) TESTING REIMBURSEMENT
      • Scope andMethodology
      • Introduction
      • Important Issues in IVD Reimbursement
      • Case Studies in Obtaining IVD Reimbursement
  • CMS and Private Insurance
    • OVERVIEW
    • THE U.S.HEALTH CARE REIMBURSEMENT SYSTEM
      • History of IVD Reimbursement Under Medicare
        • Table 2013 CLFS Selected Test Codes
      • Code Stacking
      • Billing for Stored Specimens
      • The Patient Protection and Affordable Care Act (PPACA)
      • FDA Oversight of IVDMIAs
      • ICD Codes
      • Laboratory National Coverage Determinations
        • Table List of ICD Codes, 2013
        • Table Laboratory NCDs, 2013
      • New Tests
        • Table New and Reconsidered CLFS Test Codes, 2013 (Excludes Molecular Pathology & Multi-Analyte Assays with Algorithmic Analyses)
      • Molecular Diagnostics
        • Table 2013 CLFS Gap-Fill Rates for Molecular Diagnostics
      • Multi-Analyte Assays with Algorithmic Analyses
      • Recent IVD Device Approvals
        • Table Recent IVD Device Approvals
  • Important Issues in IVD
    • OVERVIEW
    • BUDGET TIGHTENING
      • Medicare Reimbursement Cuts
      • OIG Assessment
    • OUTDATED CLFS
    • FDAINITIATIVES
      • Oversight of LDTs
      • Pilot IVD Triage Program
      • UDI Rule
    • CHALLENGES ASSESSING NEW TESTS
      • Pharmacogenomic Tests
      • PSA Tests
  • Case Studies in Obtaining IVD Reimbursement
    • OVERVIEW
    • ALLOMAP
    • MAMMAPRINT
    • ONCOTYPEDX

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