Research and Markets: Reimbursement for IVD Tests: What is the procedure, for establishing reimbursement for an IVD test product?

DUBLIN--()--Research and Markets (http://www.researchandmarkets.com/research/m6p3vw/reimbursement_for) has announced the addition of the "Reimbursement for IVD Tests" report to their offering.

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 report 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may be broadly grouped into four categories that comprise budget tightening, including Medicare cost cutting; outdated CLFS; FDA initiatives encompassing both rulemaking and new regulatory pathways; and challenges assessing new tests.

For more information visit http://www.researchandmarkets.com/research/m6p3vw/reimbursement_for

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Sector: Healthcare and Medical Devices, Oncology

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Sector: Healthcare and Medical Devices, Oncology