A CEO's Guide to Molecular Diagnostic Reimbursement

Navigating the Many Challenges of Reimbursement and Commercialization

Reimbursement and commercialization are significant challenges in this era of personalized medicine and comparative effectiveness. Many traditional clinical laboratories and early stage start-up companies are trying to enter this space and are struggling to evaluate both the market and its offerings.

This white paper specifically addresses:

• Considerations for Commercialization and Reimbursement of a New Molecular Diagnostic
• The Road to Coverage
• Reimbursement Options for Molecular Tests
• Coverage and Contracting for Molecular Tests

The following are some of the questions to consider when creating a business plan for commercialization of a genetic test:

• How can clinical utility be established prior to launch?
• What is the current environment in your targeted diagnostic area?
• What is the fully loaded cost of goods?
• What will your billing capabilities be?
• What will your billing policies and rules include?
• Diagnostic Kit or Laboratory Developed Test?