Interview with the Innovators

Drs. Geoffrey Oxnard and Lauren Ritterhouse discuss the challenges in biomarker testing—tissue stewardship and complexity of biomarker tests and results—and ways to overcome these challenges—improved communication among all members of the cancer care team and simplification of biomarker test results to focus on actionable biomarkers.

Drs. Geoffrey Oxnard and Lauren Ritterhouse deliberate on ways reimbursement issues are impacting clinical practice, particularly CMS’s “14-Day Rule.”

Drs. Geoffrey Oxnard and Lauren Ritterhouse consider the current landscape of reimbursement for molecular biomarker testing, the need to run FDA-approved tests, and the role of CMS and local Medicare providers in testing reimbursement.

Drs. David Rimm and Roy Herbst identify the top challenges in the area of biomarker testing as well as solutions to these challenges, including availability of sufficient tissue for a large number of biomarker assays, the time some biomarker tests require for completion, the need for a tight association of test results with clinical outcomes, and the development of companion diagnostics for certain immunotherapies.

Drs. David Rimm and Roy Herbst review the problems with the CMS “14-Day Rule” since some of the multigene panel biomarker tests require 21 days or longer to complete.

Drs. David Rimm and Roy Herbst discuss the challenges of reimbursement by payers and the costs to pathology department of molecular biomarker testing, especially immunohistochemistry and DNA testing.