Panel Discussion: The Road to Personalized Medicine: Clinical Utility and Reimbursement in Molecular Diagnostics

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Panelists discuss ways to improve the focus on clinical utility in molecular diagnostics given challenges in the system and needs of patients.

Joy Larsen-Haidle, MS, CGC, president of the National Society of Genetic Counselors, explained that genetic counselors need to talk with patients about family history to determine the odds of there being a genetic component to the cancer they’re developing.

Howard L. Kaufman, MD, FACS, chief surgical officer and associate director for clinical science at the Rutgers Cancer Institute of New Jersey, added that at the Cancer Institute of New Jersey, they do full genomic sequencing and will occasionally identify mutations that may have drugs available. However, sometimes there aren’t drugs approved for that particular indication, and the institute handles that with robust clinical trials.

“Then we have to convince the patients to participate in the trials to gain access to the drugs,” Dr Kaufman said.

Turnaround time for these lab results is a bigger problem than most people think, Bruce Quinn, MD, PhD, senior health policy advisor at Foley Hoag LLP said, and he lays some of the blame on Medicare, which doesn’t pay any more if the results come back in 3 days or 45 days.

Rina Wolf, vice president of commercialization strategies, consulting and industry affairs at Xifin, added that healthcare policies really encourages delays in ordering tests, especially the bundling rules, which determine who will be financially responsible for the test.