A Practical Strategy for Introducing New Molecular and Genetic Tests

The Dark Daily has just published an article addressing the complexities of introducing a new genetic or molecular diagnostic test (see: New Genetic Laboratory Tests Face Complicated Hurdles to Win Reimbursement ). It quotes Rina Wolf extensively, who is Vice President of Commercialization Strategies for Consulting and Industry Affairs, XIFIN , San Diego, California. It was so good that I repeat a portion of it below:

As physicians learn about the new laboratory test and want to order it, payers do not have policies in place to reimburse for this new genetic test—even when it delivers substantial clinical benefit to the patient. It is the chicken-and-egg conundrum: what comes first? Is it physician demand for the test (which convinces payers that it is clinically useful) or is it payer coverage and reimbursement policies (which assure physicians that, when they order the test, the patient’s insurance will reimburse for it)?

“The lessons of the marketplace over the past decade are compelling,” noted Wolf. “Every successful launch of a new molecular test has come because of a dual market introduction strategy. One side of the strategy is to provide physicians and patients with the knowledge and education they need to understand how to order the test and respond appropriately to the lab test results. The other side of the strategy is proper preparation to address all the issues raised by health insurers.”

Understanding the business pathway is critical in this process, as is persistence in the appeals process. Wolf described an interesting approach which she called “creating a reimbursement sandwich.” “The top slice of the reimbursement sandwich is the steady growth in demand by physicians who order the test appropriately—and pressure payers,” explained Wolf. “The bottom slice of the reimbursement sandwich is the persistence of your laboratory company in the appeals process. This provides an alternative pressure which is often an effective way of convincing payers to cover the new molecular test.”

I can't add anything of value beyond this quotation so I present is as originally published. The metaphor of the "reimbursement sandwich" is both useful and colorful. I will certainly refer to it in the future.