Diagnostics, Payers

Precision medicine is like anything else. The biggest enemy is the bureaucracy.

For the consumer-driven controversies, red tape is the bigger foe.

You can have your consumer-driven controversies about genetic testing. Precision medicine has a bigger question to answer, such as: “Which lab should get that test so everyone can get paid?”

On the front lines of genetic testing — from the doctors who want the tests to the genetic counselors who seek a bigger role in determining the path of precision medicine to the health insurance companies who have to pay for it — the battle is all about the red tape.

Can we get everyone on the same page when we define “medically necessary” genetic testing?

Does the doctor know if the lab getting the genetic test has a contract with the patient’s health insurance company?

“Who, in this age of transparency, is responsible for figuring it out?” asked Dr. Timothy Moss, a member of the Cleveland Clinic’s Center for Personalized Genetic Healthcare.

A discussion on reimbursement in genetic testing on Thursday at Cleveland Clinic closed out what was a largely academic symposium on integrating precision medicine into clinical practice. But the reimbursement discussion near the end of the one-day event demonstrated what still needs to happen if genetic testing wants to become more commonplace.

Genetic testing’s demand

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Cleveland Clinic has seen a 300 percent increase in terms of cost and utilization of precision medicine, said Dr. Bruce Rogen, chief medical officer at Cleveland Clinic Employee Health Plan.

“That’s not inappropriate,” Rogen said. But he said it does emphasize the need for payers to be “very judicious.”

The path to approval

Getting a genetic test approved relies on a basic rationale: Will using a genetic test change the treatment or the outcome of the patient?

Some patients (and doctors) often seek a genetic test to satisfy a personal curiosity – even if nothing else could be done, Rogen said. He also noted that many genetic testing companies are essentially beta-testing their services on the public.

“They say, ‘The main reason we’d like you to pay for this is we need to do this in a lot of people to see if there is a utility to it,’ ” Rogen said. “Generally, insurance companies are not fond of paying for research to find out whether it actually works.”

The future: Genetic counselors are the gateway

It’s clear that, in the future, genetic counselors will play a greater role in deciding which tests are approved. The audience at Cleveland Clinic saw genetic counselors as a stopgap between useless tests and relevant ones.

One question was: Shouldn’t the genetic counselor be able to veto any genetic test?

“I don’t think it would sit well with the majority of clinicians here,” said Jacqueline Riley, a genetic counselor in the Cleveland Clinic’s molecular pathology laboratory. “I think it would be a great policy clinically — and if someone closer to the top of our leadership structure would back that I would totally support it.”