Panelists Offer an Insider Perspective of the Unstable Future of Genetic Testing Reimbursement

To begin a session on the reimbursement of genetic testing during the Florida Society of Clinical Oncology’s annual meeting in Kissimmee, Florida, incoming president Luis E. Raez, MD, put things in perspective: “I’ve been practicing for more than 30 years, and it used to be that when you would explain a treatment plan to a patient, they would ask if they’re going to respond to it and you would have to say ‘I don’t know.’ Now, with genetic testing, hopefully you can say ‘yes.’”

Specifically, Raez discussed the importance of repeat genetic testing for patients, especially those with an anaplastic lymphoma kinase (ALK) mutation. “We used to test [for] genetic aberrations 1 time. That is not the future of treatment. If you want to give your patients a specific drug, when patients have ALK, once they start treatment, they develop resistant mutations [to that therapy]. That’s why you need to test again, and based on which resistant mutation the patient has, that’s how you decide which drug to give.”

However, genetic testing is expensive, and especially with repeat testing, the question then becomes, “how will this be paid for?”

James Almas, MD, vice president and national medical director of clinical effectiveness at LabCorp, and previously a medical officer at CMS in the Coverage Analysis Group, explained that he was at CMS when Foundation Medicine came in with their request for a national coverage determination (NCD).

“The NCD that was ultimately issued has flaws in it. The NCD does not allow for the same test to be used more than once, with 1 exception, and CMS is going to announce soon that it is reopening the NCD for Foundation Medicine,” said Almas.

The decision to reopen an NCD is not one that is taken lightly. Michael Kolodziej, MD, vice president and chief innovation officer at Advi Health, spoke out from the crowd during the panel to say that “When an NCD is reopened, it’s dangerous. In reality, it’s a threat to Foundation Medicine.”

Almas said that this decision was based primarily on the hesitance around the evidence of next-generation sequencing (NGS). “Most of these tests are FDA approved but they have not gone through the equivalence of a phase 3 study done for drugs. Evidence, in some cases, is weak. You have to ask solid questions when you have a lab [that] you’re basing treatment decisions off of. You have to assess the lab and then face the challenge of reimbursement,” he said.

However, he also explained that he personally hopes CMS will reconsider their stance on hereditary testing reimbursement when they reopen the NCD. “NGS is used for tons of things. The CDC uses it every day. NGS is just a tool, but they didn’t understand that at CMS. We hope that there’s a change in testing frequency, [as there are] scientific reasons to conduct repeat testing,” said Almas.

Elizabeth Dragolovich, RN, associate director of reimbursement at Foundation Medicine, offered an insider perspective. She explained that Medicare coverage of the Foundation Medicine test is pretty broad and allows for reimbursement and coverage for people with a recurrence of cancer. “It’s great coverage for the 4.5 million beneficiaries in Florida who have traditional fee-for-service or Medicare Advantage plans, but what happens with government payers doesn’t always translate to private payers. And not only between Medicare and private payers, but also things don’t seem to translate from one private payer to another. Some are open to adopting broad testing, others are not.”

Though there is confusion about where the reimbursement decision for genetic testing will end up as payers and other industry stakeholders wait for the announcement from CMS that the NCD will be reopened, Dragolovich was clear in the convictions she shares with Foundation Medicine, “We feel very strongly that patients have a right to have a full understanding of the context of their disease,” she said.