Calls intensify to get Medicare to pay for genetic sequencing of tumors
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WASHINGTON — The Obama administration is facing growing calls to allow Medicare and Medicaid to pay for advanced gene-sequencing of tumors, a step proponents say will help both cancer patients and scientific research.

The appeals have grown louder since Vice President Joe Biden announced his “moonshot” to cure cancer, and top researchers said they raised the issue in a private meeting recently with Biden’s staff. The issue also came up during the vice president’s trip last week to the World Economic Forum in Davos, Switzerland.

So-called next-generation sequencing can be used to analyze tumors in a more comprehensive way and more quickly than with previous methods. The sequencing allows doctors to determine whether emerging treatments are likely to work for a particular patient — part of a movement toward so-called personalized medicine.

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But the Centers for Medicare and Medicare Services generally does not pay for comprehensive genome-sequencing. Instead, CMS and some private contractors that administer Medicare plans make payments for limited sequencing of tumors for a limited number of conditions.

Alex Hogan and Hyacinth Empinado/STAT Personalized cancer vaccines rally the immune system to identify and kill cancerous cells based on genetic information from the patient's own tumors.

“We have this weird juxtaposition with the White House and the vice president loving personalized medicine,” said Amy Miller, executive vice president of the Personalized Medicine Coalition. “And CMS often does not pay for it.”

Experts said that the big barrier is convincing insurers and others, including CMS, that in paying for advanced sequencing they would be paying for “reasonable and necessary” care. All payers want to know they are paying for treatments that help patients now — not simply enhance scientific research.

Alex Hogan/STAT Presidents have been promising to cure cancer for 45 years, but cancer is still very much with us.

“It’s a fascinating standoff because Medicare would say, ‘You haven’t really proven this is useful so we’re not going to pay for it,’” said Dr. George Demetri, a bone oncologist at the Dana-Farber Cancer Institute and member of the American Association for Cancer Research, who attended the Biden staff meeting. “We’re saying, ‘We can’t prove it’s useful because you aren’t paying for it.’”

Hyacinth Empinado/STAT Precision medicine customizes treatments based largely on a patient's genetic profile.

Biden has said that he will oversee a task force focused on the cancer moonshot, and President Obama is expected to issue an order putting every agency in the federal government — including CMS — at his disposal. Biden has also announced an upcoming meeting with top federal officials to discuss next steps.

But it’s unclear whether Biden will press for CMS to pay for advanced sequencing. The cost of the process can vary widely but run into the thousands of dollars.

“This is one of the many ideas proposed in the some two dozen listening sessions the VP and his staff have convened,” a Biden aide told STAT. “As the VP formally convenes government leaders, they will consider this idea along with many others.”

There is some disagreement about whether the Obama administration has the regulatory authority to change CMS policy on its own — or whether Congress would need to take action.

But the administration might have regulatory wiggle room to start expanding what is covered, if, for example, it can make the case that there is a clear clinical justification for advanced sequencing. The most obvious example: Cases in which patients have exhausted all other options and, therefore, might turn to targeted therapies, which are often prescribed after comprehensive gene sequencing.

“If there’s a possibility for doing this test and finding a mutation and using a targeted therapy — where there is a theoretical rationale, but it’s in a sense, more or less, a shot in the dark — I think there’s a justification for paying for that,” said Dr. Roger Klein of the Cleveland Clinic, who also helps lead the Association of Molecular Pathology.

One Medicare contractor, Palmetto GBA, has authorized comprehensive gene sequencing for certain non-small-cell lung cancer patients. But experts said that is the only real-world example they know of in Medicare of the kind of coverage that researchers would like to see expanded.

For researchers, having a vastly larger set of genetic data would yield obvious scientific benefits. Biden and others have discussed the possibility of a national data warehouse that would allow researchers to learn more about genetic mutations and specific treatments.

But CMS cannot pay for treatments for the sake of research, and insurers have little incentive to do so.

“Obviously, a payer’s not interested in paying for research,” Adam Borden, who specializes in reimbursement issues for Avalere Health, an independent consulting firm. “Really they want to pay for what’s reasonable and necessary for that patient.”

“To get to every patient who is diagnosed, who would get a full sequence, there’s some barriers in place,” Borden said. “As payers make coverage decisions based on robust clinical evidence, it would likely take legislative action to mandate widespread coverage.”

For personalized medicine advocates, having Medicare and Medicaid pay for advanced sequencing seems like a no-brainer.

Cancer treatments are trending toward more and more targeted therapies, the kinds that often first require diagnostic tests with gene sequencing. They say the administration should get ahead of the curve — especially with Biden’s moonshot underway.

“If we’re going to have payers not paying for personalized diagnostics, we’re going to have a really big problem,” Miller said. “We need our payment policy to keep up with the science.”

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