Tuesday, July 14, 2026

Legislative victory promotes advocates of biomarker testing coverage


As biomarker testing becomes more common in cancer diagnosis, patient advocates have been pushing for better insurance coverage.

The most recent victory occurred in October, when California passed a law prohibiting insurance companies that underwrite biomarker testing from requiring advance authorization for patients with advanced cancer.

Advocates say that while the legislation is welcome, it does not meet the long-term goal: requiring coverage of biomarker testing, which helps doctors determine which therapies may be effective for the treatment of specific cancers.

“This is an important priority for our organization,” said Hilary Gee Goeckner, senior state and local events manager for the Cancer Action Network of the American Cancer Society. American Cancer Society.

Although some actions have been taken at the federal level, this is a state-by-state priority.

In 2018, the Centers for Medicaid and Medicare Services provided nationwide coverage for so-called companion tests approved by the U.S. Food and Drug Administration. These tests are combined with specific treatments designed to fight off specific cancers based on their genetic characteristics.

At the state level, two bills became laws this year. In Illinois, a new law usually requires state-regulated insurance plans to provide patients with evidence-based biomarker testing. At the same time, Louisiana lawmakers passed a bill requiring coverage of specific genetic testing menus, including somatic and germline analysis and next-generation sequencing.

Goeckner said the Cancer Action Network plans to continue lobbying next year. “We anticipate continued interest and activities.”

Goeckner said that the broader goal is to make the coverage of biomarker testing wider, noting that coverage usually depends on the patient’s health plan.

“Not everyone who can benefit from a biomarker test has got it,” Goeckner said.

Goeckner said Medicare and large employer sponsored programs tend to have better coverage. It is more popular for state Medicaid programs and smaller employer-sponsored programs.

In addition, Goeckner said, the plan may cover the pairing of specific single-gene tests with individual therapies, but does not include tests that provide a broader look. “Whole-genome sequencing provides more information,” she added. “Our position is that insurance should cover any of them, and it should be determined by the attending doctor who should order.”

Experts say that these tests can be expensive, which is one of the reasons that insurance companies may be reluctant to underwrite. Science is also new, so it may take time for insurance companies to catch up.

However, they believe that the resulting treatment is cheaper and more effective than traditional treatments involving chemotherapy.

“The cost of biomarker testing may be high, but for patients, this is the most important factor they have to consider, and the rewards are huge,” says AJ, a cancer survivor and insurance industry legal analyst from Orange, California. Patel said. .

He added that the more common testing becomes, the more costs will drop.

Start-up companies are already developing biomarker tests, which they say will be more cost-effective. These start-ups include Biofidelity, a molecular diagnostic company based in Cambridge, England, with an office in the Research Triangle Park in North Carolina, USA.

According to Biofidelity CEO Barnaby Balmforth, the company is preparing to launch its first diagnostic product, ASPYRE-Lung, which is used for lung cancer.

Balmforth says that existing polygenic tests generate a lot of information, which can make them expensive. But most of the information is of no use to doctors treating cancer patients.

Balmforth said that Biofidelity’s test is for clinically feasible content. “This is our core belief that all patients should get the information they need to ensure they get the best care.”

Balmforth added that healthcare is moving in this direction. But progress is slow and not always fair.

“Some patients have access to this information and can access life-saving treatments, while other patients cannot access this information because their insurance plan does not cover this information, or because they do not have insurance,” he said.

Photo: Andre Popov, Getty Images



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