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California Governor Vetoes Biomarker Test Coverage Bill

NEW YORK – California Gov. Gavin Newsom last Thursday vetoed a Senate bill to mandate automatic insurance coverage of biomarker tests that are supported by medical and scientific evidence.

SB 912, introduced by Sen. Monique Limón (D-Santa Barbara) and sponsored by the American Cancer Society Cancer Action Network (ACS CAN) and the University of California, sought to require coverage for biomarker testing for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of a disease or condition as long as the test is supported by medical and scientific evidence.

"While I appreciate the author's efforts to provide biomarker testing coverage, these services are already covered by Medi-Cal," Newsom wrote in an official statement explaining his rationale.

"Furthermore," he continued, "biomarker testing is valuable when it can inform a condition's diagnosis and treatment, but this bill would require Medi-Cal to cover unnecessary testing that may not inform the best treatment to care for the beneficiary."

The bill had enjoyed unanimous, bipartisan support in California's legislature and had been widely expected to be signed into law.

Experts have been calling for policy changes to lower barriers to biomarker testing, which, alongside biomarker-driven therapies, has increasingly become the standard of care. Medicaid, on which many cancer patients rely, frequently uses older data or information from insurance claims, both of which may not accurately reflect current oncology practice.

Several other states, including Illinois, Arizona, Louisiana, and Rhode Island, have already passed similar legislation, while such a bill also is under consideration in Ohio.

"Governor Newsom’s veto of SB 912 is a huge, missed opportunity to ensure more Californians — regardless of race, ethnicity, zip code, income or insurance type — can benefit from the most effective cancer treatments," Jim Knox, the managing director of California's branch of the American Cancer Society Cancer Action Network, said in a statement.

Alexander Nowak, an analyst with investment banking firm Craig-Hallum, expressed surprise at Newsom's veto in a report.

"The move is a shock politically, in our opinion, as it only benefits insurers (including CA’s state Medicaid program), while going against the American Cancer Society, patients, and diagnostic providers (many CA-based)," he wrote.

SB 912 identifies three sources of medical and scientific evidence for use in determining biomarker coverage: These are Food and Drug Administration-cleared tests or an indicated test for an FDA-approved drug, tests covered by a CMS National Coverage Determination or a MAC Local Coverage Determination, and have evidence that is recognized in national clinical practice guidelines and consensus statements.

The bill includes standard language defining biomarker tests and does not specifically state the payment amounts that Medi-Cal or private insurers would have to pay for such tests.