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California Bill Prohibiting Prior Authorizations for Cancer Biomarker Testing Becomes Law

NEW YORK – California Gov. Gavin Newsom last week signed into law bill SB535, which restricts health insurers from using prior authorizations to limit advanced cancer patients' timely access to biomarker testing.

The bill, which passed the California Legislature and was signed by the governor on Oct. 6, amends California's insurance code related to healthcare coverage and prohibits insurers from requiring prior authorization for biomarker testing for patients with metastatic stage III or IV cancer, including when their cancers progress or recur. The change in law applies to insurance policies, including those under Medi-Cal managed care plans, which have been issued, amended, or renewed as of July 1, 2000.

"Every patient deserves to have the very best treatment options," Barnaby Balmforth, CEO of cancer diagnostics firm Biofidelity, said in a statement in support of SB535. "This bill marks an important step forward in reducing the delays patients face in gaining access to the testing that makes those options available."

Under insurers' prior authorization policies, doctors must obtain approval from patients' health insurers before ordering certain tests or drugs to make sure that the intervention will be paid for. Insurers require prior authorizations to make sure healthcare services are being ordered in accordance with their coverage policies and control costs. Since insurers' spending on genetic testing has increased in recent years, many commercial payors have been requiring prior authorizations for biomarker testing that doctors rely on to identify treatments patients are likely to benefit from.

However, waiting for prior authorization approval also delays biomarker test results and access to personalized therapy for critically ill late-stage cancer patients who often cannot hold off on treatment. Biomarker testing delays "can literally mean the difference between life and death for many patients," AJ Patel, a legal analyst from Orange County and a stage IV lung cancer survivor, wrote in last week, urging passage of SB535. Patel achieved complete remission from targeted treatment that was prescribed based on timely biomarker testing that revealed a ROS1 rearrangement.

Bills to remove insurance barriers and ease access to biomarker testing have been introduced in multiple US states and several have passed, most recently in Louisiana and Illinois. Some of these bills require coverage for biomarker testing, while others, like SB535, focus on removing downstream levers, such as prior authorization, that insurers use to control utilization. According to oncologists and reimbursement experts, both coverage and utilization management policies must be addressed to improve biomarker test access for patients.