California to Become Sixth State to Cover Cancer Biomarker Testing, But Precision Medicine Screenings Are Not Included

New legislation advances accessibility of precision medicine cancer biomarker testing but only for those who already have advanced cancer

California is set to become the sixth state to require payer coverage for cancer biomarker testing. The new law, however, will only include coverage for biomarker tests that are used in treating existing diseases and not in screening for cancers. This new legislation highlights how states are beginning to focus on adopting new precision medicine technologies but also serves as a reminder of how much progress still remains to be made.

Introduced in February 2022, California Senate Bill 912 Biomarker Testing recently unanimously passed both houses of the California State Legislature. This bill will require most health insurance plans in California to cover biomarker testing for patients with advanced cancer. 

“The bill will reduce barriers patients face when accessing timely care and cost of treatment,” said Sen. Monique Limón, the bill’s author, according to an American Cancer Society Cancer Action Network article. “SB 912 will improve access to care, precision medicine, and will reduce overall healthcare costs by avoiding unnecessary hospitalizations and treatments.”

The new law has yet to be signed by California Gov. Gavin Newsom but is expected to become law by the end of September 2022. The law would go into effect in July 2023, impacting health insurance plans issued or amended after that date.

Cancer: Individualizing Choices

 Carrie L. Byington, MD, executive vice president of University of California Health and the former dean of the Texas A&M College of Medicine, biomarker testing
Carrie L. Byington, MD

“The advances in cancer treatment that have come from being able to tailor approaches to a person’s individual condition are critical for winning the fight against cancer,” Carrie L. Byington, MD, told the American Cancer Society Cancer Action Network. Byington is the executive vice president of University of California Health and the former dean of the Texas A&M College of Medicine. 

“This legislation will bring the hope and promise of precision medicine to people with a cancer diagnosis across the state on an equitable basis,” Byington continued. “California has the opportunity to be among the leaders in the nation with this legislation.”

Differences as More States Embrace Legislation for Cancer Biomarker Testing

With this new law, California will join five other states that have passed legislation improving coverage for biomarker testing. Arizona, Illinois, Louisiana, Rhode Island, and Washington have all previously passed legislation for biomarker testing. Another six states are in various steps in the process of considering similar legislation.

While California’s bill will significantly improve access to biomarker testing, it will only apply to testing being used to treat existing diseases. According to the bill’s text, “The bill would subject restricted use of biomarker testing for the purpose of diagnosis, treatment, or ongoing monitoring of a medical condition to state and federal grievance and appeal processes.”

This mirrors existing legislation in most other states that also require biomarker testing only be used for existing diseases. Only Louisiana’s biomarker legislation does not specify that coverage for biomarker testing is limited to existing diseases. Louisiana’s legislation also does not, however, explicitly endorse coverage for screening purposes.

Meanwhile, Biomarker Screening Technologies Advance in the UK

Deb Schrag, MD, MPH, chair of the Department of Medicine at Memorial Sloan Kettering Cancer Center, biomarker testing
Deb Schrag, MD, MPH

While the application of biomarkers for cancer screening is still gaining little attention from state lawmakers, new advances in screening technology are gaining traction with Britain’s National Health Service (NHS)

According to The Guardian, the NHS is in the process of conducting a biomarker screening trial involving over 164,000 individuals. The trial is examining the utility of a test that claims to be able to identify over 50 types of cancer using a simple blood draw. The trial’s results are expected to be made public next year. Plans for a larger study are underway if the initial trial is successful.

Results from a smaller study on the same test were recently announced. The Pathfinder study, hosted by Grail, the test’s developer, found that the test accurately identified the early presence of cancer in 1% of the over 6,600 study participants.

“The study found cancer in about 1% of participants, including types for which there is no established screening method. The study demonstrated the feasibility of this paradigm and solid test performance,” said Deb Schrag, MD, MPH, chair of the Department of Medicine at Memorial Sloan Kettering Cancer Center in New York, in a Grail press release. “Although continued public health efforts to optimize adherence to existing screening strategies that have been proven effective are critical, this study provides a glimpse of what the future may hold—the opportunity for screening using blood tests to detect various types of cancers at their earliest and most treatable stages.”

The results of this study are promising, but it remains to be seen if the larger, independent trial being conducted by NHS shows similar results. This undertaking demonstrates the interest that the NHS has in leveraging the benefits of cancer biomarker testing to not only treat existing disease but to also detect cancer before it becomes a problem.

While precision medicine cancer screening is still only something on the distant horizon for most people in the US, states such as California are bringing cancer biomarkers more into mainstream healthcare. Healthcare leaders should consider how they can expand precision medicine biomarker offerings to get ahead of current trends and position themselves as leaders in precision medicine.

—Caleb Williams

Related Information:

California Senate Bill 912 Biomarker Testing

Senate Introduces Legislation to Increase Californians’ Access to Lifesaving Testing and Innovative Treatments

Health Insurance State Laws: Biomarker Testing

Louisiana State Legislature RS 22:1028.3

Blood Test Spots Multiple Cancers Without Clear Symptoms, Study Finds

Pathfinder Study

GRAIL Announces Final Results From the PATHFINDER Multi-Cancer Early Detection Screening Study at ESMO Congress 2022

Senator Monique Limón

Carrie L. Byington, MD

Deb Schrag, MD, MPH

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