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Texas Law Mandating Biomarker Testing to Take Effect

NEW YORK – A new law mandating health insurance coverage of biomarker testing for eligible Texas patients will go into effect Sept. 1, making it the 11th state to enact this type of legislation.

"Biomarker testing is the cornerstone of applying innovative precision medicine to oncology care," Texas Oncology, an institution with 280 locations in the state, said in a statement lauding the implementation of the bill.

SB 989, which was signed into law in May, states that providers of health benefit plans must cover evidence-backed biomarker tests used to diagnose, treat, and manage or monitor an enrollee's condition. Under the law, evidence-based tests are those that have US Food and Drug Administration approval or clearance, are recommended as part of an FDA-approved drug indication, are nationally covered by the Centers for Medicare & Medicaid Services, are recommended within nationally recognized treatment guidelines, or are backed by consensus statements.

Similar legislation aiming to ease insurance barriers to biomarker testing has been enacted in Arizona, Arkansas, Georgia, Illinois, Kentucky, Louisiana, Maryland, Minnesota, New Mexico, and Oklahoma, and introduced in California, Colorado, Connecticut, Florida, Maine, Massachusetts, Nevada, and Ohio.

These bills come as more cancer drugs indicated for biomarker-defined populations are coming to market, necessitating broader access to molecular testing. Texas Oncology, which serves more than 71,000 new cancer patients each year, last year implemented a policy requiring that all patients with late-stage tumors undergo biomarker testing.

The New York State Senate and Assembly passed a bill in June 2023 requiring health insurers and Medicaid to cover biomarker testing that has not yet been signed into law. In October 2022, California Gov. Gavin Newsom vetoed a similar bill, SB 912, which would have mandated automatic insurance coverage of evidence-based biomarker tests, on the basis that language in the bill was not specific enough.

Texas Oncology, which spearheaded efforts to promote passage of the bill in that state, estimates that less than half of eligible patients receive biomarker testing. "Passage of this bill paves the way for Texas Oncology to achieve its goal of testing 100 percent of our patients," Sucharu Prakash, director of quality services for Texas Oncology, said in a statement. "It will increase patient access to leading-edge cancer therapies and clinical trials across Texas, including those living in rural communities."