State Legislation Requiring Coverage of Biomarker Testing Gains Momentum

Biomarker testing is a form of precision medicine that allows anti-cancer treatments to be targeted to the right patient at the right time based on the unique genetic profile of one’s specific cancer. Through comprehensive biomarker testing, the identification of targeted therapies and immunotherapies best suited to a patient’s disease can significantly improve health outcomes and prolong patient survival, particularly for those with advanced forms of cancer. Given this clear clinical benefit, biomarker testing has been incorporated into clinical guidelines, including recommendations by the National Comprehensive Cancer Network (NCCN) in the treatment of metastatic non-small cell lung cancer, metastatic breast cancer, melanoma, ovarian cancer, and colorectal cancer.

While the field of precision medicine has advanced rapidly over the last several years, coverage policies across health insurance plans have not kept pace with the speed of innovation. In fact, the variability and uncertainty of coverage by patients’ health plans have become a substantial barrier to the uptake of biomarker testing. And even when biomarker testing is covered by a patient’s insurance, high out-of-pocket costs and the need to obtain prior authorization represent additional financial and administrative hurdles to obtaining this testing. Unfortunately, these barriers to access tend to disproportionately impact individuals who are older, Black, uninsured, or Medicaid-insured, resulting in widening racial, ethnic, and socio-economic disparities in access and utilization of this diagnostic tool. 

The Centers for Medicare & Medicaid Services (CMS) issued a national coverage determination and local coverage determination that increased access to comprehensive biomarker testing and next-generation sequencing for Medicare beneficiaries in 2020 and 2022, respectively. While these CMS coverage decisions have, to some extent, impacted private payer decisions regarding coverage for biomarker testing and next-generation sequencing, commercial health plans are not bound by the same coverage requirements as Medicare. Moreover, Medicaid coverage requirements, which are determined by each state individually, are highly variable from state to state, leading to significant variability and lack of predictability in health plan coverage of this testing outside of the Medicare program. 

For this reason, there has been a lot of interest at the state level to require state-regulated health insurance plans and Medicaid programs to cover biomarker testing when a given test is supported by medical and scientific evidence. Over the past two years, state legislatures in Arizona, California, Illinois, Louisiana, and Rhode Island have passed laws mandating coverage of comprehensive biomarker testing. Effective July 1 of this year, an additional bill in California (SB-535) also prohibited state-regulated individual and group health plans from requiring prior authorization for biomarker testing for an enrollee or insured individual with advanced or metastatic Stage III or IV cancer. 

Below is a brief summary of the implementation status of the five state laws requiring health insurance coverage of comprehensive biomarker testing:

• Signed into law in June 2021 and effective in January 2022, Louisiana Senate Bill 84 requires broad health insurance coverage for genetic and molecular testing for cancer only.
• Signed into law in July 2021 and effective in January 2022, Illinois House Bill 1779 requires state-regulated insurance and managed care plans to cover biomarker testing for the purposes of diagnosis, treatment, management, or monitoring of any medical condition.
• Signed into law in May 2022 and effective in January 2023, Arizona House Bill 2144 requires health insurance coverage for biomarker testing for the purposes of diagnosis, treatment, management, or monitoring of any medical condition. 
• Signed into law in June 2022 and effective in January 2024, Rhode Island Senate Bill 2201 requires state-regulated individual and group health insurance plans to cover biomarker testing for the purposes of diagnosis, treatment, management, or monitoring of any medical condition. 
• Passed by the California State Legislature in August 2022, California Senate Bill 912 would require state-regulated insurance plans and Medi-Cal managed care plans to cover biomarker testing, including whole genome sequencing, for any medical condition effective in July 2023. On September 29, 2022, California Governor Gavin Newsom announced his decision to veto the bill, despite its passage with unanimous, bipartisan support.

Similar pieces of legislation have been introduced in Minnesota, New York, Ohio, and Washington, and efforts to pass these bills are likely to continue in the upcoming year, as well as renewed efforts in California. Additionally, campaigns to educate stakeholder groups and lawmakers about the need for this type of legislation is expected to begin in another handful of states in 2023, including Colorado, Florida, Georgia, Kentucky, Maine, Maryland, Massachusetts, Nevada, New Mexico, Pennsylvania, and Texas. Undoubtedly, state legislatures will continue to play a crucial role in expanding equitable access to biomarker testing and thereby reducing disparities in diagnosis and treatment for patients with cancer in 2023 and beyond. 

Find more tools and resources related to cancer diagnostics on the ACCC website.

Matt Devino, MPH, is the director of Cancer Care Delivery and Health Policy at ACCC. The ACCC Cancer Diagnostics education program is supported by AstraZeneca, Amgen, Bristol Myers Squibb, Lilly Oncology, and Merck.