CBSA is supporting HB23-1110, an important bill introduced in Colorado this year that would require insurance coverage for biomarker testing supported by nationally recognized clinical practice guidelines for diagnosis, treatment, and disease management. Biomarker testing is recognized as the key to unlocking precision medicine. Efforts to pass this biomarker testing bill, sponsored by Representative Dafna Michaelson Jenet, Representative Anthony Hartsook, Senator Kyle Mullica, and Senator Janice Rich, are being spearheaded by the American Cancer Society Cancer Action Network (ACS CAN) following the passage of similar bills in Arizona, Illinois, Louisiana, and Rhode Island. HB23-1110 will be heard in the House Health & Insurance Committee on February 21.

What is Biomarker Testing? 

Biomarker testing is the analysis of a patient’s tissue, blood, or other specimen for the presence of a biomarker which provides insight into the individual’s medical condition and the likelihood that the individual will respond well to a particular treatment. It looks at mutations, deletions, additions, or rearrangements in DNA or other key markers like levels of certain proteins or the amount of tumor DNA in the blood. This testing can help connect patients to the most effective, personalized treatment. 

Why is Biomarker Testing Important? 

Biomarker testing enables physicians to understand an individual patient’s specific cancer and precisely target it, so the patient may not have to undergo more generalized treatments, such as chemotherapy and radiation, that might not work as well for them. The use of biomarker testing and targeted therapies has become the standard of care for certain cancers because it improves patient outcomes and helps avoid costly, ineffective treatments. 

There are now many FDA-approved targeted therapies across several cancer types. In fact, nearly 60% of all cancer drugs approved over the last five years require or at least recommend biomarker testing before use. It’s not hard to see why biomarker testing is becoming increasingly important for new, targeted therapies, since it can lead to better quality of life and improved survivorship for cancer patients, as well as a reduction in healthcare costs since it facilitates patients getting the right treatment in a timely manner. 

In addition, the national “Cancer Moonshot” initiative, reignited by President Biden in early 2022 with a new goal of reducing the cancer death rate by half within 25 years, will rely heavily on this testing and biomarker-driven treatments. 

Disparate Coverage and Access 

There is currently limited and disparate access to biomarker testing across different insurance plans. In particular, patients who are insured by Medicaid, who have lower incomes, who are from certain marginalized groups, or who receive treatment outside of academic medical centers are all less likely to have coverage or access that would allow them to benefit from biomarker testing. This bill would help expand coverage for these populations—and others—so more Coloradans would be able to access biomarker testing and the most effective treatments for their conditions. 

In addition, biomarker testing is increasingly important for determining eligibility for clinical trials. Expanding access to biomarker testing can help promote diverse participation in clinical trials while improving scientific outcomes. 

What HB23-1110 Does 

HB23-1110 requires all individual and group health benefit plans regulated by the state, starting in 2025, to provide coverage for biomarker testing if the testing is supported by medical and scientific evidence.  

• The bill defines biomarker testing as an analysis of a patient’s tissue, blood, or other biospecimen for the presence of an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a specific therapeutic intervention. 
• Biomarker testing is subject to the health benefit plan’s annual deductibles, copayment, or coinsurance, but is not subject to any annual or lifetime maximum benefit limit. 
• If a carrier requires prior authorization for biomarker testing, the bill requires the carrier to use an expedited prior authorization process. 

Subject to federal authorization and federal financial participation, beginning July 1, 2024, the bill includes coverage for biomarker testing as part of Medicaid if the testing is supported by medical and scientific evidence. Under Medicaid, the bill requires an expedited utilization review and prior authorization process, as well as an appeal process if biomarker testing is denied. 

CBSA’s Advocacy Efforts  

The CBSA Policy + Advocacy team will collaborate with partners and policymakers to advocate for the passage of HB23-1110 as part of our work to promote policies that improve coverage for and access to groundbreaking treatments by removing unnecessary coverage barriers and reducing delays to treatment (see CBSA’s Policy Priorities). 

To get involved with CBSA’s advocacy efforts or talk about your concerns, perspective, or position on a bill, please contact CBSA’s Vice President and Counsel for Policy + Advocacy, Amy Goodman.