Expanded Access to Biomarker Testing

Weill Cornell Medicine strongly supports legislation (S.8147/A.9149) that would expand access to biomarker testing by requiring health insurance policies and Medicaid to cover biomarker testing for diagnosis, treatment, appropriate management, or ongoing monitoring of a covered person's disease or condition when the test is supported by medical and scientific evidence.

Biomarkers, also called molecular markers, are biological molecules, found in blood, tissues, or other bodily fluids that provide insight into normal or abnormal physiological processes, medical conditions, or diseases. While most current applications of biomarker testing are in oncology and autoimmune disease, there is research underway to benefit patients with other conditions including heart disease, neurological conditions like Alzheimer's disease, infectious diseases, and respiratory illness.

Biomarker testing plays a crucial role in patient care as 60 percent of oncology drugs launched in the past five years require or recommend the biomarker testing prior to use. Additionally, in 2021, 66 percent of oncology providers reported that insurance coverage is a significant or moderate barrier to appropriate biomarker testing for their patients. There has also been an increase in biomarker testing in clinical trials. In 2018, 55 percent of cancer clinical trials involved biomarkers, up from 15 percent in 2000.

Comprehensive biomarker testing looks for all recommended biomarkers based on clinical guidelines. This testing can lead to treatments with fewer side effects, longer survival and allow patients to avoid treatments that are likely to be ineffective or unnecessary. Exposure to these ineffective treatments can exacerbate the physical, emotional, and economic burdens of disease.

Increasing access to the appropriate biomarker testing can help achieve better health outcomes, improved quality of life, and reduced cost. Without action, this could increase existing disparities in cancer outcomes by race, ethnicity, income, and geography. In New York, 33% of commercial insurance plans provide coverage that is more restrictive than the National Comprehensive Cancer Center guidelines. Arizona, Illinois, Louisiana, and Rhode Island have recently passed legislation to expand coverage for comprehensive biomarker testing.

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