Battles over Biomarker Testing Shed Light on Precision Medicine’s Inaccessibility

Precision medicine—which involves tailoring treatments based on specific characteristics of patients such as their genetic makeup—has long been touted as the answer to America’s failing healthcare system, but its inaccessibility continues to stymie its impact.

There are compelling stories of people with cancer avoiding chemotherapy and radiation, which can have devastating effects on a person’s wellbeing.

One of the latest advancements in precision medicine is biomarker testing, where physicians use blood and tissue samples to look for genes, proteins, and other biological molecules that can help tailor treatment options for chronic illnesses such as arthritis, Parkinson’s, and some forms of cancer and, as a result, improve patient outcomes. By identifying the best possible treatment plan for the patient, biomarker testing carries the potential to save lives, prolong life, and improve people’s quality of life.

According to the American Lung Association, drugs that find specific molecular biomarkers can be more effective in killing cancer cells while harming fewer healthy cells in the body. Subsequently, there are compelling stories of people with cancer avoiding chemotherapy and radiation, which can have devastating effects on a person’s wellbeing. Biomarker testing has also been shown to extend the lives of people with bleak prognoses.

A patient battling esophageal cancer, for instance, shared his story with the American Cancer Society. Though doctors thought he had only five or six months to live, through biomarker testing and treatment, he has been living “with undetectable cancer for the last seven years.” Another patient, a four-year cancer survivor despite having stage 4 non-small cell lung cancer, credits biomarker testing as the reason “I’ve made it this far.” As these stories demonstrate, for those facing life-threatening disease, biomarker testing may be the difference between life or death.

Yet despite the transformative potential of biomarker testing, it’s still largely inaccessible, and these limitations call into question whether the technology’s positive impacts can be equitably distributed throughout our society.

Health Insurance Coverage for Biomarker Testing

Medicare, which insures more than 65 million Americans, covers biomarker testing for cancer patients but only under certain conditions: end stages of cancer (stage 3 or 4), particularly persistent forms of cancer (such as recurrent, relapsed, or refractory cancer), cancer that is rapidly spreading throughout the body (such as metastatic cancer), or cancer diagnoses tied to family history.

Biomarker testing is currently not available at all to Medicaid beneficiaries, and many commercial health insurance companies do not provide coverage for these tests. When they do, coverage is again only available under specific conditions.

Though biomarker testing has been extensively studied in clinical trials and has been added to clinical guidelines for several types of cancer, some in the medical policy community argue against broad mandates for insurers because there are inconsistencies in some of the published studies on biomarker testing.

Additionally, insurers have pushed back on legislation that opens access to biomarker testing because of concerns about the costs of testing and tailored treatments.

However, advocates have argued that offering biomarker testing could actually save insurance companies money in the long run by limiting unnecessary tests and excessive treatments.

Biomarker Testing on the Ballot  

There is currently a legislative push to expand insurance coverage for biomarker testing to make it accessible to a wider portion of the American public. Several states have recently passed or are considering passing legislation to make private insurance plans and Medicaid cover biomarker testing, its corresponding treatments, and other disease management strategies.

Administrative and financial obstacles disproportionately impact older people, the uninsured, and those who rely on Medicaid for health coverage, which widens racial and class disparities.

According to the American Cancer Society Cancer Action Network, by the end of 2023 14 states had enacted legislation to include comprehensive biomarker testing in health insurance coverage. And another 15 states have introduced legislation or are expected to introduce legislation to this effect. However, there have been instances of flawed or otherwise inadequate legislation that does not effectively remove barriers to biomarker testing. For example, in West Virginia, a bill that included amendments that stripped the bill of any meaningful improvement in access to biomarker testing was rejected by state lawmakers.

Biomarker testing, if it is made accessible to people with employer-sponsored health insurance and Medicaid recipients, could not only positively impact the lives of people with chronic diseases, it could also advance health equity. Accordingly, the American Cancer Society Cancer Action Network is actively campaigning to expand coverage for biomarker testing in 13 states.

Fifty health advocacy organizations—including the ALS Association, the American Lung Association, the Arthritis Foundation, the LUNGevity Foundation, and the HEAL Collaborative—have joined the American Cancer Association Cancer Action Network in the political fight to expand biomarker testing coverage.

Barriers to Biomarker Testing and Precision Medicine

With a total market size of over $80 billion in 2023 alone, precision medicine is here to stay. However, its accessibility, and the extent to which it will contribute to long-standing health inequities is still in question.

According to the Association of Cancer Care Centers, the variability and uncertainty of coverage by health insurance plans has become a barrier to its uptake in the United States. And even when biomarker testing is covered under an insurance plan, patients may still need to pay substantial out-of-pocket costs, depending on resulting recommended treatments that may not be covered by their insurer. The need to secure prior authorization before undergoing biomarker testing also creates another hurdle for those trying to utilize biomarker testing as a tool to identify better treatment options.

These administrative and financial obstacles disproportionately impact older people, the uninsured, and people with low incomes who rely on Medicaid for health coverage, which widens racial and class disparities in access. Those in rural areas which often suffer from care gaps and lack of resources and those who are not receiving care in academic medical centers are also less likely to have access to biomarker testing.

Other factors have emerged that limit biomarker testing’s utility as a tool to advance health equity. For instance, imbalances in genomic data contribute to a lack of knowledge concerning disease progression in historically marginalized and underrepresented communities. Consequently, there is still work to do in uncovering biomarkers for all patient populations rather than limiting the focus to populations of northwestern European descent.

The use of AI systems to identify genetic biomarkers and process complex health data adds another layer of complication to the relationship between biomarker testing and health equity. Because the genomic data in which AI systems are trained includes biases and exclusions, these systems often exacerbate complex inequalities in the data.

Moreover, since biomarker testing has only recently been added to electronic health records, too little is known about the use of biomarker testing in clinical practice outside of clinical research trials.

Removing systemic barriers to accessing biomarker testing for those with private health insurance plans and Medicaid, expanding coverage for biomarker testing under Medicare, and conducting more research on this approach to disease management as well as novel therapies, are all crucial for incorporating biomarker testing into routine care. Despite the financial costs, this work is crucial because the medical evidence suggests that broader access to biomarker testing will ultimately pay off in more lives saved.