The State of State Biomarker Testing Insurance Coverage Laws

In response to perceived barriers to access to care, states have enacted legislation to mandate terms and conditions of insurance coverage for a variety of circumstances, such as cancer screening and mental health treatment parity. Especially important is appropriate biomarker testing for cancer subtypes, which can determine patient eligibility for treatment. However, whether legislative mandates are the most effective way to improve access and equity remains to be seen. For example, laws pertaining to mental health parity have had little effect on the use of and spending on mental health services.¹ As more states enact such laws, it is important to examine their provisions to gauge their potential effectiveness.

There has been a recent push for legislation mandating coverage of “biomarker testing” according to evidence that receipt of such testing can depend on race and ethnicity, age, geography, or site of care.^2–4 A specific type of biomarker testing for cancer subtypes (ie, “tumor profiling”) is becoming particularly important because many newer cancer therapies target specific mutations (eg, EGFR in non–small cell lung cancer, KRAS in colorectal cancer). Although use of biomarker testing is increasing, barriers to access persist. Cost and lack of insurance coverage are common barriers to testing because insurance coverage varies across commercial payers, Medicare, and Medicaid.⁵

Although some argue that legislation is unnecessary because insurers already cover medically necessary testing, variation in use and payer coverage policies has led to an advocacy coalition headed by the American Cancer Society Cancer Action Network to urge states to pass legislation mandating that insurers cover biomarker testing. Despite the potential widespread implications of these laws, only 1 peer-reviewed publication has examined this topic, focusing on only 3 states.³ Our review of current state laws suggests that their effect may be limited by their lack of reach and implementation challenges. Their policy implications must now be carefully considered and addressed objectively to a whether the laws are useful, and additional approaches must be considered to address inequities.

Provisions of Current Biomarker Legislation

Fifteen states have passed legislation related to biomarker testing since 2021 (eTable in the Supplement). All laws apply to commercial payers; in 12 states, the laws also apply to Medicaid. One state (Arkansas) explicitly excludes Medicaid from the legislation; in 2 others (Louisiana and Rhode Island), there is no mention of Medicaid in the statute.

The statutory definitions of biomarker and biomarker testing are largely similar across all states; no types of biomarker tests are explicitly excluded. Most laws (n = 11) require coverage of biomarker testing broadly without regard to condition. Four states (Arkansas, California, Louisiana, and Nevada) specify coverage of cancer biomarkers, with California specifying coverage for testing for stage III or IV cancer only. Almost all states (n = 14) require coverage of biomarker testing for diagnosis, management, and monitoring. In contrast, there is no language in any state’s legislation that mandates coverage for screening biomarker tests, and in 3 states (California, Kentucky, and Nevada) the statute explicitly mentions screening tests are not included.

All states set forth standards for identifying the necessary criteria to trigger mandatory coverage for biomarker tests. All states except for 1 (Louisiana) mention Food and Drug Administration (FDA) approval of a test or use with an FDA-approved drug requiring testing for treatment decisions or monitoring, Medicare national coverage determinations, and clinical practice guidelines as criteria for coverage. Thirteen states also include Medicare local coverage determinations in their criteria for coverage. The determinations are not mentioned in 2 states (Illinois and Louisiana). Eleven states include consensus statements as acceptable criteria for coverage; the other 4 states (Louisiana, Maryland, New Mexico, and New York) do not include this criterion.

Implementation issues, such as enforcement and fiscal effect, are rarely mentioned in legislation. Two states (California and Maryland) mention studying the financial effect of the bills or reimbursement for testing as part of the legislation, and only 1 state (Maryland) calls for studying the effect of the law on health equity. Finally, 1 state (Minnesota) allocated funding for the administrative costs of implementing the law.

Policy Implications

State laws governing insurance coverage should expand access to coverage; in reality, we estimate that approximately 50% of insured individuals would not be covered by mandates because state insurance benefit mandate laws do not apply to Medicare or self-funded Employee Retirement Income Security Act plans. Furthermore, most bills are broadly written to include “biomarkers” generally and there is a lack of specificity on which tests will be considered to have clinical utility. Thus, the effect of such laws will be limited and implementation will be variable. To reach the goal of broader access to testing, legislators, clinicians, and patient advocates will need to consider policy strategies in addition to or instead of insurance mandates, including nonlegislative programs or federal legislation.

State biomarker testing laws also have limited effect on individuals who are most likely to experience disparities in care: the uninsured and, in some states, those covered by Medicaid. Furthermore, laws focused on insurance coverage do not address other causes of inequities in care, such as social determinants of health, potential provider bias in offering testing, or affordability of testing. States should develop metrics for tracking the effect of laws on health equity, including benefits, harms, and unintended consequences, and develop approaches to monitoring their influence. However, so far, only Maryland requires follow-up studies examining the effect of the law on biomarker use.

The broad wording of most of the laws we reviewed provides little guidance and may cause difficulties with implementation. For example, FDA approval of a test is listed as one of the criteria for determining whether insurers must cover the test. However, the FDA currently focuses on safety and efficacy rather than clinical utility, bringing up the question of whether payers will be required to cover FDA-approved biomarker tests when clinical utility has yet to be established. Additionally, the FDA currently allows laboratories to use in-house–developed tests without much oversight, and thus many biomarker tests may not meet the same standards set for tests directly approved by the FDA (although the FDA recently published a proposed rule to regulate these tests). Variation in guideline and consensus statement recommendations may also contribute to variation in coverage because there may be differences in an individual payer’s interpretation of the evidence, as has been observed with state legislative mandates for cancer screening.⁶ In some states, legislation may broaden the evidence base by including consensus guidelines, which may be less rigorous and transparent.⁷ Guideline harmonization is a critical step toward more uniform coverage policies.

Finally, potential unintended consequences of state-level mandates of biomarker testing need to be considered. For example, there is the potential for overuse of biomarker tests with questionable accuracy and clinical utility, which could harm patients both clinically and financially.

Conclusion

An increasing number of states are passing laws mandating insurance coverage of biomarker testing to broaden access because equitable access to such testing has important implications for clinical care. Our review suggests that the effect of these laws may be limited by their lack of reach and implementation challenges, particularly concerning improving health equity. Therefore, state legislation is not likely by itself to achieve broad, equitable access. Policymakers and other stakeholders will need to both monitor the effect of the laws and consider additional approaches to improve patient access and outcomes.