By Clarisa Blattner

Precision medicine is no longer a future-state discussion. It is rapidly becoming embedded into state-level healthcare policy across the United States, with biomarker testing legislation gaining significant momentum over the past several years.

Since 2021, numerous states have enacted laws requiring coverage for biomarker testing when supported by medical and scientific evidence, including FDA labeling, Medicare coverage determinations, or nationally recognized clinical guidelines. As of 2026, more than 20 states have passed some form of biomarker testing coverage legislation, with additional bills actively under consideration.
These laws are designed to improve access to precision medicine by helping ensure patients receive the most appropriate therapies based on the molecular characteristics of their disease. Biomarker testing has become increasingly important in oncology, particularly for targeted therapies, immunotherapy selection, minimal residual disease (MRD) assessment, hereditary cancer risk evaluation, and other personalized treatment strategies.

However, while legislative momentum continues to grow, the operational reality for laboratories, providers, and revenue cycle teams remains considerably more complex.

Coverage expansion does not automatically eliminate friction
One of the most important industry shifts underway is the transition from asking whether biomarker testing will be covered to evaluating how consistently and efficiently that coverage is being operationalized by payors.

Despite new state mandates, organizations continue to face challenges including:
• Prior authorization requirements
• Medical necessity documentation inconsistencies
• Delayed policy implementation
• Variable payor interpretation of legislation
• Denials despite mandated coverage
• Differences between commercial, Medicaid, and Medicare policies
• Operational confusion surrounding fully insured versus self-funded plans

This is especially important because many state biomarker laws apply primarily to state-regulated commercial insurance products and may not extend to ERISA self-funded employer plans. As a result, providers may encounter different coverage outcomes for patients within the same market depending on plan structure.

In several states, lawmakers have also begun addressing concerns related to utilization management barriers. California and Washington, for example, implemented provisions limiting prior authorization requirements for certain biomarker testing scenarios involving advanced or metastatic cancer.

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