New State Biomarker Legislation Advocated for by the Cancer Action Network Could Be a Game Changer for Expanding Commercial and Medicaid Access for Advanced Diagnostics

Comprehensive biomarker testing has become a crucial tool in guiding the choice of targeted therapies and immunotherapy for advanced cancer patients. However, despite its proven effectiveness, the adoption of biomarker testing into clinical practice has been slower than recommended by clinical guidelines. One significant barrier to widespread CBT adoption is the variability in insurance coverage across different health plans, which limits accessibility and contributes to health disparities. Even when insurance covers CBT, patients may face high out-of-pocket costs, delays due to prior authorization requirements, and administrative burdens. A recent study by the Cancer Action Network, who has been active in lobbying for legislation, has found that 58% of patients would be less likely to continue with their recommended care based upon out-of-pocket costs and for the majority the prohibitive cost level was $200 or greater. As a result, many patients, particularly older, Black, uninsured, or Medicaid-insured individuals, do not receive recommended biomarker testing, leading to disparities in cancer care outcomes.
A recent study published in 2022 in Personalized Medicine evaluated the alignment between commercial insurance policies and clinical guidelines regarding multigene panel tests (MGPTs) for cancer across the United States. Researchers reviewed NCCN Guidelines® for four cancer types and examined publicly available insurance coverage policies from insurers with the largest or second-largest number of commercial customers in each state including 38 total payers. The study found that a significant proportion (71%) of the insurance policies were “more restrictive” than the clinical guidelines, with differences varying by state. Many policies limited the number of genes to be tested (52%) and restricted testing to certain types of cancer (63%). Additionally, a number of tests that have positive national coverage decisions by Medicare are still deemed investigational by commercial insurance plans and state Medicaid coverage policies. Even when covered, commercial payers often lag Medicare coverage decisions by 3-5 years or more. There is a clear need for clearer guidelines and more standardized policies to ensure better alignment and reduce geographic disparities in access to these important tests.
Recent legislative efforts enacted in multiple states (including Arizona, New Mexico, Texas, Oklahoma, Arkansas, Louisiana, Georgia, Minnesota, Illinois, Kentucky, Maryland, and Rhode Island) aim to improve access to biomarker testing by in most instances mandating insurance coverage from both commercial payers and State Medicaid programs when certain evidence-based criteria is met. While there is some variation in these laws regarding which patients are covered and whether the legislation addresses prior authorization or only mandates coverage, the majority of states require testing when a test is deemed an evidence-based test. Evidence-based tests are typically defined as those that have US Food and Drug Administration approval or clearance, are recommended as part of an FDA-approved drug indication, are nationally covered by the Centers for Medicare & Medicaid Services, are recommended within nationally recognized treatment guidelines, or are backed by consensus statements. Most of this legislation has received significant bipartisan support.
In addition to states that have enacted legislation, many have current biomarker coverage legislation that has been introduced including New York which passed legislation in 2023 and California, Connecticut, Colorado, Florida, Massachusetts, Maine, Nevada, Ohio, and Pennsylvania. Combined the states with enacted and proposed legislation make up a population of 191 million representing well over half of the United States population. Clearly there is momentum in this legislation passing at the state level.
Most often, legislation is also not specific to cancer and covers all advanced testing. Consequently, this legislation could have a significant impact in other areas where complex biomarker-based tests are routinely used such as women’s health, autoimmune disease, cardiovascular disease, and other areas of healthcare. This is a path to coverage for a number of advanced diagnostics which often are covered by Medicare or in professional guidelines but have not received broad commercial coverage.
While many of these legislative efforts are new, based upon our discussions with commercial laboratories, this legislation has been successful in getting denied claims reversed. As it becomes even more pervasive, it could have a significant impact on both access to care and payment of commercial/Medicaid claims by insurance providers. Commercial laboratories, especially ones that offer new advanced diagnostics, often only have a small percentage of claims paid even when Medicare coverage exists. Consequently, this could be a significant source of incremental revenue and profit for the industry.
In summary, comprehensive biomarker testing is vital for guiding precision therapy in cancer care and among other major diseases, but its adoption remains uneven due to insurance coverage disparities. Typically, private payers and state Medicaid insurance programs have significantly lagged coverage recommendations by both Medicare and societal guidelines. Legislative efforts in a number of states are making progress in addressing these issues and could lead to a significant windfall for laboratories and in-vitro diagnostic test manufacturers of advanced diagnostics.