Charu Aggarwal, MD, MPH, FASCO
In the last few decades, the rapidly growing field of precision medicine has improved the survival of patients with lung cancer. Yet the benefits of these therapies do not reach all patients. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, yet most patients are diagnosed at an advanced stage and face a 5-year survival rate of less than 20%.1 Next-generation sequencing (NGS) on tissue and plasma allows for multiple genes (or biomarkers) to be tested simultaneously. This single test determines whether a patient has one or more actionable mutation(s) of their tumor, allowing for tailored, targeted, and personalized treatment if detected. Yet a 2020 survey found that 29% of patients did not have biomarker testing based on lack of coverage or out-of-pocket costs.2
Without biomarker testing, targeted therapy options cannot be identified for patients and patient-specific survival is not improved. Unfortunately, health insurance coverage of biomarker testing modalities is not universal, and patients lose access to the treatments that might benefit them most. The result is a widening gap between what clinicians know improves survival and what patients can realistically access. Coverage policy has become a rate-limiting step in the delivery of precision oncology. The urgency of this issue has intensified as the scope of biomarker-driven therapy has expanded beyond metastatic disease. Comprehensive genomic testing is increasingly recommended in earlier-stage and perioperative settings, where targeted and immunotherapy strategies are rapidly moving. As testing becomes embedded across the cancer care continuum, coverage gaps that once affected a subset of patients now threaten to affect the majority.
We call on the Centers for Medicare & Medicaid Services (CMS) to make immediate changes to the rules and for amendments to state policies to ensure that patients with lung cancer receive the testing and treatment they deserve.
Federal Policy Barriers: CMS and Medicare
Most patients with NSCLC qualify for Medicare, as the average age of diagnosis for NSCLC is 70. In 2018, CMS implemented a National Coverage Determination (NCD) for NGS testing (later amended in 2020), but an analysis found that 27.4% of claims were denied.5Although there is limited transparency into the rationale for these denials, one potential barrier is the “14-day rule” (CMS rule 42 CFR 410.508), which prohibits Medicare reimbursement for NGS tests performed in the hospital and for 14 days after an inpatient discharge. This rule not only creates an undue administrative burden on providers, but delays time to treatment for patients. Patients who do not receive timely biomarker-directed therapy miss the opportunity for the significant survival advantage associated with targeted treatments, which are most effective when delivered in the first-line setting.
Additionally, regional variation introduced by the MolDX program, which governs local coverage decisions for many molecular diagnostics, has led to inconsistent reimbursement across the country, even within the Medicare program itself. Together, these barriers introduce administrative complexity, delay care, and undermine the clinical value of precision medicine.4
At the federal level, CMS has an opportunity to align Medicare coverage with contemporary oncology practice. Modernization should include expanding the National Coverage Determination for NGS to reflect current clinical guidelines, allowing serial testing when clinically indicated, and explicitly supporting concurrent tissue and liquid biopsy. In addition, greater national consistency in molecular diagnostic coverage is needed to reduce regional variability introduced by local coverage determinations.
State-Level Barriers: Patchwork Legislation and Payer Policy
While Medicare governs coverage for older adults, the broader U.S. population, particularly those with commercial insurance or Medicaid faces an equally fragmented access landscape governed by state-level policy. Over 20 states have introduced or enacted legislation requiring insurance coverage of biomarker testing in recent years. However, the content and scope of these laws vary dramatically.
Some states, like Illinois and Arizona, have passed comprehensive mandates that include both tissue and liquid biopsy, multi-gene panels, and clear processes for appealing denials. Others, such as Delaware, limit coverage to specific biomarkers or cancer types. Many statutes exclude Medicaid populations, exacerbating access gaps for the most vulnerable patients. Only a handful of states have allocated funding for implementation, education, or outcome monitoring, rendering enforcement difficult and impact unclear.
Further complicating the landscape, employer-sponsored insurance plans regulated under the federal Employee Retirement Income Security Act (ERISA) are not subject to state insurance mandates. This means that a patient residing in a state with strong coverage laws may still face denials if their employer plan is administered out of state or falls under federal regulation. The result is an inequitable system in which access to a medically necessary test is determined not by clinical appropriateness, but by a patient’s zip code, insurance type, and employment status.5
Disparities in state legislation have also contributed to uneven coverage of multigene NGS panels capable of detecting dozens of clinically relevant biomarkers. Even biomarkers recommended by the National Comprehensive Cancer Network (NCCN) are not universally covered by commercial insurers.6 Although coverage has expanded for large multigene panels in some cancers, adoption has been inconsistent across tumor types and remains particularly limited in lung cancer.
The introduction of plasma-based NGS testing, commonly referred to as liquid biopsy has further highlighted gaps between clinical practice and coverage policy. First introduced in 2018, liquid biopsy requires only a blood sample and has demonstrated high concordance with tissue testing, along with substantially shorter turnaround times. These advantages are especially important in advanced NSCLC, where rapid identification of actionable mutations can enable timely initiation of targeted first-line therapy. Increasing evidence supports the complementary use of tissue and liquid biopsy in tandem; however, payer policies often treat these tests as substitutes rather than complementary diagnostics, resulting in frequent denials when both are ordered.
State biomarker testing legislation represents meaningful progress, but many statutes remain incomplete. Future policies must explicitly include Medicaid populations, multigene panels, and liquid biopsy testing, and should establish clear implementation and evaluation frameworks. Without these provisions, legislative gains may fail to translate into real-world improvements in access.
The clinical promise of precision medicine in lung cancer is real, however, its benefits are too often out of reach due to outdated and inconsistent coverage policies. Although this discussion focuses on lung cancer, the implications extend far beyond a single disease. NSCLC serves as a leading example of how rapidly precision oncology is advancing and how reimbursement systems are struggling to keep pace. The challenges observed in lung cancer today are likely to emerge across oncology as biomarker-driven care becomes standard in multiple tumor types. Precision oncology has outpaced the policies designed to support it. Without deliberate reform, the rapid expansion of targeted therapies risks widening disparities rather than narrowing them. Aligning coverage with clinical evidence is no longer a future goal, it is an immediate necessity.
Acknowledgements
The author is grateful to Meagan Hume, Sarah Winawer-Wetzel, Anthony Martella, and Dr. Melina Marmarelis for their thoughtful contributions to the initial draft, as well as their careful editing, feedback, and comments, which helped strengthen the final piece.
DISCLOSURE: Dr. Aggarwal has served as a consultant or advisor for Abbvie, AstraZeneca, Daiichi Sankyo, Gilead Sciences, and Pfizer; has served as a speaker for AstraZeneca; and received research funding from AstraZeneca, Candel Therapeutics, Daiichi Sankyo, Genmab, Loxo@Lilly, MedImmune, and Merck Sharp & Dohme.
REFERENCES
1. Sandy B, Morrissette J: Lung cancer biomarker speak: Teach me the language. J Adv Pract Oncol 13:302-305, 2022.
2. American Cancer Society Cancer Action Network: Payer coverage policies of tumor biomarker and pharmacogenomic testing. March 2023. https://www.fightcancer.org/sites/default/files/acs_can_payer_coverage_policies_of_tumor_biomarker_and_pharmacogenomic_testing_-_advi_final.pdfAccessed June 29, 2026.
3. Upadhyay Banskota S, Trinh JQ, Lyden E, et al: Diagnosis of metastatic non-small cell lung cancer during hospitalization: Missed opportunity for optimal supportive care? Cancers (Basel) 16:1221, 2024.
4. Triage Cancer.org: Health insurance. Biomarker testing. https://triagecancer.org/state-laws/health-insurance-biomarker-testing Accessed June 29, 2026.
5. Kurzrock R, Chaudhuri A , Feller-Kopman D, et al: Healthcare disparities, screening, and molecular testing in the changing landscape of non-small cell lung cancer in the United States: A review. Cancer Metastasis Reviews 43:1217–1231, 2024.
6. Navani N, Sharman A, Evison M, et al: Achieving equitable, timely and comprehensive biomarker testing for patients with NSCLC. Lung Cancer 205:108618, 2025. https://www.lungcancerjournal.info/article/S0169-5002(25)00510-0/fulltext Accessed June 29, 2026.
Dr. Aggarwal is Leslye M. Heisler Professor of Medicine, Section Chief, Thoracic and Head & Neck Cancer, Associate Director, Penn Center for Cancer Care Innovation (PC3I) at the University of Pennsylvania.
Disclaimer: This commentary represents the views of the author and may not necessarily reflect the views of ASCO or The ASCO Post.
