The Hidden Barrier to Precision Oncology: How Insurance Policies Delay Access to Genomic Testing

The Hidden Barrier: How Insurance Policies and Administrative Burden Are Blocking Equitable Access to Precision Oncology Testing

Precision oncology has transformed cancer care, but many patients still struggle to access genomic testing that could guide life-saving treatment. In this expert commentary, Dr. Ira Klein examines how outdated insurance policies, prior authorization requirements, and administrative burden are widening disparities in molecular testing access across the United States.

Introduction: The Problem Is Not the Science

Precision oncology has delivered on its scientific promise. We have precision medicine targeted therapies that work in cancer care. We have comprehensive next-generation molecular sequencing platforms that can identify the actionable mutations that those therapies address. We have clinical guidelines, including National Comprehensive Cancer Network (NCCN) recommendations that are updated with meaningful frequency, that tell clinicians exactly what testing to order, for whom, and when.

That is, the problem is not the science. The problem is the space between what the science says and what patients actually receive. And that space, when examined carefully, is largely manufactured. It is created not by biological complexity or by clinical uncertainty, but by a combination of administrative friction, outdated insurance policy, and physician workflow and education gaps that together function as a systematic barrier to equitable precision oncology access. Understanding this barrier — how it was built, how it operates, and who it harms most — is the necessary first step toward dismantling it.

Barrier One: Physician Knowledge Is Not the Problem, But Keeping Up Is

The first thing to understand is that the physician education problem in precision oncology is not about ignorance of NCCN guidelines. Oncologists know what guidelines are. They know how to use them. The problem is that guidelines change (sometimes substantially and quickly), and keeping current across an expanding portfolio of cancer types, drug approvals, and testing requirements is genuinely difficult.

Keeping Up With Rapidly Changing NCCN Guidelines

Consider a concrete example from the past several months: NCCN guidelines for pancreatic cancer were updated to recommend comprehensive next-generation sequencing for all patients at all stages. Not selected patients; all patients. Within that updated recommendation, a specific sentence was added to emphasize the importance of RNA testing alongside DNA sequencing—because many gene fusions, including clinically actionable ones, are detectable only at the transcriptomic level, and will be missed by DNA-only panels. The repercussions of this go beyond adding more data to avoid missing a targetable mutation. For a patient with a select gene fusion, an RNA-blind test is effectively a false negative for a life-saving therapy.

How Prior Authorization Creates Cancer Care Disparities

A community oncologist treating all solid tumors and managing a full clinic has to absorb changes of this scope across every cancer type simultaneously. NCCN guidelines are usually updated on a disease level two to four times a year. Lack of complete guideline adherence is not a failure of effort or intelligence by our oncology physicians, but a structural problem: the pace of guideline evolution has outrun the capacity of individual physicians to stay current through ordinary continuing education pathways. The result is testing that is underordered, ordered incompletely, or ordered without awareness of the specific technical requirements that make results actionable.

Barrier Two: Commercial Insurance Is Running Years Behind

The Financial Reality of Delayed Genomic Testing

The second and more consequential barrier is the state of insurance policy in the commercial health insurance market. What most commercial insurers cover, per their specific medical policy for molecular testing, does not reflect the current state of science or clinical guidelines. When the coverage policies of major national carriers are examined — as I have done — the references in the supporting documentation include studies from 2015, 2018, 2020. Some of the evidence cited was already outdated when the policies were written. The technology, the evidence base, and the clinical guidelines have all moved; the policies have not. Statements made (example from a major lab benefits management (LBM) company) assert that Description and Application of the Guidelines supports “standardization of medical practice patterns.” However, the policy references to NCCN guidelines and recommendations are extremely sparse and selective for this LBM, only covering selective aspects of selective tumors.

This matters enormously in practice. A physician orders comprehensive genomic profiling for a patient with metastatic colorectal cancer, as NCCN guidelines recommend. The insurer's automated prior authorization system denies it, because the policy was built on outdated criteria. Depending on the insurer’s policies and procedures, the lab company, the oncologist, or their staff must then spend time appealing, peer-to-peering, and navigating a system explicitly designed to create friction. In many cases, the prior authorization is eventually approved. But the delay and/or administrative friction is real. And for some patients, particularly those whose oncologists’ offices lack the administrative infrastructure to fight effectively, it never happens. Sometimes, due to overwhelming workflow pressures, the ordering of genomic testing profiles often follows the path of least resistance per the dominant health insurance payer for that practice.

How Biomarker Legislation Could Improve Testing Access

Medicare has actually been a leader in the cancer genomics policy and procedure space, which surprises people. A 2017 National Coverage Decision (NCD 90.2) established that comprehensive genomic profiling is a covered benefit for patients with advanced, recurrent, relapsed, or metastatic solid tumors. This holds true when the patient has not been previously tested with the same test using NGS for the same cancer genetic content, and has decided to seek further cancer treatment (e.g., therapeutic chemotherapy). Specialty labs that perform comprehensive genomic profiling must be Clinical Laboratory Improvement Amendments (CLIA) certified, and will be covered nationally under NCD 90.2 when all of the aforementioned requirements are met. That is a nine-year-old policy that is still more forward-thinking than most major commercial carriers in 2026.

This is not a small irony. Our government, for once, got ahead of the private sector on a clinical coverage question — and the private sector has largely not caught up. Why is that? It's possible that the rapidity of technological innovation in precision medicine, particularly in cancer care, has overwhelmed the operational, policy, network, finance, and claims system management of this new technology within large health insurance corporations. The commercial carriers are watching and slowly catching up, but not leading.

Barrier Three: Administrative Burden Is the Real Disparity Driver

The third barrier is the one that causes the most harm. Administrative burden, layered on top of already complex precision oncology workflows, is a disparity mechanism.

Oncology practices are built to treat patients. They are not built to treat insurance. The staff capacity to respond to prior authorization requests, document medical necessity, conduct peer-to-peer reviews, and appeal denials requires a specific kind of administrative infrastructure that large group practices and academic medical centers have — and that smaller community practices and rural oncology offices often do not.

The patients treated at those smaller practices and rural offices are disproportionately low-income, uninsured or underinsured, and from racial and ethnic minority communities. The administrative barrier to molecular testing, in other words, does not fall randomly across the population. It falls hardest on the patients who are already least likely to access equitable cancer care. The physician doing a prior authorization appeal or responding to an insurance company peer-to-peer while on a bathroom break (because that was the only moment the reviewer was available to call back) is not a joke. It is a real account of what physician time looks like in a practice without adequate administrative support.

I want to make something clear about prior authorization that is often obscured in these discussions: I am not categorically opposed to it. I spent a decade at Aetna in a variety of roles, including utilization management, and over three years at other health plans as a CMO. I understand why coverage management exists, and I understand that there are clinical scenarios where it is appropriate. But prior authorization for evidence-based, guideline-concordant precision oncology testing, for comprehensive genomic profiling that NCCN explicitly recommends, is not serving a quality function when clinical utility needs are easily documented. It is serving a delay function. And the cost of that delay is not only financial.

One data point: comprehensive genomic profiling at time of diagnosis is a fraction of the cost of the targeted therapies or immuno-oncology therapies it aims to identify. The targeted therapies it identifies may run $100,000 to $300,000 per year for as long as the patient is receiving them. If appropriate upfront testing directs 5% of patients to clinical trials — where therapy costs are covered by the sponsor — the savings to the payer are not marginal. They are substantial, with a significant return on investment. Also, the ability to choose a targeted therapy instead of cytotoxic chemotherapy combined with an immuno-oncology drug is both a cost saver and quality of life improver. In scenarios where a follow up genomic test is used to determine resistance to current therapy, or testing is done to look at treating to remission (minimal residual disease testing), expensive drug wastage is also curtailed. The insurers who are blocking this testing are not even saving money. They are spending it in a different column.

What Needs to Change, and What Already Is

The good news is that the policy landscape is moving, even if too slowly. State-level biomarker legislation — which Rhode Island, Washington State, and most recently Mississippi have passed — creates a floor of testing access that applies regardless of insurer coverage policy. These laws require that evidence-based molecular testing be covered for cancer patients in those states, removing the prior authorization barrier for guideline-concordant tests. They are replicable. They are bipartisan. And while ERISA plans (self-insured employer sponsored plans) may be excluded from state regulations, this legislation represents the most direct near-term lever available for improving testing access equity. Advocacy from oncology professional societies, patient organizations, and industry partners is essential to ensuring compliance with that process. This is especially important for Medicare Advantage plans, who are mandated to follow CMS coverage rules, but have been inconsistent in their application of the current National Coverage Decision (NCD).

Operationally, AI-assisted prior authorization — not in the adversarial, deny-first model that currently dominates, but in a model that uses curated clinical data to automate appropriate approvals — is currently being piloted today to reduce the time and staffing burden currently imposed on oncology practices. The technology exists. Structured, multimodal data that can be accessed by data companies such as my own (Tempus AI) makes this automation possible. The will to implement it requires policy and commercial pressure that does not yet exist at sufficient scale. Oncology practices, large and small, would be willing to devote resources to automate and reduce friction in both genomic testing and drug therapy prescribing, if more universal standards and programs existed on the commercial insurance side.

And for individual clinicians and practices: know your state's biomarker law. Know what testing your patients are entitled to regardless of what their insurer's first response says. And know that the companies whose testing you are ordering — Tempus, Foundation Medicine, Caris, and others — all have people available to help navigate the coverage and prior authorization process when results are unclear or access is denied.

Clinical Implications and Practice Takeaways

● Know your state's biomarker legislation. States that have biomarker testing coverage for all state-regulated plans include AZ, CA, CT, GA, IL, IN, IA, KY, MD, MS, NE (for a limited list of disease), NM, NJ, NY, OK, PA, RI, TX. If you practice in one of those states, your patients have coverage rights (depending on insurance type) that supersede insurer denial policies. More states are likely to follow as additional states have coverage for some plans, and others have legislation introduced in 2026.

● Do not accept the first denial. For guideline-concordant precision oncology testing, prior authorization denials are often based on outdated coverage policies. The peer-to-peer review process, while burdensome, frequently results in approvals. Build administrative infrastructure — or seek partnerships — to support that process.

● Practices need a Precision Oncology workflow checklist. There are questions that every practice, especially rural and small community practices, should ask regarding their specialty lab partner in order to reduce disparities in treatment. These should include the ability to include concurrent RNA sequencing, a partnership approach to PA appeal process, and an EMR integration capability to optimize workflow and deliver time back for patient care.

● Where Guidelines are appropriate, order RNA testing alongside DNA sequencing. The most recent NCCN updates for several cancer types specifically flag the importance of RNA testing for detecting gene fusions that DNA panels miss. Ensure that comprehensive genomic profiling at your institution or your reference lab includes RNA and continue ordering with the specific patient’s needs in mind.

● Engage Payers with advocacy channels. Engaging CMS and commercial payers as they update their policies is an opportunity for oncologists, institutions, and professional societies to advocate for expanded comprehensive genomic profiling coverage. Organized, data-supported advocacy influences these decisions, so joining those causes will yield results.

● Leverage testing company clinical support teams. Every major molecular testing company has medical affairs and clinical support staff whose explicit purpose is to help oncologists interpret results and navigate coverage issues. Use them.

Patient Perspective: What This Means for You

If your oncologist has recommended comprehensive genomic testing of your tumor and your insurance has denied the request, that denial may not be the final word. Prior authorization denials for guideline-recommended testing are frequently overturned on appeal to the specialty lab company or through a peer-to-peer review between your oncologist and the insurer's medical director. If denied, ask your oncologist's office whether they have appealed, and whether your state has a biomarker testing law that may entitle you to coverage regardless of the insurer's initial response. If the cost of testing is a barrier, ask about patient assistance programs offered by the testing laboratories — most have them on the basis of financial needs means testing. And know that getting the right test result, and getting it promptly, can meaningfully change which treatments are available to you.

Key Takeaways

● Commercial insurance coverage for precision oncology testing is years behind the science, with many major carriers citing studies from 2015 to 2020 in their coverage policies; Medicare's 2017 NCD 90.2 — which covers comprehensive genomic profiling for advanced solid tumors — is more current than most commercial payer policies almost a decade later.

● Prior authorization for guideline-concordant molecular testing functions as a delay mechanism, not a quality mechanism, and its costs fall disproportionately on smaller community practices and rural oncologists who lack the administrative infrastructure to navigate it — the same practices that disproportionately serve underrepresented and low-income patients.

● The economics favor testing: comprehensive genomic profiling costs at time of diagnosis are a fraction of the targeted or immuno-oncology therapies it identifies, which can cost $100,000–$300,000 per year. Redirecting even 5% of patients to clinical trials through appropriate testing would generate substantial savings that insurers are currently forgoing.

● State-level biomarker legislation — enacted in multiple states listed earlier — represents the most direct near-term lever for equitable testing access, requiring coverage of evidence-based genomic testing regardless of insurer policy.

● RNA testing alongside DNA sequencing is now explicitly recommended in updated NCCN guidelines for several cancer types, including pancreatic cancer; providers ordering DNA-only panels are missing gene fusions that are detectable only at the transcriptomic level.

About the Author

Dr. Ira Klein, MBA, MD, FACP, is Vice President for Medical Affairs, Payer Relations, at Tempus AI, where he focuses on improving access to precision medicine testing across diverse patient populations. He previously served as Chief Medical Officer of Health New England and spent a decade at Aetna in multiple roles, including launching their national oncology program for medical homes. He trained in Internal Medicine at the Brown University program at Rhode Island Hospital, as well as Robert Wood Johnson University Hospital, and brings a rare perspective to precision oncology access: that of a clinician who has worked extensively on both sides of the coverage table.

References and Resources

1. Michuda J, Park BH, Cummings AL, et al. Use of clinical RNA-sequencing in the detection of actionable fusions compared to DNA-sequencing alone. JCO. 2022;40(16_suppl):3077-3077. doi:10.1200/JCO.2022.40.16_suppl.3077
2. National Comprehensive Cancer Network Guidelines: Who Makes Them? What Are They? Why Are They Important? Ann Thorac Surg. 2020 Dec;110(6):1789-1795. doi: 10.1016/j.athoracsur.2020.03.022. Epub 2020 Apr 13.
3. Centers for Medicare & Medicaid Services. National Coverage Determination 90.2: Next Generation Sequencing for Medicare Beneficiaries with Advanced Cancer. Available at: cms.gov
4. National Comprehensive Cancer Network (NCCN). Oncology Clinical Practice Guidelines. Available at: nccn.org
5. Siddiq N, et al. (2022). Testing and treatment gaps in precision oncology. Journal of Precision Oncology (ASCO). (Referenced in session.)
6. https://www.fightcancer.org/what-we-do/access-biomarker-testing
7. Tempus AI. Available at: tempus.com