Precision Oncology Has Outgrown Medicare’s NGS Coverage Policy

Medicare’s National Coverage Determination 90.2 (NCD 90.2), finalized in 2018, largely reflects a precision oncology landscape built around late-stage, metastatic disease. Since then, NGS testing has become embedded in earlier-stage treatment planning, germline risk assessment, and longitudinal disease monitoring—raising the question of whether coverage policy has kept pace with the science it’s meant to support.[1]

Key Takeaways

• NCD 90.2 predates much of today’s precision oncology practice, and clinical evidence, U/S. Food and Drug Administration (FDA-) approved companion diagnostics, and National Comprehensive Cancer Network (NCCN) and the American Society of Clinical Oncology (ASCO) guidelines have all evolved substantially since 2018.
• Genomic testing now extends well beyond its original scope—supporting earlier-stage treatment decisions, minimal residual disease (MRD) assessment, and serial circulating tumor DNA (ctDNA) monitoring for treatment response and resistance detection.
• Serial molecular monitoring represents a shift from one-time diagnostic testing to continuous disease management, a distinction current coverage frameworks may not adequately recognize.
• Germline testing has expanded to inform treatment across pancreatic, prostate, colorectal, and other hereditary cancers, beyond its traditional focus on breast and ovarian malignancies.
• More flexible, evidence-based coverage pathways—able to adapt without repeated national policy overhauls—could reduce administrative burden for laboratories and providers while improving beneficiary access to validated diagnostics.

Precision Oncology

Precision oncology has transformed cancer care over the past decade. Next Generation Sequencing (NGS) is no longer reserved for identifying treatment options in patients with advanced cancers—it has become essential to diagnosis, treatment planning, therapy selection, disease monitoring, and long-term patient management across many cancer types.

Yet Medicare’s National Coverage Determination (NCD) 90.2 largely reflects the state of precision medicine as it existed in 2018. Since then, oncology has changed dramatically.

Scientific evidence, clinical guidelines, FDA-approved companion diagnostics, and molecular technologies have all advanced considerably. Today, clinicians routinely rely on genomic information not only to match patients to targeted therapies, but also to monitor treatment response, identify emerging resistance mutations, assess minimal residual disease (MRD), and support personalized treatment decisions throughout the continuum of care.

As precision medicine continues to evolve, an important question emerges: Does Medicare coverage policy adequately reflect today’s standard of oncology care?

The Precision Medicine Landscape Has Changed

When Centers for Medicare & Medicaid Services (CMS) finalized NCD 90.2, companion diagnostics were primarily associated with patients who had advanced or metastatic cancers. Since then, precision oncology has expanded significantly.

Today, Next Generation Sequencing (NGS) supports:

• Earlier-stage cancer treatment decisions
• Identification of actionable biomarkers before disease progression
• Companion diagnostics for an increasing number of FDA-approved targeted therapies
• Germline testing across numerous hereditary cancer syndromes
• Minimal residual disease (MRD) assessment [2]
• Therapy response monitoring through serial circulating tumor DNA (ctDNA) testing [2]

Professional society guidelines from organizations such as the National Comprehensive Cancer Network (NCCN) and the American Society of Clinical Oncology (ASCO) increasingly recommend molecular profiling across a broader range of clinical scenarios than existed when NCD 90.2 was originally implemented. The question is no longer whether genomic testing improves clinical decision-making. The question is whether Medicare coverage policies are evolving alongside the science.[3][4]

Opportunities to Modernize Medicare Coverage

As precision oncology continues to mature, several areas deserve thoughtful consideration when evaluating whether current Medicare policy continues to align with evidence-based clinical practice.

• Earlier-Stage Disease
  • Many targeted therapies are now indicated well before patients develop metastatic disease. Likewise, clinical guidelines increasingly recommend comprehensive molecular profiling earlier in the patient’s treatment journey. Coverage policies that recognize clinically appropriate testing across additional stages of disease could improve alignment between reimbursement and current standards of care.
• Serial Molecular Monitoring
  • Cancer biology evolves over time. Unlike traditional diagnostic testing performed once, many molecular assays—including MRD and circulating tumor DNA (ctDNA) testing—are designed to monitor disease longitudinally. As these technologies become increasingly integrated into oncology care, coverage frameworks may benefit from recognizing that repeat testing can represent distinct and medically necessary clinical decision points rather than duplicate services.
• Germline Testing
  • Our understanding of hereditary cancer syndromes continues to expand. Today, germline testing informs treatment decisions across multiple cancers beyond breast and ovarian malignancies, including pancreatic, prostate, colorectal, and other hereditary cancers. As evidence grows, reimbursement policy should continue to evolve alongside clinical recommendations. [5]
• Flexible Coverage Frameworks
  • One of the ongoing challenges in healthcare policy is balancing national consistency with the flexibility needed to accommodate rapid scientific innovation. As new diagnostics emerge and evidence develops, coverage pathways that allow appropriate evidence review without requiring repeated national policy revisions may provide a more efficient mechanism for ensuring beneficiary access while maintaining rigorous standards for medical necessity.

What This Means for Clinical Laboratories

While discussions surrounding NGS coverage often focus on reimbursement, the broader implications extend across the entire healthcare ecosystem. Modernizing Medicare coverage policies has the potential to improve operational efficiency, reduce administrative complexity, and create a more predictable pathway for bringing innovative diagnostics to patients.

For clinical laboratories, several implications stand out.

• Better alignment between clinical practice and reimbursement. As oncology guidelines continue to evolve, laboratories increasingly face situations where evidence supports testing but existing coverage policies lag behind current standards of care. Greater alignment reduces uncertainty for providers and beneficiaries alike.
• Improved patient access. Coverage policies that reflect contemporary clinical evidence help ensure Medicare beneficiaries have timely access to appropriate molecular diagnostics regardless of where they receive care.
• Recognition of emerging technologies. MRD testing and serial ctDNA monitoring represent a fundamental evolution from one-time diagnostic testing to continuous disease management. Coverage policies should recognize this shift as precision oncology continues to mature.
• Reduced administrative burden. Coverage frameworks that can adapt more efficiently to scientific advances may reduce unnecessary appeals, repeated reconsiderations, and operational complexity for laboratories, providers, Medicare contractors, and CMS.
• Greater certainty for innovation. Diagnostic developers invest years generating clinical evidence demonstrating analytical validity, clinical validity, and clinical utility. A reimbursement framework capable of evolving alongside scientific advances helps create a more predictable pathway for innovation while maintaining evidence-based decision-making.

More broadly, this discussion highlights an ongoing challenge for Medicare coverage policy. Diagnostic innovation is advancing at a pace that increasingly outstrips traditional coverage processes. As new biomarkers, companion diagnostics, and monitoring technologies emerge, coverage frameworks should remain grounded in robust clinical evidence while maintaining the flexibility to adapt as standards of care evolve. A reimbursement system that can respond to scientific progress without requiring repeated policy overhauls will better serve patients, providers, laboratories, and CMS alike.

Looking Ahead

Medicare has long played an important role in advancing access to innovative diagnostic technologies while ensuring coverage decisions remain evidence-based. As precision oncology continues to expand, ongoing evaluation of existing coverage policies will be essential to ensure beneficiaries continue to benefit from clinically validated advances in genomic medicine.

Precision oncology is no longer the future of cancer care—it is today’s standard of care. The challenge for policymakers is ensuring that coverage policy evolves alongside scientific innovation so Medicare beneficiaries can benefit from advances in genomic medicine as quickly as the evidence supports.

Reference
[1] National Coverage Determination (NCD) | Next Generation Sequencing (NGS) 90.2. Centers for Medicare & Medicaid Services (CMC). January 27, 2020. Online. Last accessed on September 21, 2026
[2] Zhang Y, Yuan X. Minimal residue disease detection in early-stage breast cancer: a review. Mol Biol Rep. 2025 Jan 7;52(1):106. doi: 10.1007/s11033-024-10198-0. Erratum in: Mol Biol Rep. 2025 Feb 11;52(1):219. doi: 10.1007/s11033-025-10295-8. PMID: 39777588.
[3] Galeș LN, Păun MA, Butnariu I, Simion L, Manolescu LSC, Trifănescu OG, Anghel RM. Next-Generation Sequencing in Oncology-A Guiding Compass for Targeted Therapy and Emerging Applications. Int J Mol Sci. 2025 Mar 28;26(7):3123. doi: 10.3390/ijms26073123. PMID: 40243903; PMCID: PMC11988731.
[4] Sheinson DM, Wong WB, Flores C, Ogale S, Gross CP. Association Between Medicare’s National Coverage Determination and Utilization of Next-Generation Sequencing. JCO Oncol Pract. 2021 Nov;17(11):e1774-e1784. doi: 10.1200/OP.20.01023. Epub 2021 May 27. PMID: 34043456; PMCID: PMC8600504.
[5] Loeb S, Vadaparampil ST, Giri VN. Germline testing for prostate cancer: current state and opportunities for enhanced access. EBioMedicine. 2025 Jun;116:105705. doi: 10.1016/j.ebiom.2025.105705. Epub 2025 May 20. PMID: 40398351; PMCID: PMC12148599.

Featured image: © 2026 Cha JCO ONC Ima. Used with permission.

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