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Updated: May 11, 2025

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Claim Denials for Cancer-Related Next-Generation Sequencing in Medicare.

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Insurance claim denials for next-generation sequencing (NGS) cancer testing increased after the National Coverage Determination (NCD). Denials were higher for tests performed at independent labs and for more comprehensive genomic profiling.

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Area of Science:

  • Oncology
  • Genomics
  • Health Services Research

Background:

  • The Centers for Medicare & Medicaid Services (CMS) established a National Coverage Determination (NCD) for next-generation sequencing (NGS) genetic testing in 2018, amended in 2020.
  • Understanding the frequency and reasons for NGS insurance claim denials is crucial for patient access and healthcare costs.

Purpose of the Study:

  • To investigate the prevalence of and factors associated with claim denials for NGS testing among Medicare beneficiaries.
  • To analyze how the NCD implementation and amendments impacted NGS testing claim denial rates.

Main Methods:

  • A cohort study analyzed a 20% sample of Medicare claims data from 2016 to 2021.
  • Multivariable logistic regression models identified factors associated with claim denials, including testing type, site, and time periods relative to the NCD.

Main Results:

  • Cancer-related NGS testing claims increased significantly from 2016 to 2021.
  • The overall claim denial rate was 23.3%, with rates increasing from 16.8% pre-NCD to 27.4% post-amended NCD.
  • Claims were more likely to be denied if performed at independent laboratories (OR 2.76) or for more genes (OR 1.32).

Conclusions:

  • NGS testing claim denial rates varied by testing site and type, and increased over time, particularly after the NCD.
  • These findings indicate ongoing uncertainty in NGS coverage despite the NCD.
  • Policy interventions are needed to reduce coverage uncertainty and financial liability for NGS testing.