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Reimbursement has been cited as a key barrier to the adoption of precision medicine into clinical care.1 This issue has recently attracted attention with the March 2018 Centers for Medicare & Medicaid Services (CMS) national coverage determination on next-generation sequencing tests for patients with advanced cancer.2 This policy represents a step forward by addressing the vexing issue of coverage for these complex tests. Private and public coverage for next-generation sequencing tests for patients with cancer and those with other conditions is currently limited and variable3 and the new policy offers a roadmap for coverage. The policy provides coverage for companion diagnostics that have approved indications by the US Food and Drug Administration for patients with advanced cancer. The final policy was significantly different from the draft issuance, which generated controversy as evidenced by 315 comments submitted to the CMS, publication of several opinion articles and editorials, and intense industry lobbying. In the draft issuance, there were 2 coverage pathways: (1) approved tests by the FDA meeting all criteria are covered and (2) other tests could be covered via Medicare’s coverage with evidence development program if laboratories collected the required data. A particularly notable change is that the final policy removed the second pathway and replaced it with the option of seeking a local coverage determination through regional Medicare administrative contractors, which means that these types of Medicare contractors will have discretion on which tests to cover. The final policy also broadened coverage to a wider group of patients with cancer (ie, recurrent, relapsed, refractory, metastatic, or advanced stage III or IV). However, issuance of the new policy does not imply that coverage issues are now resolved. It is important to address the broader policy implications of this new coverage approach. Although this policy covers only a specific type of testing for a specific patient group, it is possible that the general coverage approach used may be applied to other tests and conditions in the future. For example, next-generation sequencing tests are available for early-stage cancer, hereditary cancer, developmental delays in children, carrier and prenatal screening, drug metabolism testing, and cardiovascular and metabolic diseases. Commentators have addressed the implications of the CMS policy for patients, clinicians, health care organizations, and industry, but a health policy agenda needs to be developed to address the broader implications and to facilitate the development of the evidence needed for appropriate, efficient, and equitable policies and implementation. The following questions should be considered.

Evolving Payer Coverage Policies on Genomic Sequencing Tests