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On March 16, 2018, the Centers for Medicare and Medicaid Services (CMS) issued a decision memo for Next Generation Sequencing (NGS) tests for Medicare beneficiaries with advanced cancer. In the memo, CMS stated that NGS tests as a diagnostic lab test are reasonable and necessary if the following conditions are met:

  • It is performed in a CLIA-certified lab.
  • It is ordered by a treating physician and all the following requirements are met:
    • The patient has:
      • Recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer.
      • Not been previously tested using the same NGS test for the same primary diagnosis of cancer OR repeat testing using the same NGS test only when a new primary cancer diagnosis is made by the treating physician.
      • Decided to seek further cancer treatment
    • The diagnostic lab test using NGS must have:
      • Food and Drug Administration (FDA) approval or clearance as a companion in vitro diagnostic.
      • An FDA approved or cleared indication for use in that patient’s cancer.
      • Results provided to the treating physician for management of the patient using a report template to specify treatment options.

CMS also stated that Medicare Administrative Contractors (MACs) may determine coverage of NGS as a diagnostic lab test only if the above patient requirements are met and the test is performed in a CLIA-certified lab. The memo from CMS contains the text of the proposed Medicare National Coverage Determination (NCD) manual – although that language is subject to formal revisions prior to the release of the final NCD contractor instructions.

This decision was made following a parallel review with the FDA, which on Nov. 17, 2017, granted approval of the Foundation One CDx (F1CDxTM) test. At that time, CMS issued a proposed NCD for NGS cancer diagnostics. CMS is covering the F1CDxTM test along with other FDA approved or cleared companion in vitro diagnostics when the test has an FDA-approved or cleared indication for use in that patient’s cancer. The results must be provided to the treating physician for management of the patient, with a report template that specifies treatment options.

In the related press release announcing its decision, CMS stated that it was taking this action to advance innovative personalized medicine for Medicare patients with cancer. The press release further states “Tests that gain FDA approval or clearance as an in vitro companion diagnostic will automatically receive full coverage under this final NCD, provided other coverage criteria are also met.” The NCD removes coverage with evidence development and encouraged continued publication of the rests of studies related to these diagnostic lab tests using NGS.

If you have questions, please do not hesitate to contact any of the following attorneys.

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