Thanks to a recent update from the Centers for Medicare and Medicaid Services (CMS), practices will now be able to receive Medicare reimbursement for next generation sequencing (NGS) tests. These tests, which help predict a patient’s response to a specific cancer drug, can play a major role in helping patients receive proper cancer treatment.

Under this update, NGS tests are eligible for reimbursement as long as they meet the following criteria:

  • They have received FDA approval or clearance as companions to in vitro diagnostics.
  • They have received FDA approval or clearance for use in treating the patient’s cancer.
  • The results are reported using a specific template.
  • They are performed in a CLIA-certified laboratory.

Additionally, the patient must also meet several criteria, including:

  • Have stage III or stage IV cancer that is either recurrent, refractory, relapsed, metastatic, or advanced.
  • Not have undergone a previous test with the same NGS for the same type of cancer.
  • Have decided to seek additional cancer treatment such as chemotherapy.

As of yet, only five specific NGS tests have met all the criteria and are able to be reimbursed by CMS. These tests, along with the companies that developed them, are:

  • Foundation Focus CDxBRCA – Foundation Medicine, Inc.
  • F1CDx – Foundation Medicine, Inc.
  • Oncomine Dx Target Test – Thermo Fisher Scientific, Inc.
  • Praxis Extended RAS Panel – Illumina, Inc.
  • MSK-IMPACT – Memorial Sloan Kettering Cancer Center’s Integrated Mutation Profiling of Actionable Cancer Targets

Although this update is a major step forward for practices that administer NGS tests, there are still plenty of hurdles to overcome. Chief among these is the fact that the coding structure isn’t always specific enough; the current CPT codes merely denote genomic sequencing in general without specifying if the sequencing was conducted via an NGS test or a different means. CMS has said that it plans to remedy this problem soon, but until then, coders should treat these procedures with extra caution.