CMS Final Coverage Decision for NGS: a Victory for Lab Developed Tests and Cancer Patients

Josh Forsythe
March 23rd, 2018

When CMS initiated a national coverage analysis for NGS-based testing for advanced cancer on November 30, 2017, it stirred up a lot of debate among the leaders in precision medicine, and more specifically, PierianDx’s partner network of academic medical centers, cancer centers and health systems. For our customers, and essential community cancer centers that have CLIA-certified laboratories providing validated laboratory developed NGS-based tests, the proposed policy would supersede existing local coverage policies for most of those tests and limit Medicare beneficiaries’ access to a single test.

However, that original policy recommendation was modified significantly in CMS’s recent decision this week. Some of the highlights of the final decision include:

  • Expansion of eligible patient population to include recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer for therapy indication only.  
  • Patients may now receive an NGS test more than once when certain conditions are met and the patient has a new primary diagnosis of cancer.
  • NGS-based FDA approved or cleared companion in vitro diagnostic test for an FDA approved or cleared indication in a patient’s cancer will automatically receive full coverage.
  • Non-FDA approved tests will also remain eligible for Medicare coverage at local contractor level; Medicare Administrative Contractors (MACs) will be allowed to determine coverage of non-FDA approved NGS-based tests for advanced cancer when the test is performed in a CLIA-certified laboratory.
  • Removal of the registry requirement for tracking Medicare patient outcomes and performance of the diagnostic tests.

The CMS decision seemed to recognize the view of many clinical labs who claimed that the original policy would hamper the innovation of LDTs, a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory.  CMS stated that:

“Many commenters reported that they are already developing or have developed the evidence to demonstrate these diagnostic laboratory tests using NGS to improve health outcomes for Medicare beneficiaries with cancer – or are equipped to conduct their own studies to generate evidence that use of the test guides management and treatment, and improves health outcomes for the Medicare population. We strongly encourage continuing and publishing the results of these important studies, especially on the endpoints of overall survival, progression free survival, objective response, and patient reported outcomes relevant to the quality of life for Medicare beneficiaries.”

In a recent webinar facilitated by PierianDx, representatives from the Georgia Esoteric & Molecular Laboratory at Augusta University, NorthShore University Health System, Moffitt Cancer Center, UVA Health System and University of Vermont Health System Genomics Medicine Laboratory, all weighed in on the drawbacks to the original CMS policy.

“The modification of CMS’ original policy demonstrates the value of a partner network of precision medicine leaders who have been developing NGS tests in their own labs for years,” said Rakesh Nagarajan, founder and CEO of PierianDx. “It is important for leaders in precision oncology to continue to have a voice in these important coverage decisions for patients.  We are in one of the most transformational periods in the history of precision medicine. Our mission is to keep customers informed and ready for the changes ahead.”


  1.  Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)
  2. Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N) 
  3. HSP Report: Labs: NGS Medicare Coverage (FMI)
  4. Genomeweb: “CMS Final Coverage Policy for NGS Cancer Panels Eases Some Lab Industry Concerns” |  Mar 19, 2018 | Turna Ray 
  5. Association for Molecular Pathology Listserv []
  6. CMS: Medicare Coverage Center
  7. CMS: National Coverage Analyses (NCAs) Alphabetical Index
  8. CMS: Public Comments
  9. CMS: Coverage with Evidence Development

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