February 4, 2019 Intelligence: Late Breaking Lab News

More than 63 healthcare and medical service organizations signed a letter asking officials at the federal Centers for Medicare and Medicaid Services (CMS) to reconsider their latest interpretation of a National Coverage Determination (NCD) on the subject of next-generation sequencing (NGS). Clinicalomics wrote that “the final NCD also included repeat testing when a new primary cancer diagnosis is made by the treating physician and the patient meets other clinical criteria—but removed coverage with evidence development for tests not authorized by the FDA.”


In the letter to CMS, the undersigned organizations wrote, “It is our understanding that despite the NCD being requested for a somatic-based test, CMS has instructed Medicare Administrative Contractors (MACs) to apply the terms of the NCD to both somatic and germline NGS-based testing for patients with cancer. The implication of this interpretation is that both germline and somatic tumor NGS-based testing will become ‘non-covered’ for Medicare beneficiaries with early-stage cancer. Our organizations believe that the inclusion of NGS-based testing for germline mutations represents significant policy over-reach by CMS that will have unintended consequences on the care delivered to Medicare beneficiaries.”


On Jan. 14, Health Network Laboratories (HNL) of Allentown, Penn., announced its purchase of Connective Tissue Gene Tests, LLC (CTGT), of Allentown, Penn. CTGT offers diagnostic tests for inherited genetic disorders.


  • Metabolon of Morristown, N.C., announced that Michael Rasche is its new President of International Business. Rasche previously held executive positions at Definiens, AYOXXA Biosystems GmbH, Dako, Roche Diagnostics, and Bayer Diagnostics.
  • InReach Community Dx, of Seattle selected Francisco R. Velázquez, MD, SM, to be its Chairman of the Board. Velázquez has held executive positions at PAML and Quest Diagnostics.
  • John Lubniewski will be the new CEO at HTG Molecular Diagnostics, of Tucson, Ariz., where he is currently President and COO. Lubniewski has previously worked at Roche Diagnostics, Ventana Medical Systems, and Corning Incorporated.

That’s all the insider intelligence for this report.
Look for the next briefing on Monday, February 25, 2019.

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…how the Food and Drug Administration cleared 23andMe to report results of its direct-to-consumer pharmacogenetics test to customers without a physician’s order, thus bypassing doctors and clinical laboratories.

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