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August 2023 FDA Watch
Centers for Medicare & Medicaid Services proposes TCET pathway to expedite Medicare Coverage of newly approved breakthrough devices.
Buy or Lease: Seven Things to Consider When You Need a New Instrument
Deciding whether to purchase or lease laboratory instrumentation involves a variety of factors.
Dx Deals: Exact Sciences Makes Big Moves to Maintain Leadership of Cancer DNA Testing Market
Release of second-generation Cologuard test data and recently announced partnerships aim to position company well for the future.
M&A and Strategic Deals: Thermo Fisher, BD, and Quest Use M&A to Advance Post-COVID-19 Strategies
Diagnostics companies that invested heavily in COVID-19 products are relying on M&A transactions to restructure and transition.
Lab Company Layoff Ledger: First Half of 2023
In the first half of this year, US companies have cut the second-highest total of jobs since 2009, according to a recent report.
Brief Your CEO: New SCOTUS Case May Help Your Lab Defend Meritless Whistleblower Cases
A recent SCOTUS ruling on a healthcare fraud case could help defend labs against baseless whistleblower cases.
Billing & Coding: The Expanding Role of Z-Codes
Labs will have to submit Z-Codes with every molecular pathology testing code billed to UnitedHealthcare, starting Aug. 1.
August 2023 Labs in Court
Last month’s key cases involved the outcome of a UHC lawsuit and fines for misleading claims about a COVID-19 test.
Addressing the Challenges of Bile Acid Diarrhea Diagnosis
A new five-metabolite blood test designed by algorithm could simplify and speed up this challenging diagnosis.
Using the IQCP Process to Improve CLIA Compliance and Lab Testing System Quality
Individualized quality control plans offer flexibility and the capacity to seamlessly adopt new nonwaived tests, practices, and technologies.