TAG:

molecular pathology

Mount Sinai Health System Sells Outreach Lab to LabCorp

ANOTHER ACADEMIC MEDICAL CENTER decided to cash in on the value of its outreach lab. On Jan. 10, Laboratory Corporation of America announced it would acquire the lab outreach business of Mount Sinai Health System of New York City. Terms of the transaction and purchase price were not disclosed. The…

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OIG Comments on PAMA Plan and Exclusion of Many Labs from Reporting

ON THE SUBJECT OF LAB TEST MARKET PRICE REPORTING as required under PAMA, many clinical laboratory executives, pathologists, and industry experts see deep flaws in the process the federal Centers for Medicare & Medicaid Services has established. Yet, CMS itself seems blind to the…

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ADLT Final Rule Creates Tough Questions for Labs

IT’S GOING TO BE A DIFFERENT AND TOUGHER WORLD for laboratory companies that market proprietary molecular and genetic tests. That’s the opinion of experts who have studied the final rule governing Advanced Diagnostic Laboratory Tests (ADLTs) that the federal Centers for Medicare & Med…

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Understanding the Future Of Laboratory Medicine

CEO SUMMARY: Healthcare’s transformation is now far enough along that most clinical labs and pathology groups are either feeling the financial pain or are excitedly developing ways to deliver more value from lab testing services. On April 26-27, at the 21st annual …

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FDA Steps Up Test Enforcement, Saying Tests Need Clearance

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Palmetto GBA Issues Guidance On Billing NGS Test Panels

CEO SUMMARY: Across the lab industry, next generation sequencing is taking hold as an effective and efficient testing platform. In response, payers are developing coding and payment policies that may affect the finances of clinical labs. Last month, Palmetto GBA, a Medicare contractor, is…

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Despite Tough Anatomic Pathology Market, Bostwick Opens New Laboratory

CEO SUMMARY: Once again, entrepreneur and pathologist David G. Bostwick, MD, is starting up a new lab company. Granger Diagnostics is now open and is located in North Chesterfield, Virginia. It is designed to be an anatomic, clinical, and molecular pathology reference laboratory. In an ex…

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FDA Official Makes Case In Favor of LDT Guidance

CEO SUMMARY: Forty years ago, pathologists in hospital and academic labs worked closely with treating physicians to produce laboratory-developed tests for discrete clinical cases. Seeing that, the FDA decided not to regulate those tests, an FDA official said. Over time, however, use of L…

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Labs React with Criticism to Proposed ADLT Rule

CEO SUMMARY: Some in the lab industry had high hopes that passage of the Protecting Access to Medicare Act (PAMA) last year would favorably resolve a number of important issues. However, those hopes were dashed following the September 25 release by CMS of a proposed rule setting out how i…

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Newer, Smaller Analyzers Will Bring Big Data to Labs

CEO SUMMARY: Clinical laboratories of all sizes are poised to become the source of much of a hospital or health system’s “big data.” At many academic center labs, greater use of genetic and molecular testing requires that more space and more staff be devoted to data management. A…

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