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October 2023

FDA’s Road to Regulation of Lab Developed Tests

Genetic Testing, Lab Risk & Compliance, Laboratory Compliance /

CEO SUMMARY: Today’s generation of clinical lab managers and pathologists should understand that the FDA’s efforts to publish a draft rule defining its authority to review laboratory developed tests (LDTs) goes back at least to 2014. That’s the year when the FDA first issued a notice to Congress that it intended to regulate LDTs. Even […]

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SALSA Bill Resurfaces, Poised to Reduce Upcoming PAMA Cuts

Lab Intelligence, Lab Risk & Compliance, Laboratory Compliance /

ANOTHER ROUND OF STIFF PRICE CUTS TO THE MEDICARE PART B CLINICAL LABORATORY FEE SCHEDULE (CLFS) is just months away, with the provisions of the Protecting Access to Medicare Act (PAMA) set to resume on Jan. 1. In response to that looming threat, laboratory trade groups, including the American Clinical Laboratory Association (ACLA), are again

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Outreach Nets Hospital Lab $2.5M in One Year

Lab Intelligence, Laboratory Management, People /

CEO SUMMARY: Tucson Medical Center had sold its outreach business to a commercial laboratory two decades earlier, but wanted to bring those services back to its in-house lab. Early work with the finance department proved crucial to determining the cost of the effort, which in the end has brought in millions in new revenue. DURING

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How Private Payers Audit Labs for Possible Claims Fraud

Genetic Testing, Lab Risk & Compliance, Laboratory Billing, Laboratory Compliance, Managed Care Contracts, Molecular Diagnostics /

EDITOR’S NOTE: Our column, Virchow, is written by different anonymous insiders working within the managed care world. The column aims to help clients of The Dark Report better understand the decisions, policies, and actions of payers as they manage their laboratory networks, establish coverage guidelines, process lab test claims, and audit labs. IN RECENT YEARS,

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Labcorp and Quest Discuss Outreach Acquisition Potential

Clinical Laboratory Trends, IVD/Lab Informatics, Lab Marketplace, Laboratory Management /

GIVEN THE POTENTIAL UPSIDE OF HUNDREDS OF MILLIONS OF DOLLARS IN ADDED REVENUES, both Labcorp and Quest Diagnostics remain on the prowl to acquire more hospital laboratory outreach businesses and seize opportunities to manage inpatient hospital and health system labs. That topic figured prominently into both companies’ Q2 2023 earnings calls with financial analysts. For

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October 2, 2023, Intelligence: Late-Breaking Lab News

Late Breaking Lab News /

Forming new relationships with non-traditional care providers is one way clinical laboratories can earn additional revenue. With that in mind, here’s another sign of the changing landscape of primary care. Warehouse club Costco announced a new partnership with Sesame on Sept. 25. Sesame is a New York-based online marketplace of reduced-priced healthcare providers— including clinical

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