Since 1995, Reliable Business Intelligence for Clinical Laboratories, Pathology Groups and Laboratory Diagnostics

Volume XXX, No. 14 - October 2, 2023

FDA Releases Proposed Rule to Further Regulate LDTs

The U.S. Food and Drug Administration (FDA) has taken the first step to regulate laboratory developed tests (LDTs). Many in the clinical laboratory oppose the FDA on this point. Last week, the agency made the draft rule public, prior to its official publication this week. This move by the FDA—which picked up significant momentum over …

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Two Forces Push for More FDA Oversight of LDTs

CLINICAL AND GENETIC TESTING LABS MAY SUDDENLY FEEL THEMSELVES STUCK IN THE MIDDLE of a yin-yang situation when it comes to laboratory developed tests (LDTs). One force, the U.S. Food and Drug Administration (FDA), is pulling on laboratories by proposing more stringent requirements for LDTs. Another force, this one by means of Congress, is attempting …

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FDA Issues Proposed Rule to Further Regulate LDTs

CEO SUMMARY: Publication of the FDA’s draft rule on LDT regulation starts the clock on public comment. The proposal seeks to clearly identify laboratory developed tests (LDTs) as in vitro diagnostic devices, which then places many of these tests under increased regulatory review. Clinical laboratory managers and pathologists have until Dec. 2 to submit comments …

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FDA’s Road to Regulation of Lab Developed Tests

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

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

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

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

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

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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