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American Clinical Laboratory Association

Labcorp, Quest Diagnostics Discuss Q4 & 2023 Earnings

DURING RECENT EARNINGS CALLS WITH FINANCIAL ANALYSTS AND INVESTORS, both Labcorp and Quest Diagnostics discussed their fourth quarter (Q4) and full year 2023 financial results. Each reported some stability in the market for clinical laboratory testing services, reflected in the numbe…

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Year’s Top 10 Lab Stories Contain Surprises & Twists

CEO SUMMARY: With the SARS-CoV-2 pandemic now in the rearview mirror of the nation’s clinical labs and pathology groups, the important news stories of 2023 were mostly about developments where the consequences will influence laboratory operations in coming years. Artificial intelligence…

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Congress Delays PAMA Fee Cuts, Passage of SALSA Act Is Goal

ONCE AGAIN, THE CLINICAL LABORATORY INDUSTRY DODGED THE MEDICARE FEE-CUT BULLET. Last month, Congress passed a bill that included a one-year reprieve to the impending PAMA reimbursement cuts that were scheduled to take place on January 1, 2024. The lab industry…

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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 diagnos…

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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…

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CMS Ends Remote Reading of Pathology Glass Slides

CEO SUMMARY: On the day the federal government ended the public health emergency for SARS-CoV-2, CMS issued an updated FAQ that ended the allowance for remote reviews of glass slides…

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Best Practices for Labs to Secure MT Program Funds

CEO SUMMARY: In securing federal funds for a new MT training center, ARUP Labs and the University of Utah took steps that clinical labs can follow for their own project financing. Among the key lessons is the need to showcase the work a lab does within a community to politicians and…

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March 6, 2023, Intelligence: Late-Breaking Lab News

Since Congress did not include new regulations for laboratory-developed tests (LDTs) in a year-end spending budget, it appears the Food and Drug Administration (FDA) will take steps of its own to increase the agency’s oversight of LDTs. “We are moving forward with rulemaking,” said Eliza…

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Congress Averts PAMA Cuts to Lab Test Rates for 2023

CONGRESS ENACTED LEGISLATION LAST MONTH that suspends implementation of the next round of price cuts to the Medicare Part B Clinical Laboratory Fee Schedule (CLFS) that was scheduled to take effect on Jan. 1. This is a welcome development for the medical laboratory industry….

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Newsmaker Interview: Director of CDC’s Division of Laboratory Systems Talks COVID-19, CLIA, and More

CEO SUMMARY: In this exclusive interview, Reynolds Salerno, PhD, the Director of the Division of Laboratory Systems at the CDC, offers insightful comments about the federal agency’s response to the SARS-CoV-2 pandemic, what went right during public health efforts, and lesson…

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