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Susan Van Meter

LDT Rule Is Now a Fact! What Will Be Consequences?

TODAY, THE NEW RULE FOR REGULATION OF LABORATORY DEVELOPED TESTS …

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ACLA President Van Meter Discusses LDT Lawsuit

CEO SUMMARY: On July 5, the final laboratory developed test (LDT) rule issued by the federal Food and Drug Administration (FDA) takes effect. In response, the American Clinical Laboratory Association (ACLA) filed a lawsuit in federal court in Texas to challenge the FDA’s actions. In thi…

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Congressional Subcommittee Hears Testimony on FDA LDT Rule

DURING A MARCH 21 HEARING CONVENED by the U.S. House Energy and Commerce Subcommitt…

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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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