Tag: clinical laboratory diagnostics

FDA Issues Response to Draft Legislation to Regulate LDTs

By Joseph Burns, from the Volume XXV No. 12 – August 20, 2018 issue

DURING HER ADDRESS TO THE ANNUAL MEETING of the American Clinical Laboratory Association meeting in March, Rep. Diana DeGette (D-Colo.) explained why she and others in Congress had developed the Diagnostic Accuracy and Innovation Act (DAIA), a discussion draft that would give the FDA authority to regulate laboratory developed and in vitro diagnostic tests. At

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Study Reveals Medicare Already Pays Low Rates

By Joseph Burns, from the Volume XX No. 17 - December 23, 2013 issue

CEO SUMMARY: Researchers studied a database containing laboratory test prices paid in 2012 on behalf of 56 million Americans covered by private health plans and determined that, for most tests, and in most regions, Medicare already pays less than private health insurers for clinical laboratory tests. There are exceptions, but the findings provide a credible

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Volume XXV No. 17 – December 3, 2018

DID CONGRESS JUST PASS A LAW that makes innocent labs guilty of criminal acts? At the last minute, Congress added all clinical laboratories to a far-reaching anti-kickback provision in the newly-enacted Support for Patients and Communities Act -- a provision that makes common practices such as paying commissions to sales staff or placing phlebotomists in labs could be illegal. Worse: The experts are baffled by the language of the new law. Notes one of these experts in this issue, "Someone in the clinical lab industry may have to get prosecuted before we get some clarity, unless the Secretary of HHS issues clarifying regulations."

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Tag: clinical laboratory diagnostics

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