Tag: american clinical laboratory

ACLA Files Appeal in Federal PAMA Lawsuit

There is an important new development in the lawsuit in federal court that challenges how the Department of Health and Human Services (HHS) is implementing the Protecting Access to Medicare Act of 2014 (PAMA). An appeal was filed by attorneys representing the American Clinical Laboratory Association (ACLA).

On Friday, Oct. 19, the ACLA’s lead attorney on the case, Mark D.

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Court Dismisses ACLA Claims in PAMA Case

CEO SUMMARY: While acknowledging that the American Clinical Laboratory Association raises important questions in its case against the federal Department of Health and Human Services, a district court judge ruled that the court cannot resolve the dispute and dismissed the ACLA’s claims for lack of “subject matter jurisdiction.” While not dismissing it outright, the judge

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FDA Issues Response to Draft Legislation to Regulate LDTs

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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