July 30, 2019

CAP, ACLA Score Win in Appeals Court Ruling on PAMA

BY Dr. Keith J. Kaplan

The 2014 PAMA law drastically changed the Medicare clinical laboratory fee schedule (CLFS) by requiring reimbursements for clinical laboratory services to be based on private rates. The CAP has sought to ensure these reimbursements are accurate and reflect all sectors of the clinical laboratory market. However, the CAP found flaws in the private-market data collection process and has advocated for changes to the PAMA statute and resulting regulatory implementation.

As part of our advocacy, the CAP joined a lawsuit led by the American Clinical Laboratory Association (ACLA) against the Department of Health and Human Services (HHS) to correct its execution of the PAMA reforms to the CLFS. On December 11, 2018, the CAP filed an amicus brief in support of ACLA’s appeal to overturn a US District Court for the District of Columbia decision to dismiss the lawsuit. ACLA, the CAP, and others maintain the implementation of how the HHS defined the applicable laboratories required for data collection was arbitrary and capricious.

In September 2018, the US District Court had ruled that it lacked jurisdiction and could not compel the HHS to follow statutory requirements.

Oral arguments for the appeal were held before the US Court of Appeals for the DC Circuit on April 23 to remand the case for consideration of the arbitrary-and-capricious challenge. The CAP in its amicus brief argued that the US District Court did have legal authority. The CAP outlined precedent for the US Court of Appeals to return the case to the lower court.

In the July 30 ruling, the US Court of Appeals agreed and stated, “We leave to the district court on remand to address in the first instance the merits of petitioner’s arbitrary-and-capricious challenge.”

Source: College of American Pathologists

 

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