ACLA Files Appeal in Federal PAMA Lawsuit

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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. Polston of the law firm King & Spaulding, notified the court that the lab association would appeal the decision to the U.S. Court of Appeals for the District of Columbia Circuit. (See TDR, Oct. 1, 2018.)

The civil notice of appeal came almost 30 days after U.S. District Court Judge Amy Berman Jackson issued her Memorandum of Opinion in the case on Sept. 21. The ACLA will present its legal arguments in the case at a later date.

On Dec. 11, 2017, the ACLA filed the case in U.S. District Court for the District of Columbia against HHS Secretary Alex M. Azar. In the case, ACLA made compelling arguments that under PAMA, the HHS set clinical laboratory rates for 2018 based on a flawed data-collection process. When she dismissed the case last month, Jackson said the court lacked “subject matter jurisdiction” in the case. Under PAMA, clinical labs were precluded from challenging the rates set under the law, a provision Berman cited as a significant reason for rejecting the ACLA’s arguments.

In the same ruling, however, Jackson acknowledged that the ACLA raised important questions about how the HHS implemented PAMA and those questions so far have been unaddressed.

ACLA had argued that HHS’ rate-setting process was flawed because the HHS did not follow Congress’ intent. Instead, it collected data on what private health insurers pay labs from only 1% of the nation’s clinical laboratories, ACLA charged. ACLA believes important questions have yet to be answered and this appeal is intended to be the next step to have a higher court review the lower court’s ruling relative to those points. The entire clinical laboratory industry has a stake in whether the ACLA finally gets its day in court over the specific issues it believes have not been addressed by Judge Berman.


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