ACLA Scores Major Legal Win in PAMA Lawsuit

Publication Date: Aug 2, 2019

On July 30, the U.S. Court of Appeals ruled in favor of the American Clinical Laboratory Association (ACLA) in the case of ACLA v. Azar. The lawsuit challenges the flawed data collection process established by U.S. Department of Health and Human Services (HHS) to develop a new Clinical Laboratory Fee Schedule (CLFS).

When Congress enacted the Protecting Access to Medicare Act (PAMA), it required HHS to develop a new “market rate” CLFS based on private payer data collected from applicable clinical laboratories. However, in constructing a new fee schedule, the Agency largely ignored market rate data from hospitals and other facilities that tend to receive higher wages than independent reference laboratories, thus failing to meet Congress’s requirements.

Interestingly, PAMA prohibits judicial review of the HHS’s establishment of payment rates but ACLA argued, and the court agreed, that this did not bar the courts from reviewing the final regulations establishing the data collection process. In siding with ACLA, the Court also remanded the case back to the District Court for further proceedings consistent with this opinion. ASCP strongly supported ACLA’s lawsuit against HHS and congratulates ACLA on a truly important legal victory.

Click here to access ACLA’s press release on the Court’s decision.

Other articles in the August 2019 ePolicy:

ASCP Urges Anthem to Reconsider Cuts to Pathology, Laboratory Rates
CMS (Finally) Releases 2020 CY Physician Fee Schedule
Cervical Cancer Risk Guidelines Public Comment Now Open
NASEM Committee to Identify Gaps in Clinical Practice Guidelines for Acute Pain Opioid Prescriptions

To read more articles from ePolicy News click here.

For more information regarding ASCP's advocacy initiatives and policy positions, please contact ASCP's Center for Public Policy at (202) 408-1110.

ASCP ePolicy News is supported by an unrestricted grant from Hologic.

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