HHS’ data collection process under PAMA disregards Congressional intent, jeopardizing lab access for millions of seniors
Washington, D.C. – The American Clinical Laboratory Association (ACLA) filed a reply brief today ahead of oral arguments in the ACLA v. Azar appeal which has been scheduled for April 23, 2019. The brief reinforces ACLA’s argument that the U.S. Department of Health and Human Services (HHS) failed to implement the Protecting Access to Medicare Act (PAMA) as Congress intended. It urges the appellate court to reverse the district court’s decision dismissing the lawsuit.
The lawsuit, filed by ACLA in December 2017, was dismissed in September of 2018 after the U.S. District Court for the District of Columbia concluded that despite the fact that ACLA’s “arguments on the merits raise important questions,” ruling on “the establishment of payment amounts” under PAMA was barred by the statute. ACLA filed an appeal arguing that, “The act of promulgating a legislative rule requiring private parties to report confidential data does not itself establish payment amounts.”
As ACLA’s brief notes, “PAMA’s text and structure show that Congress directed the Secretary to undertake two separate and logically distinct actions,” the first being establishing parameters for data collection and the second being establishment of payment amounts. “Congress precluded judicial review of only ‘the establishment of payment amounts.’ It did not bar review of the Secretary’s final regulations establishing the parameters for collecting confidential data from laboratories.” HHS’ response brief filed February 25, 2019 offered no meaningful answers to these important distinctions.
“Throughout this process, HHS has advanced a data collection process that is not only flawed and incomplete in its own right but also stands to directly harm the health of millions of seniors who rely on the Medicare lab services being jeopardized,” said ACLA President, Julie Khani. “Congress intended to protect seniors’ access to care. HHS’ implementation has turned that intent on its head and puts seniors at risk, particularly the most vulnerable seniors and those who suffer from chronic disease.”
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ACLA is a not-for-profit association representing the nation’s leading clinical and anatomic pathology laboratories, including national, regional, specialty, hospital, ESRD and nursing home laboratories. The clinical laboratory industry employs nearly 277,000 people directly, and generates over 115,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $100 billion to the nation’s economy.