Labs In Court

Arizona Lab’s 20-Year Quest to Regain CLIA Certification Comes Up Empty

Case: CMS revoked an Arizona lab’s CLIA certification in 2000. Three unsuccessful appeals and one failed petition to the U.S. Supreme Court later—eight years in total—the seven CLIA deficiencies, which the lab owner continued to insist were invalid, remained unremedied and the $30,000 fine unpaid. In 2013, the owner sought new CLIA certification for the lab but the state refused to process the application unless and until the owner paid the fine and resolved the previous sanctions. A new round of appeals ensued and the case landed in an Arizona federal district court which ruled against the owner.

Analysis: The CLIA law establishes a specific process for appealing the denial of certification under which a lab must first go to an Administrative Law Judge (ALJ) before it can go to federal court. But I’m not asking for new CLIA certification, the owner argued, just reinstatement of the old one. The court didn’t buy it. CMS didn’t temporarily suspend the lab’s CLIA certification back in 2000, it permanently revoked it. As a result, this was a new application and the owner had to follow the CLIA appeals process and take its case to the ALJ.

[Ali v. United States HHS, 2020 U.S. Dist. LEXIS 110998]