9th Circuit nixes win for diagnostic test maker Agendia
July 17, 2021
10:44 AM EDT
Last Updated 5 hours ago
Barbara Grzincic
(Reuters) - A divided panel of the 9th U.S. Circuit Court of Appeals reversed a win for molecular-diagnostic test maker Agendia Inc in its challenge to Local Coverage Determinations (LCDs) — standards for Medicare coverage adopted by the private contractors who handle claims for payment.
The majority on Friday said a district court judge erred in reviving 86 claims Agendia had filed in 2012 and 2013, which a regional Medicare contractor had denied based on its 2011 LCD that nearly all molecular-diagnostic testing was “investigational.”
The lower court had agreed with Agendia’s lawyers at Hooper, Lundy & Bookman, who argued that LCDs must go through the rigorous notice-and-comment procedures the Medicare Act requires for substantive rulemaking by the U.S. Health and Human Services Department.
https://www.reuters.com/legal/litigation/9th-circuit-nixes-win-diagnostic-test-maker-agendia-2021-07-17/
