Monday, May 26, 2025

DOJ Acts Against "Standing Orders" for Molecular Tests

While it doesn't address "standing orders," a separate topic, recall there's a major MolDx article from 2024 which deals with "pathologist-originated orders," and that under appropriate circumstances, these orders can definitely be for genomic tests (not just special stains).  Here.

If you follow this area, track a whistleblower settlement in which Agenda pays $3.2M or more regarding "standing or automatic orders" for molecular tests.  

The case also makes reference to "honoraria, gift cards, and payments per referral."  See a 360Dx article on May 22, 2025, here.  For more details see the full DOJ press release, dated May 21, here.

Regarding "settlements" - The claims resolved by the settlement are allegations only and there has been no determination of liability.


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The two qui tam cases are captioned U.S. ex rel. Raymond Brig, M.D. v. Agendia, Inc. et al., Case No. 3:21-CV-286 (E.D. Tenn.) and U.S. ex rel. Lance Albertson v. Agendia, Inc., Case No. 3:23-CV-289 (E.D. Tenn.).  The relators will receive $296,725 of the proceeds from the settlement and may eventually receive as much as $921,725.