The Federal Tort Claims Act (“FTC”) imposes liability on anyone who “knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval” to the federal government. 31 U.S.C. § 3729(a)(1)(A). For a successful FCA claim under this part of the statute, the relator needs to show: (1) that there’s a “false or fraudulent claim” made to the government, (2) that the defendant “presents, or causes to be presented,” that claim, and (3) that the defendant did so “knowingly.”
The FTC defines “knowingly” to encompass three mental states: (1) a person who “has actual knowledge of the information,” (2) one who “acts in deliberate ignorance of the truth or falsity of the information,” and (3) one who “acts in reckless disregard of the truth or falsity of the information.” 31 U.S.C. § 3729(b)(1)(A)(i)-(iii).
Actual knowledge refers to whether a person is aware of information about the claim’s falsity. Deliberate
ignorance encompasses defendants who are aware of a substantial risk that their statements are false, but
intentionally avoid taking steps to confirm the statement’s truth or falsity. Reckless disregard similarly captures
defendants who are conscious of a substantial and unjustifiable risk that their claims are false, but submit the claims anyway. The scienter standard turns on the defendant’s knowledge and subjective beliefs — not on what an objectively reasonable person may have known or believed. The relevant inquiry focuses us on what the defendant thought when submitting the false claim — not what the defendant may have thought after submitting it. In short, either actual knowledge, deliberate ignorance, or recklessness regarding the claim’s falsity will suffice to show scienter.
The United States Court of Appeals for the First Circuit stated in its December 2, 2025 Opinion: “We struggle to make sense of OMNI’s litigation position about medical necessity. We strain to see how MD Labs could know, be deliberately indifferent to, or reckless about a test being medically unnecessary when it has, in-hand, a requisition form from OMNI … Accepting OMNI’s position to the contrary could also lead to dangerous consequences. Should laboratories start
second-guessing a doctor’s orders, delaying care to double-check the doctor’s work (however that might get accomplished), or even providing different, less-expensive care than the doctor ordered just to avoid FCA liability?”
“So we hold (as a matter of first impression in the First Circuit) that in FCA cases alleging Medicare fraud based on
laboratory testing, generally a laboratory can rely on a doctor’s order to show that the test is “reasonable and necessary” under 42 U.S.C. § 1395y(a)(1)(A) … the doctor’s order for medical testing will generally offer a safe harbor of medical necessity that, once raised, a relator must rebut, discredit, or undermine to raise a genuine dispute of material fact as to the lab’s scienter … Put differently, the doctor’s determination of medical necessity (inherent, if not explicitly stated, in the order for the test) demonstrates “the absence of any genuine issue of material fact” about a lab’s scienter of a false claim, such that it becomes the relator’s problem to “demonstrate that a trier of fact could reasonably resolve” the claim (and, in particular, the necessary scienter element) in its favor despite the doctor’s order.”
“[W]e see eye-to-eye with the district court in concluding that OMNI has failed to present any evidence through which a reasonable jury could find for it on the scienter issue. Because scienter is an essential element of the claim, that’s dispositive. See 31 U.S.C. § 3729(a)(1)(A).”
Source United States, ex rel. v. Omni Healthcare, Inc., No. 25-1110.
If you have information regarding false claims having been submitted to Medicare, Medicaid, TRICARE, other federal health care programs, or to other federal agencies/programs, and the information is not publicly known and no actions have been taken by the government with regard to recovering the false claims, you should promptly consult with a False Claims Act attorney (also known as qui tam attorneys) in your U.S. state who may investigate the basis of your False Claims Act allegations and who may also assist you in bringing a qui tam lawsuit on behalf of the United States, if appropriate, for which you may be entitled to receive a portion of the recovery received by the U.S. government.
Visit our website or call us toll-free in the United States at 800-295-3959 to be connected with qui tam lawyers (False Claims Act lawyers) in your U.S. state who may assist you with a False Claims Act lawsuit.
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