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Court Cuts Back FCA Coverage For Medicaid Fraud

Client Alert | 1 min read | 12.16.04

Following the lead of the D.C. Circuit in U.S. ex rel. Totten v. Bombardier Corp. (Aug. 27, 2004) [see C&M Bullet Point 9/16/2004), in U.S. ex rel. Atkins v. McInteer (Oct. 27, 2004), the Northern District of Alabama dismissed a qui tam complaint for lack of subject matter jurisdiction because, among other reasons, the complaint did not allege that the defendant health care providers “presented” claims to the federal Government for payment when making claims (or conspiring to make claims) to the Alabama Medicaid Agency, even though that agency receives 70% of its funding from the federal Government. Unwilling to wait for the then-pending (now-denied) motion for en banc rehearing of Totten, and staking out a position with far-reaching implications for contractors doing business with federal grantees, particularly Medicaid providers, the District Court broadly held: “If the Totten court is correct, fraud perpetrated upon a non-federal agency cannot form the basis for an FCA claim just because the non-federal agency thereafter presents a claim for payment to a federal official.”

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Client Alert | 9 min read | 10.21.26

Artificial Intelligence in Life Sciences: Reliability of AI-Generated Evidence in Drug Discovery and Development

The life sciences sector is uniquely vulnerable to the inherent risks of AI-generated evidence in drug development and discovery. This client alert focuses on five core challenges: hallucinations, skewed predictions from unrepresentative training data, the opacity of AI reasoning, input sensitivity that undermines reproducibility, and adversarial manipulation of training data. To address these risks, companies should use experimental validation and human oversight as the common legal and regulatory safety net. This entails among other measures auditing AI outputs, characterizing training data, and structural oversight. Companies also should prepare for evolving frameworks and guidance from the U.S. Food and Drug Administration (FDA) and the European Union (EU) that address use of AI in drug discovery and development .  ...