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Providers & payers sign U.S. pledge to develop AI responsibly, as HHS finalizes Health IT rule

The U.S. Biden administration announced Thursday that 28 health care providers and payers have signed the White House’s voluntary commitment aimed at ensuring the safe development of...

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OIG’s first-ever General Compliance Program Guidance covering all health care parties released

In November 2023, OIG released its first ever General Compliance Program Guidance (GCPG). The GCPG is a comprehensive document that applies to all individuals and entities involved in the...

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Supreme Court’s Schutte decision: the meaning of knowledge remains elusive

On June 1, 2023, the U.S. Supreme Court issued its highly anticipated opinion in the most watched False Claims Act (FCA) case in years.

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CMS Proposes Significant Changes to Medicaid Drug Rebate Program

On May 23, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled Misclassification of Drugs, Program Administration and Program Integrity Updates...

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Oral arguments suggest hesitancy from SCOTUS to agree with the Seventh Circuit on SuperValu FCA case

On April 18, 2023, the U.S. Supreme Court (SCOTUS) heard oral argument in the most significant False Claims Act (FCA) case to reach the Court in recent years. The Court is examining the...

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Sixth Circuit weighs in on meaning of causation, remuneration for False Claims based on alleged kickbacks

The Sixth Circuit expanded the existing circuit split regarding when a kickback causes a federal health care claim to be false or fraudulent under the False Claims Act (FCA) and set out a...

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New circuit split on evidence needed to prove a kickback renders a claim false or fraudulent

The Eighth Circuit released an opinion Tuesday in U.S. ex rel. Cairns v. D.S. Medical LLC that creates a new circuit split on the interpretation of the causation standard for establishing...

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World Stem Cell Summit panel cautions over stepped up HCT/P enforcement, reimbursement issues

Speaking at the World Stem Cell Summit hosted by the Regenerative Medicine Foundation last week, Hogan Lovells partners Mike Druckman, Stuart Langbein, and Thomas Beimers discussed evolving ...

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OIG green lights drug manufacturer-sponsored genetic testing program

On April 11, 2022, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published Advisory Opinion No. 22-06, concluding that a pharmaceutical...

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