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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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New Connecticut rules for drug makers employing sales reps take effect Oct. 1

The state of Connecticut recently enacted HB6669, which requires registration of pharmaceutical manufacturers employing sales representatives who interact with health care professionals...

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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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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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Reminder: New Oregon licensure requirements for pharma sales reps now in effect!

As we recently summarized online here, Oregon has approved a temporary rule implementing SB 763, which requires licensure of pharmaceutical sales representatives who visit...

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Oregon adds licensure requirements for pharma sales reps

Taking effect January 1, Oregon recently approved a temporary rule implementing SB 763, which requires licensure of pharmaceutical sales representatives who visit health care providers in...

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PhRMA responds: Code on Interactions with HCPs updated following fraud alert on speaker programs

On August 6, Pharmaceutical Research and Manufacturers of America (PhRMA) released an updated and enhanced version of its voluntary Code on Interactions with Health Care Professionals...

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HHS Regulatory Sprint takes final shape, Part 2: AKS, Stark regulatory revisions for value-based care

Following on last October’s publication of two proposed rules, the Department of Health and Human Services (HHS) published on November 20 two final rules intended to “modernize...

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