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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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OIG signals “significant concerns” with company-sponsored speaker programs

On November 16, 2020, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG) issued a rare Special Fraud Alert – a type of guidance historically ...

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OIG denies proposed manufacturer-sponsored copay support program for Medicare beneficiaries

On September 23, the HHS OIG published Advisory Opinion No. 20-05, advising that OIG found “highly suspect” a manufacturer’s proposal to create a copay subsidy program to...

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AbbVie settlement seems to end period of intense scrutiny for manufacturer patient support programs

Earlier this month, the California Insurance Commissioner announced that AbbVie had entered into a settlement agreement with the California Department of Insurance (CDOI) to resolve...

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