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News

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...

News

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...

News

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...

News

HHS Regulatory Sprint takes final shape, Part 1: Substantial Stark Law regulatory revisions adopted

Along with proposed Stark Law exceptions designed to accommodate value-based care models, the Centers for Medicare & Medicaid Services (CMS or the agency) adopted additional revisions...

News

Trump Administration revives rebate safe harbor rule in late effort to reform drug pricing

On November 20, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized its previously abandoned 2019 proposal to exclude certain rebates...

News

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 ...

News

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...

News

HHS-OIG launches portal for COVID-19 related questions about its enforcement authorities

Today, the Office of Inspector General for the U.S. Department of Health and Human Services (HHS-OIG) announced the launch of a portal that will post announcements and information issued by ...

Insights and Analysis

OIG clears manufacturer-sponsored travel and lodging support in limited circumstances

The latest advisory opinion published by the U.S. Department of Health and Human Services Office of the Inspector General (HHS OIG) approves one pharmaceutical manufacturer’s travel...

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