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Anti-Kickback Statute Pharmaceutical Industry Remuneration

The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The... more +
The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The statute aims to prevent situations where government officials channel federal healthcare dollars towards particular providers, who have offered or given the official a personal benefit. Penalties for violation of the Anti-Kickback statute apply to both sides of a prohibited transaction and can include jail time and steep monetary fines. less -
Rivkin Radler LLP

CA Pharmaceutical Company Settles AKS and FCA Claims in NJ

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The U.S. Attorney’s Office for the District of New Jersey recently announced a $750,000 settlement with Sentynl Therapeutics Inc., a California-based specialty pharmaceutical company. The settlement resolves allegations that...more

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter - October 2023

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Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more

Bass, Berry & Sims PLC

Recent False Claims Act Decisions to Know

In this post, we summarize noteworthy False Claims Act (FCA) decisions so far from 2023. Each of the three circuit court opinions discussed here ruled in favor of the defendants on different aspects of the FCA: the Sixth...more

Holland & Knight LLP

OIG Issues Favorable Advisory Opinion on Manufacturer-Provided Travel Assistance

Holland & Knight LLP on

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) on July 8, 2021, issued Advisory Opinion No. 21-08, a favorable opinion authorizing a manufacturer of gene therapy to provide...more

Mintz - Health Care Viewpoints

Are Speaker Programs a Thing of the Past? OIG’s Fraud Alert Indicates It Thinks They Should Be

In the midst of the pandemic emergency, the Department of Health and Human Services Office of Inspector General (OIG) issued a stern warning about in-person educational programs for health care professionals (HCPs), known as...more

Fox Rothschild LLP

OIG Issues Special Fraud Alert On Speaker Programs

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Earlier this week, the Office of Inspector General OIG issued a Special Fraud Alert (Alert) on speaker programs by pharmaceutical and medical device companies in connection with the Federal Anti-Kickback Statute. In the...more

ArentFox Schiff

OIG Issues Fraud Alert: Should Pharma and Device Companies Cease Speaker Programs?

ArentFox Schiff on

The Department of Health and Human Services Office of the Inspector General (OIG) published a Special Fraud Alert on November 16, 2020 (the Alert) regarding a common practice within the pharmaceutical and medical device...more

Robinson+Cole Health Law Diagnosis

Government Continues to Closely Scrutinize Pharmaceutical Marketing Practices

On September 4, 2019 the Department of Justice (DOJ) announced a $15.4 million settlement with pharmaceutical company Mallinckrodt ARD LLC (Mallinckrodt) to resolve alleged violations of the Anti-Kickback Statute (AKS) in two...more

Bricker Graydon LLP

DOJ moves to dismiss 11 False Claims Act cases

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On December 17, 2018, the Department of Justice (DOJ) moved to dismiss 11 False Claims Act (FCA) cases brought by whistleblowers against pharmaceutical manufacturers and their commercial outsourcing vendors, alleging that...more

Bass, Berry & Sims PLC

The Eliminating Kickbacks in Recovery Act: An Unprecedented Expansion of Anti-kickback Liability to Private-Pay Referrals?

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A recent piece of federal legislation intended to address the opioid crisis across the United States may have some unintended consequences. In attempting to prohibit “patient brokering” in the narrow context of addiction...more

K&L Gates LLP

The New Kickback Prohibition for Substance Use Disorder Treatment Facilities, Clinical Laboratories and Recovery Homes

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On October 24, 2018, President Trump signed into law comprehensive opioid legislation known as the “Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act” or the...more

Hogan Lovells

New anti-kickback prohibition in opioid bill creates tangled web of compliance obligations

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On October 3, the U.S. Congress passed H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the SUPPORT Act), a wide-reaching bill that aims to...more

Baker Donelson

OIG Advisory Opinion 17-03 Approves Pharmaceutical Manufacturer's Product Spoilage/Replacement Program

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A pharmaceutical manufacturer proposing to offer customers – at no additional cost – replacements for certain spoiled products that can no longer be administered to patients (Replacement Program) has been granted approval by...more

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