News & Analysis as of

Marketing Anti-Kickback Statute

Rivkin Radler LLP

NJ Biopharma Company Settles FCA/AKS Case for $5M+

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The U.S. Department of Justice announced on July 24 that Admera Health LLC, a New Jersey-based biopharmaceutical research and clinical laboratory testing company, agreed to pay $5,389,648 to resolve kickback allegations...more

Mintz - Health Care Viewpoints

The OIG Issues New FAQs on Financial Assistance Policies and Marketing to Patients

On July 8, 2024, the Office of Inspector General (OIG) updated its General Questions on Fraud and Abuse Authorities (FAQs) related to the Anti-Kickback Statute (AKS) and the Beneficiary Inducement Prohibition of Civil...more

Sheppard Mullin Richter & Hampton LLP

New Marketing Possibilities for Vendors Contracted with Medicare Providers and Suppliers Following OIG’s Favorable Advisory...

On December 28, 2023, the Office of Inspector General (the “OIG”) issued a favorable Advisory Opinion (No. 23-15) (the “Opinion”) to a consulting vendor (the “Requestor”) that wanted to provide up to $75 in gift cards to...more

Troutman Pepper

8 Ways Life Sciences Cos. Can Adapt to the Social Media Era

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Social media usage worldwide is showing no signs of slowing as it permeates all aspects of our daily lives. Originally published in Law360 - September 11, 2023....more

Holland & Knight LLP

The State of EKRA: Summer 2022

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Enacted in 2018, the Eliminating Kickbacks Recovery Act (EKRA) remains a source of anxiety and confusion in the clinical laboratory industry. In the four years since EKRA's enactment, U.S. Department of Justice (DOJ)...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - February 2021

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

MoFo Life Sciences

EHR Vendor Settles Kickback Allegations To The Tune Of $18.25 Million

MoFo Life Sciences on

On January 28, 2021, the United States’ Department of Justice (DOJ) announced an $18.25 million settlement with athenahealth Inc. (“Athena”) to resolve allegations that Athena violated the False Claims Act by paying...more

Rivkin Radler LLP

EHR Vendor To Pay $18.25 Million To Resolve Kickback Allegations

Rivkin Radler LLP on

The U.S. Department of Justice (DOJ) announced on January 28 that athenahealth Inc., a Massachusetts-based electronic health records (EHR) technology vendor, has agreed to pay $18.25 million to resolve allegations that it...more

Fox Rothschild LLP

OIG Issues Special Fraud Alert On Speaker Programs

Fox Rothschild LLP on

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

Skadden, Arps, Slate, Meagher & Flom LLP

Novartis’ $678 Million Settlement Sets Guideposts for Life Sciences Industry Speaker Programs

Novartis Pharmaceuticals Corporation (Novartis) recently entered into a civil settlement agreement with the Department of Justice (DOJ) to resolve allegations that the company paid health care practitioners (HCPs) who spoke...more

Bass, Berry & Sims PLC

DOJ Announces 2019 FCA Recovery, Majority Came from Healthcare Industry

The Department of Justice (DOJ) announced this month that it obtained over $3 billion in settlements and judgments from civil fraud and false claims cases during the fiscal year ending September 30, 2019 (FY 2019). Of this...more

Baker Donelson

OIG Advisory Opinion 19-04: OIG Approves Health Care Directory's Per-Click Fee Structure

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In Advisory Opinion 19-04, published September 10, 2019, the Office of Inspector General (OIG) approved an online health care directory operated on a per-click or per-booking fee arrangement. The proposed directory will be...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

Burr & Forman

Clinical Labs Beware: Review Your Marketing Arrangements

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On October 24, 2018, Congress enacted the Eliminating Kickbacks in Recovery Act of 2018 (EKRA). EKRA is part of the “Support for Patients and Communities Act,” comprehensive legislation designed to address the opioid crisis. ...more

Baker Donelson

New Tennessee Law Targets Marketing and Referrals by Alcohol and Drug Abuse Treatment Providers

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The growing concern over opioid abuse has prompted both the federal government and many states to address concerns over referrals for substance abuse treatment. Tennessee recently addressed the issue in House Bill No. 2068,...more

Holland & Knight LLP

Healthcare Law Update: December 2016

Holland & Knight LLP on

Prompt Payment Discounts Not an Anti-Kickback Statute Violation - In United States of Am. et al. ex rel. Ruscher v. Omnicare, No. 15-20629, 2016 WL 6407128 (5th Cir. Oct. 28, 2016), the court of appeals affirmed summary...more

Akerman LLP - Health Law Rx

When a Discount May be a Kickback

Healthcare providers of all kinds, as well as medical equipment suppliers, have traditionally relied upon discounts as a legitimate means of attracting patients and commercial clients without running afoul of the federal...more

Patrick Malone & Associates P.C. | DC Injury...

Why Industry Drug-Assistance Programs Are a Sham

You probably heard about the recent price hike for a drug critical to AIDS patients when the manufacturer sold it to an evil hedge fund manager who promptly marked it up 5,000%. This prompted Los Angeles Times columnist...more

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