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Anti-Kickback Statute › Pharmaceutical Industry

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 -
King & Spalding

OIG Issues Favorable Advisory Opinion Regarding Proposed Patient Assistance Program Operated by a Nonprofit Grant-Making...

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On August 20, 2024, OIG issued Advisory Opinion No. 24-07 in which it responded to a request for an advisory opinion regarding a nonprofit grant-making organization’s (Requestor) proposal to fund a patient assistance program...more

Husch Blackwell LLP

False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?

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Host Jonathan Porter welcomes Georgia Deputy Attorney General Jim Mooney to the show to explore the intersection of the False Claims Act (FCA) and the federal Anti-Kickback Statute (AKS). Our discussion begins with an...more

Kohn, Kohn & Colapinto LLP

DOJ and Whistleblowers Crack Down on Illegal Kickbacks: Major Qui Tam Settlements from July 2024

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In July, the U.S. Department of Justice (DOJ) and U.S. Attorneys Offices announced several large False Claims Act (FCA) settlements stemming from qui tam whistleblower suits....more

Arnall Golden Gregory LLP

OIG Issues Split Decision: Travel Assistance Approved, Fertility Support Under Scrutiny

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On July 22, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued Advisory Opinion 24-05, evaluating two manufacturer-sponsored assistance programs under the federal Anti-Kickback...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | June 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including guidance regarding hospital...more

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

The Volkov Law Group

DaVita Pays $34 Million to Settle Kickback Violations

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DaVita is a regular target of government enforcement actions involving fraud and illegal kickbacks.  It has an extensive history of violations and settlements....more

Mintz - Health Care Viewpoints

Petition for Certiorari Filed in Supreme Court in False Claims Act Case Seeking Review of Whether “Willful” Under the...

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The Supreme Court now has the opportunity to define “willfulness” under the federal criminal Anti-Kickback Statute (AKS). In a declined qui tam case filed against McKesson Corporation, a pharmaceutical wholesaler, the...more

Lathrop GPM

Nearly 200 Health Care Providers Charged in Aggressive Enforcement Action by DOJ Health Care Fraud Strike Force Alleging Schemes...

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The Department of Justice announced one if its most aggressive and wide-ranging enforcement actions to date, a coordinated two-week operation spanning 32 federal districts. The orchestrated effort involved the FBI, HHS-OIG,...more

Bass, Berry & Sims PLC

OIG Advisory Opinion 24-03 Greenlights Travel and Lodging Assistance for Gene Therapy Patients

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On June 17, the U.S. Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion 24-03, approving an arrangement under which a pharmaceutical manufacturer provides travel, lodging, and...more

Dinsmore & Shohl LLP

First Circuit Poised to Consider Anti-Kickback Statute’s Causation Element in FCA Cases, Take a Position on Circuit Split

Dinsmore & Shohl LLP on

Conflicting interpretations of the causation standard in two AKS-predicated False Claims Act cases in the District of Massachusetts, Teva and Regeneron, mirrored the circuit split on the issue and led to interlocutory appeals...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | May 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2024. We discuss several notable cases and enforcement resolutions, including the US Court of Appeals for the District of...more

K&L Gates LLP

The False Claims Act and Health Care: 2023 Recoveries and 2024 Outlook

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On 22 February 2024, the US Department of Justice (DOJ) published the statistics for federal civil fraud recoveries in Fiscal Year (FY) 2023. The DOJ announced that the “government and whistleblowers were party to 543...more

Akerman LLP - Health Law Rx

When a Gift Becomes a Kickback: Gifts from Florida Pharmacies to Long-Term Care Facilities

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The Florida Board of Pharmacy permits pharmacies serving residents and patients at long-term care facilities (nursing homes, ALFs, homes for DD residents, etc.) as either Special Closed System Pharmacies or Community...more

Foley Hoag LLP

Summary and Key Considerations of Recent HHS-OIG Advisory Opinion on Pharmaceutical Patient Assistance Program for Rare Disorders

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On April 8, 2024, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited favorable Advisory Opinion (AO 24-02) for a charitable patient assistance program (PAP) focused on rare...more

Foley & Lardner LLP

New Favorable OIG Advisory Opinion Allows Patient Assistant Programs Funded by Drug Manufacturers

Foley & Lardner LLP on

The Office of Inspector General (OIG) recently issued a new favorable advisory opinion regarding patient assistance programs (PAP) for 12 specific disease funds. PAPs help patients pay high cost-sharing obligations for...more

Bass, Berry & Sims PLC

False Claims Act Settlements to Know from Q1 2024

Bass, Berry & Sims PLC on

Despite the recent downward trend in DOJ healthcare industry settlements, the first quarter of 2024 saw many noteworthy False Claims Act (FCA) and civil healthcare fraud settlements related to alleged kickbacks, medically...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | March 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for March 2024. We summarize a US Court of Appeals for the Second Circuit decision interpreting the intent standard under the federal...more

Goodwin

DOJ Files False Claims Act Complaint Against Regeneron, Alleging Fraudulent Eylea Drug Pricing

Goodwin on

​​​​​​​As we previously reported, the U.S. Department of Justice (“DOJ”) filed a lawsuit under the Anti-Kickback Statute against Regeneron Pharmaceuticals in the District of Massachusetts regarding Regeneron’s sales of Eylea...more

Polsinelli

Health Care Fraud and Abuse 2023 Year in Review

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Introduction - Polsinelli proudly introduces the Health Care Fraud and Abuse 2023 Year in Review, a comprehensive examination of the evolving landscape surrounding the False Claims Act (“FCA”) and fraud & abuse enforcement...more

Gardner Law

[Hybrid Event] “Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies - May 1st, Austin, TX

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Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Nucleus: Life Sciences Enforcement and Regulatory Updates - March 2024

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Circuit Split Widens Over AKS-Based FCA Causation Element - The Anti-Kickback Statute (AKS) continues to form the basis of hundreds of millions of dollars of annual recoveries for the government under the federal False...more

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

Hendershot Cowart P.C.

A Pharmacist's Guide To Prescription Drug Fraud Investigations

Hendershot Cowart P.C. on

Prescription drug fraud has long been a focus for government regulators, but it has taken on new significance in the wake of America’s opioid crisis. The U.S. Department of Justice (DOJ), Department of Health and Human...more

ArentFox Schiff

Second Circuit: Whistleblower Must Adequately Allege Willfulness to Assert FCA Claims Based on AKS Violations

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On March 12, the Second Circuit affirmed in part and reversed in part a district court dismissal of False Claims Act (FCA) claims predicated on alleged Anti-Kickback Statute (AKS) violations. Adam Hart brought the claims...more

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