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Anti-Kickback Statute › Office of the Inspector General

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 -
Whiteford

Ambulatory Surgery Center Trends in Regulation, Compliance, and Enforcement

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Ambulatory Surgery Centers (ASCs) are experiencing significant shifts in regulation, reimbursement, and operational practices. These changes are driven by evolving healthcare policies, technological advancements, and the...more

Arnall Golden Gregory LLP

OIG Deems Free Drug Patient Assistance Program Low-Risk in Advisory Opinion 25-01

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On January 15, 2025, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 25-01, a favorable opinion analyzing a pharmaceutical manufacturer’s free product offering to...more

Patterson Belknap Webb & Tyler LLP

The Fourth Circuit Broadly Interprets “Inducement” and “Remuneration” Under the Anti-Kickback Statute and Creates a Circuit Split

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On January 23, 2025, in Pharmaceutical Coalition for Patient Access v. United States, the Fourth Circuit held that a proposed patient assistance program, which would help cancer patients afford certain oncology drugs, would...more

Bass, Berry & Sims PLC

HHS-OIG Year in Review 2024

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In 2024, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) provided useful insights to the healthcare industry regarding how it approaches various fraud and abuse issues in an...more

Arnall Golden Gregory LLP

Fourth Circuit Upholds OIG’s Unfavorable Advisory Opinion on Patient Assistance Program

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On January 23, 2025, the U.S. Court of Appeals for the Fourth Circuit affirmed a federal district court’s ruling against the Pharmaceutical Coalition for Patient Access (“Coalition”), rejecting its challenge to an unfavorable...more

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter - January 2025

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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

King & Spalding

OIG Issues Favorable Opinion Regarding a Program to Provide Patients with Free Access to a Pharmaceutical Product

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On January 10, 2025, OIG posted a favorable advisory opinion approving a proposed program (Program) to provide patients who meet certain financial need criteria with free access to a pharmaceutical product that has limited...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | December 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for December 2024. We discuss several civil and criminal enforcement actions pertaining to healthcare fraud and abuse authorities,...more

Rivkin Radler LLP

Hospital CEO Jailed for Conspiracy to Violate AKS

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The U.S. Department of Justice announced on January 15 that Jeffrey Paul Madison, the former chief executive officer of a Texas hospital, was sentenced to 36 months in federal prison for conspiring to violate the federal...more

Arnall Golden Gregory LLP

OIG Approves Pharmaceutical Manufacturer’s Proposed Travel-Related Subsidies

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The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-13 (the “Opinion”) to a pharmaceutical manufacturer (the...more

McGuireWoods LLP

Second Circuit Joins Other Circuits with AKS One Purpose Test

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On December 27, 2024, the United States Court of Appeals for the Second Circuit decided United States ex rel. Camburn v. Novartis Pharmaceuticals Corporation and joined a growing list of federal circuit courts that have...more

Morrison & Foerster LLP

New HHS-OIG Guidance on Sponsored Genetic-Testing Programs

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On December 17, 2024, the Department of Health & Human Services, Office of Inspector General (HHS-OIG) issued its second favorable advisory opinion involving an arrangement in which a drug manufacturer sponsors genetic...more

Epstein Becker & Green

Massachusetts District Court Applies “But-For Causation” Standard, Dismisses AKS-Based FCA Case After Evaluating Facts and...

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On January 6, 2025, the U.S. District Court for the District of Massachusetts granted a defendant laboratory’s motion for summary judgment in a False Claims Act (FCA)/Anti-Kickback Statute (AKS) case brought by a physician...more

King & Spalding

OIG Issues a Favorable Advisory Opinion to a Pharmaceutical Manufacturer Regarding Free Transportation, Lodging and Support for...

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On December 31, 2024, OIG posted Advisory Opinion No. 24-13, a favorable advisory opinion allowing a pharmaceutical manufacturer (the Requestor) to offer free transportation, lodging, and other support to eligible patients...more

Arnall Golden Gregory LLP

OIG Approves Pharmaceutical Manufacturer’s Proposed Free Genetic Testing

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The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-12 (the “Opinion”) to a pharmaceutical manufacturer (the...more

Mintz - Health Care Viewpoints

EnforceMintz — FCA Enforcement in Value-Based Care Arrangements Heated Up in 2024 and Likely to Remain a Priority in 2025

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Value-based care (VBC) is a health care delivery model that has grown increasingly common in recent years. Perhaps unsurprisingly, this growth seems to have attracted the attention of government enforcement agencies...more

Mintz - Health Care Viewpoints

EnforceMintz — Telemedicine Enforcement: Trends in 2024 Suggest More Sophisticated Enforcement to Come in 2025

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The Department of Justice (DOJ) and the Office of the Inspector General for the Department of Health and Human Services (OIG) have historically focused their virtual health care enforcement efforts on “traditional”...more

Hinshaw & Culbertson - Health Care

Healthcare Providers, Agents, and Brokers: Please Stop, Look, and Listen Before Entering Into Suspect Medicare Advantage Plan...

Hinshaw & Culbertson - Health Care on

The Office of Inspector General (OIG) of the U.S. Department of Health & Human Services (HHS) issues Special Fraud Alerts regarding healthcare fraud and abuse patterns or practices it has recently identified and intends to...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | November 2024 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for November 2024. We discuss several US Department of Justice (DOJ) enforcement actions involving the False Claims Act (FCA) and the...more

Akerman LLP - Health Law Rx

Don’t Be Suspicious, Don’t Be Suspicious: New OIG Special Fraud Alert Warns About Suspect Payments in Medicare Advantage Marketing...

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The latest Special Fraud Alert from the U.S. Department of Health and Human Services Office of Inspector General (OIG) warns about marketing schemes involving questionable payments and referrals among Medicare Advantage...more

Arnall Golden Gregory LLP

OIG Approves Dental Supplies Distributor’s Plan to Expand Loyalty Program

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The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-10 (the “Opinion”) to a dental supplies distributor (the “Requestor”...more

King & Spalding

OIG Issues Special Fraud Alert Regarding Marketing Payments Related to Medicare Advantage

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On December 11, 2024, OIG issued a Special Fraud Alert to warn the industry about the fraud and abuse risks associated with abusive Medicare Advantage (MA) organization (MAO) and agent and broker relationships with healthcare...more

Fox Rothschild LLP

OIG Publishes Special Fraud Alert on Medicare Advantage Marketing Arrangements

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On December 11, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) published a Special Fraud Alert warning against suspect payment arrangements involving the Medicare Advantage (“MA”) program...more

Proskauer - Health Care Law Brief

OIG Releases Special Fraud Alert About Suspect Payments in Marketing Arrangements Related to Medicare Advantage and Providers

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On December 11, 2024, the Office of Inspector General for the U.S. Department of Health and Human Services (“OIG”) issued a special fraud alert warning about certain marketing schemes that involve questionable payments and...more

Mintz - Health Care Viewpoints

Key Takeaways from the OIG’s New Compliance Program Guidance for Skilled Nursing Facilities

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As part of its Modernization Initiative, the Department of Health and Human Services’ Office of Inspector General (OIG) recently published its first industry-segment specific Compliance Program Guidance, which focuses on...more

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