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Anti-Kickback Statute › Compliance › Medicare

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 -
Husch Blackwell LLP

OIG Announces 2025 Work Plan Review: What Clinical Laboratories Need to Know About Medicare Payments for Diagnostic Lab Tests

Husch Blackwell LLP on

In June 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) announced a new item in its Work Plan: “Medicare Payments for Clinical Diagnostic Laboratory Tests in 2024.” This annual review,...more

Health Care Compliance Association (HCCA)

HHS OIG’s Nursing Facility: Industry Segment-Specific Compliance Program Guidance

Health Care Compliance Association (HCCA) on

In November 2024, the Office of Inspector General at Health and Human Services released its Nursing Facility: Industry Segment-Specific Compliance Program Guidance. The document is part of an effort to modernize how HHS OIG...more

ArentFox Schiff

Telehealth Staffing and Administrative Services Gain Favorable Advisory Opinion From OIG

ArentFox Schiff on

On June 6, the US Department of Health and Human Services’ Office of Inspector General (OIG) issued Advisory Opinion No. 25-03, providing important guidance for telehealth organizations and management services organizations...more

DLA Piper

OIG Issues Favorable Advisory Opinion on Telehealth Marketplace MSO-PC Arrangement

DLA Piper on

The Department of Health and Human Services, Office of Inspector General (OIG) recently issued a favorable advisory opinion under the federal Anti-Kickback Statute (AKS), wading into the world of not only telehealth but also...more

Health Care Compliance Association (HCCA)

Healthcare Industry Segment-Specific Compliance Program Guidances (ICPGs)

Health Care Compliance Association (HCCA) on

In addition to releasing its General Compliance Program Guidance, the OIG at HHS announced plans to publish a series of Industry Segment-Specific Compliance Program Guidances (ICPG). The first of these, addressing nursing...more

McDermott Will & Schulte

OIG Nursing Facility Compliance Program Guidance: Renewed Focus on Fraud and Abuse

McDermott Will & Schulte on

The US Department of Health and Human Services Office of Inspector General’s (OIG’s) release of Nursing Facility Industry Segment-Specific Compliance Program Guidance (ICPG) for the first time since 2008 reemphasizes the...more

Paul Hastings LLP

OIG Issues Favorable Opinion on Pharmaceutical Manufacturer’s Free Product Program

Paul Hastings LLP on

In its first advisory opinion of the year, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) assessed a pharmaceutical manufacturer’s free product program and found that, although the...more

Polsinelli

A Deepened Divide: Appellate Court Joins False Claims Act Circuit Split in Favor of Health Care Defendants

Polsinelli on

On February 18, 2025, the United States Court of Appeals for the First Circuit issued its opinion in United States v. Regeneron Pharmaceuticals Inc., finding that, in Anti-Kickback Statute (AKS) cases, the government must...more

Skadden, Arps, Slate, Meagher & Flom LLP

First Circuit Demands ‘But For’ Causation Between Alleged Kickback and Claim Submission

Skadden, Arps, Slate, Meagher & Flom LLP on

On February 18, 2025, a panel of the U.S. Court of Appeals for the First Circuit unanimously decided that in order to transform an Anti-Kickback Statute (AKS) violation into a false or fraudulent claim for purposes of False...more

ArentFox Schiff

Investigations Newsletter: First Circuit Joins Sixth and Eighth Circuits in Adopting Heightened, But-For Causation Standard for...

ArentFox Schiff on

First Circuit Joins Sixth and Eighth Circuits in Adopting Heightened, But-For Causation Standard for AKS-Based FCA Claims - On February 18, the US Court of Appeals for the First Circuit became the latest court to agree...more

Whiteford

Ambulatory Surgery Center Trends in Regulation, Compliance, and Enforcement

Whiteford on

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

Mintz - Health Care Viewpoints

First Circuit Adopts “But-For” Causation Standard for False Claims Act Cases Based on Anti-Kickback Statute Violations

Mintz - Health Care Viewpoints on

In United States v. Regeneron Pharmaceuticals, Inc., the First Circuit joined the emerging majority view that False Claims Act (FCA) claims based on violations of the Anti-Kickback Statute (AKS) require a showing of “but-for”...more

Baker Donelson

First Circuit Requires But-For Causation for FCA Liability Based on AKS Violations

Baker Donelson on

Key Takeaways - The First Circuit ruled in United States v. Regeneron Pharmaceuticals, Inc., that the government must prove but-for causation to establish False Claims Act (FCA) liability based on violations of the...more

Bass, Berry & Sims PLC

HHS-OIG Year in Review 2024

Bass, Berry & Sims PLC on

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

King & Spalding

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

King & Spalding on

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

Pietragallo Gordon Alfano Bosick & Raspanti,...

The Emergency Room—The Front Door to the Hospital (Fraud Schemes)?

Pietragallo Gordon Alfano Bosick & Raspanti,... on

Fraud related to hospital services – both inpatient and outpatient – has led to over $511 million in damages and hundreds of millions of dollars in False Claims Act (FCA) settlements over the past 15 years. The ER has been...more

ArentFox Schiff

Investigations Newsletter: Massachusetts District Court Judge Applies Heightened Causation Standard in FCA Case

ArentFox Schiff on

Massachusetts District Court Judge Applies Heightened Causation Standard in FCA Case - On January 6, a District Court of Massachusetts judge granted summary judgment for defendants on allegations of violating the...more

Arnall Golden Gregory LLP

OIG Approves Pharmaceutical Manufacturer’s Proposed Free Genetic Testing

Arnall Golden Gregory LLP on

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 — 2024’s Key False Claims Act Settlements Involving Hospitals and Health Systems: Continued Focus on Stark Law and...

Mintz - Health Care Viewpoints on

In 2024, the Department of Justice (DOJ) resolved several noteworthy False Claims Act (FCA) cases against hospitals and health systems. In particular, DOJ obtained a number of large recoveries in cases where Stark Law and...more

ArentFox Schiff

At Long Last, the OIG Issues Its Compliance Program Guidance for Nursing Facilities

ArentFox Schiff on

On November 20, 2024, the US Department of Health and Human Services, Office of Inspector General (OIG) issued its Industry Segment-Specific Compliance Program Guidance for Nursing Facilities (Nursing Facility ICPG)....more

Pietragallo Gordon Alfano Bosick & Raspanti,...

Second Circuit Expands Anti-Kickback Statute Liability: “At Least One Purpose” is Enough

Pietragallo Gordon Alfano Bosick & Raspanti,... on

In a significant ruling, the Second Circuit Court of Appeals recently expanded the scope of the Anti-Kickback Statute (AKS).The Court joined other circuit courts across the country in adopting, for the first time, the...more

Mintz - Health Care Viewpoints

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

Mintz - Health Care Viewpoints on

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

King & Spalding

OIG Issues Nursing Facility Compliance Guidance

King & Spalding on

On November 20, 2024, OIG released new compliance program guidelines for nursing facilities titled, “Nursing Facility Industry Segment-Specific Compliance Program Guidance” (the Nursing Facility ICPG or the Guidance). The...more

ArentFox Schiff

Investigations Newsletter: FCA Enforcement & Compliance Digest — Summer 2024 False Claims Act Newsletter

ArentFox Schiff on

Welcome to the Summer 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and...more

Foley & Lardner LLP

“Let’s Talk Compliance”: Medicare Advantage: Compliance Issues and Enforcement

Foley & Lardner LLP on

Editor’s Note: PYA and Foley & Lardner hosted the 6th Annual “Let’s Talk Compliance” two-day Virtual Conference on January 18 and 19, 2024. Panelists included Foley & Lardner attorneys and PYA experts. The event was hosted by...more

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