News & Analysis as of

Anti-Kickback Statute Department of Health and Human Services (HHS) Healthcare Fraud

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 -
Epstein Becker & Green

Vendor Fees Flagged as Kickback Risk in HHS OIG Advisory Opinion

On July 7, 2025, the Office of Inspector General (“OIG”) for the Department of Health and Human Services published Advisory Opinion 25-08 (“AO 25-08”), an unfavorable and strongly worded opinion interpreting the “arranging...more

King & Spalding

The Fourth Circuit Rejects a Non-Delegation Doctrine Challenge to the Anti-Kickback Statute

King & Spalding on

On July 22, 2025, the Fourth Circuit published its opinion in United States v. Donald Booker, No. 23-461, affirming a 200-month prison sentence for the owner of United Youth Care Services, which billed North Carolina’s...more

McDermott Will & Schulte

DOJ-HHS False Claims Act Working Group will pursue healthcare, life sciences enforcement priorities

The US Department of Justice (DOJ) and the US Department of Health and Human Services (HHS) recently announced the relaunch of the DOJ-HHS False Claims Act Working Group, intended to “strengthen[] [the agencies’] ongoing...more

Harris Beach Murtha PLLC

Scrutiny of Hospital–Physician Relationships Continues

Despite changes in many priorities, the federal government’s scrutiny of relationships between hospitals and physicians continues well into 2025. Last month, Community Health System (CHS) in California and its affiliate,...more

Bass, Berry & Sims PLC

OIG Approves Proposal that Expands Patient Access to Covered Telehealth Services

Bass, Berry & Sims PLC on

On June 11, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-03, approving a proposal by a management services organization (MSO) and its friendly PC...more

Epstein Becker & Green

OIG Says Medical Device Company's Proposal to Pay for Exclusion Screening for Customers May Violate the Anti-Kickback Statute

Epstein Becker & Green on

On June 20, 2025, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued an unfavorable advisory opinion - OIG Advisory Opinion 25-04 (“AO 25-04”)....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

Venable LLP

Defense-Friendly Anti-Kickback Statute and False Claims Act Marketing and Advertising Decisions

Venable LLP on

On April 14, 2025, the Seventh and Second Circuits each issued opinions narrowing the scope of advertising, marketing, and booking fee activities that run afoul of the federal Anti-Kickback Statute (AKS). See United States v....more

Foley Hoag LLP - White Collar Law &...

Federal District Court Upholds HHS Advisory Opinion Blocking Fertility Assistance Program

A recent decision from the United States District Court for the District of Columbia continues to give significant deference to the U.S. Department of Health and Human Services’ (HHS) interpretation of the Anti-Kickback and...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights key regulatory and enforcement activity for March 2025. This month features: - Noteworthy enforcement actions demonstrating that the Anti-Kickback Statute...more

Morrison & Foerster LLP

When Your Life Sciences Are on the Line: False Claims Act

Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s Investigations + White Collar Defense Group, hosted the ninth episode of When Your Life Sciences Are on the...more

ArentFox Schiff

Vertex’s Attempt to Redefine AKS Falls Short: Key Insights for Pharma Manufacturers

ArentFox Schiff on

In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General (OIG), manufacturers have contested the OIG’s...more

Rivkin Radler LLP

Lab Operator Convicted in Drug-Testing Scheme

Rivkin Radler LLP on

Conspiracies to rip off the Medicare system are prevalent due to the vast amounts of money flowing through the program. On February 25, Sherif Khalil of Redondo Beach, California man was convicted by a federal jury in Detroit...more

ArentFox Schiff

Investigations Newsletter: Long Island Businessman Arrested in $22 Million Medicare Fraud Scheme

ArentFox Schiff on

Long Island Businessman Arrested in $22 Million Medicare Fraud Scheme - A Long Island, New York, businessman was arrested on conspiracy, kickback, and money laundering charges stemming from an alleged scheme to defraud...more

McCarter & English, LLP

Federal Courts Decide on FCA Claims Actions

There are still several unsettled legal issues regarding the standards applicable to a False Claims Act (FCA) claim, such as the standard to prove causation when an FCA claim is based on a violation of the Anti-Kickback...more

McDermott Will & Schulte

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

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

A&O Shearman

First Circuit Ruling Requiring “But-For” Causation In FCA Kickback Claims Deepens Circuit Split

A&O Shearman on

In an opinion that may complicate the U.S. Department of Justice’s (“DOJ”) efforts to enforce the False Claims Act (“FCA”), the U.S. Court of Appeals for the First Circuit held in a unanimous opinion on February 18, 2025 that...more

K&L Gates LLP

First Circuit Adopts But-For Causation Standard for Kickback-Premised False Claims Act Actions

K&L Gates LLP on

On 18 February 2025, the First Circuit Court of Appeals issued its decision in United States v. Regeneron Pharmaceuticals, Inc., determining that “but-for” causation is the proper standard for False Claims Act (FCA) actions...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

Epstein Becker & Green

What Does the Phrase “Resulting From” Mean? Circuit Courts Split on Standard for Determining When an AKS Violation Is a False...

Epstein Becker & Green on

Dating back to the 19th century, the U.S. Supreme Court has held that when construing a statute, the courts are to “give effect, if possible, to every clause and word of a statute, avoiding, if it may be, any construction...more

Patterson Belknap Webb & Tyler LLP

The First Circuit Requires But-For Causation in False Claims Act Cases Predicated on Violations of the Anti-Kickback Statute,...

On February 18, 2025, in United States v. Regeneron Pharmaceuticals, the First Circuit held that to establish civil liability under the False Claims Act (“FCA”) premised on violations of the Anti-Kickback Statute (“AKS”), the...more

McGuireWoods LLP

Fourth Circuit Upholds OIG Advisory Opinion Process

McGuireWoods LLP on

On January 23, 2025, the United States Court of Appeals for the Fourth Circuit rejected a challenge to Advisory Opinion 22-19 (the “Advisory Opinion”) issued by the United States Department of Health and Human Services,...more

Wilson Sonsini Goodrich & Rosati

Key Considerations for Contracting with Healthcare Revenue Cycle Management Companies

Revenue cycle management companies (RCM Companies) help healthcare organizations manage billing, coding, claim submissions, and collections. Partnering with an RCM Company can enhance efficiency, accuracy, and...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

Foley & Lardner LLP

Anti-Kickback Statute Premised False Claims Cases: The “But For” Causation Standard Finds Support from First Circuit

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It’s now 3–1, with the First Circuit (2025) aligning with the Sixth (2023) and Eighth (2022) Circuits finding the meaning of the words “resulting from” — as used in a 2010 amendment to the federal Anti-Kickback Statute (AKS)...more

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