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Anti-Kickback Statute

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 -
Alston & Bird

Government Pivots to False-Certification Theory in Regeneron Case

Alston & Bird on

Our Health Care Litigation Team discusses a District of Massachusetts case holding that allows the government to switch liability theories in its False Claims Act lawsuit against Regeneron Pharmaceuticals....more

ArentFox Schiff

Investigations Newsletter: Regeneron Court Permits Government to Pursue False Certification Theory

ArentFox Schiff on

Regeneron Court Permits Government to Pursue False Certification Theory - On August 4, the district court in the closely watched Regeneron case granted the government’s request to file a second partial summary judgment...more

Rivkin Radler LLP

The Feds Have Home Care Kickback Arrangements in Their Crosshairs

Rivkin Radler LLP on

The federal government has demonstrated that it is more than willing to use the United States criminal code to prosecute home care agencies that pay unlawful financial inducements to generate referrals in violation of the...more

Morgan Lewis - Health Law Scan

Ninth Circuit Ruling Confirms Strength of the Eliminating Kickbacks in Recovery Act

Morgan Lewis - Health Law Scan on

Since its enactment in 2018, the Eliminating Kickbacks in Recovery Act (EKRA) has rapidly gained momentum as a powerful tool against healthcare kickbacks. By 2020, the US Department of Justice (DOJ) had already secured its...more

Baker Donelson

EKRA's Application to Marketing Arrangements: Laboratories and Other Providers

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The Ninth Circuit recently affirmed two decisions that provide additional guidance regarding how arrangements with marketing agents implicate and violate the Eliminating Kickbacks in Recovery Act, 18 U.S.C. § 220(a)(EKRA)....more

Epstein Becker & Green

Vendor Fees Flagged as Kickback Risk in HHS OIG Advisory Opinion

Epstein Becker & Green on

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

Troutman Pepper Locke

State AGs Join $202M Settlement Over HIV Drug Kickback

Troutman Pepper Locke on

On July 16, 49 attorneys general (AGs) announced that they joined a $202 million settlement with Gilead Sciences, Inc. (Gilead). Previously announced by the Department of Justice in April, the settlement resolved allegations...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

Arnall Golden Gregory LLP

“Longstanding and Clear”: OIG Continues Characteristic Close Scrutiny of Below-Market Benefits to Referral Sources

Arnall Golden Gregory LLP on

The United States Department of Health and Human Services, Office of Inspector General (“OIG”) recently released two unfavorable advisory opinions, OIG Advisory Opinion No. 25-04 and -08 (the “Opinions”) to medical device...more

Mintz - Health Care Viewpoints

CMMI Proposes Mandatory Ambulatory Specialty Model in 2026 PFS Proposed Rule: Key Considerations for Health Care Organizations...

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In the CY 2026 Medicare Physician Fee Schedule proposed rule (PFS Proposed Rule), released on July 14, 2025, the Center for Medicare and Medicaid Innovation (CMMI) introduced the Ambulatory Specialty Model (ASM), a new...more

Venable LLP

EKRA Has Teeth: Ninth Circuit Upholds Lab Operator’s Criminal Conviction for Paying Marketers for Referrals

Venable LLP on

In a matter of first impression, the Ninth Circuit Court of Appeals interpreted the scope of the 2018 Eliminating Kickbacks in Recovery Act (EKRA) in the context of a lab operator who allegedly paid marketers to induce...more

Warner Norcross + Judd

Federal Court Flags Stark and Anti-Kickback Risks in Physician Pay, Spotlights FCA Constitutional Questions on Appeal

Warner Norcross + Judd on

On July 28, the federal district court in the Southern District of Ohio issued a pair of orders in related whistleblower cases under the False Claims Act (FCA): United States ex rel. Murphy v. TriHealth, Inc., et al., No....more

Morgan Lewis - Health Law Scan

OIG’s Advisory Opinion No. 25-08: Negative Opinion Highlights Potential Broad Reach of AKS

Morgan Lewis - Health Law Scan on

In a relatively rare move, the US Department of Health and Human Services Office of Inspector General (OIG) recently issued an unfavorable Advisory Opinion (No. 25-08) (Opinion) reinforcing the agency’s expansive view of the...more

Orrick, Herrington & Sutcliffe LLP

4 Healthcare Regulatory Fundraising Fundamentals

Orrick, Herrington & Sutcliffe LLP on

Jeremy Sherer and Thora Johnson share insight on: Key due diligence considerations for healthtech companies State and federal regulations aimed at virtual care delivery...more

McDermott Will & Schulte

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

McDermott Will & Schulte on

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

King & Spalding

First Circuit Court of Appeals Affirms Dismissal of Qui Tam Complaint Applying “But-For” Causation Standard in FCA Case Alleging...

King & Spalding on

On June 27, 2025, the United States Court of Appeals for the First Circuit affirmed a district court’s dismissal of a qui tam complaint alleging violations of the Anti-Kickback Statute (AKS) and the federal False Claims Act...more

Haynes Boone

False Claims Act - 2025 Mid-Year Review

Haynes Boone on

The False Claims Act continues to be one of the most commonly used weapons in the government’s enforcement arsenal to address various forms of fraud. In addition to our “Year in Review” publication providing an overview of...more

Greenbaum, Rowe, Smith & Davis LLP

First Circuit Decision Regarding Anti-Kickback Statute Standard Widens Circuit Split and Creates Potential for Supreme Court...

Greenbaum, Rowe, Smith & Davis LLP on

The U.S. Court of Appeals for the First Circuit, in United States v. Regeneron, has joined the Sixth and Eighth Circuits in adopting the “but-for” standard to find that a violation of the Anti-Kickback Statute (AKS) triggers...more

Ropes & Gray LLP

[Podcast] Patient Assistance Programs: Enforcement Trends and Regulatory Challenges

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On this Ropes & Gray podcast, health care partner Michael Lampert and counsel Sam Perrone, and litigation & enforcement partner Andrew O’Connor, rejoin to discuss patient assistance programs, recent enforcement actions, and...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | June 2025 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2025, including a new Centers for Medicare & Medicaid Services (CMS) innovation model; proposed rules with significant...more

ArentFox Schiff

Investigations Newsletter: Johnson & Johnson Challenges the Constitutionality of FCA $1.6 Billion Verdict

ArentFox Schiff on

Johnson & Johnson Challenges the Constitutionality of FCA $1.6 Billion Verdict - Following a record $1.6 billion jury verdict for off-label promotion of HIV drugs Prezista and Intelence, Johnson & Johnson (J&J) subsidiary...more

Baker Donelson

OIG Advisory Opinion 25-08: Unfavorable DME – Vendor Payment Arrangement

Baker Donelson on

On July 1, 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 25-08, an unfavorable opinion discussing a proposed arrangement in which a medical device company...more

Quarles & Brady LLP

A Prescription for Caution: Senators Release Investigative Report on Direct-To-Consumer Telehealth Models

Quarles & Brady LLP on

On July 17, the offices of Senators Durbin (D. IL.), Warren (D. MA.), Sanders (I. VT.), and Welch (D. VT.) (collectively, “Senators”) released a report summarizing the results of a nine month investigation into...more

Hogan Lovells

OIG issues two unfavorable decisions, cautions against some customer service fees paid by manufacturers

Hogan Lovells on

The U.S. Department of Health and Human Services Office of Inspector General (OIG) issued two unfavorable decisions in Advisory Opinions (AOs) 25-04 and 25-08 (the “Opinions”), finding that some service fees paid by...more

Dorsey & Whitney LLP

New State-Level Anti-Kickback Statute Expands Minnesota AG’s Power to Prosecute Healthcare Fraud

Dorsey & Whitney LLP on

On May 23, 2025, Minnesota Governor Tim Walz signed the Human Services omnibus policy bill into law, which included in part, the addition of a new statutory provision in the state’s criminal code, Chapter 609....more

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