News & Analysis as of

Fraud and Abuse

Arnall Golden Gregory LLP

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

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

Venable LLP

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

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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

Morgan Lewis - Health Law Scan

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

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

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

Troutman Pepper Locke

HHS Sets Its Sights on $50B in Cost Savings: Medicare Payments to Nonhospice Providers Potentially Under Fire

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In May 2025, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a review, titled “Potential Cost Savings HHS Programs – HHS Actions,” which provided some insight into the OIG’s...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

Sheppard Mullin Richter & Hampton LLP

Inside the Ninth Circuit’s Interpretation of EKRA: Clarity for Kickback Law

On July 11, 2025, in United States v. Schena,[1] the Ninth Circuit adopted an expansive interpretation of the Eliminating Kickbacks in Recovery Act (EKRA), applying the law to any payment that could have the effect of...more

Stinson LLP

Federal Government Initiatives Combat Fraud and Promote Digitalization of Payments

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Continuing the war on fraud and the attendant financial losses for U.S. businesses, consumers and government alike, the U.S. Department of the Treasury and federal banking agencies have launched a wide-ranging initiative...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | April 2025 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2025, including Centers for Medicare & Medicaid Services (CMS) updates to Medicare Advantage (MA) and other Medicare programs....more

Foley Hoag LLP

DOJ Announces New Priorities in White-Collar Criminal Enforcement: Targeting Waste, Fraud, and Abuse and Protecting American...

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The U.S. Department of Justice’s ("DOJ") Criminal Division recently issued a memorandum outlining a shift in the DOJ’s priorities and policies for prosecuting white-collar crime (the “Memorandum”). Issued by the Head of the...more

Bradley Arant Boult Cummings LLP

SEC Enforcement Leadership Discusses New Priorities and Expectations

On May 20, 2025, as part of the annual “SEC Speaks” program, the leadership of the U.S. Securities and Exchange Commission’s (SEC) Division of Enforcement publicly discussed the enforcement priorities under new Chairman Paul...more

DarrowEverett LLP

The DOJ’s New White-Collar Agenda: Implications for Businesses

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On May 12, 2025, the Department of Justice (the “DOJ”) released its criminal—and, more specifically, white collar crime enforcement—initiatives under the current administration. This is typical each time new leadership...more

Carlton Fields

Shifting Priorities in White Collar Enforcement: May 2025 DOJ Memo and What It Means for Companies

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On May 12, 2025, the Department of Justice (DOJ) Criminal Division announced significant changes in its policies on investigating and prosecuting white collar crime, including a shift in focus toward several areas deemed to...more

Skadden, Arps, Slate, Meagher & Flom LLP

Core False Claims Act Theories Top the List of DOJ Criminal Enforcement Priorities

The May 12, 2025, memo from the head of the Department of Justice’s (DOJ’s) Criminal Division highlights 10 “high-impact” areas as the focus of DOJ’s criminal enforcement efforts. (See our May 14, 2025, client alert “In a New...more

White & Case LLP

Life Science Private Equity Risk

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Private Equity focused on investment and operations within the Life Science industry faces significant compliance, operational and business risk due to the heavily regulated nature of the investment targets and portfolio...more

Arnall Golden Gregory LLP

AGG Talks: Cross-Border Business Podcast - Episode 28: How Life Sciences Companies Can Create a Culture of Compliance When...

In this episode, Michael Burke, AGG Corporate partner and co-chair of the firm’s International practice, is joined by David Blank, AGG Healthcare partner, to discuss how foreign life sciences companies can proactively address...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

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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

Bass, Berry & Sims PLC

[Webinar] Healthcare Regulatory & Compliance Summit - May 1st - 2nd, 9:00 am - 12:45 pm CT

Please join us for the inaugural Healthcare Regulatory & Compliance Summit, hosted by Bass, Berry & Sims. The in-person event will take place in our Nashville office on Thursday, April 24 from 8:30 a.m. to 5:30 p.m. CT. The...more

Bass, Berry & Sims PLC

[Event] Healthcare Regulatory & Compliance Summit - April 24th, Nashville, TN

Please join us for the inaugural Healthcare Regulatory & Compliance Summit, hosted by Bass, Berry & Sims. The in-person event will take place in our Nashville office on Thursday, April 24 from 8:30 a.m. to 5:30 p.m. CT. The...more

American Conference Institute (ACI)

[Event] 16th Annual Advanced Forum on Managed Care Disputes and Litigation - May 1st - 2nd, Chicago, IL

Join the industry’s top litigators and leading plan counsel at ACI’s 16th Annual Advanced Forum on Managed Care Disputes and Litigation, for two days of discussions designed to address emerging areas of concern for MCOs in...more

J.S. Held

Inside the Healthcare Industry: The Critical Role of Medical Coding, Billing & Nurse Review

J.S. Held on

In what is already a highly regulated industry, it is becoming increasingly difficult for healthcare organizations to navigate the growing volume, complexity and enforcement of laws, regulations and guidance that surround...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | February 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for February 2025, including long-awaited proposed and final rules regarding the Health Insurance Portability and Accountability Act...more

Zuckerman Spaeder LLP

What to Expect in Consumer Protection in the New Administration

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At the 2025 American Bar Association (“ABA”) White Collar Crime Institute in Miami, industry veterans forecasted the new Trump Administration’s white collar objectives by examining trends during the first Trump presidency. In...more

Faegre Drinker Biddle & Reath LLP

The Latest on Pharmaceutical Company-Sponsored Diagnostic Testing Programs

Pharmaceutical company sponsorship of diagnostic testing remains an area with a gaping divide between the views of regulators and industry, with regulators focused on potential fraud and abuse concerns while industry...more

Sheppard Mullin Richter & Hampton LLP

Proving Fraud is and Should Be Hard: Lessons from a Recent Medicare Advantage False Claims Act Decision

The litigator’s adage “it’s easy to plead, it’s hard to prove” once again came true in the long-running False Claims Act (FCA) case targeting Medicare Advantage (“MA”) plans operated by UnitedHealth (United). Eight years...more

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