News & Analysis as of

Compliance Department of Justice (DOJ) Anti-Kickback Statute

Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations. ... more +
Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations.  In response to many corporate scandals evidencing rampant unethical business practices, many nations, including the United States, began passing strict regulatory frameworks aimed at curbing these abuses. Notable pieces of legislation in this area include the U.S. Foreign Corrupt Practices Act (FCPA), Sarbanes-Oxley (SOX), and the U.K. Bribery Act, to name a few. The foregoing statutes and the severe penalties often associated with them form the basis of many modern institutional compliance programs. less -
Foley & Lardner LLP

Compliance Compass: The Erlanger Complaint – A Cautionary Reminder About the Importance of FMV

Foley & Lardner LLP on

Although most health care lawyers and compliance officers who review and analyze physician compensation understand that fair market value (FMV) is important, the nuances around FMV are sometimes missed....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

NAVEX

The Supreme Court Made Its Rulings; Corporate Compliance Needs March On

NAVEX on

At the end of June, the U.S. Supreme Court issued major decisions on the enforcement power of the Securities and Exchange Commission, what does or doesn’t qualify as a bribe of government officials, and on federal judges’...more

K&L Gates LLP

The False Claims Act and Health Care: 2023 Recoveries and 2024 Outlook

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On 22 February 2024, the US Department of Justice (DOJ) published the statistics for federal civil fraud recoveries in Fiscal Year (FY) 2023. The DOJ announced that the “government and whistleblowers were party to 543...more

Health Care Compliance Association (HCCA)

In Biggest Stark-Based FCA Settlement Ever, Indiana Hospital Pays $345M, Has Unusual CIA

Community Health Network (CHN) in Indiana has agreed to pay $345 million to settle false claims allegations that it paid over-the-top salaries to hundreds of physicians and rewarded them for their referrals in violation of...more

Foley & Lardner LLP

Health-Care Fraud Scrutiny Heats Up For Companies, Providers

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This year will see a continued proliferation of enforcement against health-care fraud, with old and new theories. Some hot spots for enforcement will involve cases about new technologies; data outliers; entities perceived as...more

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter - December 2024

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

ArentFox Schiff

Investigations Newsletter: Binance to Pay Historic $4 Billion Fine

ArentFox Schiff on

Binance to Pay Historic $4 Billion Fine - Binance Holdings Limited, the operator of the world’s largest cryptocurrency exchange, agreed to pay $4.3 billion to resolve allegations that it violated the Bank Secrecy Act (BSA)...more

McDermott Will & Emery

OIG Issues General Compliance Program Guidance Updates

McDermott Will & Emery on

On November 6, 2023, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published the General Compliance Program Guidance (GCPG) as a revised reference guide for the healthcare compliance...more

Health Care Compliance Association (HCCA)

[Event] 2023 Healthcare Enforcement Compliance Conference - November 5th - 7th, Washington, DC

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - January 27th, Lake Buena Vista, FL

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education, including updates on the latest news in regulatory...more

Bass, Berry & Sims PLC

[Virtual Conference] Nashville Healthcare Fraud Conference - December 15th - 16th, 8:00 am - 1:00 pm CST

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Please join us for the 8th Annual Nashville Healthcare Fraud Conference hosted by Bass, Berry & Sims and the Tennessee Hospital Association. Eligible for more than seven hours of CLE credit (including ethics), this...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2022 Research Conference - October 6th, 8:25 am - 4:30 pm CDT

Stay on top of the latest in research compliance - Do you want to learn: - Current best practices for building and maintaining a  research compliance work plan? - How to better shift your program’s research focus in...more

Thomas Fox - Compliance Evangelist

Biotronik Anti-Kickback Enforcement Action: Bribery Schemes and Lessons Learned

Today we conclude our series on a Federal Anti-Kickback enforcement action which was announced last week, involving the Oregon based medical device manufacturer Biotronik Inc. (Biotronik). Today, I want to consider the...more

Kaufman & Canoles

Special Fraud Alert Released by OIG Following Nationwide Arrest of Dozens Accused in Telehealth Scams

Kaufman & Canoles on

On July 20, 2022, the Department of Justice announced charges against 36 criminal defendants across 13 different federal districts for healthcare fraud violations resulting in Government losses in excess of $1.2 billion. The...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - January 28th, Orlando, FL

Looking for compliance training and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance training, including updates on the latest news in regulatory...more

Kaufman & Canoles

Government Contracts & Defense Industries Team Client Alert – U.S. Government Accountability Office Releases Report Calling for...

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Key Takeaways: - Heightened Government Attention to Fraud Risk - The U.S. Government Accountability Office (GAO) recently released a report identifying ongoing vulnerabilities to fraud in the defense contracting sphere....more

Skadden, Arps, Slate, Meagher & Flom LLP

Navigating Relationships With Practice Support and Other Tech Vendors

Enforcement in Life Sciences Series: Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers - About the Enforcement in Life Sciences Series - Recent settlements between the U.S....more

Skadden, Arps, Slate, Meagher & Flom LLP

DOJ Introduces Novel Theories of Liability and Requires Unprecedented Controls in Speaker Program Settlement

Enforcement in Life Sciences Series: Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers - About the Enforcement in Life Sciences Series - Recent settlements between the U.S....more

White & Case LLP

Fraud and abuse risks in digital health: What tech companies need to know about healthcare enforcement - Part I

White & Case LLP on

Digital health is exciting, innovative and forward-looking. Investors have invested billions of dollars anticipating dividends from the next phase of the Big Data revolution: collecting and synthesizing millions of data...more

Health Care Compliance Association (HCCA)

Report on Medicare Compliance Volume 29, Number 39. News Briefs: November 2020

Report on Medicare Compliance 29, no. 39 (November 2, 2020) - Medtronic USA Inc., a medical device maker, has agreed to pay $8.1 million to settle allegations it violated the False Claims Act by paying kickbacks to induce...more

Health Care Compliance Association (HCCA)

Hospital Settles FCA Case for $50M; DOJ: CEO 'Disregarded' Concerns

Report on Medicare Compliance Volume 29, no. 32 (September 14, 2020) - Wheeling Hospital in West Virginia has agreed to pay $50 million to settle a False Claims Act (FCA) lawsuit over physician compensation, the Department...more

Thomas Fox - Compliance Evangelist

Novartis US Corruption Settlements: Part 6 – Final Thoughts

We are nearing the end of this exploration of two major corruption enforcement actions involving the pharmaceutical giant Novartis. One in the US and one for the rest of the world....more

Thomas Fox - Compliance Evangelist

Novartis US Corruption Settlements: Part 4 – CIA Structural Requirements

I have written extensively about the Novartis International AG (Novartis) Foreign Corrupt Practices Act (FCPA) settlement, which was announced in late June. However, the enforcement action paled next to the Stipulation and...more

Arnall Golden Gregory LLP

CIA Imposes Requirements for Pharmaceutical Speaker Programs and Events

On July 1, 2020, the United States Department of Justice (DOJ) announced two settlements with Novartis Pharmaceuticals Corporation (“Novartis”), resolving allegations that the company had paid illegal kickbacks to physicians...more

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