News & Analysis as of

Compliance Department of Justice (DOJ) Corporate Integrity Agreement

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 -
Mintz - Health Care Viewpoints

Violations for Excessive Physician Compensation

The Department of Justice (DOJ) recently filed a complaint against Erlanger Health System (Erlanger), a county-owned public health system, and two of its Tennessee hospitals alleging that the health system systemically...more

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

Society of Corporate Compliance and Ethics...

[Virtual Event] Corporate Compliance Enforcement Conference - June 6th, 8:00 am - 5:00 pm CT

How do enforcement priorities impact your compliance program? Supply chains, tech tools, consumer data, the use of sanctions, the list is long — there are a vast number of organizational processes and procedures under...more

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more

Harris Beach PLLC

HHS Office of Inspector General August 2023 Enforcement Activity

Harris Beach PLLC on

The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...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

King & Spalding

DOJ Corporate Enforcement Policy Revisions Target Executive Compensation, Following Multi-Agency Trend

King & Spalding on

On March 2, 2023 and March 3, 2023, in a pair of speeches by Deputy Attorney General (DAG) Lisa Monaco and Criminal Division Assistant Attorney General (AAG) Kenneth Polite, the U.S. Department of Justice (DOJ) announced...more

Foley Hoag LLP - White Collar Law &...

DOJ’s Settlement Imposes Legal Process Compliance Monitor, Highlighting the Government’s Increased Focus on Data Preservation

Google will spend the next three years with an independent compliance monitor scrutinizing its process for responding to warrants and other government data requests. This and other requirements are part of a settlement...more

Foley & Lardner LLP

Compliance Officers Lookout! DOJ and OIG Tag Team Corporate Integrity Agreements

Foley & Lardner LLP on

The Office of Inspector General of the U.S. Department of the Health and Human Services (OIG) recently changed the language describing a compliance officer’s role in relation to other responsibilities he or she may have...more

Paul Hastings LLP

Sign on the Dotted Line: Compliance Certifications by CEOs and CCOs A Likely Requirement

Paul Hastings LLP on

As it continues its focus not just on enforcement, but on compliance, members of the U.S. Department of Justice have foreshadowed a sea change for Chief Executive Officers and Chief Compliance Officers in corporate...more

Sheppard Mullin Richter & Hampton LLP

Driving Cultural Change To Reduce Corporate Risk: Lessons Learned From The Field

Government enforcement efforts are on the rise. In December 2021, the Secret Service announced an initiative to more aggressively counter pandemic-related fraud. Empowered by new personnel, new funding, and new legislation,...more

Health Care Compliance Association (HCCA)

Hospital Settles FCA Case Filed by CO Over Modifiers; Make Sure People ‘Feel Heard’

Report on Medicare Compliance 30, no. 32 (September 13, 2021) - John Peter Smith (JPS) Hospital in Fort Worth, Texas, agreed to pay $3.3 million to settle false claims allegations in a case with a hot risk area, a...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 Regional Healthcare Compliance Conference - Orlando, FL - January 29th, 8:25 am - 5:30 pm EST

Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more

WilmerHale

The Role of Compliance in Government Enforcement

WilmerHale on

As recent developments in corporate enforcement indicate, the United States Department of Justice (DOJ) continues to emphasize transparency, cooperation, and the importance of a strong compliance program. Enforcement trends...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

The Volkov Law Group

Novartis Settles False Claims Act Cases and Pays $729 Million for Domestic Bribery Schemes

The Volkov Law Group on

We have a new poster-child for a defective corporate culture of wrongdoing.  Novartis has joined the exclusive club, along with Siemens, General Motors, Wells Fargo, and others in the misconduct Hall of Fame. ...more

Health Care Compliance Association (HCCA)

DOJ Is Trying to 'Incentivize Higher-Quality Compliance,' Former Official Says

Report on Medicare Compliance 28, no. 44 (December 16, 2019) - One way to find out whether compliance and integrity have seeped into the bones of an organization is asking people who would know. There may be a compliance...more

Skadden, Arps, Slate, Meagher & Flom LLP

Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more

Skadden, Arps, Slate, Meagher & Flom LLP

Health Care Investigation Trends: Corporate Integrity Agreements No Longer a Given

2017 was slightly above average for new corporate integrity agreements (CIAs), with 46 entered into by the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) and companies and individuals...more

McDermott Will & Emery

OIG Issues New Exclusion and CIA Guidance

McDermott Will & Emery on

On April 18, 2016, Inspector General Daniel R. Levinson announced the publication of updated guidance on how the Office of Inspector General (OIG) makes decisions about using its permissive exclusion authority and requiring...more

Dorsey & Whitney LLP

Olympus Settles FCPA Charges with DOJ

Dorsey & Whitney LLP on

The Department of Justice resolved another FCPA investigation centered on payments made to health officials. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, Tokyo, Japan, and Olympus...more

Kilpatrick

Parallel Lives: How Brazil and the United States Consider Leniency Agreements and Compliance Programs

Kilpatrick on

In today’s global environment, conduct in one country can potentially violate anti-corruption laws of more than one country. When faced with this possibly debilitating scenario, companies need to understand both the...more

Manatt, Phelps & Phillips, LLP

Health Update - September 2015

Latest Healthcare False Claims Act Roundup and Top 3 Best Practices to Reduce Exposure - As the legal landscape in healthcare becomes increasingly complex, healthcare companies that receive federal program funds face...more

Baker Donelson

Deferred Prosecution Agreements: How an Effective Compliance Program Can Help You Plan for the Unpredictable

Baker Donelson on

During the past several years, prosecutors have increasingly used Deferred Prosecution Agreements (DPAs) against corporations in enforcing white collar criminal statutes. DPAs have enabled companies to avoid the costs and...more

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