News & Analysis as of

Compliance Department of Health and Human Services (HHS) Department of Justice (DOJ)

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

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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

Health Care Compliance Association (HCCA)

In This Month’s E-News: August 2024

The Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...more

Skadden, Arps, Slate, Meagher & Flom LLP

AI-Enabled Compliance: Keeping Pace With the Feds

The potential for artificial intelligence (AI) to transform business has commanded enormous attention over the past year. Little noted, however, is the U.S. government’s increasing — and increasingly sophisticated — use of AI...more

Bass, Berry & Sims PLC

Is Your Compliance House In Order? Tips for Ensuring Private Equity and Portfolio Company Compliance in the Wake of the Recent...

The recent Request for Information by the Federal Trade Commission (FTC), Department of Justice (DOJ) and Department of Health and Human Services (HHS) seeking input on the effects of private equity (PE) investment in the...more

Latham & Watkins LLP

US Regulators Announce Inquiry Into Healthcare Consolidation

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Companies should prepare for increased regulatory scrutiny into healthcare transactions and increased emphasis on compliance programs. The Federal Trade Commission (FTC), the Department of Justice (DOJ), and the...more

Health Care Compliance Association (HCCA)

An international standard for healthcare quality management

In October 2023, the International Organization for Standardization (ISO) published ISO 7101, Healthcare organization management: Management systems for quality in healthcare organizations. ISO 7101 is the latest in a series...more

Akin Gump Strauss Hauer & Feld LLP

2024 Guide to DOJ and HHS OIG Guidance on Effective Compliance Programs

The Department of Health & Human Services’ Office of Inspector General (HHS OIG) and U.S. Department of Justice (DOJ) have published important guidance and recommendations for pharmaceutical companies to develop and implement...more

NAVEX

Healthcare Organizations are Facing Increased Scrutiny – Here's What You Need to Know

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2024 is shaping up to be a very active year for regulatory and enforcement developments in the healthcare industry – developments that concern not just hospitals and nursing facilities, but many non-healthcare companies as...more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - May 9th - 10th, New York, NY

Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...more

NAVEX

Addressing Cybersecurity Expectations in Healthcare

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2024 is shaping up to be a very active year for regulatory and enforcement developments in the healthcare industry – developments that concern not just hospitals and nursing facilities, but many non-healthcare companies as...more

Society of Corporate Compliance and Ethics...

Good news, bad news

There’s good and bad news out there for compliance departments, and it’s also the same news: Governments now very much appreciate strong compliance programs. On the one hand, that is very good (if not great!) news....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

Health Care Compliance Association (HCCA)

News Briefs: January 8, 2024

H. Lee Moffitt Cancer Center & Research Institute Hospital Inc. in Tampa, Florida, has agreed to pay $19.564 million to settle false claims allegations over claims submitted to federal health care programs for items and...more

Mintz

EnforceMintz — DOJ and OIG Guidance Emphasizes the Importance of a Robust and Dynamic Compliance Program

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2023 was a busy year across several federal agencies in terms of issuing compliance guidance for corporations, including health care companies. For example, the Department of Justice (DOJ) issued significant compliance...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

NAVEX

Your Questions, Answered – Mastering DOJ Compliance Guidance: Building a Strong Resilient Foundation for Your Organization's...

NAVEX on

NAVEX recently hosted a webinar in partnership with Granite GRC about the recent updates to the U.S. Department of Justice (DOJ) and the current Evaluation of Corporate Compliance Programs (ECCP). This posts answers questions...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

NAVEX

From Healthcare Sector, a Big Push for CCO Autonomy

NAVEX on

For the better part of a decade, the U.S. Justice Department has led the way on calls for a strong, independent corporate compliance function – until recently, that is. Then the Department of Health and Human Services leaped...more

Bass, Berry & Sims PLC

HHS Releases Groundbreaking General Compliance Program Guidance, Setting New Standards for Healthcare Entities

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On November 6, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) released the most up-to-date, comprehensive, and practical general compliance guidance in decades. The new...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)

Privacy Briefs: October 2023

Report on Patient Privacy 23, no. 10 (October, 2023) Kaiser Foundation Health Plan Inc. and Kaiser Foundation Hospitals will pay California $49 million to resolve allegations that they unlawfully disposed of hazardous waste,...more

Harris Beach PLLC

HHS Office of Inspector General August 2023 Enforcement Activity

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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

Foley & Lardner LLP

Ensuring Child Labor Law Compliance Amid Growing Scrutiny

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In February, the New York Times published an investigative report regarding alleged employment of underage migrants, many from Central America, at U.S. companies. While employment of certain minors is permitted under federal...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

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