News & Analysis as of

Health Care Providers Corporate Misconduct

Goodwin

DOJ Renews Focus on Private Equity Amid Record False Claims Act Enforcement

Goodwin on

2023 was another record year for False Claims Act enforcement. On February 22, 2024, the U.S. Department of Justice (DOJ) announced that the federal government and whistleblowers were party to a record number of FCA...more

Dentons

Ep. 2 - Why Anonymous Reporting is the Cornerstone of Your Compliance Program

Dentons on

When was the last time your organization received an anonymous compliance concern?  Has it been so long you can’t recall? Maybe you consider yourself lucky that the organization has never received a concern on your watch, or...more

Foley Hoag LLP

United States v. Elizabeth Holmes and Ramesh Balwani

Foley Hoag LLP on

I. WHY THIS CASE MADE THE LIST - A highly publicized and long-running multi-agency action against the former Chief Executive Officer and the former Chief Operating Officer of Theranos Inc. resulted in criminal convictions...more

Tucker Arensberg, P.C.

2022 Federal Compliance Enforcement Outlook

Tucker Arensberg, P.C. on

There is almost universal agreement regarding predictions for 2022 federal enforcement in the following areas: ..The use of fraudulently obtained COVID relief funds in both healthcare and in general, but specifically as...more

Health Care Compliance Association (HCCA)

[Virtual Event] Healthcare Compliance Essentials Workshop - December 6th - 9th, 8:55 am - 2:45 pm CST

HCCA’s Healthcare Compliance Essentials Workshop is a four-day virtual event for those who are new to the compliance profession. The content is designed to help you develop and improve your compliance skills. Our instructors...more

The Volkov Law Group

DOJ Indicts Former CEO of Cancer Treatment Company for Conspiracy

The Volkov Law Group on

The Justice Department’s Antitrust Division’s criminal enforcement program is having a strong year.  Since completing its long-term and record-setting prosecution of Japanese auto parts suppliers, the Antitrust Division...more

Epstein Becker & Green

Fraud and Abuse Enforcement Priorities in the Wake of COVID-19 - Diagnosing Health Care Podcast

In this Diagnosing Health Care episode, hear how the government’s fraud and abuse enforcement priorities have shifted as a result of the COVID-19 pandemic and how compliance programs must also pivot to mitigate new risks. The...more

Health Care Compliance Association (HCCA)

Compliance Perspectives: Compliance Lessons from Theranos

Tyler Schultz, like many others, was entranced by the vision of Theranos and its charismatic founder Elizabeth Holmes. He would not remain so for long, ultimately sharing his concerns with her, his grandfather (a member of...more

Skadden, Arps, Slate, Meagher & Flom LLP

HHS-OIG Year in Review: Pharma and Medical Device CIAs Increase, Include Novel Provisions

Corporate integrity agreements (CIAs) continued to be an important tool for the Office of Inspector General, U.S. Department of Health and Human Services (HHS-OIG) in 2019. Notably, pharmaceutical and device manufacturers saw...more

Ruder Ware

The Federal Government Really Wants You to Self Disclose

Ruder Ware on

The Department of Justice (DOJ) along with other health care fraud enforcement agencies, continue to send strong signals that they want businesses to police themselves for potential compliance issues and self-disclose where...more

Baker Donelson

Evaluating the Effectiveness of Corporate Compliance Programs – What the Government is Looking For

Baker Donelson on

The U.S. Justice Department has updated its "Evaluation of Corporate Compliance Programs," a guidance document detailing topics and questions prosecutors should weigh when determining whether a company has demonstrated...more

King & Spalding

DOJ Releases New Guidelines on Proactive Cooperation During FCA Investigations

King & Spalding on

On May 7, 2019, the United States Department of Justice (DOJ) delivered new guidance on how potential False Claims Act (FCA) defendants can receive leniency in exchange for proactively disclosing misconduct and taking other...more

Jackson Walker

Opioids, Healthcare Enforcement, and Increased Scrutiny of Corporate Conduct for Criminal Prosecution

Jackson Walker on

The national opioid epidemic is almost unprecedented in every conceivable way—its catastrophic death toll, its broad effect on a wide swath of this country’s population, its rapid escalation (which is alleged to have been...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and Medical Device Seminar

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

Holland & Hart LLP

Minimizing Liability For Business Associate Misconduct

Holland & Hart LLP on

Healthcare providers, health plans and healthcare clearinghouses (“covered entities”) and business associates are subject to significant penalties for violations of the HIPAA Privacy, Security and Breach Notification Rules....more

Baker Donelson

Update on Regulatory Compliance in the Global Health Care Industry

Baker Donelson on

A comprehensive understanding of the constantly evolving layers that make up federal anti-corruption statutes, sanctions regulations and export control restrictions is imperative for both the pharmaceutical and health care...more

Ruder Ware

Sally Yates’ was Already Famous for Changing the Focus of Compliance Investigations - The Yates Memorandum

Ruder Ware on

By now the whole world knows about Sally Yates. We are likely to see a lot more of her as a central figure in Congressional investigations. For some of us who deal with compliance investigations, Sally Yates was famous long...more

Searcy Denney Scarola Barnhart & Shipley

Congress is About to Take Away Your Rights

The U.S. Congress is fighting hard to take away your rights and the power of individual states to protect those rights. The influence of BIG BUSINESS over your elected representatives is being used protect careless and...more

Bradley Arant Boult Cummings LLP

2016 – Health Law Year in Review

We are pleased to present our annual review of developments in the field of health law. The year was marked by key changes in False Claims Act jurisprudence and Medicare payment policy. 2016 also brought with it focused...more

Sherman & Howard L.L.C.

The Federal Government Holds Individuals Responsible for Involvement in Corporate Healthcare Fraud and Abuse

Sherman & Howard L.L.C. on

In September 2016, three corporate officers in two healthcare fraud and abuse cases settled allegations that they were personally liable for violations of federal fraud and abuse laws. These settlements come one year after...more

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