News & Analysis as of

Department of Health and Human Services (HHS) Investigations

Morrison & Foerster LLP

DOJ and HHS Announce Formation of False Claims Act Working Group and Results of National Health Care Fraud Takedown

As we reported in our recent client alert, the Trump administration has made clear that it is committed to using the False Claims Act (FCA) to prosecute healthcare fraud. Two recent Trump administration moves give important...more

ArentFox Schiff

Investigations Newsletter: Federal Court Imposes Nearly $1 Billion in FCA Damages and Penalties Against Omnicare and CVS

ArentFox Schiff on

Federal Court Imposes Nearly $1 Billion in FCA Damages and Penalties Against Omnicare and CVS - On July 7, Southern District of New York District Judge Colleen McMahon increased a False Claims Act (FCA) judgment from $136...more

Rivkin Radler LLP

DOJ and HHS Announce FCA Working Group

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On July 2, the U.S. Department of Justice (DOJ) and Department of Health and Human Services (HHS) announced the formation of the DOJ-HHS False Claims Act Working Group to strengthen “their ongoing collaboration to advance...more

Polsinelli

Five Things Every Health Care Provider Should Know About HHS OIG’s 2025 Semiannual Report

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On June 2, 2025, the Department of Health and Human Services (HHS), Office of Inspector General (OIG) published its Semiannual Report to Congress. This report covers the period from October 1, 2024, through March 31, 2025,...more

WilmerHale

HHS Office of Inspector General Issues First Semiannual Report to Congress in this Administration

WilmerHale on

On June 2, 2025, the Department of Health and Human Services Office of Inspector General (HHS-OIG) announced the release of its Spring 2025 Semiannual Report to Congress. Covering the period from October 1, 2024, to March 31,...more

Health Care Compliance Association (HCCA)

And Then There Were Nine: Disappearing OHRP To Join Enforcement Agency; NIH Cuts Outlined

When it comes to changes roiling the federally supported research landscape, April offered no letup from the first three months of the year; if anything, the pace and magnitude increased. In one instance, an agency—the HHS...more

Kilpatrick

Federal Government Launched Four Investigations into Discrimination Against Jewish Students at Higher Education Institutions

Kilpatrick on

On January 29, 2025, President Trump signed an executive order combatting antisemitism in the United States. The executive order required the Department of Justice’s (“DOJ”) “immediate action…to protect law and order, quell...more

Ropes & Gray LLP

Clinical Trial Protocol Deviations: A New FDA Draft Guidance to Ring in the New Year

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As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting protocol deviations in...more

King & Spalding

OIG Publishes the Fall 2024 Semiannual Report to Congress

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On December 4, 2024, OIG issued its fall 2024 Semiannual Report to Congress (the Report), which provides a comprehensive overview of the agency’s work completed during the reporting period of April 1, 2024, through September...more

Robinson & Cole LLP

Legal Update: Key Takeaways: HHS and DOJ’s Health Care Fraud and Abuse Control Program Report

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On December 6, 2024, the Department of Health and Human Services (HHS) and the Department of Justice (DOJ) released the Health Care Fraud and Abuse Control Program Annual Report for Fiscal Year 2023 (the Report). The Report...more

Lippes Mathias LLP

Hospital Administrators – Is Your Hospital Cyber-Secure?

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On October 2, 2024, New York adopted new regulations requiring general hospitals to implement heightened cybersecurity safeguards. General hospitals, as defined in Article 28 of the NY Public Health Law, generally must begin...more

Health Care Compliance Association (HCCA)

2nd Settlement Triggered by 2017 Ransomware Attack Costs WA Practice $100K; ‘Not a Breach’

Let’s review for a moment. It’s not a HIPAA violation to be a victim of ransomware. It’s not a HIPAA violation to pay a ransom. It’s up to the covered entity (CE) to determine if a security or privacy incident is a...more

Nelson Mullins Riley & Scarborough LLP

HHS Final Rule Targets Suspicious Billing Practices for Medical Equipment (CMS-1799-F)

Summary: On September 24, 2024, the Biden administration issued a final rule designed to address suspicious billing for durable medical equipment that may have cost the Medicare program more than $2 billion....more

K&L Gates LLP

Long-Awaited Changes to Research Misconduct Rules Have Arrived

K&L Gates LLP on

On 12 September 2024, the Office of Research Integrity (ORI) within the US Department of Health and Human Services (HHS) issued a final rule (Final Rule) that significantly modified the standards, procedures, and requirements...more

Foley & Lardner LLP

Research Misconduct: ORI Issues Final Rule with Modernized and Streamlined Regulations

Foley & Lardner LLP on

On September 17, 2024, the Office of Research Integrity (ORI) issued a final rule adopting changes to federal regulations governing research misconduct involving federally funded research (Final Rule). The regulations have...more

Gardner Law

Kickbacks and Consequences: Lessons from the Innovasis Settlement

Gardner Law on

On May 29, 2024, the U.S. Department of Health and Human Services’ Office of Inspector General (HHS OIG) announced a $12 million settlement with Innovasis Inc., a medical device manufacturer, and two of its senior executives...more

Foley & Lardner LLP

Understanding the Risk vs. Reward of Department of Justice’s Corporate Criminal Whistleblower Awards Pilot

Foley & Lardner LLP on

The Securities & Exchange Commission, the Department of Health & Human Services, and other agencies have long had established bounty programs that reward successful tipsters. On August 1, 2024, the Department of Justice’s...more

Davis Wright Tremaine LLP

21st Century Cures Act Information Blocking Rule Finally Has Teeth With Respect to Providers

On July 1, 2024, the U.S. Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC) published a final rule...more

King & Spalding

HHS Finalizes Disincentives for Healthcare Providers That Have Committed Information Blocking

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Last week, HHS published its final rule outlining disincentives for certain healthcare providers that have committed information blocking (the Final Rule). The Final Rule also provides information related to OIG’s...more

Foley & Lardner LLP

HIPAA: Amendments to Protect Reproductive Health Care Information Can Now be Implemented with OCR’s Final Rule

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Share on Twitter Print Share by Email Share Back to top HIPAA regulated entities may now begin implementing the amendments to the HIPAA Privacy Rule to provide additional protections for reproductive health care information...more

ArentFox Schiff

Providers Face HIPAA Compliance Questions After Change Healthcare Cyberattack

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Who will notify the potentially millions of individuals whose information might have been jeopardized by the massive cyberattack on Change Healthcare? Since the affiliate of UnitedHealth Group (UHG) first reported the...more

Mintz - Health Care Viewpoints

DOJ Releases COVID-19 Fraud Enforcement Task Force Report Touting Its Successes and Urging Lawmakers to Enact New Legislation

The government’s continued dedication of resources to investigating and prosecuting fraud against COVID-19 pandemic relief programs appears to have borne fruit according to the results of the COVID-19 Fraud Enforcement Task...more

King & Spalding

Senators Introduce New Bill for Transparency and Oversight in Health Care Transactions and Investment

King & Spalding on

On April 3, 2024, Senators Ed Markey (D-Mass) and Elizabeth Warren (D-Mass) released draft legislation titled the “Health Over Wealth Act” (the Proposed Bill). This Proposed Bill is another attempt to regulate private...more

Skadden, Arps, Slate, Meagher & Flom LLP

HHS Office for Civil Rights Reaches Second Health Care Ransomware Settlement

The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently announced its second settlement in four months growing out of a ransomware attack on a health care business. Maryland-based Green Ridge...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

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