News & Analysis as of

Department of Health and Human Services (HHS) Enforcement Actions

Paul Hastings LLP

At the Crossroads: Illumina Settlement Reflects the Intersection of Cybersecurity and Healthcare Law

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On July 31, the U.S. Department of Justice (DOJ) announced a settlement in United States ex rel. Lenore v. Illumina, Inc, the first case in which underlying cybersecurity issues formed the basis of a settlement under the...more

Arnall Golden Gregory LLP

Mental Health Parity Enforcement Paused: What Providers and Patients Need to Know

On May 15, 2025, the U.S. Departments of Labor, Health and Human Services, and the Treasury issued a statement related to the enforcement of the Mental Health Parity and Addiction Equity Act (“MHPAEA”)....more

Dickinson Wright

Federal Health Law Enforcement in 2025

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Much has been written about the healthcare policy changes implemented by the 2025 Trump administration. President Trump has issued numerous Executive Orders that establish new policies and rescind actions taken by previous...more

Goodwin

CCPA Settlement Signals Focus on Web Tracking Health Data

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In June 2025, California Attorney General Rob Bonta filed a proposed settlement with Healthline, a health information website, for its handling of personal information under the California Consumer Privacy Act (CCPA)....more

King & Spalding

The Fourth Circuit Rejects a Non-Delegation Doctrine Challenge to the Anti-Kickback Statute

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On July 22, 2025, the Fourth Circuit published its opinion in United States v. Donald Booker, No. 23-461, affirming a 200-month prison sentence for the owner of United Youth Care Services, which billed North Carolina’s...more

McDermott Will & Schulte

DOJ-HHS False Claims Act Working Group will pursue healthcare, life sciences enforcement priorities

The US Department of Justice (DOJ) and the US Department of Health and Human Services (HHS) recently announced the relaunch of the DOJ-HHS False Claims Act Working Group, intended to “strengthen[] [the agencies’] ongoing...more

Foley & Lardner LLP

CMS Finalizes Rule Change Applying Preponderance of the Evidence Standard to Agent, Broker, and Web-Broker Exchange Agreement...

Foley & Lardner LLP on

In its recently issued Final Rule (CMS-9884-F; 90 FR 27074-01; the Final Rule), the Centers for Medicare and Medicaid Services (CMS) finalized revisions to 45 C.F.R. § 155.220(g)(2) to specify a standard of proof for...more

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter - July 2025

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,...more

Sheppard Mullin Richter & Hampton LLP

Potential False Claims Act Liability for Providers of Gender-Affirming Care for Minors

On July 9, 2025, the U.S. Department of Justice (“DOJ”) announced it sent more than 20 subpoenas to physicians and clinics involved in providing gender-affirming care to minors, and that the subpoenas related to...more

Dinsmore & Shohl LLP

Recent OCR Settlements Emphasize the Need for Thorough HIPAA Risk Analysis

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Two settlements recently announced by the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) reinforce the agency’s emphasis on promoting thorough risk analysis to help prevent disclosure of...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | June 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2025, including a new Centers for Medicare & Medicaid Services (CMS) innovation model; proposed rules with significant...more

Hinshaw & Culbertson - Health Care

Emergency Alert! HHS Restricts Care for Immigrants—Health Centers Must Act Now

Overview of Key Changes and Immediate Impacts - Key Policy Shift: Section 330 Grants now treated as a “Federal Public Benefit” - The U.S. Department of Health and Human Services (HHS) now classifies the Health Center Program...more

Goodwin

DOJ-HHS Announces False Claims Act Working Group, Emphasizes Healthcare Fraud Enforcement Priorities

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The Trump administration recently announced the renewal of a new cross-agency collaboration between the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) in the form of the DOJ-HHS False Claims...more

Woodruff Sawyer

Enforcement of the HIPAA Reproductive Health Care Privacy Rule Vacated Nationwide

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On June 18, 2025, a federal district court in Texas vacated a significant portion of the HIPAA Privacy Rule to Support Reproductive Health Care Privacy (“Final Rule”), which was implemented on April 24, 2024, on a nationwide...more

McGuireWoods LLP

DOJ and HHS Reestablish False Claims Act Working Group, Delineate Healthcare Enforcement Priorities

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On July 2, 2025, the U.S. Department of Justice (DOJ) and U.S. Department of Health and Human Services (HHS) announced the reestablishment of the DOJ-HHS False Claims Act Working Group. Originally formed in December 2020 at...more

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

White & Case LLP

DOJ and HHS Relaunch False Claims Act Working Group, Sharpen Healthcare Enforcement Priorities

White & Case LLP on

On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the reestablishment of the DOJ-HHS False Claims Act (FCA) Working Group. While the two agencies...more

Phelps Dunbar

Trump Administration Bolsters FCA Health Care Fraud Enforcement With New DOJ-HHS Working Group

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Emphasizing its commitment to enforcing the False Claims Act (FCA) and combating health care fraud, the Trump Administration recently instituted a DOJ-HHS False Claims Act Working Group dedicated to “combating health care...more

Davis Wright Tremaine LLP

Healthcare Industry in the Crosshairs at DOJ and HHS

Any suggestion that the Trump Administration might not be committed to healthcare fraud enforcement was definitively quashed by two recent developments. First, on July 2, 2025, the U.S. Department of Justice (DOJ) and the...more

Ballard Spahr LLP

Courts Split on Enforcement of No Surprises Rules

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The Fifth Circuit and the Federal District Court of Connecticut have issued conflicting decisions on whether service providers may sue to enforce arbitration awards under the No Surprises Rules in the Consolidated...more

Kilpatrick

Healthcare Fraud in the False Claims Act Enforcement Crosshairs: Why Now is the Time to Strengthen Compliance Efforts

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The U.S. Department of Justice (DOJ) and U.S. Department of Health and Human Services (HHS) have announced that they are revitalizing the DOJ-HHS False Claims Act Working Group. The primary focus of the working group will be...more

Venable LLP

OIG Reminds Us that Flat Fee Business Arrangements Aren’t Immune from AKS Scrutiny

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On July 1, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 25-08, concluding that a medical device manufacturer’s proposed payment to access a...more

Ropes & Gray LLP

U.S. District Court Ruling Vacates HIPAA Final Rule that Strengthened Privacy Protections for Reproductive Health Information

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On June 18, 2025, the United States District Court for the Northern District of Texas Amarillo Division issued an opinion, Purl v. Department of Health and Human Services, declaring the U.S. Department of Health and Human...more

Quarles & Brady LLP

DOJ and HHS Announce New False Claims Act Working Group

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On July 2, 2025, the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Justice (DOJ) announced that they are forming the DOJ-HHS False Claims Act Working Group to further combat healthcare fraud—an...more

King & Spalding

Trump Administration Revamps Working Group to Focus on False Claims Act

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On Wednesday, July 2, 2025, HHS and DOJ announced a new working group focused on enforcement of the False Claims Act (“FCA”). According to the announcement, the DOJ-HHS False Claims Act Working Group (“Working Group”) is a...more

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