News & Analysis as of

Enforcement Actions Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS)

Davis Wright Tremaine LLP

Navigating Federal and State Oversight in Gender-Affirming Care

On August 1, Washington D.C. and 16 states sued the Department of Justice, U.S. Attorney General Pamela Bondi, and President Donald Trump, alleging that the Trump Administration unlawfully prevented transgender minors from...more

Dickinson Wright

Federal Health Law Enforcement in 2025

Dickinson Wright on

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

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

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

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

Cozen O'Connor

Democratic AGs Sue HHS, DHS Over Alleged Health Data Sharing

Cozen O'Connor on

20 Democratic AGs sued HHS and DHS for allegedly sharing personal health data with ICE. The complaint alleges that the Centers for Medicare & Medicaid Services—a division of HHS—transferred millions of individuals’ Medicaid...more

Tucker Arensberg, P.C.

DOJ and HHS Launch New False Claims Act Working Group to Target Healthcare Fraud

Tucker Arensberg, P.C. on

The U.S. Department of Health and Human Services (HHS) and the Department of Justice (DOJ) have jointly announced the launch of a reinvigorated DOJ-HHS False Claims Act Working Group aimed at enhancing interagency...more

Wiley Rein LLP

DOJ Health Care Fraud Takedown and FCA Working Group Signal New Era of Enforcement and Compliance Risks

Wiley Rein 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 next phase of the Administration’s “Whole-of-Government” approach to fighting health care...more

ArentFox Schiff

Investigation Newsletter: DOJ and HHS Emphasize Continued, Robust, and Coordinated Health Care Enforcement with Revival of False...

ArentFox Schiff on

The government has announced a renewed and expanded focus on False Claims Act (FCA) enforcement, doubling down on traditional health care priorities like kickbacks and drug pricing while signaling increased scrutiny of...more

Morgan Lewis

DOJ and HHS Announce Joint False Claims Act Working Group

Morgan Lewis on

The US Departments of Justice and Health and Human Services recently issued a press release on the formation of a new False Claims Act Working Group, signaling to the healthcare industry an increased focus on anti-fraud...more

Ropes & Gray LLP

DOJ and HHS Announce False Claims Act Working Group & Enforcement Priority Areas

Ropes & Gray LLP on

On July 2, 2025, the U.S. Department of Justice (“DOJ”) and the Department of Health and Human Services (“HHS”) announced the formation of the DOJ-HHS False Claims Act Working Group, signaling a continued and coordinated...more

Cozen O'Connor

DOJ & HHS Announce FCA Working Group to Implement Enforcement Priorities

Cozen O'Connor on

On Wednesday, July 2, 2025, the U.S. Department of Justice (DOJ) and the U.S. Department of Health and Human Services (HHS) announced the creation of a DOJ-HHS False Claims Act Working Group. The Working Group is a procedural...more

Husch Blackwell LLP

DOJ and HHS Launch New False Claims Act Working Group: What The Healthcare Industry Needs to Know

Husch Blackwell LLP on

On July 2, 2025, the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) announced the creation of the DOJ-HHS False Claims Act Working Group, a high-level interagency initiative aimed at...more

BakerHostetler

DOJ Announces Record-Breaking National Health Care Fraud Takedown Against 324 Defendants with Over $14.6 Billion in Alleged Fraud

BakerHostetler on

The DOJ announced on June 30 an unprecedented Health Care Fraud Takedown resulting in criminal charges against 324 defendants (including 96 doctors, nurse practitioners, pharmacists and other licensed providers), with an...more

Polsinelli

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

Polsinelli on

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

McDermott+

CMS Requests Hospitals Submit Gender-Affirming Care Data- (UPDATED)

McDermott+ on

On May 28, 2025, the Centers for Medicare & Medicaid Services (CMS) sent a letter to “select hospitals” that provide gender-affirming care services, requesting information about how those hospitals adhere to quality standards...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights key regulatory and enforcement activity for March 2025. This month features: - Noteworthy enforcement actions demonstrating that the Anti-Kickback Statute...more

Baker Donelson

Looking Back at 2024: Key Health Care Regulatory Legal Developments in Fraud and Abuse, Compliance, and Enforcement

Baker Donelson on

The health care regulatory space realized significant regulatory and enforcement developments in 2024 that are influencing how providers and industry stakeholders approach various compliance measures and enforcement...more

Stevens & Lee

U.S. HHS Announces Closure of Six Regional Locations of the Office of the General Counsel

Stevens & Lee on

On March 11, 2025, the U.S. Department of Health and Human Services (HHS) announced plans for a “reorganization of the Office of the General Counsel” (OGC) “[a]s part of the department’s ongoing efforts to advance the...more

ArentFox Schiff

Investigations Newsletter: Long Island Businessman Arrested in $22 Million Medicare Fraud Scheme

ArentFox Schiff on

Long Island Businessman Arrested in $22 Million Medicare Fraud Scheme - A Long Island, New York, businessman was arrested on conspiracy, kickback, and money laundering charges stemming from an alleged scheme to defraud...more

Arnall Golden Gregory LLP

HHS to Close 6 of 10 Regional OGC Offices, With Potentially Significant Impacts on Providers and Suppliers

On Tuesday, March 11, 2025, the U.S. Department of Health and Human Services (“HHS”) announced plans to close six of the nation’s 10 regional offices for the HHS Office of the General Counsel (“OGC”). These closures, which...more

McDermott Will & Schulte

HHS Signals Action on Gender-Affirming Care

On March 5, 2025, the Center for Clinical Standards and Quality (CCSQ) within the Centers for Medicare & Medicaid Services (CMS) released a Quality & Safety Special Alert Memo for hospitals related to President Trump’s...more

McDermott+

Price Transparency: A Regulatory Priority

McDermott+ on

The Trump administration is beginning to lay out its regulatory (and deregulatory) priorities, and on February 25, 2025, the administration spotlighted one of those priorities in an executive order on price transparency....more

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