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Centers for Medicare & Medicaid Services (CMS) Enforcement Actions

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | July 2025 Recap

This issue of McDermott Will & Schulte’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2025, including the results of the US Department of Justice’s (DOJ) 2025 National Health Care Fraud Takedown, DOJ...more

Maynard Nexsen

Health Care Fraud Enforcement Remains a Top Priority of the Administration

Maynard Nexsen on

There is a widely held view that the current Justice Department (DOJ) is deemphasizing white collar enforcement. While this may be true in some areas, it is certainly not the case when it comes to health care fraud. Rather,...more

WilmerHale

DOJ Health Care Fraud Unit Announces First Enforcement Action Under Updated Corporate Enforcement Policy

WilmerHale on

The U.S. Department of Justice (“DOJ”) Criminal Division and the U.S. Attorney’s Office for the Western District of North Carolina recently announced the first non-prosecution agreement (“NPA”) coming out of DOJ’s Health Care...more

Robinson+Cole Data Privacy + Security Insider

HIPAA Privacy Rule in Focus: OCR Sheds Light on PHI Disclosures and Access Rights

On August 11, 2025, the Office for Civil Rights (OCR) published updated guidance relating to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule (Privacy Rule) in the form of two new FAQs. The FAQs...more

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

WilmerHale

2024 CMS Audit and Enforcement Report

WilmerHale on

On July 15, 2025, the Centers for Medicare & Medicaid Services (CMS) released an Audit and Enforcement Report summarizing its annual Medicare Advantage (Part C) and Prescription Drug (Part D) program audits and enforcement...more

Hendershot Cowart P.C.

Qlarant, Novitas Audits Escalate as Medicare Skin Substitutes Spending Hits $1.6 Billion, CMS Seeks Evidence of Clinical...

Hendershot Cowart P.C. on

The wound care industry faces unprecedented scrutiny as Medicare Part B expenditures for skin substitutes exceeded $1.6 billion in the fourth quarter of 2023 alone. The spending surge has triggered a wave of skin substitute...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

Mintz - Health Care Viewpoints

Health Care Fraud Enforcement Developments: the 2025 Takedown and a “New” False Claims Act Working Group

This year’s National Health Care Fraud Takedown (Takedown) announced recently by the Department of Justice was touted by the Department of Justice (DOJ) as the largest to date, involving over $14.6 billion in “intended loss”...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

Polsinelli

DOJ Unveils Record-Breaking National Health Care Fraud Takedown

Polsinelli on

Key Takeaways - DOJ’s 2025 National Health Care Fraud Takedown was a record-breaking operation that resulted in criminal charges against 324 defendants and targeted schemes involving over $14.6 billion in intended losses....more

Cole Schotz

“First Do No Harm” Considerations for Healthcare Providers in Light of Historic Healthcare Fraud Enforcement Announcement by the...

Cole Schotz on

On Monday, the Department of Justice Criminal Division, led by Matthew R. Galeotti, announced its largest healthcare fraud enforcement charging individuals and entities across the globe in allegedly $14.6 billion criminal and...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

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | May 2025

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2025, including the rollout of a new Centers for Medicare & Medicaid Services (CMS) strategy to expand and enhance Medicare...more

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