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Office of the Inspector General Department of Health and Human Services (HHS) Enforcement Actions

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | June 2025 Recap

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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

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

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

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

Wiley Rein LLP

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

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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

Epstein Becker & Green

HHS OIG Continues to Highlight How Medicaid Fraud Control Units Recovered $1.4 Billion in FY 2024

On June 25, 2025, the Office of the Inspector General (“OIG”) of the U.S. Department of Health and Human Services (“HHS”) released a short video containing the highlights of the Medicaid Fraud Control Units (“MFCUs”) Annual...more

Epstein Becker & Green

Medicaid Fraud Recoveries Top More Than $1 Billion in 2024—But Will the Big Beautiful Bill Impact Those Numbers in 2025?

On June 25, 2025, the Office of the Inspector General (“OIG”) of the U.S. Department of Health and Human Services (“HHS”) released a short video containing the highlights of the Medicaid Fraud Control Units (“MFCUs”) Annual...more

King & Spalding

OIG Audit of Provider Relief Fund Payments to Hospitals Finds Substantial Noncompliance with Federal Requirements

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On June 13, 2025, OIG announced the results of an audit it conducted of 30 hospitals that received provider relief fund (PRF) payments during COVID-19 (the Audit). OIG found that 11 of the 30 audited hospitals failed to...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

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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

Foley Hoag LLP - White Collar Law &...

Federal District Court Upholds HHS Advisory Opinion Blocking Fertility Assistance Program

A recent decision from the United States District Court for the District of Columbia continues to give significant deference to the U.S. Department of Health and Human Services’ (HHS) interpretation of the Anti-Kickback and...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

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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

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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

Paul Hastings LLP

OIG Issues Favorable Opinion on Pharmaceutical Manufacturer’s Free Product Program

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In its first advisory opinion of the year, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) assessed a pharmaceutical manufacturer’s free product program and found that, although the...more

Dentons

Ep. 51 – Building Effective Compliance Committee Agendas

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Many healthcare organizations understand the importance of having a Compliance Committee but some struggle to use their committee effectively. The key to ensuring the Compliance Committee is effective is building smart...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | January 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2025. This month features long-awaited proposed and final rules regarding the Health Insurance Portability and Accountability...more

McGuireWoods LLP

Fourth Circuit Upholds OIG Advisory Opinion Process

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On January 23, 2025, the United States Court of Appeals for the Fourth Circuit rejected a challenge to Advisory Opinion 22-19 (the “Advisory Opinion”) issued by the United States Department of Health and Human Services,...more

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter - January 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, we...more

Health Care Compliance Association (HCCA)

Delayed Action on Misconduct Costs Firm $4M; FCA Whistleblower Flagged Earlier Application

Scientist and pharmaceutical researcher Andrew P. Mallon—who first reported to NIH and others in 2016 his suspicions that then-Athira Pharma CEO Leen Kawas falsified data in published papers—filed the whistleblower suit...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | December 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for December 2024. We discuss several civil and criminal enforcement actions pertaining to healthcare fraud and abuse authorities,...more

Rivkin Radler LLP

Hospital CEO Jailed for Conspiracy to Violate AKS

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The U.S. Department of Justice announced on January 15 that Jeffrey Paul Madison, the former chief executive officer of a Texas hospital, was sentenced to 36 months in federal prison for conspiring to violate the federal...more

Hendershot Cowart P.C.

Texas Healthcare Providers Paid $21.3 Million to Resolve Stark Law Violations in 2024

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Healthcare fraud enforcement continues to be a top priority for federal authorities, with Stark Law violations remaining under particular scrutiny. The complex nature of physician self-referral regulations, combined with...more

McGuireWoods LLP

Second Circuit Joins Other Circuits with AKS One Purpose Test

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On December 27, 2024, the United States Court of Appeals for the Second Circuit decided United States ex rel. Camburn v. Novartis Pharmaceuticals Corporation and joined a growing list of federal circuit courts that have...more

Morrison & Foerster LLP

New HHS-OIG Guidance on Sponsored Genetic-Testing Programs

On December 17, 2024, the Department of Health & Human Services, Office of Inspector General (HHS-OIG) issued its second favorable advisory opinion involving an arrangement in which a drug manufacturer sponsors genetic...more

Mintz - Health Care Viewpoints

EnforceMintz — Additional Health Care Provider Joins the OIG’s “Heightened Scrutiny” List in 2024

The HHS Office of Inspector General (OIG), in connection with its enforcement responsibilities, must exclude a party from the federal health care programs if the party is found to have violated certain federal laws. This type...more

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