News & Analysis as of

Healthcare False Claims Act (FCA) Compliance

White & Case LLP

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

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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 reestablishment of the DOJ-HHS False Claims Act (FCA) Working Group. While the two agencies...more

Husch Blackwell LLP

OIG Announces 2025 Work Plan Review: What Clinical Laboratories Need to Know About Medicare Payments for Diagnostic Lab Tests

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In June 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) announced a new item in its Work Plan: “Medicare Payments for Clinical Diagnostic Laboratory Tests in 2024.” This annual review,...more

ArentFox Schiff

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

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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

Dentons

Ep. 66 – Mid-year Compliance Check-in: Three New Enforcement Priorities to Add to Your 2025 Work Plan

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As we hit the halfway point of 2025, now is the perfect time to revisit your compliance work plan. While it’s always good practice to assess whether your organization is meeting its compliance goals, this year presents a...more

Greenbaum, Rowe, Smith & Davis LLP

Legal Risks and Challenges for Private Equity in Healthcare Acquisitions

Private Equity (PE) firms continue to be significant players in U.S. healthcare, acquiring assets across various sectors such as physician practices, home health, behavioral health, and urgent care. However, recent legal...more

Skadden, Arps, Slate, Meagher & Flom LLP

Speaker Program Settlement Highlights Compliance Risks for Life Sciences Companies

On April 29, 2025, the U.S. Attorney’s Office for the Southern District of New York (SDNY) announced a $202 million civil False Claims Act (FCA) settlement with Gilead based on allegations that the company’s speaker program...more

White & Case LLP

Life Science Private Equity Risk

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Private Equity focused on investment and operations within the Life Science industry faces significant compliance, operational and business risk due to the heavily regulated nature of the investment targets and portfolio...more

Gardner Law

Why Compliance Audits Are Non-Negotiable

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In today’s heightened enforcement environment, compliance auditing isn’t just a best practice—it’s a necessity. Federal and state laws and industry guidance, including the Office of Inspector General (OIG) Compliance Program...more

Mintz - Health Care Viewpoints

Health Law Diagnosed – Understanding the New Massachusetts Health Care Market Review Law

In the latest episode of Health Law Diagnosed, host Bridgette Keller discusses the new Massachusetts Health Care Market Review Law and what this means for health care providers, investors, and other key stakeholders. She is...more

Lowenstein Sandler LLP

Trump Administration Plans Aggressive FCA Enforcement

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At the Federal Bar Association’s annual qui tam conference in Washington, D.C. on Feb. 20, 2025, the Deputy Assistant Attorney General for the Department of Justice’s (DOJ) Commercial Litigation Branch, Michael Granston, said...more

Bass, Berry & Sims PLC

HHS-OIG Year in Review 2024

In 2024, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) provided useful insights to the healthcare industry regarding how it approaches various fraud and abuse issues in an...more

Foley Hoag LLP - White Collar Law &...

New Massachusetts Healthcare Law Targets Private Equity, REITs, and MSOs; Expands State False Claims Act

On January 8, 2025, Governor Maura Healey signed House Bill 5159 into law, toughening the rules and increasing the risks for private equity (PE) companies, real estate investment trusts (REITs), and management services...more

Health Care Compliance Association (HCCA)

Private-pay “crime stoppers”: Digesting the Corporate Whistleblower Awards Pilot Program

The U.S. Department of Justice’s (DOJ) Criminal Division launched its Corporate Whistleblower Awards Pilot Program (“Criminal Whistleblower Program”) in August of 2024 to encourage tips for various types of fraud, including...more

Proskauer - Health Care Law Brief

Spurred on by the Steward Health Care Bankruptcy, Massachusetts Adopts Bill Regulating Private Equity and REITs in Health Care,...

On January 8, 2025, Massachusetts Governor Maura Healey signed into law House Bill 5159 (the “Bill”). The Bill grants the state new regulatory powers to oversee and review health care transactions involving private equity...more

Verrill

Massachusetts Enacts Largest Health Care Transactions and Financial Oversight Legislation In a Decade, Private Investors and...

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Health care sector stakeholders take notice: On January 8, 2025, Massachusetts Governor Healy signed sweeping new health care legislation with transactional, financial, and ongoing operational compliance ramifications for...more

Perkins Coie

False Claims Act Qui Tam Lawsuits Increased to 979 in FY 2024—the Highest Ever

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Whistleblowers filed 979 qui tam lawsuits under the False Claims Act (FCA) in Fiscal Year 2024—the highest number in a single year and 35% more than in the prior year—the U.S. Department of Justice (DOJ) announced. Overall,...more

Mintz - Health Care Viewpoints

EnforceMintz — Healing Healthcare? DOJ’s Cybersecurity Enforcement Trained Up for 2025

In 2024, the Department of Justice (DOJ) pursued significant enforcement activity under its Civil Cyber-Fraud Initiative (CCFI). As our readers know, the Deputy Attorney General announced the creation of the CCFI in October...more

Goodwin

Massachusetts Passes Comprehensive Revisions to Healthcare Transaction Notification Law with Significant Implications for Private...

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On January 8, 2025, Massachusetts Governor Maura Healey signed House Bill 5159 (H.5159), “An Act Enhancing the Market Review Process” (the “Act”), which, among other things, broadens the scope of the state’s existing...more

McDermott Will & Emery

Massachusetts H.5159 Seeks to Reshape Private Equity in Healthcare

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On December 30, 2024, both the Massachusetts House of Representatives and the Massachusetts Senate enacted House Bill 5159 (H.5159), and Governor Maura Healey signed it on January 8, 2025. The bill seeks to strengthen...more

Ropes & Gray LLP

Massachusetts Passes Act Implementing Broad Oversight into For-Profit Investment in Health Care

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On January 8, 2025, Massachusetts Governor Maura Healey signed House Bill 5159, An Act Enhancing the Market Review Process (the “Act”) into law, effective April 8, 2025. The Act is a compromise redraft of the separate health...more

ArentFox Schiff

What Private Equity Investors and Real Estate Investment Trusts Need to Know About the Newly Enacted Massachusetts Health...

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On December 30, 2024, the Massachusetts state legislature passed House Bill 4653 (the Act), which significantly enhances regulatory oversight in the Massachusetts health care market. As signed into law by Governor Maura Healy...more

Troutman Pepper Locke

New Year, New Liability for Private Equity

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Private equity firms and health care companies operating in Massachusetts will now face enhanced liability risks following the recent passage and enactment of legislation regulating private equity investment in Massachusetts...more

Pietragallo Gordon Alfano Bosick & Raspanti,...

Second Circuit Expands Anti-Kickback Statute Liability: “At Least One Purpose” is Enough

In a significant ruling, the Second Circuit Court of Appeals recently expanded the scope of the Anti-Kickback Statute (AKS).The Court joined other circuit courts across the country in adopting, for the first time, the...more

ArentFox Schiff

FCA Enforcement & Compliance Digest — Fall 2024 False Claims Act Newsletter

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Welcome to the Fall 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and compliance...more

Health Care Compliance Association (HCCA)

Privacy Briefs: November 2024

Change Healthcare Inc. has amended its initial breach report to the HHS Office for Civil Rights (OCR) to state that 100 million individuals were impacted by its mammoth ransomware attack and breach. However, as of Oct. 24,...more

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