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Healthcare Civil Monetary Penalty

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

Mitchell, Williams, Selig, Gates & Woodyard,...

Air Enforcement: Missouri Department of Natural Resources and St. Louis Medical School Complex Enter into Administrative Order on...

The Missouri Department of Natural Resources (“MDNR”) and The Washington University (“WU”) entered into a May 2nd Administrative Order on Consent (“AOC”) addressing an alleged violation of an Air Permit. See No....more

Pietragallo Gordon Alfano Bosick & Raspanti,...

Private Equity Throws FCA Enforcement Off-Kilter

Over the last 15 years, private equity (“PE”) firms have invested hundreds of billions of dollars in the healthcare sector, infiltrating every corner of the industry from emergency rooms and labs to billing providers and...more

Gardner Law

Sunshine Act Compliance: How to Take Action to Meet Reporting Requirements and Avoid Costly Penalties

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The clock is ticking for medical device and pharmaceutical companies to fulfill their obligations under the Physician Payments Sunshine Act (the "Sunshine Act"). With the reporting deadline of March 31 looming and CMS...more

Sheppard Mullin Richter & Hampton LLP

Navigating Gainsharing Pitfalls in Value-Based Models

As the shift toward value-based care continues to transform the healthcare industry, hospitals and health systems are increasingly utilizing incentive-based physician compensation structures. Incentive-based compensation...more

Proskauer Rose LLP

Top 10 Whistleblowing and Retaliation Events of 2024

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Following our annual tradition — which started over a decade ago — we are analyzing the year's 10 most significant whistleblower and retaliation events. As you'll see, in 2024, actions taken by a range of courts and...more

Wiley Rein LLP

Section 111 Bulletin: Mitigating Medicare Section 111 Reporting Risks - With Civil Money Penalties on the Line, Are You Certain...

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Under a long anticipated Centers for Medicare & Medicaid Services (CMS) final rule that took effect in October, casualty insurers face risks of incurring Civil Money Penalties (CMPs) if they fit the Section 111 definition of...more

Troutman Pepper Locke

Precision Toxicology Agrees to Pay $27M Over Drug Testing and Kickback Allegations

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On October 15, Maryland Attorney General Anthony G. Brown announced that his office reached a $27 million settlement with Precision Toxicology to resolve allegations that it submitted false claims to government health...more

The Volkov Law Group

Teva Pharmaceuticals Pays $450 Million to Resolve Anti-Kickback and False Claims Act Violations

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Teva Pharmaceuticals USA Inc. (Teva USA) and Teva Neuroscience Inc. (“Teva”) agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA). Teva is...more

Burr & Forman

Federal Agency Deference Eliminated, Now What?

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On June 28, 2024, the U.S. Supreme Court issued a decision that overrules the “Chevron doctrine.”  This means that federal agencies are limited in their ability to rely on their own interpretation of the laws they...more

Foley & Lardner LLP

Health Care Enforcement: “Tea Leaves” in the 2024 National Health Care Fraud Summer Takedown

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Each summer in recent years, the U.S. Department of Justice (DOJ) and associated fraud enforcement partners have indicted many health care defendants, in multiple cases across the country. This summer continued the tradition....more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 4, August 2024

Welcome to our fourth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we address a variety of topics including a recent SCOTUS ruling and the potential impact on CMS, issues of patient...more

Foley & Lardner LLP

Health Care Investing: Washington’s Continued Assault Reflected in “Corporate Crimes Against Healthcare Act of 2024”

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On June 11, Senators Elizabeth Warren (D-Mass) and Edward Markey (D-Mass) introduced a bill titled “The Corporate Crimes Against Healthcare Act of 2024.” The proposed Act would criminalize acts of senior executives who...more

Hinch Newman LLP

Whoa! U.S. Lawsuit Against Telehealth Providers and Executives Should Turn Heads

Hinch Newman LLP on

On June 10, 2024, the U.S. Justice Department announced that together with the Federal Trade Commission, it filed an amended complaint against telehealth company Cerebral Inc., Cerebral’s founder and former Chief Executive...more

Gardner Law

CMS Audits on the Horizon: Prepare for Increased CMS Audits Under the Sunshine Act

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Historically, the Centers for Medicare and Medicaid Services (“CMS”) has not aggressively pursued enforcement activity under the Sunshine Act. However, this may change in 2024. Late last year, CMS updated its Open Payments...more

Health Care Compliance Association (HCCA)

Privacy Briefs: May 2024

Kaiser Permanente is notifying 13.4 million current and former members that their personal information may have been compromised when it was transmitted to tech giants Google, Microsoft Bing and X (formerly Twitter) when...more

Cozen O'Connor

Indiana AG Sues Apria Healthcare for Data Breach(ing HIPAA Duties)

Cozen O'Connor on

Indiana AG Todd Rokita sued home healthcare equipment and services provider Apria Healthcare, LLC for allegedly failing to investigate and inform consumers regarding data breaches beginning in 2019 in violation of state data...more

Health Care Compliance Association (HCCA)

In Biggest Stark-Based FCA Settlement Ever, Indiana Hospital Pays $345M, Has Unusual CIA

Community Health Network (CHN) in Indiana has agreed to pay $345 million to settle false claims allegations that it paid over-the-top salaries to hundreds of physicians and rewarded them for their referrals in violation of...more

Bass, Berry & Sims PLC

District Court Finds that $487 Million False Claims Act Judgment Violates Eighth Amendment

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On February 8, the U.S. District Court for the District of Minnesota ruled that a $487 million False Claims Act (FCA) damages award entered last year against Precision Lens and its co-founder violated the Eighth Amendment’s...more

Bass, Berry & Sims PLC

HHS-OIG Year in Review 2023

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) is tasked with providing objective oversight to protect the integrity and promote the efficiency of Medicare, Medicaid, and more than...more

Skadden, Arps, Slate, Meagher & Flom LLP

FTC Enforcement Trends in Consumer Protection Under the Biden Administration

The Federal Trade Commission (FTC or the Commission) has continued aggressive regulation in the consumer protection space under the Biden administration. This persistent approach has occurred even in the face of recent...more

Bass, Berry & Sims PLC

Déjà vu? OIG Reiterates Concerns about Providing Free Items or Services to Federal Healthcare Program Beneficiaries

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On October 25, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 23-08, in which it refused to approve a proposal by a manufacturer and distributor of hearing...more

Davis Wright Tremaine LLP

California's New Employment Laws: Get Ready for 2024

Governor Newsom signed into law a plethora of bills that significantly expand the rights of employees in California, although notably vetoing a bill that would have prohibited caste discrimination. Most of the new laws take...more

Troutman Pepper Locke

CMS Publishes Final Rule on Civil Monetary Penalties for Section 111 Reporting

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The Centers for Medicare and Medicaid Services (CMS) published the final rule outlining how civil monetary penalties will be calculated and imposed when Responsible Reporting Entities (RRE) fail to meet their Medicare...more

Quarles & Brady LLP

Million Dollar Maybe: Enforcement of Cures Act Information Blocking Prohibitions Begins

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As of September 1, 2023, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) can officially begin enforcement against Certified Health Information Technology (“HIT”) developers, health...more

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