News & Analysis as of

False Claims Act (FCA) Safe Harbors

Baker Donelson

First Circuit Requires But-For Causation for FCA Liability Based on AKS Violations

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Key Takeaways - The First Circuit ruled in United States v. Regeneron Pharmaceuticals, Inc., that the government must prove but-for causation to establish False Claims Act (FCA) liability based on violations of the...more

Burr & Forman

A Reminder for All Health Care Providers When Forming Business Arrangements

Burr & Forman on

According to a federal district judge in Mississippi, a cancer center’s investors bought themselves a lawsuit because of a conscious decision not to structure the ownership arrangement in compliance with a safe harbor. A...more

Gardner Law

OIG’s Perspective on Discount and Refund Programs

Gardner Law on

The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) recently issued Advisory Opinion No. 24-04, which primarily addressed a Refund Program offered by a U.S. pharmaceutical company affiliate....more

Akerman LLP - Health Law Rx

The Admera Health Settlement Is a Cautionary Tale for Paying Outside Sales Staff on a Commission Basis

The Office of Inspector General recently announced the more than $5.5 million settlement of a qui tam action brought against Admera Health, LLC (Admera). In addition to the fine incurred, the legal fees typically incurred for...more

WilmerHale

Second Circuit Confirms Willfulness under the Anti-Kickback Statute and False Claims Act Requires Relators to Plead that the...

WilmerHale on

The Second Circuit Court of Appeals recently issued a decision with significant implications for healthcare companies and providers facing allegations of violations of the Anti-Kickback Statute (AKS), 42 U.S.C. §...more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - May 9th - 10th, New York, NY

Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...more

Mintz

EnforceMintz — DOJ’s Efforts in 2023 to Incentivize Voluntary Self-Disclosure

Mintz on

2023 was a very active one for Department of Justice (DOJ or the “Department”) guidance, and that guidance had one clear theme: DOJ wants companies to voluntarily self-disclose their misconduct. To incentivize...more

King & Spalding

OIG Issues Favorable Advisory Opinion Concluding Bonuses to Employed Physicians Are Not Kickbacks

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Earlier this month, OIG issued Advisory Opinion 23-07, a favorable opinion regarding an employer’s proposal to pay bonuses to its employed physicians based on net profits derived from certain procedures performed by the...more

Womble Bond Dickinson

Current Trends and Real-World Best Practices in Healthcare Fraud Compliance

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Recently, Womble Bond Dickinson held its First Annual Health Care Fraud Symposium, a webinar designed to discuss critical healthcare fraud topics. WBD Partner Joe Whitley moderated a discussion with WBD attorneys Luke Cass,...more

Orrick, Herrington & Sutcliffe LLP

Supreme Court to Decide Critical Issue in False Claims Act Case

The U.S. Supreme Court recently agreed to hear two cases on the key question of when a defendant can be found to have “knowingly” violated the False Claims Act (FCA).  This sets the stage for a potential landmark FCA decision...more

Nelson Mullins Riley & Scarborough LLP

The Impact of the Decision in U.S. v. Holland on the One Purpose Test

The Court’s decision in U.S. v. Holland highlights the apparent contradiction between the judicially created and often relied upon “one purpose test” involving criminal and civil enforcement actions under the Federal...more

Bass, Berry & Sims PLC

False Claims Act Fundamentals: Anti-Kickback Statute and the Stark Law

Bass, Berry & Sims PLC on

As previous False Claims Act (FCA) Fundamentals posts have discussed, the FCA, 31 U.S.C. § 3729, et seq., can be triggered by submitting claims tied to violations of certain federal statutes. This post will explain the basics...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA’s Final Rule on Intended Use: ‘Getting Right Back to Where We Started From’

On August 2, 2021, the U.S. Food and Drug Administration (FDA) issued its final rule amending the intended use regulations codified at 21 CFR 801.4 and 21 CFR 201.128, marking the end of an effort FDA began in 2015. While the...more

Morgan Lewis - Health Law Scan

July Fast Break Recap: Fourth Circuit AKS Case Enforcement Analysis

We hope you were able to join us for our July Fast Break on the US Court of Appeals for the Fourth Circuit's recently affirmed $114 million judgment in United States v. Mallory. If not, you missed a great session, featuring...more

Proskauer - Health Care Law Brief

Developments Regarding Commission-Based Compensation Arrangements with Independent Contractors

A recent Fourth Circuit decision, United States v. Mallory (988 F.3d 730), upheld damages and penalties for more than $100 million for violations of the Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)) (the “AKS”) and the...more

Husch Blackwell LLP

50-State Update On COVID-19 Business Liability Protections - UPDATED March 2021

Husch Blackwell LLP on

A number of states have passed or are considering passing legislation to shield certain businesses from liability from claims for injury caused by exposure to COVID-19. Generally, the laws require that the business was in...more

Perkins Coie

DOJ’s First False Claims Act Settlement Against PPP Borrower Signals Robust Fraud Enforcement Ahead

Perkins Coie on

As the government revives its Paycheck Protection Program (PPP) with hundreds of billions of dollars in additional loans available to small businesses, there are fresh signs that government fraud investigations and...more

Morgan Lewis

Recent Anti-Kickback Safe Harbor Revisions: What Hospices Should Know

Morgan Lewis on

The US Department of Health and Human Services Office of Inspector General (OIG) recently issued important updates to its Anti-Kickback Statute (AKS) safe harbor rules that provide additional legal protections and...more

White & Case LLP

Trump Administration’s Eleventh-Hour Drug Pricing Regulations Face an Uncertain Path Forward

White & Case LLP on

The Trump Administration recently announced two final rules that implement policy objectives to lower drug prices by tying certain Medicare Part B payments to prices paid by other countries and by replacing an anti-kickback...more

Kilpatrick

No Harbor is Limitless: Restrictions of the Federal Anti-Kickback Statute's Safe Harbor Provisions

Kilpatrick on

The DOJ recently reached a $122 million settlement with Universal Health Services (“UHS”) and Turning Point Care Center, LLC (“Turning Point”) to resolve allegations of False Claims Act violations related to their billing...more

Kilpatrick

No Harbor is Limitless A Recent False Claims Act Settlement Involving a Georgia Healthcare Company Is a Good Reminder of the...

Kilpatrick on

The DOJ recently reached a $122 million settlement with Universal Health Services (“UHS”) and Turning Point Care Center, LLC (“Turning Point”) to resolve allegations of False Claims Act violations related to their billing...more

Mintz - Energy & Sustainability Viewpoints

SBA Issues Additional Guidance Regarding “Necessity” Certification Required under the CARES Act

Today the Small Business Administration (SBA) issued additional guidance with respect to the “necessity” certification required under the CARES Act in connection with the Paycheck Protection Program (PPP). The relevant...more

Eversheds Sutherland (US) LLP

New guidance issued on Paycheck Protection Program; loans with original amounts under $2 million will be deemed in good faith

The Treasury and the Small Business Administration (SBA) today updated its set of Frequently Asked Questions (FAQs) with respect to the Paycheck Protection Program (PPP) established under the Coronavirus Aid, Relief, and...more

Proskauer Rose LLP

Rear View Mirror: Criminal Exposure for Companies that Received PPP Loans Under the CARES Act

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On April 28, 2020, Treasury Secretary Mnuchin announced that companies that received loans of more than $2 million through the Paycheck Protection Program (“PPP”) of the CARES Act will be closely scrutinized. Mr. Mnuchin’s...more

Holland & Knight LLP

Ineligible PPP Borrowers Granted Safe Harbor Period to Return Money by May 7

Holland & Knight LLP on

The U.S. Small Business Administration (SBA) has issued a supplemental interim final rule regarding the Paycheck Protection Program (PPP) to buttress its supplemental guidance issued on April 23, 2020. In these, SBA warned...more

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