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False Claims Act (FCA) Anti-Kickback Statute Civil Monetary Penalty

Ropes & Gray LLP

[Podcast] Patient Assistance Programs: Enforcement Trends and Regulatory Challenges

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On this Ropes & Gray podcast, health care partner Michael Lampert and counsel Sam Perrone, and litigation & enforcement partner Andrew O’Connor, rejoin to discuss patient assistance programs, recent enforcement actions, and...more

Mintz - Health Care Viewpoints

EnforceMintz — Telemedicine Enforcement: Trends in 2024 Suggest More Sophisticated Enforcement to Come in 2025

The Department of Justice (DOJ) and the Office of the Inspector General for the Department of Health and Human Services (OIG) have historically focused their virtual health care enforcement efforts on “traditional”...more

King & Spalding

OIG Issues Special Fraud Alert Regarding Marketing Payments Related to Medicare Advantage

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On December 11, 2024, OIG issued a Special Fraud Alert to warn the industry about the fraud and abuse risks associated with abusive Medicare Advantage (MA) organization (MAO) and agent and broker relationships with healthcare...more

Cozen O'Connor

Connecticut’s $39 Million Award a Bitter Bill for Pharmacy to Swallow

Cozen O'Connor on

Connecticut AG William Tong obtained a judgment in his favor in his office’s lawsuit against Assured Rx, LLC (“Assured”), which alleged that the pharmacy engaged in a kickback scheme in violation of state false claims and...more

The Volkov Law Group

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

The Volkov Law Group on

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

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

Burr & Forman

Federal Agency Deference Eliminated, Now What?

Burr & Forman on

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

Health Care Compliance Association (HCCA)

Due diligence and physician financial arrangements

Conducting due diligence for physician and provider compensation arrangements during a healthcare transaction is critical for the acquirer. Appropriate due diligence is necessary, regardless of whether the transaction is a...more

Hendershot Cowart P.C.

Doctors: Don’t Fall Victim To Telemedicine Fraud Schemes

Hendershot Cowart P.C. on

Telemedicine companies are supposed to facilitate medically necessary services to beneficiaries over the telephone via licensed medical professionals. In reality, however, many of these “telemedicine companies” are...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

ArentFox Schiff

Investigations Newsletter: DC Federal Judge Dramatically Amplifies False Claims Act Damages Award

ArentFox Schiff on

DC Federal Judge Dramatically Amplifies False Claims Act Damages Award - On January 16, Judge Rudolph Contreras of the US District Court for the District of Columbia issued an opinion agreeing in part with the federal...more

Bricker Graydon LLP

A Long-Awaited Change: OIG Updates its Compliance Program Guidances

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From 1998-2008, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published compliance program guidelines for various industries in the Federal Register....more

Harris Beach Murtha PLLC

HHS Office of Inspector General September 2023 Enforcement Activity

The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country.  The enforcement actions reported...more

ArentFox Schiff

Texas Lab Settles Unnecessary Drug Testing Allegations for $6 Million

ArentFox Schiff on

A laboratory company based in Texas, Genotox Laboratories Ltd., recently reached an agreement with the federal government to resolve False Claims Act and Anti-Kickback Statute violations, stemming from allegations related to...more

Bass, Berry & Sims PLC

Recap of Webinar: Billing, Coding, and Collecting for Infusion Services

Bass, Berry & Sims PLC on

Bass, Berry & Sims attorney Shannon Wiley, with Carine Leslie and Katie Garmon of PYA, P.C., recently discussed the complexities associated with billing, coding, and collecting for infusion services as part of the Infusion...more

Nelson Mullins Riley & Scarborough LLP

Comparison of Three Federal Fraud and Abuse Laws

In the post-COVID era, health care fraud and abuse issues will be aggressively and swiftly enforced by the government. The legal framework and regulations in the health care space can be intimidating. Below is a comparison of...more

Foley & Lardner LLP

Continuing Consolidation in Orthopedic Medicine

Foley & Lardner LLP on

Physician consolidation continued on a robust pace this past year, despite, or maybe because of, the Pandemic. Physician-owned orthopedic practices appear to be no exception to this trend. Interestingly, orthopedic...more

Dorsey & Whitney LLP

HHS OIG Releases an Updated Health Care Fraud Self-Disclosure Protocol

Dorsey & Whitney LLP on

On November 8, 2021, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) released a revised Provider Self-Disclosure Protocol, renamed Health Care Fraud Self-Disclosure Protocol (“SDP”). Prior...more

Faegre Drinker Biddle & Reath LLP

HHS-OIG Updates Its Self-Disclosure Protocol

On November 8, 2021, the U.S. Department of Health and Human Services Office of Inspector General (OIG) updated and renamed its Self-Disclosure Protocol (SDP). The OIG had last updated the SDP in 2013. The update changes and...more

Holland & Knight LLP

Healthcare Law Update: April 2021

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William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...more

Holland & Knight LLP

Healthcare Law Update: February 2021

Holland & Knight LLP on

To date, there has been little consistency in how Health Insurance Portability and Accountability Act (HIPAA) requirements are enforced by the U.S. Department of Health and Human Services (HHS), or the amount of settlements...more

ArentFox Schiff

Investigations Newsletter: HHS Announces Formation of FCA Working Group

ArentFox Schiff on

HHS Announces Formation of FCA Working Group - On December 4, 2020, the US Department of Health and Human Services (HHS) announced that it is creating a False Claims Act Working Group to enhance the partnership between...more

Rivkin Radler LLP

Medtronic Settles Kickback And Open Payments Violations For $9.2M

Rivkin Radler LLP on

The U.S. Department of Justice (DOJ) announced on October 29 that Medtronic USA Inc. agreed to pay $8.1 million to settle allegations that it violated the False Claims Act (FCA) and federal Anti-Kickback Statute by paying...more

Mintz - Health Care Viewpoints

DOJ Announces the First Open Payments Program / Sunshine Act Enforcement Action

On October 29, 2020, the Department of Justice (DOJ) announced the first publicly-available settlement involving alleged violations of CMS’s Open Payments Program, otherwise known as the Sunshine Act. The $9.2 million...more

Skadden, Arps, Slate, Meagher & Flom LLP

Novartis’ $678 Million Settlement Sets Guideposts for Life Sciences Industry Speaker Programs

Novartis Pharmaceuticals Corporation (Novartis) recently entered into a civil settlement agreement with the Department of Justice (DOJ) to resolve allegations that the company paid health care practitioners (HCPs) who spoke...more

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