News & Analysis as of August 17, 2025

Anti-Kickback Statute › Healthcare Fraud › Civil Monetary Penalty

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The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The... more +

The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The statute aims to prevent situations where government officials channel federal healthcare dollars towards particular providers, who have offered or given the official a personal benefit. Penalties for violation of the Anti-Kickback statute apply to both sides of a prohibited transaction and can include jail time and steep monetary fines. less -

“Longstanding and Clear”: OIG Continues Characteristic Close Scrutiny of Below-Market Benefits to Referral Sources

Arnall Golden Gregory LLP on 8/1/2025

The United States Department of Health and Human Services, Office of Inspector General (“OIG”) recently released two unfavorable advisory opinions, OIG Advisory Opinion No. 25-04 and -08 (the “Opinions”) to medical device...more

OIG Approves Pharmaceutical Manufacturer’s Proposed Free Genetic Testing

Arnall Golden Gregory LLP on 1/17/2025

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-12 (the “Opinion”) to a pharmaceutical manufacturer (the...more

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

Mintz - Health Care Viewpoints on 1/17/2025

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

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

The Volkov Law Group on 10/23/2024

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

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

Foley & Lardner LLP on 8/29/2024

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

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

Health Care Compliance Association (HCCA) on 2/20/2024

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

HHS-OIG Year in Review 2023

Bass, Berry & Sims PLC on 2/1/2024

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

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

ArentFox Schiff on 1/22/2024

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

HHS OIG: New “General Compliance Program Guidance” Provides Voluntary Steps Towards Increased Effectiveness

Foley & Lardner LLP on 11/8/2023

In connection with the November 2023 Health Care Compliance Association’s (HCCA) Healthcare Enforcement Compliance Conference, and with acknowledgment by the Chief Counsel to the Inspector General, Rob DeConti, of the long...more

HHS Office of Inspector General September 2023 Enforcement Activity

Harris Beach Murtha PLLC on 10/6/2023

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

New OIG Developments Provide Additional Avenues for Feedback and Compliance Guidance

Paul Hastings LLP on 5/9/2023

In recent months, the Department of Health and Human Services, Office of Inspector General (“OIG” or “the agency”) announced two major developments in its effort to provide enhanced health care and life sciences industry...more

OIG 2022 Advisory Opinions: Year in Review

Sheppard Mullin Richter & Hampton LLP on 5/8/2023

The Office of Inspector General (“OIG”) within the U.S. Department of Health and Human Services (“HHS”) is responsible for detecting and preventing fraud, waste, and abuse in federal health care programs. The OIG has...more

Texas Lab Settles Unnecessary Drug Testing Allegations for $6 Million

ArentFox Schiff on 4/10/2023

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

OIG Offers Stakeholders a New Avenue for Informal Fraud and Abuse Guidance

Bass, Berry & Sims PLC on 3/30/2023

On March 23, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) announced a new, expanded frequently asked questions (FAQs) process. Although OIG has long maintained FAQs on...more

Comparison of Three Federal Fraud and Abuse Laws

Nelson Mullins Riley & Scarborough LLP on 11/10/2022

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

OIG Alert and DOJ Enforcement Action Summary: Telemedicine Arrangements

Goodwin on 7/29/2022

The July 20, 2022 Special Fraud Alert describes findings from what OIG describes as “dozens of investigations of fraud schemes involving companies that purported to provide telehealth, telemedicine, or telemarketing services”...more

[Webinar] Safeguarding Your Practice: 2022 Fraud and Abuse Updates - November 10th, 1:00 pm - 2:00 pm EST

Dickinson Wright on 7/29/2022

This presentation will provide an update on significant changes in significant cases related to the Stark Law, Civil Monetary Penalties Law, and the Anti-Kickback Statute....more

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

Dorsey & Whitney LLP on 11/29/2021

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

HHS Office of Inspector General Issues Important Update to Self-Disclosure Protocol

Snell & Wilmer on 11/12/2021

For the first time since 2013, on November 8, 2021, the Health and Human Services Office of Inspector General (“HHS-OIG” or “OIG”) made a number of significant updates to its Health Care Fraud Self-Disclosure Protocol...more

Healthcare Law Update: April 2021

Holland & Knight LLP on 4/28/2021

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

Fraud and Abuse Rules Part V: Easing Stark Law Compliance

McGuireWoods LLP on 2/17/2021

As discussed in a previous McGuireWoods alert, the U.S. Department of Health and Human Services (HHS) published final rules that significantly amend the regulations to the Physician Self-Referral Law (Stark Law), the federal...more

Fraud and Abuse Rules Part I: Changes to Patient Inducement and Kickback Policies

McGuireWoods LLP on 1/12/2021

As discussed in a previous McGuireWoods alert, the U.S. Department of Health and Human Services (HHS) published final rules expected to be effective Jan. 19, 2021, that significantly amend the Physician Self-Referral Law...more

Investigations Newsletter: HHS Announces Formation of FCA Working Group

ArentFox Schiff on 12/14/2020

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

HHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP Regulations

Robinson+Cole Health Law Diagnosis on 12/9/2020

HHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP Regulations - On November 30 and December 2, 2020, the Department of Health and Human Services Office of Inspector...more

Medtronic Settles Kickback And Open Payments Violations For $9.2M

Rivkin Radler LLP on 11/13/2020

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

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