News & Analysis as of

Anti-Kickback Statute Regulatory Requirements

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 -
Dentons

Ep. 30 – Ensuring Payments to Physicians for Administrative Services Meet a Stark Exception

Dentons on

Providers will often pay physicians for serving in important administrative roles within the organization. Compensation for administrative services can create risk to the organization under multiple laws, including the...more

NAVEX

No Free Tickets! Tackling Conflicts of Interest in Corporate Hospitality

NAVEX on

The roar of the crowd, clinking champagne flutes, and gourmet cuisine… it’s the Big Game, and the season of extravagant corporate hospitality packages is in full swing. Welcome to the high-stakes minefield of conflicts of...more

Proskauer - Health Care Law Brief

Recent Circuit Litigation Continues to Highlight “But-For” Causation Requirement for the Government to Demonstrate an FCA...

In recent years, a circuit split among the United States Courts of Appeals has emerged over how courts have interpreted the False Claims Act’s (“FCA”) causation element in cases where a violation of the Anti-Kickback Statute...more

Foley Hoag LLP

Summary and Key Considerations of Recent HHS-OIG Advisory Opinion on Pharmaceutical Patient Assistance Program for Rare Disorders

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On April 8, 2024, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited favorable Advisory Opinion (AO 24-02) for a charitable patient assistance program (PAP) focused on rare...more

Gardner Law

[Hybrid Event] “Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies - May 1st, Austin, TX

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Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more

Foley & Lardner LLP

“Let’s Talk Compliance”: Medicare Advantage: Compliance Issues and Enforcement

Foley & Lardner LLP on

Editor’s Note: PYA and Foley & Lardner hosted the 6th Annual “Let’s Talk Compliance” two-day Virtual Conference on January 18 and 19, 2024. Panelists included Foley & Lardner attorneys and PYA experts. The event was hosted by...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | December 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for December 2023. We discuss several civil and criminal enforcement actions that involve alleged violations of the False...more

Health Care Compliance Association (HCCA)

[Event] 28th Annual Compliance Institute - April 14th - 17th, Nashville, TN

Get ready to be inspired with game-changing insights and industry connections! For over two and a half decades, healthcare compliance professionals have gathered at HCCA’s Compliance Institute (CI) to share ideas, learn...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - January 26th, Atlanta, GA

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education on a wide variety of current and emerging topics...more

McDermott Will & Emery

[Hybrid Event] Healthcare Litigation, Compliance and Investigations Forum 2023 - November 1st, Chicago, IL

McDermott Will & Emery on

McDermott’s Healthcare Litigation, Compliance and Investigations Forum is back when you need it the most. Heightened regulatory scrutiny and enforcement activity pose legal, financial and reputational risks for healthcare...more

Gardner Law

[Hybrid Event] MASTERING TOMORROW'S HEALTHCARE TECH: A CUTTING-EDGE APPROACH TO REGULATORY, COMPLIANCE, AND PRIVACY DEMANDS -...

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FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more

Butler Snow LLP

Health Care Due Diligence: An Ounce of Prevention is Worth a Pound of Cure

Butler Snow LLP on

Due diligence properly performed in connection with the purchase and sale of a health care entity is simply different—vastly so—than due diligence performed in other contexts. Failure to recognize this reality can lead to...more

Gardner Law

FDA Regulatory, Compliance, and Privacy Due Diligence — Finding Your Goldilocks Zone

Gardner Law on

When conducting due diligence of an FDA-regulated company, there are several important questions that should be posed. These include questions relating to regulatory, compliance, and privacy matters. For example, questions...more

Health Care Compliance Association (HCCA)

[Event] 2023 Healthcare Enforcement Compliance Conference - November 5th - 7th, Washington, DC

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more

Mintz - Health Care Viewpoints

EnforceMintz — Significant 2022 Regulatory and Policy Developments

From an agency guidance and regulatory developments perspective, 2022 was fairly quiet until the latter part of the year. Consistent with past practice, the Office of Inspector General for the Department of Health and Human...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - January 27th, Lake Buena Vista, FL

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education, including updates on the latest news in regulatory...more

Arnall Golden Gregory LLP

OIG Approves Arrangement That Provides Cash Equivalents to Patients in Digital Contingency Management Program

On March 2, 2022, the Department of Health and Human Services, Office of Inspector General (OIG) published Advisory Opinion No. 22-04 (the “Opinion”), analyzing a program whereby the Requestor provides comprehensive digital...more

Health Care Compliance Association (HCCA)

[Virtual Event] Portland Regional Healthcare Compliance Conference - February 4th, 8:25 am - 4:30 pm PST

General and specialty compliance training from the comfort of your home or office! HCCA’s Regional Healthcare Compliance Conferences provide practitioners with virtual compliance training that includes updates on the...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - January 28th, Orlando, FL

Looking for compliance training and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance training, including updates on the latest news in regulatory...more

Health Care Compliance Association (HCCA)

[Virtual Event] Healthcare Compliance Essentials Workshop - February 14th - 17th, 8:55 am - 2:45 pm CST

HCCA’s Healthcare Compliance Essentials Workshop is a four-day virtual event for those who are new to the compliance profession. The content is designed to help you develop and improve your compliance skills. Our instructors...more

Health Care Compliance Association (HCCA)

[Virtual Event] Healthcare Compliance Essentials Workshop - December 6th - 9th, 8:55 am - 2:45 pm CST

HCCA’s Healthcare Compliance Essentials Workshop is a four-day virtual event for those who are new to the compliance profession. The content is designed to help you develop and improve your compliance skills. Our instructors...more

Health Care Compliance Association (HCCA)

[Event] Nashville Regional Healthcare Compliance Conference - November 5th, Nashville, TN

Our one-day Regional Compliance Conferences provide attendees with a forum to interact with local compliance professionals, share information about your compliance successes and challenges, and create educational...more

Health Care Compliance Association (HCCA)

[Event] Denver Regional Healthcare Compliance Conference - October 15th, Denver, CO

Our one-day Regional Compliance Conferences provide attendees with a forum to interact with local compliance professionals, share information about your compliance successes and challenges, and create educational...more

Health Care Compliance Association (HCCA)

[Virtual Event] Healthcare Compliance Essentials Workshop - October 18th - 21st, 8:55 am - 2:45 pm CDT

HCCA’s Healthcare Compliance Essentials Workshop is a four-day virtual event for those who are new to the compliance profession. The content is designed to help you develop and improve your compliance skills. Our instructors...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 Healthcare Compliance Essentials Workshop - August 16th - 19th, 8:55 am - 3:45 pm CDT

HCCA’s Healthcare Compliance Essentials Workshop is a four-day virtual event for those who are new to the compliance profession. The content is designed to help you develop and improve your compliance skills. Our instructors...more

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