News & Analysis as of November 17, 2024

Compliance

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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 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 -

OIG’s Perspective on Discount and Refund Programs

Gardner Law on 10/23/2024

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

Ultimate Guide to the Anti-Kickback Statute

Oberheiden P.C. on 5/21/2024

All healthcare providers and other businesses in the healthcare industry need to comply with the Anti-Kickback Statute (AKS). The AKS imposes criminal penalties for knowing and willful violations, and even inadvertent...more

Defensibility of a fair market value analysis

Health Care Compliance Association (HCCA) on 8/3/2023

Fair market value (FMV) is a pinnacle issue with respect to healthcare regulatory compliance and compensation agreements. This article will analyze the issues related to an FMV defensibility analysis of compensation...more

Five years on: EKRA's legacy

BCLP on 7/21/2023

Five years ago Congress enacted the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”). Aimed at combating kickbacks in the addiction treatment industry, EKRA prohibits remunerations in return for patient referrals to...more

Top IP, FDA, and Compliance Issues for Medtech Companies Transitioning to Data-Enabled Product Solutions

Goodwin on 5/26/2023

Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data. Companies that once only developed hardware-based solutions for...more

Compensating Physician Advisors with Equity: Considerations for Life Sciences Companies

Fenwick & West LLP on 7/13/2022

Life sciences companies often engage physicians as consultants and advisors to serve on scientific or clinical advisory boards, or to otherwise obtain their expertise relating to product-specific research and development,...more

“Stark” Rules: Navigating Physician Leases and Subleases

Tucker Arensberg, P.C. on 1/13/2022

Under the Federal Ethics in Patient Referrals Act (more commonly known as “Stark”), if a physician has a financial relationship with an entity, the physician may not refer patients to the entity for medical services payable...more

[Webinar] What Compliance Professionals Need to Know About the New Stark and Anti-Kickback Regulations - January 29th, 12:00 pm -...

Health Care Compliance Association (HCCA) on 1/14/2021

Learning Objectives: - Explain changes to existing concepts including fair market value, commercial reasonableness, and volume or value - Examine the new definitions, exceptions, and safe harbors and their impact on...more

A Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and Medical Device Seminar

Skadden, Arps, Slate, Meagher & Flom LLP on 12/13/2018

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

Highway 61 Revisited-Tombstone Blues and Corporate Integrity Agreements

Thomas Fox - Compliance Evangelist on 9/11/2015

I conclude my tribute to my favorite Bob Dylan album, Highway 61 Revisited with a look at the most surreal song on the disc, Tombstone Blues. I want to use it to contrast the most excellent article that appears today as a...more

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Anti-Kickback Statute › Safe Harbors › Compliance

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