News & Analysis as of

Anti-Kickback Statute False Claims Act (FCA) Sunshine Act

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 -
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

Gardner Law

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

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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

Mintz - Health Care Viewpoints

OIG Approves Physician-Owned Medical Device Company

On April 25, 2022, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued a favorable Advisory Opinion regarding a medical device company (Company) in which physicians who order the...more

Goodwin

Heating Up: Federal Sunshine Act Enforcement on the Rise

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After several years without any enforcement, the U.S. Department of Justice (“DOJ”) recently penalized medical device and life sciences companies for violating the U.S. Provider Payments Sunshine Act (“Sunshine Act”) (42...more

Skadden, Arps, Slate, Meagher & Flom LLP

DOJ Puts Teeth in Sunshine Act Reporting Requirements

Enforcement in Life Sciences Series: Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers About the Enforcement in Life Sciences Series Recent settlements between the U.S. Department of...more

MoFo Life Sciences

Do You Have The COVID-19 Blues? Don’t Forget About Sunshine!

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While the Centers for Medicare and Medicaid Services (CMS) acknowledges the impact COVID-19 has had on the healthcare industry, CMS does not have the authority to postpone the deadline for Sunshine Act reporting. Accordingly,...more

Arnall Golden Gregory LLP

Ain’t No Sunshine When the Government Comes: The DOJ and OIG Enforce the Sunshine Act

Recently, the United States Department of Justice and the Department of Health and Human Services’ Office of Inspector General entered into a Settlement Agreement with a medical drug company that caught our eye because of the...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

Akin Gump Strauss Hauer & Feld LLP

Life Sciences Due Diligence: A Reference Guide for Your Life Sciences Corporate Transactions

• Life sciences companies are subject to rapidly changing regulatory obligations, government enforcement, and increasing public scrutiny. • Conducting effective legal and regulatory due diligence can mean uncovering risks...more

Skadden, Arps, Slate, Meagher & Flom LLP

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

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

Bond Schoeneck & King PLLC

Health Care: As Sunshine Act Deadlines Approach Physicians and Hospitals Should Prepare for Transparency in Their Financial...

On September 30, 2014, in accordance with the Federal Sunshine Act (the Sunshine Act), the Centers for Medicare and Medicaid Services (CMS) will publically disclose payments and "other transfers of value" by pharmaceutical,...more

The Volkov Law Group

Doctors, Enforcement Risks And Compliance Programs

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Doctors better get used to government regulation. The Affordable Healthcare Act contains a lengthy complement of new laws and regulations. ...more

The Volkov Law Group

Healthcare Companies Need to Update Compliance

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The Supreme Court’s decision upholding most of the Affordable Care Act increased compliance responsibilities for healthcare companies. The ACA amended the False Claims Act (FCA), which was amended in 2009 in the Fraud...more

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