News & Analysis as of

Anti-Kickback Statute Unfair Competition

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 -
Goodwin

DOJ Files False Claims Act Complaint Against Regeneron, Alleging Fraudulent Eylea Drug Pricing

Goodwin on

​​​​​​​As we previously reported, the U.S. Department of Justice (“DOJ”) filed a lawsuit under the Anti-Kickback Statute against Regeneron Pharmaceuticals in the District of Massachusetts regarding Regeneron’s sales of Eylea...more

Bass, Berry & Sims PLC

Déjà vu? OIG Reiterates Concerns about Providing Free Items or Services to Federal Healthcare Program Beneficiaries

Bass, Berry & Sims PLC on

On October 25, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 23-08, in which it refused to approve a proposal by a manufacturer and distributor of hearing...more

King & Spalding

OIG Issues Advisory Opinion Rejecting Proposal to Offer Free Compatible Hearing Aids to Certain Patients

King & Spalding on

On October 20, 2023, OIG issued a negative Advisory Opinion in response to a proposal from a cochlear implant manufacturer (Requestor) to offer and provide free compatible hearing aids to certain patients (Proposed...more

Harris Beach PLLC

Office of Inspector Warns Against Proposed Surgeon-owned Turnkey Intraoperative Neuromonitoring Business

Harris Beach PLLC on

In a rarely seen “unfavorable” advisory opinion, the United States Department of Health and Human Services Office of Inspector General (“OIG”) recently warned that an entity’s (“Requestor”) proposal to assist surgeons in...more

Best Best & Krieger LLP

Best in Law: What Businesses Need to Know on Antitrust Law

There is a saying among antitrust lawyers: Don’t say you “won” an antitrust lawsuit — just by being in one means you lost. Business litigation is almost always expensive and challenging. Antitrust litigation can be several...more

King & Spalding

Anti-Kickback and Stark Law Violations Form Basis for Unfair Competition Claims

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On June 16, 2014, a federal district court jury in Florida awarded $14.755 million to plaintiff Ameritox, Ltd., a Maryland-based clinical lab, for state law claims alleging tortious interference with business relationships...more

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