News & Analysis as of

Anti-Kickback Statute Charitable Donations

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 -
The Volkov Law Group

Novartis Settles False Claims Act Cases and Pays $729 Million for Domestic Bribery Schemes

The Volkov Law Group on

We have a new poster-child for a defective corporate culture of wrongdoing.  Novartis has joined the exclusive club, along with Siemens, General Motors, Wells Fargo, and others in the misconduct Hall of Fame. ...more

Baker Donelson

OIG Advisory Opinion 18-13 Allows Charitable Donations Made by Business Affiliates to Fund Research Institute

Baker Donelson on

The Office of Inspector General (OIG) issued a favorable opinion for an arrangement involving a charitable trust and contributions of the trust's individual trustees to support a medical research center (institute) – a...more

Skadden, Arps, Slate, Meagher & Flom LLP

Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more

Sheppard Mullin Richter & Hampton LLP

Temporal Proximity Is Not Enough: Third Circuit Nixes FCA/Anti-Kickback Suit For Failure To Link Alleged Scheme to Claims

On January 19, 2018, the United States Court of Appeals for the Third Circuit affirmed a district court’s ruling granting summary judgment to a specialty pharmacy that was accused of violating the Anti-Kickback Statute and...more

Jones Day

Third Circuit Rejects False Claims Act Theory that Anti-Kickback Violations "Taint" All Related Claims

Jones Day on

The Situation: A provision in the False Claims Act ("FCA") had clarified when Anti-Kickback Statute ("AKS") violations can make a claim false, but the provision's rule of per se falsity does not answer when a claim "result[s]...more

King & Spalding

OIG Tightens Requirements of Prior Favorable Advisory Opinion on Charity Patient Assistance Program for Cancer Drugs

King & Spalding on

On December 7, 2015, OIG posted a modification adding additional strictures to a prior favorable Advisory Opinion (No. 07-11) regarding a charity’s operation of a patient assistance program (PAP) to provide financial...more

Locke Lord LLP

Locke Lord QuickStudy: Recent Health Care Updates

Locke Lord LLP on

On January 29, the Centers for Medicare & Medicaid Services (CMS) announced its plan to propose changes to the Electronic Health Record Incentive Program (EHR Incentive Program). According to CMS, the rule will address...more

Davis Wright Tremaine LLP

Legislature Amends Washington Anti-Rebate Statute

In a thoughtful amendment to Washington’s Anti-Rebate Statute, the Legislature has aligned the parameters of chapter 19.68 RCW with those of the federal Anti-Kickback Statute, granting greater protection for EHR donation...more

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