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Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback Statute

FDA Law Blog

Kirschenbaum — In a recent decision, the Second Circuit upheld the HHS Office of the Inspector General (OIG)’s position that Pfizer’s proposed copay assistance program for its high-cost heart treatment would violate the Federal Anti-Kickback Statute (AKS). The Second Circuit’s Interpretation of the Anti-Kickback Statute. Pfizer, Inc.

Statute 98
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Subjective intent of wrongdoing required to convict doctors under Controlled Substances Act

SCOTUSBlog

Even in the midst of a historic opioid crisis, and an intensely fractured Supreme Court term, the justices found common ground in longstanding presumptions of criminal law and the core principle of physician discretion. The case, Ruan v. The question was whether a doctor’s subjective intent in prescribing matters.

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No sentencing enhancements for recklessness convictions under federal Armed Career Criminal Act

SCOTUSBlog

pleaded guilty to violating a federal law barring people convicted of a felony from possessing a firearm. The ACCA, in Borden’s view, required a higher culpable state of mind, or mens rea , than recklessness. A mens rea of purpose equates to a consciously desirable outcome.

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Could the Road to an AKS Violation Be Paved with Good Intentions? Pfizer Asks SCOTUS

FDA Law Blog

Gaulkin — We previously blogged about Pfizer’s copay assistance lawsuit, which sought to challenge HHS’s interpretation of the Federal health care program anti-kickback statute (AKS) and position that the company’s proposed copay assistance program would violate the AKS. The Second Circuit’s Interpretation of the AKS and its Mens Rea Element.

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Supreme Court Clarifies First Amendment Test for True Threats

Constitutional Law Reporter

18–3–602(1)(c), a Colorado statute making it unlawful to “[r]epeatedly. Following Colorado law, the trial court rejected that argument under an objective standard, finding that a reasonable person would consider the messages threatening. Counterman’s messages put C.W. in fear and upended her daily existence: C.W.

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In opioids “pill mill” case, justices grapple with physician intent

SCOTUSBlog

Justices Clarence Thomas and Amy Coney Barrett pressed both sides on where the standard for the exception comes from, noting that the phrases “good faith” and “honest effort” appear nowhere in the statute and that the entirety of the exception, which likewise does not specify an intent standard, is the product of regulation.

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New Orleans Police Seek Arrest of Dispatcher Under Novel Criminal Charge

JonathanTurley

She was charged under Louisiana law with malfeasance in office. What is interesting about the law is how broad the language is. The statute itself reads like criminalized negligence. The mens rea element is merely eliminating involuntary failures like illness or force in the failure to perform. CORRUPT PRACTICES.