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April 18, 2018 Healthcare Fraud

Off-Label Marketing as Misbranding in Federal False Claims Act Settlements

In recent years, the Department of Justice and qui tam plaintiffs have pursued a rash of claims involving misbranding of prescription drugs based on off-label marketing (where the drug manufacturer promotes a drug for uses not approved by the FDA or makes claims about the safety or efficacy of the drug that […]
April 18, 2018 Healthcare Fraud

Offer and Inducement Under the Anti-Kickback Statute

False claims attorneys must consider the federal Anti-Kickback Statute (“AKS”) 42 U.S.C. § 1320a-7b(b) as a possible basis for a false claims action. This statute arose out of congressional concern that remuneration provided to those who can influence healthcare decisions would result in goods and services being provided that are medically unnecessary, of poor […]
April 18, 2018 Healthcare Fraud

False Claims Act Violations Regarding Controlled Substances, Prescriptions and Pill Mills

Controlled Substances & The Controlled Substances Act Section 812 of the Controlled Substances Act ( 21 U.S.C. §801 et seq.f) (“CSA”) lists substances which were controlled in 1970 when the law was enacted. Since then, approximately 160 substances have been added, removed, or transferred from one schedule to another. The current […]
April 18, 2018 Healthcare Fraud

False Claims Actions May Rise Under Medicare Part D

A recently unsealed action brought under the False Claims Act is one of the first to allege claims related to Medicare Part D. Medicare contracts with private entities known as Part D sponsors to administer prescription drug plans. A sponsor may use subcontractors to obtain and provide the medications. Medicare  makes certain […]
April 18, 2018 Healthcare Fraud

3 Types of Qui Tam Off-Label Marketing Cases

1. Off-Label Marketing vs. Off-Label Prescribing The Food and Drug Administration (“FDA”) requires that drugs be proven to be safe and effective for a particular use before they can be marketed. The FDA’s approval is always limited to use or uses for which the manufacturer has submitted evidence of safety […]
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