Category Archives: HealthCare

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OIG Report on Topical Compounded Drug Prescribing, Marketing and Billing Practices Signals Heightened Administrative and Enforcement Scrutiny

When commercially available medications’ standard dosage forms or amounts don’t quite fit a patient’s particular needs, the patient may benefit from customized compounded drugs. Medicare Part D, the prescription drug program, allows the private company sponsors that administer the benefit to cover compounded drugs under certain circumstances.[1] In recent years, Part D reimbursement to pharmacies … Continue Reading

In Case Alleging Nationwide Pharmacy Fraud, Kmart Scores Narrow Settlement

On Thursday, March 8, Kmart Corporation inked a settlement of a False Claims Act investigation[1] in which the qui tam relator initially alleged systematic pharmacy billing fraud across twenty-seven states for $525,000.[2] Brought by a pharmacist formerly employed at a Kmart in Lakeport, California, the original complaint alleged among other things that, instead of using … Continue Reading

Materiality Part I: Distinguishing Important Representations from the Minor or Insubstantial

Editor’s Note: This is the first in a five-part series on how U.S. district courts and courts of appeal have applied the materiality standard set forth in Universal Health Services, Inc. v. U.S. ex rel. Escobar. In Escobar, the Supreme Court described several factors that a district court should consider in assessing whether a particular … Continue Reading

Fourth Circuit Punts at Rare Opportunity to Rule on Statistical Sampling

Statistical sampling is always a hot topic in False Claims Act (FCA) litigation.  Courts have allowed statistical extrapolation from samples of claims to determine damages in cases where FCA liability was already established.[1]  But courts are reluctant to allow the use of sampling for determining liability in the first instance.[2]  Since the FCA’s monetary penalty … Continue Reading

DOJ Releases its 2016 False Claims Act Recovery Statistics

Yesterday, the Department of Justice (DOJ) released its annual False Claims Act (FCA) recovery statistics, which revealed that Fiscal Year 2016 has been another lucrative year for FCA enforcement.  Based on these statistics, DOJ recovered more than $4.7 billion in civil FCA settlements this fiscal year — the third highest annual recovery since the Act … Continue Reading

HHS OIG Publishes Final Rule on Anti-Kickback Statute: Safe Harbors And Monetary Penalties

On December 6, 2016 the U.S. Department of Health & Human Services, Office of Inspector General (HHS-OIG) issued two final rules relating to the Anti-Kickback Statute (AKS) and Civil Monetary Penalties (CMP).  These rules affect a wide variety of health care companies and also impact False Claims Act investigations and litigation.… Continue Reading

Fifth Circuit: No Anti-Kickback Violation When Defendant Merely Hopes or Expects Referrals from Benefits Designed for Other Purposes

The Fifth Circuit recently affirmed the grant of summary judgment in favor of Omnicare, Inc., in a qui tam action alleging violations of the False Claims Act (“FCA”) and the Anti-Kickback Statute (“AKS”). The ruling signifies that, to violate the AKS, there must be unambiguous evidence that a business specifically designed its practices to induce … Continue Reading
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