Topic: Enforcement

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Fourth circuit declines to rule on the appropriateness of statistical sampling in FCA cases

As expected after oral arguments, the Fourth Circuit Court of Appeals declined to decide whether parties may use statistical sampling to prove False Claims Act liability in United States ex rel. Michaels v. Agape Senior Community, Inc., Nos. 15-2145 and 15-2147, by finding that the issue was fact-driven and thus not appropriate for interlocutory review.  … Continue reading

How pharma cos. can shape the drug-pricing landscape

Unless you have been living under a rock, you no doubt have noticed that drug price increases have resulted in a wave of public criticism, playing right into the media’s demonization of the pharmaceutical industry, and even becoming an election year issue. The United States is one of the only developed nations that largely does … Continue reading

FDA enforcement spike targets drug promotions

The Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) focused its end-of-year enforcement efforts on drug manufacturers’ promotions on tv, social media ads, and electronic promotion efforts. The OPDP issued in December six of its eleven total enforcement letters for 2016.  The eleven disciplinary letters represents a small spike from previous years’ … Continue reading

Teva Pharmaceuticals to pay nearly US$520M in record-breaking FCPA settlement

The world’s largest manufacturer of generic pharmaceuticals, Israeli-based Teva Pharmaceutical Industries Ltd. (“Teva International”), and certain of its global subsidiaries agreed to pay nearly US$520 million and enter into a Deferred Prosecution Agreement (“DPA”) to resolve allegations that the companies bribed government officials in Russia, Ukraine, and Mexico, in violation of the U.S. Foreign Corrupt … Continue reading

No monetary penalties for manufacturer providing physicians with free vaccine refrigeration storage system

In an Advisory Opinion issued on September 23, 2016, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) announced that  it would not impose administrative sanctions against the manufacturer of a vaccine refrigeration system (the “Requestor”) for providing the devices to physicians without charge.  This development comes at a critical time … Continue reading

Ninth circuit upholds conviction for physician for re-using single use devices

Last week, the Ninth Circuit affirmed a physician’s conviction for conspiracy to distribute an adulterated device with intent to defraud or mislead in violation of Section 331(k) of the federal Food, Drug and Cosmetic Act (FDCA). The physician – who dubbed his own practice “The McDonald’s of Urology” because of the high volume of patients … Continue reading

FCA case involving interpretation of 60 day overpayment rule settles

Last week, the United States and New York announced a settlement with Mount Sinai Health System for $3 million dollars to resolve allegations that Mount Sinai violated the False Claims Act by retaining overpayments for longer than 60 days after identifying them. The settlement is the first of its kind regarding the Affordable Care Act’s … Continue reading

Physicians’ compensation structure results in $17M Stark Law fine and CIA for hospital

Lexington Medical Center (“LMC”), a 428-bed hospital in South Carolina, has agreed to pay $17 million to resolve allegations that it violated the federal False Claims Act (“FCA”), 31 U.S.C. §§ 3729 et seq., and Physician Self-Referral Law (“Stark Law”), 42 U.S.C. § 1395nn, by allegedly providing improper financial incentives to 28 physicians for referrals.… Continue reading

DOJ charges over 300 people in largest healthcare fraud “takedown” in U.S. history

On Wednesday, the Justice Department announced that it had brought criminal and civil charges against 301 healthcare professionals as part of the largest national healthcare fraud “takedown” in history. A nationwide investigation spearheaded by the Medicare Fraud Strike Force revealed claims amounting to $900 million in the form of alleged kickbacks, money laundering, and other … Continue reading

SCOTUS endorses “implied certification” FCA claims

In a closely watched decision, the U.S. Supreme Court has unanimously endorsed a version of the “implied false certification” theory of liability under the False Claims Act (“FCA”).  In a decision that leaves almost as many questions unanswered as it resolved, the Court held that a material omission on a claim for payment may give … Continue reading

FCA civil penalties to increase substantially under proposed rule

Earlier this week, the Railroad Retirement Board (RRB) became the first federal agency to promulgate an interim final rule implementing provisions of the Bipartisan Budget Act of 2015 intended to index civil penalties assessed under certain statutes to inflation. The RRB’s proposed final rule would double civil penalties assessed under the False Claims Act (FCA). … Continue reading

Ninth Circuit approves enhanced sentences for “abuse of trust” in health care fraud case

In a decision that could have wider ramifications for sentencing in health care fraud cases, a Ninth Circuit panel last week affirmed a lower court’s sentencing enhancement, applied because the defendants were found to have abused a “position of trust” by submitting false information in Medicare claims. The case involves owners of a California-based DME … Continue reading

New OIG exclusion guidance places value on self-disclosure

The OIG has issued updated guidance on the agency’s exclusion authority, as announced by Inspector General Daniel Levinson at the HCCA’s 2016 Compliance Institute. According to the new guidance, good-faith self-disclosures will place providers at the lower-risk end of the spectrum for an exclusion release without integrity obligations.  As a result, providers have additional support … Continue reading

Paxil birth defect lawsuit cannot survive exclusion of evidence of later FDA warnings

Last week, the first of nine Paxil birth defect lawsuits in line for trial in Pennsylvania was dismissed after a judge excluded evidence of the drug’s later heightened FDA warning. Judge Kenneth Powell of the Philadelphia County Court of Common Pleas granted a compulsory nonsuit in favor of defendant GlaxoSmithKline PLC (“GSK”) after portions of … Continue reading
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