Topic: Enforcement

Recent effort to regulate pharmaceutical pricing deemed unconstitutional by Fourth Circuit

In the absence of federal action, states have attempted to rein in high pharmaceutical pricing by enacting laws aimed at regulating drug pricing. Following what now has become a trend, on March 13, 2018, Oregon became the newest state to enact such legislation, The Prescription Drug Price Transparency Act, H.B. 4005. But many of these … Continue reading

Rumors of sea change in DOJ policy potentially confirmed by two recent memos

By Sarah Cummings (US), Carol Poindexter (US) and Frederick Robinson (US) on January 31, 2018 Posted in Enforcement

Rumors of a significant shift in U.S. Department of Justice (DOJ) policy were confirmed last week when a privileged and confidential internal DOJ memo was leaked to the press. The memo outlines seven factors government attorneys should use for evaluating whether the government should seek dismissal of qui tam actions filed under the federal False Claims … Continue reading

New tax law may have significant consequences for defendants settling False Claims Act suits

By Megan Engel (US) and Frederick Robinson (US) on January 31, 2018 Posted in Enforcement

The Tax Cuts and Jobs Act may significantly limit the deductibility of False Claims Act settlements for defendants going forward. … Continue reading

Relator’s pharmacy allegations dismissed; government’s U&C allegations survive

By Selina Coleman (US) and Andrew Lu (US)* on January 30, 2018 Posted in Enforcement

Although a Florida compounding pharmacy has scored a win against a whistleblower’s allegations, it continues to defend against the government’s allegations of improper inflation of its Usual & Customary charges submitted to TRICARE. The U.S. District Court for the Middle District of Florida granted motions to dismiss with prejudice in favor of the pharmacy RS … Continue reading

FDA releases 2017 enforcement statistics and recall draft guidance

By Cori Goldberg (US) and Krishna Kavi (US) on January 22, 2018 Posted in Enforcement

On January 17, 2018, the U.S. Food and Drug Administration (“FDA”) released its 2017 enforcement statistics. Overall, the statistics showed that there were no food importation debarment enforcement actions in the past year. Notably, there were 15,318 warning letters issued, 9,199 products recalled, and 2,945 recall events. There were 12 injunctions, 5 drug product debarments, … Continue reading

Court applies Escobar, overturns $350M False Claims Act verdict

By Frederick Robinson (US) and Caitlin Chambers (US) on January 16, 2018 Posted in Enforcement

In Universal Health Services v. U.S. ex rel Escobar, the United States Supreme Court emphasized the importance of the materiality standard in False Claims Act cases. Since that decision, litigants have anxiously awaited further guidance on how Escobar’s instructions would be applied by lower courts. In U.S. ex rel Ruckh v. Salus Rehabilitation, LLC et … Continue reading

OIG rescinds advisory opinion to charity

By Carol Poindexter (US) and Selina Coleman (US) on November 30, 2017 Posted in Enforcement

For the first time, the OIG has rescinded an advisory opinion issued to a charity. According to the OIG, the advisory opinion – issued in 2006 and modified in 2015 – was revoked because the charity “failed to comply with certain factual certifications” about independence from donors, potentially steering Medicare beneficiaries toward certain prescription drugs. … Continue reading

Third and Fifth circuits accept materiality arguments in throwing out qui tam cases

By Frederick Robinson (US), Megan Engel (US) and Andrew Lu (US)* on November 27, 2017 Posted in Enforcement

On November 16, 2017, the Third Circuit Court of Appeals affirmed the grant of summary judgment in favor of CVS Caremark, Corp. (“CVS Caremark”), finding that although the lower court’s reasoning was flawed, the whistleblower Anthony Spay failed to establish the requisite materiality element of a False Claims Act (“FCA”) lawsuit. In making its decision, … Continue reading

DOJ policy shift in qui tam litigation?

By Callan Edquist (US) on November 17, 2017 Posted in Enforcement

Last week, a senior US Department of Justice official appeared to announce a surprising, and potentially significant, shift in policy regarding qui tam litigation. Michael Granston, director of the commercial litigation branch of the fraud section in the DOJ’s civil division, said during a speech that the DOJ will be moving to dismiss False Claims … Continue reading

Bakery receives Warning Letter for listing “love” as an ingredient

By Benjamin Wallfisch (US) on October 4, 2017 Posted in Enforcement

The US Food & Drug Administration does not have much of a sense of humor when it comes to the mandatory ingredient list on packaged food products. Last month, FDA issued a Warning Letter to the Nashoba Brook Bakery in Concord, Massachusetts, for, among other violations, listing “love” as an ingredient in its granola and … Continue reading

Judge doubles down on finding of materiality in FCA case

By Selina Coleman (US), Joseph Keillor (US) and Sarah Jean Kilker (US) on September 26, 2017 Posted in Enforcement

Federal courts continue to grapple with applying the “materiality” standard that is needed to cause a Stark Law violation or other underlying compliance matter to trigger False Claims Act liability. Although we have recently begun to gain a clearer view of what contractual requirements will not likely be viewed as material, at least one federal … Continue reading

Government audits shift to high error rates and significant variances

By Selina Coleman (US) on August 18, 2017 Posted in Enforcement

CMS has revamped its approach to pursuing alleged improper payments. Its new audit strategy with Medicare Administrative Contractors (MACs) will target providers and suppliers with the highest error rates or the most significant deviations. This is a significant shift in strategy to focus on outliers when seeking recoupment. Under the new audit process, through a process of … Continue reading

Ambulance and telehealth services among 14 new inquiries announced by HHS OIG

By Benjamin Wallfisch (US) on July 19, 2017 Posted in Enforcement

On Monday, July 17, the Office of Inspector General for the U.S. Department of Health and Human Services announced 14 new inquiries into potentially fraudulent billing of Medicare and Medicaid. The OIG announcement is part of a new policy to update its investigative Work Plan every month rather than once or twice per year. The … Continue reading

DOJ charges 412 individuals in largest healthcare fraud takedown in US history

By Frederick Robinson (US) and Daniel Fundakowski (US) on July 17, 2017 Posted in Enforcement

On Thursday, the DOJ announced charges against 412 individuals for their alleged participation in healthcare fraud schemes involving approximately $1.3 billion in false billings. This marks the largest national healthcare fraud takedown in U.S. history—topping the DOJ’s announcement of charges against 301 individuals in June 2016. The enforcement actions spanned across 41 federal districts and … Continue reading

Bipartisan effort to provide greater transparency into federally-negotiated settlement agreements

By Michael Koon (US), Frederick Robinson (US) and Savannah Wiseman (US) on May 19, 2017 Posted in Enforcement, News from DC

This week, U.S. Senators Elizabeth Warren (D-MA) and James Lankford (R-OK) reintroduced a bill designed to provide the public with more information about settlement agreements between federal agencies and companies and individuals. The bill, called the Truth in Settlements Act, was first introduced in 2014. In September 2015, it was unanimously passed by the Senate … Continue reading

DC Circuit affirms injunction against US$54b Anthem-Cigna merger

By Yvonne Puig (US) and Eric Hoffman (US) on May 1, 2017 Posted in Enforcement

A split DC Circuit panel affirmed a U.S. District Court’s permanent injunction against the US$54 billion merger between Anthem and Cigna, holding the district court did not abuse its discretion in enjoining the merger based on Anthem’s failure to show the extraordinary efficiencies necessary to offset the anticompetitive effect of the merger in fourteen states. … Continue reading

Federal district court endorses Stark liberalization of writing requirement

By Frederick Robinson (US), Debbi Johnstone (US), Joseph Keillor (US) and Elise LeGros (US) on March 29, 2017 Posted in Enforcement, Regulatory

On March 15, a federal district court in the Western District of Pennsylvania endorsed CMS commentary from November 2015 that dramatically liberalized the “written agreement” requirement of core Stark exceptions, thus providing some new insights as to what may be the outer limits of CMS’s new approach. When ruling on cross motions for summary judgment … Continue reading

CVS customers denied class certification in lawsuit alleging overcharging for generic prescriptions

By Megan Engel (US) on March 22, 2017 Posted in Enforcement

On Tuesday, March 21st, the U.S. District Court for the Northern District of California denied class certification in a suit alleging that CVS had overcharged insurance companies for generic prescriptions, resulting in higher copayments for customers. Corcoran, et al. v. CVS Health, et al., No. 15-cv-03504-YGR. The putative class alleged that in 2008 CVS introduced … Continue reading

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

By Carol Poindexter (US) and Megan Engel (US) on February 15, 2017 Posted in Enforcement

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

By Robin Adelstein (US), Cori Goldberg (US) and Krishna Kavi (US) on January 25, 2017 Posted in Enforcement, FDA & Food Safety, News from DC, Regulatory

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

By Cori Goldberg (US) and Krishna Kavi (US) on January 5, 2017 Posted in Enforcement, FDA & Food Safety

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

By Frederick Robinson (US), Ilana Sinkin (US) and Vijay Rao (US) on December 27, 2016 Posted in Enforcement

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

DOJ recovers $4.7 billion in 2016, third highest in FCA history

By Michael Koon (US) and Sarah Cummings (US) on December 15, 2016 Posted in Enforcement

The Department of Justice (“DOJ”) announced yesterday that it recovered over $4.7 billion in fiscal year 2016 in civil cases involving claims of fraud against the government under the False Claims Act (“FCA”). This is the third largest annual recovery in FCA history and one of the largest in recent years, easily surpassing last year’s … Continue reading

First and Fourth Circuit Courts of Appeal hear oral arguments in two key FCA cases

By Megan Engel (US) and John Akin (US) on November 2, 2016 Posted in Enforcement

Last week, the Fourth Circuit and First Circuit heard oral argument in two separate cases dealing with key False Claims Act (“FCA”) issues. First, the Fourth Circuit Court of Appeals heard oral arguments for the interlocutory appeal in United States ex rel. Michaels v. Agape Senior Community Inc., Nos. 15-2145 and 15-2147. Second, in the … Continue reading