On May 13, the U.S. Supreme Court unanimously affirmed a decision by the U.S. Court of Appeals for the 11th Circuit, holding that the False Claims Act’s (“FCA”) limitations period in 31 U.S.C.(b)(2) applies to “relator-initiated actions” in which the Government declines to intervene and that a relator in a nonintervened suit is not “the … Continue reading
On May 7, the Department of Justice (“DOJ”) released an update to its previous 2017 guidance (“Updated Guidance”) outlining when the government will award cooperation credit to defendants in False Claims Act (“FCA”) investigations. Under the Updated Guidance, set forth at Justice Manual Section 4-4.112, defendants can earn cooperation credit in FCA cases in three … Continue reading
On March 25, 2019, the Office of Inspector General (OIG) published its Medicaid Fraud Control Units Fiscal Year 2018 Annual Report. Forty-nine states and the District of Columbia have a Medicaid Fraud Control Unit (MFCU) which is responsible for investigating and prosecuting Medicaid provider fraud and patient neglect and abuse. The report notes that it … Continue reading
Anthem Inc. has agreed to a US$115 million settlement to resolve a class action lawsuit relating to a 2015 cyberattack that compromised data on 79 million individuals. Anthem has denied any wrongdoing. In February of 2015, Anthem reported that hackers stole personally identifiable information from millions of current and former customers, including names, addresses, social … Continue reading
On July 11 the U.S. Department of Justice (DOJ) announced a new Task Force on Market Integrity and Consumer Fraud. The wide-ranging Task Force will be chaired by the Deputy Attorney General and work towards: [T]he investigation and prosecution of cases involving fraud on the government, the financial markets, and consumers, including cyber-fraud and other … Continue reading
Last week, the U.S. Department of Justice announced charges against 601 individuals for their alleged participation in healthcare fraud schemes. According to the announcement, the alleged fraud is estimated to have resulted in more than $2 billion in losses to federal healthcare programs. This national healthcare fraud takedown is the largest in U.S. history, surpassing … Continue reading
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 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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