Topic: Enforcement

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DOJ intervenes in FCA lawsuit against Life Spine for an illegal kickback scheme

This week, the Department of Justice (DOJ) intervened in a False Claims Act (FCA) lawsuit against Life Spine and two of its executives, filed in the U.S. District Court for the Southern District of New York. The lawsuit alleges that Life Spine violated the Anti-Kickback Statute by paying more than $7 million in consulting fees, … Continue reading

New entity added to OIG “high risk – heightened scrutiny” list

The Office of Inspector General (OIG) has added a new entity, Ridgeview Rehab & Nursing Center, LLC (Ridgeview), to its list of individuals and entities designated as “high risk – heightened scrutiny.” The “high risk – heightened scrutiny” list is part of the OIG’s fraud risk indicator tool, which the OIG made public last year. … Continue reading

OIG Publishes Guidance on Grant Self-Disclosure Program

Recently, the Office of Inspector General (OIG) published newly-issued guidance on the HHS OIG Grant Self-Disclosure Program (“Program”), which creates a formal framework for recipients, sub-recipients, and applicants for federal grant money to disclose potential violations of federal criminal, civil, or administrative law that may impact federally-awarded grants. Similar to the OIG’s Provider Self-Disclosure Protocol, … Continue reading

The Supreme Court resolves circuit split on FCA statute of limitations period

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

DOJ issues guidance on cooperation credit in FCA investigations

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

OIG publishes Medicaid Fraud Control Units Fiscal Year 2018 Annual Report

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 to pay US$115M to settle lawsuit relating to 2015 data breach

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

DOJ announces Market Integrity and Consumer Fraud Task Force

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

US DOJ charges 601 individuals in nation’s largest healthcare fraud takedown

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

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

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

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

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

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

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

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

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?

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

Judge doubles down on finding of materiality in FCA case

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

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

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

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

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
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