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On May 6, the U.S. District Court for the District of South Carolina entered final judgment dismissing with prejudice a relator’s qui tam False Claims Act (FCA) suit against the defendant wholesale pharmacy. The relator, a former pharmacist who worked for the defendant, alleged that the defendant submitted false claims to government healthcare programs in connection with prescription medications dispensed for use at nursing homes and assisted living facilities. The relator alleged a scheme in which the defendant manually filled “thousands” of prescriptions with less-expensive generic medications while billing for more-expensive alternative medications stocked in its automated dispensing system.

A qui tam complaint containing similar allegations filed against Omnicare Inc. in the U.S. District Court for the District of New Jersey resulted in an $8 million settlement in 2017. In this lawsuit, however, the defendant, represented by Bass, Berry & Sims and others, obtained full dismissal with prejudice of the relator’s FCA and retaliation claims.Continue Reading Qui Tam Complaint Against Pharmacy Dismissed for Lack of Particularity

On February 25, the U.S. District Court for the Western District of Tennessee dismissed a relator’s qui tam False Claims Act (FCA) suit alleging that the defendants had continued the “exact scheme” previously alleged in U.S. ex rel. Deming v. Jackson-Madison Cty. Gen. Hosp., et al. involving allegations of medically unnecessary cardiac testing and procedures.

The defendants in U.S. ex rel. Maur v. Cmty. Health Sys., Inc., et al., represented by Bass, Berry & Sims and others, moved to dismiss the relator’s action on two grounds.  First, the defendants argued that the FCA’s public disclosure bar prohibited the relator’s action as the lawsuit raised substantially the same allegations as those publicly disclosed in the Deming action and subsequent press releases related to that lawsuit.  Second, the defendants maintained that the relator had failed to plead any FCA claims with the requisite particularity under Federal Rule of Civil Procedure 9(b).  The district court granted the defendants’ motions and dismissed the relator’s action on both grounds.Continue Reading Public Disclosure Bar and Pleading Deficiencies Doom Tennessee FCA Case

The Tenth Circuit recently affirmed the dismissal of a declined qui tam False Claims Act lawsuit filed against Lawrence Memorial Hospital (LMH) by a former LMH employee, reasoning that the materiality inquiry focuses on the likely reaction of the Government. In U.S. ex rel. Janssen v. Lawrence Memorial Hospital, 949 F.3d 533 (10th Cir. 2020), the relator alleged that over a period of years LMH engaged in two fraud schemes:

  1. LMH falsified patient arrival times submitted to Medicare under certain programs that tied compensation to quality-of-care metrics; and,
  2. LMH falsely certified compliance with a requirement under the Deficit Reduction Act that it educate employees with detailed information about the False Claims Act.

Continue Reading Tenth Circuit Strictly Enforces Materiality Requirement to Nix FCA Lawsuit

Despite the mounting pressures on healthcare entities related to the COVID-19 (coronavirus) pandemic and recent announcements of regulatory waivers and flexibility in particular areas, regulators are still showing interest in the enforcement of federal requirements for life safety and emergency and infectious disease control preparedness for long-term care facilities.

OIG Medicaid Nursing Home Life Safety and Emergency Preparedness Reviews

On March 23, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) updated its Work Plan in response to the COVID-19 pandemic. Please see this post for more information about all of the OIG Work Plan updates. One of the areas that the OIG Office of Audit Services will focus on is Medicaid Nursing Home Life Safety and Emergency Preparedness Reviews.

OIG’s rationale for focusing on this is, in part, because the patient population in long-term care (LTC) facilities is especially vulnerable to COVID-19 and other disease outbreaks. The focus of the audit is LTC facilities’ compliance with federal requirements for life safety and emergency preparedness, as well as 2019 Centers for Medicare & Medicaid Services (CMS) expanded guidance on emerging infectious disease control.Continue Reading Increased Oversight of Long-Term Care Facilities Related to COVID-19

On March 23, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) updated its Work Plan in response to the COVID-19 pandemic.  The OIG Work Plan sets forth planned or ongoing agency evaluations, audits and inspections.

The March 2020 updates to OIG’s Work Plan related to COVID-19 include the following:

1. COVID-19 Hospital Response. As hospitals face a surge in patients due to the COVID-19 pandemic, OIG recognizes its role in helping hospitals effectively manage this public health emergency.  OIG’s Office of Evaluation and Inspections will conduct a study to gain insight from hospital administrators on hospital needs and concerns regarding diagnosing and treating COVID-19 patients and other emergency preparedness and response issues, including the availability of personal protective equipment (PPE) for hospital staff.  The study will involve interviews of hospital administrators from approximately 400 hospitals of various types, sizes and locations across the country, including rural and critical access hospitals. HHS operating and staff divisions will use the study results to tailor their support of hospitals facing the COVID-19 pandemic.Continue Reading HHS OIG Releases Five Work Plan Updates Related to COVID-19

As the impact of the COVID-19 pandemic continues to spread, the federal government is preparing to take unprecedented action to curb its effects on the nation’s health and economy by freeing up federal dollars for private businesses, manufacturers, and healthcare entities of all types. But, those receiving these dollars, directly or indirectly, should continue to…

Congress amended the Anti-Kickback Statute (AKS) in 2010 to confirm that a claim “resulting from” an AKS violation constitutes a false or fraudulent claim for purposes of the FCA.  42 U.S.C. 1320a-7b(g).  However, Congress did not define the phrase “resulting from.”  That question is immaterial in a criminal AKS case because the offer or receipt of the payment completes the crime.  But in order to prevail in a civil FCA case, a relator or the government must prove the submission of a false claim to a federal healthcare program.  In recent civil FCA cases, courts have struggled to articulate the precise link that is required in order to establish that a claim “result[s] from” an illegal kickback, often relying on traditional causal concepts to help articulate the required link.  This developing area of the law is one to watch as courts continue to grapple with the interplay between the link required by the plain language of the AKS and the body of case law related to FCA causation.

U.S. ex rel. Greenfield v. Medco Health Sys., Inc.

In U.S. ex rel. Greenfield v. Medco Health Sys., Inc., the relator alleged that the defendants illegally donated to certain charities in order to receive patient referrals and then allegedly falsely certified compliance with the AKS when seeking reimbursement.  The U.S. District Court for the District of New Jersey granted summary judgment for the defendants, reasoning that the relator had not shown a causal link between the defendants’ donations and any claims for payment.  Although discovery revealed that the defendants submitted claims for 24 federally insured patients during the relevant time period, the district court concluded that this evidence alone did not provide “the link between defendants’ 24 federally insured customers and defendants’ donations to [the charities].”  Instead, it explained that the relator was required to show that the federally insured patients were referred to the defendants as a result of the defendants’ donations to the charities.  “Absent some evidence … that those patients chose Accredo because of its donations,” the relator could not carry his burden on his claim.Continue Reading Courts Grapple with Causation Requirement in FCA Cases Based on Violations of Anti-Kickback Statute

The Department of Justice (DOJ) announced this month that it obtained over $3 billion in settlements and judgments from civil fraud and false claims cases during the fiscal year ending September 30, 2019 (FY 2019). Of this total recovery, the vast majority—$2.6 billion—arose from matters related to different sectors of the healthcare industry. DOJ noted that 2019 was the tenth consecutive year that recoveries from civil healthcare fraud cases have exceeded $2 billion, indicating that the government’s enforcement efforts remain focused on allegations of fraud in the healthcare sector.

Large Recoveries Related to Drug Manufacturers & EHR

Within the healthcare industry, the government reported significant recoveries against pharmaceutical manufacturers. Insys Therapeutics paid $195 million to resolve civil False Claims Act (FCA) allegations that it paid kickbacks to induce healthcare providers to inappropriately prescribe its fentanyl product, Subsys, to their patients. This civil settlement was part of a larger global resolution of civil and criminal allegations, with Insys agreeing to pay a total of $225 million. Reckitt Benckiser Group agreed to pay $1.4 billion to resolve criminal and civil allegations related to the marketing of the addition treatment drug Suboxone, a buprenorphine product. The global resolution included a $500 million civil settlement with the federal government.Continue Reading DOJ Announces 2019 FCA Recovery, Majority Came from Healthcare Industry

The Department of Justice (DOJ) recently released its report detailing the settlements and judgments obtained in 2019 from civil cases involving fraud and abuse claims.  As in years past, the substantial majority of these settlements and judgments—$2.1 billion of the $3 billion total—were the result of qui tam whistleblower lawsuits filed under the False Claims Act (FCA).

Following the government’s intervention decision, the first test for many of these qui tam lawsuits is surviving a motion to dismiss.  Because FCA suits allege fraud against the government, they must be pleaded with particularity as required by Rule 9(b) of the Federal Rules of Civil Procedure.  This post discusses recent developments to those standards from 2019.

Courts have held that to satisfy Rule 9(b), FCA complaints must include a detailed description of the alleged fraud scheme and facts to show the scheme resulted in a request for reimbursement from the government.  A failure on either account will result in dismissal.Continue Reading Recent Developments in False Claims Act Pleading Standards

On December 20, 2019, the U.S. Court of Appeals for the Third Circuit granted in part a petition for rehearing filed by the University of Pittsburgh Medical Center (UPMC) in a False Claims Act (FCA) case that has generated considerable attention among hospitals and health systems due to its treatment of commonplace, productivity-based physician compensation models.  Ultimately, the Third Circuit vacated its original September 17, 2019 decision and issued a revised opinion reversing its holding that the relators could establish a problematic indirect compensation arrangement simply by alleging the employed neurosurgeons’ pay for personally performed services correlated with the volume or value of their referrals to UPMC’s facilities for the corresponding hospital services.

As discussed in our October 14 post, U.S. ex rel. Bookwalter v. UPMC involved employment arrangements between UPMC’s subsidiary physician practice entities and various neurosurgeons pursuant to which the physicians earned base salaries and potential incentive bonuses tied to their personally performed work relative value units (wRVUs).  The Third Circuit previously held – in reliance on a controversial construction of the Stark Law’s “volume or value” test – that the relators pleaded facts sufficient to demonstrate the surgeons’ compensation both varied with and took into account the volume or value of their designated health service referrals to UPMC’s hospitals, thereby creating an impermissible indirect compensation arrangement.Continue Reading Update: Third Circuit Allows Allegations of Improper Compensation under the Stark Law to Proceed, but Reverses Controversial “Varies with Volume or Value” Reasoning

From the Bass, Berry & Sims Blog Network
From the Bass, Berry & Sims Blog Network

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