Avanir Pharmaceuticals (Avanir), a pharmaceutical manufacturer based in Aliso Viejo, California, was charged for paying kickbacks to a physician to induce prescriptions of its drug Nuedexta, the Department of Justice announced last week.  The Northern District of Ohio also announced indictments of four individuals, including former Avanir employees and one of the top prescribers of Nuedexta in the country, who were involved in the kickback scheme.  Avanir has also agreed to pay over $95 million to resolve civil False Claims Act allegations of kickbacks as well as its false and misleading marketing of Nuedexta to providers in long term care facilities to induce them to prescribe it for behaviors commonly associated with dementia patients, which is not an approved use of the drug.

As alleged in a one-count Information filed today in the United States District Court for the Northern District of Georgia, Avanir violated the Anti-Kickback Statute by paying a doctor to induce him to become a high prescriber of Nuedexta to beneficiaries of federal healthcare programs, offering him financial incentives to write additional Nuedexta prescriptions for beneficiaries of federal healthcare programs, and inducing him to recommend that other physicians prescribe Nuedexta to beneficiaries of federal healthcare programs.  Nuedexta is approved by the Food and Drug Administration for the treatment of pseudobulbar affect (PBA), which is characterized by involuntary, sudden, and frequent episodes of laughing or crying, and occurs secondary to a neurologic disease or brain injury.    

The Northern District of Georgia also announced a deferred prosecution agreement resolving the charge, under which Avanir admits that it paid the doctor to induce him to not only maintain, but increase his prescription volume.  Under the agreement’s terms, Avanir will pay a monetary penalty in the amount of $7,800,000, and a forfeiture in the amount of $5,074,895.  The United States will defer prosecuting Avanir for a period of three years to allow the company to comply with the agreement’s terms.  The agreement will not be final until accepted by the court.

The Northern District of Georgia entered into the deferred prosecution agreement with Avanir based on the individual facts and circumstances of this case.  Among those facts and circumstances, the agreement specifically identifies the company’s substantial and ongoing cooperation with the investigation to date, including capturing and producing text messages from employee cell phones, the extensive remedial measures taken by the company, including terminating, or permitting to resign in lieu of termination, multiple employees, at various levels of the organization, including senior executives, and its enhanced compliance program.  Other facts and circumstances include: Avanir has agreed to resolve all civil claims relating to federal health care programs arising from its conduct; and a conviction (including a guilty plea) would likely result in the Office of the Inspector General of the Department of Health and Human Services imposing mandatory exclusion of Avanir from all federal health care programs under 42 U.S.C. § 1320a-7 for a period of at least five years, which would result in substantial consequences, including to American consumers.  The agreement can ensure that integrity has been restored to Avanir’s operations and preserve its financial viability while preserving the United States’ ability to prosecute it should material breaches occur.

The Northern District of Ohio also announced indictments of four individuals who paid or received kickbacks from Avanir.  Named in the 83-count indictment are: Deepak Raheja, 63, of Hudson; Gregory Hayslette, 43, of Aurora; Frank Mazzucco, 41, of Dublin, and Bhupinder Sawhny, 70, of Gates Mills.  All four are charged with conspiracy to solicit, receive, offer and pay health care kickbacks. Avanir has agreed to cooperate in the prosecution of these individuals.

In a separate civil resolution, Avanir has agreed to pay $95,972,017 to the United States to resolve allegations under the False Claims Act related to its marketing of Nuedexta.  The government alleged that Avanir provided remuneration in the form of money, honoraria, travel, and food to certain physicians and other health care professionals to induce them to write prescriptions for Nuedexta.  One form of remuneration included Avanir’s payment to certain health care professionals to give talks (commonly known as “speaker’s programs”) about Nuedexta based on their willingness to prescribe Nuedexta.  These events were primarily social, with no educational value. 

The government further alleged that Avanir implemented a strategy to market Nuedexta in long-term care (LTC) facilities for uses other than PBA that had not been approved by the FDA and were not medically accepted indications as defined by the statutes and regulations governing the Federal health care programs.  In particular, Avanir sought to capitalize on efforts by the Centers for Medicare and Medicaid Services to reduce the use of anti-psychotics on dementia patients in LTC facilities, based in part on CMS’s concern that anti-psychotics can be and have been used as a form of chemical restraint for residents.  Avanir did so by instructing its sales force to initiate discussions in LTCs regarding anti-psychotic use and how Nuedexta could be used to reduce a LTC facility’s reliance on anti-psychotics even though Avanir’s own studies demonstrated that the actual population of patients with PBA is limited.  In order to counter the objection by certain physicians that they had few, if any, patients that exhibited signs of PBA in their facilities, Avanir instructed sales representatives to provide false and misleading information that PBA patients could be exhibiting a wide variety of “behaviors” such as crying without tears, moaning, or making other inarticulate sounds, when, in fact, those symptoms are commonly observed in patients who have dementia but do not have a diagnosis of PBA.  This strategy worked, and Nuedexta utilization in LTC facilities increased. 

In one example of the impact of these strategies, the government alleged that an Avanir employee reported that one doctor, who was also a paid speaker for Nuedexta, had “entire units” of patients on Nuedexta at the LTC facility where he worked, which contained a large number of dementia patients with behavioral issues.  And while another doctor, a geriatrician, who also worked in the same LTC facility routinely discontinued Nuedexta for patients, the doctor paid by Avanir “constantly re-initiat[ed]” the treatment.

Contemporaneous with the civil settlement, Avanir entered into a Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General.  The CIA requires, among other things, that Avanir implement additional controls around its interactions with physicians and conduct internal and external monitoring of promotional and other activities.  It also increases individual accountability by requiring compliance-related certifications from its Board and key executives.    

The civil settlement resolves lawsuits filed by Kevin Manieri, Duane Arnold, and Mark Shipman, all former employees of Avanir, under the qui tam or whistleblower provisions of the False Claims Act, which permit private individuals, known as relators, to sue on behalf of the government for false claims and to share in any recovery.  The qui tam suits were filed in the Northern District of Ohio and the Northern District of Georgia and are captioned United States ex rel. Kevin Manieri v. Avanir Pharmaceuticals, Inc. and Deepak Raheja, Action No. 5:15-cv-611 (N.D. Ohio), and United States ex rel. Duane Arnold and Mark Shipman v. Avanir Pharmaceuticals, Inc., Action No. 1:15-cv-01250 (N.D. Ga.).  Manieri will receive $12,389,823 of the civil settlement, and Arnold and Shipman will receive $5,365,000 of the civil settlement.  In addition to the $95,972,017 being paid to resolve the United States’ civil claims, Avanir will pay an additional $7,027,983 to resolve state Medicaid claims. 

The Chanler Group, in association with the Hirst Law Group, represents whistleblowers who take action under the False Claims Act to report fraud committed against the federal and state governments.  We have years of experience representing whistleblower clients who expose every kind of fraud against the government, including health care fraud, contract fraud, and tax fraud.  Read more about our expertise in False Claims Act cases and how you can take action.

ITT Cannon has agreed to pay the United States $11 million to settle False Claims Act allegations that it supplied electrical connectors to the military that had not been properly tested, the Justice Department announced today.  ITT sold the untested connectors both directly to the Government and through distributors and other government contractors which incorporated them into technology and equipment sold to the Government. 

The settlement resolves allegations that ITT did not conduct the required periodic testing on six models of electrical connectors.  The Government learned that ITT had not done this testing and ITT promised the Government that it would conduct remedial testing and report the result to the Government.  Shortly thereafter, ITT experienced several failures in its remedial testing.  ITT did not immediately disclose these failures but represented to the Government that it was merely behind in the remedial testing. 

The Defense Logistics Agency (DLA) issued an order stopping the shipment of the six connectors.  ITT issued six Government Industry Data Exchange Program notices (GIDEP) disclosing to industry its failure to conduct required testing, its test failures, and changes in the processes, materials, construction, sourcing and design of the connectors.  DLA then removed the six ITT connectors from the Qualified Products List (QPL).  The QPL lists products that have met the qualification requirements set forth in the applicable Military Specifications (Mil Specs), which are uniform engineering and technical requirements for certain products used by the Department of Defense.  DLA’s removal of ITT from the QPL precluded ITT from selling parts to the military covered by the Mil Specs.  Recently, ITT has requalified one of the connectors for sale to the Government.

The settlement resolves allegations filed in a lawsuit by Ralph Tatgenhorst, the former regional quality manager at ITT’s Santa Ana facility, in federal court in Los Angeles, California, under the whistleblower (or “qui tam”) provisions of the False Claims Act.  These provisions permit private individuals to sue on behalf of the Government for false claims and to share in any recovery.  Mr. Tatgenhorst will receive $2,090,000 as his share of the settlement amount. 

The Chanler Group, in association with the Hirst Law Group, represents whistleblowers who take action under the False Claims Act to report fraud committed against the federal and state governments.  We have years of experience representing whistleblower clients who expose every kind of fraud against the government, including health care fraud, contract fraud, and tax fraud.  Read more about our expertise in False Claims Act cases and how you can take action.

Skyline Urology has agreed to pay the United States $1.85 million to resolve allegations that it violated the False Claims Act by submitting improper claims to the Medicare program for evaluation and management services, the Department of Justice announced last month.

Skyline Urology allegedly submitted false claims to the Medicare program for evaluation and management (E&M) services that were not allowable under Medicare.  Medicare generally prohibits healthcare providers from separately billing for E&M services provided on the same day as another medical procedure, unless the E&M services are significant, separately identifiable, and above and beyond the usual preoperative and postoperative care associated with the medical procedure.  If an E&M service satisfies these criteria, the provider can use a billing code known as “Modifier 25” to bill for the significant and separately identifiable E&M services.  In this case, the government alleged that Skyline Urology used Modifier 25 to improperly unbundle routine E&M services that were not separately billable from other procedures performed on the same day, and, as a result, improperly claimed compensation from Medicare for certain urological services.

Skyline Urology has also entered into an Integrity Agreement with the U.S. Department of Health and Human Services, Office of Inspector General that will require regular monitoring of its billing practices for three years. 

The settlement resolves allegations in a lawsuit filed in the District of Maryland by James M. Cesare, the founder of the consulting firm Bay Area Healthcare Advisors LLC.  The lawsuit was filed under the qui tam, or whistleblower, provisions of the False Claims Act, which permit private individuals to sue on behalf of the government for false claims and to share in any recovery.  As part of the resolution, Mr. Cesare will receive approximately $323,750.

The Chanler Group, in association with the Hirst Law Group, represents whistleblowers who take action under the False Claims Act to report fraud committed against the federal and state governments.  We have years of experience representing whistleblower clients who expose every kind of fraud against the government, including health care fraud, contract fraud, and tax fraud.  Read more about our expertise in False Claims Act cases and how you can take action.

The Department of Justice obtained more than $2.8 billion in settlements and judgments from civil cases involving fraud and false claims against the government in the fiscal year ending Sept. 30, 2018, Principal Deputy Associate Attorney General Jesse Panuccio and Assistant Attorney General Jody Hunt of the Department of Justice’s Civil Division announced earlier this month.  Recoveries since 1986, when Congress substantially strengthened the civil False Claims Act, now total more than $59 billion.

Of the $2.8 billion in settlements and judgments recovered by the Department of Justice this past fiscal year, $2.5 billion involved the health care industry, including drug and medical device manufacturers, managed care providers, hospitals, pharmacies, hospice organizations, laboratories, and physicians.  This is the ninth consecutive year that the Department’s civil health care fraud settlements and judgments have exceeded $2 billion.  The recoveries included in the $2.5 billion reflect only federal losses but, in many of these cases, the Department was instrumental in recovering additional millions of dollars for state Medicaid programs.

In addition to combatting health care fraud, the False Claims Act serves as the government’s primary civil remedy to redress false claims for federal funds and property involving a multitude of government operations and contracts.  These areas range from defense and national security to import tariffs and small business programs. 

In 1986, Congress strengthened the Act by increasing incentives for whistleblowers to file lawsuits alleging false claims on behalf of the government.  These whistleblower, or qui tam, actions comprise a significant percentage of the False Claims Act cases that are filed.  If the government prevails in a qui tam action, the whistleblower, also known as the relator, receives up to 30 percent of the recovery.  Whistleblowers filed 645 qui tam suits in fiscal year 2018, and this past year the Department recovered over $2.1 billion in these and earlier filed suits. 

Of the $2.8 billion in settlements and judgments reported by the government in fiscal year 2018, over $2.1 billion arose from lawsuits filed under the qui tam provisions of the False Claims Act.  During the same period, the government paid out $301 million to the individuals who exposed fraud and false claims by filing these actions.

The Chanler Group, in association with the Hirst Law Group, represents whistleblowers who take action under the False Claims Act to report fraud committed against the federal and state governments.  We have years of experience representing whistleblower clients who expose every kind of fraud against the government, including health care fraud, contract fraud, and tax fraud.  Read more about our expertise in False Claims Act cases and how you can take action.

Health Management Associates, LLC (HMA), formerly a U.S. hospital chain headquartered in Naples, Florida, will pay over $260 million to resolve criminal charges and civil claims relating to a scheme to defraud the United States, the U.S. Department of Justice announced this week.  The government alleged that HMA knowingly billed government health care programs for inpatient services that should have been billed as outpatient or observation services, paid remuneration to physicians in return for patient referrals, and submitted inflated claims for emergency department facility fees. 

HMA was acquired by Community Health Systems Inc. (CHS), a major U.S. hospital chain, in January 2014, after the alleged conduct at HMA occurred.  Since July 2014, HMA has been operating under a Corporate Integrity Agreement (CIA) between CHS and the HHS-OIG.

As part of the criminal resolution, HMA entered into a three-year Non-Prosecution Agreement (NPA) with the Criminal Division’s Fraud Section in connection with a corporate-driven scheme to defraud Federal health care programs by unlawfully pressuring and inducing physicians serving HMA hospitals to increase the number of emergency department patient admissions without regard to whether the admissions were medically necessary.  The scheme involved HMA hospitals billing and obtaining reimbursement for higher-paying inpatient hospital care, as opposed to observation or outpatient care, from Federal health care programs, increasing HMA’s revenue.  Under the terms of the NPA, HMA will pay a $35 million monetary penalty.  Under the terms of the NPA, HMA and CHS, the current parent company, agreed to cooperate with the investigation, report allegations or evidence of violations of Federal health care offenses, and ensure that their compliance and ethics program satisfies the requirements of an amended and extended CIA between CHS and HHS-OIG.

In addition, an HMA subsidiary, Carlisle HMA, LLC, formerly doing business as Carlisle Regional Medical Center, has agreed to plead guilty to one count of conspiracy to commit health care fraud.  The plea agreement remains subject to acceptance by the court.  Up until 2017, Carlisle HMA, LLC owned and operated Carlisle Regional Medical Center, an acute care hospital located in Carlisle, Pennsylvania.  Carlisle HMA, LLC was charged in a criminal information filed today in the District of Columbia with conspiracy to commit health care fraud.

According to admissions made in the resolution documents, HMA instituted a formal and aggressive plan to improperly increase overall emergency department inpatient admissions at all HMA hospitals, including at Carlisle Regional Medical Center.  As part of the plan, HMA set mandatory company-wide admission rate benchmarks for patients presenting to HMA hospital emergency departments – a range of 15 to 20 percent for all patients presenting to the emergency department, depending on the HMA hospital, and 50 percent for patients 65 and older (i.e. Medicare beneficiaries) - solely to increase HMA revenue.  HMA executives and HMA hospital administrators executed the scheme by pressuring, coercing and inducing physicians and medical directors to meet the mandatory admission rate benchmarks and admit patients who did not need impatient admission through a variety of means, including by threatening to fire physicians and medical directors if they did not increase the number of patients admitted.

HMA also agreed to pay $216 million as part of a related civil settlement. The civil settlement resolves HMA’s liability for submitting false claims between 2008 and 2012 as part of its corporate-wide scheme to increase inpatient admissions of Medicare, Medicaid and the Department of Defense’s (DOD) TRICARE program beneficiaries over the age of 65.  The government alleged that the inpatient admission of these beneficiaries was not medically necessary, and that the care needed by, and provided to, these beneficiaries should have been provided in a less costly outpatient or observation setting.  HMA agreed to pay $62.5 million to resolve these allegations with $61,839,718 being paid to the United States and $706,084 being paid to participating States.

The civil settlement also resolves allegations that during the period from 2003 through 2011, two HMA hospitals in Florida, Charlotte Regional Medical Center and Peace River Medical Center, billed federal health care programs for services referred by physicians to whom HMA provided remuneration in return for patient referrals.  To induce patient referrals, Charlotte Regional provided a local physician group with free office space and staff, as well as direct payments, which purportedly covered overhead and administrative costs incurred by the group for its management of a Charlotte Regional physician.  HMA also provided another local physician with free rent and upgrades to his office space.  HMA agreed to pay $93.5 million to resolve these civil allegations, with the United States receiving $87.96 million, and the State of Florida receiving $5.54 million.

Additional allegations that are resolved by the civil settlement are that between 2009 and 2012, two former HMA hospitals, Lancaster Regional Medical Center and Heart of Lancaster Medical Center in Pennsylvania, billed federal health care programs for services referred by physicians with whom the facilities had improper financial relationships.  These relationships stemmed from HMA’s excessive payments to (1) a large physician group in return for two businesses owned by the group and for services allegedly performed by the group, and (2) a local surgeon that exceeded the value of the services provided.  The government alleged that these arrangements were structured in this manner to disguise payments intended to induce the referral of patients.  HMA agreed to pay $55 million to the United States to resolve these civil allegations.

Finally, the civil settlement will also resolve claims that Crossgates Hospital, an HMA facility in Brandon, Mississippi, leased space to a local physician from Jan. 15, 2005 through Jan. 14, 2007, but required the physician to pay rent for only half of the space he was actually occupying, in return for patient referrals to Crossgates Hospital.  HMA agreed to pay $425,000 to the United States to resolve these civil allegations.

Federal law, including the Anti-Kickback Statute and the Stark Law, prohibits hospitals from providing financial inducements to physicians for referrals.  These provisions are designed to ensure that physician decision-making is not compromised by improper financial incentives.

The government further alleged that from September 2009 through December 2011, certain HMA hospitals submitted claims to Medicare and Medicaid seeking reimbursement for falsely inflated emergency department facility charges.  HMA agreed to pay $12 million to resolve these civil allegations, with $11.028 million being paid to the United States and $972,000 being paid to participating States.

The allegations resolved by the settlement were originally brought in eight lawsuits filed under the qui tam, or whistleblower, provisions of the False Claims Act, which permit private parties to sue on behalf of the government for false claims and to receive a share of any recovery. The whistleblower in United States ex rel. Nurkin will receive approximately $15 million as a share of the recovery, and the whistleblowers in United States ex rel. Miller will receive approximately $12.4 million as their share of the recovery.  The whistleblower shares to be awarded in the remaining cases have not yet been determined.

The Chanler Group, in association with the Hirst Law Group, represents whistleblowers who take action under the False Claims Act to report fraud committed against the federal and state governments.  We have years of experience representing whistleblower clients who expose every kind of fraud against the government, including health care fraud, contract fraud, and tax fraud.  Read more about our expertise in False Claims Act cases and how you can take action.