Eli Lilly has agreed to the resolution in order to resolve allegations that it promoted its drug, Zyprexa, for uses not approved by the Food and Drug Administration. The Food, Drug, and Cosmetic Act (FDCA) mandates that companies specify the planned uses of a product in its “new drug” application to the FDA. The FDA then determines whether or not the drug is safe and effective for its intended use. After its approval, a drug may not be marketed or promoted for non-specified, or off-label, uses.

Zyprexa, originally approved in 1996 as a treatment for manifestations of psychotic disorders and in 2000 for the short-term treatment of schizophrenia, was promoted by Eli Lilly for unapproved uses included the treatment for dementia, including Alzheimer’s dementia, in elderly people. The information contained in the agreements the Eli Lilly has signed allege that the company knowingly promoted Zyprexa for off-label uses, and trained its sales force to disregard the law. It also claims that Eli Lilly marketed Zyprexa to primary care physicians, despite Zyprexa having virtually no approved use in the primary care market. Through false marketing, Eli Lilly caused false claims for payment to be submitted to Medicaid, TRICARE, and the Federal Employee Health Benefits Program, none of which provide coverage for off-label uses.

“Off-label promotion of pharmaceutical drugs is a serious crime because it undermines the FDA’s role in protecting the American public by determining that a drug is safe and effective for a particular use before it is marketed,” said Gregory G. Katsas, Assistant Attorney General for the Civil Division. “This settlement demonstrates the Department’s ongoing diligence in prosecuting cases involving violations of the Food, Drug, and Cosmetic Act, and recovering taxpayer dollars used to pay for drugs sold as a result of off-label marketing campaigns.”

“The illegal scheme used by Eli Lilly significantly impacted the integrity of TRICARE, the Department of Defense’s healthcare system,” said Ed Bradley, Special Agent-in-Charge, Defense Criminal Investigative Service. “This illegal activity increases patients’ costs, threatens their safety and negatively affects the delivery of healthcare services to the over nine million military members, retirees and their families who rely on this system. Today’s charges and settlement demonstrate the ongoing commitment of the Defense Criminal Investigative Service and its partners in law enforcement to investigate and prosecute those that abuse the government’s healthcare programs at the expense of the taxpayers and patients.”

The global resolution includes the following agreements:

A plea agreement signed by Eli Lilly admitting guilt to the criminal charge of misbranding. Specifically, Eli Lilly admits that between Sept. 1999 and March 31, 2001, the company promoted Zyprexa in elderly populations as treatment for dementia, including Alzheimer’s dementia. Eli Lilly has agreed to pay a $515 million criminal fine and to forfeit an additional $100 million in assets.

A civil settlement between Eli Lilly, the United States and various States, in which Eli Lilly will pay up to $800 million to the federal government and the states to resolve False Claims Act claims and related state claims by Medicaid and other federal programs and agencies including TRICARE, the Federal Employees Health Benefits Program, Department of Veterans Affairs, Bureau of Prisons and the Public Health Service Entities. The federal government will receive $438,171,544 from the civil settlement. The state Medicaid programs and the District of Columbia will share up to $361,828,456 of the civil settlement, depending on the number of states that participate in the settlement.

The qui tam relators will receive $78,870,877 from the federal share of the settlement amount.

A Corporate Integrity Agreement (CIA) between Eli Lilly and the Office of Inspector General of the Department of Health and Human Services. The five-year CIA requires, among other things, that a Board of Directors committee annually review the company’s compliance program and certify its effectiveness; that certain managers annually certify that their departments or functional areas are compliant; that Eli Lilly send doctors a letter notifying them about the global settlement; and that the company post on its website information about payments to doctors, such as honoraria, travel or lodging. Eli Lilly is subject to exclusion from Federal health care programs, including Medicare and Medicaid, for a material breach of the CIA and subject to monetary penalties for less significant breaches.

If you are seeing fraud on the government, contact us by calling 800-377-1812 for strictly confidential advice from experienced counsel, with no fee obligation.

Under the agreement, FORBA will pay the United States and participating states $24 million, plus interest, to resolve allegations that it caused bills to be submitted to state Medicaid programs for medically unnecessary dental services performed on children insured by Medicaid, which is funded jointly by the federal and state governments. These services included performing pulpotomies (baby root canals), placing crowns, administering anesthesia (including nitrous oxide), performing extractions, and providing fillings and/or sealants.

FORBA has further agreed to put in place various remedial measures designed to prevent similar unlawful conduct from occurring in the future. The government’s investigation of individual dentists is ongoing, and FORBA is cooperating with that investigation by providing information about dentists who may have violated professional standards.

“We will not tolerate Medicaid providers who prey on vulnerable children and seek unjust enrichment at taxpayers’ expense,” said Daniel R. Levinson, Inspector General of the U.S. Department of Health and Human Services. “This settlement reaffirms our commitment to protect the health and well-being of Medicaid beneficiaries and to ensure the integrity of this essential health care program.”

The government’s investigation was initiated by three lawsuits filed under the qui tam, or whistleblower, provisions of the False Claims Act, which permit private citizens to sue on behalf of the United States and share in any recovery. As part of today’s resolution, the three whistleblowers will receive payments totaling more than $2.4 million from the federal share of the settlement.

If you are seeing fraud on the government, contact us by calling 800-377-1812 for strictly confidential advice from experienced counsel, with no fee obligation.

Specifically, the United States determined that St. John made payments to 23 individual physicians or physician groups to induce referrals for medical services. Federal law prohibits healthcare providers from billing federal health care programs for referrals from doctors with whom they have a financial relationship, unless that relationship falls within certain exceptions.

St. John’s fraudulent financial relationships were disclosed in a report filed by the health provider to the Department of Health and Human Service’s Office of Inspector General. The report suggested that the agreements with physicians may have violated federal law.

“The resolution of this matter yielded a substantial recovery for taxpayers, and it underscores our commitment to ensure that services reimbursable by federal health care programs are based on the best interests of patients rather than the personal financial interests of referring physicians,” said Tony West, Assistant Attorney General for the Department’s Civil Division.

If you are seeing fraud on the government, contact us by calling 800-377-1812 for strictly confidential advice from experienced counsel, with no fee obligation.

Under the terms of the settlement, B&H Health Care Services, Inc., known as Nursing Personnel Home Care, Excellent Home Care Services, LLC, and Extended Nursing Personnel CHHA, LLC, will return $23,963,100 to Medicaid–a program jointly funded by the state and federal governments. Of this amount, the State of New York will receive a total of $14,377,860.

The settlements were initiated by lawsuits filed under the whistleblower provisions of the False Claims Act, which allow private citizens to file suit on behalf of the United States for fraud and share in any recovery. Maurice Keshner will receive approximately $1,693,343 from New York’s recovery from Nursing Personnel. Deborah Yannicelli will receive approximately $994,080 from New York’s recovery from Extended and Excellent. The Act also provides protection against job retaliation for whistleblowing.

Medicaid requires home health aides – who primarily care for elderly patients, administer medication, and provide services such as catheter care, colostomy care and wound care – to successfully complete a training program licensed by the Department of Health or the State Education Department. All such aides must receive a minimum of 75 hours of training, including sixteen hours of supervised practical training conducted by a registered nurse.
If you are seeing fraud on the government, contact us by calling 800-377-1812 for strictly confidential advice from experienced counsel, with no fee obligation.

The suit alleged that Schering deliberately inflated the average wholesale price it reported to California for Albuterol, a treatment for asthma and other breathing problems, as well as other drugs. As a result, California’s Medi-Cal program overpaid millions of dollars in pharmacy reimbursements.

Schlering was recently acquired by Merck & Co. of New Jersey. Merck didn’t admit wrongdoing and said its pricing practices complied with regulations and contracts. The settlement amount was reserved and significantly funded by Schering-Plough prior to its merger with Merck in November, Merck said.
If you are seeing fraud on the government, contact us by calling 800-377-1812 for strictly confidential advice from experienced counsel, with no fee obligation.

Kyphoplasties, which are minimally-invasive procedures used to treat osteoporosis-evoked spinal fractures, are typically performed on an outpatient basis. “Outpatient” procedures do not require admission to a hospital and can even be performed outside hospital facilities. By performing kyphoplasties on an inpatient basis, patients were unnecessarily admitted to the hospital and closely monitored before, during, and after the procedure. 

In this fashion, the hospitals overcharged Medicare thousands of dollars for each kyphoplasty they performed.

“By keeping patients overnight, hospitals could seek greater reimbursement from Medicare and make much larger profits on kyphoplasty,” said Kathleen Mehltretter, Acting U.S. Attorney for the Western District of New York in Buffalo.

The whistleblower suit was brought under the False Claims Act, which permits private citizens to bring lawsuits on behalf of the United States and receive a portion of the proceeds of any settlement or judgment awarded against a defendant. The lawsuit was filed in 2008 in federal district court in Buffalo, N.Y. by Craig Patrick and Charles Bates. Mr. Patrick of Hudson, Wis., is a former reimbursement manager for Kyphon, and Mr. Bates was formerly a regional sales manager for Kyphon in Birmingham, Ala.

If you are witnessing fraud on the government, contact us by calling 800-377-1812 for strictly confidential advice from experienced counsel, with no fee obligation.

According to the case, Regency sought Medicare and Medicaid reimbursement for services that nursing home residents did not qualify for, were unnecessary, and were unsupported by required certification. 

“With the number of Medicare and Medicaid beneficiaries increasing every year, we will take whatever action is necessary to make certain healthcare providers are reimbursed only for legitimate services provided to qualified beneficiaries,” said Tim Johnson, Acting U.S. Attorney for the Southern District of Texas.

If you are witnessing fraud on the government, contact us by calling 800-377-1812 for strictly confidential advice from experienced counsel, with no fee obligation.

False Claims Act Attorney Group Settles with Nation’s Largest Pharmacy

Along with pharmacists Daniel Bieurance and Neil Thompson, the False Claims Act Attorney Group of Vanderlinden, Christensen, and Wojtalewicz is proud to announce the $9.9 million settlement of a False Claims Medicaid Fraud Case against the giant pharmacy chain Walgreens. Learn more here.
]]> http://www.false-claims-act.com/2008/10/16/walgreens-settlement/feed/ 0 http://www.false-claims-act.com/2008/10/09/small-pharmacy-chain-does-the-right-thing/ http://www.false-claims-act.com/2008/10/09/small-pharmacy-chain-does-the-right-thing/#comments Thu, 09 Oct 2008 20:24:29 +0000 nick http://www.false-claims-act.com/?p=192 With Medicare and Medicaid fraud becoming more and more prevalent it is imperative that whistleblowers like Dan Bieurance and Neil Thompson do the right thing when companies like Walgreens repeatedly over-bill taxpayers. Not all pharmacy chains are as suspect. Take The Stop & Shop Supermarket Company (Stop & Shop), which recently voluntarily reported and returned $269,000 to the Massachusetts Medicaid Program.

From the Press Release:

Stop & Shop…discovered during an audit in 2006 that it had not reported the lowest price it had accepted for certain prescription drug products to MassHealth.  By not reporting the lower prices to MassHealth, Stop and Shop was overpaid by $269,000.  Massachusetts law requires pharmacies to charge Medicaid no more than the lowest price they are willing to accept from any “payer.”  If the pharmacies’ price is lower than the price calculated by the state’s pricing formula, then the state will pay the lowest price.

It is encouraging to see companies self-policing themselves and doing the right thing for their companies and American tax payers. When companies do engage in fraud, either as a mater of practice or oversight, whistleblowers must come forward to do the right thing for them.