TAP Pharmaceutical Products Inc. and Seven Others Charged With Health Care Crimes; Company Agrees To Pay $875 Million To Settle Charges, Reports U.S. Attorney

BOSTON, Oct. 3 , 2001/PRNewswire/ -- United States Attorney Michael J. Sullivan, Department of Health and Human Services Inspector General Janet Rehnquist, Assistant Inspector General for Investigations and Director of the Department of Defense Criminal Investigation Service Carol Levy, Special Agent in Charge of the Federal Bureau of Investigation in New England Charles S. Prouty, and Terry Vermillion, Director of the Office of Criminal Investigations, for the Food and Drug Administration, announced today that:

(1) TAP Pharmaceutical Products Inc. ("TAP"), a major American pharmaceutical manufacturer, has agreed to pay $875,000,000 to resolve criminal charges and civil liabilities in connection with its fraudulent drug pricing and marketing conduct with regard to Lupron, a drug sold by TAP primarily for treatment of advanced prostate cancer in men. The global agreement includes:

(a) TAP has agreed to plead guilty to a conspiracy to violate the Prescription Drug Marketing Act and to pay a $290,000,000 criminal fine, the largest criminal fine ever in a health care fraud prosecution. The plea agreement between the United States and TAP specifically states that TAP's criminal conduct caused losses of 145,000,000.

(b) TAP has agreed to settle its federal civil False Claims Act liabilities and to pay the U.S. Government $559,483,560 for filing false and fraudulent claims with the Medicare and Medicaid programs as a result of TAP's fraudulent drug pricing schemes and sales and marketing misconduct.

(c) TAP has agreed to settle its civil liabilities to the fifty states and the District of Columbia and to pay them $25,516,440 for filing false and fraudulent claims with the states, as a result of TAP's drug pricing and marketing misconduct, and from TAP's failure to provide the state Medicaid programs TAP's best price for those drugs as required by law. "

(d) TAP has agreed to comply with the terms of a sweeping corporate integrity agreement which, among other things, significantly changes the manner in which TAP supervises its marketing and sales staff, and ensures that TAP will report to the Medicare and Medicaid programs the true average sale price for drugs reimbursed by those programs.

(2) A federal grand jury returned an indictment unsealed today, charging one physician and six TAP managers with conspiracy to pay kickbacks to doctors and other customers, conspiracy to defraud the state Medicaid programs on TAP's obligation to sell products to those programs at its best price, and conspiracy to violate the Prescription Drug Marketing Act by causing free samples to be illegally billed to the Medicare program. The indictment charges that the TAP defendants offered to give things of value, including free drugs, so-called educational grants, trips to resorts, free consulting services, medical equipment, and forgiveness of debt, to physicians and other customers to obtain their referrals of prescriptions for Lupron to Medicare program beneficiaries, in violation of the anti-kickback statute. The indictment also charges that the TAP defendants aided and abetted, and caused the billings to hundreds of elderly Medicare program beneficiaries and to the Medicare program directly, for thousands of free samples of Lupron, used in the treatment of prostate cancer, in violation of the Prescription Drug Marketing Act.

The seven individuals charged in the indictment unsealed today are:

(1) ALAN MACKENZIE, age 49, of 27068 Wellington Court, Barrington, Illinois, and formerly Vice President of Sales for TAP.

(2) JANICE SWIRSKI, age 40, of 6 Bellingham Drive, Chestnut Hill, Massachusetts, and formerly a National Account Manager with TAP.

(3) HENRY VAN MOURICK, age 43, of 23 Golfwood Court, Roseville, California, and currently a District Manager employed by TAP.

(4) DONNA TOM, age 37, of 141 East 56th Street, New York, New York, and formerly a District Manager employed by TAP.

(5) KIMBERLEE CHASE, age 35, of 108 Dedham Street, Dover, Massachusetts, and formerly a District Manager employed by TAP.

(6) DAVID GUIDO, age 30, of 131 New London Road, Colchester, Connecticut, and currently a Hospital Account Executive employed by TAP.

(7) DR. JOHN ROMANO, age 48, of 110 Long Pond Road, Plymouth, Massachusetts, an urologist with a practice in Plymouth, Massachusetts.

Prior to yesterday's indictment, four other physicians have been charged and have pleaded guilty in this investigation: Dr. Rodney Mannion, a urologist practicing in LaPorte and Michigan City, Indiana, was charged on February 28, 2000 with healthcare fraud. Dr. Mannion pleaded guilty to that charge on April 25, 2000. Dr. Jacob Zamstein, a urologist practicing in Bloomfield, Connecticut, was charged on November 3, 2000 with healthcare fraud and pleaded guilty on December 27, 2000. Dr. Joseph Spinella, a urologist practicing in Bristol, Connecticut, was charged on December 8, 2000 with healthcare fraud and pleaded guilty on March 29, 2001. Dr. Joel Olstein, a urologist practicing in Lewiston, Maine, was charged on April 11, 2001 with healthcare fraud and pleaded guilty on July 18, 2001.

Lupron is marketed by TAP primarily for the treatment of prostate cancer. Lupron is identical in effectiveness to the drug Zolodex, produced by a competitor, which was also available for prescription in the 1990s. While Medicare does not pay for most drugs needed by Medicare beneficiaries, Medicare does cover drugs, such as Lupron, that must be injected under the supervision of a physician. Medicare paid for 80% of either the urologist's charge for Lupron or the average wholesale price reported by TAP, whichever was lower, and the patient was responsible for the remaining 20% as a copayment.

As part of its civil allegations, the Government alleged that throughout the 1990s, TAP set and controlled the price at which the Medicare program reimbursed physicians for the prescription of Lupron by reporting its average wholesale price ("AWP"). The AWP reported by TAP was significantly higher than the average sales price TAP offered physicians and other customers for the drug. The Government alleged that TAP marketed the spread between its discounted prices paid by physicians and the significantly higher Medicare reimbursement based on AWP as an inducement to physicians to obtain their Lupron business. The Government further alleged that TAP concealed the true discounted prices paid by physicians from Medicare, and falsely advised physicians to report the higher AWP rather than their real discounted price for the drug. The Government further alleged that TAP set its AWPs of Lupron at levels far higher than the price for which wholesalers or distributors actually sold the drug, resulting in falsely inflated prices that were neither the physician's actual cost nor the true wholesaler's average price.

"The Medicare and Medicaid drug programs are bulwarks against the financial hardship that can be caused by the need for life-saving medical treatments," said Robert D. McCallum, Jr., Assistant Attorney General for the Justice Department's Civil Division. "These programs cannot afford abuses that enrich doctors or drug companies at the expense of taxpayers and patients. This settlement agreement and the compliance steps that TAP has agreed to take will reinforce the government's long-standing objective of paying Medicare and Medicaid providers for the reasonable costs of the drugs they administer."

"The urologists and the TAP employees who knowingly participated in this broad conspiracy took advantage of older Americans suffering from prostate cancer. The indictment unsealed today alleges that TAP employees sought to influence the doctors' decisions about what drug to prescribe to patients by giving them kickbacks and bribes, from free samples to free consulting services to expensive trips to golf and ski resorts to so-called educational grants," said U.S. Attorney Sullivan. "In all instances where the kickbacks worked to ensure the prescription of TAP's product Lupron, the Medicare Program and the elderly Americans suffering from prostate cancer paid more for their care than if the doctor had prescribed the competitor's product."

"Medicare beneficiaries and all American patients need to get the right pharmaceuticals, based on medical criteria, and at a fair price. This is crucial both to ensure good quality health care and to use our resources effectively. Today's settlement is a clear message that the federal government will protect the best interests of beneficiaries and taxpayers," said HHS Secretary Tommy G. Thompson.

"This prosecution has resulted in the largest criminal and civil recoveries in any health care fraud case in the country. The fraud schemes used by TAP Pharmaceuticals and others impacts significantly on the integrity of TRICARE, the Department of Defense's healthcare system," stated DCIS Special Agent in Charge Edward Bradley. "Healthcare fraud increases patients' costs and negatively effects the delivery of health care services to over 8 million military members, retirees, and their dependents."

The indictment unsealed today against the seven individuals alleges that inducements to physicians included free products; free consulting services; trips to expensive golf and ski resorts; money disguised as "educational grants," but in fact was used and intended to be used for many purposes, including cocktail party bar tabs, office Christmas parties, medical equipment, travel expenses for urologists and their staff to attend conferences; and discounts on Lupron sold to treat endometriosis in women to effect a lower price on Lupron used in the treatment of men with prostate cancer.

The investigation commenced in the District of Massachusetts in 1997 after a urologist employed by Tufts Associated Health Maintenance Organization ("Tufts HMO") in Waltham, Dr. Joseph Gerstein, reported to law enforcement authorities that he had been offered an educational grant if he would reverse a decision he had made on behalf of Tufts that it would only cover the less expensive drug Zoladex. As charged in the indictment, SWIRSKI and CHASE met with Dr. Gerstein after he began working with the FBI and the Office of Inspector General, and during those meetings, offered him $65,000 in educational grants that he could use for any purpose "whatever," together with discounts on other products, if he would reverse Tufts' decision not to include Lupron on its formulary for treating patients that it insured who were suffering from prostate cancer. The investigation was also triggered by a civil False Claims Act suit filed in 1996 by Douglas Durand, after he had quit his employment at TAP as Vice President of Sales, after just one year because of his concerns about the illegal marketing conduct of some of TAP's employees.

The civil False Claims Act provides that where persons submit, cause others to submit, or conspire to submit, false or fraudulent claims to the United States Government, including its federal health care programs, the Government is entitled to recover treble damages and $5,500 to $11,000 for each false or fraudulent claim submitted. Private individuals, like Dr. Gerstein and Douglas Durand, are allowed to file whistleblower suits under the False Claims Act to bring the government information about wrongdoing, and if the government is successful in resolving or litigating their claims, to share in the recovery by receiving generally 15% to 25% of the amount recovered. As a part of today's resolution, those two individuals together with Tufts Associated HMO will share as whistleblowers, pursuant to the Congressional directive in the False Claims Act, 17% of the civil recovery, or an amount of approximately $95 million.

"The payment by TAP of nearly $900 million including the highest criminal fine ever imposed on any health care company, and the indictment of the six TAP employees sends a very strong signal to the pharmaceutical industry that it best police its employees' conduct and deal strongly with those who would gain sales at the expense of the health care programs for the poor and the elderly and the persons insured by those programs," said U.S. Attorney Sullivan.

As part of a condition for doing business in the future with providers who are members of the Medicare and Medicaid programs, TAP agreed to enter into an extensive Corporate Integrity Agreement. That agreement provides for significant training of TAP's sales and marketing employees and changes in supervision and controls. It also requires TAP to report to the Medicare and Medicaid programs accurate pricing information showing TAP's true average sales price.

"In recent years, the pharmaceutical industry has come under increasing scrutiny for its pricing, sales, and marketing practices. The OIG, together with other government agencies, will use all available enforcement authorities, where appropriate, to address these practices," said HHS Inspector General Janet Rehnquist.

The entire amount of the $290 million criminal fine paid by TAP will go to the Department of Justice's Crime Victims Fund. The Fund was established in 1984 by the Victims of Crime Act ("VOCA") and serves as a major funding source for victim services throughout the country. Each year, millions of dollars are deposited into this fund from criminal fines, forfeited bail bonds, penalty fees, and special assessments collected by U.S. Attorney's Offices, U.S. Courts, and the Bureau of Prisons. State assistance programs use VOCA funds to provide or contract for services to victims of rape, drunk driving, child abuse, domestic violence, homicide, and other crimes. Victims of federal, as well as state crimes, are eligible to receive VOCA-funded services.

The investigation is continuing.

The investigation has been conducted by the agents from the Federal Bureau of Investigation, the Office of Investigations for the Office of Inspector General for the Department of Health and Human Services, the Food and Drug Administration's Office of Criminal Investigations and the Department of Defense's Defense Criminal Investigation Service. On the criminal side, the investigation and prosecution are being handled by Assistant U.S. Attorney Michael K. Loucks, Health Care Fraud Chief. On the civil side, the investigation and prosecution are being handled by Assistant U.S. Attorney Susan Winkler, assisted by Department of Justice Trial Attorney T. Reed Stephens. The Corporate Integrity Agreement was negotiated by Office of General Counsel, Office of Inspector General Assistant Counsel Mary Riordan.