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On November 15, 2012, the United States Attorney's Office for the Northern District of Illinois filed a False Claims Act lawsuit against Dr. Michael J. Reinstein, alleging that Dr. Reinstein accepted kickbacks from various drug companies to prescribe Clozapine, an antipsychotic drug known to have life-threatening side effects, to indigent, mentally ill nursing home residents in the Chicago area.
The Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b), prohibits making or accepting a payment to induce a referral of government funded healthcare services. Because kickbacks to those who can influence healthcare decisions can result in the provision of goods and services that are medically unnecessary, of poor quality or even harmful to a vulnerable patient population, and because kickback schemes can be difficult to detect, the Anti-Kickback Statute prohibits kickbacks in any form, and regardless of whether the kickback actually resulted in unnecessary or inappropriate medical care.
Doctors, hospitals, nursing homes, and anyone else who submits claims for payment to government healthcare programs, like Medicare or Medicaid, certifies that they have complied with the Anti-Kickback Statute. Any claim tainted by an Anti-Kickback Statute violation is a false claim within the meaning of the False Claims Act, subjecting the submitting party to treble damages, plus penalties. 42 U.S.C. § 1320a-7b(g).
The United States, in a five-count complaint, alleges that Dr. Reinstein has been providing psychiatric services in the Chicago area since 1973, operating in Chicago's Uptown neighborhood since 1999. Most of Dr. Reinstein's patients were poor, mentally ill patients living in one of 30 nursing homes and long-term care facilities. Dr. Reinstein frequently prescribed Clozaril, an atypical antipsychotic drug, to his patients. Clozaril can effectively treat some forms of schizophrenia, but carries with it the risk of several serious side effects, including seizures, inflammation of the heart, and increased mortality in elderly patients. As a result, Clozaril is a treatment of last resort for the elderly. Dr. Reinstein nonetheless routinely prescribed Clozaril, and later, its generic equivalent, Clozapine to thousands of his mentally ill nursing home patients.
The government's complaint alleges that Dr. Reinstein did so after soliciting and receiving kickbacks from drug companies that manufactured Clozaril and generic Clozapine. For example, the complaint alleges that Dr. Reinstein accepted from drug companies annual $50,000 payments under "speaker agreements" and "consulting agreements"; funding for a "Clozapine research study"; and multiple, fully-paid trips to Miami, Florida during which he and his guests enjoyed a boat cruise, a golf outing, and multiple thousand-dollar dinners.
After accepting these benefits, Dr. Reinstein became the largest prescriber of generic Clozapine in the country. While Clozapine accounted nationally for only about 2% of atypical antipsychotic drugs prescribed to nursing home residents, Dr. Reinstein prescribed Clozapine to more than 50% of his patients. At one nursing home, Dr. Reinstein had 75% of the four hundred patients on Clozapine.
Dr. Reinstein's alleged scheme vividly demonstrates the harm that the Anti-Kickback Statute was designed to prevent. Thousands of Chicago's most vulnerable patients have been prescribed drugs with dangerous side effects by a doctor tainted by payments he received from the drugs' manufacturers. And the government has all the while been paying the bill for these prescriptions. The United States' complaint demonstrates that Anti-Kickback Statute violations are taken seriously. Indeed, on November 20, 2012, just days after the federal complaint was filed, the Illinois Department of Healthcare and Family Services suspended payments to Dr. Reinstein, and the Illinois Department of Financial and Professional Regulation has also filed a complaint against Dr. Reinstein that could result in the revocation of his medical license.
While kickback schemes can be difficult to detect, whistleblowers who come forward with information revealing such schemes can be eligible to share in any government recovery.