(MCT) — CHICAGO — A federal lawsuit accuses a Chicago psychiatrist of getting illegal kickbacks from pharmaceutical companies and submitting at least 140,000 false claims to Medicare and Medicaid for anti-psychotic medications he prescribed for thousands of mentally ill patients in nursing homes.
Dr. Michael J. Reinstein also submitted at least 50,000 claims to Medicare and Medicaid falsely claiming he had provided “pharmacologic management” for his patients at more than 30 area nursing homes and long-term care facilities, according to the health care fraud lawsuit filed by the U.S. attorney’s office.
“This is the largest civil case alleging prescription medication fraud against an individual ever brought in Chicago,” said Acting U.S. Attorney Gary S. Shapiro.
Reinstein was the subject of an investigation by ProPublica and the Chicago Tribune in 2009 that found Reinstein, 69, had compiled a worrisome record of providing assembly-line care with a highly risky drug.
Searching publicly available documents, reporters discovered that Reinstein had been accused of overmedicating his mentally ill patients. His unusually heavy reliance on the drug clozapine — a potent psychotropic medication that carries five “black box” warnings — has been linked to at least three deaths.
In 2007 he prescribed various medications to 4,141 Medicaid patients, including more prescriptions for clozapine than were written by all the doctors in Texas put together, Medicaid records show. Records also showed he was getting government reimbursement for seeing an improbably large number of patients.
Reinstein has provided psychiatric medical services in the Chicago area since 1973. Since at least 1999, he has maintained an office in the Uptown neighborhood, which prosecutors said has the densest concentration of mentally ill nursing home residents in Illinois.
According to the federal lawsuit, Reinstein routinely prescribed anti-psychotic and other psychiatric medications to his patients based, not on their need but on his receipt of kickbacks from pharmaceutical companies.
Reinstein routinely prescribed Clozaril, the trade name for clozapine manufactured by Novartis, and he often had more than 1,000 patients using the medication at any given time, the lawsuit states. For many years, Novartis paid Reinstein to promote Clozaril, it alleges.
After Novartis’ patent for Clozaril expired in 1998, Reinstein resisted pharmacy and drug company efforts to switch his patients to generic clozapine and he continued to be the largest prescriber of Clozaril to Medicaid recipients in the United States, the lawsuit states.
In July 2003, Novartis notified Reinstein that it would be withdrawing its support for Clozaril, and ended the regular payments that it had been making to Reinstein.
In August 2003, the lawsuit says Reinstein offered to switch his patients to generic clozapine manufactured by Ivax Pharmaceuticals if the company met several conditions: agree to pay Reinstein $50,000 under a one-year “consulting agreement”; pay his nurse to speak on behalf of clozapine; and fund a clozapine research study by a Reinstein-affiliated entity known as Uptown Research Institute.
Ivax agreed and Reinstein immediately began switching his patients from Clozaril to Ivax’s clozapine, according to the lawsuit, which noted that he “quickly became the largest prescriber of generic clozapine in the country.”
“Reinstein’s inordinate prescribing of clozapine stands in stark contrast to its extremely limited use by other physicians,” the lawsuit stated.
The suit noted that, generally, 4 percent of schizophrenia patients who were prescribed antipsychotics received clozapine. But during the time Reinstein was allegedly accepting kickbacks from Ivax, more than 50 percent of his patients were prescribed Ivax’s clozapine, it charged.
At one nursing home, Reinstein had 75 percent of the 400 residents on Ivax’s clozapine.
In January 2006, Ivax became a subsidiary of Teva Pharmaceuticals Industries. From 2007 to 2009, the suit alleges, Teva and Reinstein entered into annual “speaker agreements” that resulted in Teva paying Reinstein more than $100,000.