In a news release, the government says that Dr. Michael Reinstein "received illegal kickbacks from pharmaceutical companies and submitted at least 140,000 false claims to Medicare and Medicaid for antipsychotic medications he prescribed for thousands of mentally ill patients in area nursing homes."
ProPublica and the Tribune reported in 2009 that Reinstein prescribed more of the risky antipsychotic clozapine to patients in Illinois' Medicaid program in 2007 than all of the doctors in the Medicaid programs of Texas, Florida and North Carolina.
The government accuses Reinstein of billing Medicare and Medicaid for managing his patients' medications, "knowing that he did not engage in substantive evaluations of his patients' medical and psychiatric conditions to properly manage their medications," the U.S. attorney's office said in its release. "Instead, he allegedly prescribed medications to his patients based on his receipt of kickbacks from pharmaceutical companies."
Prosecutors allege that Reinstein's prescribing decisions were motivated by money and perks from pharmaceutical companies. He allegedly switched patients from one brand of clozapine to another based on money and other enticements he received from a pharmaceutical maker.
Before August 2003, the government alleged, Reinstein prescribed Clozaril, brand name for clozapine made by Novartis, which paid him to promote the drug.
When the drug went off patent in 1998, the lawsuit says, Reinstein resisted attempts to switch his patients to cheaper, generic versions. But when Novartis stopped paying Reinstein in 2003, the lawsuit says, he switched his patients to a generic version made by IVAX Pharamceuticals.
That company had agreed to pay him a consulting fee, pay his nurse to speak on the drug's behalf and fund a research study at an affiliated institute, according to the lawsuit.
"While generally only four percent of schizophrenia patients who were prescribed antipsychotics received clozapine, during the time Reinstein was allegedly accepting kickbacks from IVAX, more than 50 percent of his patients were prescribed IVAX's clozapine," the U.S. Attorney's office said in its news release. "At one nursing home, Reinstein had 75 percent of the 400 residents on IVAX's clozapine."
Ivax paid other perks to Reinstein and his associates, including airfare, entertainment expenses, a fishing trip, a boat cruise and a golf outing, the lawsuit says.
In 2006, Reinstein began switching to clozapine made by a different company but moved some patients back when he received additional perks and funds, the lawsuit says.
In an interview, federal prosecutor Eric Pruitt would not comment on whether his office would pursue criminal charges against Reinstein or whether any legal action would be taken against the pharmaceutical companies that allegedly paid the physician kickbacks.
A call left at the office of Reinstein's attorney was not immediately returned.
The 2009 investigation by ProPublica and the Tribune showed that Reinstein's high prescribing had serious consequences for his patients. Autopsy and court records showed that by 2009 at least three patients under Reinstein's care had died of clozapine intoxication. One of them, a 50-year-old man, had five times the toxic level of clozapine in his blood when he died, according to his medical records.
Reporters determined that, based on his Medicaid prescribing alone, Reinstein he would have to work 21 hours a day, seven days a week to see each of his patients for 10 minutes. Research has found that the typical U.S. psychiatrist sees about 35 patients per week; Reinstein was seeing 60 each day, he wrote in an audit report in 2007.
In the 2009 investigation, Reinstein strongly defended his reliance on clozapine, saying the medication is underprescribed and is the most effective in its class for schizophrenic patients.
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