ILLINOIS – A doctor, who got kickbacks totaling nearly $600,000 from pharmaceutical companies to prescribe the anti-psychotic drug – clozapine – to his patients, plead guilty to violating the federal kickback statute, officials announced Friday.
Dr. Michael J. Reinstein caused the submission of false claims to Medicare and Medicaid for the clozapine he prescribed for thousands of elderly and indigent patients in at least 30 Chicago-area nursing homes and other facilities.
Reinstein also agreed to pay the United States and the state of Illinois $3.79 million to settle a parallel civil lawsuit, officials said.
The lawsuit alleges that, by prescribing clozapine in exchange for kickbacks, Reinstein caused the submission of false claims to Medicare and Medicaid for the clozapine he prescribed for thousands of elderly and indigent patients in at least 30 Chicago-area nursing homes and other facilities.
Both Reinstein’s criminal and civil cases involve the promotion of generic clozapine, a rarely prescribed anti-psychotic drug that has serious potential side effects and is generally considered a drug of last resort, particularly for elderly patients, authorities said.
While clozapine has been shown to be effective for treatment-resistant forms of schizophrenia, officials said it is also known to cause numerous side effects, including a potentially deadly decrease in white blood cells, seizures, inflammation of the heart muscle and increased mortality in elderly patients.
Reinstein pleaded guilty to one count of violating the federal Medicare and Medicaid Anti-Kickback Statute after he was charged on Feb. 3.
In March 2014, Teva Pharmaceuticals USA Inc. and IVAX LLC, paid the United States and the state of Illinois $27.6 million to settle allegations that they violated the state and federal FalseClaims Acts by making payments to Reinstein in return for him prescribing clozapine to his patients.
In addition to direct payments to Reinstein, IVAX allegedly also provided all-expenses paid trips to Miami for Reinstein, his wife and various employees of Reinstein.
Reinstein quickly became the largest prescriber of generic clozapine in the country and prescribed the drug to many elderly patients.
Allegedly, officials said the payments and other forms of remuneration from IVAX and later Teva Pharmaceuticals continued for many years and resulted in the submission of thousands of false claims to the Medicare Part D and Illinois Medicaid programs.
The Anti-Kickback Statute ensures that a physician’s medical judgment is not compromised by improper financial incentives and is instead based on the best interests of the patient.
The prohibits offering, paying, soliciting or receiving remuneration to induce referrals of items or services covered by Medicare, Medicaid and other federally funded programs, according to federal prosecutors.
“The Department of Justice is committed to ensuring that physicians who accept payments from pharmaceutical manufacturers to influence prescribing decisions are held accountable,” said Acting Assistant Attorney General Joyce R. Branda of the Justice Department’s Civil Division. “Schemes such as this one undermine the health care system and take advantage of elderly patients who are among the most vulnerable health care recipients.”
Since January 2009, the Justice Department has recovered a total of more than $23.6 billion through False Claims Act cases, with more than $15.1 billion of that amount recovered in cases involving fraud against federal health care programs, according to authorities.