Κυριακή, 20 Μαρτίου 2016

DRUG INDUSTRY KICKBACKS IN USA

An Illinois-based psychiatrist has been sentenced to 9 months in federal prison and ordered to pay nearly $600,000 for accepting hundreds of thousands of dollars in pharmaceutical industry kickbacks.
Michael J. Reinstein, MD, was convicted of accepting payments from industry in the form of consulting fees, entertainment, and all-expense-paid vacations in exchange for prescribing and promoting first the brand-name version and then the generic version of the antipsychotic clozapine (multiple brands) to thousands of indigent elderly patients in Chicago-area nursing homes and hospitals.
In addition to the 9-month sentence, ordered by US District Judge Sharon Johnson Coleman, Dr Reinstein was ordered to forfeit $592,000 and perform 120 hours of community service following his release from federal prison.
Last year, the 72-year-old psychiatrist pleaded guilty to one count of violating the federal Medicare and Medicaid Anti-Kickback Statute. In the early 2000s, Dr Reinstein was the largest prescriber of clozapine to Medicaid recipients in the United States.
"Reinstein abused his position of public trust as a physician and took advantage of the faith and trust of his mentally ill patients in order to enrich himself," Assistant US Attorney Eric S. Pruitt said in the government's sentencing memorandum.
Sentencing Too Stiff?
As previously reported by Medscape Medical News, state authorities revoked the medical license of Dr Reinstein in August 2014, claiming that he had received illegal direct and indirect remuneration from three companies involved in the manufacture and marketing of brand-name and, later, generic clozapine.
Last year, Dr Reinstein, who is now 72 years of age and has bladder cancer and diabetes, pleaded guilty to one count of violating the federal Medicare and Medicaid Anti-Kickback Statute.
According to an earlier report, the Chicago-area psychiatrist, who had been in practice since 1973, submitted at least 50,000 claims to Medicare and Medicaid, falsely stating that the clozapine prescriptions were for the treatment of mentally ill patients at more than 30 nursing homes and long-term care facilities in the Chicago area.
Terence Campbell, Dr Reinstein's defense attorney, argued that the loss of his medical license, together with his client's age, absolutely guarantees that Dr Reinstein will never again work as a physician.
"Dr Reinstein's conduct involved in this case ended more than 5 years ago, in November 2009, when he stopped accepting speaking contracts and other remuneration," Campbell wrote in a position paper on Dr Reinstein's sentencing.
During the next 5 or so years, Dr Reinstein continued to practice medicine and to prescribe clozapine, mainly for patients with treatment-resistant mental illness, Campbell continued. The US Food and Drug Administration long ago approved clozapine for treatment-resistant forms of schizophrenia.
"Dr Reinstein is truly remorseful for his misconduct and the effect it already has had on his family, especially his wife and his former patients," said Campbell. "We can confidently state — and the Court can confidently find — that Reinstein poses no risk of reoffending in any manner."
Campbell argued that rather than send a first-time offender with no history of illegal drug abuse to prison, Dr Reinstein should, at worst, be sentenced to home or community confinement, where he could continue his volunteer work and care for his wife, who also is undergoing treatment for cancer.
Medscape Medical News contacted Campbell for further comment, but the calls were not returned.
Largest Clozapine Prescriber
Pruitt noted that until 2003, Dr Reinstein almost exclusively prescribed Clozaril, a branded version of clozapine, although the patent on the drug expired in 1997.
By 2003, Dr Reinstein was among the largest prescribers of Clozaril in the United States, and more than 1000 of his patients in and around Chicago were receiving the drug.
Dr Reinstein did eventually switch patients to a less expensive generic version of the drug, but only after IVAX Pharmaceuticals LLC and Teva Pharmaceuticals USA Inc agreed to pay him consulting fees and finance a clozapine research study carried out by an affiliated entity with a paid assistant specified by the psychiatrist.
In March 2014, TEVA and IVAX paid the United States federal government and the state of Illinois more than $27.6 million to settle state and federal allegations that they induced Dr Reinstein to prescribe the drug.
Prosecuting attorney Pruitt originally asked the court to sentence the defendant to 18 months in prison.
However, as defense lawyer Campbell pointed out, Dr Reinstein fully cooperated with the government in its ongoing investigation into healthcare practices in the Chicago area.
In recognition of this cooperation, Dr Reinstein's sentence was reduced to 9 months in a federal prison.

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