Dr. Michael Reinstein, psychiatrist in Chicago, submitted at least 50,000 claims to Medicare and Medicaid, falsely stating that he provided "pharmacologic management" for patients at more than 30 area nursing homes and long-term facilities. If that weren't enough, he also accepted kickbacks from Novartis, IVAX and Teva Pharmaceutical companies to medicate elderly patients with serious anti-psychotic medication.
The kickbacks go back as far as the 1990's and Dr. Reinstein had more than 1000 patients at a time on a rarely used medication called Clozaril. Clozaril is typically used only as a last resort in treatment-resistant psychotic patients and is of particular risk to the elderly. It is extremely rare to have a nursing home patient on Clozaril. Reinstein was the largest prescriber of Clozaril to Medicaid recipients in the United States and at one nursing home 75% of the residents were on Clozaril. It should only be used for severely schizophrenic patients that have failed other treatment, yet in 2000 and 2001 Dr. Reinstein prescribed more Clozaril than the next 9 top prescribing physicians in the United States combined.
Even after the Novartis patent for Clozaril expired in 1998, Dr. Reinstein, who was still receiving payments, kept hundreds of patients on the brand name drug and refused to switch to the generic form. He only switched to the generic clozapine when Novartis stopped making the drug and he struck a new kickback deal with IVAX Corp, maker of a generic clozapine. He then became the largest prescriber in the country for the generic form.
Dr. Reinsten's kickbacks included cash, trips for himself and his entourage, support of his pharmacy owner wife, support of his assistant, research support, boat cruises and tickets to sporting events. He also received annual speaker fees for promoting the drug to others.
There are so many things wrong with this case that go beyond fraud and greed. This is a dangerous drug and by 2009 allegedly 3 of his patients died of clozapine intoxication. One 50 year old man had 5 times the toxic level of clozapine in his blood when he died.
But there are no criminal charges here, simply civil penalties. It is unknown if the pharmaceutical companies involved will face charges relating to anti-kick-back laws. In my opinion, fines are not enough. I think jail time is warranted.
If you want to read the full False Claims Act complaint from the Illinois Eastern Division Court go here.
Addendum: I'm not an investigative reporter but if I had time I'd look into the illegal kick-backs from Astra Zenica Corp also. It seems Reinstein was also the top prescriber of Seroquel and was paid over $490,000 in 2000-2001 for that honor. Thanks to the internet it wasn't hard to find confidential communication between him and Astra Zenica. Astra Zenica admits that Reinstein and his partner are not respected by their peers and that they do bad research on patients, but then said is a "win-win" to fund them. The internal document says, if they don't give him the money, Reinstein will switch patients off Seroquel to a competitor. They are an "important source of business" for Astra Zenica.
For more on Reinstein:
See Pro-publica here
I feel so sorry for the patients.