Wednesday, February 18, 2015
A long-running investigation of a doctor in Illinois for Medicaid and Medicare fraud is coming to a close. Michael Reinstein, "who for decades treated patients in Chicago nursing homes and mental health wards," has pleaded guilty to a felony charge for taking kickbacks from a pharmaceutical company. As detailed by the Chicago Tribune, on February 13, Reinstein admitted prescribing, and thus generating public payment for, various forms of the drug clozapine, widely described as a "risky drug of last resort."
The 71-year old doctor has been the target of the state and federal prosecutors for months, and he's also agreed to pay (which is, of course, different than actually paying) more than $3.7 million in penalties. He may still be able to reduce his prison time from 4 years to 18 months, if he "continues to assist investigators."
The investigation traces as far back as 2009, as detailed by a Chicago-Tribune/ProPublica series that revealed he had prescribed more of the antipsychotic drug in question to patients in "Medicaid's Illinois program in 2007 than all doctors in the Medicaid programs of Texas, Florida and North Carolina combined." Further, the Tribune/ProPublica series pointed to autopsy and court records that showed that, "by 2009, at least three patients under Reinstein's care had died of clozapine intoxication." Reinstein's, and one assumes, the pharmaceutical company's, defense was that the drug could have appropriate, therapeutic effects for patients, beyond the limited "on-label" realm.
Assuming that the government ever sees a dime in repayment, from either the doctor or the drug company, my next question is what happens to that money? At a minimum, shouldn't there be review of the effect of the drugs on these patients, some of whom may have been administered the drug for years? We keep reading that the drugs are "risky," but shouldn't there be evidence of real harm -- or perhaps even benefit -- from the documented "off-label" use? Certainly, prosecutions for off-label drugs are understandable attempts to claw-back, or at least reduce, public expenditures. But isn't more at stake, including the search for relief or workable solutions for patients who are in distress?
In March 2014, for example, Teva Pharmaceutical Industries Ltd., the maker of generic clozapine, reportedly agreed to pay more than $27.6 million to settle state and federal allegations that it induced Reinstein to prescribe the drug. Recovering misspent dollars is important. But I also would like to see evidence of the harm alleged by the government -- or the benefit asserted by the defendants -- from the administration of the drugs. Isn't objective study of the history of these real patients a very proper use of the penalties?