Opioid fraud and diversion prosecutions continue to hit hard. The Firm represents organizations, pharmacies, and medical professionals accused of or under investigation for opioid fraud and/or diversion of opioids. Since the inception of the Opioid Fraud Unit established by Jeff Sessions the Government has been pretty busy. In October, the DOJ returned the first of its kind indictment against 2 Chinese nationals for the internet sales of millions of dollars in synthetic opioids, including fentanyl.
In the first case originated from Opioid Fraud Unit, the Government has alleged that a doctor operating a holistic pain management practice prescribed methadone, oxycodone, and hydrocodone outside the usual course of professional practice and not for legitimate medical purpose and that there was a pattern of illegally prescribing opioid painkillers to patients with no legitimate medical purpose and without examination, evaluation or testing. The criminal complaint also makes it clear that the Government had interviewed former and current employees and had relied heavily on data mining in its investigation before filing charges.
In another case, which targeted violations of the Anti-Kickback statute for prescriptions of a fentanyl-based spray, known as Subsys, the operator of a defunct pain management practice in Rhode Island, pleaded guilty. In his plea, Dr. Rosenberg admitted to soliciting and receiveing kickbacks in return for the prescribing of the drug Subsys, a fast-acting, powerful, and highly-addictive version of the opioid drug Fentanyl that is administered as an under-the-tongue spray.
Subsys is manufactured by Arizona based company Insys Therapeutics, Inc. (“Insys”). This spray was approved by the U.S. Food and Drug Administration in 2012 exclusively for “the management of breakthrough cancer pain in . . . patients who are already receiving and who are already tolerant of opioid therapy for their underlying persistent cancer pain.” Dr. Rosenberg falsely and fraudulently indicated that his patients had breakthrough pain from cancer in order to secure insurance approvals for prescriptions of Subsys. Dr. Rosenberg also conceded that he conspired with Insys officials to receive speaker fees amounting to $188,000 in return for prescribing a high volume of Subsys to patients. As an aside, his son was also a sales representative for Insys whose commissions were, in part, derived from his Subsys prescriptions.
The doctor’s plea also fell on the heels of the indictment against the CEO of Insys, John Kappor, in what the Government hopes will be a successful Yates prosecution against Mr. Kapoor in the District of Massachusetts. Although Mr. Kapoor’s indictment is largely based on allegations related to violations of the Anti-Kickback statute related to speaker fees and heavy prescribing of Subsys fentanyl spray, a central theme in that prosecution is that Kapoor and the sales representatives who operated under the umbrella of Insys throughout the United States peddled a heavily addictive opioid based spray to doctors in exchange for lucrative speaker fees, resulting in patients receiving addictive, potentially life threatening sprays that were intended to treat cancer.
Since then, in December, there have been additional indictments related to opioid fraud or diversion, including a recent indictment against another Pennsylvania doctor, Dr. Gartland. The indictment alleges that the doctor perpetrated a scheme to defraud two health care benefit programs, WellSpan Health of York, PA and Medicare, by writing 221 prescriptions between September 2014 and August 2017, for Hydrocodone, Oxycodone, Fentanyl, Morphine and other controlled substances. According to the indictment, the prescriptions were issued by Gartland and were never intended for the medical care or treatment of the family members, but instead were intended for Dr. Gartland’s personal use. The indictment further alleges that Gartland deceived the pharmacies into giving him the pills by making them believe they were intended for his family member and that WellSpan and Medicare were allegedly defrauded when they paid claims submitted by the pharmacies for the prescriptions.
The takeaway from these prosecutions is straightforward – there will be an uptick in investigations and prosecutions related to opioids and opioid fraud. The ongoing nationwide investigation into speaker fees received from doctors prescribing Subsys is also continuing and will only ramp up as the Government edges closer and closer to a trial against the CEO of Insys and seeks to collect as much data and information from witnesses – sales reps and doctors – to avoid, in the aftermath of Yates, another humiliating trial loss against an executive in that District.
Author: Andrew Feldman
Mr. Feldman represents professionals, corporations, health care providers, and health care marketers in government investigations and prosecutions throughout the United States. Mr. Feldman works tirelessly for his clients from the time an investigation begins until the time a jury renders a verdict.
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