Before joining Burr & Forman, LLP, I was a federal prosecutor for a little over a decade specializing in health care fraud and general white collar matters. In that role, I was the member of a prosecution team that secured guilty verdicts earlier this year against two pain management doctors in Mobile, Ala., following a protracted jury trial. The doctors were convicted of a litany of federal crimes arising from their operation of a pain management clinic, including, among others, violations of the Controlled Substances Act and the Anti-Kickback Statute. The doctors received substantial prison sentences of 20 and 21 years, respectively, and forfeited virtually all of their assets (including bank accounts, houses and cars) to the government.
The doctors in this case were convicted of running what the government calls a “pill mill,” a pain management clinic that allegedly prescribes narcotics for illegitimate purposes. Pain management professionals should be aware this is just one example of what will likely be an onslaught of “pill mill” and other opioid-related prosecutions by the Department of Justice (DOJ) during the current administration. In fact, just a few months after the convictions in the Mobile case, Attorney General Jeff Sessions announced a nationwide takedown of 120 doctors, pharmacists and nurses – dubbed “Operation Pilluted” – who were charged with various federal crimes related to their alleged “unlawful distribution of opioids and other prescription narcotics.” In announcing the takedown, Sessions noted the DOJ would continue to “aggressively pursue corrupt medical professionals,” and “the Department’s work is not finished. In fact, it is just beginning.”
On the heels of that announcement, in August of this year, Sessions heralded a new DOJ pilot program called the “Opioid Fraud and Abuse Detection Unit.” According to Sessions, the unit “will focus specifically on opioid-related health care fraud using data to identify and prosecute individuals that are contributing to the opioid epidemic.” Sessions warned, “If you are a doctor illegally prescribing opioids or a pharmacist letting these pills walk out the door and onto our streets based on prescriptions you know were obtained under false pretenses, we are coming after you.” Sessions explained the DOJ would be appointing a special federal prosecutor in 12 select districts across the country whose sole purpose will be to prosecute “pill mill” and other opioid-related cases.
One of the districts, which has received one of the special “pill mill” prosecutors, is the Northern District of Alabama, in Birmingham. The U.S. Attorney for that district, Jay Town, separately confirmed the new prosecutor will spend “100 percent of their time working these types of cases…What we’re going after is the medical providers who are operating outside the boundaries of the law and the medical practice.” Echoing the Attorney General’s statements, Town vowed, “We’re going to rid the Northern District of these pill mills.”
Note “pill mills” are not the only opioid-related cases on the DOJ’s radar. In fact, it is also concentrating on the “diversion” of opioids in hospital settings. Such “diversion” schemes include, for instance, the theft of opioids from a hospital “Pxyis” machine (a device hospitals utilize to regulate the dispensing of controlled substances) by nurses, or the forgery or fraudulent creation of opioid prescriptions by hospital personnel.
In sum, the DOJ has fired a warning shot that physicians, pharmacists and other medical professionals involved in the treatment of patients will be under intense scrutiny for the foreseeable future. This is especially true for physicians who operate pain management clinics. These doctors should, in general, prescribe opioids reasonably and carefully in the context of each patient’s presentation and thoroughly document their treatment.
To that end, doctors should, among other things: maintain a thorough intake procedure, which requires the patient to give a detailed medical history and provide previous diagnostic studies; have the patient sign, if applicable, an “opioid treatment agreement” requiring the patient to abide by certain opioid use guidelines; perform exhaustive physical examinations during the initial visit and at regular intervals during the patient’s treatment (which should be carefully documented); consider alternatives to opioid treatment, such as non-narcotics drugs, physical therapy and surgery (and, where applicable, carefully document why alternative treatments would be ineffective); prescribe the lowest dosage and quantity of opioids possible to treat the patient’s condition; closely monitor for signs of diversion and addiction by regularly ordering urine drug screens and reviewing the patient’s prescription drug monitoring data; and have regular independent audits conducted by a billing consultant or another pain management specialist to ensure compliance with all regulations and laws. Implementing these practices should help doctors avoid government scrutiny as part of the DOJ’s new initiative to crack down on alleged “pill mill” operations.
Adam Overstreet is counsel at Burr & Forman, LLP. Prior to joining Burr, Adam practiced with the U.S. Attorney’s office and gained extensive experience with health care fraud matters. Burr & Forman, LLP, is a partner with the Medical Association. Please read other articles from Burr & Forman, LLP, here.