The name of retired NFL quarterback Brett Favre has surfaced in the latest chapter of the federal government’s ongoing investigation into pain creams concocted and sold by compounding pharmacies.
If the past is any indicator, physicians’ names could surface in the scandal, too.
In January, federal and state law enforcement agents raided compounding pharmacies in Mississippi, Alabama, Florida, and Utah, according to the Mississippi Bureau of Narcotics. One of the pharmacies was Aspire Pharmacy Compounding in Jackson, Mississippi, local television station WAPT reported. Some $15 million in assets were seized in the raids, including 24 vehicles, five planes, and two boats, said Mississippi Bureau of Narcotics spokesperson Dolores Lewis in an interview with Medscape Medical News.
Last week, the Wall Street Journal reported that the Federal Bureau of Investigation was investigating a compounding pharmacy in Jackson, Mississippi, called World Health Industries, which does business as Aspire Rx. That company, a division of Aspire Health, makes a compounded pain cream called Rx Pro that Favre, newly inducted into the National Football League Hall of Fame, has pitched in television and print ads.
For several years, the Department of Justice (DOJ) has been chasing down compounding pharmacies and their accomplices nationwide that participate in what one federal prosecutor calls a “systemic fraud” against TRICARE, the healthcare program for members of the armed services and their families. As revealed in a string of civil settlements and criminal convictions, physicians have received kickbacks to write bogus prescriptions for pain cream produced by compounding pharmacies.
These pharmacies use marketing companies to cold-call TRICARE beneficiaries and pitch the use of the creams and how the insurance program covers the cost, according to the Department of Defense website. The marketers collect TRICARE information and the name of the beneficiary’s physician over the telephone to generate a prescription, often delivered without an office visit beforehand. TRICARE has been billed as much as $15,000 for a single prescription. The Department of Defense has said that this pain cream gravy train helps explain why its spending on all compounded drugs ballooned from $5 million in fiscal 2004 to $514 million in fiscal 2014.
None of the compounding pharmacies targeted in the latest DOJ investigation have been charged with fraud or any other crimes, according to the Wall Street Journal. Jason Rutland, the president of World Health Industries/Aspire Rx, declined to be interviewed by Medscape Medical News, as did James “Bus” Cook, Favre’s agent.
According to Mississippi corporation records, both Cook and Favre formed a business several years ago called 3B Medical Group. The DOJ is looking at whether 3B Medical has helped market pain cream, the Wall Street Journal said, citing “people close to the probe.”
Pain Creams Pose Central Nervous System, Cardiac Risks
Compounded pain creams are made with ingredients that may include not only pain relievers such as ketamine but also local anesthetics, blood pressure agents, muscle relaxants, nonsteroidal anti-inflammatory drugs, and antidepressants. The pharmacy may convert the ingredients into a cream from their original form as a liquid, tablet, capsule, or bulk dry powder.
Although individual ingredients are approved by the US Food and Drug Administration, the pain creams themselves, similar to all other compounded drugs, are not. Still, compounding pharmacies are allowed to operate, and are reimbursed by third-party payers, because they offer patients customized versions of drugs that meet their needs in ways a drug approved by the US Food and Drug Administration cannot (think adding a flavor to a child’s cough syrup).
The pain creams, marketed to weekend athletes and the elderly alike, come with risks similar to any other drug. The Institute for Safe Medication Practices warns that many of the creams include ingredients that can cause “central nervous system depression or cardiac affects that result in slow breathing, a low heart rate or irregular beat, and drowsiness or loss of consciousness.” Children have experienced severe toxicity — resulting in at least one death — when parents applied such cream on their bodies, according to the Institute for Safe Medication Practices.
Physician Kickbacks Disguised as Research and Speaking Fees
Physicians have played a central role in scams involving compounded pain creams, according to the DOJ.
Last year, a batch of compounding pharmacies in Florida agreed to pay close to $40 million to settle claims that they had bilked TRICARE. “The most persistent fraud scheme identified involves improper relationships between marketing firms, physicians and compounding pharmacies to induce the referral of prescriptions for unnecessary compounded pain and scar creams to the pharmacies,” according to the US Attorney’s Office in Tampa, Florida.
Prosecutors said two pharmacies paid kickbacks to prescribing physicians in the form of “research fees.” Another Florida pharmacy disguised $70,000 in kickbacks as speaker’s fees for an Indiana physician. Marketing firms that steered TRICARE beneficiaries to compounding pharmacies received kickbacks as well, prosecutors said.
At least one physician receiving this tainted money has wound up as a felon. In June 2015, sports medicine specialist James Morales, MD, in Toms River, New Jersey, pleaded guilty to accepting $60,000 in cash bribes for referring pain cream scripts to a compounding pharmacy in nearby Lakewood, as well as falsifying health records. Dr Morales is scheduled to be sentenced in June. The president and pharmacist-in-charge of the pharmacy, Vladimir Kleyman, pleaded guilty to fraud charges and was sentenced to 20 months in prison.
This April, Elena Polukhin, MD, goes on trial in a federal district court in St Paul, Minnesota, for allegedly receiving more than $40,000 for referring pain cream prescriptions to a compounding pharmacy. Prosecutors said the pharmacy funneled the kickbacks to Dr Polukhin through a charitable organization that she founded. Dr Polukhin has pleaded not guilty.