The statistics are startling. According to the Centers for Disease Control (CDC), while the amount of pain suffered by Americans has remained steady over the past 15 years, the number of prescription opioids has quadrupled. And, tragically, so has the number of overdose deaths from prescription opioids.
The U.S. opioid addiction crisis can trace it genesis to the proliferation of “pill mills” in Florida in the late 2000s. The now-defunct Florida Office of Drug Control defined a pill mill as “a [physician’s] office, clinic, or health care facility that routinely colludes in the prescribing and dispensing of controlled substances outside the scope of the prevailing standards of medical practice in the community or violates [state or federal laws] regarding the prescribing or dispensing of controlled prescription drugs.”
In the Sunshine State, pill mills typically set up shop under the guise of being pain clinics, advertising on craigslist for prescribing doctors and advertising on highway billboards and in newspapers for addicts and would-be addicts. A rogue pain clinic was often part of a multisite operation, with its onsite dispensary fulfilling up to 500 cash-only opioid prescriptions daily. By the time the state found itself in the Drug Enforcement Administration’s (DEA) crosshairs, Florida doctors accounted for 90 of the nation’s top 100 oxycodone-purchasing physicians. The agency launched “Operation Pill Nation” in Florida on February 14, 2010. A year later, five doctors and 20 others were arrested in a massive sweep that also confiscated $9.5 million in assets. By the time the operation had wrapped up, more than two dozen physicians had been arrested and $18.9 million had been seized.
Subsequent two-step state legislation prevented rogue pain clinics from getting another toehold in Florida. Initially, pain clinics were banned from advertising the sale of opioids, restricted from dispensing more than a 72-hour supply of narcotics, and required to be owned by or licensed to physicians. The following year, additional statutory provisions required pain clinics to relinquish their Schedule II and Schedule III controlled substances, prevented pain clinics from dispensing these drugs, and prohibited affiliations with any physicians that had lost their DEA number.
As a result of Florida’s stricter legislation, pill mills began to populate other states. In Georgia, for example, there were approximately 20 legitimate pain clinics in 2010. With the incursion of rogue pain clinics, the total number skyrocketed to 125 by 2012. In the intervening years, as the opioid addiction crisis escalated, public policy and law enforcement efforts to reverse the trend have ratcheted up. For example, in March 2016, the CDC doubled the number of states (to 26) receiving between $75,000 and $1 million annually to fund prescription drug monitoring programs (PDMPs), community and health system interventions, policy evaluations, and rapid response projects.
High-Profile Arrests and Blurred Lines
On the law enforcement side, pill mill doctors are routinely arrested in high-profile cases. As if to prove that Florida hasn’t yet rid itself of rogue pain clinics, Dr. Lynn Averill was arrested in the Miami area on manslaughter charges in conjunction with prescribing medically unnecessary oxycodone, alprazolam, and methadone that resulted in at least eight patients dying of overdoses. The number of pills she purchased over a six-month period was the 25th highest in the U.S. and the 12th highest in Florida. If convicted, she faces up to 180 years in prison.
That’s a big “if,” because Florida has had a hard time making murder charges stick. Prosecutors initially announced they would seek the death penalty against the Sunshine State’s Dr. John Christensen in conjunction with the overdose deaths of two patients. Subsequently, they reduced his charges to manslaughter. Pill mill doctor Gerald Klein was tried for first-degree murder last year, but the jury instead convicted him of a third-degree felony drug charge. Dr. Sergio Rodriguez was also charged with first-degree murder, but plea-bargained the charges down to four counts of manslaughter and 27 years in prison.
On the opposite coast, prosecutorial results have been mixed. California’s Dr. Hsiu-Ying “Lisa” Tseng was sentenced to 30 years to life in prison following her second-degree murder conviction in the overdose deaths of three patients who received their drugs from her storefront medical office’s onsite dispensary. In contrast, Dr. Julio Diaz, whose nickname was “Candyman,” was charged with murder but later sentenced to 27 years after being found guilty of 79 drug trafficking charges.
Lesser charges are more likely to results in convictions. For example, Texas anesthesiologist Dr. Theodore Okechuku was sentenced to 25 years in federal prison following a conviction for conspiracy to unlawfully distribute hydrocodone. Okechuku’s partners recruited “patients” at homeless shelters and drove them in groups to Okechuku’s rehabilitation clinic, where they were typically diagnosed with back pain and provided 30-day prescriptions for hydrocodone. The “patients” were then driven to pharmacies and given money to fill the prescriptions, and then handed over the drugs to Okechuku’s co-conspirators, who sold the drugs on the street. After being arrested and released on bail in December 2013, the anesthesiologist went back to writing prescriptions – at four times his previous rate – until mid 2014, when the Texas Medical Board suspended his license.
Around the same time, orthopedist Dr. Harvey Jenkins, Jr. was arrested and charged with more than two dozen offenses in Oklahoma City, including felony drug counts and Oklahoma Medicaid fraud. In Alabama, Dr. Francisco Huidor-Figuereoa pleaded guilty to two federal charges, namely conspiring to distribute oxycodone and conspiring to commit money laundering. He faces up to 20 years in prison on each count, and up to $1.5 million in fines.
While Okechuku, Jenkins, Tseng, and others may have generated headlines (along with arrests and convictions) for operating pill mills, other doctors have come under scrutiny for what they believe is sound medical practice. In February, Cape Cod’s Dr. Conrad Benoit drew attention when one of his patients was arrested on drug charges in the wake of having filled a prescription Benoit wrote for 420 30mg oxycodone pills. The patient told authorities that she had bladder and breast cancer, and Benoit defended his 30-day prescription of 14 pills per day, claiming he uses Massachusetts’ PDMP and requires patients to sign opioid treatment agreements.
Law Enforcement Players
Charges against pill mill doctors run the gamut. At one end there’s murder, and at the other, there’s income tax fraud and Medicare fraud. Drug trafficking, money laundering, and racketeering fall along the spectrum. As a result, a multitude of governmental agencies can have their fingers in the enforcement pie. Federal crimes can warrant the involvement of the DEA, FBI, IRS and even the U.S. Postal Service, all of which are often aided by local police and sheriff departments. Investigative units of state regulatory agencies can also climb aboard, as can state medical and licensing boards.
According to the DEA, leads about potential pill mills come from several sources. Pharmacies are typically the front line (and often the last line) of defense in identifying irregular prescribing practices. Consumer complaints about the comings and goings of “patients” and local law enforcement reports can trigger undercover investigations of potential pill mills. Intercepted mail deliveries may also tip off authorities. Medical examiners’ offices, which investigate overdose deaths, often trace prescriptions to their source and detect problematic prescribing patterns.
In an attempt to stem the tide of opioid addiction in the U.S., states have enacted a patchwork of legislation, regulations, board requirements, and recommendations regarding pain management and prescribing practices. For example, according to the National Alliance for Model State Drug Laws, 23 states require practitioners to obtain continuing education in topics such as identifying substance abuse, pain management, and prescribing controlled substances. This requirement ranges from Connecticut’s one hour of continuing education every two years to Kentucky’s requirement that physicians who work in pain management facilities take a minimum of ten hours of Category I continuing medical education in pain management during each registration period.
Thirty-six states address the need – in the form of requirements or recommendations – for patient treatment agreements and/or informed consent to be used in conjunction with opioids. There is also widespread agreement that discussing non-opioid treatment modalities with the patient should be included in the treatment plan. These requirements and recommendations largely mirror those put forth by the Federation of State Medical Boards, American Academy of Pain Medicine, and American Pain Society, among others.
In 38 states, practitioners are required or recommended to both perform a physical examination on the patient and to assess potential substance abuse disorder prior to prescribing opioids. The same number of states require or recommend that, if a patient’s pain levels don’t improve, if there is suspected or documented substance abuse, if a practitioner is considering increasing the dose of an opioid, or if a patient has a psychiatric disorder, then a consultation with or referral to a specialist is called for.
When it comes to prescribing Schedule II drugs, physicians are bound by a mosaic of federal and state law. For example, the federal Controlled Substances Act allows prescriptions for narcotics to be faxed only for drugs that are compounded and directly administered to patients. However, some states have more restrictive regulations. Similarly, federal law allows narcotics to be ordered orally within certain emergency parameters, but 47 states have additional statutory restrictions.
When it comes to quantity, federal law doesn’t limit the number of days’ supply that can be prescribed, yet some states limit prescriptions to a 30-day supply, while others limit prescriptions to 120 dosage units and others carve out certain exceptions. The same holds true for prescription expirations: federal law doesn’t include such a provision, but state laws may mandate 30-, 60-, or 120-day expirations. While federal law prohibits refilling prescriptions, it does allow doctors to write multiple prescriptions – but only if that’s allowed under state law.
Because the original pill mills were set up under the guise of pain clinics, ten states have laws on the books that define and regulate pain management facilities. While the statutes have common purposes and threads, they do not mirror one another. To be regulated as a pain clinic, a facility may meet a definition involving how the clinic’s services are advertised, the rate that controlled substances are prescribed in comparison with the state’s other physicians, or the percentage of patients treated for non-terminal chronic pain conditions. Nine out of the ten states also regulate who may own a pain clinic, typically limiting ownership to physicians licensed within the state. Other state-specific restrictions – such as holding specialty certifications – also come into play. In addition, the ten states set out disparate requirements for pain clinics’ owners or medical directors. Moreover, half of those states have prescribing and dispensing limitations that apply only to pain treatment centers.
Because anti-pill mill regulations and enforcement actions most often target pain clinics, other types of pill mills can slip through the cracks. For example, Atlanta psychiatrist Dr. Narendra Nagareddy had allegedly been overprescribing for years prior to his January arrest for the deaths of more than three dozen patients. Certified as a specialist by the American Board of Addiction Medicine, Nagareddy had a patient’s relative file a complaint about the psychiatrist’s prescribing practices in 2012 – but to no avail. The doctor’s reputation was so well known that pharmacies refused to fill his prescriptions and a probation officer prohibited his probationers from visiting Nagareddy. While Georgia is one of the ten states that regulates pain clinics, it doesn’t restrict other types of medical practices. And, while Georgia has a PDMP, privacy concerns fueled the legislature actions to disable the program’s automatic alert system and mandate that data be erased after one year.
Appropriate Opioid Prescriptions for Chronic Pain
With pill mill horror stories, arrests, and convictions, the question becomes one of how well-intentioned physicians ethically – and legally – treat patients who are legitimately experiencing chronic pain. In March 2016, the CDC released guidelines for primary care clinicians in outpatient settings who prescribe opioids to adults for purposes other than cancer treatment, palliative care, and end-of-life care.
The CDC’s recommendations covered three areas: when to prescribe or continue opioids; the selection, dosage, and duration of opioid use; and weighing the risks and harms of opioids. In the first arena, the CDC recommends first using non-drug and non-opioid therapies to treat chronic pain, and then using opioids only in conjunction with non-drug and non-opioid therapies. Prior to prescribing opioids, the clinician should outline treatment goals; the drugs should only be continued if pain improvement is clinically significant and outweighs the drugs’ risks. Finally, the CDC recommends discussing risks and benefits of opioids with the patient, as well as the roles both the patient and clinician play in managing the therapy.
In the second realm, the CDC recommends prescribing immediate-release opioids in the lowest effective dosages. Prior to increasing dosages to ≥ 50 MME (morphine milligram equivalent) per day, the CDC says that the clinician should weigh individual risks and benefits. The CDC advises against dosages of ≥ 90 MME per day, but that if the clinician can justify increasing the dosage to that level, to titrate the dosage. For acute pain, the lowest possible dosage should typically be prescribed for three days or less, and rarely more than seven days. Finally, when starting or increasing doses, benefits and harmful effects should be evaluated within one to four weeks, and then at least every three months. When possible, dosages should be tapered, or tapered and then discontinued.
In the arena of weighing the risks and harms, the CDC recommends that clinicians evaluate risk factors and mitigate those risks – including offering naloxone. A patient’s PDMP data should be reviewed at the start of opioid therapy, and then every time a prescription is written or every three months. In addition, clinicians should perform urine drug testing on patients before starting opioid therapy, and annually thereafter. The CDC recommends refraining from prescribing opioids and benzodiazepines at the same time, and suggests offering or arranging for treatment for patients with opioid abuse disorders.
Most importantly, slow down and “put a stethoscope on the patients”. What is meant by that phrase is to interview, examine, and assess the patients each time they return to the clinic and not just write a prescription. Record vital signs, alertness, and the patient’s functional status. Maintain detailed medical records of your care with indication for treatment clearly define. In the cases where physician extenders are used, the physician should still interview and examine those patients. As the arrest of Fort Wayne, Indiana pain specialist Dr. Michael Cozzi proves, it’s impossible to legitimately claim that you can see 90 – 100 patients a day, prescribe 1 million doses of Oxycodone per year, and provide legitimate care. But he isn’t alone, there are plenty of diversion cases in lower volume scenarios: http://www.deadiversion.usdoj.gov/crim_admin_actions/doctors_criminal_cases.pdf
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