Defending Doctors, Pharmacists, and Nurses in “Pill Mill” Strike Force Cases

On April 17, 2019, the DOJ announced in a press release that the government is bringing federal criminal charges against 60 individuals, including 31 doctors, 7 pharmacists, 8 nurse practitioners, and several other licensed medical professionals, based on allegations that these healthcare providers were unlawfully distributing prescription opioid medication and committing healthcare fraud.

The charges were the result of the government’s Appalachian Regional Prescription Opioid Strike Force (“ARPO”) and are being brought against defendants in over seven states, including Tennessee, Kentucky, and West Virginia.

How can these healthcare providers be charged with federal crimes for prescribing or dispensing medicine?

Cases like these have become increasingly common in recent years. In response to what prosecutors and the media refer to as the “Opioid Crisis,” the federal government has become very aggressive in charging doctors, nurses, and other healthcare professionals with unlawfully distributing controlled substances, especially opioids, based on the way they examine patients and prescribe them pain medication. The government often lumps together the clinics and facilities where these professionals work and, often inaccurately, calls them “pill mills.”

What makes pill mill charges especially serious is that doctors, nurses, and pharmacists are charged as if they were street-level dealers, even though these cases are much more complex than typical federal drug charges. In garden-variety drug cases, the government can usually secure a conviction based on a defendant’s possession of an illegal drug or communications between the defendant and others discussing the distribution of illegal drugs.

Unlike drug dealers, doctors, nurses, and pharmacists have licenses that allow them to prescribe and distribute controlled substances that would normally be illegal. To win a “pill mill” case, the government must prove that the doctor or other medical professional was abusing their license by issuing illegitimate prescriptions. There are several elements the government must prove to establish that a licensed healthcare professional was unlawfully prescribing or dispensing controlled substances:

• The healthcare provider issued a prescription or dispensed prescription medicine;
• The prescription was for a scheduled controlled substance;
• The prescription was issued or dispensed without a legitimate medical purpose or was issued or dispensed outside the usual course of medical practice.

As anyone can see, these are vague standards, and these cases are ripe for prosecutorial overreach since healthcare providers have to exercise their medical judgment based on many subjective factors, such as a patient’s medical history, how the patient describes their condition, and even the patient’s credibility. It isn’t hard to see how prosecutors can take a simple medical malpractice case or a doctor’s negligence and try to turn it into a federal criminal case.

What kind of evidence does the government rely on in unlawful prescription cases?

In “pill mill” prosecutions, the government tends to minimize the inherently subjective aspects of practicing medicine and uses several types of evidence to frame a defendant doctor or pharmacist’s practices as objectively illegitimate.

While we don’t yet have access to the evidence gathered by the ARPO strike force, these cases almost always involve evidence collected by the DEA and other federal law enforcement agents, as well as medical professionals who the government hires to serve as “experts.”

Agents usually stake out a clinic and record patients coming in and out, take pictures of patients’ license plates, and arrest street-level drug dealers in an effort to connect the clinic’s prescriptions to the illegal drug market. It’s also very likely that the government sent in confidential informants or undercover agents to these clinics to pose as patients with chronic pain in order to give the government direct evidence of a doctor prescribing medication to a patient who doesn’t need them—essentially tricking the doctor into committing a crime.

With the benefit of hindsight, the government’s “experts” then review the evidence collected by law enforcement, including their patient records and prescribing practices, to determine whether the defendant acted issued a prescription or dispensed controlled substances for a legitimate medical purpose and in the usual course of medical practice.

The prosecutors in these cases will undoubtedly use their “experts” and agents to identify several “red flags” at these clinics and pharmacies to suggest they were operating as “pill mills.” These red flags include:

• Clinics receiving frequent visits from a high volume of out-of-state patients;
• Clinics charging high fees or accepting cash payments;
• Doctors failing to take certain steps before prescribing medications, such as failing to conduct an adequate physical examination for patients or failing to review their medical history or request an MRI;
• Doctors failing to discharge patients when there are signs a patient is an addict or is “doctor-shopping”;
• Clinics that receive a high volume of young patients who are less likely to be chronic pain patients or in need of prescription pain medicine;
• Clinics or pharmacies that prescribe or dispense controlled substances that end up in the illegal drug market;
• Doctors prescribing a high volume of certain controlled substances in high dosages, such as oxycodone, hydrocodone, fentanyl, morphine, Soma, and Xanax;
• Doctors prescribing combinations of these controlled substances, such as issuing a prescription for opioids, benzodiazepines, and carisoprodols, which the government refers to as “cocktails.”

The government is relying on the presence of these “red flags” in several of these ARPO cases. In the Ohio case, for example, prosecutors argue that a pharmacist dispensing 1.75 million pills over two years is evidence that he was operating a “pill mill.” In the Western District of Tennessee, prosecutors have built four separate cases against three doctors and a nurse based on the high volume of pills they prescribed over several years, as well as salacious allegations that one of them traded his medical services for sex and that they prescribed controlled substances to “known addicts.” In the Northern District of Alabama, prosecutors are arguing that a doctor was illegally distributing controlled substances because he prescribed medication to patients who failed drug screens and because his clinic preferred cash payments.

How can the doctors, nurses, and pharmacists in this case defend themselves?

Fortunately, the government cannot convict individuals through sensational headlines and press conferences, and there are several defenses available to the healthcare providers in these cases and in other “pill mill” cases.

The best thing a healthcare professional can do in these cases is hire a credible medical expert to refute the government’s case. A defense expert can review all of the evidence gathered by the government, including patient records, recorded physical examinations, and other evidence, and apply it under the appropriate medical standards in order to determine whether the prescriptions were legitimate under the circumstances.

A defense expert can then make a persuasive argument that the doctor or pharmacist acted properly and reasonably in issuing prescriptions. They can also provide an effective counter-weight to the government’s expert witness. And even in close cases, where a doctor may have acted negligently in prescribing medicine to some patients who didn’t need them, a defense expert can make it clear that there was no criminal intent. This is crucial because the law allows doctors and other providers to raise the “good faith” defense in “pill mill” cases.

The good faith defense allows doctors and other providers to argue that they were acting with a reasonable belief that the patient in question had a legitimate medical need for the prescription. The good faith defense is especially powerful in pill mill cases like these since there are many reasons a doctor may legitimately prescribe controlled substances despite the presence of “red flags.” In fact, the FDA has recently warned doctors and pharmacists not to abruptly discontinue opioid prescriptions for patients, especially if they show signs of addiction. This leaves healthcare providers with a tough choice—they are told not provide opioid prescriptions to addicts, but they are also warned not to suddenly cut them off.

Of course, there is nothing inherently illegal about “red flags.” In many cases, folks have to travel outside of their state to seek treatment for their pain or fill their prescriptions because the DEA’s aggressive measures have made doctors and pharmacists in their state hesitant to treat chronic pain. There is also nothing illegal or unusual about accepting cash payments or charging high fees for medical treatment, especially where a doctor is very experienced in his or her field.

There is also nothing wrong with running a successful medical clinic that treats many patients (and therefore prescribes a lot of medicine), and there are legitimate medical reasons a doctor may prescribe combinations of opioids and benzodiazepine. After all, these medications serve different functions and a patient may have several conditions that require different treatments.

What are the potential sentences facing the doctors and other healthcare providers in these cases?

Even though the medical context makes these cases distinct, the government prosecutes doctors and pharmacists as if they were drug dealers and, increasingly, seeks the same serious sentences.

Federal defendants are sentenced under the Federal Sentencing Guidelines, which provide a formula for calculating a defendant’s sentence based on the specific facts of their case. In drug cases, the length of the sentence is largely based on the type and quantity of drugs involved in a case. A kilo of heroin, for example, will result in a much longer sentence than a gram of cocaine. Judges don’t have to stick to the sentences calculated by the Guidelines, but they are required to consider them, and many inevitably sentence defendants according to the Guidelines.

What makes “pill mill” cases tough for defendants is that medical clinics and pharmacies, by their nature, distribute a very large quantity of controlled substances. Even though prescription medicine is not usually Schedule I, like heroin and other dangerous drugs, the sheer quantity of drugs a doctor prescribes over a period of time can result in unreasonably long prison sentences.

There are also several “enhancements” under the Guidelines that can add years to a defendant’s sentence based on their specific conduct. Doctors, nurses, and pharmacists, for example, are likely to face enhancements for using their “special skills” as healthcare professionals and “abusing a position of trust.” The “vulnerable victim” enhancement is another enhancement that could apply in these cases if the government can show the doctor knew a patient was an addict or otherwise vulnerable.

Doctors, pharmacists, and nurses can face high mandatory minimum sentences if the government proves that the pills they prescribed or dispensed caused an overdose death.

Just like in cases involving street drugs, the government can add “death counts” to unlawful prescription charges if they think they can prove that the pills prescribed by a doctor or dispensed by a pharmacist caused one or more overdose deaths, even if the pills were sold to someone else after the patient initially received them.

Death counts can add a significant amount of time to a sentence. Worse, it can trigger certain mandatory minimum sentences, which judges must impose. That’s why it is important to retain an experienced federal defense attorney and a credible medical expert to establish that the overdose was not foreseeable to the defendant, or that the defendant’s prescription didn’t actually cause the overdose.

While the charges announced by the DOJ do not contain any death counts, that can change at any time. The government may obtain more evidence that they can use to accuse a doctor or pharmacist of causing a victim’s overdose death. Or the government could be using the threat of death counts as leverage to secure guilty pleas from these providers. Unfortunately, it is common for the government to threaten new charges, particularly death counts with high mandatory minimum sentences, to pressure doctors to plead guilty.

“Pill mill” charges are often accompanied by healthcare fraud charges.

These days, cases centering around a healthcare provider’s unlawful prescriptions  increasingly include federal healthcare fraud charges. Several of the defendants in these cases are being charged with billing fraud by filing false claims with federal healthcare programs.

Just as the Government is accusing the healthcare providers in this case of issuing or dispensing prescriptions to patients without a legitimate medical need, the government also charges them with defrauding federal healthcare programs like Medicare and Medicaid by billing them for examinations, lab tests, and prescription drugs that were “medically unnecessary.” Others are accused of paying or receiving “kickbacks” in exchange for issuing or writing illegitimate prescriptions.

Like in unlawful prescription cases, the government must prove that the defendants in these cases acted with an intent to defraud, meaning they knew they were billing for services that were unnecessary or that they were making or receiving illegal kickbacks. The good faith defense also protects doctors and pharmacists who had a a reasonable belief that they were acting appropriately. The defense is even stronger for pharmacists, who only see the patients and their prescriptions after the doctor has determined the patient needs that particular prescription medicine.

Call an experienced federal defense attorney if you have been charged or investigated.

There is no question that “pill mill” cases are serious. A successful defense requires the coordination of the professional being charged, an experienced federal defense lawyer like me, and consulting medical experts. In many cases, we also rely on medical billing experts and seasoned investigators to assist us in building a winning defense.

In my experience, the most effective way to respond to “pill mill” allegations and related healthcare fraud charges is to start working on a defense strategy immediately. In many cases, our clients find us before they are indicted, usually after the execution of a search warrant or having received a grand jury subpoena or target letter. But that doesn’t mean we can’t still prepare a winning defense if we aren’t hired until after an arrest. As with most criminal matters, the earlier we can get involved, the better.

While each case is different, I have successfully defended people charged with serious federal criminal charges for over 25 years. I have successfully defended several doctors, pharmacists, and other healthcare providers in “pill mill” cases across the country, including some of the districts mentioned in today’s press release. Call me if you or someone close to you is caught up in one of these cases. If I can’t help with your particular case, I will refer you to someone who can.