The federal government has enacted laws that prohibit unlawfully distributing or dispensing any of the listed drugs on the Controlled Substance Schedules. The Controlled Substance Schedule rates substances from schedule I to schedule V, with schedule I and II carrying the harshest penalties. Schedule I substances are the classic street drugs for which there is no legal procedure to possess or distribute the substance. These drugs include cocaine, heroin, and methamphetamine. Schedule II drugs carry a high potential for abuse or addiction, but do possess recognized benefits for a subsect of patients. These drugs include opioids (hydrocodone and oxycodone), methadone, and fentanyl. This second class of drugs form the foundation for criminal investigations and prosecutions for medical professionals and pharmacies across the country. These cases are highly specialized and those under investigation for distribution of any scheduled substance should retain qualified unlawful distribution attorneys as quickly as possible.
Congress has criminalized writing or filling prescriptions for these schedule II drugs unless the prescription is “authorized” under federal regulations. 21 U.S.C. § 841. A prescription is authorized if it is written for a legitimate medical purpose and during the normal course of medical practice. These two overarching principles are at the center of every § 841 prosecution. Doctors and physician’s assistants are playing with fire when they write a long term prescription for any schedule II substance; however, opioids bring the most scrutiny based on the opioid crisis across the United States and the high demand for the narcotic on the streets. The government’s experts believe there is no legitimate reason to prescribe a patient any opioid for longer than a couple of weeks for acute pain treatment. Those medical professionals that use opioids as a treatment for long term, chronic pain run the risk of government oversight and a criminal probe into their practices.
§ 841 criminalizes both the unauthorized distribution (writing the prescription) and dispensing (filling a prescription) of schedule II substances. The latter act normally involves the investigation of a pharmacy who is filling opioid prescriptions at a rate that exceeds their competitors. Most large pharmacies (Walgreens, CVS, chain grocery stores) are diligent in following up with doctors on any schedule II prescription. Even legitimate patients will deal with scrutiny when trying to fill their schedule II prescriptions at these locations. However, smaller pharmacies often have looser rules and less scrutiny. This reality makes them vulnerable to federal inquiry if their activities make them outliers in the market.
The Use of the PMP to Isolate Outliers
Every state pharmacy board has an electronic database that tracks schedule II prescriptions. The database logs the physician’s DEA registration number for every issued prescription and the pharmacy location for every filled prescription. The database allows the federal government to search for activity from specific doctors, clinics, or pharmacies. If a particular doctor is writing 10x the schedule II prescriptions as his counterparts in a similar field, the government will take notice. If a particular pharmacy is filling a large amount of schedule II prescriptions in a particular city, their outlying behavior will be noted as well. The tracking systems ensure no professional can hide their numbers from government scrutiny. The state PMP systems are an efficient tool for isolating persons that may be writing or filling unauthorized prescriptions.
Undercover Buys to Seal the Government’s Case
Once a particular clinic or pharmacy has been flagged for potential criminal behavior, the government will send in an undercover to act as a patient. Often, these “patients” are carrying a hidden recording device to detail the events in the clinic or pharmacy. Their goal is to detail the inner workings of the facility to see if they are adhering to federal regulations. The government is looking for certain red flags during the clinic operations: 1) existence of a cash only payment system, 2) prescriptions being written without an examination by a professional, 3) packed waiting rooms, 4) the existence of armed guards, 5) the existence of drug dealers or runners who are bringing patients to the clinic, 6) a doctor’s involvement in writing the prescription, and 7) payments based on the prescription written instead of the work performed. When the government sends an informant into a pharmacy, they are looking for high volume of schedule II prescriptions, suspicious looking paper prescriptions, and large cash fees tied to the particular drug.
These undercover buys are integral to all § 841 investigations. It allows the government to paint their narrative without the need for co-defendant witnesses or flipping drug runners. Those witnesses often suffer from credibility issues, and the government knows they cannot solely rely on their testimony.
Unlawful Distribution Attorneys – Defending the Case
The government must prove the doctor or pharmacy is issuing or dispensing an unauthorized prescription(s). This means they must show the prescription was issued without a legitimate medical purpose or outside the normal course of practice under federal regulations. Each element must be defended. Each element brings unique defensive issues to the case. Under the medical purpose element, an unlawful distribution attorney must have a full understanding of the medical procedures and basis for the prescriptions. The government will argue that all prescriptions for opioids, written for longer than a couple of weeks, are not for a legitimate medical purpose. The government’s stance is not shared by much of main stream science. Even the CDC offers guidelines for issuing opioids for long term pain patients. Their guidelines center around the doctors’ need to monitor signs for addiction and adjust the treatment accordingly. If a physician has a legitimate treatment protocol, there is a defense to the “legitimate medical purpose” element at trial. The question will be whether the jury believes science supports the doctor’s protocol for treating long term pain patients with opioids.
The normal course of practice element above is less straight forward. The Courts of Appeals have used the violation of various regulations to affirm convictions under this element. And remember, a prescription is only authorized if it is both for a legitimate medical purpose AND issued within the normal course of of medical practice. The physician must follow federal regulations while operating under a legitimate treatment protocol. If either fails, the government has grounds for a guilty verdict. One of the regulatory violations that appears in many cases is pre-signing prescriptions. Federal regulations require a prescription to be issued on the same date the prescription is signed. If a physician pre-signs a prescription pad (100 prescriptions), and allows a nurse practitioner to fill in the drug and patient information at a later date (issuance), this regulation has been violated. That violation alone would allow the government to argue those 100 prescriptions were done outside the normal course of medical practice. Regardless of the treatment protocol, the elements of § 841 could be met.
Ruan Changes the Defensive Case
In Ruan v. United States, the Supreme Court provided guidance that is helpful to defending § 841 allegations. The Supreme Court ruled the mens rea for the offense (intentionally and knowingly) applied to the “except as authorized” language in the statute. This means the government must prove 1) the prescription was in fact not authorized as outlined above AND 2) the physician or pharmacist knew it was not authorized when the medication was issued or dispensed. Prior to Ruan, § 841 prosecutions were fact based inquiries; the jury had to decide whether the prescriptions were in fact authorized. The case turned on the juries finding on the two elements above; often, the case was decided through a fight between government and defense experts. Now, the government must show the physician or pharmacist knew it was not authorized.
Under the “legitimate treatment” element, this opens the door to treatment protocols that may have failed prior to Ruan. If the treatment procedures and scientific backing of that treatment are strong enough, the physician can now argue he believed the prescriptions were for a legitimate medical purpose even if he is incorrect in that belief. The success of the defense does not turn on whether the treatment choices were in fact legitimate. It is now a question of whether they were legitimate enough to support the physician’s belief the prescription was authorized when it was issued. A treatment option with limited scientific backing can still support a valid defense as long as the jury finds the physician believed it was a legitimate treatment.
Under the “normal course of practice” element, a violation of the regulation alone will not support a conviction. Post-Ruan, the government, arguably, must prove the physician knew of the regulation when the prescription was issued. This removes the potential for technical regulatory violations supporting a conviction when the doctor was truly unaware. Obviously, the viability of this defensive narrative will depend on how well known the regulation was and how reasonable it was for the physician to lack awareness of its existence.
Ruan was decided in 2022. I expect additional cases to emerge that fine tune the Supreme Court’s holding. Having said that, the base line rule issued by the highest court is here to stay. And it provides physicians and pharmacies with a new line of defense in § 841 allegations.
Unlawful Distribution Attorneys – Odom, Davis & Hobson
Our firm has represented numerous physicians and pharmacies under investigation for, or charged with, unlawful distribution of a controlled substance under 21 U.S.C. § 841. We have a network of experts to assist in reviewing patient charts, developing the treatment protocol, interpreting individual regulations, and challenging the government’s stance there is no legitimate reason to prescribe certain schedule II substances for long durations. Our firm is equipped to handle these prosecutions. If you are contacted by the DEA or any other government agency, please contact a lawyer immediately. These cases are serious and the government is hyper focused on prosecuting professionals in federal courts across the country.
Contact us today for consultation.