Opioid-related compliance enforcement actions 

Enforcement actions to beat back the opioid epidemic.

C.J. Wolf, MD provides enforcement action summaries for the YouCompli blog. These summaries provide real-world examples of regulators’ response to practices that don’t fully comply with regulations. This month’s article looks at opioid-related incidents.     

Government enforcement agencies continue to put the pressure on healthcare providers to ensure compliance with opioid prescribing guidelines. And for good reason: We saw 92,000 drug overdose deaths in the United States in 2020. A full 75% of these deaths involved an opioid. 

Multiple presidential administrations have focused on beating back the opioid epidemic. One way that is being done is by enforcement against healthcare providers who are contributing to the problem. The U.S. Department of Justice, through its Consumer Protection Branch, is pursuing both criminal and civil actions against entities and individuals committing wrongdoing throughout the prescription opioid supply chain. 

Providers investigated for overprescribing opioids 

For example, a pain management physician in Ohio was recently convicted for unlawfully distributing opioids through his clinic. The convictions involved the distribution of a controlled substance, outside the usual course of professional practice, and not for a legitimate medical purpose. The prescriptions greatly exceeded recommended dosages and were in dangerous, life-threatening combinations. For each charge, he faces a maximum penalty of 20 years in prison. The physician required clients to pay cash for prescriptions and they would often travel hundreds of miles to visit this physician’s particular clinic. During a four-and-a-half-year period, the physician prescribed over 111,000 pills to nine clients. Sentencing has not yet occurred. 

Non-physicians have also been subject to enforcement. In one case, a Maryland physician assistant was enjoined by the court from dispensing, prescribing, or administering any controlled substances. Officials specifically called out anyone, regardless of their credentials, to be aware of their responsibilities. The U.S. Attorney involved in the enforcement noted that the Controlled Substances act applies to physician assistants and nurse practitioners.

They “cannot overprescribe opioids and hide behind their affiliations with physicians in an attempt to shield themselves from criminal and civil liability.”    

U.S. Attorney Erek L. Barron for the District of Maryland.

The court’s action brought to close a civil complaint filed by the government against the physician’s assistant. Allegedly, she issued hundreds of opioid prescriptions that had no legitimate medical purpose and fell outside the usual course of professional medical practice. In some especially concerning examples, it was alleged she prescribed morphine milligram equivalent (MME) dosages exceeding 700 MME per day. By comparison, the Centers for Disease Control and Prevention (CDC) generally recommends that primary care clinicians avoid daily dosages of opioids over 90 MME daily. The court’s ruling requires she never again apply for or seek the reinstatement of her Drug Enforcement Administration (DEA) registration. DEA registration is required to prescribe controlled substances.  

Manufacturer fined for opioid kickback scheme 

It is not just prescribers coming under scrutiny from enforcement agencies. The agencies have also publicized major financial settlements with opioid manufacturers. For example, Insys Therapeutics is the manufacturer of a sublingual fentanyl spray, known as Subsys. The company allegedly participated in kickbacks and other illegal marketing schemes to influence prescribers. These schemes were intended to induce providers to write more prescriptions of the drug typically used for breakthrough cancer pain. Insys settled the allegations with the government by agreeing to pay $225 million.  

The primary alleged scheme was a sham speakers’ program. The company would recruit physicians, physician assistants and other prescribers to ostensibly participate as paid speakers about the drug. The program was simply a mechanism to funnel kickbacks to the providers. One physician assistant in New Hampshire had not written a single prescription for the drug before joining the speaker program. After signing on, he was soon writing over 670 prescriptions after being a paid speaker. A substantial number of other prescribers have also participated and have either settled financially with the government or pleaded guilty to accepting kickbacks. 

What should compliance officers do to stay ahead of opioid regulation violations? 

Compliance officers often include opioid monitoring on their workplan, to protect the wellbeing of patients and to safeguard their organizations against fines and reputational hits. Here are two strategies compliance officers can use. 

Know who the high-volume prescribers are.  

Are patients traveling longer distances to visit a particular clinic or provider? Are patients asked to pay cash for services? Are patients doctor shopping?  

The HHS OIG offers a toolkit and computer programming tools to assist healthcare entities with monitoring potentially concerning prescription patterns.

According to the HHS, “These toolkits and the accompanying computer code can be used to analyze claims data for prescription drugs and identify patients who may be misusing or abusing prescription opioids and may need additional case management or other follow up.”

Learn more about the toolkits – HHS OIG Toolkits for Calculating Opioid Levels and Identifying Patients at Risk of Misuse or Overdose.

Utilize your medical directors or clinical resources to assess compliance with opioid guidelines.  

Though clinical guidelines are not the end-all of clinical decision making, compliance programs can start with these respected guidelines when assessing opioid risks. 

Opioid clinical guideline examples include:  

While the enforcement actions noted in this article are focused on individual providers or manufacturers, healthcare organizations are under scrutiny as well. Staying aware of opioid-related regulatory changes and monitoring for compliance are critical steps you can take to protect patients and your organization.  

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