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.  

CJ Wolf, MD, M.Ed is a healthcare compliance professional with over 22 years of experience in healthcare economics, revenue cycle, coding, billing, and healthcare compliance. He has worked for Intermountain Healthcare, the University of Texas MD Anderson Cancer Center, the University of Texas System, an international medical device company and a healthcare compliance software start up. Currently, Dr. Wolf teaches and provides private healthcare compliance and coding consulting services as well as training. He is a graduate of the University of Illinois at Chicago College of Medicine, earned a master’s in education from the University of Texas at Brownsville and was magna cum laude as an undergraduate at Brigham Young University in Provo, UT. In addition to his educational background, Dr. Wolf holds current certifications in medical coding and billing (CPC, COC) and healthcare compliance, ethics, privacy and research (CHC, CCEP, CHPC, CHRC).

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Is telehealth getting a new lease on life?

6 PHE-Related Waivers

Through 2019, telehealth was mainly for rural patients living far from healthcare providers. Then came COVID and the Public Health Emergency (PHE) declaration from the Department of Health and Human Services (HHS). Since 2020, a series of rolling 90-day waivers opened telehealth to everyone, temporarily. 

Thanks to a recent surge in COVID cases, the current PHE extends to October 2022. When it ends, so does CMS’s authority to continue telehealth’s expended capabilities (unless there’s a further extension). That’s why Congress stepped in. The Consolidated Appropriations Act, which became law March 15, extends telehealth’s lifespan by five months (151 days, to be specific) after the PHE expires. (Related: Six key steps to reduce the impact of telehealth audits) 

That means telehealth is alive and well at least through year’s end. So are many of the PHE-related coverage flexibilities. Here are some of the highlights: 

  • Telehealth from anywhere Before the PHE, Medicare covered only services delivered to patients at hospitals and other provider facilities. The Act redefines “originating site” to mean “any site in the United States at which the eligible telehealth individual is located at the time the service is furnished.” This could be patients’ homes, their cars – anywhere with phone or Wi-Fi connectivity. 
  • More practitioners In addition to physicians, nurse practitioners, physician assistants and other specialized providers, occupational and physical therapists’, speech language pathologists’ and audiologists’ services will be covered. 
  • Payment for audio-only services will continue for 151 days after the PHE ends. 
  • Relaxed in-person mental health services requirement The waivers ensure that the requirement that mental health patients have in-person visits of the first telehealth visit and every 12 months afterwards won’t take effect until the 152nd day after the PHE ends. 
  • Reinstated first-dollar coverage Until the end of 2021, telehealth services to High Deductible Health Plan and Health Savings Account patients were not subject to plan deductibles. The new law reinstated this relief through December 31 of this year. 
  • More data transparency The Medicare Payment Advisory Commission is required to analyze telehealth utilization, expenditures, payment policies, and implications on access to and quality of patient care. Starting July 1, the HHS Secretary must publicly post quarterly telehealth utilization data. 

For more lasting, but not permanent, relief, the bipartisan Telehealth Extension and Evaluation Act, which would extend the telehealth waivers for two years, is inching its way through Congress. 

If all the flux and uncertainty at the federal level weren’t enough, there’s also the state level. As I posted almost a year ago, the states have their own telehealth coverage, reimbursement, and privacy regulations. For now, patients and providers can continue on through at least the end of 2022 with access to telehealth. Beyond that, healthcare organizations are working hard to future proof their approach to telehealth. Stay tuned! 

Read how one health system created a scalable repeatable process to address regulatory changes during the PHE. The hospital system is now fully prepared to revert those changes or update them to the new requirements. 

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