Protection in purpose: Legal considerations in prescribing and documenting opioid therapies

There are countless ways to place blame for how the United States developed a massive drug overdose crisis, largely involving opioids.

Between misinformation from companies producing the medications and the pressures on physicians from patients rating them on how well they control pain, there was a perfect storm in which “there was no ceiling to how much you could prescribe,” according to John Bowman, chief executive officer, Sure Med Compliance.

“The pendulum was over on one side where physicians were being told, ‘treat pain as if it’s a vital sign,’ … and then all of a sudden, we started to realize that maybe some of the information that we had wasn’t right,” Bowman said. This led to a very abrupt and aggressive change to how physicians are expected to prescribe.

Bowman previously lived in Manatee County, Florida, which was home to the top prescriber of oxycodone and hydrocodone in the state. At one time, the county also had the highest number of heroin overdoses per capita — roughly nine deaths a day in a county of about 150,000 people. Looking at the issue with a friend who was a sheriff’s deputy, Bowman began to see the correlation between opioid prescriptions and heroin use.

“It was breaking his heart, it was breaking my heart, running into people that we had gone to high school with and that we knew for many years, overdosing,” Bowman said.

That experience spurred him into action. Bowman had spent about a decade in the pharmaceutical industry, which gave him special insight into the relationships between drug manufacturers and clinicians.

“One of the things that kind of stuck out to me from my pharma experience is that if you could get in front of a physician a certain number of times, that you could change behavior,” Bowman noted, recounting how he turned his attention to helping re-educate physicians on proper opioid prescribing.

In his current work, Bowman says there is one clear enemy of the well-meaning physician when promoting the safe initiation and continuation of opioid therapies: Time.

“If you’re a doctor and you’ve spent the last 15 years prescribing opioids a certain way, you built your practice that way,” Bowman said. If that workflow is contingent on spending only five to 10 minutes with the patient, it may be insufficient to truly screen for today’s patients.

“We’re in a completely different place now. We’ve got a whole population of patients that have been biologically dependent and can’t stop even if they wanted to,” Bowman said. Add in the regulatory scrutiny of prescribing physicians and a curbing of the amount of prescriptions being written in the past decade, it should come as no shock that some patients turn to illegal fentanyl and analogs on the street.

“It’s hard to tell a doctor, ‘you’ve been spending five to 10 minutes with these patients, but really, if you’re going to actively verify each patient’s suitability, you need to spend 30 minutes, an hour with these patients,’” Bowman said. Without that type of individualized care, it’s likely that some patients “are still going to fall through the cracks.”

A crisis of confidence and compliance

Recognizing a problem led to new prescribing guidelines from the Centers for Disease Control and Prevention (CDC) in 2016 and greater scrutiny of prescribing physicians in general.

However, that well-intentioned focus to combat the opioid crisis has left some providers feeling less than confident about taking on patients who may become a liability, Bowman said.

To adequately manage patients today amid the opioid crisis, it begins with understanding which patients have the disease of addiction and those who have a higher likelihood of experiencing adverse events, Bowman said. Physicians regularly do well in managing these patients, but they face legal issues in doing so.

Bowman said it’s generally accepted that, for a physician to be found guilty of a prescription drug crime, there must be three conditions met:

1. The physician must prescribe a controlled substance.
2. The physician prescribes it willfully and knowingly.
3. The prescription is made “outside the course of usual professional practice or business.”

“One of the most important questions is how a practice is defining that, based on some of the case law that we’ve seen,” Bowman said, noting the origins of the “course of usual practice” phrase in the Controlled Substances Act. “Did a physician prescribe it while they were practicing medicine? Was this a patient that came in and received this opioid in the normal course of their business?”

Legal sanctions for being “outside the course of usual professional practice” tend to involve physicians who have sold the medicine or traded it for favors outside the practice.

Another key legal phrase that causes compliance issues for prescribing physicians is “legitimate medical purpose.” While the Department of Justice (DOJ) and Drug Enforcement Administration (DEA) are charged with preventing drug abuse through enforcement, DOJ cannot define what a “legitimate medical purpose” is for physicians.

“Even when the DOJ is using that terminology in court cases against physicians, they’re usually having to defer to the state definition of [legitimate medical purpose],” Bowman said. However, Bowman cautioned that many state boards of medicine, now thrust into a federal compliance legal arena, have not been vocal on aiding to define the phrase.

Bowman points to unique data points in case law to help understand what would be pertinent in defining these phrases in a federal compliance case, such as drug indication, which includes determining onset and duration, measuring a patient’s pain score and other factors.

Active verification also matters; for example, checking the suitability or the level of suitability of that patient for opioid therapy is vital, Bowman noted. That includes mental health screening, drug screening for aberrant behavior, checking the prescription drug monitoring program (PDMP) and documenting witness behavior in the office.

Whether the treatment plan is in the best interest of patient safety is another key consideration for determining legitimate medical purpose. Bowman says that entails safe initiation of treatment, prescribing the lowest therapeutic dose the first time and other factors. “Did the patient fail on an alternative treatment before they were even started on that medication? Are you making sure you’re not concomitantly prescribing opioids and benzodiazepine therapy together?” he said.

Other considerations include therapy continuation and how a physician determines need for a long-term opioid therapy.

Documentation and intent

Bowman said that airline pilots have a fine perspective on the role of documentation, which is just as applicable to providers prescribing opioid therapy: They run through a lengthy preflight checklist “because lives are at stake.”

Building a checklist or other policy to ensure all the components of your practice’s prescribing policies are met is an important step. Being able to point to proper protocol being followed with each initiation and each continuation is important, Bowman noted.

Also important is understanding intent. A chart should help document how a therapy is substantiated, what method was used to determine it and what was the desired outcome of the therapy. In civil cases, opposing attorneys are “going to try and make a case [of] what the physician was thinking or not thinking when they prescribed that medicine,” Bowman said. “Documenting clear thought processes and intent are important.”

While charts are often pulled for physicians to look at, Bowman said it is important to consider what that chart will look like when an attorney is looking at it. “Did you prove that the benefit [of opioid therapy] outweighs the risk?” Bowman said.

While most physicians provide good care and don’t need to worry about criminal intervention, the concerns for potential civil cases involving opioid therapies are where clear documentation and an understanding of the definitions the provider’s actions will be judged become vital.

“The goal is to really give [physicians] the tools that they need to be successful at treating patients — to go back to being able to have those conversations with patients about pain and not worrying every single day about the compliance part of it,” Bowman said.