"Ladies and gentlemen of the jury," is how attorney Jennifer Bolen, JD, opened her presentation to attendees at the Painweek 2016 conference, in the panel session, "If 6 were 9: The CDC's Prescribing Guidelines and the Veil of Secrecy."
Bolen, who is the founder of Legal Side of Pain, Knoxville, Tennessee, proceeded to lay out a mock trial, "final argument" defense of a practitioner indicted for over-prescribing opioids, and in so doing identified the elements of best practice that are necessary, not only to optimize pain care treatment, but to avoid or successfully defend against such accusations.
Although the March 2016 CDC Guideline for Prescribing Opioids for Chronic Pain indicates that the recommendations are "voluntary rather than prescriptive standards,” Bolen anticipates that they will become proscriptive. She cited examples of state legislators and medical boards that have already incorporated some of the recommendations into regulation, and demonstrated in the mock defense how the guideline document can be represented in litigation arguments as a standard of practice.
|Although the March 2016 CDC Guideline for Prescribing Opioids for Chronic Pain indicates that the recommendations are "voluntary rather than prescriptive standards,” Bolen anticipates that they will become proscriptive.|
The points of defense that she utilized in the mock trial presentation "are not going to be available to you, in a board proceeding, or, God forbid, in a criminal proceeding...[unless you take] steps that a usual or reasonable practitioner would take. Somebody who is reasonably prudent, that's the standard," Bolen said.
Key arguments for a robust defense will only be available, Bolen cautioned, to practitioners who, among other essential steps, do the following:
► Set up periodic "toll booth" patient assessments based on duration and dose
► Read and consider all the CDC Guidelines, and respective state requirements
► Be clear when documenting rationale in the medical record
► Provide clear explanation of reasons for deviating from any federal or state "recommendation"
And, she warned, "If you're not going to follow something that [is] recommended to do or [you’re] told to do, you better have a darn good reason why not, in this particular environment." She also stressed that if you do circumvent the guidance, not only should you have a good reason, you should also have that reason well-documented.
Documenting Best Practices
In another session, "Managing the Risks of Prescribing Controlled Medications," attorney Michael Barnes, JD, Managing Partner, DCBA Law and Policy LLP, Washington, DC also discussed the importance of documenting best practices when prescribing controlled medications.
In particular, Barnes emphasized the importance of documenting the following:
► that there is legitimate medical need for the controlled prescription
► that the prescription is within the ordinary course of professional practice, consistent with labeling or accepted practice in literature
► that reasonable steps are taken to prevent harm
To establish that there is a legitimate medical need for a controlled medication prescription, Barnes indicated, the medical record should include the medical history, physical examination, and verified basis for the diagnosis. He recommended documenting particular considerations for special populations such as older adults, pregnant women, and for those with special risks, notably a history of substance abuse.
An important part of establishing the legitimate medical need for opioids, Barnes emphasized, is to have tried and documented results with non-pharmacologic or non-controlled pharmacologic options with lower risk than opioids. These trials do not have to precede and fail before opioids are prescribed, but may have been insufficient alone, and valuable as concurrent, synergistic treatment.
Demonstrating that the prescribing occurs within the ordinary course of professional practice entails obtaining informed consent, counseling on risks and benefits, and having a written treatment plan with documentation for adjustments, according to Barnes.
Monitoring should ensure that the treatment remains suitable. Barnes suggested documenting responses to such questions as, "How has this treatment improved your life?"
Reasonable steps to prevent harm from opioid prescribing that should be taken and documented, said Barnes, include screening for drug misuse with state prescription monitoring programs and/or urine drug testing. He noted that mental health examination and pregnancy testing before prescribing when appropriate can be useful in preventing harm.
In the event of drug misuse, Barnes urged the attendees to consider adjusting the treatment plan before discontinuing treatment. He noted that abandonment of the patient has consequences in civil law and professional regulations.
Barnes related a recommendation from Jane Ballantyne, MD, University of Washington, a contributor to the development of the CDC Guideline, to "Kick up, not out" and increase the level of care and supervision, with increased frequency of appointments and fewer prescribed doses at each appointment, within the capacity of the practice.
"You've got to balance what the risks are, both for the patient as well as to you (the prescriber), Barnes said, "in the event of non-adherence to the treatment plan or to an adjustment, based on the fact that the risk-benefit analysis is not working out in your favor or for the patient."