Delaware Board of Medical Licensure and Discipline Issues Proposed Rule on Use of Controlled Substances for the Treatment of Pain

On September 30, the Delaware Board of Medical Licensure and Discipline issued a proposed rule, “Use of Controlled Substances for the Treatment of Pain,” and has asked for comments preceding a public hearing in November. The proposed rule adopts the Federation of State Medical Board’s Model Policy for the Use of Controlled Substances for the Treatment of Pain and is meant to “alleviate licensed practitioner’s uncertainty, to encourage better pain management, and to minimize practices that deviate from the appropriate standard of care.”

The Board recognizes that the appropriate treatment of pain is fundamental to the practice of medicine, but it notes that practitioners may lack knowledge regarding pain management or may fear investigation or sanction by federal, state and local agencies, which have been focusing on pain management practices. These factors contribute to the “inappropriate treatment of pain.” The rule implies that the failure to become knowledgeable about treating pain is considered inappropriate just as the failure to follow statutory requirements in prescribing controlled substances. The proposed rule will consider the inappropriate treatment of a pain “a departure from standards of medical practice,” and such departures will result in investigations and potential discipline. Thus, the purpose of the proposed rule is to establish specific requirements for using controlled substances to treat chronic pain as well as the required safeguards to minimize risks of drug abuse and diversion. The comment period, which is open up to and including the date of the public hearing, November 1, 2011, is the provider’s opportunity to influence the final regulation.

The preamble to the rule states that the Board will not discipline a licensed practitioner for ordering, prescribing, dispensing or administering controlled substances “for a legitimate medical purpose and in the course of professional practice.” The prescribing of a controlled substance must be in the course of a practitioner-patient relationship and “should be based on a diagnosis of unrelieved pain.” The decision to prescribe controlled substances will be considered “a legitimate medical purpose” if it is based on “sound clinical judgment.” The takeaway for providers from the preamble is an emphasis on documentation. While the Board recognizes the place for controlled substances in the treatment of pain, the overriding concerns of abuse and diversion require extensive documentation of the practitioner-patient relationship. Under the rule:

“[t]he practitioner’s conduct will be evaluated to a great extent by the outcome of pain treatment, recognizing that some types of pain cannot be completely relieved, and by taking into account whether the drug used is appropriate for the diagnosis, as well as improvement in patient functioning and/or quality of life.”

The proposed rule requires a documented evaluation of the patient and a treatment plan. The benefits and risks of controlled substances must be discussed and if a patient is considered “high risk” for medication abuse, the patient must enter into a treatment agreement with the practitioner and submit to, among other conditions, random urine drug screening.

Importantly, the proposed rule does not envision the decision to treat pain with controlled substances as the end of the treatment continuum; practitioners shall review the course of pain treatment on a continued basis to determine whether alternative treatment modalities are more appropriate for the patient. This raises a few issues. First, it is possible that pain patients being treated with controlled substances may have different goals than their provider. There is any number of reasons that a patient may refuse alternative treatment options, such as invasive surgeries. Communication will be of the utmost importance, but the rule does not envision potentially common scenarios where the patient and practitioner disagree on the continued use controlled substances days, weeks, or months into the treatment relationship. And when patient and practitioner disagree during an ongoing treatment regimen, the specter of abandonment looms overhead.

Again, documentation requirements are stressed, and a section of the proposed rule addresses the maintenance of accurate and complete medical records. However, practitioners can look at these requirements as protective measures to assure compliance not only with appropriate standards of treatment, but also pain treatment coding and billing, which is receiving high levels of scrutiny from government payers and enforcement agencies.

A public hearing will be held on November 1, 2011 at 3:00 PM in the second floor conference room A of the Cannon Building, 861 Silver Lake Boulevard, Dover. Those in attendance will be invited to share their comments. Written comments may also be submitted to this address up to the date of the public hearing. For more information and to read the full proposed rule, visit http://regulations.delaware.gov/register/october2011/proposed/15%20DE%20Reg%20498%2010-01-11.htm.