New Regulation Imposes Strict Requirements on Medical Practitioners who Prescribe Controlled Substances for Treatment of Chronic Pain

On October 14th, we posted on the Delaware Health Law Blog that the Board of Medical Licensure and Discipline had proposed a rule regarding the use of controlled substances for the treatment of pain. A public hearing was held on November 1, 2011 without comment in opposition to the rule. On February 1st, Rule 32 was adopted as proposed and will go into effect on February 11, 2012. The Rule is designed to assist practitioners by providing them with the minimum requirements for meeting the necessary standard of care in prescribing controlled substances for the treatment of pain. In order to demonstrate that your practice has met the standard of care, you must be vigilant in documenting specific aspects of care and medical decision-making.

This new regulation is likely to change the way most medical practitioners treat chronic pain patients and it imposes significant documentation requirements.

What is Required

The Board will consider prescribing, ordering, dispensing or administering controlled substances for pain to be for a legitimate medical purpose if based on sound clinical judgment. The key to the standard of care is to document a diagnosis with unrelieved pain and the sound clinical judgment to prescribe controlled substances. Additional specific requirements are listed below.

Evaluation of Patient

A medical history and physical examination must be obtained, evaluated, and documented in the medical record. The following must be documented in the evaluation:

• One or more recognized medical indications for the use of a controlled substance
• Etiology, the nature, and intensity of pain
• Current and past treatments for pain
• Underlying or coexisting diseases or conditions
• The effect of the pain on physical and psychological function
• History of substance abuse

Treatment Plan

A written treatment plan is required, and must outline the goals and objectives that will be used to determine treatment success. The plan should note all diagnostic evaluations and any planned alternative treatments. Importantly, the plan must note whether other treatment modalities or rehabilitation programs are necessary.

Informed Consent

You must discuss the risks and benefits of treatment with controlled substances with the patient and document that discussion, including the patient’s informed consent.

Pain Treatment Agreement

You must use a written treatment agreement only if the patient is at “high risk” for medication abuse or has a history of substance abuse. The agreement must include required medication level screenings upon request, the number and frequency of prescription refills, the reasons drug therapy will be discontinued, and the requirement that the patient receive prescriptions from one physician and one pharmacy, where possible.

Periodic Review

The course of drug therapy must be periodically reviewed and documented, including any new information about the etiology of the pain and the patient’s state of health. A periodic review must include whether the treatment should be continued or modified, whether the patient’s pain has improved, and whether the patient has an increased level of function or improved quality of life. If not, it should be noted that the practice has considered the appropriateness of continued drug therapy or alternative modalities. A periodic review must also consider all objective evidence of improved or diminished function, including information from family members or other caretakers.

Consultation

During the course of treatment, the practitioner must refer the patient as necessary for additional evaluation and treatment in order to meet the goals and objectives of treatment. “The management of pain in patients with a history of substance abuse or with a co-morbid psychiatric disorder requires extra care, monitoring, documentation and may require consultation with or referral to an expert in the management of such patients.” Importantly, the rule states that “practitioners who regularly treat patients for chronic pain must educate themselves about the current standards of care applicable to those patients.”


Records must be maintained in an accessible manner. The record should also include documentation appropriate for each visit’s level of care, including interim history, vital signs, an assessment of progress, and the continued medication plan.

With the final rule becoming effective in ten days, it is important make sure that new documentation meet these standards. Notes used for initial and follow-up visits should be scrutinized to ensure that each of these new requirements is achieved in order to meet the these regulatory requirements.

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.