Senate Enrolled Act No. 246 (“SEA 246”), which was signed into law earlier this year, required the Medical Licensing Board of Indiana (“MLB”) to adopt an Emergency Rule (“Rule”) to establish standards and protocols for physicians prescribing substances for pain management treatment. The MLB adopted the Rule on Oct. 24, 2013, with an effective date of Dec. 15, 2013. The MLB is required to develop final regulations by Nov. 1, 2014. Although this Rule only applies to physicians and specifically excludes physician assistants and advanced practice nurses, SEA 246 requires other licensing boards who license professions that oversee controlled substances registrations to adopt similar regulations promulgated by the MLB.

It is strongly recommended that all physicians become familiar with this new Rule if they treat patients for symptoms related to chronic but non-terminal pain. Due to the uniqueness of health care diagnosis and decision making, a physician must use his or her best medical judgment in applying the requirements to his or her practice on a patient-by-patient basis. Failure to do so could have negative consequences on the physician’s practice and affiliated organizations.

Related Definitions

Pursuant to the Rule, “chronic pain” is defined as “a state in which pain persists beyond the usual course of an acute disease or healing of an injury, or that may or may not be associated with an acute or chronic pathologic process that causes continuous or intermittent pain over months or years.” The Rule also defines “terminal” as “a condition caused by injury, disease, or illness from which, to a reasonable degree of medical certainty: (1) there can be no recovery; and (2) progression to death can be anticipated as an eventual consequence of that condition.” Both of these definitions rely on the physician using his or her best medical judgment.

Application of the Rule

The Rule applies to physicians who prescribe opioids for chronic pain management for patients in instances when, for more than three consecutive months, the patient has been prescribed more than 60 opioid-containing pills a month or a morphine equivalent dose of more than 15 milligrams per day. The Rule does not apply to the following exceptions:

• Patients with a terminal condition.
• Residents of a health facility licensed under IC 16-28.
• Patients enrolled in a hospice program.
• Patients enrolled in an inpatient or outpatient palliative care program of a licensed hospital or hospice.

The period of time a patient who was in but is no longer a resident or patient of a health facility, hospice program or palliative care program referenced above shall be included in the three consecutive month calculation.

Requirements

1. Physicians who have a patient to whom the Rule applies are required to perform their own evaluation and risk stratification of the patient by completing the following during an initial evaluation:
   • Thoroughly review the patient’s history, conduct a physical examination and order appropriate tests.
   • Make and document a “diligent effort” to obtain the patient’s medical records from other providers to help the physician understand the patient’s chronic pain problem. This should include past treatments.
   • Ask the patient to complete an objective pain assessment tool.
   • Utilize validated screening tools to assess the patient’s mental health status and risk of substance abuse.
   • Once the initial evaluation is complete, establish a working diagnosis and tailor the treatment plan to meet established goals that will be reviewed on a continuous basis.
   • When medically appropriate, use non-opioid options.
      
2. In addition, physicians who have a patient to whom the Rule applies are required to discuss with the patient the potential risks and benefits of opioid treatment and the expectations related to prescription requests and proper medication use. The physician must:
   • Discuss alternative modalities to opioids for pain management, if they exist.
   • Provide a simple explanation so the patient understands the key elements of the treatment plan.
   • Counsel women with child bearing potential between the ages of 14 and 55 about the potential risks to a fetus if a pregnant woman takes opioids.
   • With the patient, review and sign a “Treatment Agreement”, a copy of which shall be placed in the patient’s chart and must include the following:
     • Treatment goals.
     • Patient’s consent to drug monitoring testing.
     • Physician’s prescribing policies which state, at the very least, that the patient must take the medication as prescribed and which prohibit the patient from sharing the medication with others.
     • Requirement that the patient inform the physician of any other controlled substances he or she is taking or is prescribed.
     • Permit the physician to conduct random pill counts.
     • Explain the reasons why the physician may change or discontinue the opioid therapy.
        
3. Physicians are not allowed to prescribe opioids to patients without periodic scheduled visits. For patients with a stable treatment plan, the visits must occur, in person, at least every four months. If the physician changes the medication and treatment plan, patient visits must occur two months until the treatment plan has been stabilized. During the patient visits, the physician is required to evaluate patient progress and compliance with the treatment plan.  
    
4. When commencing an opioid treatment plan, the physician must run an INSPECT report and document in the patient’s chart whether the report is consistent with the physician’s knowledge of the patient’s controlled substance use history. The Rule postponed this requirement until Nov. 1, 2014.
    
5. Also when starting an opioid treatment plan, the physician prescribing the opioids must perform or order a drug monitoring test, which must include a confirmatory test, on the patient. This must occur at least annually thereafter. If the testing reveals inconsistent medical use patterns or the presence of illicit substances, the physician is required to review the treatment plan. Any revision of the plan and discussion must be documented in the patient’s chart. The Rule postponed this requirement until Jan. 1, 2015.
    
6. If a patient’s opioid dose reaches a morphine equivalent dose of more than 60 milligrams per day, the physician must conduct a face-to-face review of the treatment plan and schedule a patient evaluation that includes the consideration of a referral to a specialist. If the physician elects to continue that dosage, he or she must revise the assessment and plan for ongoing treatment, which must be documented in the patient’s chart and include an assessment of increased risk of adverse outcomes, including death.

For more information about the Emergency Rule, please contact Rick Swett in Taft's Indianapolis office or your primary Taft Health and Life Sciences attorney.