On December 23, 2018, new State Medical Board of Ohio regulations became effective which marked another change in the legal standards governing provider use of opiates for treatment of pain.^[1] Notably, these new regulations also serve to rescind and replace Ohio’s previously long-standing “Chronic Pain Rules,” also known as the “Intractable Pain Rules,” which were first adopted as a component of the earlier “5^th Vital Sign” era which preceded the current opioid epidemic. In this respect, these new rules eliminate the last remaining regulatory vestige of that prior era.

In rescinding and replacing the previous law, the new rule combines standards for the use of opiates in the treatment of non-acute pain – meaning pain that has lasted for more than six weeks.  The new definitions include those for “sub-acute pain” and “chronic pain.” Further, an added time component to the definition of “acute pain” has also been implemented. These new rules do not apply to hospice care patients or patients being treated for a terminal condition.

The new rules impose significant changes in provider approach to the use of these medications, as well as specific documentation requirements. For example, providers are now required to consider and document non-pharmacologic and non-opioid treatment options. If opioids are used, the provider must prescribe the minimum quantity and potency to treat the expected duration of the pain and to improve patient functionality. 

Moreover, explicit treatment and documentation requirements now imposed by the new rules include the following: 1) history and physical examination, including prior treatment response, patient compliance, and screening for substance misuse or substance use disorder; 2) laboratory and diagnostic testing, specifically to include urine drug screening if evidence of substance misuse or a substance use disorder exists; 3) functional pain assessment; 4) comprehensive treatment plan, including but not limited to clinical rationale for the choice and dosage of medication and planned duration of treatment, and steps for further assessment and follow-up; 5) discussions with the patient as to risks and benefits of the medication, including potential for addiction and overdose risks, as well as patient responsibility for safe drug storage and appropriate disposal; and 6) offering of naloxone prescription under certain circumstances.^[2]

The new rules also impose varying standards based upon the patient’s Morphine Equivalent Dose (“MED”) – creating benchmarks at MED levels equal to or greater than 50, 80, and 120. While these standards vary based on the MED level, they can consist of written informed consent, specialist consultations, detailed pain treatment agreements, naloxone recommendations, and medication therapy management review, among other required features. Finally, specific requirements are set forth as to mandatory follow-up assessments.

It is clear that these new rules mark another chapter in the evolution of treatment and documentation standards for the use of opiates in Ohio.  Should you have any questions regarding these significant new rules, please contact your Dinsmore health care attorney for further information.

_{[1] The new rules are located at Ohio Administrative Code (OAC) 4731-11-14. See here.}

_{[2] Providers must also obtain and document review the results of an OARRS check in compliance with OAC 4731-11-11.}