State Medical Board’s proposed rules expands physician duties by increasing mandatory use of OARRS and creating new “red flags” of abuse and diversion.

Following a number of recent statutory changes requiring mandatory utilization of the Ohio Automated Rx Reporting System (OARRS), the State Medical Board of Ohio has issued a proposed amendment to its existing OARRS “red flag” regulationsⁱ. While the proposed rule incorporates the provisions of Ohio House Bill 341 with existing “red flag” and other controlled substance regulations, it also proposes changes to the existing regulations and creates new requirements on Ohio physicians when prescribing controlled substances.

Mandatory OARRS Review

The proposed rule includes the requirements established by Ohio House Bill 341, effective April 1, 2015, requiring Ohio physicians to obtain and review an OARRS report before the initial prescribing or dispensing of opioid analgesic or benzodiazepine medicationⁱⁱ. Additionally, the proposed rule includes the Ohio House Bill 341 requirement that the physician obtain and review an OARRS report at least every 90 days after the initial report if the patient’s therapy with an opioid analgesic or benzodiazepine continues beyond 90 days.

The proposed rule includes the same exceptions identified in Ohio House Bill 341. As a result, Ohio physicians will not be required to obtain OARRS reports under the proposed rule in the following settings or situations:

• When treating hospice patients or the terminally ill;

• When treating cancer or another condition associated with cancer;

• When treating patients in a hospital, nursing home, or residential care facility;

• When treating acute pain resulting from a surgery or other invasive procedure or a delivery;

• When the amount of the drug prescribed or furnished does not exceed a 7-day supply; and

• When OARRS is not available for use, although such unavailability must be documented in the patient’s medical record.

The above exceptions do not apply if the physician believes or has reason to believe the patient may be abusing or diverting reported drugs.

Proposed Changes to Existing OARRS “Red Flag” Regulations

The proposed rule also makes changes to the existing OARRS “red flag” regulations. Under the current rule, the Board makes a distinction between certain patient behaviors which create a mandatory duty to check OARRS (a “red flag”) and other patient behaviors that make checking OARRS discretionary. The proposed rule eliminates the distinction and mandates an OARRS check in all of the existing mandatory and discretionary circumstances and, additionally, creates three new “red flag” circumstances which would also mandate an OARRS check. In total, under the proposed regulation Ohio physicians would need to be aware of 19 “red flag” situations under which an OARRS check would be required. For a complete listing of all 19 “red flag” situations, see:

http://med.ohio.gov/Portals/0/DNN/PDF-FOLDERS/Laws-Rules/Proposed-Rules/Common-Sense/4731-11-11-Rule.pdf

New Documentation and Step Required When “Red Flag” is Present

The proposed regulations also require specific actions and medical record documentation if an Ohio physician decides to continue to prescribe controlled substances when one or more of the 19 “red flags” are present. In such cases, the physician must do the following:

1. Review and document in the patient record the reasons why the physician believes or has reason to believe the patient may be abusing or diverting drugs;

2. Review and document in the patient's record the patient's progress toward treatment objectives over the course of treatment;

3. Review and document in the patient record the functional status of the patient, including activities for daily living, adverse effects, analgesia, and aberrant behavior over the course of treatment;

4. Consider using a patient treatment agreement, including more frequent and periodic reviews of OARRS reports. The agreement may also include more frequent office visits, different treatment options, drug screens, use of one pharmacy, use of one provider for the prescription or personally furnishing of reported drugs, and consequences for non-compliance with the terms of the agreement. The patient treatment agreement shall be maintained as part of the patient record; and

5. Consider consulting with or referring the patient to a substance abuse specialist.

Clearly, a physician's documentation of his or her clinical judgment will be crucial for complying with the proposed rule but also in demonstrating the basis for the continuation of prescribing or personal furnishing of controlled substances after any indication of aberrant patient behavior. Moreover, failure to document the clinical rationale for continued utilization of controlled substances would likely limit the physician's ability to defend him- or herself in the event regulatory review, as state agencies frequently adhere to the adage of, “if it’s not in the medical record, it didn’t happen.” Hence, an even greater emphasis on record keeping and documentation is a likely outcome of the proposed rule.

New Documentation and Steps Required for Prescribing for More Than 90 Days

The new documentation requirements apply not only when physicians are confronted with “red flags” but also apply when prescribing an opioid analgesic or benzodiazepine for greater than 90 days when no “red flag” or aberrant patient behavior is present. In this regard, the proposed rule will require Ohio physicians to create such additional specific documentation and take such steps even when treating a fully compliant patient receiving necessary and indicated medication solely on the basis that the medication has been prescribed for greater than 90 days.

Violation of the Rule

Under the Ohio Medical Practices Act, a physician’s failure to comply with an administrative rule constitutes a disciplinary offense and may subject the physician to licensure sanctions.

Considering the strong emphasis Ohio regulatory agencies have placed on combating and reducing prescription drug abuse and diversion, Ohio physicians should familiarize themselves with the proposed rule to ensure compliance with the new standards. Additionally, Ohio physicians who desire to voice comments about the proposed rule can do so by submitting such comments to both the State Medical Board of Ohio (at Sallie.Debolt@med.ohio.gov) and the Ohio Governor’s Common Sense Initiative Office (at csipubliccomments@governor.ohio.gov) on or before August 10, 2015. For more information on the proposed rule and/or submitting comments about the rule, please contact a Dinsmore health care attorney.

^{i OAC 4731-11-11}

^{ii Similarly established on April 1, 2015, Ohio physicians who practice primarily in an Ohio county that adjoins another state must also request the adjoining state’s prescription drug information through OARRS.}