March 24, 2017

The State Medical Board of Ohio (SMBO) has released Rules 4731-11-01 and 4731-11-09 which take effect March 23, 2017.  As previously reported in , the SMBO has chosen to take an approach consistent with several other states’ more recent statutory/regulatory amendments to their telemedicine rules.  That is, rather than delineating a set of specific  requirements as to how a physical exam should be conducted remotely, the SMBO has taken a more balanced approach focusing instead on documentation of the visit, informed consent, follow-up care, etc.  With regard to the issue of how to properly conduct a remote physical exam, the rule leaves the discretion of whether or not telemedicine is the appropriate forum for the patient visit where it belongs, with the provider.

As an initial matter, Rule 4731-11-09 defines “informed consent” as:

[a] process of communication between a patient and physician discussing the risks and benefits of, and alternatives to, treatment through a remote evaluation that results in the patient’s agreement or signed authorization to be treated through an evaluation conducted through appropriate technology when the physician is in a location remote from the patient.

Further, a “patient” is defined as:

[a] person for whom the physician provides healthcare services or the person’s representative.

Additional definitions and references of importance are contained within Rule 4731-11-01.

With regard to the central purpose of 4731-11-09, Prescribing to persons not seen by the physician, the rule now authorizes a provider to prescribe non-controlled substances to a patient whom the provider has never physically examined and who is in a remote location from the provider, when the provider:

• Establishes the patient’s identity and physical location;
• Obtains the patient’s informed consent for treatment through remote examination;
• Obtains the patient’s consent to forward the medical record to the patient’s PCP or other healthcare provider;
• Completes a medical evaluation through interaction with the patient that meets the minimal standards of care appropriate to the condition for which the patient presents;
• Establishes a diagnosis and treatment plan, including documentation of necessity for the utilization of a prescription (non-narcotic) drug; including contraindications to the recommended treatment;
• Documents the consent to remote care, pertinent history, contraindications and referrals made to other providers;
• Provides appropriate follow-up care or recommended follow-up care;
• Makes the medical record of the visit available to the patient; and
• Uses appropriate technology that is sufficient for the physician to conduct all of the above steps and as if the medical evaluation occurred in-person.

In a departure from other states, Ohio’s new regulation also permits prescribing of controlled substances to a patient located remotely from the provider in the following instances:

• On-call/cross-coverage arrangements of active patients of a physician and the physician complies with the standards of prescribing non-controlled substances to remotely located patients;
• The patient is: (1) physically located in a hospital/clinic that is DEA registered to personally furnish or provide controlled substances; (2) is being treated by a healthcare provider acting in the usual course of their practice and within the scope of their license, and they are DEA registered to prescribe controlled substances in Ohio;
• The patient is being treated by, and in the physical presence of, a healthcare provider acting in the usual course of their practice and within the scope of their professional license, and is DEA registered to prescribe controlled substances in Ohio;
• The physician has obtained from the DEA a special registration to prescribe or otherwise provide controlled substances in Ohio; and
• The physician is: (1) the medical director, hospice physician, or attending physician for a “hospice program” licensed in Ohio or, (2) is a medical director or attending physician for an “institutional facility” licensed in Ohio, and (3) in either instance: (a) the patient is enrolled in that hospice program or is an inpatient at the institutional facility, and (b) the prescription is transmitted to the pharmacy consistent with Ohio board of pharmacy rules.

Interestingly, the regulation points out that “[n]othing in this rule shall be construed to imply that one in-person physician examination demonstrates that a prescription has been issued for a legitimate medical purpose within the course of professional practice.”  Again, in my opinion, this emphasizes that the burden is on the provider to demonstrate that the appropriate standard of care has been met for each patient seen, whether or not in-person or remotely.

With regard to disciplinary enforcement by the SMBO, the regulation notes that “A violation of any provision of this rule, as determined by the board, shall constitute any or all of the following”:

1. “Failure to maintain minimal standards applicable to the selection or administration of drugs,” as that clause is used in division (B)(2) of section 4731.22 of the Revised Code;
2. “Selling, prescribing, giving away, or administering drugs for other than legal and legitimate therapautic purposes,” as that clause is used in division (B)(3) of section 4731.22 of the Revised Code; or
3. “A departure from or the failure to conform to minimal standards of care of similar practitioners under the same or similar circumstances, whether or not actual injury to a patient is established,” as that clause is used in division (B)(6) of section 4731.22 of the Revised Code.

For a copy of the new rule, click on the following embedded links: 4731-11-09 and 4731-11-01.