Ohio Medical Board Telemedicine Prescribing Rule Update
. . . WITH A SEUSSIAN TWIST (STRICTLY FOR FUN)
BACKGROUND – “FROM THERE TO HERE, FROM HERE TO THERE. . . “
Currently, Ohio Admin. Code 4731-11-09 entitled “Prescribing to persons the physician has never personally examined” requires an in-person physical examination to be performed by a physician prior to the physician issuing a prescription for any drug, with limited exceptions (e.g., institutional settings, on-call situations, cross-coverage situations, certain hospice settings, etc.). This requirement has been the subject of a fair amount of review and debate over the past four to five years by the State Medical Board of Ohio (SMBO), the Ohio Legislature, Ohio Governor John Kasich, and other interested parties.
Without any change to Rule 4731-11-09, the SMBO in a 2012 interpretive guideline addressing Rule 4731-11-09, opined that when remotely prescribing a non-controlled substance, “[t]he examination need not be in-person if the technology is sufficient to provide the same information to the licensee as if the exam had been performed face-to-face.” In this interpretive guideline, the technology that is considered “sufficient” is medical equipment capable of transmitting in real-time the patient’s vital signs and other physical data, and requires appropriate diagnostic medical equipment capable of transmitting in real-time high-quality images (including the ability to adjust images to conditions) of the patient’s symptoms.
In mid-2014, the SMBO began the process of formally reviewing Rule 4731-11-09 with the intention of updating this rule, seemingly to bring it in line with the aforementioned 2012 interpretative guideline. The SMBO issued an initial draft release of the rule on October 8, 2014, and subsequently released a revised draft on December 17, 2014. These two drafts of the rule both allowed for a physician to prescribe non-controlled substances to a patient that the physician had not previously examined, provided the physician utilized medical equipment to secure vital signs and images in real-time prior to writing the prescription. The rule also contained a limited number of exceptions which, for the most part, were consistent with the current set of exceptions set forth in Ohio Admin. Code 4731-11-09.
DISAGREEMENTS ARISE – “YOU DO NOT LIKE THEM, SO YOU SAY. . . .”
On February 11, 2015, the Ohio House of Representatives introduced the State’s biennial budget, H.B. 64. Interestingly, the biennial budget bill contained an amendment to the Ohio Revised Code definition of “Telehealth Service” and certain provisions that addressed the standard of care for remote prescribing by physicians.
Specifically, the proposed amendment to the Ohio Revised Code authorized a physician to:
“ C) [* * * *] prescribe, dispense, or otherwise provide, or cause to be provided a prescription drug that is not a controlled substance to a person on whom the physician has never conducted a medical evaluation, and who is at a location remote from the physician, if the physician meets all of the following requirements:
(1) In a manner that is consistent with the standard for in-person care by a physician, the remote physician shall complete and document a medical evaluation of the patient and collect clinical data as needed to establish a diagnosis, identify any underlying conditions, and identify any contra-indications to the treatment that is recommended or provided.
(2)(a) Except as provided in division (C)(2)(b) of this section, the remote physician shall complete an examination of the patient using appropriate technology that is capable of all of the following:
(i) Transmitting images of the patient’s condition in real time;
(ii) Transmitting information regarding the patient’s physical condition and other relevant clinical data needed for compliance with division (C)(1) of this section;
(iii) Being adjusted for better image quality and definition.”
See Ohio H.B. 64.
On May 13, 2015, while H.B. 64 was still pending in the legislature, the SMBO revised Rule 4731-11-09 a third time. This version of the proposed rule deleted the words “vital signs” and replaced them with the words “physical data” as being required to be transmitted to a remote prescribing physician.
The proposed draft of Rule 4731-11-09 read in relevant part:
(1) A physician shall complete and document a clinical assessment and collection of relevant clinical history which conforms to minimal standards of care consistent with an assessment that was completed in a face-to-face interaction necessary to establish the diagnosis and identify any underlying condition and/or contra-indications to the treatment recommended or provided;
(2) The physician shall complete an examination of the patient using appropriate diagnostic medical equipment that meets both of the following criteria:
(a) The diagnostic medical equipment is capable of transmitting in real-time the patient’s physical data;
(b) The diagnostic medical equipment is capable of transmitting in real-time images of the patient’s physical condition and also has the ability to be adjusted for better quality and definition.
“A PERSON’S A PERSON, NO MATTER HOW SMALL . . . “
As a result of the dueling attempts by the SMBO and the Ohio Legislature to set forth the standard of care for remote physician prescribing, two factions came to the fore: (1) Those that believe a physical examination (regardless of whether it is done in-person or via video conferencing with the patient) requires a physician to secure basic vital signs (or stated another way “physical data”), and (2) Those that believe that the need for such information should be left to the discretion of the treating physician on a case-by-case basis depending upon the symptoms the patient is presenting with.
For example, the Ohio Academy of Family Physicians believes that the amendment was written to accommodate a specific telemedicine company that wished to do business in the Ohio Market. In a May 27, 2015 letter from the Academy directed to Ohio State Senator David Burke, the Academy expressed its opposition to the telemedicine amendment added to H.B. 64.
The Academy, in its letter, advised Senator Burke that the Academy had been working along with physician organizations and stakeholders with the SMBO to draft rules and interpretive guidelines that provide safeguards for the use of telemedicine, “and that a lot of time and energy has been invested into drafting Rule 4731-11-09, which was approved during the Medical Board’s meeting held May 13, 2015”.
Similarly, the SMBO forwarded a letter to Representative Ryan Smith expressing its opposition to the amendment. In its letter, the Executive Director of SMBO noted that in order “[t]o ensure a high quality of remote medical care” the provider/prescriber should, among other things, have appropriate diagnostic medical equipment capable of transmitting:
• In real-time, the patient’s vital signs and other physical data;
• A real-time image of the patient’s symptoms and that also has the ability to adjust for better image quality and definition.
Notwithstanding the opposition by the Ohio Academy of Family Physicians and the SMBO, H.B. 64 was reported out of conference committee and ultimately sent to Governor Kasich with the legislature’s language regarding telehealth and the standard of care for remote prescribing intact.
On June 30, 2015, Governor Kasich exercised his right of line-item veto to the biennial budget, and in doing so, struck, among other provisions, the specific provisions relating to the amendment to the definition of “telehealth service”, including the prescribing language.
At around the same time period H.B. 64 was making its way through the legislative process, the SMBO approved on May 13, 2015 a third revised draft of Rule 4731-11-09 and announced that it was being forwarded to Ohio’s Common Sense Initiative for administrative review (and public comment). However, the SMBO subsequently pulled the Rule from consideration by the Common Sense Initiative. It seems plausible that this third proposed rule was pulled from further consideration in light of the legislative activity surrounding H.B. 64 and the Governor’s subsequent line-item veto of the telehealth provisions.
WHAT’S A BOARD TO DO? – “THE MORE THAT YOU READ, THE MORE THINGS YOU WILL KNOW, THE MORE THAT YOU LEARN, THE MORE PLACES YOU’LL GO”
On December 22, 2015, Governor Kasich signed H.B. 188 into law with an effective date of 90 days. This law enacted Section 4731.74, Ohio Revised Code, which requires, among other things, the SMBO to adopt revised rules governing the prerequisites for a physician to prescribe, personally furnish, otherwise provide, or cause to be provided a prescription drug to a person on whom the physician has never conducted a physical examination and who is at a location remote from the physician. The rule is required to be adopted not later than March 23, 2017. The new rule will be applicable to physician assistants who have prescriptive authority.
After enactment of Section 4731.04, the SMBO acted swiftly. On February 10, 2016, the board convened a hearing, inviting interested parties to present information to the board about the adoption of appropriate rules for physician prescribing for patient’s not previously seen by a physician. Several diverse interests were represented at the hearing and there was a fair amount of productive dialog exchanged between board members and the different speakers.
Last week, the SMBO released a complete overhaul of its proposed Rule 4731-11-09. In its latest draft, the SMBO has seemingly taken the same approach that many other progressive states recently have taken with their telemedicine rules: rather than delineating a set of specific rules, SMBO has reverted to a more neutral and balanced approach, focusing on minimal standards of care applicable to the condition for which the patient presents to the physician. In other words, the onus is on the physician to conduct a proper telemedicine visit (and proper prescribing) depending upon the facts and circumstances for which the patient presents. Should the physician fail, the physician could be the subject of disciplinary review by the SMBO. This is, in reality, the standard that all physicians are subject to in order to maintain their license in any given state.
Specifically, the proposed rule would now authorize a physician to prescribe non-controlled substances to a person whom the physician has never conducted a physical examination on and who is at a remote location from the physician when the physician:
- 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 contra-indications to the recommended treatment;
- Documents the care provided and referrals made to other providers;
- Provides appropriate follow-up care or recommend 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;
The proposed rule also addresses prescribing of controlled substances in a telemedicine context and limits such prescriptions to on-call/cross-coverage arrangements, consistent with telemedicine practice as defined under federal law (21 CFR 1300.04), or the patient is an inpatient or resident of an “institutional facility”.
What is the next step you ask? The SMBO seeks public input on proposed rules several times during the rule-making process. Public input is sought after the SMBO has conducted its initial review of rules, after rules are filed with the Common Sense Initiative Office, and at the public hearing that occurs after the rules are formally filed with the Joint Committee on Agency Rule Review.
The SMBO is currently seeking public comment on the proposed Rule 4731-11-09. Comments are due by May 12, 2016. Comments that are received will be reviewed by the SMBO and could possibly result in changes to the initially proposed language before the rule is filed with the Common Sense Initiative Office.
While it remains to be seen what the final result will be, the SMBO (along with many other state medical boards) is certainly to be commended for continuing to tackle this issue in a forthright manner – seeking to balance its mandate to protect the interests of the public on the one hand, with the current and future status of the daily practice of medicine on the other. With disquieting projected physician shortages, increasing financial burdens on government and family budgets, and inconceivable technological advances being made at precipitous pace, telemedicine is destined to become indispensable to the provision of medical care in all settings and circumstances.
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