The Texas Medical Board ("Board" and "TMB") adopts amendments to §§174.2, 174.5, 174.6, and 174.8, concerning Telemedicine, without changes to the proposed text as published in the March 6, 2015, issue of the Texas Register (40 TexReg 1015). The sections will not be republished.

TMB sought stakeholder input through Stakeholder Groups, which made comments on the suggested changes to the rules at a meeting held on October 31, 2014. The comments were incorporated into the proposed rules.

§174.2 - Definitions

The amendment to §174.2, relating to Definitions, adds language to the definition for "Established Medical Site", under paragraph (2), clarifying that a defined physician-patient relationship is defined by §190.8(1)(L) of this title (relating to Violation Guidelines). Amendments are also made to the rule stating that a patient's private home is not considered to be an established medical site, by striking the phrase "except when the care provided to the patient is limited to mental health" and adding language stating "except as provided in §174.6(d) of this title (relating to Telemedicine Medical Services Provided at an Established Medical Site)." Further amendments provide that an established medical site includes all Mental Health and Mental Retardation Centers (MHMRs) and Community Centers, as defined by Health and Safety Code, Chapter 534, where the patient is a resident and the medical services provided to the patient are limited to mental health services.

The amendments further adds a new paragraph (11), which adds a definition for "group or institutional setting," thereby including residential treatment facilities, halfway houses, jails, juvenile detention centers, prisons, nursing homes, group homes, rehabilitation centers, and assisted living facilities.

§174.5 - Notice to Patients

The amendments to §174.5, relating to Notice to Patients, strikes the phrase "and counsel" in subsection (c).

§174.6 - Telemedicine Medical Services Provided at an Established Medical Site

The amendments to §174.6, relating to Telemedicine Medical Services Provided at an Established Medical Site, amends language to be consistent with other parts of this rule and §190.8(1)(L) by substituting the term "defined" for "proper" before the phrase "physician-patient relationship." Section 174.6(c) is further amended to clarify that patient site presenters are not required at established medical sites when mental health services are being provided, unless there are "behavioral emergencies." The term "behavioral emergencies" is defined to provide clarity as to what constitutes a behavioral emergency. Subsection (d)(1) is added to expand which types of patient residential locations may be considered established medical sites, and the limits of services that may be provided at these locations. The amendment allows a patient's private home, which includes a group or institutional setting where the patient is a resident, to be considered an established medical site, if the medical services being provided in this setting are limited to mental health services. Subsection (d)(2) is added, setting forth the requirements that must be met in order for medical services, other than mental health services, to be provided at the patient's home, including a group or institutional setting where the patient is a resident. They include requirements that: a patient site presenter be present; a defined physician-patient relationship be established; and the patient site presenter have sufficient communication and remote medical diagnostic technology to allow the physician to carry out an adequate physical examination while seeing and hearing the patient in real time, with all such examinations being held to the same standard of acceptable medical practices as those in traditional clinical settings. The amendments further clarify that the use of an online questionnaire or questions and answers exchanged through email, electronic text, chat, telephonic evaluation or consultation with a patient, do not meet the requirements to establish a defined physician-patient relationship.

§174.8. Evaluation and Treatment of the Patient.

The amendments to §174.8, relating to Evaluation and Treatment of the Patient, changes language to be consistent with other parts of this rule stating that medical treatment and diagnosis via telemedicine is held to the same standards for acceptable medical practices as those in traditional in-person clinical settings. In subsection (a)(2), language is amended related to establishing a diagnosis through the use of acceptable medical practices. Such practices include establishing a defined physician-patient relationship, including documenting and performing a patient history, mental status examination, and physical examination, all of which must be performed as part of a face-to-face or in-person evaluation as defined in §174.2(3) and (4) of this title (relating to Definitions). This amendment further restates the exception to the requirement for a patient-site presenter that applies to mental health services, except in cases of behavioral emergencies, and the need for appropriate diagnostic and laboratory testing to establish diagnoses, as well as identify underlying conditions or contra-indications, to treatment recommended or provided.

TMB received public written comments regarding proposed rules in Chapter 174 from the following: Texas Medical Association (TMA); Texas Tech University Health Science Center (TTUHSC); University of Texas Medical Branch at Galveston (UTMB); University of Texas System, Office of General Counsel; Texas e-Health Alliance; Texas Academy of Family Physicians; Texas Chapter of the American College of Physician Services; Texas Pain Society; Texas Osteopathic Medical Association; Texas Ophthalmological Association; American Telemedicine Association; Teladoc; and approximately 200 individuals. The individual commenters included patients, sellers of certain telehealth products, business owners, and physicians, including several physicians that are employees of Teladoc.

In addition, oral comments on the proposed amendments were received from approximately 11 individuals at a public hearing on Thursday, April 9, 2015. Additionally, a number of commenters gave responses to questions from members of TMB during the public meeting. The commenters included: the Executive Vice President of the Texas Tech University Health Science Center (TTUHSC), who is a physician and is responsible for administration and operation of the TTUHSC Telemedicine Division; an individual physician practicing telemedicine; an individual physician practicing psychiatry; an individual physician associated with telehealth facilitation company, AVIA; three individuals associated with Teladoc, including the Chief Medical Officer, Chief Financial Officer and a physician employee; CEO of Texas Association of Business; an individual physician, who is a member of the American College of Emergency Physicians; an individual physician, who is a family physician; a physician who is the owner of Nuphysia, a telemedicine company and is former owner and co-founder of Teladoc, Inc.

Certain commenters submitted written and oral comments designated as being in response to the proposed amendments to §190.8(1)(L), the proposed amendments to Chapter 174, or both in combination. Amendments to both chapters are interconnected, as proposed amendments to §190.8(1)(L) mirrors the proposed revisions in Chapter 174 with respect clarifying the requirements for the establishment of a defined physician-patient relationship prior to prescribing medications/drugs. Therefore, since the comments relate to both proposed §190.8(1)(L) and the rules in Chapter 174 and are interconnected, all comments submitted in response to one or both chapters have been included in this Notice, with corresponding TMB responses.

The following is a summary of the comments and the TMB responses:

Commenter: Texas Tech University Health Science Center (TTUHSC)

1. TTUHSC utilizes telemedicine, supports the amendments to the rule, and agrees with the necessity of forming a defined physician-patient relationship prior to prescribing medication/drugs.

2. TTUHSC recommended providing an exception "to what is required to establish a physician-patient relationship in emergent care to allow for the use of telemedicine technology in emergency medical services (EMS) units, stating in part that it would "allow EMT/Paramedics to have a new resource for linking victims of trauma or other urgent care conditions through telemedicine technology to the Trauma Centers or other physician providers, such as cardiologists or neurologists."

3. TTUHSC recommended adding language to the purpose section under §174.1 that would further clarify that the TMB priority is to "protect the public health and welfare in matters pertinent to the practice of medicine."

TMB Response

With respect to TTUHSC's comments on the role of telemedicine in an emergent care setting, it should be noted that under the adopted amendments, patients can interact with their physicians via telemedicine beyond the traditional office visit including receiving appropriate care from their homes, between multiple health care settings, and from other medical sites like a school nurse's office, a fire station or even an oil rig, contingent upon the site having sufficient diagnostic equipment and a trained medical professional, such as a licensed vocational nurse, available to assist in presenting the patient's vital signs and other objective medical information needed by the physician.

Further, the amendments adopted do not affect existing rules under Chapter 197, related emergency medical services and the delegation of certain medical tasks by a physician to emergency personnel. While TMB agrees generally with TTUHSC's statements with respect to TMB's purpose in protecting the public through the regulation of the practice of medicine, including the use of telemedicine, TMB disagrees that such additional language is necessary, as such language is clearly stated in the Board's mission statement.

Commenter: University of Texas Medical Branch (UTMB)

1. UTMB utilizes telemedicine, supports the amendments to the rule, and agrees with the necessity of forming a defined physician-patient relationship prior to prescribing medication/drugs.

2. UTMB recommended consideration of clarification of the term "dangerous drug."

Commenter: University of Texas System (UT)

1. UT supports the amendments to the rule.

2. UT recommended consideration of clarification of the term "dangerous drug" by citing to the applicable portions of the Texas Health and Safety Code.

TMB Response:

TMB disagrees with UTMB and UT's comments related to "dangerous drugs," as the term is specifically defined in the Health and Safety Code.

Commenter: Texas Academy of Family Physicians (TAFP), Texas Chapter of the American College of Physician Services (TEX-ACPS), Texas Pain Society (TPS); Texas Osteopathic Medical Association (TOMA), Texas Ophthalmological Association (TOA)

1. In a combined statement, TAFP, TEX-ACPS, TPS, TOMA, and TOA expressed support for the use of telemedicine in Texas, support for the amendments to the rule, and agreement with the necessity of forming a defined physician-patient relationship prior to prescribing medication/drugs through the performance of a face-to-face visit or in person evaluation, as those terms are defined in the board rules.

2. The commenters drew a distinction between telemedicine and "telephonic consultation" utilized by certain vendors.

3. The commenters acknowledged that the amended rule does not prevent the use of the long-established model of "call coverage" between physicians, but recommended clarifying that the use of this model is allowed under the amendments, in view of claims by certain telephone service companies that they are providing call coverage.

4. The commenters suggested that §174.11 be amended to clarify the parameters of appropriate on-call service arrangements.

TMB Response:

TMB acknowledges the comments regarding "call coverage." The amended rules continue to allow "call coverage" and this was confirmed by TMB's discussion on Friday, April 10, 2015 in open session at the TMB meeting. Call coverage is a long-established model where physicians cover one and other when an established patient's regular physician is not on call or is absent short-term from being available.

TMB declines to make the amendments as suggested to §174.11 at this time, but will continue to review and consider revising the rule to add clarifying parameters of appropriate on-call service arrangements via the stakeholder and rulemaking process.

Commenter: Texas e-Health Alliance (TEHA)

TEHA supports the amendments to the rules, and agrees with the necessity of forming a defined physician-patient relationship prior to prescribing medication/drugs.

Commenter: Physician practicing psychiatry

This individual supports the amendments to the rule and acknowledged the expansion of the locations and circumstances where mental health services can be provided, and to consider further possible expansion of the locations and circumstances where telemedicine maybe utilized.

Commenter: Texas Medical Association (TMA)

1. TMA supports the amendments to the rule, and agrees with the necessity of forming a defined physician-patient relationship prior to prescribing medication/drugs.

2. TMA fully supports the use of telemedicine, citing to its Policy No. 290.008 (Telemedicine Use in protecting the Health and Welfare of Citizens), and stating, "For example, if a traditional in-person visit requires a physical examination of the patient prior to prescribing medication, the same standard should apply to a telemedicine consultation or treatment plan." TMA distinguishes telemedicine from "telephonic consultations" offered by various vendors.

3. TMA acknowledged that the rule did not prevent the use of the long-established model of "call coverage" between physicians, but recommended clarifying the use of this model in view of claims that the amendments to rule 190.8, as adopted, somehow prohibits "call coverage" for medical services provided via the traditional office or hospital-based setting.

4. TMA recommended that §174.11 be amended to clarify the parameters of appropriate on-call service arrangements, in order to "ensure that patient care is properly coordinated and that the patient has access to locally available follow-up in-person care", stating that the "availability of local in-person follow-up care is critically important to patient care and treatment plan management."

TMB Response:

TMB concurs with the comments from TMA in part. The rules do not create any new standard related to the necessity of a defined physician-patient relationship. The amendments to rule 174 also conform to and mirror the requirements in §190.8(1)(L) related to the requirements for establishing a defined physician-patient relationship. The amended rule allows for either a face-to-face visit or in-person evaluation which is consistent with TMA's policy related to telemedicine.

The rule has an expanded definition of an established medical site, which now includes a patient's home, subject to certain requirements. The rule also further increases access to care by expansion of methods and requirements for providing mental health services. The increased access to mental health services was in direct response to the telemedicine stakeholders' input.

The TMA Policy is consistent with the amended rules in §174.8(b), which provides: "Treatment and consultation recommendations made in an online setting, including issuing a prescription via electronic means, will be held to the same standards of acceptable medical practices as those in traditional in-person clinical settings."

The amended rule continues to allow "call coverage" and this was confirmed by TMB's discussion on both April 9 and April 10, 2015. Call coverage is a long-established model where physicians cover one and other when an established patient's regular doctor is not on call or is absent short-term from being available..

When considering the proposed amendments, one of the physician TMB members made the following statement regarding call coverage:

"The benchmark of my entire career -- and I'll let the other physicians speak for themselves -- has been the relationship that I share with each patient because with that relationship is not only my obligation to give them my best advice but making myself accountable to that patient. And accountability is absolutely crucial and can't be thrown aside. And I -- the comments yesterday said, well, getting telephone advice is the same as talking to someone's partner on the weekend. That is absolutely not true."

The whole purpose of on-call is to maintain continuity of care between the physician who specifically arranged for the call coverage and the covering physician who agreed to provide the coverage. Many times the physicians are in same practice which ensures continuity of care. Additionally, the traditional on-call coverage arrangement ensures physician accountability because there is an existing physician-patient relationship.

TMB declines to make the amendments as suggested to §174.11 at this time, but will continue to review and consider revising the rule to add clarifying parameters of appropriate on-call service arrangements via the stakeholder and rulemaking process.

Commenter: Individual physician specializing in family practice

The physician spoke in favor of the necessity of a defined physician-patient relationship. The physician described a situation in which he actually treated a patient who had utilized a telephone only medical consult, by a physician who had never seen the patient, prior to the telephone encounter (meaning there had not been either a face-to-face visit or in-person evaluation). That telephone consult resulted in the prescribing of an antibiotic for a diagnosed "respiratory infection." This treatment failed to improve the patient's condition. When the patient was actually seen in-person and evaluated by the commenter, which included listening to the patient's lungs, it was determined that the patient was having a severe asthma attack and had significantly reduced lung capacity. The finding of asthma demonstrated the diagnosis of respiratory infection was incorrect, and the prescribing of an antibiotic was unnecessary and non-therapeutic for the actual condition.

This commenter stressed that in addition to discussing a patient's concern and complaints, it is imperative that a physician see the patient, take vital signs, such as listening to the lungs, etc., and compile this data, which are indispensable to enable a physician to make a correct diagnosis and determine how a patient should be treated.

TMB Response: