The example specifically demonstrates TMB's rational connection between the factual basis for the rule and the rule as adopted, which is to ensure patient safety, and reduce inherent risks of misdiagnosis and improper treatment of patients if there is not a defined physician-patient relationship, including the ability to perform a physical examination.

Commenter: Individual, owner of Nuphysician and former owner/founder of Teladoc

1. This physician spoke in favor of the amendments to the rule, and agreed with the necessity of forming a defined physician-patient relationship prior to prescribing medication/drugs.

2. This individual stated he owns a telemedicine company that complies with existing rules and that will be in compliance with the adopted rules. The company uses two-way communication with video conferencing and related peripheral devices.

TMB Response:

The comments demonstrate the rule allows, and as amended will continue to allow for the practice of telemedicine.

Commenter - Individual physician, owner of Doc-Aid, and who practices emergency medicine as well as telemedicine

1. This physician spoke in favor of requiring a face-to-face visit or in person evaluation to establish a proper physician-patient relationship, and asserted that she does not believe a physician can rely on a patient's self-reported history alone. She asserted that the mere use of a telephone call to diagnose and treat a patient is inadequate.

2. This individual commented against requiring a patient site presenter on follow-up visits or for the need to have an annual face-to-face visit or in-person evaluation yearly for all patients.

TMB Response:

TMB concurs in part with the comments of the individual. This physician articulated a healthcare model that comports with both the existing and newly adopted rule. The physician requires a patient to establish a physician-patient relationship with an in-person evaluation at one of her clinics and then provides follow-up care to the patient via using real-time videoconferencing, which complies with both the existing and amended rule.

This commenter also stated, "Any physician who's worked in the ER or been in practice for some time knows that you cannot rely solely on a new patient's self-reported symptoms." This comment clearly demonstrates a rational connection between the factual basis for the rule and the rule as adopted, i.e., improving patient safety by establishing a defined physician-patient relationship.

TMB believes the comments regarding the patient site presenter need to be clarified. Under the both the existing rule and amended rule the need for a patient site presenter is not necessarily needed if the physician continues to treat the patient for a diagnosis established during the initial clinic visit. If a new condition arises the physician can provide treatment for 72 hours, and if the problem does not resolve they need to have either a face-to-face visit or in-person evaluation.

TMB disagrees with commenter regarding her statement that a yearly face-to-face visit or in-person evaluation visit is unnecessary. The yearly requirement is to ensure that there is updated information necessary for the physician to ensure continuity of care, and to verify the patient's health status, and changes in health status, if any.

Texas Association of Business (TAB)

TAB asserted support for the use of telemedicine in Texas, and asserted general opposition to the proposed amendments. TAB requested that TMB withdraw the proposed amendments and "postpone issuing rules until the Legislature is able to address the use of telemedicine."

TMB Response:

TMB disagrees that the amendments will limit the use of telemedicine or harm the telemedicine industry's growth in the state. To the contrary, the amendments adopted will result in expanded opportunities for patients to interact with their physicians beyond the traditional office visit and clarify that a physician-patient relationship can be established through a "face-to-face" visit held either in person or via telemedicine. The rules expand the scenarios already allowed to include greater access to treatment from a patient's home and greater access to treatment for behavioral and mental health. Essentially, the only scenario prohibited in Texas is one in which a physician treats an unknown patient using telemedicine, without any objective diagnostic data, and no ability to follow up with the patient. Therefore, TMB declines to withdraw the proposed amendments.

Commenter - American Telemedicine Association (ATA)

1. ATA asserted some support for the amendments related to the provision of mental health services via the use of telemedicine, but commented generally against the remaining proposed amendments, stating that they will result in "barriers that are less useful and more problematic as it is implemented."

2. ATA expressed concerns that the amended rules interfere with the physician's ability to prescribe over the telephone to a patient with whom the physician has an existing relationship.

3. ATA was against requiring a patient site presenter.

4. ATA wanted clarification on the rules related to follow-up requirements when treating an existing patient for a new, previously undiagnosed condition.

5. ATA equated call coverage to "telephone based-services for patients with whom they have no prior relationship. In the majority of circumstances the physician providing such care has little or no access to a medical history of the patient, other than that provided orally by the patient."

6. ATA agreed that any telemedicine care must meet the same standard of care as that which applies to the traditional in-clinic setting.

TMB Response:

TMB disagrees with the commenter and declines to withdraw or make changes to the amendments opposed. The amended rules apply equally to all Texas licensed physicians. The amended rule sets out requirements for prescribing medications/drugs, along with amendments to Chapter 174, which will increase access to healthcare by expanding sites where patients can obtain healthcare, including their homes.

TMB disagrees with ATA's comment #2. The commenter seems to misunderstand the rules' application to patients with whom there is an existing physician-patient relationship.

With respect to ATA's comment #3, the amendments' requirements related to site presenters and/or peripheral devices are designed to ensure that objective medical information, such as vital signs, temperature, blood pressure, and the condition of eyes, ears, nose, throat, and lungs are obtained so as to assist a physician in formulating a correct diagnosis and prescribing therapeutic medications/drugs.

While a patient's self-description of symptoms is one element utilized to make a diagnosis and treatment decision, it is insufficient to rely on the patient's self-reported history alone. Physicians are trained to palpate, use tactile skills and make physical observations, in addition to asking questions, to confirm or rule out patient reported symptoms.

The cornerstone of the physician-patient relationship is seeing the patient in person or via a face-to-face visit, in order to "put hands on" the patient and take vital signs. Observation of the patient in real time is of paramount importance. In order to formulate a correct diagnosis and adequately treat disease, it requires using evidence-based medicine after evaluating the entire patient's clinical presentation, not just based on a subjective history provided over the telephone by a complete stranger to a physician with no ability to take any type of vital signs or visually observe the patient. Obtaining such objective information is consistent with the generally accepted standard of care utilized in a traditional in office visit.

The amended rule will allow greater access to healthcare, as the amendments adopted will result in expanded opportunities for patients to interact with their physicians beyond the traditional office visit and clarify that a physician-patient relationship can be established through a "face-to-face" visit held either in person or via telemedicine. Essentially the only scenario prohibited in Texas is one in which a physician treats an unknown patient using telemedicine, without any objective diagnostic data, and no ability to follow up with the patient.

Contrary to the individual's statements, the rules do not limit a patient to an in-person visit to establish a physician-patient relationship before receiving treatment, as the relationship can also be established via appropriate face-to-face telemedicine.

Regarding ATA's comment #4, under both the existing and amended rule, a patient site presenter is not strictly required for continued treatment for a diagnosis established during the initial clinic visit. If a new, previously undiagnosed condition arises the physician can provide treatment for 72 hours, and if the problem does not resolve the patient must have either a face-to-face visit or in-person evaluation.

TMB disagrees with ATA's characterization of call coverage. Call coverage is a long-established model where physicians cover one and other when the primary doctor is not on call or is absent short-term from being available to patients.

This practice is not prohibited by the adopted amendments to the rule. Specifically, §174.11, states: On-call Services.

Physicians, who are of the same specialty and provide reciprocal services, may provide on-call telemedicine medical services for each other's active patients.

TMB agrees that telemedicine is held to the same standard of care as that in a traditional office setting, as is expressly set out in the amended rule. This statement by ATA is consistent with the comments of TMA.

Commenter: Teladoc- Although Teladoc's comments specifically pertained to the proposed amendments to §190.8(1)(L), such proposed language is incorporated and referenced in the proposed rules in Chapter 174. As such, since Teladoc's comments pertain to both proposed the amendments to Chapter 174 and §190.8(1)(L), they are included herein.

1. Teladoc comments that the amendments will limit access to health care.

2. Teladoc asserts the amendments destroy the ability to provide safe medical services to its patients in Texas. Teladoc asserts that it provides increased access to healthcare.

3. As part of its written comments, Teladoc provided an article published in Health Affairs in February 2014. The article described a study related to Teladoc based on approximately 3,700 consults done in California for a large public employer.

4. Teladoc asserts that the amendments will increase health care costs for Texas individuals. Companies have been performing telephone only consults without an established physician-patient relationship for years.

5. Teladoc asserts the amendments will impose additional burdens, conditions, or restrictions on physicians in excess of or inconsistent with relevant statutory provisions of the Texas Medical Practice Act.

6. Teladoc asserts they have not been subject of a medical malpractice claim.

7. Teladoc commented that the amendments prohibit "on-call coverage."

8. In its public oral comment on Thursday, April 9, 2015, Teladoc generally asserted that the amendments create an unnecessary burden on patients by requiring a defined physician-patient relationship. Teladoc further asserted that the amendments are unnecessary and will cause harm to Teladoc.

TMB Response to Teladoc's Comment Nos. 1 and 2:

TMB disagrees with Teladoc's comments and assertions. The statements of Teladoc were unsupported assertions of a general nature with only self-serving anecdotal evidence in support.

TMB agrees that the purpose of the rules is to increase access to healthcare; however, access must be balanced with patient safety and ensuring continuity of care, by applying the generally accepted standard of care to all models of health care that is the same as that which applies to the traditional in-clinic setting. The balance is achieved by requiring the establishment of a defined physician-patient relation using several acceptable modalities, including a traditional office visit, in-person evaluation, or a face-to-face visit using two-way audio and video technology coupled with either a site presenter or peripheral devices.

The types of sites that can be utilized under the amended rule to treat patients and prescribe medication/drugs, if needed, include an oil rig, clinic school nurses offices, fire station, a kiosk at the mall, and any other location where two-way video and audio communication devices exist, and where a site presenter and peripherals, diagnostic equipment is present. The amended rule sets the same standards for all physicians before prescribing medication/drugs, and expands access to health care by allowing such evaluations to be performed via a face to face visit, including at locations such as a patient's home, subject to certain requirements, including that for non-mental health conditions, a health care provider come with proper equipment, such as a stethoscope, thermometer, blood pressure monitor, etc., so vital signs can be taken, and the eyes, ears, nose and throat can be examined.

The purpose of a site presenter and/or peripheral devices is to obtain objective medical information that is obtained by listening to lungs, obtaining temperatures, blood pressure, and/or looking at skin, or in ears, nose, and mouth. While a patient's self-description of symptoms is one element utilized to make a diagnosis and treatment decision, it is insufficient to rely on the patient's self-reported history alone. Physicians are trained to palpate, use tactile skills and make physical observations, in addition to asking questions.

The cornerstone of the physician-patient relationship is seeing the patient in person or via a face-to-face visit, in order to "put hands on" the patient and take vital signs. Observation of the patient in real time is of paramount importance. In order to formulate a correct diagnosis and adequately treat disease, it requires using evidence-based medicine after evaluating the entire patient's clinical presentation, not just based on a subjective history provided over the telephone by a complete stranger to a physician with no ability to take any type of vital signs or visually observe the patient.

One example of the importance of taking vital signs is demonstrated by the following pilot study regarding diagnosis and treatment of sepsis in the emergency room, done by Wolters Kluwer jointly with Huntsville Hospital of Alabama.

Sepsis is the most common cause of death in hospital critical care, causing nearly 258,000 deaths in the U.S. each year. The importance of seeing the patient by face-to-face visit or in-person evaluation is demonstrated by the statement in the pilot study that, "... early detection and diagnosis was elusive because sepsis initial presentation can be very subtle and shares many symptoms of multiple illnesses." In order to effectively diagnose sepsis, even in a hospital, it requires obtaining critical vital signs to determine if a patient is experiencing hypothermia, hyperthermia, rigors with chills, tachycardia, or tachypnea along with certain other specific clinical information, along with related laboratory tests. None of this can be done via a one-time telephone only consult. This commenter admitted that Teladoc's treatment decisions are based solely on history and answers to questions over the telephone.

Teladoc uses only telephone consults in Texas; however, it admitted that it utilizes video technology in other states. The amended rules do not preclude the use of video technology. Several commenters stated utilizing video technology that complies with both the existing and amended rule in the use of telemedicine to provide care. Teladoc has opted to use telephone only consults with unknown patients, to gain a competitive advantage over telemedicine providers by not having to purchase the required technology or employ a site presenter, and therefore lack the means to obtain objective medical information before making a diagnosis or treatment decisions. This reliance on only subjective patient described symptoms does not meet the standard of care that applies to the traditional in-clinic setting, as stated by TMB members during consideration of the amendments and several physician commenters.

TMB disagrees that the rule limits access to healthcare. The rules, as adopted, increase access by designating that a patient's home may be an established medical site, which was previously not allowed under the unamended rules. The amended rules expand opportunities for patients to interact with their physicians beyond the traditional office visit and clarify that a physician-patient relationship can be established through a "face-to-face" visit held either in person or via telemedicine. Essentially the only scenario prohibited in Texas is one in which a physician treats an unknown patient without conducting a face-to-face visit or in person evaluation, without any objective diagnostic data, and no ability to follow up with the patient.

TMB Response to Teladoc's Comment No. 3:

The study results, as provided to TMB, demonstrate a rational connection between the factual basis for the rule and the rule as adopted. The amended rules increase access to healthcare while meeting statutory mandate of TMB, as set out by the Legislature, which is to ensure patient safety.

The most important overall conclusion of the study was that, "... more study was needed to actually determine if access to care was enhanced." The study's conclusions also support TMB points of disagreement with the commenter. The study found:

Teladoc's model could actually further fragment healthcare;

Teladoc physicians are unable to use visual cues to aid in diagnosis;

The limitations of telephone only consult could lead to misdiagnosis and higher rates of follow-up care- findings that have already been demonstrated with e-visits and telephone consultations;

The adult users of Teladoc, in the study, were younger and healthier and lived in more affluent communities; and

The population of patients attracted to Teladoc -- a more affluent and likely more technologically savvy group -- might have fewer access needs than people living in areas characterized by shortage of primary care or socio-economic disadvantage. And further research is needed to understand whether Teladoc might be improving access for patients with lower income and those in rural areas, and if not, can it be positioned do so in the future.

TMB Response to Teladoc's Comment No. 4: