The Board disagrees with this comment. The proposed rule provides for a significant expansion of the use of telemedicine in Texas over what is authorized in the current rules. Any extension of the current prohibitive rule places practitioners using telemedicine into potential non-compliance with those rules. The Board does not want to unreasonably limit the use of telemedicine, instead the Board wants to ensure that the regulation of telemedicine is fair, responsible, and provides the appropriate balance between access to health care and patient safety. This is in keeping with our mission to safeguard the citizens of Texas through professional accountability of our licensees. For these reasons, the Board does not believe that any changes should be made to this proposed rule as published. The Board has adopted the amendments to this section as published, without changes.

COMMENT NO. 5

Texas Conservative Coalition in conjunction with the Rural Caucus commented that "the proposed definitions of established medical site and patient site presenter have the unintended consequence of restricting, rather than enabling telemedicine... subsection (c) would require that all patients who receive telemedicine services outside of an established medical site, as defined by the proposed rule, must be seen by a physician for an in-person evaluation at least once a year. Creating an in-person 72-hour requirement for a follow-up face-to-face visit with a physician (subsection (e)) would place an additional burden on rural communities that are currently faced with a shortage of primary care physicians... the new rule requires a "distant provider to discontinue care to a patient who is not seen within 72 hours. This approach to medical care delivery could leave medical issues unresolved." "In lieu of a 72 hour requirement, we suggest a rule under which the distant site provider, in collaboration with the patient site presenter, would determine if and when an in-person visit is necessary."

The Board has responded to this comment as described above in responses to Comments 1 - 4. In addition, in response to concerns about the 72-hour requirement, the 72-hour provision in subsection (e) pertains only to patients being treated at home with new symptoms unrelated to the preexisting conditions they are being treated for via telemedicine. If a patient's symptoms resolve within 72 hours then an in-person visit is not required. Because this provision only pertains to patients receiving treatment at home, or somewhere besides an established medical site, there would likely be no patient site presenter available to confer with the distant site provider to determine whether the patient needs an in-person visit. For these reasons, the Board does not believe that any changes should be made to this proposed rule as published. The Board has adopted the amendments to this section as published, without changes.

COMMENT NO. 6

State Representative Eddie Rodriguez commented that the 72-hour requirement would limit access to health care to those in rural and urban areas.

The Board disagrees with this comment as stated in its response to Comment 5. For these reasons, the Board does not believe that any changes should be made to this proposed rule as published. The Board has adopted the amendments to this section as published, without changes.

COMMENT NO. 7: Texas Conservative Coalition Research Institute

The commenter commented that the provisions of §174.7 could limit telemedicine practice especially in rural areas.

First, the commenter questions the basis for the "face-to-face visit" requirement of subsection (a)(1). The commenter states that if the Board's concern is that a patient might be misdiagnosed via telemedicine, there is no evidence that a face-to-face visit will completely eliminate that possibility, since the vast majority of preventable medical errors occur under direct physician supervision. The commenter further challenges the Rule's presumption that "face-to-face visits" are superior to the other types of patient encounters that can be achieved via telemedicine.

The commenter also states that requiring patients to see a physician for a face-to-face visit within 72 hours of the telemedicine encounter places (1) creates an "arbitrary time frame" that places an additional burden on rural communities that are currently faced with a shortage of primary care physician; (2) could potentially put physicians in harm's way; and (3) regulates patient behaviors in an unwarranted fashion. The commenter suggests waiving the 72 hour requirement in rural areas.

In addition, the commenter disagrees with the wording of subsection (c) which requires that "all patients must be seen by a physician for an in-person evaluation at least once a year", stating that it (1) conflicts with the requirement of a face-to-face visit within 72 hours; (2) increases costs for employers, individuals and the state; and (3) could create a basis for disciplinary action against a physician if a patient fails to schedule an appointment within a year. The commenter also asks whether the proposed rule (1) means that a patient must see a doctor once a year in perpetuity; (2) would allow a patient to see any licensed physician; and (3) would require the in-person evaluation with the doctor that authorized the telemedicine service. In addition, the commenter asks whether the word "physician" means a Primary Care Physician (PCP).

The Board disagrees with this comment as discussed in its above responses. In addition, the Board rule does not disallow providing care without an in-person examination for all telemedicine encounters, it merely requires that if telemedicine services are provided at sites other than established medical sites, then an in-person evaluation is required. Further, the distant site providers are not required to have patients seen annually by a physician, but may not continue to treat a patient who has not received an in-person annual evaluation by a physician who is appropriately trained to evaluate a patient's medical condition based on the patient's medical history and current treatment.

COMMENT NO. 8: Texas Medical Association

The commenter asked whether, in subsection (b), patient site presenters are required for all other visits?

The commenter also suggested that the phrase "medical practice site" in subsection (d) be changed to "established medical site" in order to maintain consistency with the definition section of the rule.

The Board has determined that patient site presenters are not required for other visits, and will address this issue on its website related for Telemedicine FAQs and amend the language in the future to clarify the rule. The Board agrees with the comment on subsection (d) and that a nonsubstantive change is to be made to reference "established medical site."

COMMENT NO. 9: Teladoc Medical Services

The commenter objects to the requirement of an in-person physical examination of the patient at a site other than an established medical site, stating that there are many other generally accepted means that telemedicine physicians can use to provide medical services that meet the standard of care, including (a) use of medical or health records; (b) question and answers between the patient and physician using the interactive media to establish medical condition of the patient, and (c) use of lab tests.

This commenter also states that this section does not recognize the latest proposed Interim Final Rule promulgated by the US DOJ concerning the Ryan Haight Online Pharmacy Consumer Protection Act at US Federal Register 15596 et seq., in which DOJ allowed telemedicine providers to prescribe controlled substances without an in-person examination.

Finally, this commenter objects to subsection (d), stating that it fails to recognize the valuable and cost-saving service telemedicine provides for the treatment of chronic conditions.

The Board disagrees with these comments as addressed in its responses to comments 1 - 7. In addition, state law may be more restrictive than federal law and again the Board rule does not disallow prescribing medication without an in-person examination, it merely requires that if telemedicine services are provided at sites other than established medical sites, then an in-person evaluation is required.

COMMENT NO. 10: Texas Health and Human Services Commission

The commenter expressed concern that subsection (e) was vague and subject to misinterpretation. He also made numerous grammatical suggestions. The Board agreed with these comments and made changes to the rule as proposed.

COMMENT NO. 11: Texas Association of Business

The commenter objects to subsection (e), stating that it appears on its face to create obstacles to receiving treatment via telemedicine if a patient cannot get an in-person appointment with a physician within 72 hours, and thus severely limits physicians' ability to offer needed access to telemedicine services in rural areas.

The Board disagrees with this comment as discussed in its responses to comments 1 - 5.

COMMENT NO. 12: Texas Public Policy Foundation and Representative Warren Chisum

The commenters oppose subsection (e), stating that requiring a patient who receives a telemedicine consultation to see a physician in person within 72 hours would place additional burdens on areas and families already struggling to access health care, and would cripple the potential benefits of telemedicine. They state this is especially significant in view of additional strains on health care resources that will occur as a result of the newly enacted federal health care law. They state that this Subsection would also send a signal that free-market medical innovation is discouraged.

Representative Chisum also stated that this subsection is not needed because "doctors have the ability to request an in-person visit with the patient should their medical training deem it necessary", and that "superseding their medical judgment by rule is unnecessary and intrusive".

The Board disagrees with this comment as discussed in its responses above.

COMMENT NO. 13: Representative Jim Jackson

The commenter proposed deleting the requirement of subsection (a)(1) that would require an in-person examination for the treatment of all medical conditions prior to a telemedicine consultation via video webcam. He also stated that if this is not possible, he would recommend making an exception to the proposed rule amendments so that minor non-emergency medical conditions can be treated via live, interactive web-based video conferencing so long as appropriate clinical standards and QA protocols are met.

The Board disagrees with this comment as discussed in its responses above. As a final response to the comments on this section, the Texas Medical Board believes that the rules development process is a dynamic one that requires constant feedback from stakeholders for needed updates and changes. The Board's acknowledges that there will need to be continuous revisions of Chapter 174 to meet the changing needs of technology in medical practice. The Board does not want to unreasonable limit the use of telemedicine, instead the Board wants to ensure that the regulation of telemedicine is fair, responsible, and provides the appropriate balance between access to health care and patient safety. This is in keeping with our mission to safeguard the citizens of Texas through professional accountability of our licensees.

§174.8

The Board received comments regarding §174.8 from Teladoc Medical Services and Texas Health and Human Services Commission.

COMMENT ONE: Teladoc Medical Services

The commenter objects to subsection (a)(4) as overly restrictive, claiming that its requirement that the telemedicine physician "ensure the availability of the distant site provider or coverage of the patient for appropriate follow-up care" may not be necessary for the patient's condition, and that follow-up care may be provided by the telemedicine physician.

The Board disagrees with this comment. The telemedicine physician is the distant site provider and therefore it is appropriate to require that provider or someone else who provides coverage to be available for follow-up care. In addition this rule is consistent and mirrors the language of 22 TAC §190.8(1)(L) that was adopted in 2003 and defined practice inconsistent with public health and welfare as the prescribing of any dangerous drug or controlled substance without first establishing a proper professional relationship with a patient to include appropriate follow-up care. This section therefore is adopted without changes except for those changes made in response to Comment 2.

COMMENT TWO: Texas Health and Human Services Commission

The commenter made numerous grammatical suggestions. The Board agreed with the suggestions and made the corrections to the rule.

§174.9

The Board received comments regarding §174.9 from Senator Carlos Uresti.

COMMENT NO. 1

Sen. Carlos Uresti commented that the propose rules will "eliminate the ability of primary care physicians to use video conferencing to provide telemedicine services to Texas patients". The Board disagrees with this comment. Section 174.9 provides that advanced communication technology must be used for telemedicine encounters. Stakeholders who worked on this rule commented that the term "advanced communication technology" should not be further defined, as technology by its very nature keeps changing. The Board does interpret "advanced communication technology" to include web-based video conferencing, however. For this reason, the Board does not believe that any changes should be made to this proposed rule as published. The Board has adopted the amendments to this section as published, without changes.

§174.11

The Board received comments regarding §174.11 from Teladoc Medical Services and Texas Health and Human Services Commission.

COMMENT ONE: Teladoc Medical Services

The commenter recommends that this section be deleted because it is outside the scope of telemedicine.

The Board disagrees with this comment. The rule relates to telemedicine and the practice of medicine that are both within the scope of the authority of the Board to regulate. The Board therefore adopts the proposed language without amendment except as provided below.

COMMENT TWO: Texas Health and Human Services Commission

The commenter asks whether the term "current patients" refers to a physician's "active" patients.

The Board agrees that clarification is needed and therefore amended the language.

The amendments and new rules are adopted under the authority of the Texas Occupations Code Annotated, §153.001 and §154.006, which provide authority for the Board to adopt rules and bylaws as necessary to govern its own proceedings, perform its duties, regulate the practice of medicine in this state, enforce this subtitle, and establish rules related to licensure.