TMB disagrees that the rule will increase the cost of healthcare. For purposes of clarification, contrary to Teladoc's statements that it has been operating for years with TMB's knowledge and approval, Teladoc's continued operation in known violation of the rules has continued only because TMB has been enjoined from taking disciplinary action due to court imposed limitations.. Importantly TMB is a complaint driven agency, and does not have audit or inspection authority, except in limited circumstances; however, TMB will investigate all complaints regarding prescribing or treating patient without a defined physician-patient relationship. Historically, TMB has disciplined a number of physicians for prescribing medication/drugs in absence of a physician-patient relationship.

TMB Response to Teladoc's Comment No. 5:

TMB disagrees that it is acting in excess of or inconsistent with relevant statutory provisions. TMB has express statutory authority to promulgate rules as follows:

Tex. Occ Code, Sec. 153.001. ADOPTION OF RULES. The board may adopt rules and bylaws as necessary to:

(1) govern its own proceedings;

(2) perform its duties;

(3) regulate the practice of medicine in this state; and

(4) enforce this subtitle.

Sec. 151.003. LEGISLATIVE FINDINGS. The legislature finds that:

(1) the practice of medicine is a privilege and not a natural right of individuals and as a matter of public policy it is necessary to protect the public interest through enactment of this subtitle to regulate the granting of that privilege and its subsequent use and control; and

(2) the board should remain the primary means of licensing, regulating, and disciplining physicians.

Sec. 151.056. APPLICATION TO TELEMEDICINE. (a) A person who is physically located in another jurisdiction but who, through the use of any medium, including an electronic medium, performs an act that is part of a patient care service initiated in this state, including the taking of an x-ray examination or the preparation of pathological material for examination, and that would affect the diagnosis or treatment of the patient, is considered to be engaged in the practice of medicine in this state and is subject to appropriate regulation by the board.

(b) This section does not apply to the act of:

(1) a medical specialist located in another jurisdiction who provides only episodic consultation services on request to a physician licensed in this state who practices in the same medical specialty;

(2) a physician located in another jurisdiction who is providing consultation services to a medical school as defined by Section 61.501, Education Code;

(3) a physician located in another jurisdiction who is providing consultation services to an institution subject to:

(A) Subchapter C, Chapter 73, Education Code; or

(B) Subchapter K, Chapter 74, Education Code; or

(4) a physician located in another jurisdiction of a state having borders contiguous with the borders of this state who is the treating physician of a patient and orders home health or hospice services for a resident of this state to be delivered by a home and community support services agency licensed in this state.

Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999. Amended by Acts 2001, 77th Leg., ch. 1420, Sec. 14.022(a), eff. Sept. 1, 2001.

Tex. Occ. Code, Sec. 111.004. RULES. The Texas State Board of Medical Examiners, in consultation with the commissioner of insurance, as appropriate, may adopt rules necessary to:

(1) ensure that patients using telemedicine medical services receive appropriate, quality care;

(2) prevent abuse and fraud in the use of telemedicine medical services, including rules relating to the filing of claims and records required to be maintained in connection with telemedicine medical services;

(3) ensure adequate supervision of health professionals who are not physicians and who provide telemedicine medical services;

(4) establish the maximum number of health professionals who are not physicians that a physician may supervise through a telemedicine medical service; and

(5) require a face-to-face consultation between a patient and a physician providing a telemedicine medical service within a certain number of days following an initial telemedicine medical service only if the physician has never seen the patient.

Added by Acts 2003, 78th Leg., ch. 1274, Sec. 22, eff. April 1, 2005.

The case of Hines v. Texas Veterinary Board, No. 14-40403 (Hines) supports TMB's rule, and is instructive on the rationale for the adopted rules. The rationale articulated by the Court, when applied to the amended rules, proves the legal and medical soundness of this rule, and demonstrates a rational connection between the factual basis for the rule and the rule as adopted. This case clearly supports TMB's amended rules and the rationale underlying the amended rules, which meets the reasoned justification requirements of the APA.

In Hines, a licensed vet began providing advice to pet owners via e-mail and the telephone without ever seeing the animal in question, although he did review veterinary records provided by the pet owner.. Hines also referred some people to a vet and refused to give advice if he felt a physical exam was needed. The Court first found that it was undisputed -- Hines remotely provided services constituted the practice of veterinary medicine, and that this "was a problem." Under Texas law "a person may not practice veterinary medicine unless a veterinarian-client-patient relationship exists." Just like the TMB's amended rule at issue, the Veterinary Board statute stated "a veterinarian-client-patient relationship may not be established solely by telephone or electronic means." The Court termed this as the "physical examination requirement," which is the equivalent of the amended rules face-to-face visit or in-person requirement.

There were several grounds of legal challenge; however, the Court found "States have broad power to establish standards for licensing practitioners and regulating the practice of professions."

Finally, and mostly importantly the Court stated, "Here, the requirement that veterinary care be provided only after the veterinarian has seen the animal is, at a minimum, rational: it is reasonable to conclude that the quality of care be higher, and the risk of misdiagnosis and improper treatment lower, if the veterinarian physically examines the animal in question before treating it."

The factual basis for the amendments to §190.8 and Chapter 174 surrounds patient safety and TMB's concerns over the quality of care, possible misdiagnosis, and improper treatment of patients if there is not a defined physician-patient relationship, which is consistent with stated legislative policy and the statutory scheme enacted by the Legislature. It seems incongruent to require that a veterinarian conduct a physical examination for a dog or cat prior to treatment, while not requiring physicians not to do the same for their patients. If one accepts a telephone only consult model of healthcare, the level of care for humans would be less than that required for a pet.

TMB Response to Teladoc's Comment No. 6:

TMB does not believe this statement is relevant to the purpose of the rule. The lack of malpractice claims is not a good indicator of the safe medical practices. Texas has strict limitations on damages available for medical malpractice. TMB receives numerous complaints involving patient deaths, medication errors and other breaches of the standard of care each year. These claims are brought to TMB as complaints, and in many of these cases, the victims or their family members disclose that no lawyer is willing to bring a medical malpractice claim, usually because of costs to develop the case and lack of potential recovery. Given a situation where the patient interaction is usually a single call with no follow-up, which is the commenter's business model, the likelihood of finding an attorney willing to bring a medical malpractice claim is very limited.

Additionally, TMB does have at least one pending case against a Teladoc physician, and TMB has historically taken a number of actions against physicians for prescribing over the telephone without ever seeing the patient, and therefore having failed to establish a defined physician-patient relationship. TMB also continues to investigate any and all complaints it may receive regarding any physicians who violate board statutes and rules.

TMB Response to Teladoc's Comment No. 7:

TMB disagrees that the rule outlaws "on-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 amended rule.

Additionally, the commenter's own statements indicate that on-call coverage is allowed under both the existing and amended rules: "But at the very least the Texas Medical Board should allow regulatory permission for traditional on-call arrangements and services like Teladoc on the same terms." This statement demonstrates the commenter knows call coverage is not outlawed, but rather wants parity for its business model.

Call coverage is about continuity of care and physician accountability. The adopted rule by requiring an existing physician-patient relationship ensures there is physician accountability. The rationale for this was summarized during TMB discussion, by a physician member of the TMB, as follows:

"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."

TMB's concerns over a lack of accountability and continuity of care provided by a telephone-only consultation model was articulated by the physician speaker for Teladoc when he stated, "Teladoc did not want to establish a physician/patient relationship," and that patients were discouraged from speaking to the same doctor twice.

The concern over continuity and lack of accountability was further demonstrated in a published article in Modern Health, dated February 2015, where the CEO of Teladoc, Jason Gorevic, stated, "Teladoc matches patients with doctors randomly, filtering only by whether the visit is for general medicine, dermatology or behavioral health."

The whole purpose of on-call coverage is to have continuity of care, rather than a "one and done" arrangement that does not provide for any continuity of care. In traditional call coverage, the physician covering the patient has full access to patient records, and is normally in close proximity if the patient needs to be seen in person or via a face-to-face visit. Teladoc only has a 72-hour follow-up period, and after that any call from a patient is a new consult. Based on the commenter's own statements indicating that patients are discouraged from speaking with the same physician twice, this will not be a consult with the Teladoc physician who handled the initial interaction. This model does not provide any continuity of care.

TMB Response to Teladoc's Comment No. 8:

TMB disagrees with the unsupported claims of damages asserted by Teladoc. Teladoc's own written submission indicates it had 60,000 consults in Texas in 2014 which represents approximately only a 4% utilization rate of the individuals who, Teladoc claims, have access to Teladoc services. Based on individual commenters stating they have used Teladoc services on multiple occasions it is unclear as to whether the 60,000 consults represent individual patient interactions. Moreover, 60,000 consults to a population of 27 million is negligible when combined with the fact that from comments submitted it appears, a significant portion of individual commenters who submitted written comments supporting Teladoc and provided location information were not in medically underserved areas, but rather were from large urban/metropolitan/affluent areas. Further, many of the individual commenters reported having a primary care physician.

In addition, Teladoc submitted to TMB an article published in Modern Health, dated February 21, 2015, entitled, Telehealth Services Surging Despite Questions About Value. The following are excerpts taken from that article, which further demonstrate that the claim of harm by the Teladoc is unsupported. Statements below were made by the Teladoc CEO:

Teladoc, which offers access to doctors through voice or video, raised $50 million in September.

Teladoc's revenue has doubled in each of the past two years, and it has signed up 2.5 million new members as of Jan. 1.

Teladoc charges a per-member per-month fee. This payment model is necessary to cover his company's costs for marketing its services to its clients' covered populations.

Indeed, Teladoc has recently launched behavioral-health services.

All of these statements demonstrate that claims of harm by Teladoc are unsupported, and actually show that Teladoc is expanding in both scope and market placement.

Individual Comments:

TMB received approximately 200 comments from individuals, primarily patients, all opposed to the adoption of proposed Chapter 174 and §190.8(1)(l). The comments opposing the proposed rules reflected several common objections, which are set out and summarized below. Several comments did not set forth a basis for opposition but rather simply stated the commenter's opposition to the adoption of the proposed amendments to Chapter 174 and §190.8(1)(L).

1. Increased Cost. Several commenters voiced concerns that the rule would result in increased costs for healthcare treatment. Generally the commentators suggest that the proposed rule, being a form of regulation, would automatically increase costs. None of the commenters articulated reasons why or how the proposed rule would increase costs, other than to suggest that using telephone only services was less expensive than going a physician's office. Several cited that the cost out of pocket for telephone only service was helpful due to high deductibles under certain Affordable Care Act plans.

2. Infringement on Personal Freedoms. Many commenters stated that they were opposed to the proposed rule because it infringes on their personal freedoms. Several commenters stated that the rule would take away their freedom in deciding how to receive healthcare.

3. Unnecessary Regulation by the Government. Several commenters stated they were opposed to the proposed rule because it represents unnecessary regulation by the government and the imposition of more government "red tape."

4. Proposed Rule will Interfere with Convenience. Several commenters stated that the current system is convenient for them and expressed their concerns that the rules would interfere with this current convenience and limit their treatment options.

5. Rule will Limit Access to Healthcare. Several commenters suggested that the result of the proposed rule would completely eliminate telehealth or be to limit consumers' access to healthcare.

6. Physical Examination is Unnecessary. Several individual commenters opined that the physical examination required under the proposed rules was not necessary for the purpose of providing medical services.

7. Call Coverage will be Prohibited. Certain commenters also claimed the rule outlaws "call-coverage."

8. Inconvenience to Physicians. Certain commenters stated the rule creates an inconvenience for the physician.

TMB Response to Comment Nos. 1 to 5:

The Board disagrees with the comments 1 - 5. TMB believes a clarification is necessary to place the individual comments in proper context. A majority of the commenters that were against the amended rule used 1 of 3 form letters. A large percentage of these letters cited a specific company, Teladoc. In many cases, the commentators used identical wording that lacked specific examples. TMB knows these are form letters, as two different commenters included a copy of the form letter with their comments. In addition, a number of the patient commenters were also sellers of the telehealth products, including Teladoc services. These "dual" role commenters have a strong monetary interest to oppose the rule, and to endorse the Teladoc model to increase sales for their own personal economic benefit.

There were a number of duplicate letters from certain individual or batches of letters from a specific group of employees.

Many of these commenters admitted that they had a primary care provider, but stated they used telephone only services for convenience, or the desire not to have to wait in the doctor's office, and face exposure to illness from other patients.

The commenters confuse lack of access to care, i.e., no doctors in an area or county such as far West Texas, with consumer convenience. Few, if any of the commenters asserted they lacked access to healthcare and many reported having a primary care physician. Rather, the commenters said they did not want leave work, they did not like waiting in a physician's office, they did like being around sick people in physician's office, and they did not want to wait get an appointment to their see their primary physician.

As stated previously, a significant portion of the commenters who provided location information were from large affluent urban/metropolitan/affluent areas of Texas, including Austin, Fort Worth and Dallas (including suburbs like Richardson, Frisco, Allen, and Plano). There was no evidence of increased access in underserved counties demonstrated by such commenters. None of the commenters discussed using medical exchange to contact their primary care physician on the weekend or after office hours, rather it appears the use of a telephonic consult was used solely for convenience.

As previously stated, the amended rule actually increases the access to health care by expanding the definition of established medical site to include a patient's home. The amended rule also enhances methods and access when providing certain mental health services by providing an exception the physical examination requirement.

The amended rule continues to allow telemedicine services. The amendments to the rules in Chapter 174 clarify what is required to establish a defined physician-patient relationship prior to a physician issuing prescription medication/drugs, which applies to all physicians including those providing telemedicine, based on the ruling of the Third Court. The amendments to TMB rules in Chapter 174 clearly demonstrate there will be increased access to healthcare as a result of the amended rules.