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Texas Register Preamble


The Texas Medical Board (Board) adopts amendments to §§174.1 - 174.3 and 174.5, the repeal of §174.4 and §174.6 and new §§174.6 -174.12, concerning Telemedicine. The amendments to §§174.1, 174.3 and 174.5 and the repeal of §174.4 and §174.6 and new §174.10 and §174.12 are adopted without changes to the proposed text as published in the April 30, 2010, issue of the Texas Register (35 TexReg 3390) and will not be republished. New §174.6 and §174.8 are adopted with minor changes to the proposed text as published in the April 30, 2010, issue of the Texas Register (35 TexReg 3390). The text of the rule will be republished. The amendment to §174.2 and new §174.9 and §174.11 are adopted without changes to the proposed text as published in the July 16, 2010, issue of the Texas Register (35 TexReg 6175) and will not be republished. New §174.7 is adopted with a minor change to the proposal as published in the July 16, 2010, issue of the Texas Register (35 TexReg 6175). The text of the rule will be republished.

The amendments to §174.1, concerning Purpose, adds statutory authority for the chapter and exempts out-of-state telemedicine license holders, federally qualified health centers, and health insurance help lines from the chapter. The Board has determined that the changes are necessary to have the rules applied to only certain telemedicine providers.

The amendments to §174.2, concerning Definitions, define distant site provider, established medical site, face-to-face visit, patient site location, patient site presenter; amend the definitions for physician-patient e-mail, telemedicine medical services; and deletes the definition for telepresenter. The Board has determined that it is necessary to establish uniform definitions for those who practice telemedicine in Texas.

The amendments to §174.3, concerning Telemedicine Medical Services, deletes reference to the Telecommunications Infrastructure Fund Board (TIFB). The Board has determined that references to the TIFB must be eliminated since it no longer exists.

The repeal of §174.4, concerning Use of the Internet in Medical Practice, is moved to Chapter 164 as new §164.6. The Board has determined that this section is more appropriately placed in Chapter 164, which relates to advertising.

The amendments to §174.5, concerning Notice of Privacy Practices, provides that physicians that communicate electronically with patients and provide telemedicine medical services, must provide notice to patients of privacy practices, limitations of telemedicine, when in-person evaluations are necessary, and how to file complaints with the Board. The Board has determined that it is necessary to ensure that patients are given appropriate notice to make informed decisions about their care and their rights as consumers. The amendment also changes the name from "Notice of Privacy Practices" to "Notice to Patients".

The repeal and replacement of §174.6, concerning Delegation to and Supervision of Telepresenters, repeals §174.6 and adds new language for new §174.6, concerning Telemedicine Medical Services Provided at an Established Medical Site. The Board has determined that the new language is necessary to establish standards for the provision of telemedicine medical services at established medical sites.

New §174.7, concerning Telemedicine Medical Services Provided at Sites other than an Established Medical Site, establishes under what conditions a distant site provider may provide telemedicine medical services at sites other than an established medical site, such as a patient's home.

New §174.8, concerning Evaluation and Treatment of the Patient, establishes standards for physicians that use telemedicine medical services for the evaluation and treatment of patients.

New §174.9, concerning Technology and Security Requirements, establishes requirements relating to technology and security regarding the provision of telemedicine medical services and physician-patient communications through email. The Board has determined that the new rule will protect confidential electronic communications between physicians and their patients and that electronic medical records are appropriately safeguarded.

New §174.10, concerning Medical Records for Telemedicine Medical Services, establishes the requirements for the maintenance of medical records for telemedicine medical services and what documents are considered part of the medical records. The Board has determined that the changes ensure that medical records are appropriately maintained for patients who receive telemedicine medical services.

New §174.11, concerning On-call Services, establishes that physicians in the same specialty who provide reciprocal services may provide on-call telemedicine medical services for each other's patients. The Board has determined that changes allow for the use of telemedicine medical services through on-call services when a patient's distant site provider is not available.

New §174.12, concerning State Licensure, provides that persons who treat and prescribe through advanced communications technology are engaged in the practice of medicine and must have appropriate licensure unless otherwise exempt. The Board has determined that the changes ensure that those who reside outside of Texas and provide medical services to Texas residents are appropriately licensed.

Sections 174.2, 174.7, 174.9 and 174.11 were previously published for proposal in the April 30, 2010, issue of the Texas Register, however these sections were withdrawn and re-proposed in the July 16, 2010, issue of the Texas Register. These sections were withdrawn and re-published with changes based on comments received from the April 30, 2010 proposal. The Board received and reviewed comments at the June and August meetings. Some entities made comments twice (repeating their comments) and the relevant sections (§§174.2, 174.7, 174.9 and 174.11) were withdrawn and republished with changes in July. The comments were again reviewed at the August meeting and no further changes were made to the rules, therefore the rules are adopted without changes at this time. A summary of the comments follows.

The Board sought stakeholder input through Stakeholder Groups, which made comments on the suggested changes to the rules at a meeting, held on March 9, 2010. The comments were incorporated into the proposed rules.

The Board received support for the rules without change from the Texas Department of Insurance, the University of Texas Medical Branch at Galveston, Texas e-Health Alliance and Texas Organization of Rural and Community Hospitals.

Comments:

No comments were received regarding §§174.1, 174.3, 174.4, 174.6, 174.10 and 174.12.

§174.2

The Board received comments regarding §174.2 from the Texas Medical Association and Health and Human Services Commission.

COMMENT ONE: Texas Medical Association

The commenter asked the following questions and made the following suggestions:

(1): Paragraph (1) should be clarified to indicate that a distant site provider also includes physician assistants or advanced practice nurses who are supervised by and delegated authority from a licensed Texas physician in accordance with Title 3 Texas Occupations Code, Chapter 157. Otherwise, this provision could be misinterpreted to mean that the usual delegation requirements do not apply to Telemedicine.

(2): Although paragraph (2) states that an established medical site requires a defined physician-patient relationship, it is unclear as to when exactly the creation of a physician-patient relationship must occur. Does the relationship need to be established before the patient arrives at an established medical site for the first time, or can it take place during the initial visit?

(3): Paragraphs (3) and (4) are very similar in definition. Listing examples under each definition may assist in minimizing confusion.

(4): The definition of "patient-site presenter" in paragraph (7)(A) should be amended by adding another subdivision that would permit either the licensed health care individual or a person delegated and supervised by the distant site physician to be the patient site presenter. The commenter states that the provisions of Section 157.001, Occupations Code would permit such delegation and supervision, and contends that this ability to delegate and supervise is extremely important to assure access in the rural areas where health care providers are few and far between.

(5): In paragraph (7)(B), there should be an additional sentence stating that all delegation tasks and activities must be done in accordance with the provisions of Chapter 157 of the Occupations Code. This should be done in order to put physicians on notice that compliance with the statute is not limited to solely PAs and APNs.

The Board agrees with comment (1) and amended the language to include PAs and APNs in the definition of distant site provider. Section 174.6(a) addresses comment (2) as it provides that a telemedicine encounter at an established medical site may be used for an initial evaluation and therefore the rules already provide that the relationship does not need to precede the patient's visit to the site. The Board agrees in part with comment (3) and will develop a link on its website for frequently asked questions, including examples for these definitions. The Board disagrees with comment (4) and has determined that patient site presenters must be licensed or certified in a health-related field to ensure patient safety. In addition, this rule is consistent with regulations established by the Health and Human Services Commission as it relates to Medicaid reimbursement requirements for telemedicine services. The Board disagrees with comment (5) and does not believe additional language is necessary as Chapter 157 applies to all delegated acts and additional notice is not required.

COMMENT TWO: Health and Human Services Commission

The commenter recommends adding the word "private" to the last sentence in paragraph (2) so that it would read "a patient's private home is not considered an established medical site." He states that otherwise, the definition excludes a residential facility or other institutional setting where a patient resides. The commenter also recommended substituting "in real time" for "contemporaneously" in paragraph (10). Several grammatical suggestions were also made. The Board agreed with these comments, and changes were made to the section.

§174.5

The Board received comments regarding §174.5 from the Texas Medical Association and Teladoc Medical Services.

COMMENT ONE: Texas Medical Association

The commenter contends that this section of the rule is inconsistent with federal HIPAA privacy requirements. She states that as written, this section would require physicians who are not otherwise subject to the "notice and acknowledgment" requirements of HIPAA to be subject to those provisions, even though telemedicine services are not covered by HIPAA. She notes that even HIPAA provides an exemption from those requirements for medical practices with 10 or fewer full time employees, and that to impose these requirements upon all physicians would have an adverse impact upon both small practices and those in rural areas. She suggests that if the agency seeks to keep this Section of the Rule, it should retain only a "notice" requirement, and delete any references to "written acknowledgment".

The Board disagrees with this comment. After review of the federal HIPAA notice and privacy requirements, the Board has determined that the rules are not in violation with HIPAA. The following was obtained from the HHS Office of Civil Rights' website that supports the Board's position and therefore the Board has adopted the proposed language without amendment:

"The HIPAA Privacy Rule is intended to be flexible enough to address the various types of relationships that covered health care providers may have with the individuals they treat, including those treatment situations that are not face-to-face ... For service provided electronically, the notice must be sent electronically automatically and contemporaneously in response to the individual's first request for service. In this situation, an electronic return receipt or other return transmission from the individual is considered a valid written acknowledgment of the notice."

COMMENT TWO: Teladoc Medical Services

The commenter objects to the references in subsections (b) and (c) that advise the patient to seek additional follow-up care. He states that the language is overly restrictive and that the telemedicine physician can provide appropriate follow-up care.

The Board disagrees with this comment. Stakeholder input led to the inclusion of this language so that patients would be able to give proper informed consent when seeking medical care through the use of telemedicine services.

§174.7

The Board received comments regarding §174.7 from Texas Hospital Association, OptumHealth (national care management organization that provides health care via telemedicine), AmericanWell (technology partner of OptumHealth), Rural Caucus of the Texas Legislature, the Texas Conservative Coalition, Texas Conservative Coalition Research Institute, Texas Medical Association, Teladoc Medical Services, Texas Health and Human Services Commission, Texas Association of Business, Texas Public Policy Foundation, and State Representative Jim Jackson.

COMMENT NO. 1

Texas Hospital Association commented that they have some concern about the proposed language that would require an established patient with new symptoms to be seen in person within 72 hours or at an established medical site. They recommend that the Texas Medical Board, with input from telemedicine experts, health care facilities and professionals, monitor this provision closely on an ongoing basis with regard to its impact on resources and access to health care, particularly in underserved areas, and be prepared to respond to those concerns if necessary by considering a future rule change.

The Board disagrees with this comment in part. The 72-hour provision in subsection (e) pertains only to patients being treated at home with new conditions unrelated to the preexisting conditions they are being treated for via telemedicine. IF the 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 medicine 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. In addition, Chapter 111 of the Texas Occupations Code pertaining to telemedicine and telehealth services authorizes the Board to adopt rules to ensure that patients receiving care via telemedicine receive appropriate, quality care and to "require a face-to-face consultation between a patient and 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". The adopted rules are in keeping with the intent of the current statute. 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, but plans to work with stakeholders in the future to monitor how the rules will affect patient care.

COMMENT NO. 2

OptumHealth commented that the rules should focus "on the roles and responsibilities of health professionals providing care, rather than distinguishing based upon how healthcare information is transmitted." OptumHealth also raised concerns that the rules "do not clearly define what is and what is not permitted through various modes of information transmission" and that rules should provide a "flexible regulatory framework that both recognizes the rapidly changing information infrastructure and protects patients and care providers."

The Board disagrees with this comment. The Board has set out requirements for when face-to-face visits are necessary and when the use of advanced communication technology may be used, in part based on where the patient is being treated (established medical site v. site other than an established medical site) and the condition being treated (preexisting condition v. new condition unrelated to previously diagnosed condition). 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. 3

AmericanWell commented that the amendments will "deny access to online healthcare services to Texas residents, except for some established patients at established medical sites with established conditions only."

The Board disagrees with this comment. An established medical site can be interpreted to mean almost any location where there is diagnostic equipment available as well as space for a patient site presenter to assist with a physician's evaluation of a patient. For example, this could be a nurse's office at an elementary school or a volunteer fire department, in addition to sites such as local health clinics or hospitals. A "patient site presenter" can be any level or type of health professional as long as they have some form of licensure or certification. The rules also permit the use of telemedicine at locations in addition to established medical sites. For example, a patient with a chronic condition such as diabetes who has difficulty leaving his or her home, would be able to receive treatment via telemedicine while at home for up to one year. The requirements for an in-person evaluation in subsection (a) are in place to ensure that a physician or delegated professional is able to gather necessary diagnostic information on a patient so that appropriate treatment is provided. The requirement in subsection (c) that a patient receiving treatment at home via telemedicine must be seen by a physician at least once a year is again considered to be necessary since the physician will likely have no other way to gather diagnostic information. 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. 4

Rural Caucus of the Texas Legislature ("Rural Caucus") commented that the proposed rules would limit access to health care for those residing in rural communities.

Cont'd...

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