The Texas Medical Board (TMB) adopts amendments to §§174.1 - 174.3, 174.5 - 174.9 and new §174.4, concerning Mental Health Services and adopts the repeal of §§174.10-174.12, concerning Telemedicine. Sections 174.1 - 174.7 and 174.10 - 174.12 are adopted without changes to the proposed text as published in the September 15, 2017, issue of the Texas Register (42 TexReg 4756) and will not be republished. Sections 174.8 and 174.9 are adopted with non-substantive changes to the proposed text as published in the September 15, 2017, issue of the Texas Register (42 TexReg 4756). The text of the rules will be republished.

TMB sought stakeholder input through its Telemedicine Stakeholder Group, which met on July 17, 2017. At the meeting, all the members of the Stakeholder Group expressed support for the proposed rules. There were several comments made at that meeting concerning relatively minor changes to the proposed rules. These minor changes were incorporated into the proposed rules published for notice and comment. All the changes proposed are made to insure the rules comport with statutory changes by virtue of Senate Bill 1107.

The amendment to §174.1, concerning Purpose, adds language stating that the purpose of the telemedicine rules is to clarify the requirements of Chapter 111 of the Texas Occupations Code related to the provision of telemedicine medical services. Other language referring to the "standards for the use of the Internet" is deleted as it is no longer relevant and is too vague.

The amendment to §174.2, concerning Definitions, deletes multiple definitions pertaining to telemedicine that are no longer valid or necessary, while adding new definitions of "Prescription," "Store and Forward Technology," "Telehealth Services," Telemedicine Medical Services," and Ultimate User." All these changes are adopted to comport with the new definitions in Senate Bill 1107 dealing with telemedicine and telehealth services.

The amendment to §174.3, concerning Prevention of Fraud and Abuse, deletes language outlining a list of written protocols required in order to establish that a physician has made a good faith effort to prevent fraud and abuse through the use of telemedicine medical services, and substitute with new language requiring that the physician adopt protocols to prevent fraud and abuse that are consistent with standards established by the Health and Human Services Commission Pursuant to §531.02161 of the Government Code. These changes clarify requirements for adopting protocols related to preventing fraud and abuse, and comport with the language in Senate Bill 1107.

New §174.4, concerning Notice to Patients, adds language setting forth two subsections outlining requirements for physicians who communicate with patients by electronic communications other than telephone or facsimile. Paragraph (1) provides that such physicians must provide patients with written or electronic notification of privacy practices prior to evaluation or treatment via a telemedicine medical service and that in addition, a good faith effort be made to obtain the patient's written or electronic acknowledgement. Paragraph (2) requires that the notices of privacy practices include language that is consistent with federal standards under 45 CFR Parts 160 and 164. Paragraph (3) sets forth language requiring that physicians who utilize telemedicine medical services provide patients with notice of how to file a complaint with the Board. These changes were made to comport with Senate Bill 1107.

The amendment to §174.5, concerning Issuance of Prescriptions, deletes language related to requirements for notification of privacy practices and moves it to new §174.4 of this title (relating to Notice to Patients). Other language related to other notification requirements, including the necessity of an in-person evaluation, is repealed. New language is added that sets out minimum requirements for the validity of prescriptions issued as a result of a telemedicine medical service. The amendments add language limiting the treatment of chronic pain through telemedicine medical services. The Texas Medical Board consulted with Texas Board of Pharmacy to insure the amendments to this section comport with statutes and rules related to pharmacies and pharmacists. These changes were also made to comport with Senate Bill 1107.

The amendment to §174.6, concerning Minimum Standards for the Provision of Telemedicine Medical Services, deletes multiple requirements for providing telemedicine services through an "established medical site." New language is added setting forth simplified minimum requirements for providing a health care service or procedure through telemedicine that comport with Senate Bill 1107. This amendment addresses requirements related to the standard of care, medical record keeping, and patient communications.

The amendment to §174.7, concerning Enforcement Authority, deletes requirements related to providing telemedicine services at locations other than "established medical sites." Language is added clarifying the Board's enforcement authority to investigate and discipline physicians for violations of statutes and rules related to telemedicine services. These changes were made to comport with Senate Bill 1107.

The amendment to §174.8, concerning State Licensure, deletes language related to requirements for the evaluation and treatment of a patient by telemedicine that was superseded by Senate Bill 1107. The amendment further adds language clarifying that physicians providing telemedicine services must possess a full Texas medical license when treating residents of Texas.

The amendment to §174.9, concerning Provision of Mental Health Services, deletes language regarding technology and security requirements and adds language setting forth requirements related to the provision of mental health services. These requirements include: a requirement of licensure or certification; establishment of a provider/patient relationship; and a requirement to meet the standard of care. The amendment makes clear that technology may be used to provide mental health services to patients in a different location from the licensed or certified provider. The amendment also recognizes that mental health services can be provided by a number of different providers who are not physicians. Many of these providers have their own licensing requirements and defined scope of practices. The rule insures these mental health providers may continue services as long as in compliance with all applicable laws and rules. The amendment also makes clear that the Board may investigate and discipline Board licensees for violations of rules related to the providing of mental health services, or refer those not subject to Medical Board authority to the proper regulatory agency. These changes were made to comport with Senate Bill 1107.

Section 174.10, concerning Medical Records for Telemedicine Medical Services, is repealed, as the language under this rule was moved to §174.6 of this title (relating to Minimum Standards for the Provision of Telemedicine Medical Services).

Section 174.11, concerning On Call Services, is repealed, as call coverage rules are now located under Chapter 177 of this title (relating to Business Organizations and Agreements).

Section 174.12, concerning State Licensure, is repealed, as the language was added to §174.8 of this title (relating to State Licensure).

TMB received public written comments regarding proposed rules in Chapter 174 from the following commenters: Teladoc; Texas e-health Alliance; Texas Medical Association; Coalition for Nurses in Advanced Practice; Erisa Industry Committee; Texas Nurses Association; Texas Nurse Practitioners; Texas Psychological Association; Texas Society for Clinical Social Work; Texas Association for Marriage and Family Therapy; National Association of Social Workers; Texas Counseling Association; Texas State Board Examiners of Marriage and Family Therapists, Texas State Board of Examiners of Professional Counselors; Texas State Board of Social Work Examiners; Texas Council of Community Centers; Texas EMS Alliance; City of Houston Fire Department, Texas Academy of Physician Assistants, the Texas Hospital Association, and approximately 65 individuals. The individual commenters included were almost exclusively mental health providers other than physicians, and the comments were provided through primarily a standardized form letter.

In addition, oral comments on the proposed amendments were received from three individuals at a public hearing on Friday, October 20, 2017.

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

Commenter: Teladoc

Teladoc is a telemedicine provider in Texas and fully supported the proposed revisions. They were also a stakeholder and involved in the drafting of SB 1107. Teladoc recommended making the following non-substantive changes: fixing one typographical comma error found in §174.5 and deleting text published as remaining under §174.8(a). The Board agrees with the recommendations. The text under §174.8(a) contained formatting errors and was not published accurately. Accordingly, the Board adopts §174.8 with non-substantive changes to the published amendments. The amendments to the rule will be republished.

Commenter: Texas e-Health Alliance

Texas e-Health Alliance represents a number of telemedicine providers in Texas. Texas e-Health Alliance fully supported the proposed revisions. It was also a stakeholder and involved in the drafting of SB 1107.

Commenter: Texas Academy of Physician Assistants (TAPA)

TAPA represents approximately 8,000 physician assistants practicing in Texas. TAPA expressed full support for the proposed amendments.

Commenter: Texas Hospital Association (THA)

THA represents over 450 hospitals and health care systems in Texas. THA expressed full support for the proposed amendments.

Commenter: Texas Medical Association (TMA)

TMA is a professional association representing 50,000 physicians in Texas. It was also a stakeholder and involved in the drafting of SB 1107.

The TMA physician stakeholder who attended the meeting on July 17, 2017, fully supported the proposed amendment.

TMA legal staff submitted written comments that generally supported the proposed rules as a major proponent of SB 1107. Although, in support of rules, certain TMA legal staff comments seem to be in conflict with the TMA physician representative's comments of full support made at the July meeting, and recommendation of no changes.

1. This comment concerned the striking of rules and asked that detailed requirements related to the physician-patient relationship be maintained as set out in the previous rule.

TMB Response:

TMB disagrees with TMA's assertion of the necessity of keeping any of the defined terms or elements to comprise a physician-patient relationship. SB 1107 clearly states what is required to establish a physician-patient relationship. Further, Senate Bill 1107 applies the same standard of care as that of an in -erson setting and limits TMB from requiring any higher standard of care than specified in Senate Bill 1107.

2. This comment concerned the issuing of prescriptions, stating that the amendments will result in a lack of clarity for the requirements related to the establishment of a physician-patient relationship prior to issuing prescriptions in a non-telemedicine setting and telemedicine settings. In addition, TMA asserted the amendments lack sufficient guidance to physicians on what is required for telemedicine encounters not resulting in issuance of a prescription.

TMB Response:

TMB disagrees with the TMA comments. SB 1107 requires rules that define a valid prescription, but that does not mean that a telemedicine encounter has to result in a prescription. The bill does not impact a non-telemedicine prescription. Any encounter whether by telemedicine or in-person, whether resulting in the issuance of a prescription, is held to the same standard of care.

3. This comment stated TMB should not just rely on the standard of care in regulating telemedicine.

TMB Response:

TMB disagrees with the TMA comments. Any encounter whether by telemedicine or in-person is held to the same standard of care. This standard is long recognized in Texas as the legal standard utilized to evaluate patient care and complaints concerning a physician's care to a patient.

4. This comment requested clarity on Privacy Notice Requirements.

TMB Response:

TMB disagrees with the TMA comments. The privacy notice provision is flexible, as long as the notice is provided. There are any number of ways to provide said notice, and TMB does not believe it is necessary to be overly prescriptive. Additionally, TMA asks about an instance where previous notice has been given. The rule does not intend duplicate notices, but rather insure that a patient when initially utilizing telemedicine is informed of privacy practice related to this delivery method.

5. This comment requested consistency in use of terms, practitioner, physician and health professional.

TMB Response:

TMB disagrees with the TMA comments that the terms as used are confusing or inconsistent. None of the stakeholders or subsequently received comments expressed any confusion over the use of these terms.

6. This comment requested clarity on amendments adding language related to licensing requirements set forth under §174.8.

TMB Response:

TMB agrees with the TMA comments, and removed the term "advanced."

Accordingly, the Board adopts §174.8 with non-substantive changes to the published amendments. The amendments to the rule will be republished.

7. This comment requested clarity on §174.9 related to mental health services.

TMB Response:

TMB agrees with the TMA comments. TMB is adopting the amendments striking the phrase, "practice of medicine" to recognize other mental health providers provide mental health services according to their licensure or certification, and the scope of their practice as defined in law and rule. Non-substantive changes are also adopted to the amendments published, to recognize other mental health providers provide mental health services according to their licensure or certification, and the scope of their practice as defined in law and rule. Any action related to these mental health providers will be under the jurisdiction of the respective state regulatory authority and agency.

Commenters: Texas Nurses Association (TNA)

TNA generally supported the proposed rules but expressed concern over the language in §174.9 stating that mental health services are the practice of medicine. The concern was that this would limit access to mental health services, and expanded TMB's regulatory authority.

TMB agrees with the TNA's comments. TMB is adopting the amendments striking the phrase, "practice of medicine", to recognize other mental health providers provide mental health services according to their licensure or certification, and the scope of their practice as defined in law and rule. Accordingly, TMB adopts §174.9 with non-substantive changes to the published amendments. The amendments to the rule will be republished.

Commenter: Coalition for Nurses in Advanced Practice (CNAP)

CNAP opposed the proposed definition under §174.2 setting forth the definition for "telehealth", stating that TMB does not have the authority to regulate telehealth. CNAP expressed concern over the language in §174.9 stating that mental health services are the practice of medicine. The concern was that this would limit access to mental health services, and expanded TMB's regulatory authority.

TMB disagrees that the definition under §174.2 is unnecessary, as including it will provide better clarity to TMB's licensees on the distinction between telehealth and telemedicine.

TMB agrees with the CNAP's comment as to §174.9. TMB is adopting the amendments striking the phrase, "practice of medicine" to recognize other mental health providers provide mental health services according to their licensure or certification, and the scope of their practice as defined in law and rule.

Commenters: Erisa Industry Committee (ERIC)

ERIC expressed concerns that the proposed amendments are vague, and recommended retaining language requiring written protocols to address fraud and abuse, notice to patients about the limitations of telemedicine and steps to take if there is a need for in-person follow up care, adding language §174.6 clarifying that an in-person evaluation is not required to establish a physician-patient relationship, and retain language required under the unamended rule for the evaluation and treatment of a patient by telemedicine, including the discussion of a diagnosis and the evidence for it, as well of a discussion of the need for an in-person follow up care should the need arise.

TMB declines to adopt the recommended changes and disagrees that the amendments to the rules are vague. TMB disagrees that retaining language under the unamended rule would comport with Senate Bill 1107's requirements.

Commenters:

The Texas Psychological Association; Texas Society for Clinical Social Work; Texas Association for Marriage and Family Therapy; National Association of Social Workers; Texas Counseling Association; Texas State Board of Examiners of Professional Counselors; Texas State Board of Examiners of Marriage and Family Therapists, Texas State Board of Social Work Examiners; Texas Council of Community Centers and approximately 65 individuals.

All of these comments centered on proposed §174.9 and expressed concern over the proposed language that stated providing mental health services is the practice of medicine. The concern was that this would severely limit access to mental health services, and expanded TMB's regulatory authority.

TMB Response:

TMB agrees, and adopts the rule with non-substantive amendments striking the language related to the "practice of medicine," to recognize other mental health providers provide mental health services according to their licensure or certification, and the scope of their practice as defined in law and rule.

The rule is further amended to recognize other mental health providers, and their allowed scope for providing mental health services according to their licensure or certification, and the scope of their practice as defined in law and rule. Any action related to these mental health providers will be under the jurisdiction of the respective state regulatory authority and agency.

Commenters: Texas EMS Alliance and City of Houston Fire Department:

These two commenters were concerned that the proposed rules would somehow supersede or interfere with ability of EMS providers to continue operating under their current statutory and regulatory scheme.

TMB Response:

TMB disagrees. The regulation of EMS is under a completely different statutory provision and rules, and are not affected or changed in any way by these rules. A written letter to that affect has also been provided to the City of Houston Fire Department in response.

The amendments and new rule are adopted under the authority of the Texas Occupations Code Annotated, §153.001, which provide authority for TMB 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. The rules are also authorized by Chapter 111 of the Texas Occupations Code, as amended by Senate Bill 1107 (Regular Session, 2017).