TITLE 22. EXAMINING BOARDS

PART 9. TEXAS MEDICAL BOARD

CHAPTER 163. LICENSURE

22 TAC §§163.2, 163.4, 163.6, 163.13

The Texas Medical Board (Board) proposes amendments to §§163.2, 163.4, 163.6, 163.13, and the repeal of §163.7, concerning Licensure.

The amendment to §163.2, concerning Full Texas Medical License, proposes to delete language under subsection (d)(5)(A) setting forth requirements related to §163.7 of this title (relating to the Ten Year Rule). The amendments are proposed to reflect the proposed repeal of §163.7 of this title, which is also published in this issue.

The amendment to §163.4, concerning Procedural Rules for Licensure Applicants, proposes to delete language under subsection (d)(5)(D) related to §163.7 of this title. The amendments are proposed to reflect the proposed repeal of §163.7 of this title.

The amendment to §163.6, concerning Examinations Accepted for Licensure, proposes to delete language under subsection (e)(1), requiring that an applicant pass the jurisprudence examination within three attempts. The changes are made pursuant to Senate Bill 674 (85th Legislature, Regular Session).

The repeal of §163.7, concerning Ten Year Rule, proposes to repeal requirements that an applicant have passed an examination listed in §163.6(a) of this title (relating to Examinations Accepted for Licensure) for licensure within the ten-year period prior to the filing date of the application. The requirements under §163.7 represent unnecessary impediments and additional steps to licensure for physicians who may have taken an approved licensing exam more than 10 years prior to an application's filing date, yet have maintained competency through years of practice, and otherwise meet all general eligibility requirements.

The amendment to §163.13, concerning Expedited Licensure Process, proposes to add a new subsection (b), creating an expedited licensing process for out-of-state psychiatrists. The new language is proposed in accordance with Senate Bill 674, 85th Legislative Regular Session, which requires the Board to create an expedited licensing process for applicants who hold an unrestricted license to practice medicine issued in another state, are board certified in psychiatry, and meet other general eligibility requirements.

Scott Freshour, General Counsel for the Board, has determined that for each year of the first five years the sections as proposed are in effect, the public benefit anticipated as a result of enforcing the proposal will be to have rules that comport with applicable statutes, are internally consistent and clear, address Texas's shortage of psychiatrists, and remove unnecessary impediments to licensure for qualified and experienced physicians, better enabling the Board to address Texas's increasing need for qualified physicians.

Mr. Freshour has also determined that for the first five-year period that the sections are in effect, there will be no fiscal implication to state or local government as a result of enforcing the sections as proposed. There will be no effect to individuals required to comply with the rules as proposed. There will be no effect on small or micro businesses.

Comments on the proposal may be submitted to Rita Chapin, P.O. Box 2018, Austin, Texas 78768-2018, or email comments to: rules.development@tmb.state.tx.us. A public hearing will be held at a later date.

The amendments are proposed under the authority of the Texas Occupations Code Annotated, §153.001, which provides 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. The amendments are further proposed under the authority of Texas Occupations Code Annotated, Chapter 155, as amended by Senate Bill 674 (85th Leg. R.S.)(2017).

No other statutes, articles or codes are affected by this proposal.

§163.2.Full Texas Medical License.

(a) - (c) (No change.)

(d) Alternative License Procedures for Military Service Members, Military Veterans, and Military Spouses.

(1) - (4) (No change.)

(5) Alternative Demonstrations of Competency Allowed. Applicants qualifying under this subsection, [:]

[(A) are not required to comply with §163.7 of this title (relating to Ten Year Rule); and]

[(B)] in demonstrating compliance with §163.11(a) of this title (relating to Active Practice of Medicine), must only provide sufficient documentation to the board that the applicant has, on a full-time basis, actively diagnosed or treated persons or has been on the active teaching faculty of an acceptable approved medical school, within one of the last three years preceding receipt of an Application for licensure.

(e) (No change.)

§163.4.Procedural Rules for Licensure Applicants.

(a) - (c) (No change.)

(d) Review and Recommendations by the Executive Director.

(1) - (4) (No change.)

(5) If the Executive Director determines that the applicant is ineligible for licensure based on one or more of the statutory or regulatory provisions listed in subparagraphs (A) - (D) [(E)] of this paragraph, the applicant may appeal that decision to the Licensure Committee before completing other licensure requirements for a determination by the Committee solely regarding issues raised by the determination of ineligibility. If the Committee overrules the determination of the Executive Director, the applicant may then provide additional information to complete the application, which must be analyzed by board staff and approved before a license may be issued. Grounds for ineligibility under this subsection include noncompliance with the following:

(A) Section 155.003(a)(1) of the Act that requires the applicant to be 21 years of age;

(B) Section 155.003(b) and (c) of the Act that require that medical or osteopathic medical education received by an applicant must be accredited by an accrediting body officially recognized by the United States Department of Education, or meet certain other requirements, as more fully set forth in subsection (a)(8) of this section, §§163.5(b)(11), 163.5(c)(2)(C), 163.5(c)(2)(D), and 163.1(11)(B)(iii) and (iv) of this chapter;

(C) Sections 155.051 - 155.0511, and 155.056 of the Act that relates to required licensure examinations and examination attempts; and

[(D) Section 163.7 of this chapter (relating to the Ten Year Rule); and]

(D) [(E)] Section 163.6(e) of this chapter (relating to Examinations Accepted for Licensure) that requires passage of the Jurisprudence Examination.

§163.6.Examinations Accepted for Licensure.

(a) - (d) (No change.)

(e) Texas Medical Jurisprudence Examination (JP Exam).

(1) In this chapter, when applicants are required to pass the JP exam, applicants must pass the JP exam with a score of 75 or better. [within three attempts, unless the Board allows an additional attempt based upon a showing of good cause. An applicant who is unable to pass the JP exam within three attempts must appear before the Licensure Committee of the board to address the applicant's inability to pass the examination and to re-evaluate the applicant's eligibility for licensure. It is at the discretion of the committee to allow an applicant additional attempts to take the JP exam.]

(2) - (5) (No change.)

(f) (No change.)

§163.13.Expedited Licensure Process.

(a) Applications for licensure shall be expedited by the board's licensure division provided the applicant meets the criteria for applying for licensure under §163.2(d) of this title (relating to Full Texas Medical License) or submits an affidavit stating that:

(1) the applicant intends to practice in a rural community as determined by the Office of Rural Health Initiatives; or

(2) the applicant intends to practice medicine in a medically underserved area or health professional shortage area designated by the United States Department of Health and Human Services that has a shortage of physicians.

(b) Applications for licensure by certain psychiatrists shall be expedited by the board's licensure division.

(1) To be eligible, the applicant must meet the following criteria:

(A) holds an unrestricted license to practice medicine issued by another state;

(B) is board certified in psychiatry by the American Board of Psychiatry and Neurology or the American Osteopathic Board of Neurology and Psychiatry; and

(C) is not ineligible for licensure under §155.003(e) of the Medical Practice Act.

(2) The board's licensure division shall review all applications upon receipt to determine whether an applicant is eligible for expedited licensure.

(3) Subsection (b) of this section is effective September 1, 2017, and expires on January 1, 2022.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on September 1, 2017.

TRD-201703483

Mari Robinson, J.D.

Executive Director

Texas Medical Board

Earliest possible date of adoption: October 15, 2017

For further information, please call: (512) 305-7016


22 TAC §163.7

The repeal is proposed under the authority of the Texas Occupations Code Annotated, §153.001, which provides 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. The amendments are further proposed under the authority of Texas Occupations Code Annotated, Chapter 155, as amended by Senate Bill 674 (85th Leg. R.S.)(2017).

No other statutes, articles or codes are affected by this proposal.

§163.7.Ten Year Rule.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on September 1, 2017.

TRD-201703484

Mari Robinson, J.D.

Executive Director

Texas Medical Board

Earliest possible date of adoption: October 15, 2017

For further information, please call: (512) 305-7016


CHAPTER 171. POSTGRADUATE TRAINING PERMITS

22 TAC §171.3

The Texas Medical Board (Board) proposes an amendment to §171.3, concerning Physician-in-Training Permits.

The amendment to §171.3 adds language to subsection (d)(2)(C), clarifying that a physician-in-training permit shall expire not only upon the date the permit holder obtains full licensure, but temporary or limited licensure as well. The purpose of the amendment is to align the language of §171.3 with §163.9 of this title (relating to Only One License), which provides that a person may not have more than one license or permit at the same time, and that upon the issuance of any license or permit, all previously issued licenses and permits, including postgraduate training permits, shall be considered to be terminated.

Scott Freshour, General Counsel for the Board, has determined that for each year of the first five years the section as proposed is in effect, the public benefit anticipated as a result of enforcing this proposal will be to have rules that are internally consistent and clear.

Mr. Freshour has also determined that for the first five-year period that the section is in effect, there will be no fiscal implication to state or local government as a result of enforcing the section as proposed. There will be no effect to individuals required to comply with the rule as proposed. There will be no effect on small or micro businesses.

Comments on the proposal may be submitted to Rita Chapin, P.O. Box 2018, Austin, Texas 78768-2018, or email comments to: rules.development@tmb.state.tx.us. A public hearing will be held at a later date.

The amendment is proposed under the authority of the Texas Occupations Code Annotated, §153.001, which provides 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. The amendment is further proposed under the authority of Texas Occupations Code Annotated, Chapter 155.

No other statutes, articles or codes are affected by this proposal.

§171.3.Physician-in-Training Permits.

(a) - (c) (No change.)

(d) Expiration of Physician-in-Training Permit.

(1) Physician-in-Training permits shall be issued with effective dates corresponding with the beginning and ending dates of the postgraduate resident's training program as reported to the board by the program director.

(2) Physician-in-training permits shall expire on any of the following, whichever occurs first:

(A) on the reported ending date of the postgraduate training program;

(B) on the date a postgraduate training program terminates or otherwise releases a permit holder from its training program; or

(C) on the date the permit holder obtains full, temporary, or limited licensure, or temporary licensure pending full, limited, or other temporary licensure pursuant to §155.002 of the Act.

(3) (No change.)

(e) (No change.)

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on September 1, 2017.

TRD-201703485

Mari Robinson, J.D.

Executive Director

Texas Medical Board

Earliest possible date of adoption: October 15, 2017

For further information, please call: (512) 305-7016


CHAPTER 172. TEMPORARY AND LIMITED LICENSES

SUBCHAPTER B. TEMPORARY LICENSES

22 TAC §172.4. §172.8

The Texas Medical Board (Board) proposes amendments to §172.4, concerning State Health Agency Temporary License and §172.8, concerning Faculty Temporary License.

The amendments to §172.4, propose to delete language under paragraphs (1)(C) and (2)(A) referencing §163.7 of this title (relating to the Ten Year Rule). The amendments are proposed to reflect the proposed repeal of §163.7 of this title, which is also published in this issue.

The amendments to §172.8, propose to delete language under subsection (a)(2), requiring that an applicant pass the jurisprudence examination within three attempts. The changes are made pursuant to Senate Bill 674 (85th Legislature, Regular Session). Further amendments are proposed to subsection (k), deleting language referencing §163.7 of this title. The amendments are proposed to reflect the proposed repeal of §163.7, which is also published in this issue.

Scott Freshour, General Counsel for the Board, has determined that for each year of the first five years the sections as proposed are in effect, the public benefit anticipated as a result of enforcing this proposal will be to have rules that comport with applicable statutes and are internally consistent and clear.

Mr. Freshour has also determined that for the first five-year period that the sections are in effect, there will be no fiscal implication to state or local government as a result of enforcing the sections as proposed. There will be no effect to individuals required to comply with the rules as proposed. There will be no effect on small or micro businesses.

Comments on the proposal may be submitted to Rita Chapin, P.O. Box 2018, Austin, Texas 78768-2018, or email comments to: rules.development@tmb.state.tx.us. A public hearing will be held at a later date.

The amendments are proposed under the authority of the Texas Occupations Code Annotated, §153.001, which provides 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. The amendments are further proposed under the authority of Texas Occupations Code Annotated, Chapter 155, as amended by Senate Bill 674 (85th Leg. R.S.)(2017).

No other statutes, articles or Codes are affected by the amendments.

§172.4.State Health Agency Temporary License.

An applicant may elect to apply for a state health agency temporary license in lieu of licensure.

(1) The executive director of the board may issue such a temporary license to an applicant:

(A) who holds a valid license in another state or Canadian province on the basis of an examination, that is accepted by the board for licensure;

(B) who has passed the Texas medical jurisprudence examination;

(C) whose application has been filed, processed, and found to be in order. The application shall be complete in every detail [with the exception of compliance with §163.7 of this title (relating to Ten Year Rule)]; and

(D) who holds a salaried, administrative, or clinical position with an agency of the State of Texas.

(2) The state health agency temporary license shall be requested by the chief administrative officer of the employing state agency and shall be issued exclusively to that agency. The chief administrative officer shall state whether the temporary license is for a:

(A) clinical position. This temporary license will be valid for a one-year period from the date of issuance and will not be renewable. The temporary license is revocable at any time the board deems necessary. [To practice beyond one year, the holder of the temporary license must fully comply with §163.7 of this title (relating to Ten Year Rule).] During the period that the state health agency clinical temporary license is in effect, the physician will be supervised by a licensed staff physician who will regularly review the temporary license holder's skill and performance. This temporary license will be marked "clinical"; or

(B) (No change.)

§172.8.Faculty Temporary License.

(a) The board may issue a faculty temporary license to practice medicine to a physician in accordance with §155.104, Texas Occupations Code. "Physician," as used in that statute and in this section, is interpreted to mean a person who holds an M.D., D.O., or equivalent degree and who is licensed to practice medicine in another state or a Canadian province or has completed at least two years of postgraduate residency, but does not hold a license to practice medicine in this state.

(1) Each medical license held in any state, territory, or Canadian province must be free of any restrictions, disciplinary order or probation.

(2) The physician must have passed the Texas medical jurisprudence examination [within three attempts,] with a score of 75 or better.[, unless the board allows an additional attempt based upon a showing of good cause. An applicant who is unable to pass the JP exam within three attempts must appear before the licensure committee of the board to address the applicant's inability to pass the examination and to re-evaluate the applicant's eligibility for licensure. It is at the discretion of the committee to allow an applicant additional attempts to take the JP exam.]

(b) - (j) (No change.)

[(k) Six months under a faculty temporary license may be used to meet the requirements under §163.7(2) of this title (relating to Ten Year Rule).]

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on September 1, 2017.

TRD-201703486

Mari Robinson, J.D.

Executive Director

Texas Medical Board

Earliest possible date of adoption: October 15, 2017

For further information, please call: (512) 305-7016


CHAPTER 174. TELEMEDICINE AND MENTAL HEALTH SERVICES

The Texas Medical Board (Board) proposes amendments to §§174.1 - 174.3, 174.5 - 174.9 and new §174.4, concerning Mental Health Services and the repeal of §§174.10 - 174.12, concerning Telemedicine.

The title of Chapter 174 is renamed to "Telemedicine and Mental Health Services" and creates a new Subchapter A, "Telemedicine" and a new Subchapter B, "Mental Health Services".

The amendments to §174.1, concerning Purpose, add language 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 health services.

The amendments to §174.2, concerning Definitions, delete multiple definitions dealing with telemedicine while adding new definitions of "Prescription," "Store and forward technology," "Telehealth services," "Telemedicine medical services," and "Ultimate user" to comport with the new definitions in Senate Bill 1107 dealing with telemedicine and telehealth services.

The amendments to §174.3, concerning Prevention of Fraud and Abuse, delete the current detailed requirements for protocols to prevent fraud and abuse through the use of telemedicine services, and substitute a requirement that a consistent physician's protocols to prevent fraud and abuse must be consistent standard established by the Health and Human Services Commission pursuant to §531.02161 of the Government Code.

New §174.4, concerning Notice to Patients, adds language requiring physicians communicating with patients by electronic communications other than telephone or facsimile to provide patients with written or electronic notification of the physician's privacy practices prior to providing telemedicine services. The amendment further requires that the notices of privacy practice be consistent with federal standards under 45 CFR Parts 160 and 164. Additionally, the amendments require physicians providing telemedicine medical services to provide patients with notice of how to file a complaint with the Board.

The amendments to §174.5, concerning Issuance of Prescriptions, sets out requirements for valid prescriptions issued as a result of a telemedicine medical service and limits the treatment of chronic pain through telemedicine medical services.

The amendments to §174.6, concerning Minimum Standards for the Provision of Telemedicine Medical Services, delete multiple requirements for providing telemedicine services and substitute simplified minimum requirements for providing a health care service or procedure as a telemedicine medical service that comport with Senate Bill 1107.

The amendments to §174.7, concerning Enforcement Authority rename the section and delete language related to providing telemedicine services under the Board’s former definitions and requirements. The amendments clarify the Board's enforcement authority to investigation and discipline physicians for violations of statutes and rules to telemedicine services.

The amendments to §174.8, concerning State Licensure, rename the section, delete language related to evaluation and treatment of the patient superseded by SB 1107, and add language clarifying that physicians providing telemedicine services must possess a full Texas Medical license when treating residents of Texas.

The amendments to §174.9, concerning Provision of Mental Health Services, delete former rules regarding the provision of mental health care through telemedicine services and substitute simplified requirements for providing mental health services as telemedicine services. These requirements include: a requirement of licensure or certification; establishment of a provider/patient relationship; and a requirement to conform with the standard of care. The amendments make clear that technology may be used to provide mental health services to patients in a different location from the licensed or certified provider. The amendments also make clear that the Board may investigate and discipline providers for violations of rules related to the provision of mental health services.

The Board also proposes the repeal of §174.10, concerning Medical Records for Telemedicine Medical Services, §174.11, concerning On Call Services, and §174.12, concerning State Licensure. The repeals are necessary to ensure that the Board rules comport with SB 1107 and are not duplicative of other Board rules related to the provision of telemedicine and telemedicine services.

Scott Freshour, General Counsel for the Board, has determined that for each year of the first five years the sections as proposed are in effect the public benefit anticipated as a result of enforcing this proposal will be to make clear to the public the purpose and scope of the Board's telemedicine rules; to have rules that closely comport to Senate Bill 1107 and follow the legislature's intent in regard to the regulation of telemedicine and telehealth services; to establish one clear standard, consistent with Health and Human Services Commission rules for physicians to create protocols to help avoid fraud and abuse through the use of telemedicine and telehealth services; to insure that patients have an understanding of the privacy policy of physicians utilizing telemedicine services and how to file a complaint with the board; providing physicians clear guidelines on requirements for providing privacy notices; to establish clear guidelines for the validity of prescriptions issued as a result of a telemedicine service; to follow the legislature's intent to limit the treatment of chronic pain through telemedicine medical services and thus protect the public health; to provide clear and simple rules regarding minimum standard for providing telemedicine medical services to the public and physicians providing telemedicine services. An additional public benefit anticipated will be to increase access to healthcare by the public; to clarify to the public and Board licensees that the Board retains enforcement authority to investigate and discipline licensees' violations of statutes and rules related to telemedicine medical services; to protect the public health by insuring that physicians treating Texas residents through telemedicine services possess a full Texas Medical license and to increase public access to mental health care services while insuring public safety by Board oversight.

Mr. Freshour has also determined that for the first five-year period the sections are in effect there will be no fiscal implication to state or local government as a result of enforcing the sections as proposed. There will be no effect to individuals required to comply with the rules as proposed. There will be no effect on small or micro businesses.

Comments on the proposal may be submitted to Rita Chapin, P.O. Box 2018, Austin, Texas 78768-2018, or email comments to: rules.development@tmb.state.tx.us. A public hearing will be held at a later date.

SUBCHAPTER A. TELEMEDICINE

22 TAC §§174.1 - 174.8

The amendments and new rule are proposed under the authority of the Texas Occupations Code Annotated, §153.001, which provides 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.

No other statutes, articles or codes are affected by this proposal.

§174.1.Purpose.

(a) Pursuant to Chapter 111 of the Texas Occupations Code, and §151.056, §153.001 and §157.001 of the Medical Practice Act, the Board is authorized to adopt rules relating to the practice of medicine, including telemedicine medical services.

(b) This chapter is promulgated to clarify the requirements in Chapter 111 of the Texas Occupations Code related to the provision of telemedicine medical services [establish standards for the use of the Internet and the provision of telemedicine medical services by physicians who are licensed to practice medicine in this State]. This chapter does not apply to out-of-state telemedicine licenses issued by the Board pursuant to §151.056 of the Act and §172.12 of this title (relating to Out-of-State Telemedicine License), federally qualified health centers (FQHCs), or to consultations provided by health insurance help lines.

§174.2.Definitions.

The following words and terms, when used in this chapter shall have the following meanings unless the context indicates otherwise.

(1) Prescription--Any medication(s) that require a prescription issued to the ultimate user as the result of a telemedicine medical service, by:

(A) a Texas licensed physician, and if the prescription is for a controlled substance, the physician must have a current valid DEA registration number; or

(B) issued by a Texas licensed practitioner, acting under the delegated authority of a Texas licensed physician, and in accordance with the required prescriptive authority agreement or other permissible forms of delegation as set out by Chapter 157 of the Medical Practice Act, and, if the prescription is for a controlled substance, the licensed practitioner must have a current, valid DEA registration. In addition, if the prescription is for a controlled substance listed in schedule II, the licensed practitioners may only use the official prescription forms issued with their name, address, phone number, and DEA numbers, and the delegating physician's name and DEA number.

(C) The use of electronic prescriptions (e-scripts) is allowed as permitted by state and federal law.

(2) Store and forward technology--is defined in §111.001(2) of the Texas Occupations Code.

(3) Telehealth services--is defined in §111.001(3) of the Texas Occupations Code.

(4) Telemedicine medical services--is defined in §111.001(4) of the Texas Occupations Code.

(5) Ultimate user--is the same definition used in the Texas Pharmacy Act.

[(1) Distant site provider--A physician or a physician assistant or advanced practice nurse who is supervised by and has delegated authority from a licensed Texas physician, who uses telemedicine to provide health care services to a patient in Texas. Distant site providers must be licensed in Texas.]

[(2) Established medical site--A location where a patient will present to seek medical care where there is a patient site presenter and sufficient technology and medical equipment to allow for an adequate physical evaluation, as appropriate for the patient's presenting complaint. It requires establishing a defined physician-patient relationship, as defined by §190.8(1)(L) of this title (relating to Violation Guidelines). A patient's private home is not considered an established medical site, except as provided in §174.6(d) of this title (relating to Telemedicine Medical Services Provided at an Established Medical Site). An established medical site includes all Mental Health and Mental Retardation Centers (MHMRs), and Community Centers, as defined by Health and Safety Code, Chapter 534, where the patient is a resident and the medical services provided are limited to mental health services.]

[(3) Face-to-face visit--An evaluation performed on a patient where the provider and patient are both at the same physical location or where the patient is at an established medical site.]

[(4) In-person evaluation--A patient evaluation conducted by a provider who is at the same physical location as the location of the patient.]

[(5) Medium--Any mechanism of information transfer including electronic means.]

[(6) Patient site location--The patient site location is where the patient is physically located.]

[(7) Patient site presenter--The patient site presenter is the individual at the patient site location who introduces the patient to the distant site physician for examination and to whom the distant site physician may delegate tasks and activities. A patient site presenter must be:]

[(A) licensed or certified in this state to perform health care services or a qualified mental health professional-community services (QMHP-CS) as defined in 25 TAC §412.303(48); and]

[(B) delegated only tasks and activities within the scope of the individual's licensure or certification.]

[(8) Person--An individual unless otherwise expressly made applicable to a partnership, association, or corporation.]

[(9) Physician-patient e-mail--An interactive communication via an interactive electronic text messaging system between a physician (or their medical staff and patients within a professional relationship in which the physician has taken on an explicit measure of responsibility for the patient's care.]

[(10) Telemedicine medical service--The practice of medical care delivery, initiated by a distant site provider, who is physically located at a site other than the site where the patient is located, for the purposes of evaluation, diagnosis, consultation, or treatment which requires the use of advanced telecommunications technology that allows the distant site provider to see and hear the patient in real time.]

[(11) Group or Institutional Setting--These include residential treatment facilities, halfway houses, jails, juvenile detention centers, prisons, nursing homes, group homes, rehabilitation centers, and assisted living facilities.]

§174.3.Prevention of Fraud and Abuse. [Telemedicine Medical Services]

[(a)] All physicians utilizing [that use] telemedicine medical services in their practices shall adopt protocols to prevent fraud and abuse through the use of telemedicine medical services. In order to establish that a physician has made a good faith effort these protocols [These standards] must be consistent with standards [those] established by the Health and Human Services Commission pursuant to §531.02161 of the Government Code.

[(b) In order to establish that a physician has made a good faith effort in the physician's practice to prevent fraud and abuse through the use of a telemedicine medical services, the physician must implement written protocols that address the following:

[(1) authentication and authorization of users;]

[(2) authentication of the origin of information;]

[(3) the prevention of unauthorized access to the system or information;]

[(4) system security, including the integrity of information that is collected, program integrity, and system integrity;]

[(5) maintenance of documentation about system and information usage;]

[(6) information storage, maintenance, and transmission; and]

[(7) synchronization and verification of patient profile data.]

§174.4.Notice to Patients.

Privacy Practices.

(1) Physicians that communicate with patients by electronic communications other than telephone or facsimile must provide patients with written or electronic notification of the physicians' privacy practices prior to evaluation or treatment via a telemedicine medical service. In addition, a good faith effort must be made to obtain the patient's written or electronic acknowledgement, including by e-mail, of the notice.

(2) The notice of privacy practices shall include language that is consistent with federal standards under 45 CFR Parts 160 and 164 relating to privacy of individually identifiable health information.

(3) Complaints to the Board. Physicians that utilize telemedicine medical services must provide notice of how patients may file a complaint with the Board on the physician's website or with informed consent materials provided to patients prior to the telemedicine medical service. Content and method of the notice must be consistent with §178.3 of this title (relating to Complaint Procedure Notification).

§174.5.Issuance of Prescriptions [Notice to Patients]

(a) The validity of a prescription issued as a result of a telemedicine medical service is determined by the same standards that would apply to the issuance of the prescription in an in-person setting.

(b) This rule does not limit the professional judgment, discretion or decision-making authority of a licensed practitioner. A licensed practitioner is expected to meet the standard of care and demonstrate professional practice standards and judgment, consistent with all applicable statutes and rules when issuing, dispensing, delivering, or administering a prescription medication as a result of a telemedicine medical service.

(c) A valid prescription must be:

(1) issued for a legitimate medical purpose by a practitioner as part of patient-practitioner relationship as set out in §111.005, of Texas Occupations Code; and

(2) meet all other applicable laws before prescribing, dispensing, delivering or administering a dangerous drug or controlled substance.

(d) Any prescription drug orders issued as the result of a telemedicine medical service, are subject to all regulations, limitations, and prohibitions set out in the federal and Texas Controlled Substances Act, Texas Dangerous Drug Act and any other applicable federal and state law.

(e) Limitation on Treatment of Chronic Pain. Chronic pain is a legitimate medical condition that needs to be treated but must be balanced with concerns over patient safety and the public health crisis involving overdose deaths. The Legislature has already put into place laws regarding the treatment of pain and requirements for registration and inspection of pain management clinics. Therefore, the Board has determined clear legislative intent exists for the limitation of chronic pain treatment through a telemedicine medical service.

(1) For purposes of this rule, chronic pain has the same definition as used in §170.2(4) of this title (relating to Definitions).

(2) For purposes of this rule, acute pain has the same definition as used in §170.2(2) of this title.

(A) Treatment of chronic pain with scheduled drugs through use of telemedicine medical services is prohibited, unless otherwise allowed under federal and state law.

(B) Treatment of acute pain with scheduled drugs through use of telemedicine medical services is allowed, unless otherwise prohibited under federal and state law.

[(a) Privacy Practices.]

[(1) Physicians that communicate with patients by electronic communications other than telephone or facsimile must provide patients with written notification of the physicians' privacy practices prior to evaluation or treatment. In addition, a good faith effort must be made to obtain the patient's written acknowledgement, including by e-mail, of the notice.]

[(2) The notice of privacy practices shall include language that is consistent with federal standards under 45 CFR Parts 160 and 164 relating to privacy of individually identifiable health information.]

[(b) Limitations of Telemedicine. Physicians who use telemedicine medical services must, prior to providing services, give their patients notice regarding telemedicine medical services, including the risks and benefits of being treated via telemedicine, how to receive follow-up care or assistance in the event of an adverse reaction to the treatment or in the event of an inability to communicate as a result of a technological or equipment failure. A signed and dated notice, including an electronic acknowledgement, by the patient establishes a presumption of notice.]

[(c) Necessity of In-Person Evaluation. When, for whatever reason, the telemedicine modality in use for a particular patient encounter is unable to provide all pertinent clinical information that a health care provider exercising ordinary skill and care would deem reasonably necessary for the practice of medicine at an acceptable level of safety and quality in the context of that particular medical encounter, then the distant site provider must make this known to the patient prior to the conclusion of the live telemedicine encounter and advise the patient, prior to the conclusion of the live telemedicine encounter, regarding the need for the patient to obtain an additional in-person medical evaluation reasonably able to meet the patient's needs.]

[(d) Complaints to the Board. Physicians that use telemedicine medical services must provide notice of how patients may file a complaint with the Board on the physician's website or with informed consent materials provided to patients prior to rendering telemedicine medical services. Written content and method of the notice must be consistent with §178.3 of this title (relating to Complaint Procedure Notification).]

§174.6.Minimum Standards for the Provision of Telemedicine Medical Services [Provided at an Established Medical Site].

(a) A health professional providing a health care service or procedure as a telemedicine medical service:

(1) is subject to the same standard of care that would apply to the provision of the same health care service or procedures in an in person setting;

(2) must establish a practitioner-patient relationship; and

(3) must maintain complete and accurate medical records as set out in §165.1 of this title (relating to Medical Records).

(b) Adequate measures must be implemented to ensure that patient communications, recordings and records are protected consistent with Federal and State privacy laws.

[(a) Telemedicine medical services provided at an established medical site may be used for all patient visits, including initial evaluations to establish a defined physician-patient relationship between a distant site provider and a patient.]

[(b) For new conditions, a patient site presenter must be reasonably available onsite at the established medical site to assist with the provision of care. It is at the discretion of the distant site physician if a patient site presenter is necessary for follow-up evaluation or treatment of a previously diagnosed condition.]

[(1) A distant site provider may delegate tasks and activities to a patient site presenter during a patient encounter.]

[(2) A distant site provider delegating tasks to a patient site presenter shall ensure that the patient site presenter to whom delegation is made is properly supervised.]

[(c) If the only services provided are related to mental health services, a patient site presenter is not required, except in cases of behavioral emergencies, as defined by 25 TAC §415.253 (relating to Definitions).]

[(d) For the purposes of this chapter the following shall be considered to be an established medical site:]

[(1) The patient's home, including a group or institutional setting where the patient is a resident, if the medical services being provided in this setting are limited to mental health services;]

[(2) For medical services, other than mental health services, to be provided at the patient's home, including a group or institutional setting where the patient is a resident, the following requirements must be met:]

[(A) a patient site presenter is present;]

[(B) there is a defined physician-patient relationship as set out in §174.8 of this title (relating to Evaluation and Treatment of the Patient);]

[(C) the patient site presenter has sufficient communication and remote medical diagnostic technology to allow the physician to carry out an adequate physical examination appropriate for the patient's presenting condition while seeing and hearing the patient in real time. All such examinations will be held to the same standard of acceptable medical practices as those in traditional clinical settings; and]

[(D) An online questionnaire or questions and answers exchanged through email, electronic text, or chat or telephonic evaluation of or consultation with a patient do not meet the requirements for subparagraph (C) of this paragraph.]

§§174.7.Enforcement Authority [Telemedicine Medical Services Provided at Sites other than an Established Medical Site].

Complaints regarding violations of statutes and rules related to telemedicine medical services may result in an investigation and discipline under the Medical Practice Act and applicable rules and procedures, or referral to the proper regulatory authority of the practitioner proving telemedicine medical services.

[(a) A distant site provider who provides telemedicine medical services at a site other than an established medical site for a patient's previously diagnosed condition must either:]

[(1) see the patient one time in a face-to-face visit before providing telemedicine medical care; or]

[(2) see the patient without an initial face-face to visit, provided the patient has received an in-person evaluation by another physician who has referred the patient for additional care and the referral is documented in the medical record.]

[(b) Patient site presenters are not required for pre-existing conditions previously diagnosed by a physician through a face-to-face visit.]

[(c) All patients must be seen by a physician for an in-person evaluation at least once a year.]

[(d) Telemedicine medical services may not be used to treat chronic pain with scheduled drugs. at sites other than medical practice sites.]

[(e) A distant site provider may treat an established patient's new symptoms which are unrelated to a patient's preexisting condition provided that the patient is advised to see a physician in a face-to-face visit within 72 hours. A distant site provider may not provide continuing telemedicine medical services for these new symptoms to a patient who is not seen within 72 hours. If a patient's symptoms are resolved within 72 hours, such that continuing treatment for the acute symptoms is not necessary, then a follow-up face-to-face visit is not required.]

§174.8.State Licensure [Evaluation and Treatment of the Patient].

Physicians who treat and prescribe through advanced communications technology are practicing medicine and must possess a full Texas medical license when treating residents of Texas. An out-of-state physician may provide episodic consultations without a Texas medical license, as provided in Texas Occupations Code, §151.056, §172.2(g)(4) of this title (relating to Construction and Definitions), and §172.12(f) of this title (relating to Out-of-State Telemedicine License).

[(a) Evaluation of the Patient. Distant site providers who utilize telemedicine medical services must ensure that a defined physician-patient relationship is established which at a minimum includes:]

[(1) establishing that the person requesting the treatment is in fact who the person claims to be;]

[(2) establishing a diagnosis through the use of acceptable medical practices, including documenting and performing patient history, mental status examination, and physical examination that must be performed as part of a face-to-face or in-person evaluation as defined in §174.2(3) and (4) of this title (relating to Definitions). The requirement for a face-to-face or in-person evaluation does not apply to mental health services, except in cases of behavioral emergencies, as defined by 25 TAC §415.253 (relating to Definitions), and appropriate diagnostic and laboratory testing to establish diagnoses, as well as identify underlying conditions or contra-indications, or both, to treatment recommended or provided;]

[(3) discussing with the patient the diagnosis and the evidence for it, the risks and benefits of various treatment options, and]

[(4) ensuring the availability of the distant site provider or coverage of the patient for appropriate follow-up care.]

[(b) Treatment. Treatment and consultation recommendations made in an online setting, including issuing a prescription via electronic means, will be held to the same standards of acceptable medical practices as those in traditional in-person clinical settings.]

[(c) An online questionnaire or questions and answers exchanged through email, electronic text, or chat or telephonic evaluation of or consultation with a patient are inadequate to establish a defined physician-patient relationship.]

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on September 1, 2017.

TRD-201703487

Mari Robinson, J.D.

Executive Director

Texas Medical Board

Earliest possible date of adoption: October 15, 2017

For further information, please call: (512) 305-7016


SUBCHAPTER B. MENTAL HEALTH SERVICES

22 TAC §174.9

The amendment is proposed under the authority of the Texas Occupations Code Annotated, §153.001, which provides 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.

No other statutes, articles or codes are affected by this proposal.

§174.9.Provision of Mental Health Services [Technology and Security Requirements].

The Board recognizes that mental health services are expressly exempt from the provisions of Section 111, Texas Occupations Code. However, these services are the practice of medicine. Pursuant to §§151.056, 153.001 and 157.001 of the Medical Practice Act, the Board has authority to promulgate rules concerning mental health services. Given that many areas of the state lack access to mental health services and providers, the use of technology can help alleviate this shortage. Therefore, the following rules are enacted to provide greater access to care, while insuring patient safety:

(1) Licensure or Certification Required--Any individual providing mental health services must be properly licensed or certified in this state to perform health care services, or be a qualified mental health professional-community services (QMHP-CS) as defined in 25 TAC §412.303(48) (relating to Definitions); and be delegated only tasks and activities within the scope of the individual's licensure or certification.

(2) Use of Technology to Provide Mental Health Services--Mental health services may be provided to a patient at a different location from the location of the licensed or certified provider using telecommunications or information technology.

(3) Establishing the Provider/Patient relationship--When providing mental health services, the provider must establish the provider-patient relationship, which can be established through use of telecommunications or information technology.

(4) Standard of Care--When providing mental health services, such services must be conducted in the same manner as those in a traditional in-person setting. This includes keeping of proper medical records, performing observations and evaluations, and treatment. If treatment involves the use of prescription medication, all applicable federal and state laws and rules apply.

(5) Investigations and Discipline--Complaints regarding violations of rules related to mental health services may result in an investigation and discipline under the Medical Practice Act and applicable board rules and procedures, or referral to the proper regulatory authority of the practitioner providing the mental health services.

(6) Chronic Pain Treatment Prohibited--Treatment of chronic pain with scheduled drugs through use of telecommunications or information technology is prohibited, unless otherwise allowed under federal and state law.

[(a) At a minimum, advanced communication technology must be used for all patient evaluation and treatment conducted via telemedicine.]

[(b) Adequate security measures must be implemented to ensure that all patient communications, recordings and records remain confidential.]

[(c) Electronic Communications.]

[(1) Written policies and procedures must be maintained when using electronic mail for physician-patient communications. Policies must be evaluated periodically to make sure they are up to date. Such policies and procedures must address:]

[(A) privacy to assure confidentiality and integrity of patient-identifiable information;]

[(B) health care personnel, in addition to the physician, who will process messages;]

[(C) hours of operation and availability;]

[(D) types of transactions that will be permitted electronically;]

[(E) required patient information to be included in the communication, such as patient name, identification number and type of transaction;]

[(F) archival and retrieval; and]

[(G) quality oversight mechanisms.]

[(2) All relevant patient-physician e-mail, as well as other patient-related electronic communications, must be stored and filed in the patient's medical record.]

[(3) Patients must be informed of alternative forms of communication for urgent matters.]

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on September 1, 2017.

TRD-201703488

Mari Robinson, J.D.

Executive Director

Texas Medical Board

Earliest possible date of adoption: October 15, 2017

For further information, please call: (512) 305-7016


CHAPTER 174. TELEMEDICINE

22 TAC §§174.10 - 174.12

The repeals are proposed under the authority of the Texas Occupations Code Annotated, §153.001, which provides 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.

No other statutes, articles or codes are affected by this proposal.

§174.10.Medical Records for Telemedicine Medical Services.

§174.11.On-Call Services.

§174.12.State Licensure.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on September 1, 2017.

TRD-201703489

Mari Robinson, J.D.

Executive Director

Texas Medical Board

Earliest possible date of adoption: October 15, 2017

For further information, please call: (512) 305-7016


CHAPTER 175. FEES AND PENALTIES

22 TAC §175.1, §175.2

The Texas Medical Board (Board) proposes amendments to §175.1, concerning Application and Administrative Fees; and §175.2, concerning Registration and Renewal Fees.

The amendment to §175.1 deletes language tying fee calculation for the Prescription Drug Monitoring Program (PMP) to Article IX, §18.55 of House Bill 1, 84th Legislature, and adds language requiring fee calculation to be made in accordance with the Texas General Appropriations Act. The amendment will increase flexibility under the rules for any future PMP fee changes necessitated by amendments made to the Medical Board’s cost allocation for PMP administration through the General Appropriations Act.

The amendment to §175.2 deletes language tying fee calculation for the Prescription Drug Monitoring Program to Article IX, §18.55 of House Bill 1, 84th Legislature, and adds language requiring fee calculation to be in accordance with the Texas General Appropriations Act. The amendment will increase flexibility under the rules for any future PMP fee changes necessitated by amendments made to the Medical Board’s cost allocation for PMP administration through the General Appropriations Act.

Scott Freshour, General Counsel for the Board, has determined that for the first five-year period the sections are in effect there will be no fiscal implication to state or local government as a result of enforcing the sections as proposed. The effect to individuals required to comply with the rules as proposed will be the increase to PMP fees for a license affected by these changes, necessitated by increases made to the Medical Board’s total cost allocation by Article VIII, Senate Bill 1, (85th Legislature, R.S.). For FY18, physician PMP fees will increase by an estimated $4.82, and then decreased by $.82 for FY 19. Physician Assistant PMP fees will increase by an estimated $2.41 for FY18, and then decrease by $.41 for FY19. There will be no effect on small or micro businesses.

Mr. Freshour has determined that for each year of the first five years the sections as proposed are in effect, the public benefit anticipated as a result of enforcing this proposal will be to allow the agency to carry out its statutory mandates related to PMP administration costs.

Comments on the proposal may be submitted to Rita Chapin, P.O. Box 2018, Austin, Texas 78768-2018 or email comments to: rules.development@tmb.state.tx.us. A public hearing will be held at a later date.

The amendments are proposed under the authority of the Texas Occupations Code Annotated, §153.001, which provides 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. The amendments are also authorized by Texas Occupations Code Annotated, §156.001; §554.006, and Article VIII, Senate Bill 1, 85th Legislature, Regular Session (2017).

No other statutes, articles or codes are affected by this proposal.

§175.1.Application and Administrative Fees.

The board shall charge the following fees for processing an application for a license or permit:

(1) Physician Licenses:

(A) - (H) (No change.)

(I) In accordance with §554.006 of the Texas Occupations Code, for those physician license types that confer the authority to prescribe controlled substances and access the Prescription Drug Monitoring Program described by §§481.075, 481.076, and 481.0761 of the Texas Health and Safety Code, the Board shall charge an additional reasonable and necessary fee sufficient to cover the Board's responsible portion for costs related to the Texas Pharmacy Board's establishment and implementation of the drug monitoring program. The fee amount will be calculated in accordance with the Texas General Appropriations Act [appropriation match amount assigned to the Board under Article IX, §18.55 of House Bill 1, 84th Legislature, Regular Session (2015)].

(2) Physician Assistants:

(A) - (C) (No change.)

(D) In accordance with §554.006 of the Texas Occupations Code, the Board shall charge an additional reasonable and necessary fee sufficient to cover the Board's responsible portion for costs related to the Texas Pharmacy Board's establishment and implementation of the Prescription Drug Monitoring Program described by §§481.075, 481.076, and 481.0761 of the Texas Health and Safety Code. The fee amount will be calculated in accordance with the Texas General Appropriations Act [appropriation match amount assigned to the Board under Article IX, §18.55 of House Bill 1, 84th Legislature, Regular Session (2015)].

(3) - (9) (No change.)

§175.2.Registration and Renewal Fees.

The board shall charge the following fees to continue licenses and permits in effect:

(1) Physician Registration Permits:

(A) - (C) (No change.)

(D) In accordance with §554.006 of the Texas Occupations Code, for those physician license types that confer the authority to prescribe controlled substances and access the Prescription Drug Monitoring Program described by §§481.075, 481.076, and 481.0761 of the Texas Health and Safety Code, the Board shall charge an additional reasonable and necessary fee sufficient to cover the Board's responsible portion for costs related to the Texas Pharmacy Board's establishment and implementation of the drug monitoring program. The fee amount will be calculated in accordance with the Texas General Appropriations Act [appropriation match amount assigned to the Board under Article IX, §18.55 of House Bill 1, 84th Legislature, Regular Session (2015)].

(2) Physician Assistant Registration Permits:

(A) - (B) (No change.)

(C) In accordance with §554.006 of the Texas Occupations Code, the Board shall charge an additional reasonable and necessary fee sufficient to cover the Board's responsible portion for costs related to the Texas Pharmacy Board's establishment and implementation of the Prescription Drug Monitoring Program described by §§481.075, 481.076, and 481.0761 of the Texas Health and Safety Code. The fee amount will be calculated in accordance with the Texas General Appropriations Act [appropriation match amount assigned to the Board under Article IX, §18.55 of House Bill 1, 84th Legislature, Regular Session (2015)].

(3) - (7) (No change.)

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on September 1, 2017.

TRD-201703490

Mari Robinson, J.D.

Executive Director

Texas Medical Board

Earliest possible date of adoption: October 15, 2017

For further information, please call: (512) 305-7016


CHAPTER 178. COMPLAINTS

22 TAC §178.3

The Texas Medical Board (Board) proposes amendments to §178.3, concerning Complaint Procedure Notification.

The amendment deletes the word "Procedure" from the title, deletes language related to the type size of printed copies of the board approved notification statement regarding complaints on billing statements and written contracts for services. The amendment adds language setting allowing telemedicine providers to provide the Board approved complaint notification statement through: a prominently displayed link on a website, in a provider app; by recording, or in a bill for services.

Scott Freshour, General Counsel for the Board, has determined that for each year of the first five years the section as proposed is in effect the public benefit anticipated as a result of enforcing this proposal will be to insure that members of the public receiving telemedicine medical services are notified of procedures for filing complaints with the Board. The amendment provide the further benefit of allowing physicians providing telemedicine services to provide such notification through means consistent with the manner in which telemedicine services are provided.

Mr. Freshour has also determined that for the first five-year period the section is in effect there will be no fiscal implication to state or local government as a result of enforcing the section as proposed. There will be no effect to individuals required to comply with the rule as proposed. There will be no effect on small or micro businesses.

Comments on the proposal may be submitted to Rita Chapin, P.O. Box 2018, Austin, Texas 78768-2018, or e-mail comments to: rules.development@tmb.state.tx.us. A public hearing will be held at a later date.

The amendment is proposed under the authority of the Texas Occupations Code Annotated, §153.001, which provides 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. The amendments are also proposed under the authority of Texas Occupations Code Annotated, §152.006.

No other statutes, articles or codes are affected by this proposal.

§178.3.Complaint [Procedure] Notification.

(a) Methods of Notification.

(1) Complaints against licensees. Pursuant to the Act, for the purpose of directing complaints to the board, the board and its licensees shall provide notification to the public of the name, mailing address, [and] telephone number and website address of the board by one or more of the following methods:

(A) displaying in a prominent location at a licensee's place of business, signs in English and Spanish of no less than 8 1/2 inches by 11 inches in size with the board-approved notification statement printed alone and in its entirety in black on white background in type no smaller than standard 24-point Times Roman print with no alterations, deletions, or additions to the language of the board-approved statement; or

(B) placing the board-approved notification statement printed in English and Spanish in black type no smaller than standard 10-point 12-pitch typewriter print on each bill for services by a licensee with no alterations, deletions, or additions to the language of the board-approved statement; or] if providing telemedicine medical services, by a prominently displayed link on the provider website; in a provider app; by recording; or in a bill for services, the approved notification statement described in subsections (b) and (c) of this section. The notice must be no less than a 10-point easily readable font, and with no alterations, deletions, or additions to the language of the board-approved statement.

[(C) placing the board-approved notification statement printed in English and Spanish in black type no smaller than standard 10-point, 12-pitch typewriter print on each registration form, application, or written contract for services of a licensee with no alterations, deletions, or additions to the language of the board-approved statement.]

(2) A private autopsy facility, as defined under §671A.001 of the Health and Safety Code, must post notice in a conspicuous place in a public area of the facility that substantially complies with the notice of subsection (b) of this section with included language on filing complaints against physicians who perform autopsy services.

(b) - (c) (No change.)

(d) Figures 1 - 4 are the required Board approved statements to be utilized under this rule [samples of the type print referenced in subsection (a)(1) and (2) of this section].

Figure 1: 22 TAC §178.3(d) (No change.)

Figure 2: 22 TAC §178.3(d) (No change.)

Figure 3: 22 TAC §178.3(d) (No change.)

Figure 4: 22 TAC §178.3(d) (No change.)

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on September 1, 2017.

TRD-201703491

Mari Robinson, J.D.

Executive Director

Texas Medical Board

Earliest possible date of adoption: October 15, 2017

For further information, please call: (512) 305-7016


CHAPTER 187. PROCEDURAL RULES

The Texas Medical Board (Board) proposes amendments to §187.16, concerning Informal Show Compliance Proceedings (ISCs), §187.18, concerning Informal Show Compliance Proceeding and Settlement Conference Based on Personal Appearance, and §187.83, concerning Proceedings for Cease and Desist Orders.

The amendments to §187.16 set out a finding that the statutory minimum requirements related to the Informal Show Compliance Proceedings (ISCs), as set out in the Texas Occupations Code, §164. et.seq., are comprehensive and complete. The amendments state that rules related to ISC proceedings will be promulgated only as necessary to be consistent with statutory requirements. The amendment deletes provisions duplicative of §164 of the Texas Occupations Code and deletes an incorrect reference to providing 30 rather than 45 days notice prior to an ISC.

The amendment to §187.18, deletes ISC requirements duplicative of those set out in §164.003 and §164.0031 of the Occupations Code and clarify the procedures for conducting an ISC.

The amendment to §187.83, corrects a typographical error in a citation to Texas Occupations Code §164.052.

Scott Freshour, General Counsel for the Board, has determined that for each year of the first five years the sections as proposed are in effect the public benefit anticipated as a result of enforcing this proposal will be to ensure that the rules regarding ISCs are more consistent with the statutory requirements for ISCs as set out in the Occupations Code and provide clear information as to the notice requirements for an ISC; to create rules that are clear and unambiguous, and better aligned with both the Board's current procedures and the Occupation Code's requirements for ISCs. The public will further benefit from a clear understanding of the procedures for conducting an ISC and to ensure the public may rely on accurate legal citations.

Mr. Freshour has also determined that for the first five-year period the sections are in effect there will be no fiscal implication to state or local government as a result of enforcing the sections as proposed. There will be no effect to individuals required to comply with the rules as proposed. There will be no effect on small or micro businesses.

Comments on the proposal may be submitted to Rita Chapin, P.O. Box 2018, Austin, Texas 78768-2018, or e-mail comments to: rules.development@tmb.state.tx.us. A public hearing will be held at a later date.

SUBCHAPTER B. INFORMAL BOARD PROCEEDINGS

22 TAC §187.16, §187.18

The amendments are proposed under the authority of the Texas Occupations Code Annotated, §153.001, which provides 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. The amendments are also proposed under the authority of Texas Occupations Code Annotated, §152.006.

No other statutes, articles or codes are affected by this proposal.

§187.16.Informal Show Compliance Proceedings (ISCs).

(a) Texas Medical Board finds that statutory minimum requirements related to the Informal Show Compliance Proceedings (ISCs) as set out in the Texas Occupations Code, §164. et.seq. are comprehensive and complete. Pursuant to §153.001 and §164.003 of the Medical Practice Act, the Board is authorized to adopt rules relating to the ISCs and how they are to be conducted. These rules are promulgated to clarify the ISC process and procedures only as necessary to be consistent with the statutory requirements.

(b) [(a)] Notice of the time, date and place of the ISC shall be extended to the licensee and the complainant(s) in writing, by hand delivery, regular mail, certified mail - return receipt requested, overnight or express mail, courier service, or registered mail, to the address of record of the complainants and the address of record of the licensee or the licensee's authorized representative to [be sent by the Board at least 30 days prior to the date of the ISC for complaints filed before September 1, 2011. For complaints filed on or after September 1, 2011, the notice shall] be sent at least 45 days prior to the date of the ISC. The notice to the licensee or the licensee's authorized representative shall also include:

(1) a statement that the licensee has the opportunity to attend and participate in the informal meeting;

(2) a written statement of the nature of the allegations; and

(3) a copy of the information the board intends to use at the ISC. If the complaint includes an allegation that the licensee has violated the standard of care, the notice shall also include a copy of the Expert Physician Reviewers' Report, prepared in accordance with §154.0561, Texas Occupations Code. [In addition, the board will also provide the licensee with the rules governing the proceeding and guidelines to assist the licensee to prepare for the ISC, including requirements regarding requests to reschedule the ISC.] The information required by this section may be given in separate communications at different times, provided all of the information has been provided at least [30 days prior to the date of the ISC for complaints filed before September 1, 2011. For complaints filed with the board on or after September 1, 2011, the information to the licensee shall be sent at least] 45 days prior to the date of the ISC.

[(b) If the information that the board intends to use at the ISC includes only excerpts of any medical record, the licensee has a right to obtain the complete medical record within 14 days after a request is mailed.]

[(c) A licensee may be asked to respond in writing to questions from the board staff concerning the matter. If the licensee is asked to respond to written questions, the licensee shall respond within 14 days after the notice is mailed. The licensee's response may include any additional information the licensee wants the board representatives to consider.]

(c) [(d)] All information provided by the board staff and the licensee shall be provided to the board representatives for review prior to the board representatives making a determination of whether the licensee has violated the Act, board rules, remedial plan, or board order.

(d) [(e)] All informal show compliance proceedings shall be scheduled not later than the 180th day after the date the board's official investigation of the complaint is commenced, unless good cause is shown by the board for scheduling the informal meeting after that date. For purposes of this subsection:

(1) "Scheduled" means the act of the agency to reserve a date for the ISC.

(2) "Good cause" shall have the meaning set forth in §179.6 of this title (relating to Time Limits).

§187.18.Informal Show Compliance Proceeding and Settlement Conference Based On Personal Appearance.

(a) After referral of an investigation to the agency's legal division, the Hearings Coordinator of the board shall schedule an ISC before an ISC Panel in accordance with the requirements set forth in §164.003(b)(4) and §164.0031 of the Act[, composed of two or more board representatives to be held after proper notice to the licensee. One board representative must be a public member. If the matter is before the Medical Board, at least one board representative must be a physician member].

(b) Requests to reschedule the ISC by a licensee must be in writing and shall be referred to the Hearings Counsel for consideration. To avoid undue disruption of the ISC schedule, the Hearings Counsel should grant a request [only after conferring with the Hearings Coordinator and strictly] applying the following guidelines:

(1) A request by a licensee to reschedule an ISC must be in writing and may be granted only if the licensee provides satisfactory evidence of the following requirements:

(A) A request received by the agency within five business days after the licensee received notice of the date of the ISC, must provide details showing that:

(i) the licensee has a conflicting event that had been scheduled prior to receipt of notice of the ISC;

(ii) the licensee has made reasonable efforts to reschedule such event but a conflict cannot reasonably be avoided.

(B) A request received by the agency more than five business days after the licensee received notice of the date of the ISC must provide details showing that an extraordinary event or circumstance has arisen since receipt of the notice that will prevent the licensee from attending the ISC. The request must show that the request is made within five business days after the licensee first becomes aware of the event or circumstance.

(2) A request by a licensee to reschedule an ISC based on the failure of the agency to send timely notice before the date scheduled for the ISC, as required by §164.003 of the Act, shall be granted, provided the request is received by the agency within five business days after the late notice is received by the licensee.

(c) Prior to the ISC, the board representatives shall be provided with the information sent to the licensee by the board staff and any responses received in accordance with §164.003(f) of the Act [and all information timely received in response from the licensee. Information must be received from the licensee at least five business days prior to the ISC for complaints filed before September 1, 2011. For complaints filed with the board on or after September 1, 2011, the information must be received at least 15 days prior to the date of the ISC].

[(d) An ISC may be conducted by only one panelist if:]

[(1) the ISC is related to an order of the board, such as to show compliance, a probation appearance, or a request for termination or modification, or]

[(2) the affected licensee waives the requirement that at least two panelists conduct the ISC. In such situations, the panelist may be either a physician, physician assistant, or acupuncturist (depending on the licensee involved) or a member who represents the public.]

(d) [(e)] Informal proceedings shall be conducted in accordance with §164.003 and §164.0032 of the Act. The board representatives may [shall allow]:

[(1) the board staff to present a summary of the allegations and the facts that the board staff reasonably believes could be proven by competent evidence at a formal hearing;]

[(2) the licensee to reply to the board staff's presentation and present facts the licensee reasonably believes could be proven by competent evidence at a formal hearing;]

[(3) presentation of evidence by the board staff and the licensee, which may include medical and office records, x-rays, pictures, film recordings of all kinds, audio and video recordings, diagrams, charts, drawings, and any other illustrative or explanatory materials which in the discretion of the board representatives are relevant to the proceeding;]

[(4) representation of the licensee by an authorized representative;]

[(5) presentation of oral or written statements by the licensee or authorized representative;]

[(6) presentation of written statements by witnesses;]

[(7) questioning of the witnesses in a manner prescribed by the panel;]

(1) [(8)] ask questions [questioning] of the licensee and staff, and allow clarifying questions by staff;

(2) [(9)] allow a closing summary [statement] by both the licensee or the licensee's authorized representative and board staff.[;]

[(10) closing statement by the board's staff; and]

[(11) upon request by board representatives the board staff may propose appropriate disciplinary action and the licensee or authorized representative may respond.]

[(f) The board representatives, board staff, the licensee, and the licensee's authorized representative shall be present during the presentation of statements and testimony during the ISC.]

(e) [(g) The [Notwithstanding subsection (f) of this section, the] board representatives may allow a complainant, [or witness] to make an oral statement. Such statement may be given [testify] outside the physical presence of the licensee [to protect the person from harassment and/or undue embarrassment, for personal safety concerns, or] for a [any other] demonstrated and legitimate need. If such statement [testimony] is allowed, arrangements will be made to allow the licensee to listen to the statement [testimony] contemporaneously as it is given.

(f) [(h)] The board representatives may refuse to consider any information [evidence] not submitted in a timely manner without good cause. If the board representatives allow the licensee to submit late information [evidence], the representatives may reschedule. [and/or recommend an additional administrative penalty for the late submission.]

(g) [(i)] A board attorney, who has not been involved with the preparation of the case, shall be designated as the Hearings Counsel, and act in accordance with §164.003 and §164.0032 of the Act. [and shall be present during the ISC and the panel's deliberations to advise the panel on legal issues that arise during the ISC. The Hearings Counsel shall be permitted to ask questions of participants in the ISC to clarify any statement made by the participant. The Hearings Counsel shall provide to the ISC panel a historical perspective on comparable cases that have appeared before the board, keep the proceedings focused on the case being discussed, and ensure that the board's employees and the licensee have an opportunity to present information related to the case.]

[(j) At the ISC, the board representatives shall attempt to resolve disputed matters and the representatives may call upon the board staff at any time for assistance in conducting the ISC.]

[(k) The board representatives shall prohibit or limit access to the board's investigative file by the licensee, the licensee's authorized representative, the complainant(s), witnesses, and the public consistent with the Act, §164.007(c).]

(h) [(l)] A [On] request by a licensee to make [, the board shall make] a recording of the ISC, as allowed by §164.003(i) of the Act,[. The request] must be submitted in writing, and received by the Board at least 15 days prior to the date of the ISC. Deliberations of the ISC panel shall be excluded from any such recording. [The media format of the recording shall be determined by the board.] The recording is part of the investigative file and may not be released to a third party unless authorized under the Act. The [board may charge the] licensee may be charged a fee to cover the cost of recording the proceeding. Licensees and their representatives may not independently record an ISC.

(i) [(m)] The ISC shall be informal and shall not follow the procedures established under this title for formal board proceedings.

(j) [(n)] At the conclusion of the presentations, the board representatives shall deliberate in order to make recommendations for the disposition of the complaint or allegations. [An employee of the board who participated in the presentation of the allegation or information gathered in the investigation of the complaint, the affected licensee, the licensee's authorized representative, the complainant, the witnesses, and members of the public may not be present during the deliberations. The Hearings Counsel may be present only to advise the panel on legal issues and to provide information on comparable cases that have appeared before the board.]

(k) [(o)] The board representatives may:

(1) make recommendations to dismiss the complaint or allegations. The dismissal of any matter is without prejudice to additional investigation and/or reconsideration of the matter at any time;

(2) make recommendations regarding an agreed order and propose resolution of the issues to the licensee to be reduced to writing and processed in accordance with §187.19 of this title (relating to Resolution by Agreed Order);

(3) defer the ISC, pending further investigation;

(4) direct that a formal Complaint be filed with SOAH;

(5) recommend to the President of the board that a Disciplinary Panel be convened to consider the temporary suspension or restriction of the licensee's license;

(6) recommend the imposition of an administrative penalty pursuant to §§187.75 - 187.82 of this chapter (relating to Procedural Rules); or

(7) recommend that a remedial plan be issued to resolve the complaint pursuant to §187.9 of this chapter (relating to Board Actions).

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on September 1, 2017.

TRD-201703492

Mari Robinson, J.D.

Executive Director

Texas Medical Board

Earliest possible date of adoption: October 15, 2017

For further information, please call: (512) 305-7016


SUBCHAPTER I. PROCEEDINGS FOR CEASE AND DESIST ORDERS

22 TAC §187.83

The amendment is proposed under the authority of the Texas Occupations Code Annotated, §153.001, which provides 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. The amendments are also proposed under the authority of Texas Occupations Code Annotated, §152.006.

No other statutes, articles or codes are affected by this proposal.

§187.83.Proceedings for Cease and Desist Orders.

(a) - (d) (No change.)

(e) Cease and Desist Hearing.

(1) - (3) (No change.)

(4) Procedures before the panel.

(A) In accordance with the Act, §165.052 [§165.051], before a cease and desist order may be issued, the board must provide an individual with notice and opportunity for a hearing.

(B) - (C) (No change.)

(5) (No change.)

(f) (No change.)

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on September 1, 2017.

TRD-201703493

Mari Robinson, J.D.

Executive Director

Texas Medical Board

Earliest possible date of adoption: October 15, 2017

For further information, please call: (512) 305-7016


CHAPTER 190. DISCIPLINARY GUIDELINES

SUBCHAPTER B. VIOLATION GUIDELINES

22 TAC §190.8

The Texas Medical Board (Board) proposes amendments to §190.8(1)(L), concerning Violation Guidelines.

The amendment deletes language and requirements related to establishing a defined physician-patient relationship before prescribing any dangerous drug or controlled substance, and substitutes language requiring establishing a valid practitioner-patient relationship, a term defined by SB 1107 in amended Texas Occupations Code §111.005.

Scott Freshour, General Counsel for the Board, has determined that for each year of the first five years the section as proposed is in effect the public benefit anticipated as a result of enforcing this proposal will be to treat all physicians prescribing dangerous drugs or controlled substances in the same manner while harmonizing this Board rule with the requirements of SB 1107 related to valid practitioner-patient relationships.

Mr. Freshour has also determined that for the first five-year period the section is in effect there will be no fiscal implication to state or local government as a result of enforcing the section as proposed. There will be no effect to individuals required to comply with the rule as proposed. There will be no effect on small or micro businesses.

Comments on the proposal may be submitted to Rita Chapin, P.O. Box 2018, Austin, Texas 78768-2018, or e-mail comments to: rules.development@tmb.state.tx.us. A public hearing will be held at a later date.

The amendment is proposed under the authority of the Texas Occupations Code Annotated, §153.001, which provides 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. The amendments are also proposed under the authority of Texas Occupations Code Annotated, §152.006.

No other statutes, articles or codes are affected by this proposal.

§190.8.Violation Guidelines.

When substantiated by credible evidence, the following acts, practices, and conduct are considered to be violations of the Act. The following shall not be considered an exhaustive or exclusive listing.

(1) Practice Inconsistent with Public Health and Welfare. Failure to practice in an acceptable professional manner consistent with public health and welfare within the meaning of the Act includes, but is not limited to:

(A) failure to treat a patient according to the generally accepted standard of care;

(B) negligence in performing medical services;

(C) failure to use proper diligence in one's professional practice;

(D) failure to safeguard against potential complications;

(E) improper utilization review;

(F) failure to timely respond in person when on-call or when requested by emergency room or hospital staff;

(G) failure to disclose reasonably foreseeable side effects of a procedure or treatment;

(H) failure to disclose reasonable alternative treatments to a proposed procedure or treatment;

(I) failure to obtain informed consent from the patient or other person authorized by law to consent to treatment on the patient's behalf before performing tests, treatments, procedures, or autopsies as required under Chapter 49 of the Code of Criminal Procedure;

(J) termination of patient care without providing reasonable notice to the patient;

(K) prescription or administration of a drug in a manner that is not in compliance with Chapter 200 of this title (relating to Standards for Physicians Practicing Complementary and Alternative Medicine) or, that is either not approved by the Food and Drug Administration (FDA) for use in human beings or does not meet standards for off-label use, unless an exemption has otherwise been obtained from the FDA;

(L) prescription of any dangerous drug or controlled substance without first establishing a valid practitioner-patient [defined physician-patient] relationship.

[(i) A defined physician-patient relationship must include, at a minimum:]

[(I) establishing that the person requesting the medication is in fact who the person claims to be;]

[(II) establishing a diagnosis through the use of acceptable medical practices, which includes documenting and performing:]

[(-a-) patient history;]

[(-b-) mental status examination;]

[(-c-) physical examination that must be performed by either a face-to-face visit or in-person evaluation as defined in §174.2(3) and (4) of this title (relating to Definitions). The requirement for a face-to-face or in-person evaluation does not apply to mental health services, except in cases of behavioral emergencies, as defined by 25 TAC §415.253 (relating to Definitions); and]

[(-d-) appropriate diagnostic and laboratory testing.]

[(III) An online questionnaire or questions and answers exchanged through email, electronic text, or chat or telephonic evaluation of or consultation with a patient are inadequate to establish a defined physician-patient relationship;]

[(IV) discussing with the patient the diagnosis and the evidence for it, the risks and benefits of various treatment options; and]

[(V) ensuring the availability of the licensee or coverage of the patient for appropriate follow-up care.]

[(ii) A proper professional relationship is also considered to exist between a patient certified as having a terminal illness and who is enrolled in a hospice program, or another similar formal program which meets the requirements of clause (i)(I) - (IV) of this subparagraph, and the physician supporting the program. To have a terminal condition for the purposes of this rule, the patient must be certified as having a terminal illness under the requirements of 40 TAC §97.403 (relating to Standards Specific to Agencies Licensed to Provide Hospice Service) and 42 CFR 418.22].

[(iii)] [Notwithstanding the provisions of this subparagraph, establishing] Establishing a practitioner-patient [professional] relationship is not required for:

(i) [(I)] a physician to prescribe medications for sexually transmitted diseases for partners of the physician's established patient, if the physician determines that the patient may have been infected with a sexually transmitted disease; or

(ii) [(II)] a physician to prescribe dangerous drugs and/or vaccines for post-exposure prophylaxis of disease for close contacts of a patient if the physician diagnoses the patient with one or more of the following infectious diseases listed in subclauses (I) - (VII) of this clause [items (-a-) - (-g-) of this subclause], or is providing public health medical services pursuant to a memorandum of understanding entered into between the board and the Department of State Health Services. For the purpose of this clause, a "close contact" is defined as a member of the patient's household or any person with significant exposure to the patient for whom post-exposure prophylaxis is recommended by the Centers for Disease Control and Prevention, Texas Department of State Health Services, or local health department or authority ("local health authority or department" as defined under Chapter 81 of the Texas Health and Safety Code). The physician must document the treatment provided to the patient's close contact(s) in the patient's medical record. Such documentation at a minimum must include the close contact's name, drug prescribed, and the date that the prescription was provided.

(I) [(-a-)] Influenza;

(II) [(-b-)] Invasive Haemophilus influenzae Type B;

(III) [(-c-)] Meningococcal disease;

(IV) [(-d-)] Pertussis;

(V) [(-e-)] Scabies;

(VI) [(-f-)] Varicella zoster; or

(VII) [(-g-)] a communicable disease determined by the Texas Department of State Health Services to:

(-a-) [(-1-)] present an immediate threat of a high risk of death or serious long-term disability to a large number of people; and

(-b-) [(-2-)] create a substantial risk of public exposure because of the disease's high level of contagion or the method by which the disease is transmitted.

(M) inappropriate prescription of dangerous drugs or controlled substances to oneself, family members, or others in which there is a close personal relationship that would include the following:

(i) prescribing or administering dangerous drugs or controlled substances without taking an adequate history, performing a proper physical examination, and creating and maintaining adequate records; and

(ii) prescribing controlled substances in the absence of immediate need. "Immediate need" shall be considered no more than 72 hours.

(N) providing on-call back-up by a person who is not licensed to practice medicine in this state or who does not have adequate training and experience.

(O) delegating the performance of nerve conduction studies to a person who is not licensed as a physician or physical therapist without:

(i) first selecting the appropriate nerve conductions to be performed;

(ii) ensuring that the person performing the study is adequately trained;

(iii) being onsite during the performance of the study; and

(iv) being immediately available to provide the person with assistance and direction.

(2) - (8) (No change.)

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on September 1, 2017.

TRD-201703494

Mari Robinson, J.D.

Executive Director

Texas Medical Board

Earliest possible date of adoption: October 15, 2017

For further information, please call: (512) 305-7016