BILL ANALYSIS
|
Senate Research Center |
H.B. 173 |
|
88R2004 BEE-F |
By: Klick (Johnson) |
|
|
Business & Commerce |
|
|
5/18/2023 |
|
|
Engrossed |
AUTHOR'S / SPONSOR'S STATEMENT OF INTENT
Genetic counseling is a healthcare service that provides information about an existing diagnosis of a genetic condition or the likelihood of being diagnosed with genetic diseases. The service is designed to assist individuals and families in making informed healthcare decisions about genetic testing for, managing, or participating in research related to a genetic condition.
Genetic counselors are board-certified health care professionals who are trained in medical genetics and psychological counseling at a Masters-level training program accredited by the Accreditation Council for Genetic Counseling. These health care professionals interpret genetic testing results, provide support counseling, and serve as patient advocates.
In the state of Texas the practice of genetic counseling is not regulated. In fact, any individual can call himself or herself a genetic counselor with no training or certification, and the state has little recourse to regulate that individual or to protect patients from negligent and substandard care.
There are several cases that detail the dangers of unregulated practice of unlicensed individuals practicing genetic counseling. Examples below include:
� A patient was seen by a private oncology office for cancer genetic testing. She was seen by the genetic counselor, a health care provider whose only training was provided by the medical laboratory that offers the testing. Upon testing, the patient was found to have a genetic variant of unknown significance in a gene associated with breast and ovarian cancer, which is typically not an indication for clinical action. However, this was misinterpreted by the healthcare provider as a POSITIVE result, and the patient was encouraged to undergo costly surgeries that were risky and unnecessary.
� A pediatric patient was misdiagnosed with a debilitating neurologic genetic syndrome because of misinterpreted genetic test results by an individual who was not properly trained in medical genetics, resulting in unnecessary testing and procedures that required sedation. After referral to a genetic counselor, who was able to correctly interpret the results, the family was informed of the mistake. This led to negative health and financial impacts for the patient and their family.
Key provisions of H.B. 173:
H.B. 173 amends current law relating to the licensing and regulation of genetic counselors, requires an occupational license, and authorizes a fee.
RULEMAKING AUTHORITY
Rulemaking authority is expressly granted to the Texas Commission of Licensing and Regulation in SECTION 2 (Sections 508.101, 508.103, and 508.105, Occupations Code) of this bill.
SECTION BY SECTION ANALYSIS
SECTION 1. Amends Section 51.2031(a), Occupations Code, as follows:
(a) Provides that Section 51.2031 (Rules Regarding Health-Related Programs; Provision of Information) applies only to the regulation of certain professions, including genetic counselors, by the Texas Department of Licensing and Regulation (TDLR). Makes nonsubstantive changes.
SECTION 2. Amends Subtitle I, Title 3, Occupations Code, by adding Chapter 508, as follows:
CHAPTER 508. LICENSED GENETIC COUNSELORS
SUBCHAPTER A. GENERAL PROVISIONS
Sec. 508.001. SHORT TITLE. Authorizes this chapter to be cited as the Licensed Genetic Counselor Act.
Sec. 508.002. DEFINITIONS. Defines "advisory board," "certifying entity," "commission," "department," "executive director," and "licensed genetic counselor."
Sec. 508.003. PRACTICE OF GENETIC COUNSELING. (a) Defines "practice of genetic counseling."
(b) Provides that the practice of genetic counseling:
(1) consists of:
(A) obtaining and evaluating individual, family, and medical histories to determine the risk for a genetic or medical condition or disease in a patient, the patient's offspring, or other family members of the patient;
(B) discussing the features, natural history, means of diagnosis, genetic and environmental factors, and management of risk for a genetic or medical condition or disease;
(C) identifying, coordinating, ordering, and explaining the results of genetic laboratory tests and other diagnostic studies as appropriate for genetic assessment;
(D) integrating the results of laboratory tests and other diagnostic studies with medical histories to assess and communicate risk factors for a genetic or medical condition or disease;
(E) evaluating a patient's or family member's response to a genetic or medical condition or disease, including the risk of recurrence, and providing patient-centered counseling and anticipatory guidance;
(F) identifying and using community resources that provide medical, educational, financial, and psychosocial support and advocacy; and
(G) providing written documentation of medical, genetic, and counseling information for a patient's family members and health care providers; and
(2) does not include the diagnosis of disorders.
Sec. 508.004. PRACTICE OF MEDICINE NOT AUTHORIZED. Provides that this chapter does not authorize the practice of medicine as defined by the law of this state.
Sec. 508.005. APPLICABILITY; EXEMPTIONS. (a) Provides that this chapter does not apply to a physician licensed to practice medicine in this state unless the physician is a licensed genetic counselor.
(b) Authorizes a person to engage in the practice of genetic counseling without holding a license under this chapter if the person:
(1)� is licensed, certified, or registered to practice in this state in a health care-related occupation and:
(A) acts within the occupation's scope of practice; and
(B) does not use the title "genetic counselor" or represent or imply that the person is licensed as a genetic counselor under this chapter;
(2) is a student or intern:
(A) pursuing a course of study or engaged in a training program for an occupation regulated by this state and acting within the occupation's scope of practice; or
(B) enrolled in a graduate-level supervised genetic counseling training program approved or accepted by TDLR and engaged in an activity constituting the practice of genetic counseling as a required part of the training program; or
(3) is a genetic counselor who:
(A) is certified by a certifying entity;
(B) is not a resident of this state;
(C) performs an activity or provides a service in this state for not more than 30 days during any year; and
(D) meets any other requirement established by TCLR rule.
(c) Provides that a student or intern described by Subsection (b)(2) includes a person who:
(1) is trained as:
(A) a genetic counselor and has applied to take the certification examination; or
(B) a doctoral medical geneticist and has applied to take the certification examination; and
(2) has not failed the certification examination more than twice.
SUBCHAPTER B. LICENSED GENETIC COUNSELOR ADVISORY BOARD
Sec. 508.051. LICENSED GENETIC COUNSELOR ADVISORY BOARD. (a) Provides that the Licensed Genetic Counselor Advisory Board (advisory board) consists of nine members appointed by the presiding officer of the Texas Commission of Licensing and Regulation (TCLR) with the approval of TCLR, as follows:
(1) six licensed genetic counselors, each of whom has at least two years of experience practicing genetic counseling as a genetic counselor and is:
(A) licensed under this chapter; or
(B) certified by a certifying entity;
(2) one physician who has experience with genetic counseling; and
(3) two members who represent the public.
(b) Requires that appointments to the advisory board be made without regard to the race, color, disability, sex, religion, age, or national origin of the appointee.
Sec. 508.052. DUTIES OF ADVISORY BOARD. Requires the advisory board to provide
advice and recommendations to TDLR on technical matters relevant to the
administration of this chapter.
Sec. 508.053. TERMS; VACANCY. (a) Provides that members of the advisory board serve staggered six-year terms, with the terms of three members expiring February 1 of each odd-numbered year.
(b) Prohibits a member of the advisory board from serving more than two consecutive six-year terms.
(c) Requires the presiding officer of TCLR, if a vacancy occurs during a term of a member of the advisory board, to with TCLR's approval appoint a replacement who meets the qualifications for the vacant position to serve for the remainder of the term.
Sec. 508.054. PRESIDING OFFICER. Requires the presiding officer of TCLR to designate a member of the advisory board to serve as the presiding officer of the advisory board for a term of two years. Authorizes the presiding officer of the advisory board to vote on any matter before the advisory board.
Sec. 508.055. MEETINGS. Requires the advisory board to meet as requested by the presiding officer of TCLR or the executive director of TDLR (executive director).
Sec. 508.056. GROUNDS FOR REMOVAL. Authorizes a member of the advisory board to be removed as provided by Section 51.209 (Advisory Boards; Removal of Advisory Board Member).
Sec. 508.057. COMPENSATION;� REIMBURSEMENT. (a) Prohibits a member of the advisory board from receiving compensation for service on the advisory board.
(b) Entitles a member of the advisory board to reimbursement for actual and necessary expenses incurred in performing functions as a member of the advisory board, subject to any applicable limitation on reimbursement provided by the General Appropriations Act.
SUBCHAPTER C. POWERS AND DUTIES
Sec. 508.101. GENERAL POWERS AND DUTIES. (a) Requires TCLR to adopt rules consistent with this chapter for the administration and enforcement of this chapter.
(b) Requires TDLR to:
(1) administer and enforce this chapter;
(2) evaluate the qualifications of license applicants;
(3) provide for the examination of license applicants;
(4) issue licenses;
(5) in connection with a hearing under this chapter, issue subpoenas, examine witnesses, and administer oaths under the laws of this state; and
(6) investigate persons engaging in practices that violate this chapter.
Sec. 508.102. CONFIDENTIALITY OF COMPLAINT AND DISCIPLINARY INFORMATION. (a) Provides that all information and materials subpoenaed or compiled by TDLR in connection with a complaint and investigation, except as provided by Subsection (b), are confidential and not subject to disclosure under Chapter 552 (Public Information), Government Code, and not subject to disclosure, discovery, subpoena, or other means of legal compulsion for their release to anyone other than TDLR or its employees or agents involved in discipline of a license holder.
(b) Authorizes information described by Subsection (a) to be disclosed in accordance with Chapter 51 (Texas Department of Licensing and Regulation) to:
(1) persons involved with TDLR in a disciplinary action against a license holder;
(2) a respondent or the respondent's authorized representative;
(3) a governmental agency, if:
(A) the disclosure is required or permitted by law; and
(B) the agency obtaining the disclosure protects the identity of any patient whose records are examined;
(4) a professional genetic counselor licensing or disciplinary board in another jurisdiction;
(5) peer assistance programs approved by TCLR under Chapter 467 (Peer Assistance Programs), Health and Safety Code;
(6) law enforcement agencies; and
(7) persons engaged in bona fide research, if all individual-identifying information has been deleted.
(c) Provides that notices of alleged violations issued by TDLR, TCLR, or the executive director, and final disciplinary actions, including warnings and reprimands, by TDLR, TCLR, or the executive director, as provided by Chapter 51, are not confidential and are subject to disclosure in accordance with Chapter 552, Government Code.
(d) Provides that the requirements of Chapter 51 related to the confidentiality of complaint and investigation information for a health-related program, notwithstanding any other law, are applicable to complaint and investigation information under this chapter.
Sec. 508.103. STANDARDS OF ETHICAL PRACTICE. Requires TCLR to adopt rules under this chapter that establish standards of ethical practice.
Sec. 508.104. ASSISTANCE FILING COMPLAINT. Requires TDLR, in accordance with Section 51.252 (Complaints), to provide reasonable assistance to a person who wishes to file a complaint with TDLR regarding a person or activity regulated under this chapter.
Sec. 508.105. FEES. Requires TCLR by rule to set fees in amounts reasonable and necessary to cover the costs of administering this chapter.
SUBCHAPTER D. LICENSING REQUIREMENTS
Sec. 508.151. LICENSE REQUIRED. (a) Prohibits a person, except as provided by Section 508.005, from acting as a genetic counselor or engaging in the practice of genetic counseling in this state unless the person holds a license under this chapter.
(b) Prohibits a person, except as provided by Section 508.005, unless the person holds a license under this chapter, from:
(1) using the title or representing or implying that the person has the title "genetic counselor," "certified genetic counselor," "licensed genetic counselor," "gene counselor," "genetic consultant," or "genetic associate"; or
(2) using any other word, abbreviation, or insignia indicating or implying that the person is a licensed genetic counselor.
(c) Prohibits this chapter from being construed to prohibit a physician or an employee or other person acting under a physician's delegated authority from representing to a patient or the public that the physician, employee, or person provides genetic counseling.
Sec. 508.152. LICENSE APPLICATION. Requires an applicant for a license to:
(1) submit an application in the manner and on a form prescribed by TDLR;
(2) successfully complete a state-approved criminal background check; and
(3) pay the application fee set by TCLR.
Sec. 508.153. LICENSE ELIGIBILITY. Requires a genetic counselor license applicant, to be eligible for a license, to present evidence to TDLR that the applicant:
(1) has passed an examination by a certifying entity or an equivalent examination in genetic counseling approved by TDLR;
(2) is currently certified by a certifying entity in genetic counseling or medical genetics;
(3) has met the educational requirements of a certifying entity, which is required to include a master's degree in genetic counseling or medical genetics or an equivalent educational standard adopted by the certifying entity;
(4) is in compliance with all professional, ethical, and disciplinary standards established by the certifying entity; and
(5) is not subject to any disciplinary action by the certifying entity.
Sec. 508.154. ISSUANCE OF LICENSE. Requires TDLR to issue a genetic counselor license to an applicant who:
(1) complies with the requirements of this chapter;
(2) meets any additional requirements TCLR establishes by rule; and
(3) pays the required fees.
Sec. 508.155. TERM. Provides that a license issued under this chapter expires on the second anniversary of the date of issuance.
Sec. 508.156. RENEWAL. Authorizes a license, before the expiration of a license, to be renewed by:
(1) submitting an application for renewal;
(2) paying the renewal fee imposed by TCLR; and
(3) providing verification to TDLR of continued certification by a certifying entity, which signifies that the applicant for renewal has met any continuing education requirements established by the certifying entity.
SUBCHAPTER E. DISCIPLINARY PROCEDURES
Sec. 508.201. GROUNDS FOR DISCIPLINARY ACTION. Authorizes TCLR or the executive director, in accordance with Section 51.353 (License Denial; Administrative Sanctions), to deny, revoke, or suspend a license, refuse to renew a license, place on probation a person whose license has been suspended, or reprimand a license holder for a violation of this chapter, a rule adopted under this chapter, or an order of TCLR or the executive director.
SUBCHAPTER F. ENFORCEMENT PROCEDURES
Sec. 508.251. ENFORCEMENT PROCEEDINGS. Authorizes TCLR, TDLR, or the executive director to enforce this chapter, a rule adopted under this chapter, or an order of TCLR or the executive director as provided by Subchapters F (Administrative Penalty) and G (Other Penalties and Enforcement Provisions), Chapter 51.
SECTION 3. (a) Requires the presiding officer of TCLR, as soon as practicable after the effective date of this Act, to appoint nine members to the advisory board in accordance with Chapter 508, Occupations Code, as added by this Act. Requires the presiding officer of TCLR, in making the initial appointments, to designate three members for terms expiring February 1, 2025, three members for terms expiring February 1, 2027, and three members for terms expiring February 1, 2029.
(b) Authorizes a person who meets the requirements of Section 508.153, Occupations Code, as added by this Act, notwithstanding Section 508.051, Occupations Code, as added by this Act, to be appointed as an initial licensed genetic counselor member of the advisory board, regardless of whether the person holds a license issued under Chapter 508, Occupations Code, as added by this Act.
SECTION 4. Requires TCLR, not later than May 1, 2024, to adopt the rules, procedures, and fees necessary to administer Chapter 508, Occupations Code, as added by this Act.
SECTION 5. (a) Effective date, except as provided by Subsection (b) of this section: September 1, 2023.
(b) Effective date, Section 508.151, Occupations Code, as added by this Act, and Subchapter F, Chapter 508, Occupations Code, as added by this Act: September 1, 2024.