PART 1. HEALTH AND HUMAN SERVICES COMMISSION
CHAPTER 568. STANDARDS OF CARE AND TREATMENT IN PSYCHIATRIC HOSPITALS
SUBCHAPTER C. EMERGENCY TREATMENTS
The Texas Health and Human Services Commission (HHSC) adopts new §568.42, concerning Responding to a Psychiatric Emergency.
New §568.42 is adopted with changes to the proposed text as published in the July 19, 2024, issue of the Texas Register (49 TexReg 5308). This rule will be republished. HHSC withdraws the proposed amendment to §568.22.
BACKGROUND AND JUSTIFICATION
The new section is necessary to increase consistency in emergency medication monitoring requirements between state rules and federal Centers for Medicare & Medicaid Services (CMS) Conditions of Participation for psychiatric hospitals.
COMMENTS
The 31-day comment period ended August 19, 2024.
During this period, HHSC received comments regarding the proposed new rule from four commenters, including Texas Hospital Association (THA), Texas Association of Behavioral Health Systems (TABHS), Disability Rights Texas (DRTx), and Hill Country MHDD Centers. A summary of comments relating to the rule and HHSC's responses follows.
Comment: THA stated it supports increased consistency in emergency medication monitoring requirements between state rules and CMS Conditions of Participation and offered suggestions, which are described in a subsequent comment. THA stated it hoped its comments would improve the rule and minimize operational impacts to hospitals.
Response: HHSC acknowledges this comment.
Comment: THA stated §568.42 will have significant operational impacts on facilities and requested HHSC provide enough time for facilities to implement changes to comply with the rule. THA expressed that additional time for implementation would ease the administrative burden and allow the rule's safe implementation without adverse consequences for patients.
Response: HHSC acknowledges this comment. HHSC notes CMS-certified facilities are already expected to comply with similar CMS Conditions of Participation. HHSC will work with facilities to ensure they are compliant after the rule's effective date.
Comment: TABHS stated its member hospitals already comply with the psychoactive medication requirements described by §568.42.
Response: HHSC acknowledges this comment.
Comment: DRTx recommended HHSC revise §568.42(a)(1) to add language stating an emergency psychoactive medication "is not used as a restriction to manage the patient's behavior, restrict the patient's freedom of movement, and is not a standard treatment or dosage for the patient's condition" to align with the CMS Conditions of Participation at Code of Federal Regulations Title 42 §482.13(e)(1)(i)(B) and the CMS interpretive guidelines for this regulation.
Response: HHSC declines to revise §568.42(a)(1) because emergency psychoactive medications as allowed by this rule are to stop an emergency behavioral issue.
Comment: THA requested HHSC amend §568.42(a)(2) to clarify a psychiatric emergency is when it is necessary to administer medication without the patient's consent. THA stated hospitals already monitor a patient according to the proposed rule after the patient receives emergency psychoactive medication, but that monitoring a patient according to the proposed rule when medication is given voluntarily and with the patient's consent is not necessary.
Response: HHSC declines to revise §568.42(a)(2) because the definition of psychiatric emergency is consistent with Texas Health and Safety Code (THSC) §576.025(g) and §574.101(2).
Comment: DRTx recommends HHSC revise §568.42(a) by adding the definition of the term "imminent" from 25 TAC §414.403(2).
Response: HHSC declines to revise §568.42(a) because the common meaning of "imminent" is sufficient for the purposes of this rule.
Comment: DRTx recommended HHSC revise the definition of psychiatric emergency at §568.42(a)(2) to align more closely with the definition at 25 TAC §414.403(9).
Response: HHSC declines to revise §568.42(a)(2) because the definition of psychiatric emergency is consistent with THSC §576.025(g) and §574.101(2).
Comment: THA requested HHSC amend §568.42(a)(3)(E)-(F) to remove stimulant, sedative, hypnotics, and other sleep-promoting drugs from the list of emergency medications. THA stated these medications are inappropriate in a psychiatric emergency medication situation.
Response: HHSC declines to revise §568.42(a)(3)(E)-(F) because the language is consistent with THSC §576.025(g) and §574.101(3).
Comment: THA expressed concern about §568.42(b), which restricts the ordering of emergency medication orders to physicians. THA stated only allowing physicians to order emergency medications could slow down treatment in emergencies, risking more harm to patients and staff. THA noted advanced practice nurses and physician assistants are authorized by law to order these medications under an appropriate physician delegation. THA expressed concern that the language misinterprets 25 TAC §414.410, which THA noted is incorrectly cited as 25 TAC §414.41 in the proposed rule, and contradicts the CMS Conditions of Participation, which allow other licensed practitioners, not just physicians, to order emergency medications if state law and hospital policy allow it. THA recommended changing §568.42(b) to allow advanced practice nurses and physician assistants to order emergency medications as their licenses and state law allow to ensure patients get the care they need without unnecessary delays.
Hill Country MHDD also commented on §568.42(b) and stated a nurse practitioner should be allowed to give the order under §568.42(b) because the prescriptive authority agreement between a physician and nurse practitioner allows a nurse practitioner to prescribe controlled substances and dangerous drugs.
Response: HHSC revises §568.42(b) to correct the typographical error to the reference of 25 TAC §414.410. HHSC declines to further revise §568.42(b) as requested because this subsection aligns with 25 TAC §414.410(b) and there are health and safety concerns with allowing a nurse practitioner or physician assistant to give orders under this subsection. In an emergency imminent risk situation, a physician cannot review a nurse practitioner's or physician assistant's decision promptly enough, and the physician has training to decide the appropriate medication to administer. Further, 25 TAC §415.260(b) requires a physician to initiate a restraint or seclusion, so it is the physician's decision to determine whether restraint or seclusion or an emergency psychoactive medication is appropriate to the situation.
Comment: DRTx recommended adding language to §568.42(b) to require either the patient's or patient's legally authorized representative's consent. DRTx also questioned if 25 TAC §414.41 referred to §414.410 and stated it would be more advisable to incorporate the necessary language into this rule since rules often move.
Response: HHSC revises §568.42(b) to correct the typographical error to the reference of 25 TAC §414.410. HHSC declines to further revise §568.42(b) as requested because the suggestions are redundant.
Comment: DRTx recommended HHSC revise §568.42 to add a new subsection (c) to clarify a physician's order for emergency psychoactive medication must only address the immediate psychiatric emergency and cannot be to justify concurrent personal restraints or administration of psychoactive medication for subsequent psychiatric emergencies. DRTx stated this language will ensure a physician will give a separate order if another emergency intervention is necessary before or after administration of the emergency psychoactive medication.
Response: HHSC declines to revise §568.42 because HHSC does not have the authority to determine a physician's practice of medicine.
Comment: DRTx recommended HHSC add language to §568.42(c) to state the treating physician may issue the emergency psychoactive medication order only if there is an existing psychoactive emergency and suggested HHSC add legally authorized representative's consent in addition to patient consent.
Response: HHSC declines to revise 568.42(c) because the additional language is unnecessary since the definition of emergency psychoactive medication states that the medication is only administered during a psychiatric emergency. HHSC declines to revise §568.42(c) to add legally authorized representative because it is redundant.
Comment: DRTx commented that the policies and procedures listed under §568.42(e) do not include the process for determining staff competency or language about re-training staff. DRTx recommended adding a requirement for a re-occurring training and competency test.
Response: HHSC declines to revise §568.42(e) because the requirements regarding training competency are located at §568.121 and 26 TAC §301.331(a)(4).
Comment: DRTx stated the knowledge of the side effects of psychoactive medication or any contraindications should be included in the training under §568.42(e)(1).
Response: HHSC declines to revise §568.42(e)(1) because knowledge of psychoactive medications implies knowledge of side effects and contraindications.
Comment: DRTx requested HHSC clarify what "safe and appropriate" administration means under §568.42(e)(2).
Response: HHSC revises §568.42(e)(2) to clarify "safe and appropriate" is in accordance with hospital policy. HHSC also revised subsections (d) and (e)(2) to add "monitoring," added "and appropriate" to subsection (d), and added "and duration" and "to ensure the health and safety of the patient" to (d)(3).
Comment: Hill Country MHDD commented on §568.42(f) and stated examining a person within one hour is the standard for restraint and seclusion, but administering psychoactive medication in a psychiatric emergency should not require this level of monitoring and documentation because it is a different situation. Hill Country MHDD noted that 25 TAC §414.410 includes this distinction.
Response: HHSC declines to revise §568.42(f) because of health and safety concerns and to align with the CMS Conditions of Participation.
Comment: DRTx requested HHSC include a definition for "other licensed practitioner" at §568.42(f).
Response: HHSC revises §568.42(d) by adding new paragraph (4) under subsection (d) to require the hospital's policies and procedures identify the licensed practitioners authorized to examine the patient under subsection (f).
Comment: DRTx requested HHSC clarify §568.42(f)(4) because emergency medication should not require the patient to withdraw because it is a one-time administration, so DRTx was unclear as to why an emergency psychoactive medication would need to be safely discontinued.
Response: HHSC revises §568.42(f)(4) to clarify the practitioner under this subsection shall evaluate and document whether to return to or modify the patient's plan of care.
Comment: DRTx recommended adding language to §568.42(g) regarding a process of documenting completion of the training, require a standardized competency evaluation, and requirements for maintaining competency through re-training and re-assessment.
Response: HHSC revises §568.42(g) to require the practitioner to receive training and demonstrate competency in the areas listed under this subsection.
Comment: DRTx recommended HHSC add language to §568.42(i) to ensure the evaluation findings describe specific behaviors that the individual exhibited to create the psychiatric emergency and demonstrate the clinical necessity of the emergency psychoactive medication used to treat the behaviors.
Response: HHSC revises §568.42(i) to change "and" to "or" and remove "as applicable" in paragraph (1) of this subsection.
Comment: DRTX recommended HHSC adding language from 25 TAC §414.410(f) to §568.42(i)(6) to ensure that a facility does not use the designation of a psychiatric emergency inappropriately to circumvent obtaining consent or applying a court order for administering psychoactive medication.
Response: HHSC declines to revise §568.42(i)(6) because in an emergency situation consent is not required. HHSC notes that facilities are required to comply with 25 TAC §414.10(f).
HHSC also revised §568.42(a)(1) to clarify emergency psychoactive medications are medications that create an immediate effect on the central nervous system to ensure staff do not use oral medications.
STATUTORY AUTHORITY
The new section is adopted under Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies, and THSC §577.010, which requires that the Executive Commissioner of HHSC adopt rules and standards the Executive Commissioner considers necessary and appropriate to ensure the proper care and treatment of patients in a private mental hospital or mental health facility required to obtain a license under THSC Chapter 577.
§568.42.Responding to a Psychiatric Emergency.
(a) The following words and terms, when used in this section, have the following meanings, unless the context clearly indicates otherwise.
(1) Emergency psychoactive medication--A psychoactive medication administered to a patient in a psychiatric emergency that is used to exercise an immediate effect on the central nervous system.
(2) Psychiatric emergency--A situation in which it is immediately necessary to administer medication to a patient to prevent:
(A) imminent probable death or substantial bodily harm to the patient because the patient:
(i) overtly or continually is threatening or attempting to commit suicide or serious bodily harm; or
(ii) is behaving in a manner that indicates that the patient is unable to satisfy the patient's need for nourishment, essential medical care, or self-protection; or
(B) imminent physical or emotional harm to another because of threats, attempts, or other acts the patient overtly or continually makes or commits.
(3) Psychoactive medication--A medication prescribed for the treatment of symptoms of psychosis or other severe mental or emotional disorders and that is used to exercise an effect on the central nervous system to influence and modify behavior, cognition, or affective state when treating the symptoms of mental illness. "Psychoactive medication" includes the following categories when used as described in this section:
(A) antipsychotics or neuroleptics;
(B) antidepressants;
(C) agents for control of mania or depression;
(D) antianxiety agents;
(E) sedatives, hypnotics, or other sleep-promoting drugs; and
(F) psychomotor stimulants.
(b) In accordance with 25 TAC §414.410 (relating to Psychiatric Emergencies), only a treating physician may issue an order to administer emergency psychoactive medication without a patient's consent.
(c) A treating physician may only issue an order to administer emergency psychoactive medication without a patient's consent when less restrictive interventions are determined ineffective to protect the patient or others from harm.
(d) A hospital shall adopt, implement, and enforce written policies and procedures to ensure safe and appropriate administration and monitoring of an emergency psychoactive medication. These policies and procedures shall:
(1) identify the staff members authorized to administer an emergency psychoactive medication;
(2) identify the psychoactive medications permitted and approved by the hospital for administration in a psychiatric emergency;
(3) prescribe how and with what frequency and duration a staff member shall monitor a patient who has received an emergency psychoactive medication to ensure the health and safety of the patient, in addition to the in-person evaluation conducted as required by subsection (f) of this section;
(4) identify the licensed practitioners authorized to examine the patient as required by subsection (f) of this section; and
(5) ensure staff members follow all monitoring and evaluation requirements under this section and all hospital policies and procedures regarding administration of an emergency psychoactive medication each time a patient receives a separate dose of an emergency psychoactive medication.
(e) Staff members authorized by the hospital's policies and procedures to administer an emergency psychoactive medication shall receive training on and demonstrate competency in the following:
(1) knowledge of the psychoactive medications permitted and approved by the hospital for administration in a psychiatric emergency;
(2) safe and appropriate administration and monitoring of an emergency psychoactive medication per hospital policies and procedures as required by subsection (d) of this section; and
(3) management of emergency medical conditions in accordance with the hospital's policies and procedures and other applicable requirements for:
(A) obtaining emergency medical assistance; and
(B) obtaining training in and using techniques for cardiopulmonary respiration and airway obstruction removal.
(f) When a staff member administers a psychoactive medication to a patient experiencing a psychiatric emergency, a physician, other licensed practitioner, or registered nurse trained in accordance with the requirements specified in subsection (g) of this section shall examine the patient in person within one hour after the administration of the psychoactive medication to evaluate and document in the patient's clinical record:
(1) the patient's immediate situation;
(2) the patient's reaction to the medication;
(3) the patient's medical and behavioral condition; and
(4) whether to return to or modify the patient's plan of care.
(g) A physician, other licensed practitioner, or registered nurse who conducts the in-person evaluation specified in subsection (f) of this section shall receive training and demonstrate competency in the following:
(1) techniques identifying staff member and patient behaviors, events, and environmental factors that may trigger a psychiatric emergency;
(2) use of nonphysical intervention skills;
(3) choosing the least restrictive intervention based on an individualized assessment of the patient's medical or behavioral status or condition;
(4) safe administration of emergency psychoactive medications and how to recognize and respond to signs of physical and psychological distress;
(5) clinical identification of specific behavioral changes indicating the psychiatric emergency's conclusion;
(6) monitoring the physical and psychological well-being of the patient who has received an emergency psychoactive medication, including the patient's respiratory and circulatory status, vital signs, and any special requirements specified by hospital policy associated with conducting the in-person evaluation; and
(7) the use of first aid techniques and certification in the use of cardiopulmonary resuscitation, including required periodic recertification.
(h) If a trained registered nurse conducts the in-person evaluation specified in subsection (f) of this section, the trained registered nurse shall consult the attending physician or other licensed practitioner responsible for the patient's care as soon as possible after completing the evaluation.
(i) The physician or other licensed practitioner responsible for the patient's care shall document in the patient's clinical record in specific medical and behavioral terms:
(1) the information required by 25 TAC §414.410(b) (relating to Psychiatric Emergencies);
(2) the evaluation findings specified in subsection (f)(1) - (4) of this section;
(3) a description of the patient's behavior and the emergency psychoactive medication used;
(4) alternatives or other less restrictive interventions attempted, as applicable;
(5) the patient's condition or symptoms warranting the emergency psychoactive medication; and
(6) the patient's response to the emergency psychoactive medication, including the rationale for continued use of the medication.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on December 17, 2024.
TRD-202406048
Karen Ray
Chief Counsel
Health and Human Services Commission
Effective date: January 6, 2025
Proposal publication date: July 19, 2024
For further information, please call: (512) 834-4591