The Health and Human Services Commission (HHSC), on behalf of the Department of Aging and Disability Services (DADS), adopts amendments to §§19.101, 19.403, 19.408, and 19.601 in Chapter 19, governing Nursing Facility Requirements for Licensure and Medicaid Certification. The amendments to §19.101 and §19.601 are adopted with changes to the proposed text published in the February 24, 2006, issue of the Texas Register (31 TexReg 1239). The amendments to §19.403 and §19.408 are adopted without changes to the proposed text.

The amendments are adopted to implement Senate Bill (SB) 325, 79th Legislature, Regular Session, 2005, which added Chapter 322 to the Texas Health and Safety Code. Chapter 322 requires DADS to prohibit certain restraints in a variety of health care facilities, including nursing facilities. To comply with Chapter 322, the amendments are adopted to (1) define acceptable restraint holds, (2) develop practices to decrease the frequency of the use of restraint and seclusion, (3) allow less use of restraint than allowed by the rules in the chapter, and (4) ensure that each resident and the resident's legally authorized representative are notified of the rules and policies related to restraints and seclusion. Although Health and Safety Code, §322.051(b) allows the use of prone and supine holds as transitional holds, the amendment to §19.601 prohibits nursing facilities from administering a restraint that places a resident in a prone and supine hold under any circumstance.

The amendment to §19.408 is adopted to comply with Health and Safety Code, §322.054, which prohibits a facility from retaliating against a person because the person in good faith provides information relating to the misuse of restraint or seclusion at the facility or against a resident because someone on behalf of the resident in good faith provides information relating to the misuse of restraint or seclusion at the facility.

In addition, the amendments are adopted to clarify and update rule language, including replacing references to the former Texas Department of Human Services with references to DADS.

DADS received written comments from Advocacy, Incorporated. A summary of the comments and the responses follow.

Comment: Concerning §19.101(126), the commenter stated the definition of "restraint hold" implies that an intervention that restricts the free movement or normal functioning of all or a portion of an individual's body is not a restraint if it is used for physical guidance or prompting of brief duration. The determining factor of whether a hold is a restraint should be whether it is voluntary or if the person is resistant. Physical guidance or prompting may still be a restraint if the individual resists the guidance or prompt either verbally or by their actions. The commenter suggested that "except for physical guidance or prompting of brief duration" be deleted from the definition, and that additional language be added to indicate restraint does not include physical guidance or prompting if it is voluntary.

Response: The agency agrees in part with the comment and has added language to §19.101(126) to indicate that physical guidance or prompting of brief duration becomes a restraint if the resident resists the guidance or prompting. However, DADS did not remove the phrase "except for physical guidance or prompting of brief duration," because there are situations in which physical guidance or prompting can calm the resident or prevent the situation from escalating.

Comment: Concerning §19.601(a)(2)(D), the commenter asked for clarification on the proposed language prohibiting placing the resident in a prone or supine position. The commenter interprets the language to mean that a facility is prohibited from restraining a resident in bed. The concern is that prone or supine restraints may be used but not categorized as such.

Response: The agency agrees in part with the comment and has changed §19.601(a)(2)(D) to indicate that a facility must not administer to a resident a restraint that places the resident in a prone or supine hold. The agency does not interpret the prohibition of a prone or supine hold as a prohibition of a restraint that is applied to a resident in bed. The current rule at §19.601(a)(1) indicates that restraints may be required to treat the resident's medical condition. Therefore, there will be cases in which a restraint may be used on a resident in bed to treat a medical condition as determined by the treating physician, but that would not be considered placing a resident in a prone or supine hold.

Comment: The commenter was concerned that mechanical restraints can leave residents particularly vulnerable to the risk of harm from others, particularly other residents. The commenter recommended that the agency add strong language related to the care, monitoring and safety measures provided to the type of restraint imposed on the individual.

Response: The agency agrees that mechanical restraints leave residents particularly vulnerable to risk of harm from others, particularly other residents, but disagrees that its current rules on the care and monitoring of mechanical restraints are inadequate to protect residents. The agency has not changed the language in response to the comment. It is DADS' belief that nursing facility staff should protect the safety of the residents while monitoring the use of mechanical restraints. Current rule language addresses the care and monitoring of mechanical restraints in §19.601(a)(1), which states that if physical restraints (which include mechanical restraints) are used because they are required to treat the resident's medical condition, the restraints must be released and the resident repositioned as needed to prevent deterioration in the resident's condition. The use of restraints must be documented in the clinical record. Additionally, residents must be monitored hourly and, at a minimum, restraints must be released every two hours for a minimum of ten minutes, and the resident repositioned. Also, current rule language in §19.601(c) states that the facility must develop and implement written policies and procedures that prohibit mistreatment, neglect, and abuse of residents. This would include the protection and promotion of rights of each resident.

Subchapter B. DEFINITIONS

The Health and Human Services Commission (HHSC), on behalf of the Department of Aging and Disability Services (DADS), adopts the repeal of §42.12 and simultaneously adopts new §42.12 in Chapter 42, governing the Medicaid Waiver Program for People Who Are Deaf-Blind with Multiple Disabilities (DBMD), without changes to the proposed text as published in the February 24, 2006, issue of the Texas Register (31 TexReg 1245).

The new section is adopted to implement Senate Bill 626, 79th Texas Legislature, Regular Session, 2005, which added §32.058 to the Texas Human Resources Code. Section 32.058 prohibits DADS from providing services in certain medical assistance waiver programs, including the DBMD Program, if the cost of services exceeds the specified individual cost limit. However, the law makes two specific exceptions to the prohibition and allows the HHSC executive commissioner to adopt a rule allowing DADS to grant an exemption in individual cases. The new section is adopted to govern the specific exceptions to the prohibition and to allow the DADS commissioner to grant an exemption in individual cases.

The repeal is adopted because the section contained provisions concerning exceptions to the individual cost limit that were superseded by the exceptions codified in Human Resources Code, §32.058.

DADS received one written comment from the Texas Association for Home Care in support of the new section.

The Health and Human Services Commission (HHSC), on behalf of the Department of Aging and Disability Services (DADS), adopts the repeal of §48.2123 and §48.6099 and simultaneously adopts new §48.2123 and §48.6099 in Chapter 48, governing Community Care for Aged and Disabled, without changes to the proposed text published in the February 24, 2006, issue of the Texas Register (31 TexReg 1246).

The new sections are adopted to implement Senate Bill 626, 79th Texas Legislature, Regular Session, 2005, which added §32.058 to the Texas Human Resources Code. Section 32.058 prohibits DADS from providing services in certain medical assistance waiver programs, including the Community Living Assistance and Support Services (CLASS) and Community Based Alternatives (CBA) programs, if the cost of services exceeds the specified individual cost limit. However, the law makes two specific exceptions to the prohibition and allows the HHSC executive commissioner to adopt a rule allowing DADS to grant an exemption in individual cases. The new sections are adopted to govern the specific exceptions to the prohibition and to allow the DADS commissioner to grant an exemption in individual cases. New §48.6099 is also adopted to continue the provision in the repealed section that allows an individual receiving Medically Dependent Children Program services to transition into the CBA Program at age 21 under the 133% cost limit provisions of the section.

The repeal is adopted because the sections contained provisions concerning exceptions to the individual cost limit that were superseded by the exceptions codified in Human Resources Code, §32.058.

DADS received one written comment from the Texas Association for Home Care in support of the new sections.

Subchapter C. MEDICAID WAIVER PROGRAM FOR PERSONS WITH RELATED CONDITIONS

The Health and Human Services Commission (HHSC), on behalf of the Department of Aging and Disability Services (DADS), adopts the repeal of §50.50 and simultaneously adopts new §50.50 in Chapter 50, governing the §1915(c) Consolidated Waiver Program (CWP), without changes to the proposed text published in the February 24, 2006, issue of the Texas Register (31 TexReg 1249).

The new section is adopted to implement Senate Bill 626, 79th Texas Legislature, Regular Session, 2005, which added §32.058 to the Texas Human Resources Code. Section 32.058 prohibits DADS from providing services in certain medical assistance waiver programs, including the CWP, if the cost of services exceeds the specified individual cost limit. However, the law makes two specific exceptions to the prohibition and allows the HHSC executive commissioner to adopt a rule allowing DADS to grant an exemption in individual cases. The new section is adopted to govern the specific exceptions to the prohibition and to allow the DADS commissioner to grant an exemption in individual cases.

The repeal is adopted because the section contained provisions concerning exceptions to the individual cost limit that were superseded by the exceptions codified in Human Resources Code, §32.058.

DADS received one written comment from the Texas Association for Home Care in support of the new section.

Subchapter B. ELIGIBILITY, ENROLLMENT, AND SERVICES

The Health and Human Services Commission (HHSC), on behalf of the Department of Aging and Disability Services (DADS), adopts amendments to §90.3 and §90.42, and adopts new §90.328 in Chapter 90, Intermediate Care Facilities for Persons with Mental Retardation or Related Conditions. The amendments to §90.3 and §90.42 are adopted with changes to the proposed text published in the February 24, 2006, issue of the Texas Register (31 TexReg 1253). New §90.328 is adopted without changes to the proposed text.

The amendments and new section are adopted to implement Senate Bill (SB) 325, 79th Legislature, Regular Session, 2005, which added Chapter 322 to the Texas Health and Safety Code. Chapter 322 requires DADS to prohibit certain restraints in a variety of health care facilities, including an intermediate care facility for persons with mental retardation (ICF/MR) licensed by DADS under Chapter 252 of the Texas Health and Safety Code.

To comply with Chapter 322, the amendments to §90.3 and §90.42 are adopted to (1) define acceptable restraint holds (referred to in the adopted rules as "personal holds"), (2) add a definition for "seclusion" to reflect its definition in Chapter 322, (3) develop practices to decrease the frequency of the use of restraint and seclusion, (4) allow less use of restraint than allowed by the rules in the chapter, (5) permit prone and supine holds only as transitional holds, and (6) ensure that each resident and the resident's legally authorized representative are notified of the rules and policies related to restraint and seclusion. In addition, the amendments are adopted to clarify and update rule language, including replacing references to the former Texas Department of Human Services with references to DADS.

New §90.328 is adopted to comply with Health and Safety Code, §322.054, which prohibits a facility from retaliating against a person because the person in good faith provides information relating to the misuse of restraint or seclusion at the facility or against a resident because someone on behalf of the resident in good faith provides information relating to the misuse of restraint or seclusion at the facility.

DADS received written comments from Advocacy, Inc., and the Private Providers Association of Texas. A summary of the comments and the responses follow.

Comment: A commenter stated that, although Senate Bill 325 focused on the use of restraint and seclusion in emergency situations, the proposed amendments and new section address the use of restraint not only in emergency situations but also as an approved intervention in behavior therapy programs. The commenter stated that this creates confusion in interpreting the rules, particularly concerning the use of mechanical devices.

Response: The agency does not agree with the commenter's reasoning that ICF/MR providers will be confused. Providers use restraints as an intervention in a behavioral therapy program plan and now will be allowed to use them as a response to a behavioral emergency. The agency believes rules addressing both situations are necessary.

Comment: Concerning §90.3(7)(A), a commenter stated that the phrase "substantial bodily harm" is ambiguous and has the potential to result in significant variation in its interpretation by direct support staff and, hence, significant variation in their judgment about whether or not an incident constitutes a behavioral emergency allowing for protective restraint. The commenter recommends clarification of the phrase or that the agency provide examples of what it considers "substantial bodily harm."

Response: The agency declines to provide examples, as it is up to the provider to document the justification for the use of the restraint and to have trained staff in the use of emergency restraints.

Comment: Concerning §90.3(7)(C), a commenter stated that the phrase "could not reasonably have been anticipated" is ambiguous. Does the phrase refer to the specific circumstances, time, and place in which the behavior occurs or more generally to the aggressor's behavioral history, which may include infrequent, but occasional, aggressive behavior or frequent aggressive behavior?

Response: The agency agrees with the comment and has deleted "could not reasonably have been anticipated" from the rule language.

Comment: Concerning §90.3(25) and §90.3(44), a commenter stated that the definition of "large facility" parallels the definition of "large facility" in the ICF/MR licensure rules but differs from the definition used in the Home and Community-based Services Program rules (§9.153 (22)) and the ICF/MR reimbursement methodology rules (1 TAC §355.456(b)(1)). The commenter also pointed out that the definition of "small facility" parallels the definition of "small facility" in the ICF/MR licensure rules but differs from the definition used in the ICF/MR reimbursement methodology rules. The commenter recommended that the definitions be consistent across all rules, or that the basis for differences be explained in the rules.

Response: The agency declines to change the definition of "large facility" and "small facility." The agency believes the definitions used in this chapter are appropriate for its purposes. Including an explanation of the differences between the definitions in this rule and other rules that use the terms "small" and "large" facility is beyond the scope of the proposed rules.

Comment: Concerning §90.3(37), two commenters requested clarification of the definition of "personal hold." One of the commenters was unclear about what differentiates "physical guidance or prompting of brief duration" and "restraint" and what amount of time is "brief"? Another commenter stated that the definition of "personal hold" implies that an intervention that restricts the free movement or normal functioning of all or a portion of an individual's body is not a restraint if the reason it is used is for physical guidance or prompting of brief duration. The determining factor of whether a hold is a restraint should be whether it is voluntary or if the person is resistant. Physical guidance or prompting may still be a restraint if the individual resists the guidance or prompt either verbally or by their actions. The commenter suggested that "except for physical guidance or prompting of brief duration" be deleted from the definition and that additional language be added to indicate restraint does not include physical guidance or prompting if it is voluntary.

Response: The agency agrees in part with the comments and has added language to §90.3(37) to indicate that physical guidance or prompting of brief duration becomes a restraint if the individual resists the guidance or prompting. However, the agency did not remove the phrase "except for physical guidance or prompting of brief duration," because there are situations in which physical guidance or prompting can calm the individual or prevent the situation from escalating.

Comment: Concerning §90.3(42), a commenter asked that if the use of mechanical restraints is allowed, more direction be provided on their use, particularly care and safety issues. The commenter recommended that future versions of the rule provide more direction related to who can initiate, who can order, what assessments occur and how frequently, time frames, safety and protection issues, and release procedures.

Response: The agency believes that the definition of restraint is adequately addressed by the proposed rules but agrees to consider the commenter's concerns in future revisions of the rules.

Comment: A commenter stated that the use of a mechanical device to restrain an individual, especially when the individual is placed in two- or four-point restraint, makes the individual vulnerable to harm, including harm by other individuals. The commenter further stated that the use of mechanical devices to restrain an individual requires that staff be physically present to provide continuous, one-on-one monitoring of an individual who is being restrained with a mechanical device. The commenter recommended that DADS add such a provision to ensure the protection of the individual.

Response: The agency declines to make continuous, one-to-one monitoring a requirement, as it may not be necessary in every instance in which a mechanical restraint is used. The proposed rule amendment at §90.42(e)(4)(D)(ii) requires a facility to "use the minimal amount of force.. to ensure the safety of the resident and others," and §90.42(e)(4)(D)(iii) requires a facility to "safeguard the resident's dignity, privacy, and well-being." The agency believes these provisions are adequate to ensure a facility appropriately monitors a resident in a mechanical restraint.

Comment: Concerning §90.42(e)(4)(A)(i)(III), a commenter stated that prohibiting the use of restraint in a manner that interferes with an individual's ability to communicate appears to preclude the use of restraint with an individual who communicates primarily with hands or eyes. The commenter explained that staff might be unable to effectively intervene to prevent injury to the individual or others and recommended that the provision be removed or modified to allow flexibility in the use of communication during restraint contingent on the situation and the individual's mode of communication.

Response: The agency declines to make the recommended revision and explains that Texas Health and Safety Code §322.051, as added by SB 325, requires the prohibition.

Comment: A commenter stated that the phrase "disciplinary purposes" at §90.42(e)(4)(A)(ii) is ambiguous and subject to multiple interpretations. The commenter suggested that the agency's intention appeared to be to prohibit penal, retaliatory, or vengeful use of restraint and recommended clarification of the phrase.

Response: The agency does not believe that the phrase is ambiguous and cites its use in federal ICF/MR regulations at 42 CFR §483.450(b)(3). The agency has revised the provision, however, to include "retaliation" and "retribution," which are clarifying terms the Centers for Medicare and Medicaid Services uses in its "interpretive guidelines" to the federal ICF/MR regulations.

Comment: Concerning §90.42(e)(4)(B)(ii) and (iv), a commenter requested clarification or reconsideration of the use of the word "voluntarily" to describe inappropriate behavior exhibited by an individual that may be addressed in a behavior therapy program and of "involuntary" to describe inappropriate and often self-injurious behavior from which an individual should be protected. The commenter stated that professionals disagree on "when, whether or not, and to what extent behavior is 'voluntary.'" The commenter further stated, "involuntary behaviors may also be therapeutically modified or managed through the appropriate use of restraint" and questioned why the distinction is necessary or useful.

Response: The agency has not changed the rule in response to the comment. The agency believes the distinction between "voluntary" and "involuntary" is both necessary and useful to distinguish those behaviors that can be successfully addressed through a behavior therapy program.

Comment: Concerning §90.42(e)(4)(C)(i), a commenter requested that clarification be included in the rule of whether the identification by an interdisciplinary team (IDT) of "conditions, factors, and limitations" for the use of restraint with an individual refers to the development of behavior therapy interventions utilizing restraint or only to the use of restraint to address a behavioral emergency. The commenter also recommended that the IDT be required to "consider" the conditions and factors in the design of a restraint intervention.

Response: The agency disagrees with the comment and has not changed the rule in response to the comment. Section 90.42(e)(4)(D)(i) requires a provider to "take into account the conditions, factors, and limitations on specific restraint techniques or mechanical restraint devices" identified by the IDT not only when restraining an individual in a behavioral emergency or as approved in a behavior therapy program, but also, in accordance with §90.42(e)(4)(B)(iii) - (v), a provider must take into account those conditions, factors, and limitations (1) in response to a medical or dental procedure or to promote healing, (2) to protect an individual from involuntary self-injury, and (3) to provide postural support to an individual or assist the individual in obtaining and maintaining normative bodily functioning.

Comment: Concerning §90.42(e)(4)(E)(i) - (ii), the provisions related to restraint techniques proposed in this section of the rule may place the resident and direct support staff at risk of injury. Why must staff be prone and perpendicular to the resident? It appears that their control and ability to monitor the resident would be diminished in this position. Their ability to control and monitor the resident would be enhanced if allowed to be in a kneeling position.

Response: The language the commenter referenced was not in the rule as proposed in the Texas Register .

Comment: Concerning §90.42(e)(4)(E)(ii)(I), a commenter requested clarification of the term "transitional hold."

Response: The proposed text of §90.42(e)(4)(E)(ii) reads: "if a resident rolls into a prone or supine position during a restraint, the facility must transition the resident to a side, sitting, or standing position as soon as possible. The facility may only use a supine or prone hold: (I) as a transitional hold." The agency believes that the definition of transitional hold is adequately addressed in the proposed rules and declines to make the recommended revision. Texas Health and Safety Code, §322.052(b), as added by SB 325, states that the rules must permit prone and supine holds only as transitional holds for use on a resident of a facility.

Subchapter A. INTRODUCTION

The Health and Human Services Commission (HHSC), on behalf of the Department of Aging and Disability Services (DADS), adopts amendments to §§92.3, 92.41, and 92.559 in Chapter 92, Licensing Standards for Assisted Living Facilities. The amendments to §92.3 and §92.41 are adopted with changes to the proposed text published in the February 24, 2006, issue of the Texas Register (31 TexReg 1258). The amendment to §92.559 is adopted without changes to the proposed text.

The amendments are adopted to implement Senate Bill (SB) 325, 79th Legislature, Regular Session, 2005, which added Chapter 322 to the Texas Health and Safety Code. Chapter 322 requires DADS to prohibit certain restraints in a variety of health care facilities, including assisted living facilities. To comply with Chapter 322, the amendments are adopted to (1) define acceptable restraint holds; (2) revise the definition for "seclusion" to reflect the definition for that term as it appears in Chapter 322; (3) develop practices to decrease the frequency of the use of restraint and seclusion; (4) allow less use of restraint than allowed by the rules in the chapter; and (5) ensure that each resident and the resident's legally authorized representative are notified of the rules and policies related to restraint and seclusion. Although Health and Safety Code, §322.051(b) allows the use of prone and supine holds as transitional holds, the amendment to §92.41 prohibits assisted living facilities from using a restraint that places a resident in a prone or supine position under any circumstance.

The amendment to §92.41 is also adopted to reflect Health and Safety Code, §322.054, which prohibits a facility from retaliating against a person because the person in good faith provides information relating to the misuse of restraint or seclusion at the facility or against a resident because someone on behalf of the resident in good faith provides information relating to the misuse of restraint or seclusion at the facility. Chapter 322 also allows an administrative penalty to be assessed against a facility for violating the prohibition against retaliation in §322.054; the amendment to §92.559 is adopted to incorporate such a penalty.

In addition, the amendments are adopted to clarify and update rule language, including replacing references to the former Texas Department of Human Services with references to DADS.

A minor change was made to the text of §92.41(a)(4)(B)(vi) and (C) to clarify the language concerning staff training requirements.

DADS received written comments from Advocacy, Incorporated. A summary of the comments and the responses follows.

Comment: Concerning §92.3(35), the commenter stated that the definition of "restraint hold" implies that an intervention that restricts the free movement or normal functioning of all or a portion of an individual's body is not a restraint if it is used for physical guidance or prompting of brief duration. The determining factor of whether a hold is a restraint should be whether it is voluntary or if the person is resistant. Physical guidance or prompting may still be a restraint if the individual resists the guidance or prompt either verbally or by their actions. The commenter suggested that "except for physical guidance or prompting of brief duration" be deleted from the definition, and that additional language be added to indicate that restraint does not include physical guidance or prompting if it is voluntary.

Response: The agency agrees in part with the comment and has added language to §92.3(35) to indicate that physical guidance or prompting becomes a restraint if it is involuntary. DADS did not remove the phrase "except for physical guidance or prompting of brief duration," because an assisted living resident may require physical guidance or prompting of brief duration. The phrase "except for physical guidance or prompting of brief duration" was included in the definition of "restraint hold" to acknowledge such circumstances.

Comment: The commenter was concerned that the proposed language allows for the use of mechanical restraints that can be administered by any staff member in an emergency, yet the required staff training on the use of emergency interventions and de-escalation techniques is minimal. Mechanical restraints leave individuals particularly vulnerable to risk of harm from others, particularly other residents. Since mechanical restraints are allowed in assisted living facilities, the language should be strengthened in terms of the care and monitoring that occurs during a mechanical restraint, including time limitations. The commenter strongly recommended that language be added to address the safety measures that should be provided that would be appropriate to the type of restraint imposed on the individual.

Response: The agency disagrees with the comment and has not changed the rule in response to the comment. Restraints in an assisted living facility are mechanical/supportive devices. Mechanical restraints are physical restraints as stated in the definition of "restraints" in §92.3(36). Restraints are not allowed in an assisted living facility unless a physician authorizes them in writing. If they are so prescribed, then qualified medical personnel, who are either on staff in the facility or provided by the facility for those purposes, must administer them. The qualified medical personnel administering and monitoring the mechanical restraints ensure that the physicians' orders are adhered to and provide protection for the residents from harm to themselves or from other residents. DADS' current rule language in §92.125 (relating to Resident's Bill of Rights and Provider Bill of Rights) governing the care and monitoring of mechanical restraints, including time limitations, and the rule language as proposed in §92.41(p)(1) indicating the authorized use, circumstances, and duration for restraint are adequate to protect residents.

Regarding staff training, current rule language in §92.41(4)(B) and (C) specifies staff training requirements for restraint purposes, and §92.125 specifies the circumstances under which a restraint can be used in an assisted living facility (physician authorization and administration by qualified medical personnel, except during an emergency). The administration of restraints only by qualified medical personnel or, in an emergency, facility staff who have been trained as required in §92.41(4)(B) and (C), and the use of restraints only according to the prescribed order of a physician limits the risk of harm to the resident. The agency believes that its current rules on the use of restraints and required training for a facility's staff are adequate to protect residents.

Subchapter A. INTRODUCTION