PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:
Action taken:
Amendment of Parts 81, 624, 633 and 681 of Title 14 NYCRR.
Statutory authority:
Mental Hygiene Law, sections 13.07, 13.09(b) and 16.00
Subject:
Person-Centered Behavioral Intervention.
Purpose:
To establish requirements for interventions used in the OPWDD system to modify or control challenging behavior.
Substance of final rule:
The final regulations establish new requirements concerning behavioral interventions in the OPWDD system. OPWDD is adding a new 14 NYCRR Section 633.16, which contains comprehensive requirements for supports and interventions related to challenging behavior. These new requirements will help agencies provide high quality services, and will protect the rights and welfare of individuals receiving services.
The new Section 633.16 contains a number of provisions to protect the health, safety and rights of individuals who engage in challenging behaviors. Among the provisions of Section 633.16 are the following:
• Aversive conditioning is prohibited.
• Agencies must conduct a functional behavioral assessment to obtain relevant information for effective intervention planning before a behavior support plan is developed to address challenging behavior. Specific components must be addressed or included in the functional behavioral assessment.
• Behavior support plans must be developed that are specific to each person who exhibits challenging behavior. These plans specify the interventions that may be used. The regulations establish a number of components that must be included in the plan. Among the specific required components of behavior support plans is the inclusion of a hierarchy of behavioral approaches, strategies, and supports to address the behavior(s) requiring intervention, with the preferred methods being positive approaches, strategies and supports.
• Additional safeguards are established for plans that contain “restrictive/intrusive interventions” or limitations on a person’s rights.” “Restrictive/intrusive interventions” are defined in the regulation and include specific behavioral interventions such as “intermediate” and “restrictive” physical intervention techniques (hands-on techniques), use of “time-out,” use of mechanical restraining devices, and use of medication to modify or control challenging behavior.
• Safeguards and protections related to restrictive/intrusive interventions and limitations on a person’s rights include:
• Additional components must be included in the person’s behavior support plan. Plans must be developed or supervised by a licensed psychologist, licensed clinical social worker, or behavioral intervention specialist (either Level 1 or 2, with the appropriate supervision outlined in the regulation). Those providers who demonstrate sustained hardship in recruiting employees or contractors who meet the specified qualifications, may apply to OPWDD for a waiver.
• Plans must be reviewed and sanctioned before implementation by a behavior plan review /human rights committee. Required membership and procedures for these committees are established. (The requirement for committee review does not apply to monitoring plans that include medication to treat a co-occurring diagnosed psychiatric condition. The regulations describe standards for determining what constitutes a “co-occurring diagnosed psychiatric disorder”)
• Informed consent is required for the use of restrictive/intrusive interventions and for the use of psychotropic medications. Procedures are established to determine whether the person receiving services is capable of providing informed consent. If an individual is not capable of providing informed consent, procedures are established for obtaining informed consent from designated surrogate decision makers (e.g. actively involved parents and actively involved family members). In the event that no other surrogate is reasonably available and willing, consent can be sought from the Willowbrook Consumer Advisory Board or an informed consent committee. Required membership and procedures are established for the informed consent committee. Consent can also be obtained from a court.
• Procedures are established for objecting to interventions in behavior support plans, and addressing a lack of informed consent. Procedures are also established concerning refusal by the individual receiving services to take medication.
• Requirements are included for training of staff, family care providers and respite substitute providers.
• Additional safeguards are established for the use of physical intervention techniques (hands-on techniques). Physical intervention techniques are categorized as protective, intermediate or restrictive. Among these safeguards are requirements for training and certification in the use of the techniques.
• Additional safeguards are established for the limitations on a person’s rights.
• Additional safeguards are established for the use of “time-out.” “Time-out” includes both exclusionary time-out (placing a person in a specific time-out room), and non-exclusionary time-out (removing the positively reinforcing environment from the individual.) Environmental requirements are established for time-out rooms.
• Additional safeguards are established for the use of mechanical restraining devices.
• Additional safeguards are established for the use of medication to modify or control challenging behavior, and/or to treat a diagnosed co-occurring psychiatric disorder. Safeguards include monitoring plans to be completed when medication is used to treat co-occurring diagnosed psychiatric conditions.
• The new Section 633.16 references existing requirements in Section 633.17(a)(18) concerning medication regimen reviews. Results of these reviews must be provided to prescribers and the program planning team.
• The regulations specify that restrictive/intrusive interventions cannot be used in an emergency, except for intermediate and restrictive physical intervention techniques and the use of medication. Limitations on a person’s rights can also be used in an emergency.
• Provisions are established for phasing-in the requirements. Requirements for new behavior support plans (and associated informed consent) are applied 60 days after the regulation becomes effective (May 31, 2013), and requirements for existing plans (and associated informed consent) are applied a year after that (May 31, 2014). This will enable agencies to apply the new development standards to existing behavior support plans during regularly scheduled reviews.
The regulation also amends 14NYCRR Section 681.13, which contains requirements applicable to behavior management in ICF/DD facilities. The provisions of this section address many of the same issues that are addressed in Section 633.16. The amendments to Section 681.13 phase out the requirements of that section in conjunction with the phase-in of the requirements of the new Section 633.16. Once Section 633.16 is fully phased in, Section 681.13 will no longer be effective. Outdated and duplicative requirements in Part 81 are deleted.
14NYCRR Part 624 is amended so that new definitions of categories of abuse become effective once Section 633.16 is fully phased in. These new definitions conform to Section 633.16 so that if interventions are used which are not in accordance with the requirements of the new section, their use is considered to be abuse (unless actions were taken that were necessary to address an immediate risk to the health or safety of the person or others). Definitions in the glossary of Part 624 are also changed to conform to the new definitions in Section 633.16.
14NYCRR Part 633 is amended to enhance protections related to limiting the rights of a person receiving services and to conform to protections related to limitation of rights in the new Section 633.16. Definitions in Section 633.99 are also changed to conform to the new definitions used in Section 633.16.
Final rule as compared with last published rule:
Nonsubstantive changes were made in sections 624.4, 624.6(f), 624.20, 633.16(a), (f), (j)(3) and 681.13.
Text of rule and any required statements and analyses may be obtained from:
Barbara Brundage, Director, Regulatory Affairs Unit, OPWDD, 44 Holland Avenue, Albany, NY 12229, (518) 474-1830, email: barbara.brundage@opwdd.ny.gov
Additional matter required by statute:
Pursuant to the requirements of the State Environmental Quality Review Act, OPWDD, as lead agency, has determined that the action described herein will have no effect on the environment, and an E.I.S. is not needed.
Minor changes were made to the proposed regulation as follows:
Throughout the text - The actual dates were substituted for phrases used in the text such as “the effective date” and “60 days after the effective date.” For example, the final text substitutes “April 1, 2013” for “the effective date” which was in the revised proposed regulations. These changes are clearly non-substantive.
Subdivision 624.6(f) –A conforming change was added to eliminate a reference to “restraint” as a category of incident. “Restraint” as a category of incident was deleted in the revised proposed regulations so this is a non-substantive change.
Subparagraph 633.16 (f)(1)(i) and paragraph (f)(3) – Changes were made to increase the clarity and emphasize the distinction made regarding medication to treat a co-occurring psychiatric disorder, and restrictive intrusive interventions – including medication used solely to modify challenging behaviors. The addition of the adjective “monitoring” in paragraph (f)(3) was, again, a clarification to ensure that all references to medications for co-occurring psychiatric disorder and their required monitoring plans are consistent and clear. These were deemed non-substantive as they did not change the requirements or meaning of the regulation or its terms.
These changes do not necessitate revisions to the previously published Regulatory Impact Statement, Regulatory Flexibility Analysis for Small Business and Local Governments, Rural Area Flexibility Analysis, or Job Impact Statement.
Assessment of Public Comment
OPWDD received several comments concerning the revised proposed regulations from a variety of sources. Specifically, OPWDD received comments from a number of not-for-profit providers of services to individuals with developmental disabilities.
1) Comment: One comment asserted that the diagnosis of psychiatric disorders in the DD population is dependent on the motivation, skill, knowledge and experience of the prescribing psychiatrist or physician’s assistant. Thus, the distinction between the proposed uses and/or purpose of psychotropic medication – for the treatment of symptoms associated with co-occurring psychiatric disorders or to address and control the expression of challenging behavior – would be “subjective,” and often arbitrary or random. The revised proposed regulations treat this as an exact science and propose totally different procedures for addressing these situations.
Response: This distinction has been the basis of research on the issue of dual diagnosis among the ID/DD population. While recognition of the distinction – and occasions of overlap – between some extreme behavioral expressions of specific symptoms associated with a co-occurring psychiatric disorder and certain challenging behaviors (described in the Definitions section of the regulation) will require competent, thoughtful evaluation and adequate training/experience in both areas, the differentiation does not have to be made in a “random” or “arbitrary” way. A review of the literature makes it clear that such a distinction – while sometimes complex and reliant on clinical judgment – must be made by qualified practitioners, to ensure that effective and appropriate clinical and behavioral services are provided to individuals who experience more than one limiting condition. The expectation is that assessment and prescribed interventions of any kind will be based on and informed by data collected from careful observation, creation/review of an adequate clinical history, and reports from the individual, caregivers and other service providers.
2) Comment: Most LCSWs lack any relevant training or experience in providing the required behavioral services. It would make sense to create a 3rd category of BIS, possibly called a BIS Supervisor. Another commenter requested that consideration be given to expanding the list of qualified supervisors for clinicians writing non-restrictive plans to include LMSWs and LMHCs with 5 years of experience working with people with disabilities and 3 years of supervisory experience.
Response: Intervention services or plans involving restrictive/intrusive interventions will require oversight by the most rigorously qualified licensed professional. According to the NY State Office of the Professions, “The major difference between the two is that the LMSW may only provide ‘clinical social work’ services (diagnosis, psychotherapy, and assessment-based treatment planning) under supervision; the LCSW may provide those services without supervision.” A licensed clinical social worker does not necessarily lack training or experience in providing, supervising, or teaching about behavioral intervention services; the field practicum and clinical coursework or post-degree supervised experience requirements exceed those of the other mental health practitioners mentioned in the comment.
The qualifications for supervisors of non-restrictive plans may already include LMHCs who meet the education and experience criteria in the regulation. OPWDD does not consider that an additional three years of supervisory experience is necessary if the employing agency provides adequate oversight and mentoring.
3) Comment: The use of the December 31, 2012 date is confusing. This may prohibit future new hires as they may not meet the specified criteria. It is not clear if that is what OPWDD intended.
Response: This was intended to refer to those who are hired by or before December 31, 2012. The intent is to require that individuals hired after this date have, at minimum, a graduate degree at the Master’s level.
4) Comment: Requires that the provider notify MHLS of any Informed Consent Committee meetings. This is a very cumbersome requirement. The Informed Consent Committee reviews and approves psychotropic medication for individuals who lack capacity and have no family to sign. The frequency of these meetings makes this notification requirement burdensome.
Response: The agency is only required to notify MHLS regarding the schedule of meetings.
5) Comment: One agency stated that monitoring restrictive devices every 30 minutes during overnight periods will be very challenging because there are several IRA homes that do not require overnight staff.
Response: An individual who engages in behavior that may require such a restrictive device during overnight hours must have adequate available supervision on a 24-hour basis.
6) Comment: Data collection for behavior support plans and monitoring plans, ongoing data collection that includes frequency, duration and intensity of both positive and challenging behaviors, would be very difficult. This would require a high staff to participant ratio and would be a financial burden to increase staff ratio.
Response: OPWDD believes that manageable systems for data collection are available or can be created; this type of data collection is already being done.
7) Comment: One commenter stated that a functional behavioral assessment (FBA) would be challenging and would not provide accurate information due to the progressive cognitive and medical decline secondary to Dementia. For individuals with a diagnosis of Dementia, a monitoring plan without an FBA would be beneficial.
Response: Individuals with one of the dementias may exhibit behaviors that are internally driven; it is important to distinguish these from behaviors that are reactive to certain environmental stimuli or elements, identify interventions that may maintain or eliminate reactive behaviors seen in the dementias, and create plans that address both challenging and non- challenging symptoms of the dementia.
8) Comment: One commenter stated that items of apparel that restrict an individual’s access to his or her body in order to prevent self-injury or other unsafe challenging behaviors, should not require the approval of a physician every six months. This is excessive and will make our working relationships with physicians difficult.
Response: When physical restrictions are employed on a regular basis for an extended period, medical oversight and review of continued need, and prevention of any potentially harmful effects must be part of the plan.
9) Comment: Currently the nursing team and pharmacy are reviewing and monitoring in conjunction with the physician. We do not believe the review by the program planning team and prescriber are necessary.
Response: The program planning team is responsible to review both the behavioral data associated with intervention outcomes, and any effects or side effects of medication use that may influence behavior. These outcomes should not be viewed in isolation, but as components of the BSP or monitoring plan that are reviewed. The results of the reviews should be shared among those who plan and provide clinical services – including the prescriber – in order to create integrated and informed intervention plans.
