PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following revised rule:
Proposed Action:
Addition of section 633.16; and 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 revised rule:
The revised proposed regulations establish new requirements concerning behavioral interventions in the OPWDD system. OPWDD is proposing the addition of 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 45 days after the regulation becomes effective, and requirements for existing plans (and associated informed consent) are applied a year after that. This will enable agencies to apply the new development standards to existing behavior support plans during regularly scheduled reviews.
The regulation also amends 14 NYCRR 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.
14 NYCRR 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.
14 NYCRR 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.
Revised rule compared with proposed rule:
Substantial revisions were made in sections 633.16, 633.17 and 633.99.
Text of revised proposed rule and any required statements and analyses may be obtained from
Barbara Brundage, Director, Regulatory Affairs Unit, Office for People With Developmental Disabilities, 44 Holland Ave., 3rd floor, Albany, NY 12229, (518) 474-1830, email: barbara.brundage@opwdd.ny.gov
Data, views or arguments may be submitted to:
Same as above.
Public comment will be received until:
30 days after publication of this notice.
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.
Revised Regulatory Impact Statement
1. Statutory Authority:
a. OPWDD has the statutory responsibility to provide and encourage the provision of appropriate programs and services in the area of care, treatment, rehabilitation, education and training of persons with developmental disabilities, as stated in the New York State Mental Hygiene Law Section 13.07.
b. OPWDD has the statutory authority to adopt rules and regulations necessary and proper to implement any matter under its jurisdiction as stated in the New York State Mental Hygiene Law Section 13.09(b).
c. OPWDD has the statutory authority to adopt regulations concerning the operation of programs, provision of services and facilities pursuant to the New York State Mental Hygiene Law Section 16.00.
2. Legislative Objectives: These proposed amendments further the legislative objectives embodied in sections 13.07, 13.09(b), and 16.00 of the Mental Hygiene Law. The proposed amendments would improve the quality of services in the OPWDD system by establishing protections for individuals with challenging behaviors and/or diagnosed psychiatric disorders.
3. Needs and Benefits: Interventions for challenging behaviors are an important component of the OPWDD system. Appropriate, person-centered behavioral supports and interventions can significantly enrich the lives of individuals with developmental disabilities, and enable them to become more independent and successful in many aspects of their lives. Further, poor behavioral intervention practices can have tragic consequences, and have been a contributing factor in serious injuries and deaths in the OPWDD system.
OPWDD is proposing the addition of a new section containing comprehensive requirements for behavioral supports and interventions in response to challenging behavior and symptoms of diagnosed psychiatric disorders. These new requirements will help agencies provide higher quality services and will protect the rights and welfare of individuals receiving services.
The regulation emphasizes that positive approaches, strategies, and supports are always the preferred method of intervention for challenging behavior. In addition, the regulation establishes specific procedures that must be followed in order to actively monitor and control the use of specific behavioral interventions that limit rights or have potential adverse impacts.
The implementation of the new provisions would require that agencies incur additional expenses and redirect existing staff resources toward compliance activities. OPWDD considers that the additional costs and staff time involved are more than justified by the enhanced protections afforded to individuals receiving services. Further, OPWDD is phasing-in the new requirements so that agencies will have adequate time to hire the necessary staff and integrate the new required processes into existing agency procedures. OPWDD has also delayed the imposition of the new planning requirements on existing behavior support plans so that the new requirements can be implemented during regularly scheduled reviews of the current plans. OPWDD realizes that some rural areas may be unable to access the full range of staffing qualifications set in the regulations. In an effort to assist providers in those areas, OPWDD has included a hardship waiver in the revised proposed regulations. Voluntary agencies may apply for the waiver, demonstrating a good faith effort in recruiting the necessary staff, and individual approvals for waivers will be determined by the Commissioner.
Among its provisions, the proposed regulations prohibit aversive conditioning. OPWDD considers that the use of behavior modification techniques that involve deliberately inflicting sensations that are uncomfortable, painful or noxious is inappropriate and unnecessary.
The regulations also modify the definitions of abuse in Part 624 to conform to the provisions of the new behavioral intervention requirements and add additional clarity.
The new Section 633.16 also references existing regulations in Section 633.17(a)(18), which requires the review of medications prescribed for and taken by individuals receiving services (including psychotropic medications). The results of these reviews must be documented and shared with the prescriber and the program planning team. This will assist healthcare providers and the team to evaluate whether the benefits of continuing the medication(s) outweigh the risk inherent in potential side effects.
The provisions of Section 681.13 are phased out in conjunction with the phase-in of the new Section 633.16. These provisions contain requirements for behavior management in Intermediate Care Facilities (ICF/DDs). Since ICF/DDs are required to comply with the provisions of Section 633.16 concerning behavior management, these requirements are duplicative and are therefore being phased out.
Outdated and duplicative requirements contained in Part 81 which concerned review of “untoward incidents” and “extra risk procedures” in “Schools for the Mentally Retarded” have been deleted. These areas are addressed in Part 624 and the new Section 633.16.
4. Costs:
a. Costs to the Agency and to the State and its local governments: There are no anticipated impacts on Medicaid rates, prices or fees. Consequently, there is no impact on the federal government, New York State or local governments due to changes in Medicaid expenditures. As a provider of services, OPWDD will need to redirect staff resources to compliance activities required by the proposed regulations. State-operated services have already instituted many of the new required procedures and OPWDD expects that the enhanced requirements in the proposed regulations can be implemented with existing staff in state-operated services. Consequently, OPWDD does not expect to incur any additional costs.
b. Costs to private regulated parties: There are no initial capital investment costs. There may be initial non-capital expenses related to the costs of hiring or retaining new psychologists, licensed clinical social workers, behavioral intervention specialists, and other clinicians. OPWDD estimates that the aggregate annual expense for agencies to hire or retain the necessary clinicians will be approximately $10.1 million. However, as stated earlier, agencies will have the option to apply for a hardship waiver, subject to approval by the Commissioner.
5. Local Governmental Mandates: There are no new requirements imposed by the rule on any county, city, town, village; or school, fire, or other special district.
6. Paperwork: The regulation includes significant new paperwork requirements. For example, it requires the development of policies and procedures, creation or revision of functional behavioral assessments and written behavior support plans for individuals who have challenging behaviors, and monitoring plans for individuals with diagnosed psychiatric disorders all of which address a number of specific elements. The regulation also requires documentation of the individual’s behavior(s) and use of specific behavioral interventions. In some instances, the use of behavioral interventions must be reported to OPWDD. The regulation requires training, which would involve the dissemination of training materials and documentation of training. In some cases, these requirements can be met through electronic reporting and record-keeping. OPWDD considers that the increased paperwork is justified by the need for additional protections for individuals receiving services concerning behavioral intervention.
7. Duplication: The proposed amendments do not duplicate any existing State or Federal requirements that are applicable to services for persons with developmental disabilities.
8. Alternatives: OPWDD considered applying all regulatory requirements imposed for restrictive/intrusive interventions to medications used to treat a diagnosed psychiatric disorder. However, upon reflection, OPWDD determined that that not all requirements were necessary to safeguard individuals who are prescribed these medications. The requirement for review by the behavior plan review/human rights committee was consequently removed.
9. Federal Standards: The proposed amendments do not exceed any minimum standards of the federal government for the same or similar subject areas.
10. Compliance Schedule: OPWDD plans to promulgate these regulations effective January 1, 2013. OPWDD may delay the effective date of the regulation to accommodate the need for agencies to hire staff (especially psychologists, licensed clinical social workers, and behavioral intervention specialists), and for other changes necessary for agencies to come into compliance, such as training staff, establishing the required committees, and creating or changing policies and procedures. The proposed regulation incorporates delays in the timeframe for implementation after the effective date for specific requirements that necessitate a more involved level of compliance activities. In addition, requirements applicable to the development of behavior support plans and obtaining informed consent will be phased in so that existing behavior support plans can be revised at the time of regularly scheduled reviews. Delays in the timeframe for implementation of the conforming changes have also been incorporated for consistency during the transition.
Revised Regulatory Flexibility Analysis
1. Effect on small business: OPWDD has determined, through a review of the certified cost reports, that most OPWDD-funded services are provided by non-profit agencies which employ more than 100 people overall. However, some smaller agencies which employ fewer than 100 employees overall would be classified as small businesses. Currently, there are 670 agencies which provide one or more of the facilities and services which are required to comply with the proposed regulations. These are agencies which operate any facility certified by OPWDD (except for free-standing respite facilities), which provide day habilitation or prevocational services regardless of whether the services are certified, and which provide hourly community habilitation. OPWDD is unable to estimate the portion of these providers that may be considered to be small businesses.
The proposed regulations impose significant compliance requirements on these providers, if they serve individuals with challenging behaviors. Many agencies have current policies which incorporate some of these requirements, however, in nearly all instances agencies will need to institute or enhance current policies and procedures related to behavioral intervention.
2. Compliance requirements: Specific compliance requirements imposed on providers (including small businesses) by the proposed regulations include: the development of policies/procedures, conducting functional behavioral assessments, developing behavior support plans and monitoring plans (including reviews and updates), convening a behavior plan review/human rights committee, documenting the work of the committee and use of behavioral interventions, obtaining informed consent for “restrictive/intrusive interventions,” training staff in the use of specific supports and interventions, training staff in the use of “physical intervention techniques” (hands-on techniques), reporting the use of restrictive physical interventions to OPWDD, and complying with a number of requirements applicable to specific interventions (physical intervention techniques, rights limitations, use of “time-out,” use of mechanical restraining devices, and use of medication to modify or control challenging behavior. The provider is also required to document these activities.
The proposed regulations have no impact on local governments.
3. Professional services: The proposed regulations specify certain functions that must be performed by clinicians, such as the development and/or approval of behavior support plans and evaluation of the capacity of individuals to provide informed consent in some circumstances. Various functions are required to be performed by licensed psychologists, licensed clinical social workers (LCSWs), and/or behavioral intervention specialists (BIS), and/or clinicians with training in behavioral intervention techniques. In addition, the regulation requires the supervision of BIS (some Level 1 and all Level 2) by a licensed psychologist or licensed clinical social worker, which may mean that a supervising licensed psychologist or LCSW must be hired or retained. Although many agencies already employ or retain these professionals, and in some instances the clinicians already perform some or many of the functions that will be required, OPWDD expects that some agencies will need to hire more of these clinicians, or make arrangements for their services, in order to comply with the new requirements.
Other regulatory requirements require the involvement of health care professionals. While OPWDD generally expects that agencies will be able to comply using existing staff, in some instances agencies may need to hire or increase arrangements for contractors or consultants who are clinicians or other professionals to satisfy these requirements.
The proposed regulations will not add to the professional service needs of local governments.
4. Compliance costs: No increased capital costs will be incurred. Some agencies will incur costs to hire or arrange for clinicians as discussed above. OPWDD estimates that the aggregate annual expense for agencies to hire or retain the necessary clinicians will be approximately $10.1 million.
5. Economic and technological feasibility: The proposed amendments do not impose on regulated parties, the use of any new technological processes.
6. Minimizing adverse impact: In general, individuals with more significant challenging behaviors are served by agencies which are not small businesses. Further, the development of related policies and procedures are only required for agencies which serve individuals in need of behavior support plans. Smaller providers which do not serve individuals in need of behavior support plans will not need to undertake any of the compliance activities, including the development of related agency policies and procedures. OPWDD expects that even if small providers serve individuals who need behavior support plans, that the plans will typically be less complex and will typically not include “restrictive/intrusive interventions” (except for the use of medication to treat a diagnosed mental illness), and that the agencies can consequently forgo compliance with many of the specific provisions applicable to those interventions. OPWDD has specifically exempted use of medication to treat a diagnosed mental illness from review by a behavior plan review/human rights committee, recognizing that small business providers are more likely to serve these individuals than individuals who need medication or other interventions solely to address challenging behavior, and thereby offering some relief to small providers. Further, OPWDD recognizes that it could be difficult for each smaller agency to convene the required behavior plan review/human rights committee. The regulations specifically allow agencies to coordinate with other agencies in the creation of a shared behavior plan review/human rights committee.
Due to the fact that more rural communities may not have access to appropriately licensed professionals, OPWDD has developed a hardship waiver regarding compliance with requirements for specific qualifications of those who may develop a behavior support plan, including those containing restrictive/intrusive interventions, and/or the supervision of a BIS (Level 1 or 2) who develops such a plans. Agencies who demonstrate a sustained hardship will have the option to apply for such a waiver, pending the individual review and approval by the Commissioner. OPWDD expects that some of these providers will be small businesses.
7. Small business participation: The proposed regulations were discussed with representatives of providers, including the New York State Association of Community and Residential Agencies (NYSACRA), at several meetings. In addition, draft proposed regulations were sent to selected reviewers in October 2011 and July 2012, including NYSACRA and other provider associations. Some of the members of NYSACRA have fewer than 100 employees. OPWDD mailed the proposed regulations to approximately 700 providers (including small businesses) in January, 2012, and received over 100 comments regarding the proposed regulations. Finally, OWPDD will be mailing these revised proposed amendments to all providers, including providers that are small businesses.
Revised Rural Area Flexibility Analysis
1. Description of the types and estimation of the number of rural areas in which the rule will apply: OPWDD services are provided in every county in New York State. 44 counties have a population less than 200,000: Allegany, Cattaraugus, Cayuga, Chautauqua, Chemung, Chenango, Clinton, Columbia, Cortland, Delaware, Essex, Franklin, Fulton, Genesee, Greene, Hamilton, Herkimer, Jefferson, Lewis, Livingston, Madison, Montgomery, Ontario, Orleans, Oswego, Otsego, Putnam, Rensselaer, St. Lawrence, Saratoga, Schenectady, Schoharie, Schuyler, Seneca, Steuben, Sullivan, Tioga, Tompkins, Ulster, Warren, Washington, Wayne, Wyoming and Yates. 9 counties with certain townships have a population density of 150 persons or less per square mile: Albany, Broome, Dutchess, Erie, Monroe, Niagara, Oneida, Onondaga and Orange.
The proposed amendments have been reviewed by OPWDD in light of their impact on entities in rural areas. The proposed amendments are expected to result in additional expenditures of approximately $10.1 million for non-state providers of services in the OPWDD system for all of New York State. Due to the additional requirements and the possible difficulty of recruiting certain professionals for the more rural counties and/or the adverse fiscal impact on providers, the geographic location of any given program (urban or rural) may contribute to any such impact. In such cases, the regulation will allow some providers to apply for a hardship waiver from the Commissioner. If such a waiver request is approved, a provider in a more rural county may not have to comply with some of the qualification requirements applying to those who may develop or supervise the development of behavior support plans containing restrictive intrusive interventions.
2. Compliance requirements: Specific compliance requirements imposed on providers (including small businesses) by the proposed regulations include: the development of policies/procedures, conducting, revising, or updating functional behavioral assessments, developing, revising, or updating behavior support plans, convening a behavior plan review/human rights committee, documenting the work of the committee and use of behavioral interventions, obtaining informed consent for “restrictive/intrusive interventions,” including medications, training staff in the use of specific interventions, training staff in the use of “physical intervention techniques” (hands-on techniques), reporting the use of restrictive physical interventions to OPWDD, and complying with a number of requirements applicable to specific interventions (physical intervention techniques, rights limitations, use of “time-out,” use of mechanical restraining devices, and use of medication to modify or control maladaptive or inappropriate behavior to treat a diagnosed psychiatric disorder. The provider is also required to document these activities.
The proposed regulations have no impact on local governments.
3. Professional services: The proposed regulations specify certain functions that must be performed by clinicians, such as the development and/or approval of behavior support plans and evaluation of individuals’ capacity to provide informed consent in some circumstances. Various functions are required to be performed by licensed psychologists, licensed clinical social workers (LCSWs), and/or behavioral intervention specialists (BIS) (Level 1 or Level 2 with a Master’s degree) and/or clinicians with specific training in behavior assessment and management techniques. In addition, the regulation requires the supervision of a BIS (some Level 1 and all Level 2) by a licensed psychologist or LCSW, which may mean that the supervising licensed psychologist or LCSW must be hired or retained to provide contracted services. Although many agencies already employ or retain these professionals and, in some instances, the clinicians already perform some or many of the functions that will be required, OPWDD expects that some agencies may need to hire more of these clinicians or contract for their services to comply with the new requirements.
Other regulatory conditions require the involvement of health care professionals. While OPWDD generally expects that agencies will be able to comply using existing staff, in some instances agencies may need to hire or increase arrangements for contractors or consultants who are clinicians or other professionals to satisfy these requirements.
The proposed regulations will not add to the professional service needs of local governments.
4. Compliance costs: The estimated cost of compliance is $10.1 million for all voluntary providers statewide (not just those in rural areas). There are no costs to local governments.
5. Minimizing adverse economic impact: OPWDD has reviewed and considered the approaches for minimizing adverse economic impact as suggested in section 202-bb(2)(b) of the State Administrative Procedure Act. OPWDD recognizes that agencies in rural areas may be smaller in size than other agencies in general. The economic impact of the proposed regulations is attributable to the need for additional clinicians, especially licensed psychologists, LCSWs, and Behavioral Intervention Specialists. Smaller providers which do not serve individuals who need behavior support plans will not need to undertake any of the compliance activities, including the work that would have to be performed by these clinicians. OPWDD expects that even if small providers serve individuals who need behavior support plans, that the plans will typically be less complex and will typically not include “restrictive/intrusive interventions” (except for the use of medication to treat a diagnosed psychiatric disorder), and that the agencies can consequently forgo compliance with many of the specific provisions applicable to those interventions. OPWDD has specifically exempted use of medication to treat a diagnosed mental illness from review by a behavior plan review/human rights committee, recognizing that small service providers (including those in rural areas) are more likely to serve these individuals, than individuals who need medication or other interventions to address challenging behavior. This exemption thereby offers some relief to small providers (including those in rural areas). Further, OPWDD recognizes that it could be difficult for each smaller agency to convene the required behavior plan review/human rights committee. Thus, the regulations specifically allow agencies to coordinate with other agencies in the creation of a shared behavior plan review /human rights committee.
Given that providers in some rural areas may have limited access to certain licensed professionals, OPWDD has developed a hardship waiver that would afford some flexibility, or alternatives, regarding compliance with specific qualification requirements for those who may provide certain assessments, or develop behavior support plans, including those containing restrictive intrusive interventions, and/or supervise a BIS (Level 1 or 2). Agencies will have the option to apply for such a waiver, subject to individual review prior to any determination of approval by OPWDD.
6. Participation of public and private interests in rural areas: The proposed regulations were discussed with representatives of providers at several meetings. In addition, draft proposed regulations were sent to selected reviewers in October 2011 and July 2012, including provider associations. Provider associations include those, such as NYSARC, the NYS Association of Community and Residential Agencies, NYS Catholic Conference, and CP Association of NYS, which represent providers throughout New York State including those in rural areas. In addition, OPWDD sent proposed regulations to approximately 700 providers, including those in rural areas. OWPDD will be mailing these revised proposed amendments to all providers, including providers that are located in rural areas.
Revised Job Impact Statement
A Job Impact Statement for these proposed amendments is not being submitted because OPWDD does not anticipate a substantial adverse impact on jobs and employment opportunities. The proposed amendments require agencies to institute new protections for individuals related to behavior management. As noted in the other impact statements, there may be a modest increase in job opportunities for clinicians, especially psychologists and licensed clinical social workers, as a result of these amendments. To the extent that agencies implement new efficiencies to compensate for the cost of retaining the necessary clinicians, this might decrease staff performing other functions which would likely be less compensated at a lower level. In this case, there could be a minor overall decrease in jobs and employment opportunities. However, OPWDD would not expect that any overall decrease would result in a loss of more than 100 jobs statewide.
Assessment of Public Comment
OPWDD received more than 100 comments from multiple sources, including: self-advocates, family members, agency and not-for-profit provider representatives, and public advocates. In response to the comments received, OPWDD has revised selected language, terms, and requirements contained within the original proposed regulation. Below is a summary of the comments received and OPWDD’s responses. A more detailed assessment of the Public Comments received is available on the OPWDD website at www.opwdd.ny.gov.
I. Comments on specific subdivisions of Section 633.16.
A. Applicability
One comment recommended that this regulation apply to all developmentally disabled individuals receiving services in any setting, including those located outside New York State. The scope of OPWDD’s regulatory authority was clarified: the legislature gives the agency authority to regulate only the programs which are operated and/or certified by OPWDD.
B. Definitions
There were a number of helpful comments received regarding suggestions for revisions to specific definitions (e.g., Functional Behavioral Assessment; membership of the program planning team, etc.). Review of the public comments resulted in some significant changes being made to the language and/or terms in the proposed regulation, including: clarifying the distinction between medication prescribed solely for the purpose of behavioral control, and medication prescribed for co-occurring diagnosed psychiatric disorders; emphasis on an active approval of behavior support plans by the Behavior Plan/Human Rights Committee; the required title, scope, and qualifications levels for Behavior Intervention Specialists and their supervisors.
C. General Provisions
In this subdivision, the primary issue focused on the question of whether there is an actual need for a functional behavioral assessment and behavior support plan for individuals who may only take medication for a co-occurring diagnosed psychiatric condition and do not display challenging behaviors. OPWDD clarified its position regarding the use and review of psychiatric medications and made changes throughout the regulation to reflect this view.
D. Functional Behavioral Assessment
Several comments supported OPWDD’s requirement for a functional behavioral assessment when planning interventions to prevent, modify or control challenging behaviors. The adequacy of the required time frame for completion of these assessments was questioned; in response, OPWDD increased the time allowed for completion. Some comments expressed concern that when this regulation is implemented, existing assessments would no longer be valid, OPWDD clarified that there is a one-year grace period for update or revision of existing behavior support plans. The functional behavior assessment is the basis for developing such a plan, and is included in that grace period.
E. Behavior Support Plan
Some agencies expressed concern about a potential for conflict when more than one agency provides services for an individual in different settings. OPWDD supports a collaborative approach in these situations, and expects that agencies will reach an agreement regarding interventions, in order to provide consistency and prevent confusion in behavioral interventions for the individual.
F. Behavior Plan/Human Rights Committee (BP/HRC)
There were concerns raised regarding the qualifications, and function of the BP/HRC membership. OPWDD clarified who may serve on the BP/HRC and review plans that include medications.
G. Written Informed Consent
Although some agency representatives expressed the view that a “detailed written opinion and analysis” is unnecessary to support a determination of an individual’s lack of capacity, OPWDD disagrees. It is necessary for the program planning team to document specifically which elements of capacity the individual lacks.
Agencies noted the difficulty that they often experience in obtaining written informed consent within the original proposed 30-day timeframe following a witnessed verbal consent. OPWDD extended the time frame for valid verbal consent to 45 days.
OPWDD determined that if a New York State licensed psychologist or licensed physician was a member of the individual’s program planning team determining that individual’s capacity, and the team was unanimous in its finding of lack of capacity, no further review was needed by an independent licensed psychologist.
H. Objections
There were concerns raised by a few agencies concerning the notification requirements, particularly with regard to notification given to the surrogate consent-givers when an individual refuses medication. Some felt it would be too burdensome to notify the consent-giver at each instance of refusal. OPWDD disagrees and believes that there are instances when immediate notification is necessary.
I. Training
There appeared to be some confusion regarding the purpose, type and documentation for training staff the proper use of restrictive/intrusive and other intervention techniques. Guidance documents and a curriculum are currently being developed to assist with this process. Further, the Quality Assurance protocols used for evaluating agencies and providers will be developed to coincide with the regulations once they are implemented.
J. Specific Interventions
1) Physical Intervention Techniques:
Several commenters expressed concern about the proposed time frame for reporting physical interventions to OPWDD, with most indicating that the time frame proposed (24 hours or by close of next business day) was too short. A number of agencies proposed alternate reporting time frames ranging from 72 hours to quarterly. After reviewing all the suggestions, OPWDD adjusted the reporting time to conforms to the current reporting requirement of ADM 2012-03, which is 5 business days.
In addition, there were concerns expressed regarding how soon the individual should be checked for injuries following a physical intervention. In response, the language of the regulation was modified to allow for some flexibility regarding a specific time frame, while still ensuring that the individual is checked for injuries and that medical care is provided when an injury is suspected following a physical intervention.
2) Rights Limitations:
There was a specific request for the regulations to state that informed consent is required for any and all rights limitations included in an individual’s behavior support plan.
3) Time Out:
There were a number of comments regarding the use of Time Out. A few of these comments were related to a simple clarification of the definition of Time Out (that it is the temporary removal of positive reinforcement), and OPWDD modified the definition in response. Other comments were mixed. Some advocated for banning the use of Time Out rooms or reducing the maximum amount of time allowable for usage, others specifically requested that existing Time Out rooms not be subject to the physical plant requirements set forth in the regulation. In addition, the requirement that program planning teams review Time Out room use if it is used 5 or more times in a 24-hour period generated a number of comments with both higher and lower thresholds suggested. OPWDD is committed to reducing or eliminating the use of restrictive interventions, including time out, whenever possible. The emphasis in the regulation on positive behavior supports and the increased reporting and accountability requirements will allow for greater tracking and oversight, but it would be imprudent to prohibit Time Out suddenly without possibly increasing the risk for harm. In terms of the maximum time allowable and the requirement for program planning team review, OPWDD believes that the parameters identified in the regulation are appropriate. Nonetheless, nothing would prevent agencies from setting more stringent parameters as part of their policy.
4) Mechanical Restraints:
The most prominent objection was expressed by two parents and two agencies who believe that, despite the prohibition of aversive conditioning, by this paragraph the regulations still appear to permit what they consider to be harmful, abusive interventions. In these regulations, OPWDD specifically requires informed consent, and significant levels of scrutiny, approval, oversight, limits and documentation regarding any plan that includes a restrictive or intrusive intervention, including rights restrictions. The expectation is that staff will be trained to follow plans that use primarily positive behavioral approaches. OPWDD did not agree with an observation that designating a “senior staff person” for oversight of these and other interventions would be an increased financial and staffing burden; all agencies currently have an equivalent of “senior staff.” Comments for this paragraph also included suggestions of alternatives to the required frequency for reviewing the use of these devices and specific monitoring activities when such devices are used. The current time frames for reviewing use and for monitoring conditions during actual usage conform to federal regulations. The language of the regulation was revised to require OPWDD approval of devices that are not commercially produced, or are not designed specifically for human use.
5) Medications:
There were multiple concerns and objections raised regarding the requirement of a separate consultative panel to perform a semi-annual review of psychotropic medications. In response, OPWDD has incorporated in 633.16 the required review as outlined in Section 633.17; the results of this review will be provided to the prescriber and to the program planning team. Questions regarding the monitoring of and notification about emergency medication use were addressed. Finally, OPWDD recognizes that not every co-occurring psychiatric disorder for which medication is prescribed would be expressed in challenging behavior or require a behavior support plan. The regulatory requirements for behavior support plans and supportive monitoring plans were designed to provide clinical flexibility and distinction of approaches to differing circumstances and treatment needs.
II. General Comments
Concern was expressed by many of the commenters that implementation of Section 633.16 would be costly and would provide little benefit to individuals with disabilities. OPWDD believes that these regulations are needed – to enable providers to identify the true needs and potential, and protect the rights of individuals with disabilities. These regulations maintain a strong emphasis on conducting person-centered assessments, and encouraging positive behavioral supports when addressing challenging behavior. The regulations also clearly articulate the parameters regarding interventions for challenging behaviors. OPWDD believes that there will be many tangible benefits and protections for individuals with disabilities when the proposed regulations are adopted.
There were also concerns expressed that the regulation as a whole was “anachronistic,” “regressive,” and reflected a “hierarchical approach used over 20 years ago.” OPWDD notes that a regulation is not a surrogate or substitute for an agency’s policy statements and practices regarding the philosophy of care on which the agency’s approach to behavioral supports and intervention is based. A regulation simply sets forth certain standards and parameters that must be met under specific circumstances. At the basis of these regulations, there is an expectation that the individual being served, and those with whom he or she may have close personal ties and/or shared advocacy goals, will be included to the fullest extent possible in the development of services, opportunities, and behavior support or monitoring plans. Agency policies are free to eschew restrictive/intrusive interventions without penalty from OPWDD.
OPWDD would like to thank those who provided their comments and suggestions for these regulations.
