PDD-52-11-00020-P Behavior Management - Modifying or Controlling Maladaptive or Inappropriate Behavior

12/28/11 N.Y. St. Reg. PDD-52-11-00020-P

NEW YORK STATE REGISTER

VOLUME XXXIII, ISSUE 52

December 28, 2011

RULE MAKING ACTIVITIES

OFFICE FOR PEOPLE WITH DEVELOPMENTAL DISABILITIES

PROPOSED RULE MAKING

NO HEARING(S) SCHEDULED

 

I.D No. PDD-52-11-00020-P

Behavior Management - Modifying or Controlling Maladaptive or Inappropriate Behavior

PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following proposed 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, section 13.07, 13.09 and 16.00

Subject:

Behavior Management - Modifying or controlling maladaptive or inappropriate behavior.

Purpose:

To establish requirements for interventions used in the OPWDD system to modify or control maladaptive or inappropriate behavior.

Substance of proposed rule (Full text is posted at the following State website:www.opwdd.ny.gov):

The proposed regulations establish new requirements concerning behavior management in the OPWDD system. OPWDD is proposing the addition of a new 14NYCRR Section 633.16, which contains comprehensive requirements for the management of maladaptive or inappropriate 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 maladaptive or inappropriate 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 maladaptive or inappropriate 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 maladaptive or inappropriate 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 maladaptive or inappropriate behavior or treat a co-occurring diagnosed psychiatric condition.

• 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 by a licensed psychologist or applied behavior sciences specialist (who has at least a Master's degree and meets specified qualifications).

• Plans must be reviewed and sanctioned before implementation by a behavior management/human rights committee. Required membership and procedures for these committees are established. (The requirement for committee review does not apply to plans that include medication to treat a co-occurring diagnosed psychiatric condition. The regulations describe standards for determining what constitutes a "psychiatric condition.")

• Informed consent is required for the use of restrictive/intrusive interventions. 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 behavior support plans and addressing a lack of informed consent. Procedures are also established concerning refusal of 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 maladaptive or inappropriate behavior. This includes the use of medication to treat co-occurring diagnosed psychiatric conditions.

• 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 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.

Text of proposed rule and any required statements and analyses may be obtained from:

Barbara Brundage, Director, Regulatory Affairs Unit, OPWDD, 44 Holland Avenue, Albany, NY 12229, [phone], email: [e-mail]

Data, views or arguments may be submitted to:

Same as above.

Public comment will be received until:

45 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.

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 maladaptive or inappropriate behaviors.

3. Needs and Benefits: The management of maladaptive or inappropriate behaviors is an important component of the OPWDD system. Managing behavior appropriately 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 behavior management 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 the management of maladaptive and inappropriate behavior. 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 managing maladaptive or inappropriate behavior. In addition, the regulation establishes specific procedures that must be followed in order to safeguard 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.

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 behavior management requirements and add additional clarity.

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, applied behavioral sciences 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.

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 and written behavior support plans for individuals who have maladaptive or inappropriate behavior which address a number of specific elements, including a functional behavioral assessment. The regulation also requires documentation of the individual's behavior and use of 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 behavior management.

7. Duplication: The proposed amendments do not duplicate any existing State or Federal requirements that are applicable to services for persons with developmental disabilities. The proposed amendments include the repeal of specific requirements in OPWDD regulations that govern behavior management in Intermediate Care Facilities (ICF/DDs), since those requirements would have been duplicative.

8. Alternatives: OPWDD considered applying all regulatory requirements imposed for restrictive/intrusive interventions to medications used to treat a diagnosed mental illness. 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 management/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 as soon as possible within the timeframes established by the State Administrative Procedure Act. OPWDD may delay the effective date of the regulation to accommodate the need for agencies to hire staff (especially psychologists and applied behavioral sciences specialists), and for other changes necessary for agencies to come into compliance, such as training staff, establishing the required committees, and 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.

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 and clinics), which provide day habilitation or prevocational services regardless of whether the services are certified, and/or 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 maladaptive or inappropriate 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 behavior management.

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 (including reviews and updates), convening a behavior management/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 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 or to treat a diagnosed mental illness). 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 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 and/or applied behavior sciences specialists (ABSS) (which have a Master's degree) and/or clinicians with training in behavior management techniques. In addition, the regulation requires the supervision of ABSS by a licensed psychologist which may mean that the supervising licensed psychologist 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 to comply with the new requirements or make arrangements for their services.

Certain functions specified by the proposed regulation require the involvement of health care professionals. While OPWDD generally expects that agencies will be able to comply using existing staff who are health care professionals, 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 maladaptive or inappropriate behaviors are served by agencies which are not small businesses. Further, the development of 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 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 management/human rights committee, recognizing that small business providers are more likely to serve these individuals than individuals who need medication or other interventions to address maladaptive or inappropriate 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 management/human rights committee. The regulations specifically allow agencies to coordinate with other agencies in the creation of a shared behavior management/human rights committee.

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, including NYSACRA and other provider associations. Some of the members of NYSACRA have fewer than 100 employees. Finally, OWPDD will be mailing these proposed amendments to all providers, including providers that are small businesses.

Rural Area Flexibility Analysis

1. Types and estimated numbers of rural areas: 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. While the additional requirement will have an adverse fiscal impact on providers, the geographic location of any given program (urban or rural) will not be a contributing factor to any such impact.

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 (including reviews and updates), convening a behavior management/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 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 or to treat a diagnosed mental illness. 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 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 and/or applied behavior sciences specialists (ABSS) (which have a Master's degree) and/or clinicians with training in behavior management techniques. In addition, the regulation requires the supervision of ABSS by a licensed psychologist which may mean that the supervising licensed psychologist 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 to comply with the new requirements or make arrangements for their services.

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: 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 are generally smaller in size than agencies in general. The economic impact of the proposed regulations is attributable to the need for additional clinicians, especially licensed psychologists and applied behavioral sciences specialists. 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 work that would need 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 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 management/human rights committee, recognizing that small business providers are more likely to serve these individuals than individuals who need medication or other interventions to address maladaptive or inappropriate 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 management/human rights committee. The regulations specifically allow agencies to coordinate with other agencies in the creation of a shared behavior management/human rights committee.

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, including provider associations. Provider associations which were present, such as NYSARC, the NYS Association of Community and Residential Agencies, NYS Catholic Conference, and CP Association of NYS, represent providers throughout New York State including those in rural areas. OWPDD will be mailing these amendments to all providers, including providers that are located in rural areas.

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, as a result of these amendments.