Specifically, the amendments:

- Update the “background and intent” provisions of 14 NYCRR Part 526 to reflect new “person-first” language, and to set forth the intent of the Office of Mental Health with respect to the use of restraint and seclusion as emergency interventions in facilities under its jurisdiction;

- Amend the “legal base” provisions to more comprehensively reflect the agency’s statutory authority with respect to quality of care, and to include applicable references to federal regulations governing restraint and seclusion;

- Update provisions governing the definitions and use of restraint and seclusion, reflecting current State statutory authority and incorporating, as appropriate, applicable federal Centers for Medicare and Medicaid regulations;

- Implement the requirements of Mental Hygiene Law Section 33.04 that orders for restraint and seclusion must be written by a physician, after examination, or if the physician is unavailable, by the most senior, qualified staff member present, by permitting acceptance of a verbal order of the physician, followed by confirmation of the order by the physician in writing within 30 minutes (and in no event beyond an hour);

- Require monitoring/documentation of the patient’s condition during the use of restraint or seclusion;

- Prohibit the simultaneous use of mechanical restraint and seclusion;

- Require order renewals to be signed after evaluation by physician and at least every 4 hours for adults; 1 hour for children 9-17 years and ½ hour for children under 9 years;

- Incorporate the federal requirement of notice to parents or guardians when restraint or seclusion is used at residential treatment facilities for children;

- Require facilities to conduct post-event analysis and debriefing activities by staff and patients to identify preventive measures that may be implemented in the future;

- Clarify that certain actions, when performed as defined in the regulation, do not constitute “restraint” or “seclusion,” i.e. “time out”, “mechanical support”, and “physical escort;” and

- Clarify that outpatient programs licensed by the Office of Mental Health shall not use restraint as a treatment intervention or in response to a crisis situation.

1. Statutory Authority:

Section 7.09 of the Mental Hygiene Law grants the Commissioner of the Office of Mental Health the authority and responsibility to adopt regulations that are necessary and proper to implement matters under his/her jurisdiction.

Section 31.19 of the Mental Hygiene law provides that no individual who is or appears to be mentally disabled shall be detained, deprived of his/her liberty, or otherwise confined without lawful authority, or inadequately, unskillfully, cruelly, or unsafely cared for or supervised by any person.

Section 33.04 of the Mental Hygiene Law establishes requirements for the application of restraint in facilities under the jurisdiction of the Office of Mental Health.

42 C.F.R. Section 482.13(e) and (f) establish standards governing the use of restraint and seclusion in hospitals as a term and condition of participation in the federal Medicaid program.

42 CFR Sections 483.358, 483.360, 483.362, 483.364, 483.366, 483.368, 483.370, 483.372, and 483.376 establish standards governing the use of restraint and seclusion in psychiatric residential treatment facilities providing inpatient psychiatric services for individuals under age 21 as a term and condition of participation in the federal Medicaid program.

2. Legislative Objectives:

Articles 7 and 31 of the Mental Hygiene Law reflect the Commissioner’s authority to establish regulations regarding mental health programs.

Section 33.03 of the Mental Hygiene Law evinces the Legislature’s intent to authorize the Commissioner to promulgate regulations with respect to quality of care and treatment in facilities under its jurisdiction, and Section 33.04 of such law authorizes the Commissioner to set standards with respect to the use of restrictive interventions including restraint.

3. Needs and Benefits:

Restraint is an emergency intervention that has historically been utilized to control the behavior of persons with mental illness in psychiatric facilities. However, this intervention has come under intense scrutiny, due to the significant physical and psychological risks associated with its use, on the part of both patients and staff.

In June 2000, the federal Centers for Medicare and Medicaid Services (CMS), promulgated new regulations governing restraint (42 C.F.R. Part 482) for inpatient psychiatric facilities. These regulations apply to most inpatient mental health facilities in New York, since most of these facilities are hospitals which participate in the federal Medicaid and Medicare programs. Subsequently, in January 2001, CMS promulgated interim final regulations governing restraint in non-hospital residential treatment facilities (RTFs), which serve patients with mental illness under age 21, at 42 C.F.R. Parts 441 and 483.

The National Association of State Mental Health Program Directors reported in a recent White Paper that “most States and providers with laws, regulations, or policies governing the use of restraint and seclusion have adopted an approach that mirrors the minimum standards as provided in the Federal regulation.” (Haimowitz, S. and Urff, J. Ending Harm from Restraint and Seclusion: the Evolving Efforts, submitted for publication). While existing Mental Hygiene Law conforms in some ways to the federal law and regulations that govern mental health providers, in several ways it is critically incongruent with the federal requirements governing mental health providers.

Specifically, under the federal CMS regulations for hospitals and non-hospital RTFs, the term “restraint” includes a drug used as a restraint, manual restraint, and mechanical restraint. Under 14 NYCRR Section 27.7 the term is much more narrowly defined as the “use of an apparatus,” i.e., mechanical restraint. This has caused confusion for mental health providers struggling to comply with disparate requirements and, in some cases, has resulted in facilities being cited by CMS upon audit for not having policies that accurately reflect federal regulations. Current regulations at 14 NYCRR Section 27.7 apply only to facilities under the jurisdiction of OMH (OPWDD has superseded these provisions for their facilities in 14 NYCRR Part 633), and are outdated with respect to mental health facilities, (e.g., they permit orders for restraint or seclusion to be renewed daily and allow use of restraint as part of an individual service plan).

These amendments bring State regulations governing the use of restraint and seclusion in mental health facilities up to date, and make them consistent with applicable federal regulations. Without these amendments, the incongruity between federal standards and state regulations is not in the best interest of mental health consumers. As such, the amendments reflect the current evidence-based practice approach to the use of restraint and seclusion in facilities serving persons with mental illness.

Notably, although these amendments represent significant change to 14 NYCRR Section 27.7, providers subject to these regulations will not experience dramatic change in their daily practices as a result of their adoption. Because the regulations do not apply to any provider that is not already subject to the Medicaid regulations and the amendments conform the state regulations to the federal standards, the actions necessary to comply with the state regulations have already been instituted by regulated parties. These amendments offer overwhelming benefits with respect to mental health providers. The amendments are designed to enhance the safety of mental health consumers, assist providers in maintaining compliance with federal regulations necessary for reimbursement in the Medicaid program, and prevent mental health consumers from abuse in settings not authorized to utilize restraint.

4. Costs:

The proposed amendments conform the state regulations to federal standards, which have been in place since 2001. The actions necessary to comply with state regulations should have already been instituted by regulated parties. As such, the regulation will maintain ongoing costs of compliance, which may include updating policy/procedure manuals, education and training, reporting, professional staffing; and notice provision by certain providers. Because compliance has been required for several years, to the extent any new costs will be incurred, they should not be significant.

(a) cost to State government: These regulatory amendments will not result in any additional costs to State government. Automated data are reported to OMH on an ongoing basis through the New York State Incident Management and Reporting System (NIMRS). NIMRS is implemented at State-operated psychiatric hospitals and OMH-licensed residential treatment facilities; and use of the incident module is required in all OMH licensed Article 28 and Article 31 hospitals as of December 31, 2010. Education and training programs are made available by the State. Preventing and Managing Crisis Situations (PMCS) curriculum is used in state-operated facilities and the program is available to OMH licensed residential treatment facilities, Article 28 and Article 31 hospitals at no cost. OMH also makes available the Safety in the Community program for OMH-licensed community-based programs. In this Program, physical restraint techniques are omitted (because restraint is not allowed in these settings).

OMH has made training available through the Positive Alternatives to Restraint and Seclusion (PARS) Learning Collaboratives, through a 3-year grant from the U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration. OMH is conducting learning collaboratives in which 29 licensed programs are participating.

(b) cost to local government: These regulatory amendments will not result in any additional costs to local government. Ongoing costs of implementation, including reporting, education and training, and professional staffing should be absorbed into existing budgets.

(c) cost to regulated parties: These regulatory amendments will not result in any additional costs to regulated parties. Ongoing costs include reporting, education and training of staff; professional staffing, updating of facility policy and procedure manuals, and notices to patients/parents (for RTFs) are already requirements under federal regulations; thus, to the extent any new costs will be incurred, they should not be significant.

5. Local Government Mandates:

The proposed amendments conform the state regulations to the minimum federal standards, which have been in place since 2001, as a term and condition of Medicaid reimbursement. The higher standard imposed by OMH on time frames applicable to use of restraint of children (which reflect current practice) will apply, but use of restraint is not mandated, and in any event, will have no significant cost impact on local governments. Use of a higher standard is warranted because children are subjected to restraint and seclusion at higher rates than adults and also are at greater risk of injury and/or death. The majority of hospital and RTF providers already utilize reduced time limits; the maximum duration for a restraint order in an RTF is half an hour.

6. Paperwork:

The proposed amendments conform the state regulations to the federal standards, which have been in place since 2001. Therefore, actions necessary to comply with state regulations should have already been instituted by regulated parties. However, the proposed amendments require updating of facility policy and procedures to conform with these changes and OMH guidelines. The conditions justifying use of restraint and seclusion have not changed and the requirement for written orders is not new; both reflect current State law and federal regulations. Some procedural changes, though in practice, may increase paperwork for those not complying with current expectations, e.g., post-event analysis and debriefing. These requirements are rationally related to the compliance with the federal minimum regulations and reflect best practices in the care and treatment of persons with mental illness. Continued reduction in the use of restraint and seclusion as a behavioral management intervention via the use of proven de-escalation strategies should continue to off-set any increase in paperwork or costs associated with these requirements.

7. Duplication:

These regulatory amendments do not duplicate existing State or federal requirements, but conform State regulations to applicable federal standards.

8. Alternatives:

Banning the use of restraint and seclusion in OMH facilities was rejected as an option because it is a legally permissible emergency intervention in carefully prescribed circumstances, and in some cases, is the only option available to protect a patient or others from imminent harm. The regulation incorporates state and federal requirements and reflects the expertise of interested parties, such as the PARS grant providers, to ensure that when restraint or seclusion is used, it is done safely and in compliance with governing authority. Inaction would perpetuate the current confusion that exists for providers now, so that alternative was rejected.

9. Federal Standards:

The regulatory amendments conform to the minimum standards of the federal government for the same or similar subject areas, except as explained herein.

10. Compliance Schedule:

Effective immediately upon adoption.

New York State has a large, multi-faceted mental health system that serves more than 500,000 individuals each year. OMH operates psychiatric centers across the State, and also regulates, certifies and oversees more than 2,500 programs, which are operated by local governments and nonprofit agencies. These programs include various inpatient and outpatient programs, emergency, community support, residential and family care programs. The proposed amendments apply to hospitals operated by OMH as identified in Section 7.17 of the Mental Hygiene Law; licensed inpatient units and hospitals (there are 112 licensed psychiatric inpatient units in general hospitals, and 6 licensed inpatient psychiatric hospitals); and 19 licensed residential treatment facilities for children (RTFs), which serve persons under age 21.

The proposed amendments to 14 NYCRR Parts 27, 526, and 587 would not impose any adverse economic impact or reporting, recordkeeping or other compliance requirements on small business and local government because the amendments merely update provisions that reflect outdated statutory references, nomenclature, practices or principles. They are also intended to conform the state regulations to federal standards, which have been in place since 2001. Therefore, providers that are subject to the proposed amendments are already required to comply with them, either as a matter of State law and regulation or federal Conditions of Participation in the Medicaid program.

For example, providers subject to these amendments are required to have a current restraint/seclusion policy, and to train staff. State reviews include interviews of staff to ensure they understand issues on the use of restraint, which is indicative of competence. Medical records already must include written orders for no more than four hours duration. Documentation that patients were monitored, assessments done minimum every thirty minutes, with half-hour assessment notes, is required. OMH reviews check to see whether there are any cases of an emergency requiring restraint authorized by senior professional staff where a physician was not available, and, if so, whether a physician arrived within 30 minutes to personally assess the patient and write the order. Further, reviews examine if there was a delay, and if the reason was documented. Reviews also check to ensure families of children are notified of restraint/seclusion use, and to determine whether documentation indicates that patients were debriefed after an episode of restraint and seclusion.

The providers to whom the regulatory amendments will apply must already comply with the federal Conditions of Participation related to restraint and seclusion. The proposed amendments bring the state closer to federal regulation with which providers already have to comply. The federal standard, in some cases, will remain much more prescriptive than the state regulation. For example, with respect to the federal Condition of Participation applicable to the RTFs, the Condition is more prescriptive about the frequency and required documentation for education and training of staff related to preventing and managing emergency safety situations and Cardiopulmonary Resuscitation (CPR).

The proposed amendments would not impose any adverse economic impact or reporting, recordkeeping or other compliance requirements on public or private entities in rural areas. New York State has a large, multi-faceted mental health system that serves more than 500,000 individuals each year. OMH operates psychiatric centers across the State, and also regulates, certifies and oversees more than 2,500 programs, which are operated by local governments and nonprofit agencies. These programs include various inpatient and outpatient programs, emergency, community support, residential and family care programs. The proposed amendments apply to hospitals operated by OMH as identified in Section 7.17 of the Mental Hygiene Law; licensed inpatient units and hospitals (there are 112 licensed psychiatric inpatient units in general hospitals, and 6 licensed inpatient psychiatric hospitals); and 19 licensed residential treatment facilities for children (RTFs), which serve persons under age 21.

The proposed amendments to 14 NYCRR Parts 27, 526, and 587 would not impose any adverse economic impact or reporting, recordkeeping or other compliance requirements on providers in rural areas, because the amendments merely update provisions that reflect outdated statutory references, nomenclature, practices or principles. They are intended to conform the state regulations to federal standards, which have been in place since 2001. Therefore, providers that are subject to the proposed amendments are already required to comply with them, either as a matter of State law and regulation or federal Conditions of Participation in the Medicaid program. The amendments are intended to protect the health, safety and welfare of persons with mental illness, regardless of where they are served.

For example, all providers subject to these amendments are required to have a restraint/seclusion policy, and to train staff. State reviews include interviews of staff to ensure they understand issues on the use of restraint, which is indicative of competence. Medical records already must include written orders for no more than four hours duration. Documentation that patients were monitored, assessments done minimum every thirty minutes, with half-hour assessment notes, is required. OMH reviews check to see whether there are any cases of an emergency requiring restraint authorized by senior professional staff where a physician was not available, and, if so, whether a physician arrived within 30 minutes to personally assess the patient and write the order. Reviews examine whether, if there was a delay, the reason was documented. Reviews also check to ensure families of children are notified of restraint/seclusion use, and to determine whether documentation indicates that patients were debriefed after an episode of restraint and seclusion.

The providers to whom the regulatory amendments will apply must already comply with the federal Conditions of Participation related to restraint and seclusion. The proposed regulation brings the state closer to federal regulation, with which providers already have to comply. The federal standard, in some cases, will remain much more prescriptive than the state regulation. For example, with respect to the federal Condition of Participation applicable to the RTFs, the Condition is more prescriptive about the frequency and required documentation for education and training of staff related to preventing and managing emergency safety situations and Cardiopulmonary Resuscitation (CPR). The amendments will assist providers in rural areas in identifying more clearly and concisely what is necessary for compliance to maintain Medicaid funding and state certification.

A Job Impact Statement is not being submitted with this notice because it is evident from the subject matter of the amendments that they will have no impact on jobs and employment opportunities. The proposed amendments to 14 NYCRR Parts 27, 526, and 587 would not impose any adverse impact on hiring, impose new requirements that could compromise job retention, or necessarily offer new opportunities for employment. The amendments merely update provisions that reflect outdated statutory references, nomenclature, practices or principles. They are intended to conform the state regulations to federal standards, which have been in place since 2001. Therefore, providers that are subject to the proposed amendments are already required to comply with them, either as a matter of State law and regulation or federal Conditions of Participation in the Medicaid program. For example, providers subject to these amendments are already required to have a restraint/seclusion policy, and are already required to train staff. State reviews include interviews of staff to ensure they understand issues on the use of restraint, which is indicative of competence.

The providers to whom the regulatory amendments will apply must already comply with the federal Conditions of Participation related to restraint and seclusion. The proposed regulation brings the state much closer to federal regulation with which providers already have to comply. The federal standard, in some cases, will remain much more prescriptive than the state regulation. It is likely that providers will find the proposed changes easier to understand and implement because the proposed rule brings the state and federal requirements closer.