[Federal Register Volume 66, Number 14 (Monday, January 22, 2001)]
[Rules and Regulations]
[Pages 7148-7164]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 01-1649]



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Part X





Department of Health and Human Services





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Health Care Financing Administration



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42 CFR Parts 441 and 483



Medicaid Program; Use of Restraint and Seclusion in Psychiatric 
Residential Treatment Facilities Providing Psychiatric Services to 
Individuals Under Age 21; Final Rule

Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Rules 
and Regulations

[[Page 7148]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

42 CFR Parts 441 and 483

[HCFA-2065-IFC]
RIN 0938-AJ96


Medicaid Program; Use of Restraint and Seclusion in Psychiatric 
Residential Treatment Facilities Providing Psychiatric Services to 
Individuals Under Age 21

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Interim final rule with comment period.

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SUMMARY: This interim final rule with comment period establishes a 
definition of a ``psychiatric residential treatment facility'' that is 
not a hospital and that may furnish covered Medicaid inpatient 
psychiatric services for individuals under age 21. This rule also sets 
forth a Condition of Participation (CoP) that psychiatric residential 
treatment facilities that are not hospitals must meet to provide, or to 
continue to provide, the Medicaid inpatient psychiatric services 
benefit to individuals under age 21. Specifically, this rule 
establishes standards for the use of restraint or seclusion that 
psychiatric residential treatment facilities must have in place to 
protect the health and safety of residents. This CoP acknowledges a 
resident's right to be free from restraint or seclusion except in 
emergency safety situations. We are requiring psychiatric residential 
treatment facilities to notify a resident (and, in the case of a minor, 
his or her parent(s) or legal guardian(s)) of the facility's policy 
regarding the use of restraint or seclusion during an emergency safety 
situation that occurs while the resident is in the program. We believe 
these added requirements will protect residents against the 
inappropriate use of restraint or seclusion.

DATES: Effective date: These regulations are effective on March 23, 
2001.
    Comment date: Comments will be considered if we receive them at the 
appropriate address, as provided below, no later than 5 p.m. on March 
23, 2001.

ADDRESSES: Mail written comments (one original and three copies) to the 
following address ONLY: Health Care Financing Administration, 
Department of Health and Human Services, Attention: HCFA-2065-IFC, P.O. 
Box 8010, Baltimore, MD 21244-8010.
    If you prefer, you may deliver your written comments (one original 
and three copies) by courier to one of the following addresses: Room 
443-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., 
Washington, DC 20201, or C5-15-03, Central Building, 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    Comments mailed to those addresses may be delayed and could be 
considered late.
    Because of staffing and resource limitations, we cannot accept 
comments by facsimile (FAX) transmission. In commenting, please refer 
to file code HCFA-2065-IFC.
    Comments received timely will be available for public inspection as 
they are received, generally beginning approximately 3 weeks after 
publication of a document, in Room 443-G of the Department's offices at 
200 Independence Avenue, SW., Washington, DC, on Monday through Friday 
of each week from 8:30 a.m. to 5 p.m. (Phone (202) 690-7890).
    For comments that relate to information collection requirements, 
mail a copy of comments to: Health Care Financing Administration, 
Office of Information Services, Security and Standards Group, Division 
of HCFA Enterprise Standards, Room N2-14-26, 7500 Security Boulevard, 
Baltimore, MD 21244-1850, Attn: Julie Brown, HCFA-2065-IFC.

FOR FURTHER INFORMATION CONTACT: Mary Kay Mullen, (410)786-5480.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 1902(a)(9)(A) of the Social Security Act (the Act) requires 
the State health agency or other State medical agency to establish and 
maintain health standards for private and public institutions in which 
recipients of medical assistance, under the State plan, may receive 
care or services. Section 1905(h) of the Act defines the term 
``inpatient psychiatric hospital services for individuals under age 
21'' as inpatient services that are provided in an institution (or 
distinct part thereof) that is a psychiatric hospital or in another 
inpatient setting that the Secretary has specified in regulations. In 
this interim final rule, we are defining psychiatric residential 
treatment facilities as an inpatient setting in conformity with the 
definition of an institution as set forth in section 1905(h).
    The Medicaid program makes Federal funding available for State 
expenditures under an approved State Medicaid plan for inpatient 
psychiatric services for eligible individuals under 21 years of age in 
hospital and nonhospital settings. Nonhospital settings, which we are 
defining as psychiatric residential treatment facilities (facilities), 
are rapidly replacing hospitals in treating children and adolescents 
with psychiatric disorders. These facilities are generally a less 
restrictive alternative to a hospital for treating children and 
adolescents whose illnesses are less acute but who still require a 
residential environment.
    On November 17, 1994, we published in the Federal Register (56 FR 
59624) proposed regulations to establish standards for nonhospital 
psychiatric residential treatment facilities, to be contained in a new 
subpart F of 42 CFR part 483. Among the proposed standards was a 
prohibition on physical restraints and psychoactive drugs for purposes 
of discipline or convenience, when not required to treat the resident's 
psychiatric symptoms, or when not specified in the plan of treatment. 
Also included was a prohibition on the use of involuntary seclusion. 
Moreover, limitations were proposed on the use of drugs in doses that 
would interfere with the resident's daily living activities, or the use 
of drugs to control inappropriate behavior. These drugs would not be 
used unless they were an integral part of a plan of care directed 
specifically toward reducing and eventually eliminating that behavior, 
or when the harmful effects of the behavior clearly outweighed the 
potential harmful effects of the drugs.
    We, as well as the Congress, have grown increasingly concerned 
about the danger posed to residents in psychiatric residential 
treatment facilities as a result of improper restraint and seclusion 
practices. Improper restraint and seclusion practices can lead to 
serious injury and even death of residents as well as staff. In March 
1999, during the first session of the 106th Congress, members of the 
Senate and House of Representatives introduced three separate bills (S. 
736, S. 750 and H.R. 1313) intended to protect individuals from the 
improper use of restraint or seclusion in Medicare and Medicaid-funded 
facilities. These bills were incorporated into the enactment of the 
Children's Health Act of 2000, which was signed by the President on 
October 17, 2000.
    Advocates for persons with mental illness as well as the media have 
raised the public's awareness of restraint and seclusion practices that 
can lead to serious injury and death. The Hartford Courant (Courant), a 
Connecticut newspaper, published a series of articles in October 1998 
citing the results of a

[[Page 7149]]

50-state survey that confirmed 142 deaths, that occurred during the 
previous decade, while or shortly after a patient was restrained or 
secluded. The first of a series of articles entitled ``A Nationwide 
Pattern of Death,'' was published October 11, 1998. The survey focused 
on mental health and mental retardation facilities and group homes 
nationwide. According to a statistical estimate commissioned by the 
Courant that was conducted by the Harvard Center for Risk Analysis, 
between 50 and 150 deaths related to the use of restraint or seclusion 
occur every year across the country. The article further stated that of 
the 142 restraint-related deaths confirmed by the Courant's 
investigation, ages could be confirmed in 114 cases, and that more than 
26 percent of those were children--nearly twice the proportion they 
represent in mental health institutions.
    In 1999, at the request of the Congress, the General Accounting 
Office (GAO) conducted a study that focused on individuals receiving 
services in mental health and mental retardation facilities and group 
homes nationwide that receive public funding, primarily from the 
Medicare and Medicaid programs. Some objectives of the study were to 
determine the dangers of restraint and seclusion, the extent to which 
restraint and seclusion are used in inpatient and residential treatment 
facilities for individuals with mental illness or mental retardation, 
and the number of related injuries and deaths from their use. To gain 
at least a partial indication of the scope of the problem, the GAO 
obtained data on the number of deaths related to restraint or seclusion 
investigated by the Protection and Advocacy agencies in all 50 states 
and the District of Columbia in fiscal year 1998. On the basis of the 
partial information available from the 51 agencies, the GAO identified 
24 deaths associated with restraint or seclusion during fiscal year 
1998.
    In September of 1999, the GAO issued a report titled ``Improper 
Restraint or Seclusion Use Places People at Risk'' (GAO/HEHS-99-176), 
which concluded that the improper use of restraint and seclusion can be 
dangerous to both people receiving treatment and to staff. The report 
stated that the full extent of related injuries and deaths from 
improper restraint or seclusion is unknown because there is no 
comprehensive reporting system to track injuries and deaths, or to 
track the rates of restraint or seclusion use by facility. In addition, 
according to the report, most facilities are not even required to 
report these data to oversight agencies. The report stated that because 
reporting is so fragmentary, there may be many more deaths related to 
the use of restraint or seclusion than are being reported.
    The Courant series and the GAO report underscore our concern for 
the safety and welfare of children and adolescents when restraints or 
seclusion are employed in residential treatment facilities. We have 
therefore developed standards that describe the conditions under which 
restraint or seclusion can be used; that set an upper limit on the 
permissible length of time for each instance of restraint or seclusion 
use; that require education and training of staff, including the safe 
use of restraint and the safe use of seclusion; that require staff to 
directly monitor residents who are restrained or secluded for the 
entire duration of the procedure; and that prohibit the simultaneous 
use of restraints and seclusion.
    On July 2, 1999, we published in the Federal Register an interim 
final rule that addressed, in part, the use of restraint and seclusion 
in hospitals, including psychiatric hospitals, entitled ``Medicare and 
Medicaid Programs; Hospital Conditions of Participation; Patients' 
Rights'' (64 FR 36070). We conducted substantial academic research on 
the issue of restraint and seclusion, which was discussed in the 
referenced hospital interim final rule. Although the research primarily 
involved elderly patients, its findings, we believe, are also relevant 
to individuals under age 21. As we said there: ``Research indicates 
that the potential for injury or harm with the use of restraint is a 
reality. In a 1989 article published in the Journal of the American 
Geriatrics Society, Evans and Strumpf pointed to an association between 
the use of physical restraint and death during hospitalization (Evens, 
LK and Strumpf, NE: Tying down the elderly: A review of the literature 
on physical restraint. J Am Geriatr Soc (1989) 37:65-74; also see 
Robbins, LJ, Boyko E, Lane, J, et al.: Binding the elderly: A 
prospective study of the use of mechanical restraint in an acute care 
hospital. J Am Geriatr Soc (1987) 35:290; Frengley, JD and Mion, LC: 
Incidence of physical restraints on acute general medical wards. J Am 
Geriatr Soc (1986) 34:565; Strumpf, NE and Evans, LK: Physical 
restraint of the hospitalized elderly: Perceptions of patients and 
nurses. Nursing Research (1998) 37:132.) The FDA estimates that at 
least 100 deaths from the improper use of restraints may occur 
annually. Mion et al. further noted that `Some evidence exists that the 
use of physical restraints is not a benign practice and is associated 
with adverse effects, such as longer length of hospitalization, higher 
mortality rates, higher rates of complications, and negative patient 
reactions. Physical restraints have a detrimental effect on the 
psychosocial well-being of the patient' (see Mion et al.: A further 
exploration of the use of physical restraints in hospitalized patients. 
J Am Geriatr Soc (1989) 37:955; Schafer, A: Restraints and the elderly: 
When safety and autonomy conflict. Can Med Assoc J (1985) 132:1257-
1260.)''
    ``Research findings on the impact of restraints use have lead to 
research on and development of alternative methods for handling the 
behaviors and symptoms that historically prompted the application of 
restraint. However, various studies provide evidence that restraint is 
still being used when alternate solutions are available (see Donat, DC: 
Impact of a mandatory behavior consultation on seclusion/restraint 
utilization in psychiatric hospitals. J Behav Ther Exp Psychiatry (1998 
March) 29:1, 13-9; Dunbar, J: Making restraint-free care work. Provider 
(1997 May) 75-76, 79; and Moss RJ: Ethics of mechanical restraints. 
Hasting Center Report (1991 Jan-Feb) 21 (1):22-25.)''
    In the preamble of the July 1999 hospital interim final rule, we 
asked for comments on whether we should apply the hospital behavioral 
health standards on the use of restraint and seclusion to psychiatric 
residential treatment facilities that provide inpatient psychiatric 
services to individuals under age 21, or whether more stringent 
standards were warranted. Consumer advocacy groups that commented on 
extending the restraint and seclusion requirements to other types of 
providers and settings generally agreed that more stringent regulations 
should be applied with respect to the treatment of children. Their 
opinion was that the restraint of children and adolescents in these 
settings presents special hazards and concerns. Those comments will be 
addressed more specifically in the hospital final rule. Additionally, 
the 1999 GAO report described a study sponsored by the Center for 
Mental Health Services which indicated that there are higher restraint 
rates for children, including one State in which children in State-run 
facilities were restrained four times more frequently than adults. This 
report also noted that children are smaller and weaker than adults, so 
staff who are used to overpower adults may apply too much preasure or 
force when restraining children. For all of these reasons, HCFA has 
included standards in this rule that provide greater protection than 
those in

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existence or required by the Children's Health Act of 2000.
    Generally, the requirements set forth in this rule governing the 
use of restraint and seclusion are consistent with both the November 
1994 proposed rule and the July 1999 hospital interim final rule. 
Moreover, this rule also meets the specific requirements of section 
3207 of the Children's Health Act of 2000 (Pub. L. 106-310) which 
requires that health care facilities receiving support in any form from 
any program supported in whole or in part with funds appropriated to 
any Federal department or agency shall protect and promote the rights 
of each resident of the facility, including the right to be free from 
any restraints or involuntary seclusion imposed for purposes of 
discipline or convenience. Specifically, section 591(c) of the 
Children's Health Act permits the Secretary to issue regulations that 
afford residents greater protections regarding restraint and seclusion 
than the standards published in the new law. Consistent with this 
section, this rule provides greater protections than those required in 
section 3207.
    Psychiatric residential treatment facilities are fast replacing 
hospitals in providing long-term mental health services to children and 
adolescents, a highly vulnerable population. The dangers associated 
with the inappropriate use of restraint and seclusion, especially with 
this population were well documented in the GAO Report and the Courant 
series. According to the GAO Report, children are subjected to 
restraint and seclusion at higher rates than adults and are at greater 
risk of injury. Based on the mounting evidence of harm that can result 
from the use of restraint and seclusion, we are being more prescriptive 
in the way our restraint and seclusion standards are applied in 
psychiatric residential treatment facilities.

II. Provisions of the Interim Final Rule Effect of This Rule on the 
Survey and Certification Requirements

    This interim final rule implements only one of the conditions of 
participation (CoPs) set forth in our November 1994 proposed rule. We 
are not implementing the remainder of the CoPs in that proposed rule at 
this time because many of the comments we received on that proposed 
rule are still under evaluation. We plan to address the remainder of 
the CoPs in our November 1994 proposed rule in a separate rule in the 
future. As discussed below, we are moving forward with this CoP because 
evidence indicates a pressing need for the promulgation and enforcement 
of restraint and seclusion rules for psychiatric residential treatment 
facilities.
    Requiring psychiatric residential treatment facilities to meet 
these CoPs will require us to develop additional survey protocols and 
implementing guidelines to enforce these new requirements. We will 
solicit public comment on these survey protocols. Until such protocols 
are issued, we are requiring each psychiatric residential treatment 
facility that provides inpatient psychiatric services to individuals 
under age 21 under a State plan to attest, in writing, that the 
facility is in compliance with the standards set forth in this rule 
governing the use of restraint and seclusion. This attestation must be 
signed by the facility director. In addition, we are requiring the 
facility to provide the State Medicaid agency with its attestation of 
compliance. Since the facility will need time to implement these 
restraint and seclusion standards before it can come into compliance, 
we are allowing the facility 120 days from the effective date of this 
interim final rule to provide the State Medicaid agency with its 
attestation of compliance.
    We will work with the States to develop a process for sampling 
psychiatric residential treatment facilities to validate their 
attestations of compliance with the restraint and seclusion standards.
    This interim final rule establishes a definition of a psychiatric 
residential treatment facility as a facility other than a hospital that 
provides inpatient psychiatric services and sets forth a CoP entitled 
``Use of Restraint or Seclusion in Psychiatric Residential Treatment 
Facilities Providing Inpatient Psychiatric Services for Individuals 
Under Age 21.'' This CoP is in addition to the existing regulatory 
requirements for these facilities in 42 CFR 441.151 through 441.182, 
which specify requirements applicable if a State plan provides for 
inpatient psychiatric services to individuals under age 21.

Section 441.151  General Requirements

    This regulation amends Sec. 441.151 by redesignating existing 
paragraphs, by adding explicit reference to residential treatment 
facilities, and by adding a new paragraph (b) to establish a CoP in 
part 483, subpart G, that facilities must meet in order to provide 
these services.

Section 483.352  Definitions

    We have included in this section, definitions of terms as they 
apply to the standards in this rule governing the use of restraint and 
seclusion in psychiatric residential treatment facilities.
    The definitions we have employed for ``mechanical restraint'' and 
``personal restraint'' in this rule are modeled on the hospital 
definition of ``restraint'' codified in Sec. 482.13(f)(1). In this 
rule, we distinguish between ``personal'' and ``mechanical'' restraint 
to clarify that mechanical restraint means any device attached or 
adjacent to a person's body, while personal restraint means the 
application of physical force on a person's body without the use of any 
device.

Section 483.354  General Requirements for Psychiatric Residential 
Treatment Facilities

    This section clarifies that in addition to the requirements 
specified in this rule, psychiatric residential treatment facilities 
must meet the requirements in Secs. 441.151 through 441.182 of this 
chapter.

Section 483.356  Protection of Residents

    The purpose of this CoP is to protect residents in psychiatric 
residential treatment facilities from the inappropriate use of 
restraint or seclusion by addressing the right of each resident to be 
free from restraint or seclusion, in any form, imposed as a means of 
coercion, discipline, convenience, or retaliation.
    An example of the inappropriate use of seclusion or restraint for 
purposes of coercion would be the use of seclusion or restraint with a 
resident whose behavior would not require its use, and who is not 
endangering others, but where seclusion or restraint is being used 
until the resident takes prescribed medications or attends a required 
group therapy session. We are seeking public comment on the use of the 
term coercion.
    The CoP provides for the use of restraint or seclusion only in 
emergency safety situations to ensure the safety of the resident or 
others, and only until the emergency safety situation ends. An order 
for restraint or seclusion cannot be issued as a standing order. We 
also are prohibiting the simultaneous use of restraint and seclusion in 
psychiatric residential treatment facilities. Combining a mechanical 
restraint intervention with isolation (seclusion) is extremely 
restrictive and dangerous.
    In Sec. 483.356(c) we are requiring each facility to inform both 
the resident and, in the case of a minor, his or her parent(s) or legal 
guardian(s) of its policy regarding the use of restraint or seclusion. 
To comply with Executive Order 13166 (Improving Access to

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Services for Persons with Limited English Proficiency) which was issued 
on August 11, 2000, each facility is required to communicate its 
restraint and seclusion policy in a language that the resident, or his 
or her parent(s) or legal guardian(s) understands (including American 
Sign Language, if appropriate) and that, when necessary, interpreters 
or translators are provided. We believe that the resident (and, in the 
case of a minor, the parent(s) or legal guardian(s)) must be informed 
of the facility's restraint and seclusion policy at the time of 
admission to foster the selection of a provider best suited to meet the 
physical and mental health needs of the resident. We are also requiring 
the facility to provide a copy of the facility's policy to the 
resident, and if a minor, a copy to both the resident and the 
resident's parent(s) or legal guardian(s). The facility's policy must 
provide the information needed for contacting the State Protection and 
Advocacy Organization.

Section 483.358  Orders for the Use of Restraint or Seclusion

    Under this new standard, restraint or seclusion may be imposed only 
in emergency safety situations.
    This standard provides that only a board-certified psychiatrist, or 
a licensed physician with specialized training and experience in 
diagnosing and treating mental disorders, may order restraint or 
seclusion in emergency safety situations. This person must be the 
resident's treatment team physician, if available. When he or she is 
not available, the physician covering for the treatment team physician 
may order restraint or seclusion. The covering physician must meet 
these same requirements for training and experience.
    We are limiting the authority to order the use of restraint and 
seclusion in psychiatric residential treatment facilities to a board-
certified psychiatrist or a licensed physician with specialized 
training and experience in diagnosing and treating mental disorders. 
Our requirement that only a board-certified psychiatrist or a licensed 
physician may order restraint or seclusion is consistent with existing 
physician admission and certification of need for services requirements 
applicable if a State provides inpatient psychiatric services to 
individuals under age 21 in psychiatric facilities. Regulatory 
requirements at 42 CFR part 441, subpart D and part 456, subpart D 
require that inpatient psychiatric services for individuals under age 
21 be provided under the direction of a physician, and that a physician 
must certify, in writing, that inpatient psychiatric services are 
necessary in the setting in which they will be provided.
    Any order for restraint or seclusion must be the least restrictive 
intervention that is most likely to be effective in resolving the 
emergency safety situation based on consultation with staff and must be 
limited to no longer than the duration of the emergency safety 
situation. If the physician is not present in the facility to order the 
use of restraint or seclusion, we are requiring in Sec. 483.358(d) that 
a registered nurse obtain the physician's verbal order at the time the 
emergency safety intervention is initiated by staff. The physician's 
verbal order must be followed with the physician's signature verifying 
the verbal order. The ordering physician must be available to staff at 
least by phone for the duration of the restraint or seclusion to ensure 
the resident's safety.
    The time limits for restraint or seclusion orders in this rule are 
consistent with the July 1999 hospital interim final rule: no more than 
4 hours for residents ages 18 to 21, 2 hours for residents ages 9 to 
17, and 1 hour for residents under age 9. We are soliciting comments on 
these time limits.
    In Sec. 483.358, we are also requiring that within 1 hour of the 
initiation of an emergency safety intervention, a face-to-face 
assessment of the physical and psychological well-being of the resident 
be conducted. We believe this assessment is necessary to ensure the 
safety of the resident during and immediately after he or she is 
restrained or secluded. We believe that requiring that this assessment 
be performed by a physician would be unrealistic because unlike 
hospitals, a psychiatric residential treatment facility may not have a 
physician present 24 hours a day. Therefore, when a physician is not 
present, we are allowing a clinically qualified registered nurse 
trained in the use of emergency safety interventions to perform the 
face-to-face assessment. Both the face-to-face assessment and the 
restraint or seclusion order must be documented in the resident's 
record by staff involved in the emergency safety intervention before 
the end of their shifts. The ordering physician must sign the order as 
soon as possible.

Section 483.360  Consultation With Treatment Team Physician

    If the physician who orders the use of restraint or seclusion is 
not part of the resident's treatment team, the facility must consult 
with the resident's treatment team physician as soon as possible. We 
believe it is important that the team physician be made aware of any 
circumstances that have disrupted the physical or psychological well-
being of the resident as soon as possible so that the team physician 
can evaluate the situation(s) that required the resident to be 
restrained or secluded and make appropriate modifications to the 
resident's plan of treatment. We are requiring documentation in the 
resident's record that the treatment team physician was contacted.

Section 483.362  Monitoring of the Resident in and Immediately After 
Restraint

    We are requiring that clinical staff trained in the use of 
emergency safety interventions be physically present, continually 
assessing and monitoring the resident in restraint. If the emergency 
safety situation continues beyond the time limits of the order, a 
registered nurse must immediately contact the ordering physician in 
order to receive further instructions. A physician or registered nurse 
must evaluate the resident immediately after the restraint is removed. 
We believe these requirements will futher ensure resident safety.

Section 483.364  Monitoring of the Resident in and Immediately After 
Seclusion

    We are requiring a resident in seclusion to be continually 
monitored and assessed by clinical staff, trained in the use of 
emergency safety interventions and that the staff monitoring the 
resident must be physically present in or immediately outside the 
seclusion room to ensure the safety of the resident. Video monitoring 
of the resident in seclusion will not meet this requirement because 
such monitoring cannot determine if a resident is experiencing a 
medical emergency such as cardiac arrest or asphyxiation.
    This standard also specifies the characteristics of a room used for 
seclusion, including the requirements that the interior of the 
seclusion room be fully visible to staff and be free of any potentially 
hazardous conditions. We also are requiring that a physician or 
registered nurse evaluate the resident immediately after the resident 
is removed from seclusion. As stated in the discussion of Sec. 483.262, 
we believe these requirements will ensure resident safety.

Section 483.366  Notification of Parent(s) or Legal Guardian(s)

    We are requiring the facility to notify the parent(s) or legal 
guardian(s) whenever a resident who is a minor (as defined in this 
subpart) is restrained or

[[Page 7152]]

secluded. Notification must be made as soon as possible after the 
initiation of each emergency safety intervention and must be documented 
in the resident's record.

Section 483.368  Application of Time Out

    We have defined ``time out'' in Sec. 483.352 ``Definitions'' to 
clarify that it is not a form of seclusion, because the resident in 
time out is not physically prevented from leaving the time out area. 
The regulation also clarifies that time out can take place away from 
other residents (exclusionary) or in the area of activity or in the 
presence of other residents (inclusionary). This section further 
requires staff to monitor the resident while he or she is in time out. 
We considered establishing time limits for time out, but because age, 
maturity level, health status, and other factors must be considered, we 
believe that the duration of time out should be based on professional 
judgement. We welcome comments on this issue.

Section 483.370  Postintervention Debriefings

    In order to ensure the safety of resident's and others, we believe 
it is critical that the facility begin to quickly assess the 
circumstances that warranted the use of restraint or seclusion and to 
identify alternatives to reduce or eliminate their use. Therefore, we 
are requiring that within 24 hours after a resident has been restrained 
or secluded, staff involved in the emergency safety intervention and 
the resident, participate in a face-to-face discussion. This discussion 
can also include other staff and the resident's parent(s) or legal 
guardian(s) when it is deemed appropriate by the facility. As stated 
earlier, the facility must ensure that such discussions are conducted 
in a language that is understood by the resident and the resident's 
parent(s) or legal guardian(s). The discussion will provide both the 
resident and staff involved an opportunity to discuss the circumstances 
that resulted in the use of restraint or seclusion and strategies that 
all parties could employ to prevent the need for restraint or 
seclusion. However, we recognize that there may be clinical reasons why 
it may not be appropriate for a particular staff person involved in the 
emergency safety intervention to be part of the debriefing. If the 
presence of a particular staff person jeopardizes the well-being of the 
resident, it may not be advisable to include that staff person in a 
debriefing session. Therefore, this rule provides an exception to the 
requirement for those situations when the presence of a particular 
staff person jeopardizes the well-being of the resident.
    We also are requiring a separate debriefing of staff involved in 
the emergency safety intervention, and a review by appropriate 
supervisory and administrative staff of the situation that required the 
use of restraint or seclusion. However, we are not requiring that this 
debriefing be face-to-face.
    We believe staff debriefings may identify areas requiring 
modification of administrative policy and procedures pertaining to the 
use of restraint or seclusion, and may serve to reduce use of restraint 
or seclusion. We believe the debriefing is critical to ensuring the 
safety of the resident and others and should take place within 24 hours 
after the use of restraint or seclusion. We are specifically requesting 
comments regarding the 24 hour requirement for debriefings involving 
staff and a resident, as well as debriefings between staff involved in 
an intervention and appropriate administrative and supervisory staff.

Section 483.372  Medical Treatment for Injuries Resulting from an 
Emergency Safety Intervention

    This standard requires qualified medical personnel to immediately 
provide medical treatment to a resident who is injured during restraint 
or seclusion and to document these injuries in the resident's record. 
Injuries sustained by staff during the restraint or seclusion of a 
resident must also be documented in the resident's record. We believe 
this information will be important in assisting the facility in 
identifying measures to improve the safety of its staff through 
modifications of existing policies and procedures in the safe use of 
restraint and seclusion, and modificaion of training programs. We are 
also requiring staff involved in an emergency safety intervention that 
results in injury to the resident or staff to meet with supervisory 
staff to evaluate the circumstances that caused the injury and develop 
a plan to prevent future injuries.
    In our November 1994 proposed rule, we proposed a separate 
condition of participation in Sec. 483.220 entitled ``Health 
Services,'' which would require each facility to have written transfer 
agreement(s) in effect with one or more Medicaid-approved hospitals 
that reasonably ensures a resident will be transferred in a timely 
manner from the facility to the hospital when transfer is medically 
necessary for medical care or acute psychiatric care. In addition, we 
proposed to require that medical and other information needed for care 
of the resident be exchanged between the institutions, and that medical 
care be available to each resident 24 hours a day as may be necessary.
    We received one comment on the transfer agreement requirement 
stating that it would be difficult to meet this requirement because 
most facilities are not affiliated with a hospital and that admission 
criteria and placement authority rests with each county and insurance 
provider. We considered the commenter's rationale but believe these 
agreements are necessary because the use of restraint or seclusion may 
place a resident at risk for an acute medical crisis. Therefore, we are 
incorporating in this CoP the requirement that each facility have 
written transfer agreement(s) or affiliations in place.

Section 483.374  Facility Reporting

    According to the GAO report, reporting requirements play a central 
role in reducing restraint use and improving the safety of individuals 
in treatment settings. The report further states that in addition to 
tracking restraint rates, reporting of deaths or other significant 
events to an independent agency can contribute to improved safety for 
individuals in treatment settings. The GAO report specifically 
recommended that we mandate that any hospital or residential facility 
that treats persons with mental illness or mental retardation, as a 
requirement for receiving Medicare and Medicaid funds, report promptly 
to the State licensing body and the appropriate State Protection and 
Advocacy (P&A) system, all patient deaths and serious injuries among 
persons with mental illness or mental retardation, and to indicate 
whether restraint or seclusion was used during or immediately prior to 
the death or injury.
    This interim final rule requires each facility to report a 
resident's death, any serious injury to a resident as defined in this 
subpart, and a resident's suicide attempt to the State Medicaid agency 
and, unless prohibited by State-law, the State-designated P&A system. 
These serious occurrences involving a resident must be reported to the 
State Medicaid agency and the State-designated P&A system no later than 
the close of business the next business day following the occurrence. 
We are also requiring each facility to document all serious occurrences 
in the resident's record. In the case of a minor, we are requiring the 
facility to notify (within 24 hours of the occurrence) the resident's 
parent(s) or legal guardian(s) in order to provide the parent(s) or 
legal guardian(s) the opportunity to participate in decisions that may 
have to

[[Page 7153]]

be made regarding the resident. We are requiring staff to document in 
the resident's record that these contacts were made. It should be noted 
that the facility reporting requirements in this rule exceed the 
minimum requirements for facility reporting in section 3207 of the 
Children's Health Act of 2000.
    Regulations titled ``Substance Abuse and Mental Health Services 
Administration; Requirements Applicable to Protection and Advocacy of 
Individuals with Mental Illness' published by the Department of Health 
and Human Services on October 15, 1997 (62 FR 53548) grant the P&A 
system the authority to protect and advocate for the rights of 
individuals with mental illness and to investigate reports of abuse and 
neglect in residential facilities that care for and treat individuals 
with mental illness. The P&As may have access to public and private 
facilities, residents, and clients, and to facilities' records of 
individuals with mental illness for the specific purpose of conducting 
independent investigations of incidents of abuse and neglect.
    Under seperate guidance or rulemaking (as appropriate), we will 
direct the State Medicaid agency to report serious occurrences 
involving a resident of a psychiatric residential treatment facility to 
the State survey agency. Section 1902(a)(33)(B) of the Act requires 
States to survey institutional providers, to certify that they meet our 
regulations for participation in the Medicaid program under the State 
plan.

Section 483.376  Education and Training

    We are requiring the facility to provide ongoing education and 
training for staff including training in the safe and appropriate use 
of restraint and seclusion, as well as alternative nonintrusive 
behavior modification techniques. We also are requiring that staff be 
certified in the use of cardiopulmonary resuscitation. This training 
must be performed by individuals qualified by education, training, and 
experience. Staff must be able to successfully demonstrate, in 
practice, all techniques learned related to emergency safety 
interventions. Staff personnel records must document that this training 
was successfully completed. Staff must demonstrate their competencies 
on a semiannual basis. Each facility must make all training programs 
and materials available for review by HCFA, the State Medicaid agency, 
and the State survey agency. It should be noted that the education and 
training requirements in this rule exceed the minimum requirements for 
education and training in section 3207 of the Children's Health Act of 
2000.
    We believe this training is essential because restraint and 
seclusion can be dangerous to both the individual being restrained or 
secluded and to staff applying restraint or seclusion. Restraining 
individuals can involve physical struggle, pressure on the chest, or 
other interruptions in breathing. Having staff trained in alternative 
techniques to avoid restraint use is important, but staff should also 
be trained in the proper application and removal of restraints and in 
how to monitor individuals in restraint or seclusion. The GAO report 
stated that the Joint Commission on Accreditation of Health Care 
Facilities (JCAHO) had reviewed 20 restraint-related deaths and found 
that in 40 percent, the cause of death was asphyxiation, while 
strangulation, cardiac arrest, or fire had caused the remainder. The 
report recommended that we require any inpatient or residential 
facility that treats persons with mental illness to ensure that staff 
regularly receives training and refresher courses in alternate methods 
to handle agitated or potentially violent patients and document their 
receipt of training as a requirement for receiving Medicare and 
Medicaid funds.

III. Response to Comments on November 1994 Proposed Standards 
Governing Restraints and Seclusion

    In response to our November 1994 proposed rule, we received the 
following comments, which specifically addressed our proposed standards 
for restraints. Most of the commenters suggested that our standards 
address seclusion as well as restraints. We agree with the commenters 
and have included in this interim final rule standards addressing the 
use of both seclusion and restraint.
    One commenter stated that we should prohibit the use of any type of 
restraint, including seclusion and time-out rooms. Six commenters 
stated we should prohibit restraints because they are not therapeutic 
and if they are allowed for one purpose, they cannot be monitored for 
other uses.
    While we recognize that serious consequences can result from the 
inappropriate use of restraint or seclusion as discussed previously, we 
believe that restraint or seclusion used only in an emergency safety 
situation to ensure the safety of the resident or others is permissible 
when staff have been properly trained in the safe use of such 
interventions. Therefore, we have rejected these comments because we 
believe that the type of intervention used to ensure the safety of a 
resident or others during an emergency safety situation should be the 
decision of the professionals involved in the situation.
    Three commenters contended that restraints/seclusion should not be 
included in the plan of care and should be used only when an individual 
is a danger to himself or others, or is a serious disruption to the 
therapeutic environment. They also stated that restraints should be 
used only as long as physical danger continues. We generally agree with 
these comments, and as discussed previously, have limited the use of 
restraint or seclusion to emergency safety situations to ensure the 
safety of the resident or others in the facility. We are permitting the 
use of restraint or seclusion only until the emergency safety situation 
has ceased and the safety of the resident or safety of others can be 
ensured, even if the restraint or seclusion order has not expired. We 
are specifically prohibiting the use of standing orders for restraint 
or seclusion in these facilities.
    Two commenters suggested deleting ``involuntary'' before seclusion 
in the proposed ``freedom from abuse standard'' and suggested we 
include seclusion under our ``restraint'' standard. We are not 
including a standard entitled ``freedom from abuse'' in this rule. 
Rather, we have separately defined restraint, seclusion, and time out 
in this rule. We believe our definitions of seclusion and time out 
sufficiently address the difference between ``voluntary'' and 
``involuntary seclusion'' and therefore address the commenter's 
concerns.
    Seven commenters stated that we should allow seclusion because it 
is less intrusive and restrictive than restraints, but that we should 
specify procedures governing its use, including authorization by the 
attending physician within a brief period before it is imposed, 
observation at frequent intervals and access to meals and toilet. These 
commenters stated that parents should be notified within 24 hours and 
that the treatment team should meet as soon as possible but within 24 
hours to discuss any potential modification of the treatment plan based 
on the conditions that led to seclusion, and that a discussion with the 
individual should take place following seclusion. As noted previously, 
we have included standards governing the use of seclusion as well as 
restraints in this rule including the requirement that a physician must 
order restraint or seclusion. We are allowing a registered nurse to 
obtain the physician's verbal order at the time that restraint or

[[Page 7154]]

seclusion is initiated, but are requiring that the physician's verbal 
order be followed up with the physician's signature verifying the 
order. We are requiring that staff be physically present continually 
assessing and monitoring a resident in restraint or seclusion. We are 
also requiring that if a resident is a minor as defined in this 
subpart, the parent or guardian must be notified of the use of 
restraint or seclusion as soon as possible after the initiation of an 
emergency safety intervention. While we are not requiring that the 
treatment team meet within 24 hours of a resident being restrained or 
secluded, we are requiring that if the physician ordering the use of 
restraint or seclusion is not the resident's treatment team physician, 
then the ordering physician or a registered nurse must consult with the 
resident's treatment team physician as soon as possible. Some of these 
commenters recommended that seclusion be supervised by a psychiatrist 
or licensed psychologist. We agree with the need for supervision of a 
resident in restraint as well as seclusion but do not agree that 
supervision should be performed by a psychiatrist or licensed 
psychologist because the services of a psychiatrist or licensed 
psychologist may not always be available in these facilities. However, 
to ensure resident safety, we are requiring that clinical staff 
continually monitor and assess a resident in restraint or seclusion.
    One commenter stated that only the least intrusive passive 
restraints for the protection of the individual or others be used and 
that we not allow seclusion or time out rooms or chemical restraints, 
mechanical restraints or adverse conditioning. We are not adopting the 
recommendation that we restrict a facility's use of restraints to the 
least intrusive passive restraints. While we recognize the commenter's 
concern, we believe that the type of intervention used to protect a 
resident should be the decision of the professionals involved with the 
situation. Our standards governing orders for restraint and seclusion 
require a physician to order the least restrictive intervention that is 
most likely to be effective in the emergency safety situation. 
Furthermore, we have included standards requiring that staff receive 
education and training in identifying behavior and events that may 
trigger an emergency safety situation, as well as education and 
training in the use of nonphysical intervention skills such as de-
escalation, active listening and mediation conflict resolution. With 
regard to the comment that time out not be allowed, we have defined 
``time out'' to clarify that it is not a form of seclusion, because the 
resident in time out cannot be physically prevented from leaving the 
time-out area.
    Four commenters stated we should entirely prohibit the use of 
restraints on youngsters and that only time out and other means should 
be used in times of crisis. As stated above, we believe that the type 
of intervention used to ensure the safety of a resident or others in an 
emergency safety situation should be the decision of the professionals 
involved in that specific situation. These commenters also contended 
that restraints are too often justified on the basis of self-protection 
when they are really used for staff convenience, and that if restraints 
are allowed in certain circumstances, it is not possible to monitor for 
improper use. We recognize the commenter's concern and, therefore, our 
restraint and seclusion policy states that a resident has the right to 
be free from restraint or seclusion, of any form, used as a means of 
coercion, discipline, convenience, or retaliation. We believe that the 
standards governing restraint and seclusion, including allowing only a 
board-certified psychiatrist or a licensed physician to order restraint 
or seclusion, imposing time limits on the use of restraint and 
seclusion that are consistent with JCAHO standards, requiring continual 
monitoring and assessment of residents in restraint or seclusion, and 
requiring that a resident's record be documented each time restraint or 
seclusion is used, will serve to ensure the safety of residents and 
diminish the inappropriate use of restraint and seclusion.
    One commenter stated that a resident's parents should be notified 
within 24 hours whenever seclusion is used and that the treatment team 
should meet as soon as possible to discuss any needed modification to 
the plan. The commenter suggested that plan modifications should be 
based on analysis of the conditions leading to seclusion and discussion 
with the individual following seclusion. We partially agree with these 
comments and are requiring a facility to notify the parent(s) or legal 
guardian(s) of a minor resident who is restrained or placed in 
seclusion as soon as possible after the initiation of each emergency 
safety intervention. In addition, we are requiring that 
postintervention debriefings be conducted within 24 hours after the use 
of restraint or seclusion. The first debriefing will provide the 
resident and staff involved in the use of a restraint or seclusion the 
opportunity to discuss the circumstances that resulted in its use, as 
well as opportunity for the resident and staff to develop strategies 
that can be employed to prevent the future use of restraint or 
seclusion. A second debriefing between appropriate supervisory and 
administrative staff and staff directly involved in the restraint or 
seclusion of a resident must be provided to allow for a review and 
discussion of the situation that required the use of restraint or 
seclusion, including a discussion of alternative techniques that staff 
might have employed and procedures staff could implement to prevent 
future restraint or seclusion. We are requiring that changes identified 
through these debriefings be documented in the resident's treatment 
plan.
    One commenter suggested we delete the provision that a facility may 
not administer any psychoactive drugs for purposes of discipline or 
convenience from our standard on restraints. The commenter stated that 
facilities do not ``use'' drugs, and stated that drugs are prescribed 
by a physician as clinically appropriate in his or her opinion. The 
commenter asserted that this provision interferes with the practice of 
medicine. We agree and have not included this language in our standards 
governing restraints in this interim final rule. However, we are 
prohibiting the use of any form of restraint or seclusion used as a 
means of coercion, discipline, convenience, or retaliation.
    One commenter stated that we need program standards for the 
prescription and administration of medication, especially psychoactive 
medication. We have rejected the suggestion that we set standards 
governing the use of medications because we believe to do so would 
amount to our practicing medicine. We have generally declined to set 
standards that would limit or preclude the professional discretion of 
physicians. However, we are prohibiting the use of any form of 
restraint when used for coercion, discipline, or convenience because 
these uses are medically unnecessary. Another commenter argued that the 
standard governing drugs is much too loose and suggested six conditions 
relating to drug therapy that we should include as part of our 
standard. As stated above, we do not believe that we have authority to 
set standards of practice regarding the use of medications. Two 
commenters suggested we establish a separate condition of participation 
for pharmacy services because medication is a primary component of 
active treatment, and risk of medication error is substantial. We have 
rejected this suggestion at this time because we are currently 
publishing only standards

[[Page 7155]]

governing the use of restraint and seclusion in this interim final 
rule.

IV. Response to Comments on This Interim Final Rule

    Because of the large number of items of correspondence we normally 
receive on Federal Register documents published for comment, we are not 
able to acknowledge or respond to them individually. We will consider 
all comments we receive by the date and time specified in the DATES 
section of this document, and, when we proceed with a subsequent 
document, we will respond to the comments in the preamble to that 
document.

V. Waiver of Proposed Rulemaking

    In accordance with the requirements of the Administrative 
Procedures Act (APA), we ordinarily publish a notice of proposed 
rulemaking in the Federal Register and invite public comment on the 
proposed rule before the final rule is made effective. The notice of 
proposed rulemaking required by the APA includes a reference to the 
legal authority under which the rule is proposed, and the terms and 
substance of the proposed rule or a description of the subject matter 
and issues involved. Consistent with that practice, the November 1994 
proposed rule proposed limitations on the use of restraint and 
seclusion by psychiatric residential treatment facilities that provide 
inpatient psychiatric services to individuals under age 21 that we have 
clarified and further developed in this interim final rule. In 
addition, we provided the public with notice of our heightened concern 
on this issue in our request for comment in the July 1999 interim final 
rule on hospital restraint and seclusion standards.
    We have made some important additions to the 1994 proposed rule 
based both on comments received in response to the proposed rule and on 
the information sources referenced in this preamble. To the extent that 
there are provisions of this interim final rule that are not a logical 
outgrowth of the 1994 proposed rule, we are waiving the APA rulemaking 
procedure. The APA rulemaking procedure can be waived if the agency 
finds good cause that a notice-and-comment procedure is impracticable, 
unnecessary, or contrary to the public interest and incorporates a 
statement of the finding and its reasons in the rule issued.
    We believe that the danger and risks to children and adolescents 
from inappropriate restraint and seclusion practices are substantiated 
by continued reports of deaths and serious injuries that are occurring 
in residential settings. To protect the health and safety of residents, 
we believe we are justified in applying more prescriptive standards in 
this interim final rule governing the use of restraint and seclusion in 
psychiatric residential treatment facilities than those proposed in the 
November 1994 proposed rule or those promulgated in the July 1999 
hospital interim final rule.
    Significant public attention has been focused on restraint and 
seclusion practices in psychiatric residential treatment facilities 
providing services to children and adolescents. In response to concerns 
about the inappropriate use of restraint and seclusion in these 
facilities, the Congress passed and the President signed in October 
2000, legislation to regulate the use of restraint and seclusion in 
facilities that receive Medicare and Medicaid funding. That 
legislation, the Childrens Health Act of 2000, provides additional 
explicit statutory authority for many of the provisions of this rule.
    As we noted, the Courant articles of October 1998 reported that 142 
individuals had died in restraint-related incidents in the preceding 
decade. It was reported that many of these deaths were the result of 
improper use of mechanical restraints and that some could have been 
prevented by routine monitoring of the individual. One-third of the 
deaths reported by the Courant were due to asphyxia, and one-quarter 
were due to cardiac-related causes. As noted earlier, a GAO report 
published in September 1999, identified 24 deaths associated with 
restraint or seclusion in fiscal year 1998. The GAO indicated that the 
source of the data on the number of deaths reported was restraint or 
seclusion-related deaths that were investigated by the Protection and 
Advocacy agencies in all 50 states and the District of Columbia in 
fiscal year 1998. The GAO study concluded that the full extent of 
related injuries and deaths from improper restraint or seclusion 
practices is unknown because there is no comprehensive reporting system 
to track injuries and deaths, or a system that tracks the rates of 
restraint or seclusion use by a facility. The report stated that 
because reporting is so fragmentary, many more deaths related to 
restraint or seclusion may have occurred. And finally, even as we 
prepare to publish this rule, the media continue to investigate and 
report abusive practices, including deaths and injuries to children 
that are the result of inappropriate use of restraint and seclusion in 
psychiatric residential treatment facilities.
    Therefore, we find good cause to waive the notice of proposed 
rulemaking and to issue this final rule on an interim basis because 
delaying the effective date of the rule would be contrary to public 
interest. We are providing a 60-day period for public comment.

VI. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, we are required to 
provide a 60-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. In 
order to fairly evaluate whether an information collection should be 
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act 
of 1995 (PRA) requires that we solicit comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our estimate of the information collection 
burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    We are soliciting public comment on each of these issues for the 
sections that contain information collection requirements.

Section 441.151  General Requirements

    Paragraph (a)(4) of this section requires that inpatient 
psychiatric services for individuals under age 21 must be certified in 
writing to be necessary in the setting in which the services will be 
provided (or are being provided in emergency circumstances) in 
accordance with Sec. 441.152.
    The certification requirement of this section is not new. The 
paperwork burden is contained in the referenced Sec. 441.152, which 
specifies the certification requirements, has been approved under OMB 
#0938-0754.

Section 483.356  Protection of Residents

    Paragraph (c) of this section, ``Notification of facility policy,'' 
requires facility staff to inform each incoming resident (and, in the 
case of a minor, the resident's parent(s) or legal guardian(s)) at 
admission, of the facility's policy regarding the use of restraint or 
seclusion during an emergency safety situation that may occur while the 
resident is in the facility. Staff must obtain an acknowledgment, in 
writing, from the resident, or in the case of a minor, the

[[Page 7156]]

resident's parent(s) or legal guardian(s), that he or she has been 
informed of the facility's policy. Staff must file the written 
acknowledgment in the resident's record.
    In order to estimate the burden of this requirement on facilities, 
we used data from National Center for Health Statistics, Health, United 
States published in 1999 (page 278) which indicated that there were 459 
psychiatric residential treatment facilities in 1994, the latest year 
for which data are available. We estimate an annual growth rate in the 
number of these facilities to be 2 percent. Using this growth rate, we 
determined that there would be approximately 475 to 500 psychiatric 
residential treatment facilities nationally as of FFY 2001. These data 
showed that there are approximately 70 residents per facility at any 
one time. This equates to a total nationwide bed capacity approximating 
35,000 beds. Through an informal survey of providers, we estimate an 
average resident length of stay to be 9 months and based on a 9-month 
stay, each facility would admit an estimated average of 95 residents 
per year, or an estimated total of up to 47,500 residents nationally. 
We believe it will take each facility 8 hours to develop a policy 
statement regarding the use of restraints and seclusion, and an average 
of 30 minutes to present the information to each incoming resident and 
the parent(s) or guardian(s), and to obtain and file the 
acknowledgment.
    Thus, there will be a one-time burden of 4,000 hours nationwide to 
develop the statement and an annual burden of 48 hours per psychiatric 
residential treatment facility and 23,750 hours nationally to disclose 
the policy.

Section 483.358  Orders for the Use of Restraint or Seclusion

    In accordance with paragraph (d) of this section, a physician's 
verbal order must be obtained by a registered nurse at the time the 
emergency safety intervention is initiated by staff if a written order 
cannot be easily obtained, and the verbal order must be followed with 
the physician's signature verifying the verbal order.
    While the information collection requirement in this paragraph is 
subject to the PRA, we believe the burden associated with it is exempt 
as defined in 5 CFR 1320.3(b)(2) because the time, effort, and 
financial resources necessary to comply with the requirement are 
incurred by persons in the normal course of their activities.
    In accordance with paragraph (h) of this section, each order for 
restraint or seclusion must be documented in the resident's record. 
Documentation must include--
    (1) The ordering physician's name;
    (2) The date and time the order was obtained;
    (3) The emergency safety intervention ordered, including the length 
of time for which the physician authorized its use;
    (4) The time the emergency safety intervention actually began and 
ended;
    (5) The time and results of any 1 hour assessments required in 
paragraph (f) of this section.
    (6) The emergency safety situation that required the resident to be 
restrained or put in seclusion; and
    (7) The name, title, and credentials of staff involved in the 
emergency safety intervention.
    There are an estimated average of 47 situations per month per 
psychiatric residential treatment facility where restraint or seclusion 
is used, or approximately 282,000 situations nationally, per year. We 
estimate that it will take approximately 30 minutes per situation, or 
282 hours annually per psychiatric residential treatment facility, for 
a national total of 141,000 hours annually to comply with the 
documentation requirements.
    In accordance with paragraph (i) of this section, the facility must 
maintain an aggregate record of all emergency safety situations, the 
interventions used, and their outcomes.
    Based on 15 minutes per situation, we estimate that it will take 
141 hours per psychiatric residential treatment facility, and a 
national total of 70,500 hours annually to comply with this 
documentation requirement.
    In accordance with paragraph (j) of this section, the physician 
ordering the restraint or seclusion must sign the order in the 
resident's record as soon as possible, but no later than 24 hours after 
the order is issued.
    While these information collection requirements are subject to the 
PRA, we believe the burden associated with them is exempt as defined in 
5 CFR 1320.3(b)(2) because the time, effort, and financial resources 
necessary to comply with the requirement are incurred by persons in the 
normal course of their activities.

Sec. 483.360  Consultation With Treatment Team Physician

    Paragraph (a) of this section requires that, if the physician 
ordering the use of restraint or seclusion is not part of the 
resident's treatment team, the facility must consult with the 
resident's treatment team physician as soon as possible and inform the 
team physician of the emergency safety situation that required the 
resident to be restrained or placed in seclusion. Paragraph (f) of this 
section requires the facility to document in the resident's record the 
date and time the team physician was consulted.
    We estimate that it will take approximately 30 minutes per 
situation, 282 hours annually per psychiatric residential treatment 
facility, or 141,000 hours nationally to comply with the documentation 
and disclosure requirements of this section, based on an assumption 
that approximately half of the situations will require that the 
facility staff separately notify the treatment team physician.

Section 483.366  Notification of Parent(s) or Legal Guardian(s)

    If the resident is a minor as defined in Sec. 483.352, paragraph 
(a) of this section requires the facility to notify the parent(s) or 
legal guardian(s) of a resident who has been restrained or placed in 
seclusion as soon as possible after the initiation of each emergency 
safety intervention.
    Paragraph (b) of this section requires the facility to document in 
the resident's record that the parent(s) or legal guardian(s) has been 
notified of the emergency safety intervention, including the date and 
time of notification and the name of the staff person providing the 
notification.
    We estimate that it will take 30 minutes to notify a parent or 
guardian and 15 minutes to document that notification. The total annual 
burden will be 423 hours per psychiatric residential treatment facility 
and 211,500 hours nationally, based on the assumption that virtually 
all of the residents will be minors as defined in Sec. 483.352.

Section 483.370  Postintervention Debriefings

    Paragraph (c) of this section requires that staff document in the 
resident's record that the debriefing sessions required by this section 
took place.
    This documentation will take approximately 30 minutes per 
situation, or an annual burden of 282 hours per psychiatric residential 
treatment facility and 141,000 hours nationally.

Section 483.372  Medical Treatment for Injuries Occurring as a Result 
of an Emergency Safety Situation

    Paragraph (b) of this section requires the psychiatric residential 
treatment facility to have affiliations or written transfer agreements 
in effect with one or more hospitals approved for participation under 
the Medicaid program that reasonably ensure that--
    (1) A resident will be transferred from the facility to the 
hospital and admitted

[[Page 7157]]

in a timely manner when a transfer is medically necessary for medical 
care or acute psychiatric care;
    (2) Medical and other information needed for care of the resident 
in light of such a transfer, will be exchanged between the institutions 
in accordance with State medical privacy law, including any information 
needed to determine whether the appropriate care can be provided in a 
less restrictive setting; and
    (3) Services are available to each resident 24 hours a day, 7 days 
a week.
    Paragraph (c) of this section requires that staff document in the 
resident's record all injuries that occur as a result of an emergency 
safety situation, including injuries to staff resulting from that 
intervention.
    While these information collection requirements are subject to the 
PRA, we believe the burden associated with them is exempt as defined in 
5 CFR 1320.3(b)(2) because the time, effort, and financial resources 
necessary to comply with the requirement are incurred by persons in the 
normal course of their activities.

Section 483.374  Facility Reporting

    Paragraph (a) of this section requires each psychiatric residential 
treatment facility that provides inpatient psychiatric services to 
individuals under age 21 to attest, in writing, that the facility is in 
compliance with our standards governing the use of restraint and 
seclusion. This attestation must be signed by the facility director.
    We estimate that it will take 8 hours per facility to be able to 
attest to compliance with the standards. This is a one-time burden. The 
national burden will be 500 multiplied by 8, or 4,000 hours.
    Paragraph (b) of this section requires that the facility report 
serious occurrences involving a resident to both the State Medicaid 
Agency and, unless prohibited by State law, the State-designated 
Protection and Advocacy System. The report must include the name of the 
resident involved in the serious occurrence, a description of the 
occurrence, and the name, street address, and telephone number of the 
facility. In the case of a minor, the facility must also notify the 
parent(s) or legal guardian(s) of the resident involved in a serious 
occurrence.
    Staff must document in the resident's record that the contacts 
above were made.
    The burden for notifying parent(s) or legal guardian(s) is 
addressed under Sec. 483.366.
    We estimate that it will take an additional 15 minutes to document 
that these contacts were made, for an average annual burden of 141 
hours per psychiatric residential treatment facility, with an annual 
national total of 70,500 burden hours.

Section 483.376  Education and Training

    Paragraph (f) requires facilities to provide for assessments of 
staff education and training needs by requiring staff to demonstrate 
their competencies related to the use of emergency safety interventions 
on a semiannual basis. This section also provides for staff to 
demonstrate, on an annual basis, their competency in the use of 
cardiopulmonary resuscitation.
    Paragraph (g) of this section requires the facility to document in 
the staff personnel records that the training required by Sec. 483.376 
was successfully completed.
    While these information collection requirements are subject to the 
PRA, we believe the burden associated with them are exempt as defined 
in 5 CFR 1320.3(b)(2) because the time, effort, and financial resources 
necessary to comply with the requirement are incurred by persons in the 
normal course of their activities.

Comments

    If you comment on these information collection and recordkeeping 
requirements, please mail copies directly to the following:

Health Care Financing Administration, Office of Information Services, 
Security and Standards Group, Attn: Julie Brown, Room N2-14-26, 7500 
Security Boulevard, Baltimore, MD 21244-1850;
      and
Office of Information and Regulatory Affairs, Office of Management and 
Budget, Room 10235, New Executive Office Building, Washington, DC 
20503, Attn: Brenda Aguilar, HCFA Desk Officer.

VII. Regulatory Impact Statement

A. Overall Impact

    We have examined the impact of this interim final rule as required 
by Executive Order 12866 and the Regulatory Flexibility Act (RFA) 
(Public Law 96-354). Executive Order 12866 directs agencies to assess 
all costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity).
    The RFA requires agencies to analyze options for regulatory relief 
of small entities. For purposes of the RFA, small entities include 
small businesses, nonprofit organizations and government agencies. Most 
hospitals and most other providers and suppliers are small entities, 
either by nonprofit status or by having revenues of $5 million or less 
annually. For purposes of the RFA, all psychiatric residential 
treatment facilities are considered to be small entities. Individuals 
and States are not included in the definition of a small entity. 
Consistent with the RFA, we prepare a regulatory flexibility analysis 
unless we certify that a rule will not have a significant economic 
impact on a substantial number of small entities.
    Also, section 1102(b) of the Act requires us to prepare a 
regulatory impact analysis if a rule may have a significant impact on 
the operations of a substantial number of small rural hospitals. That 
analysis must conform to the provisions of section 604 of the RFA. For 
purposes of section 1102(b) of the Act, we define a small rural 
hospital as a hospital that is located outside of a Metropolitan 
Statistical Area and has fewer than 50 beds. This regulation does not 
have an impact on small rural hospitals. However, to the extent the 
rule may have significant effects on psychiatric residential treatment 
facilities and their residents, or be viewed as controversial, we 
believe it is desirable to inform the public of our projections of the 
likely effects of the proposals.
    The Unfunded Mandates Reform Act of 1995 requires (in section 202) 
that agencies prepare an assessment of anticipated costs and benefits 
for any rule that may result in a mandated expenditure in any 1 year by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100 million or more. This rule has no mandated 
consequential effect on State, local, or on tribal governments, or the 
private sector. We have described the anticipated effects of this 
regulation below.
    We have reviewed this interim final rule with comment under the 
threshold criteria of Executive Order 13132, Federalism. We have 
determined that this interim final rule with comment does not 
significantly affect the rights, roles, and responsibilities of States.
    This rule is the product of serious concern about improper use of 
restraints and seclusion in psychiatric residential treatment 
facilities. This led us to set forth this interim final rule with 
comment to ensure the protection of residents of these facilities from 
improper restraint and seclusion

[[Page 7158]]

practices that could contribute to death or serious injury.

B. Anticipated Effects

1. Effect on Psychiatric Residential Treatment Facilities
    We believe that many psychiatric residential treatment facilities 
are already in compliance with this rule because of State laws 
governing the use of restraint and seclusion, as well as their own 
quality assurance and improvement systems. Additionally, psychiatric 
residential treatment facilities must meet current Federal requirements 
for accreditation in order to provide inpatient psychiatric services to 
individuals under age 21. We are aware that the national accrediting 
organizations are currently in the process of revising their standards 
governing the use of restraint and seclusion. Therefore, the impact of 
this rule will not be determinable to the extent that the accrediting 
organizations' revised restraint and seclusion standards are or are not 
compatible with the requirements of this rule.
    There are several provisions that will have an impact on 
psychiatric residential treatment facilities. The facilities will have 
to notify a parent(s) or a legal guardian(s) when restraint or 
seclusion is used, and ensure that staff are provided with initial and 
ongoing education and training in the proper and safe use of seclusion 
and the proper and safe use of restraint, and in techniques and 
alternative methods for handling resident behavior, symptoms, and 
situations that traditionally have been treated by the use of 
restraints or seclusion.
    There will be facility costs associated with developing a policy on 
the use of restraint and seclusion in emergency safety situations and 
ensuring that this policy statement is available to residents and 
family members as well as facility staff.
    We anticipate that some facilities will need additional registered 
nurses to be present during all shifts, including weekends, because we 
are requiring that, when a physician is not present to order the use of 
restraint or seclusion, a registered nurse must be present to obtain 
the physician's verbal order, and to contact the ordering physician 
should an emergency safety situation continue beyond the time limit of 
the physician's order. In addition, when a physician is not available, 
we are requiring a registered nurse to perform the 1 hour assessment of 
an individual who is restrained or secluded, and to evaluate the 
resident's well-being after he or she is removed from restraint or 
seclusion.
    While psychiatric residential treatment facilities generally offer 
a less restrictive alternative to hospital treatment of psychiatric 
conditions, they are recognized as an inpatient setting for the 
purposes of providing mental health services under the Medicaid 
Inpatient Psychiatric Services Under Age 21 benefit. Unlike hospitals, 
which have a full cadre of medical professional staff present on a 24-
hour basis, psychiatric residential treatment facilities may not be 
required to provide 24-hour coverage by licensed medical professional 
staff. In our informal research, we found that some facilities employ 
medical professional staff on a less than 24-hour basis. One facility 
contracts with a physician to provide 24-hour ``on-call'' coverage 
which does not equate to continual onsite coverage by medical staff. 
Since these facilities are providing medically necessary services in an 
inpatient setting, we believe that medical professional staff should be 
present on a 24-hour basis.
    An emergency safety situation involving a resident of a facility 
can occur at any time, requiring staff to use restraints or seclusion 
as an emergency intervention to ensure the resident's safety or the 
safety of others. These emergencies often occur in the evening or on 
weekends when staffing levels may be lower than during the day. When 
such a situation occurs in a hospital, trained medical professional 
staff are onsite 24 hours a day to assist in the proper and safe 
application and monitoring of restraints. However, while psychiatric 
residential treatment facilities provide essentially the same inpatient 
care to vulnerable children and adolescents, trained medical 
professional staff are not required to be present 24 hours a day. This 
disparity creates increased risk for serious injury or even death when 
staff are faced with an emergency safety situation requiring the use of 
restraint or seclusion. Therefore, we believe that it is not only 
reasonable but critical to resident safety that we require these 
facilities to provide 24-hour onsite coverage by a registered nurse. It 
would be irresponsible not to extend the same level of protections to 
children and adolescents in these facilities that are provided in a 
hospital.
    In addition, this rule requires psychiatric residential treatment 
facilities to report both to the State Medicaid agency and the State-
designated P&A system, any serious occurrence, including a resident's 
death, a serious injury to a resident, or a resident's suicide attempt. 
In the case of a minor, the facility must also notify the parent(s) or 
legal guardian(s) of the resident involved in a serious occurrence. We 
believe that this new reporting requirement will have only a minimal 
cost impact on facilities.
    The Hartford Courant, a Connecticut newspaper, heightened public 
awareness of this issue with a series of articles in October 1998 
citing the results of a study that identified 142 deaths from the use 
of seclusion and restraint in behavioral health treatment facilities 
over the past 10 years. However, this number includes deaths from the 
use of seclusion and restraint in more than just the psychiatric 
residential treatment facility setting. We believe the nationwide 
reporting of deaths and serious injuries in psychiatric residential 
treatment facilities will contribute to the reduction of deaths or 
serious injuries that result from the inappropriate use of restraint 
and seclusion.
    We believe that there will be costs associated with developing and 
implementing training programs for facility staff. However, we are not 
prescribing how facilities will meet the training requirements. 
Therefore, psychiatric residential treatment facilities will be 
afforded the flexibility to provide the training directly through ``in-
house'' training or to obtain a contractor to provide the training 
either at the facility or off-site.
2. Effect on Beneficiaries
    The implementation of this regulation will serve to protect 
residents and staff of psychiatric residential treatment facilities. We 
anticipate that the benefits will include a significant reduction in 
the inappropriate use of restraint and seclusion which will result in a 
reduction in the number of deaths and serious injuries to residents and 
facility staff.
3. Effect on Medicaid Program
    We expect the implementation of this regulation will generate some 
costs to the Medicaid program. There will be additional facility costs 
as described in the table below.

C. Summary of Estimated Costs

    The following are the assumptions and the methodology we used to 
derive the estimated costs for implementing this rule. We are 
soliciting public comments regarding any available information that may 
affect the cost estimates associated with the implementation of this 
rule.

[[Page 7159]]



                                                   Annual Cost
                                                  [$ Millions]
----------------------------------------------------------------------------------------------------------------
                                      FY 2001         FY 2002         FY 2003         FY 2004         FY 2005
----------------------------------------------------------------------------------------------------------------
Psych. Residential Treatment
 Facility Costs:
    Medicaid--Federal Share.....              16              31              31              33              34
    Medicaid--State Share.......              12              24              24              25              26
    Other Payers................               1               3               3               3               3
                                 -------------------------------------------------------------------------------
        Total...................              29              58              58              61              63
                                 ===============================================================================
State Medicaid Administrative
 Costs:
    Federal Share...............               1               1               1               1               1
    State Share.................               1               1               1               1               1
                                 -------------------------------------------------------------------------------
        Total...................               2               2               2               2               2
                                 ===============================================================================
Fed. Admin. Costs for Survey and
 Certification
        Total...................           \(1)\           \(1)\           \(1)\           \(1)\          \(1)\
----------------------------------------------------------------------------------------------------------------
\1\Less than $0.5 million.

Psychiatric Residential Treatment Facility Costs
    Psychiatric residential treatment facility costs are comprised of 
three categories: (1) additional registered nursing staff, (2) staff 
training, and (3) facility reporting.
    Data from Health, United States, 1999 (National Center for Health 
Statistics, p. 278) indicate that there were 459 psychiatric 
residential treatment facilities in 1994, the latest year for which 
data are available. Resident care staff in these facilities totaled 
about 44,000 in that same year. Using a 2 percent growth rate trend 
developed from the Health US 1999 data above, we projected the number 
of facilities and the number of resident care staff for Federal fiscal 
years (FFY) 2001 through 2005.
    1. New staff costs. The Health US 1999 data on staffing for 
psychiatric residential treatment facilities shows an average of 3.2 
full-time-equivalent (FTE) registered nurses per facility. The 
requirement for 24 hour per day registered nurse coverage would require 
a minimum of 4.2 FTEs (168 hours per week divided by 40 hours per week 
per FTE). Each facility would, at a minimum, have to provide for an 
average of one additional FTE registered nurse. For these estimates we 
have assumed an increase of 1.5 FTE registered nurses per facility, 
which translates into a requirement for approximately 790 additional 
registered nurses to provide the necessary coverage in all psychiatric 
residential treatment facilities in FFY 2001. We trended the registered 
nurse staffing requirement forward through 2005 based on our estimation 
that resident population growth would approximate 2 percent per year. 
The numbers of registered nurses needed to provide coverage in years 
subsequent to FFY 2001 will vary with changes in the numbers of 
residents. We assumed the total annual compensation (salary and fringe 
benefits) for each registered nurse to be $56,000 in FFY 2001, 
totalling $44.2 million nationally. The total costs are estimated to 
increase by 3 percent per year thereafter. Data taken from the Nursing 
Department Compensation Report 1999-2000 (Hospital and Healthcare 
Compensation Service, Oakland New Jersey, page 18) indicate that the 
annual national average base salary for inpatient hospital psychiatric 
nursing positions (equivalent in skills and payment level to the nurses 
working in psychiatric residential treatment facilities) would 
approximate $19.99 per hour or $41,580 annually for 1999, the latest 
year for which data are available. The Report indicates that the 
average increase in psychiatric nursing salaries approximates 3 percent 
per year. Using a 3 percent growth rate we projected the annual salary 
for psychiatric nurses for Federal fiscal years 2001 through 2005. We 
added a factor of 27.0 percent to psychiatric nurses salary for fringe 
benefit costs. The term fringe benefits includes paid leave, 
supplemental pay, insurance, retirement, savings and other benefits. 
The 27.0 percent was shown for nurse fringe benefit costs in the 
publication: Employer Costs for Employee Compensation, 1986-1998, Table 
2, Employer Costs Per Hour Worked for Employee Compensation and Costs 
as a Percent of Total Compensation: Civilian Workers, by Occupational 
and Industry Group, March 1998'' (U.S. Department of Labor, Bureau of 
Labor Statistics, page 10). The rate of fringe benefits to salary 
ranged from 27.0 to 27.7 percent over the period from March 1994 
through March 1998, with the majority at 27.0 percent, as shown in 
Tables 2, 18, 34, 50, and 66 of the same publication. The year 1998 is 
the latest period for which such data are available. As a result, we 
used 27.0 percent as a constant in our cost projection for Federal 
fiscal years 2001 through 2005 as any variation in rate would represent 
a very limited change in projected fringe benefit costs.
    2. Training costs. Existing Federal Medicaid regulations at 42 CFR 
441.151 require that a psychiatric facility that provides inpatient 
psychiatric services to individuals under age 21 be accredited by the 
Joint Commission on Accreditation of Healthcare Organizations (JCAHO), 
the Commission on Accreditation of Rehabilitation Facilities, the 
Council on Accreditation of Services for Families and Children, or by 
any other accrediting organization, with comparable standards that is 
recognized by the State. Most of these facilities are currently 
accredited by JCAHO. In August 2000, JCAHO published its Comprehensive 
Accreditation Manual for Hospitals, which includes revised behavioral 
health care standards governing the use of restraint and seclusion. 
These revised restraint and seclusion standards apply to all behavioral 
health care settings, including residential treatment centers. 
Specifically, JCAHO strengthened existing standards governing training 
requirements for direct care staff in the safe use of restraint and 
seclusion and the requirement for education and assessment of staff 
competence in minimizing the use of restraint and seclusion. These new 
standards will take effect January 1, 2001.
    We have made the following assumptions with regard to staff 
training: (1) That the revised JCAHO

[[Page 7160]]

training requirements for facility accreditation will not fully meet 
the training requirements under this interim final rule, and therefore 
have included estimated costs for staff training which we obtained 
through research on consultants who provide this specific service; (2) 
that, at a minimum, staff training to meet the requirements of this 
rule would cost approximately $250 per staff person for initial 
training, and approximately $100 annually for ongoing staff training, 
and (3) that only 10 percent of staff would fully meet the training 
requirements under this rule.
    We estimated that by FFY 2001 the facility staff would have grown 
to approximately 50, 000 from the 44,000 staffing estimate for 1994 
(see page 69). We assume that approximately 90 percent of the facility 
staff, or about 45,000 employees would require training in the use of 
restraint and seclusion,. We estimate that approximately 75 percent of 
the staff to be trained, or 33,750, would require initial training at 
an estimated $250 per person, totaling approximately $8.4 million. The 
remaining 11,250 staff would require ongoing training at about $100 per 
employee, amounting to an estimated $1.1 million.
    In addition to direct training costs, we also assumed that 
facilities would incur related consulting costs averaging 10 hours per 
month per facility at a cost of $40 per hour. Inflation for all 
training and related costs was assumed to be 5 percent per year.
    3. Reporting costs. In the absence of any current verifiable data 
on serious occurrences involving residents in psychiatric residential 
treatment facilities, we have assumed the costs of the required 
reporting of these events to be approximately $250 per facility, per 
year. We are soliciting comments regarding any available information on 
actual reporting costs.
    Total estimated facility costs of compliance, as shown in the above 
table, are estimated to be $58 million in the first full year of 
implementation (FFY 2002). This figure represents about 1.6 percent of 
the total projected expenditures of $3.3 billion for psychiatric 
residential treatment facilities in that year, as derived from the 
Health US 1999 data.
State Medicaid Administration Costs
    States will have additional responsibilities and costs for survey 
and certification requirements associated with the requirements of this 
regulation. Beginning in Federal fiscal year 2001, we project there 
will be 500 residential treatment facilities, or an average of 10 
facilities per state. For each state, we estimated an annual survey 
agency cost equivalent to 5 days to conduct 2 onsite reviews (20 
percent sample) to validate facility attestation to our new restraint 
and seclusion standards. We also estimated that documentary reviews of 
facility attestations, including any necessary follow up with 
facilities in conjunction with the attestation would require the survey 
agency to incur costs equivalent to 5 days. We also estimated costs 
associated with restraint and seclusion complaints which would require 
investigation by the survey agency. We estimated 2 complaints annually 
requiring onsite follow up by the survey agency, including enforcement 
activities and appeals-related activities. We estimated each complaint 
would require 2 days for onsite visits, 2 days for follow up and 1 day 
for appeals-related activities for a total of 10 days for 2 complaints. 
We assumed the need for an additional one-tenth of an FTE per state to 
support this additional workload.
    Current expenditures indicate an average cost (salary and benefits) 
of $50,000 for state survey agency professional personnel; one-tenth of 
one FTE would cost $5,000 per year. Because these are Medicaid-only 
facilities, the survey and certification costs will be paid under the 
Medicaid program. Based on the current 75/25 Federal-state match, the 
average expenditures for each state would be $3,750 in Federal Medicaid 
funds, and $1,250 in state-matching funds.
Other Assumptions
    Available evidence indicates that residents of psychiatric 
residential treatment facilities are overwhelmingly Medicaid-eligible. 
Therefore, we have assumed that 95 percent of the costs incurred by 
these facilities to implement these new regulations would be defrayed 
by the Medicaid program and 5 percent by other payers. We are assuming 
that States will continue to fully fund the costs of this benefit.

D. Alternatives Considered

    We originally considered developing one set of requirements 
regulating the use of restraint and seclusion for all provider types in 
the Medicare and Medicaid programs. However, based on public comments 
received in response to the interim final regulation addressing a 
similar CoP for hospitals, and recent concerns about restraint and 
seclusion use for behavior management situations, we concluded that one 
set of requirements did not afford all patients (or residents) with 
adequate protections. Moreover, with the enactment of the Children's 
Health Act of 2000, the Secretary no longer has the discretion to leave 
this benefit unregulated.

E. Conclusion

    The CoP for psychiatric residential treatment facilities sets forth 
a series of requirements to ensure each resident's physical and 
emotional health and safety. These requirements address each resident's 
right to be free from restraint or seclusion, of any form, used as a 
means of coercion, discipline, convenience, or retaliation. The CoP is 
a new requirement for facilities that provide inpatient psychiatric 
residential treatment services to Medicaid eligible individuals under 
age 21. In accordance with the Regulatory Flexibility Act, we have 
examined the burden this rule may impose on small entities and certify 
that this rule will not have a significant impact on a substantial 
number of intities.
    In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by the Office of Management and Budget.

List of Subjects

42 CFR Part 441

    Family planning, Grant programs-health, Infants and children, 
Medicaid, Penalties, Reporting and recordkeeping requirements.

42 CFR Part 483

    Grant programs-health, Health facilities, Health professionals, 
Health records, Medicaid, Medicare, Nursing homes, Nutrition, Reporting 
and recordkeeping requirements, Safety.

    For the reasons set forth in the preamble, 42 CFR chapter IV is 
amended as follows:

PART 441--SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC 
SERVICES

    A. Part 441 is amended as set forth below:
    1. The authority citation for part 441 continues to read as 
follows:


    Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 
1302).


    2. Section 441.151 is revised to read as follows:


Sec. 441.151  General requirements.

    (a) Inpatient psychiatric services for individuals under age 21 
must be:
    (1) Provided under the direction of a physician;
    (2) Provided by--
    (i) A psychiatric hospital or an inpatient psychiatric program in a 
hospital, accredited by the Joint Commission on Accreditation of 
Healthcare Organizations; or

[[Page 7161]]

    (ii) A psychiatric facility that is not a hospital and is 
accredited by the Joint Commission on Accreditation of Healthcare 
Organizations, the Commission on Accreditation of Rehabilitation 
Facilities, the Council on Accreditation of Services for Families and 
Children, or by any other accrediting organization with comparable 
standards that is recognized by the State.
    (3) Provided before the individual reaches age 21, or, if the 
individual was receiving the services immediately before he or she 
reached age 21, before the earlier of the following--
    (i) The date the individual no longer requires the services; or
    (ii) The date the individual reaches 22; and
    (4) Certified in writing to be necessary in the setting in which 
the services will be provided (or are being provided in emergency 
circumstances) in accordance with Sec. 441.152.
    (b) Inpatient psychiatric services furnished in a psychiatric 
residential treatment facility as defined in Sec. 483.352 of this 
chapter, must satisfy all requirements in subpart G of part 483 of this 
chapter governing the use of restraint and seclusion.

PART 483--REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES

    B. Part 483 is amended as set forth below:
    1. The authority citation for part 483 continues to read as 
follows:


    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).


    2. A new subpart G, consisting of Secs. 483.350 through 483.376, is 
added to part 483 to read as follows:
Subpart G--Condition of Participation for the Use of Restraint or 
Seclusion in Psychiatric Residential Treatment Facilities Providing 
Inpatient Psychiatric Services for Individuals Under Age 21
Sec.
483.350   Basis and scope.
483.352   Definitions.
483.354   General requirements for psychiatric residential treatment 
facilities.
483.356   Protection of residents.
483.358   Orders for the use of restraint or seclusion.
483.360   Consultation with treatment team physician.
483.362   Monitoring of the resident in and immediately after 
restraint.
483.364   Monitoring of the resident in and immediately after 
seclusion.
483.366   Notification of parent(s) or legal guardian(s).
483.368   Application of time out.
483.370   Postintervention debriefings.
483.372   Medical treatment for injuries resulting from an emergency 
safety intervention.
483.374   Facility reporting.
483.376   Education and training.

Subpart G--Condition of Participation for the Use of Restraint or 
Seclusion in Psychiatric Residential Treatment Facilities Providing 
Inpatient Psychiatric Services for Individuals Under Age 21


Sec. 483.350  Basis and scope.

    (a) Statutory basis. Sections 1905(a)(16) and (h) of the Act 
provide that inpatient psychiatric services for individuals under age 
21 include only inpatient services that are provided in an institution 
(or distinct part thereof) that is a psychiatric hospital as defined in 
section 1861(f) of the Act or in another inpatient setting that the 
Secretary has specified in regulations. Additionally, the Children's 
Health Act of 2000 (Pub. L. 106-310) imposes procedural reporting and 
training requirements regarding the use of restraints and involuntary 
seclusion in facilities, specifically including facilities that provide 
inpatient psychiatric services for children under the age of 21 as 
defined by sections 1905(a)(16) and (h) of the Act.
    (b) Scope. This subpart imposes requirements regarding the use of 
restraint or seclusion in psychiatric residential treatment facilities, 
that are not hospitals, providing inpatient psychiatric services to 
individuals under age 21.


Sec. 483.352  Definitions.

    For purposes of this subpart, the following definitions apply:
    Drug used as a restraint means any drug that--
    (1) Is administered to manage a resident's behavior in a way that 
reduces the safety risk to the resident or others;
    (2) Has the temporary effect of restricting the resident's freedom 
of movement; and
    (3) Is not a standard treatment for the resident's medical or 
psychiatric condition.
    Emergency safety intervention means the use of restraint or 
seclusion as an immediate response to an emergency safety situation.
    Emergency safety situation means unanticipated resident behavior 
that places the resident or others at serious threat of violence or 
injury if no intervention occurs and that calls for an emergency safety 
intervention as defined in this section.
    Mechanical restraint means any device attached or adjacent to the 
resident's body that he or she cannot easily remove that restricts 
freedom of movement or normal access to his or her body.
    Minor means a minor as defined under State law and, for the purpose 
of this subpart, includes a resident who has been declared legally 
incompetent by the applicable State court.
    Personal restraint means the application of physical force without 
the use of any device, for the purpose of restricting the free movement 
of a resident's body.
    Psychiatric Residential Treatment Facility means a facility other 
than a hospital, that provides psychiatric services, as described in 
subpart D of part 441 of this chapter, to individuals under age 21, in 
an inpatient setting.
    Restraint means a ``personal restraint,'' ``mechanical restraint,'' 
or ``drug used as a restraint'' as defined in this section.
    Seclusion means the involuntary confinement of a resident alone in 
a room or an area from which the resident is physically prevented from 
leaving.
    Serious injury means any significant impairment of the physical 
condition of the resident as determined by qualified medical personnel. 
This includes, but is not limited to, burns, lacerations, bone 
fractures, substantial hematoma, and injuries to internal organs, 
whether self-inflicted or inflicted by someone else.
    Staff means those individuals with responsibility for managing a 
resident's health or participating in an emergency safety intervention 
and who are employed by the facility on a full-time, part-time, or 
contract basis.
    Time out means the restriction of a resident for a period of time 
to a designated area from which the resident is not physically 
prevented from leaving, for the purpose of providing the resident an 
opportunity to regain self-control.


Sec. 483.354  General requirements for psychiatric residential 
treatment facilities.

    A psychiatric residential treatment facility must meet the 
requirements in Sec. 441.151 through Sec. 441.182 of this chapter.


Sec. 483.356  Protection of residents.

    (a) Restraint and seclusion policy for the protection of residents. 
(1) Each resident has the right to be free from restraint or seclusion, 
of any form, used as a means of coercion, discipline, convenience, or 
retaliation.
    (2) An order for restraint or seclusion must not be written as a 
standing order or on an as-needed basis.

[[Page 7162]]

    (3) Restraint or seclusion must not result in harm or injury to the 
resident and must be used only--
    (i) To ensure the safety of the resident or others during an 
emergency safety situation; and
    (ii) Until the emergency safety situation has ceased and the 
resident's safety and the safety of others can be ensured, even if the 
restraint or seclusion order has not expired.
    (4) Restraint and seclusion must not be used simultaneously.
    (b) Emergency safety intervention. An emergency safety intervention 
must be performed in a manner that is safe, proportionate, and 
appropriate to the severity of the behavior, and the resident's 
chronological and developmental age; size; gender; physical, medical, 
and psychiatric condition; and personal history (including any history 
of physical or sexual abuse).
    (c) Notification of facility policy. At admission, the facility 
must--
    (1) Inform both the incoming resident and, in the case of a minor, 
the resident's parent(s) or legal guardian(s) of the facility's policy 
regarding the use of restraint or seclusion during an emergency safety 
situation that may occur while the resident is in the program;
    (2) Communicate its restraint and seclusion policy in a language 
that the resident, or his or her parent(s) or legal guardian(s) 
understands (including American Sign Language, if appropriate) and when 
necessary, the facility must provide interpreters or translators;
    (3) Obtain an acknowledgment, in writing, from the resident, or in 
the case of a minor, from the parent(s) or legal guardian(s) that he or 
she has been informed of the facility's policy on the use of restraint 
or seclusion during an emergency safety situation. Staff must file this 
acknowledgment in the resident's record; and
    (4) Provide a copy of the facility policy to the resident and in 
the case of a minor, to the resident's parent(s) or legal guardian(s).
    (d) Contact information. The facility's policy must provide contact 
information, including the phone number and mailing address, for the 
appropriate State Protection and Advocacy organization.


Sec. 483.358  Orders for the use of restraint or seclusion.

    (a) Only a board-certified psychiatrist, or a physician licensed to 
practice medicine with specialized training and experience in the 
diagnosis and treatment of mental diseases, may order the use of 
restraint or seclusion.
    (b) If the resident's treatment team physician is available, only 
he or she can order restraint or seclusion. If the resident's treatment 
team physician is unavailable, the physician covering for the treatment 
team physician can order restraint or seclusion. The covering physician 
must meet the same requirements for training and experience described 
in paragraph (a) of this section.
    (c) The physician must order the least restrictive emergency safety 
intervention that is most likely to be effective in resolving the 
emergency safety situation based on consultation with staff.
    (d) If the physician is not available to order the use of restraint 
or seclusion, the physician's verbal order must be obtained by a 
registered nurse at the time the emergency safety intervention is 
initiated by staff and the physicians verbal order must be followed 
with the physician's signature verifying the verbal order. The ordering 
physician must be available to staff for consultation, at least by 
telephone, throughout the period of the emergency safety intervention.
    (e) Each order for restraint or seclusion must:
    (1) Be limited to no longer than the duration of the emergency 
safety situation; and
    (2) Under no circumstances exceed 4 hours for residents ages 18 to 
21; 2 hours for residents ages 9 to 17; or 1 hour for residents under 
age 9.
    (f) Within 1 hour of the initiation of the emergency safety 
intervention, a physician or clinically qualified registered nurse 
trained in the use of emergency safety interventions must conduct a 
face-to-face assessment of the physical and psychological well being of 
the resident, including but not limited to--
    (1) The resident's physical and psychological status;
    (2) The resident's behavior;
    (3) The appropriateness of the intervention measures; and
    (4) Any complications resulting from the intervention.
    (g) Each order for restraint or seclusion must include--
    (1) The ordering physician's name;
    (2) The date and time the order was obtained; and
    (3) The emergency safety intervention ordered, including the length 
of time for which the physician authorized its use.
    (h) Staff must document the intervention in the resident's record. 
That documentation must be completed by the end of the shift in which 
the intervention occurs. If the intervention does not end during the 
shift in which it began, documentation must be completed during the 
shift in which it ends. Documentation must include all of the 
following:
    (1) Each order for restraint or seclusion as required in paragraph 
(g) of this section.
    (2) The time the emergency safety intervention actually began and 
ended.
    (3) The time and results of the 1-hour assessment required in 
paragraph (f) of this section.
    (4) The emergency safety situation that required the resident to be 
restrained or put in seclusion.
    (5) The name of staff involved in the emergency safety 
intervention.
    (i) The facility must maintain a record of each emergency safety 
situation, the interventions used, and their outcomes.
    (j) The physician ordering the restraint or seclusion must sign the 
order in the resident's record as soon as possible.


Sec. 483.360  Consultation with treatment team physician.

    If the physician ordering the use of restraint or seclusion is not 
the resident's treatment team physician, the ordering physician or 
registered nurse must--
    (a) Consult with the resident's treatment team physician as soon as 
possible and inform the team physician of the emergency safety 
situation that required the resident to be restrained or placed in 
seclusion; and
    (b) Document in the resident's record the date and time the team 
physician was consulted.


Sec. 483.362  Monitoring of the resident in and immediately after 
restraint.

    (a) Clinical staff trained in the use of emergency safety 
interventions must be physically present, continually assessing and 
monitoring the physical and psychological well-being of the resident 
and the safe use of restraint throughout the duration of the emergency 
safety intervention.
    (b) If the emergency safety situation continues beyond the time 
limit of the physician's order for the use of restraint, a registered 
nurse must immediately contact the ordering physician in order to 
receive further instructions.
    (c) A physician, or a registered nurse trained in the use of 
emergency safety interventions, must evaluate the resident's well-being 
immediately after the restraint is removed.


Sec. 483.364  Monitoring of the resident in and immediately after 
seclusion.

    (a) Clinical staff, trained in the use of emergency safety 
interventions, must be physically present in or immediately outside the 
seclusion room, continually

[[Page 7163]]

assessing, monitoring, and evaluating the physical and psychological 
well-being of the resident in seclusion. Video monitoring does not meet 
this requirement.
    (b) A room used for seclusion must--
    (1) Allow staff full view of the resident in all areas of the room; 
and
    (2) Be free of potentially hazardous conditions such as unprotected 
light fixtures and electrical outlets.
    (c) If the emergency safety situation continues beyond the time 
limit of the physician's order for the use of seclusion, a registered 
nurse must immediately contact the ordering physician in order to 
receive further instructions.
    (d) A physician, or a registered nurse trained in the use of 
emergency safety interventions, must evaluate the resident's well-being 
immediately after the resident is removed from seclusion.


Sec. 483.366  Notification of parent(s) or legal guardian(s).

    If the resident is a minor as defined in this subpart:
    (a) The facility must notify the parent(s) or legal guardian(s) of 
the resident who has been restrained or placed in seclusion as soon as 
possible after the initiation of each emergency safety intervention.
    (b) The facility must document in the resident's record that the 
parent(s) or legal guardian(s) has been notified of the emergency 
safety intervention, including the date and time of notification and 
the name of the staff person providing the notification.


Sec. 483.368  Application of time out.

    (a) A resident in time out must never be physically prevented from 
leaving the time out area.
    (b) Time out may take place away from the area of activity or from 
other residents, such as in the resident's room (exclusionary), or in 
the area of activity or other residents (inclusionary).
    (c) Staff must monitor the resident while he or she is in time out.


Sec. 483.370  Postintervention debriefings.

    (a) Within 24 hours after the use of restraint or seclusion, staff 
involved in an emergency safety intervention and the resident must have 
a face-to-face discussion. This discussion must include all staff 
involved in the intervention except when the presence of a particular 
staff person may jeopardize the well-being of the resident. Other staff 
and the resident's parent(s) or legal guardian(s) may participate in 
the disussion when it is deemed appropriate by the facility. The 
facility must conduct such discussion in a language that is understood 
by the resident's parent(s) or legal guardian(s). The discussion must 
provide both the resident and staff the opportunity to discuss the 
circumstances resulting in the use of restraint or seclusion and 
strategies to be used by the staff, the resident, or others that could 
prevent the future use of restraint or seclusion.
    (b) Within 24 hours after the use of restraint or seclusion, all 
staff involved in the emergency safety intervention, and appropriate 
supervisory and administrative staff, must conduct a debriefing session 
that includes, at a minimum, a review and discussion of--
    (1) The emergency safety situation that required the intervention, 
including a discussion of the precipitating factors that led up to the 
intervention;
    (2) Alternative techniques that might have prevented the use of the 
restraint or seclusion;
    (3) The procedures, if any, that staff are to implement to prevent 
any recurrence of the use of restraint or seclusion; and
    (4) The outcome of the intervention, including any injuries that 
may have resulted from the use of restraint or seclusion.
    (c) Staff must document in the resident's record that both 
debriefing sessions took place and must include in that documentation 
the names of staff who were present for the debriefing, names of staff 
that were excused from the debriefing, and any changes to the 
resident's treatment plan that result from the debriefings.


Sec. 483.372  Medical treatment for injuries resulting from an 
emergency safety intervention.

    (a) Staff must immediately obtain medical treatment from qualified 
medical personnel for a resident injured as a result of an emergency 
safety intervention.
    (b) The psychiatric residential treatment facility must have 
affiliations or written transfer agreements in effect with one or more 
hospitals approved for participation under the Medicaid program that 
reasonably ensure that--
    (1) A resident will be transferred from the facility to a hospital 
and admitted in a timely manner when a transfer is medically necessary 
for medical care or acute psychiatric care;
    (2) Medical and other information needed for care of the resident 
in light of such a transfer, will be exchanged between the institutions 
in accordance with State medical privacy law, including any information 
needed to determine whether the appropriate care can be provided in a 
less restrictive setting; and
    (3) Services are available to each resident 24 hours a day, 7 days 
a week.
    (c) Staff must document in the resident's record, all injuries that 
occur as a result of an emergency safety intervention, including 
injuries to staff resulting from that intervention.
    (d) Staff involved in an emergency safety intervention that results 
in an injury to a resident or staff must meet with supervisory staff 
and evaluate the circumstances that caused the injury and develop a 
plan to prevent future injuries.


Sec. 483.374  Facility reporting.

    (a) Attestation of facility compliance. Each psychiatric 
residential treatment facility that provides inpatient psychiatric 
services to individuals under age 21 must attest, in writing, that the 
facility is in compliance with HCFA's standards governing the use of 
restraint and seclusion. This attestation must be signed by the 
facility director.
    (1) A facility with a current provider agreement with the Medicaid 
agency must provide its attestation to the State Medicaid agency by 
July 21, 2001.
    (2) A facility enrolling as a Medicaid provider must meet this 
requirement at the time it executes a provider agreement with the 
Medicaid agency.
    (b) Reporting of serious occurrences. The facility must report each 
serious occurrence to both the State Medicaid agency and, unless 
prohibited by State law, the State-designated Protection and Advocacy 
system. Serious occurrences that must be reported include a resident's 
death, a serious injury to a resident as defined in Sec. 483.352 of 
this part, and a resident's suicide attempt.
    (1) Staff must report any serious occurrence involving a resident 
to both the State Medicaid agency and the State-designated Protection 
and Advocacy system by no later than close of business the next 
business day after a serious occurrence. The report must include the 
name of the resident involved in the serious occurrence, a description 
of the occurrence, and the name, street address, and telephone number 
of the facility.
    (2) In the case of a minor, the facility must notify the resident's 
parent(s) or legal guardian(s) as soon as possible, and in no case 
later than 24 hours after the serious occurrence.
    (3) Staff must document in the resident's record that the serious 
occurrence was reported to both the State Medicaid agency and the 
State-designated Protection and Advocacy system, including the name of 
the person to whom the incident was reported. A copy of the report must 
be maintained in the resident's record, as

[[Page 7164]]

well as in the incident and accident report logs kept by the facility.


Sec. 483.376  Education and training.

    (a) The facility must require staff to have ongoing education, 
training, and demonstrated knowledge of--
    (1) Techniques to identify staff and resident behaviors, events, 
and environmental factors that may trigger emergency safety situations;
    (2) The use of nonphysical intervention skills, such as de-
escalation, mediation conflict resolution, active listening, and verbal 
and observational methods, to prevent emergency safety situations; and
    (3) The safe use of restraint and the safe use of seclusion, 
including the ability to recognize and respond to signs of physical 
distress in residents who are restrained or in seclusion.
    (b) Certification in the use of cardiopulmonary resuscitation, 
including periodic recertification, is required.
    (c) Individuals who are qualified by education, training, and 
experience must provide staff training.
    (d) Staff training must include training exercises in which staff 
members successfully demonstrate in practice the techniques they have 
learned for managing emergency safety situations.
    (e) Staff must be trained and demonstrate competency before 
participating in an emergency safety intervention.
    (f) Staff must demonstrate their competencies as specified in 
paragraph (a) of this section on a semiannual basis and their 
competencies as specified in paragraph (b) of this section on an annual 
basis.
    (g) The facility must document in the staff personnel records that 
the training and demonstration of competency were successfully 
completed. Documentation must include the date training was completed 
and the name of persons certifying the completion of training.
    (h) All training programs and materials used by the facility must 
be available for review by HCFA, the State Medicaid agency, and the 
State survey agency.

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical 
Assistance Program)

    Dated: December 21, 2000.
Robert A. Berenson,
Acting Deputy Administrator, Health Care Financing Administration.

    Dated: December 28, 2000.
Donna E. Shalala,
Secretary.
[FR Doc. 01-1649 Filed 1-19-01; 8:45 am]
BILLING CODE 4120-01-P