[Federal Register Volume 66, Number 99 (Tuesday, May 22, 2001)]
[Rules and Regulations]
[Pages 28110-28117]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 01-13041]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

42 CFR Parts 441 and 483

[HCFA-2065-IFC2]
RIN 0938-AJ96


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

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

ACTION: Interim final rule; amendment and clarification with request 
for comment.

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SUMMARY: On January 22, 2001, we published an interim final rule with 
comment period (66 FR 7148) that established 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. The interim final rule established 
standards for the use of restraints or seclusion that psychiatric 
residential treatment facilities must have in place to protect the 
health and safety of residents.
    In response to some of the concerns submitted in comments on that 
interim rule, this document clarifies what facilities are subject to 
the requirements of the interim final rule, modifies reporting 
requirements to facilitate HCFA monitoring, and amends staffing 
requirements applicable to restraints and seclusion.
    Due to the operational significance of these issues, amendment to 
the interim final rule is required by the May 22, 2001 effective date 
of the interim final rule. Without such amendments, we are concerned 
that substantial numbers of facilities would not be able to comply with 
certain requirements of our interim final rule, and that beneficiaries 
will suffer needless displacement from those facilities. We are also 
concerned that HCFA will not be able to timely obtain data necessary to 
monitor for situations involving jeopardy to program beneficiaries. We 
will accept comments on these amendments, and will address all comments 
on the interim final rule and these amendments at a later date.

DATES: Effective date: May 22, 2001.
    Comment date: Comments concerning these amendments to the interim 
final rule will be considered if we receive them at the appropriate 
address, as provided below, no later than 5 p.m. on July 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-IFC2, 
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-IFC2.
    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

    On January 22, 2001, we published an interim final rule with 
comment period (66 FR 7148) that defined a ``psychiatric residential 
treatment facility'' that is not a hospital and that may furnish 
covered Medicaid inpatient psychiatric services for individuals under 
age 21. The interim final rule established standards for the use of 
restraints or seclusion in psychiatric residential treatment facilities 
to protect the health and safety of residents.
    Section 3207 of the Children's Health Act of 2000 (Pub. L. 106-310) 
requires that health care facilities receiving support in any form from 
any program supported in whole or part with funds appropriated to any 
Federal department or agency shall protect and promote the

[[Page 28111]]

rights of each resident of a facility, including the right to be free 
from any restraint or involuntary seclusion imposed for purposes of 
discipline or convenience. This Act permits the Secretary to issue 
regulations that afford residents greater protections regarding 
restraint and seclusion than the standards published in the new law. 
Our interim final rule provides greater protections than those required 
in section 3207.

II. Clarification of Applicability of the Rule

    This document clarifies the facilities that are subject to the 
requirements of the January 22, 2001 interim final rule. It became 
apparent from the number of comments we received to the interim final 
rule that many facilities are unclear whether or not they are subject 
to the requirements of the interim final.
    The interim final rule applies to psychiatric residential treatment 
facilities that receive payment for providing the Medicaid inpatient 
psychiatric services benefit for individuals under age 21. The Medicaid 
inpatient psychiatric services benefit for individuals under age 21 may 
be provided in a psychiatric hospital (that meets the applicable 
hospital conditions of participation set forth in 42 CFR part 482) or 
in ``another inpatient setting that the Secretary has specified in 
regulations'' pursuant to section 1905(h) of the Social Security Act. 
As set forth in the interim final rule, psychiatric residential 
treatment facilities are facilities that are not licensed as hospitals 
but meet the requirements in 42 CFR part 441 subpart D, the 
requirements of 42 CFR part 483, subpart G, and have a provider 
agreement with the state Medicaid agency.
    A psychiatric residential treatment facility's payment for 
inpatient psychiatric services to individuals under age 21 includes 
compensation for the resident's room and board as well as a 
comprehensive package of services. This rule does not apply to other 
providers that receive Medicaid compensation on a service-by-service 
basis and do not receive Medicaid payment for the individual's room and 
board. An example would be a facility receiving Medicaid payment for 
outpatient rehabilitation services.
    If a facility is uncertain whether or not this rule applies, it 
should contact the state Medicaid agency for further information 
regarding the applicability of this regulation.
    Additionally, we have received numerous inquiries regarding the 
attestation date contained in Sec. 483.374(a)(1). This document does 
not change the requirement that facilities with a current provider 
agreement must provide its attestation to the State Medicaid agency by 
July 21, 2001.

III. Amendments to the Interim Final Rule

    This document also makes amendments to sections of the rule 
relating to orders for the use of restraint and seclusion; consultation 
with the resident's treatment team physician; monitoring of the 
resident in seclusion or restraint; and facility reporting 
requirements. The changes being made are in response to the serious and 
immediate concerns raised by comments submitted on the interim final 
rule. These comments described the severe shortage of registered nurses 
as well as the unavailability of psychiatrists as the two major reasons 
why facilities would not be able to comply with the requirements of our 
interim final rule. They stated that the shortage of these personnel is 
a national problem. Although we considered the ordinary costs of 
additional personnel in additional staffing in issuing the interim 
final rule, we did not take into account the lack of availability of 
sufficient numbers of trained individuals to meet those staffing needs. 
We agree that the scope of the shortage of professionals to provide 
services in psychiatric residential treatment facilities is critical. 
As a result, we are concerned that substantial numbers of facilities 
will be unable to meet the conditions of participation to participate 
in the Medicaid program and that beneficiaries will be left without 
adequate placements. Therefore, we have reviewed the requirements in 
the interim final rule and are amending the rule to permit staffing 
alternatives that ensure sufficient beneficiary protection but are less 
burdensome for facilities.
    This document also amends our definition of ``personal restraint'' 
to clarify that briefly holding without undue force a resident for the 
purpose of comforting him or her, or holding a resident's hand or arm 
to safely escort him or her from one area to another is not a 
restraint. Many commenters stated that our definition is so broad that 
staff would be prohibited from comforting an upset resident, or holding 
a resident's hand to safely escort him or her across a street. This was 
not our intention, and we are concerned that this reading could prevent 
facilities from participating in the Medicaid program, and result in 
needless displacement of Medicaid beneficiaries.
    This document also amends our requirements for facility reporting 
of serious occurrences. We are adding the requirement that a facility 
must report the death of any resident to the Health Care Financing 
Administration (HCFA) regional office. This change is required to 
ensure that HCFA has sufficient timely information to identify threats 
to beneficiary health and welfare.
    The specific changes made in this document are as follows:

Section 483.352  Definitions

    In Sec. 483.352, we are amending the definition of ``personal 
restraint'' by adding a clarifying statement that ``personal 
restraint'' does not include briefly holding without undue force a 
resident in order to calm or comfort him or her, or holding a 
resident's hand to safely escort him or her from one area to another.

Section 483.358  Orders for the Use of Restraint or Seclusion

    We are amending Sec. 483.358(a) to state that orders for restraint 
or seclusion must be by a physician, or other licensed practitioner 
permitted by the state and the facility to order restraint or seclusion 
and trained in the use of emergency safety interventions. We have 
included ``other licensed practitioner permitted by the state and the 
facility to order restraint or seclusion'' to be consistent with the 
language in the Children's Health Act of 2000. As with all staff, other 
licensed practitioners permitted by the state and the facility to order 
restraint or seclusion and trained in the use of restraints and 
seclusion as set out in Sec. 483.376. Section 441.151 also requires 
that inpatient psychiatric services for recipients under age 21 be 
furnished under the direction of a physician.
    We are amending Sec. 483.358(b) to state that if the resident's 
treatment team physician is available, only he or she can order 
restraint or seclusion.
    We are amending Sec. 483.358(c) to state that a physician or other 
licensed practitioner permitted by the state and the facility to order 
restraint or seclusion 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.
    We are amending Sec. 483.358(d) to state that if the order for 
restraint or seclusion is verbal, the verbal order must be received by 
a registered nurse or other licensed staff, such as a licensed 
practical nurse. The physician or other licensed practitioner permitted 
by the state and the facility to order restraint or seclusion must 
verify the verbal order in a signed written form in the resident's 
record. The physician or other licensed

[[Page 28112]]

practitioner permitted by the state and the facility to order restraint 
or seclusion must be available to staff for consultation, at least by 
telephone, throughout the period of the emergency safety intervention.
    We are amending Sec. 483.358(f) to state that a physician or 
``other licensed practitioner trained in the use of emergency safety 
interventions, and permitted by the state and the facility to assess 
the physical and psychological well being of residents'' must conduct a 
face-to-face assessment of the physical and psychological well being of 
the resident within 1 hour of the initiation of the emergency safety 
intervention.
    We are amending paragraphs (g)(1) and (g)(3) and (j) to include 
``other licensed practitioner permitted by the state and the facility 
to order restraint or seclusion''.

Section 483.360  Consultation With Treatment Team Physician

    We are amending Sec. 483.360 to state that if a physician or other 
licensed practitioner permitted by the state and the facility to order 
restraint or seclusion orders the use of restraint or seclusion, the 
resident's treatment team physician must be contacted, unless the 
ordering physician is in fact the resident's treatment team physician.

Section 483.362  Monitoring of the Resident In and Immediately After 
Restraint

    We are amending Sec. 483.362(b) to state that if the emergency 
safety situation continues beyond the time limit of the order for the 
use of restraint, a registered nurse or other licensed staff, such as a 
licensed practical nurse, must immediately contact the ordering 
physician or other licensed practitioner permitted by the state and the 
facility to order restraint or seclusion to receive further 
instructions.
    We are amending Sec. 483.362(c) to state that a physician, or other 
licensed practitioner permitted by the state and the facility to 
evaluate the resident's well-being and trained in the use of emergency 
safety interventions, must evaluate the resident's well-being 
immediately after the restraint is removed.

Section 483.364  Monitoring of the Resident in and Immediately After 
Seclusion

    We are amending Sec. 483.364(c) to state that if the emergency 
safety situation continues beyond the time limit of the order for the 
use of seclusion, a registered nurse or other licensed staff, such as a 
licensed practical nurse, must immediately contact the ordering 
physician or other licensed practitioner permitted by the state and the 
facility to order restraint or seclusion to receive further 
instructions.
    We are amending Sec. 483.364(d) to state that a physician, or other 
licensed practitioner permitted by the state and the facility to 
evaluate the resident's well-being and trained in the use of emergency 
safety interventions, must evaluate the resident's well-being 
immediately after the resident is removed from seclusion.

Section 483.374  Facility Reporting

    We are amending Sec. 483.374 by adding a new paragraph (c) to 
require that facilities report the death of any resident to the Health 
Care Financing Administration (HCFA) regional office.

IV. Response to Comments on This Interim Final Rule

    We will be accepting comments concerning the amendments to the 
interim final rule contained in this document.
    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 and Waiver of the 30-Day Delay in 
the Effective Date

    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.
    In November 1994, we issued a proposed rule that contained 
limitations on the use of restraints and seclusion by psychiatric 
residential treatment facilities. The interim final rule clarified and 
further developed these proposed limitations. To the extent that the 
interim final rule could not be viewed as a logical outgrowth of the 
1994 proposed rule, we found good cause to waive requirements for 
proposed rulemaking. The APA permits waiver of these requirements if 
the agency finds good cause that 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 found good cause based on the strong public interest in 
preventing deaths and injuries to children that are the result of 
inappropriate use of restraint and seclusion in psychiatric residential 
treatment facilities. The full rationale for this finding was set forth 
in the preamble to the January 22, 2001 interim final rule.
    Because we believe that the amendments and clarifications set forth 
in this document are essential to the effective implementation of the 
basic requirements of the January 22, 2001 interim final rule, the same 
concerns expressed in our waiver of proposed rulemaking for that rule 
apply here. In addition, without the amendments and clarifications set 
forth in this document, we believe there is a risk that beneficiaries 
will be needlessly displaced as substantial numbers of facilities 
terminate participation in the Medicaid program as psychiatric 
residential treatment facilities. In particular, absent clarification 
of the term ``personal restraint,'' facilities could be terminated for 
failure to meet conditions of participation for actions that do not 
warrant concern. Absent changes to staffing requirements, nationwide 
nurse and psychiatrist shortages could mean that numerous facilities 
would become unable to meet the conditions of participation. The 
amendments contained in this document will provide adequate beneficiary 
protections in a less burdensome manner and will minimize potential 
beneficary displacement. In addition, the changes in this document to 
include HCFA in reporting requirements are necessary to ensure that 
HCFA has timely information to monitor jeopardy to program 
beneficiaries.
    In sum, we find good cause to waive asking for comment on these 
amendments to the January rule before making them effective, based on 
the public interest of avoiding displacement and other potential harm 
to program beneficiaries. We invite parties to submit comments on these 
changes, which we will consider in crafting the final rule that applies 
to these psychiatric residential treatment facilities.
    In addition, we find good cause to waive requirements for a 30 day 
delay in the effective date of these clarifications and amendments to 
the interim final rule. Under the APA, publication of a substantive 
rule must

[[Page 28113]]

be not less than 30 days before its effective date, unless otherwise 
provided by the agency for good cause found and published with the 
rule. These clarifications and amendments are an integral operational 
part of the overall interim final rule. A delay in the effective date 
for these clarifications and amendments would be contrary to public 
interest because a delay would result in inconsistent standards for 
affected facilities over a relatively short time period. Moreover, 
there would be some possibility of disruption of services to program 
beneficiaries to the extent that facilities elect not to continue 
participation in the Medicaid program until the amendments and 
clarifications become effective. Moreover, a delay in the effective 
date would be impracticable to administer because facility guidance, 
quality monitoring and surveyor training are not designed to 
accommodate rapid changes in applicable standards. In sum, we find that 
a 30 day delay in the effective date would be both impracticable and 
contrary to the public interest because the delay would not be 
administratively feasible and would risk inconsistent facility 
standards and potential disruption of services to beneficiaries.

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.
    The information collection requirements in the interim rule 
published in the Federal Register on January 22, 2001, as well as the 
amendments made in this regulation have been approved by OMB through 
November 30, 2001 under OMB control number 0938-0833. We solicited 
comments on these requirements in the January 22, 2001 interim final 
rule, and have made minimal changes to the requirements in this rule. 
We are again soliciting public comment on each of these issues for the 
sections that contain information collection requirements. Comments 
will be considered in evaluating these information collection 
requirements under the Paperwork Reduction Act.
    The following is a summary of the information collection 
requirements contained in both the January 22 interim rule and in this 
amendment to the interim rule.

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 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 or 
other licensed practitioner's verbal order must be obtained by a 
registered nurse or other licensed staff, such as a licensed practical 
nurse, while the emergency safety intervention is being initiated by 
staff, or immediately after the emergency safety situation ends. The 
verbal order must be followed with the physician's or other licensed 
practitioner's signature verifying the verbal order.
    This document changes the January 22 interim rule to allow a 
registered nurse or other licensed staff such as a licensed practical 
nurse to obtain a verbal order from a physician or ``other licensed 
practitioner permitted by the state and the facility to order restraint 
or seclusion'', and requires the physician or the other licensed 
practitioner permitted by the state and the facility to order restraint 
or seclusion that gave the verbal order to verify, by signature, that 
he or she gave the 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 (g) of this section, each order for 
restraint or seclusion must be documented in the resident's record. 
Documentation must include--
    (1) The name of the physician or other licensed practitioner 
permitted by the

[[Page 28114]]

state and the facility to order restraint or seclusion;
    (2) The date and time the order was obtained;
    (3) The emergency safety intervention ordered, including the length 
of time for which the physician or other licensed physician permitted 
by the state and the facility to authorize 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 or 
other licensed practitioner permitted by the state and the facility to 
order 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.
    The revision to this paragraph requires an ``other licensed 
practitioner permitted by the state and the facility to order restraint 
or seclusion'' to sign orders he or she has given. This does not 
increase the facility's burden, since only one person is still signing.
    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

    This section requires that, if a physician or other licensed 
practitioner permitted by the state and the facility to order restraint 
or seclusion orders the use of restraint or seclusion and he or she is 
not the resident's treatment team physician, then the ordering 
physician or other licensed practitioner permitted by the state and the 
facility to order restraint or seclusion 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 and document the time 
the team physician was consulted.
    Paragraph (b) of this section requires the facility to document in 
the resident's record the date and time the team physician was 
consulted.
    The amendments to the January 22 interim rule, made by this 
document, require an ``other licensed practitioner permitted by the 
state and the facility to order restraint or seclusion'' to follow the 
same procedures as a physician. This change does not change the burden 
from that stated in the original interim rule. In that rule, we stated 
that 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 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.

[[Page 28115]]

    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.
    In this document, we have added an amendment to Sec. 483.374 by 
adding a new paragraph (c) to require that the facility report the 
death of any resident to the HCFA regional office. 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.
    We estimate that these notifications will take a total of 15 
minutes. This will total an estimated 141 hours per year per facility 
and 70,500 nationally, for the estimated 282,000 incidents per year.

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.
    The total information collection requirements associated with this 
regulation will total an estimated 877,750 hours.

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) (Pub. 
L. 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 practices that could contribute to 
death or serious injury.

B. Anticipated Effects

Effect on Psychiatric Residential Treatment Facilities
    We still maintain that some facilities will need additional staff 
as a result of the previous interim final rule. The January 22 interim 
final rule estimated this burden based on the requirement for only 
registered nurses. This rule does not eliminate that requirement but 
permits facilities to fullfill this

[[Page 28116]]

requirement by allowing other licensed practitioners in lieu of 
registered nurses.
    As stated in our impact statement of January 22, 2001, 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 or other licensed practitioner permitted by the State 
and the facility. We believe it is appropriate to extend the same level 
of protections to children and adolescents in these facilities that are 
provided to them in a hospital.
    We are adding a requirement for facilities to report the death of 
any resident to the HCFA regional office. We are soliciting comments 
only on this additional HCFA reporting requirement. We believe this 
additional reporting requirement will have a minimal financial impact 
on facilities.

C. Summary of Estimated Costs

Psychiatric Residential Treatment Costs
    Because of our modification of the rule concerning the use of 
registered nurses, we have revised this section of the impact statement 
concerning new staff costs. We recognize that some facilities will need 
to hire either additional registered nurses or other licensed 
practitioners permitted by the State and the facility to meet the 
requirement for 24-hour per day coverage in these facilities. As a 
result of our modification of the rule, each facility would have to 
provide for one additional FTE registered nurse or other licensed 
practitioner permitted by the state and the facility. We did not change 
the overall estimated numbers of additional FTEs to provide the 
necessary coverage in all facilities. Our earlier impact analysis can 
be found in the January, 22, 2001 interim final rule.

D. Alternatives Considered

    The changes made in this document are being made after further 
consideration of alternatives discussed in the January 22, 2001 interim 
final rule.

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 entities.
    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, as 
amended at 66 FR 7148 (January 22, 2001) and 66 FR 15800 (March 21, 
2001) is further amended as follows:

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

    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. In Sec. 483.352, the definition of ``Personal restraint'' is 
revised to read as follows:


Sec. 483.352  Definitions.

* * * * *
    Personal restraint means the application of physical force without 
the use of any device, for the purposes of restraining the free 
movement of a resident's body. The term personal restraint does not 
include briefly holding without undue force a resident in order to calm 
or comfort him or her, or holding a resident's hand to safely escort a 
resident from one area to another.
* * * * *
    3. Section 483.358 is amended by:
    A. Revising paragraphs (a), (c), and (d), (f) introductory text, 
(g)(1), (g)(3) and (j)
    B. Amending paragraph (b) by removing the last two sentences.


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

    (a) Orders for restraint or seclusion must be by a physician, or 
other licensed practitioner permitted by the State and the facility to 
order restraint or seclusion and trained in the use of emergency safety 
interventions. Federal regulations at 42 CFR 441.151 require that 
inpatient psychiatric services for recipients under age 21 be provided 
under the direction of a physician.
* * * * *
    (c) A physician or other licensed practitioner permitted by the 
state and the facility to order restraint or seclusion 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 order for restraint or seclusion is verbal, the verbal 
order must be received by a registered nurse or other licensed staff 
such as a licensed practical nurse, while the emergency safety 
intervention is being initiated by staff or immediately after the 
emergency safety situation ends. The physician or other licensed 
practitioner permitted by the state and the facility to order restraint 
or seclusion must verify the verbal order in a signed written form in 
the resident's record. The physician or other licensed practitioner 
permitted by the state and the facility to order restraint or seclusion 
must be available to staff for consultation, at least by telephone, 
throughout the period of the emergency safety intervention.
* * * * *
    (f) Within 1 hour of the initiation of the emergency safety 
intervention a physician, or other licensed practitioner trained in the 
use of emergency safety interventions and permitted by the state and 
the facility to assess the physical and psychological well being of 
residents, must conduct a face-to-face assessment of the physical and 
psychological well being of the resident, including but not limited 
to--
* * * * *
    (g) * * *
    (1) The name of the ordering physician or other licensed 
practitioner permitted by the state and the facility to order restraint 
or seclusion;
* * * * *
    (3) The emergency safety intervention ordered, including the length 
of time for which the physician or other licensed practitioner 
permitted by the state and the facility to order restraint or seclusion 
authorized its use.
* * * * *
    (j) The physician or other licensed practitioner permitted by the 
state and the facility to order restraint or seclusion must sign the 
restraint or seclusion order in the resident's record as soon as 
possible.
* * * * *

[[Page 28117]]

    4. Section 483.360 is amended by revising the introductory text to 
read as follows:


Sec. 483.360  Consultation with treatment team physician.

    If a physician or other licensed practitioner permitted by the 
state and the facility to order restraint or seclusion orders the use 
of restraint or seclusion, that person must contact the resident's 
treatment team physician, unless the ordering physician is in fact the 
resident's treatment team physician. The person ordering the use of 
restraint or seclusion must--
* * * * *
    5. Section 483.362 is amended by revising paragraphs (b) and (c) to 
read as follows:


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

* * * * *
    (b) If the emergency safety situation continues beyond the time 
limit of the order for the use of restraint, a registered nurse or 
other licensed staff, such as a licensed practical nurse, must 
immediately contact the ordering physician or other licensed 
practitioner permitted by the state and the facility to order restraint 
or seclusion to receive further instructions.
    (c) A physician, or other licensed practitioner permitted by the 
state and the facility to evaluate the resident's well-being and 
trained in the use of emergency safety interventions, must evaluate the 
resident's well-being immediately after the restraint is removed.
    6. Amending section 483.364 by revising paragraphs (c) and (d) to 
read as follows:


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

* * * * *
    (c) If the emergency safety situation continues beyond the time 
limit of the order for the use of seclusion, a registered nurse or 
other licensed staff, such as a licensed practical nurse, must 
immediately contact the ordering physician or other licensed 
practitioner permitted by the state and the facility to order restraint 
or seclusion to receive further instructions.
    (d) A physician, or other licensed practitioner permitted by the 
state and the facility to evaluate the resident's well-being and 
trained in the use of emergency safety interventions, must evaluate the 
resident's well-being immediately after the resident is removed from 
seclusion.
    7. Section 483.374 is amended by adding paragraph (c) to read as 
follows:


Sec. 483.374  Facility reporting.

* * * * *
    (c) Reporting of deaths. In addition to the reporting requirements 
contained in paragraph (b) of this section, facilities must report the 
death of any resident to the Health Care Financing Administration 
(HCFA) regional office.
    (1) Staff must report the death of any resident to the HCFA 
regional office by no later than close of business the next business 
day after the resident's death.
    (2) Staff must document in the resident's record that the death was 
reported to the HCFA regional office.

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical 
Assistance Program)
    Dated: May 17, 2001.
Michael McMullan,
Acting Deputy Administrator, Health Care Financing Administration.

    Dated: May 17, 2001.
Tommy G. Thompson,
Secretary.
[FR Doc. 01-13041 Filed 5-21-01; 8:45 am]
BILLING CODE 4120-01-P