[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