28110 Federal Register / Vol. 66, No. 99 / Tuesday, May 22, 2001 / Rules and Regulations

deletion areas of the California Gulch

Superfund Site remain eligible for

future Fund-financed response actions.

Furthermore, this partial deletion does

not alter the status of the other OUs of

the Site which are not being deleted and

remain on the NPL. EPA, with

concurrence from the State of Colorado,

has determined that all appropriate

CERCLA response actions have been

completed at OU 2 and protection of

human health and the environment has

been achieved in this area. Therefore,

EPA is deleting the Malta Gulch area of

the California Gulch Superfund Site

from the NPL. This action will be

effective July 23, 2001. However, if EPA

receives dissenting comments by June

21, 2001, EPA will publish a document

that withdraws this action.

List of Subjects in 40 CFR Part 300

Environmental protection, Air

pollution control, Chemicals, Hazardous

substances, Hazardous waste,

Intergovernmental relations, Penalties,

Reporting and recordkeeping

requirements, Superfund, Water

pollution control, Water supply.

Dated: February 12, 2001.

Jack W. McGraw,

Acting Regional Administrator, Region 8.

Part 300, Title 40 of Chapter 1 of the

Code of Federal Regulations is amended

as follows:

PART 300—[AMENDED]

1. The authority citation for part 300

continues to read as follows:

Authority: 42 U.S.C. 9601–9657; 33 U.S.C.

1321(c)(2); E.O. 12777, 56 FR 54757, 3 CFR,

1991 Comp.; p. 351, E.O. 12580, 52 FR 2923,

3 CFR 1987 Comp., p. 193.

[Amended]

2. Table 1 of appendix B to part 300

is amended by revising the entry for

‘‘California Gulch’’ so that it reads as

follows:

TABLE 1.—GENERAL SUPERFUND

SECTION

State Site name City/County Notes

****

CO California

Gulch.

Leadville ..... P

****

P = Sites with partial deletion(s).

[FR Doc. 01–12710 Filed 5–21–01; 8:45 am]

BILLING CODE 6560–50–P

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.

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

Federal Register / Vol. 66, No. 99 / Tuesday, May 22, 2001 / Rules and Regulations 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

§ 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 § 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 § 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

§ 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 § 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 § 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 § 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

28112 Federal Register / Vol. 66, No. 99 / Tuesday, May 22, 2001 / Rules and Regulations

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 § 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 § 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 § 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 § 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 § 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 § 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 § 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

Federal Register / Vol. 66, No. 99 / Tuesday, May 22, 2001 / Rules and Regulations 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 § 441.152.

The certification requirement of this

section is not new. The paperwork

burden is contained in the referenced

§ 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

28114 Federal Register / Vol. 66, No. 99 / Tuesday, May 22, 2001 / Rules and Regulations

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.

§ 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 § 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

§ 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.

Federal Register / Vol. 66, No. 99 / Tuesday, May 22, 2001 / Rules and Regulations 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 Statedesignated 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

§ 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 § 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 § 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

28116 Federal Register / Vol. 66, No. 99 / Tuesday, May 22, 2001 / Rules and Regulations

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 programshealth, 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 § 483.352, the definition of

‘‘Personal restraint’’ is revised to read as

follows:

§ 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.

§ 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.

* * * * *

Federal Register / Vol. 66, No. 99 / Tuesday, May 22, 2001 / Rules and Regulations 28117

4. Section 483.360 is amended by

revising the introductory text to read as

follows:

§ 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:

§ 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:

§ 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:

§ 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

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 64

[CC Docket Nos. 00–257 and 94–129; FCC

01–153]

2000 Biennial Review—Review of

Policies and Rules Concerning

Unauthorized Changes of Consumers

Long Distance Carriers

AGENCY: Federal Communications

Commission.

ACTION: Final rule.

SUMMARY: The streamlined procedures

the Commission adopts here will

replace the current, burdensome waiver

process. The Commission’s new

procedures provide for an acquiring

carrier to simply self-certify to the

Commission, in advance of the transfer,

that the carrier will follow the required

procedures. This will protect the

interests of the affected subscribers by

giving them adequate advance notice of

the carrier change and ensuring that the

change will not cause them financial

harm.

DATES: This document contains

information collection requirements that

have not been approved by the Office of

Management Budget (OMB). The

Commission will publish a document in

the Federal Register announcing the

effective date of this final rule.

FOR FURTHER INFORMATION CONTACT:

Michele Walters, Associate Division

Chief, or Dana Walton-Bradford,

Attorney, Common Carrier Bureau,

Accounting Policy Division, (202) 418–

7400.

SUPPLEMENTARY INFORMATION: This is a

summary of the Commission’s First

Report and Order in CC Docket No. 00–

257 and Fourth Report and Order in CC

Docket No. 94–129 released on May 15,

2001. The full text of this document is

available for public inspection during

regular business hours in the FCC

Reference Center, Room CY–A257, 445

Twelfth Street, SW., Washington, DC,

20554.

I. Introduction

1. As part of our biennial regulatory

review effort, we are amending our

carrier change rules to provide a

streamlined process for compliance

with section 258 of the Communications

Act of 1934 (Act), as amended by the

Telecommunications Act of 1996 (1996

Act) in situations involving the carrierto-carrier sale or transfer of subscriber

bases. The streamlined procedures we

adopt in this Order will replace the

current, more burdensome waiver

process. Our new procedures provide

for an acquiring carrier to simply selfcertify to the Commission, in advance of

the transfer, that the carrier will follow

the required procedures. This will

protect the interests of the affected

subscribers, consistent with section 258

and our rules, by giving them adequate

advance notice of the carrier change and

ensuring that the change will not cause

them financial harm.

2. The Commission adopted carrier

change authorization and verification

requirements to protect consumers from

fraudulent changes in presubscribed

carriers. It has become clear, however,

that the need to obtain a waiver of these

requirements imposes undue burdens

on carriers seeking to buy, sell, or

transfer customer accounts and on the

Commission that could be avoided

without sacrificing consumer

protection. These burdens include the

time and resources required to prepare

and process the waiver petition and any

supplemental filings, the regulatory

uncertainty inherent in any waiver

process, and, oftentimes, delay. Given

the dynamic marketplace, and the

likelihood that carriers will continue to

buy, sell, and transfer customer lines in

the future, we believe it is appropriate

to streamline our carrier change rules to

ensure that they do not inadvertently

inhibit routine business transactions,

while ensuring that consumers are

protected from fraudulent carrier

changes, consistent with section 258

and our rules.