[Federal Register Volume 71, Number 236 (Friday, December 8, 2006)]
[Rules and Regulations]
[Pages 71378-71428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-9559]



[[Page 71377]]

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Part IV





Department of Health and Human Services





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Centers for Medicare & Medicaid Services



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42 CFR Part 482



Medicare and Medicaid Programs; Hospital Conditions of Participation: 
Patients' Rights; Final Rule

Federal Register / Vol. 71, No. 236 / Friday, December 8, 2006 / 
Rules and Regulations

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 482

[CMS-3018-F]
RIN 0938-AN30


Medicare and Medicaid Programs; Hospital Conditions of 
Participation: Patients' Rights

AGENCY: Centers for Medicare & Medicaid Services (CMS), DHHS.

ACTION: Final rule.

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SUMMARY: This final rule finalizes the Patients' Rights Condition of 
Participation (CoP) which is applicable to all Medicare- and Medicaid-
participating hospitals and contains standards that ensure minimum 
protections of each patient's physical and emotional health and safety. 
It responds to comments on the following standards presented in the 
July 2, 1999 interim final rule: Notice of rights; exercise of rights; 
privacy and safety; confidentiality of patient records; restraint for 
acute medical and surgical care; and seclusion and restraints for 
behavior management. As a result of comments received, we have revised 
the standards regarding restraint and seclusion and set forth standards 
regarding staff training and death reporting.

DATES: Effective Date: These regulations are effective on January 8, 
2007.

FOR FURTHER INFORMATION CONTACT: Patricia Chmielewski, RN, MS (410) 
786-6899, Janice Graham, RN, MS (410) 786-8020, Monique Howard, OTR/L 
(410) 786-3869, Jeannie Miller, RN, MPH (410) 786-3164, Rachael 
Weinstein, RN, MPA (410) 786-6775.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
    A. Overview
    B. Key Statutory Provisions
    C. Regulatory Background
    D. Requirements for Issuance of Regulations
    E. Restraint and Seclusion in Other Settings
II. Provisions of the Proposed and Interim Final Rules Regarding 
Patients' Rights
III. Comments on and Responses to the Provisions of the Interim 
Final Rule With Comment Period
    A. General Comments on the Requirements for Use of Restraint and 
Seclusion
    1. Is There Cause for Concern?
    2. The Difference Between Standards (e) and (f)
    3. The Roles of CMS and JCAHO
    4. Applicability of the Patients' Rights CoP
    5. Debriefing After the Use of Restraint/Seclusion
    B. Comments Received on Specific Provisions
    1. The Right to Be Free From Restraint (Sec. Sec.  482.13(e)(1) 
and (f)(1))
    2. Definition of ``Restraint'' and ``Physical Restraint'' 
(Sec. Sec.  482.13(e)(1) and (f)(1))
    3. Definition of a ``Drug Used as a Restraint'' (Sec. Sec.  
482.13(e)(1) and (f)(1))
    4. Use of Restraints (Sec. Sec.  482.13(e)(2) and (e)(3)(i))
    5. Ordering of Restraint/Seclusion (Sec. Sec.  482.13(e)(3)(ii) 
and (f)(3)(ii))
    a. Definition of Licensed Independent Practitioner (LIP) 
(Sec. Sec.  482.13(e)(3)(ii) and (f)(3)(ii))
    b. Physician Only
    c. Elimination of Protocols
    d. Initiate versus Order
    6. Prohibition on Standing and PRN Orders (Sec. Sec.  
482.13(e)(3)(ii)(A) and (f)(3)(ii)(A))
    7. Consultation with the Treating Physician (Sec. Sec.  
482.13(e)(3)(ii)(B) and (f)(3)(ii)(B))
    8. Written Modification of the Plan of Care (Sec. Sec.  
482.13(e)(3)(iii) and (f)(3)(iii))
    9. Implementation of and Appropriate Use of Restraint/Seclusion 
(Sec. Sec.  482.13(e)(3)(iv), (e)(3)(v), (f)(3)(iv), and (f)(3)(v))
    10. Discontinuing the Use of Restraint/Seclusion (Sec. Sec.  
482.13(e)(3)(vi) and(f)(3)(vi))
    11. Assessment, Monitoring, and Evaluation of the Restrained/
Secluded Patient (Sec. Sec.  482.13(e)(4) and (f)(5))
    12. Staff Training in the Use of Restraints/Seclusion 
(Sec. Sec.  482.13(e)(5) and (f)(6))
    13. Definition of Seclusion (Sec.  482.13(f)(1))
    14. Use of Restraint/Seclusion for Behavior Management (Sec.  
482.13(f)(2))
    15. One Hour Rule (Sec.  482.13(f)(3)(ii)(C))
    a. Comments Objecting to a Physician or LIP Seeing the Patient 
Within 1 Hour
    b. Comments Supporting Telephone Consultation with a Nurse 
Onsite Performing the Patient Assessment
    c. Comments Opposing Telephone Orders, Nurse Evaluation, and LIP 
Involvement
    d. Comments Stating that the 1-Hour Rule Did Not Address the 
Problem
    16. Limits for Restraint/Seclusion Orders (Sec.  
482.13(f)(3)(ii)(D))
    17. Simultaneous Use of Restraint and Seclusion (Sec.  
482.13(f)(4))
    18. The Use of Video and Audio Monitoring
    19. Reporting of Death(s) Related to Restraint/Seclusion (Sec.  
482.13(f)(7))
IV. Provisions of the Final Rule
V. Collection of Information Requirements
VI. Regulatory Impact Analysis
    A. Overall Impact
    B. Anticipated Effects
    1. Effects on Providers
    a. Section 482.13(e) Standard: Restraint or Seclusion
    b. Section 482.13(f) Standard: Restraint or Seclusion: Staff 
Training Requirements
    c. Section 482.13(g) Standard: Death Reporting Requirements
    2. Effect on Beneficiaries
    3. Effect on the Medicare and Medicaid Programs
    C. Alternatives Considered

Regulations Text

I. Background

A. Overview

    This rule set forth final requirements for Patients' Rights in 
hospitals, provides strong patient protections, provides flexibility to 
providers, and is responsive to comments. This regulation focuses on 
patient safety and the protection of patients from abuse. These 
standards support and protect patients' rights in the hospital setting; 
specifically, the right to be free from the inappropriate use of 
restraint and seclusion with requirements that protect the patient when 
use of either intervention is necessary. It recognizes the legitimate 
use of restraint for acute medical and surgical care as a measure to 
prevent patient injury, as well as the use of restraint or seclusion to 
manage violent or self-destructive behavior that jeopardizes the 
immediate physical safety of the patient, a staff member, or others. In 
addition, this rule finalizes, without modification, the standards for 
Notice of Rights, Exercise of Rights, Privacy and Safety, and 
Confidentiality of Patient Records.

B. Key Statutory Provisions

    Sections 1861(e) (1) through (8) of the Social Security Act (the 
Act) define the term ``hospital'' and list the requirements that a 
hospital must meet to be eligible for Medicare participation. Section 
1861(e)(9) of the Act specifies that a hospital must also meet such 
other requirements as the Secretary finds necessary in the interest of 
the health and safety of the hospital's patients. Under this authority, 
the Secretary has established in regulations at 42 CFR part 482 the 
requirements that a hospital must meet to participate in the Medicare 
program.
    Section 1905(a) of the Act provides that Medicaid payments may be 
applied to hospital services. Regulations at Sec.  440.10(a)(3)(iii) 
require hospitals to meet the Medicare CoPs to qualify for 
participation in Medicaid.
    The Children's Health Act of 2000 (CHA) (Pub. L. 106-310) was 
enacted October 17, 2000. Section 3207 of the CHA amended Title V of 
the Public Health Service Act (PHSA) by adding a new part H, which 
contains requirements relating to the rights of residents of certain 
facilities. Specifically, section 591 of the PHS Act, as added by the 
CHA (42 U.S.C. 290ii), establishes certain minimum requirements with 
regard to the use of restraint and seclusion in facilities that receive 
support in any form from any program supported in whole or in part

[[Page 71379]]

with funds appropriated to any Federal department or agency. In 
addition, Sections 592 and 593 of the PHS Act (42 U.S.C. 290ii and 
290ii-3) establish minimum mandatory death reporting and staff training 
requirements. This final rule conforms to the requirements of the CHA.
    As implementing regulations are issued, a critical point for 
consideration is that Title V, part H of the PHS Act is not an isolated 
enactment, but part of a trend of legislation and regulations aimed at 
protecting and promoting resident, patient, and client rights. Part H, 
section 591(c) of the PHS Act states ``This part shall not be construed 
to affect or impede any Federal or State law or regulations that 
provide greater protections than this part regarding seclusion and 
restraint.'' The value of preserving existing law and regulations is 
recognized while extending protections to those facilities that are 
currently without the protection intended by the Congress.

C. Regulatory Background

    In the December 19, 1997 Federal Register (62 FR 66726), we 
published a proposed rule entitled ``Medicare and Medicaid Programs; 
Hospital Conditions of Participation; Provider Agreements and Supplier 
Approval'' to revise the entire set of CoPs for hospitals found at 42 
CFR part 482. This proposed rule included a CoP for patients' rights. 
In the July 2, 1999 Federal Register (64 FR 36070), we published the 
Patients' Rights CoP as an interim final rule with comment. This CoP 
was separated from the other proposed hospital CoPs in response to 
Congressional and public interest. Although we have modified some of 
the provisions to address public comments, these modifications do not 
lessen protections afforded patients who are restricted or secluded. We 
note that we have revised the regulation to expand training 
requirements and have added a requirement that the attending physician 
or other licensed independent practitioner (LIP) responsible for the 
care of the patient be consulted as soon as possible when the ``one 
hour'' evaluation of a patient in restraint or seclusion is conducted 
by a trained registered nurse (RN) or physician assistant (PA).

D. Requirements for Issuance of Regulations

    Section 902 of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (MMA) amended section 1871(a) of the Act and 
requires the Secretary, in consultation with the Director of the Office 
of Management and Budget, to establish and publish timelines for the 
publication of Medicare final regulations based on the previous 
publication of a Medicare proposed or interim final regulation. Section 
902 of the MMA also states that the timelines for these regulations may 
vary but shall not exceed 3 years after publication of the preceding 
proposed or interim final regulation except under exceptional 
circumstances. In a notice published December 30, 2004 (69 FR 78442), 
we implemented section 902 of the Act by announcing that all 
outstanding interim final rules as of December 8, 2003 would be 
finalized by December 8, 2006 or expire.
    This final rule finalizes provisions set forth in the July 2, 1999 
interim final rule with comment. In accordance with section 902 and our 
notice of 2004, this final rule is being published within 3 years of 
the date of enactment of the MMA, which was December 8, 2003, in order 
to finalize the 1999 interim final rule with comment.

E. Restraint and Seclusion in Other Settings

    In the preamble of the July 2, 1999 interim final rule with comment 
period, we explained that we were considering the advisability of 
adopting a consistent restraint and seclusion standard that would apply 
not only to hospitals but to other kinds of health care entities with 
which CMS has provider agreements, including those that provide 
inpatient psychiatric services for individuals under 21 years of age (a 
program under Medicaid). We asked the public whether we should adopt 
the same standards that appeared in the July 2, 1999 interim final rule 
with comment period, or whether we should adopt more stringent 
standards.
    Consumer advocacy groups that commented on extending these 
requirements to other settings generally argued for more stringent 
expectations for the care of children, citing special hazards and 
concerns that arise when children and adolescents are restrained. Some 
commenters encouraged CMS to apply the restraints and seclusion 
standards of the interim final rule with comment period to all other 
Medicaid-funded facilities, particularly residential treatment centers 
for children and adolescents.
    Other commenters did not agree with this approach, arguing that the 
fields of mental health and developmental disabilities are very 
different and that similarities between the two should not be assumed. 
For example, some commenters stated that little research exists on the 
use of restraint/seclusion in mental health, but that in contrast, a 
considerable amount of research in the developmental disabilities field 
supports the effectiveness of restraint and seclusion for severe 
behavior problems. Thus, the field of developmental disabilities 
already has extensive guidelines, standards, and rules governing the 
use of restraint and seclusion.
    Some of those commenters who supported uniform restraint and 
seclusion standards across settings offered detailed suggestions for 
what those standards should require. For example, commenters suggested 
that the regulation forbid the use of mechanical restraints for 
children under a certain age (these commenters offered varying 
suggestions regarding the threshold age (17 and 21 years of age were 
two of these suggestions)), or permit therapeutic holding for periods 
no longer than 15 minutes. Some of the commenters expressed concern 
about proposing requirements that paralleled existing requirements for 
hospitals because of the differences in patient acuity and 
characteristics and treatment.
    We considered the comments we received in developing specific 
restraint and seclusion requirements for inpatient psychiatric services 
for individuals under 21 years of age. These requirements were 
published in an interim final rule with comment period entitled, 
``Medicaid Program; Use of Restraint and Seclusion in Psychiatric 
Residential Treatment Facilities Providing Services to Individuals 
under Age 21'' in the January 22, 2001 Federal Register (66 FR 7148). 
In the May 22, 2001 Federal Register (66 FR 28110), we published an 
additional interim final rule with comment period to amend and further 
clarify the January 22, 2001 interim final rule with comment period.
    There was little comment on extending restraint and seclusion 
requirements to specific non-behavioral or non-psychiatric types of 
settings or providers, such as home health agencies, ambulatory 
surgical centers, or providers of x-ray services. While a few 
commenters gave blanket support to this idea, they did not supply a 
rationale for applying one set of standards versus another. Several 
commenters discussed their concern about extending the restraint and 
seclusion requirements to the nursing home setting and strongly 
disagreed with any adoption of the standards presented in the interim 
final rule with comment period in that setting. One nursing home 
industry association argued for consistency in terminology and 
philosophy, but recognized that the settings where beneficiaries 
receive services are diverse, as are the beneficiaries

[[Page 71380]]

themselves, and that adopting a blanket approach might not be practical 
or appropriate.
    After considering these comments and engaging in internal 
deliberations, we have decided that it would not be appropriate to 
adopt a detailed, technical approach that would create an identical 
standard for all of the providers with which CMS has agreements. 
Instead, the needs of specific treatment populations and settings 
should drive the types of standards developed. Therefore, we do not 
plan to adopt the hospital requirements verbatim for other provider 
types.
    However, we are concerned about beneficiaries receiving care in 
settings where no regulatory protections regarding the use of restraint 
or seclusion currently exist. The CHA provides statutory protection to 
patients at any facility receiving Federal funding. While it is 
impractical, in our view, to take the requirements for hospitals, 
nursing homes, or intermediate care facilities for the mentally 
retarded and adopt them as a whole in any other given setting, we can 
instead develop any new requirements with the same philosophical 
foundation that underlies the three existing sets of standards and 
requirements. This foundation encompasses the belief that the patient 
has the right to be free from unnecessary restraint or seclusion, that 
using a restraint for convenience, punishment, retaliation, or coercion 
is never acceptable, and that each patient should be treated with 
respect and dignity. These beliefs are true in every care setting and 
are legally enforceable in accordance with the CHA. As appropriate, we 
will develop regulations that support these concepts. However, given 
the variations in treatment populations and settings, the individual 
case setting will drive the type of standards developed which will vary 
as appropriate.

II. Provisions of the Proposed and Interim Final Rules Regarding 
Patients' Rights

    The December 19, 1997 hospital CoP proposed rule included a 
patients' rights CoP that proposed to establish standards for the 
following:
    <bullet> Notice of rights.
    <bullet> Exercise of rights regarding care.
    <bullet> Privacy and safety.
    <bullet> Confidentiality of patient records.
    <bullet> Seclusion and restraint.
    With the exception of the standard for seclusion and restraint, we 
received few comments in response to these proposed requirements.
    In the July 2, 1999 Federal Register, we published an interim final 
rule with comment period that separated the patients' rights CoP from 
the other hospital CoPs and introduced modifications to proposed 
standard (e) and added a new standard (f), governing the use of 
restraint and seclusion. Because we received few comments on the other 
provisions of the patients' rights section (standards a through d), 
these four provisions were not reopened for public comment in the July 
2, 1999 interim final rule with comment period.
    In the 1997 proposed rule, standard (e) was entitled ``Seclusion 
and restraint,'' and covered the patient's right to be free of 
restraint or seclusion used as a means of coercion, convenience, or 
retaliation by staff. The proposed language set forth several basic 
ideas and expectations; namely, that restraint (including 
psychopharmacological drugs used as restraints) and seclusion must be 
used in accordance with the patient's plan of care; that restraints or 
seclusion may be used only as a last resort and in the least 
restrictive manner possible to protect the patient or others from harm; 
and that restraint or seclusion must be removed or ended at the 
earliest possible time.
    The interim final rule with comment period introduced two standards 
on restraint and seclusion--one governing the use of restraint in the 
provision of acute medical and surgical care and the other governing 
the use of seclusion and restraint for behavior management. The revised 
standard (e) included definitions that had not specifically appeared in 
the proposed rule and also included: (1) A prohibition on standing 
orders or orders on an as needed basis (that is, PRN) for restraint; 
(2) an emphasis on continual assessment and monitoring; and re-
evaluation of the condition of the restrained patient; (3) a 
requirement that the hospital notify the patient's treating physician 
if he/she did not issue the restraint order personally; and (4) a 
training requirement for all staff with direct patient contact. 
Standard (f) offered definitions and provided more prescriptive 
requirements than the proposed or revised standard (e). The focus on 
behavior management in standard (f) was intended to apply in situations 
where the patient's aggressive or violent behavior creates an emergency 
situation that places his or her safety or that of others at risk. The 
more prescriptive elements, such as--(1) requiring a physician or 
licensed independent practitioner (LIP) to see and evaluate the need 
for restraint or seclusion within 1-hour of the initiation of the 
intervention; (2) the limitation on the length of orders and required 
re-evaluation; and (3) the requirement for continual face-to-face 
monitoring or continual monitoring using both video and audio equipment 
if restraint and seclusion are used simultaneously, were meant to be 
commensurate with the increased risk to patient health and safety when 
these interventions are used to address violent or aggressive patient 
behavior.
    In both standards (e) and (f) of the July 2, 1999 interim final 
rule with comment period, the phrase ``psychopharmacological drugs used 
as restraints'' was replaced with the phrase ``drug used as a 
restraint,'' in recognition of the idea that singling out one type of 
medication encourages the misperception that only one class of drugs is 
used to restrain patients.
    Concern for patient health and safety prompted us to make these 
requirements effective on August 2, 1999. However, given the changes to 
the proposed standard (e) and the addition of standard (f), we believed 
that the public should have an opportunity to comment on the revised 
restraint and seclusion provisions. For these reasons, we published the 
July 2, 1999 rule as an interim final rule with comment period.

III. Comments on and Responses to the Provisions of the Interim Final 
With Comment Period

    We received approximately 4,200 timely comments on the interim 
final rule with comment period. Comments were received from hospitals, 
mental health treatment facilities, physicians, nurses, attorneys, 
professional associations, accrediting bodies, state agencies, national 
and State patient protection and advocacy groups, and members of the 
general public. Many commenters applauded the addition of the restraint 
and seclusion provisions in the Patients' Rights CoP, even if they 
disagreed with specific requirements or concepts. A summary of the 
comments received on these provisions (standards (e) and (f)) and our 
responses follows.
    We received comments on issues out of the scope of the interim 
final rule with comment period; these comments will not be addressed in 
this final rule.

A. General Comments on the Requirements for the Use of Restraint and 
Seclusion

    Some commenters suggested that the 1-hour physician or LIP visit 
and assessment were not consistent with the goal of creating a 
government that works better and costs less. A few commenters stated 
that the rapid introduction of standards (e) and (f) was a ``knee-jerk

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reaction'' to the lobbying of certain groups and the sensationalized 
media coverage of a limited number of cases. One commenter stated, ``It 
is time the legislature and administrative agencies stop reacting to 
sensational headlines and layering the health care system with costly 
and time consuming regulations to meet.'' Another commenter questioned 
the validity of the 1998 Hartford Courant series of articles (cited in 
the preamble to the interim final rule with comment period), asserting 
that the articles did not clearly determine that the use of restraint 
and seclusion were the proximate and sole cause of deaths in the cases 
cited. The same commenter asked in which setting these deaths occurred, 
stating that it makes no sense to regulate a hospital on this point if 
there is no evidence that restraint-related deaths are problematic in 
hospitals. Another commenter questioned the FDA's estimate of at least 
100 deaths per year from improper use of restraints, specifically 
noting that he believes that these are not cases where restraint use 
was unmerited. Another commenter stated that while the abuse and deaths 
that have occurred are unfortunate, they do not represent an emergency 
situation meriting the actions that were taken by CMS. The commenter 
made the following statement:

    While 142 deaths in 10 years is unfortunate, the number pales 
when compared to the 3 million people hospitalized per year for 
adverse drug reactions and 150,000 deaths resulting from drugs taken 
properly as prescribed by the physician.

    A commenter stated that CMS has given too much credence to over-
dramatized accounts of restraint and seclusion use. Many hospitals 
reported having no injuries or deaths associated with restraint or 
seclusion use. A number of physicians also noted that none of their 
patients have suffered serious injuries or died due to the use of 
restraints. One commenter stated that it was unfair to subject the 
industry as a whole to highly prescriptive requirements when the events 
that triggered such concern occurred in a handful of facilities. The 
commenter argued that only the hospitals where the deaths occurred 
should be governed by these rules. Another commenter suggested that in 
the situations where these deaths occurred, the practices used were out 
of compliance with the hospitals' own policies and procedures. 
Accordingly, the commenter stated that prescriptive regulations do not 
represent the gateway to reduced injuries and deaths, and that 
enforcement of existing requirements would be more effective. Still 
other commenters have suggested that even if death and injury are of 
concern, CMS has not yet hit upon the correct solution.
    To balance these comments, we mention those received from advocacy 
groups, patients, and hospital staff. Some of the anecdotal information 
provided was clearly disturbing, including accounts of patients being 
choked during takedowns even though staff had been trained in proper 
procedures, and patients suffering broken limbs or other injuries. 
Other commenters described situations where patients had been placed in 
restraints for extended periods of time (up to 10 consecutive hours) 
and staff did not take vital signs regularly, did not offer food, 
fluids, or use of the toilet at all, or offered them only once while 
the patient was restrained. Comments also related concerns about the 
over use and inappropriate use of restraint or seclusion. One commenter 
stated that a lawsuit was filed on behalf of a patient dually diagnosed 
with mental retardation and organic brain syndrome who was placed in 
restraints 48 times within a six month period. The commenter stated 
that in the six months after the lawsuit was settled, the patient had 
only been restrained twice.
    Many commenters applauded the regulatory action. Commenters stated 
that the action was long overdue and important for the safety of 
vulnerable populations most in need of protection from abuse of 
restraints and seclusion. Commenters see this rule as a major step 
forward in addressing issues surrounding the use of restraint and 
seclusion in inpatient facilities and support further movement toward 
the goals of ultimately eliminating the use of seclusion and restraint, 
and preserving patients' rights and dignity. In addition, many 
commenters stated that they would like to see even more stringent 
requirements for the use of restraint and seclusion for behavior 
management.
1. Is There Cause for Concern?
    Given the prevalence of restraint use, we believe that awareness 
and vigilance are justified. On October 11, 1998, the Hartford Courant 
reported that of the 142 deaths it confirmed, 59.6 percent occurred in 
the hospital setting (including psychiatric hospitals and psychiatric 
wards of general hospitals). The Courant further stated that 47.2 
percent of the 142 deaths involved physical restraints or therapeutic 
holds, while 44.1 percent involved mechanical restraint, 3.1 percent 
involved a combination of the two, and the remaining 5.5 percent were 
seclusion-related. Although the Courant did not claim that restraint 
and seclusion use were the sole and proxmate cause of death in each 
case, we question the usefulness of this criterion in determining 
whether restraint and seclusion pose significant risk to health and 
safety. Obviously, when a patient's trachea is crushed during a 
takedown, restraint would constitute the ``sole and proximal'' cause of 
death. However, a case cited by one commenter illustrates how this 
characterization may fail to take into account the many times that 
restraint or seclusion can play a part in injury. The commenter 
reported that one young man died after suffering a severe asthma attack 
soon after fighting with another patient and being restrained. The 
death was ruled to be due to natural causes, even though the medical 
examiner found that both the stress of the fight and the restraint 
triggered the asthma attack. One cannot only consider whether restraint 
or seclusion is the sole cause of death when examining whether the use 
of restraint or seclusion poses a significant risk to the patient.
    One commenter questioned the statistical significance of 142 deaths 
over a 10-year period. This number may not reflect the actual number of 
such deaths that occur each year. In explaining how it conducted its 
investigation, the Courant noted, ``Throughout the reporting * * * it 
became clear that many deaths go unreported.'' To better determine the 
national annual death rate, the Courant hired statistician Roberta 
Glass, a research specialist for the Harvard Center of Risk Analysis at 
the Harvard School of Public Health. The Courant reported the 
following:

    Glass projected that the annual number of deaths could range as 
high as 150. ``Admittedly, the estimates are only rough 
approximations,'' Glass said. ``The data needed for precise 
estimation are not collected in a systematic way nationwide.''

    On October 26, 1999, Associate Director Leslie Aronovitz of the 
U.S. Government Accountability Office provided testimony before the 
Senate Committee on Finance entitled, ``Extent of Risk from Improper 
Restraint or Seclusion is Unknown.'' Aronovitz testified to the 
following:

    Neither the federal government nor the states comprehensively 
track the use of restraint or seclusion or injuries related to them 
across all types of facilities that serve individuals with mental 
illness or mental retardation * * * Because reporting is so 
piecemeal, the exact number of deaths in which restraint or 
seclusion was a factor is not known. We contacted the P&As

[[Page 71382]]

[protection and advocacy agencies] for each state and the District 
of Columbia and asked them to identify people in treatment settings 
who died in fiscal year 1998 and for whom restraint or seclusion was 
a factor in their death. The P&As identified 24, but this number is 
likely to be an understatement, because many states do not require 
all or some of their facilities to report such incidents to P&As.

    The lack of systemic information collection is an important point. 
The Joint Commission on Accreditation for Healthcare Organizations 
(JCAHO), which accredits 80 percent of the hospitals that participate 
in Medicare and Medicaid, does not require hospitals to report 
``sentinel events'' such as injuries or deaths related to restraint or 
seclusion use, but encourages voluntary reporting through its sentinel 
event program. JCAHO defines a sentinel event as ``an unexpected 
occurrence involving death or serious physical or psychological injury, 
or the risk thereof.'' Even if each of the accredited hospitals 
scrupulously and voluntarily reports sentinel events, the 20 percent of 
Medicare- and Medicaid-participating hospitals that are non-accredited 
do not provide this information to JCAHO. Since reporting is voluntary 
rather than mandatory, accredited hospitals may choose not to inform 
JCAHO. Hospitals may fear that reported information might be used 
against them in court, which would provide a clear disincentive to 
consistent and voluntary reporting.
    Even if Glass' projection of up to 150 deaths per year is correct, 
some may question its statistical significance when compared with the 
number of deaths that result from other factors, such as medical 
errors. We believe that while deaths are a focal point, it is important 
not to discount patient injuries. If deaths are under-reported, injury 
data are even more elusive. Estimating the psychological and social 
impact of restraint or seclusion is more challenging still. We do not 
imply that most of the nation's providers recklessly seclude or 
restrain patients without regard to their emotional well-being. To the 
contrary, many who commented on this regulation stated that restraint 
or seclusion are measures of last resort and that they do not undertake 
these interventions unless absolutely necessary. However, even when a 
restraint or seclusion is needed, the patient may feel dehumanized, 
isolated, or depressed as a result. Physical impact, although arguably 
not simple to measure, is more easily monitored and reported than 
impact on the spirit.
    In summary, we suspect that patient deaths and injuries are 
underreported, and, even if all parties voluntarily report incidents 
involving restraint or seclusion or comply with State and local 
reporting requirements, there are gaps in the system that thwart 
conclusive calculation of the number of physical injuries and deaths 
associated with restraint and seclusion use. Given the prevalence of 
use, the potential for injury, death, or adverse psychological impact, 
we maintain our original position--that this area deserves regulatory 
attention to safeguard patient health and safety.
2. The Difference Between Standards (e) and (f)
    Comment: Many commenters stated that it is unclear which standard 
applies in any given situation. One commenter recommended that we 
delineate a clear, objective explanation of when application of the 
behavior management standard outside the psychiatric care setting is 
expected. One commenter objected to the creation of separate 
requirements for the care of psychiatric patients versus those 
receiving acute medical treatment, and asserted that all patients 
should be treated equally. However, most commenters agreed that 
different requirements should apply to restraints used for violent, 
aggressive patients as opposed to restraints used in the provision of 
medical care; some suggested that setting-specific requirements are 
more reasonable than behavior-specific ones.
    Response: Based on public comment regarding the lack of clarity 
between the application of standard (e) Restraint for acute medical and 
surgical care, and the application of standard (f) Restraint and 
seclusion for behavior management, we have revised and combined these 
requirements into a single standard in the final rule. This combined 
standard, entitled ``Restraint or seclusion,'' is subparagraph (e) 
under Sec.  482.12 Patients' Rights in the final rule. This combined 
standard (e) applies to all uses of restraint or seclusion regardless 
of the patient's location. Although we have modified some of the 
provisions to address public comments, these modifications do not 
lessen protections afforded patients who are restricted or secluded. We 
note that we have revised the regulation to expand training 
requirements, and have added a requirement that the attending physician 
or other licensed independent practitioner (LIP) responsible for the 
care of the patient be consulted as soon as possible when the one-hour 
restraint or seclusion evaluation of the violent or self-destructive 
patient is conducted by a trained registered nurse (RN) or physician 
assistant (PA).
    Comment: A few commenters noted the challenge of making a 
determination on the standard of care for a patient with multiple 
diagnoses and behaviors.
    Response: We agree that multiple diagnosis and behaviors can make 
determination on the standard of care a challenge. Therefore, even 
though several requirements were revised based on public comments, none 
of the current requirements in standards (e) and (f) have been deleted. 
All of the requirements contained in the current standard (e) are also 
contained in the current standard (f). These requirements, in their 
entirety, have been moved to the combined standard (e) in the final 
rule. All of the requirements contained in the current standard (f), 
have also been moved, in their entirety, to the combined standard (e) 
in the final rule.
    Comment: One commenter noted the difficulty in enforcing behavior-
specific standards. However, another commenter supported writing the 
standards to focus on patient behavior or circumstances rather than on 
the setting. Some commenters requested clarification on what ``behavior 
management'' means.
    Response: For the purpose of clarity we have eliminated the term 
``behavior management'' and are using more specific language. The 
management of violent or self-destructive behavior can occur as part of 
medical and surgical care as well as part of psychiatric care. The use 
of the language ``violent or self-destructive behavior'' is intended to 
clarify the application of these requirements across all patient 
populations. It is not intended to single out any particular patient 
population. Based on public comments, we have eliminated the language 
``behavior management,'' and have used clearer, more descriptive 
language in the final rule. Specifically, we have revised the 
regulations text at 482.13(e) to provide that restraint or seclusion 
may only be imposed to ensure the immediate physical safety of the 
patient, a staff member, or others, and must be discontinued at the 
earliest possible time. This combined standard clearly outlines the 
requirements any time restraint or seclusion is used, regardless of the 
patient's location. We do not support a setting-based approach because 
interventions and protections provided without considering the 
patient's behavior and symptoms may fail to adequately safeguard the 
health and safety of patients. In addition, this standard is not 
targeted only at patients on psychiatric units or those with 
behavioral/mental health care needs. The patient protections contained 
in this standard apply to all patients when

[[Page 71383]]

the use of restraint or seclusion becomes necessary.
    Although a patient's violent or self-destructive behavior may 
jeopardize the immediate physical safety of the patient, a staff 
member, or others more frequently in a psychiatric unit or in a 
psychiatric hospital, this behavior also appears in the acute medical/
surgical care settings, including emergency and critical care settings. 
Some examples follow. A patient may experience a severe medication 
reaction that causes him or her to become violent. A patient may be 
withdrawing from alcohol and having delirium tremors (DTs). The patient 
is agitated, combative, verbally abusive, and attempting to hit staff. 
Regardless of facility type, such emergencies generally pose a 
significant risk for patients and others. For the safety of the patient 
and others, the use of restraint or seclusion may be necessary to 
manage the patient's violent or self-destructive behavior that 
jeopardize the immediate physical safety of the patient, a staff 
member, or others when less restrictive interventions have been 
determined to be ineffective to protect the patient, staff, or others 
from harm. It is not targeted only at patients on psychiatric units or 
those with behavioral/mental health care needs. The patient protections 
contained in this standard apply to all patients when the use of 
restraint or seclusion becomes necessary.
    Comment: One commenter suggested adding language in Sec.  
482.13(f)(2) to indicate that standard (f) applies when a restraint or 
seclusion is used, ``In an emergency situation to manage an 
unanticipated outburst of severely aggressive or destructive behavior 
that poses an imminent danger to the patient or others.'' Several 
commenters suggested changing the title of standard (f), examples 
include, ``Emergency behavior management'' and ``Seclusion/restraint 
for patients with primary behavioral health care needs.''
    Response: The current standard (e) contains two requirements that 
are more stringent, if restraint or seclusion is used when a patient 
jeopardizes the immediate physical safety of the patient, a staff 
member, or others. They are: time limits on length of each order, and 
the 1-hour face-to-face evaluation. The intent of these more stringent 
requirements is to add additional patient protections when restraint or 
seclusion is used for behavior management. We do not intend for these 
two more stringent requirements to apply to all uses of restraint. We 
have added clarifying language in the final rule that these 
requirements apply when restraint or seclusion are used for the 
management of violent or self-destructive behavior that jeopardizes the 
immediate physical safety of the patient, a staff member, or others. We 
have also specified that seclusion is only permitted to manage violent 
or self-destructive behavior that jeopardizes the immediate physical 
safety of the patient, a staff member, or others.
    Since publication of the interim final rule with comment period, we 
have repeatedly responded to inquiries regarding the criteria for 
differentiating between emergency situations where the patient's 
behavior is violent or self-destructive and jeopardizes the immediate 
physical safety of the patient, a staff member, or others versus the 
non-emergency use of restraint. Most of the individuals to whom we 
spoke indicated that this distinction was clear and understandable. 
Clinicians are adept at identifying behavior and symptoms, and can 
readily recognize violent and self-destructive behavior that 
jeopardizes the immediate physical safety of the patient, a staff 
member, or others. Asking them to act based on evaluation of the 
patient's behavior is no different than relying on the clinical 
judgment that they use daily in assessing the needs of each patient and 
taking actions to meet those individual needs.
    In the final rule, we adopted the restraint definition contained in 
the CHA. Because the requirements governing the use of restraint or 
seclusion have been combined in a single standard, we also have a 
single, consistent definition of restraint. A restraint is any manual 
method, physical or mechanical device, material, or equipment that 
immobilizes or reduces the ability of a patient to move his or her 
arms, legs, body, or head freely; or a drug or medication when it is 
used as a restriction to manage the patient's behavior or restrict the 
patient's freedom of movement and is not a standard treatment or dosage 
for the patient's condition. The final rule also clarifies that a 
restraint does not include devices, such as orthopedically prescribed 
devices, surgical dressings or bandages, protective helmets, or other 
methods that involve the physical holding of a patient for the purpose 
of conducting routine physical examinations or tests, or to protect the 
patient from falling out of bed, or to permit the patient to 
participate in activities without the risk of physical harm (this does 
not include a physical escort). The devices and methods described above 
are typically used in medical/surgical care, and would not be 
considered restraints, and thus not subject to these requirements.
    The final, combined standard (e) applies to the use of restraint, 
the use of seclusion, as well as the simultaneous use of restraint and 
seclusion. To clarify this point, we have adopted use of the word 
``or'' in the final, combined standard for restraint and seclusion. The 
use of ``or'' imports the ``and,'' whereas ``and'' standing alone 
requires that both happen. It is not our intent that the requirements 
in this standard only apply when both restraint and seclusion are used. 
Therefore, throughout the regulation text, we have deleted ``and'' and 
inserted ``or.'' The regulations apply to the use of restraint or 
seclusion. This means they also apply when both restraint and seclusion 
are used.
3. The Roles of CMS and JCAHO
    Comment: Regarding any provision that was not identical to JCAHO's 
policy, a host of commenters expressed concern that CMS's standards did 
not parallel or actually ran counter to JCAHO's. One commenter stated 
that these discrepancies would create an implementation burden for 
hospitals. A number of commenters expressed concern that CMS was 
straying from its stated intent of maintaining consistency between 
Federal and accreditation standards.
    Response: In the interim final rule with comment period (64 FR 
36079), we stated, ``We believe it is appropriate to recognize JCAHO's 
work in this area [regarding the length of physician or LIP orders] and 
maintain consistency between Federal and accreditation standards when 
possible.'' We adopted JCAHO's standard for time limited orders 
because, upon examination, we found nothing to suggest that these 
timeframes have been found faulty or that any more appropriate ones 
have been scientifically determined. However, we did not intend to 
suggest that we planned to follow JCAHO's standards in all respects.
    Comment: One commenter suggested that the requirement that a 
physician or LIP see a patient who is restrained or secluded for 
behavior management within 1-hour is unnecessary because current 
practice provides good patient care. The commenter cited JCAHO's 
revision of its standards regarding restraints and seclusion and noted 
that the hospital agreed with JCAHO and implemented those standards. 
Further, the commenter reported that the hospital has an ongoing 
improvement process, which has significantly decreased the use of 
restraints and seclusion for its adult population.

[[Page 71384]]

    To govern the use of restraint and seclusion for children, another 
commenter suggested an approach similar to JCAHO's. The commenter 
further suggested that national accreditation bodies could establish a 
certification and approval process for nonviolent intervention regimes. 
Additionally, the commenter suggested that accreditation surveys or 
regulatory reviews could include thorough individual and aggregate 
review of documentation of restraint and seclusion use.
    Response: The hospital CoPs are minimum health and safety standards 
that hospitals must meet to participate in the Medicare and Medicaid 
programs. The CoPs are intended to protect patient health and safety 
and to ensure that high quality care is provided to all patients. While 
we applaud JCAHO's progress in the areas of examining restraint and 
seclusion use, JCAHO accreditation is voluntary and not the only way 
hospitals participate in the Medicare and Medicaid programs. Twenty 
percent of the hospitals that participate in Medicare and Medicaid are 
non-accredited. Non-accredited hospitals are surveyed by State survey 
agencies to determine compliance with the CoPs. We have the 
responsibility to ensure that all Medicare- and Medicaid-participating 
hospitals have certain protections in place. Before July 2, 1999, the 
CoPs contained no requirements concerning Patients' Rights.
    Our minimum requirements need to exist in regulatory form in order 
to carry the weight of the law and be enforceable. This final rule 
informs the public and provider community of our minimum requirements 
for the protection of patient health and safety while providing a sound 
basis for legal action if we find that those requirements are not met. 
While quality improvement initiatives and other internal efforts to 
track restraints and seclusion use and eliminate inappropriate use are 
important, we do not believe that they serve as a substitute for stated 
minimum Federal requirements.
    Comment: One commenter stated, ``Let's leave the seclusion and 
restraint abusers to the civil courts and JCAHO, who are quite capable 
of creating over-regulations without help from CMS.'' Conversely, 
another commenter asserted,

    ``CMS bears a great deal of the blame for the deaths, injuries, 
and serious long-term psychological harm which those aforementioned 
patients and their families have endured because it did not amend 
its CoPs to assure such desirable outcomes. The JCAHO standards were 
available to CMS during those many years but it chose--for 
unexplainable and unacceptable reasons--to maintain the status-
quo.''

    Response: There were other such polarized responses to the interim 
final rule with comment period. However, many commenters acknowledged 
the appropriateness of regulation in this area even if they disagreed 
with individual provisions of the interim final rule with comment 
period.
    The Congress has charged us with creating standards that protect 
the nation's Medicare and Medicaid beneficiaries and ensure that these 
beneficiaries receive high quality care. Many commenters came forward 
with ideas about how the regulation could be changed and improved. Our 
task is to reconcile these ideas when feasible, and determine the best, 
most reasonable approach that promotes patient health and safety and 
yet does not create a disincentive for providers to serve those 
populations who most critically need their help.
    Comment: A commenter stated that CMS's interest in alerting the 
public to the potential dangers associated with the use of restraint 
and seclusion is ``faddish.''
    Response: This commenter's statement stood in stark contrast to 
those of many of his contemporaries who wrote of their tireless efforts 
to avert the potential hazards associated with the use of restraint and 
seclusion, and of the seriousness with which they undertake such 
interventions. While accounts of efforts to minimize use of restraint 
and seclusion and assure patient safety were heartening, a few of the 
letters we received were disturbing in their conceptualization of a 
restraint or seclusion not only as wholly appropriate, but as a ``time-
honored'' standard of care. To that argument, we reply that standards 
of care continually evolve. For example, at one time patient shackles 
were considered a standard intervention. Habit does not justify the 
continued use of an intervention when alternative methods that are 
safer or more effective are available. The numerous training programs 
that emphasize alternative techniques for handling violent or self-
destructive behavior and symptoms demonstrate that clinicians recognize 
the risks inherent in the use of restraint and seclusion. Practitioners 
in the field of medicine are constantly searching for better ways to 
manage symptoms and conditions that have been traditionally treated 
through the use of restraint or seclusion or both. We fully support 
these efforts.
4. Applicability of the Patients' Rights CoP
    Comment: One commenter stated that the preamble should explain the 
application and effect of the new regulation on psychiatric hospitals. 
If the regulation applies to psychiatric hospitals, the commenter 
stated the requirements specified in standard (f) (among others) might 
not be appropriate.
    Response: In the summary of the interim final rule with comment 
period (64 FR 36070), we explained, ``The Patients'' Rights CoP, 
including the standard regarding seclusion and restraint, applies to 
all Medicare- and Medicaid-participating hospitals, that is, short-
term, psychiatric, rehabilitation, long-term, children's, and alcohol-
drug.'' This final rule, including its provisions concerning the use of 
restraint and seclusion, is explicitly intended to apply in the 
psychiatric hospital setting.
    We disagree with the opinion that the requirements in the current 
standard (e) might not be appropriate for the psychiatric hospital 
setting. While violent or self-destructive patient behavior that 
jeopardizes the immediate physical safety of the patient, a staff 
member, or others occasionally occurs on an acute care unit in a 
hospital, it occurs more often on a psychiatric unit or in a 
psychiatric hospital. When a patient's behavior becomes violent or 
self-destructive, the immediate physical safety of the patient, a staff 
member, or others is at risk. In such an emergency situation, it is 
critical to ensure that staff is well trained in alternative 
interventions and techniques; to ensure the safety and well being of 
the patient and others; to manage the patient's behavior; and, to 
competently apply restraints or use seclusion. Additionally, the 
protections provided ensure that: the restrained or secluded patient is 
appropriately monitored and that the patient's condition is reassessed; 
the patient's medical and psychological conditions are evaluated; and, 
the intervention is ended as quickly as possible. Therefore, we believe 
that the protections in the current standard (f) that have been 
relocated to the combined standard (e) in the final rule are 
appropriate for the psychiatric care setting.
    Comment: One commenter suggested that we need to develop a separate 
category of patient rights for children that address their 
developmental needs rights and other basic needs.
    Response: The provisions contained in the Patients' Rights CoP 
apply universally to all hospital patients,

[[Page 71385]]

including children. Although there is no separate category for 
patient's rights on the basis of age, the regulations recognize 
differences. Timeframes on orders for the use of restraints or 
seclusion are different based on age. For example, for children and 
adolescents 9 to 17 years of age, orders for restraint or seclusion are 
limited to a maximum of 2 hours. When implementing these regulations, 
we expect hospitals to develop and implement an approach that meets the 
individualized needs of the patient populations that they serve.
    Comment: One commenter stated that since there are no attending 
physicians in religious non-medical facilities, amendments should be 
made to incorporate the provisions of section 1861(ss) of the Act.
    Response: Effective January 31, 2000, religious non-medical 
facilities are not governed by the hospital CoPs, but by their own 
requirements. The new requirements for religious non-medical facilities 
do not permit the use of restraint or involuntary seclusion (Sec. Sec.  
403.730(c)(4) and (5)). (For additional information, see the November 
30, 1999 and November 28, 2003 Federal Registers (64 FR 67028) and (68 
FR 66710), respectively).
5. Debriefing After the Use of Restraint/Seclusion
    Comment: Many consumer advocates suggested creating a requirement 
for debriefing staff and patients following each incident of restraint 
or seclusion, and documenting the use of either procedure in the 
patient's record. The debriefing's purpose would be to--(1) develop an 
understanding of the factors that may have evoked the behaviors 
necessitating the use of restraint or seclusion; (2) give the patient 
time to verbalize his or her feelings and concerns; and (3) identify 
strategies to avoid future use of seclusion or restraint. Another 
commenter recommended that staff debriefing, followed by patient 
debriefing, occur within 24 hours of each incident of restraint or 
seclusion. One commenter noted that its hospital requires staff 
debriefing as part of an approach that has dramatically reduced its 
incidence of restraint and seclusion use.
    Another commenter argued that debriefing is unnecessary in many 
cases of restraint use. The commenter further stated that requiring 
debriefing after each use of restraint or seclusion would create 
unnecessary work.

    ``It is not uncommon for patients to require restraint or 
seclusion for multiple episodes of aggression in a 24-hour time 
period. The underlying rationale for debriefings, to avoid future 
uses of restraint or seclusion, can be handled by other means, 
including consultation with the physician or advance practice nurse 
who authorizes restraint use. There could be debriefings when 
incidents are critical in nature.''

    Response: We agree that debriefing can be a useful, productive 
exercise that helps both the patient and staff understand what has 
happened and how such situations can be averted in the future. However, 
we see the argument made by the opposing commenter as valid. The use of 
restraint or seclusion is only permitted while the unsafe situation 
persists, and must be discontinued at the earliest possible time. A 
patient may have multiple uses of restraint or seclusion in a fairly 
short timeframe. Requiring that a debriefing occur after each use may 
be impractical or unnecessary. We believe that hospitals and clinicians 
will use debriefing as a component of the treatment plan designed to 
safely manage violent or self-destructive patient behavior that 
jeopardizes the immediate physical safety of the patient, a staff 
member, or others as necessary. Therefore, we are not requiring 
debriefing.
    Comment: One commenter suggested that a multidisciplinary team 
should review each incident within 24 hours. Their review should be 
part of the hospital's quality assurance and peer review procedures.
    Response: We believe that hospitals will monitor restraint and 
seclusion use through their Quality Assessment Performance Improvement 
(QAPI) programs. Mandating that a multidisciplinary team review each 
incident within 24 hours would be unnecessarily burdensome. Therefore, 
we are not specifying that this must occur in this rule.

B. Comments Received on Specific Provisions

1. The Right To Be Free From Restraint (Sec. Sec.  482.13(e)(1) and 
(f)(1))
    We stated that the patient has the right to be free from restraints 
of any form that are not medically necessary, or are used as a means of 
coercion, discipline, convenience, or retaliation by staff. Section 
482.13(f)(1) paralleled this requirement and stated that the patient 
has the right to be free from seclusion and restraints, of any form, 
imposed as a means of coercion, discipline, convenience, or retaliation 
by staff.
    Comment: Many commenters agreed with this general statement and 
applauded our efforts to eliminate the inappropriate use of restraint. 
However, some commenters stated that the procedural requirements 
specified in the interim final rule for the appropriate use of 
restraint were too idealistic.
    Response: We appreciate the support expressed by many commenters. 
Regarding concerns about the practicality of the current requirements, 
we believe that some commenters have interpreted current standard to 
require face-to-face monitoring in every clinical situation. Our intent 
is that the restrained or secluded patient's condition be assessed and 
monitored by a physician, other licensed independent practitioner or 
trained staff at an interval determined by hospital policy. In this 
final rule, we have amended the regulatory language at Sec.  
482.13(e)(10) to reflect this. Hospital policies should address the 
frequency of assessment and the assessment parameters (for example, 
vital signs, circulation checks, hydration needs, elimination needs, 
level of distress and agitation, mental status, cognitive functioning, 
skin integrity). Hospital policies should guide staff in how to 
determine an appropriate interval for assessment and monitoring based 
on the individual needs of the patient, the patient's condition, and 
the type of restraint used. It may be that a specific patient needs 
continual face-to-face monitoring; or that the patient's safety, 
comfort, and well-being are best assured by periodic checks. Continual 
face-to-face monitoring is only required when restraint and seclusion 
are used simultaneously to address violent or self-destructive behavior 
that jeopardizes the immediate physical safety of the patient, a staff 
member, or others. The hospital is responsible for providing the level 
of monitoring and frequency of reassessment that will ensure the 
patient's safety. In this final rule, we have also added language to 
clarify that a restraint does not include devices, such as 
orthopedically prescribed devices, surgical dressings or bandages, 
protective helmets, or other methods that involve the physical holding 
of a patient for the purpose of conducting routine physical 
examinations or tests, or to protect the patient from falling out of 
bed, or to permit the patient to participate in activities without the 
risk of physical harm (this does not include a physical escort).
    Comment: One commenter stated that he could not find legal 
authority for health professionals to restrain their patients, absent 
specific court orders. The commenter also noted that health 
professionals might be excused for restraining patients only if the 
purpose of restraint is to minimize an imminent risk of great bodily 
harm, and only

[[Page 71386]]

when the need for restraint is not provoked by the health professional.
    Response: We agree that consideration of the safety of the patient, 
staff, or others is the basis for applying a restraint. We have 
supported this approach in combined standard (e) by stating that all 
patients have the right to be free from physical or mental abuse, and 
corporal punishment, and have the right to be free from restraint or 
seclusion, of any form, imposed as a means of coercion, discipline, 
convenience, or retaliation by staff. Restraint or seclusion may only 
be imposed to ensure the immediate physical safety of the patient, 
staff or others and must be discontinued at the earliest possible time. 
In the final rule, we have also stated that restraint or seclusion may 
only be used when less restrictive interventions have been determined 
to be ineffective to protect the patient or others from harm. Finally, 
we have stated that the type or technique of restraint or seclusion 
used must be the least restrictive intervention that will be effective 
to protect the patient or others from harm.
    Comment: Several commenters argued that few effective means of 
therapeutic intervention for significant behavioral problems exist, and 
that disallowing the use of restraint or seclusion might result in a 
denial of treatment for individuals with significant problems because 
of the limitation on what providers can do to address symptoms. These 
commenters argued that providers would be unwilling to jeopardize staff 
and others' safety or incur any liability associated with untreated 
behaviors. Some commenters suggested that this regulation would result 
in the increased use of other interventions, such as psychotropic 
medications, to address behavioral challenges. Some suggested that 
without the use of restraint or seclusion, patients would remain 
incapacitated by their problems. Several commenters said that CMS 
inappropriately excluded ``therapeutic'' uses of restraint, such as 
therapeutic holding and medications.
    Response: This final rule does not ban the use of restraint or 
seclusion. However, it does prohibit the use of restraint or seclusion 
that are imposed as a means of coercion, discipline, convenience, or 
retaliation by staff. This final rule also establishes parameters to 
assure patient safety when less restrictive interventions have been 
determined to be ineffective to protect the patient, staff, or others 
from harm. In the final rule, a restraint is any manual method, 
physical or mechanical device, material, or equipment that immobilizes 
or reduces the ability of a patient to move his or her arms, legs, 
body, or head freely; or a drug or medication when it is used as a 
restriction to manage the patient's behavior or restrict the patient's 
freedom of movement and is not a standard treatment or dosage for the 
patient's condition. A restraint does not include devices, such as 
orthopedically prescribed devices, surgical dressings or bandages, 
protective helmets, or other methods that involve the physical holding 
of a patient for the purpose of conducting routine physical 
examinations or tests, or to protect the patient from falling out of 
bed, or to permit the patient to participate in activities without the 
risk of physical harm (this does not include a physical escort. The 
devices and methods listed here that would not be considered 
restraints, and thus not subject to these requirements, are typically 
used in medical surgical care. Although physical holding of a patient 
for the purpose of conducting routine physical exams or tests is not 
considered a restraint, all patients have the right to refuse 
treatment. This patient right is addressed at Sec.  482.13(b)(2). The 
use of therapeutic holds to manage violent or self-destructive behavior 
that jeopardizes the immediate physical safety of the patient, a staff 
member, or others would be considered a form of restraint and 
therefore, would be subject to the requirements contained in this final 
rule. If the definition of restraint is met, then that practice or 
device (whether it is therapeutic holding or a mechanical device) is 
considered a form of restraint and may be employed so long as all of 
the requirements for restraint use are met.
    In the interim final rule with comment period, the definition of 
``drug used as a restraint'' specifically exempted medications that are 
used as a standard treatment for the patient's medical or psychiatric 
condition. Some commenters criticized this definition as being too 
broad and subjective. This regulation is not intended to interfere with 
the clinical treatment of patients who are suffering from serious 
mental illness and who need appropriate therapeutic doses of 
medications to improve their level of functioning so that they can more 
actively participate in their treatment. Similarly, the regulation is 
not intended to interfere with appropriate doses of sleeping medication 
prescribed for patients with insomnia or anti-anxiety medication 
prescribed to calm a patient who is anxious. Thus, those medications 
that are a standard treatment for a patient's condition are not subject 
to the requirements of this regulation.
    In this final rule, we have defined a drug used as a restraint as a 
drug or medication that is used as a restriction to manage the 
patient's behavior or restrict the patient's freedom of movement and is 
not a standard treatment or dosage for the patient's condition. We 
believe this revised definition more clearly supports the role of 
medications that facilitate the patient's participation in their care 
and maintenance of the patient's functional status.
    Comment: A commenter suggested that the word ``discipline'' should 
be replaced with ``punishment,'' since the two words are not the same 
in meaning and there are situations where patient discipline is 
necessary.
    Response: The distinction between the word ``discipline'' and 
``punishment'' is a more relevant issue in the developmental 
disability/mental retardation setting, as opposed to the psychiatric 
and acute care settings. Therefore, we have retained the use of the 
word ``discipline.''
    Comment: One commenter opined that this regulation provides the 
``right to fall and break a hip'' or ``crack your head open.'' Another 
commenter who provides care to patients with dementia who ``need a vest 
restraint [commonly referred to as a Posey vest] at night to prevent 
them from falling out of bed, or getting up and falling in the 
bathroom,'' questioned whether allowing these patients to fall 
unnecessarily is more humane than restraining them. The commenter also 
stated that while some patients can be medicated and restrained briefly 
on an occasional basis, others--those with dementia or Alzheimers or 
both, for example, need some type of restraint most of the time on a 
permanent basis for their own safety.
    Response: The final regulation states that devices that protect the 
patient from falling out of bed are not restraints. However, when the 
clinician raises all four side rails in order to restrain a patient, 
(defined in this regulation as immobilizing or reducing the ability of 
a patient to move his or her arms, legs, body, or head freely) to 
ensure the immediate physical safety of the patient then the rule 
applies. Raising fewer than four side rails when the bed has more than 
two side rails, would not necessarily immobilize or reduce the ability 
of a patient to move as defined in this regulation.
    Practitioners and hospitals utilize a variety of measures to ensure 
patient safety. Use of a restraint is only one of the possible 
interventions.

[[Page 71387]]

Comprehensive assessment of the patient and the environment, in 
conjunction with individualized patient care planning, should be used 
to determine those interventions that will best ensure the patient's 
safety and well-being with the least risk. However, as part of 
clinician's decision-making, we would expect such an assessment to be 
conducted regardless of whether or not the intervention to ensure 
patient safety is considered a restraint under this regulation. 
Clinical decision making, which includes assessments, would govern the 
use of restrictions that are not covered by these requirements.
    Regarding the idea that some patients require permanent restraint, 
we contend that every patient is entitled to an individualized 
assessment and treatment that takes into account the patient's 
individual strengths, weaknesses, choices, needs, and concerns. For 
example, most adults sleep at home in their beds each night without 
being tied down or otherwise protected from falling out of bed. All use 
of restrictions, whether governed by these regulations or not, should 
be based on an individualized patient assessment and the use of all 
available innovative alternatives and approaches to address patient 
care needs. Again, we have not prohibited the use of restraints; but we 
do prohibit using restraints as a substitute for adequate staffing, 
monitoring, assessment, or investigation of the reasons behind patient 
behavior such as wandering or getting up in the night, which may be 
indicative of unmet patient care needs. When the use of restraints is 
necessary, the combined standard (e) applies.
    Comment: One commenter suggested adding the words, ``Or as a 
replacement for adequate levels of staff,'' to the statement that 
restraint may not be used as a means of coercion, discipline, 
convenience, or retaliation by staff.
    Response: The final regulation language states that all patients 
have the right to be free from restraint or seclusion, of any form, 
imposed for convenience. This language precludes using restraint or 
seclusion as a substitute for adequate staffing levels. Therefore, we 
have not accepted this comment.
    Comment: One commenter suggested removing the words, ``medically 
necessary,'' from (e)(1), arguing that physicians would not order 
treatments that were not medically necessary. Another commenter, 
however, described just such a case; namely, interventions undertaken 
at the voluntary request of the patient, such as a cognitively intact 
patient asking to have his or her bed's side rails put up. This 
commenter asked if a voluntary request would be exempted from meeting 
the regulatory requirements.
    Response: In the final rule, ``not medically necessary'' has been 
removed from the definition of restraint. Restraint may only be used to 
ensure the immediate physical safety of the patient, staff, or others. 
In addition, a restraint does not include devices, such as 
orthopedically prescribed devices, surgical dressings or bandages, 
protective helmets, or other methods that involve the physical holding 
of a patient for the purpose of conducting routine physical 
examinations or tests, or to protect the patient from falling out of 
bed, or to permit the patient to participate in activities without the 
risk of physical harm (this does not include a physical escort).
    Often with the best of intentions, a patient or the patient's 
family may ask for a restraint to be applied. For example, a concerned 
husband may ask that his frail elderly wife be tied into bed to prevent 
her from wandering. In both examples, the concern may be valid, and a 
responsive intervention may be appropriate. However, a patient or 
family member may be unfamiliar with the many innovative, less 
restrictive alternatives available to address a patient's needs. Such a 
request, like any other patient or family request for an intervention, 
should prompt a patient and situational assessment to determine whether 
an intervention is needed. If a need is confirmed, the practitioner 
must then determine the type of intervention that will meet the 
patient's needs with the least risk and most benefit to the patient. A 
request from a patient or family member for the application of a 
restraint which they would consider to be beneficial is not a 
sufficient basis for the use of a restraint intervention. Regardless of 
whether restraint use is voluntary or involuntary, if restraint (as 
defined by the regulation) is used, then the requirements of the 
regulation must be met. Finally, this rule would not preclude a 
patient, or a patient's family member from requesting that his or her 
side rail be raised.
    Comment: One commenter asked whether the rule requires adding the 
rights provided by standards (e) and (f) to the hospital's patients' 
rights policies and procedures and/or a written notification provided 
to the patient. The commenter argued that specifically stating these 
rights would require increased staff time, would be a risk management 
``nightmare,'' and would require a patient/family member release form 
to be signed authorizing the use of a restraint, even when a restraint 
is medically necessary.
    Response: Standard (a), Notice of rights, requires patient 
notification of his or her rights. We are not convinced that notifying 
the patient of the right to be free from restraint or seclusion imposed 
as a means of coercion, discipline, convenience, or retaliation by 
staff, will take significantly more time than informing the patient of 
his or her other rights, particularly since the hospital retains 
extreme flexibility in how and when this notice is provided. We are 
also uncertain why informing the patient of his or her rights would 
present a risk management ``nightmare.'' Concerning the commenter's 
third point, the rule does not require that the patient or his or her 
representative sign release forms. A hospital may choose to introduce 
this policy; however, depending on the mechanism the hospital uses to 
provide this notification (for example, as a standard part of each 
admissions packet; in posted forms in the admissions office or 
emergency room area; bundled with existing required notices) such a 
step may be unnecessary.
2. Definition of ``Restraint'' and ``Physical Restraint'' (Sec. Sec.  
482.13(e)(1) and (f)(1))
    In the interim final rule with comment period, we stated that the 
term ``restraint'' includes either a physical restraint or a drug that 
is being used as a restraint. A physical restraint is any manual method 
or physical or mechanical device, material, or equipment attached or 
adjacent to the patient's body that he or she cannot easily remove that 
restricts freedom of movement or normal access to one's body.
    Comment: One commenter recommended uniform definitions of restraint 
and physical restraint across care settings to avoid confusion. Another 
commenter suggested defining restraint as, ``the forcible and 
involuntary deprivation of the liberty to move about.'' The same 
commenter recommended classifying restraints in three categories: least 
restrictive (manual restraint or holding); intermediate (seclusion, to 
be defined as ``restricting voluntary movement by locking a patient in 
a room. If an individual cannot leave the room at will, the room is 
considered locked, whether the door is actually locked or not''); and 
most restrictive and intrusive (mechanical restraints such as belts, 
cuffs, or soft ties). Several other commenters argued for similar 
categorization, with corresponding monitoring and ordering requirements

[[Page 71388]]

(that is, with consideration for the differences between interventions 
such as a four-point restraint and a restraint used for frail 
patients). One commenter argued that physical and mechanical restraints 
should be defined separately rather than lumped into one category.
    Response: We agree that a uniform definition of restraint across 
care settings is a good approach, adds clarity, and avoids confusion. 
In the final rule, we have combined the regulations governing the use 
of restraint or seclusion into a single standard, and have adopted a 
single, consistent restraint definition. This definition applies to all 
uses of restraint in all hospital care settings. A restraint is any 
manual method, physical or mechanical device, material, or equipment 
that immobilizes or reduces the ability of a patient to move his or her 
arms, legs, body, or head freely; or a drug or medication when it is 
used as a restriction to manage the patient's behavior or restrict the 
patient's freedom of movement and is not a standard treatment or dosage 
for the patient's condition. The final rule also clarifies that a 
restraint does not include devices, such as orthopedically prescribed 
devices, surgical dressings or bandages, protective helmets, or other 
methods that involve the physical holding of a patient for the purpose 
of conducting routine physical examinations or tests, or to protect the 
patient from falling out of bed, or to permit the patient to 
participate in activities without the risk of physical harm (this does 
not include a physical escort). This definition renders unnecessary the 
otherwise impossible task of naming each device and practices that can 
inhibit a patient's movement.
    The concept of liberty of movement as proposed in this comment is 
incorporated in the final rule at the beginning of combined standard 
(e). All patients have the right to be free from restraint or 
seclusion, of any form, imposed as a means of coercion, discipline, 
convenience, or retaliation by staff. Restraint or seclusion may only 
be imposed to insure the immediate physical safety of the patient, 
staff, or others and must be discontinued at the earliest possible 
time.
    However, we did not break restraints into three classes or view 
seclusion as a subset of restraint. We believe that the categorization 
proposed by the commenter is somewhat arbitrary, particularly in light 
of the fact that several of the deaths reported by the Hartford Courant 
occurred during physical holds, which the commenter would have 
categorized as ``least restrictive.'' This fact makes us wary of 
suggesting, even implicitly, that physical holds are preferable to 
mechanical restraint. The deaths resulting from other traditional 
mechanical devices also persuade us of the hazards of using mechanical 
restraints. The type of restraint used is not the defining hazard--
other variables, such as lack of patient assessment in choosing the 
restraint, inappropriate application of the physical restraint 
mechanism or technique, or inadequate patient monitoring could render 
many interventions dangerous. Accordingly, given the unique 
circumstances presented by each patient, we believe that it would be 
inappropriate and would place patients at risk to arbitrarily suggest 
that one form of restraint is categorically preferable to another.
    Finally, we have streamlined and clarified monitoring requirements 
in combined standard (e). The final rule states that the condition of 
the patient who is restrained or secluded must be monitored by a 
physician, other licensed independent practitioner or trained staff at 
an interval determined by hospital policy. When restraint or seclusion 
is used to manage violent or self-destructive behavior that jeopardizes 
the immediate physical safety of the patient, a staff member, or 
others, the patient must be seen and evaluated face-to-face within one 
hour after the initiation of the intervention. This final rule provides 
flexibility for trained staff to determine the monitoring parameters 
necessary when a restraint or seclusion is used. The more stringent 
continual monitoring requirements have been retained only for patients 
who are simultaneously restrained and secluded for management of 
violent or self-destructive behavior that jeopardizes the immediate 
physical safety of the patient, a staff member, or others.
    Comment: Some commenters asked whether the following constitute 
restraint: therapeutic holding; comforting children through holding; 
escorting or touching for de-escalation; virtually any type of 
touching, like holding a patient's arm to prevent him from hitting the 
wall; basket holds; or touching to encourage the patient to lie still 
for a procedure. Many commenters argued that therapeutic holding is 
necessary, and that the regulation should allow individualized 
treatment.
    Response: Several commenters mentioned different types of holding, 
including therapeutic holding. For the purposes of this regulation, a 
staff member picking up, redirecting, or holding an infant, toddler, or 
preschool-aged child to comfort the patient is not considered 
restraint. If an intervention meets the regulatory definition of 
restraint, then that intervention constitutes a restraint and the 
standards for restraint use must be followed. A restraint is any 
method, physical or mechanical device, material, or equipment that 
immobilizes or reduces the ability of a patient to move his or her 
arms, legs, body, or head freely. A restraint does not include devices, 
such as orthopedically prescribed devices, surgical dressings or 
bandages, protective helmets, or other methods that involve the 
physical holding of a patient for the purpose of conducting routine 
physical examinations or tests, or to protect the patient from falling 
out of bed, or to permit the patient to participate in activities 
without the risk of physical harm (this does not include a physical 
escort. The devices and methods listed here that would not be 
considered restraints, and thus not subject to these requirements, are 
typically used in medical surgical care.
    The regulation permits the physical holding of a patient for the 
purpose of conducting routine physical examinations or tests. However, 
patients do have the right to refuse treatment. See Sec.  482.13(b)(2). 
This includes the right to refuse physical examinations or tests. 
Holding a patient in a manner that restricts the patient's movement 
against his or her will would be considered a restraint. This includes 
therapeutic holds. Many deaths have involved these practices and may be 
just as restrictive and potentially dangerous as restraining methods 
that involve devices. However, the opportunity for individualized 
treatment of the patient is still available, since the regulation does 
not prohibit the use of any particular type of restraint. This 
regulation requires individualized patient assessment and use of the 
least restrictive intervention when restraint is needed to protect the 
patient, a staff member, or others from harm.
    Comment: Several commenters asked whether a side rail was a 
physical restraint. One commenter stated that ``the majority'' of 
hospitals require that side rails be raised for safety reasons, and 
that patients do not perceive this common safety practice as a 
restraint. This commenter also cited a need for side rails to be raised 
to protect patients who are confused or disoriented by narcotics or 
controlled substances. Another commenter wanted to know if crib rails 
are a restraint.
    Response: The final rule states that a restraint does not include 
methods that protect the patient from falling out of

[[Page 71389]]

bed. It is standard practice to raise the side rails when a patient is 
on a stretcher, recovering from anesthesia, sedated, experiencing 
involuntary movement, or on certain types of therapeutic beds to 
prevent the patient from falling out of the bed. However, the use of 
side rails to prevent a patient from exiting a hospital bed may pose 
risk to the patient's safety, particularly for the frail elderly who 
may be at risk for entrapment between the mattress and the bed frame. A 
disoriented patient may see the side rail as a barrier to be climbed 
over or may attempt to wriggle through split rails or to the end of the 
bed to exit the bed. As a result, this patient may have an increased 
risk for a fall or other injury by attempting to exit the bed with the 
side rails raised. The risk presented by side rail use should be 
weighed against the risk presented by the patient's behavior as 
ascertained through individualized assessment. Clinical judgment 
determines whether or not the use of siderails is governed by the rule. 
When the clinician raises all four siderails in order to restrain a 
patient, defined in this regulation as immobilizing or reducing the 
ability of a patient to move his or her arms, legs, body, or head 
freely to ensure the immediate physical safety of the patient, then the 
rule applies. Raising fewer than four siderails when the bed has more 
than two siderails, would not necessarily immobilize or reduce the 
ability of a patient to move as defined in the regulation.
    Regarding the question of whether crib rails are a restraint, 
placement in a crib with raised rails is an age-appropriate standard 
safety practice for every infant or toddler. Therefore, placement of an 
infant or toddler in the crib with raised rails would not be regarded 
as a restraint. Age or developmentally appropriate protective safety 
interventions, such as stroller safety belts, swing safety belts, high 
chair lap belts, raised crib rails, and crib covers, that a safety-
conscious child care provider outside a health care setting would 
utilize to protect an infant, toddler, or preschool-aged child would 
not be considered restraint or seclusion for the purposes of these 
regulations. The use of these safety interventions should be addressed 
in hospital policies or procedures.
    Comment: Several commenters believed that mechanical restraints 
should never be used in the mental health treatment of children and 
adolescents. One commenter suggested banning both mechanical restraint 
and seclusion for patients who are 17 years of age or younger. Several 
commenters offered permutations of this suggestion, such as a ban on 
the use of mechanical restraint for patients under 17 years of age.
    Response: Situations exist where it may become necessary to 
restrain or seclude a child or adolescent to ensure the safety of the 
patient or others. Regardless of age, the selection of an intervention 
must be individualized for each patient. When a restraint is used to 
manage self-destructive or violent behavior that jeopardizes the 
immediate physical safety of the patient, a staff member, or others, a 
variety of factors, such as medical condition, disability, psychiatric 
condition, history of abuse, height, and weight, as well as age, must 
be assessed and evaluated to determine the least restrictive 
intervention that will effectively ensure the safety of the patient and 
others. In unique emergencies, a mechanical restraint may be necessary 
for a patient under 17 years of age. For example, if a 250-pound 16-
year old male is physically attacking another patient, staff may have 
limited options to stop the attack. At times, the child's size may 
eliminate the ability to safely use a physical hold with the staff 
available. The child's medical condition (for example, asthma or a 
fractured limb) could also contraindicate the use of a physical hold.
    However, we recognize that children and adolescents, as well as 
adults, are vulnerable and at risk when restrained or secluded to 
manage violent or self-destructive behavior that jeopardizes the 
immediate physical safety of the patient, a staff member, or others. 
Therefore, we have retained the time limits on each order for restraint 
or seclusion to manage aggressive destructive in combined standard (e). 
Orders are limited to 4 hours for adults 18 years of age or older; 2 
hours for children and adolescents 9 to 17 years of age; and 1-hour for 
children under 9 years of age. The restraint or seclusion order may 
only be renewed in accordance with these limits for up to a total of 24 
hours. Before writing a new order, a physician or licensed independent 
practitioner must see and assess the patient.
    Comment: Many commenters indicated that the restraint definition is 
too broad and includes items that are typically used in the provision 
of care, such as catheters, drainage tubes, plastic casts, and 
bandages, which can restrict freedom of movement. Several commenters 
asked whether adaptive or protective devices such as helmets, or 
devices that are used for postural support, meet the definition of 
restraint. One commenter asked whether CMS would permit the use of 
devices to assist with chronic conditions or for physically frail 
patients. One commenter asked that we address the use of restraint for 
dental, diagnostic, and surgical procedures. The commenter stated that 
devices used for medical immobilization are given an exemption by 
JCAHO. The commenter asked if CMS would create a mirroring exemption.
    Response: In response to comments, we have added language that 
limits the application of this definition. In the final rule, a 
restraint does not include devices, such as orthopedically prescribed 
devices, surgical dressings or bandages, protective helmets, or other 
methods that involve the physical holding of a patient for the purpose 
of conducting routine physical examinations or tests, or to protect the 
patient from falling out of bed, or to permit the patient to 
participate in activities without the risk of physical harm (this does 
not include a physical escort). The devices and methods listed here 
that would not be considered restraints, and thus not subject to these 
requirements, are typically used in medical surgical care. Adaptive 
devices or mechanical supports used to achieve proper body position, 
balance, or alignment to allow greater freedom of mobility than would 
be possible without the use of such a mechanical support is not 
considered a restraint. For example, some patients are unable to walk 
without the use of leg braces, or are unable to sit upright without 
neck, head or back braces. Such devices generally permit the patient to 
participate more fully in activities without the risk of physical harm.
    Comment: Several commenters suggested that devices used for 
security purposes should be exempt from the regulatory requirements. 
Another commenter argued that forensic hospitals or units should be 
exempted from the regulatory requirements because they compromise the 
hospital's ability to manage behavior.
    Response: The use of handcuffs or other restrictive devices applied 
by law enforcement officials who are not employees of the hospital for 
custody, detention, and public safety reasons are not governed by this 
rule. The law enforcement officers who maintain custody and direct 
supervision of their prisoner (the hospital's patient) are responsible 
for the use, application, and monitoring of these restrictive devices 
in accordance with Federal and State law. However, the hospital is 
still responsible for providing safe and appropriate care to the 
patient.
    Comment: One commenter argued for the need for ``programmatic'' use 
of restraint for mentally retarded patients

[[Page 71390]]

in a psychiatric or an acute care unit and stated that the interim 
final rule with comment period created a barrier to using a restraint 
as part of a treatment plan.
    Response: Our expectation is that restraint or seclusion will not 
be a standard response to a particular behavior or situation. The use 
of such interventions is a temporary measure that protects the safety 
of patients and others, but is not a long-term solution for handling 
problematic behavior.
3. Definition of ``Drug Used as a Restraint'' (Sec. Sec.  482.13(e)(1) 
and (f)(1))
    We stated that a drug used as a restraint is a medication used to 
control behavior or restrict the patient's freedom of movement and is 
not a standard treatment for the patient's medical or psychiatric 
condition.
    Comment: Some commenters indicated that the definition of ``drug 
used as a restraint'' was too broad, subjective, and confusing. One 
commenter suggested that we adopt the definition of chemical restraint 
found in the long-term care interpretive guidelines--that is, ``A 
medication used for discipline or convenience that is not required to 
treat medical symptoms.''
    Several commenters argued that the determination of what 
constitutes a ``standard treatment'' for certain medical or psychiatric 
conditions is too subjective. One commenter observed that physicians 
may legitimately order nonstandard treatments for their patients. 
Another commenter noted that problems present in mentally retarded 
patients do not correspond closely to any medical or psychiatric 
diagnosis and that the rule only discusses these two sorts of standard 
uses of medication. One commenter explained that in acute care, 
medications are changed based on the patient's medical condition and 
symptoms. This commenter also stated that this regulation creates a 
burden for the administrative staff that will have to distinguish a 
drug used as ongoing medical management from a drug that, at some 
point, has evolved into a restraint that is not part of standard 
treatment.
    Other commenters grappled with how to characterize the appropriate 
role of medications in a patient's care. For example, one commenter 
expressed alarm at the apparent ban on PRN orders for medications that 
might affect a patient's behavior or restrict a patient's movement. The 
commenter argued that medications for behavioral health patients are 
used precisely to affect behavior so that the patient can participate 
more fully in his or her care, treatment, and therapy. The commenter 
stated that they are administered in order to avoid the emergence or 
escalation of specific behaviors that might prompt the use of more 
restrictive physical restraints or seclusion. The commenter also stated 
behavioral health providers recognize that the use of the same drug may 
be therapeutic in one instance and not in another, and have indicated 
that a drug used as a restraint should not be applied when its use 
impedes a person's ability to participate in his or her care. Some 
commenters noted that drug therapy should be part of an effective 
treatment plan to manage behavior.
    There was little agreement among commenters as to how drugs used to 
restrain patients should be handled. While a few commenters agreed with 
the concept that a drug used as a restraint is not a standard treatment 
(one stating that ``prohibition is critical''), several recommended 
deleting any reference to a drug used as a restraint. One commenter 
argued that the use of medications is already closely scrutinized 
through pharmacy oversight and the physician ordering process. The 
requirements of the interim final rule with comment period add an 
unnecessary layer of oversight.
    Another commenter stated that the use of a drug as a restraint 
should appear in its own standard, as the use of a medication differs 
from physical interventions.
    The idea of a medication ``controlling'' behavior garnered 
considerable comments which included the following:
    <bullet> All psychotropic medications control behavior to the 
extent that they reduce psychiatric symptoms;
    <bullet> The idea of a medication controlling behavior is not as 
straightforward as it appears;
    <bullet> No medication ``controls'' behavior. A better word would 
be ``directs,'' ``contains,'' or ``ameliorates;''
    <bullet> All drugs have effects as a restraint; and
    <bullet> The phrase ``control behavior'' should be removed, and a 
drug used as a restraint should be defined as a drug used with the 
intent to restrain or restrict the patient's freedom of movement.
    One commenter asked for clarification regarding the classification 
of paralytic drugs, sedatives, and analgesics, and how they would be 
affected by the regulation.
    A commenter suggested that if a patient has consented to the use of 
a medication, it should not be classified as a drug used as a 
restraint. Another commenter argued that if a drug is used as a one-
time dose to help aid in the plan of care but is not part of the care 
plan, it is not a drug used as a restraint.
    Many commenters characterized the use of a drug as possibly the 
least restrictive alternative to deal with violent or aggressive 
behavior, arguing that its use is more humane than allowing the patient 
to escalate and lose self-control.
    Response: Patients have a fundamental right to be free from 
restraints that are imposed for coercion, discipline, convenience, or 
retaliation by staff, including drugs that are used as restraints. In 
the interim final rule with comment period, the definition of ``drug 
used as a restraint'' was phrased so that medications that are used as 
part of a patient's standard medical or psychiatric treatment would not 
be subject to the requirements of standards (e) or (f). These 
regulations are not intended to interfere with the clinical treatment 
of patients who are suffering from serious mental illness and who need 
therapeutic doses of medication to improve their level of functioning 
so that they can more actively participate in their treatment. 
Similarly, these regulations are not intended to interfere with 
appropriate doses of sleeping medication prescribed for patients with 
insomnia, anti-anxiety medication prescribed to calm a patient who is 
anxious, or analgesics prescribed for pain management. This language 
was intended to provide flexibility and recognize the variations in 
patient conditions.
    A standard treatment for a medication used to address a patient's 
condition would include all of the following:
    <bullet> The medication is used within the pharmaceutical 
parameters approved by the Food and Drug Administration (FDA) and the 
manufacturer for the indications it is manufactured and labeled to 
address, including listed dosage parameters.
    <bullet> The use of the medication follows national practice 
standards established or recognized by the medical community and/or 
professional medical association or organization.
    <bullet> The use of the medication to treat a specific patient s 
clinical condition is based on that patient's symptoms, overall 
clinical situation, and on the physician's or other LIP's knowledge of 
that patient's expected and actual response to the medication.
    An additional component of ``standard treatment'' for a medication 
is the expectation that the standard use of a medication to treat the 
patient's condition enables the patient to more effectively or 
appropriately function in the world around them than would be

[[Page 71391]]

possible without the use of the medication. If the overall effect of a 
medication is to reduce the patient's ability to effectively or 
appropriately interact with the world around the patient, then the 
medication is not being used as a standard treatment for the patient's 
condition. We believe that trained practitioners possess the skills and 
abilities necessary to identity when a drug or medication is being used 
as a standard treatment for the patient's condition and when it is not.
    Whether or not the use of a medication is voluntary, or even 
whether the drug is administered as a one time dose or PRN are not 
factors in determining if a drug is being used as a standard treatment. 
The use of PRN medications is only prohibited if the drug is being used 
as a restraint. The regulation supports existing State laws that 
provide more vigorous promotion of the patient's choice and rights.
    Of course, as with any use of restraint, staff must conduct a 
patient assessment to determine the need for other types of 
interventions before using a drug as a restraint. For example, a 
patient may be agitated due to pain, an adverse reaction to an existing 
medication, or other unmet care need or concern.
    There are situations where the use of a medication is clearly 
outside the standard for a patient or a situation, or a medication is 
not medically necessary but is used for patient discipline or staff 
convenience (neither of which is permitted by the regulation). In such 
situations, the patient has the right to be free from the use of a drug 
as a restraint.
    For example, a patient has Sundowner's Syndrome, a syndrome in 
which a patient's dementia becomes more apparent at the end of the day 
than the beginning of the day. The patient may become agitated, angry, 
or anxious at sundown. This may lead to wandering, pacing the floors, 
or other nervous behaviors. The unit's staff find the patient's 
behavior bothersome, and ask the physician to order a high dose of a 
sedative to ``knock out'' the patient and keep him in bed. The patient 
has no medical symptoms or condition that indicates that he needs a 
sedative. In this case, for this patient, the sedative is being used as 
a restraint for staff convenience. Such use is not permitted by the 
regulation. The regulation does not allow a drug to be used to restrain 
the patient for staff convenience, to coerce or discipline the patient, 
or as a method of retaliation.
    While the characterization of medications as more humane and less 
invasive was quite common in comments on the interim final rule with 
comment period, we put forth the caveat offered by one physician--that 
overuse of antipsychotic medications can result in severe, sometimes 
irreversible neurological side effects or Neuroleptic Malignant 
Syndrome, which is potentially fatal. Also increased psychotropic 
medication use may lead to excessive sedation and cognitive dulling 
that impairs the patient's ability to benefit from therapy. While 
medications can be a beneficial part of a carefully constructed, 
individualized treatment plan for the patient, medication use should be 
based on the assessed needs of the individual patient and the effects 
of medications on the patient should be carefully monitored.
    We agree with the many comments regarding the idea of a medication 
``controlling'' behavior. To further clarify our intent and respond to 
public comments, we have revised the definition of ``drugs used as a 
restraint.'' In this final rule, a drug used as a restraint is now 
defined as ``a drug or medication when it is used as a restriction to 
manage the patient's behavior or restrict the patient's freedom of 
movement and is not a standard treatment or dosage for the patient's 
condition.''
    Comment: One commenter asked whether the time-limited orders and 
the assessment, documentation, and monitoring requirements of standards 
(e) and (f) apply to a drug used as a restraint.
    Response: Yes. If the use of the medication for the patient meets 
the definition of a drug used as a restraint, the requirements of 
combined standard (e) apply.
    Comment: One commenter asked that orders for PRN medications be 
deemed appropriate. Many commenters objected to the ban on PRN orders 
for drugs used as a restraint.
    Response: In the final rule, PRN orders for medications are not 
prohibited. The use of PRN orders is only prohibited for drugs or 
medications that are being used as restraints. We believe that ongoing 
assessment, monitoring, and re-evaluation by the ordering practitioner 
are even more critical when a patient is receiving treatment that is 
not standard, or is administered in amounts or at a frequency greater 
than recommended by the manufacturer or current standard of practice, 
for the patient's condition. Therefore, we are retaining this 
requirement.
4. Use of Restraints (Sec. Sec.  482.13(e)(2) and (e)(3)(i))
    Section 482.13(e)(2) states that a restraint can only be used if 
needed to improve the patient's well-being and less restrictive 
interventions have been determined to be ineffective. Section 
482.13(e)(3)(i) states that the use of a restraint must be selected 
only when other less restrictive measures have been judged to be 
ineffective to protect the patient or others from harm. These two 
provisions are redundant, and in the final rule we have collapsed them 
into one requirement. We will discuss them together, as the public 
comments tended to apply to both.
    Comment: One commenter believed that the regulation should include 
illustrations of less restrictive interventions and alternative methods 
for handling behavior, including a requirement that when there is a 
history of a particular less restrictive intervention being 
ineffective, other interventions must be tried.
    Response: Including such illustrations in the regulation is not 
feasible. Putting aside the fact that regulations generally provide 
requirements rather than best practice suggestions, each care situation 
consists of a unique combination of factors. What seems least 
restrictive for one patient may not be an appropriate option for 
another patient. The underpinning of this regulation is the concept 
that good patient care hinges on looking at the patient as an 
individual and assessing the patient's needs, strengths, weaknesses, 
and preferences. Such an approach relies on caregivers who are skilled 
in individualized assessment and in tailoring interventions to 
individual patient's needs after weighing factors such as the patient's 
condition, behaviors, and history. A list of progressive interventions 
that should be taken would undermine the emphasis on individualized 
care, and could discourage creativity in meeting patient needs. 
However, there are resources available. For example, the American 
Psychiatric Association (APA), American Psychiatric Nurses Association 
(APNA), and the National Association of Psychiatric Health Systems 
(NAPHS), with support from the American Hospital Association (AHA), 
have sponsored the publication of a document entitled, ``Learning from 
Each Other--Success Stories and Ideas for Reducing Restraint/Seclusion 
in Behavioral Health.'' This document, published in 2003, was developed 
through dialogue with the field and extensive input from behavioral 
healthcare providers throughout the country who have been working to 
reduce the use of restraint and seclusion, and to improve care within 
their facilities. To access this document and other useful resources, 
visit the web sites of the sponsoring organizations:

[[Page 71392]]

http://www.naphs.org; http://www.psych.org; http://www.apna.org; http://www.aha.org.
    Comment: One commenter argued that it would be impossible to comply 
both with the Patients' Rights CoP standard (c), which protects patient 
safety and the patient's right to be free from all forms of harassment, 
and standard (f). The commenter included the following example, a manic 
or psychotic patient may be verbally abusive to another patient or 
destructive of that patient's property without actually being a 
physical threat to the other patient. The commenter stated that such 
behavior has often been handled by the use of seclusion until 
medication can relieve the patient's agitation and abusiveness.
    Response: Standard (c) provides that each patient has the right to 
receive care in a safe setting, and the right to be free from all forms 
of abuse or harassment. This standard clearly prohibits the behavior 
described by this commenter, and some type of intervention would be 
warranted. However, such behavior need not prompt the automatic use of 
restraint or seclusion. The training requirements in standard (f) of 
this final rule ensure that patients are attended to by staff that are 
trained and skilled in utilizing an array of techniques and skills for 
handling aggression. Depending on this situation, various interventions 
(other than restraint or seclusion) may address the patient's behavior 
and simultaneously promote the right of others to safety and freedom 
from harassment and abuse.
    Comment: One commenter suggested that seclusion and restraint 
should be used only when less restrictive interventions, such as time-
outs and one-to-one staffing, are ineffective in preventing immediate 
injury of the patient or others. Several commenters asked whether less 
restrictive interventions actually had to be tried and shown to fail 
before a more restrictive intervention was used. A number of these 
commenters also questioned whether the patient or another person must 
be injured before more restrictive intervention may be undertaken.
    Response: Less restrictive interventions should be considered 
before resorting to the use of restraint or seclusion. However, it is 
not always appropriate for less restrictive alternatives to be 
attempted prior to the use of restraint or seclusion. For example, when 
a patient physically attacks another patient, immediate action is 
needed. When a patient's behavior presents an immediate and serious 
danger to the patient or others, immediate action is needed. While 
staff should be mindful of using the least intrusive intervention, it 
is critical that the intervention selected be effective in protecting 
the patient or others from harm. Therefore, we have retained the 
requirement that a restraint or seclusion can only be used when less 
restrictive interventions have been determined to be ineffective to 
protect the patient or others from harm.
    Comment: One commenter suggested adding, ``The patient has the 
right to be treated in a safe manner when special procedures are 
required for the patient's care.''
    Response: While we agree that the patient has the right to be 
treated in a safe manner, we believe that this right exists regardless 
of whether or not the patient is undergoing a special procedure.
    Comment: One commenter suggested considering an issue raised by a 
New England Journal of Medicine article; specifically, that the 
regulation should state plainly that a competent patient may refuse the 
use of physical restraint in the patient's acute care or treatment. The 
commenter further suggested that an incompetent patient's 
representative should be able to exercise this right to refuse physical 
restraint on the patient's behalf. Similarly, another commenter stated 
that the regulation should consider the individual's right to make 
choices regarding their health care. The commenter further stated that 
after complete information is provided about the method, risks, and 
effects of these procedures, individuals and families should have the 
right to either reject their use or select them as part of an overall 
treatment regime.
    Response: The Patients' Rights CoP promotes the patient's right to 
be involved in and make decision about the patient's health care. 
Standard (b)(2) states that the patient or his or her representative 
(as allowed under State law) has the right to make informed decisions 
regarding his or her care. The patient's rights include being informed 
of his or her health status, being involved in care planning and 
treatment, and being able to request or refuse treatment. This right 
must not be construed as a mechanism to demand the provision of 
treatment or services deemed medically unnecessary. In this context, 
the use of a restraint would be considered a ``treatment.'' Before the 
patient decides to request or refuse the use of restraint or seclusion, 
the patient must be informed of the risks associated with refusing the 
use of a restraint. While the hospital should work with the patient 
regarding preferences as much as possible, the hospital is not 
obligated to come up with a menu of alternative options because of the 
patient's refusal. The hospital may refuse to perform a procedure or 
render care if it believes that it is unable to safely and 
appropriately do so because of the patient's refusal to allow certain 
aspects of the prescribed treatment. In addition, if the patient's 
violent or self-destructive behavior jeopardizes the immediate physical 
safety of the patient, a staff member, or others, the patient does not 
have the right to refuse the use of restraint or seclusion. In this 
situation, the use of restraint or seclusion is an emergency measure to 
protect the safety of the patient, staff, or others. If the patient or 
the patient's representative requests the use of restraint or 
seclusion, the attending practitioner would need to decide whether the 
intervention is appropriate.
    In conclusion, the restraint or seclusion requirements do not 
prevent the patient from making informed decisions or participating in 
the patient's healthcare. The rule establishes the patient's right to 
be free from inappropriate restraint or seclusion, and lays out basic 
protections in the event that these interventions are needed.
    Comment: One commenter questioned whether, because of the 
``Patients'' Rights'' provisions regarding patient privacy and safety, 
a restrained patient must be restrained in a separate, private room, 
and not in the day room.
    Response: A hazard of restraining a patient is the damage that may 
be done to the patient's dignity. The patient may feel dehumanized or 
humiliated, which could be exacerbated by having peers witness the 
experience. Certainly, we would not expect that a patient put in four-
point restraint would be placed in the midst of the day room in a 
psychiatric facility since this would be humiliating to the patient. 
The restrained patient should be afforded as much privacy as possible. 
Since an underlying therapeutic goal for any psychiatric patient is the 
development of a strong sense of self-worth and dignity, the hospital 
should take steps to protect the privacy of the restrained patient.
    However, an individual wearing mitts to prevent self-mutilating 
behaviors is also being restricted. These individuals may desire 
socialization and group activity notwithstanding these restraints that 
a patient in the midst of a psychiatric crisis would not. We provide 
these examples to stress that it is critical for the hospital to use an 
individualized approach that is in the best interest of the patient and 
promotes

[[Page 71393]]

the patient's health, safety, dignity, self-respect, and self-worth.
    Comment: Several commenters believed that the documentation of 
clinical justification for the use of seclusion and restraint, the 
alternative methods used, and the reasons for their ineffectiveness 
should be included in the patient's record. Another commenter was 
concerned that staff's time for direct patient care would be diverted 
into creating documentation if we require demonstration that less 
restrictive interventions were proven ineffective in cases that involve 
medical immobilization.
    Response: We agree with the commenters. In the final rule under 
combined standard (e), we have specified that when restraint or 
seclusion is used, the following must be documented in the patient s 
medical record:
    <bullet> The 1-hour face-to-face medical and behavioral evaluation 
when restraint or seclusion is used to manage violent or self-
destructive behavior that jeopardizes the immediate physical safety of 
the patient, a staff member, or others;
    <bullet> A description of the patient's behavior and the 
intervention used;
    <bullet> Alternatives or less restrictive interventions attempted 
(as applicable);
    <bullet> The patient's condition or symptom(s) that warranted the 
use of the restraint or seclusion; and
    <bullet> The patient's response to the intervention used, including 
the need for continued use of the intervention.
    We believe that such documentation is a usual and customary 
recordkeeping practice. This information will provide a valuable tool 
for charting the patient's course of treatment as well as examining 
trends of use.
    In response to comments, we have added language that limits the 
application of the restraint definition. In the final rule, a restraint 
does not include devices, such as orthopedically prescribed devices, 
surgical dressings or bandages, protective helmets, or other methods 
that involve the physical holding of a patient for the purpose of 
conducting routine physical examinations or tests, or to protect the 
patient from falling out of bed, or to permit the patient to 
participate in activities without the risk of physical harm (this does 
not include a physical escort). The devices and methods listed here, 
typically used in medical/surgical care, would not be considered 
restraints and, therefore, not subject to these requirements. We 
believe that this addresses the commenter's concern regarding the 
burden of documentation in such cases.
    Comment: Several commenters asked that the word ``determined'' be 
replaced with the word ``found.''
    Response: We consulted the dictionary to determine whether there 
was some significant difference between these two words. We found none. 
When we combined the two requirements, we retained the word 
``determined.''
    Comment: One commenter suggested moving the sentence, ``A restraint 
can only be used if needed to improve the patient's well-being and less 
restrictive interventions have been determined ineffective,'' from 
paragraph (e)(2) to paragraph (e)(1). The commenter stated that this 
would place a greater emphasis on the fact that less restrictive 
measures must be demonstrated to be ineffective first.
    Response: Although we agree that the language in paragraph (e)(2) 
is an essential component of standard (e), we do not believe that it is 
necessary to relocate this language to paragraph (e)(1). We also note 
that we have revised the regulatory text in the final rule to state 
that ``a restraint can only be used when less restrictive interventions 
have been determined to be ineffective to protect the patient or others 
from harm.'' We deleted the language ``to enhance the patient's well-
being'' for clarity.
    Comment: One commenter asked which individual(s) would be 
responsible for making the determination that a less restrictive 
intervention was ineffective, and suggested that we use the phrase 
``clinically determined'' to indicate that this decision would be made 
by the nursing staff.
    Response: Since any trained clinical staff could make such 
decisions, we have decided not to specify further who should determine 
that a less restrictive intervention is ineffective for a particular 
patient.
    Comment: One commenter stated that positive reinforcement should be 
used prior to restraint or seclusion.
    Response: Combined standard (e) specifies that restraint or 
seclusion may only be used when less restrictive interventions have 
been determined to be ineffective to protect the patient or others from 
harm. The intent, as suggested by the commenter, is to encourage staff 
to use alternative, less restrictive methods, such as positive 
reinforcement, in the patient's treatment.
5. Ordering of Restraint/Seclusion (Sec.  482.13(e)(3)(ii) and 
(f)(3)(ii))
    In this section, we stated that the use of a restraint must be in 
accordance with the order of a physician or other licensed independent 
practitioner (LIP) permitted by the State and hospital to order a 
restraint. Section 482.13(f)(3)(ii) reiterated this requirement when a 
restraint is used for behavior management, but added that the use of 
seclusion must also be in accordance with such an order.
a. Definition of Licensed Independent Practitioner (LIP) (Sec. Sec.  
482.13(e)(3)(ii) and (f)(3)(ii))
    Comment: Many commenters stated that the definition of LIP was 
unclear and open to interpretation. These commenters were unsure of how 
delegated authority affected whether a practitioner was considered an 
LIP, of which ``independent'' practitioners qualify as LIPs, and of how 
the counter-signing of orders affected the determination of whether a 
practitioner is independent.
    Several independently licensed health professionals, such as nurse 
practitioners and physician assistants, applauded our inclusion of the 
LIP as recognition of highly trained individuals with strong patient 
assessment skills. These commenters stated that it was important to 
recognize the contribution of the multidisciplinary team in today's 
health care settings.
    Many commenters asked for an explanation of who would be considered 
an LIP. Some commenters wanted explicit recognition of registered 
nurses as LIPs; one commenter suggested replacing ``LIP'' with the term 
``health care professional,'' so that registered nurses would clearly 
be included. Many licensed professionals such as physician assistants, 
nurse practitioners and advanced practice registered nurses were 
concerned that narrow interpretation of the term ``LIP'' might limit 
their ability to be fully involved in patient care. One organization 
stated that ``LIP'' is the most problematic language in JCAHO's 
standards and argued that use of this term might result in 
inappropriate limits on its constituents' scope of practice. This 
organization explained that the phrase is given wide and varied 
interpretations by both hospitals and JCAHO surveyors.
    Another concern expressed by commenters was that this regulation 
marked the first appearance of this term in the CoPs. Several 
commenters questioned how LIPs might be introduced in the remaining 
hospital CoPs.
    One commenter viewed the term ``LIP,'' with its requirement that 
the practitioner be able to independently order restraint or seclusion, 
as restricting existing practice. This

[[Page 71394]]

commenter argued that such a restriction should only occur after a 
finding that the existing practice has had an adverse effect on patient 
care or that limiting this authority to physicians would improve 
patient care. The commenter believed that neither the former nor the 
latter point have been demonstrated or proven. This commenter also 
noted that State law usually addresses when an LIP may order 
restraints.
    Response: The introduction of an alternative practitioner who could 
order interventions, assess patients, and renew orders was an attempt 
to accommodate existing State laws that acknowledge the role of non-
physicians in patient care and treatment. We originally used the term 
``LIP'' to describe these practitioners to be consistent with existing 
JCAHO standards.
    For the purposes of this rule, a LIP is any individual permitted by 
State law and hospital policy to order restraints and seclusion for 
patients independently, within the scope of the individual's license 
and consistent with the individually granted clinical privileges. This 
provision is not to be construed to limit the authority of a physician 
to delegate tasks to other qualified healthcare personnel, that is, 
physician assistants and advanced practice nurses, to the extent 
recognized under State law or a State's regulatory mechanism, and 
hospital policy. It is not our intent to interfere with State laws 
governing the role of physician assistants, advanced practice 
registered nurses, or other groups that in some States have been 
authorized to order restraint and seclusion or, more broadly, medical 
interventions or treatments.
    Each State faces the issue of how to best provide its citizens with 
access to needed health care services. The issue is complex, as some 
States have special considerations such as geographic barriers to care 
delivery, medically underserved areas, and special population needs, 
all of which would affect how a State resolves this issue. To disregard 
a State's decision about who is qualified to order medical treatments 
and interventions and render patient care would be unproductive and 
arbitrary.
    To clarify this, in combined standard (e), we have revised the 
standard to state that the use of a restraint or seclusion must be in 
accordance with the order of a physician or other licensed independent 
practitioner who is responsible for the care of the patient as 
specified under Sec.  482.12(c) and authorized to order restraint or 
seclusion by hospital policy in accordance with State law.
b. Physician Only
    Comment: While some commenters supported deferring to the States' 
determination of which health professionals are allowed to order 
seclusion or restraint, one contingent opposed allowing anyone other 
than a physician to order restraint or seclusion, evaluate the patient, 
or renew an order for restraint or seclusion. This group pushed for the 
rule to override existing State laws that would allow these functions 
to be performed by anyone other than a physician. Several of these 
commenters stated that the clinical skills and qualifications of some 
licensed therapists are not necessarily indicative of an understanding 
and knowledge of the medical needs or risks of patients in seclusion or 
restraint. Without this understanding or knowledge, there continues to 
be risk to patients if other medical symptoms are overlooked.
    Some commenters cited national legislation pending at the time that 
would permit only a physician to order restraint/seclusion. Advocacy 
organizations charged that by permitting someone other than a physician 
to order restraint or seclusion, CMS would be allowing any 1 of over 
600,000 mental health professionals to authorize the use of restraint 
and seclusion, effectively undermining the purpose of the rule. Many 
commenters reminded us that the motivation behind the promulgation of 
this rule is the increasing concern regarding injuries, deaths or harm 
associated with the use of restraint and seclusion. One commenter 
maintained that by significantly narrowing the categories of clinicians 
permitted to authorize the use, the risk of misuse or overuse of 
restraint and seclusion would be minimized.
    Several commenters cited the importance of physicians' clinical 
training, the fact that they are individually accountable, and the fact 
that they are distanced from the daily stress and conflicts that arise 
between non-physician staff members and patients. Other commenters 
asserted that it is reasonable to require that only a physician 
authorize the use of procedures that can have serious and dangerous 
consequences for patients. A number of factors may lead to a patient 
displaying violent or agitated behavior, including inappropriate 
medication, which often times can be corrected immediately. One 
national organization representing physicians also opposed the 
recognition of non-physicians as being able to order restraints and 
seclusion.
    Response: Some States have issues such as geographic barriers to 
care delivery, medically underserved areas, and special population 
needs. States have handled these difficult issues through a variety of 
mechanisms. If a State has decided that a group of practitioners may 
order medications or treatments exclusively, we defer to State laws.
    Physicians are individually accountable for the care of their 
patients. The physician has the discretion to delegate, or to withhold 
the delegation of, tasks or responsibilities as he or she deems 
appropriate. We believe that the physician is more than capable of 
making the determination regarding whether his or her direct oversight 
is necessary, or whether in some situations, as permitted by hospital 
policy, these functions can be performed by another practitioner. The 
continued physician accountability for actions taken under his or her 
license provides a direct incentive for taking the decision to delegate 
very seriously.
    As commenters pointed out, clinical psychologists or other 
practitioners who may be authorized by the State to order restraint or 
seclusion may lack the technical medical skills and training to conduct 
a comprehensive physical assessment. Therefore, the practitioner who 
conducts the 1-hour face-to-face evaluation must be able to complete, 
under their scope of practice, both a physical and psychological 
assessment of the patient. To ensure physician oversight of restraint 
and seclusion, we have retained the requirement that the attending 
physician must be consulted as soon as possible if the attending 
physician did not order the restraint or seclusion.
    Comment: Some commenters representing independent residential 
treatment centers, day programs, skilled nursing facilities, and other 
non-hospital provider types mistakenly believed that the requirements 
in these hospital CoPs were applicable to them. Accordingly, a number 
of the commenters cited physician access as a problem.
    Response: We reiterate that these requirements apply to Medicare- 
and Medicaid-participating hospitals only, that is, short-term, 
psychiatric, rehabilitation, long-term, children's and alcohol-drug 
hospitals. The pending regulations based on the CHA will address the 
use of restraint and seclusion in the other settings noted above.

[[Page 71395]]

    Comment: Several commenters expressed concern that practitioners 
without psychiatric training may be allowed to order seclusion or 
restraint to manage aggressive, self-destructive or violent patient 
behavior.
    Response: We have revised combined standard (e) to specify that the 
use of restraint or seclusion must be ordered by a physician or other 
LIP who is responsible for the care of the patient and authorized to 
order restraint or seclusion by hospital policy in accordance with 
State law. We have also tied the order for restraint or seclusion to 
the patient's attending physician. The attending physician must be 
consulted as soon as possible if the attending physician did not order 
the restraint or seclusion. We believe that this modification will 
alleviate concerns about a practitioner who may not have psychiatric 
training, or is unfamiliar with the patient's condition or diagnosis 
providing orders for the patient's care.
    Comment: One commenter wrote that when fewer staff at the hospital 
are allowed to routinely approve seclusions or restraint, there is less 
likelihood of a serious review and a reduction of their use.
    Response: As part of a hospital's QAPI program, we would expect the 
use of restraint and seclusion to be monitored and evaluated on an 
ongoing basis. We believe that the number of staff permitted to order 
restraint or seclusion is irrelevant to the QAPI process.
    Comment: Several commenters were concerned that the regulation 
could be interpreted as precluding physicians enrolled in residency 
training programs from ordering restraints or seclusion, or from 
evaluating the need for their continued use. For example, in Maryland, 
residents generally do not hold a State medical license, but are 
authorized to practice without completing the usual licensing process. 
A commenter stated this is permitted because of the close supervision 
that residents receive during their training, and because required 
licensing is impractical since residents often move to another State to 
complete their training or to set up permanent practice.
    Response: In many States a resident is authorized by State law to 
practice as a physician. Therefore, there is no question that a 
resident can carry out the functions reserved for a physician or LIP by 
this regulation in accordance with State law.
    Comment: One commenter opined that psychologists and behavior 
analysts, not just physicians, should assume responsibility for the 
design and oversight of restraint and seclusion. Physicians should 
regulate chemical restraint and assume principal responsibility for the 
oversight of psychiatric problems and the design of pharmacological and 
psychiatric interventions.
    Response: We recognize the important role that psychologists and 
other behavioral health professionals play as members of the 
multidisciplinary team. We believe that these practitioners should 
participate in the design and oversight of restraint and seclusion 
practices, as well as participate in patient care. However, we do not 
believe Congress gave us the authority to create ordering authority for 
psychologists or other professionals in States that have not granted 
them this authority. Wherever State law and hospital policy have 
afforded ordering rights to these practitioners, we have honored that 
decision.
    Comment: One commenter stated that if the patient or the patient's 
surrogate voluntarily consents to the use of the restraint in the 
provision of acute medical and surgical care, an order from the 
physician or other LIP is not required per JCAHO's requirements. The 
commenter also stated that if restraints are clinically justified and 
consent is obtained, the care of the patient is consistent with the 
standards, and no order should be needed.
    Response: The current JCAHO standard at PC.11.40 requires that 
restraint use be based upon an individual order from an LIP. If an 
intervention meets the definition of a restraint, the regulatory 
requirements apply regardless of whether use of the restraint is 
voluntary or involuntary. This would include the requirement for a 
physician or other LIP order. The use of restraint is inherently risky. 
The risks associated with any intervention must be considered within 
the context of an ongoing process of assessment, intervention, 
evaluation, and re-evaluation.
c. Elimination of Protocols
    Many commenters discussed the key differences between acute medical 
and psychiatric settings and the use of protocols in specified 
situations in each of these settings. The more commonly cited examples 
included the use of arm boards to protect an IV site, or the restraint 
of a patient's arms to prevent the removal of an endotracheal tube. 
Commenters argued that in these situations, the need for restraint 
could be anticipated given the medical procedure or symptoms and 
condition of the patient. Before publication of the interim final rule 
with comment period, acute medical and postsurgical protocols were used 
to handle such situations. Use was triggered by the existence of 
specified criteria. Some commenters argued that disallowing acute 
medical and postsurgical protocols increases the risk of needless 
reintubating or replacement of IVs. Most hospitals use physician-
reviewed protocols to determine the need for restraint in the medical/
surgical context, a practice that is accepted by JCAHO. JCAHO affirmed 
this, and recommended allowing the use of protocols in certain 
situations with medical staff approval. JCAHO explained that during the 
treatment of certain specific conditions (for example, post-traumatic 
brain injury) or certain specific clinical procedures (for example, 
intubation), restraints might often be necessary to prevent significant 
harm to the patient. For those conditions or procedures, protocols for 
the use of restraint may be established based upon the frequent 
presentation of patient behavior that seriously endangers the patient 
or compromises the effectiveness of the procedures. Such protocols 
would include guidelines for assessing the patient, and criteria for 
application, monitoring, reassessment, and termination of the 
restraint. JCAHO stated that it was unaware of any evidence or studies 
indicating that the use of protocols in this manner has in any way 
diminished patient care. Some commenters expressed strong support for 
these types of protocols.
    One commenter stated that we should not prohibit the use of such 
protocols and the use of PRN orders by LIPs or physicians, and asked 
that we expressly state that those sorts of protocols are acceptable.
    One commenter pointed to a passage in the interim final rule with 
comment period (64 FR 36083) which discussed the initiation of 
restraint/seclusion according to protocols developed by hospital and 
medical staff, as permitting the use of acute medical and surgical 
protocols.
    Response: Protocols are not banned by the regulation. A protocol 
may contain information that is helpful for staff, such as how a 
restraint is to be applied and monitored. However, a protocol cannot 
serve as a substitute for obtaining a physician or other LIP order 
before initiating each episode of restraint or seclusion use, and the 
requirements of the regulation must still be met. The philosophy that 
serves as the foundation for the regulation is that restraint or 
seclusion use is an exception, not a routine response to a certain 
condition or behavior. Each patient should be thoroughly assessed. 
Interventions should be tailored to meet the individual patient's 
needs. The creation

[[Page 71396]]

of a protocol can run counter to this philosophy if it sets up the 
expectation that restraint will be used as a normal part of care. The 
use of restraint or seclusion is a last resort when less restrictive 
measures have been determined ineffective to protect the patient or 
others from harm, not a standard response to a behavior or patient 
need.
    As discussed previously, we have added language to combined 
standard (e) that limits the application of the definition of 
restraint. In the final rule, a restraint does not include devices, 
such as orthopedically prescribed devices, surgical dressings or 
bandages, protective helmets, or other methods that involve the 
physical holding of a patient for the purpose of conducting routine 
physical examinations or tests, or to protect the patient from falling 
out of bed, or to permit the patient to participate in activities 
without the risk of physical harm (this does not include a physical 
escort). The devices and methods listed here, typically used in 
medical/surgical care, would not be considered restraints and, 
therefore, not subject to these requirements. This revision clarifies 
the definition of a restraint and addresses many of the examples cited 
by commenters.
    When implementing a protocol that includes the use of an 
intervention that meets the definition of a restraint, a separate order 
must be obtained for the restraint. In addition, the patient's medical 
record must include documentation of an individualized patient 
assessment indicating that the patient's symptoms and diagnosis meet 
use-triggering criteria listed in the protocol. Hospitals that utilize 
protocols in the situations commenters described would be expected to 
provide evidence that there has been medical staff involvement in the 
development, review, and quality monitoring of their use.
d. Initiate versus Order
    Comment: Many facilities stated that they do not have a physician 
present 24 hours a day. One commenter suggested that the registered 
nurse be given the ability to assess and respond to emergency life 
threatening situations. Another commenter suggested that we should 
permit an emergency protocol that could be initiated by a health care 
professional if a physician or LIP was not present.
    Several commenters questioned whether an order would have to be 
obtained before initiating restraint or seclusion and requested 
clarification regarding who may initiate seclusion or restraint. One 
commenter suggested we require that, ``If an order cannot be obtained 
prior to instituting restraint or seclusion, their use must be 
authorized by a registered nurse, who shall document in the patient 
record both the reasons for restraint or seclusion as well as the need 
to use them prior to obtaining an order.'' One commenter stated that 
given the unpredictable frequency of emergencies and the need for 
intervention for certain conditions and populations, requiring a 
physician's order for each intervention is impractical. Others 
expressed concern that the regulations do not specifically say that a 
registered nurse can initiate restraint in an emergency situation, 
which is most often what happens.
    Response: We understand that physicians are not always onsite when 
an emergency occurs. Registered nurses play a vital role in ensuring 
patient safety and well being. We do not expect staff to stand by and 
let the patient injure himself or others without intervening simply 
because a physician is not present. The hospital may develop emergency 
procedures that staff follow before obtaining the order for restraint 
or seclusion; however, an order must be obtained as soon as possible.
    Many types of emergencies can occur, and staff are expected to 
effectively respond. In some emergency situations, the need for a 
restraint or seclusion intervention may occur so quickly that an 
appropriate order cannot be obtained before the application of 
restraints. In these emergency situations, the order must be obtained 
either during the emergency application of the restraint or seclusion, 
or immediately after the restraint has been applied. The hospital 
should address this process in its restraint policies and procedures. 
These hospital procedures should specify who could initiate the use of 
restraint or seclusion in an emergency prior to obtaining an order from 
a physician or other LIP.
6. Prohibition on Standing and PRN Orders (Sec.  482.13(e)(3)(ii)(A) 
and (f)(3)(ii)(A))
    We stated that an order for restraint must never be written as a 
standing or on an as needed basis (that is, PRN). Section 
482.13(f)(3)(ii)(A) contains a parallel provision for behavior 
management that also applies to orders for seclusion.
    Comment: We received many comments arguing that PRN orders for 
medication should be permitted. Many commenters, who objected to the 
PRN prohibition stated that it represents a departure from current 
practice. Some commenters supported the use of PRN medications as 
humane and efficacious, in that their administration may help the 
patient retain self-control and avert escalation of behavior that would 
require seclusion or physical restraint. These commenters argued that a 
professional registered nurse is able to appropriately assess and 
determine the need to administer a PRN. Other commenters argued that 
PRN medications are not a form of chemical restraint. One such 
commenter requested that we clarify that orders for PRN medications are 
appropriate.
    One commenter argued that the elimination of PRN medications could 
inhibit a patient's efforts to manage his/her own behaviors. Another 
commenter suggested that prohibiting PRN medications might backfire and 
lead to more routine orders for behavior-controlling medications, with 
some patients receiving more medication than they would have received 
with a PRN order. Other commenters stated that they were unsure of how 
the ban on PRN orders would effect the administration of medications 
prescribed for agitation.
    Conversely, several commenters stated that in their experience, PRN 
orders are overused for the convenience of staff, and de-escalation 
techniques are less likely to be attempted in any meaningful manner if 
such orders are available.
    Response: As discussed earlier, the use of PRN orders for 
medications is only prohibited when a medication is being used as a 
restraint. A drug is deemed to be a restraint only if it is not a 
standard treatment or dosage for the patient's condition. Using a drug 
to restrain the patient for staff convenience is expressly prohibited.
    Comment: Several commenters recommended deleting the word, 
``written'' from the provision, ``The order must never be written as a 
standing or on an as needed basis (that is, PRN).''
    Response: As we understand it, the commenters' objection to 
``written'' is that it fails to acknowledge that orders may be given 
verbally. Under Sec.  482.23(c)(2), all orders need to be documented in 
the patient's medical record either manually or electronically. Verbal 
orders need to be documented in the medical record by the person 
accepting the verbal order. This regulation does not prohibit the use 
of verbal orders for restraint or seclusion, but they must be used 
infrequently. Regardless of whether the order is written by the 
ordering practitioner or documented as a verbal order, the order may 
not be written as a standing or on an as needed basis.

[[Page 71397]]

    Comment: One commenter asked that we replace the word ``must'' with 
``shall'' in this section as well as throughout the regulation.
    Response: We currently use the word ``must'' rather than ``shall'' 
in regulations. Both terms mean that the action/activity is mandatory, 
and as such, the use of ``must'' provides a solid legal basis for 
enforcement. Therefore, we have maintained the use of ``must''.
    Comment: Several commenters indicated that PRN orders for any type 
of restraint or seclusion should never be used with children or 
adolescents and that all orders for seclusion should be time-limited 
based on the individual needs of the youth.
    Response: We agree and have maintained these provisions. An order 
for restraint or seclusion must never be written on a PRN basis. Orders 
for restraint or seclusion to manage self-destructive or violent 
behavior that jeopardizes the immediate physical safety of the patient, 
a staff member, or others must be time limited and should be tailored 
to the individual needs of the patient. An individualized assessment 
that considers the patient's characteristics, such as age, history, 
size, medical and mental condition, and preferences, should be the 
basis of any intervention. The regulation identifies maximum time 
limits on the length of order based on age. The physician or LIP has 
the discretion to write the order for a shorter length of time. The 
length-of-order requirement identifies critical points at which there 
is mandatory contact with a physician or LIP responsible for the care 
of the patient. In addition, the time limits do not dictate how long a 
patient is in restraint or seclusion. Staff should be continually 
assessing and monitoring the patient to ensure that the patient is 
released from restraint or seclusion at the earliest possible time. 
Restraint or seclusion may only be employed while the unsafe situation 
continues. Once the unsafe situation ends, the use of restraint or 
seclusion must be discontinued. In the final rule, combined standard 
(e) explicitly states that the intervention must be discontinued at the 
earliest possible time, regardless of the length of time identified in 
the order.
7. Consultation With the Treating Physician (Sec. Sec.  
482.13(e)(3)(ii)(B) and (f)(3)(ii)(B))
    We stated that this order must be followed by consultation with the 
patient's treating physician as soon as possible if the restraint is 
not ordered by the patient's treating physician. Sec.  
482.13(f)(3)(ii)(B) paralleled that requirement in the behavior 
management standard, and imposed the same requirement on seclusion if 
it is used.
    Comment: A few commenters suggested that the requirement for 
notifying the treating physician be deleted. Most comments on this 
provision revolved around the question of who the treating physician 
is, particularly when many physicians or specialists are involved in 
the patient's care. One commenter suggested that the ``treating 
physician'' should be the physician responsible for the part of care 
that requires the use of restraint, for example, the pulmonologist 
would write the order if the patient was on a ventilator. Another 
commenter indicated that the treating physician for the purposes of an 
emergency situation after hours is the medical officer on call. Other 
commenters stated that each hospital should be permitted to determine 
who the patient's treating physician is.
    Response: We agree with the commenters who recommended that 
hospital medical staff policies determine who is considered the 
treating (attending) physician. In addition, we have revised combined 
standard (e) to change the term ``treating physician'' to ``attending 
physician.'' We do not believe restraint or seclusion use is the only 
instance where the question of who is in charge of managing the overall 
medical care of the patient is of concern. Our intent is to ensure that 
the physician who has overall responsibility and authority for the 
management and care of the patient is aware of and involved in the 
intervention. The attending physician information regarding the 
patient's history may have significant impact on selection of a 
restraint or seclusion intervention.
    Comment: Several commenters asked what was meant by notification of 
the treating physician ``as soon as possible.'' Most of those who 
commented on this provision were not in favor of our use of ``as soon 
as possible.'' One commenter noted that when a restraint or seclusion 
incident occurs in the middle of the night, it is not realistic to 
request a consultation with the treating physician. In such a case, the 
consultation might be delayed 8 hours, possibly longer if ordered on a 
Friday evening. The commenter was concerned that an oversight review 
might not consider this standard practice as being ``as soon as 
possible.'' To clarify this point, the commenter suggested the 
following wording after ``as soon as possible': ``or the next working 
day if after hours, if the restraint or seclusion is not ordered by the 
patient's treating [that is, attending] physician(s).''
    One commenter argued that the more familiar the physician present 
at the time of the restraint or seclusion intervention is with the 
individual and the treatment plan, the less urgency there would be to 
obtain the required notification. One commenter suggested incorporating 
parameters or standards for how quickly this communication must be 
initiated and accomplished.
    Response: The purpose of attending physician notification is to 
promote continuity of care, to assure patient safety, and to elicit 
information from the attending physician that might be relevant in 
choosing the most appropriate intervention for the patient. Therefore, 
consultation should occur as soon as possible. Hospital policies and 
procedures should address the definition of ``as soon as possible'' 
based on the needs of their particular patient population. We have 
retained the requirement that the attending physician must be consulted 
as soon as possible if a restraint or seclusion is ordered by a 
practitioner other than the patient's attending physician.
    Comment: One commenter noted that primary physicians often have 
another physician on call for their patients when they are unavailable, 
such as during surgery or vacation. In these instances, the physician 
on call should be considered the treating physician.
    Response: We agree. When the attending physician is unavailable and 
has delegated responsibility for a patient to another physician, then 
the covering physician is considered the attending physician.
    Comment: A commenter indicated that this provision is ``cumbersome 
and can lead to problems, especially if the treating physician was 
listed on the admission and does not come into the hospital for twenty-
four hours if the patient was admitted on the weekend.''
    Response: This provision does not specify that consultation with 
the attending physician be face-to-face. The consultation can occur via 
telephone. In addition, when the attending physician is not available, 
responsibility for the patient must be delegated to another physician 
who would then be considered the attending physician.
    Comment: One commenter asked that we clarify that the patient can 
be under the care of a treating LIP other than a physician.
    Response: The hospital CoPs do permit the patient to be under the 
care of a treating LIP other than a physician. Section 482.12(c)(1) 
requires every Medicare patient to be under the care of a doctor of 
medicine or osteopathy; or

[[Page 71398]]

a doctor of dental surgery or dental medicine, a doctor of podiatry, 
chiropractor, or clinical psychologist within the scope of their 
license. The individual overseeing the patient's care may be the 
attending physician or a health professional practicing with the 
delegated authority or supervision of a doctor of medicine or 
osteopathy as permitted by State law and hospital policy. As noted 
earlier, we also defer to State laws that recognize the ordering rights 
of other types of practitioners. For the purposes of the use of 
restraint or seclusion, the attending practitioner must be able to 
conduct both a physical and psychological assessment of the patient in 
accordance with State law, their scope of practice, and hospital 
policy.
    Comment: One commenter stated that this requirement was highly 
prescriptive and unusual to be included in a CoP. Another commenter 
stated that this notification was unnecessary since the treating 
physician has the opportunity before the need for restraint or 
seclusion arises to alert hospital staff and other physicians or LIPs 
that use of restraint or seclusion would be an inappropriate 
intervention for the patient. These commenters recommended elimination 
of this requirement.
    Response: It is not the information in the medical record alone 
that should determine the course of treatment for a patient. Decisions 
about how best to manage a patient's care, engage the patient in 
treatment, and ensure continued progress in recovery require the 
oversight of the person with the authority and responsibility for the 
patient--the patient's attending physician.
8. Written Modification of the Plan of Care (Sec. Sec.  
482.13(e)(3)(iii) and (f)(3)(iii))
    We stated in this provision that an order for a restraint must be 
in accordance with a written modification to the patient's plan of 
care. A parallel provision in Sec.  482.13(f)(3)(iii) extended this 
provision into situations where restraint or seclusion is used to 
manage violent, self-destructive behavior that jeopardizes the 
immediate physical safety of the patient, a staff member, or others.
    Comment: Several commenters found this provision confusing and 
asked for clarification. One commenter was unsure of whether this 
requirement entails having the nurse explain the patient's behavior in 
a note, or having the nurse provide a more detailed, written plan. Some 
of these commenters suggested that the use of seclusion and restraint 
should not be stated in the patient's plan of care; instead, the 
behavior(s) that caused the use of seclusion or restraint and other 
interventions to address the behavior(s) should be documented.
    One commenter suggested that as written, this provision indicates 
that a modification to the plan of care would be required before the 
order being written for seclusion or restraint. The commenter observed 
that written modifications might not be possible prior to the renewal 
of the order because the review and modification should be conducted by 
the treating physician, while the on-call physician may be involved in 
assessing an episode of dangerous behavior. This commenter preferred to 
have a review of the patient's treatment plan within a certain 
timeframe after the episode, such as the next business day or within 72 
hours.
    One commenter stated that because restraint and seclusion should be 
exceptional rather than ordinary interventions, the regulation should 
incorporate the requirement that multiple restraint and seclusion 
orders trigger a re-evaluation of the plan of care. Another commenter 
agreed, recommending that the following language be added at Sec.  
482.13(f)(3)(ii)(D):

    Because multiple restraint and seclusion orders may indicate a 
need to evaluate and change the current placement and/or behavior 
management plan, where there are two or more restraint and seclusion 
orders within a one-week period, the chart shall indicate treatment 
team actions in evaluating the current placement and plan of care 
and the results of that evaluation.

    Response: The regulation does not require that a modification to 
the patient's plan of care be made before initiating or obtaining an 
order for the use of restraint or seclusion. The use of a restraint or 
seclusion intervention should be reflected in the patient's plan of 
care or treatment plan based on an assessment and evaluation of the 
patient. The plan of care or treatment plan should be reviewed and 
updated in writing within a timeframe specified by hospital policy. We 
have not required that multiple restraint and seclusion episodes 
trigger a re-evaluation of a placement or behavior management plan. We 
are retaining the language specified in the interim final rule with 
comment.
    In this final rule, we are specifying that the use of restraint or 
seclusion be documented in the patient's medical record. In response to 
comments, we have specified the required elements of documentation 
under the combined standard. Such documentation is a usual and 
customary recordkeeping practice. Therefore, we are retaining the 
language as specified in the interim final rule with comment period.
    Comment: Another commenter feared that much detail, such as a 
description of the event, what led to it, and key data and information 
typically available to anyone reading the patient's record, will be 
lost because the provision only requires a written modification to the 
plan of care. The commenter suggested that facilities would avoid 
placing such information in the patient's record to assure that the 
facilities are ``discovery protected.'' To remedy this, the commenter 
suggested expanding the regulation to require that each instance of 
seclusion or restraint and certain details must be entered into the 
patient's record.
    Response: We agree. We have revised combined standard (e) to 
require that the use of restraint or seclusion be documented in the 
patient's medical record and have specified the documentation elements. 
Under combined standard (e), the patient's medical record must contain 
documentation that includes: the 1-hour face-to-face medical and 
behavioral evaluation if restraint or seclusion is used to manage 
violent or self-destructive behavior that jeopardizes the immediate 
physical safety of the patient, a staff member, or others; a 
description of the patient's behavior and the intervention used; 
alternatives or other less restrictive interventions attempted (as 
applicable); the patient's condition or symptom(s) that warranted the 
use of the restraint or seclusion; and the patient's response to the 
intervention(s), including the rationale for continued use of the 
intervention. This type of documentation is a usual and customary 
recordkeeping practice. This information will provide a valuable tool 
for charting the patient's course of treatment as well as examining 
trends of use.
    Comment: One commenter believed that restraint date, time, and 
duration should be documented in the patient's record. Another 
commenter stated that the name, title, and credentials of staff members 
involved in the procedure should be included in the record.
    Response: We have required that when restraint or seclusion is 
used, certain elements must to be documented in the patient's medical 
record. We believe that some of the information that the commenter has 
suggested would indeed appear as part of the patient's medical record. 
Additional elements of documentation, such as name, title, and 
credentials of staff members involved in the procedure, should be 
specified in hospital policy.

[[Page 71399]]

    Comment: Several commenters recommended removing the word 
``written'' from the provision, ``in accordance with a written 
modification of the patient's plan of care.''
    Response: We have retained the word ``written'' in the provision, 
``in accordance with a written modification of the patient's plan of 
care.'' The use of restraint or seclusion constitutes a change in a 
patient's plan of care. Changes in a patient's plan of care must be 
documented. Documentation in the patient's medical record can be 
``written'' manually or electronically.
    Comment: One commenter suggested that the regulations should 
provide special protections for hearing impaired individuals who 
communicate in sign language using their hands and arms. To this end, 
this commenter recommended adding language to Sec.  482.13(f)(3): ``For 
a person whose mode of communication is through sign language, designed 
so that the person is able to effectively communicate in sign language 
despite restraints and/or seclusion.''
    Response: Providers are expected to meet the communication needs of 
their atients, whether those patients speak another language, are 
hearing or vision impaired, or have other conditions or characteristics 
that merit special intervention to assure smooth communication. 
However, there may be situations when it is necessary to place a 
patient with special communication needs in restraint or seclusion. In 
these situations, the hospital is expected to make reasonable efforts 
to meet these needs.
9. Implementation of and Appropriate Use of Restraint/Seclusion 
(Sec. Sec.  482.13(e)(3)(iv), (e)(3)(v), (f)(3)(iv), and (f)(3)(v))
    We stated that the use of restraint and seclusion must be 
implemented in the least restrictive manner possible and must be in 
accordance with safe and appropriate restraining techniques.
    No comments were received on these provisions. However, based on 
inquiries received after closure of the comment period, we have 
determined that the phrase ``used in the least restrictive manner'' 
needed further clarification; for example, how would a four-point 
restraint be used in ``the least restrictive manner''? Our intent is 
that if a restraint is necessary, the least restrictive intervention 
(which may vary, depending on the patient's history and condition) that 
effectively protects the patient's safety or that of others must be 
selected.
10. Discontinuing the Use of Restraint/Seclusion (Sec. Sec.  
482.13(e)(3)(vi) and (f)(3)(vi))
    We stated that restraint or seclusion, whether for acute medical 
and surgical care or for behavior management, must be ended at the 
earliest possible time.
    Comment: While some commenters expressed support for this provision 
as written, many hoped to clarify this language and offered either new 
wording or guiding concepts to be used in developing new wording. 
Several commenters recommended amending the regulatory text to read, 
``Ended at the earliest possible time, namely when no longer needed to 
ensure the patient's physical safety or whenever a less restrictive 
measure would protect the patient or others from harm. If restraint and 
seclusion are used simultaneously, the restraint and seclusion shall be 
independently evaluated to determine when either or both may be 
ended.'' A few commenters suggested that restraint use should be ended 
when it is no longer justified or when the emergency situation has 
subsided, rather than being dependent on an arbitrary timeframe. One 
commenter noted that the patient's release from seclusion and his or 
her rapid return to the therapeutic environment is desirable. Another 
commenter stated that a patient should be restrained or secluded only 
so long as necessary for the patient to regain self-control. One 
commenter noted that if the patient is able to take a bathroom break or 
eat a meal without incident, the restraint or seclusion should be 
discontinued. These commenters believed that the regulation did not 
clearly state that the intervention would end when the emergency was 
over.
    Response: These comments tended to be aimed at standard (f) rather 
than (e); overall, they seemed to reflect the concern that what 
constitutes ``at the earliest possible time'' may be subject to 
interpretation. To address this concern, we have revised the 
requirement in combined standard (e) to state that restraint or 
seclusion must be discontinued at the earliest possible time, 
regardless of the length of time identified in the order.
    Comment: One group of commenters wanted to allow the patient a 
trial period out of restraints, during which the patient would be 
closely observed. If the patient again exhibited the symptoms that had 
prompted the prior use of restraints, the patient would be placed in 
restraint again and this episode would be considered as part of the 
original episode/order.
    Response: The approach suggested by these commenters is equivalent 
to a PRN order, which is not permitted by combined standard (e). If 
staff ends an ordered intervention, they have no authority to start it 
again without the initiation of a new order. For example, a patient is 
released from restraint or seclusion. If this patient later exhibits 
violent or self-destructive behavior that jeopardizes the immediate 
physical safety of the patient, a staff member, or others that can only 
be handled through the use of restraint or seclusion, a new order would 
be required. Staff cannot discontinue an order and then restart it 
because that would constitute a PRN order. However, a temporary release 
that occurs for the purpose of caring for a patient's needs, for 
example, toileting, feeding, and range of motion, is not considered a 
discontinuation of the intervention.
11. Assessment, Monitoring, and Evaluation of the Restrained/Secluded 
Patient (Sec. Sec.  482.13(e)(4) and (f)(5))
    We stated that the condition of the restrained patient must be 
continually assessed, monitored, and reevaluated. Section 482.13(f)(5) 
created a parallel requirement when a patient is restrained or secluded 
for behavior management.
    Comment: There was much confusion over the meaning of 
``continually.'' One commenter pointed out that ``continually'' appears 
to refer to constant face-to-face observation in one portion of the 
interim final rule with comment period, while in another it seems to 
mean ongoing, but not constant, monitoring. Several commenters 
misinterpreted the requirement as forcing physicians and nurses to 
remain in a restrained patient's room for the duration of the restraint 
use, and argued that this would be a poor use of resources.
    Response: Ongoing assessment and monitoring of the patient's 
condition are crucial for prevention of patient injury or death. We are 
still requiring these activities, but leave it to staff discretion how 
frequently they are conducted based upon hospital policy and an 
individualized patient assessment. In the final rule, monitoring and 
assessment may occur periodically (for example, every 15 minutes) or 
continually (that is, moment to moment), depending on the patient's 
needs. With the exception of the simultaneous use of restraint and 
seclusion, one-to-one observation with a staff member in constant 
attendance is not required. To clarify this point, we have deleted the 
word ``continually'' from the monitoring requirements in combined 
standard (e) with one exception. We have retained the word 
``continually'' in the monitoring

[[Page 71400]]

requirements for the simultaneous use of restraint and seclusion.
    We expect hospital policies to guide staff in determining 
appropriate intervals for assessment and monitoring based on the 
individual needs of the patient, the patient's condition, and the type 
of restraint used. For example, placing staff at the bedside of a 
patient with wrist restraints may be unnecessary. However, for a more 
restrictive or risky intervention and/or a patient who is suicidal, 
self injurious, or combative, staff may determine that continual face-
to-face monitoring is needed. The hospital is responsible for providing 
the level of monitoring and frequency of reassessment that will protect 
the patient's safety. Based on public comments, we have revised 
combined standard (e) to clarify that the condition of the patient who 
is in restraint or seclusion must be monitored and assessed by a 
physician, or other licensed independent practitioner or trained staff 
at an interval determined by hospital policy. The criteria for staff to 
be considered ``trained'' are specified under Sec.  482.13(f).
    We have also added language to clarify that all requirements 
specified under combined standard (e) apply in the simultaneous use of 
restraint and seclusion, which is not permitted unless the patient is 
continually monitored. If restraint and seclusion are used 
simultaneously to manage self-destructive or violent patient behavior 
that jeopardizes the immediate physical safety of the patient, a staff 
member, or others, the patient must be continually monitored, face-to-
face, by an assigned, trained staff member; or continually monitored by 
trained staff using both video and audio equipment. This monitoring 
must be in close proximity to the patient. For the purposes of this 
provision, ``continually'' means ongoing without interruption.
    Comment: Some commenters requested clarification on the aspects of 
the patient's physical condition that must be monitored when the 
patient is in restraint or seclusion (indicators such as vital signs, 
circulation, hydration, level of distress, agitation), when staff re-
evaluate the need for continued use of restraint or seclusion, and when 
an LIP is deciding whether to renew the order for the intervention. 
Some commenters also suggested that the patient should be permitted 
bathroom breaks and the opportunity to eat meals.
    Response: The importance of appropriate assessment and monitoring 
of the patient's physical, emotional and behavioral condition when 
restraint or seclusion is used cannot be overemphasized. As the interim 
final rule with comment period stated, research indicates that the 
potential for injury or harm with the use of restraint is a reality. 
However, evaluation of the situation and each patient's individual 
medical needs and health status should be paramount considerations in 
choosing the intervention method, level of monitoring, and frequency of 
assessment. Hospital policies should address frequency of assessment 
and monitoring components of monitoring (for example, vital signs, 
hydration and circulation, level of distress and agitation, mental 
status, cognitive functioning, skin integrity), nutritional needs, 
range of motion, elimination needs, and other care needs. We cannot 
provide an exhaustive list of the items to be monitored because they 
will vary with the type of intervention used and the patient's 
condition. For example, the use of a restraint that keeps the patient 
immobilized would require a check of the patient's skin integrity and 
steps to prevent skin breakdown. Depending on the duration of the 
intervention, range of motion exercises might be necessary. The 
patient's mental status, as well as vital signs, should be assessed, 
particularly when the restraint is initiated to manage self-destructive 
or violent behavior that jeopardizes the immediate physical safety of 
the patient, a staff member, or others. The patient should be provided 
the opportunity for toileting, hydration, and eating if the 
intervention used impedes these activities.
    Reassessments of the patient's condition are essential to assure 
that the intervention ends as soon as possible. Again, we expect 
frequency of reassessments to be addressed by hospital policies. When 
the patient's self-destructive or violent behavior presents an 
immediate risk to the patient, a staff member, or others, frequent 
reassessments ensure the intervention is used only while the unsafe 
situation continues and is discontinued at the earliest possible time, 
regardless of the length of time identified in the order.
    The interim final rule with comment period did not, and this final 
rule does not, require that the practitioner who ordered the 
intervention be physically present to re-evaluate the need for 
continuing the intervention. The patient's attending practitioner 
should, however, be contacted with an update on the patient's status 
and an evaluation of the patient's mental and physical condition when 
the order for restraint or seclusion is about to expire if it appears 
that the intervention is still necessary. In this final rule, we have 
retained and revised the provision under combined standard (e) 
requiring that after 24 hours, a physician or other licensed 
independent practitioner who is responsible for the care of the patient 
as specified under Sec.  482.12(c) and authorized to order restraint or 
seclusion by hospital policy in accordance with State law must see and 
assess the patient before writing a new order for the use of restraint 
or seclusion for the management of violent or self-destructive behavior 
that jeopardizes the immediate physical safety of the patient, a staff 
member, or others. We have also specified that each order for restraint 
used to ensure the physical safety of the non-violent or non-self-
destructive patient may be renewed as authorized by hospital policy.
    Comment: A commenter asked what time frames were meant for 
``continuously assessed'' (that is, every 5 minutes, every 30 minutes). 
Some members of the public and one hospital argued that we should 
incorporate required 15-minute checks for restrained and secluded 
patients, as we had mentioned in the December 19, 1997 proposed rule. 
One commenter suggested that vital signs be taken every 2 hours, with 
written documentation of such checks in the medical record. Some 
commenters urged retaining flexibility in allowing clinical judgment to 
determine timeframes or intervals. Some commenters questioned the value 
of continual monitoring for a restrained patient who is sleeping or 
only awakening intermittently.
    Response: As discussed previously, we expect hospital policies to 
guide staff in determining appropriate intervals for assessment and 
monitoring based on the individual needs of the patient, the patient's 
condition, and the type of restraint used.
    Regarding the sleeping patient scenario, a staff person may or may 
not need to be permanently posted at a sleeping, restrained patient's 
bedside. The fact that a patient is at one point asleep does not 
guarantee that the patient will remain asleep hours on end and will 
therefore need no reassessment or monitoring. The selection of an 
intervention and determination of the necessary frequency of assessment 
and monitoring should be individualized, taking into consideration 
variables such as the patient's condition, cognitive status, risks 
associated with the use of the chosen intervention, and other relevant 
factors. In some cases, checks every 15 minutes or vital signs taken 
every 2 hours may not be sufficient to ensure the patient's safety. In 
others, it may be excessive or disruptive to patient care (for example, 
mandating that a patient with wrist restraints who

[[Page 71401]]

is asleep be checked every 15 minutes and awakened every 2 hours to 
take the patient's vital signs may be unnecessary). Similarly, 
depending on the patient's needs and situational factors, seclusion may 
require either periodic or constant monitoring. We expect staff to 
determine the appropriate level of monitoring and frequency of 
assessment based on hospital policy, an individualized patient 
assessment, and type of intervention used.
    Comment: Commenters discussed who should perform the assessment, 
monitoring, and re-evaluation. Some mental health consumer advocacy 
groups and their members suggested that a clinically licensed 
registered nurse should perform these tasks; another commenter 
suggested that they be performed by licensed professionals trained in 
mental health procedures.
    Response: We have revised combined standard (e) to provide 
hospitals flexibility in determining which staff performs the 
assessment and monitoring. This determination, of course, must be in 
accordance with the practitioner's scope of practice and State law. For 
example, assessment and monitoring are activities within a registered 
nurse's scope of practice. However, some trained, unlicensed staff may 
perform components of monitoring (for example, checking vital signs, 
hydration and circulation; the patient's level of distress and 
agitation; or skin integrity), and may also provide for general care 
needs (for example, eating, hydration, toileting, range of motion). 
Standard (f) requires that before applying restraints, implementing 
seclusion, or performing associated monitoring and care tasks, staff be 
trained and able to demonstrate competency in the performance of these 
actions. Combined standard (e) has been amended to require that the 
condition of the restrained patient be assessed and monitored by a 
physician, other LIP or by trained staff.
    Comment: One commenter suggested that a history of sexual 
victimization should be considered when restraining a patient. The 
commenter provided the following example: ``Most females who are raped 
are raped in the supine position, and therefore supine position is more 
likely to recreate the trauma. Similarly, it seems that most males who 
are raped are raped in a prone position, therefore prone restraint 
might well be contraindicated.''
    Response: The hospital should conduct a thorough individualized 
assessment of the patient that integrates the patient's salient history 
into the treatment plan. However, we will not be mandating this 
particular consideration in the regulation's text.
    Comment: One commenter urged that children not be left alone for 
long periods of time, as an hour can seem quite long when a child is 
distressed. Another commenter argued that children in restraint or 
seclusion should be monitored one-on-one.
    Response: We agree that children, as well as adults, may become 
distressed when left alone. We expect staff to determine the frequency 
and level of monitoring necessary based on hospital policy, an 
individualized patient assessment, and the type of intervention used.
    Comment: One commenter suggested that because the lack of vigorous 
physical activity may contribute to behaviors triggering restraint and 
seclusion, the regulations should include a section requiring vigorous 
physical activity for children.
    Response: The multidisciplinary team that works with each patient 
is able to create an individualized treatment plan that meets the 
patient's needs. We do not believe that arbitrarily mandating vigorous 
physical activity is wise or necessary.
    Comment: One commenter asked how continual assessment, monitoring 
and reevaluation would be documented.
    Response: How this information is documented will vary with the 
policies and practices of each hospital.
    Comment: One commenter asked whether a patient restrained for 
medical purposes could be monitored from a distance as long as the 
patient is kept within eyesight.
    Response: A patient restrained under combined standard (e) does not 
have to be continually monitored face-to-face unless restraint and 
seclusion are used simultaneously or continual face-to-face monitoring 
is clinically indicated.
12. Staff Training in the Use of Restraints/Seclusion (Sec. Sec.  
482.13(e)(5) and (f)(6))
    We stated that all clinical staff that have direct patient contact 
must have ongoing education and training in the proper and safe use of 
restraints. Section 482.13(f)(6) contains a similar requirement that 
specifies that all staff who have direct patient contact must have 
ongoing education and training in the proper and safe use of seclusion 
and restraint application and techniques and alternative methods for 
handling behavior, symptoms, and situations that traditionally have 
been treated through the use of restraints or seclusion.
    Comment: These provisions enjoyed much support from commenters. 
Several commenters quoted the Hartford Courant series (October 11, 
1998) as naming better staff training as a low cost mechanism for 
averting the situations described in the articles. Many hospitals 
agreed that the key to patient safety is staff training and competency, 
suggesting that this element more directly affects patient care than 
other factors suggested by CMS. One commenter stated the following:

    The death of a patient while in restraints or seclusion should 
never occur. To that end, steps need to be taken to assure that 
staff that initiate a restraint or seclusion intervention and those 
who later monitor and evaluate the patient are appropriately 
educated, trained, and demonstrate competencies in these practices. 
We see these issues as key to the safety and well being of patients 
and staff.

    One commenter reported that it provides staff with a minimum of 16 
hours of annual training that emphasizes verbal de-escalation 
techniques. This step, in combination with others, has resulted in 
dramatic reduction in restraint/seclusion use for that hospital in the 
past 2 years. Many other commenters reported that their hospitals 
employ extensive training for clinical staff; one commenter noted that 
training direct care staff is a good investment of its resources. 
Another commenter voiced its ``complete agreement'' with the training 
and educational requirements.
    One commenter expressed enthusiastic support for stringent and 
appropriate training, noting that this area needs to be expanded and 
enforced. This commenter stated, ``Until service providers are 
adequately trained in the proper use of restraints, all the regulations 
and rules in the world will not be able to ensure safety.'' Another 
commenter suggested that CMS should focus on ensuring that restraint 
and seclusion are used properly by monitoring training, education, 
proper privileging, and proper/effective staff monitoring by 
appropriate and available facility staff.
    Response: We appreciate the support expressed by commenters and 
share the belief that without adequate training and competency among 
the direct care staff, patients, staff and others are placed at risk. 
Patients have a right to the safe application of restraint or seclusion 
by trained and competent staff. We recognize the important role that 
staff training and education play in the reduction of restraint and 
seclusion use in a hospital. We applaud hospitals that currently 
provide extensive training and education for staff as part of a 
comprehensive program to ensure patient safety and minimize the use of 
restraint and seclusion.

[[Page 71402]]

    Based on public comments, we have revised our regulatory language 
to provide additional requirements for staff training that focus on 
demonstrated competencies and building a skill set for working with 
patients. We have also moved the training requirements from current 
standards (e) and (f), and created a separate standard (standard (f)) 
that addresses staff training. This was done to emphasize the 
importance of staff training in the safe use of restraint or seclusion.
    Standard (f) requires that staff be trained and able to demonstrate 
competency prior to applying restraints, implementing seclusion, or 
performing associated monitoring and assessment of, or providing care 
for a patient in restraint or seclusion. The hospital must require 
appropriate staff to have education, training, and demonstrated 
knowledge based on the specific needs of the patient population. Staff 
must demonstrate competencies as outlined in standard (f) initially, as 
part of orientation, and subsequently on a periodic basis. Individuals 
providing staff training must be qualified as evidenced by education, 
training, and experience in techniques used by hospitals to address 
patients' behaviors. Successful completion of training and 
demonstration of competency must be documented in staff personnel 
records.
    Comment: Many hospitals reported that they have instituted training 
programs and have made efforts to carefully examine and review their 
use of restraints. Some argued that such efforts, rather than 
regulatory standards, are the answer to reducing restraint-related 
injuries and deaths.
    Response: Some of the commenting hospitals stated that they have 
never had an injury or death related to restraints or seclusion use, 
and it is appropriate to acknowledge this achievement. As its 
appearance in our regulation affirms, we believe that a critical piece 
of ensuring the health and safety of the patient, staff, and others is 
comprehensive training. However, while training programs are a critical 
step to assuring patient safety, they do not serve as a substitute for 
a statement of basic performance expectations.
    Comment: One commenter requested that we define, ``direct patient 
contact.'' Several commenters questioned whether we intended that all 
staff be trained, including nonclinical personnel or those who have no 
part in the provision of care (that is, those who would be unlikely to 
take part in a restraint or seclusion intervention). Some disagreed 
with a broad training requirement, stating that it would be cost-
prohibitive. These commenters argued that the current wording could be 
construed as including housekeeping staff, service staff, clerical 
staff, administrative personnel, environmental services staff, dietary 
staff, laboratory staff, and all clinical staff. Many commenters argued 
that this level of education should be limited to clinical staff who 
apply and remove restraints or who provide primary direct care to 
patients who may require restraints. One commenter suggested that all 
staff should be trained ``commensurate with the amount of contact with 
patients'' rather than using direct contact alone as a criterion.
    Response: We have accepted the suggestions of these commenters. We 
have replaced the phrase, ``direct patient contact,'' with more 
specific language to clarify this requirement. We have revised our 
standards to require training for the staff who are involved with the 
application of a restraint, implementation of seclusion, providing care 
for a patient in restraint or seclusion, or with assessing and 
monitoring the condition of the restrained or secluded patient.
    Comment: One commenter asked whether training would be required for 
house medical staff/covering psychiatrists.
    Response: In the final rule, combined standard (e) specifies that 
physician and other LIP training requirements must be specified in 
hospital policy. At a minimum, physicians and other LIPs authorized to 
order restraint or seclusion by hospital policy in accordance with 
State law must have a working knowledge of hospital policy regarding 
the use of restraint and seclusion. Hospitals have the flexibility to 
identify training requirements above this minimum based on the 
competency level of their physicians and other LIPs and the needs of 
the patient population that they serve. Physicians receive training in 
the assessment, monitoring and evaluation of a patient's condition as 
part of their medical school education. However, physicians generally 
do not receive training regarding application of restraint or 
implementation of seclusion as part of their basic education. Depending 
on the level and frequency of involvement that a physician has in the 
performance of these activities, the physician or other LIP may or may 
not require training. If house staff, hospitalists or covering 
psychiatrists are the medical staff that are directly involved in the 
care of a patient in restraint or seclusion, a hospital may determine 
that training is necessary to insure competency of these individuals in 
this area. We believe the hospital is in the best position to determine 
if physician training is necessary based on the model of care, level of 
physician competency, and the needs of the patient population(s) that 
the hospital serves. Therefore, we have only mandated a minimum level 
of physician and other LIP training. Instead, we have provided 
hospitals with the flexibility to specify additional physician and 
other LIP training requirements, if any, in hospital policy.
    Comment: One commenter suggested that staff be required to talk to 
the patient intermittently to assist the patient's efforts to regain 
self-control and to explain what the patient needs to do for the 
restraint or seclusion to end.
    Response: The training requirements are intended to equip staff 
with skills that can be used in this fashion.
    Comment: One commenter suggested that there should be Federal 
compensation for the added cost of providing such training.
    Response: Staff training is generally included in administrative 
costs and is recognized in calculating payments under the hospital 
inpatient prospective payment system. Therefore, we are not providing 
separate compensation to fund this training.
    Comment: Several commenters asked about the frequency of training. 
One commenter suggested that the term ``ongoing'' should be replaced 
with ``annually.''
    Response: We have modified the regulatory text to require staff to 
demonstrate the competencies specified in standard (f) initially as 
part of orientation and subsequently on a periodic basis consistent 
with hospital policy. We believe the hospital is in the best position 
to identify a timeframe for ongoing training based on the level of 
staff competency, and the needs of the patient population(s) served.
    Comment: Commenters had varying ideas about what topics training 
should cover, and whether the regulation should specify training 
content in detail. Several commenters asked whether training must be 
obtained from Federally-specified programs.
    One commenter urged that requirements for the training curriculum 
be described in the regulations. A few commenters suggested that the 
current standard (f) training requirement should not be limited to the 
proper and safe use of restraints; one commenter suggested more 
emphasis on positive behavioral supports and less on ``proper'' use. 
One commenter supported education on alternatives to restraint use and 
safe handling of a patient in restraints. Another commenter suggested 
that the training should include personally experiencing being 
restrained. One commenter argued that staff should be

[[Page 71403]]

trained in values clarification, cultural diversity, and counter-
transference since it is commonly acknowledged that patients become 
more agitated and lose control when staff responds in a manner that 
provokes the patient.
    Response: We have adopted more detailed training requirements in 
this final rule. In addition, we have moved the training requirements 
from the current standards (e) and (f), and have created a separate 
standard (f) that addresses staff training requirements.
    Standard (f) states that the hospital must require appropriate 
staff to have education, training, and demonstrated knowledge based on 
the specific needs of the patient population in at least the following:
    <bullet> Techniques to identify staff and patient behaviors, 
events, and environmental factors that may trigger circumstances that 
require the use of restraint or seclusion;
    <bullet> The use of nonphysical intervention skills;
    <bullet> Choosing the least restrictive intervention based on an 
individualized assessment of the patient's medical, or behavioral 
status or condition;
    <bullet> The safe application and use of all types of restraint or 
seclusion used in the hospital, including training in how to recognize 
and respond to signs of physical and psychological distress (for 
example, positional asphyxia);
    <bullet> Clinical identification of specific behavioral changes 
that indicate that restraint or seclusion is no longer necessary;
    <bullet> Monitoring the physical and psychological well-being of 
the patient who is restrained or secluded, including, but not limited 
to, respiratory and circulatory status, skin integrity, vital signs, 
and any special requirements specified by hospital policy associated 
with the 1-hour face-to-face evaluation; and
    <bullet> The use of first aid techniques and certification in the 
use of cardiopulmonary resuscitation, including required periodic 
recertification.
    Staff need to employ a broad range of clinical interventions to 
maintain the safety of the patient and others in the provision care. 
The hospital is expected to provide education and training at the 
appropriate level to the appropriate staff based upon the specific 
needs of the patient population being served. For example, staff 
routinely providing care for violent or self-destructive behavior that 
jeopardizes the immediate physical safety of the patient, a staff 
member, or others (such as in an emergency department or on a 
psychiatric unit) generally require more in-depth training in the areas 
included in the regulation than staff routinely providing medical/
surgical care.
    Lastly, we have not required that training be obtained from 
Federally-specified programs. Hospitals may develop and implement their 
own training programs or use an outside training program. However, 
standard (f) specifies that individuals providing staff training must 
be qualified as evidenced by education, training and experience in 
techniques used to address patients' behaviors.
    Comment: One commenter suggested that training should include 
instruction on--(1) how to identify patients who may have conditions 
that would require special attention, (for example, a history of 
respiratory or cardiac problems); (2) how to monitor patients in 
restraints; and (3) what conditions are necessary for a person to be 
released from restraints. This commenter suggested that in standard 
(f), the training requirement should include instructions on how to 
screen patients for special problems that could affect the use, type, 
or duration of restraints (for example, emotional problems associated 
with a history of abuse or neglect).
    Response: We agree and have incorporated the suggested elements in 
standard (f).
    Comment: One commenter suggested that staff that has not completed 
training should be prohibited by regulation from initiating and 
complying with orders for restraint or seclusion.
    Response: We agree. In standard (f), we require that staff be 
trained and able to demonstrate competency before applying restraints, 
implementing seclusion, or performing associated monitoring and 
assessment of, or providing care for, a patient in restraint or 
seclusion. Application of restraint or seclusion by an untrained staff 
member, including contract staff, would constitute a violation of this 
requirement.
13. Definition of Seclusion (Sec.  482.13(f)(1))
    We defined seclusion as the involuntary confinement of a person in 
a room or an area where the person is physically prevented from 
leaving.
    Comment: Several commenters suggested adding the word ``alone'' to 
the definition of seclusion. Several commenters pointed out that the 
definition that appeared in the interim final rule with comment period 
would define a patient confined involuntarily on a locked unit as being 
secluded. Additionally, one commenter believed the word ``area'' was 
too broad and might be read as including being on a unit or ward with 
others.
    Response: In the final rule, we have added the word ``alone'' to 
this definition for clarity and retained the use of the word ``area''. 
Seclusion does not include confinement on a locked unit, ward, or other 
area where the patient is with others. Seclusion is not just confining 
a patient to an area but involuntarily confining the patient alone in a 
room or area where the patient is physically prevented from leaving. A 
situation where a patient is restricted to a room or area alone and 
staff are physically intervening to prevent the patient from leaving 
the room or area is also considered seclusion. In addition, we have 
clarified that seclusion may only be used for the management of violent 
or self-destructive behavior that jeopardizes the immediate physical 
safety of the patient, a staff member, or others.
    Comment: One commenter stated that physical restraint is more 
frequently associated with injury and death than is monitored 
seclusion. This commenter argued against categorizing seclusion with 
restraint, stating that its use should not be governed by the same 
requirements. Another commenter said that linking the terms 
``seclusion'' and ``restraint'' is misleading in that it creates the 
inaccurate perception that the two interventions are equivalent in all 
respects. This commenter could not imagine a death resulting from 
seclusion, other than from self-inflicted injury (which would indicate 
a possible need for restraint initially) or from the total and gross 
neglect of an acutely ill patient, which no amount of regulation would 
prevent, since this would represent unacceptable, deviant practice.
    One commenter stated that seclusion is therapeutically different 
from restraint. Seclusion is indicated when a patient's behavior poses 
a significant threat to others or is profoundly disturbing in the 
therapeutic environment (such as a patient disrobing in public). This 
commenter suggested that while this behavior is not violent, it is 
appropriately, humanely, and therapeutically addressed through 
seclusion.
    Response: The frequency and level of monitoring and assessment of 
the condition of a patient who is in restraint or seclusion are 
determined by staff based on hospital policy and an individualized 
patient assessment. These parameters would differ based on the type of 
intervention used. We would not necessarily expect these parameters to 
be identical for all types of restraint and the use of seclusion.

[[Page 71404]]

    In response to the comment about the therapeutic use of seclusion, 
we note that the use of seclusion is a means to an end, not the end 
itself. In the example given, simply secluding a patient who habitually 
disrobes is not a long-term solution to eliminating this inappropriate 
behavior. The patient should be assessed and engaged in an active, 
individualized treatment program.
    Comment: A commenter, concerned about the needs of students 
receiving special education, asked whether this regulation would define 
a child who has been restricted from attending a school program as 
having been ``secluded,'' and requested that the regulation prohibit 
this action except when the requirements of the regulation are met.
    Response: Not allowing a patient to attend a school program or 
removing a patient from a classroom setting would not meet the 
definition of seclusion as defined in this rule, and also outside the 
scope of this regulation which addresses restraint and seclusion in 
hospitals.
    Comment: One commenter stated that there should be minimum 
standards for the cubic dimensions and ventilation of a seclusion room, 
which were not provided in the interim final rule with comment period.
    Response: We believe that setting these types of standards is 
beyond the scope of this rule.
    Comment: Commenters concerned with children's issues discussed the 
use of ``time outs.'' Several commenters argued that CMS should 
distinguish between seclusion (where a child is locked in a room) and a 
time out, and that time outs should not be governed by the regulation. 
These commenters believed that a ``time out'' should be defined as 
actions to require the child or adolescent to retire to an alternative 
setting, either in his or her room or in a separate quiet room, but 
without restraining or locking up the child. Several commenters 
expressed concern that the regulation prohibits so called ``open door'' 
and ``decreased stimulation'' time outs, which are used to prevent the 
escalation of behavior leading to emergency situations. One commenter 
asked whether a child voluntarily removing himself from a current 
activity and spending 15 minutes calming his or her emotions 
constitutes seclusion.
    Response: For the purposes of this final rule, seclusion is the 
involuntary confinement of a patient alone in a room or area from which 
the patient is physically prevented from leaving. Seclusion may only be 
used for the management of violent or self-destructive behavior. If a 
patient is free to leave a time out area whenever the patient chooses, 
this would not be considered seclusion based on this definition. The 
key distinction in deciding whether an intervention is seclusion or a 
time out is whether the patient is physically prevented from leaving a 
room or area. Another distinction is the patient's level of personal 
control. In the case of seclusion, boundaries are placed on the 
patient's behavior based on the clinical determination that the 
patient's behavior poses a risk to the safety of the patient or others. 
In a time out, the patient is able to respond to staff direction 
encouraging a time out or to independently decide that such action is 
needed. In a time out, the staff and patient collaboratively determine 
when the patient has regained self-control and is able to return to the 
treatment milieu. In seclusion, this judgment is made by the 
clinicians--that is, an agitated patient may feel that he or she should 
be released, even though the patient's behavior continues to be violent 
or self-destructive.
    Comment: One commenter inquired whether seclusion requires a 
physician's order and all related monitoring and documentation.
    Response: The use of seclusion for the management of violent or 
self-destructive behavior is regulated by combined standard (e). If an 
intervention meets the definition of seclusion in standard (e), all of 
the requirements under standard (e) would apply, including those 
related to a physician or other LIP's order, the 1-hour face-to-face 
evaluation, monitoring and documentation.
    Comment: One commenter expressed concern that the definition of 
``seclusion'' covers typical hospital practices, such as keeping 
visitors and patients out of certain areas for purposes of infection 
control, security, patient privacy, or prevention of disruption of 
treatment.
    Response: Our modification to the definition, that is, adding the 
word ``alone,'' should alleviate this concern. In the cases cited, the 
hospital is keeping patients or visitors out of an area versus 
involuntarily confining the patient alone within a room or area from 
which the patient is physically prevented from leaving for management 
of violent or self-destructive behavior that jeopardizes the immediate 
physical safety of the patient, a staff member, or others. It is not 
the intent of this rule to interfere with hospital infection control 
practices, security measures, patient privacy or measures intended to 
prevent the disruption of treatment. Additionally, State law outlines 
requirements for quarantining a patient. If the need to quarantine a 
patient arises, the hospital would follow State law. Quarantining, as 
governed by State law, would not be considered seclusion.
14. Use of Restraint/Seclusion for Behavior Management (Sec.  
482.13(f)(2))
    We stated that seclusion or restraint for behavior management can 
only be used in emergency situations if needed to ensure the patient's, 
a staff member, or others' physical safety and less restrictive 
interventions have been determined to be ineffective.
    Comment: Many commenters stated that the use of restraint or 
seclusion is a treatment failure. In contrast, several commenters 
argued that the regulation's requirements are not guided by solid 
clinical information, nor do they take into account the realities of 
inpatient psychiatric treatment. One commenter stated, ``While I am 
aware of individuals who think that medications and/or restraints for 
[violent, aggressive] patients should never be applied, such thinking 
is naive, unrealistic, and idealistic.'' The commenter recommended that 
we study how many deaths/injuries/assaults are prevented by appropriate 
use of restraints.
    Response: The role of restraint and seclusion for behavior 
management was a point of fundamental disagreement among commenters. 
While we believe that restraint and seclusion are not desirable 
interventions, we recognize the diversity of patients and situations 
that clinicians must address. In some of these situations, the patient 
poses a real safety risk to self or others, and alternative, less 
restrictive interventions are not sufficient to assure the safety of 
the patient or others.
    Comment: A few commenters strongly agreed that restraints should 
only be used for emergency safety situations. Some physicians and 
hospitals indicated that they view restraint as a last resort which is 
only used when absolutely necessary to protect the safety of the 
patient or others. One commenter indicated that seclusion and restraint 
have a valuable place in treatment, but only when used minimally, such 
as in cases of extreme violence or when needed to protect clients. One 
commenter stated that the rule does not define the term ``emergency,'' 
and cited a Maryland regulation that defines an emergency as a 
situation in which the patient's behavior poses a serious and imminent 
danger to the physical safety of self or others.
    In contrast, a commenter suggested removing ``in emergency 
situations.'' Another commenter agreed with this

[[Page 71405]]

suggestion, arguing that the rule does not permit the use of seclusion 
and restraint as therapeutic interventions as part of a treatment plan 
for serious behavioral problems. The commenter argued that although 
short-term, crisis-based use of seclusion and restraint is necessary, 
it is not the only appropriate use of restraint, since short-term 
behavioral restrictions can be the most humane way to prevent the 
patient from self-injury and reduce the need for invasive medical 
therapies that can have serious, long-term adverse consequences.
    Response: The use of restraint or seclusion should not be a routine 
response when a patient's behavior begins to escalate. Restraint or 
seclusion may only be imposed to ensure the immediate physical safety 
of the patient or others. Seclusion may only be used for the management 
of violent or self-destructive behavior of patients when there is an 
immediate danger of harm to the patient, a staff member, or others. We 
recognize that there may be circumstances in which the use of restraint 
or seclusion may be necessary to prevent a situation from escalating 
into an emergency situation in which a patient is in immediate danger 
of harming himself, staff, or others. In the therapeutic environment, 
staff often skillfully intervene with alternative techniques that 
redirect the patient, engage the patient in constructive discussion or 
activity, or otherwise help the patient maintain self-control and avert 
escalation. Therapy is a building process in which the patient gains 
the skills necessary to appropriately handle daily stressors and 
situations. The use of restraint or seclusion to manage violent or 
self-destructive behavior is an emergency measure that temporarily 
protects the safety of the patient, staff, and others. However, neither 
restraint nor seclusion is a long-term solution for handling 
problematic behavior.
    Based on public comment, we have clarified this provision by 
replacing the reference to emergency situations with more descriptive 
language. Therefore, combined standard (e) states that restraint or 
seclusion can only be imposed to ensure the immediate physical safety 
of the patient, staff, or others, must be discontinued at the earliest 
possible time, and less restrictive interventions have been determined 
to be ineffective. Seclusion may only be used to manage violent or 
self-destructive behavior of patients that jeopardizes the immediate 
physical safety of the patient, a staff member, or others.
    Comment: One commenter suggested permitting the use of restraints 
to control anticipated catastrophic behavior associated with conditions 
such as Lesch Nyhan Disease (manifested by self-mutilation) or other 
self injurious or assaultive behaviors. The commenter argued that such 
use would be appropriate to address intractable behaviors that have not 
responded to medications or other treatment interventions. This type of 
use would be part of an individualized plan of care addressing the 
underlying cause of the behavior and would involve rigorous monitoring 
and active treatment to allow for the removal of restraints.
    Response: The regulation has not barred the use of restraint to 
manage catastrophic behavior. If a patient has a diagnosed chronic 
medical or psychiatric condition such as those associated with Lesch-
Nyhan Syndrome, and he or she engages in repetitive self-mutilating 
behavior, the use of restraint would need to meet the requirements of 
combined standard (e). In these situations where the patient exhibits 
chronic self-injurious behavior, a PRN order that is applied in 
accordance with the specific parameters established in the treatment 
plan would be permitted (note that PRN application of restraint is not 
otherwise permitted). Again, this use of restraint would need to be 
integrated into the plan for the patient's care and treatment. As 
always, the use of alternative interventions should be pursued when 
feasible, and use of restraint should be discontinued as quickly as 
possible. Since the use of restraints to prevent self-injury for these 
types of rare, severe medical and psychiatric conditions have been 
intergrated into the patient's care and treatment plan, the requirement 
for the 1-hour face-to-face evaluation and the limitation of length of 
orders (4, 2, or 1 hour(s) depending on the patient's age) are not 
applicable.
    Comment: One commenter suggested a series of steps for treating a 
patient who has a known history of assault or who exhibits aggression. 
First, the patient must have a treatment plan to address the problem. 
Second, if the treatment plan does not work, a back-up plan must 
provide the patient relief from whatever seems to be provoking the 
attack. Third, if the back-up plan fails, staff should try to coach or 
encourage some alternative to assault. The commenter suggested that 
assault is almost always goal directed, and that staff's task is to 
determine the goal and suggest an alternative to achieve it. If 
alternatives are not accepted, staff should ``reduce their verbiage'' 
and ``exaggerate simple non-verbal messages.'' If an attack is 
initiated, staff should continue the use of verbal de-escalation 
techniques while physically evading attack. If all these interventions 
fail and the attack continues, ``some form of bodily restraint may be 
justified.''
    Response: We appreciate the commenter's insights. However, the 
level of detail provided is more typical of hospital policy on how to 
handle assaultive behavior than of regulatory text. When a patient is 
exhibiting violent or self-destructive behavior and the patient is in 
danger of harming themselves or others, and less restrictive 
interventions have been determined to be ineffective, we expect staff 
to implement appropriate interventions to ensure the safety of the 
patient and others. While the steps described by the commenter may be 
appropriate in some situations, they may not be appropriate in others. 
For example, a patient is attacking another patient. In this situation, 
immediate intervention, that is, restraint or seclusion in conjunction 
with ongoing verbal de-escalation and communication with the patient 
may be necessary to ensure the safety of all involved. The use of less 
restrictive interventions that are ineffective in this scenario may, in 
fact, further jeopardize the safety of those involved. Therefore, it is 
critical that staff employ the least restrictive interventions that 
will be effective in ensuring the safety of the patient, other 
patients, staff and others.
    Comment: One commenter observed that insuring the safety of 
patients (as required by the Patients' Rights CoP) will not be possible 
unless restraining patients who endanger the safety of others is 
permitted. The commenter stated that the interim final rule with 
comment period precludes this type of use of restraint or seclusion. A 
second commenter agreed, noting that provision (f)(2) of the interim 
final rule with comment period contradicts (f)(3)(i) in that only 
patient safety (not that of others as provided in (3)(i)) is mentioned 
in (f)(2). One commenter suggested the following rewording for (f)(2) 
to remedy this contradiction: ``Seclusion or restraint can only be used 
in emergency situations if needed to ensure the patient's physical 
safety or the safety of others and less restrictive interventions with 
the patient have previously been determined to be ineffective.'' Other 
commenters echoed the concern that the requirement should take the 
safety of other patients and staff into account.
    Response: The interim final rule with comment period stated that 
the use of restraint or seclusion must be selected only when ``less 
restrictive measures have been found ineffective to protect

[[Page 71406]]

the patient or others from harm.'' We have revised the final rule to 
state that restraint or seclusion may only be used when less 
restrictive interventions have been determined to be ineffective to 
protect the patient or others from harm. In addition, we have specified 
the type or technique of restraint or seclusion used must be the least 
restrictive that will be effective to protect the patient or others 
from harm.
    Comment: One commenter stated that ``absolute danger'' cannot be 
the only qualifier for restraint or seclusion use in behavior 
management. The hospital cited examples of highly agitated behavior 
that disrupts the treatment milieu, such as a patient yelling 
profanities, disrobing, or destroying property. In addition, another 
commenter stated that Maryland regulation permits the use of seclusion 
or restraint when an individual presents a serious disruption to a 
therapeutic environment (behavior of such a grave or protracted nature 
that it significantly interferes with the emotional well-being of other 
patients or with their treatment).
    Response: We recognize that situations do occur in which highly 
agitated behaviors can disrupt the therapeutic environment. A 
disruption to the therapeutic environment that jeopardizes the safety 
of patients, staff, and others could be a situation where the use of 
restraint or seclusion may be necessary. In these situations, there may 
be no other intervention short of the use of restraint or seclusion 
that will assure the safety of the patients, staff and others. Based on 
these comments, we have revised combined standard (e) to state that 
restraint or seclusion can only be used to manage violent or self-
destructive behavior of patients when they are in danger of harming 
themselves or others, and less restrictive interventions have been 
determined to be ineffective. However, we have not accepted the 
commenter's recommendation regarding ``agitated behavior.'' A patient's 
agitated behavior may or may not pose a physical safety threat to the 
patient, staff or others. We caution against automatic responses, where 
the situation is oversimplified and the intervention is not tailored to 
the individual patient. For example, the fact that a patient is yelling 
profanities is not an automatic trigger for restraint use. A patient 
might yell because of pain or any number of factors, which could 
perhaps be addressed by other types of intervention. In the examples 
cited, the patient's behavior should prompt individualized assessment 
and treatment. A patient who is shouting profanities may be calmed by 
one-to-one interaction with a staff member. A patient who is trying to 
destroy an object can, in some cases, be distracted or encouraged to 
redirect his or her energies. Again, we emphasize that the decision of 
how to handle any given situation will depend on the patient, the 
patient's history, the patient's symptoms, and the seriousness and 
immediate danger presented by the patient's behavior.
    Comment: One commenter stated that each patient who is restrained 
or secluded should be given a complaint form when the intervention 
ends, with instructions on how to fill it out, and privacy and 
protection in submitting it.
    Response: The hospital is required by standard (a) to establish a 
process for prompt resolution of patient grievances and must inform 
each patient who to contact to file a grievance. If the patient or the 
patient's representative wants to file a grievance, this can be done 
verbally or in writing.
    Comment: One commenter recommended sanctions against providers who 
misuse or abuse any chemical or physical intervention be significant, 
sure, and swiftly applied.
    Response: We appreciate this commenter's support for vigorous 
enforcement. Hospital noncompliance with these requirements is of the 
same gravity as noncompliance with existing standards, and could result 
in enforcement action.
    Comment: A commenter stated that the regulation should reflect the 
fact that to reduce the use of restraints, it is necessary for hospital 
leadership to make clear that this is their policy and their goal. The 
commenter also stated that leadership must create an atmosphere where 
the use of restraints is not tolerated, unless absolutely necessary.
    Response: We agree that hospital leadership plays a critical role 
in the reduction of restraint and seclusion use. There are many 
challenges associated with initiating and sustaining reduced use of 
restraint and seclusion. Strong organizational leadership is essential 
in creating the culture change necessary to minimize the use of 
restraint and seclusion. The responsibilities of the governing body and 
Medical staff are addressed in other CoPs.
15. One Hour Rule (Sec.  482.13(f)(3)(ii)(C))
    We stated that a physician or other licensed independent 
practitioner must see and evaluate the need for restraint or seclusion 
within 1-hour after the initiation of this intervention.
    This provision was the lightning rod for public comment. Almost 
every commenting physician opposed the provision as written, and the 
majority of commenters strenuously objected to it, with most asking 
that the words, ``see and'' be eliminated to leave only the requirement 
for a physician or LIP evaluation. A core of commenters from advocacy 
groups and the general public stated that this provision should be 
modified by shortening the timeframe to half an hour and eliminating 
the recognition of an LIP's ability to perform this function.
    Many commenters asked what the face-to-face requirement of the 
interim final rule with comment period accomplished. In the preamble of 
the July 2, 1999 interim final rule (64 FR 36079) we stated the 
following:

    In situations where a restraint must be used for behavior 
management, increased vigilance is required because of the 
heightened potential for harm or injury as the patient struggles or 
resists. Furthermore, there is an immediate need for assessment of 
what has triggered this behavior and for continuous monitoring of 
the patient's condition. To address the need for quick assessment of 
the condition, we are specifying that the physician or licensed 
independent practitioner see the patient face-to-face within 1-hour 
of the application of the restraint or the use of seclusion.

    The one-hour requirement of the interim final rule with comment 
period was intended to assure patient safety with a quick assessment by 
a physician or other LIP to rule out possible underlying factors that 
might be contributing to the patient's behavior, to assess the 
patient's physical and psychiatric condition, and to decide whether 
restraint or seclusion continue to be necessary.
    Commenters were divided on whether this provision would promote 
patient safety or address adequately the problems identified by the 
media. While some commenters stated that deaths that occur during the 
first hour of restraint or seclusion support the need for this mandated 
onsite physician or LIP assessment within the first hour, a second 
group stated that by the time the physician arrived in the 59th minute, 
if staff were not properly trained, the patient might already be dead. 
This latter group of commenters argued that our proposed ``fix'' did 
not directly address the key problem and that we were essentially 
adding a process without proof of an improved outcome for patients.
    Some commenters referred us to a Pennsylvania policy used in its 
ten State-operated psychiatric hospitals, which requires a physician's 
face-to-face evaluation within half an hour, and accompanying data that 
shows a reduction in restraint and seclusion use.

[[Page 71407]]

The Commonwealth's policy and data were cited as proof that a half-hour 
physician face-to-face assessment improves patient care and assures 
patient safety. In preparing the final rule, we were interested in the 
Commonwealth's experience, including any outcomes data or research 
related to its half-hour physician assessment policy. We asked for and 
received a package of information from the Commonwealth that described 
its policies regarding restraint and seclusion and data showing use 
over time.
    The Commonwealth's policies provide that--(1) only a physician may 
order restraint or seclusion; (2) orders may not exceed 1 hour; (3) if 
a verbal order is given, the physician must physically evaluate the 
patient within 30 minutes; (4) persons in restraint must be kept under 
constant observation; (5) each reorder may not exceed 1-hour and 
requires physical examination; (6) each incident must be followed by 
patient debriefing; and (7) each use triggers clinical, administrative, 
and continuous quality improvement review, plus a revision to the 
treatment plan.
    After reviewing the information received, we did not find any 
claims by the Commonwealth that physician assessment within half an 
hour had directly contributed to reduced restraint and seclusion use. 
Furthermore, to make such an attribution would be to ignore the fact 
that the Commonwealth introduced a multi-pronged approach that embraces 
many methods to address the issues of patient and staff safety. An 
important aspect of the approach is that physicians are on staff around 
the clock in the Commonwealth's psychiatric facilities. The 
requirements referenced earlier do not exist in isolation, but are part 
of the Commonwealth's integrated approach and ongoing efforts to work 
collaboratively toward the goals of restraint and seclusion reduction 
and patient and staff safety.
    To summarize, given the comprehensive restraint and seclusion 
policies instituted by the Commonwealth, it is simply unclear whether 
one could point to the half-hour evaluation and demonstrate a direct, 
causal effect on the reduction in restraint and seclusion initiation 
and duration in Pennsylvania's State psychiatric hospitals.
    Based on our analysis of the information supplied by the 
Commonwealth, and given the numerous public comments we received on 
this requirement, we have revised the regulatory language to broaden 
the types of practitioners who may conduct the 1-hour face-to-face 
evaluation to include a trained RN or PA unless superseded by State law 
that is more restrictive. We have also addressed the criteria by which 
staff are to be considered ``trained'', and specify the components of 
the 1-hour evaluation. In making these changes, we acknowledge the 
comments of many psychiatrists and other physicians who noted that they 
are appropriately consulted within 1-hour of the initiation of 
restraint or seclusion by the onsite staff. Many such commenters argued 
that a RN is entirely capable of assessing the patient's condition, and 
that to suggest otherwise ignores RNs' training and high level of 
expertise.
    How quickly the patient needs to be seen by his or her attending 
physician (or other practitioner, as noted in the regulation) is left 
to the medical judgment of the physician or other LIP. We have revised 
standard (f) to state that if the 1-hour face-to-face evaluation is 
conducted by a trained RN or PA, the attending physician or other LIP 
responsible for the care of the patient must be consulted as soon as 
possible. The attending physician or other LIP is responsible for 
assuring that the patient receives a timely and adequate face-to-face 
assessment based on the clinical need presented by the individual 
patient's case.
    Comment: One commenter noted that in California, the contractual 
relationship between a physician and hospital may affect the hospital's 
ability to ask physicians to meet the 1-hour requirement.
    Response: The comments submitted (some of which came from 
physicians from California) indicated that a high level of physician 
involvement in the patient's care already exists. Many reported routine 
contact with hospital staff if a patient under their care becomes 
violent or self-destructive and restraint or seclusion may be 
indicated. Most of these physicians argued for the removal of the word 
``see,'' noting that they are willing to be and indeed already are 
involved with these sorts of decisions, but that their objection was to 
the onsite visit. We have revised the requirements to permit a trained 
RN or PA to conduct the 1-hour evaluation, and do not require the 
physician to come to the hospital to see and evaluate the patient 1-
hour after the initiation of the restraint or seclusion. Because this 
change permits more flexibility and clinical judgment on the 
physician's part, we believe that the cause for physician objection is 
largely removed.
a. Comments Objecting to a Physician or LIP Seeing the Patient Within 1 
Hour
    The majority of commenters objected to our requirement that a 
physician or LIP see the patient within 1-hour of the initiation of 
restraint or seclusion for behavior management. They provided the 
following arguments regarding this requirement as written in the 
interim final rule with comment period. The rule--
    <bullet> Is impractical. By the time the physician or LIP arrives, 
the patient's episode may already be over, leaving some physicians 
asking what they are supposed to evaluate when they arrive. One 
physician asked whether he must awaken a patient to perform an 
evaluation after the intervention has ended if the patient is asleep 
afterward.
    <bullet> Forces free standing facilities to hire under qualified 
and ill-prepared physicians to see and evaluate patients with whom they 
are unfamiliar.
    <bullet> Pits the physician against staff.
    <bullet> Creates hesitation to use an intervention to address 
violent or aggressive behavior that places the patient, the staff, and 
other patients at risk. One commenter believed that psychiatrists will 
tell nursing staff to tolerate aggression or violence until they find 
time to come and see the patient, which also places those present at 
the hospital at risk. To provide evidence of the risk to staff, 
commenters referred to various data sources: the Occupational Safety 
and Health Administration has named health care workers as one of the 
most injured-on-the-job occupational groups; the National Institute for 
Occupational Safety and Health has found that most non-fatal workplace 
assaults occur in service settings such as hospitals, nursing homes, 
and social service agencies. Forty-eight percent of nonfatal assaults 
in the workplace are committed by health care patients; and the 
Department of Justice has found that mental health professionals rank 
sixth (behind taxi-drivers, police officers, security guards, prison 
guards, and bartenders) on a list of occupations with the greatest risk 
of attack. This requirement, commenters argued, will add risk of on-
the-job injury that could otherwise be avoided.
    <bullet> Inappropriately dictates medical practice. Requiring 
timely and appropriate medical evaluation is reasonable, but it is not 
feasible or clinically necessary to require a face-to-face evaluation 
by a physician in each case. A physician assessment of the situation 
should always be done, but whether face-to-face evaluation is necessary 
should be left to the physician's discretion.

[[Page 71408]]

    <bullet> Nullifies the professional clinical decisions of 
registered nurses and insults their professionalism and training.
    <bullet> Adversely impacts staff morale, recruitment, and 
retention. One physician described getting good staff as a continuing 
challenge since the job is inherently dangerous. He believed that he 
will lose staff who decide that the increased hassle of inpatient work 
is not worth the trouble when plenty of outpatient work is available. 
Other commenters voiced similar concerns, noting that nurses must deal 
with belligerent and uncontrollable patients, and limiting their 
available options will make retaining nursing personnel difficult.
    <bullet> Will cause hospitals to place patients immediately in 
restraint without trying seclusion (that is, move to the most 
restrictive intervention first) so that the physician only has to make 
one visit to assess the patient.
    <bullet> Will adversely affect patient access to care. Admitting 
teams will refuse to accept any potentially violent or disruptive 
patients because of this requirement and thereby increase the number of 
patients routed to State hospitals, the criminal justice system, or 
juvenile hall, and increase the number of patients who are put out on 
the street. Persons with the most severe mental illness will be denied 
a choice of physicians and hospitals although their treatment needs are 
the greatest.
    <bullet> May be impossible to implement. Existing psychiatrist 
shortages may thwart hospitals' attempts to hire coverage so that this 
requirement can be met. One facility commented that it has tried to 
recruit personnel, but was repeatedly told that psychiatrists can make 
more money with considerably fewer disruptions in their lives by 
choosing not to do inpatient psychiatry. As a result of these 
regulations, three of that facility's current physicians are 
questioning whether they will continue with their inpatient privileges. 
The commenter also states that a nearby psychiatric unit may close its 
inpatient services as a result of its entire psychiatric staff 
resigning. Another hospital reported that no local physicians were 
willing to be on call and onsite within 1 hour. Many physicians stated 
that this provision has caused them to question whether they should 
continue rendering inpatient services.
    <bullet> Cannot be implemented because of geographical/logistical 
issues. While large organizations may have house staff and residents 
with which to meet this requirement, it will be difficult to accomplish 
in community or rural hospitals.
    <bullet> May require onsite physicians (usually emergency room 
physicians) to leave less stable patients simply to comply with this 
regulation.
    <bullet> In effect will require all hospitals to have physicians 
present 24 hours a day, 7 days a week. One hospital noted that hiring 
an onsite physician would be costly and impractical given the low 
occurrence of restraint and seclusion.
    <bullet> Has no clear clinical rationale.
    <bullet> Will result in patient overmedication in an attempt to 
avoid such situations. One physician cautioned that overuse of 
antipsychotic medications can result in severe (sometimes irreversible) 
neurologic side effects or Neuroleptic Malignant Syndrome, which is 
potentially fatal. Increased use of psychotropic medications may lead 
to excessive sedation and cognitive dulling, which could affect the 
patient's ability to benefit from therapy and other interventions.
    <bullet> Will be disruptive of care provided to outpatients by 
requiring that practitioners drop everything to come into the hospital 
to meet the requirement. This disruptiveness will discourage 
practitioners from providing inpatient services, and thereby adversely 
impact patient care and access to good practitioners.
    <bullet> Is not based in any empirical evidence that suggests that 
a face-to-face evaluation by a physician or LIP will improve the 
outcomes of care for patients who are secluded or restrained; nor is it 
based on any information that suggests that a telephone consultation is 
less effective than a face-to-face evaluation.
    <bullet> Will cost too much. Various hospitals provided estimates 
that ranged from a cost of $62,000 to $750,000 per year. One commenter 
stated that the economics of small community facilities that provide 
inpatient psychiatric care are tenuous at best. This regulation may 
force these facilities to close or go bankrupt. The commenter alleged 
that we have ``tolled the death knell of inpatient psychiatric services 
across the country.'' Another commenter believed that most providers 
will go out of business, and those that remain will have to pass the 
increased costs on to the payors and patients. One hospital stated that 
this requirement will force it to ``close its doors.'' One physician 
reported that nearly all psychiatric facilities and programs operate on 
a slim margin at best. Studies have shown that mental health program 
budgets have been reduced by 54 percent over the past decade, compared 
to 7 percent in non-psychiatric medical programs. Programs that 
specialize in treating geriatric and juvenile patients will be severely 
affected by this rule. It is likely, he argued, that administrators 
will be forced to divert resources for staffing levels, equipment, 
patient education, case management, and other critical patient care 
activities to offset the cost of implementing the rule. One hospital 
sent in a notice of closure as a comment.
    <bullet> Will be costly, both in time and resources. Each time the 
physician is required to see a restrained/secluded patient, there will 
be an additional fee for the visit. Most often, a physician who is 
unfamiliar with the patient will have to spend time reading the chart 
and examining the patient, and talking to staff. This may also result 
in confusion about treatment.
    <bullet> May be used to manipulate the physician since the patient 
can escalate his/her behavior, knowing that the physician will have to 
appear within 1-hour as a response.
    <bullet> Will be ignored by the medical community. One physician 
indicated that the unanimous response he has received from colleagues 
is that ``it ain't gonna happen.''
    <bullet> Does not allow for treatment that is individualized and 
based on medical necessity.
    <bullet> Is unreasonable. Physicians in independent private 
practice have full out-patient office schedules after hospital rounds 
and cannot be expected to cancel an entire schedule and ignore the 
clinical needs of outpatients to drive to the hospital on an 
unpredictable and irregular basis. Family practitioners and specialists 
have a full daytime schedule and will not be able to provide quality 
services if they are exhausted and unpredictable in their schedules.
b. Comments Supporting Telephone Consultation With a Nurse Onsite 
Performing the Patient Assessment
    Many of these commenters suggesting deleting the word ``see'' from 
the requirement to allow staff consultation with the physician or LIP 
by phone. A large number of these commenters agreed with the revised 
language proposed by the American Hospital Association (AHA) and the 
National Association of Psychiatric Health Systems (NAPHS), ``A 
physician or other licensed independent practitioner must evaluate the 
need for restraint or seclusion within one hour after the initiation of 
this intervention.'' AHA and NAPHS believed that the evaluation may be 
done by the physician or LIP in consultation with a registered nurse 
who has demonstrated competency in the evaluation of a patient in 
restraint or

[[Page 71409]]

seclusion and who is in face-to-face contact with the patient. Many 
commenters argued that this change would be appropriate because 
qualified registered nurses are more readily accessible in emergency 
situations. Because of the RN's involvement at the earliest stages of 
an event, the RN would be able to provide additional information about 
the situation and provide the physician with rapid, appropriate 
consultation. The RN would carry out the physician's order and direct 
staff in the use of least restrictive methods and in the 
discontinuation of restraint or seclusion at the earliest possible 
time, as specified in the interim final rule with comment period.
    The NAPHS further suggested that the content of the nurse/physician 
consultation include the following elements in order to promote an 
informed evaluation of the patient: (1) Consideration of organic causes 
for the behavior; (2) known medical disorders; (3) the patient's 
medications; (4) the patient's mental status; (5) a brief neurological 
examination; and (6) vital signs. If data from this evaluation 
supported the need for a face-to-face visit, then the physician would 
come to see the patient.
    Other commenters argued that by limiting the ability to assess the 
patient to an LIP or physician, CMS is contradicting JCAHO standards 
which permit a RN to assess and document the need for restraint. Many 
commenters supported RN or psychiatric nurse assessment of the patient.
    One commenter noted that the interim final rule with comment period 
permitted the evaluation to be performed by ANY physician, even one 
with no training in psychiatry and no direct knowledge of the 
individual's medical and treatment history--but would not permit the 
evaluation to be conducted by a psychiatric nurse or other licensed 
professional who is an integral part of the patient's individual 
treatment team. This organization urged CMS to ensure that orders for 
these interventions and evaluations following initiation of the 
interventions be conducted by licensed practitioners who are specially 
trained and qualified to assess and monitor both the inherent medical 
and the psychological risks. This may involve physicians or LIPs, or 
nurses or psychologists who are more familiar with the individual's 
psychological history. Another commenter echoed this concern, arguing 
that non-psychiatric physicians do not necessarily have the 
competencies for treating people with mental illness.
    One commenter interpreted the rule to inappropriately devalue and 
undermine the profession of psychiatry, as well as psychiatric care, by 
requiring face-to-face assessment for psychiatrists, but not for other 
physicians. This commenter asked whether physicians who are not 
psychiatrists have greater reasoning ability and better judgment in 
matters that involve assessing the appropriateness of restraint and 
seclusion, or whether nurses in medical hospitals are somehow more 
adept at reporting reliable and accurate information to treating 
physicians than those nurses who work in psychiatric hospitals. The 
commenter also supported the use of telephone consultation.
    A commenter stated that the requirement would in all probability be 
unproductive. The commenter also stated, ``Patients requiring seclusion 
or restraint have shown behaviors potentially dangerous to themselves 
or others; such behaviors are caused by impaired reasoning, distorted 
thinking, or other irrational stimuli. It is extremely unlikely that 
such an event would have resolved in an hour; either the patient would 
continue to be irrational or would be sedated from concomitant 
therapeutic use of medication so that an assessment would not be 
possible.'' The commenter stated that telephone contact between staff 
and physician is perfectly adequate. In addition, the commenter noted 
that an appropriate review of the circumstances is much more likely 
several hours (8 to 12) after the initiation of the intervention.
    A few commenters' disagreements were based on the idea that 
episodes requiring restraint and seclusion typically involve such gross 
behavioral problems that they cannot be mistaken for anything other 
than emergencies, so a physician's visit to assess the need for 
restraint is not essential. A commenter who had experience in a 
hospital with a 2-hour face-to-face rule reported that he has never 
disagreed with a nurse's assessment that a given patient needed to be 
restrained.
    One commenter pointed out that the physician is always accountable 
for the medical care his or her patient receives, as well as for what 
actions are taken under his or her direction or license. Another 
commenter noted that since the order has already been implemented, the 
physician has already accepted responsibility, so requiring face-to-
face evaluation is unnecessary.
c. Comments Opposing Telephone Orders, Nurse Evaluation, and Other LIP 
Involvement
    Some commenters strongly disagreed with allowing telephone orders 
for restraint and seclusion and with allowing anyone other than a 
physician to perform the face-to-face evaluation of the patient. One 
commenter, an RN/PhD, made the following statements:

    This letter comes to urge members of the regulatory task force 
to require that physicians complete a face-to-face assessment of the 
patient within the hour after initiation of the restraint or 
seclusion and every hour thereafter. There are many reasons for a 
patient to become ``out of control,'' among which are reactions to 
medications, delirium secondary to metabolic dysfunction, hypoxia, 
and so forth. These need to be assessed thoroughly and with all due 
respect to my own profession [the commenter is a RN and Ph.D.], most 
practicing nurses are not educationally equipped to make such 
evaluations. In my years of practice, I have seen patients placed in 
restraints when they had akathesia and when they were confused as a 
result of impending pulmonary edema with nurses labeling this as 
``out of control.'' In fact, I had opportunity to render an expert 
opinion in a lawsuit involving the death of a gentleman who died in 
congestive heart failure--he was hypoxic, became confused, and the 
nurses tied him down. It is not a pretty thought that he drowned in 
his own fluid tied to a bed.

    Similarly, another commenter wrote,

    Sometimes it is important for us to do what is right instead of 
what is convenient. For the last 40 years that I can remember, we 
have looked for easy ways to restrain uncooperative patients without 
infringing on our own time and effort. There is no proper way to do 
it. One hour of restraint or seclusion is certainly a maximum that 
should be allowed before personal examination and evaluation by 
someone who is authorized to directly give such an order. Think of 
the patient, a decent human being, not yet properly evaluated for 
the patient's ``bad'' or ``uncontrollable'' behavior. One hour is a 
long time to be physically restrained for no or improper reasons. 
The time allotted to a temporary restraining order must be minimal. 
The person providing the evaluation and giving the regular order 
must do so very quickly thereafter and be able to accept 
responsibility for doing it without proper indication. There will be 
a lot of opposition to this position, as there has been continuously 
ever since these treatments were first used. But that does not make 
it right to use them improperly. There is no other way to treat our 
fellow men and women.
d. Comments Stating That the 1-Hour Provision Did Not Address the 
Problem
    Other commenters took issue with the idea that the requirement for 
a physician's onsite visit would prevent the sorts of situations 
described in the Hartford Courant's series. A physician who serves as 
an expert consultant to Protection and Advocacy, Inc. has reviewed 
several cases of deaths occurring in chronic and acute care facilities. 
He stated,


[[Page 71410]]


    Several of these deaths occurred among patients who were at the 
time of their death contained (or in the process of being contained) 
in seclusion or restraints. These deaths were tragic and in some 
cases due to serious, preventable errors. However, I do not believe 
that the outcome in any of these cases that I have reviewed would 
have been changed by the proposed rule that patients requiring 
seclusion or restraint be evaluated face-to-face by a physician or 
LIP within one hour after the initiation of these interventions.

    Many facilities that opposed the provision reported having had no 
injuries or deaths associated with restraints use. Many discussed their 
use of training programs to assure staff competency and argued that 
training and monitored staff competency, not the 1-hour requirement for 
a physician's onsite visit, was the key to assuring patient safety.
    Many commenters argued that better training in restraint use, 
constant or frequent monitoring of patients in restraints, the banning 
of dangerous techniques such as face-down floor holds, and CPR training 
for all direct care workers could prevent the deaths associated with 
restraint use. One hospital reported that during a recent three-month 
period, it identified 94 patients who would have been covered by the 1-
hour provision. Of these 94 cases, no restraint-related injury 
occurred.
    Some commenters believed that this provision was excessive and 
unnecessary, given that they had no problems with deaths or injuries 
caused by restraint.
    Another commenter argued that the problems that have caused the 
reported deaths and injuries have been due to the administrative 
policies of the problematic facilities. The commenter therefore 
believed that it is unnecessary to develop new rules to cover a 
``problem'' that for the most part does not exist. Another commenter 
affirmed this point, stating,

    Several years ago, the California Psychiatric Association 
investigated the causes of deaths of persons who had died in 
seclusion and/or restraint in California over a period of several 
years. Our investigation found that in nearly every case, the 
seclusion and/or restraint was in violation of the hospital's own 
policies and procedures. The better answer to seclusion and 
restraint deaths is enforcement of existing laws, not the enactment 
of a law which will have the unintended consequence of denying the 
sickest of the sick hospitalization.

    One commenter characterized this requirement as, ``A very arbitrary 
decision and obviously made without much thought at all.'' The 
commenter further stated, ``While there have been instances of deaths, 
to make an unreasonable demand upon all physicians because of a few 
instances that can be corrected is extremely unreasonable and would 
greatly change how psychiatrists and physicians practice medicine in a 
negative way and would not add anything positive in terms of health 
care. Hospitals and physicians will work hard with CMS to eradicate 
such abuses as have been reported.'' Another commenter agreed, stating 
the following:

    While it is desirable to remedy the shortcomings of our current 
restraint and seclusion practices, it is immediately apparent to me 
that your new requirement will result in more patient injuries 
because of the difficulty of compliance with the new standard. Since 
you are demanding a new type of treatment protocol, I suggest that 
the burden is yours to demonstrate in a controlled trial that your 
solution will indeed be more effective than the existing policy. 
This is the same process by which all proposed therapies are judged 
in our field. To do less is to subject all patients to a cruel mass 
experiment.

    One hospital agreed with many of the points raised by CMS in the 
interim final rule with comment period, and with the position of the 
National Alliance for the Mentally Ill (NAMI), and supported standards 
that protect people with mental illness from abuse or unnecessary risk. 
The hospital noted that it has adopted most of NAMI's best practices 
initiatives in their institution. However, the hospital stated this 
provision provides no additional benefit to the patient and may cripple 
its ability to provide a high standard of care to its patients.
    Response: The revised requirement in no way prohibits a physician 
from coming to the hospital to assess the patient in person. In the 
final rule, combined standard (e) requires that if a trained RN or PA 
conducts the 1-hour face-to-face evaluation, the attending physician or 
other LIP responsible for the care of the patient must be consulted as 
soon as possible after completion of the evaluation. As many commenters 
noted, telephone consultation may be effective in this context. Other 
steps may be critical in addressing the problems identified in the 
Hartford Courant series. We are not persuaded that it is practical or 
necessary in all cases for a physician to physically be present within 
1-hour to assess the patient. We believe that the patient's attending 
physician or other LIP responsible for the care of the patient is 
sufficiently qualified to determine whether the patient's symptoms, 
condition, and history indicate the need for an immediate onsite visit.
    Based on the arguments and information submitted by the commenters, 
we have revised these requirements. When restraint or seclusion is used 
to manage violent or self-destructive behavior, a physician or other 
LIP, or a RN or PA trained in accordance with the requirements 
specified under Sec.  482.13(f), must see the patient face-to-face 
within 1-hour after the initiation of the intervention to evaluate: (1) 
The patient's immediate situation; (2) the patient's reaction to the 
intervention; (3) the patient's medical and behavioral condition; and, 
(4) the need to continue or terminate the restraint or seclusion. As is 
the case with all CoPs, States are free to have requirements that are 
more restrictive than these requirements. For example, States have the 
flexibility to limit who may conduct the 1-hour face-to-face 
evaluation, require that the evaluation be completed in less than an 
hour, or require additional training. Finally, if the 1-hour face-to 
face evaluation is conducted by a trained RN or PA, the attending 
physician or other LIP who is responsible for the care of the patient 
as specified under Sec.  482.12(c) must be consulted as soon as 
possible after completion of the 1-hour face-to-face evaluation.
    Comment: One commenter suggested that the psychiatrist be 
thoroughly informed of the events that led to the need for an 
intervention, vital signs, and other pertinent clinical information by 
telephone, and be required to conduct the onsite evaluation ``within a 
reasonable time, not to exceed two hours.'' This wording, the commenter 
noted, will allow some flexibility without completely abandoning time 
limits.
    Response: We agree that the attending physician (psychiatrist) 
should be kept informed about the patient's status. The final rule 
specifies that the attending physician must be consulted as soon as 
possible if the attending physician did not order the restraint or 
seclusion. It also specifies that the attending physician or other LIP 
responsible for the care of the patient must be consulted as soon as 
possible after the completion of the 1-hour face-to-face evaluation if 
this evaluation is completed by a trained RN or PA. During these 
consultations, we would expect that the patient's status and areas 
suggested by the commenter are discussed with the attending physician. 
We do not believe that it is necessary to require that the attending 
physician conduct an onsite evaluation within 2 hours. How quickly the 
patient needs to be seen by his or her attending physician (or other 
practitioner, as noted in the regulation)

[[Page 71411]]

is left to the medical judgment of the physician.
    Comment: One commenter noted that under Commonwealth of Virginia 
law, only physicians and licensed clinical psychologists are able to 
order restraint and seclusion. The commenter stated that the 
recognition of LIPs in this provision did nothing to lessen the 
facility's burden.
    Response: This regulatory provision is applicable unless superseded 
by State law that is more restrictive. It is not our intent to 
interfere with State laws governing who may order restraint and 
seclusion.
    Comment: Some commenters argued that licensed practitioners such as 
social workers and psychologists (who may be recognized under some 
State laws as being LIPs) do not have training in physiology or 
pharmacology and therefore may not be able to assess the patient 
appropriately in an emergency situation.
    Response: In this final rule, we have specified that while these 
types of practitioners may order restraint or seclusion if permitted to 
do so by State law and hospital policy, the patient's attending 
physician (or other practitioner) must be contacted to assure continued 
medical oversight and continuity of care. The 1-hour face-to-face 
evaluation includes both a physical and behavioral assessment of the 
patient. Therefore, the practitioner who conducts this evaluation must 
be able to complete both a physical and behavioral assessment of the 
patient in accordance with State law, his or her scope of practice, and 
hospital policy. Generally, practitioners such as social workers, 
psychologists and other mental health workers are not qualified to 
conduct a physical assessment, nor is it in their scope of practice.
    Comment: One hospital association questioned why we distinguished 
restraint and seclusion from other medical interventions initiated when 
the patient undergoes a sudden change in condition.
    Response: Our focus on restraint and seclusion is not to 
distinguish these interventions from others initiated when a patient 
suddenly undergoes a change in status; to the contrary, this focus only 
serves to bring the use of these interventions the same level of 
attention and concern. As we read through comments, we found that many 
commenters use restraint or seclusion only when individualized 
assessment for that particular patient indicates that one or both are 
necessary as a last resort. However, some seemed to think that 
restraining a patient was not only acceptable, but a standard, sound, 
or unavoidable practice. Restraint and seclusion are not standard, 
benign, or desirable interventions to address a patient's behavior. The 
use of restraint or seclusion to manage violent or self-destructive 
behavior that jeopardizes the immediate physical safety of the patient, 
a staff member, or others is of the same gravity as other interventions 
that require the physician's or other attending practitioner's (as 
noted in the regulation) attention and concern.
    Comment: One commenter argued for the onsite presence of the 
attending physician, since it would introduce someone who did not 
participate in the incidents leading up to the use of restraint or 
seclusion who may be more objective in determining whether the 
intervention is appropriate or whether the restraint or seclusion was 
imposed as a means of coercion, discipline, retaliation, or 
convenience.
    Response: Including such a requirement would be unnecessarily 
burdensome. The regulation requires that the attending physician be 
notified as soon as possible if a restraint or seclusion has not been 
ordered by the attending physician. The attending physician has a 
vested interest in determining whether the intervention is appropriate 
since the physician is ultimately responsible for oversight of the 
patient's care. If the attending physician believes that the 
intervention is not needed, he or she may instruct staff to release the 
patient. If the attending physician wants to speak to the patient or 
evaluate the patient in person to gather more information, he or she 
can do so.
    Comment: Several commenters suggested that this standard only be 
applied to those hospitals where deaths or other sentinel events 
related to restraints or seclusion have occurred.
    Response: Once codified, this standard as well as the entire set of 
existing hospital CoPs are the requirements that all hospitals must 
meet to participate in the Medicare and Medicaid programs. The CoPs are 
minimum health and safety standards. They are intended to protect 
patient health and safety, and to ensure that high quality care is 
provided to all patients. Although the majority of hospitals are in 
compliance with the requirements, we cannot develop rules that only 
apply to some participants or a particular provider group.
    Comment: One commenter asked whether any physician who performs the 
assessment can be any physician, or whether if it must be the patient's 
attending physician.
    Response: As revised in this final rule, standard (e) permits a 
physician or other LIP, or a trained RN or PA to perform the 1-hour 
face-to-face evaluation of the patient. We have not specified that the 
evaluation must be completed by the patient's attending physician. 
However, if the evaluation is conducted by a trained RN or PA, the 
attending physician or other LIP responsible for the care of the 
patient must be consulted as soon as possible. The physician may 
determine, based on clinical need, how soon he or she should see the 
patient.
    Comment: One hospital stated that it is the facility's 
responsibility to identify and provide the right number of competent 
staff to meet the patients' needs. The hospital opposed the one-hour 
provision as it has adequate, competent staff to assure patient safety 
and well being.
    Response: Based on public comment, we have amended the 1-hour face-
to-face evaluation requirement. We agree with the commenter's emphasis 
on the importance of adequate levels of competent staff.
    Comment: One commenter suggested moving away from the requirement 
for an onsite physician visit, but suggested adding language requiring 
that, ``If the evaluation is made by telephone, a physician or LIP must 
personally sign, date, and note the time of the telephone order within 
24 hours of the time the order was issued.''
    Response: Signature and review of telephone orders arises for other 
types of orders, not just those involving restraint or seclusion. We 
see no need to establish separate requirements for how orders for these 
interventions would be documented.
    Comment: One commenter alleged that hospitals are dodging the 1-
hour requirement by releasing the patient from restraint or seclusion 
and starting over with a new order before reaching the 1-hour point.
    Response: Ending the intervention prior to the 1-hour point does 
not mean that the mandated assessment and consultation are no longer 
necessary. These steps are still required, even if the intervention 
ends within one hour of initiation.
    Comment: Many commenters pointed out that this provision was not in 
the proposed revision of the hospital CoPs.
    Response: Several organizations used this argument as a basis for 
bringing suit against the Secretary to block implementation of this 
provision, but the court upheld the validity of the regulation. (See 
National Association of Psychiatric Health Systems v. Shalala, 120 F. 
Supp. 2d 33 (D.D.C. 2000).) As we stated before the court, we believe 
that this provision is a logical outgrowth

[[Page 71412]]

of the December 19, 1997 proposed rule. The court agreed with our 
position.
    Comment: One commenter asked whether the patient has to be released 
from restraint or seclusion if the physician is unable to arrive within 
1 hour.
    Response: Since we have revised combined standard (e) to no longer 
require a physician's onsite visit within 1 hour, this question is no 
longer pertinent. However, if the face-to-face evaluation is not 
completed by a physician, other LIP, or a trainer RN or PA, the 
hospital would be out of compliance.
    Comment: Several commenters were concerned that the onsite visit 
would not be covered by Medicare, since additional visits on the same 
day cannot be billed for as per the Medicare Claims Processing Internet 
Only Manual (IOM) pub 100-04, chapter 12, section 30.6.9B.
    Response: While multiple visits in the same day by the same 
practitioner (or another practitioner within the same practice, with 
the same specialty) cannot be separately billed, practitioners should 
select a code that reflects all services provided during the date of 
service (Medicare Claim Processing Internet Only Manual (10m) Pub. 100-
04, Chapter 12, section 30.6.9B).
    Comment: One commenter asked that both children and adults be 
monitored by a physician every 15-30 minutes and that documentation be 
provided.
    Response: We do not believe that this high degree of physician 
involvement is necessarily merited, practical, or reasonable in every 
case. Based on the patient's status and type of intervention used, more 
frequent monitoring by a physician, LIP or other trained staff may be 
necessary. The condition of the patient who is restrained or secluded 
must be monitored by a physician, other LIP, or trained staffed at an 
interval determined by hospital policy and based on assessed patient 
needs.
    Comment: Several commenters asked whether CMS will accept a 
telemedicine evaluation in lieu of face-to-face evaluation.
    Response: Since the requirement for face-to-face evaluation has 
been changed to include a trained RN or PA, there would not necessarily 
be any need to use telemedicine evaluation unless clinically indicated.
    Telemedicine is an important developing field. We are looking at 
the role of telemedicine in providing healthcare. However, telemedicine 
is not addressed in this rule. Telemedicine will be addressed at a 
future date.
    Comment: One commenter asked whether an advanced registered nurse 
practitioner can perform the 1-hour assessment.
    Response: In the final rule, combined standard (e) permits an 
advanced registered nurse practitioner (if recognized by State law and 
hospital policy as having these abilities within the scope of the 
individual's license and consistent with individually granted clinical 
privileges) as being able to order the intervention as well as perform 
the 1-hour face-to-face evaluation.
    Comment: One commenter noted that managed care reimbursement for 
psychiatric inpatient services is minimal, and the physician will 
either have to demand that the hospital pay for the physician's time or 
refuse to extend his or her time ``to unnecessarily observe a patient 
who has been safely contained by competent mental health 
professionals.''
    Response: This final rule permits the attending physician or other 
attending practitioner (as noted in the rule) to determine whether and 
how quickly the physician's presence is merited without arbitrarily 
requiring it.
16. Limits for Restraint/Seclusion Orders (Sec.  482.13(f)(3)(ii)(D))
    We stated that each written order for a physical restraint or 
seclusion is limited to 4 hours for adults, 2 hours for children and 
adolescents ages 9 to 17; or 1-hour for patients under 9. The original 
order may only be renewed in accordance with these limits for up to a 
total of 24 hours. After the original order expires, a physician or 
licensed independent practitioner (if allowed under State law) must see 
and assess the patient before issuing a new order.
    Although a few commenters agreed with the timeframes for length of 
order specified in the interim final rule with comment period, the 
majority of comments on this requirement were from advocacy 
organizations wanting further restriction on the time limits and 
seeking clarity on who can renew the order. However, one commenter did 
object to the timeframes for length of order, arguing that they were 
not based in research and were arbitrary.
    Recommendations on this provision varied and included the 
following:
    <bullet> Limiting the timeframes for length of order to no more 
than one-half hour for children, 1-hour for adolescents, and 2 hours 
for adults.
    <bullet> Making the timeframes for length of order different for 
seclusion and restraint use.
    <bullet> Not using age as the determining criterion since it is an 
arbitrary factor. Patients present with a variety of clinically 
important indicators, such as size, weight, gender, history of abuse, 
disability and medical conditions that should also be used to determine 
the length of time a patient remains in restraint or seclusion.
    Other commenters suggested that each renewal of the order should be 
accompanied by another face-to-face examination of the patient by the 
physician. A few commenters were uncertain of who would perform the 
assessment of the patient prior to renewing the order for the 
intervention. These commenters asked whether the interim final rule 
with comment period required physician or LIP face-to-face re-
evaluation of the patient before renewal of the order.
    Response: We conclude from the nature and number of comments that 
we did not emphasize our intent for this standard strongly enough. The 
regulation identifies maximum time limits on the length of each order 
for restraint or seclusion used for the management of violent or self-
destructive behavior that jeopardizes the immediate physical safety of 
the patient, a staff member, or others. The physician or LIP has the 
discretion to write the order for a shorter length of time. The length-
of-order requirement identifies critical points at which there is 
mandatory contact with a physician or LIP responsible for the care of 
the patient. In addition, the time limits do not dictate how long a 
patient is in restraint or seclusion. Staff should be continually 
assessing and monitoring the patient to ensure that the patient is 
released from restraint or seclusion at the earliest possible time. 
Restraint or seclusion may only be employed while the unsafe situation 
continues. Once the unsafe situation ends, the use of restraint or 
seclusion should be discontinued. In the final rule, combined standard 
(e) explicitly states that the intervention must be discontinued at the 
earliest possible time, regardless of the length of time identified in 
the order. For example, if a patient's behavior responds to the 
intervention in 20 minutes, then the restraint or seclusion should be 
discontinued, even if the order was given for up to 4 hours. If 
restraint or seclusion is discontinued prior to the expiration of the 
original order, a new order must be obtained prior to reinitiating the 
use of restraint or seclusion.
    We leave to the physician's or other LIP's discretion whether an 
onsite assessment prior to renewing the order (for up to 4 hours, 2 
hours, or 1 hour, as permitted by the regulation) is necessary. While 
we agree that prompt physician involvement is important, requiring 
face-to-face reassessment by a

[[Page 71413]]

physician prior to renewal of an order as proposed by the commenters 
would be overly burdensome. Once the physician or other LIP has 
assessed the patient's condition, the physician or other LIP chooses a 
course of action to be followed and directs staff to implement it. We 
believe that an RN can follow the physician's or other LIP's direction 
and reassess the patient. Without evidence indicating that a 
physician's own evaluation versus that of an RN, nurse practitioner, 
physician's assistant, etc.) somehow better assures patient safety, we 
cannot accept this suggestion. However, after 24 hours, a face-to-face 
assessment by a physician or other LIP must occur before a new order is 
written for restraints or seclusion for the violent or self-destructive 
patient.
    We are unaware of any research or data that suggest that limiting 
orders to 1 hour is better than limiting them to 4 hours for adults 18 
years of age or older, 2 hours for children and adolescents 9 to 17 
years of age, or 1 hour for children under 9 years of age. We stress 
that the timeframes outlined in the regulation are maximums. The 
ordering practitioner has the discretion to provide an order for a 
shorter timeframe based on the patient's condition and factors 
suggested by commenters.
    Comment: Some commenters were confused by the term ``renewal'' of 
an order. We were asked to differentiate between the original order, a 
renewal order, etc. One commenter stated that under policies in place 
before the publication of the interim final rule with comment period, 
continuation of a restraint order beyond the 4-hour time limit was a 
decision that could be delegated to an RN. The commenter asked whether 
this rule would require a repeat order from the physician, or whether a 
4-hour continuation could be decided upon by other qualified staff, 
such as an RN. Some commenters supported orders being renewed in this 
manner for up to 24 hours without a new (physician's) order. One 
commenter argued that not allowing nurses to evaluate the need to 
continue the use of restraint or seclusion and, thus, the need to renew 
an order would create a burden for hospitals.
    Response: Each order for restraint or seclusion for the management 
of violent or self-destructive behavior that jeopardizes the immediate 
physical safety of the patient, a staff member, or others is limited to 
the maximum timeframes in the regulation before the physician or other 
LIP responsible for the care of the patient must be contacted again. At 
the end of the timeframe, if the continued use of restraint or 
seclusion is deemed necessary based on a patient assessment, another 
order is needed. These limited timeframes apply regardless of whether 
each order is considered a separate, distinct, original order, or 
whether an order is considered a continuation or renewal of the 
original order. Because the use of restraint or seclusion is considered 
an intervention that can only be authorized by the order of a physician 
or other LIP, it is consistent to require that the determination to 
continue the intervention meet this standard as well. We believe that 
it is reasonable to have a trained RN reassess the patient when the 
original order is about to expire, and then contact the physician or 
other LIP to obtain direction as to whether the intervention is to be 
continued and whether other steps are to be taken. The key is the 
continued medical oversight. There is no prohibition of telephone 
renewals. We note, however, that at the 24-hour point, if the patient 
is still in restraint or seclusion for the management of violent or 
self-destructive behavior that jeopardizes the immediate physical 
safety of the patient, a staff member, or others, the patient must be 
seen and assessed by a physician or other LIP before a new order can be 
written. In the final rule, we have also specified that each order for 
restraint used to ensure the physical safety of the non-violent or non-
self-destructive patient may be renewed as authorized by hospital 
policy.
    Comment: One commenter agreed that this provision is clinically 
sound and warranted. However, the commenter believed that once 
evaluated, the physician should have the right, based on years of 
clinical training and supervision and board certification, to continue 
seclusion or restraint with periodic nursing evaluation for 24 hours.
    Response: We believe that the timeframes for length of order, as 
established by the regulation, are reasonable. We note that the 
regulatory timeframes do not mandate how long the intervention 
continues; they only provide check points at which the ordering 
practitioner, and subsequently the attending physician, must be 
contacted with updated information regarding the patient.
    Comment: One commenter suggested that the timeframes for seclusion 
should be consistent with professional standards of practice, rather 
than being regulated by this rule.
    Response: We believe the timeframes for seclusion are consistent 
with professional standards of practice. Seclusion should only be 
employed while the unsafe situation persists. Once the unsafe situation 
ends, the use of seclusion should be discontinued. The length-of-order 
requirements identify intervals at which the ordering practitioner, and 
subsequently the patient's attending physician, must be informed of the 
patient's condition so that he or she can make a decision as to how 
treatment should proceed.
    Comment: One commenter suggested that a physician's review of the 
documentation of the need for restraint [for the management of violent 
or self-destructive behavior] should be done within 24 hours of the 
order being issued.
    Response: A documentation review alone may not adequately protect 
the patient. We expect that a physician or other LIP will see the 
patient if the patient is still restrained or secluded at the 24-hour 
point. Twenty-four hours of restraint or seclusion for the management 
of violent or self-destructive behavior that jeopardizes the immediate 
physical safety of the patient, a staff member, or others is an extreme 
measure which could potentially seriously harm the patient.
    Comment: One commenter believed that allowing 24 hours to elapse 
before the physician is required to physically see and reassess the 
patient is too long an interval. If the patient remains extremely 
agitated after 12 hours in restraint or seclusion, it is evident that 
the intervention is not successful, and some other intervention is 
needed. Another commenter argued that if the patient has been 
restrained or secluded for 4 hours, but preferably 3, a physician 
consultation is necessary. The medical director needs to be called in 
to help chart a course of action that will get the patient out of 
restraint or seclusion if it is proving ineffective.
    Response: We agree with the commenter's concern that a patient's 
continued agitation may indicate a need to consider another course of 
treatment. However, the reason for the use of restraint or seclusion is 
to protect the patient or others from harm. The use of these 
interventions must not end efforts to treat the underlying cause of the 
behavior; nor is it expected that treatment will come to a complete 
halt. We expect that the use of restraint or seclusion will only last 
while the unsafe situation persists. Certainly, trained staff should 
work with the patient toward release as quickly as possible and use 
other interventions to de-escalate the crisis behavior.
17. Simultaneous Use of Restraint and Seclusion (Sec.  482.13(f)(4))
    We stated that restraint and seclusion may not be used 
simultaneously unless

[[Page 71414]]

the patient is--(1) continually monitored face-to-face by an assigned 
staff member; or (2) continually monitored by staff using both video 
and audio equipment. This monitoring must be in close proximity to the 
patient.
    Comment: One commenter questioned whether our intent is that a 
patient who has been medicated and placed in seclusion must be 
continually monitored.
    Response: The regulation only requires continual monitoring when 
restraint and seclusion are used simultaneously. If the use of a drug 
meets the definition of a restraint, and the patient is simultaneously 
placed in seclusion, all the requirements related to the simultaneous 
use of restraint and seclusion apply, including the requirement for 
continual monitoring.
    Comment: One commenter asked for definition of the word ``staff.'' 
Another commenter asked for more detail regarding the type of 
monitoring and the level of expertise of the monitors. One commenter 
argued that children should be monitored by a person who is trained to 
interact and counsel.
    Response: The word ``staff,'' as used in the regulation, has the 
standard definition found in any dictionary and includes anyone 
employed by the hospital directly or under a contract. Staff who 
monitor the patient face-to-face should be trained not only in 
restraint and seclusion techniques, but also in how to monitor physical 
and emotional status (taking vital signs, checking physical well-being, 
working with the patient to help the patient regain self-control, 
recognizing when the emergency situation has abated and the 
interventions (either one or both) can be ended). The components of 
continual monitoring must be determined by staff based on hospital 
policy, an individualized patient assessment, and the intervention 
used. Standard (f) specifies the criteria CMS will apply to staff to 
ascertain whether they have been ``trained''within the meaning of our 
regulation.
    Comment: Some commenters stated that the rule does not explain why 
restraint and seclusion would be used simultaneously and argued that 
restraint and seclusion should not be used simultaneously. Some 
commenters asked to have simultaneous restraint and seclusion banned. 
These commenters voiced their belief that there is no clinical 
justification for subjecting a patient to both restraint and seclusion 
at the same time, other than for convenience of staff, for discipline, 
coercion, or retaliation. If simultaneous use continues to be 
permitted, these commenters suggest that patients should be constantly 
monitored by staff that is in the room or right outside the seclusion 
room, but in direct visual sight.
    Response: Although simultaneous use of restraint and seclusion may 
be inappropriate in many cases, clinical situations exist where the 
simultaneous use of restraint and seclusion may legitimately be needed 
to protect the patient or others from harm. Staff must take extra care 
to protect the safety of the patient when more restrictive 
interventions are used. Restraint limits a patient's ability to move or 
escape from harm. Seclusion of a restrained patient may be necessary to 
protect a patient from possible abuse, assault or self injury during 
the intervention. For example, a patient is restrained alone in a room 
to maintain the patient's privacy. Shielding the patient from contact 
with others may be more humane and supportive of personal dignity than 
permitting everyone on the unit to witness what is happening to the 
patient. In this situation, it may be necessary to lock the door and 
seclude the patient if a staff member is not assigned to sit with the 
patient one on one in order to protect the patient.
    When the simultaneous use of restraint and seclusion is employed, 
we would expect to see adequate documentation that justifies the 
decision for simultaneous use as well as vigilance in continuously 
monitoring the patient so that the patient's care needs are met. We 
would expect that the simultaneous use of restraint or seclusion be 
discontinued at the earliest possible time, regardless of the length of 
time identified in the order.
    We do not agree with the commenters' assertions that these uses 
necessarily constitute patient abuse. However, there are risks 
associated with the simultaneous use of restraint and seclusion. 
Therefore in this final rule, we clarify that all requirements 
specified under standard (e) apply in the simultaneous use of restraint 
and seclusion, which is not permitted unless the patient is continually 
monitored face-to-face by an assigned, trained staff member, or 
continually monitored by trained staff using both video and audio 
equipment. This monitoring must be in close proximity to the patient. 
The hospital is responsible for providing the level of monitoring and 
frequency of reassessment that will protect the patient's safety.
    Comment: One commenter questioned whether the use of a restraint is 
considered to be seclusion when the restraint prevents the patient from 
leaving the room. The commenter further queried whether a patient 
restrained in a seclusion room with the door open and unlocked would be 
considered to be in seclusion, and whether a patient restrained in the 
patient's room would be ``in seclusion.''
    Response: In a situation where the patient is being restrained by a 
technique or device that interferes with the patient's mobility, the 
fact that the patient is confined in a room is a secondary effect. This 
situation is not equivalent to the use of seclusion. It is important to 
examine what would happen if the restraint were removed--if the patient 
would be free to leave the room if the restraint were removed, the 
patient is not being secluded. Conversely, if the restraint were 
removed and the door is locked or the staff otherwise physically 
prevent the patient from leaving the room, then the patient is being 
secluded.
18. Use of Video and Audio Monitoring
    The use of video and audio monitoring met with mixed response. 
However, overall, the commenters viewed it negatively. Consumer 
advocates tended to see it as inappropriately depriving the patient of 
human contact when such contact would be beneficial to help the patient 
regain self-control, and as not assuring that the patient's physical 
and psychiatric status are adequately monitored.
    Comment: One commenter stated that audio/video monitoring would be 
``particularly odious to an individual already trussed up, tied down, 
and left alone.'' The use of video and audio equipment further 
alienates a patient who may be craving attention and engaging in the 
only behavior that will bring about human contact.
    Another commenter argued that there is no substitute for face-to-
face monitoring with periodic checks of patient's vital signs. The 
commenter recounted two separate instances where patients died while in 
restraints and seclusion. In both instances, the paramedics were unable 
to ventilate the patients because they were unable to place a tube down 
the throat of the patient. The onset of rigor mortis demonstrated that 
these patients had been dead for several hours before hospital staff 
discovered them and called the paramedics. The nursing logs for both 
patients indicated that the patients had been checked every 15 minutes. 
In these instances, ``checked'' meant looked at through a window into 
the seclusion room.
    Some commenters argued that audio and video monitoring is costly 
and would result in financial burden to the hospitals. One commenter 
explained

[[Page 71415]]

that his hospital does not have the financial resources to hire 
additional nurses or nurse aides to perform one-to-one monitoring, nor 
does it have the resources to buy video systems for monitoring. Another 
commenter characterized electronic monitoring as costly and invasive of 
privacy.
    A commenter argued that face-to-face monitoring only increases 
patient agitation and that both face-to-face and video/audio monitoring 
confirm the misperceptions of psychotic patients who are paranoid or 
delusional.
    Other commenters did not object to alternative methods for 
monitoring, but had suggestions about requiring both. One commenter 
asked that we permit audio monitoring, but not require it. Another 
commenter suggested that we reconsider the need for audio monitoring if 
video monitoring is in place.
    One commenter believed that video monitoring and taping was 
appropriate to ensure proper patient monitoring and quality control; 
however, this commenter believed that the regulations should also 
require staff to be in the patient's room. One commenter recommended 
ongoing audio/video monitoring to protect patient safety.
    Another commenter asked for a more prescriptive definition of 
``close proximity.'' The commenter understood that the intent of 
requiring staff to be in close proximity is to assure that hospital 
staff could quickly reach a patient should a safety issue arise.
    Response: We agree that audio and video monitoring are not 
substitutes for the therapeutic intervention that should be occurring 
to help the patient regain self-control or for the level of monitoring 
necessary to assure that the patient is safe and that the patient's 
care needs are met. The use of video and audio monitoring equipment 
does not eliminate the need for other therapeutic interventions or 
frequent assessment of the patient's needs and status. For one patient, 
continual monitoring face-to-face by an assigned staff member may be 
appropriate and necessary. For another patient, the continual presence 
of an assigned staff member may cause the patient to become more 
agitated. In this situation, continual monitoring by trained staff 
using both video and audio equipment with periodic in-room monitoring 
may be more appropriate. In either situation, vigilant monitoring is 
necessary to protect the patient from harm, and ensure that the 
intervention is discontinued at the earliest possible time.
    The hospital is responsible for providing the level of monitoring 
and frequency of reassessment that will protect the patient's safety. 
Continual monitoring cannot happen solely from outside the seclusion 
room. Staff must enter the seclusion room in order to--(1) monitor a 
patient's vital signs, circulation, hydration needs, elimination needs, 
level of distress and agitation, mental status, cognitive functioning, 
etc., and assess and re-evaluate the patient; (2) provide for 
nutritional needs; range of motion, and elimination needs; and (3) 
provide other necessary therapeutic interventions and patient care. In 
response to comments, we have therefore revised combined standard (e) 
to clarify that all requirements specified under standard (e) apply in 
the simultaneous use of restraint and seclusion.
    In response to comments that requested that we reconsider requiring 
both video and audio monitoring, we believe that neither video nor 
audio monitoring alone adequately protect patient safety when restraint 
and seclusion are used simultaneously. We do not require video and 
audio monitoring; instead, it is one method the facility can use to 
monitor its patients.
    In response to the request for a more prescriptive definition of 
``close proximity,'' the intent is to ensure that staff is immediately 
available to intervene and render appropriate interventions to meet the 
patient's needs. However, based on the number of possible unit 
configurations, we believe an outcome-oriented requirement is more 
appropriate than a more prescriptive one.
    Comment: One commenter suggested that the regulations should 
specify that under no circumstances should a restrained patient be left 
unattended, as a patient in restraint is vulnerable to attack or 
mistreatment from others.
    Response: Including such a requirement would be unnecessarily 
burdensome. As discussed earlier, we agree that a patient is more 
vulnerable to possible abuse, assault, or self injury during a more 
restrictive intervention. We expect staff to take extra care to protect 
the safety of the patient when more restrictive interventions are used. 
Regardless of the intervention used, the hospital is responsible for 
providing the level of monitoring and frequency of assessment necessary 
to protect the patient's safety. We believe hospitals should have the 
flexibility to provide the level of monitoring and frequency of 
assessment necessary to protect the patient's safety based on hospital 
policy and an individualized patient assessment.
    Comment: Due to nationwide staff shortages, one commenter stated 
that his facility would be unable to meet the requirement.
    Response: As one commenter offered earlier, it is the hospital's 
responsibility to assure that it has adequate staff available to meet 
the patients' needs. Given the acuity of a patient in restraint and 
seclusion simultaneously, we believe that heightened monitoring and 
intervention are merited.
    Comment: One commenter stated that the requirement for face-to-face 
monitoring places staff at higher risk for injury.
    Response: We believe that the required training elements within 
this regulation will promote staff awareness and expertise in handling 
potentially hazardous situations.
    Comment: One commenter suggested that a better approach for 
increasing physician oversight and involvement would be to require a 
log of restraint use to be kept by the hospital, along with quarterly 
reports generated for local peer review organizations to track 
restraint and seclusion use. Patterns of excessive use would emerge 
more readily than they would otherwise under the current requirements.
    Several commenters suggested requiring a restraint/seclusion log, 
and included elements that should be part of this log, such as the time 
initiated, discontinued, time physician was contacted, documentation of 
physical exams, etc. Additionally, other commenters believed that 
quality improvement efforts could more appropriately address the 
concerns regarding patient safety and quality of care.
    Response: We agree. Although not mandated in this rule, we expect a 
hospital will address, as part of its quality assessment and 
performance improvement (QAPI) program, patient safety and quality of 
care issues. We also believe that this sort of tracking and monitoring 
may be appropriate as part of a hospital's QAPI program. However, 
including such a requirement would be unnecessarily burdensome. 
Hospitals should have the flexibility to identify and monitor the 
quality indicators that are most critical to the patient population(s) 
that they serve.
    Comment: One commenter questioned how face-to-face monitoring 
should be documented.
    Response: The regulation does not specify how face-to-face 
monitoring will be documented. This should be addressed by hospital 
policy.
19. Reporting of Death(s) Related to Restraint/Seclusion (Sec.  
482.13(f)(7))
    We stated that the hospital must report to CMS any death that 
occurs

[[Page 71416]]

while a patient is restrained or in seclusion, or where it is 
reasonable to assume that a patient's death is a result of restraint or 
seclusion.
    Comment: Several commenters noted that all deaths are routinely 
reported to State authorities.
    Response: As noted earlier in this preamble, while there may be 
local mechanisms for reporting deaths, there is, at present, no 
nationwide system for reporting these deaths. We have estimated that 
the total number of deaths related to the use of restraint and 
seclusion in hospitals will be less than 10 per year. Therefore, given 
that the average number of reports per hospital is one or less, we do 
not believe that it is burdensome to ask that the hospital notify the 
CMS regional office if a patient dies while in restraint or seclusion, 
or where it is reasonable to assume that restraint or seclusion 
contributed directly or indirectly to the patient's death.
    Comment: One commenter who supported the provision as written 
opposed requiring more detailed reporting and expressed concern about 
routine reporting to the Protection and Advocacy organizations (P&As). 
(Providing the P&As with information was mentioned in the preamble of 
the interim final rule with comment period.) Some commenters echoed 
this concern, expressing serious reservations about CMS's ability to 
maintain the confidentiality of the sensitive information provided in 
accordance with the new rule. These commenters did not believe that 
information provided to the P&As would be protected from disclosure or 
legal discovery. One commenter asked whether CMS would maintain the 
confidentiality of the information, or share it with outside entities.
    Those commenters who opposed sharing the information with other 
entities argued that forcing hospitals to report injuries and the 
circumstances around them would in many cases require release of 
information that hospitals gather through their own peer review 
activities. Almost all 50 States protect information gathered in peer 
review and other quality internal improvement processes from discovery 
by lawyers. One commenter referred to Bredice v. Doctor's Hospital, 
Inc. (50 FRD 249 (D.D.C. 1970)), citing it as a case in which the court 
found that it was in the overwhelming public interest to maintain the 
confidentiality of the minutes and reports of medical staff meetings 
during which doctors critically analyze the hospital's medical care. 
The commenter argued that self-critical analysis privilege is now 
judicially recognized as a result of this case.
    In contrast, a core of commenters from the public and the patient 
advocacy community supported sharing this information with the P&As, 
stressing the importance of partnering between CMS and P&As. These 
commenters encouraged a mandatory, detailed system of reporting to the 
P&As to ensure comprehensive investigations of incidents where patients 
die or are injured during restraint or seclusion use.
    Response: Since the publication of the interim final rule with 
comment period, we have implemented a process for restraint or 
seclusion death reporting. We centrally track reports of death from 
restraints or seclusion occurring in hospitals. We use this information 
to: Authorize onsite investigations and complaint surveys of these 
hospitals, in accordance with the current complaint investigation 
process; and to inform the Federally-mandated P&A entity in the 
respective State or territory. P&A programs are congressionally 
authorized (in accordance with 42 U.S.C. 10801 et seq.) to access 
facilities and to investigate abuse and neglect complaints.
    Comment: One commenter asked what information must be provided by 
the hospital and the timeframe within which the hospital must report 
the information to CMS. Some commenters proposed introducing timeframes 
for reporting, such as contacting the CMS regional office within 4 days 
of a patient death and the P&A within an additional 3 days. The 
commenters who supported such timeframes cited proposed national 
legislation, The Children's Health Act of 2000 (the CHA). The 
commenters who asked for definite timeframes stated that delays in 
reporting compromise the ability to investigate effectively (staff may 
leave, medical/documentary evidence may be lost or concealed, and 
potentially deadly practices continue). Other commenters suggested that 
CMS require reporting to the P&A within 24 hours of an incident.
    Response: The CHA was signed into law on October 17, 2000 (Pub. L. 
106-310). Section 592 of the CHA establishes minimum death reporting 
requirements. This final rule conforms to these requirements. We have 
revised our requirements to specify that the hospital report each death 
to the CMS regional office by telephone no later than the close of 
business the next business day following knowledge of the patient's 
death. This information will be relayed to CMS central office and the 
State survey agency, inasmuch as it acts as a direct agent of CMS. Our 
central office maintains a database to compile information related to 
deaths associated with seclusion or restraint.
    Comment: Some commenters suggested that the regulation excuses 
hospitals from revealing many deaths precipitated by the misuse of 
restraint or seclusion by allowing the hospital to make the 
determination of whether a patient's death is reasonably assumed to 
have resulted from restraint or seclusion. These commenters strongly 
believed that providers tend to dismiss restraint-related deaths as 
``unfortunate isolated incidents,'' not the manifestation of individual 
abuse or systemic failures, and that hospitals can rationalize that 
deaths were due to a patient's underlying condition or ``natural 
causes.'' Several commenters cited an example of the death of a young 
man who suffered a severe asthma attack soon after fighting with 
another patient and being restrained. According to the commenters, the 
death was ruled to be due to natural causes, even though the medical 
examiner found that the stress of the fight and restraint triggered the 
attack. Some commenters indicated that a complicating issue is that 
death may occur after a patient has been restrained or secluded in an 
originating facility, and is then transferred to another facility. The 
receiving facility may be unaware of what has transpired at the 
originating facility and may not report the death.
    To address this issue, these commenters suggested that at a 
minimum, CMS specify that any deaths that occur within one week of 
restraint or seclusion use be assumed to be the result of restraint or 
seclusion. Optimally, however, these commenters argued for reporting 
all deaths of patients with a psychiatric diagnosis or mental 
retardation. The commenters stated that in this way, CMS could remove 
the subjectivity currently permitted by allowing the hospital to make a 
determination that the death is ``reasonably assumed'' to be a result 
of restraint or seclusion use.
    These commenters also stated that a requirement for reporting the 
deaths of all patients with a mental retardation or psychiatric 
diagnosis would also permit CMS and the P&As to capture deaths that 
occurred post-transfer, as a result of restraint and seclusion 
practices at another facility.
    Response: We have revised the reporting requirements. The hospital 
must report to CMS each death that occurs while a patient is in 
restraint or in seclusion or both at the hospital; and, each death 
known to the hospital that occurs within 1 week after restraint

[[Page 71417]]

(whether physical restraint or drugs used as a restraint) or seclusion, 
in cases in which it is reasonable to assume that use of restraint or 
placement in seclusion contributed directly or indirectly to a 
patient's death. We have also clarified the meaning of ``reasonable to 
assume.'' As a result, ``reasonable to assume'' includes, but is not 
limited to, deaths related to restrictions of movement for prolonged 
periods of time, or deaths related to chest compression, restriction of 
breathing, or asphyxiation. In addition, we have moved the reporting 
requirements from standard (f) and created a separate standard 
(standard (g)) that addresses these requirements. This was done to 
clarify that all deaths associated with the use of seclusion or 
restraint or both must be reported. The reporting requirements in 
standard (g) are applicable to restraint and seclusion use.
    We are not adopting the commenter's suggestion that all deaths of 
patients with a psychiatric or mental retardation diagnosis be reported 
to CMS; nor will we assume that all deaths that occur within 1 week of 
the use of restraint or seclusion are the result of restraint or 
seclusion.
    Comment: A commenter stated that the reporting process is severely 
deficient because inadequate information would be provided to CMS and 
the P&As. The commenter suggested specific elements that should be 
reported, including--
    <bullet> Identity of deceased/injured patient;
    <bullet> Patient's age;
    <bullet> Identity of patient's guardian, if applicable;
    <bullet> Identification of next of kin, in cases involving patient 
death;
    <bullet> Date of death/injury;
    <bullet> Patient's home address;
    <bullet> Medications patient was taking/other medical services 
provided;
    <bullet> Cause and circumstances of death/injury;
    <bullet> Whether/by whom death/injury is being investigated; and
    <bullet> Identity of person making report.
    Some commenters believed that the report submitted to CMS should be 
standardized and in writing.
    Response: We agree that the suggested elements should be reported. 
However, to allow some flexibility for hospitals, we are not specifying 
these elements in the regulation text. In the final rule, standard (g), 
we have specified that each death referenced in this section must be 
reported to CMS by telephone no later than the close of business the 
next business day following knowledge of the patient's death. In 
addition, we have added a requirement that staff must document in the 
patient's medical record the date and time the death was reported to 
CMS.
    Comment: One commenter suggested replacing the word ``assume'' with 
``suspicion or belief.''
    Response: We have retained use of the word ``assume'' and added 
language to clarify the meaning of ``reasonable to assume.''
    Comment: One commenter indicated that the accrediting organization 
should also receive this information as deaths would be ``sentinel 
events'' under JCAHO policy.
    Response: We currently inform the hospital's accrediting 
organization when we receive a death report from a hospital. In 
addition, hospitals should report deaths to their accrediting 
organization in accordance with their accreditation standards. JCAHO 
instituted a sentinel events reporting policy (effective October 31, 
1998) that encourages hospitals to voluntarily report such occurrences 
within 7 days of the incident.
    Comment: One commenter opposed the reporting requirement, stating 
that there is no need to increase the number of people involved with 
the monitoring and/or investigating patient deaths. Another commenter 
echoed this sentiment, noting that this requirement is duplicative of 
JCAHO's sentinel event reporting requirement, and that we should simply 
share data with the JCAHO instead.
    In contrast, a private psychiatric health system agreed with this 
provision, saying it makes good sense. Many commenters supported this 
provision, although they suggested measures that they believed would 
strengthen it, such as requiring that serious injuries be reported and 
specifying lists of elements to be provided to CMS.
    Response: Section 592 of the CHA mandates death reporting and this 
final rule incorporates/addresses these requirements. These 
requirements address gaps in existing reporting systems that inhibit 
the ability to conduct meaningful analysis of trends and target 
problems. JCAHO's system is voluntary, not mandatory, and 20 percent of 
the hospitals that participate in Medicare and Medicaid are not JCAHO 
accredited. To adequately track deaths, mandatory reporting is needed 
by all hospitals.
    We believe that injury reporting is beyond the scope of the CHA; 
and therefore, we are not incorporating injury reporting provisions in 
this final rule. However, we would expect that serious injuries related 
to the use of restraint or seclusion would be monitored through the 
hospital's QAPI program.
    Comment: Several commenters suggested that reporting should include 
not only deaths of patients, but injuries to staff during the restraint 
or seclusion procedure.
    Response: We do not require reporting of staff injuries associated 
with the use of seclusion or restraint. However, hospitals may 
establish their own systems for tracking such information.
    Comment: One commenter suggested requiring hospitals to report the 
number of seclusion or restraint occurrences; the total number of 
patients secluded or restrained; the average number of hours per 
occurrence; and, the average number of hours in seclusion or restraint 
per patient. The commenter also recommended that we protect patient 
privacy by withholding of identifying information but otherwise 
reporting demographic data.
    Response: We believe that the burden of such an approach would have 
the opposite effect; that is, it would most likely result in hospital 
under-reporting of patients in restraint or seclusion. However, 
although not mandated in this rule, we expect that a hospital will 
address utilization of restraint and seclusion as part of their QAPI 
program. Regarding the recommendation to this information is withheld 
identifying information, required to investigate or otherwise follow-up 
on a reported death, if necessary.
    Comment: Some commenters believed that serious injuries, both 
physical and psychological, must be reported to be proactive and to 
prevent deaths. These commenters realized that there may be some 
additional burden on hospitals, but believed that burden could be 
minimized by limiting reports to more severe types of injuries. One 
commenter asked that if we do add injury reporting, that it be limited 
to injuries that require medical attention.
    Some commenters offered a general argument that the P&As would be a 
better entity than CMS to receive the information and investigate the 
incidents. For example, commenters stated that the P&As have trained 
investigators who are already a part of the Department of Health and 
Human Services. Commenters also stated that the P&As need to be 
involved to adequately perform the necessary investigations.
    In contrast, several commenters questioned why the P&As should be 
provided this information, since they have no authority to sanction a 
hospital and are not able to act as CMS's agent. The commenters stated 
that this

[[Page 71418]]

provision would expose the provider to two possible investigations 
without any clear and convincing rationale.
    Response: We are not adding any injury reporting requirement in 
this rule. Aside from the issue of hospital burden and potential 
disagreement on what constitutes a reportable event, a fundamental 
problem in requiring injury reporting for this setting is the 
administrative burden on the program itself. Many commenters seemed to 
acknowledge this limitation, in that they used it as an argument for 
the need for increased P&A involvement. So, these commenters may argue, 
even if CMS cannot administratively handle injury reporting, this 
information could be routed to the P&As for investigation or made 
available to the public.
    We believe that this points to a misperception of the roles of the 
various agencies. A P&A cannot act as our agent. There is no statutory 
connection between CMS and the P&As, as there is between CMS and the 
State survey agencies. The P&A cannot take an enforcement action on our 
behalf. While we support the role of the P&As, and we believe that a 
coordinated effort between agencies is appropriate, we also believe 
that the roles should not blur into each other. We have a distinct 
interest in the health and safety of patients, which is shared by the 
P&As. However, we also have a statutorily-governed relationship with 
the providers of services. That relationship is built on the 
expectation of confidentiality. We need information from the hospitals 
inasmuch as we evaluate whether they are meeting the standards for care 
we have set.
    Comment: Mental health advocacy groups and P&A organizations 
requested that the name, address, phone number, and brief description 
of services provided by the P&A be required to be posted in each 
hospital.
    Response: We believe requiring that this information be posted 
would be unnecessarily burdensome. Hospitals are already required to 
provide patients with contact information if the patient wishes to file 
a grievance.
    Comment: One commenter stated that if serious injury or death 
occurs, that event needs to be recorded and an independent auditor 
needs to investigate the incident. The auditor should be clinically 
oriented, not of an administrative background.
    Response: We only require that deaths be reported. Upon receipt of 
the information, we can initiate an independent investigation of the 
death. We are not requiring that hospitals report serious injuries, but 
this type of information could be reviewed while surveyors are onsite. 
In addition, we will not require that the hospital hire an independent 
auditor to investigate deaths and serious injuries.
    Comment: One commenter charged that the reporting requirement is 
not consistent with initiatives to create a government that works 
better and costs less.
    Response: We disagree. We do not believe that the revised reporting 
requirements are overly burdensome. Furthermore, the reporting system 
serves as an outcome indicator that can be used to target our 
investigational efforts.
    Comment: One P&A supported the reporting of serious injuries, but 
argued for added resources for P&As so that meaningful and prompt 
investigations can occur.
    Response: We agree with the importance of P&A investigations. 
However, we do not allocate funding for the P&A programs.
    Comment: One commenter indicated that it is burdensome for a 
hospital to have to review charts on all patient deaths to determine if 
restraints or seclusion were used with the patient. The commenter 
questioned whether only Medicare and Medicaid beneficiary deaths need 
to be reported, or if all patient deaths related to restraint or 
seclusion must be reported.
    Response: The CoPs apply to all patients in a Medicare- and 
Medicaid-participating hospital, not just Medicare/Medicaid 
beneficiaries. Therefore, all patient deaths associated with the use of 
restraint or seclusion or both must be reported. We do not view this as 
particularly burdensome since these deaths should be infrequent.
    Comment: A commenter stated that the regulation does not discuss a 
penalty for failure to report.
    Response: Noncompliance with this requirement, as with any of the 
others in these standards, constitutes a violation of the CoPs that 
would potentially be subject to termination of the hospital provider 
agreement as described at 42 CFR 489.53.

IV. Provisions of the Final Rule

    For reasons specified in section III of the preamble to this final 
rule, we are codifying the Patients' Rights CoP within the current 
hospital CoPs under Subpart B--Administration at Sec.  482.13. The 
eight standards specified in this final rule establish minimum 
protections and rights for patients. Any changes that have been made to 
clarify or strengthen the provisions that appeared in the interim final 
rule with comment period are noted in the following description of the 
provisions.
    The first standard, ``Notice of Rights,'' requires the patient or 
the patient's representative, as permitted by State law, to be informed 
of the patient's rights prior to furnishing or discontinuing care 
whenever possible. The standard also requires that the hospital have a 
grievance process, that the patient be informed of whom to contact to 
file a grievance, and that the process include specific elements. This 
standard has not been revised; and therefore, is being finalized 
without change.
    The second standard, ``Exercise of Rights,'' provides the patient 
the right to participate in the development and implementation of his 
or her plan of care, and to request or refuse treatment. This standard 
supports the patient's right to make decisions regarding his or her 
care and to formulate advance directives and have hospital staff and 
practitioners who provide care in the hospital comply with these 
directives, in accordance with Sec.  489.102 (Requirements for 
providers). This standard also supports the patient's right to have a 
family member or representative of his or her choice and his or her 
physician notified promptly of the patient's admission to the hospital. 
This standard has not been revised; and therefore is being finalized 
without change.
    The third standard, ``Privacy and Safety,'' which includes the 
right to personal privacy, to receive care in a safe setting, and to be 
free from all forms of abuse or harassment. This standard has not been 
revised; and therefore is being finalized without change.
    The fourth standard, ``Confidentiality of Patient Records,'' 
provides the patient's right to the confidentiality of his or her 
records, and to access those records. This standard has not been 
revised; and therefore is being finalized without change.
    The fifth standard, ``Restraint or seclusion,'' differs both in 
content and in application from the standard presented in the interim 
final rule with comment period. We have revised and combined the 
requirements contained in standards (e) and (f) in the interim final 
rule into a single, combined standard in the final rule. The final, 
combined standard (e) applies to the use of restraint, the use of 
seclusion, as well as the simultaneous use of restraint and seclusion 
regardless of patient location.
    The revised, combined standard (e) states that all patients have 
the right to be free from physical or mental abuse, and corporal 
punishment. It retains the patient's right to be free from restraint or 
seclusion, of any form, imposed by staff as a means of coercion, 
discipline,

[[Page 71419]]

convenience, or retaliation. It also states that restraint or seclusion 
may only be imposed to ensure the immediate physical safety of the 
patient, staff or others and must be discontinued at the earliest 
possible time.
    A significant change from the interim final rule with comment 
period to this final rule is that standard (e) provides a revised 
definition of ``restraint.'' In the final rule, we adopted the 
restraint definition contained in the CHA. A restraint is any manual 
method, physical or mechanical device, material, or equipment that 
immobilizes or reduces the ability of a patient to move his or her 
arms, legs, body, or head freely; or a drug or medication when it is 
used as a restriction to manage the patient's behavior or restrict the 
patient's freedom of movement and is not a standard treatment or dosage 
for the patient's condition. The final rule also clarifies that a 
restraint does not include devices, such as orthopedically prescribed 
devices, surgical dressings or bandages, protective helmets, or other 
methods that involve the physical holding of a patient for the purpose 
of conducting routine physical examinations or tests, or to protect the 
patient from falling out of bed, or to permit the patient to 
participate in activities without the risk of physical harm (this does 
not include a physical escort). The seclusion definition contained in 
the interim final rule with comment period has been retained with minor 
content revisions. Seclusion is the involuntary confinement of a 
patient alone in a room or area from which the patient is physically 
prevented from leaving. Standard (e) also clarifies that seclusion may 
only be used for the management of violent or self-destructive behavior 
that jeopardizes the immediate physical safety of the patient, a staff 
member, or others.
    All of the requirements contained in the current standard (e) 
``Restraint for acute medical and surgical care'' are also contained in 
the current standard (f) ``Seclusion and restraint for behavior 
management.'' These requirements have been moved to the combined 
standard (e) in the final rule. The more stringent requirements 
contained in the current standard (f), but not in the current standard 
(e) have also been moved to the combined standard (e) in the final 
rule. These more stringent requirements are: Time limits on the length 
of each order, and the 1-hour face-to-face evaluation. The final rule 
clarifies that these two requirements only apply when restraint or 
seclusion are used to manage violent or self-destructive behavior that 
jeopardizes the immediate physical safety of the patient, a staff 
member, or others. Requirements for the simultaneous use of restraint 
and seclusion have also been retained in the final rule.
    Standard (e) retains the following requirements: Restraint or 
seclusion may only be used when less restrictive interventions have 
been determined to be ineffective to protect the patient or others from 
harm; the type or technique of restraint or seclusion used must be the 
least restrictive intervention that will be effective to protect the 
patient or others from harm; and, the use of restraint or seclusion 
must be in accordance with a written modification to the patient's plan 
of care, and implemented in accordance with safe and appropriate 
restraint and seclusion techniques as determined by hospital policy in 
accordance with State law.
    Standard (e) retains and clarifies the requirement that use of a 
restraint or seclusion must be in accordance with the order of a 
physician or other LIP who is responsible for the care of the patient 
as specified under Sec.  482.12(c) and is authorized to order restraint 
or seclusion by hospital policy in accordance with State law. The 
standard also requires that the restraint or seclusion order never be 
written as a standing order or on an as needed basis (PRN), and that 
the attending physician must be consulted as soon as possible if 
restraint or seclusion is not ordered by the patient's attending 
physician. Standard (e) also sets limits on the length of each order 
for restraint or seclusion used to manage violent or self-destructive 
behavior that jeopardizes the immediate physical safety of the patient, 
a staff member, or others based on the age of the patient, and states 
that the order may only be renewed in accordance with these limits for 
up to a total of 24 hours unless superseded by State law that is more 
restrictive. After 24 hours, before writing a new order for the use of 
restraint or seclusion for the management of violent or self-
destructive behavior that jeopardizes the immediate physical safety of 
the patient, a staff member, or others, a physician or other LIP (if 
allowed by State law) must see and assess the patient. Each order for 
restraint used to ensure the physical safety of the non-violent or non-
self-destructive patient may be renewed as authorized by hospital 
policy. Restraint or seclusion must be discontinued at the earliest 
possible time, regardless of the length of time identified in the 
order.
    Further, standard (e) specifies that the condition of the patient 
who is restrained or secluded must be monitored by a physician, other 
LIP or by trained staff at an interval determined by hospital policy. 
The criteria for staff to be considered ``trained'' are specified under 
Sec.  482.13(f). In addition, physician and other LIP training 
requirements must be specified in hospital policy. At a minimum, 
physicians and other LIPs authorized to order restraint or seclusion by 
hospital policy in accordance with State law must have a working 
knowledge of hospital policy regarding the use of restraint or 
seclusion.
    A significant change from the interim final rule with comment 
period to this final rule is that standard (e) has been revised to 
expand the type of practitioners permitted to conduct the 1-hour face-
to-face evaluation. When restraint or seclusion is used for the 
management of violent or self-destructive behavior that jeopardizes the 
immediate physical safety of the patient, a staff member, or others, a 
physician or other LIP, or a RN or PA trained in accordance with the 
requirements specified under Sec.  482.13(f), must see the patient 
face-to-face within 1-hour after the initiation of the intervention. 
This practitioner must evaluate the patient's immediate situation, the 
patient's reaction to the intervention, the patient's medical and 
behavioral condition, and the need to continue or terminate the 
restraint or seclusion. As specified at Sec.  482.13(e)(13), State law 
(by statute or regulation) regarding the 1-hour face-to-face evaluation 
may be more restrictive than these requirements. If the 1-hour face-to-
face evaluation is conducted by a trained RN or PA, the attending 
physician or other LIP who is responsible for the care of the patient 
as specified under Sec.  482.12(c) must be consulted as soon as 
possible after completion of the evaluation.
    Standard (e) clarifies requirements related to the simultaneous use 
of restraint and seclusion. All requirements specified under standard 
(e) apply in the simultaneous use of restraint and seclusion, which is 
not permitted unless the patient is continually monitored face-to-face 
by an assigned, trained staff member, or continually monitored by 
trained staff using both video and audio equipment. This monitoring 
must be in close proximity to the patient.
    Finally, standard (e) has been amended to specify elements of 
documentation. When restraint or seclusion is used, there must be 
documentation in the patient's medical record of the following: The 1-
hour face-to-face medical and behavioral evaluation if restraint or 
seclusion is used to manage violent or self-destructive behavior that 
jeopardizes the

[[Page 71420]]

immediate physical safety of the patient, a staff member, or others; 
alternatives or other less restrictive interventions attempted (as 
applicable); the patient's condition or symptom(s) that warranted the 
use of the restraint or seclusion; and, the patient's response to the 
intervention(s) used, including the rationale for continued use of the 
intervention. When restraint or seclusion is used for violent or self-
destructive behavior, documentation must also include findings from the 
1-hour face-to-face assessment.
    Standard (f) is a new standard that addresses staff training 
requirements. A patient has a right to the safe implementation of 
restraint or seclusion by trained staff. Staff must be trained and able 
to demonstrate competency in the application of restraints, 
implementation of seclusion, monitoring, assessment, and providing care 
for a patient in restraint or seclusion before performing any of these 
actions, as part of orientation, and subsequently on a periodic basis 
consistent with hospital policy.
    In addition, standard (f) states that the hospital must require 
appropriate staff to have education, training, and demonstrated 
knowledge based on the specific needs of the patient population in at 
least the following:
    <bullet> Techniques to identify staff and patient behaviors, 
events, and environmental factors that may trigger circumstances that 
require restraint or seclusion;
    <bullet> The use of non-physical intervention skills;
    <bullet> Choosing the least restrictive intervention based on an 
individualized assessment of the patient's medical, or behavioral 
status or condition;
    <bullet> The safe application and use of all types of restraint or 
seclusion used in the hospital, including training in how to recognize 
and respond to signs of physical and psychological distress (for 
example, positional asphyxia);
    <bullet> Clinical identification of specific behavioral changes 
that indicate that restraint or seclusion is no longer necessary;
    <bullet> Monitoring the physical and psychological well-being of 
the patient who is restrained or secluded, including but not limited 
to, respiratory and circulatory status, skin integrity, vital signs, 
and any special requirements specified by hospital policy associated 
with the 1-hour face-to-face evaluation; and,
    <bullet> The use of first aid techniques and certification in the 
use of cardiopulmonary resuscitation, including required periodic 
recertification.
    Individuals providing staff training must be qualified as evidenced 
by education, training, and experience in techniques used to address 
patients' behaviors. The hospital must document in the staff personnel 
records that the training and demonstration of competency were 
successfully completed.
    Standard (g) is a new standard that addresses reporting 
requirements for deaths associated with the use of restraint or 
seclusion. The hospital must report to CMS each death that: occurs 
while a patient is in restraint or in seclusion at the hospital; occurs 
within 24 hours after the patient has been removed from restraint or 
seclusion; and, each death known to the hospital that occurs within 1 
week after restraint or seclusion where it is reasonable to assume that 
use of restraint or placement in seclusion contributed directly or 
indirectly to a patient's death. For the purposes of this regulation, 
``reasonable to assume'' includes, but is not limited to deaths related 
to restrictions of movement for prolonged periods of time, or death 
related to chest compression, restriction of breathing or asphyxiation. 
Each death referenced in this section must be reported to CMS by 
telephone no later than the close of business the next business day 
following knowledge of the patient's death. Staff must document in the 
patient's medical record the date and time the death was reported to 
CMS. Although we have modified some of the provisions to address public 
comments, these modifications do not lessen protections afforded 
patients who are restrained or secluded.

V. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, we are required to 
provide 30-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 requires that we solicit comment on the following issues:
    <bullet> The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
    <bullet> The accuracy of our estimate of the information collection 
burden.
    <bullet> The quality, utility, and clarity of the information to be 
collected.
    <bullet> Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    Section 482.13 of this document contains information collection 
requirements; however, these information collection requirements are 
currently approved under OMB control number 0938-0328, ``Hospital 
Conditions of Participation'' with a current expiration date of January 
31, 2008.
    This document makes changes to the requirements in the following 
paragraphs within Sec.  482.13 that contain information collection 
requirements. In this final rule, we have combined the requirements 
that were set forth in the interim final rule under standard Sec.  
482.13(e) Standard: Restraint or Seclusion used in the provision of 
acute medical, pre and post surgical care and Sec.  482.13(f) Standard: 
Seclusion and restraint for management of violent, self destructive or 
aggressive behavior into a single standard, Sec.  482.13(e) Standard: 
Restraint and seclusion. This change is designed to address restraint 
and seclusion use regardless of the treatment setting in which it 
occurs.

Section 482.13(e) Standard: Restraint or Seclusion

    Although we believe many hospitals are already complying with the 
requirements in this standard through usual and customary practices, 
the revisions, reformatting, and additions to the existing regulatory 
text may result in increased burden. However, we believe this increased 
burden should be offset by reduced burden upon the physicians and LIPs 
since the need to assess the patient within 1-hour of the initiation of 
restraint or seclusion can be performed by other qualified LIPS as 
well.

Section 482.13(f) Standard: Restraint or Seclusion: Staff Training 
Requirements

    As we have discussed in greater detail in sections III. and IV. of 
the preamble to this final rule, revisions have been made to the 
proposed Sec.  482.13(e). Paragraph (e)(15) has been added to address 
the documentation requirements when restraint and seclusion are used 
simultaneously. We believe the majority of hospitals already maintain 
such documentation. Therefore, the burden associated with this 
requirement will not impose undue hardship on most hospitals. We 
believe that compliance with these standards constitutes a usual and 
customary business practice and the burden associated with the 
requirements is exempt from the PRA as stipulated under 5 CFR 
1320.3(b)(2).

[[Page 71421]]

Section 482.13(g) Standard: Death Reporting Requirements

    The requirements contained in this section were previously 
contained in paragraph (f)(7) of this section and are currently 
approved under OMB control number 0938-0328. See section VI. of the 
preamble to this final rule for a summary of the estimated burden hours 
associated with this section.
    If you comment on these information collection and recordkeeping 
requirements, please mail copies directly to the following: Centers for 
Medicare and Medicaid Services, Office of Strategic Operations and 
Regulatory Affairs, Regulations Development Group, Room C4-26-05, 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: Carolyn 
Lovett, CMS Desk Officer. Fax (202) 395-6974.

VI. Regulatory Impact Analysis

A. Overall Impact

    We have examined the impact of this rule as required by Executive 
Order 12866 (September 1993, Regulatory Planning and Review), the 
Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), 
section 1102(b) of the Social Security Act (the Act), the Unfunded 
Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
    Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety 
effects, distributive impacts, and equity). A regulatory impact 
analysis (RIA) must be prepared for major rules with economically 
significant effects ($100 million or more in any 1 year). This final 
rule revises the restraints and seclusion provisions of the Patients' 
Rights CoP that were published in the July 2, 1999 interim final rule 
with comment period. The CoPs are the basic health and safety 
requirements that a hospital must meet in order to participate in the 
Medicare program. This rule will implement regulations that are 
intended to reduce the use of restraint and seclusion, eliminate the 
potential for adverse outcomes when restraint, seclusion or both are 
implemented, and minimize the burden associated with compliance with 
the rule. While it is not possible at this point to determine 
definitively the additional costs to the Medicare program resulting 
from this rule, we estimate that the impact will be below $100 million; 
and therefore, we have determined that this final rule is not a major 
rule.
    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 jurisdictions. 
Individuals and States are not included in the definition of small 
entity. We are not preparing analyses for either the RFA or section 
1102(b) of the Act because we have determined, and we certify, that 
this rule will not have a significant economic impact on a substantial 
number of small entities or a significant impact on the operations of a 
substantial number of small rural facilities. In addition, 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 since superseded 
by ``core based statistical areas'' and has fewer than 100 beds.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule that may result in expenditures in any one year by 
State, local, or tribal governments, in the aggregate, or by the 
private sector, of $120 million. This rule has no impact on the 
expenditures of State, local, or tribal governments, and the impact on 
the private sector is estimated to be less than $120 million.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on State 
and local governments, preempts State law, or otherwise has Federalism 
implications. Thus rule will not have any effect on State and local 
governments.
    In the December 19, 1997 Federal Register, we issued a proposed 
rule that detailed our plans to revise all of the hospital CoPs which 
emphasized lessening Federal regulation to eliminate unnecessary 
structural and process requirements, focus on outcomes of care, allow 
greater flexibility to hospitals and practitioners to meet quality 
standards, and place a stronger emphasis on quality assessment and 
performance improvement. The proposed rule indicated our intent to 
include a new Patients' Rights CoP for hospitals that contained rights 
not addressed in the then current CoPs. We solicited comments on the 
Patients' Rights CoP and received strong support for its establishment 
from the public, mental health advocacy groups, media, and the 
Congress. These groups and individuals expressed serious concern about 
improper care of patients in the hospital setting, particularly with 
regard to the use of seclusion and restraint.
    On July 2, 1999, we issued an interim final rule with comment 
period that set forth requirements supporting and protecting patients' 
rights in the hospital setting. It included four standards that were 
finalized to ensure minimum protections of each patient's physical and 
emotional health and safety. These standards address each patient's 
right to: Notification of his or her rights; the exercise of his or her 
rights in regard to his or her care; privacy and safety; and 
confidentiality of patient's records.
    Additionally, this interim final rule specifically addressed the 
right to be free from the use of seclusion and restraint and included 
various requirements to protect the patient when use of these 
interventions is necessary.

B. Anticipated Effects

1. Effects on Providers
    We anticipate the impact of these finalized standards will vary 
widely among hospitals. However, we do not have the benefit of several 
key pieces of information. For example, we do not have reliable data on 
the prevalence of restraint and seclusion use, data on the volume of 
staff in hospitals, or data on the varying levels and qualifications of 
hospital staff who may be involved in restraint and seclusion use. 
Given these and a variety of other factors, it would be unfair to 
calculate an estimate based on the average of the limited available 
data. In another example, with respect to training, this rule will have 
significantly less impact on a hospital that already has a proactive 
training program in place and has significantly reduced its restraint 
and seclusion use than it will in a hospital that has not independently 
taken such an approach.
    Factors such as size, services rendered, staffing, and patient 
populations vary as well. An additional consideration was noted when 
one caller who telephoned for clarification on the provisions of the 
interim final rule with comment period complained that some hospitals 
specifically screen out patients with potentially violent,

[[Page 71422]]

self-destructive behavior, so that this population is diverted to State 
systems, in turn, resulting in these State systems potentially bearing 
the brunt of this burden. We are hesitant to make impact estimates in 
this final rule that may not account for these and other unforeseen 
variations. Thus, we reserve the right to provide estimates when 
feasible. Below we discuss the anticipated effects on providers of the 
standards related to restraints and seclusion.
a. Section 482.13(e) Standard: Restraint or Seclusion
    Standard 482.13(e), previously entitled ``Restraint for acute 
medical and surgical care'' in the interim final rule with comment 
period, is now entitled ``Restraint or seclusion'' in this final rule. 
The existing regulation sets out the patient's rights in the event he 
or she is restrained or secluded, and limits when and by whom restraint 
or seclusion can be implemented. We have combined the existing 
standards 482.13(e) and 482.13(f) for clarity since it is our goal to 
have the use of restraint or seclusion reduced in all settings of the 
hospital. The revisions, reformatting, and additions to the existing 
regulatory language will not result in additional impact upon hospitals 
associated with their efforts to comply with this regulation. Instead, 
since we have provided more clarity in the definition of a restraint 
with respect to medical and surgical services, burdens on hospitals 
should decrease.
    In previous Sec.  482.13(e)(3)(B), we stated the patient's 
``treating'' physician be consulted in the event of restraint or 
seclusion. However, based on comments we have revised the requirement 
at Sec.  482.13(e)(7) to reflect the need to consult the ``attending'' 
physician instead of the ``treating'' physician as soon as possible if 
the attending physician did not order the restraint or seclusion.
    We have revised and expanded Sec.  482.13(e)(4) to specify, at 
Sec.  482.13(e)(10), that a physician, other licensed independent 
practitioner or trained staff meet the training criteria specified in 
paragraph (f) of this section at an interval determined by hospital 
policy. We also recognize there will be some impact associated with 
performing patient assessment and monitoring. However, we view patient 
assessment and monitoring as a standard component of patient care.
    Section 482.13(f)(3)(ii)(c), now Sec.  482.13(e)(7), clarifies that 
the ``attending'' physician must be consulted as soon as possible if 
the attending physician did not order the restraint or seclusion. 
Although this may minimally increase burden to hospitals, we believe it 
is a best practice for patient safety.
    We have added elements at Sec.  482.13(e)(15) that monitoring must 
occur face-to-face by trained staff or by using both video and audio 
equipment, when there is simultaneous use of restraint and seclusion. 
We have added elements at Sec.  482.13(e)(16) regarding the 
documentation that must be included in the patient's medical record 
when the patient is restrained or secluded, including the 1-hour face-
to-face medical and behavioral evaluation if restraint or seclusion is 
used to manage violent or self-destructive behavior, the patient's 
behavior and intervention used, alternatives or other less restrictive 
interventions attempted (as applicable), the patient's condition or 
symptom(s) that warranted restraint or seclusion use, and the patient's 
response to the use of the restraint or seclusion intervention, 
including the need for continued use of restraint or seclusion. We do 
not believe additional burdens are imposed by this requirement since it 
is a routine and customary practice to document the circumstances 
surrounding such an event for comprehensiveness of patient care.
    In the interim final rule with comment period at Sec.  
482.13(f)(3)(ii)(c), we required that the physician or other LIP must 
see and evaluate the patient's need for restraint or seclusion within 
1-hour after the initiation of restraint or seclusion. This 1-hour on-
site physician or LIP evaluation was the most controversial provision 
of the interim final rule with comment period.
    Limited data has been gathered in the industry to date regarding 
the prevalence of restraint and seclusion use. However, among the 
limited data that is available, it reflects the use of restraint or 
seclusion for behavior management only per the current requirement at 
482.13(f).
    For example, based on information provided to us by the National 
Association of Psychiatric Health Systems (NAPHS), fifty NAPHS members 
supplied data for the cost of complying with the CMS requirements that 
a physician or LIP evaluate a patient face-to-face within 1 hour of the 
initiation of restraint or seclusion. The data that was supplied 
combined: (1) The cost of maintaining a physician or LIP on call to be 
available in case there is an event of a restraint or seclusion and (2) 
the cost of having a physician or LIP come to the facility to evaluate 
a patient within 1 hour when a restraint or seclusion episode occurs. 
The average cost was $80,789 per facility per year.
    The NAPHS further discussed that there are approximately 250 
freestanding specialty hospitals in the United States. This number does 
not include the approximately 1,400 behavioral health units of general 
hospitals or government (state and county) psychiatric specialty 
hospitals. The 1 hour rule applies to all these facilities.
    An average NAPHS member hospital is a 60-80 bed community-based 
specialty hospital. The NAPHS stated the average total budget of such 
facilities is approximately $10-$15 million hence the NAPHS views this 
$80,000 to be a very significant portion of its operating budget.
    We heard from many hospitals that this requirement was impossible 
to fulfill because of the lack of available personnel, geographic 
challenges, and the high costs associated with maintaining this degree 
of coverage. This was particularly noted among rural hospitals. 
Furthermore, these commenters stated that a required onsite visit is 
costly with no demonstrable benefit in many cases.
    We determined that the heightened degree of intervention and 
restriction of who can perform this assessment was excessive and would 
not be feasible in many rural or remote areas. In response to industry 
concerns, we have expanded who may perform the 1-hour face-to-face 
evaluation. Conversely, some commenters requested on-site mandatory 
physician presence within half an hour of initiation of restraint or 
seclusion. Again, we believe this would be too burdensome for hospitals 
in rural or remote areas to comply.
    Thus, we anticipate the expansion of who may perform the 1-hour 
face-to-face evaluation will be less burdensome to hospitals. We 
believe the training required by this rule will equip staff with 
appropriate skills for handling escalating or aggressive patient 
behavior and should reduce overall use of restraints. However, we are 
aware that the facility's size, progress in reducing the use of 
restraint or seclusion, and other characteristics will have a varying 
impact upon each facility's performance of this requirement.
    Again, the NAPHS stated their respondents reported it took an 
estimated 30 minutes to 1 hour to document all the specific elements 
required by CMS after a restraint or seclusion episode. This included 
several elements unique to the rule such as notifying the attending 
physician if the restraint was ordered by someone other than the 
patient's attending physician.

[[Page 71423]]

Thus, our burden estimate is based on a median timeframe (that is, 45 
minutes) that we believe it takes to complete the required 
documentation in the patient's medical record. However, since we are 
unable to estimate the prevalence of restraint and seclusion, we can 
not apply this estimate to assess the associated burden across 
behavioral health and medical surgical settings.
b. Section 482.13(f) Standard: Staff Training Requirements
    Standard 482.13(f), previously entitled ``Restraint or seclusion: 
Seclusion and restraint for behavior management,'' has been revised to 
read ``Staff training requirements.'' This standard will specifically 
address the requirements that have been significantly changed or are 
new regarding staff training.
    In section 482.13(f) Standard: Staff training requirements. Staff 
training requirements have been expanded to include various training 
specifications. While we have tried to minimize the burden which will 
be placed on hospitals in order to meet this requirement, we believe it 
is important for the provision of safe and effective restraint or 
seclusion use.
    We require that before staff apply restraints, implement seclusion, 
perform associated monitoring and assessment of the restrained or 
secluded patient, or provide care for a restrained or secluded patient, 
the staff must be trained and able to demonstrate competency in the 
performance of these actions. We have revised the staff training 
requirements to address the following broad areas: Training intervals, 
training contents, trainer requirements, and trainer documentation.
    When developing this final rule, we considered public comments 
regarding the impact associated with the requirement that all staff 
with direct patient contact be trained in the use of restraint or 
seclusion. Some argued that this broad requirement would entail 
training dietary, administrative, housekeeping, and other types of 
nonprofessional staff who are not direct care providers and not 
involved in the application or use of restraint or seclusion. To reduce 
burden and create a more reasonable requirement while assuring patient 
safety, we have mandated that only those staff who are involved in the 
application of restraint or seclusion or performing associated 
monitoring and assessment of, or providing care for restrained or 
secluded patients have this training. While we expect physicians and 
LIPs to be trained in the proper use of restraint or seclusion, we do 
not expect that they will be trained with the other hospital staff. 
Thus, we have not included physicians and LIPs in the burden associated 
with these requirements. Instead, we require the remaining hospital 
staff who have direct contact with patients must be trained in 
restraint or seclusion use.
    We also considered commenters'suggestions that training be provided 
by a nationally-recognized training program, such as the Crisis 
Training Institute. Others asked that we provide a list of criteria to 
be covered in this training. In this final rule, we have specified 
broad topics to be covered in training, and have not required that 
staff be trained by an outside organization. We believe that in-house 
training may be more economical than sending staff off-site for 
instruction. However, hospitals would still have the option of sending 
either selected or all staff to outside training if they believe that 
this is warranted.
    Thus, we have based our burden estimate on having the actual number 
of trainers attend such training from an outside organization one time. 
We believe that most facilities would, in turn, have these trained 
individuals function as program developers and trainers of the 
appropriate hospital staff. We believe in most instances this 
professional will be a registered nurse. Thus, we used $38.88 as the 
nursing hourly rate in this estimate.
    Train-the trainer programs are the way many facilities provide 
staff instruction. The four day instructor certification program given 
by the Crisis Prevention Institute (CPI, INC.) costs $1,200 dollars in 
tuition plus travel, lodging, and participant salary (http://www.crisisprevention.com).
    We estimate, on average, that roundtrip travel for each nurse will 
cost approximately $400 to cover the need for either local or distant 
travel, lodging for each nurse will costs approximately $120 per night 
x 3 nights, and the meals and incidental expenses (M&IE) will be 
approximately $50 per day depending upon the location within the 
designated state. Thus, we anticipate the cost to train one nurse per 
the 6,200 hospitals to be $1,200 for the course, an estimated $400 
airfare based on location, $360 for 3 days lodging, $150 for 3 days 
M&IE, $112.50 for partial day M&IE, and $1,244.16 for the nurse's 
salarysat $38.88 per hour x 8 hours per day x 4 days. These expenses 
would total $466.66 per nurse per hospital. If all 6,200 hospitals were 
to send one nurse to such training, the total cost for the 6,200 
hospitals would be $21,493,292.00.

------------------------------------------------------------------------
                                           Annual burden   Annual costs
Hours/est. salary/<greek-i> of hospitals       hours         estimate
------------------------------------------------------------------------
Off-site training of the trainer:
    Cost of course x 1 nurse............  ..............       $1,200.00
    Airfare x 1 nurse...................  ..............          400.00
    Lodging x 1 nurse...................  ..............          360.00
    M&IE x 1 nurse......................  ..............          262.50
    Salary for 1 nurse x $38.88 per hr.               32        1,244.16
     x 8 hrs. day x 4 days each for a
     one time training..................
                                         -------------------------------
        Total for 1 nurse per hospital x         198,400   21,493,292.00
         6,200 hospitals................
------------------------------------------------------------------------

    To be responsive to requests for more detail regarding our 
expectations and to assure staff competency, we have described the 
content to be covered during training. Given that most facilities 
already have some type of training program, as noted in many comments 
from hospitals, we believe that these requirements will only serve to 
refine existing programs, not mandate new ones. The current JCAHO 
standards which apply to approximately 80 percent of the Medicare- and 
Medicaid-participating hospitals address staff training and competence 
with respect to the use of restraint or seclusion at PC.12.30. The 
current JCAHO standard which applies to the hospital leadership's 
approach to the use of restraint for acute medical and surgical (non-
psychiatric) care at PC.11.10 refers to staff orientation and 
education. In effect, these JCAHO standards already require training of 
this kind for staff involved with the application of restraint or 
seclusion. Thus, there may be some initial cost for revising

[[Page 71424]]

programs' materials to incorporate the elements specified in the 
regulation.

------------------------------------------------------------------------
                                           Annual burden   Annual costs
Hours/est. salary/<greek-i> of hospitals       hours         estimate
------------------------------------------------------------------------
Developing a new training program (20%
 of hospitals = 6,200 / 20% = 1,240):
    1 clinical trainer @ $38.88 hr. x 40          49,600   $1,928,448.00
     hrs. on average one-time x 1,240
     hospitals..........................
                                         -------------------------------
        Total...........................          49,600    1,928,448.00
------------------------------------------------------------------------
Note: Salary data used in this estimate is based on the salary estimates
  reported on-line at http://www.salary com. Estimates based on median
  annual salary ($80,867.00 including benefits) for a Staff nurse-RN
  divided by 2,080 hours per year worked by a full-time employed Staff
  RN.

    We require that each individual who will potentially be involved in 
restraint and seclusion of a patient have training in the proper 
techniques. According to the National Association of Psychiatric Health 
Systems (NAPHS), initial training in de-escalation techniques, 
restraint and seclusion policies and procedures, and restraint and 
seclusion techniques range from 7 to 16 hours of staff and instructor 
time.
    Using data from the American Hospital Association's (AHA) 2004 
Annual Survey, the average number of total full-time and part-time 
clinical employees per hospital are 248 and 113 respectively. Clinical 
employees include physicians and dentists, medical and dental residents 
and interns, other trainees, registered nurses, licensed practical 
(vocational Nurses), and nursing assistants. While we recognize this 
does not include clinical staff in such areas as rehabilitation 
services, this total of 361 persons per hospital should provide an 
estimate on which to base this analysis. We realize that some hospitals 
will have more or less employees in which to train.
    Additionally, the CMS' OSCAR data, reveals the average number of 
beds per hospital is 160. We estimate that an average size hospital may 
have 361 staff persons who will require this training.

------------------------------------------------------------------------
                                             Annual
Hours/est. salary/<greek-i> of hospitals     burden       Annual costs
                                             hours          estimate
------------------------------------------------------------------------
Attendance in the training program:
    1 clinical trainer @ $38.88 hr. x 8        49,600      $1,928,448.00
     hrs. x 6,200 hospitals.............
    361 trainees x 16 hours per hospital   17,905,600  .................
     x 6,200 hospitals..................
                                         -------------------------------
        Total...........................   17,955,200       1,928,448.00
------------------------------------------------------------------------

    We require that each individual will receive annual updates to the 
training and that the annual training will also be documented. Again, 
according to NAPHS, annual updates are about 7 hours of staff and 
instructor time per each employee who has direct patient contact. 
Again, an average size hospital has 361 employees who have direct 
patient contact that must be trained in de-escalation techniques.

------------------------------------------------------------------------
                                             Annual
Hours/est. salary/<greek-i> of hospitals     burden       Annual costs
                                             hours          estimate
------------------------------------------------------------------------
Annual updates in the training program:
    1 clinical trainer @ $.38.88 hr. x 4       24,800         964,224.00
     hrs. on average annually x 6,200
     hospitals..........................
361 trainees x 4 hours per hospital x       8,952,800  .................
 6,200 hospitals........................
                                         -------------------------------
        Total...........................    8,977,600         964,224.00
------------------------------------------------------------------------

    Additionally, we required recordkeeping for documenting in each 
trained individual's personnel record that he or she has successfully 
completed training as discussed in Section V. of the preamble to this 
final rule. As noted there, we believe that such records are kept by 
the hospital in the normal course of business. Therefore, we do not 
believe that these requirements would have a significant economic 
impact on hospitals.

------------------------------------------------------------------------
                                             Annual
Hours/est. salary/<greek-i> of hospitals     burden       Annual costs
                                             hours          estimate
------------------------------------------------------------------------
Documenting attendance in the training
 program:
    1 clinical trainer @ $38.88 hr. x 5       179,056       6,691,697.20
     minutes on average x 361 trainees
     annually x 6,200 hospitals.........
                                         -------------------------------
        Total...........................      179,056       6,961,697.20
------------------------------------------------------------------------

    Finally, we require that each hospital revise its training program 
annually as needed. We estimate this task to take approximately 4 hours 
annually per hospitals.

[[Page 71425]]



------------------------------------------------------------------------
                                             Annual
Hours/est. salary/<greek-i> of hospitals     burden       Annual costs
                                             hours          estimate
------------------------------------------------------------------------
Revising the training program:
    1 clinical trainer @ $38.88 hr. x 4        24,800         964,224.00
     hours per average size hospital x
     6,200 hospitals....................
                                         -------------------------------
        Total...........................       24,800         964,224.00
------------------------------------------------------------------------

c. Section 482.13(g) Standard: Death Reporting Requirements
    This requirement, previously an element in the interim final rule 
with comment period, has been revised to be a separate standard. In 
revising this to form a separate standard, we have made it applicable 
to all deaths associated with the use of restraint or seclusion 
throughout the hospital. We have added the requirements at Sec.  
482.13(g)(1)(i) that a hospital must report to CMS each death that 
occurs while a patient is in restraint or seclusion at the hospital, at 
Sec.  482.13(g)(1)(ii) each death that occurs within 24 hours after the 
patient has been removed from restraint or seclusion, and at Sec.  
482.13(g)(1)(iii) that the hospital must report each death known to the 
hospital that occurs within 1 week after restraint or seclusion where 
it is reasonable to assume that the use of restraint seclusion 
contributed directly or indirectly to a patient's death.
    At Sec.  482.13(g)(2) and Sec.  481.13(g)(3), we require that each 
death referenced in this section must be reported to CMS by telephone 
no later than the close of business the next business day following 
knowledge of the patient's death. We believe that the number of deaths 
related to restraint or seclusion use are still under-reported. In 
October 1998, the Hartford Courant cited the results of a study that 
identified 142 deaths from seclusion and restraint use in behavioral 
health treatment facilities over the past 10 years. Since the Patients 
Rights CoP became effective in 1999, the annual total of patient deaths 
related to restraint and seclusion use has been reported to CMS as 
follows: 1999 (14), 2000 (34), 2001 (22), 2002 (19), 2003 (17), 2004 
(24), 2005 (30), and 2006 (5) year-to-date respectively as of June 19, 
2006. These numbers include deaths from seclusion or restraint use in 
behavioral health settings not the medical-surgical settings in the 
hospital.
    Although our goal is to reduce the utilization of restraint or 
seclusion and associated deaths, we are aware that the actual number of 
deaths from seclusion and restraint use may increase due to the 
increased reporting requirements of deaths due to seclusion and 
restraint use in all treatment settings in the hospital. Thus, we 
anticipate there will be burden associated with this requirement due to 
the increased number of deaths that will be reported by the various 
units within the hospital. For the purposes of calculating burden, we 
are assuming the number of deaths based on current levels and are not 
considering the reduction in the number of deaths we expect to result 
from this regulation.
    Given this historical data, we believe the number of reports 
certainly should average less than one per hospital per year (that is, 
the total number of deaths in 8 years (165) divided by the total number 
of hospitals 6,200 divided by 8 years equals .0033). Thus, we believe 
the impact associated with this provision (that is, making a telephone 
call and filling in a written form to report a death to the CMS) to be 
negligible.
    We estimate that one clerical person would report the death to CMS 
and document the death in the patient's medical record. The burden 
associated with the completion of this task would be .25 (15 minutes 
divided by 60 minutes in one hour) x an average of 20 occurrences per 
year throughout the 6,200 hospitals, .25 x 20 = 5 hours. The estimated 
cost associated would be 5 hours x $.31 (that is, $18.88 hour divided 
by 60minutes per hour x 15 minutes = 4.71 x 20 occurrences per year = 
$94.20 annually).

------------------------------------------------------------------------
                                           Annual burden   Annual costs
Hours/est. salary/<greek-i> of hospitals       hours         estimate
------------------------------------------------------------------------
Reporting death to CMS and documenting
 in medical record:
    1 clerical person @ $18.88 hr. x 15                5          $94.20
     min. x average of 20 occurrences in
     hospital annually..................
                                         -------------------------------
        Total...........................               5           94.20
------------------------------------------------------------------------
Note: Salary data used in this estimate is based on salary estimates
  reported on-line at http://www.salary com. Estimates based on median
  annual salary ($39,190.00 including benefits) for an admitting clerk
  divided by 2,080 hours per year worked by a full-time employed
  admitting clerk.

2. Effect on Beneficiaries
    The implementation of the Patients Rights CoP will serve to protect 
not only Medicare and Medicaid beneficiaries but all patients receiving 
care in all Medicare-participating hospitals (that is, short-term, 
psychiatric, rehabilitation, long-term, children's, and alcohol-drug), 
including small rural hospitals. With the finalization of standards a-g 
of the Patient's Rights CoP, we forsee better protection regarding 
notification of the patient's rights, exercise of the patient's rights 
with regard to his or her care, privacy and safety, confidentiality of 
the patient's records, and restraint and seclusion use. Thus, all 
patients will benefit from the hospital's focus on patients' rights. 
Through these protections, patient care can be delivered in an 
atmosphere of respect for an individual patient's comfort, dignity, and 
privacy. We also believe that implementation of this final rule will 
lead to a reduction in the numbers of restraint or seclusion related 
injuries and deaths in hospitals.
3. Effect on Medicare and Medicaid Programs
    Given that hospitals have been required to comply with the 
regulations at Sec.  482.13(a) through Sec.  482.13(f) since 1999, we 
do not expect the implementation of the finalized Patients' Rights 
provisions to generate significant cost to the Medicare or Medicaid 
programs. We do not believe there will be any additional costs to the 
survey and certification program as compliance with this CoP will 
either be reviewed through a routine, nonaccredited hospital survey,

[[Page 71426]]

validation survey or as part of the existing complaint survey process 
for hospitals.

C. Alternatives Considered

    We originally considered developing one set of very general 
requirements regulating restraint or seclusion use in all hospitals for 
all situations. However, based on public comments and recent concerns 
about restraint or seclusion use for behavior management situations, we 
concluded that one set of requirements did not afford patients with 
adequate protections. In addition, we noted that JCAHO has more 
prescriptive standards for behavioral health care accreditation than 
for hospital accreditation.
    We considered recognizing only physicians as the individuals able 
to order restraints or seclusion. However, in recognizing that other 
types of practitioners provide a great deal of care in rural and 
frontier areas, we did not adopt that approach.
    We considered keeping standards e and f separate as originally 
proposed. However, due to public comment we found it to be more prudent 
to address the use of restraint or seclusion in either medical-surgical 
or behavioral treatment contexts in a single standard.
    We considered finalizing the training section as proposed. In turn, 
we planned to let hospitals establish, implement, and monitor their own 
training programs. However, industry concerns were the impetus for 
providing further direction regarding training. Additionally, we 
considered mandating training for physicians and other LIPs; however, 
the industry believed this was too prescriptive.
    Regarding the timeframes in which a patient must be evaluated if 
restraint or seclusion is used to manage violent or self-destructive 
behavior, we considered more restrictive options including adopting the 
Pennsylvania Office of Mental Health policy that requires an onsite 
evaluation by a physician within half an hour of initiation of the 
intervention. However, we rejected this idea on the basis that it is 
unrealistic for rural areas because of geographical barriers and 
practitioner shortages, cost (as noted by commenters).
    We considered adopting more restrictive requirements for the 
maximum time frames for the length of an order for restraint or 
seclusion. However, since there was no supporting literature or 
studies, we decided to adopt the approach and timeframes developed and 
articulated by JCAHO for its hospital accreditation and behavioral 
health care accreditation programs. These standards were developed by 
experts from the health care field and represent consensus on the 
approach and time frames for uses of seclusion or restraints. In 
addition, approximately 80 percent of the Medicare- and Medicaid-
participating hospitals are already subject to these requirements 
through accreditation. Therefore, we believe it is reasonable to adopt 
requirements similar to those of JCAHO.
    In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by the Office of Management and Budget.

List of Subjects in 42 CFR Part 482

    Grants programs--health, Hospitals, Medicaid, Medicare, Reporting 
and recordkeeping requirements.


0
For the reasons set forth in the preamble, the interim rule amending 42 
CFR chapter IV published on July 2, 1999 Federal Register (64 FR 36070) 
is adopted as final with the following changes:

PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS

0
1. The authority citation for part 482 continues to read as follows:

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


0
2. Section 482.13 is revised to read as follows:


Sec.  482.13  Condition of participation: Patient's rights.

    A hospital must protect and promote each patient's rights.
    (a) Standard: Notice of rights. (1) A hospital must inform each 
patient, or when appropriate, the patient's representative (as allowed 
under State law), of the patient's rights, in advance of furnishing or 
discontinuing patient care whenever possible.
    (2) The hospital must establish a process for prompt resolution of 
patient grievances and must inform each patient whom to contact to file 
a grievance. The hospital's governing body must approve and be 
responsible for the effective operation of the grievance process and 
must review and resolve grievances, unless it delegates the 
responsibility in writing to a grievance committee. The grievance 
process must include a mechanism for timely referral of patient 
concerns regarding quality of care or premature discharge to the 
appropriate Utilization and Quality Control Quality Improvement 
Organization. At a minimum:
    (i) The hospital must establish a clearly explained procedure for 
the submission of a patient's written or verbal grievance to the 
hospital.
    (ii) The grievance process must specify time frames for review of 
the grievance and the provision of a response.
    (iii) In its resolution of the grievance, the hospital must provide 
the patient with written notice of its decision that contains the name 
of the hospital contact person, the steps taken on behalf of the 
patient to investigate the grievance, the results of the grievance 
process, and the date of completion.
    (b) Standard: Exercise of rights. (1) The patient has the right to 
participate in the development and implementation of his or her plan of 
care.
    (2) The patient or his or her representative (as allowed under 
State law) has the right to make informed decisions regarding his or 
her care. The patient's rights include being informed of his or her 
health status, being involved in care planning and treatment, and being 
able to request or refuse treatment. This right must not be construed 
as a mechanism to demand the provision of treatment or services deemed 
medically unnecessary or inappropriate.
    (3) The patient has the right to formulate advance directives and 
to have hospital staff and practitioners who provide care in the 
hospital comply with these directives, in accordance with Sec.  489.100 
of this part (Definition), Sec.  489.102 of this part (Requirements for 
providers), and Sec.  489.104 of this part (Effective dates).
    (4) The patient has the right to have a family member or 
representative of his or her choice and his or her own physician 
notified promptly of his or her admission to the hospital.
    (c) Standard: Privacy and safety. (1) The patient has the right to 
personal privacy.
    (2) The patient has the right to receive care in a safe setting.
    (3) The patient has the right to be free from all forms of abuse or 
harassment.
    (d) Standard: Confidentiality of patient records. (1) The patient 
has the right to the confidentiality of his or her clinical records.
    (2) The patient has the right to access information contained in 
his or her clinical records within a reasonable time frame. The 
hospital must not frustrate the legitimate efforts of individuals to 
gain access to their own medical records and must actively seek to meet 
these requests as quickly as its record keeping system permits.
    (e) Standard: Restraint or seclusion. All patients have the right 
to be free from physical or mental abuse, and corporal punishment. All 
patients have the right to be free from restraint or seclusion, of any 
form, imposed as a

[[Page 71427]]

means of coercion, discipline, convenience, or retaliation by staff. 
Restraint or seclusion may only be imposed to ensure the immediate 
physical safety of the patient, a staff member, or others and must be 
discontinued at the earliest possible time.
    (1) Definitions. (i) A restraint is--
    (A) Any manual method, physical or mechanical device, material, or 
equipment that immobilizes or reduces the ability of a patient to move 
his or her arms, legs, body, or head freely; or
    (B) A drug or medication when it is used as a restriction to manage 
the patient's behavior or restrict the patient's freedom of movement 
and is not a standard treatment or dosage for the patient's condition.
    (C) A restraint does not include devices, such as orthopedically 
prescribed devices, surgical dressings or bandages, protective helmets, 
or other methods that involve the physical holding of a patient for the 
purpose of conducting routine physical examinations or tests, or to 
protect the patient from falling out of bed, or to permit the patient 
to participate in activities without the risk of physical harm (this 
does not include a physical escort).
    (ii) Seclusion is the involuntary confinement of a patient alone in 
a room or area from which the patient is physically prevented from 
leaving. Seclusion may only be used for the management of violent or 
self-destructive behavior.
    (2) Restraint or seclusion may only be used when less restrictive 
interventions have been determined to be ineffective to protect the 
patient a staff member or others from harm.
    (3) The type or technique of restraint or seclusion used must be 
the least restrictive intervention that will be effective to protect 
the patient, a staff member, or others from harm.
    (4) The use of restraint or seclusion must be--
    (i) In accordance with a written modification to the patient's plan 
of care; and
    (ii) Implemented in accordance with safe and appropriate restraint 
and seclusion techniques as determined by hospital policy in accordance 
with State law.
    (5) The use of restraint or seclusion must be in accordance with 
the order of a physician or other licensed independent practitioner who 
is responsible for the care of the patient as specified under Sec.  
482.12(c) and authorized to order restraint or seclusion by hospital 
policy in accordance with State law.
    (6) Orders for the use of restraint or seclusion must never be 
written as a standing order or on an as needed basis (PRN).
    (7) The attending physician must be consulted as soon as possible 
if the attending physician did not order the restraint or seclusion.
    (8) Unless superseded by State law that is more restrictive--
    (i) Each order for restraint or seclusion used for the management 
of violent or self-destructive behavior that jeopardizes the immediate 
physical safety of the patient, a staff member, or others may only be 
renewed in accordance with the following limits for up to a total of 24 
hours:
    (A) 4 hours for adults 18 years of age or older;
    (B) 2 hours for children and adolescents 9 to 17 years of age; or
    (C) 1 hour for children under 9 years of age; and
    (ii) After 24 hours, before writing a new order for the use of 
restraint or seclusion for the management of violent or self-
destructive behavior, a physician or other licensed independent 
practitioner who is responsible for the care of the patient as 
specified under Sec.  482.12(c) of this part and authorized to order 
restraint or seclusion by hospital policy in accordance with State law 
must see and assess the patient.
    (iii) Each order for restraint used to ensure the physical safety 
of the non-violent or non-self-destructive patient may be renewed as 
authorized by hospital policy.
    (9) Restraint or seclusion must be discontinued at the earliest 
possible time, regardless of the length of time identified in the 
order.
    (10) The condition of the patient who is restrained or secluded 
must be monitored by a physician, other licensed independent 
practitioner or trained staff that have completed the training criteria 
specified in paragraph (f) of this section at an interval determined by 
hospital policy.
    (11) Physician and other licensed independent practitioner training 
requirements must be specified in hospital policy. At a minimum, 
physicians and other licensed independent practitioners authorized to 
order restraint or seclusion by hospital policy in accordance with 
State law must have a working knowledge of hospital policy regarding 
the use of restraint or seclusion.
    (12) When restraint or seclusion is used for the management of 
violent or self-destructive behavior that jeopardizes the immediate 
physical safety of the patient, a staff member, or others, the patient 
must be seen face-to-face within 1 hour after the initiation of the 
intervention--
    (i) By a--
    (A) Physician or other licensed independent practitioner; or
    (B) Registered nurse or physician assistant who has been trained in 
accordance with the requirements specified in paragraph (f) of this 
section.
    (ii) To evaluate--
    (A) The patient's immediate situation;
    (B) The patient's reaction to the intervention;
    (C) The patient's medical and behavioral condition; and
    (D) The need to continue or terminate the restraint or seclusion.
    (13) States are free to have requirements by statute or regulation 
that are more restrictive than those contained in paragraph (e)(12)(i) 
of this section.
    (14) If the face-to-face evaluation specified in paragraph (e)(12) 
of this section is conducted by a trained registered nurse or physician 
assistant, the trained registered nurse or physician assistant must 
consult the attending physician or other licensed independent 
practitioner who is responsible for the care of the patient as 
specified under Sec.  482.12(c) as soon as possible after the 
completion of the 1-hour face-to-face evaluation.
    (15) All requirements specified under this paragraph are applicable 
to the simultaneous use of restraint and seclusion. Simultaneous 
restraint and seclusion use is only permitted if the patient is 
continually monitored--
    (i) Face-to-face by an assigned, trained staff member; or
    (ii) By trained staff using both video and audio equipment. This 
monitoring must be in close proximity to the patient.
    (16) When restraint or seclusion is used, there must be 
documentation in the patient's medical record of the following:
    (i) The 1-hour face-to-face medical and behavioral evaluation if 
restraint or seclusion is used to manage violent or self-destructive 
behavior;
    (ii) A description of the patient's behavior and the intervention 
used;
    (iii) Alternatives or other less restrictive interventions 
attempted (as applicable);
    (iv) The patient's condition or symptom(s) that warranted the use 
of the restraint or seclusion; and
    (v) The patient's response to the intervention(s) used, including 
the rationale for continued use of the intervention.
    (f) Standard: Restraint or seclusion: Staff training requirements. 
The patient has the right to safe implementation of restraint or 
seclusion by trained staff.

[[Page 71428]]

    (1) Training intervals. Staff must be trained and able to 
demonstrate competency in the application of restraints, implementation 
of seclusion, monitoring, assessment, and providing care for a patient 
in restraint or seclusion--
    (i) Before performing any of the actions specified in this 
paragraph;
    (ii) As part of orientation; and
    (iii) Subsequently on a periodic basis consistent with hospital 
policy.
    (2) Training content. The hospital must require appropriate staff 
to have education, training, and demonstrated knowledge based on the 
specific needs of the patient population in at least the following:
    (i) Techniques to identify staff and patient behaviors, events, and 
environmental factors that may trigger circumstances that require the 
use of a restraint or seclusion.
    (ii) The use of nonphysical intervention skills.
    (iii) Choosing the least restrictive intervention based on an 
individualized assessment of the patient's medical, or behavioral 
status or condition.
    (iv) The safe application and use of all types of restraint or 
seclusion used in the hospital, including training in how to recognize 
and respond to signs of physical and psychological distress (for 
example, positional asphyxia);
    (v) Clinical identification of specific behavioral changes that 
indicate that restraint or seclusion is no longer necessary.
    (vi) Monitoring the physical and psychological well-being of the 
patient who is restrained or secluded, including but not limited to, 
respiratory and circulatory status, skin integrity, vital signs, and 
any special requirements specified by hospital policy associated with 
the 1-hour face-to-face evaluation.
    (vii) The use of first aid techniques and certification in the use 
of cardiopulmonary resuscitation, including required periodic 
recertification.
    (3) Trainer requirements. Individuals providing staff training must 
be qualified as evidenced by education, training, and experience in 
techniques used to address patients' behaviors.
    (4) Training documentation. The hospital must document in the staff 
personnel records that the training and demonstration of competency 
were successfully completed.
    (g) Standard: Death reporting requirements: Hospitals must report 
deaths associated with the use of seclusion or restraint.
    (1) The hospital must report the following information to CMS:
    (i) Each death that occurs while a patient is in restraint or 
seclusion.
    (ii) Each death that occurs within 24 hours after the patient has 
been removed from restraint or seclusion.
    (iii) Each death known to the hospital that occurs within 1 week 
after restraint or seclusion where it is reasonable to assume that use 
of restraint or placement in seclusion contributed directly or 
indirectly to a patient's death. ``Reasonable to assume'' in this 
context includes, but is not limited to, deaths related to restrictions 
of movement for prolonged periods of time, or death related to chest 
compression, restriction of breathing or asphyxiation.
    (2) Each death referenced in this paragraph must be reported to CMS 
by telephone no later than the close of business the next business day 
following knowledge of the patient's death.
    (3) Staff must document in the patient's medical record the date 
and time the death was reported to CMS.

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

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)


    Dated: December 14, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
    Approved: November 16, 2006.
Michael O. Leavitt,
Secretary.
[FR Doc. 06-9559 Filed 12-7-06; 8:45 am]
BILLING CODE 4120-01-P