Medicare and Medicaid Programs; Hospital Conditions of Participation: Patients' Rights, 71378-71428 [06-9559]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

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



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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

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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

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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:
     Notice of rights.
     Exercise of rights regarding care.
     Privacy and safety.
     Confidentiality of patient records.
     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 jeopar