Chairman Roth, Senator Moynihan, distinguished Committee members, thank you for
inviting me to discuss the importance of preventing inappropriate use of seclusion and
restraints in psychiatric treatment facilities. We applaud the efforts of Senators
Lieberman and Dodd and Congresswoman DeGette to address this issue. We also
recognize the importance of the work done by journalists at the Hartford Courant on
this issue. And we greatly appreciate the insights and advice provided to us on this by
our colleagues at the General Accounting Office.
We are profoundly disturbed by the reports of deaths and injuries resulting from the
inappropriate use of seclusion and restraints in mental health facilities. We strongly
agree with patient advocates that use of seclusion and restraints must be recorded,
reported, and always a last resort. We are taking steps to ensure that use of restraints
or seclusion to manage behavior is an emergency measure reserved for unanticipated,
severely aggressive or destructive behavior that places the patient or others in imminent
danger. We have removed certification from facilities where egregious violations have been
documented. And we have a comprehensive review underway of facilities owned by the Charter
Corp. because of the extent of problems identified in this chain.
In July, we mandated that all hospitals providing services to Medicare and Medicaid
beneficiaries recognize specific patient rights, including the right to be free from
inappropriate use of seclusion and restraints. Under these important new rules:
- seclusion and restraints may not be used in any form as a means of coercion, discipline,
convenience, or retaliation;
- hospitals must report to us any death that occurs while a patient is restrained or in
seclusion, and we in turn will report it to the state Protection and Advocacy Agencies;
- a physician or state-approved licensed independent practitioner must conduct a
face-to-face evaluation for any patient placed in seclusion or restraints for behavioral
management within one hour of initiation;
- hospital staff must have training in the appropriate and safe use of seclusion and
restraints; and
- hospitals must provide a patient or family members with a formal notice of the right to
be free from inappropriate seclusion and restraints and other rights at the time of
admission.
In addition to the reporting of deaths, we are considering regulations defining
"serious injuries" related to seclusion and restraints for which reporting
should be mandatory. We are working with other federal and state agencies to determine the
best system for maintaining comprehensive records of seclusion and restraints incidents.
And we are working to extend strong protections to individuals in residential treatment
facilities, congregate care centers, and community-based settings.
We are confident that our regulations will be effective in reducing inappropriate use
of seclusion and restraints in inpatient hospitals. We have had solid success we have had
for patients in nursing homes with regulations published in 1990, and for patients in
intermediate care facilities for the mentally retarded with regulations published in 1988.
We also are encouraged by the success of states, such as Pennsylvania and New York, in
dramatically reducing use of seclusion and restraints in mental health facilities.
Also, importantly, we are working with the Joint Commission on Accreditation of
Healthcare Organizations to improve its performance in monitoring use of seclusion and
restraints. Under law, the Joint Commission, rather than federal or state surveyors,
monitors the quality of care and certifies compliance with federal regulations in most
hospitals, including psychiatric hospitals. In August, we met one of our key goals for
improving Joint Commission performance when it announced that hospitals will no longer be
given notices of random surveys.
BACKGROUND
Medicare and Medicaid play a key role in serving and protecting individuals with
psychiatric disorders. Regulations for institutional health care providers serving
individuals enrolled in these programs, known as "conditions of participation,"
apply to all patients they treat, not just those covered by Medicare or Medicaid.
We first proposed protections from inappropriate use of seclusion and restraints in
psychiatric and other hospitals in a 1997 Notice of Proposed Rule Making that included a
number of important patient protections in our conditions of participation for hospitals.
Because of the urgent need to enact protections against inappropriate use of seclusion
and restraints, we "carved out" the patient’s rights section of this
proposed regulation that includes seclusion and restraint requirements and issued it as an
interim final regulation in July of this year. It became effective August 2, 1999. Other
patient rights in this regulation include the right to privacy and confidentiality, to
file grievances, to have advance directives followed, to participate in developing and
implementing care plans, and to be free from verbal and physical abuse.
Under this rule, restraints can, of course, be used in the normal course of medical or
surgical care, for example to protect intravenous tubing or when a patient is undergoing
surgery. Use for managing behavioral management is allowed only when all less restrictive
measures have failed and unanticipated severely aggressive or destructive behavior places
the patient or others in imminent danger of harm.
If patients are placed in seclusion or restraints because they have become violent or
aggressive, they must be seen and evaluated by a physician (or other qualified licensed
independent practitioner as determined by each state) within one hour. This one-hour rule
is designed to ensure that the seclusion or restraints are warranted and properly applied,
and it must be met regardless of how briefly seclusion or restraints are used.
The new protections apply to all acute care, psychiatric, rehabilitation, long-term,
children’s, and substance abuse treatment hospitals. The rule is what is known as an
"interim final" rule, for which public comments were accepted through September
2. We specifically solicited comments on key outstanding issues. For example, we asked for
input on how to define "serious injuries" related to seclusion or restraints
that should be reported, and on the utility of such reports. We hope to address these
outstanding issues in a final rule.
To further assist providers and the public in understanding this regulation, we are
developing a list of frequently asked questions about it to post on our medicare.gov
website. We also are developing further interpretive guidance for providers on how to
comply with the regulation.
Recording and Reporting
It is essential that all facilities maintain records in a standard way and report when
deaths are associated with seclusion and restraints for incorporation into a comprehensive
database. State experience makes it abundantly clear that reporting systems are highly
effective. New York, for example, requires that all deaths of mental health consumers be
reported to the state’s Protection and Advocacy agency, which is authorized to
investigate. Recommendations based on these investigations have significantly reduced use
of seclusion and restraints and brought about other substantial improvements in care.
We solicited public comments on how the optimal database would function in the Patient
Rights regulation we published in July. We will work with federal and state colleagues to
determine whether any existing databases can help meet this need. The Food and Drug
Administration receives data on deaths and other problems related to restraints that are
considered medical devices. The Substance Abuse and Mental Health Services Administration
and state Protection and Advocacy agencies also monitor data on seclusion and
restraint-related problems. The HHS Inspector General is conducting studies on existing
patient abuse reporting systems and oversight of psychiatric hospitals. And we are working
with states and survey agencies to develop a standardized form for reporting deaths to
ensure consistency and comparability of data from across the nation.
For the time being, individuals concerned about the quality of care provided at any
specific facility can contact state survey agencies or Health Care Financing
Administration Regional Offices. These offices are able to verify whether a specific
facility has been cited for violation of these or other patient safety protections.
Staff Training
Training for staff on use of seclusion and restraints is essential to minimizing any
inappropriate use. Our July Patient’s Rights regulation specifically mandates that
"all staff who have direct patient contact must have ongoing education and training
in proper and safe use of seclusion and restraint application and techniques." They
must also have ongoing training on "alternative methods for handling behavior,
symptoms, and situations that traditionally have been treated through the use of restraint
or seclusion."
Restraint in Other Facilities
We first published regulations addressing use of restraints in1988 for intermediate
care facilities for the mentally retarded. These regulations require that restraints be
used only when the danger of the behavior outweighs the danger of the use of restraints as
an intervention. And they may only be used as an integral part of an individual program
plan intended to lead to less restrictive means of managing the behavior causing the use
of restraints.
These facilities must maintain documentation for each use of seclusion and restraints,
and we intend to reevaluate these rules as part of an overall assessment of reporting
requirements. Extensive training requirements for staff in intermediate care
facilities for the mentally retarded specifically include education on proper use of, and
alternatives to, seclusion and restraints.
We published regulations addressing the use of restraints in nursing homes in 1990.
Nursing home residents were given the right to be free from seclusion and physical
restraints, as well as "chemical" restraints with psychoactive drugs, for any
reason other than the treatment of a medical condition.
In a 1998 Report to Congress, we found that these regulations have helped to
dramatically cut the inappropriate use of physical restraint and psychoactive drugs. Also
in 1998, we launched a broad initiative to increase the quality and level of both state
and federal oversight of nursing home care, which also is helping to increase protections
against inappropriate use of seclusion and restraints. This initiative features enhanced
survey procedures and guidelines for preventing abuse and neglect in nursing homes,
including review of training for nursing home staff.
We collect data on use of restraints in nursing homes through the "minimum data
set," which must be completed and periodically updated for each patient, as well as
through routine annual surveys. This allows us to track the number and types of patients
for whom restraints are used at each facility.
We are considering crosscutting seclusion and restraint standards that would affect all
providers that receive Medicare and Medicaid funding. And we are currently developing
regulations to ensure that protections against inappropriate use of seclusion and
restraints are in place for other specific settings where vulnerable psychiatric patients
receive care.
For example, individuals receiving services under Medicaid provisions for covering
psychiatric services to those under age 21 are not currently covered by existing
regulations when receiving care in residential treatment centers. We have solicited
comments from patient advocacy organizations, as well as state Administrators and provider
groups, on how this regulation should be constructed. We expect to publish a regulation
affording such protection next Spring. As with our other regulations governing
participation in Medicare and Medicaid, the rules would apply to all patients served by
these facilities.
We also are working together with states to explore both regulatory and non-regulatory
protections for the increasing number of individuals with psychiatric disorders who are
receiving services under "home and community based services" Medicaid waivers.
These individuals can receive services in their private residences, group homes, day
treatment facilities, and a variety of other non-institutional settings. We are seeking
more information on the extent to which seclusion and restraints are used in such
settings. We are working with states to develop guidance for monitoring care in these
settings. We are looking for innovative quality assurance practices among the states in
these community-based care settings. We want to ensure that patient advocacy groups have a
strong voice in these efforts as we proceed.
Accreditation
Accreditation of facilities providing psychiatric care, which includes certification of
compliance with all Medicare and Medicaid regulations, is primarily carried out by private
bodies. The Joint Commission on Accreditation of Healthcare Organizations accredits most
psychiatric hospitals. Other accrediting bodies for psychiatric care providers include the
Council on Accreditation of Services for Families and Children, the Commission on
Accreditation of Rehabilitation Facilities, and the American Osteopathic Association.
We have initiated an accreditation action plan to improve the quality of oversight by
the Joint Commission, which should help to further increase protection from inappropriate
seclusion and restraints. In this action plan, we will:
- articulate clear criteria for Joint Commission performance;
- review and strengthen federal oversight of Joint Commission surveys;
- conduct federal investigations of complaints about substandard care in facilities that
the Joint Commission has said are in compliance with federal standards;
- work with the Joint Commission as it develops its annual survey priorities to encourage
a focus on critical issues such as medication errors;
- encourage more rigorous review of hospitals’ internal quality improvement efforts;
- encourage more random selection of records for review;
- urge the Joint Commission to conduct more unannounced surveys; and
- evaluate removal of restrictions on releasing Joint Commission survey data to the
public.
As mentioned above, we met one of these key goals when the Joint Commission in August
announced that it will no longer give hospitals notices of random surveys and instead will
conduct these surveys unannounced. We expect that, as we have seen in our nursing home
enforcement initiative, unannounced surveys will provide better insight into the true
quality of care being provided and any problems that need to be addressed.
CONCLUSION
Our new regulations are a major step in directly addressing the inappropriate use of
seclusion and restraints in mental health facilities. We intend to enforce them vigorously
and to aggressively address situations in which patients are endangered. We are committed
to developing further regulations and exploring other avenues for protecting vulnerable
psychiatric patients and ensuring that they are treated with dignity and the highest
professional standards. And we look forward to continued collaboration in these efforts
with patient advocates, provider groups, and our federal and state colleagues. I thank you
for holding this hearing, and I am happy to answer your questions.
