New Patient Rights Rule
Effective August 2, 1999
[Federal Register: July 2, 1999 (Volume 64, Number 127)]
[Rules and Regulations]
[Page 36069-36089]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02jy99-8]
[[Page 36069]]
Rights; Interim Final Rule
[[Page 36070]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
42 CFR Part 482
[HCFA-3018-IFC]
RIN 0938-AJ56
Medicare and Medicaid Programs; Hospital Conditions of
Participation: Patients' Rights
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Interim final rule with comment.
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SUMMARY: This rule introduces a new Patients' Rights Condition of
Participation (CoP) that hospitals must meet to be approved for, or to
continue participation in, the Medicare and Medicaid programs. This
interim final rule with comment sets forth six standards that 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; confidentiality of his or her records;
freedom from restraints used in the provision of acute medical and
surgical care unless clinically necessary; and freedom from seclusion
and restraints used in behavior management unless clinically necessary.
The issue of patients' rights has been a longstanding concern for
the Health Care Financing Administration. In December 1997, we
published a proposed rule that introduced the proposed revision of all
hospital CoPs, including a new Patients' Rights CoP. Work to finalize
the complete revision of the hospital CoPs continues; however, the
Patients' Rights CoP is being finalized separately in an accelerated
time frame as recent reports have evidenced a pressing need for the
codification and enforcement of these fundamental rights. Of particular
concern is the danger posed to patient health and safety by violations
of basic patients' rights, such as freedom from restraints and
seclusion.
The Patients' Rights CoP, including the standard regarding
seclusion and restraints, applies to all Medicare- and Medicaid-
participating hospitals, that is, short-term, psychiatric,
rehabilitation, long-term, children's, and alcohol-drug.
DATES: Effective Date: These regulations are effective on August 2,
1999.
Comment date: Comments on 42 CFR 482.13(e) (Standard: Restraint for
acute medical and surgical care) and (f) (Standard: Seclusion and
restraint for behavior management) will be considered if we receive
them at the appropriate address as provided in the ADDRESSES section,
no later than 5 p.m. on August 31, 1999. We will not consider comments
on provisions of the regulation that remain unchanged from the December
19, 1997 proposed rule or on provisions that were changed based on our
consideration of public comments.
ADDRESSES: Mail comments (an original and three copies) to the
following address: Health Care Financing Administration, Department of
Health and Human Services, Attention: HCFA-3018-IFC, P.O. Box 7517,
Baltimore, MD 21207-0517.
If you prefer, you may deliver your comments (an original and three
copies) to one of the following addresses:
Room 443-G, Hubert Humphrey Building, 200 Independence Avenue, SW.,
Washington, DC 20201, or
Room C5-16-03, 7500 Security Boulevard, Baltimore, MD 21244-1850
Because of staffing and resource limitations, we cannot accept
comments by facsimile (FAX) transmission. In commenting, please refer
to file code HCFA-3018-IFC. Comments received timely will be available
for public inspection as they are received generally beginning
approximately 3 weeks after publication of a document, in Room 443-G of
the Department's offices at 200 Independence Avenue, SW., Washington,
DC, on Monday through Friday of each week from 8:30 a.m. to 5 p.m.
(phone: (202) 690-7890).
FOR FURTHER INFORMATION CONTACT: Monique Howard, OTR (410-786-3869);
Julie Moyers (410-786-6772); Anita Panicker, RN, LCSW (410-786-5646);
or Rachael Weinstein, RN (410-786-6775).
I. Background
A. General
On December 19, 1997, we published a proposed rule entitled
``Medicare and Medicaid Programs; Hospital Conditions of Participation;
Provider Agreements and Supplier Approval'' at 62 FR 66726 to revise
the entire set of conditions of participation (CoPs) for hospitals that
are found at 42 CFR part 482. The CoPs are the requirements that
hospitals must meet to participate in the Medicare and Medicaid
programs. These CoPs are intended to protect patient health and safety
and to ensure that high quality care is provided to all patients. The
State survey agencies (SAs), under contract with us, survey hospitals
to assess compliance with the CoPs. The SAs conduct these surveys using
the State Operations Manual (SOM) (HCFA Publication No. 7). The SOM
contains the regulatory language of the CoPs as well as interpretive
guidelines and survey probes that elaborate on regulatory intent and
give in-depth detail about how to maintain compliance. The SOM also
outlines the survey process and provides guidance for State
administration of the survey program. Under Sec. 489.10(d), the SAs
determine whether hospitals meet the CoPs and make corresponding
recommendations to us about the hospital's certification, (that is,
whether the hospital has met the standards required to provide Medicare
and Medicaid services and receive Federal and State reimbursement).
Under section 1865 of the Act and Sec. 488.5 (Effect of JCAHO or
AOA accreditation of hospitals), hospitals accredited by the Joint
Commission on Accreditation of Healthcare Organizations (JCAHO) or the
American Osteopathic Association (AOA) are not routinely surveyed for
compliance by the SAs but are deemed to meet the requirements in the
CoPs based on their accreditation.
B. Why a Patients' Rights CoP Is Needed
In recent years, State surveyors, patient advocacy groups, the
media, and the general public have brought complaints about hospitals
violating patients' rights to our attention. These violations have
consisted of denying or frustrating a patient's access to care, denying
a patient's full involvement in his or her treatment, disregarding a
patient's advance directives, denying a patient's access to his or her
medical records, or inappropriately using seclusion or restraints.
Particularly within the past year, the public, media, and the Congress
have grown increasingly concerned about the need to ensure basic
protections for patient health and safety in hospitals, especially with
regard to the use of restraints and seclusion. The Hartford Courant, a
Connecticut newspaper, heightened public awareness of this issue with a
series of articles in October 1998 citing the results of a study that
identified 142 deaths from seclusion or restraints use in behavioral
health treatment facilities over the past 10 years. The majority were
adolescent deaths.
C. Intent To Examine Restraint and Seclusion in Other Settings
Federal regulations for nursing homes already stress the right to
be free of restraints, and over the past 10 years, significant strides
have been made in
[[Page 36071]]
reducing inappropriate restraints used in this care setting. The
Patients' Rights CoP will further extend these protections to another
major provider of health care. However, this rule will not cover all
care settings. As we finalized this rule, various stakeholders lobbied
for a much broader application of the seclusion and restraint
provisions. We are looking into the advisability of adopting a cross-
cutting restraints and seclusion standard that would affect other kinds
of health care entities with whom we have provider agreements and the
inpatient psychiatric services for individuals under age 21 benefit. We
are requesting comment on whether we should set forth the same
requirements as promulgated in this rule or whether more stringent
standards would be appropriate. For example, is the current standard
for continual monitoring of patients in restraint adequate for children
or should all restraints for children be monitored only by direct staff
observation? In addition, we acknowledge that more stringent standards
exist in the Medicaid requirements for restraint use in intermediate
care facilities for the mentally retarded. We are requesting comments
on whether we should consider the same requirements for the hospital
setting. We plan to make a decision on our approach to restraints and
seclusion across these other settings and services by the end of the
winter.
Some patient advocates have asked that we go well beyond these
entities and regulate care furnished by providers with whom we have no
provider agreements or care provided in settings where we may lack
statutory authority under the Social Security Act (the Act). Barring a
legislative change, we cannot mandate a restraint and seclusion
standard for those care settings or providers.
D. Conformance of Patients' Rights in Hospitals with the Consumer Bill
of Rights and Responsibilities (CBRR)
In February 1998, President Clinton directed the Department of
Health and Human Services (DHHS), among other departments, to bring our
health care programs into compliance with the CBRR, as recommended by
the Presidential Advisory Commission on Consumer Protection and Quality
in the Health Care Industry. We are strongly committed to achieving
this goal and are continuing to work to ensure that the important
consumer protections articulated in the rights are available to our
beneficiaries, whether Medicare or Medicaid, whether in managed care or
fee-for-service settings.
We have endeavored to incorporate the protections of the Bill of
Rights into the structures and operations of the providers and plans
that provide care to our beneficiaries. Some of the rights included in
the proposed section Sec. 482.10 (now Sec. 482.13) have direct
correlates in the Consumer Bill of Rights, but other significant
protections provided by the CBRR were not mentioned in the December
1997 proposed rule. Even though some of these protections currently
exist due to requirements on hospitals that are not affected by the
revisions to the CoPs, we have decided not to add new regulatory
requirements to the Patients' Rights standard without subjecting them
to a more public vetting than is provided by an interim final rule. We
therefore ask for comment on the following additional consumer rights,
which we believe would need to be incorporated in the CoPs in order to
achieve compliance with the Bill of Rights:
<bullet> Information Disclosure: According to the Bill of Rights,
consumers should receive the following information from health care
facilities:
+ Corporate form of the facility (that is, public or private;
nonprofit or profit; ownership and management; affiliation with other
corporate entities).
+ Accreditation status.
+ Whether specialty programs meet guidelines established by
specialty societies or other appropriate bodies (for example, whether a
cancer treatment center has been approved by the American College of
Surgeons, the Association of Community Cancer Centers or the National
Cancer Institute).
+ Volume of certain procedures performed at each facility.
+ Consumer satisfaction measures.
+ Clinical quality performance measures.
+ Procedures for registering a complaint and for achieving
resolution of that complaint.
+ The availability of translation or interpretation services for
non-English speakers and people with communication disabilities.
+ Numbers and credentials of providers of direct patient care (for
example, registered nurses, other licensed providers, and other
caregivers).
+ Whether the facility's affiliation with a provider network would
make it more likely that a consumer would be referred to health
professionals or other organizations in that network.
+ Whether the facility has been excluded from any Federal health
programs (that is, Medicare or Medicaid).
In addition, although not specifically mentioned in the CBRR, patient
safety necessitates that all hospitals should publicly disclose whether
and when they provide emergency services.
<bullet> Protection of Whistleblowers: Hospitals should be
prohibited from penalizing or seeking retribution against health care
professionals or other health workers for advocating on behalf of their
patients. Individuals would be assured of this right in the Patients'
Rights section.
<bullet> Respect and Nondiscrimination: While the preamble
discusses the applicable Federal and State laws that prohibit
discrimination, an explicit patient right to nondiscrimination is not
currently included and would be added to the Patients' Rights section.
E. Other Patients' Rights
The remainder of the hospital CoPs and other Federal requirements
provide patients with additional rights that do not appear in the new
Patients' Rights CoP. The fact that we have not explicitly stated or
cross-referenced these rights in the final rule does not mean that they
are not available to the patient, or that they are in any way less
important than the rights that this rule establishes.
Some of these rights are stated elsewhere in law or regulation. For
example, various the civil rights laws uphold the patient's right to be
free of discrimination. When the hospital enters into a provider
agreement with us, a condition of that agreement is that the hospital
will abide by the principles and requirements of title VI of the Civil
Rights Act, as implemented in regulation at 42 CFR part 80; section 504
of the Rehabilitation Act of 1973, as implemented by 45 CFR part 84;
the Age Discrimination Act of 1975, as implemented by 45 CFR part 90;
and other requirements of the Office for Civil Rights of DHHS (see 42
CFR 489.10, Basic requirements). These requirements span all of the
provider types with whom we hold an agreement and provide individuals
with important protections against discrimination. A second relevant
example is the patient's right that springs from the anti-dumping
regulations at Sec. 489.24 (Special responsibilities of Medicare
hospitals in emergency cases). The anti-dumping regulations prohibit
Medicare-participating hospitals with emergency medical departments
from refusing to examine or to treat medically unstable patients.
While these two examples are clear cut instances where patients'
rights are already codified, less visible rights also exist. For
example, since the hospital is required to have adequate nurse staffing
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to provide nursing care to all patients as needed (see Sec. 482.23,
Condition of participation: Nursing services), one could argue that the
patient is thereby afforded the right to receive adequate nursing
services and care. Or, since the hospital is required to have dietary
menus that meet the needs of the patients (see Sec. 482.28, Condition
of participation: Food and dietetic services), the patient has the
right to a diet that meets his needs.
We considered an approach that would have grouped all conceivable
patients' rights within this CoP; however, the practical value of this
approach is questionable as these elements are codified elsewhere, and
an approach that attempts to be all-inclusive often inadvertently omits
key elements. We believe that it suffices to say that we expect the
hospital to honor and promote all of the rights and protections that
Federal law and the hospital CoPs offer. The rights codified by this
rule either do not appear elsewhere, or, as evidenced by reports,
require a special emphasis.
II. Legislation
Sections 1861(e) (1) through (8) of 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 Medicare.
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.
III. Provisions of the Proposed Regulations
In our December 19, 1997 proposed rule, we proposed revision of the
Medicare hospital CoPs in concert with Vice President Gore's
Reinventing Government (REGO) initiative. The REGO initiative
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 strong emphasis on quality assessment and
performance improvement.
In the proposed rule, we proposed setting forth a new Patients'
Rights CoP in Medicare- and Medicaid-participating hospitals. The
provisions of this CoP set forth minimum protections and promote
patients' rights, including an individual's right to--(1) notification
of his or her rights; (2) the exercise of his or her rights in regard
to his or her care; (3) privacy and safety; (4) confidentiality; and
(5) freedom from the use of seclusion or restraint of any form unless
clinically necessary. In the preamble, we solicited comments on a more
prescriptive approach to the use of restraints and seclusion and
provided relevant examples.
Although we proposed codifying the new Patients' Rights CoP as
Sec. 482.10, in the final rule it is designated as Sec. 482.13 to
coordinate with the numbering system used in the current regulations.
When the remaining hospital CoPs are finalized, we will renumber the
standards in part 482.
Our commitment to the revision of the remaining hospital CoPs to
focus on patient-centered, outcome-oriented care remains unchanged. We
continue to work on analysis of the over 60,000 comments received on
the proposed rule and will finalize the remaining hospital CoPs in the
future.
IV. Comments and Responses
Of the 60,000 comments received on the December 1997 proposed rule,
approximately 300 focused on the Patients' Rights CoP. Comments were
received from hospitals, mental health treatment facilities,
professional associations, accrediting bodies, SAs, patient advocacy
groups, and members of the general public. Half of the comments, and
the strongest opposition, came in response to the proposed fifth
standard under Patients' Rights--seclusion and restraints. While many
of the respondents did not favor prescriptive regulations that extended
beyond the proposed regulations text, some welcomed more prescriptive
language under the standard for seclusion and restraints.
A summary of the comments received on the five standards, major
issues, and our responses follows.
A. Notice of Rights
We proposed that a hospital must inform each patient of his or her
rights in advance of furnishing care and that the hospital must have a
grievance process and indicate who the patient can contact to express a
grievance.
Comment: Commenters indicated that what constitutes sufficient
notification needs to be clarified. One commenter stated this
requirement should be satisfied by providing written displays of
patients' rights in the hospital lobby and in each patient's room, and
in verbal or written form with initial and additional information
included in the admission packet.
Response: We appreciate the suggestions of how and where patients'
rights should be displayed or conveyed. However, hospitals will need
flexibility to establish policies and procedures that effectively
ensure that patients and their representatives have the information
necessary to exercise their rights. These policies and procedures will
need to address how, where, and when to notify patients of the full
gamut of rights to which they are entitled under the Act. As hospitals
assess the effectiveness of their proactive notification techniques,
they need flexibility to continuously improve their performance in
promoting patients' rights.
This CoP covers hospitals of varying sizes operating in a wide
range of locations, serving diverse populations, with a variety of
required notices; thus, flexibility and creativity to allow for the
effective implementation of this requirement without undue burden is
critical. Therefore, we are not including further prescriptive language
detailing exactly where, how, when, and by whom this requirement must
be carried out.
While we are committed to preserving flexibility on this point, we
note that one method for efficiently handling aspects of this
requirement may be to bundle notices with the existing information that
must be provided to patients to fulfill Civil Rights requirements. The
regulations implementing title VI of the Civil Rights Act of 1964,
section 80.6(d), section 504 of the Rehabilitation Act of 1973 (45 CFR
84.8), and the Age Discrimination Act of 1975, section 91.32, require
recipients of financial assistance from the DHHS to provide notice of
their responsibility to comply with the appropriate nondiscrimination
provisions and other pertinent requirements of the Office for Civil
Rights. For a hospital that falls under this requirement, some
patients' rights notices could be effectively posted next to these
nondiscrimination notices. For some of the educational notices the
patient will receive as part of the new Patients' Rights CoP, this
public posting may be appropriate.
Comment: One commenter believed that the standards in the Patients'
Rights CoP are generally reflected in common hospital practice;
however, she objected to the general language that appeared at the
beginning of the condition; specifically, the phrase, ``A hospital must
protect and promote each patient's rights.'' This commenter was
concerned
[[Page 36073]]
that the wording would be presented in isolation to juries during
medical malpractice cases, and that it would be used to cover all legal
and ethical rights. The commenter noted that a hospital staff person
could not know or be responsible for providing this degree of
information. The commenter suggested that the language be amended to
read, ``A hospital is responsible to have policies and procedures in
place which protect and promote the patient's rights as reflected in
the following standards.''
Response: As stated earlier, we do expect the hospital to honor and
promote each patient's rights, regardless of whether they appear in the
Patients' Rights CoP. With respect to the commenter's concern that this
statement will be taken in isolation and used in medical malpractice
cases, we do not want to provide a foothold for frivolous cases. With
that said, however, it could very well be that a patient who brings
suit against a provider has a legitimate cause for concern or complaint
because that provider failed to acknowledge his or her rights as
established under these regulations. Such a case would generally
require some substantiation and elaboration on specifically which right
the provider failed to uphold. We are not persuaded that this language
opens up an otherwise closed avenue for pursuing legal action.
Accordingly, we are retaining this language.
Comment: One commenter noted that enumeration of the patient's
rights is of little use if his or her only recourse is a grievance
process that is controlled by the hospital. This commenter suggested
adding a requirement that the patient also be notified that he or she
could lodge a complaint with the State survey agency either after or
during the course of the hospital stay, regardless of whether the
patient decided to file a grievance with the hospital's system.
Response: The patient's right to file a complaint with or contact
the accreditation body or the State to report an infraction on these
rights is implicit; therefore, we do not believe it is necessary to add
this to the regulations text. To address the commenter's concern,
however, we will specify in the interpretive guidelines that patient
notification of the grievance process must include the fact that the
patient also may address his or her concerns to the State survey
agency, regardless of whether he has first used the hospital's
grievance process. Patients or residents of all Medicare-certified
facilities have always had the ability to lodge complaints about the
quality of care they receive with the State survey agency or HCFA, and
nothing in this rule alters this opportunity. We will further specify
that the patient be given a phone number and address for lodging a
complaint with the SA.
Comment: Some commenters stated the proposed rule should account
for the fact that in certain situations, the patient's age, condition,
health problem, and emergency situation will inhibit the hospital's
ability to notify the patient of his or her rights before the provision
or discontinuation of care. Commenters believed that the rule should
free hospital personnel from the responsibility of informing the
patient of his or her rights if he or she is experiencing an emergency
medical condition, is unconscious, or is at the hospital for a brief
outpatient encounter.
Response: A hospital should make every effort to inform the patient
of his or her rights before care provision or cessation of care.
However, in some instances a patient's age, condition, health problem,
or emergency situation does not allow the opportunity to communicate
with the patient regarding his or her rights. For this reason, we are
adding language to allow the hospital to communicate these rights to
the patient's representative (as allowed under State law). In the
absence of State law to cover particular health care decisions, the
hospital may also communicate these rights to a legal representative
whom the patient has appointed as an ``ad hoc'' decision maker in the
event of temporary inability to make health care decisions. We still
expect that as soon as the patient can be informed of his or her
rights, the hospital will provide that information to the patient.
Comment: Some commenters stated that this discussion should be
tailored to the patient's level of understanding or communication needs
by using alternate means of communication (for example, audiotape,
radio, sign language, and Braille, or other culturally competent
vehicles), as necessary.
Response: Existing civil rights legislation (section 504 of the
Rehabilitation Act of 1973 and the Americans with Disabilities Act
(ADA)) emphasize the provision of effective aids, benefits, or services
to individuals with disabilities. The ADA defines auxiliary aids and
services as including qualified interpreters, notetakers, transcription
services, written materials, telephone handset amplifiers, assistive
listening devices, assistive listening systems, telephones compatible
with hearing aids, closed captioning, telecommunications devices for
deaf persons, videotext displays, or other effective methods of making
aurally delivered materials available to individuals with hearing
impairments; and qualified readers, taped texts, audio recordings,
Brailled materials, large print materials, or other effective methods
of making visually delivered materials available to individuals with
visual impairments. Title VI of the Civil Rights Act of 1964 also
requires recipients of certain public funds to serve persons who are
``Limited English Proficient'' (LEP). Translation of LEP documents, use
of bilingual staff, and provision of interpreters are usually used to
convey necessary information to LEP persons.
While we recognize the value of appropriate communication
techniques, we do not offer further regulation in this area since
existing laws ensure that appropriate attention will be given to
providing information to those who require special accommodation based
on their special needs.
Comment: Some commenters believed that the proposed rule needed to
further define the patient's role and responsibility when being
informed of his or her medical condition and that the standard should
place more emphasis on discussion of prevention of complications and
rehospitalization.
Response: The Patients' Rights CoP upholds the patient's right to
full, informed involvement in his or her care. Under circumstances
defined by State law, this right may also be exercised by the patient's
legal representative on his or her behalf. We recognize that
involvement in the plan of care and the choice of treatment option may
be open to interpretation. We would like to clarify that this right to
involvement in health care decisions cannot be equated with the ability
to demand medically unnecessary treatments or care. The patient has the
right to be informed of his or her status, to be involved in care
planning and treatment, and to request and refuse treatment. The
patient should be consulted about changes in care and treatment. Issues
arising out of patient dissatisfaction with the hospital's response may
be dealt with under the hospital's grievance process required under
Sec. 482.13(a); however, the patient may choose to lodge a complaint
with the SA or accrediting body in addition to or instead of using the
hospital's grievance system.
We agree that the patient's health and well-being are most likely
affected by the degree of collaboration between the patient and
physician. The patient should make every effort to bring medical
problems to the attention of the physician in a timely fashion, provide
information about his or her medical condition to the best of his or
her knowledge, and work in a mutually respectful manner with the
physician.
[[Page 36074]]
However, the patient's physical, mental, psychological, and emotional
status may directly affect his or her ability to offer this degree of
cooperation.
Comment: A commenter stated that a member of the interdisciplinary
treatment team should document (in the medical record) that the
patient's rights have been reviewed with the patient and whether the
patient or his or her legal representative comprehends the information
covered. A few commenters stated that social workers should notify
patients of their rights at the time of the intake or screening
interview.
Response: All of these suggestions have potential merit. However,
as stated above, we believe it is necessary to provide the hospital
with flexibility in developing policies and procedures that fulfill the
requirement's intent, that is, to ensure that each patient's rights are
protected.
Comment: A few commenters believed that no further details should
be included in the regulation as more detail would add an unnecessary
paperwork burden during the admission process while not guaranteeing
improved quality of patient care.
Response: We have mandated neither the process that a hospital must
use nor the extent to which these rights must be discussed as part of
the admission process. In some cases, notification of these rights must
occur later in the hospital stay to ensure that the patient's rights
are protected. Hospitals will have the flexibility and accountability
to determine how they can best ensure the protection of patients'
rights.
Comment: A few commenters stated that the patient should be
informed of the credentials, licensure, and professional
qualifications, including certifications, of all personnel involved in
his or her care through clear disclosure of this information on the
hospital badge.
Response: We believe that this is an issue that hospitals should
consider in developing their policies and procedures on notification of
rights. We agree that it is important for patients to be aware of the
identities of individuals who provide care in the hospital.
Comment: A few commenters suggested a patient should have the right
to request care by a registered nurse (RN).
Response: Under the current hospital CoPs, hospitals are required
to have 24-hour nursing services and an RN who supervises or evaluates
the nursing care for each patient (Sec. 482.23(b)(3)). In addition, an
RN must assign the nursing care of each patient to other nursing
personnel in accordance with the patient's needs and the specialized
qualifications and competence of the nursing staff available
(Sec. 482.23(b)(5)). We believe that the patient has a right to nursing
care in hospitals; however, we disagree with the commenter's assertion
of the patient's inherent right to request and receive the direct
services of an RN. In rural areas where access to health care
practitioners can be problematic, to mandate this requirement is
impractical and burdensome. The current nursing services requirement
provides for RN services for each patient through supervision of the
nursing care provided. Existing regulations address and provide for the
appropriate level of care in situations where a patient's condition
warrants an RN's direct service.
Comment: One commenter agreed with our proposal that hospitals
should have a formal grievance process for complaints and
recommendations. However, we received more comments in opposition to
this requirement. Those who opposed the provision believed it to be
unnecessary, burdensome to establish, and limited in scope since it
pertains only to patients' rights. A commenter noted that we did not
specify how the hospital should plan to investigate complaints or the
time frame within which hospitals would be required to respond to
grievances.
Response: As we stated in the December 1997 proposed rule, whenever
possible, we have attempted to adopt an outcome-oriented focus rather
than establish process requirements. However, we believe that the
establishment of a grievance process promotes patient empowerment in
health care. We recognize that in and of itself this process may not be
sufficient to resolve all potential sources of conflict. For example,
in a situation where a patient disagrees with a course of treatment,
the disagreement might be between the patient and an independent
physician or health plan rather than with the hospital itself. Some
issues may more logically be pursued under Medicare or Medicaid
complaint processes or through a State mechanism. For example,
hospitals already have procedures for referring Medicare beneficiaries'
complaints about quality and concerns about premature discharge to peer
review organizations for investigation and review. Whatever the type of
concern, we expect that the hospital's grievance process will
facilitate prompt, fair resolution. The grievance process should route
each concern timely to the appropriate decision-making body. This
expectation for coordination has been added to the text of the final
rule.
As noted earlier, the interpretive guidelines will reiterate that
the notification of a grievance process must include the fact that the
patient has the right to file a complaint with the SA regardless of
whether he or she chooses to use the hospital's process, and that he
must be provided with the SA's phone number and address.
We considered the commenters' concerns about burden; however, to
remain silent on general expectations for the grievance process could
result in the absence of key ingredients that promote a meaningful,
substantial process that addresses patients' concerns and promotes
their rights. To promote the creation of an effective grievance
process, in Sec. 482.13(a)(2), we are establishing general elements
that should be common to grievance processes across all hospitals.
Development of more detailed strategies and policies to comply with the
requirement will be left to the discretion of each hospital.
Exercise of Rights
B. We proposed That the Patient Has the Right To Be Informed of His or
Her Rights and To Participate in the Development and Implementation of
His or Her Plan of Care
Comment: Commenters stated that the patient should be informed if
the treatment is experimental in nature and informed of the types of
outcomes the hospital has encountered from the care. Commenters also
suggested that the patient and his or her representative should be
informed of the nature, expected outcome, and potential complications
of treatment options that are going to be undertaken, as well as the
potential outcomes if the treatment is refused.
Response: The hospital should foster an atmosphere that supports
two-way communication with the patient regarding his or her care. We
expect that the hospital will hold the responsible physician
accountable for discussing all information regarding treatment,
experimental approaches (hospitals are required to comply with 45 CFR
part 46, protection of subjects of human research), and possible
outcomes of care to promote quality care delivery. We believe it is
unnecessary to codify the elements that must be discussed with a
patient regarding development of his or her plan of care, or with whom
among the hospital's staff or practitioners the patient must speak to
develop that plan of care. Flexibility is necessary because discussions
of treatment information will differ for each patient.
[[Page 36075]]
C. We Proposed That the Patient Has the Right To Make Decisions
Regarding His or Her Care
Comment: Some commenters stated that the final rule should
emphasize the patient participating fully in his or her care.
Commenters believed that this could be achieved by allowing the patient
to receive second opinions before starting a procedure that
significantly differs from the pre-admission plan of treatment. These
commenters stated that the final rule should require the patient to
``sign-off on treatment options'' and should acknowledge the patient's
ability to refuse treatment and to refuse to participate in
experimental research.
Response: We agree that the patient must be adequately informed of
these options so that he or she can make educated decisions regarding
his or her care. The requirement supports this emphasis and implicitly
includes the commenters' concerns that a patient be able to refuse a
certain treatment or participation in experimental research. However,
in light of this comment, we decided to introduce a higher degree of
specificity in the final rule. First, we noted that the patient's
representative (as allowed under State law) can also exercise the right
to make informed decisions on the patient's behalf. Second, we
introduced a more detailed description of what the patient's right to
make informed decisions entails. The patient has the right to be
informed of his or her health status, to be involved in care planning
and treatment (this includes pain management, as this aspect of
treatment planning is often not discussed with patients), and to be
able to request and refuse treatment. Abridgement of these patients'
rights would be subject to the grievance process required by
Sec. 482.13(a). It is critical to note, however, that the standard does
not provide the patient with the right to demand treatment or services
that are not clinically or medically indicated.
D. We proposed that 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
Comment: One commenter wanted the issue of advance directives to be
addressed at the time of the patient's Medicare enrollment rather than
at the time of an acute care admission. This commenter stated that,
``Medicare beneficiaries could be required to designate their wishes
with regard to `do not resuscitate' (DNR) status and their surrogate
healthcare decision-maker[s] as a condition of receiving the [Medicare]
benefit. The CoP for the acute setting should address validating the
beneficiary's `pre-selected designations.'' '
Response: Section 1866(f) of the Act contains the provider
requirements concerning the acknowledgment and handling of advance
directives. The implementing regulations appear at 42 CFR part 489,
Provider Agreements and Supplier Approval; specifically, at
Secs. 489.100 through 489.104. When we developed the December 1997
proposed rule, we believed that it was appropriate to reference advance
directives in the Patients' Rights CoP, consistent with other Medicare
provider CoPs (for example, existing regulations for nursing homes and
home health agencies). The regulations governing advance directives and
their implementation are not directly affected or under debate in this
rule. This rule is not the appropriate venue for addressing the more
general issue of advance directives, which spans provider types and is
not specific to the hospital CoPs.
Comment: A commenter stated that the language regarding advance
directives should encourage increased communication about and access to
palliative care for the terminally ill. Another commenter believed that
detailed advance directives should apply to inpatients, but not
outpatients.
Response: Regarding the commenter's concern that advance directives
should apply to inpatients not outpatients, section 1866(f) of the Act
and implementing regulations at Sec. 489.102 require that the hospital
give each individual (1) written information concerning an individual's
rights under State law to make decisions concerning medical care,
including the right to accept or refuse medical or surgical treatment
and the right to formulate, at the individual's option, advance
directives, and (2) written policies of the provider or organization
with respect to the implementation of advance directives. Section
1866(f)(2)(A) specifically notes that this information must be provided
when an individual is admitted as an inpatient to a hospital;
therefore, the hospital need not provide this information to those who
are receiving outpatient services.
We appreciate the commenter's suggestion that the language about
advance directives incorporate increased information about and access
to palliative care for the terminally ill. However, neither the statute
nor the existing regulations about advance directives discuss linking
increased discussion of and access to palliative care with the advance
directives requirement. Further, as noted earlier, the proposed rule
did not contemplate amending the existing advance directives
requirements. We do believe, however, that referencing the patient's
right to formulate and have hospital staff comply with advance
directives in the new Patients' Rights CoP will lead to increased
communication regarding end-of-life decisions, pain management, and
other palliative care.
Comment: One commenter believed that a hospital should be required
to check and adhere to advance directives, including those pertaining
to psychiatric emergencies, by incorporating the appropriate training
to ensure patients are knowledgeably consenting and by including
quality improvement efforts to study the issue.
Response: We believe that existing regulations at Secs. 489.100,
489.102, and 489.104 already address these concerns. The final rule
cross-references these citations and supports the existing regulatory
expectation. However, the commenter touched upon a point that merits
additional response: specifically, that advance directives are not
limited to end-of-life decisions. In the mental health setting, a
patient may form advance directives that relate to what should be done
if he or she experiences a psychiatric crisis. In an advance directive,
a person with a mental disorder leaves instructions as to his or her
health care when he or she no longer has decision-making capacity.
These instructions may include, for example, the name of the health
care proxy, the name of the facility in which one wishes to receive
services, the name of the provider from whom one wishes to receive
treatment, names of medications and dosages that work best, and the
methods to be used to de-escalate a crisis to avoid the use of
seclusion and restraint. In the interpretive guidelines, we will
further describe the aspect of advance directives that relates to
psychiatric emergencies to place a greater emphasis on and encourage
responsiveness to these situations.
E. Privacy and Safety
We Proposed That the Patient Has the Right to Privacy and To Receive
Care in a Safe Setting
Comment: One commenter stated that language of the preamble that
referred to the patient's respect, comfort, and dignity was not
included in the regulations text.
Response: We believe that patient respect, dignity, and comfort are
the foundation of the expectations outlined
[[Page 36076]]
by the regulation--freedom from all forms of abuse and harassment, the
right to privacy, and the right to care provided in a safe setting. As
we have noted earlier, these standards are intended to provide
protection for the patient's physical and emotional health and safety.
Respect, dignity, and comfort would be components of an emotionally
safe environment. This point will be reinforced when we prepare
corresponding interpretive guidelines to implement this final rule.
Comment: Commenters agreed with the concept of the patient's right
to privacy but believed that the term ``privacy'' is broad and
undefined. Some stated that ``personal privacy'' should be defined and
a statement should be included to relieve hospitals of the
responsibility of providing each patient with a private room, since
``privacy'' could be misinterpreted to mean that a patient has a right
to a private room.
Response: We understand the commenters' concerns but are not
including a description of ``privacy'' in the final rule. We intend to
address the accommodation of privacy rights through the interpretive
guidelines, as that venue permits a more thorough explanation of
expectations.
We agree that ``privacy'' does not mean that each patient has a
right to a private room. However, even if a patient is in a semiprivate
room, the hospital should provide a patient with privacy by steps such
as pulling curtains closed for exams and requesting visitors to leave
the room when treatment issues are being discussed.
Comment: Some commenters believe ``personal privacy'' and ``receive
care in a safe setting'' should not be combined since they are separate
issues.
Response: We agree and have separated the two elements under the
standard ``Privacy and Safety.''
F. We Proposed That the Patient Has the Right To Be Free From Verbal or
Physical Abuse or Harassment
Comment: Some commenters wanted the word ``free'' to be replaced by
``protected'' and the phrase ``from hospital staff'' included in the
standard. One commenter observed that patients can misinterpret
hospital staff's helpful verbalizations as abusing and harassing.
Commenters believed that this section should clarify that verbal
warnings or physician contact with a patient, visitor, or employee,
that are reasonably necessary to protect others from intimidation or
threat of violence will not be construed as verbal or physical abuse.
Other commenters wanted the regulation to express sensitivity to the
fact that hospital personnel will not always be able to anticipate the
potential for harassment and harm inflicted by another patient.
Response: While the patient is under the hospital's care and on its
property, the hospital is responsible for ensuring the patient's health
and safety and his or her physical, emotional, and psychological well-
being. We recognize that there is always a chance a patient can
misinterpret staff's intentions. We expect that hospital staff would
intervene in a timely, appropriate manner to correct any
misinterpretations in a timely, appropriate manner, if this situation
were present.
In the final rule, we have amended the language to address all
forms of abuse rather than just physical and verbal abuse. We recognize
that any sort of abuse, including verbal, physical, psychological,
sexual, and emotional, is unacceptable.
G. Confidentiality of Patient Records
We Proposed That the Patient Has the Right to Confidentiality of His or
Her Clinical Records
Comment: A commenter stated that without specific language
regarding privacy and confidentiality, research efforts may be stifled
by the regulation.
Response: Presumably, the commenter is concerned that without a
clear statement regarding the confidentiality of patient records,
patients would be reluctant to participate in medical research if
asked. We have maintained the proposed language regarding
confidentiality; however, we agree with the commenter's assertion that
patients need to have a clear understanding of how a hospital
operationalizes this requirement. We will discuss this further in
interpretive guidelines.
Comment: A commenter questioned whether the stated language is
expressing a concern for each patient's ability to access his or her
records or whether the language views a hospital's tendency to
``systemically'' frustrate individuals' legitimate attempts to gain
access to medical records as a violation of the requirement.
Response: We believe it is each patient's inherent right to have
access to his or her clinical record, as well as to have his or her
clinical record kept confidential. We are setting forth this
requirement in the final rule.
Comment: A few commenters noted that there was no definition
provided for the term ``reasonable'' when it was used to describe the
time frame within which the hospital must provide the patient with
access to information in his or her records. They believed that this
lack of specificity would make it difficult for JCAHO to determine
hospitals' compliance with the standard. A few commenters believed that
the regulation should state that the patient has a right to a copy of
his or her records within 4 hours of an inpatient stay and within 48-72
hours for a patient who has been discharged. A few commenters believed
that the regulations text should clearly account for the impact of
variations in location of data, record complexity, urgency, and staff
workload.
Response: Regarding the definition of ``reasonable,'' we believe
that ``reasonable'' means that the hospital (1) will not frustrate the
legitimate efforts of individuals to gain access to their own medical
records, and (2) will actively seek to meet these requests as quickly
as its recordkeeping system permits. We have included these
expectations in the regulations text at Sec. 482.13(d)(2).
We agree with the commenters who asserted that we should account
for the impact of various factors such as location of data, urgency,
and staff workload. Rather than attempting to stipulate time frames
within the regulation that would cover all possible combinations of
factors, we are simply retaining the word ``reasonable.'' We trust that
if the patient believes that he is being subjected to unreasonable
treatment as he tries to obtain a copy of his medical records, he will
use the hospital's grievance process or will report difficulties to the
SA or JCAHO. While setting a concrete time frame might provide a better
measuring stick for performance, it would not adequately account for
the kinds of variation that are apt to occur in different hospital
settings.
Comment: Some commenters suggested that the rule be expanded to
state, ``In accordance with local and State laws, the patient has a
right to confidentiality of his or her clinical and personal
information and records and a right to a copy of his or her medical
record or information in his or her medical record within a reasonable
time frame.''
Response: This comment could have several meanings. The idea of
deferring to local and State law could apply to the confidentiality
provision, the access requirement, the reasonable time frame, or all
three. Specifically, it could be construed to mean that--
(1) ``The patient's right to the confidentiality of his or her
record is governed by State or local law (rather than Federal law).''
Currently, DHHS's position on this point is to defer to State
[[Page 36077]]
rules that are more protective of privacy than Federal rules whenever
possible.
While our intention is that the Patients' Rights CoP protects
record confidentiality to the greatest extent possible, we recognize
that some disclosure may be necessary. For example, in the December
1997 proposed rule, we proposed under the revised Information
Management CoP that the patient's medical information must be available
to all authorized professional personnel providing medical care to the
patient. If the patient's care is to be well integrated and planned,
those who are providing the various professional services involved in
the patient's treatment may need to review the patient's medical status
and history. It is expected that there will be management choices and
policies determining what uses and disclosures of patient information
are authorized, and that there will be administrative, management, and
technical safeguards to ensure that only persons using records for
authorized purposes may have access to them. For example, the release
of the patient's record may occur if the patient is transferred to
another facility, to comply with the provisions of Federal law and
State law (where State law is not inconsistent with Federal law), when
allowed under third party payment contract, as approved by the patient,
and when inspection by authorized agents of the Secretary is required
for the administration of the Medicare program.
(2) ``The patient's right to access his or her record should be
governed by State and local law.'' A discussion of DHHS's position is
in order. The general policy position of the DHHS on this topic is set
out in ``Confidentiality of Individually-identifiable Health
Information, Recommendations of the Secretary of Health and Human
Services, pursuant to section 264 of the Health Insurance Portability
and Accountability Act of 1996,'' in which the Secretary recommended
Federal legislation to protect the rights of patients with respect to
their health information.
The policy recommended there is that the patient should be allowed
to inspect and copy health information about himself or herself held by
providers and payers, but that providers and payers could, in their
discretion, withhold information from the patient under very narrowly
defined circumstances:
<bullet> The information is about another person (other than a
health care provider) and the holder determines that patient inspection
would cause sufficient harm to another individual to warrant
withholding.
<bullet> Inspection could be reasonably likely to endanger the life
or physical safety of the patient or anyone else.
<bullet> The information includes information obtained under a
promise of confidentiality (from someone other than a health care
provider), and inspection could reasonably reveal the source.
<bullet> The information is held by an oversight agency and access
by the patient could be reasonably likely to impede an ongoing
oversight or law enforcement activity.
<bullet> The information is collected in the course of a clinical
trial, the trial is in progress, an institutional review board has
approved the denial of access, and the patient has agreed to the denial
of access when consenting to participate.
<bullet> The information is compiled principally in anticipation
of, or for use in, a legal proceeding.
DHHS's policy also provides that those holding these health care
records be permitted to deny inspection if the information is used
solely for internal management purposes and is not used in treating the
patient or making any administrative determination about the patient,
or if it duplicates information available for inspection by the
patient.
The DHHS's policy sets forth the expectation that in general,
patients should be able to see and copy their records, and that
recordholders should only be able to deny access to the portion of the
record that meets the aforementioned criteria. The recordholder should
redact the portions allowed to be denied and should give the patient
the rest of the information. The accompanying discussion of DHHS's
policy recommendations supports patient access to his or her own
records. At least 31 States explicitly provide this right by law.
While we acknowledge the provider's right to exercise judgment in
the release of a patient's record in these narrow instances, we firmly
believe that a patient cannot take an active, meaningful role in his or
her health care decisions if he or she is not allowed to know what is
happening to his or her own body or mind. If he or she cannot
comprehend that information, then it should be available to his or her
representative (as allowed under State law), who then acts on his or
her behalf. The patient's right to be informed of his treatment, his
health status, and his prognosis is just that--his inherent right, to
be exercised by the individual or at his or his representative's (as
allowed under State law) discretion. We believe that this right is best
supported by giving the patient access to his or her own record in all
but the most extreme cases.
(3) ``The patient will receive his or her medical records within
the time frame prescribed by State or local law.'' We would defer to
either State or local guidance on this point.
The criteria we have set out above, that would describe
circumstances that might limit access by patients to their hospital
medical records, are not being incorporated into this final rule.
Rather, we are raising them now as examples of the narrow areas in
which providers should exercise discretion. Once we have reviewed the
comments, we will consider whether further guidance is necessary.
Comment: One commenter stated the regulation should require records
to be supplied at a fair market rate.
Response: Pricing must not create a barrier to the individual
receiving his or her medical records. Records should be supplied at a
cost not to exceed the community standard. If State law establishes a
rate for the provision of records, State law should be followed.
However, in the absence of State law, the rate charged by organizations
such as the local library, post office, or a local commercial copy
center that would be selected by a prudent buyer can be used as a
comparative standard.
We are finalizing the requirement as proposed and believe that
charging excessive fees for copies of a patient's medical record would
constitute a violation of the Patients' Rights CoP as this practice
could be used to frustrate the legitimate efforts of individuals to
gain access to their own medical records. We expect that we would
receive and investigate complaints if hospitals charged excessive fees
for medical records.
Comment: Some commenters stated that consideration should be given
to risk management issues involved in the release of incomplete medical
records.
Response: We are unsure whether the commenter is referring to a
closed record that may be incomplete or to a request for a copy of a
current, open record that, until the patient is discharged, will be
incomplete. In either situation, we believe it is a patient's inherent
right to have access to his or her clinical record. A hospital may
decide to provide a staff member to review the record with the patient
as necessary to minimize misunderstandings and respond to concerns.
[[Page 36078]]
H. Seclusion and Restraint
(1) We Received Approximately 150 Comments Regarding the Proposal That
Patients Have the Right To Be Free From the Use of Seclusion or
Restraint, of Any Form, as a Means of Coercion, Convenience, or
Retaliation by Staff
Comment: None of the commenters voiced an objection to the addition
of this standard under Patients' Rights.
Response: Since we proposed the rule in 1997, interest in the use
of seclusion and restraint and its consequences has increased markedly.
Part of this heightened awareness is due to media attention devoted to
this topic. One of the most controversial series of newspaper reports
appeared in October 1998 in Connecticut's Hartford Courant. The
articles cited the results of a study that identified 142 deaths from
seclusion and restraint use in behavioral health treatment facilities,
including psychiatric hospitals and psychiatric treatment units in
general hospitals, over the past 10 years. Restraint use has also been
covered in the broadcast media and has been investigated by the General
Accounting Office. All of this attention has generated a great deal of
concern for patient safety and well-being within the public, private,
and regulatory sectors.
While we find the reports of deaths associated with restraint use
disturbing, we are equally concerned with the impact that restraint use
has on acute and long-term care patients. The prevalence of injuries
and accidents involving restraint is difficult to gauge. If
manufacturers learn of a death or serious injury caused by a medical
device, they must report it to the Food and Drug Administration (FDA).
Device user facilities (hospitals, nursing homes, outpatient treatment
facilities, outpatient diagnostic facilities) must report a death of
one of their patients caused by the medical device to FDA and the
manufacturer, and a serious injury to the manufacturer only. No other
entities are required to report to FDA or the manufacturer.
Research indicates that the potential for injury or harm with the
use of restraint is a reality. In a 1989 article published in the
Journal of the American Geriatrics Society, Evans and Strumpf pointed
to an association between the use of physical restraint and death
during hospitalization (Evans, LK and Strumpf, NE: Tying down the
elderly: A review of the literature on physical restraint. J Am Geriatr
Soc (1989) 37:65-74; also see Robbins, LJ, Boyko E, Lane, J, et al.:
Binding the elderly: A prospective study of the use of mechanical
restraint in an acute care hospital. J Am Geriatr Soc (1987) 35:290;
Frengley, JD and Mion, LC: Incidence of physical restraints on acute
general medical wards. J Am Geriatr Soc (1986) 34:565; Strumpf, NE and
Evans, LK: Physical restraint of the hospitalized elderly: Perceptions
of patients and nurses. Nursing Research (1998) 37:132.) The FDA
estimates that at least 100 deaths from the improper use of restraints
may occur annually. Mion et al. further noted that, ``Some evidence
exists that the use of physical restraints is not a benign practice and
is associated with adverse effects, such as longer length of
hospitalization, higher mortality rates, higher rates of complications,
and negative patient reactions. Physical restraints have a detrimental
effect on the psychosocial well-being of the patient'' (see Mion et
al.: A further exploration of the use of physical restraints in
hospitalized patients. Jour Am Geriatr Soc (1989) 37:955; Schafer, A:
Restraints and the elderly: When safety and autonomy conflict. Can Med
Assoc J (1985) 132:1257-1260).
Research findings on the impact of restraints use have lead to
research on and development of alternative methods for handling the
behaviors and symptoms that historically prompted the application of
restraint. However, various studies provide evidence that restraint is
still being used when alternate solutions are available (see Donat, DC:
Impact of a mandatory behavior consultation on seclusion/restraint
utilization in psychiatric hospitals. J Behav Ther Exp Psychiatry (1998
March) 29:1, 13-9; Dunbar, J: Making restraint-free care work. Provider
(1997 May) 75-76, 79; and Moss, RJ: Ethics of mechanical restraints.
Hasting Center Report (1991 Jan-Feb) 21(1):22-25.)
While we acknowledge that in some emergency situations the use of
restraint may be the least potentially harmful way to protect the
individual's safety or that of others, the patient's right to be free
from restraint is paramount. Restraint use should be the exception to
the rule, not a standard practice. The question that arises is how we
and the medical community, with the common goal of the well-being of
each patient, can eliminate the inappropriate use of restraint and can
ensure the safety and health of the patient in emergency situations
where a restraint is applied. In considering how to achieve these
goals, we refer to the article by Evans and Strumpf:
`` * * * the consideration of the anticipated length of time in
restraint, goals of care, and the likely outcome for the patient
become extremely important questions to answer in those instances
where restraints are contemplated or in use * * * Further, more
attention to staff education regarding selection of appropriate
restraints by type and size and their proper application and
monitoring seems to be warranted if restraint-related accidental
injuries and deaths are to be avoided.'' (J Am Geriatr Soc (1989)
37:70).
In its Safety Alert of July 15, 1992, the FDA echoed the need for
training to decrease the incidence of deaths and injuries involving
restraining devices. The FDA suggested that institutions provide in-
service training for staff as regularly as possible, including a
demonstration of proper application of restraint. Given the stated need
for training if accidental injuries and deaths are to be avoided and
the use of alternative measures promoted, we have added language to the
final rule that will require a training program on restraint for staff.
We have also noted that these training programs should review
alternatives to restraint and seclusion, to teach skills so that staff
who have direct patient contact are well equipped to handle behaviors
and symptoms as much as possible without the use of restraints or
seclusion.
In the final rule, we have added the word ``discipline'' to the
standard statement to read, ``The patient has the right to be free from
the use of seclusion or restraint, of any form, as a means of coercion,
discipline, convenience, or retaliation by staff.'' Discipline is not
an acceptable reason for secluding or restraining a patient. In the
treatment environment, it is impossible to distinguish between
``discipline'' and ``punishment.''
Another addition to the final rule are definitions of ``physical
restraint,'' ``drug that is used as a restraint,'' and ``seclusion.''
We believe that codifying the definitions of these terms will provide a
clear legal basis for the enforcement of these standards.
We have decided upon a division of the restraint and seclusion
standard in the final rule. As we began work on the final rule, we
discovered a pattern of differences between an intervention used in the
provision of acute medical and surgical care and one used to manage
behavioral symptoms. This difference was situation-specific rather than
necessarily linked to provider type. While the definition of
``restraint'' spans care settings, the circumstances and expected
outcomes for restraints use vary.
In the final rule, we have attempted to differentiate between
situations where a restraint is being used to provide acute-level
medical and surgical care and those where restraint or seclusion is
used to manage behavior.
[[Page 36079]]
This approach is similar to that adopted in existing standards that
JCAHO has created for restraint and seclusion. When a restraint is
applied in the course of acute medical and surgical care, the
intervention is generally not undertaken because of an unanticipated
outburst of severely aggressive or destructive behavior that poses an
imminent danger to the patient and others. In medical and surgical
care, a restraint may be necessary to ensure that an intravenous (IV)
or feeding tube will not be removed, or that a patient who is
temporarily or permanently mentally incapacitated will not reinjure him
or herself by moving after surgery has been completed. Using a device
such as an IV arm board to provide medication that, if skipped, would
cause the patient considerable injury or harm may be the least
restrictive intervention that accomplishes the necessary administration
of the medication. The use of a restraint in this circumstance is
necessary for the patient's well-being (to receive effective treatment)
when less restrictive interventions, such as keeping the patient's arm
free and mobile have been determined to be ineffective.
Depending on the patient's diagnosis and health status, whether the
acute medical and surgical care patient requires constant monitoring
while restrained or can be monitored and reassessed at regular
intervals is a matter of clinical judgment. Additionally, seclusion is
not an intervention selected to help with the provision of medical or
surgical services; therefore, references to seclusion have been removed
from the final standard that appears as subsection (e).
A critical point to remember is that these standards are not
specific to the treatment setting, but to the situation the restraint
is being used to address. For example, if a hospital has a wing for
psychiatric patients where it uses restraint or seclusion to manage
behavior, it must meet the restraint and seclusion behavior management
standard for those patients.
The use of restraints or seclusion to manage behavior is an
emergency measure that should be reserved for those occasions when an
unanticipated, severely aggressive or destructive behavior places the
patient or others in imminent danger. While different factors may
precipitate this type of psychiatric, behavioral, and physical outburst
for an individual patient, the need for rapid assessment and continuous
monitoring is applicable in each case.
Accordingly, we are accepting commenters' suggestions to regulate
the time frames within which certain actions must occur in the behavior
management scenario. We are adopting the concept of time-limited orders
that appears in JCAHO's 1999 Hospital Accreditation Standards.
Specifically, the intent statement for standard TX.7.1.3.1.8 provides
that written orders for restraint or seclusion for behavioral health
patients are limited to 4 hours for adults, 2 hours for children and
adolescents ages 9 to 17, or 1 hour for patients under age 9. These
time frames were created for JCAHO's use by a committee of experts in
the field. We stress, however, that these time frames represent the
maximum time intervals for which each order can be written. Physicians
or licensed independent practitioners may write orders for shorter
increments of time. A licensed independent practitioner is any
individual permitted by law and by the hospital to provide care and
services, without direction or supervision, within the scope of the
individual's license and consistent with individually granted clinical
privileges. Additionally, under regulation, while the patient is being
restrained or secluded, his or her status must be continually
monitored, assessed, and reevaluated, with an eye toward releasing him
or her from the restraint or seclusion at the earliest possible time.
We believe that these factors will ensure that the patient is
restrained or secluded for as brief a time as possible. In addition, we
are requiring that if the restraint or seclusion order is written by a
physician or licensed independent practitioner other than the
``treating'' physician, the treating physician must be consulted as
soon as possible The ``treating'' physician is the physician who is
responsible for the management and care of the patient. We believe that
this is important because the ``treating'' physician may have
information regarding the patient's history which may have a
significant impact on the selection of restraint or seclusion as an
intervention. For example, the patient may have a history of sexual
abuse and restraints or seclusion may actually cause psychological
harm.
JCAHO also states in its explanation of intent for standard
TX.7.1.3.1.7 that each licensed independent practitioner best carries
out his or her responsibility when he or she participates in daily
reviews of restraints and seclusion use related to his or her patients.
We are adopting a parallel philosophy by specifying in the regulation
that an order for restraint or seclusion may only be renewed in the
previously mentioned increments (4 hours for adults; 2 hours for
patients ages 9 to 17; 1 hour for patients under 9) for up to a total
of 24 hours--to that point, the practitioner must reevaluate his or her
patient face-to-face before writing a new order. We believe that it is
appropriate to recognize JCAHO's work in this area and maintain
consistency between Federal and accreditation standards when possible.
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 standard for restraint use in the provision of acute medical
and surgical services and the standard for restraints and seclusion use
for behavior management are built on the same foundation; however, the
behavior management standard contains more rigorous requirements for
the timeliness of actions that must be taken by a physician or other
licensed independent practitioner who is granted authority under State
law and by the hospital to order restraints use or seclusion. The
creation of two restraints standards does not represent any lessening
in our commitment to restraint reduction and, as much as possible,
elimination in both the provision of acute care and behavior management
situations. The distinction does acknowledge, however, that it may not
be reasonable to have identical standards for two very different
situations. The absence of time frames for the acute care standard
should not be construed as permission to restrain patients without
timely interaction with the physician or other licensed independent
practitioner who is permitted by the State and the hospital to order
restraint. When restraint is used to provide acute medical or surgical
care, we still expect the patient to be continually assessed,
monitored, and reevaluated by hospital staff. The patient's care needs
will dictate how frequently reassessment by a physician or other
licensed independent practitioner is necessary. In any case, we expect
the discontinuation of the restraint at the earliest possible time.
[[Page 36080]]
(2) We Proposed That if Seclusion and Restraints Are Used (Including
Drugs Used as Restraints), They Must be Used in Accordance With the
Patient's Plan of Care, Used Only as a Last Resort, in the Least
Restrictive Manner Possible, and Removed or Ended at the Earliest
Possible Time
Comment: One commenter suggested that there needs to be better
understanding of why seclusion and restraints are used, and development
of efforts to reduce their use. However, this commenter did not believe
further prescriptive Federal regulation is necessary.
Response: There is a need to understand why seclusions and
restraints are used; however, the reasons behind the use of restraints
have been studied and to some extent documented (see Strumpf NE and
Evans, LK: Physical restraint of the hospitalized elderly: Perceptions
of patients and nurses. Nursing Research (1988) 37:132-137; Evans LK
and Strumpf NE: Tying down the elderly: A review of the literature on
physical restraint. Jour Amer Geriatr Soc (1989) 37:65-74; Janelli, LM:
Physical restraint use in acute care settings. J Nurs Care Qual (1995
Apr) 9(3) 86-92.) Various studies substantiate that restraints are
being used when alternate solutions are available (see Donat, DC:
Impact of a mandatory behavior consultation on seclusion/restraint
utilization in psychiatric hospitals. J Behav Ther Exp Psychiatry (1998
March) 29:1, 13-9; Dunbar, J: Making restraint-free care work. Provider
(1997 May) 75-76, 79; and Moss, RJ: Ethics of mechanical restraints.
Hasting Center Report (1991 Jan-Feb) 21(1):22-25.)
While restraints reduction and education programs are underway and
should be encouraged, we believe that it is critical to reinforce
appropriate restraints reduction by acknowledging the patient's right
to be free from restraints except when the use of a restraint is the
least restrictive option that will provide the greatest benefit to the
patient (that is, the risks associated with the use of the restraint
are outweighed by the risk of not using it). When used to manage
behavior, the use of restraint or seclusion is only an emergency
measure and requires careful assessment and monitoring to ensure
patient safety.
Comment: Some commenters suggested that this regulation display
consistency between HCFA and JCAHO requirements.
Response: We understand and appreciate concerns about consistency
between HCFA and JCAHO standards. As mentioned above, we have modified
the final rule to introduce separate standards to address restraint or
seclusion used for behavior management and restraint used in the
provision of acute medical and surgical care. This change reflects the
differing emphases contained within JCAHO's current requirements. As we
further develop the guidelines, we will continue to work closely with
JCAHO.
Comment: A number of commenters suggested that the terms ``as a
last resort'' should be replaced with, ``when medically indicated,''
or, ``when medically necessary,'' or ``when other appropriate measures
have been found to be ineffective.''
Response: We have replaced the term, ``as a last resort'' with
``when other less restrictive measures have been found to be
ineffective.'' We reaffirm that restraints use should not be a standard
practice, and restraints should be used only when other less
restrictive alternatives are ineffective to protect the safety of the
patient or others.
Comment: A few comments suggested including ``and hospital policy''
after ``patient's plan of care'' to link patient care to the hospital
requirements.
Response: To meet the restraint and seclusion requirements,
hospitals may develop their own policies focusing on alternatives to
seclusion and restraint, the underlying patient condition, and the
discontinuation of seclusion or restraint as soon as possible. However,
it seems redundant to require hospitals to then follow their own
policies. Our primary concern is that the requirements of the
regulation be met. Ensuring the connection between the regulations and
standards of practice and smooth implementation is part of the
hospital's responsibility to meet the CoPs. Accordingly, we are not
adopting the commenter's suggestion.
Comment: One commenter suggested that less restrictive and more
restrictive devices should be held to different standards.
Response: We do not want to apply unnecessary multiple standards
when the overarching principle is that the patient has the right to be
free from restraints, whether artificially or scientifically classed,
that restrict normal movement or access to his or her body. We
recognize the difference between an arm restraint applied to enable the
provision of needed medication versus a posey vest or four point
restraint; however, when their use is avoidable, we expect that the
hospital will refrain from using any of these devices. When this
intervention is absolutely necessary to the safety and well-being of
the patient or others, the hospital does have the ability to use these
devices.
We expect hospital policies and procedures regarding all use of
restraints or seclusion to comply with the same fundamental standard:
At the very least and before all else, the intervention should do no
harm. Any intervention must be made in the context of an ongoing loop
of assessment, intervention, evaluation, and reintervention. A
corollary principle is that the greater the risks associated with an
intervention, the more careful and thorough the assessment must be.
Comment: Seclusion and restraint should never be used
simultaneously and should not cause physical pain to the patient.
Response: We are strengthening the final rule by specifying that
physical restraints may not be used in combination with seclusion
unless the patient is either (1) continually monitored face-to-face by
an assigned staff member; or (2) is continually monitored by staff
using both video and audio equipment. This monitoring must be in close
proximity to the patient.
We agree that the use of a restraint should not harm or cause pain
to the patient. We will address this topic in the interpretive
guidelines. We believe that these concepts should be covered as part of
the staff training in the proper use of seclusion and restraint.
A slightly different issue is the use of a drug as a restraint in
combination with a physical restraint or seclusion. As acknowledged
elsewhere in this preamble, drugs may be used for a variety of purposes
and may have positive value as part of a well-planned therapeutic
strategy. Some are appropriate given the individual's plan of care and
specific situation. The regulation supports the patient's right to be
free from drugs that are used to restrain the resident in the absence
of medical symptoms or for the purpose of discipline, convenience,
retaliation, or coercion; however, we do not wish to introduce
regulations that might block the strides made to appropriately medicate
patients who are, for example, in pain or clinically depressed.
Comment: A few commenters suggested that the requirement for
patient records include alternative approaches attempted before the use
of seclusion and restraints.
Response: Documentation included in the patient's medical record
was discussed in the proposed rule of December 1997 at proposed
Sec. 482.120(a), the Information Management CoP. The proposed
Information Management CoP requires
[[Page 36081]]
recording the diagnosis, comprehensive assessment and plan of care,
evaluations, consent forms, notes on treatments, nursing, medications,
reactions, a summary report with provisions for follow-up care, and any
relevant reports. The CoP also requires that revisions to the plan of
care be documented in the patient's record. Accordingly, as the general
requirements are addressed in another section that will be addressed in
the hospital CoP rule when it is published as final, we are not
adopting the commenter's suggestion. However, we expect that the
medical record will contain information on less restrictive measures
that may have been considered before the selection of seclusion or
restraint use. In the interpretive guidelines, however, we will go into
further detail about the expectation surrounding the requirement that
restraint or seclusion only be used after less restrictive
interventions are shown to be ineffective. The interpretive guidance
will describe what surveyors should look for in examining compliance
with this standard.
Comment: Data showing the use of seclusion and restraints and any
patient injuries incurred as a result should be reported.
Response: It is possible that States and localities may have
requirements for reporting these incidents. Additionally, Federal law
requires that deaths involving restraining devices be reported to the
FDA, and that both deaths and serious injuries associated with
restraint use be reported to the device's manufacturer. However, this
reporting does not cover the situations where patients are suffocated
or critically injured during physical holds. To be more inclusive, we
are adding a Sec. 482.13(f)(7) (under the behavior management standard)
that requires each hospital to report to us any death that occurs while
a patient is restrained or in seclusion, or where it is reasonable to
assume that a patient's death is as result of restraint or seclusion.
HCFA will track the reports of deaths from restraints or seclusion
occurring in hospitals. HCFA will use this information to (1) authorize
onsite investigations (complaint surveys) of these hospitals in
accordance with the current complaint investigation process; and (2)
inform the Federally-mandated Protection and Advocacy (P&A) entity in
the respective State or territory. Protection and Advocacy programs are
Congressionally authorized (in accordance with 42 U.S.C. 10101 et.seq.)
to access facilities and to investigate abuse and neglect complaints.
Furthermore, we are soliciting comment on the pros and the cons of
requiring the reporting of serious injury or abuse related to the use
of restraints or seclusion, as well as the type of injury or abuse that
would be reported, and the process whereby these incidents would be
reported.
Comment: Some commenters suggested the need for hospitals to
develop and implement hospital-based performance and outcome measures
for restraints and seclusion.
Response: We are not mandating the development of these standards
at this time. However, we expect that a hospital, as part of its
internal quality assessment and performance improvement program, will
evaluate itself in patient care activities that have potential safety
issues, including the use of restraints and seclusion.
Comment: Commenters stated the need to provide periodic educational
sessions for hospital staff on the proper use of seclusion and
restraint in compliance with HCFA guidelines.
Response: We agree. We are adding a requirement that as part of
ongoing training, staff who have direct patient contact are trained in
the proper and safe use of seclusion and restraints, as well as trained
in techniques and alternatives to handle the symptoms, behaviors, and
situations that have historically prompted restraint or seclusion. For
example, topics of training could include cardiopulmonary resuscitation
techniques, methods for appropriately positioning a restrained
patient's head and body to ensure proper respiration and circulation,
or methods for monitoring cardiovascular status. We will provide a more
detailed description of safe, appropriate restraining techniques in the
interpretive guidelines.
Research on restraints supports education as the key component in
decreasing or eliminating the use of seclusion or restraints (see
Stilwell, EM: Nurses' education related to use of restraints. (1991
Feb) 17(2) 23-6; Cruz, V: Research-based practice: Reducing restraints
in acute care setting. (1997 Feb) 23(2)31-40; and Janelli, LM: Acute/
critical care nurses' knowledge of physical restraints-implications for
staff development. (1994 Jan-Feb) 10(1)6-11). As noted earlier,
education may also be crucial in efforts to reducing and eliminating
restraints-related injuries.
Comment: A commenter requested further clarification of the
definition of ``restraint,'' the types of restraints, and the types of
situations where these measures should be used. Commenters wanted HCFA
and the medical community to collaborate in developing these working
definitions, giving consideration to differences in patient care issues
that are age and population specific in acute care hospitals,
behavioral health treatment facilities, and nursing homes. These
commenters requested inclusion and clarification of when the use of
side rails constitutes a restraint and a discussion of leather versus
soft restraints.
Response: We have provided definitions of ``physical restraint,''
``drug that is used as a restraint,'' and ``seclusion'' in the final
rule and plan to provide further guidance in the interpretive
guidelines in the SOM. To adequately respond to commenters' questions,
we will respond in three parts.
1. Physical Restraint
The functional definition of ``physical restraint'' parallels
existing guidance regarding restraints found in HCFA's SOM Appendix P
(nursing home requirements). A restraint is a restraint regardless of
setting. A posey vest is no less restrictive when applied in a hospital
than when used in a nursing home.
Similarly, we are not categorizing varieties of physical
restraints, such as soft versus leather. An object is a restraint by
functional definition; that is, when it restricts the patient's
movement and access to his or her body. Under this definition, all
sorts of devices and practices could constitute a restraint. For
example, tucking a patient's sheets in so tightly that he or she cannot
move is restraining him or her. In that instance, a sheet is a
restraint. One has to examine how the device or object is being used.
Putting up side rails that inhibit the patient's ability to get out of
bed when he or she wants to constitutes a restraint. In summary, we
have adopted a functional definition that does not name each device and
situation that can be used to inhibit an individual's movement simply
because we believe that this approach is counterproductive. One could
not possibly capture all scenarios or devices in regulation, and a
functional approach promotes looking at individual situations. From our
experience with nursing homes, we know that many people look for a
clear-cut list of restraints. We believe that clinicians will agree,
however, that each case is different. A device that acts as a restraint
for one individual may not inhibit the movement of another.
Accordingly, we have incorporated a definition that focuses on function
for the individual.
Concerning leather and soft restraints, patient safety and comfort
are primary
[[Page 36082]]
considerations in selecting a restraining technique or device. We do
not feel qualified to comment on one being preferable to the other, but
would offer that restraints in general should be avoided as much as
possible.
2. Drug Used as a Restraint
We have noted in the regulations text at Sec. 482.13(e)(1) and
Sec. 482.13(f)(1) that a drug used as a restraint is a medication used
to control behavior or to restrict the patient's freedom of movement
and is not a standard treatment for the patient's medical or
psychiatric condition. Before discussing the concepts behind this
definition, we would point out that the language that precedes this
definition clearly sets forth that the patient has the right to be free
from seclusion or restraint, of any form, imposed as a means of
coercion, discipline, convenience, or retaliation by staff. This right
is provided under both the acute medical and surgical care provisions
and the behavior management provisions.
Even when there are medical indications for the use of a drug as a
restraint, we believe that the precautions outlined in the regulation
are necessary to protect the patient. The definition contains a phrase
that merits some discussion--``and is not a standard treatment for the
patient's medical or psychiatric condition.'' As stated elsewhere, we
do not want to unintentionally interfere with the administration of
drugs that are part of a patient's therapeutic plan of care--for
example, for a patient with a psychiatric diagnosis, a mood or
behavior-affecting drug may be part of the patient's overall care plan.
To address this consideration, we added language to address what we see
as the primary point the standard hopes to address--not the drug that
is being used as an integrated part of the care plan, but the drug that
is not part of a standard treatment for the patient's medical or
psychiatric condition.
3. Seclusion
The definition adopted, ``the involuntary confinement of a person
in a room or an area where the person is physically prevented from
leaving,'' is an adaptation of JCAHO's definition.
Comment: We proposed a more prescriptive set of requirements for
restraints and seclusion in the preamble to the proposed rule. Many
commenters cited a potential burden, inefficiency of care, expense, and
safety issues that may arise as a direct result of mandating physician
consultation to evaluate for restraint utilization, to write orders
every 2 hours for pediatric patients or every 6 hours for adult
patients (instead of every 24 hours), to have face-to-face contact, and
to have primary authority to initiate written orders for seclusion and
restraints. A commenter pointed out that the proposed rule will exceed
the current law in his State. In that State, seclusion and restraint
orders may be issued by either a physician, Ph.D., licensed clinical
psychologist, or master's prepared registered nurse. One commenter
believed that frequency of assessment should be based on the patient's
presenting factors. Many commenters believed the proposed rule would be
restrictive and impractical, thereby encouraging false documentation
and limiting the ability of the registered nurse in ``sound clinical
decision making.''
Response: We acknowledge the perceived burden of a more
prescriptive set of standards. As we explained above, in this rule we
have attempted to differentiate between situations where a restraint is
being used to provide acute-level medical and surgical care and those
when restraint or seclusion is used to manage behavior.
To address the concerns about the burden of requiring all of these
functions to be performed by the physician, as well as the comment that
some States permit other licensed independent practitioners to order
restraint and seclusion, we have changed the final regulation to
indicate the possible involvement of these other types of professionals
as permitted by State law and hospital policy. However, we are
interested in receiving comments on whether we should adopt more
restrictive requirements that would allow only physicians to order
restraints or seclusion for behavior management.
We considered the other commenters' concerns about the
restrictiveness and impracticality of the requirements, the adverse
effect that the requirements might have on the RN's ability to make
sound clinical judgments, and the potential for falsification of
records. We disagree with these comments on several counts. First, the
RN's decision-making skills and judgment are a cornerstone of good
patient care. This rule is not curtailing the RN's role in patient
care. Second, the standard for restraint use for acute medical and
surgical care maintains flexibility. We have avoided being overly
prescriptive in this standard because of the need for sound clinical
judgment in meeting the patient's individual care needs. In the
provision of acute medical and surgical care, we agree with the
commenter who observed that patient assessment should be based on his
or her presenting condition. (Earlier, we described the rationale for
codifying a greater degree of specificity for the standard for
restraint and seclusion in behavior management.) Regardless of the
situation that is presented to the hospital, the nurse's observation
and intervention in patient care remains critical. Concerning the
falsification of records, we see no connection between the requirements
we are establishing in this rule and an increase in the behavior.
Comment: A commenter wanted to prohibit PRN orders and mandate 15-
minute checks on restrained patients. Some responders believed that
there should not be a defined time limit for restraint use, while a few
believed that this limit should be instituted. One commenter believed
that patients under age 18 should be in seclusion or restraint for
shorter periods than adults. One responder suggested a maximum of 16
hours.
Response: We agree that PRN orders should never be used with or as
a part of seclusion and restraints, and this concept has been added to
the final rule. The use of PRN orders for seclusion and restraints
would allow a facility to indiscriminately seclude or restrain
patients. As noted earlier, in the acute medical and surgical care
standard, the need for monitoring continually versus periodic checks is
a determination that will largely be correlated with the individual
patient's diagnosis, treatment, and health status. Basically, the
determination of frequency of monitoring must be made on an individual
basis. However, we are mandating that restraints or seclusion be ended
at the earliest possible time based on continuous assessment and
reevaluation of the patient's condition. We expect that this assessment
would include items such as vital signs, circulation, hydration needs,
level of distress, and agitation. In interpretive guidance, we will
specify what is meant by ``continuous assessment and reevaluation of
the patient.''
In response to the commenter who believed in differentiating
between the length of restraint for adults and patients under the age
of 18, we have adopted JCAHO's approach to time-limited orders for
restraints or seclusion. Concerning the comment that restraint should
be limited to 16 hours, we understand the desire to put some sort of a
cap on the amount of time that an individual can be restrained.
However, we found no precedent for a 16-hour or any other time-specific
cap, and we believe that it is clinically ill-advised to set an
absolute maximum on how long an individual can be restrained. As
discussed earlier, we have indicated that orders for physical
[[Page 36083]]
restraint and seclusion may be renewed in the previously mentioned
increments for up to a total of 24 hours. At that point, the physician
or licensed independent practitioner who ordered the use of restraints
or seclusion must see his or her patient in person to determine whether
the issuance of a new order is appropriate. The requirement that
patients who are restrained for behavioral purposes are continually
assessed, monitored, and reevaluated, combined with the regulatory
expectation that restraints use will be discontinued at the earliest
possible time, should ensure that restrained patients are released as
soon as they can commit to safety and no longer pose a threat to
themselves or others.
While the regulation stresses the minimal use of restraint or
seclusion, when these steps are necessary, the staff's training should
provide a good groundwork for ensuring that staff know how to meet each
patient's basic needs. As a result of their training, staff should be
equipped to assess, monitor, and reevaluate each restrained patient as
well as provide care to meet basic needs.
Comment: Suggestions were made that nurses should be allowed (1) to
receive verbal or telephone orders from physicians who are prescribing
restraint or seclusion orders and (2) to use ongoing assessment and a
standardized restraint protocol.
Response: Current requirements at Sec. 482.23(c)(2)(i) allow nurses
to receive verbal or telephone orders. In addition, many States have
laws regarding telephone orders. We agree that professional staff
should be able to use standard seclusion or restraint protocols, in
accordance with medical standards of practice and hospital policies and
procedures that are consistent with these regulations. If a hospital
and medical staff develop and authorize the use of this protocol for
emergency situations, it would meet the requirement that restraints be
used in accordance with the order of a physician or other licensed
independent practitioner who is approved by the State and the hospital
to issue this order. We will explain this further in interpretive
guidelines. We expect that the nurse or other professional who
initiates the protocol will contact the appropriate physician at the
earliest possible time to obtain a verbal order for the restraint or
seclusion intervention.
Comment: Provisions need to be made for the emergency application
of restraints.
Response: We agree. Hospitals may develop an emergency protocol
approved by the medical staff to be used in emergency situations in a
manner consistent with these regulations.
Comment: Commenters stated that we are singling out the use of
psychopharmacological drugs in the overall proposed rule. One commenter
asked that references to psychopharmacological drugs be removed from
the CoP.
Response: We agree that there is no need to specify
``psychopharmacological'' drugs and have removed the term. Any drug
that alters mood, mental status, or behavior can be used as a restraint
depending on the situation.
Comment: Many comments centered around linking the valid use of
restraints (including drugs used as restraints) to the patient's plan
of care and the hospital's policy.
Response: The use of restraints must be linked to the patient's
modified plan of care, and we have put this language in the regulation.
We refer to the ``modified'' plan of care to reinforce our expectation
that restraint or seclusion should not be a standard response to a
particular behavior or situation. The use of these interventions is an
emergency measure that temporarily protects the safety of the patient
and others; however, it is not a long-term solution for handling
problematic behavior.
If restraints are used, their use must be in accordance with a
physician's order (or other licensed independent practitioner's order,
as noted earlier) and the patient's modified plan of care; used in the
least restrictive manner possible; used in accordance with appropriate
restraining techniques; use only when other appropriate measures have
been found to be ineffective to protect the patient or others from
harm; and ended at the earliest possible time. The patient's treating
physician must be consulted as soon as possible, if the treating
physician did not order the restraint. In addition, the condition of
the restrained patient must be continually assessed, monitored, and
reevaluated.
Comment: A commenter believed that no further details need to be
included in the regulation as it only increases the paperwork burden
for the hospital while not guaranteeing improved quality of patient
care.
Response: We have adopted more prescriptive requirements based on
recent public health concerns, as noted above. The paperwork aspect of
both the acute medical and surgical restraint use and the behavior
management restraints and seclusion are minimal. As other factors, such
as the professionalism and training of staff, will affect patient
outcomes, we agree that a detailed process does not necessarily in and
of itself guarantee quality of care. However, we believe that we have
established a framework in regulations that promotes the patient's
right to be free of restraints and seclusion and protects him or her
when their use is instituted.
Comment: One commenter asserted that particularly in psychiatric
institutions, restraints and seclusion can be used to prevent patients
from filing complaints or taking steps to initiate discharge. The
commenter further noted that even those patients who are not in
seclusion may effectively be prevented from using the phone to notify
family or a primary physician of their hospitalization by an
unscrupulous provider. To address this situation, the commenter
recommended that we include the patient's right to request that a
family member of his or her choice and his or her physician be notified
promptly of his or her admission to the hospital.
Response: In the final rule, we have added a requirement that
addresses this right.
General Comments
Comment: Recommendations were made for us to provide more guidance
on the specific documentation hospitals are required to provide to
surveyors to indicate compliance and, ultimately, for us to be aware of
how these regulations may impact patient safety.
Response: We intend to issue interpretive guidance that will
elaborate on the hospital's responsibilities, what the surveyors should
evaluate to determine compliance with this requirement, and the extent
to which the use of seclusion or restraints in each individual instance
provides demonstrable evidence that the intervention is clearly tied to
the individual patient's plan of care. Through our on-site survey
presence in initial certification surveys, recertification surveys and
the investigation of complaints, HCFA will monitor how well hospitals
are meeting these new standards.
Comment: A commenter suggested the use of measurement and
assessment processes that would identify opportunities to reduce the
risk associated with restraint use through introducing preventive
strategies, innovative alternatives, and process improvement.
Response: We think this is an excellent suggestion; however, we are
not mandating specific measures or assessment protocols. We expect a
hospital, through its quality assessment
[[Page 36084]]
and performance improvement activities, to assess itself in this
regard.
Comment: A commenter suggested including the right to
nondiscriminatory treatment--which should include a prohibition against
discrimination on the basis of mental or physical disability and
socioeconomic status.
Response: As a result of their receipt of Federal funds, Medicaid-
and Medicare-participating hospitals are already prohibited from
discriminating on the basis of race, color, or national origin (under
title VI of the Civil Rights Act of 1964), age (under the Age
Discrimination Act of 1975), and disability (under section 504 of the
Rehabilitation Act of 1973). In addition, the Americans with
Disabilities Act protects persons with disabilities from
discrimination.
The regulations governing the Medicare provider agreement recognize
these protections and discuss them at Sec. 489.10(b). Specifically,
this section, entitled ``Basic requirements,'' requires the provider to
meet the applicable civil rights requirements of title VI of the Civil
Rights Act of 1964, as implemented by 45 CFR part 80, which provides
that no person in the United States shall, on the ground of race,
color, or national origin, be excluded from participation in, be denied
the benefits of, or be subject to discrimination under any program or
activity receiving Federal financial assistance. Section 489.10(b) also
requires compliance with section 504 of the Rehabilitation Act of 1973
(which provides protection against discrimination to qualified persons
with disabilities), the Age Discrimination Act of 1975 (which provides
protection against discrimination based on age), and other pertinent
requirements of the Office for Civil Rights of the Department of Health
and Human Services. Moreover, if a facility is funded under title VI or
title XVI of the Public Health Service Act, it is prohibited from
denying services to persons unable to pay for needed services if the
persons are seeking emergency services and reside in the hospital
service area or if those persons are eligible under the uncompensated
services provision of the Act. The facility is also prohibited from
discriminating based on method of payment.
V. Provisions of the Final Rule
For reasons specified in the preamble, we are codifying the
Patients' Rights CoP within the current hospital CoPs under Subpart B--
Administration at Sec. 482.13. The six standards to the CoP will set
forth minimum protections and will promote patients' rights. Changes
have been made to strengthen the proposed regulation and are set forth
as follows.
The first standard, Notice of Rights, states, ``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.'' This
standard also requires that the hospital have a grievance process and
indicate who the patient can contact to express a grievance. The
minimum elements that must be common to all hospital grievance
processes are specified.
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. The Exercise of
Rights standard sets forth the patient's right to make decisions
regarding his or her care and the right to formulate advance directives
and to have hospital staff and practitioners who provide care in the
hospital comply with those directives, in accordance with Sec. 489.100
(Definition), Sec. 489.102 (Requirements for providers), and
Sec. 489.104 (Effective dates). We have added a requirement that the
patient has the right to have a family member or representative of his
or her choice and his or her physician notified promptly of his or her
admission to the hospital.
Response: Regarding the definition of ``reasonable,'' we believe
that ``reasonable'' means that the hospital (1) will not frustrate the
legitimate efforts of individuals to gain access to their own medical
records, and (2) will actively seek to meet these requests as quickly
as its recordkeeping system permits. We have included these
expectations in the regulations text at Sec. 482.13(d)(2).
We agree with the commenters who asserted that we should account
for the impact of various factors such as location of data, urgency,
and staff workload. Rather than attempting to stipulate time frames
within the regulation that would cover all possible combinations of
factors, we are simply retaining the word ``reasonable.'' We trust that
if the patient believes that he is being subjected to unreasonable
treatment as he tries to obtain a copy of his medical records, he will
use the hospital's grievance process or will report difficulties to the
SA or JCAHO. While setting a concrete time frame might provide a better
measuring stick for performance, it would not adequately account for
the kinds of variation that are apt to occur in different hospital
settings.
Comment: Some commenters suggested that the rule be expanded to
state, ``In accordance with local and State laws, the patient has a
right to confidentiality of his or her clinical and personal
information and records and a right to a copy of his or her medical
record or information in his or her medical record within a reasonable
time frame.''
Response: This comment could have several meanings. The idea of
deferring to local and State law could apply to the confidentiality
provision, the access requirement, the reasonable time frame, or all
three. Specifically, it could be construed to mean that--
(1) ``The patient's right to the confidentiality of his or her
record is governed by State or local law (rather than Federal law).''
Currently, DHHS's position on this point is to defer to State
[[Page 36077]]
rules that are more protective of privacy than Federal rules whenever
possible.
While our intention is that the Patients' Rights CoP protects
record confidentiality to the greatest extent possible, we recognize
that some disclosure may be necessary. For example, in the December
1997 proposed rule, we proposed under the revised Information
Management CoP that the patient's medical information must be available
to all authorized professional personnel providing medical care to the
patient. If the patient's care is to be well integrated and planned,
those who are providing the various professional services involved in
the patient's treatment may need to review the patient's medical status
and history. It is expected that there will be management choices and
policies determining what uses and disclosures of patient information
are authorized, and that there will be administrative, management, and
technical safeguards to ensure that only persons using records for
authorized purposes may have access to them. For example, the release
of the patient's record may occur if the patient is transferred to
another facility, to comply with the provisions of Federal law and
State law (where State law is not inconsistent with Federal law), when
allowed under third party payment contract, as approved by the patient,
and when inspection by authorized agents of the Secretary is required
for the administration of the Medicare program.
(2) ``The patient's right to access his or her record should be
governed by State and local law.'' A discussion of DHHS's position is
in order. The general policy position of the DHHS on this topic is set
out in ``Confidentiality of Individually-identifiable Health
Information, Recommendations of the Secretary of Health and Human
Services, pursuant to section 264 of the Health Insurance Portability
and Accountability Act of 1996,'' in which the Secretary recommended
Federal legislation to protect the rights of patients with respect to
their health information.
The policy recommended there is that the patient should be allowed
to inspect and copy health information about himself or herself held by
providers and payers, but that providers and payers could, in their
discretion, withhold information from the patient under very narrowly
defined circumstances:
<bullet> The information is about another person (other than a
health care provider) and the holder determines that patient inspection
would cause sufficient harm to another individual to warrant
withholding.
<bullet> Inspection could be reasonably likely to endanger the life
or physical safety of the patient or anyone else.
<bullet> The information includes information obtained under a
promise of confidentiality (from someone other than a health care
provider), and inspection could reasonably reveal the source.
<bullet> The information is held by an oversight agency and access
by the patient could be reasonably likely to impede an ongoing
oversight or law enforcement activity.
<bullet> The information is collected in the course of a clinical
trial, the trial is in progress, an institutional review board has
approved the denial of access, and the patient has agreed to the denial
of access when consenting to participate.
<bullet> The information is compiled principally in anticipation
of, or for use in, a legal proceeding.
DHHS's policy also provides that those holding these health care
records be permitted to deny inspection if the information is used
solely for internal management purposes and is not used in treating the
patient or making any administrative determination about the patient,
or if it duplicates information available for inspection by the
patient.
The DHHS's policy sets forth the expectation that in general,
patients should be able to see and copy their records, and that
recordholders should only be able to deny access to the portion of the
record that meets the aforementioned criteria. The recordholder should
redact the portions allowed to be denied and should give the patient
the rest of the information. The accompanying discussion of DHHS's
policy recommendations supports patient access to his or her own
records. At least 31 States explicitly provide this right by law.
While we acknowledge the provider's right to exercise judgment in
the release of a patient's record in these narrow instances, we firmly
believe that a patient cannot take an active, meaningful role in his or
her health care decisions if he or she is not allowed to know what is
happening to his or her own body or mind. If he or she cannot
comprehend that information, then it should be available to his or her
representative (as allowed under State law), who then acts on his or
her behalf. The patient's right to be informed of his treatment, his
health status, and his prognosis is just that--his inherent right, to
be exercised by the individual or at his or his representative's (as
allowed under State law) discretion. We believe that this right is best
supported by giving the patient access to his or her own record in all
but the most extreme cases.
(3) ``The patient will receive his or her medical records within
the time frame prescribed by State or local law.'' We would defer to
either State or local guidance on this point.
The criteria we have set out above, that would describe
circumstances that might limit access by patients to their hospital
medical records, are not being incorporated into this final rule.
Rather, we are raising them now as examples of the narrow areas in
which providers should exercise discretion. Once we have reviewed the
comments, we will consider whether further guidance is necessary.
Comment: One commenter stated the regulation should require records
to be supplied at a fair market rate.
Response: Pricing must not create a barrier to the individual
receiving his or her medical records. Records should be supplied at a
cost not to exceed the community standard. If State law establishes a
rate for the provision of records, State law should be followed.
However, in the absence of State law, the rate charged by organizations
such as the local library, post office, or a local commercial copy
center that would be selected by a prudent buyer can be used as a
comparative standard.
We are finalizing the requirement as proposed and believe that
charging excessive fees for copies of a patient's medical record would
constitute a violation of the Patients' Rights CoP as this practice
could be used to frustrate the legitimate efforts of individuals to
gain access to their own medical records. We expect that we would
receive and investigate complaints if hospitals charged excessive fees
for medical records.
Comment: Some commenters stated that consideration should be given
to risk management issues involved in the release of incomplete medical
records.
Response: We are unsure whether the commenter is referring to a
closed record that may be incomplete or to a request for a copy of a
current, open record that, until the patient is discharged, will be
incomplete. In either situation, we believe it is a patient's inherent
right to have access to his or her clinical record. A hospital may
decide to provide a staff member to review the record with the patient
as necessary to minimize misunderstandings and respond to concerns.
[[Page 36078]]
H. Seclusion and Restraint
(1) We Received Approximately 150 Comments Regarding the Proposal That
Patients Have the Right To Be Free From the Use of Seclusion or
Restraint, of Any Form, as a Means of Coercion, Convenience, or
Retaliation by Staff
Comment: None of the commenters voiced an objection to the addition
of this standard under Patients' Rights.
Response: Since we proposed the rule in 1997, interest in the use
of seclusion and restraint and its consequences has increased markedly.
Part of this heightened awareness is due to media attention devoted to
this topic. One of the most controversial series of newspaper reports
appeared in October 1998 in Connecticut's Hartford Courant. The
articles cited the results of a study that identified 142 deaths from
seclusion and restraint use in behavioral health treatment facilities,
including psychiatric hospitals and psychiatric treatment units in
general hospitals, over the past 10 years. Restraint use has also been
covered in the broadcast media and has been investigated by the General
Accounting Office. All of this attention has generated a great deal of
concern for patient safety and well-being within the public, private,
and regulatory sectors.
While we find the reports of deaths associated with restraint use
disturbing, we are equally concerned with the impact that restraint use
has on acute and long-term care patients. The prevalence of injuries
and accidents involving restraint is difficult to gauge. If
manufacturers learn of a death or serious injury caused by a medical
device, they must report it to |
