[Federal Register Volume 64, Number 127 (Friday, July 2, 1999)]
[Rules and Regulations]
[Pages 36070-36089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-16543]



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Part II





Department of Health and Human Services





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Health Care Financing Administration



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42 CFR Part 482



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

  Federal Register / Vol. 64, No. 127 / Friday, July 2, 1999 / Rules 
and Regulations  

[[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.

-----------------------------------------------------------------------

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:
     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.
     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.
     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

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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:
     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.
     Inspection could be reasonably likely to endanger the life 
or physical safety of the patient or anyone else.
     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.
     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.
     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.
     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.
    The third standard, Privacy and Safety, has been changed so that 
``personal privacy'' and ``receive care in a safe setting'' could be 
made into two separate elements under this standard as requested by 
commenters. The final regulation states that ``The patient has the 
right to personal privacy,'' and, ``The patient has the right to 
receive care in a safe setting.'' We have altered the requirement that 
the patient has the right to be free from verbal or physical abuse and 
harassment to state that the patient has the right to be free from all 
forms of abuse or harassment.
    The fourth standard, Confidentiality and Patient Records, contains 
the provisions of the proposed rule; specifically, the right to the 
confidentiality of his or her record and the right to access 
information contained in his or her clinical records within a 
reasonable time frame. To this standard, we have added a requirement 
stating that the hospital must not frustrate the legitimate efforts of 
individuals to gain access to their own medical records and must 
actively seek to meet these requests as quickly as its recordkeeping 
system permits.
    The fifth standard, Restraint for Acute Medical and Surgical Care, 
codifies the patient's right to be free from both physical restraints 
and drugs that are used as a restraint that are not medically necessary 
or are used as a means of coercion, discipline, convenience, or 
retaliation by staff. The rule defines ``restraint,'' ``physical 
restraint,'' and ``drug used as a restraint.'' In accordance with 
commenters' suggestions, we removed the term ``psychopharmacological'' 
from the standard to acknowledge that a wide range of drugs may be used 
as a restraint.
    The regulation states that a restraint can only be used when less 
restrictive interventions have been determined to be ineffective. It 
also acknowledges the ability of licensed independent practitioners 
authorized by the State and the hospital to write orders for 
restraints. The regulation states that the patient's treating physician 
must be contacted, as soon as possible, if the restraint is not ordered 
by the patient's treating physician. We have added language that 
mandates that restraints must never be written as a standing order, or 
on an as needed basis (that is, PRN). The final rule states that 
restraint use must be in accordance with a written modification to the 
patient's plan of care; in the least restrictive manner possible; in 
accordance with safe and appropriate restraining techniques; and 
selected only when other less restrictive measures have been found to 
be ineffective to protect the patient or others from harm. The standard 
regarding restraint use related to acute medical and surgical care also 
requires that the condition of the patient in restraints must be 
continually assessed, monitored, and reevaluated; the restriction of 
patient movement or activity by restraints be ended at the earliest 
possible time; and all direct care staff must have ongoing education 
and training in the proper and safe use of restraints.
    The last standard, Seclusion and Restraint for Behavior Management, 
contains many of the same elements stated in the fifth standard 
(related to restraints used in acute medical and surgical care) but 
goes further by discussing the use of seclusion and provides specific 
requirements for the monitoring and evaluation of a secluded or 
restrained patient for behavior management.
    This standard provides that seclusion or restraint for behavior 
management can only be used in emergency situations if it is needed to 
ensure the patient's physical safety, and less restrictive 
interventions have been

[[Page 36085]]

determined to be ineffective. This standard also provides that 
seclusion or restraint use must be in accordance with the order of a 
physician or other licensed independent practitioner who is permitted 
by the State and hospital to order seclusion or restraint use. It also 
requires that the patient's treating physician be consulted, as soon as 
possible, if the restraint or seclusion is not ordered by the patient's 
treating physician. The final rule also states explicitly that the 
requirement for restraint or seclusion use for behavior management will 
be superseded by existing State laws that are more restrictive.
    This standard provides that seclusion or restraints may not be 
ordered on a standing or PRN basis. The regulation requires a physician 
or other licensed independent practitioner to see and evaluate the need 
for restraint or seclusion within 1 hour after the initiation of this 
intervention.
    The final rule sets limits for each written order for physical 
restraints or seclusion based on a patient's age. For adults, the 
written order is limited to 4 hours; for children and adolescents (age 
9-17), the written order is limited to 2 hours; for patients under age 
9, the written order is limited to 1 hour. The final rule states that 
the original order may only be renewed for up to a total of 24 hours. 
After the original order expires, a physician or licensed independent 
practitioner (if permitted by State law) must see and assess the 
patient before issuing a new order.
    The final rule states that any restraint or seclusion use must be 
in accordance with a written modification to the patient's plan of 
care, implemented in the least restrictive manner possible, in 
accordance with appropriate restraining techniques, and selected only 
when less restrictive measures have been found to be ineffective to 
protect the patient or others from harm.
    The standard discusses restraints and seclusion used in 
combination, and provides that they may not be used simultaneously 
unless the patient is continually visually monitored, in person, by an 
assigned staff member, or is continually monitored by staff by audio 
and video equipment. This audio and video monitoring must occur in 
close proximity to the patient. It also states that the condition of 
the patient who is in restraints or seclusion must continually be 
assessed, monitored, and reevaluated and that the restriction of 
patient movement or activity by seclusion or restraint use must be 
ended at the earliest possible time.
    The rule also requires that all staff who have direct patient 
contact have ongoing training in both the proper and safe use of 
seclusion and restraints and alternative techniques and methods for 
handling the behaviors, symptoms, and situations that traditionally 
have been treated through restraint and seclusion. While we are not 
detailing the sorts of behaviors, symptoms, and situations here, we 
plan to further describe them in the interpretive guidelines that will 
implement this regulation.
    Finally, the regulation requires the 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 a result 
of restraint or seclusion.

VI. Regulatory Impact Statement

A. Overall Impact

    We have examined the impact of this rule as required by Executive 
Order (E.O.) 12866 and the Regulatory Flexibility Act (RFA) (Public Law 
96-354). E.O. 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits, including 
potential economic, environmental, public health and safety effects, 
distributive impacts, and equity.
    The RFA (5 U.S.C. 601 through 612) requires agencies to analyze 
options for regulatory relief for small entities. Consistent with the 
RFA, we prepare a regulatory flexibility analysis unless we certify 
that a rule will not have a significant economic impact on a 
substantial number of small entities. For purposes of the RFA, we treat 
most hospitals and most other providers, physicians, health care 
suppliers, carriers, and intermediaries as small entities, either by 
nonprofit status or by having revenues of $5 million or less annually. 
Individuals and States are not included in the definition of a small 
entity.
    Also, section 1102(b) of the Act requires us to prepare a 
regulatory impact analysis if a rule may have a significant impact on 
the operations of a substantial number of small rural hospitals. That 
analysis must conform to the provisions of section 604 of the RFA. For 
purposes of section 1102(b) of the Act, we define a small rural 
hospital as a hospital that is located outside of a Metropolitan 
Statistical Area and has fewer than 50 beds. Although the provisions of 
this interim final rule with comment do not lend themselves to a 
quantitative impact estimate, we do not anticipate that they would have 
a substantial economic impact on most Medicare-participating hospitals. 
However, to the extent the rule may have significant effects on 
providers or beneficiaries, or be viewed as controversial, we believe 
it is desirable to inform the public of our projections of the likely 
effects of the proposals.
    The Unfunded Mandates Reform Act of 1995 requires (in section 202) 
that agencies prepare an assessment of anticipated costs and benefits 
for any rule that may result in an annual mandated expenditure by 
State, local, and tribal governments, in the aggregate or by both the 
private sector, of $100 million. This rule has no mandated 
consequential effect on State, local, or tribal governments, or the 
private sector and will not create an unfunded mandate.
    In December 1997, we proposed to revise all of the hospital CoPs in 
concert with Vice President Gore's 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 to place a stronger emphasis on quality assessment and 
performance improvement.
    Within this newly revised CoP, we proposed the establishment of a 
Patients' Rights CoP for hospitals that contains rights not addressed 
in the current provisions. We solicited comments on the Patients' 
Rights CoP and received strong support for its establishment. There was 
consensus among the public, mental health advocacy groups, media, and 
the Congress that we should move toward establishing such a CoP. This 
consensus was prompted by serious concern about improper care of 
patients in the hospital setting, with regard to all aspects of patient 
care, including the use of seclusion and restraint. These factors led 
us to set forth this final rule with comment to ensure the protections 
of patients' rights in the hospital setting, including the right to be 
free from the use of seclusion and restraint. We believe that this 
regulation will broaden the consumer's role in safeguarding and 
participating in his or her care.
    Consumer protections are of vital importance in the hospital 
setting. The recent focus of efforts such as the formulation of the 
Consumer Bill of Rights and Responsibilities points to the public 
acknowledgment of the important role that each individual is called 
upon to play in his or her care. We believe that Medicare CoPs must 
foster each individual's rights as an informed consumer and decision 
maker. Accordingly, we are promoting the

[[Page 36086]]

concepts in the Consumer Bill of Rights and Responsibilities, and we 
are asking the public for comments on incorporating additional consumer 
rights into the hospital CoPs in order to promote compliance with the 
Consumer Bill of Rights.

B. Anticipated Effects

1. Effect on Hospitals
    Since the Patients' Rights CoP set forth below is a newly 
established CoP, we have no factual reports, studies, or data to aid in 
the development of cost or savings estimates. However, we believe most 
hospitals are already fulfilling many of the requirements of this 
regulation due to State requirements, and hospital policies and 
procedures, especially existing policies and procedures to meet the 
Life Safety Code and Physical Environment requirements of the current 
hospital CoP, which cover safe environment issues. Therefore, there may 
be no significant increase in burden to most hospitals.
    Given the shift toward regulatory flexibility, for the most part, 
we are not prescribing the exact process hospitals must follow to meet 
the regulatory requirements regarding Patients' Rights. However, there 
are several provisions that will impact hospitals to a greater or 
lesser degree. Specifically, hospitals will have to establish policies 
and procedures necessary for compliance with this regulation: 
notification of rights, exercise of rights, privacy and safety, 
confidentiality, and patient access to records. Hospitals will have to 
develop a grievance process and ensure that staff are provided with 
ongoing education and training in the proper and safe use of seclusion 
and restraint application and techniques and alternative methods for 
handling behavior, symptoms, and situations that traditionally were 
treated through the use of restraints or seclusion. In addition, 
hospitals will have to report to the appropriate HCFA regional office 
any deaths that result from restraint or seclusion use for behavior 
management.
    Regarding the grievance process, hospitals may use different 
approaches to effectively meet this CoP. We are setting forth the 
general elements that should be common to grievance processes across 
all hospitals, but we are not explicitly delineating strategies and 
policies to comply with the requirement. Also, we are setting forth 
more detailed, prescriptive requirements than were contained in the 
proposed rule for the use of seclusion and restraint for behavior 
management situations. Despite the potential burden associated with the 
implementation of some portions of this regulation, we believe that by 
recognizing and attending to patients' rights, hospitals may find 
improvements in patient collaboration and satisfaction with care, a 
reduction of patient-initiated lawsuits regarding care, and through the 
hospital's own grievance process, find a wealth of information to guide 
quality improvement efforts.
    We expect hospitals to develop different approaches to compliance 
with the Patients' Rights CoP based on their varying resources and 
patient populations, differences in laws in various localities, and 
other factors. However, even in situations where the regulation could 
result in some immediate costs to an individual hospital (that is, 
developing and implementing a process to notify patients of their 
rights and allow patients to exercise their rights), we believe that 
the changes that the hospital would make would produce real long-term 
economic benefits to the hospital (that is, a reduction in lawsuits). 
It is important to note that because of the flexibility afforded 
hospitals to implement this regulation, the extent of the economic 
impact on individual hospitals will vary and is subject in large part 
to their decision-making. The impact will also vary according to each 
hospital's current policies and procedures and level of compliance with 
existing State law and regulations.
    Overall, we believe that the benefits of complying with the 
Patients' Rights CoP will far outweigh the costs involved. We also note 
that with regard to the restraint and seclusion standards for both 
acute medical and surgical care and behavior management, there should 
be no significant additional burden for, at least, the 80 percent of 
Medicare-participating hospitals accredited by JCAHO since the 
requirements are modeled on JCAHO's standards for both their hospital 
accreditation program and their behavioral health care accreditation 
program. For the other 20 percent of hospitals that are nonaccredited, 
there may be some one-time costs associated with developing policies 
and procedures for restraint and seclusion use. However, we believe 
that the benefits far outweigh the costs because, from a risk 
management viewpoint, clear policies will protect the hospital from 
situations of inappropriate restraint and seclusion use and situations 
that may lead to patient injuries and death. There may be costs 
associated with developing training programs for staff regarding 
restraint and seclusion use and alternative interventions; however, we 
are not dictating how a hospital meets this requirement. Therefore, 
hospitals will be afforded the flexibility of deciding how to meet this 
requirement (for example, provide the training directly through ``in-
house'' training, obtain a contractor to provide the training either at 
the hospital or off-site, etc.). We believe that the benefits 
associated with training staff far outweigh the costs involved since 
proper training will protect the hospital from situations of 
inappropriate restraint and seclusion use and situations that may lead 
to patient injuries and death.
    Finally, hospitals will have to report to HCFA, through the 
appropriate HCFA regional office, any deaths that result from restraint 
or seclusion use for behavior management. We believe that the number of 
deaths related to restraint or seclusion use may be under reported in 
the United States; however, we have no concrete estimate of the number 
of deaths that occur per year. 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 and restraint use in behavioral health 
treatment facilities over the past 10 years. However, this number 
includes deaths from seclusion and restraint use in more than just the 
hospital setting. There may be a small cost involved in making a 
telephone call to the HCFA regional offices; however, because we expect 
this regulation to reduce the number of deaths from restraint and 
seclusion use, the number of reports certainly will average less than 
one call per hospital per year. Therefore, we think the cost will be 
negligible.
2. Effect on Beneficiaries
    The implementation of the Patients' Rights CoP will serve to 
protect not only Medicare and Medicaid beneficiaries but all patients 
receiving care in any of the 6,163 (4,734 accredited and 1,429 
nonaccredited) Medicare-participating hospitals (that is, short-term, 
psychiatric, rehabilitation, long-term, children's, and alcohol-drug), 
including small rural hospitals. Our goal is to safeguard against the 
mistreatment of all patients in these facilities including, but not 
limited to, deaths due to inappropriate seclusion and restraint use, 
violation of patients' privacy and confidentiality in various aspects 
of the health care delivery process, and systematic frustration of the 
patient's efforts to acquire his or her medical record. We believe the 
patient will benefit from the hospital's focus on patients' rights. 
Through these

[[Page 36087]]

protections, patient care can be delivered in an atmosphere of respect 
for an individual patient's comfort, dignity, and privacy. We also 
believe that implementation of the Patients' Rights CoP will lead to a 
reduction in the numbers of restraint-related injuries and deaths in 
hospitals.
3. Effect on Medicare and Medicaid Programs
    We do not expect the implementation of the new Patients' Rights CoP 
to generate any significant cost to the Medicare or Medicaid programs. 
Also, we do not believe there will be any additional costs to the 
survey and certification program as compliance with this new CoP will 
either be reviewed through a routine, nonaccredited hospital survey, 
validation survey or as part of the existing complaint survey process 
for hospitals.

C. Alternatives Considered

    We considered adding more prescriptive requirements regarding 
exactly where, how, when, and by whom ``notification of rights'' must 
be carried out. However, in the interest of flexibility and the 
recognition that this requirement will apply to hospitals of varying 
size, operating in wide ranges of localities, serving diverse 
populations, we did not adopt this approach. We considered very general 
regulations text language addressing the establishment of a hospital 
grievance process. However, based on public comment, we decided that 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. We believe that the establishment of a grievance process 
promotes patient empowerment in health care. To promote the creation of 
an effective grievance process, 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.
    We originally considered developing one set of very general 
requirements regulating restraint and seclusion use in all hospitals 
for all situations. However, based on public comments and recent 
concerns about restraint and seclusion use for behavior management 
situations, we concluded that one set of requirements did not afford 
patients with adequate protections. In addition, we noted that JCAHO 
has more prescriptive standards for behavioral health care 
accreditation than for hospital accreditation.
    We considered recognizing only physicians as the individuals able 
to order restraints or seclusion. However, in recognizing that 
licensure and scope of practice are within a State's domain, and 
considering that other types of licensed independent practitioners 
provide a great deal of care in rural and frontier areas, we did not 
adopt that approach. However, we are requesting comment on whether we 
should adopt more restrictive requirements that would allow only 
physicians to order restraints or seclusion for behavior management.
    Regarding the time frames in which a physician or licensed 
independent practitioner must see and assess a patient after initiation 
of restraints or seclusion for behavior management, we considered 
adopting the Pennsylvania Office of Mental Health policy of a \1/2\ 
hour time frame. However, we recognized that this requirement might not 
be realistic for rural or frontier areas where it may be impossible to 
get a physician or licensed independent practitioner to the hospital in 
\1/2\ hour. Therefore, we propose a 1 hour time frame and ask the 
public for comment.
    We considered adopting more restrictive requirements for the 
maximum time frames for the length of an order for restraint and 
seclusion. However, since there was no supporting literature or 
studies, we decided to adopt the approach and time frames developed and 
articulated by JCAHO for its hospital accreditation and behavioral 
health care accreditation programs. These standards were developed by 
experts from the health care field and represent consensus on the 
approach and time frames for issues of seclusion and restraints. In 
addition, 80 percent of the Medicare- and Medicaid-participating 
hospitals are already subject to these requirements. Therefore, we 
believe it is reasonable to adopt requirements similar to those of 
JCAHO.

D. Conclusion

    The new Patients' Rights CoP for hospitals 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 (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 of his or her records; (5) freedom from restraints used 
in the provision of acute medical and surgical care unless clinically 
necessary; and (6) freedom from seclusion and restraints used in 
behavior management unless clinically necessary. The Patients' Rights 
CoP is a new requirement for hospitals. Therefore, we have prepared a 
voluntary analysis consistent with the analysis set forth by the RFA. 
We solicit public comments on the extent that any of the entities would 
be significantly economically affected by these provisions.

VII. Collection of Information Requirements

    Under the Paperwork Reduction Act (PRA) of 1995, agencies are 
required to provide 60-day notice in the Federal Register and solicit 
public comment before a collection of information requirement is 
submitted to the Office of Management and Budget (OMB) for review and 
approval. In order to fairly evaluate whether an information collection 
should be approved, section 3506(c)(2)(A) of the PRA requires that we 
solicit comment on the following issues:
     Whether the information collection is necessary and useful 
to carry out the proper functions of the agency;
     The accuracy of the agency's estimate of the information 
collection burden;
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    Therefore, we are soliciting public comment on each of these issues 
for the information collection requirements summarized and discussed 
below.

Section 482.13 Condition of Participation: Patients' Rights

    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 patient care whenever possible.
    We anticipate that a hospital will provide a single ``Notice of 
Patients'' Rights'' to each patient or his or her representative at the 
time of admission. As referenced in this regulation the disclosure 
notice must inform each patient of his or her right to (1) File a 
grievance and whom the patient can contact to file a grievance; (2) 
participate in the development and implementation of his or her plan of 
care; (3) make decisions regarding his or her care; (4) be informed of 
his or her status, involved in care planning and treatment, and the 
ability to refuse treatment; (5) formulate advance directives and to 
have hospital staff and practitioners who provide care in the hospital 
comply with these directives, in accordance with Sec. 489.100, 
Sec. 489.102, and Sec. 489.104; (6) personal privacy; (7)

[[Page 36088]]

receive care in a safe setting, free from verbal or physical abuse or 
harassment; (8) confidentiality of his or her clinical records and the 
ability to access information contained in his or her clinical records 
within a reasonable time frame; and (9) be free from restraints and 
seclusion of any form used as a means of coercion, discipline, 
convenience, or retaliation by staff.
    The burden associated with this requirement is the time and effort 
necessary to disclose the notice requirements referenced above to each 
patient. We estimate that on average it will take each of the 6,097 
estimated hospitals 8 hours to develop the required notice and that it 
will take each hospital 5 minutes to provide each notice, with an 
average of 5,515 notices provided per hospital on an annual basis. 
Therefore, the total annual burden associated with this requirement is 
2,850,801 hours.
    In its resolution of the grievance, a hospital must provide the 
patient with written notice of its decision that contains the name of 
the hospital contact person, the steps taken on behalf of the patient 
to investigate the grievance, the results of the grievance process, and 
the date of completion.
    The burden associated with this requirement is the time and effort 
necessary to disclose the written notice to each patient who filed a 
grievance. We estimate that on average it will take each hospital 15 
minutes to develop and disseminate the required notice. We further 
estimate that 6,097 hospitals will provide 55 notices on an annual 
basis, a total annual burden of 83,834 hours.
    Hospitals will have to report to HCFA, through the appropriate HCFA 
regional office, any deaths that result from restraint or seclusion use 
for behavior management. The burden associated with this requirement is 
for hospitals to notify HCFA, via telephone call, of any deaths. Based 
upon current data, we estimate the number of reports to average less 
than 10 calls on an annual basis. Therefore, this requirement is not 
subject to the PRA, as defined under 5 CFR 1320.3(c).
    Hospitals must maintain documentation that each of the standards 
and related requirements referenced in this regulation have been met. 
While this requirement is subject to the PRA, we believe that the 
burden associated with this requirement is exempt from the PRA, as 
defined in 5 CFR 1320.3(b)(2) and 1320.3(b)(3) because this requirement 
is considered a usual and customary business practice; is required 
under State or local law; and is used to satisfy accreditation 
requirements.
    We have submitted a copy of this final rule to OMB for its review 
of the information collection requirements in Sec. 482.13. These 
requirements are not effective until they have been approved by OMB.
    If you have any comments on any of these information collection and 
recordkeeping requirements, please mail the original and three copies 
directly to the following:

Health Care Financing Administration, Office of Information Services, 
Standards and Security Group, Division of HCFA Enterprise Standards, 
Room N2-14-26, 7500 Security Boulevard, Baltimore, MD 21244-1850, Attn: 
John Burke HCFA-3018-IFC.

    and

Office of Information and Regulatory Affairs, Office of Management and 
Budget, Room 10235, New Executive Office Building, Washington, DC 
20503, Attn: Allison Eydt, HCFA Desk Officer.

List of Subjects in 42 CFR Part 482

    Grant programs--health, Health facilities, Medicaid, Medicare, 
Reporting and recordkeeping requirements.
    For the reasons set forth in the preamble, 42 CFR chapter IV, part 
482 is amended as follows:

PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS

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

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

Subpart B--Administration

    2. Section 482.13 is added to subpart B to read as follows:


Sec. 482.13  Condition of participation: Patients' rights.

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

[[Page 36089]]

frustrate the legitimate efforts of individuals to gain access to their 
own medical records and must actively seek to meet these requests as 
quickly as its recordkeeping system permits.
    (e) Standard: Restraint for acute medical and surgical care. (1) 
The patient has the right to be free from restraints of any form that 
are not medically necessary or are used as a means of coercion, 
discipline, convenience, or retaliation by staff. The term 
``restraint'' includes either a physical restraint or a drug that is 
being used as a restraint. A physical restraint is any manual method or 
physical or mechanical device, material, or equipment attached or 
adjacent to the patient's body that he or she cannot easily remove that 
restricts freedom of movement or normal access to one's body. 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.
    (2) A restraint can only be used if needed to improve the patient's 
well-being and less restrictive interventions have been determined to 
be ineffective.
    (3) The use of a restraint must be--
    (i) Selected only when other less restrictive measures have been 
found to be ineffective to protect the patient or others from harm;
    (ii) In accordance with the order of a physician or other licensed 
independent practitioner permitted by the State and hospital to order a 
restraint. This order must--
    (A) Never be written as a standing or on an as needed basis (that 
is, PRN); and
    (B) Be followed by consultation with the patient's treating 
physician, as soon as possible, if the restraint is not ordered by the 
patient's treating physician;
    (iii) In accordance with a written modification to the patient's 
plan of care;
    (iv) Implemented in the least restrictive manner possible;
    (v) In accordance with safe and appropriate restraining techniques; 
and
    (vi) Ended at the earliest possible time.
    (4) The condition of the restrained patient must be continually 
assessed, monitored, and reevaluated.
    (5) All staff who have direct patient contact must have ongoing 
education and training in the proper and safe use of restraints.
    (f) Standard: Seclusion and restraint for behavior management. (1) 
The patient has the right to be free from seclusion and restraints, of 
any form, imposed as a means of coercion, discipline, convenience, or 
retaliation by staff. The term ``restraint'' includes either a physical 
restraint or a drug that is being used as a restraint. A physical 
restraint is any manual method or physical or mechanical device, 
material, or equipment attached or adjacent to the patient's body that 
he or she cannot easily remove that restricts freedom of movement or 
normal access to one's body. 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. Seclusion is the involuntary confinement of a 
person in a room or an area where the person is physically prevented 
from leaving.
    (2) Seclusion or a restraint can only be used in emergency 
situations if needed to ensure the patient's physical safety and less 
restrictive interventions have been determined to be ineffective.
    (3) The use of a restraint or seclusion must be--
    (i) Selected only when less restrictive measures have been found to 
be ineffective to protect the patient or others from harm;
    (ii) In accordance with the order of a physician or other licensed 
independent practitioner permitted by the State and hospital to order 
seclusion or restraint. The following requirements will be superseded 
by existing State laws that are more restrictive:
    (A) Orders for the use of seclusion or a restraint must never be 
written as a standing order or on an as needed basis (that is, PRN).
    (B) The treating physician must be consulted as soon as possible, 
if the restraint or seclusion is not ordered by the patient's treating 
physician.
    (C) A physician or other licensed independent practitioner must see 
and evaluate the need for restraint or seclusion within 1 hour after 
the initiation of this intervention.
    (D) Each written order for a physical restraint or seclusion is 
limited to 4 hours for adults; 2 hours for children and adolescents 
ages 9 to 17; or 1 hour for patients under 9. The original order may 
only be renewed in accordance with these limits for up to a total of 24 
hours. After the original order expires, a physician or licensed 
independent practitioner (if allowed under State law) must see and 
assess the patient before issuing a new order.
    (iii) In accordance with a written modification to the patient's 
plan of care;
    (iv) Implemented in the least restrictive manner possible;
    (v) In accordance with safe appropriate restraining techniques; and
    (vi) Ended at the earliest possible time.
    (4) A restraint and seclusion may not be used simultaneously unless 
the patient is--
    (i) Continually monitored face-to-face by an assigned staff member; 
or
    (ii) Continually monitored by staff using both video and audio 
equipment. This monitoring must be in close proximity the patient.
    (5) The condition of the patient who is in a restraint or in 
seclusion must continually be assessed, monitored, and reevaluated.
    (6) All staff who have direct patient contact must have ongoing 
education and training in the proper and safe use of seclusion and 
restraint application and techniques and alternative methods for 
handling behavior, symptoms, and situations that traditionally have 
been treated through the use of restraints or seclusion.
    (7) The hospital must report to HCFA 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 a result of restraint or seclusion.

    (Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare Hospital Insurance; Program No. 93.778, Medical Assistance 
Program)

    Dated: May 24, 1999.
Nancy-Ann Min DeParle,
Administrator, Health Care Financing Administration.

    Approved: June 9, 1999.
Donna E. Shalala,
Secretary.
[FR Doc. 99-16543 Filed 6-24-99; 4:29 pm]
BILLING CODE 4120-01-P