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

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

[[Page 36072]]

to provide nursing care to all patients as needed (see Sec. 482.23,

Condition of participation: Nursing services), one could argue that the

patient is thereby afforded the right to receive adequate nursing

services and care. Or, since the hospital is required to have dietary

menus that meet the needs of the patients (see Sec. 482.28, Condition

of participation: Food and dietetic services), the patient has the

right to a diet that meets his needs.

We considered an approach that would have grouped all conceivable

patients' rights within this CoP; however, the practical value of this

approach is questionable as these elements are codified elsewhere, and

an approach that attempts to be all-inclusive often inadvertently omits

key elements. We believe that it suffices to say that we expect the

hospital to honor and promote all of the rights and protections that

Federal law and the hospital CoPs offer. The rights codified by this

rule either do not appear elsewhere, or, as evidenced by reports,

require a special emphasis.

II. Legislation

Sections 1861(e) (1) through (8) of the Act define the term

``hospital'' and list the requirements that a hospital must meet to be

eligible for Medicare participation. Section 1861(e)(9) of the Act

specifies that a hospital must also meet such other requirements as the

Secretary finds necessary in the interest of the health and safety of

the hospital's patients. Under this authority, the Secretary has

established in regulations at 42 CFR part 482 the requirements that a

hospital must meet to participate in Medicare.

Section 1905(a) of the Act provides that Medicaid payments may be

applied to hospital services. Regulations at Sec. 440.10(a)(3)(iii)

require hospitals to meet the Medicare CoPs to qualify for

participation in Medicaid.

III. Provisions of the Proposed Regulations

In our December 19, 1997 proposed rule, we proposed revision of the

Medicare hospital CoPs in concert with Vice President Gore's

Reinventing Government (REGO) initiative. The REGO initiative

emphasized lessening Federal regulation to eliminate unnecessary

structural and process requirements, focus on outcomes of care, allow

greater flexibility to hospitals and practitioners to meet quality

standards, and place a strong emphasis on quality assessment and

performance improvement.

In the proposed rule, we proposed setting forth a new Patients'

Rights CoP in Medicare- and Medicaid-participating hospitals. The

provisions of this CoP set forth minimum protections and promote

patients' rights, including an individual's right to--(1) notification

of his or her rights; (2) the exercise of his or her rights in regard

to his or her care; (3) privacy and safety; (4) confidentiality; and

(5) freedom from the use of seclusion or restraint of any form unless

clinically necessary. In the preamble, we solicited comments on a more

prescriptive approach to the use of restraints and seclusion and

provided relevant examples.

Although we proposed codifying the new Patients' Rights CoP as

Sec. 482.10, in the final rule it is designated as Sec. 482.13 to

coordinate with the numbering system used in the current regulations.

When the remaining hospital CoPs are finalized, we will renumber the

standards in part 482.

Our commitment to the revision of the remaining hospital CoPs to

focus on patient-centered, outcome-oriented care remains unchanged. We

continue to work on analysis of the over 60,000 comments received on

the proposed rule and will finalize the remaining hospital CoPs in the

future.

IV. Comments and Responses

Of the 60,000 comments received on the December 1997 proposed rule,

approximately 300 focused on the Patients' Rights CoP. Comments were

received from hospitals, mental health treatment facilities,

professional associations, accrediting bodies, SAs, patient advocacy

groups, and members of the general public. Half of the comments, and

the strongest opposition, came in response to the proposed fifth

standard under Patients' Rights--seclusion and restraints. While many

of the respondents did not favor prescriptive regulations that extended

beyond the proposed regulations text, some welcomed more prescriptive

language under the standard for seclusion and restraints.

A summary of the comments received on the five standards, major

issues, and our responses follows.

A. Notice of Rights

We proposed that a hospital must inform each patient of his or her

rights in advance of furnishing care and that the hospital must have a

grievance process and indicate who the patient can contact to express a

grievance.

Comment: Commenters indicated that what constitutes sufficient

notification needs to be clarified. One commenter stated this

requirement should be satisfied by providing written displays of

patients' rights in the hospital lobby and in each patient's room, and

in verbal or written form with initial and additional information

included in the admission packet.

Response: We appreciate the suggestions of how and where patients'

rights should be displayed or conveyed. However, hospitals will need

flexibility to establish policies and procedures that effectively

ensure that patients and their representatives have the information

necessary to exercise their rights. These policies and procedures will

need to address how, where, and when to notify patients of the full

gamut of rights to which they are entitled under the Act. As hospitals

assess the effectiveness of their proactive notification techniques,

they need flexibility to continuously improve their performance in

promoting patients' rights.

This CoP covers hospitals of varying sizes operating in a wide

range of locations, serving diverse populations, with a variety of

required notices; thus, flexibility and creativity to allow for the

effective implementation of this requirement without undue burden is

critical. Therefore, we are not including further prescriptive language

detailing exactly where, how, when, and by whom this requirement must

be carried out.

While we are committed to preserving flexibility on this point, we

note that one method for efficiently handling aspects of this

requirement may be to bundle notices with the existing information that

must be provided to patients to fulfill Civil Rights requirements. The

regulations implementing title VI of the Civil Rights Act of 1964,

section 80.6(d), section 504 of the Rehabilitation Act of 1973 (45 CFR

84.8), and the Age Discrimination Act of 1975, section 91.32, require

recipients of financial assistance from the DHHS to provide notice of

their responsibility to comply with the appropriate nondiscrimination

provisions and other pertinent requirements of the Office for Civil

Rights. For a hospital that falls under this requirement, some

patients' rights notices could be effectively posted next to these

nondiscrimination notices. For some of the educational notices the

patient will receive as part of the new Patients' Rights CoP, this

public posting may be appropriate.

Comment: One commenter believed that the standards in the Patients'

Rights CoP are generally reflected in common hospital practice;

however, she objected to the general language that appeared at the

beginning of the condition; specifically, the phrase, ``A hospital must

protect and promote each patient's rights.'' This commenter was

concerned

[[Page 36073]]

that the wording would be presented in isolation to juries during

medical malpractice cases, and that it would be used to cover all legal

and ethical rights. The commenter noted that a hospital staff person

could not know or be responsible for providing this degree of

information. The commenter suggested that the language be amended to

read, ``A hospital is responsible to have policies and procedures in

place which protect and promote the patient's rights as reflected in

the following standards.''

Response: As stated earlier, we do expect the hospital to honor and

promote each patient's rights, regardless of whether they appear in the

Patients' Rights CoP. With respect to the commenter's concern that this

statement will be taken in isolation and used in medical malpractice

cases, we do not want to provide a foothold for frivolous cases. With

that said, however, it could very well be that a patient who brings

suit against a provider has a legitimate cause for concern or complaint

because that provider failed to acknowledge his or her rights as

established under these regulations. Such a case would generally

require some substantiation and elaboration on specifically which right

the provider failed to uphold. We are not persuaded that this language

opens up an otherwise closed avenue for pursuing legal action.

Accordingly, we are retaining this language.

Comment: One commenter noted that enumeration of the patient's

rights is of little use if his or her only recourse is a grievance

process that is controlled by the hospital. This commenter suggested

adding a requirement that the patient also be notified that he or she

could lodge a complaint with the State survey agency either after or

during the course of the hospital stay, regardless of whether the

patient decided to file a grievance with the hospital's system.

Response: The patient's right to file a complaint with or contact

the accreditation body or the State to report an infraction on these

rights is implicit; therefore, we do not believe it is necessary to add

this to the regulations text. To address the commenter's concern,

however, we will specify in the interpretive guidelines that patient

notification of the grievance process must include the fact that the

patient also may address his or her concerns to the State survey

agency, regardless of whether he has first used the hospital's

grievance process. Patients or residents of all Medicare-certified

facilities have always had the ability to lodge complaints about the

quality of care they receive with the State survey agency or HCFA, and

nothing in this rule alters this opportunity. We will further specify

that the patient be given a phone number and address for lodging a

complaint with the SA.

Comment: Some commenters stated the proposed rule should account

for the fact that in certain situations, the patient's age, condition,

health problem, and emergency situation will inhibit the hospital's

ability to notify the patient of his or her rights before the provision

or discontinuation of care. Commenters believed that the rule should

free hospital personnel from the responsibility of informing the

patient of his or her rights if he or she is experiencing an emergency

medical condition, is unconscious, or is at the hospital for a brief

outpatient encounter.

Response: A hospital should make every effort to inform the patient

of his or her rights before care provision or cessation of care.

However, in some instances a patient's age, condition, health problem,

or emergency situation does not allow the opportunity to communicate

with the patient regarding his or her rights. For this reason, we are

adding language to allow the hospital to communicate these rights to

the patient's representative (as allowed under State law). In the

absence of State law to cover particular health care decisions, the

hospital may also communicate these rights to a legal representative

whom the patient has appointed as an ``ad hoc'' decision maker in the

event of temporary inability to make health care decisions. We still

expect that as soon as the patient can be informed of his or her

rights, the hospital will provide that information to the patient.

Comment: Some commenters stated that this discussion should be

tailored to the patient's level of understanding or communication needs

by using alternate means of communication (for example, audiotape,

radio, sign language, and Braille, or other culturally competent

vehicles), as necessary.

Response: Existing civil rights legislation (section 504 of the

Rehabilitation Act of 1973 and the Americans with Disabilities Act

(ADA)) emphasize the provision of effective aids, benefits, or services

to individuals with disabilities. The ADA defines auxiliary aids and

services as including qualified interpreters, notetakers, transcription

services, written materials, telephone handset amplifiers, assistive

listening devices, assistive listening systems, telephones compatible

with hearing aids, closed captioning, telecommunications devices for

deaf persons, videotext displays, or other effective methods of making

aurally delivered materials available to individuals with hearing

impairments; and qualified readers, taped texts, audio recordings,

Brailled materials, large print materials, or other effective methods

of making visually delivered materials available to individuals with

visual impairments. Title VI of the Civil Rights Act of 1964 also

requires recipients of certain public funds to serve persons who are

``Limited English Proficient'' (LEP). Translation of LEP documents, use

of bilingual staff, and provision of interpreters are usually used to

convey necessary information to LEP persons.

While we recognize the value of appropriate communication

techniques, we do not offer further regulation in this area since

existing laws ensure that appropriate attention will be given to

providing information to those who require special accommodation based

on their special needs.

Comment: Some commenters believed that the proposed rule needed to

further define the patient's role and responsibility when being

informed of his or her medical condition and that the standard should

place more emphasis on discussion of prevention of complications and

rehospitalization.

Response: The Patients' Rights CoP upholds the patient's right to

full, informed involvement in his or her care. Under circumstances

defined by State law, this right may also be exercised by the patient's

legal representative on his or her behalf. We recognize that

involvement in the plan of care and the choice of treatment option may

be open to interpretation. We would like to clarify that this right to

involvement in health care decisions cannot be equated with the ability

to demand medically unnecessary treatments or care. The patient has the

right to be informed of his or her status, to be involved in care

planning and treatment, and to request and refuse treatment. The

patient should be consulted about changes in care and treatment. Issues

arising out of patient dissatisfaction with the hospital's response may

be dealt with under the hospital's grievance process required under

Sec. 482.13(a); however, the patient may choose to lodge a complaint

with the SA or accrediting body in addition to or instead of using the

hospital's grievance system.

We agree that the patient's health and well-being are most likely

affected by the degree of collaboration between the patient and

physician. The patient should make every effort to bring medical

problems to the attention of the physician in a timely fashion, provide

information about his or her medical condition to the best of his or

her knowledge, and work in a mutually respectful manner with the

physician.

[[Page 36074]]

However, the patient's physical, mental, psychological, and emotional

status may directly affect his or her ability to offer this degree of

cooperation.

Comment: A commenter stated that a member of the interdisciplinary

treatment team should document (in the medical record) that the

patient's rights have been reviewed with the patient and whether the

patient or his or her legal representative comprehends the information

covered. A few commenters stated that social workers should notify

patients of their rights at the time of the intake or screening

interview.

Response: All of these suggestions have potential merit. However,

as stated above, we believe it is necessary to provide the hospital

with flexibility in developing policies and procedures that fulfill the

requirement's intent, that is, to ensure that each patient's rights are

protected.

Comment: A few commenters believed that no further details should

be included in the regulation as more detail would add an unnecessary

paperwork burden during the admission process while not guaranteeing

improved quality of patient care.

Response: We have mandated neither the process that a hospital must

use nor the extent to which these rights must be discussed as part of

the admission process. In some cases, notification of these rights must

occur later in the hospital stay to ensure that the patient's rights

are protected. Hospitals will have the flexibility and accountability

to determine how they can best ensure the protection of patients'

rights.

Comment: A few commenters stated that the patient should be

informed of the credentials, licensure, and professional

qualifications, including certifications, of all personnel involved in

his or her care through clear disclosure of this information on the

hospital badge.

Response: We believe that this is an issue that hospitals should

consider in developing their policies and procedures on notification of

rights. We agree that it is important for patients to be aware of the

identities of individuals who provide care in the hospital.

Comment: A few commenters suggested a patient should have the right

to request care by a registered nurse (RN).

Response: Under the current hospital CoPs, hospitals are required

to have 24-hour nursing services and an RN who supervises or evaluates

the nursing care for each patient (Sec. 482.23(b)(3)). In addition, an

RN must assign the nursing care of each patient to other nursing

personnel in accordance with the patient's needs and the specialized

qualifications and competence of the nursing staff available

(Sec. 482.23(b)(5)). We believe that the patient has a right to nursing

care in hospitals; however, we disagree with the commenter's assertion

of the patient's inherent right to request and receive the direct

services of an RN. In rural areas where access to health care

practitioners can be problematic, to mandate this requirement is

impractical and burdensome. The current nursing services requirement

provides for RN services for each patient through supervision of the

nursing care provided. Existing regulations address and provide for the

appropriate level of care in situations where a patient's condition

warrants an RN's direct service.

Comment: One commenter agreed with our proposal that hospitals

should have a formal grievance process for complaints and

recommendations. However, we received more comments in opposition to

this requirement. Those who opposed the provision believed it to be

unnecessary, burdensome to establish, and limited in scope since it

pertains only to patients' rights. A commenter noted that we did not

specify how the hospital should plan to investigate complaints or the

time frame within which hospitals would be required to respond to

grievances.

Response: As we stated in the December 1997 proposed rule, whenever

possible, we have attempted to adopt an outcome-oriented focus rather

than establish process requirements. However, we believe that the

establishment of a grievance process promotes patient empowerment in

health care. We recognize that in and of itself this process may not be

sufficient to resolve all potential sources of conflict. For example,

in a situation where a patient disagrees with a course of treatment,

the disagreement might be between the patient and an independent

physician or health plan rather than with the hospital itself. Some

issues may more logically be pursued under Medicare or Medicaid

complaint processes or through a State mechanism. For example,

hospitals already have procedures for referring Medicare beneficiaries'

complaints about quality and concerns about premature discharge to peer

review organizations for investigation and review. Whatever the type of

concern, we expect that the hospital's grievance process will

facilitate prompt, fair resolution. The grievance process should route

each concern timely to the appropriate decision-making body. This

expectation for coordination has been added to the text of the final

rule.

As noted earlier, the interpretive guidelines will reiterate that

the notification of a grievance process must include the fact that the

patient has the right to file a complaint with the SA regardless of

whether he or she chooses to use the hospital's process, and that he

must be provided with the SA's phone number and address.

We considered the commenters' concerns about burden; however, to

remain silent on general expectations for the grievance process could

result in the absence of key ingredients that promote a meaningful,

substantial process that addresses patients' concerns and promotes

their rights. To promote the creation of an effective grievance

process, in Sec. 482.13(a)(2), we are establishing general elements

that should be common to grievance processes across all hospitals.

Development of more detailed strategies and policies to comply with the

requirement will be left to the discretion of each hospital.

Exercise of Rights

B. We proposed That the Patient Has the Right To Be Informed of His or

Her Rights and To Participate in the Development and Implementation of

His or Her Plan of Care

Comment: Commenters stated that the patient should be informed if

the treatment is experimental in nature and informed of the types of

outcomes the hospital has encountered from the care. Commenters also

suggested that the patient and his or her representative should be

informed of the nature, expected outcome, and potential complications

of treatment options that are going to be undertaken, as well as the

potential outcomes if the treatment is refused.

Response: The hospital should foster an atmosphere that supports

two-way communication with the patient regarding his or her care. We

expect that the hospital will hold the responsible physician

accountable for discussing all information regarding treatment,

experimental approaches (hospitals are required to comply with 45 CFR

part 46, protection of subjects of human research), and possible

outcomes of care to promote quality care delivery. We believe it is

unnecessary to codify the elements that must be discussed with a

patient regarding development of his or her plan of care, or with whom

among the hospital's staff or practitioners the patient must speak to

develop that plan of care. Flexibility is necessary because discussions

of treatment information will differ for each patient.

[[Page 36075]]

C. We Proposed That the Patient Has the Right To Make Decisions

Regarding His or Her Care

Comment: Some commenters stated that the final rule should

emphasize the patient participating fully in his or her care.

Commenters believed that this could be achieved by allowing the patient

to receive second opinions before starting a procedure that

significantly differs from the pre-admission plan of treatment. These

commenters stated that the final rule should require the patient to

``sign-off on treatment options'' and should acknowledge the patient's

ability to refuse treatment and to refuse to participate in

experimental research.

Response: We agree that the patient must be adequately informed of

these options so that he or she can make educated decisions regarding

his or her care. The requirement supports this emphasis and implicitly

includes the commenters' concerns that a patient be able to refuse a

certain treatment or participation in experimental research. However,

in light of this comment, we decided to introduce a higher degree of

specificity in the final rule. First, we noted that the patient's

representative (as allowed under State law) can also exercise the right

to make informed decisions on the patient's behalf. Second, we

introduced a more detailed description of what the patient's right to

make informed decisions entails. The patient has the right to be

informed of his or her health status, to be involved in care planning

and treatment (this includes pain management, as this aspect of

treatment planning is often not discussed with patients), and to be

able to request and refuse treatment. Abridgement of these patients'

rights would be subject to the grievance process required by

Sec. 482.13(a). It is critical to note, however, that the standard does

not provide the patient with the right to demand treatment or services

that are not clinically or medically indicated.

D. We proposed that the patient has the right To Formulate Advance

Directives and To Have Hospital Staff and Practitioners Who Provide

Care in the Hospital Comply With These Directives

Comment: One commenter wanted the issue of advance directives to be

addressed at the time of the patient's Medicare enrollment rather than

at the time of an acute care admission. This commenter stated that,

``Medicare beneficiaries could be required to designate their wishes

with regard to `do not resuscitate' (DNR) status and their surrogate

healthcare decision-maker[s] as a condition of receiving the [Medicare]

benefit. The CoP for the acute setting should address validating the

beneficiary's `pre-selected designations.'' '

Response: Section 1866(f) of the Act contains the provider

requirements concerning the acknowledgment and handling of advance

directives. The implementing regulations appear at 42 CFR part 489,

Provider Agreements and Supplier Approval; specifically, at

Secs. 489.100 through 489.104. When we developed the December 1997

proposed rule, we believed that it was appropriate to reference advance

directives in the Patients' Rights CoP, consistent with other Medicare

provider CoPs (for example, existing regulations for nursing homes and

home health agencies). The regulations governing advance directives and

their implementation are not directly affected or under debate in this

rule. This rule is not the appropriate venue for addressing the more

general issue of advance directives, which spans provider types and is

not specific to the hospital CoPs.

Comment: A commenter stated that the language regarding advance

directives should encourage increased communication about and access to

palliative care for the terminally ill. Another commenter believed that

detailed advance directives should apply to inpatients, but not

outpatients.

Response: Regarding the commenter's concern that advance directives

should apply to inpatients not outpatients, section 1866(f) of the Act

and implementing regulations at Sec. 489.102 require that the hospital

give each individual (1) written information concerning an individual's

rights under State law to make decisions concerning medical care,

including the right to accept or refuse medical or surgical treatment

and the right to formulate, at the individual's option, advance

directives, and (2) written policies of the provider or organization

with respect to the implementation of advance directives. Section

1866(f)(2)(A) specifically notes that this information must be provided

when an individual is admitted as an inpatient to a hospital;

therefore, the hospital need not provide this information to those who

are receiving outpatient services.

We appreciate the commenter's suggestion that the language about

advance directives incorporate increased information about and access

to palliative care for the terminally ill. However, neither the statute

nor the existing regulations about advance directives discuss linking

increased discussion of and access to palliative care with the advance

directives requirement. Further, as noted earlier, the proposed rule

did not contemplate amending the existing advance directives

requirements. We do believe, however, that referencing the patient's

right to formulate and have hospital staff comply with advance

directives in the new Patients' Rights CoP will lead to increased

communication regarding end-of-life decisions, pain management, and

other palliative care.

Comment: One commenter believed that a hospital should be required

to check and adhere to advance directives, including those pertaining

to psychiatric emergencies, by incorporating the appropriate training

to ensure patients are knowledgeably consenting and by including

quality improvement efforts to study the issue.

Response: We believe that existing regulations at Secs. 489.100,

489.102, and 489.104 already address these concerns. The final rule

cross-references these citations and supports the existing regulatory

expectation. However, the commenter touched upon a point that merits

additional response: specifically, that advance directives are not

limited to end-of-life decisions. In the mental health setting, a

patient may form advance directives that relate to what should be done

if he or she experiences a psychiatric crisis. In an advance directive,

a person with a mental disorder leaves instructions as to his or her

health care when he or she no longer has decision-making capacity.

These instructions may include, for example, the name of the health

care proxy, the name of the facility in which one wishes to receive

services, the name of the provider from whom one wishes to receive

treatment, names of medications and dosages that work best, and the

methods to be used to de-escalate a crisis to avoid the use of

seclusion and restraint. In the interpretive guidelines, we will

further describe the aspect of advance directives that relates to

psychiatric emergencies to place a greater emphasis on and encourage

responsiveness to these situations.

E. Privacy and Safety

We Proposed That the Patient Has the Right to Privacy and To Receive

Care in a Safe Setting

Comment: One commenter stated that language of the preamble that

referred to the patient's respect, comfort, and dignity was not

included in the regulations text.

Response: We believe that patient respect, dignity, and comfort are

the foundation of the expectations outlined

[[Page 36076]]

by the regulation--freedom from all forms of abuse and harassment, the

right to privacy, and the right to care provided in a safe setting. As

we have noted earlier, these standards are intended to provide

protection for the patient's physical and emotional health and safety.

Respect, dignity, and comfort would be components of an emotionally

safe environment. This point will be reinforced when we prepare

corresponding interpretive guidelines to implement this final rule.

Comment: Commenters agreed with the concept of the patient's right

to privacy but believed that the term ``privacy'' is broad and

undefined. Some stated that ``personal privacy'' should be defined and

a statement should be included to relieve hospitals of the

responsibility of providing each patient with a private room, since

``privacy'' could be misinterpreted to mean that a patient has a right

to a private room.

Response: We understand the commenters' concerns but are not

including a description of ``privacy'' in the final rule. We intend to

address the accommodation of privacy rights through the interpretive

guidelines, as that venue permits a more thorough explanation of

expectations.

We agree that ``privacy'' does not mean that each patient has a

right to a private room. However, even if a patient is in a semiprivate

room, the hospital should provide a patient with privacy by steps such

as pulling curtains closed for exams and requesting visitors to leave

the room when treatment issues are being discussed.

Comment: Some commenters believe ``personal privacy'' and ``receive

care in a safe setting'' should not be combined since they are separate

issues.

Response: We agree and have separated the two elements under the

standard ``Privacy and Safety.''

F. We Proposed That the Patient Has the Right To Be Free From Verbal or

Physical Abuse or Harassment

Comment: Some commenters wanted the word ``free'' to be replaced by

``protected'' and the phrase ``from hospital staff'' included in the

standard. One commenter observed that patients can misinterpret

hospital staff's helpful verbalizations as abusing and harassing.

Commenters believed that this section should clarify that verbal

warnings or physician contact with a patient, visitor, or employee,

that are reasonably necessary to protect others from intimidation or

threat of violence will not be construed as verbal or physical abuse.

Other commenters wanted the regulation to express sensitivity to the

fact that hospital personnel will not always be able to anticipate the

potential for harassment and harm inflicted by another patient.

Response: While the patient is under the hospital's care and on its

property, the hospital is responsible for ensuring the patient's health

and safety and his or her physical, emotional, and psychological well-

being. We recognize that there is always a chance a patient can

misinterpret staff's intentions. We expect that hospital staff would

intervene in a timely, appropriate manner to correct any

misinterpretations in a timely, appropriate manner, if this situation

were present.

In the final rule, we have amended the language to address all

forms of abuse rather than just physical and verbal abuse. We recognize

that any sort of abuse, including verbal, physical, psychological,

sexual, and emotional, is unacceptable.

G. Confidentiality of Patient Records

We Proposed That the Patient Has the Right to Confidentiality of His or

Her Clinical Records

Comment: A commenter stated that without specific language

regarding privacy and confidentiality, research efforts may be stifled

by the regulation.

Response: Presumably, the commenter is concerned that without a

clear statement regarding the confidentiality of patient records,

patients would be reluctant to participate in medical research if

asked. We have maintained the proposed language regarding

confidentiality; however, we agree with the commenter's assertion that

patients need to have a clear understanding of how a hospital

operationalizes this requirement. We will discuss this further in

interpretive guidelines.

Comment: A commenter questioned whether the stated language is

expressing a concern for each patient's ability to access his or her

records or whether the language views a hospital's tendency to

``systemically'' frustrate individuals' legitimate attempts to gain

access to medical records as a violation of the requirement.

Response: We believe it is each patient's inherent right to have

access to his or her clinical record, as well as to have his or her

clinical record kept confidential. We are setting forth this

requirement in the final rule.

Comment: A few commenters noted that there was no definition

provided for the term ``reasonable'' when it was used to describe the

time frame within which the hospital must provide the patient with

access to information in his or her records. They believed that this

lack of specificity would make it difficult for JCAHO to determine

hospitals' compliance with the standard. A few commenters believed that

the regulation should state that the patient has a right to a copy of

his or her records within 4 hours of an inpatient stay and within 48-72

hours for a patient who has been discharged. A few commenters believed

that the regulations text should clearly account for the impact of

variations in location of data, record complexity, urgency, and staff

workload.

Response: Regarding the definition of ``reasonable,'' we believe

that ``reasonable'' means that the hospital (1) will not frustrate the

legitimate efforts of individuals to gain access to their own medical

records, and (2) will actively seek to meet these requests as quickly

as its recordkeeping system permits. We have included these

expectations in the regulations text at Sec. 482.13(d)(2).

We agree with the commenters who asserted that we should account

for the impact of various factors such as location of data, urgency,

and staff workload. Rather than attempting to stipulate time frames

within the regulation that would cover all possible combinations of

factors, we are simply retaining the word ``reasonable.'' We trust that

if the patient believes that he is being subjected to unreasonable

treatment as he tries to obtain a copy of his medical records, he will

use the hospital's grievance process or will report difficulties to the

SA or JCAHO. While setting a concrete time frame might provide a better

measuring stick for performance, it would not adequately account for

the kinds of variation that are apt to occur in different hospital

settings.

Comment: Some commenters suggested that the rule be expanded to

state, ``In accordance with local and State laws, the patient has a

right to confidentiality of his or her clinical and personal

information and records and a right to a copy of his or her medical

record or information in his or her medical record within a reasonable

time frame.''

Response: This comment could have several meanings. The idea of

deferring to local and State law could apply to the confidentiality

provision, the access requirement, the reasonable time frame, or all

three. Specifically, it could be construed to mean that--

(1) ``The patient's right to the confidentiality of his or her

record is governed by State or local law (rather than Federal law).''

Currently, DHHS's position on this point is to defer to State

[[Page 36077]]

rules that are more protective of privacy than Federal rules whenever

possible.

While our intention is that the Patients' Rights CoP protects

record confidentiality to the greatest extent possible, we recognize

that some disclosure may be necessary. For example, in the December

1997 proposed rule, we proposed under the revised Information

Management CoP that the patient's medical information must be available

to all authorized professional personnel providing medical care to the

patient. If the patient's care is to be well integrated and planned,

those who are providing the various professional services involved in

the patient's treatment may need to review the patient's medical status

and history. It is expected that there will be management choices and

policies determining what uses and disclosures of patient information

are authorized, and that there will be administrative, management, and

technical safeguards to ensure that only persons using records for

authorized purposes may have access to them. For example, the release

of the patient's record may occur if the patient is transferred to

another facility, to comply with the provisions of Federal law and

State law (where State law is not inconsistent with Federal law), when

allowed under third party payment contract, as approved by the patient,

and when inspection by authorized agents of the Secretary is required

for the administration of the Medicare program.

(2) ``The patient's right to access his or her record should be

governed by State and local law.'' A discussion of DHHS's position is

in order. The general policy position of the DHHS on this topic is set

out in ``Confidentiality of Individually-identifiable Health

Information, Recommendations of the Secretary of Health and Human

Services, pursuant to section 264 of the Health Insurance Portability

and Accountability Act of 1996,'' in which the Secretary recommended

Federal legislation to protect the rights of patients with respect to

their health information.

The policy recommended there is that the patient should be allowed

to inspect and copy health information about himself or herself held by

providers and payers, but that providers and payers could, in their

discretion, withhold information from the patient under very narrowly

defined circumstances:

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