Medicare and Medicaid Programs; Advance Directives

SUMMARY: This final rule responds to public comments on the March 6,

1992 interim final rule with comment period that amended the Medicare

and Medicaid regulations governing provider agreements and contracts to

establish requirements for States, hospitals, nursing facilities,

skilled nursing facilities, providers of home health care or personal

care services, hospice programs and managed care plans concerning

advance directives. An advance directive is a written instruction, such

as a living will or durable power of attorney for health care,

recognized under State law, relating to the provision of health care

when an individual's condition makes him or her unable to express his

or her wishes. The intent of the advance directives provisions is to

enhance an adult individual's control over medical treatment decisions.

This rule confirms the interim final rule with several minor changes

based on our review and consideration of public comments.

DATES: Effective date: This final rule is effective on July 27, 1995.

FOR FURTHER INFORMATION CONTACT: Julie Stankivic, (410) 966-5725.

SUPPLEMENTARY INFORMATION:

I. Background

Advance directives are written instructions recognized under State

law relating to the provision of health care when adult individuals are

unable to communicate their wishes regarding medical treatment.

Note: For purposes of this final rule, the terms ``individual,''

``patient,'' or ``resident'' refer only to adults as defined by

State law.

The advance directive may be a written document authorizing another

person, such as a relative or close friend, to make decisions on an

individual's behalf (a durable power of attorney for health care), a

written statement (a living will), or some other form of instruction

recognized under State law specifically addressing the provisions of

health care. The various legal devices that exist serve to enhance the

ability of individuals to have their desires carried out in the event

that they become unable to make their own medical treatment decisions.

Most States have enacted legislation defining an individual's right

to make decisions regarding medical care, including the right to accept

or refuse medical or surgical treatment and the right to formulate

advance directives. However, prior to the enactment on November 5,

1990, of the Omnibus Budget Reconciliation Act of 1990 (OBRA '90),

Public Law 101-508, there were no requirements relating to advance

directives under Federal Medicare or Medicaid laws.

II. Legislative Amendments

A. Medicare Provisions

Section 1866 of the Social Security Act (the Act) requires that

providers of services under Medicare enter into an agreement (that is,

provider agreements) with the Secretary and comply with the

requirements specified in that section. Section 4206(a) of OBRA '90

amended section 1866(a)(1) of the Act relating to Medicare provider

agreements by adding a new subparagraph (Q), which specifies that to

participate in the Medicare program, hospitals, skilled nursing

facilities, home health agencies, and hospice programs must file an

agreement with the Secretary to comply with the statutory requirements

in new subsection 1866(f) of the Act concerning advance directives.

Section 1866(f)(3) of the Act defines an advance directive as a written

instruction, such as a living will or durable power of attorney for

health care, recognized under State law, relating to the provision of

health care when an individual is incapacitated. The State law may

either be established by statute or as recognized by the courts of the

State.

Section 1866(f)(1) of the Act specifies that a provider of services

or prepaid or eligible organization (that is, a health maintenance

organization (HMO), competitive medical plan (CMP) as defined in

section 1876(b) of the Act, or a health care prepayment plan (HCPP) as

defined in section 1833(a)(1)(A) of the Act) must maintain written

policies and procedures on advance directives with respect to all adult

individuals receiving medical care through the provider or

organization. The provider or organization must provide written

information to each individual 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. The

provider or organization must also furnish each individual with the

written policies of the provider or organization with respect to the

implementation of advance directives.

Section 1866(f)(2) of the Act requires that this written

information must be provided at the time an individual is admitted as

an inpatient to a hospital, at the time of admission to a skilled

nursing facility, before an individual comes under the care of a home

health agency, at the time of initial receipt of hospice care, or at

the time of enrollment of the individual with an eligible prepaid

health care organization or HCPP.

Section 1866(f)(1) of the Act also contains provisions that require

the provider or organization to document in the individual's medical

record whether or not the individual has executed an advance directive,

not to discriminate against individuals based on whether or not they

have executed an advance directive, to ensure compliance with State

law, and to provide for education of staff and community on issues

concerning advance directives.

Section 4206(b)(1) of OBRA '90 amended section 1876(c) of the Act

by adding a new paragraph (8), which provides that the contract between

the Secretary and an eligible organization must provide that the

organization meets the advance directives requirements specified in

section 1866(f) of the Act.

Section 4206(b)(2) of OBRA '90 also amended section 1833 of the Act

by adding a new subsection (r), which specifies that the Secretary may

not provide for payment under the Medicare program to an organization

unless the organization provides assurances satisfactory to the

Secretary that the organization meets the requirements relating to the

maintenance of written policies and procedures regarding advance

directives in section 1866(f) of the Act.

Section 4206(c) of OBRA '90 provides that sections 4206(a) and (b)

do not prohibit the application of a State law that allows for an

objection on the basis of conscience for any health care provider or

any agent of such provider which, as a matter of conscience, cannot

implement an advance directive.

Section 4206(d) made conforming amendments to sections 1819(c)(1)

and 1891(a) of the Act, requiring that skilled nursing facilities and

home health agencies, respectively, comply with the advance directives

requirements in section 1866(f) of the Act. Enforcement

[[Page 33263]] procedures are explained in section II.D of this

preamble.

B. Medicaid Provisions

Section 1902 of the Act sets forth State plan requirements for

medical assistance that must be submitted to the Secretary for

approval. Section 4751 of OBRA '90 amended section 1902 of the Act

relating to requirements for State plans by adding provisions

concerning advance directives similar to the Medicare provisions in

section 4206 of OBRA '90. Specifically, section 4751 of OBRA '90

amended section 1902 of the Act by adding new paragraph (57) to

subsection (a) and a new subsection (w). Section 1902(a)(57) of the Act

mandates, as a State Medicaid plan requirement, compliance with section

1902(w), which requires all hospitals, nursing facilities, providers of

home health care and personal care services, hospices, or health

maintenance organizations (as defined in section 1903(m)(1)(A) of the

Act) that are receiving funds under a State plan to maintain written

policies and procedures to inform, educate, and distribute written

information on advance directives to all adult individuals receiving

medical care by or through the provider or organization, in the manner

described in the law.

Section 4751(a) also amended section 1902 of the Act by adding a

new paragraph (58) to subsection (a) to require that States, acting

through a State agency, association, or other private non-profit

entity, develop a written description of the State law concerning

advance directives for distribution to Medicaid providers and

coordinated care plans.

Section 4751(b) made conforming amendments to sections

1903(m)(1)(A) and 1919(c)(2) of the Act. These requirements are to be

enforced under applicable State plan provisions.

C. Public Education Requirements

Section 4751(d) of OBRA '90 requires the Secretary to conduct a

public education campaign on advance directives. HCFA, primarily

through our Office of Beneficiary Services, has worked in concert with

State and local agencies and consumer groups to carry out this

requirement. Examples of public awareness activities include:

Information Kit and Press Package. An information kit was

forwarded to major beneficiary organizations and the national news

media. We also have issued a press package that includes a bibliography

of related publications, as well as a list of organizations that have

addressed the statutory requirements concerning advance directives.

Medicare Hotline: 1-800-638-6833. Information concerning

advance directives is available through the Medicare hotline. Staff

members provide basic information from the information kit, answer

questions, and forward booklets concerning advance directives upon

request.

Articles. A kit containing standard articles concerning

advance directives was sent to all suburban daily and weekly papers.

This material generated 244 articles in 25 States with a readership of

an estimated 4 million persons. We also sent materials to national and

local broadcast organizations, including articles and scripts and/or

slides for radio and television public service announcements. The radio

material is known to have been used on 258 radio stations that

cumulatively reach 4.8 million homes servicing 15 million listeners.

The TV material is known to have appeared on 32 stations in 23 States,

cumulatively reaching 37.3 million homes.

Other Publications. The following is a brief list of other

publications concerning advance directives:

* Medicare Handbook. The Medicare Handbook now includes information

regarding advance directives. We routinely send this publication,

available in both English and Spanish, to each new Medicare enrollee

(about 200,000 individuals per month) and more than 1 million other

copies have been distributed to current beneficiaries through HCFA

publication distribution channels.

* Medicare and Advance Directives Leaflet. Approximately 500,000

copies of this leaflet have been distributed to hospitals, beneficiary

groups, agencies on aging and similar offices, as well as to some

supermarkets with a high concentration of elderly clients.

* Cartoon Booklet. HCFA has distributed approximately 10,000 copies

of an easy-to-read cartoon booklet on advance directives that is

designed for audiences with low literacy levels.

In addition to these activities, we are continuing to plan and

carry out further initiatives related to our public service

responsibilities that are designed to further educate the public

concerning advance directives.

We note that the Office of the Inspector General (OIG) conducted an

early implementation study in December, 1992, to determine compliance

with the advance directive provision and facility and patient responses

(OEI-06-91-01130 and OEI-06-91-01131). This study found that at that

time, two-thirds of the patients in the facilities studied had some

understanding of advance directives. We believe that this finding

indicates that HCFA, in concert with other members of the health care

industry, has made significant strides towards educating the public on

advance directives.

D. Enforcement Procedures

For hospitals and hospices, compliance with the advance directives

requirements is considered part of the provider agreement with HCFA.

The provider agreement obligates a provider to comply with the

applicable requirements of title XVIII of the Act and includes some

specific provisions, such as the advance directives requirements. The

Secretary may refuse to enter into a provider agreement or may refuse

to renew or may terminate an agreement after the Secretary: (1)

Determines that the provider fails to comply substantially with the

provisions of the agreement or with the provisions of title XVIII and

the implementing regulations; (2) determines that the provider fails

substantially to meet the applicable provisions of section 1861 of the

Act (definition of services, institutions, etc.); or (3) has excluded

the provider from participation under sections 1128 or 1128A of the Act

(exclusion and civil monetary penalty provisions).

On-site surveys of providers are performed by State agency or

Federal surveyors to determine compliance with the advance directive

requirements or the conditions of participation. However, providers are

assumed to be in compliance with the general requirements of the

provider agreement as set forth in title XVIII. HCFA does not routinely

seek information to confirm that the provider is complying with

specific requirements of the provider agreement. If information

concerning a provider's compliance with the agreement of the provisions

of title XVIII is needed, it may be obtained in several ways, including

the performance of an on-site survey.

Each hospital and hospice provider has been informed of its

obligation to comply with the advance directive provisions and that

these provisions are required as a part of its provider agreement with

HCFA. Compliance with these provisions is necessary for continued

participation in the Medicare and Medicaid programs. These providers

were required to inform HCFA, in writing, of the date they achieve

compliance.

Our regional offices recently completed random surveys to determine

the percentage of providers who have complied with the advance

directive [[Page 33264]] requirements. Based on results from 8 regions,

reported compliance rates range between 97 and 100 percent. (We

anticipate similar findings for the other two regions).

For hospices, and hospitals not accredited by the Joint Commission

on Accreditation of Healthcare Organizations (JCAHO) or the American

Osteopathic Association (AOA), compliance is verified as part of the

routine survey process.

Periodic Federal recertification surveys are not conducted in

hospitals that are accredited by JCAHO and/or AOA because such

hospitals are ``deemed'' to meet Medicare's certification requirements.

However, since the advance directive requirements for hospitals and

hospices are part of the provider agreement requirement, we will

investigate complaints and conduct surveys at these hospitals as

needed. We will verify compliance with the advance directive provisions

at accredited hospitals in response to complaints and at the time of

these surveys.

For skilled nursing facilities (SNFs), nursing facilities (NFs) and

home health agencies (HHAs), enforcement procedures employ the Federal

on-site survey process. State agency or Federal surveyors are

responsible for evaluating compliance with the Medicare and Medicaid

requirements for SNFs and NFs or conditions of participation for HHAs.

Therefore, State agency or Federal surveyors are able to evaluate on-

site compliance with the advance directive requirements through the use

of the survey protocol for SNFs, NFs and HHAs. Also, JCAHO and

Community Health Accreditation Program, Inc. (CHAP) standards address

for long-term care facilities and HHAs advance directive issues, which

should enhance compliance with these rules by educating these entities

concerning advance directives and suggesting methods of complying with

statutory and regulatory advance directive requirements.

A facility that does not comply with the provisions of its provider

agreement may be terminated by HCFA. HCFA must give the provider notice

of termination at least 15 days before the effective date of

termination of the provider agreement. This notice must state the

reasons for, and effective date of termination and explain the extent

to which services may continue after that date. A provider may appeal

the termination of its provider agreement in accordance with 42 CFR

part 498.

Under Medicaid, a provider must enter into an agreement with the

State Medicaid agency. State agency surveyors or Federal surveyors

(during a validation or ``look-behind'' survey) perform a function

similar to that under Medicare. However, the State Medicaid agency is

responsible for assuring compliance with the Medicaid provider

agreement and the advance directive requirements contained therein.

For eligible or prepaid health care organizations, initial approval

of a Medicare contract under sections 1833 and 1876 of the Act requires

compliance with the advance directives requirements. The organization's

continued adherence to these requirements is reviewed by HCFA during

routine monitoring activities which include site visits, and

examination of marketing materials and provider contracts. Failure to

comply with the advance directives requirements may result in

termination of the organization's contract with HCFA.

E. Effective Dates

The amendments made by sections 4206(a) and (d) of OBRA '90

pertaining to Medicare providers are effective with respect to services

furnished on or after December 1, 1991.

The amendments made by section 4206(b) of OBRA '90 pertaining to

prepaid and eligible organizations participating in the Medicare

program (that is, contracts with HMOs and CMPs under section 1876(b),

and Medicare payments to HCPPs under section 1833(a)(1)(A) of the Act)

are effective December 1, 1991.

The amendments made by section 4751 of OBRA '90 pertaining to the

Medicaid program are effective with respect to services furnished on or

after December 1, 1991.

III. Provisions of the March 6, 1992 Interim Final Rule

On March 6, 1992, we published an interim final rule with comment

period that set forth in regulations the new advance directive

provisions (57 FR 8194). The March 6, 1992 interim final rule

implemented the provisions of sections 4206 and 4751 of OBRA '90 by

requiring that all hospitals, skilled nursing facilities, nursing

facilities, providers of home health care or personal care services,

hospices, and prepaid health plans provide written information to each

adult individual receiving medical care through the provider or

organization concerning his or her 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.

General Requirements

Under these regulations, the term ``advance directive'' is defined

as a written instruction, such as a living will or durable power of

attorney for health care, recognized under State law, relating to the

provision of health care when the individual is incapacitated. These

regulations do not require an individual to execute an advance

directive prior to the provision of treatment and services.

Furthermore, we note that these requirements do not apply to providers

of outpatient hospital services.

The provider must inform the individual, in writing, of State laws

regarding advance directives; inform the individual, in writing, of the

policies of the provider regarding the implementation of advance

directives, including if permitted under State law, a clear and precise

explanation of any objection a provider (or any agent of such provider)

may have, on the basis of conscience, to honoring an individual's

directive; document in the individual's medical record whether or not

the individual has executed an advance directive; educate staff on

issues concerning advance directives; and provide for community

education on issues concerning advance directives. In accordance with

OBRA'90, the interim final rule required providers to communicate

information to individuals about their right to accept or refuse

medical treatment and the right to formulate an advance directive by

furnishing written descriptions of State law and provider policies and

practices regarding the implementation of such rights. However, with

the exception of these general notification requirements, the law has a

narrow and explicit focus solely on the handling of written directives

for medical care made by persons who later become incapacitated.

Therefore, the interim final rule did not address other related issues

such as informed consent to medical care, determination of mental

capacity, provision of medical care to minors, wills leaving property,

or organ donation.

Content and Format of Written Information

The interim final rule also did not prescribe the content and

format of the written information to be provided to each adult

individual. However, in connection with our technical assistance

responsibilities to States in meeting the Medicaid requirements of the

law, HCFA's Administrator sent a letter to each State Medicaid Director

to which was attached a sample public [[Page 33265]] information

document for use in informing adult individuals about advance

directives.

Note: The materials contained in the HCFA Administrator's

information package, including the sample public information

document, were published as Appendix I to the preamble of the

interim final rule. These materials are not being republished in

this final rule.

This sample public information document is suggestive of what we

believe an acceptable document should include. As stated in the interim

final rule, it would be consistent with the statute to develop a

considerably shorter discussion than that contained in the sample

document. It would also be possible to use a short summary notice,

several paragraphs rather than pages long, that notified the patient

that a longer and more specific document was available upon request.

However, the summary notice would have to cover the legally required

elements (for example, describing the purpose and the concept of an

advance directive, an individual's rights under State law to accept or

refuse medical or surgical treatment, the right to formulate an advance

directive, and the provider's policies concerning the implementation of

those rights).

As also discussed in the March 6, 1992 document, we are aware that

State law on advance directives is not always clear or comprehensive.

Nonetheless, Congress has mandated that, as of December 1, 1991,

providers and organizations participating in Medicare or Medicaid must

distribute the required materials that inform an individual of his or

her right under State law to accept or refuse medical treatment and the

right to formulate advance directives. This requirement relates to

current State law. Therefore, changes in State law, by statute or court

case, must be incorporated into subsequent provider information

packages. We specifically sought public comments on what would be a

reasonable period of time within which such changes should be made.

Timing for Dissemination of Written Information

Written information on advance directives must be provided to an

individual upon each admission to a medical facility and each time an

individual comes under the care of an HHA, personal care provider, or

hospice. For example, if a person is admitted first as an inpatient to

a hospital and then to a nursing home, both the hospital and the

nursing home would be required to provide information on advance

directives to the individual. We suggested that if an individual is

being transferred from a hospital to a nursing home, the hospital

discharge planner may provide the information (including the nursing

home's policies regarding the implementation of advance directives) on

behalf of the nursing home in the course of coordinating the smooth

transfer of the patient. However, we reemphasize that the nursing home

is still responsible for inquiring about the existence of an advance

directive and documenting in the individual's medical record whether or

not the individual has executed an advance directive.

If a patient is incapacitated at the time of admission and is

unable to receive information (due to the incapacitating condition or a

mental disorder) or articulate whether or not he or she has executed an

advance directive, the facility should give advance directive

information to the patient's family or surrogate to the extent that it

issues other materials about policies and procedures to the family of

the incapacitated patient or to a surrogate or other concerned persons

in accordance with State law. This does not, however, relieve the

facility of its obligation to provide this information to the patient

once he or she is no longer incapacitated or unable to receive such

information.

Description of State Laws Concerning Advance Directives

As a part of the Medicaid requirements contained in section 4751 of

OBRA '90, we also required in the interim final rule that each State,

acting through a State agency, association, or other private nonprofit

entity, develop a written description of the State law (that is,

statutory or otherwise recognized in the courts) concerning advance

directives for distribution by providers. Given the requirements in the

Federal law, we noted that States have a wide range of options in

describing State law and in prescribing informational materials for use

by providers. For example, the State materials describing an

individual's rights to accept or refuse medical or surgical treatment

and the right to formulate an advance directive may include lengthy or

extended requirements for executing an advance directive, or they may

be a short, simple statement expressing the individual's rights

concerning advance directives.

The interim final rule also included some discussion of possible

approaches that States and providers may take in providing the required

information and that we believed would produce results consistent with

the statutory requirements. In accordance with the requirements of

section 4751 of OBRA '90, States may require that Medicaid providers

use the State-developed description of State law only. Alternatively,

States may allow providers to incorporate the general information

contained in the State-developed description of State law into the

providers' own package of materials that include the providers' written

policies regarding the implementation of an individual's rights.

Although the statute does not specifically require that Medicare

providers use the State-developed description of State law, we

encouraged States and providers, and organizations to work together to

ensure that a complete and accurate description of State law is

distributed consistently to all adult patients or residents.

Sources of Information and Technical Assistance

As mentioned earlier, HCFA provided technical assistance to the

States, including the technical assistance information package released

by HCFA's Administrator in September 1991. At that time, HCFA also

released a State Medicaid Manual issuance (HCFA-Pub. 45-2, Transmittal

#73) concerning advance directive requirements to inform the States of

their responsibilities in this area. Copies can be obtained by the

general public by contacting the National Technical Information Service

(NTIS), ORDER #PB88-952399. You may call to order at (703) 487-4630 or

send a request to NTIS Subscription Department, 5285 Port Royal Road,

Springfield, VA 22161.

Finally, we note that a number of other private entities have

prepared pertinent documents that States may find helpful. HCFA's

Administrator issued a press package that included a bibliography of

these publications, as well as a list of organizations that have

addressed the statutory requirement that providers disseminate

information to individuals regarding their rights under State law to

accept or refuse medical treatment and the right to formulate advance

directives. These materials were printed as Appendix II to the preamble

of the interim final rule and are not being reprinted in this final

rule.

Methods of Complying With Advance Directive Requirements

The law requires that the existence of an advance directive be

documented in an individual's medical record. We recognize,

particularly in the case of prepaid health care organizations, that

such documentation will occur when the medical record is created.

Although the statute does not specifically require

[[Page 33266]] providers or organizations to have direct dialogue with

each adult individual to ascertain whether he or she has executed an

advance directive, we believe that this type of interaction is an

acceptable method for obtaining this information.

Although it is acceptable that the patient be asked and respond to

a specific question, we recognized that these procedures are not the

only appropriate methods for obtaining the information needed to

document medical records. It is also acceptable for providers to

include in preadmission materials a form, to be completed by the

patient, that sets forth whether or not the patient has executed an

advance directive. Such form, when completed and returned by the

patient at the time of admission, would supply the provider the

information needed to document the medical record, or the form itself

could be attached to such record. There are, however, issues with

respect to whether these methods may impose too great a burden on the

patient or may not result in eliciting the desired information from a

sufficient number of patients. Therefore, we requested comments on

these and other methods of obtaining the information needed to document

the medical record.

As discussed in the interim final rule, there are also several

options available to accomplish the requirement that a provider or

organization provide for community education. The educational materials

must inform the public of their rights under State law to make

decisions concerning the receipt of medical care by or through the

provider or organization; the right to formulate advance directives;

and the provider's or organization's implementation policies concerning

an individual's advance directive.

Under the interim final regulations, the provider or organization

cannot condition the provision of care or discriminate against an

individual based on whether or not the individual has executed an

advance directive. For example, all patients are generally entitled to

the medically necessary care ordered by a physician which a provider,

under normal procedures, would be required to furnish and cannot delay

or withhold because the individual has not executed an advance

directive or the provider is waiting for an advance directive to be

executed. However, once it is documented that an advance directive has

been executed, then the directive takes precedence over the facility's

normal procedures, to the extent required by State law.

As specified in the statute, we also required prepaid or eligible

health care organizations to provide information on advance directives

to enrollees at the time of enrollment. Organizations must give

enrollees the advance directive material prior to the effective date of

coverage. However, we encouraged organizations to give enrollees the

material as early as possible after the application for enrollment is

received.

We recognize that an organization may have contracts with a variety

of providers (in order to assure widespread access to care), and that

some of these providers may have policies with respect to advance

directives that are more limited than others (for example, a hospital

exercising an objection on the basis of conscience that is consistent

with State law). In such cases, the organization could adopt a policy

that embraces the variety of practices of its providers, and

disseminate the information regarding those various practices to its

enrollees as prescribed by the interim final rule. This information

would be provided along with the written description of State law. On

the other hand, the organization could simply note, in the material

regarding State law and provider practices, that its providers have, in

accordance with State law, varying practices regarding the

implementation of an individual's advance directive. In this case, such

varying practices must be made available to each adult individual

selecting or receiving care from such providers.

For a description of the specific changes to the regulations text

that were necessary to implement the above statutory provisions, see

the March 6, 1992 interim final rule, 57 FR 8198.

IV. Discussion of Public Comments

In response to the March 6, 1992 interim final rule with comment

period, we received 85 timely items of correspondence. We have

summarized the comments and are presenting them below along with our

responses.

Section IV.A contains our response to general comments. In

responding to comments, the term ``provider'' generally encompasses

hospitals, skilled nursing facilities (SNFs), nursing facilities (NFs),

hospices, and home health agencies (HHAs). When the comments and

responses deal with a specific provider type, the appropriate term is

used.

Section IV.B responds to comments that deal specifically with what

the statute refers to as ``prepaid or eligible organizations'' (that

is, HMOs, CMPs, and HCPPs). In responding to comments, we generally use

the term ``managed care plans'' to refer to these types of

organizations. (We note that on July 15, 1993, we published a final

rule (57 FR 38072) that replaced the term ``prepaid or eligible

organization'' with the term ``HMOs and CMPs'' throughout 42 CFR part

417. Thus, all references in the regulation text now use the term HMOs

and CMPs.)

In addition, we received some comments concerning Appendices I and

II to the interim final rule. These documents were included in the

interim final rule as a source of technical assistance only and are not

being republished in this final rule; however, a discussion of these

comments is contained in section IV.C.

A. General

Scope of Regulations

Comment: Two commenters asserted that these regulations are

inconsistent with the requirement in sections 1866(f)(1)(A)(i) and

1902(w)(1)(A)(i) of the Act that providers give patients 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 advance

directives. Specifically, the commenters objected to the following

statements in the preamble of the interim final rule:

``Nothing in either the statute or this interim final rule

addresses patient or provider rights or decisions regarding medical

or non-medical care, except when the patient has left written

instructions which become effective only after the individual

becomes incapacitated''. For example, this regulation neither

creates nor affects requirements with respect to informed consent to

medical care * * * These and many other significant subjects are not

addressed under OBRA '90. The law has a narrow and explicit focus

concerning the handling of written directives for medical care made

by persons who later become incapacitated. (57 FR 8196)

The commenters asserted that to be more consistent with the statute

these regulations should require providers to disseminate information

concerning: (1) The right to accept or refuse treatment both

``contemporaneously and in advance, the latter via advance

directives;'' (2) informed consent; and (3) the fact that the effective

dates of advance directives may vary in accordance with applicable

State law.

Response: Sections 1866(f)(3) and 1902(w)(4) of the Act make clear

that the term ``advance directive'' relates to the provision of health

care when an individual is incapacitated. We agree that the statute

also requires providers to furnish individuals with written information

about their rights under State law to direct their medical

[[Page 33267]] treatment before incapacitation (that is, the right to

accept or refuse medical or surgical treatment). However, we do not

believe that the statute authorizes us to broaden the scope of these

regulations as suggested by the commenter nor do we believe that the

law intends that hospitals provide patients with an exhaustive briefing

about medical decision making under State law. States and providers are

free to provide additional information that might further educate

patients about additional rights regarding medical decision-making that

exist under State law.

Comment: Two commenters requested that HCFA limit the scope of the

law so that providers and organizations need to provide only Medicare

and Medicaid patients with information on advance directives.

Response: Sections 1866(f)(1) and 1902(w)(1) of the Act specify

that information on advance directives be provided to all adult

individuals. Narrowing the scope of the requirement to Medicare and

Medicaid patients would not be consistent with the explicit language of

the law and could not be done without a statutory change.

Comment: Two commenters opposed the statutory definition of an

advance directive because it includes only written instructions

recognized under State law. The commenter believes this definition is

too narrow and precludes the recognition of other types of

instructions, such as oral instructions given by competent patients,

which are already commonly used in many States.

Response: Sections 1866(f)(3) and 1902(w)(4) of the Act clearly

specify that the term ``advance directive'' applies only to ``written

instructions''; legislative action would be necessary to amend this

definition. It is important to note, however, that in describing an

individual's right to make decisions concerning medical care, sections

1866(f)(1)(A)(i) and 1902(w)(1)(A)(i) of the Act recognize both the

``right to accept or refuse medical or surgical treatment'' and ``the

right to formulate advance directives''. Thus, we believe that the

statute does not preclude an individual from making oral instructions

or a provider from executing such instructions, consistent with State

law.

Comment: Several commenters requested that we define certain terms

for purposes of these rules, such as ``admission,'' ``adult,''

``incapacitation,'' ``incompetence,'' ``mental disorder,'' and others.

The commenters offered many examples of applicable State definitions,

particularly with regard to the meaning of ``incapacitation'' for

decision-making purposes. Another commenter suggested that we should

require States to furnish their Medicaid providers with a written

description of all applicable State laws that determine the

circumstances under which an individual under 18 is entitled to make

his or her own decisions concerning advance directives and other

medical care issues under the purview of this regulation.

Response: We recognize that many of these terms have already been

given varying definitions under State law. In that the statute is

silent on defining these terms, we believe that Congress intended to

defer to State law. Therefore, we are not defining these terms in the

regulations. Section 1902(a)(58) of the Act already requires that the

State, acting through a State agency, association, or other private

nonprofit entity, develop a written description of the law of the State

(whether statutory or as recognized by the courts of the State)

concerning advance directives that would be distributed by providers or

organizations. Sections 1866(f)(1)(a) and 1902(w)(1) of the Act require

that providers furnish written information to each individual

concerning an individual's rights under State law to accept or refuse

medical or surgical treatment and to formulate an advance directive. If

there were a State law in effect that addressed the rights of

individuals under the age of 18 to formulate an advance directive and

make medical treatment decisions, a description of this law should be

furnished to all Medicaid providers. As stated above, terms such as

adult individual are defined in accordance with applicable State law.

Comment: Two commenters questioned the effectiveness of oral

instructions, especially those given before the enactment of the

advance directive provisions. The commenters know of some long-term

care residents who are unable to execute an advance directive, but have

already given oral instructions to their physicians (for example, no

tubes, no cardiopulmonary resuscitation), and this has been clearly

documented in the medical record. Also, a commenter noted that some

physicians and attorneys believe that if there is no written advance

directive, then the patient has lost his or her right to choice and

these patients are therefore subject to the physician's decision based

on accepted medical standards.

Response: Sections 1866(f)(3) and 1902(w)(4) of the Act define an

advance directive as a written instruction recognized by the State and

relating to the provision of health care when an individual is

incapacitated. The advance directives provisions apply to patients

admitted after December 1, 1991. As we have repeatedly noted, however,

this statute in no way abridges any rights a patient may have under

Federal or State law to specify or refuse medical treatment. The

statute simply establishes requirements with respect to the

dissemination of specific information about individuals' rights

regarding medical treatment, including an individual's right to accept

or refuse medical or surgical treatment and the right to formulate an

advance directive. Individuals are not required to execute an advance

directive. In fact, providers are specifically prohibited from

conditioning the provision of care on whether or not an individual has

executed an advance directive. Moreover, the provider must disseminate

copies of its written policies respecting the implementation of such

rights.

These regulations in no way contravene any existing instructions

concerning an individual's medical treatment. Therefore, previous

instructions remain in effect, unless amended or altered by subsequent

instructions submitted in accordance with State law. Generally, such

subsequent instructions can be in the form of the patient's oral

instructions or the discovery of new instructions contained in or

authorized by a new advance directive, subject to applicable State law.

Comment: Several commenters asserted that the statutory

requirements concerning advance directives are derived from the more

fundamental right of the competent individual to accept or refuse any

suggested medical intervention. These commenters believe that to

require notification of the derivative right to formulate an advance

directive without explanation of the underlying right is likely to

result in an incomplete and potentially misleading statement of

patients' rights.

The commenters further asserted that our suggestion that the

statute applies only to circumstances in which the individual has left

written instructions that become effective only after the individual

becomes incapacitated construes the definition of advance directive too

narrowly. They believe that the statutory language is intentionally

general and should not be interpreted as a specific limitation on the

date an advance directive becomes effective. In some States, a durable

power of attorney for health care may be effective when signed, rather

than effective only upon the determination of

[[Page 33268]] incapacity. Although the instrument may be effective

immediately, the individual still maintains the power to control health

care decisions while competent; so, as a practical matter, the

instrument may not be used until the principal loses capacity.

Nevertheless, legally the instrument is effective when signed. Since

the statute is not intended to change substantive State law or limit

the kinds of advance directives recognized by the States, the limiting

language in the preamble of the interim final rule should be avoided.

Other commenters argued that the regulations should emphasize that

providers and organizations must give equal weight to the right to

accept or refuse treatment, the right to sign or not sign a directive,

and the right to sign a legal directive other than the form drawn up by

the State so long as that directive comports with State law.

Response: We recognize that every individual has an underlying

right to accept or refuse any suggested medical intervention. These

regulations are not intended to place limitations on this right. We

agree with the commenters that there is nothing in the law or these

regulations that diminishes an existing right to make or execute a

directive (or to request or to refuse medical treatment) under current

State or Federal law. We did not intend to give the impression that

this was the case in the preamble to the March 6, 1992 interim final

rule. In this final rule, we emphasize in several responses to comments

that an individual's right to accept or refuse medical treatment is not

limited by these advance directive provisions, and we have been very

careful to ensure that our regulations do not extend a broader reach to

these provisions than the law allows. In fact, sections 1866(f) and

1902(w) of the Act and Secs. 417.436(d)(1)(i) and 489.102(a)(1)(i) of

the regulations specifically require that the written instructions

disseminated to adult individuals must include information about an

individual's rights under State law to accept or refuse medical and

surgical treatment and the right to formulate advance directives.

As noted above, sections 1866(f) and 1902(w) of the Act define an

advance directive as ``Written instructions, such as a living will or

durable power of attorney for health care, recognized under State law

(whether statutory or as recognized by the courts of the State) and

relating to the provision of such care when the individual is

incapacitated.''

Thus, we continue to believe that the focus of these regulations is

two-fold: to ensure the dissemination of information about an

individual's right to accept or refuse medical or surgical treatment

and about an individual's right to formulate an advance directive.

Comment: A commenter suggested that we clarify the statement in the

preamble to the March 6, 1992 interim final rule that ``care cannot be

delayed or withheld because the individual has not executed an advance

directive or the provider is waiting for an advance directive'' (57 FR

8198). Another commenter suggested that we make it clear that the

restriction against delaying care applies only to treatment decisions

made by providers. If the patient requests that care be delayed because

he or she is waiting for an advance directive to be executed (or for

any other reason), the provider must, by law, respect the patient's

wishes.

Response: Under sections 1866(f)(1)(c) and 1902(w)(1)(c) of the

Act, providers may not condition the provision of care or otherwise

discriminate against an individual based on whether or not the

individual has executed an advance directive. Thus, in general, a

patient is entitled to receive the necessary care ordered by a

physician that a provider under normal procedures must furnish. In

addition, a provider cannot delay or deny care while waiting for an

advance directive to be executed, unless otherwise instructed by the

patient in accordance with applicable State law. However, the last

sentence of both section 1866(f)(1) and 1902(w) of the Act makes clear

that a provider cannot be required to furnish care that conflicts with

an advance directive. Therefore, once the provider learns that an

advance directive has been executed that stipulates refusal of care,

that directive takes precedence over any physician orders or normal

provider procedures, unless there is a State law that permits a

provider, or any agent of such provider, to conscientiously object to

implementing an advance directive.

We agree that the patient always has the option to refuse

treatment, and the advance directive regulations do not impede an

individual from exercising that option. Thus, as long as a patient is

capable of communicating his or her wishes regarding treatment, the

contents of an advance directive may not be controlling. By definition,

implementation of an advance directive takes place at the time the

individual is incapable of communicating his or her preference to

accept or refuse medical or surgical treatment.

Written Information Provided to Individuals

Comment: Several commenters suggested that we permit the use of as

many health care disciplines as possible to distribute and obtain

information on advance directives from patients. Another commenter

suggested that only qualified healthcare professionals (for example,

nurses, physicians, social workers, etc.) be used. This would preclude

admission clerks, nursing assistants, and other support personnel from

disseminating and collecting information on advance directives.

Response: Sections 1866(f)(1)(A) and 1902(w)(1)(A) of the Act

require the dissemination of written information concerning both State

law and provider policies. However, these sections do not identify any

particular disciplines or persons to disseminate this information, and

we do not believe that any particular training is required to

disseminate written materials or obtain information from patients

regarding whether or not they have executed an advance directive.

Therefore, we do not believe it is appropriate to restrict providers

and other eligible organizations in terms of the type of personnel they

decide to use to meet these requirements. We recognize that many

providers may wish to accompany advance directives materials with an

explanation and direct personal contact. However, an accompanying

explanation and direct personal contact are not required by the

statute, but are left to the provider's discretion and to applicable

State law.

Comment: One commenter suggested that we require individuals to

discuss their wishes regarding future medical care with their

physician. In addition, the commenter believes that these regulations

should require that physicians be responsible for documenting this

discussion in detail in the patient's medical record. In accordance

with State law, this document would serve as an advance directive if no

actual written document is drawn up and executed.

Response: Sections 1866(f)(1)(A) and 1902(w)(1)(A) of the Act

clearly place the obligation to provide information and document the

existence of an advance directive on certain specific health care

providers, with which the Medicare and Medicaid programs have

agreements. We believe it would be inconsistent with the statute to

implement a requirement as broad as that suggested by the commenter.

Comment: One commenter asserted that, when disseminating

information about advance directives, a provider's staff should not be

required or expected to give detailed explanations of State law,

regulation or judicial decisions or to assist the client to develop an

advance directive. The commenter [[Page 33269]] believes that most

agencies and facilities do not have the legal expertise necessary to

perform these activities. In addition, the commenter suggests that

HCFA's interpretive guidelines should address an individual's right to

refuse to discuss the subject of advance directives (for example, when

an individual's religious or personal beliefs preclude discussion).

Response: Sections 1866(f)(1)(A) and 1902(w)(1)(A) of the Act

require providers to provide written information concerning an

individual's rights under State law (whether statutory or as recognized

by the courts of the State) concerning the right to accept or refuse

medical or surgical treatment and to formulate an advance directive.

These sections do not require detailed explanations of State law

concerning such rights. We believe that the exact content and

complexity of laws concerning these rights vary from State to State and

thus it may be burdensome for some States to provide detailed

explanations of State law. As we stated in the interim final rule, we

believe that it would be consistent with the statute to use a summary

notice that covered the legally-required elements (that is, describing

the purpose and the concept of an advance directive and the

individuals' rights under State law to accept or refuse medical or

surgical treatment under State law, and describe the provider's policy

and procedures). However, we do not wish to discourage providers from

voluntarily training staff to assist patients in developing an advance

directive, in any way permissible by State law. We do not believe it is

necessary to state explicitly in our guidelines that an individual may

refuse to discuss advance directives. We expect that providers or other

eligible organizations will address this sort of situation merely by

documenting in the medical record that the individual was provided

written information concerning advance directives and chose not to

discuss his or her rights in this area.

Comment: One commenter suggested that a hospital should not be

required to distribute exact copies of its policies and procedures to

patients upon admission to the hospital. Instead, the commenter

suggested that it should be sufficient to supply a statement that the

hospital follows the State law and a statement concerning the

availability of the hospital's policy and procedures. Other commenters

expressed concern that the provision of exact copies of policies and

procedures to individuals would mean that they would receive voluminous

materials that they would probably find somewhat meaningless, confusing

and much less useful than they would find prepared summaries written

more for their understanding. Several commenters believe that

furnishing patients with written policies with respect to

implementation of advance directives can be time-consuming because

existing medical policy documents would have to be converted into more

easily understood summaries. Yet, these more easily understood

summaries may inordinately simplify a complex decision-making process.

Response: We agree that exact copies of medical staff policy

documents need not be provided to patients. Sections 1866(f)(1)(A) and

1902(w)(1)(A) of the Act require that the individual receive certain

basic information concerning an individual's rights under State law,

including the right to accept or refuse medical and surgical treatment,

the right to formulate advance directives, and the policy of the

hospital or other provider with respect to implementing such rights

under the law. While we recognize that preparing this material may be a

challenge, the law requires that it be done, and providers must take

the necessary steps to ensure the written information is understandable

to the patients. We provided a detailed bibliography of published

materials on this matter in the March 6, 1992 interim final rule (57 FR

8200), and a number of national groups have continued to work to

provide materials that will assist hospitals and other providers in

this task. Although we do not intend to prescribe the content and

format of the written information, it must clearly convey to

individuals the required basic information about the individual's

rights under State law to accept or refuse medical or surgical

treatment, the right to formulate advance directives and the provider's

written policies respecting the implementation of such rights. Further

explanation of an individual's rights pertaining to advance directives

should be made available upon request.

Comment: One commenter believes that good patient/physician

decision-making practices may be hampered since other disciplines such

as nurses actually may be disseminating advance directive material to

the patient, as well as answering any questions the patient may have

concerning advance directives. To avoid misunderstandings and potential

trauma to patients, the commenter suggested that physicians or State

health officials distribute this information to a patient before

admission to a hospital.

Response: We believe that a clear understanding of an individual's

rights in this area should improve the quality of patient/physician

decision-making, regardless of who disseminates the information. We

agree that the optimum time for the individual to receive this sort of

information is before entering the hospital and presume that the

community education programs will accomplish this over time. As noted

above, we have no statutory authority to designate specific disciplines

to present this information to individuals and, in the absence of State

law, we believe that this matter should be left to the discretion of

the provider.

Comment: One commenter opposed the statement in the interim final

rule that when a patient is being transferred from a hospital to a

nursing home, the hospital discharge planner may provide the

information (including the nursing home's policies regarding the

implementation of advance directives) on behalf of the nursing home in

the course of coordinating the smooth transfer of the patient (57 FR

8197). The commenter believes that such coordination promotes the

possibility that some patients may not receive the information. In

addition, the commenter expressed concern that these arrangements may

result in disputes between hospitals and nursing facilities concerning

responsibility for errors in disseminating required information.

Response: While we recognize that coordination between hospitals

and nursing homes with respect to advance directives should be

carefully planned and implemented, we do not believe that these

arrangements should be prohibited. However, providers and organizations

are by no means relieved of their responsibility for meeting all

advance directive requirements when they enter into a coordinated

arrangement such as the one discussed above between a hospital and a

nursing home. Any deficiencies found on the part of a hospital or

nursing home in complying with the advance directive requirements will

be subject to the enforcement procedures described above in section

II.D. We note that the illustration of a hospital providing a nursing

facility's information about rights under State law on behalf of the

nursing facility was an example of permissible coordinating efforts and

not a requirement. We have revised Secs. 489.102(a)(1)(i) and

483.10(b)(8) to state that providers are permitted to contract with

other entities to furnish this information but are still legally

responsible for ensuring that the advance directive requirements are

met.

Comment: One commenter suggested that there is a potential conflict

between the implementation of an advance [[Page 33270]] directive

executed by a client of a home health agency (HHA) and the requirements

for a physician order under 42 CFR 484.18. Those regulations require

that HHAs administer drugs and treatment only under the orders of a

physician. A conflict may occur if the patient's physician refuses to

provide orders to enable the HHA to implement the patient's advance

directive. To resolve this potential conflict, the commenter suggests

that documentation of contact with the physician and of the physician's

orders or refusal of orders to implement the client's directive be

recognized as sufficient to comply with the advance directive

requirements.

Response: The potential conflict identified by the commenter can be

addressed in the written information regarding the HHA's policies. This

information should alert the patient to the HHA's reliance on physician

orders to effectuate an advance directive or otherwise respond to a

patient's request to accept or refuse treatment. It also would explain

how its employees would routinely follow those orders or whether an

objection on the basis of conscience (by the physician or the HHA)

would prevent it. Therefore, if a patient is informed that the HHA

would rely on the physician's orders to effectuate the advance

directive, a patient should, prior to beginning to receive care,

discuss his or her advance directive with the physician. If the patient

is informed that the physician, due to an objection on the basis of

conscience, would not implement the advance directive, then the patient

may request either treatment from another physician who would honor the

advance directive or transfer to another HHA.

A related issue involves HHA compliance with the advance directive

requirements. Compliance with the advance directive provisions is a

condition of participation. If an HHA fails to honor an advance

directive and it has not informed the patient of a reservation of

conscience permitted by State law, the HHA would be in violation of a

standard under the HHA patient rights condition of participation (see

Sec. 484.10(c)(2)(ii)). If it failed to correct the deficiency, the HHA

would be subject to termination of the provider agreement under

Sec. 489.53.

Comment: One commenter stated that there should be a hospital

billing code for counseling the patient regarding rights to have an

advance directive.

Response: The advance directive provisions do not include authority

to modify the current hospital payment system in order to assist

providers in complying with the advance directives requirements.

Therefore, we have not included provisions relating to payment (or

billing codes) in this regulation. However, hospitals as well as other

providers reimbursed under the cost reimbursement system can receive

reimbursement for the incurred administrative costs associated with the

advance directive requirements. No separate billing code is necessary.

Comment: One commenter suggested that we revise the regulations to

require that a hospital disseminate information on organ donation at

the same time it disseminates information on advance directives.

Response: Section 1138(a)(1) of the Act requires hospitals to have

organ procurement protocols, including procedures for approaching

appropriate donors or their families. We have carefully considered

requiring that hospitals disseminate information on both subjects at

the same time. However, unlike section 1866(f)(2)(A) of the Act,

section 1138 of the Act does not require that a hospital disseminate

organ donation information upon admission. Consequently, we believe

that organ donation information should be disseminated when it is

deemed most appropriate by the provider.

Documenting the Medical Record

Comment: Two commenters suggested that any information documented

in an individual's medical record concerning the execution of an

advance directive be kept confidential to protect each individual's

privacy interests.

Response: Information about advance directives that is documented

in an individual's medical record would be subject to the same

confidentiality protection as other information in the medical record.

For example, under the ``Medical record services'' hospital condition

of participation, Sec. 482.24(b)(3) specifies that hospitals must

ensure the confidentiality of patient medical records and that

information from or copies of records may be released only to

authorized individuals. Hospitals are also required to ensure that

unauthorized individuals cannot gain access to or alter patient

records. These requirements apply to information entered into the

medical record as a result of the advance directive requirement.

Similar confidentiality protections are set forth in the regulations

governing other providers.

Comment: We received a number of comments concerning access to the

advance directive. One commenter questioned the logistics of how a

provider will gain access to an individual's advance directive. The

commenter suggested that the regulations should establish a mechanism

through which the contents of a person's advance directive document are

communicated to the health care provider. Two commenters suggested that

we require that providers collect a copy of the individual's advance

directive or information as to where the advance directive can be

located. One commenter recommended that we require providers to

document any known changes to or rescissions of previous advance

directives.

Response: These comments suggest that HCFA should specify

procedures and requirements that are beyond the scope of this

legislation. The statute does not address the issue of how a provider

will locate or gain access to an advance directive. Sections

1866(f)(1)(B) and 1902(w)(1)(B) of the Act require only that the

provider document in the medical record whether or not an individual

has executed an advance directive. The statute does not require the

collection of copies of an advance directive or the collection of

information about the location of an advance directive, nor does it

require a provider to document known changes or rescissions to prior

advance directives. However, section 1866(f)(1)(D) of the Act does

specify that providers must maintain policies and procedures that

ensure compliance with requirements of State law. Thus, providers must

comply with State laws that may require the documentation of

information concerning the location of and access to advance

directives, and copies of advance directives would need to be located

and possibly held by the provider when the State law requires this

result.

In summary, we believe that the document will be provided by the

patient when asked or will be located when its use becomes necessary.

Moreover, the statute intended to defer to State law the questions

about the creation and preservation of advance directives. Providers

should look to State statutory and case law for guidance on access to

advance directives. We encourage providers to incorporate State

statutory and case law into their written policies.

Comment: One commenter stated that our suggestions in the preamble

to the interim final rule (57 FR 8197) on possible methods for

ascertaining whether or not an individual has executed an advance

directive, for example, the use of direct dialogue and preadmission

forms, would, if made mandatory, place an unfair burden upon providers.

Another commenter suggested that in order to prevent an administrative

burden and potential [[Page 33271]] liability issue, the final

regulations require that providers make reasonable efforts to acquire

information as to whether or not an individual has an advance directive

and document this information in the medical record. The commenter

requests clarification regarding a provider's liability if it could not

determine if an individual has executed an advance directive and later

learns that one does exist. The commenter requests more information

about the provider's responsibility for any treatment decisions that

may have been taken that may run counter to the advance directive.

Response: We recognize that there are many possible methods by

which providers may determine the existence of an advance directive.

The interim final rule did not mandate any method but suggested several

alternatives. We agree that a provider should have to make only a

reasonable effort to determine if an adult individual has an advance

directive. Except when an individual is incapacitated at the time of

admission, a reasonable effort can be defined as simply giving out the

information and documenting in the medical record whether or not the

individual has executed an advance directive. If the patient is

incapacitated at the time of admission, then the provider should have

follow-up procedures to determine if the patient has an advance

directive or when the patient may be given the information directly.

(This issue is further discussed below under the heading ``Individuals

Incapacitated at Admission.'')

For Federal compliance and enforcement purposes, we would not hold

a provider responsible for failing to ensure compliance with an advance

directive if the patient never furnished it to the provider or

responded negatively when the inquiry was made about having an advance

directive. However, in accordance with State law, the provider may be

liable for treatment decisions made after learning that an advance

directive exists, that may run counter to the advance directive. Also,

we note, that if State law holds providers to a higher standard, State

law would prevail.

Comment: Two commenters asserted that the requirement in

Sec. 489.102(a)(2) that providers ``document in the individual's

medical record whether or not the individual has executed the

implementation of such rights'' was unclear. The commenters suggested

that the phrase ``implementation of such rights'' be replaced with ``an

advance directive in accordance with State law.'' The commenters

believe that the requirement as written could be broadly interpreted to

include documenting all acceptances and refusals of treatment, thus

resulting in an increased burden on providers and a waste of direct

care nursing time, as well as increasing costs associated with these

requirements.

Response: We agree that Sec. 489.102(a)(2) is unclear and are

revising it to state that providers must ``Document in the individual's

medical record whether or not the individual has executed an advance

directive.''

Comment: Three commenters suggested that the final regulations

require that providers ask patients if they have executed an advance

directive.

Response: The statute does not specifically require that direct

dialogue be the method for obtaining the information. Although we

believe that this is frequently the most effective way to obtain the

information, we are also aware of situations in which other methods may

be appropriate. For example, some health maintenance organizations deal

with new enrollees primarily by mail, including providing and obtaining

information concerning advance directives by mail. Thus, we do not

believe that the regulations should prohibit the use of methods other

than direct dialogue to discover whether or not an individual has

executed an advance directive.

Comment: Several commenters supported our suggestion in the interim

final rule that providers could use the preadmission process to obtain

the information necessary to document in the medical record the

existence of an advance directive. One of these commenters suggested

that another method to obtain information regarding the existence of an

advance directive is at the time of preadmission testing. Another

commenter suggested that more guidance be issued concerning other

possible methods of obtaining this information.

One commenter suggested that if a provider chooses to obtain

information about whether individuals have advance directives through

its preadmission process, HCFA should not specify the type of form to

be used. The commenter recommended that we leave this decision to the

discretion of the provider.

Response: We agree that information concerning whether or not an

individual has executed an advance directive may be obtained at the

time of preadmission testing. In addition, we agree that there are many

ways to determine whether or not an individual has executed an advance

directive. However, we have not required any particular method in order

to enhance provider flexibility in this area.

Although we suggested in the interim final rule that providers may

use forms to obtain advance directive information, we do not intend to

specify any form for the provider's use.

Information Collection Estimate

Comment: We estimated in the interim final rule that the

information collection burden associated with the requirement that

providers document in the medical record whether an advanced directive

exists would be approximately 3 minutes per medical record. Many

commenters stated that the 3-minute estimate appears to account only

for making notation in the medical record and does not include the time

needed to help individuals understand their rights, consult with other

disciplines, for example, doctors, nurses, social workers, pastoral

care clergy, etc. Others believe our estimate should include time spent

in responding to phone calls and written inquiries by affected

individuals. Some commenters suggested that it would take at least 15

to 30 minutes to explain the characteristics of advance directives,

obtain the required signatures and follow up to assure compliance.

Another commenter asserted that it will take an immeasurable amount of

time to accomplish this documentation; therefore, it is an unfair

burden to enforce this requirement, especially without separate

reimbursement.

Response: The 3-minute estimate only takes into account the amount

of time required to document in the medical record whether an advance

directive exists. The Paperwork Reduction Act is concerned only with

the burden of recordkeeping under this requirement as a result of these

regulations. This estimate is not based on the time necessary to

develop policies and procedures, printing costs and assembling of the

material for the information packets for adult individuals. This

estimate does not include the time spent explaining an individual's

rights under Federal and State laws, nor any consultation with other

disciplines to help the individual execute an advance directive that

the provider or organization may choose to provide. The statute merely

requires the dissemination of information, obtaining information as to

whether the individual has executed an advance directive and the

documentation of this information in the individual's medical record.

Therefore, we believe that the estimated burden of 3 minutes per

medical record is accurate. [[Page 33272]]

Comment: In light of the requirement placed upon nursing facilities

by the Omnibus Budget Reconciliation Act of 1987 (OBRA '87) that rights

must be explained to residents in a manner that they can understand, a

commenter asserted that the 3-minute information estimate is inaccurate

for nursing facilities. The commenter believes that the burden imposed

on these facilities is at least 30 minutes to explain the advance

directives requirement in a manner the resident can understand.

Response: The commenter is correct that, in accordance with

resident rights provisions of OBRA '87, Sec. 483.10(b) requires

facilities to inform residents both orally and in writing in a language

that the resident understands of his or her rights, including the

advance directive provision. However, as explained above, the

information collection estimate does not include time to explain the

advance directives requirements. Therefore, the burden to which the

commenter refers is not appropriately part of the advance directives

estimate.

Comment: One commenter misinterpreted the estimate of 15 million

individuals used in the calculation of the information collection

burden as representing the number of individuals who have executed

advance directives.

Response: Fifteen million did not represent the number of persons

who have executed advance directives, rather it represented the

projected number of Medicare beneficiaries and Medicaid recipients who

were expected to receive services from providers and organizations

subject to these regulations. In other words, in the interim final

rule, we projected that in FY 1992 providers and eligible organizations

would be required to meet the advance directive requirements, including

proper documentation of the medical record, for at least 15 million

Medicare and Medicaid beneficiaries/recipients.

Discrimination Based on Advance Directive

Comment: Although opposed to the statutory requirements concerning

advance directives because they appear to place the Federal government

in the role of advancing euthanasia in the United States, one commenter

urged HCFA to promulgate regulations that ensure that providers and

organizations are prohibited from exerting any form of coercion, or

undue influence to make an individual feel that he or she must execute

an advance directive. In addition, the commenter believes we should

make it clear that States are not obligated by these regulations to

pass laws addressing advance directives.

Response: Sections 1866(f)(1)(C) and 1902(w)(1)(C) of the Act, as

well as our implementing regulations, clearly prohibit any type of

discrimination against individuals based on whether or not an

individual has executed an advance directive. Thus, we agree with the

commenter that providers and organizations are not permitted to coerce

or pressure any individual into executing an advance directive. As

stated in the sample public information document published in the

interim final rule (57 FR 8199), the law does not require an individual

to execute an advance directive. Similarly, we agree with the commenter

that these rules do not require States to enact legislation to address

advance directive requirements.

Comment: Two commenters recommended that we make it clear that

discriminating against an individual because he or she has an advance

directive is strictly prohibited. One commenter believes there is a

real danger that an advance directive may deprive patients of the

normal care that they would receive if there were no advance directive.

Response: Again, sections 1866(f)(1)(C) and 1902(w)(1)(C) of the

Act and the regulations both prohibit any discrimination based on

whether or not the individual has an advance directive. In addition, in

the event that problems are encountered, individuals have the right to

submit a complaint to the State agency or regional office for

investigation.

Provider Responsibilities To Ensure Compliance With the Requirements of

State Law Concerning Advance Directives

Comment: A commenter suggested that the regulations require that a

facility's policies for objections on the basis of conscience be

reviewed annually for compliance with State law. In addition, the

commenter suggested that the facility's advance directive informational

packages should contain a statement that its policies have been

reviewed and found in compliance with State law and should cite the

State law authority.

Response: Under sections 1866(f)(1) and 1902(w)(1) of the Act,

providers have been required since December 1, 1991 to maintain and

distribute written policies and procedures concerning an individual's

rights under State law to accept or refuse medical or surgical

treatment and to formulate advance directives, and the providers'

policies for ensuring compliance with such rights. Section

489.102(a)(1)(ii) specifies that providers must provide written

information to all adult individuals concerning its written policies

respecting the implementation of such rights, including a clear and

precise statement of limitation if the provider cannot implement an

advance directive on the basis of conscience. As discussed in further

detail below, we are revising Sec. 489.102(a)(1)(i) to require that

providers must update and disseminate amended information as soon as

possible, but no later than 90 days from the effective date of the

changes to State law. Therefore, we do not believe it is necessary to

require a separate annual review of compliance with State laws

concerning objections on the basis of conscience. HCFA has various

mechanisms, such as certification surveys, for assessing provider

compliance with rules and regulations. We do not believe it is

necessary for a provider's documents to contain a statement addressing

approval findings of compliance surveys. In general, we will rely upon

the State (for example, during its licensure inspections) to determine

if its advance directives laws are being enforced properly.

Comment: Two commenters suggested that the regulations address the

extent of the provider's responsibility to determine the validity of an

advance directive. They believe that the advance directive is valid if

it appears to meet the formal requirements of applicable State law,

unless the provider knows, or has reason to know, otherwise. Also, the

commenters suggested that a provider's written policy should explain

the extent to which advance directives that are prepared in other

jurisdictions will be honored if they meet the formal requirements of

applicable State law. One commenter suggested that we clarify that the

most recently executed advance directive should be the one the provider

relies upon in making determinations relating to health care delivery.

Response: The statute does not address the issues raised by these

commenters. As a practical matter, State laws typically govern the

procedures for determining the validity of advance directives and how

such documents from other jurisdictions will be honored. In general, we

would expect that providers will comply with the advance directives of

individuals from other States, unless the directive conflicts with

State law or the provider conscientiously objects, in accordance with

State law. In addition, although not required by the statute, we

believe it is appropriate for providers to confirm with individuals the

contents of their advance directive to ensure that the

[[Page 33273]] provider is relying upon the most recently executed

advance directive.

Comment: One commenter argued that it is inappropriate to require

providers to ensure compliance with State law because the commenter

believes that a provider is prohibited from practicing law and

interpreting the meaning of statutes and case law. The commenter

suggested that the requirement of Sec. 489.102(a)(4) that providers

``ensure compliance with requirements of State law'' be revised to read

``Review the advance directive to ascertain whether or not there are

advance directive requirements in the execution of the document that

have not been met.''

Response: Sections 1866(f)(1)(D) and 1902(w)(1)(D) of the Act

specify that providers are required to ensure compliance with the

requirements of State law. Thus, the regulations implementing these

provisions are not discretionary. Moreover, we do not agree with the

commenter that this requirement involves the unauthorized practice of

law by providers. It has been a long-standing policy of the Medicare

and Medicaid programs to hold participating providers responsible for

compliance with applicable State and Federal laws related to the

overall health and safety of patients. For example, Sec. 482.11

establishes compliance with Federal, State and local laws as a

condition of Medicare participation for hospitals.

Comment: One commenter suggested amending Sec. 489.102(a)(4) to

clarify that interference with a physician's conduct toward his or her

patient is prohibited. The commenter believes that this provision may

be interpreted as constituting the practice of medicine by the hospital

and would, therefore, be illegal under State laws prohibiting the

``corporate practice of medicine.'' Another commenter asserted that

since we are not giving guidance to providers on what is meant by the

phrase ``ensure compliance with requirements of State law regarding

advance directives'', we need to acknowledge that providers cannot

control the medical judgement of physicians in individual cases.

Response: We do not agree that existing language at

Sec. 489.102(a)(4) is illegal under State laws prohibiting the

``corporate practice of medicine''. While it may be true that a

hospital or other provider may not direct the specific actions of an

individual physician in a case, a provider may determine who may or may

not be a member of its medical staff and may set conditions for

membership. We believe that it may be prudent for a provider's advance

directives policy to be developed with input from its medical staff and

that, during the process of granting admitting privileges to

physicians, it would be reasonable to require physicians to comply with

provider policies and State law on the matter of advance directives.

Therefore, because most hospitals include compliance with advance

directives requirements as a condition of membership for physicians, we

do not believe it is necessary to issue regulations regarding this

issue.

Comment: One commenter requested we amend Sec. 489.102(a) by adding

new language to require that a documented advance directive would

``take precedence over the facility's normal procedures, to the extent

required by State law''.

Response: We agree that an advance directive should take precedence

over a facility's normal procedures to the extent authorized by State

law. However, we believe existing regulations at Secs. 489.102(c) and

417.436(d)(2)(i), which state that providers and organizations are not

required to provide care that conflicts with an advance directive,

already establish that advance directives take precedence over a

facility's normal procedures.

Comment: Some commenters had questions concerning our discussion in

the interim final rule (57 FR 8197) of situations in which State law on

advance directives is not clear or where there is no State law

addressing advance directives. Two commenters asserted that in the

absence of State law on the subject, it is imperative that the

regulations be flexible enough to include common law and institutional

practices. Two other commenters questioned our suggestion to rely on

``institutional practice'' in lieu of a State statute. The commenters

believe that few institutions or organizations have had enough direct

experience to dictate the best way to accomplish statutory requirements

concerning advance directives. These commenters noted that the American

Bar Association has stated that many providers have interpreted State

laws concerning advance directives in an overly restrictive manner. The

commenters believe that, as a result, many providers have failed to

develop a full range of effective patient-oriented decision-making

practices. The commenters suggested that providers be encouraged to

interpret statutory silence as an invitation to develop ``best

practice'' procedures based on emerging notions of good clinical

practice and professional standards.

Response: Sections 1866(f)(1)(D) and 1902(w)(1(D) of the Act

specify that providers are to ensure compliance with requirements of

State law (whether statutory or as recognized by the courts of the

State). We agree that common law and institutional practices can be of

assistance when the law is unclear or there is no State law regarding

advance directives and believe that these regulations are flexible

enough to include common law and institutional practices along with

statutory law.

Also, we encourage providers to develop ``best practice''

procedures based on emerging notions of good clinical practice and

professional standards. We also encourage the American Bar Association

and other professional organizations to continue working with providers

and State legislatures to ensure that State laws are clearly written,

revised and updated where necessary, and to ensure that the Federal

advance directives requirements are implemented in accordance with

applicable State law.

Community Education

Comment: Two commenters asserted that the interim final rule lacks

guidance on what constitutes minimally sufficient educational efforts.

The commenters suggested that the final rule should require that the

provider's written community education plan include at a minimum: (1)

its intended target audiences, (2) the frequency of its educational

efforts, and (3) the expected penetration of the target population to

be attained by the educational efforts.

Response: We believe that the intent of the community education

requirement is to educate as large a number of individuals as would be

reasonable for that provider. However, as noted by the commenters, the

interim final rule did not specify a minimum level of activity for the

community education effort. In an effort to determine if further

guidance was needed in this area, our regional offices recently

conducted a survey of a small sample of providers to determine the

level of community education efforts among providers. For sample

purposes, the regional offices accepted copies of any document

generated to publicize and conduct community education efforts. The

results indicated that providers are using a variety of methods, for

example, workshops, seminars, public meetings, health fairs, civic

affairs, and the media.

Our review of the many methods and types of community education

documentation maintained by providers leads us to believe that

providers are reaching targeted audiences, are conducting frequent

campaigns, and raising the advance directive issue

[[Page 33274]] before new audiences. Therefore, most of the commenter's

suggestions are currently being achieved by providers without explicit

guidance.

Based on the survey, we do not feel it is necessary to establish

the type of prescriptive requirements suggested by the commenters.

Instead, we are revising the regulations at Secs. 417.436(d)(1)(B)(vii)

and 489.102(a)(6) to require that providers must be able to document

their community education efforts. Although we are not limiting

provider flexibility in meeting this requirement, one possible method

for a provider to document its efforts would be to maintain copies of

any materials used as part of its community education programs. We

believe that the maintenance of community education documentation will

strengthen our ability to enforce the community education requirement

without limiting provider flexibility in this area.

While we believe that the requirement that providers maintain

documentation will assist us in evaluating the level of community

education efforts achieved by providers, we considered whether it would

be an added burden to require the maintenance of such documentation.

However, in all likelihood, providers will maintain copies of the

materials used as part of their community education efforts for their

own purposes, and we are not limiting the type of documentation that

would be acceptable. Thus, we do not believe that this requirement

constitutes an added burden.

Comment: One commenter suggests that physicians be targeted for

much of the national educational campaigns conducted by Federal and

State governments. The commenter believes that a national educational

campaign for physicians would ensure that terms such as medical and

surgical treatment are explicitly defined and consistently applied. The

commenter believes that this is necessary, particularly in nursing

facilities, because physicians are the critical link in implementing an

individual's advance directives. The commenter believes that a national

educational campaign would ensure that all parties (physicians,

residents, surrogate decision-makers) are knowledgeable concerning the

advance directives requirements.

Response: National educational campaigns are being addressed

separately from these rules. However, in accordance with sections

1866(f)(1)(E) and 1902(w)(1)(E), providers are responsible for the

education of physicians who are provider staff members or under

contract concerning advance directives. Also, we note that medical

schools and professional associations are providing training and

education to physicians on issues concerning advance directives and

patient's rights. With respect to what constitutes medical or surgical

treatment, State laws typically govern the definition of these terms.

Comment: One commenter suggested that for any written or oral

presentation concerning State law, a provider be required to: (1)

Obtain approval by the State; (2) use State material or; (3) conduct

joint presentations with State-recognized experts in the field.

Response: Individual States have the latitude to stipulate the use

of specific documents but may also permit providers, at their

discretion, to use other methods of informing patients. Also, we do not

believe it would be appropriate to require State approval of

presentations or to mandate the use of State-recognized experts in this

field. We believe adopting the commenter's suggestions would place an

unfair burden on both the State and providers. Therefore, we have left

this matter up to the discretion of the individual States.

Comment: One commenter asserted that enforcement of the community

education requirements would violate a provider's First Amendment

rights to freedom of religion. Therefore, the commenter recommended

that providers be allowed to exempt themselves from any community

education activities based on conscience.

Response: The statute does not permit providers to exempt

themselves from the community education requirement. However, both

sections 4206(c) of OBRA '90 and 1902(w)(3) of the Act permit a

provider, in accordance with State law, to object to implementing an

advance directive on the basis of conscience. Accordingly, we believe

it would be appropriate for a provider to register that objection as it

conducts its community education requirement. That is, the provider

must meet its obligation to conduct community education on advance

directives, but may inform the community that the State law offers a

choice that, because of a conscientious objection, it would not honor.

We believe that this information is valuable for community members to

have since it may affect their choice of a provider. Therefore, we are

not adopting the suggestion that providers be allowed exemptions from

the community education requirements.

Comment: One commenter believes that the community education

requirement is duplicative, inefficient, and does not provide any

further information to consumers concerning advance directives.

Therefore, the commenter suggested this requirement should be

eliminated. Another commenter suggested that this requirement is an

undue burden on hospitals and believes the responsibility to educate

the community should be borne only by Federal and State governments.

Another commenter objected to the requirement that facilities engage in

community education presentations or outreach efforts as a condition of

participation in Medicare. Rather, the commenter believes that

surveyors should find a facility in compliance with this requirement if

it produces evidence that it provides written materials to individuals

who come to the facility to investigate admission or to visit family

members.

Response: Section 1866(a)(1)(A) of the Act requires that in order

to participate in Medicare, any provider of services must meet the

advance directives requirements set forth in section 1866(f) of the

Act. Section 1902(a)(57) of the Act establishes a similar requirement

for Medicaid participation. Thus, the elimination of the community

education portion of the advance directive requirement would require

statutory changes. As to the scope of community education activities,

we do not believe it is appropriate to restrict this to individuals

expressing interest in admission, since many individuals in the

community who ultimately may require admission would profit from the

chance to learn about State laws on advance directives.

Comment: Several commenters requested clarification of the

statement in the preamble to the March 6, 1992 interim final rule (57

FR 8197) that ``whatever method is used, it must be in writing and

subject to survey review for compliance with Federal requirements.''

The commenters believe that many readers would presume ``in writing''

to refer to a provider's description of activities with respect to

community education, rather than the educational materials to be

distributed. Finally, some facilities believe that distributing copies

of their policies to the general public may be viewed as a form of

unwanted advertising by those individuals who are not interested in

particular facilities.

Another commenter objected to our suggestion that written

information distributed could be similar to what is required to be

disseminated to individuals upon admission. The commenter asserted that

Congressional intent is simply to foster discussion about advance

directives instead of [[Page 33275]] actively encouraging individuals

to execute an advanced directive.

Response: As discussed above, we have revised

Secs. 417.436(d)(1)(B)(vii) and 489.102(a)(6) to require that providers

must be able to document their community education efforts. The

community education itself may be carried out through a variety of

methods or formats, at the discretion of the provider. We are not

requiring the distribution of any particular written material as part

of a provider's community education efforts, although we recognize that

many providers may choose to distribute written descriptions of their

policies.

While we recognize that some individuals may view these programs as

a form of unwanted advertising, we note that community education is a

requirement under sections 1866(f)(1)(E) and 1902(w)(1)(E) of the Act

and thus, we have no discretion to permit exceptions to these

provisions.

We agree Congress intended to foster discussion about advanced

directives, but we do not believe that community education constitutes

encouraging individuals to execute advance directives. Again, community

education concerning advance directives should involve not only a

discussion of an individual's right to execute an advance directive,

but also of a patient's broader right to accept or refuse medical or

surgical treatment.

Comment: One commenter asserted that when community education is

done in concert with other providers and organizations, it would be

inappropriate for the attendees to receive written information

detailing policies and procedures specific to each provider

participating in community education efforts. Also, some commenters

believe that creativity among providers and organizations, such as the

use of lectures, seminars, videotaped programs and health fairs, will

be discouraged if they are required to use the same material

distributed to patients upon admission. Therefore, the commenter

suggested that we modify Sec. 489.102(a)(6), which requires that

community education materials regarding advance directives include a

provider's written policies regarding an individual's rights under

State law and a provider's policies concerning the implementation of

those rights. The commenter believes that we should instead require a

provider to make the information about its policies on the

implementation of the advance directives provisions available to

attendees only upon request.

Response: We agree with the commenter that, for community education

purposes, it may not be appropriate for a provider to distribute the

same documents as are used by the provider to meet its internal advance

directive obligations, especially when community education

presentations are conducted by several different providers or provider

types. The interim final rule merely presented several acceptable

options aimed at assuring providers that they would not necessarily

need to develop separate materials for both advance directive and

community education purposes. Clearly, separate materials could be

developed for each purpose, at the discretion of providers, and they

would not need to use the same written materials in all contexts. We

have amended Secs. 489.102(a)(6) and 417.436(d)(1)(vii) to clarify that

separate materials may be developed for both the advance directive and

community education requirements.

Comment: One commenter, although in support of the community

education requirement, was concerned that some health care providers,

particularly small rural hospitals and other isolated or financially

struggling institutions, may have problems meeting this requirement.

Therefore, the commenter suggested that HCFA provide funding support

for the educational initiatives.

Response: The advance directive provisions do not include authority

to modify the current hospital payment system in order to assist

providers in complying with the advance directives requirements.

Therefore, we have not included provisions relating to payment in this

regulation. However, hospitals as well as other providers reimbursed

under the cost reimbursement system can receive reimbursement for

incurred administrative costs, associated with the advance directive

requirements.

Comment: One commenter believes that the use of the public

relations offices to educate the community would preclude providers

from obtaining State and Federal funding for advertisement campaigns.

Another commenter believes the regulations should be revised to specify

that the use of Federal and State funds is permitted for reimbursement

of advance directive community education activities. The commenter

believes that the cost of advance directive activities should be

considered an allowable cost.

Response: Medicare policy has long provided that a provider's costs

of advertising to the general public are not allowable if the

advertising seeks to increase utilization of the provider's services.

However, advertising costs incurred in connection with a provider's

public relations activities are allowable if they are directly or

indirectly related to patient care. (See section 2136 of the Provider

Reimbursement Manual.) Thus, our suggestion in the interim final rule

that public relations offices be used to inform the community about

advance directives was not intended to suggest that we believe the

associated costs should be disallowed. To the contrary, we believe

public relations activities to inform the community on advance

directives should be common and accepted activities in the provider

community and that their costs generally would be related to patient

care. In summary, we agree with the commenter that for Medicare

providers that are paid on the basis of cost, the cost of advance

directives activities could be considered an allowable cost related to

patient care.

For Medicaid purposes, Federal financial participation at the 50

percent matching rate is available for expenses paid for by the State

for administrative costs the State incurs for implementing the Medicaid

requirements of this section. To the extent that States make additional

payments to providers for their costs of advance directives activities,

Federal financial participation is available at the Federal Medicaid

Assistance Percentage.

Comment: Two commenters requested that the final rule explicitly

define the size and parameters of the community for purposes of

defining a provider's obligation to participate in community education

efforts. The commenters suggested that, for nursing homes, these

regulations limit the facility's community education program

responsibilities to residents, their family members, resident and

family councils (if any) and staff. Another commenter believes that

education of the public at large should be solely the responsibility of

the Secretary of the Department of Health and Human Services (HHS).

Response: In general, we believe that Congress intended that the

concept of community encompass members of the general population that

could potentially be served by a provider, rather than the much

narrower interpretation suggested by the commenters. We believe that

the concept of ``community'' as embodied in the law relates to the

catchment area of the individual provider, which means that an HMO and

a hospital, for example, would likely have community areas very

different in scope. However, we do not intend to define the size and

parameters of a community for each facility subject to this final rule

because it would be cumbersome and overly prescriptive.

We note that the location, size, and other characteristics of the

population served by different providers are some [[Page 33276]] of the

factors that would impact on the manner in which a provider defines its

community for purposes of the community education requirement. The

various possible combinations of these factors make developing a fair,

equitable definition of community difficult. For example, the use of

geographical distances might place an unfair financial burden on rural,

isolated hospitals while it might not further educate the public in

urban areas where there are frequently multiple facilities in closer

proximity who may possibly serve some of the same patients.

Moreover, as noted above, we believe that our survey of community

education efforts by providers indicates that establishing more

prescriptive requirements in this area is not necessary. Providers are

already utilizing many different formats, working jointly to minimize

the financial costs associated with community education and have done

an excellent job without explicit guidance. Therefore, except with

regard to managed care plans, we do not intend to define the term

``community'' for the purposes of this regulation but instead will

afford providers the flexibility to define their own ``community''. As

noted below in section IV, community has been defined as ``service

area'' for managed care plans.

With regard to the suggestion that community education should be

solely the responsibility of the Secretary of HHS, we believe that

Congressional intent is clear on this subject. Sections 1866(f)(1)(E)

and 1902(w)(1)(E) of the Act require that providers conduct community

education activities, and section 4751(d) of Public Law 101-508 directs

the Secretary to conduct a national campaign addressing public and

medical and legal professions. The Secretary's public education

responsibilities clearly are separate and distinct from provider

responsibilities in this area. We note that providers, for example

would bear the responsibility for informing the public about applicable

State law requirements, which would be impossible to address in a

national public education campaign.

Comment: One commenter suggested that the final rule require

nursing facilities to conduct community education activities in the

context of the resident rights requirements that were established under

the nursing home reform provisions of OBRA '87. The commenter believes

that community education programs should include diverse points of view

on the issue of advance directives, including the right not to make an

advance directive, and that providers should not limit a patient's

options or influence patients as to the specific content of their

advance directive. In addition, providers should ensure that all

material presented is consistent with State law.

Response: Each nursing facility has the discretion to develop and

conduct education programs that best suit their targeted population,

and we encourage providers to coordinate their efforts to educate their

residents and the community. When Congress enacted the advance

directives provisions, it also amended the resident rights provisions

of the statute (1819(c)(1)(E) of the Act) to effectuate the advance

directives requirement for nursing homes. Therefore, it is expected

that nursing facilities will incorporate advance directive information

into their policies for informing residents of their rights. We note

that Sec. 483.10(b)(8) already specifies that facilities must ``inform

and provide written information to all adult residents concerning the

right to accept or refuse medical or surgical treatment and, at the

individual's option, formulate an advance directive.'' In addition,

Sec. 483.10(b)(8) requires that facilities include ``a written

description of the facility's policies to implement advance directives

and applicable State law.''

Comment: Two commenters noted that the outpatient setting is the

optimal forum for initial discussion of advance directives, rather than

at the time of acute illness. Accordingly, one commenter suggested that

we stress the need for providers to distribute information regarding

patients' rights under State law to the widest audience possible,

including outpatients and minors who have the capacity to be involved

in decision-making.

Response: Sections 1866(f)(1)(E) and 1902(w)(1)(E) specify that a

provider of services or eligible organization must provide

(individually or with others) for education for staff and the community

on issues concerning advance directives. As the commenter suggests, we

believe that the clear intent of these provisions is that information

concerning advance directives be made available to the widest possible

audience. We have not provided more explicit guidelines on this matter

because we believe that there must be sufficient flexibility to

accommodate a variety of community and provider responses to this

requirement.

As discussed above, sections 1866(f)(2) and 1902(w)(2) of the Act

specify that hospitals, SNFs, and NFs must provide written information

concerning an individual's rights under State law to accept or refuse

medical or surgical treatment, including the right to formulate an

advance directive to all adult individuals upon admission. However, we

agree with the commenter that it would be beneficial to hospital

patients and nursing home residents if information concerning advance

directives were available before admission. Again, we believe that this

eventually will be achieved through the providers' community education

activities and the Secretary's national education campaign.

Comment: Although generally supportive of the need for the

community education requirement, three commenters objected to

permitting providers to use community education activities to fulfill

their requirement to document the medical record concerning whether or

not an individual had executed an advance directive. In particular, the

commenters disagreed with our suggestion in the interim final rule that

providers may ask attendees if they have executed an advance directive

and then later document this information in the medical record (57 FR

8197). The commenters generally believe that these campaigns are

primarily oral presentations to community groups and any attendee may

or may not be subsequently admitted to the facility represented by the

speaker. Thus, there would be great logistical problems as well as

confidentiality problems in implementing our suggestion. Also, the

commenter notes that providers do not have record systems to

accommodate information regarding individuals who are not patients.

Response: We believe that the commenter raises several valid

points. Therefore, in this final rule, we have omitted any suggestion

that providers consider using the community education forum to obtain

information as to whether or not an individual has executed an advance

directive. We note that information about advance directives that is

documented in an individual's medical record would be subject to the

same confidentiality protection as other information in the medical

record. For example, the regulations setting forth conditions for

hospital participation in Medicare, Sec. 482.24(b)(3) specify that

hospitals must ensure the confidentiality of patient medical records

and that information from or copies of records may be released only to

authorized individuals. Hospitals are also required to ensure that

unauthorized individuals cannot gain access to or alter patient

records. These requirements apply to information entered into the

medical [[Page 33277]] record as a result of the advance directive

requirement.

Comment: Three commenters were concerned that the regulations

neither require nor encourage providers to address the level of

literacy for written English, the use of non-technical language in

developing informational materials, etc., to ensure that the materials

disseminated would be easily understood by the recipients. Many of the

recipients of this information may not speak English or may speak

English as a second language. Therefore, the commenter suggested that

the regulations require that basic patient information materials be

developed in other languages where the community composition warrants

it. In addition, the commenter recommended that language barriers be

anticipated, understood and handled appropriately with the assistance

of interpreters.

Response: We believe that the statute and regulations require that

providers distribute material that is clear and understandable to each

patient. Sections 1866(f) and 1902(w) of the Act, and implementing

regulations, specifically require that providers develop and

disseminate to adult individuals written information about an

individual's rights under State law to accept or refuse medical and

surgical treatment and the right to formulate advance directives.

Providers must also describe and distribute their written policies

respecting the implementation of such rights. To meet the intent of the

law (that is, to educate individuals concerning such rights), the

written information must be clear and understandable. Therefore, we

believe that it is inherent in the distribution requirement that the

information be communicated in a language that the patient understands.

If the patient's knowledge of English or the predominate language

of the facility is inadequate for comprehension, a means to communicate

the information concerning patient rights and providers responsibility

and practices must be available and implemented. For foreign languages

commonly encountered in a provider locale, the provider should have

written translations of its description of State law and its statement

of procedures, and should, when necessary, make the services of an

interpreter available. In the case of less commonly encountered foreign

languages, providers may rely on the patient's representative to attest

that he or she has explained the material to the patient.

Comment: Three commenters believe these regulations should consider

differences in patients' cultural backgrounds. They stated that

patients in today's American health system have diverse cultural and

religious backgrounds and that, for some patients, discussions of even

the possibility of death, whether imminent or remote, are a violation

of their own cultural mores. The commenters view these regulations as

an imposition on personal beliefs and values and believe that patients

should be exempted on this basis; otherwise, clergy or other relevant

staff members need appropriate experience or training in dealing with

individuals on these sensitive issues.

Response: Although the law does not deal with these issues, we

would expect a provider to be sensitive to the cultural differences in

its community. We do not, however, believe the law provides for an

exception to the requirement that all adult individuals receiving care

be informed about their rights to accept or refuse medical or surgical

treatment or to formulate an advance directive. We note that

disseminating information and inquiring about the existence of an

advance directive does not necessarily require that an individual

discuss issues related to death. Instead, the focus should be on

offering individuals information about their rights to enhance their

control over medical treatment.

Comment: One commenter acknowledged that area hospitals, with or

without outside help, have endeavored to instruct the public about

advance directive requirements in order to avoid undue concerns when

the patient is hospitalized. The commenter requested that HCFA

distribute, or make available, publications that describe how hospitals

have successfully instructed the community about this topic.

Response: In Appendix II to the preamble of the interim final rule,

we identified a sampling of organizations and publications that could

provide technical assistance on advance directive issues. While the

statute does not require HCFA to become a ``depository'' for

publications developed under this requirement, HCFA does maintain

numerous materials concerning advance directives, as summarized in the

preamble. Some materials may be obtained through the Medicare Hotline

and others are disseminated to new Medicare enrollees. In addition to

the resources that we have, we strongly encourage area providers and

organizations to share experience and expertise in order to help one

another develop the best informational packages possible for any given

community.

Dissemination of Information

Comment: Several commenters requested clarification as to whether

the requirement that hospitals provide information about an

individual's right to accept or refuse medical or surgical treatment

and to formulate advance directives to individuals upon admission also

applied to ``providers of outpatient hospital services.'' Among the

areas of concern were applicability to ``in-and-out'' surgical suites,

dialysis facilities, and any patients undergoing general anesthesia,

regardless of setting. Another commenter believes that emergency

medical technicians or paramedics performing emergency services and

ambulance transports should be subject to this regulation. The

commenter argued that it is grossly unfair for the patient to receive

CPR in the ambulance so that he can be ``allowed to die'' at the

hospital.

Response: Sections 1866(f)(2)(A) and 1902(w)(2) of the Act specify

that written information concerning an individual's rights to accept or

refuse medical or surgical treatment and to formulate advance

directives should be provided to an adult individual, in the case of a

hospital, at the time of admission as an inpatient. We agree with the

commenters that there are other health care situations in which it

might be appropriate for a patient to be advised about advance

directives; however, the statute is very specific concerning the

settings to which these requirements apply. We note that these

regulations do not preclude a State from requiring or a provider from

voluntarily providing this information in any case where it believed it

to be appropriate.

Section 1866(f) and 1902(w) do not require information to be

provided in any outpatient settings except for home health, hospice,

and personal care services. Thus, the statute does not require

emergency medical technicians and paramedics to implement the advance

directives requirements, although there is nothing in it that would

prevent the operators of these services from giving individuals this

information.

Comment: One commenter suggested that, for certain types of

patients, a hospital be permitted to modify its procedures in order to

implement this rule logically. For example, the commenter believes that

it is inappropriate to disseminate advance directive information to

hospital patients being admitted for labor/delivery, or to repeatedly

disseminate information to multiple admissions patients. If these

procedures are not modified, multiple admission patients

[[Page 33278]] may find themselves collecting large numbers of the same

brochure on advance directives. The commenter also recommended that we

not require hospitals to disseminate advance directives information to

individuals undergoing same-day outpatient surgery or emergency room

treatment.

Response: Sections 1866(f)(2)(A) and 1902(w)(2)(A) of the Act

explicitly require that hospitals disseminate advance directive

information to individuals at the time of their admission as

inpatients. Neither the statute nor the regulations require the

dissemination of this information to outpatients or emergency room

patients unless they are admitted to the hospital. When a patient is

admitted, however, we have no discretion to permit exceptions to this

requirement. We note that hospitals repeat many admission procedures as

part of every separate admission, often in accordance with applicable

State and Federal laws. Even in multiple admission cases, the

dissemination of information and inquiry about the existence of an

advance directive should not impose a significant burden on hospitals

and helps ensure that the patient is knowledgeable about his or her

rights, along with verifying that the hospital has the most recent copy

of an individual's advance directive. Patients are always free to

return the brochure or refuse the information if they have already

received it.

Comment: Some commenters suggested that the final rule address the

tendency of individuals, once presented with this written information,

to desire to execute advance directives upon admission or ``on the

spot.'' The commenters believe that the time of admission may not

always be the best time to complete and execute advance directives

because of the tension, anxiety and depression often experienced by

individuals about to be admitted. The commenters added that advance

directives should be executed only after prudent reflection.

Response: The commenter has raised several valuable points. A

hospital could address the commenter's concerns by providing advance

directives information on a preadmission basis (for elective

admissions) and also through its efforts to educate the community as to

the advance directives options available under State law. Although

these regulations do not prevent a provider from assisting a patient in

completing an advance directive if the patient so desires and the

hospital is willing, the provider should ensure that there are no State

laws that may preclude this activity. We would stress that the law and

this regulation contain a limited range of requirements relating to

advance directives. We do not believe it is appropriate to extend the

requirements of this final rule beyond the confines of law. Instead, we

believe it is appropriate that providers retain the flexibility to

continue to refine their application of the advance directive

provisions based on their experience.

Comment: Two commenters strongly suggested that the final rule

expressly direct providers not to disseminate or execute advance

directive forms routinely at the point of admission, but only upon

request. Another commenter suggested that if copies of advance

directives forms are given out, that a representative sample be given,

or be made available upon request, so that the patient can be fully

aware of the various kinds available. Finally, a few commenters argued

that while it may be legally permissible for providers to disseminate

advance directive forms, actively assisting an individual in the

preparation of a will, a durable power of attorney, or other documents

of legal import would constitute the practice of law. Therefore, the

commenters recommended that the final rule should explicitly forbid the

provider from drafting, interpreting, advising and assisting

individuals in the execution of such documents by persons who are not

licensed to do so under State law.

Response: This final rule neither requires providers to disseminate

advance directives forms upon admission nor does it prohibit them from

doing so. We know that different groups of hospitals have adopted

different policies as to the appropriateness of this practice, and we

also believe that State laws may bear on this activity. Again, the

statute and this rule focus on ensuring that individuals are informed

of their rights with regard to the advance directives, not on

prescribing procedures for executing directives.

We decided not to adopt the suggestion that we require providers to

supply a representative sample of forms since we have no statutory

authority to do so. Also, this final rule does not address the issue of

whether assisting an individual in preparing a living will, a durable

power of attorney or other documents of legal import would constitute

an unauthorized practice of law. Providers should look to State laws

that may address the legality of these actions.

Comment: Several commenters suggested that the widest latitude be

offered for providers to disseminate information to patients about

their advance directives rights under State law and the provider's

policies concerning the implementation of those rights. One commenter

specifically suggested that the timing for dissemination of materials

be adjusted by the nursing facility according to its admissions

practices. For example, one facility's ``admission process'' may not

involve the level of personnel who would have the education and

training to provide advance directive information in a manner most

helpful to patients. Yet, another facility's ``admission process'' may

include the use of qualified staff, such as a nurse, and may involve an

initial nursing/comprehensive assessment that is usually completed

within 6 hours of admission. Another commenter suggested that these

regulations be applied in conjunction with other nursing home

requirements, for example, the free choice provision under the resident

rights requirement (Sec. 483.10(d)) or the scope of services provisions

under the plan of care requirement (Sec. 483.20(d)(1)), which would

provide the additional time needed to disseminate information regarding

advance directives. The commenters further suggested that the advance

directive documentation should be done as part of the care plan and

revisited at the quarterly care planning meetings. Finally, the

commenters suggested that, for home health agencies and personal care

providers, the required information should be disseminated during the

first visit but before actual delivery of care, in the same manner as

other patient rights information.

Response: We have attempted to address these concerns in this final

rule within the confines of the statute. Hospitals and nursing

facilities must follow the explicit language of sections 1866(f)(2) and

1902(w)(2) of the Act, which require that information concerning

advance directives be provided ``at the time of admission.'' We do not

believe that the statute affords us the discretion to implement any of

the commenters' suggestions for revising the meaning of ``at the time

of admission'' as it applies to nursing homes.

For HHAs, sections 1866(f)(2) and 1902(w)(2) of the Act require

that the information be provided ``in advance of the individual coming

under the care of the agency,'' without specifying a particular time.

We believe it is reasonable to permit this function to be performed at

the time of the first home visit, as long as the information is given

before care is provided. This visit traditionally encompasses patient

assessment and the administrative details necessary for the start of

home [[Page 33279]] care, and we believe it would be appropriate to

comply with the advance directive requirements at this time. Therefore,

we have amended regulations at Secs. 484.10(c)(2)(ii) and

489.102(b)(3)(i) to clarify that an HHA may furnish advance directive

information to a patient at the time of the first home visit, as long

as the information is furnished before care is provided.

A similar requirement has been adopted with regard to personal care

providers. We have amended regulations at Secs. 489.102(b)(3)(ii) to

clarify that they may furnish advance directive information to a

patient at the time of the first home visit, as long as the information

is furnished before care is provided. (For further discussion of the

timing issue as it concerns HMOs and CMPs, see Section II.B of this

preamble below).

Comment: One commenter asserted that some nursing home patients are

unable to receive this information immediately upon admission and noted

that, in accordance with OBRA `87, nursing homes have an added

requirement to advise these individuals in a way that they will

understand. The commenter believes that the best method to achieve this

is through some sort of discussion. Some patients have experienced

emotional breakdowns upon being informed of their rights with regards

to advance directives because they think they are about to die. The

commenter suggested that for SNF and NF residents who appear likely to

be threatened by this conversation at the time of admission, these

regulations permit the dissemination of information and discussion to

occur at some time between entry to the facility and completion of the

initial minimum data set (or resident assessment). Therefore, the

commenter suggested that we define ``at the time of admission'' to mean

that the information must be given promptly upon (but no later than 14

days after the date of admission), which is in accordance with the

meaning of ``upon admission'' under section 1819(b)(3)(C)(i) of the

Act.

Response: We do not believe that it is appropriate to permit

information routinely to be delayed simply because it is of a sensitive

nature. However, some residents may well be incapacitated by virtue of

a physical or mental disorder, in which case the information could be

provided at a later time, if feasible. We believe this is a medical

decision to be made by the facility after considering the patient's

medical condition and the likelihood of any negative effect upon the

patient. This determination should be made on a case-by-case basis by

the facility in accordance with State law. This issue also is discussed

below under the heading ``Individuals Incapacitated at Admission''.

Sections 1819(b)(3)(C)(i) and 1919(b)(3)(C)(i) of the Act specify

that a SNF and NF must conduct a comprehensive resident assessment for

each individual promptly upon admission, but not later than 14 days

after the date of admission. In general, nursing homes use registered

nurses or other trained personnel to conduct resident assessments, and

depending on the medical condition of the resident, this assessment may

become a lengthy process. In contrast, sections 1866(f)(1) and

1902(w)(1) of the Act do not specify any particular health care

discipline or trained personnel to disseminate information on advance

directives or to document in the resident's medical record whether or

not the individual has executed an advance directive. Therefore, we

believe that it is not necessary or consistent with the advance

directives statute to revise the regulations to routinely allow up to

14 days to disseminate this information as the commenter suggests.

Individuals Incapacitated at Admission

Great concern was voiced by commenters concerning the provision of

advance directive information to psychiatric patients, and to patients

suffering from Alzheimer's disease or other diseases affecting an

individual's decision-making capacity. In particular, commenters

suggested that the advance directive information may exacerbate the

symptoms of mental illness and hamper psychiatric treatment, especially

for suicidal patients. The commenters offered the following suggestions

to address the overall issue of individuals incapacitated at the time

of admission and other related issues.

Comment: One commenter suggested that the regulations implementing

the advance directive requirements include a provision for a ``good

faith exception to the Act'' for all psychiatric hospital admissions

or, at a minimum, for those persons involuntarily admitted for

psychiatric treatment because they have been determined to be

dangerously mentally ill.

Response: Sections 1866(f)(1) and 1902(w)(1) of the Act specify

that the advance directives requirements apply to all adult individuals

receiving medical care. Therefore, we believe that a general ``good

faith'' exception is precluded by the law. Although we recognize that

certain individuals may not be able to receive information about

advance directives due to incapacity, we believe that such a

determination must always be made on a case-by-case basis by the

facility in accordance with State law.

Comment: Two commenters noted that the interim final rule did not

specify the personnel that would be responsible for determining whether

or not an individual was capable of receiving information concerning

advance directives. The commenters believe that further guidance is

needed in this area and suggested that the final rule require that the

professional judgment of a qualified healthcare professional (such as a

physician, nurse or social worker) be used to determine when an

individual can receive this information.

Response: Since the statute is silent on this issue, we do not

believe it would be appropriate to impose on providers by regulation a

requirement that only a physician or nurse is permitted to make the

professional judgment concerning an individual's capacity to receive

this information. Therefore, we defer to State law addressing the

subject. Where there are no State laws concerning this subject, then

the institution may make the decision.

Comment: Some commenters interpreted the discussion of the

incapacitation issue in the interim final rule (57 FR 8197) as

requiring hospitals to disseminate information concerning a patient's

right to accept or refuse medical or surgical treatment and to

formulate an advance directive to family members or surrogates when the

individual is incapacitated upon admission. They stated that such a

requirement would extend beyond the scope of the statute and suggested

it be deleted. One commenter stated that, in some States, third parties

(for example, family and/or surrogates) may execute advance directives

or otherwise act without meaningful restriction on behalf of an

incapacitated patient, in the absence of an advance directive executed

by the patient. The commenter suggested that the regulations explicitly

state that the advance directive requirements only apply to an

individual patient's rights; thus third parties should have no further

role but to receive the information on behalf of the incapacitated

individual.

Response: We did not require that family members or surrogates

receive advance directives information in place of incapacitated

patients. We merely suggested that providing them with this

information, to the extent the facility provides such individuals with

other information related to the patient's care, would be appropriate

and might help the provider discover the existence of an advance

directive. We agree that [[Page 33280]] sections 1866(f) and 1902(w) of

the Act apply only to individual patient's rights and that these

statutory provisions do not create a right for third parties to receive

information on advance directives or to execute advance directives on

behalf of incapacitated patients. However, we are aware that some

States permit third parties to execute advance directives on behalf of

an incapacitated patient. We believe that defining rights of third

parties as the commenter suggested would conflict with Congressional

intent that issues not addressed through explicit provisions of the

statute be decided under State law.

Comment: One commenter stated that there has been some confusion

among facilities concerning the implementation of advance directive

requirements for incapacitated patients. As a result, some facilities

are requiring the appointment of a guardian over their residents for

purposes of meeting these requirements. The commenter suggests we

address this issue.

Response: The determination of whether or not an individual is

incapacitated and unable to receive advance directives information and

the role of surrogate third parties are issues that involve both the

individual's medical condition and State law regarding decision-making

authority in such cases. We defer to State law on these issues. The

appointment of a guardian is not required by the statute but is left to

the discretion of the facility in accordance with applicable State law.

Comment: One commenter suggested that the regulations clarify that

no assumptions be made by third parties regarding an incapacitated

resident's right to accept or refuse medical or surgical treatment in

the event the resident has not executed an advance directive.

Response: The statute does not grant authority for actions on the

part of the family or surrogate for the incapacitated individual.

Therefore, providers should look to State laws that address

responsibility for treatment decisions in those instances where an

individual is incapacitated.

Comment: One commenter suggested that, in order to facilitate the

development of policies concerning incapacitated individuals, we allow

national organizations such as the American Psychiatric Association,

the National Association of Private Psychiatric Hospitals and the

American Hospital Association to develop guidelines or recommendations

on how to address incapacitated patients in providers' written policies

concerning advance directives.

Response: Providers and organizations should have already completed

their policies and procedures on these advance directive requirements.

However, particularly in light of the changes in the regulations

included in this final rule concerning providing advance directives

information to surrogate decision-makers, we encourage national

organizations to work with providers to help them refine their policies

concerning this portion of the advance directive requirements.

Comment: We received several comments on the statement in the

preamble of the interim final rule that indicated that providers are

obligated to track patients who are unconscious on admission in order

to determine when they are able to receive information concerning

advance directives (57 FR 8197). Some commenters stated that this

requirement was unnecessary in cases in which hospitals provided the

information upon admission to family members, or surrogates, since it

is likely that the family would pass the information on to the patient

when he or she regained consciousness. Other commenters supported the

requirement and suggested that we require periodic reassessments of

comatose patients to determine when they are able to receive the

information. One commenter asserted that some patients may never regain

decision-making capacity while hospitalized and are often discharged

without ever having been in a condition to receive the required

information. The commenter suggested we specifically address whether a

facility still is obligated to provide the information under these

conditions.

Response: Sections 1866(f)(1)(A) and 1902(w)(1)(A) of the Act

specify that it is the patient's right to formulate an advance

directive and the provider's obligation to inform the patient of that

right. We do not believe that a provider can meet this obligation by

providing information to surrogate decision-makers or family members.

In this final rule, we have clarified this point by adding language at

Secs. 417.436(d)(1)(ii), 483.10(b)(8), and 489.102(e) to specify that

facilities may give advance directive information to the patient's

family or surrogate, but this does not relieve the facility of its

obligation to provide this information to the patient once he or she is

no longer incapacitated or unable to receive such information.

Therefore, the provider will need to develop follow-up procedures to

determine if and when the patient may be given the information

directly.

We agree that it would be appropriate to conduct periodic

reassessments of comatose patients; however, we believe that the timing

of reassessments should be determined by the provider based on the

medical condition of the individual patient. If an individual remains

incapacitated throughout an entire hospital stay, we recognize that

there may never be an opportunity for the advance directives

information to be provided. In such cases, we would expect the provider

to document in the patient's medical record its awareness of its

obligation and its continuing judgment that the patient's medical

condition does not permit the information to be provided.

Objections Based on Conscience

Comment: Several commenters requested additional information on our

policy in situations in which a health care provider, as a matter of

conscience, cannot implement an advance directive. Specifically, the

commenters requested that we clarify the requirement under

Secs. 417.436(d)(1)(i)(B) and 489.102(a)(1)(ii) that the written

policies of a provider or organization include ``a clear and precise

statement of limitation if the provider cannot implement an advance

directive on the basis of conscience.'' One commenter suggested that

the explanation of State law concerning objections on the basis of

conscience mirror either the State law or the State-developed

description of the State law concerning this topic. Two other

commenters suggested that, where State law permits a conscientious

objection, the regulations should require that the provider's

explanation: (1) Clarify any differences between institution-wide

conscience objections and those that may be raised by individual

physicians; (2) explain the basis for the objection (that is, whether

it is based on various religious, moral, or professional grounds); (3)

identify the State legal authority permitting such objection; (4)

describe the range of medical conditions or procedures affected by the

conscience objection; (5) describe what steps will be taken to transfer

or otherwise accommodate individuals whose wishes are impeded by the

institution's policy; and (6) describe what, if any, burden will be

placed on the patient or the patient's surrogate decision-maker to help

effectuate the implementation of the advance directive. Finally, one

commenter asked whether Medicare and Medicaid payments would be

terminated if an entire institution objects to implementing advance

directives on the basis of conscience. [[Page 33281]]

Response: Sections 1866(f)(1)(A) and 1902(w)(1)(A) of the Act

require that providers and organizations furnish individuals receiving

medical care with written information concerning an individual's rights

under State law and the provider's policies concerning the

implementation of these rights. Also, section 4206(c) of OBRA '90 and

section 1902(w)(3) of the Act provide that the statutory advance

directive requirements do not prohibit the application of a State law

that allows for an objection on the basis of conscience for any

provider (or its agent) that, as a matter of conscience, cannot

implement an advance directive. As the commenter noted, implementing

regulations at Sec. 417.436(d)(1)(i)(B) and 489.102(a)(1)(iii) require

that this information include a statement of limitation if a provider

cannot implement an advance directive on the basis of conscience. We

agree that the written information may mirror State-developed

descriptions of State law concerning advance directives. However, we do

not believe that requiring a provider to supply copies of applicable

State law is necessary, because the statute requires the dissemination

of descriptions of State laws. We believe that Congress imposed this

requirement because many State statutes may be written in technical

terms that may be misunderstood. We have reviewed the six suggested

requirements for statements of limitation. We believe that the

commenters have highlighted some important minimum points of

information that should be given to all affected individuals, but we

also believe some of the suggestions go beyond the intent of this law.

As a result, we have decided to implement the first, third and fourth

of the commenters' suggested requirements.

We have several reasons for not adopting the second, fifth and

sixth suggested requirements. We have not adopted the second suggestion

because the basis for the objection is not necessarily material as long

as the objection raised is permitted by State law. A provider may wish

to explain an institutional policy; however, an individual physician or

practitioner may not wish to do so, and neither of them is required by

this law to do so. We have not adopted the commenter's fifth suggestion

concerning transfers for a similar reason. The law does not require

this level of information. We note that if an individual is given

information regarding the provider's conscientious objection, and he or

she does not request a transfer, the provider is not obligated to

implement any elements of an individual's advance directive that

conflict with the provider's conscientious objection. However, it is

reasonable to expect that assistance would be provided for a transfer

at the patient's request. We did not accept the commenter's last

recommendation because we do not believe it would be reasonable to

require that a provider speculate on what, if any, burden would be

placed on patients or surrogate decision-makers to help effectuate the

implementation of an advance directive. Therefore, we are revising the

regulations at Secs. 417.436(d)(1)(i)(B) and 489.102(A)(1)(ii) to

include only the first, third, and fourth points.

Finally, when a entire facility opts to object on the basis of

conscience, assuming the objection is permitted under State law and the

facility complies with all other provisions of the statute and

regulations, neither Medicare nor Medicaid reimbursement will be

interrupted.

Comment: One commenter requested that we clarify that a provider is

not required to implement an advance directive to which the provider

objects on the basis of conscience when the State law is silent or does

not specifically prohibit such objection.

Response: The advance directives legislation does not give us

authority to make such a clarification. We believe that, unless State

law allows a provider to object to implementing an advance directive as

a matter of conscience, the provider is required to honor the advance

directive as written. As discussed in the preceding response, we have

revised Secs. 417.436(d)(1)(i)(B)(3) and 489.102(a)(1)(ii)(C) to

specify that a provider's statement of limitation must identify the

``State legal authority'' permitting an objection on the basis of

conscience.

We note that State statutory law may be silent on a particular

issue, such as whether a provider may decline to follow a directive to

which it objects on the basis of conscience. As we suggested in the

interim final rule, in the absence of statutory law, providers should

look to common law or case law for guidance (57 FR 8197).

Comment: One commenter asserted that religiously-sponsored

facilities have the right to exercise an objection on the basis of

conscience to the requirement that facilities conduct community

education. Otherwise, enforcement of the community education

requirement would violate provider's First Amendment rights to adhere

to their religious beliefs.

Response: Section 1902(w)(3) of the Act and section 4206(c) of OBRA

'90 specifically refer to the application of State laws regarding

conscientious objections. These statutory provisions permit exceptions

to implementing advance directives based on a conscientious objection

as prescribed under applicable State law. No provision is made for an

exception to sections 1866(f)(1)(E) and 1902(w)(1)(E) of the Act

concerning community education efforts. Thus, the provider must meet

the requirements relating to community education; that is, the provider

must furnish information to the community concerning State law

regarding the right to accept or refuse medical or surgical treatment

and to formulate an advance directive, even if the provider

simultaneously informs the community that it is exercising a conscience

objection that would permit it to refuse to honor an advance directive.

Comment: One commenter believes that it would be difficult if not

impossible for many providers, especially Roman Catholic facilities, to

provide a precise statement of limitation if a provider cannot

implement an advance directive on the basis of conscience. According to

the commenter, there are various ethical, religious and moral

restrictions on whether or not a particular advance directive can be

implemented at a Catholic facility. Another commenter believes that

providers may not always be able to write clear and precise statements

of limitation when objecting on the basis of conscience and requested

that the regulations permit alterations to the written policy based

upon case-by-case determinations of issues not previously considered by

the facility.

Response: As discussed above, we have revised the regulations at

Secs. 417.436(d)(i)(B) and 489.102(a)(1)(ii) to provide further

clarification on the content of the statement of limitation. Regardless

of their religious affiliation, facilities may comply with the law by

providing patients with written materials containing the minimum points

of information required by these regulations. These revisions describe

the minimum amount of information that should be included in the

statement of limitation. For the most part, we believe that the

statement of limitation can be written to accommodate or reflect the

case-by-case approach. Although we cannot readily envision a situation

in which the required information, if properly provided, would not

adequately inform the patient, we agree that such a situation would

permit an individualized notice. [[Page 33282]]

Where an individualized notice is needed, facilities may comply

with the law by providing patients with written materials indicating

the basis upon which decisions will be made, that each decision would

be unique, and how the patient may predict the decision in his or her

own case. It is not necessary that the written material distributed to

patients contain enough information to permit the patients to make a

definitive determination about what action the provider will take in

every situation. It is only necessary for the provider to state its

policy with respect to complying with the provisions of State law

regarding an adult individual's right to accept or refuse medical or

surgical treatment or formulate an advance directive, even if that

policy is to make individual decisions based on religious rules.

Comment: Two commenters requested more guidance on how providers

are to deal with individual health care professionals who object to

executing an advance directive on the basis of conscience. One

commenter stated that although the interim final rule did not require

that lists of members of a hospital medical staff be provided to

individuals, the regulation text should clarify that hospitals are not

expected to provide information about the moral reservations of

individual members of the medical staff. Any document describing each

physician's position on advance directives would be potentially

lengthy, constantly in need of updating, and of little use to patients,

who typically choose their physicians before entering the hospital.

Response: We believe a provider may well have a policy under which

an individual physician or its medical staff may determine (consistent

with State law) whether to honor advance directives. If this is the

case, the provider would need to inform the patient of this policy, so

that the patient could consult with his or her physician on the

subject, as necessary. It would be up to the patient, having been

informed of the provider's policy, to consult with the physician.

Although a hospital with a complicated policy may need detailed

documents to describe it, we do not believe that this would always be

the case. In addition, as the commenter noted, many individuals choose

their physicians long before admission and may already have discussed

these issues with them. However, although we agree with the commenter

that a document describing the positions of individual physicians

concerning advance directives would be quite lengthy and of little use

to patients, we do not believe it is necessary or appropriate to state

in regulations that hospitals are not expected to provide information

about the moral reservations of medical staff.

Comment: One commenter noted that the requirements at

Secs. 417.436(d)(2) and 489.102(a)(1)(ii) specify that a provider is

not required to provide care that would conflict with an advance

directive and is not required to implement an advance directive if, as

a matter of conscience, the provider cannot implement an advance

directive and State law allows any health care provider or any agent of

such provider to conscientiously object. The commenter believes that

these requirements would permit the transfer of a patient when a

provider cannot honor his or her advance directive and thus are in

conflict with the ``anti-dumping'' rules, which prohibit the transfer

of emergency patients except under limited conditions. The commenter

suggested that the advance directive provisions be amended to prohibit

patient transfers, except under the permissible circumstances in the

anti-dumping rules concerning stabilizing the patient.

Response: We disagree with the commenter's assertion that the

provisions of this regulation permitting a patient transfer would

violate the ``anti-dumping'' statute. The anti-dumping statute (section

1867 of the Act) provides for patient-initiated transfers so long as

they are properly documented and done in accordance with applicable

Federal and State law. Therefore, we do not believe that a transfer

that is requested by a patient after being informed by a provider that

it cannot honor an advance directive on a basis of conscience (to a

provider who will honor the advance directive) would violate the

``anti-dumping'' statute.

Comment: One commenter believes that physicians are not normally

considered agents of health care providers, and thus providers are not

responsible for the actions of their individual physicians. The

commenter suggested that the final rule clearly acknowledge the need

for a collaborative judgment between providers, their agents, and

physicians as to when a provider or its agent chooses to exercise an

objection on the basis of conscience.

Response: As noted above, section 4206(c) of OBRA '90 and section

1902(w)(3) of the Act do not prohibit the application of State laws

that allow for an objection on the basis of conscience for any provider

or any agent of a provider that, as a matter of conscience, cannot

implement an advance directive. The meaning of the term ``agent''

varies from State to State, and Congress did not define this term in

the advance directives provisions. Therefore, for purposes of this

final rule, the term ``agent'' is defined by applicable State law.

Regardless of whether or not State law defines a physician as an

agent of the provider, sections 1866(f)(1) and 1902(w)(1) of the Act

clearly establish that it is the health care provider's responsibility

to have a policy on advance directives and to assure that it is

followed. Implementing regulations at Secs. 417.436(d) and

489.102(a)(1)(ii) require that a provider's policies include a

statement of limitation if the provider cannot implement an advance

directive as a matter of conscience. To the extent that close

collaboration between provider medical staff and other staff is

necessary to implement the provider's advance directive policies, it is

the responsibility of the provider to assure that it occurs. Ordinarily

providers assure compliance through such mechanisms as medical staff

by-laws, which physicians agree to observe in return for staff

privileges.

Comment: One commenter stated that before a patient's admission,

providers should be required to publicize their position on any advance

directive they cannot fulfill. As part of this process, the commenter

suggested we require providers and organizations to place this

information in preadmission packages to be received by the individuals

within 10 days before elective admission.

Response: As we have noted elsewhere, we do not believe that the

provisions of this regulation should limit individual provider choices

on such issues as when to send out pre-admission information packages.

Sections 1866(f)(1)(A) and 1902(w)(1)(A) of the Act require that

providers provide written information to each individual concerning an

individual's rights under State law to accept or refuse medical

treatment, the right to formulate an advance directive, and the written

policies of the provider respecting the implementation of these rights.

Sections 1866(f)(2)and 1902(w)(2) specify when this information must be

furnished. These requirements are also set forth in regulations. Also,

as discussed in detail above, we require that if a provider cannot

implement an advance directive due to a conscientious objection, its

written policies must include a clear and precise statement of

limitation, as described under Secs. 417.436(d)(1)(i)(B) and

489.102(a)(1)(ii).

We believe that these requirements are sufficient to ensure that

there is a [[Page 33283]] timely exchange of information between

providers and patients with respect to advance directives, without

unnecessarily limiting provider flexibility. Thus, although we

encourage providers to include any statement of limitation in pre-

admission materials, we do not believe it would be appropriate to

impose requirements concerning pre-admission materials.

Descriptions of State Law

Comment: One commenter suggested that we prescribe in regulations

the process that States must follow when developing the written

descriptions of State law concerning advance directives. At a minimum,

the commenter believes that the process should include participation by

providers, consumers, community advocacy groups, bar association groups

and others. The commenter believes that the written description of the

State's advance directive requirements should be reviewed in draft form

to ensure that it can be understood by non-experts of average reading

ability. Also, the description should be certified as to its accuracy

by the State's Attorney General or other legal advisor with the

necessary expertise in this area (for example, a commission, committee,

court, judicial panel, etc.). Other commenters recommended that

information distributed to patients should be subject to review by the

State agency upon the receipt of any complaint that the information

does not comply with the standard of strict objectivity in describing

State law.

Response: The requirement that each State develop a written

description of its law concerning advance directives has been in effect

since December 1, 1991, and States have followed varying practices in

meeting the requirements of the law. At least a few States have

consulted widely while other States have issued requirements prepared

by the State's Attorney General. This is in keeping with alternatives

offered by the statute, and we do not believe it would be appropriate

to limit State flexibility on this matter in this final rule. We note

that State survey agencies would have the opportunity to review the

contents of provider advance directive packages, which could include

ensuring that descriptions of State law are accurate.

Comment: One commenter suggested that we request that the Attorney

General in each State publish a written description of the State law

concerning advance directives and update it regularly.

Response: Section 1902(a)(58) of the Act requires that each State,

``acting through a State agency, association, or other private

nonprofit entity, develop a written description of the law of the State

(whether statutory or as recognized by the courts of the State)

concerning advance directives that would be distributed by providers or

organizations under . . . [the Medicaid requirements].'' While we are

not making this a requirement, a State may use its Attorney General to

prepare the description of State law. In addition, we note that under

the Medicaid program, we are requiring that States revise their

descriptions of State law and furnish copies of revised descriptions to

providers and managed care plans within 60 days fr

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