[Federal Register: June 27, 1995 (Volume 60, Number 123)]
[Rules and Regulations]
[Page 33261-33294]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27jn95-30]

[[Page 33261]]

Part II

Department of Health and Human Services

42 CFR Part 417, et al.

Medicare and Medicaid Programs; Advance Directives; Final Rule

[[Page 33262]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

42 CFR Parts 417, 430, 431, 434, 483, 484, and 489

[BPD-718-F]
RIN 0938-AF50

Medicare and Medicaid Programs; Advance Directives

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Final rule.

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:
<bullet> 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.
     <bullet> 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.
     <bullet> 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.
     <bullet> 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