[Federal Register Volume 60, Number 123 (Tuesday, June 27, 1995)]
[Rules and Regulations]
[Pages 33262-33294]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15550]




[[Page 33261]]

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Part II





Department of Health and Human Services





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Health Care Financing Administration



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42 CFR Part 417, et al.



Medicare and Medicaid Programs; Advance Directives; Final Rule

  Federal Register / Vol. 60, No. 123 / Tuesday, June 27, 1995 /  Rules 
and Regulations  

[[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.

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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 from the effective date 
of a change in State law (see revised Sec. 431.20(b)). Under both 
Medicare and Medicaid, managed care plans and all providers must 
provide updated written information to adult individuals within 90 days 
of the effective date of any new State law.
    Comment: Two commenters suggested that we require Medicare 
providers to use the State-developed description of State law in their 
informational materials. The commenters believe that Congress intended 
to mandate the use of the State-developed description similar to the 
requirement for Medicaid providers and that the lack of such a 
requirement in section 1866(f) of the Act was a Congressional 
oversight. The commenters suggested we amend Sec. 431.20(b) to 
implement this requirement.
    Response: As the commenters point out, section 1902(a)(58) of the 
Act specifically mandates the use of the State-developed description 
for Medicaid providers, but there is no statutory provision regarding 
the use of the State-developed description for Medicare providers. 
Also, we have found no evidence in the legislative history that the 
Congress intended to implement this requirement for the Medicare 
program. Therefore, we have not mandated the use of the State-developed 
description for Medicare providers.
    Comment: Four commenters disagreed with our suggestion in the 
interim final rule that States may prescribe the content of the 
information disseminated by Medicaid providers, including requiring 
``that Medicaid providers use the State-developed descriptions of State 
law only'' (57 FR 8197). These commenters urged that we withdraw this 
suggestion in the final rule. Another commenter asserted that providers 
may misconstrue our suggestion to mean that they should use the State's 
description only, when providers should be allowed to supplement these 
descriptions with their own materials as needed. This commenter 
suggested that we avoid the use of the word ``only'' in this context. 
Alternatively, States could allow providers to incorporate the general 
information contained in the State-developed descriptions of State law 
into their own packages of materials that include their written 
policies regarding the implementation of an individual's rights under 
the advance directive provision.
    Response: States have the authority to administer the Medicaid 
program under broad Federal guidelines coupled with each State's own 
statutory and regulatory requirements. The advance directive provisions 
of the statute, as well as the implementing regulations, have been 
designed to ensure that States maintain maximum autonomy and 
flexibility in this area. The discussion in the preamble to the interim 
final rule merely reflected possible approaches that States could take 
in providing the required information, and we continue to believe that 
the approaches are consistent with the statutory requirements. 
Therefore, each State's law determines if providers are restricted to 
using only the State-developed descriptions of State law regarding 
advanced directives or if providers are permitted to supplement these 
descriptions with their written policies concerning advanced 
directives.
    Comment: Several commenters suggested that, to the extent that 
providers are allowed to develop their own descriptions of State law, 
the final rule should require States to have a process in place to 
evaluate and pre-approve the provider's particular version of the 
description of the State's law. The commenter believes that without 
such a requirement, the various descriptions being used by different 
providers may be inaccurate or inconsistent. To ensure uniformity, the 
commenter suggested that HCFA actively encourage States to use a 
single, uniform State description.
    Response: We believe it to be beyond the intent of the statute to 
require that States evaluate and pre-approve the provider's versions of 
any description of State law. The States themselves are best equipped 
to determine whether or not they should evaluate and pre-approve a 
provider's description of State law, and we have preserved the 
flexibility for them to do so in this final regulation. However, it is 
important to note that section 1902(a)(58) of the Act requires that the 
State, acting through a State agency, association, or other private 
non-profit entity, develop a written description of the State law 
[[Page 33284]] concerning advance directives to be distributed to 
Medicaid providers and HMOs. HCFA believes that the availability of 
this document and the coordination among all providers will ensure that 
the descriptions are accurate and consistent.
    Comment: Many commenters responded to our request for 
recommendations on what would be a reasonable time period for States 
and providers to incorporate descriptions of changes in State law into 
provider information packages and for providers to distribute this 
information. The recommended time periods varied widely, ranging from 
as soon as practicable, to 60 days, not less than 90 days, not more 
than 4 to 6 months, annually (requested by HMOs, in particular, to 
coincide with the annual schedule for reprinting and distribution of 
enrollment materials, also see section II.B, below), and no later than 
by the time of the effective date of individual State law. In addition, 
a number of commenters suggested a two-step time frame--a deadline on 
States to revise the State description of the law and issue copies to 
providers and organizations and a second deadline on providers to 
revise and disseminate their materials to adult individuals coming 
under their care. Two commenters suggested that we prescribe the timing 
requirements in the regulations.
    In addition, one commenter expressed concern that providers may 
think they have some obligation for monitoring and interpreting changes 
in State law. This commenter believes that it is inappropriate to 
depend on providers to monitor or interpret changes in State law and 
that Congress would not require States to develop descriptions of their 
laws without the implicit intent that States would also be responsible 
for updating the descriptions. Unless States are required to update 
their own description, the commenter believes that consistency will be 
lost over time. The commenter suggested that HCFA clarify that it is 
the responsibility of States, not the providers, to update these 
descriptions.
    Response: In general, we believe that States, as well as providers 
and managed care plans, will wish to revise advance directive 
information packages promptly in order to ensure that they disseminate 
the most accurate information possible concerning State law changes 
relating to advance directive issues. Realistically, however, we know 
that it will take some time to receive the information, revise their 
summary descriptions of State law, and print and disseminate these 
updated summaries. Based on our review of all recommendations, we are 
imposing two new independent requirements for States and providers for 
updating descriptions of State law. First, 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 from the effective date of a change in State law. 
Second, under both Medicare and Medicaid, managed care plans and all 
providers must provide updated written information to adult individuals 
within 90 days of the effective date of any new State law. Thus, in 
situations where States have an obligation under the Medicaid program 
to develop descriptions of State law, we are allowing providers an 
additional 30 days in order to permit them sufficient time to adopt 
language from State law or State-developed descriptions where 
necessary.
    We are revising Secs. 431.20(b) and 489.102(a)(1)(i) to reflect 
these two requirements. (See the discussion in section II.B below 
regarding timeframes for managed care plans.) States or providers that 
disseminate outdated materials during the grace periods established by 
this regulation would not be violating the Federal requirements 
regarding the dissemination of written information about an 
individual's rights under State law only. However, this grace period 
will not protect a provider from an action in State or Federal court 
resulting from any harm caused by the dissemination of outdated 
material. In addition, States are free to impose more restrictive 
requirements on the dissemination of updated materials.
    Also, Sec. 430.12(c)(1)(ii) requires that a State amend its State 
plan to reflect material changes in State law. Since the State is 
required to include a written description of its law concerning advance 
directives in its State plan, any changes in State law concerning 
advance directives must not only be furnished to providers 
participating in the Medicaid program, but must also be included in the 
State plan. To be consistent, we are revising Sec. 430.12(c)(1)(ii) to 
require the amendment to be submitted as soon as possible, but no later 
than 60 days from the effective date of the law.
    Comment: Another commenter suggested that the Secretary be given 60 
days to notify State Medicaid agencies, licensure agencies and 
providers of changes in Federal law, and that these groups then have 60 
days from the date of Federal notification to implement corresponding 
changes in their respective responsibilities.
    Response: Changes in Federal law take effect in accordance with the 
effective dates established by the Congress in the statute in which 
they are enacted. The Secretary generally is not responsible for 
notifying States or providers of statutory changes; nor are the 
effective dates of statutory changes generally subject to the 
Secretary's discretion.
    Comment: One commenter suggested that the determination of when 
State case law has changed for purposes of mandatory alteration of 
policies and procedures be uniformly fixed at the highest appellate 
court of a State, so that informational materials may be amended at a 
consistent time throughout affected States. However, the commenter also 
believes that some provision should be made for discretionary changes 
in the statement of State law disseminated by the State, based upon an 
analysis of intermediate appellate or trial court decisions.
    Response: We have already outlined the timeframes for providers to 
incorporate descriptions of State law into their policies and 
procedures. With regards to revisions or amendments that may occur as a 
result of appellate or trial court decisions, we believe that States 
are best suited to respond timely to such changes. Therefore, States 
should be responsible, on a case-by-case basis, for determining when 
State law has changed and thus, when providers must revise 
informational materials. Medicare and Medicaid providers may have wide 
discretion in designing informational materials for dissemination to 
patients and residents, or States may institute more specific 
requirements under either or both programs. We do not choose to abridge 
State flexibility on this issue.
Provider Agreements
    Comment: One commenter expressed concern that Sec. 431.107(b)(4) of 
the interim final rule appears to require that the State Medicaid 
agency revise provider agreements to incorporate the requirement that 
providers comply with the advance directives requirements. The 
commenter believes that this requirement can be made binding upon the 
State Medicaid agencies and providers without the administrative burden 
associated with issuing new provider agreements.
    Response: Section 431.107(b)(4) requires that a State plan must 
provide for an agreement between the Medicaid agency and each provider 
or organization furnishing services under the plan in which the 
provider or organization agrees to comply with the applicable advance 
directive [[Page 33285]] requirements. The changes to 
Sec. 431.107(b)(4) do not require that States issue new provider 
agreements. States frequently use provider agreements that are general 
in nature but that bind the provider to adhere to the provider 
requirements stipulated in the State's regulations or manuals. It is 
not our intention to change, by this regulation, the mechanics by which 
States impose requirements upon their Medicaid providers.
    States have flexibility to prescribe procedures for complying with 
additional Federal requirements relating to its provider agreement. A 
determination should be made by each State regarding whether revisions 
or new provider agreements are necessary, or whether the agreement is 
all-inclusive, that is, the provider agrees to comply with all 
additional Federal requirements, and no revisions are needed.
Enforcement Procedures
    Comment: Some commenters requested further instructions on the 
statement in the preamble of the interim final rule that hospitals and 
hospices must inform HCFA in writing of the ``date they achieve 
compliance'' (57 FR 8195), while another believes this requirement is 
unnecessary. One commenter suggested that Secs. 417.436(d) and 483.10 
be amended to include an address and telephone number at which HCFA 
will receive non-compliance complaints.
    Response: The process for hospitals and hospices to inform HCFA of 
the day they achieved compliance was set forth through instructions 
issued by HCFA in October, 1992. The reporting process is now complete. 
The purpose of this process was to provide us with evidence that 
hospitals and hospices were maintaining policies that would provide 
written information to adult individuals of their rights to accept or 
refuse medical or surgical treatment and to formulate an advance 
directive. These rights are subsequently referred to as the ``advance 
directive requirements''. This mechanism was designed so we would not 
need to conduct immediate on-site inspections of the nearly 8,000 
hospitals and hospices to determine compliance with the advance 
directive requirements.
    In addition, we note that to ensure that HHAs, SNFs and NFs are 
complying with the advance directives requirements, these entities will 
be assessed for compliance during the next routine on-site survey. The 
advance directive requirements are part of the resident rights 
requirements at Sec. 483.10(b)(8) for SNFs and NFs and the patient 
rights condition of participation at Sec. 484.10(c)(2)(ii) for HHAs.
    Concerning where an individual can file a complaint for non-
compliance, we have decided to follow the usual procedure and delegate 
the responsibility to receive complaints and initiate investigations to 
the State survey and certification agency under the authority of 
Regional Administrators. We have added new provisions at 
Secs. 417.436(d)(3) and 489.102(a)(4) to require that providers and 
HMOs and CMPs must inform individuals that complaints concerning non-
compliance with the advance directive requirements may be filed with 
the State survey and certification agency. This may be accomplished, 
for example, by posting a statement of an individual's rights under the 
advance directives requirements of the law and the name, address and 
telephone number of the State survey and certification agency to which 
the individual should file his or her complaint. In addition, we are 
amending Sec. 483.10(b)(7)(iv) to require a facility to include in its 
written description of a resident's legal right a statement that the 
resident may file a complaint with the survey and certification agency 
concerning noncompliance with the advance directives requirements. 
Section 484.10(f) of the HHA patient rights condition of participation 
also has been amended to specify that the patient also has the right to 
use the home health hotline to lodge complaints concerning the 
implementation of the advance directive requirements. In addition, the 
Medicare Hotline (1-800-638-6833) is another avenue to register 
complaints.
    Comment: One commenter asked how soon after a hospital adds a new 
unit or service would it have to report to HCFA regarding achieving 
compliance with the advance directive requirements.
    Response: We are not requiring hospitals to notify HCFA concerning 
compliance with the advance directive requirements each time a new unit 
or service is added. However, any new unit or service that is added to 
a hospital would be expected to meet the advance directive requirements 
for all new admissions as soon as it began operation and would be 
monitored in accordance with the normal enforcement procedures, as 
outlined above.
    Comment: One commenter suggested that we grant hospitals that are 
accredited by the Joint Committee on the Accreditation of Hospitals 
(JCAHO) deemed status for advance directive requirements now that the 
JCAHO has incorporated advance directives requirements into its 
standards. Another commenter questioned if HCFA will ask State 
departments of health to monitor compliance with the advance directive 
requirements within the context of the Medicare validation survey 
process.
    Response: National organizations that have been granted recognition 
of their accrediting programs are required to provide reasonable 
assurance to HCFA that the providers that they accredit meet the 
Medicare conditions of participation. However, since the advance 
directives requirements are not part of the Medicare conditions of 
participation for hospitals, accredited hospitals are not deemed to 
meet this requirement based on an accreditation survey.
    Instead, each hospital and hospice must comply with the advance 
directive requirements as part of its provider agreement with HCFA. As 
discussed above, each hospital (including any accredited by JCAHO or 
AOA) was required to inform HCFA, in writing, of the date that it 
achieved compliance with the advance directive requirements. As part of 
the compliance process, each hospital submitted an attestation 
statement signed and dated by its hospital administrator that informed 
HCFA of compliance. Compliance with the advance directive requirements 
is verified as part of the next routine on-site survey for hospices and 
non-accredited hospitals. For accredited hospitals, compliance is 
verified during any complaint investigation and at the time of 
validation surveys. This verification is a one-time event for both 
hospitals and hospices, unless a specific complaint is received about 
advance directives. All complaints about advance directives are 
investigated; failure to comply with the advance directives 
requirements is a cause for termination of a hospice's or hospital's 
provider agreement.
    Comment: Two commenters suggested we extend the time period for the 
State agency to conduct an investigation to determine if a facility is 
in compliance with the advance directives provisions to the date when 
the provider agreement with HCFA is terminated. Currently, the time 
period for written notification of deficiencies is 15 days from the 
initial visit and the commenters are requesting that this be changed to 
30 days. The commenters believe that 15 days is not sufficient time to 
permit adequate communication with all entities involved in many health 
care systems, particularly when providers are members of hospital 
chains, where information needs to be exchanged between corporate 
headquarters, attorneys, and the particular facility cited. 
[[Page 33286]] 
    Response: Although we give providers 15 days' advance notice before 
termination of the provider agreement, the provider usually has 90 days 
to correct a deficiency, between the time of the survey and the 
effective date of termination. Furthermore, enforcement procedures for 
deficiencies in meeting the advance directives requirements are handled 
in the same manner as other types of deficiencies. Medicare operational 
guidelines establish procedures and timeframes that we believe allow a 
provider ample opportunity to make corrections and to exchange 
information related to the deficiencies before the effective date of 
the actual termination. The communication needs cited by the commenters 
are not unique to situations involving non-compliance with the advance 
directives provisions, and thus we do not believe that changes in our 
termination procedures are warranted.
Miscellaneous Issues
    Comment: One commenter expressed concern with the applicability of 
the provider obligations contained in the advance directive 
requirements to independent personal care providers, as opposed to a 
home health agency, and the consequences of requiring individual 
personal care providers to comply with these requirements. The 
commenter asserted that independent personal care providers typically 
are semi-skilled workers who, in many instances, perform non-medical 
functions. The commenter believes that in many cases these individuals 
would not be able to comply with the advance directive requirements for 
providers. Therefore, the commenter requested that R.N. supervisors, 
rather than the personal care attendants, fulfill the requirements for 
personal care services. Furthermore, the commenter asserted that the 
obligations of the statute appear to apply only to providers and 
organizations that furnish ``medical care.'' Since independent personal 
care providers generally do not furnish medical care, they are not 
subject to the statute.
    Response: Section 1902(a)(57) of the Act specifically requires that 
each State Medicaid program assure that all affected providers, 
including personal care providers, meet the requirements of section 
1902(w) of the Act as well as all other Medicaid requirements. The 
statute does not prohibit a personal care provider from contracting 
with another entity to carry out the advance directive requirements, 
but personal care providers should enter into these contracts with the 
knowledge that they will still be legally responsible for ensuring that 
advance directive requirements are met. To clarify this point, we have 
revised Sec. 489.102(b)(3)(ii) to specify that all providers, including 
personal care providers, are permitted to contract with another entity 
to furnish this information but are still legally responsible for 
ensuring that advance directive requirements are met.
    Thus, a personal care provider may either perform the requirements 
of the advance directive provisions, or it may work with others to 
fulfill the requirements of this provision. If a personal care provider 
enters into a contract or other written agreement with another entity 
(for example, case manager, local home health agency, hospital 
discharge planner, or others) to satisfy the requirements of section 
1902(w) of the Act, we suggest that such a written agreement specify 
that the person or entity is satisfying the requirements of section 
1902(w) of the Act. Thus, the agreement should specify that the person 
or entity would (1) furnish written information (usually prepared by 
the State) to individuals receiving care regarding their rights under 
State law to make decisions concerning medical care; (2) furnish the 
providers written policies respecting the implementation of such rights 
(including any conscientious objections allowed by State law); (3) 
document in the individual's medical record whether or not the 
individual has executed an advance directive; (4) not discriminate 
against an individual based on whether or not the individual has 
executed an advance directive; (5) ensure compliance with State law; 
and (6) educate staff (if applicable) and community (which can be 
defined as the population served) on issues concerning advance 
directives.
    Although the commenter's question centered on the applicability of 
the provider obligations for personal care providers, we have revised 
Secs. 489.102(a)(1)(i), 417.436(d)(1)(i)(A) and 483.10(b)(8) to permit 
all providers to enter into agreements such as the one described above.
    Comment: One commenter expressed confusion over what he believes to 
be an apparent conflict between the advance directive provisions of 
this regulation and the election procedures for Medicare hospice 
patients. Medicare-certified hospice programs are required to inform 
new patients at the time they elect hospice care of what types of care 
the hospice provides. At that point, the patient exercises a choice 
with respect to services that may include an acknowledgement that life 
sustaining treatment would be withheld.
    Response: We do not believe that there is an inconsistency between 
the advance directives provisions of this regulation and the election 
procedures for Medicare hospice patients. In fact, we believe these 
requirements are entirely consistent with the intended exchange of 
views and information that takes place when an individual elects 
hospice care. Hospice patients may appropriately be asked if they have 
an advance directive even though their choice of hospice care reflects 
a preference for palliative rather than curative treatment. We rely 
upon the hospice to inform the patient fully at the time of the hospice 
election as to the nature of the care. The hospice, after being 
informed of the patient's choice, will inform the patient of its 
treatment plan, policies and whether the patient's advance directive 
may be implemented. As part of the process, the patient will be 
informed if the advance directive will not be honored because State law 
permits the facility to object to implementing an advance directive on 
the basis of conscience.

B. Comments Specific to Managed Care Plans

Scope
    Comment: One commenter questioned whether the advance directive 
requirements apply to both risk-based and cost-reimbursed Medicare HMOs 
and CMPs.
    Response: 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 concerning the right to accept or 
refuse medical or surgical treatment and to formulate an advance 
directives with respect to all adult individuals receiving medical care 
through the provider or organization. These requirements apply to both 
risk-based and cost-reimbursed Medicare HMOs and CMPs. In addition, 
organizations providing services to Medicaid enrollees, such as health 
insurance organizations, prepaid health plans and Medicaid HMOs, also 
must meet these requirements. The statute does not authorize exceptions 
for certain model types.
Advance Directives Information Provided by Managed Care Plans
    Comment: Several commenters suggested that HMOs and CMPs be allowed 
to provide information [[Page 33287]] concerning an adult individual's 
right to accept or refuse medical or surgical treatment and to 
formulate an advance directive only to the subscriber of the plan, who 
would then share this information with his or her covered dependents. 
This would prevent multiple mailings of material to the same address.
    Response: We concur with the commenter that HMOs and CMPs are 
permitted to provide information concerning advance directives only to 
the subscriber of the plan. Typically, HMOs and CMPs send enrollment 
packages to the subscriber who in turn shares the information with his 
or her dependents. All the information that a subscriber needs, 
including membership cards, evidence of coverage, and listings of 
participating providers are usually sent in this package. Sections 
1866(f)(1) and 1902(w)(1) of the Act require that written materials 
concerning an individual's right to accept or refuse medical or 
surgical treatment and to formulate an advance directive be provided to 
all adult individuals receiving medical care by or through the provider 
or organization. However, since it is customary for subscribers to 
share membership material with adult dependents, we believe that 
permitting HMOs and CMPs to send advance directives material only to 
subscribers (who would then be instructed to share the material with 
adult dependents) would fulfill the statutory requirement. The 
membership material should indicate to subscribers that they are 
expected to share the advance directives information with adult 
dependents.
    Comment: One commenter requested clarification as to what kind of 
documentation an HMO or CMP is required to keep to prove that written 
information regarding advance directives was provided to new enrollees 
(for example, a patient's signature acknowledging receipt).
    Response: Section 1866(f)(2)(E) of the Act requires HMOs or CMPs to 
provide written information to adult individuals concerning their 
rights under State law to accept or refuse medical or surgical 
treatment and to formulate an advance directive to enrollees at the 
time of enrollment. Although we encourage recordkeeping actions such as 
a notation in the beneficiaries' medical record, we are not requiring 
that an HMO document that it has provided the material to each 
individual enrollee. Rather, we will verify compliance with this 
requirement by reviewing the materials provided to new enrollees and 
examining an HMO's or CMP's systems and procedures to ensure that it 
provides the materials timely.
    Comment: A few commenters expressed concern over the meaning of 
``at the time of enrollment.'' Many individuals join HMOs or CMPs 
through their employers. However, employers often do not relay 
enrollment information to health care plans until after the effective 
date of coverage, making the requirement impossible to meet. In 
addition, the requirement that information be provided at the time of 
enrollment could force health care plans to mail the advance directive 
information before other membership materials, such as membership cards 
and directories, creating unnecessary added costs.
    Response: In accordance with section 1866(f)(1)(B) of the Act, 
Sec. 417.436(d)(1)(ii) requires that an HMO or CMP provide written 
information concerning its policies that implement advance directives 
to adult individuals at the time of enrollment (57 FR 8198). In view of 
the comments we received on this issue, we recognize that it would be 
helpful to clarify how managed care plans may meet this requirement. 
For enrollees that join managed care plans as individuals, the meaning 
of ``at the time of enrollment'' is relatively straightforward, that 
is, as soon as possible after the application is received, but before 
the effective date of coverage. However, for individuals that join 
managed care plans through an employer group, we are clarifying that 
``at the time of enrollment'' means at the time that the employer group 
enrolls the beneficiary into the plan. In such situations, the managed 
care plan may not be informed of the enrollment immediately; therefore, 
to implement the requirements of the statute, we believe it would be 
permissible for the employer group to provide, on behalf of the 
organization, information concerning an adult individual's right to 
accept or refuse medical or surgical treatment and to formulate an 
advance directive. In keeping with other provisions of this rule, the 
HMO or CMP may incorporate such information into the marketing material 
that the managed care plan supplies to employer groups so that the 
information is disseminated when the employer distributes other plan 
marketing materials to potential enrollees.
    Comment: One commenter questioned whether ``at the time of 
enrollment'' referred not only to individuals' initial enrollments but 
also to individuals' annual re-enrollments.
    Response: We believe that the intent of the legislation is to 
require that the written advance directives information be provided at 
the time of initial enrollment. Therefore, we are not requiring that 
written advance directives material be provided for individuals 
renewing their enrollments. We have revised Sec. 417.436(d)(1)(ii) to 
clarify that this information needs to be provided only at the time of 
initial enrollment.
    Comment: Several commenters requested clarification regarding 
whether a managed care plan's written policies on advance directives 
must provide detailed information regarding the advance directive 
policies of its contracting providers. Commenters believe that 
requiring a plan to disseminate information regarding the policies of 
its contracting providers would be overly burdensome and duplicative. 
These commenters believe that health care plans should be allowed to 
inform enrollees that each provider has its own policies and that 
enrollees may request more information from the individual provider.
    Response: We believe that information regarding whether contracting 
providers will implement advance directives is an integral part of each 
managed care plan's advance directives policies. Without such 
information, enrollees will not be able to make informed decisions 
regarding advance directives. The interim final rule provided two 
options describing contracting providers' policies. The first option 
allows a managed care plan to develop a policy that embraces all of its 
providers' policies. The second option allows a managed care plan to 
simply note that differences among its providers policies exist, and 
that more information is available from the organization upon request. 
These options do not necessarily require detailed information regarding 
each provider's policies. For example, if all contracting providers 
implement all advance directives that meet State requirements, the plan 
could simply note this information. On the other hand, if one or more 
of the contracting providers have a more limited policy (for example, a 
hospital exercising a reservation of conscience), the plan may either 
(1) provide a written policy that states the restrictions these 
providers placed on advance directives or (2) note that some providers 
may object to implementing an advance directive, but that more 
information is available upon request. At a minimum, plans should have 
information available upon request as to which contracting institutions 
place limits on implementing advance directives.
    Comment: One commenter believes that the discussion in the preamble 
to the interim final rule concerning the content and format of the 
written [[Page 33288]] information to be provided to each adult 
individual exceeded the provisions of section 1866(f) of the Act. (See 
57 FR 8196.) Specifically, the commenter objected to our statement that 
the legally required elements of the written information would include 
a description of the provider's ``policies and procedures''. The 
commenter believes that the term ``policies and procedures'' overstates 
the provisions of section 1866(f) of the Act.
    Response: We believe that the commenter has misinterpreted a 
parenthetical statement in the interim final rule that the summary 
notice would need to contain the legally required elements, including a 
description of the provider's policy and procedures. In accordance with 
section 1866(f) of the Act, Secs. 417.436(d)(1)(i)(B) and 
489.102(a)(1)(ii) specify that the written information provided to each 
adult individual include a description of ``the written policies'' of 
an organization or a provider concerning the organization's policies 
respecting the implementation of an individual's advance directive 
rights. The information provided to enrollees should be specific to the 
plan, and include information on the organization's written policies 
regarding the execution of a beneficiary's advance directive.
    Comment: One commenter questioned whether the regulations require 
physicians that contract with HMOs to develop policies regarding 
advance directives or if physicians are required to comply with the HMO 
policy.
    Response: The statute and our regulations do not address this 
issue. The individual physician's role and responsibilities will be 
determined by State law and the HMO's contracts and policy. For plans 
that operate in more than one State, the HMO should insure that 
contracting physicians follow the applicable statutes of the State or 
States in which they practice.
    Comment: One commenter suggested that managed care plans should 
have to maintain written policies and procedures only for individuals 
for whom they provide care directly. Thus, plans that arrange for 
services, but do not provide them directly, would not have to develop 
policies.
    Response: Under sections 1866(f)(1), 1902(a)(57), and 1902(w) of 
the Act, all managed care plans with Medicare or Medicaid contracts are 
required to maintain written policies concerning advance directives, 
with respect to all adult individuals receiving medical care by or 
through the organization. As noted above, the statute does not 
authorize exceptions for certain model types.
    Comment: One commenter asserted that HMOs and CMPs should not be 
solely responsible for locating alternate providers if a provider will 
not honor an advance directive as a matter of conscience.
    Response: In accordance with section 1866(f)(1)(B) of the Act, 
Sec. 417.436(d)(1)(iii) requires that an HMO or CMP document in the 
medical record whether or not an individual has executed an advance 
directive. Section 417.436(d)(1)(iii) also specifies that HMOs and CMPs 
are 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 to conscientiously object. 
However, neither the statute nor the regulations require an HMO or CMP 
to locate alternative providers when a provider chooses, as a matter of 
conscience, not to honor an individual's advance directive. We do not 
believe it is appropriate to require this. However, it is reasonable to 
expect that assistance would be provided for a transfer at the 
patient's request. We note that an HMO or CMP would be required to 
comply with any applicable State law to that effect.
Description of State Law
    Comment: One commenter requested that we explicitly state that the 
requirement for managed care plans to provide information to their 
enrollees concerning an individual's rights under State law applies 
only to the law of the State in which the HMO or CMP provides services.
    Response: We concur and have revised Sec. 417.436(d)(1)(i)(A) to 
clarify that HMOs or CMPs are required to provide information that 
relates to the law of the State in which services are being provided. 
For plans that have multi-state provider networks, the information 
should reference the advance directive laws of all States in the 
service area.
Documentation in Individual Medical Records
    Comment: Several commenters questioned who should be ultimately 
responsible for documenting in an enrollee's medical record whether or 
not the individual has executed an advance directive--the physician or 
physician group. Most of these commenters recommended that physicians 
that practice in HMOs or CMPs should be held responsible, and that the 
HMO or CMP should not have to ensure that these physicians document the 
medical record. Another commenter asserted that physicians should not 
be required to obtain advance directives information on behalf of HMOs 
or CMPs. This commenter believes that a HMO or CMP should be required 
to maintain its own advance directives records and relay the 
information to the physicians.
    Response: Sections 1866(f)(1), 1902(a)(57) and 1902(w)(1) of the 
Act clearly specify that the advance directives requirements apply to 
``providers and organizations''. Thus, we believe that an HMO or CMP is 
ultimately responsible for ensuring that the existence of an advance 
directive is documented in an enrollee's medical records. HMOs or CMPs 
may use any procedures they wish, consistent with State law, to ensure 
that this requirement is met. We do not believe it would be consistent 
with the intent of the statute to require any particular process. One 
possible process would be for the HMO or CMP to amend contracts with 
its physicians to require them to obtain the information. However, the 
HMO or CMP would still need to verify that its physicians document in 
the medical record whether or not an individual has executed an advance 
directive.
    Comment: One commenter requested confirmation that HMOs or CMPs 
will not be out of compliance with the requirement to document the 
medical record if some enrollees never have a medical record because 
they never used medical services.
    Response: We agree that if a medical record is not created, the 
requirement to document in the medical record whether or not an advance 
directive exists would not apply.
    Comment: Several commenters stated that the requirement concerning 
the documentation of medical records should not be made applicable to 
individual practice associations (IPAs), network-model or group-model 
HMOs because these organizations characteristically do not generate or 
have access to patient medical records. Therefore, these organizations 
cannot fulfill the requirement that they document in the enrollee's 
medical record whether or not the individual has executed an advance 
directive. One commenter suggested that managed care plans, 
particularly IPAs, should be allowed to use a centralized recordkeeping 
system rather than the individual medical record to document whether or 
not the individual has executed an advance directive.
    Response: Under sections 1866(f)(1)(B) and 1902(w)(1)(B) of the 
Act, all managed care organizations must document in the individual's 
medical record whether or not the individual has executed an advance 
[[Page 33289]] directive. Managed care plans may use a centralized 
recordkeeping system to maintain information on whether or not an 
individual has executed an advance directive. However, the use of a 
centralized recordkeeping system may not necessarily meet the 
requirement that managed care plans document in each enrollee's medical 
record whether or not the individual has executed an advance directive. 
If the central file is a medical record file, then the use of the 
centralized file would meet the requirement. If the central file is not 
a medical file (for example, it only contains enrollment and general 
policy information concerning advance directives), the managed care 
plan also would have to document in the medical record whether or not 
an individual has executed an advance directive. Again, the statute 
does not authorize exemptions for certain managed care plans due to 
their organizational structure.
    Comment: Several commenters stated that clarification is needed 
regarding the reasonable steps a managed care plan must take to 
document in the member's record whether or not the member has executed 
an advance directive. Several commenters believed that enrollees should 
be responsible for notifying their health care plan as to whether they 
have executed an advance directive.
    Response: As noted above, the statute requires that each enrollee's 
medical record contain documentation as to whether or not the enrollee 
has executed an advance directive. The interim final rule gives several 
examples of appropriate methods for obtaining the information needed to 
document medical records (57 FR 8197). For example, a managed care plan 
may modify its contracts with its primary care providers to require 
that the advance directive information be recorded when an enrollee's 
medical record is created. Alternatively, plans could request members 
to provide this information by mail. Whatever method the plan uses, it 
must obtain some response from the enrollee. If an enrollee refuses to 
disclose information regarding whether or not he or she has an advance 
directive, the managed care plan should record the enrollees refusal to 
answer.
    Comment: One commenter asked if a managed care plan is required to 
contact patients and ask definitive questions concerning life-
sustaining treatment.
    Response: Section 417.436(d)(1)(iii) requires only that an HMO or 
CMP document in the medical record whether or not an enrollee has 
executed an advance directive. It does not require HMOs or CMPs to 
document the type of advance directive or ask specific questions 
regarding an enrollee's wishes for life-sustaining treatment. As we 
have noted earlier, an HMO or CMP would be required to comply with any 
applicable State law or other Federal requirement that may make it 
necessary to take additional steps such as those discussed by the 
commenter.
    Comment: One commenter noted that the interim final rule is unclear 
as to whether or not the documentation must be done for all current 
enrollees as well as for all new enrollees.
    Response: Section 4206(e)(2) of OBRA '90 specifies that for managed 
care plans, the advance directive provisions took effect on December 1, 
1991. Therefore, documentation of the medical record is required only 
for new enrollees since that date.
    Comment: One commenter expressed concern that managed care plans 
may face liability if enrollees change, cancel or execute new advance 
directives after the plan has documented the medical record, since the 
plan's information may not match the enrollees' wishes.
    Response: Neither the statutory provisions nor the regulations 
concerning advance directives address the issue of liability in cases 
where the patient changes an advance directive. We would defer to State 
law for a decision on liability in this type of situation.
    Sections 1866(f)(1)(B) and 1902(w)(1)(B) of the Act and 
implementing regulations require only that the managed care plan 
document whether or not the enrollee has executed an advance directive, 
not necessarily the contents of the advance directive. After the 
medical record is documented, we are not imposing further medical 
record documentation requirements on managed care plans in this rule. 
However, if an enrollee informed the plan that he or she had changed or 
cancelled an advance directive, we would expect a health plan to update 
the medical record information. In addition, the plan would be 
responsible for complying with applicable State and Federal 
requirements regarding the implementation of the new advance directive.
Time Required To Update Descriptions of State Law
    Comment: Many managed care plans responded to our request for an 
estimate of an appropriate amount of time to update information on 
advance directives after changes in State law. The estimated time 
frames ranged from 30 days to 1 year after all approvals are obtained.
    Response: We have thoroughly reviewed the many suggestions 
concerning timeframes for updating information on advance directives 
after changes in State law. Since information concerning advance 
directives is often included in marketing material, which is reviewed 
by federal or State regulators on an annual basis, we considered 
permitting plans to update their advance directive information on an 
annual basis. For some individuals, however, one of the factors that 
may contribute to the selection of a plan may be the individual's 
belief that the plan would honor its advance directive. We believe that 
distributing erroneous or outdated advance directive information to 
potential enrollees could unfairly influence their decision to enroll 
in a given plan. Therefore, as discussed above in section IV.A, managed 
care plans, like all other providers, are required to update their 
advance directives information as soon as possible but no later than 90 
days after the effective date of a change in State law. Applying the 
90-day time limit for plans to update changes in State laws will ensure 
that potential enrollees are provided with accurate information before 
enrolling in a plan while at the same time providing managed care plans 
with a reasonable amount of time in which to update their information. 
We have revised Secs. 417.436(d)(1)(i)(A) and 434.28 to reflect this 
requirement.
    We also have revised Sec. 431.20(b) to require that revisions to 
the written descriptions of State law must be incorporated in such 
advance directive information and distributed to Medicaid providers, 
and HMOs and CMPs, as soon as possible, but no later than 60 days from 
the effective date of the change. We believe that this requirement is 
necessary to keep potential and existing enrollees informed about 
advance directive changes that could affect their care decisions. We 
note that, in addition to the use of marketing materials, plans may 
disseminate information about changes in State law concerning advance 
directive by using their community education programs and procedures, 
mailing information directly to all enrollees, or using any other 
method they believe may help further provide enrollees with updated 
information.
Ensuring Compliance With State Law
    Comment: One commenter believes that organizations that contract 
with providers to provide health care, but do not provide health care 
directly, should not be required to ensure that providers comply with 
State law. [[Page 33290]] 
    Response: Sections 1866(f)(1)(D) and 1902(w)(1)(D) of the Act and 
implementing regulations at Sec. 417.436(d)(1)(i)(A) require that a 
prepaid or eligible organization maintain written policies and 
procedures that ensure compliance with the requirements of applicable 
State law regarding an adult individual's right under State law to 
accept or refuse medical or surgical treatment and to formulate an 
advance directive. As discussed above, there is no statutory basis 
under which we could exempt certain prepaid health care plans due to 
their organizational structure.
    Comment: One commenter wanted general standards for managed care 
plans to use in ensuring compliance with State law.
    Response: We note that plans have followed varying practices in 
complying with State law and we do not believe it is necessary or 
appropriate to prescribe standards to achieve this. State survey 
agencies would have the opportunity to ensure that plans have complied 
with State law concerning an adult individual's rights under State law 
to accept or refuse medical or surgical treatment and to formulate an 
advance directive.
Education of Staff and Community
    Comment: One commenter requested that we define ``community'' for 
purposes of a managed care plan's community education responsibilities.
    Response: Typically, the community served by a managed care plan is 
defined as the organization's service area.
    Comment: One commenter suggested that HMOs and other health care 
providers be allowed to combine their community education programs to 
meet the community education requirement.
    Response: In accordance with sections 1866(f)(1)(E) and 
1902(w)(1)(E) of the Act, Sec. 417.436(d)(1)(vii) specifically permits 
HMOs or CMPs to provide community education regarding advance 
directives either directly or in concert with other providers.
    Comment: One commenter requested clarification on what constitutes 
community education in the case of managed care plans. Specifically, 
the commenter questioned whether including information on advance 
directives in the marketing brochure would be adequate.
    Response: The meaning of community education is no different for 
managed care plans than it is for other Medicare and Medicaid 
providers. Plans can distribute educational materials to the public on 
advance directives, or they can provide seminars to the public. As 
mentioned earlier, the community education requirement does not need to 
be conducted through a community relations department, but information 
on advance directives must be conveyed to the community. A marketing 
brochure that contains the required information, and is distributed to 
the relevant community, may contribute to the statute's community 
education goals. Although we will evaluate the community education 
efforts of each managed care plan on an individual basis, generally we 
believe that activities such as seminars or direct community mailing, 
in combination with the distribution of marketing materials regarding 
advance directives, would be needed to satisfy the community education 
requirements. In summary, there are numerous methods for conducting 
community education, and we encourage creativity among the plans to 
reach as large a number of individuals as would be reasonable for their 
service area.
    Comment: One commenter requested clarification regarding whether 
the educational materials must be approved by HCFA.
    Response: Any marketing material that discusses the risk-based or 
cost-reimbursed HMO programs and is provided to Medicare beneficiaries 
must be approved by HCFA. Material that discusses advance directives, 
but does not discuss these programs, does not need to be approved. We 
do not approve marketing material for HCPPs and Medicaid organizations; 
however, these organizations must comply with applicable State 
requirements regarding approval for materials.
    Comment: Two commenters questioned how HMOs and CMPs could obtain 
information on the existence of advance directives through the 
community education campaigns.
    Response: The interim final rule stated that it may prove 
acceptable for a provider or organization to obtain information on the 
existence of advance directives through a community education campaign 
(57 FR 8197). The point of this statement was that we do not wish to 
limit the alternatives available to a provider or an HMO or CMP for 
obtaining this information. Thus, if an HMO finds it feasible to 
collect such information from some of its enrollees during a community 
education campaign, we would not object. The interim final rule 
discussed several other more likely methods for obtaining information 
about the existence of an advance directive, and we urge providers and 
organizations to use the approach that they find most effective.
    Comment: One commenter requested clarification of the requirement 
for educating staff concerning advance directives.
    Response: Sections 1866(f)(1)(E) and 1902(w)(1)(E) of the Act 
require that a provider or organization educate both staff and the 
community on issues concerning advance directives. In general, we would 
expect an organization to provide parallel educational information to 
its staff as it does for the community, that is, 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 or organization's 
implementation policy concerning advance directives. Thus, a managed 
care plan is responsible for providing staff education to ensure that 
its advance directive policies and procedures are executed timely and 
correctly.

C. Comments on Appendices

    Comment: Two commenters requested that in our public information 
document, ``Advance Directives--The Patient's Right to Decide'', which 
was published as Appendix I to the interim final rule, nurses should be 
specifically mentioned as one of the disciplines individuals may wish 
to talk to. Another commenter suggested that, under the question ``What 
Should I Do With My Advance Directive If I Choose to Have One?'', we 
should recommend that individuals review their advance directives at 
least annually and communicate any revisions to their physicians. In 
addition, several organizations submitted suggestions for additions to 
the organizations and publications listed as ``National Resources on 
Advance Directives'', which was published as Appendix II to the 
preamble of the interim final rule.
    Response: We are not reprinting either of these two documents in 
this final rule. However, we have passed these suggestions on to HCFA's 
Office of Public Affairs, which is responsible for the development and 
distribution of this information. We note that the following 
organizations and publications were suggested by commenters for 
addition to the national resource list on advance directive issues:
    ``American Life League, Inc.'', P.O. Box 1350, Stafford, Virginia 
22554, (703) 659-4171.
    ``Advance Directive Protocols and the Patient Self-Determination 
Act: A Resource Manual for the Development of Institutional 
Protocols.'' Choice in [[Page 33291]] Dying, 200 Varick Street, New 
York 10014.
    ``Patient Self-Determination Act of 1990, Implementation Issues.'' 
This document deals specifically with long-term care issues. American 
Association of Homes and Services for the Aging, 901 E. Street, N.W., 
Suite 500, Washington, D.C. 20004-2037.

V. Changes to Provisions of the Interim Final Rule

    As discussed above in section IV of this preamble, we are making 
several changes to the regulations based on public comments. The 
specific revisions to the current advance directive regulations are as 
follows:
     We are revising Secs. 417.436(d)(1)(i)(A), 483.10(b)(8), 
and 489.102(a)(1)(i) to clarify that providers and HMOs or CMPs are 
permitted to contract with other entities to furnish information 
concerning the advance directive requirements but are still legally 
responsible for ensuring that the statutory requirements are met.
     We are revising Secs. 417.436(d)(1)(i)(A), 
430.12(c)(1)(ii), 431.20(b), 434.28, and 489.102(a)(1)(i) to clarify 
our requirements when changes to State advance directive laws are 
enacted.
     When changes to State laws are enacted, States are required under 
Sec. 431.20(b) to provide revised copies of their descriptions of State 
law to Medicaid providers and HMOs and CMPs as soon as possible, but no 
later than 60 days from the effective date of the law. Within that same 
timeframe, States are required under Sec. 430.12(c)(ii) to amend their 
State plan.
    In turn, providers are required under Sec. 489.102(a)(1)(i) to 
revise and disseminate the amended informational materials as soon as 
possible, but no later than 90 days from the effective date of the 
change in State law. Under Secs.  417.436(d)(1)(i)(A)) and 434.28, HMOs 
and CMPs are required to revise their informational material as soon as 
possible, but no later than 90 days from the effective date of a change 
in State law.
     In Secs. 417.436(d)(1)(i)(B) and 489.102(a)(1)(ii), we are 
adding a description of the minimum information that should be 
contained in a provider's, HMO's, or CMP's statement of limitation if 
an advance directive cannot be implemented because of an objection on 
the basis of conscience.
     We are revising Secs. 417.436(d)(1)(ii), 483.10(b)(8), and 
489.102(e) to clarify our policy on the provision of information about 
advance directives to family members or a surrogate when an individual 
is incapacitated. This change codifies in the regulations policy that 
was set forth in the preamble to the interim final rule.
     We are revising Secs. 417.436(d)(1)(vii) and 489.102(a)(6) 
to clarify that a provider, HMO, or CMP is not required to disseminate 
during community education efforts the same material it gives to adult 
individuals at admission. Providers, HMOs and CMPs are not restricted 
to disseminating the same type of information in all settings; but at a 
minimum the community education materials should define what 
constitutes an advance directive, emphasizing that an advance directive 
is designed to enhance an incapacitated individual's control over 
medical treatment, and describe applicable State law concerning advance 
directives. In addition, we have added the requirement that a provider, 
HMO, or CMP must be able to document its community education efforts.
     We have added new Sec. 417.436(d)(3) and revised 
Sec. 489.102(a)(4) to require that providers and HMOs or CMPs must 
inform individuals that complaints concerning non-compliance with the 
advance directive requirements may be filed with the State survey and 
certification agency. We have also revised Sec. 484.10(f) to specify 
that a patient has the right to use the home health hotline to lodge 
complaints concerning the implementation of the advance directives 
requirements.
     In Secs. 484.10(c)(2)(ii) and 489.102(b)(3)(i), we are 
specifying 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. In addition, we are revising 
Sec. 489.102(b)(3)(ii) to specify that providers of personal care 
services 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. Personal care providers are permitted to 
contract with another entity to furnish advance directives information 
but are still legally responsible for ensuring that the advance 
directive requirements are met.

VI. Impact Statement

    For final rules such as this, we generally prepare a regulatory 
flexibility analysis that is consistent with the Regulatory Flexibility 
Act (RFA) (5 U.S.C. 601 through 612) unless the Secretary certifies 
that a final rule will not have a significant impact on a substantial 
number of small entities. For purposes of the RFA, we do not consider 
States or individuals to be small entities.
    In our March 6, 1992 interim final rule, we set forth regulations 
amending the Medicare and Medicaid regulations governing provider 
agreements and contracts by implementing certain changes made by OBRA 
'90. Those regulations establish requirements concerning advance 
directives for States, hospitals, nursing facilities, skilled nursing 
facilities, providers of home health care or personal care services, 
hospice programs and managed care plans such as HMOs and CMPs. In our 
analysis of the impact of the interim final rule, we concluded that 
performing the functions necessary to meet the requirements of the 
interim final rule, as required by the statute, would not cause a 
consequential expenditure of time and effort. Although we received 
several comments regarding our estimate of the information collection 
burden associated with these requirements (see section IV of this 
preamble), commenters generally did not object to our overall 
conclusion that the advance directives requirements set forth in the 
interim final rule would not cause a consequential increase in 
expenditure of time and effort.
    This final rule largely confirms provisions of the interim final 
rule with comment. This final rule makes only minor changes to the 
current advance directives regulations, such as clarifying our policy 
on incapacitated individuals. None of the changes to the interim final 
rule has more than a marginal effect on the overall costs or benefits 
of the advance directive requirements.
    Section 1102(b) of the Act requires the Secretary to prepare a 
regulatory impact analysis if a final rule will have a significant 
impact on the operations of a substantial number of small rural 
hospitals. Such an analysis must conform to the provisions of section 
603 of the RFA. For purposes of section 1102(b) of the Act, we define a 
small rural hospital as a hospital that has fewer than 50 beds and is 
located outside a Metropolitan Statistical Area.
    We have determined, and the Secretary certifies, that this final 
rule will not have a significant economic impact on the operations of a 
substantial number of small entities or small rural hospitals. 
Therefore, we have not prepared a regulatory flexibility analysis or an 
analysis of the impact of this rule on small rural hospitals.
    This regulation was not reviewed by the Office of Management and 
Budget.

VII. Collection of Information Requirements

    Sections 417.436(d)(iii), 417.801(b)(5), 431.107(b)(4), 434.28, 
483.10(b)(8), 484.10(c)(2)(ii), and 489.102(a)(2) of the 
[[Page 33292]] interim final rule imposed information collection 
requirements that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 
et seq.). These information collections require hospitals, nursing 
facilities, skilled nursing facilities, providers of home health care 
or personal care services, hospice programs and HMOs and CMPs to 
document in the medical record whether or not an individual has 
executed an advanced directive. We received several comments on our 
estimates of the collection burdens involved. The comments and our 
responses are presented in detail in section IV.A of the preamble to 
this final rule. OMB has approved the information collection 
requirements set forth in our March 6, 1992 interim final rule through 
June 30, 1996 (Approval Number 0938-610).

List of Subjects

42 CFR Part 417

    Administrative practice and procedure, Health maintenance 
organizations (HMOs), Medicare, Reporting and recordkeeping 
requirements.

42 CFR Part 430

    Grants to States for Medical Assistance Programs.

42 CFR Part 431

    Grant programs--health, Health facilities, Medicaid, Privacy, 
Reporting and recordkeeping requirements.

42 CFR Part 434

    Grant programs--health, Health maintenance organizations (HMO), 
Medicaid, Reporting and recordkeeping requirements.

42 CFR Part 483

    Grant programs--health, Health facilities, Health professions, 
Health records, Medicaid, Nursing homes, Nutrition, Reporting and 
recordkeeping requirements, Safety.

42 CFR Part 484

    Administrative practice and procedure, Health facilities, Health 
professions, Home health agencies, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 489

    Health facilities, Medicare, Reporting and recordkeeping 
requirements.

    42 CFR chapter IV is amended as follows:
    A. Part 417 is amended as set forth below:

PART 417--HEALTH MAINTENANCE ORGANIZATIONS, COMPETITIVE MEDICAL 
PLANS, AND HEALTH CARE PREPAYMENT PLANS

    1. The authority citation for part 417 continues to read as 
follows:

    Authority: Secs. 1102, 1833(a)(1)(A), 1861(s)(2)(H), 1871, 1874, 
and 1876 of the Social Security Act (42 U.S.C. 1302, 13951(a)(1)(A), 
1395x(s)(2)(H), 1395hh, 1395kk, and 1395mm); sec. 114(c) of Pub. L. 
97-248 (42 U.S.C. 1395mm note); secs. 1301 through 1318 of the 
Public Health Service Act (42 U.S.C. 216 and 300e through 300e-17), 
unless otherwise noted.

    2. In Sec. 417.436, the introductory text of paragraph (d)(1) is 
republished, paragraphs (d)(1)(i), (d)(1)(ii) and (d)(1)(vii) are 
revised, the introductory text of paragraph (d)(2) is republished, 
paragraph (d)(2)(ii) is revised, and paragraph (d)(3) is added to read 
as follows:


Sec. 417.436  Rules for enrollees.

* * * * *
    (d) Advance directives. (1) An HMO or CMP must maintain written 
policies and procedures concerning advance directives, as defined in 
Sec. 489.100 of this chapter, with respect to all adult individuals 
receiving medical care by or through the HMO or CMP and are required 
to:
    (i) Provide written information to those individuals concerning--
    (A) Their rights under the law of the State in which the 
organization furnishes services (whether statutory or recognized by the 
courts of the State) to make decisions concerning such 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. Providers are permitted to contract with other entities to 
furnish this information but are still legally responsible for ensuring 
that the requirements of this section are met. Such information must 
reflect changes in State law as soon as possible, but no later than 90 
days after the effective date of the State law; and
    (B) The HMO's or CMP's written policies respecting the 
implementation of those rights, including a clear and precise statement 
of limitation if the HMO or CMP cannot implement an advance directive 
as a matter of conscience. At a minimum, this statement should:
    (1) Clarify any differences between institution-wide conscience 
objections and those that may be raised by individual physicians;
    (2) Identify the state legal authority permitting such objection; 
and
    (3) Describe the range of medical conditions or procedures affected 
by the conscience objection.
    (ii) Provide the information specified in paragraphs (d)(1)(i) of 
this section to each enrollee at the time of initial enrollment. If an 
enrollee is incapacitated at the time of initial enrollment 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 HMO or CMP may give advance directive 
information to the enrollee's family or surrogate in the same manner 
that it issues other materials about policies and procedures to the 
family of the incapacitated enrollee or to a surrogate or other 
concerned persons in accordance with State law. The HMO or CMP is not 
relieved of its obligation to provide this information to the enrollee 
once he or she is no longer incapacitated or unable to receive such 
information. Follow-up procedures must be in place to ensure that the 
information is given to the individual directly at the appropriate 
time.
* * * * *
    (vii) Provide for community education regarding advance directives 
that may include material required in paragraph (d)(1)(i)(A) of this 
section, either directly or in concert with other providers or 
entities. Separate community education materials may be developed and 
used, at the discretion of the HMO or CMP. The same written materials 
are not required for all settings, but the material should define what 
constitutes an advance directive, emphasizing that an advance directive 
is designed to enhance an incapacitated individual's control over 
medical treatment, and describe applicable State law concerning advance 
directives. An HMO or CMP must be able to document its community 
education efforts.
    (2) The HMO or CMP--(i) * * *
    (ii) Is not required to implement an advance directive if, as a 
matter of conscience, the HMO or CMP cannot implement an advance 
directive and State law allows any health care provider or any agent of 
such provider to conscientiously object.
    (3) The HMO or CMP must inform individuals that complaints 
concerning non-compliance with the advance directive requirements may 
be filed with the State survey and certification agency.
    B. Part 430 is amended as set forth below: [[Page 33293]] 

PART 430--GRANTS TO STATES FOR MEDICAL ASSISTANCE PROGRAMS

    1. The authority citation for part 430 continues to read as 
follows:

    Authority: Sec. 1202 of the Social Security Act (42 U.S.C. 
1302).

Subpart B--State Plans

    2. In Sec. 430.12, the introductory text of paragraph (c)(1) is 
republished, and paragraph (c)(1)(ii) is revised to read as follows:


Sec. 430.12  Submittal of State plan and plan amendments.

* * * * *
    (c) Plan amendments. (1) The plan must provide that it will be 
amended whenever necessary to reflect--
* * * * *
    (ii) Material changes in State law, organization, or policy, or in 
the State's operation of the Medicaid program. For changes related to 
advance directive requirements, amendments must be submitted as soon as 
possible, but no later than 60 days from the effective date of the 
change to State law concerning advance directives.
* * * * *
    C. Part 431 is amended as set forth below:

PART 431--STATE ORGANIZATION AND GENERAL ADMINISTRATION

    1. The authority citation for part 431 continues to read as 
follows:

    Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 
1302).

Subpart A--Single State Agency

    2. In Sec. 431.20, paragraph (b) is revised to read as follows:


Sec. 431.20  Advance directives.

* * * * *
    (b) A State Plan must provide that the State, acting through a 
State agency, association, or other private nonprofit entity, develop a 
written description of the State law (whether statutory or as 
recognized by the courts of the State) concerning advance directives, 
as defined in Sec. 489.100 of this chapter, to be distributed by 
Medicaid providers and health maintenance organizations (as specified 
in section 1903(m)(1)(A) of the Act) in accordance with the 
requirements under part 489, subpart I of this chapter. Revisions to 
the written descriptions as a result of changes in State law must be 
incorporated in such descriptions and distributed as soon as possible, 
but no later than 60 days from the effective date of the change in 
State law, to Medicaid providers and health maintenance organizations.
    D. Part 434 is amended as set forth below:

PART 434--CONTRACTS

    1. The authority citation for part 434 continues to read as 
follows:

    Authority: 1102 of the Social Security Act (42 U.S.C. 1302).

Subpart C--Contracts with HMOs and PHPs: Contract Requirements

    2. In subpart C, Sec. 434.28 is revised to read as follows:


Sec. 434.28  Advance Directives.

    A risk comprehensive contract with an HMO must provide for 
compliance with the requirements of subpart I of part 489 of this 
chapter relating to maintaining written policies and procedures 
respecting advance directives. This requirement includes provisions to 
inform and distribute written information to adult individuals 
concerning policies on advance directives, including a description of 
applicable State law. Such information must reflect changes in State 
law as soon as possible, but no later than 90 days after the effective 
date of the State law.
    E. Part 483 is amended as set forth below:
PART 483--REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES

    1. The authority citation for part 483 continues to read as 
follows:

    Authority: Secs. 1102, 1819(a)-(d), 1861 (j) and (l), 1863, 
1871, 1902(a)(28), 1905 (a),(c), and (d), and 1919(a)-(f) of the 
Social Security Act (U.S.C. 1302, 1395(i)(3)(a)-(f), 1395x (j) and 
(l), 1395z, 1395hh, 1396a(a)(28), 1396d (a),(c) and (d) and 
1396r(a)-(f)), unless otherwise noted.

Subpart B--Requirements for Long-Term Care Facilities

    2. In Sec. 483.10, paragraph (b)(7) introductory text is 
republished, and paragraphs (b)(7)(iv) and (b)(8) are revised to read 
as follows:


Sec. 483.10  Resident rights.

* * * * *
    (b) Notice of rights and services. * * *
    (7) The facility must furnish a written description of legal rights 
that includes-- * * *
    (iv) A statement that the resident may file a complaint with the 
State survey and certification agency concerning resident abuse, 
neglect, misappropriation of resident property in the facility, and 
non-compliance with the advance directives requirements.
    (8) The facility must comply with the requirements specified in 
subpart I of part 489 of this chapter relating to maintaining written 
policies and procedures regarding advance directives. These 
requirements include provisions to 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. This includes a written description of 
the facility's policies to implement advance directives and applicable 
State law. Facilities are permitted to contract with other entities to 
furnish this information but are still legally responsible for ensuring 
that the requirements of this section are met. If an adult individual 
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 may give advance directive information to the 
individual's family or surrogate in the same manner that it issues 
other materials about policies and procedures to the family of the 
incapacitated individual or to a surrogate or other concerned persons 
in accordance with State law. The facility is not relieved of its 
obligation to provide this information to the individual once he or she 
is no longer incapacitated or unable to receive such information. 
Follow-up procedures must be in place to provide the information to the 
individual directly at the appropriate time.
* * * * *
    F. Part 484 is amended as set forth below:

PART 484--CONDITIONS OF PARTICIPATION: HOME HEALTH AGENCIES

    1. The authority citation for part 484 continues to read as 
follows:

    Authority: Sec. 1102, 1861, 1866(a), 1871, and 1891 of the 
Social Security Act (42 U.S.C. 1302, 1395x, 1395cc(a), 1395hh, and 
1395bbb).

Subpart B--Administration

    2. In Sec. 484.10, paragraphs (c)(2)(ii) and (f) are revised to 
read as follows:


Sec. 484.10  Condition of participation: Patient rights.

* * * * *
    (c) * * *
    (2) * * *
    (ii) The HHA complies with the requirements of subpart I of part 
489 of this chapter relating to maintaining written policies and 
procedures [[Page 33294]] regarding advance directives. The HHA must 
inform and distribute written information to the patient, in advance, 
concerning its policies on advance directives, including a description 
of applicable State law. The HHA may furnish advance directives 
information to a patient at the time of the first home visit, as long 
as the information is furnished before care is provided.
* * * * *
    (f) Standard: Home health hotline. The patient has the right to be 
advised of the availability of the toll-free HHA hotline in the State. 
When the agency accepts the patient for treatment or care, the HHA must 
advise the patient in writing of the telephone number of the home 
health hotline established by the State, the hours of its operation, 
and that the purpose of the hotline is to receive complaints or 
questions about local HHAs. The patient also has the right to use this 
hotline to lodge complaints concerning the implementation of the 
advance directives requirements.
    G. Part 489 is amended as set forth below:

PART 489--PROVIDER AND SUPPLIER AGREEMENTS

    1. The authority citation for part 489 continues to read as 
follows:

    Authority: Secs. 1102, 1861, 1864, 1866, 1867, and 1871 of the 
Social Security Act (42 U.S.C. 1302, 1395x, 1395aa, 1395cc, 1395dd, 
and 1395hh) and sec. 602 (k) of Pub. L. 98-21 (42 U.S.C. 1395ww 
note).

Subpart I--Advance Directives

    2. In Sec. 489.102, paragraph (a) introductory text is republished, 
paragraphs (a)(1), (a)(2), (a)(4) and (a)(6) are revised, paragraph (b) 
introductory text is republished, paragraph (b)(3) is revised, 
paragraph (c) introductory text is republished, paragraph (c)(2) is 
revised, and paragraph (e) is added to read as follows:


Sec. 489.102  Requirements for providers.

    (a) Hospitals, rural primary care hospitals, skilled nursing 
facilities, nursing facilities, home health agencies, providers of home 
health care (and for Medicaid purposes, providers of personal care 
services), and hospices must maintain written policies and procedures 
concerning advance directives with respect to all adult individuals 
receiving medical care by or through the provider and are required to:
    (1) Provide written information to such individuals concerning--
    (i) An individual's rights under State law (whether statutory or 
recognized by the courts of the State) to make decisions concerning 
such 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. Providers are permitted to contract with 
other entities to furnish this information but are still legally 
responsible for ensuring that the requirements of this section are met. 
Providers are to 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; and
    (ii) The written policies of the provider or organization 
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. At a minimum, a 
provider's statement of limitation should:
    (A) Clarify any differences between institution-wide conscience 
objections and those that may be raised by individual physicians;
    (B) Identify the state legal authority permitting such objection; 
and
    (C) Describe the range of medical conditions or procedures affected 
by the conscience objection.
    (2) Document in the individual's medical record whether or not the 
individual has executed an advance directive;
* * * * *
    (4) Ensure compliance with requirements of State law (whether 
statutory or recognized by the courts of the State) regarding advance 
directives. The provider must inform individuals that complaints 
concerning the advance directive requirements may be filed with the 
State survey and certification agency;
* * * * *
    (6) Provide for community education regarding issues concerning 
advance directives that may include material required in paragraph 
(a)(1) of this section, either directly or in concert with other 
providers and organizations. Separate community education materials may 
be developed and used, at the discretion of providers. The same written 
materials do not have to be provided in all settings, but the material 
should define what constitutes an advance directive, emphasizing that 
an advance directive is designed to enhance an incapacitated 
individual's control over medical treatment, and describe applicable 
State law concerning advance directives. A provider must be able to 
document its community education efforts.
    (b) The information specified in paragraph (a) of this section is 
furnished: * * *
    (3) (i) In the case of a home health agency, in advance of the 
individual coming under the care of the agency. The HHA may furnish 
advance directives information to a patient at the time of the first 
home visit, as long as the information is furnished before care is 
provided.
    (ii) In the case of personal care services, in advance of the 
individual coming under the care of the personal care services 
provider. The personal care provider may furnish advance directives 
information to a patient at the time of the first home visit, as long 
as the information is furnished before care is provided.
* * * * *
    (c) The providers listed in paragraph (a) of this section--* * *
    (2) Are 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.
* * * * *
    (e) If an adult individual is incapacitated at the time of 
admission or at the start of care and is unable to receive information 
(due to the incapacitating conditions or a mental disorder) or 
articulate whether or not he or she has executed an advance directive, 
then the provider may give advance directive information to the 
individual's family or surrogate in the same manner that it issues 
other materials about policies and procedures to the family of the 
incapacitated individual or to a surrogate or other concerned persons 
in accordance with State law. The provider is not relieved of its 
obligation to provide this information to the individual once he or she 
is no longer incapacitated or unable to receive such information. 
Follow-up procedures must be in place to provide the information to the 
individual directly at the appropriate time.

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; Program No. 93.774, Medicare--
Supplementary Medical Insurance Program; and Program No. 93.778, 
Medical Assistance Program)

    Dated: May 31, 1995.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
[FR Doc. 95-15550 Filed 6-26-95; 8:45 am]
BILLING CODE 4120-01-P