[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]]
_______________________________________________________________________
Part II
Department of Health and Human Services
_______________________________________________________________________
Health Care Financing Administration
_______________________________________________________________________
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
