[Federal Register Volume 70, Number 229 (Wednesday, November 30, 2005)]
[Rules and Regulations]
[Pages 71772-71774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-23505]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 17

RIN 2900-AJ28


Medical: Advance Health Care Planning

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

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SUMMARY: This document amends VA medical regulations to codify VA 
policy regarding advance health care planning. The final rule sets 
forth a mechanism for the use of written advance directives, i.e., a VA 
living will, a VA durable power of attorney for health care, and a 
State-authorized advance directive. The final rule also sets forth a 
mechanism for honoring verbal or non-verbal instructions from a patient 
when the patient is admitted to care when critically ill and loss of 
capacity may be imminent and the patient is not physically able to sign 
an advance directive form, or the appropriate form is not readily 
available. This is intended to help ensure that VA acts in compliance 
with patients' wishes concerning future health care.

DATES: Effective Date: December 30, 2005.

FOR FURTHER INFORMATION CONTACT: Ruth Cecire, Ph.D., Policy Analyst, 
Ethics Policy Service, National Center for Ethics in Health Care (10E), 
Veterans Health Administration, Department of Veterans Affairs, 810 
Vermont Avenue, NW., Washington, DC 20420; 202-501-0364 (this is not a 
toll-free number).

SUPPLEMENTARY INFORMATION: In a document published in the Federal 
Register on November 2, 1998 (63 FR 58677), the Department of Veterans 
Affairs (VA) proposed to amend its medical regulations (38 CFR part 17) 
to codify VA policy concerning advance health care planning. Advance 
health care planning provides an opportunity for patients to give 
guidance to their caregivers regarding their treatment preferences for 
the future should they become incapable of participating fully in the 
decision-making process. We requested comments for a 60-day period that 
ended January 4, 1999. We received three comments. Based on the 
rationale set forth in the proposed rule and this document, we are 
adopting the proposed rule as a final rule with the changes indicated 
below.
    This final rule sets forth a mechanism for the use of written 
advance directives, i.e., a VA living will, a VA durable power of 
attorney for health care, and a State-authorized advance directive. The 
rule also sets forth a mechanism for honoring verbal or non-verbal 
instructions from a patient when the patient is admitted to care when 
critically ill and loss of capacity may be imminent and the patient is 
not physically able to sign an advance directive form, or the 
appropriate form is not readily available. The advance health care 
planning discussion and completion of a written advance directive 
ideally would take place prior to a patient being admitted to care in a 
crisis situation. However, we recognize that this is not always the 
case. The mechanism for honoring the verbal and non-verbal instructions 
of patients in this circumstance enables such patients to communicate 
their preferences regarding their future health care and ensures this 
information will be carefully documented in the patient's health record 
and available to guide caregivers should the patient lose capacity. The 
final rule also states that

[[Page 71773]]

a patient who has decision-making capacity may revoke an advance 
directive or instructions in a critical situation at any time by using 
any means expressing the intent to revoke. In addition, the final rule 
emphasizes the obligation of any surrogate, including a health care 
agent named in the advance directive, making decisions on behalf of a 
patient who lacks decision-making capacity, to act in compliance with 
the patient's clearly expressed wishes. The term surrogate is defined 
in 38 CFR 17.32(a). Those authorized to act as surrogates under VA 
policy are identified in 38 CFR 17.32(e).
    One commenter requested clarification regarding proposed Sec.  
17.32(h)(2), which describes ``Instructions in Critical Situations,'' 
particularly with respect to the meaning of ``non-verbal 
instructions.'' The commenter suggests that ``specific guidelines must 
be established'' to define what would constitute acceptable 
instructions. We agree with the commenter's point that this paragraph 
could be more explicit, but do not believe it would be possible, for 
example, to specify all of the possible variety and appearances in the 
way that a patient who is unable to speak or write might use to 
communicate. In the final rule we are modifying this paragraph to state 
more clearly the circumstances and types of instructions to which this 
paragraph would apply. Those changes include adding that the patient 
must have decision-making capacity and the patient's verbal or non-
verbal instructions must be unambiguous.
    A second commenter suggested that the language in proposed Sec.  
17.32(h)(1), which describes ``Witnesses,'' was overly restrictive, and 
could be interpreted to prevent appropriate individuals from serving as 
a witness. The commenter stated: ``Since a witness'' sole function is 
to attest to the fact that the witness saw the patient sign the VA 
Living Will or VA Durable Power of Attorney for Health Care, the 
general rule should be that a witness' potential conflict of interest 
in making that attestation may be raised by any person seeking to 
challenge the validity and enforceability of the VA Living Will or VA 
Durable Power of Attorney for Health Care, as part of an attempt to 
discredit the truth of the witness' attestation.'' We agree and in the 
final rule are modifying this paragraph to make the requirements less 
restrictive. However, we continue to think it best, in order to avoid 
even the appearance of a conflict of interest, that persons named in 
the patient's will, or as health care agent in the advance directive, 
or financially responsible for the patient's care, should not sign as 
witnesses on the advance directive form. In the final rule we are 
removing the proposed rule's requirement that the witness not be 
``entitled to, or a claimant against, any portion of the patient's 
estate; or be financially responsible for the patient's care'' and 
replacing it with the requirement that the witness not ``to the 
witnesses'' knowledge be named in the patient's will, appointed as 
health care agent in the advance directive, or financially responsible 
for the patient's care.'' The VA Advance Directive: Living Will and 
Durable Power of Attorney for Health Care form expressly provides that 
by signing the form, the witness attests to the fact that he or she 
lacks such knowledge. In the final rule, we are also removing, because 
we have concluded that it is unnecessarily restrictive, the proposed 
rule's requirement that VA employees of the Chaplain Service, 
Psychology Service, Social Work Service, or nonclinical employees 
(e.g., Medical Administration Service, Voluntary Service or 
Environmental Management Service) may serve as witnesses only ``when 
other witnesses are not reasonably available.''
    The third commenter expressed concern that the proposed rule ``is 
supposed to address VA employees' responsibilities in following 
patient's expressed desires in end-of-life decisions,'' but did not go 
far enough to clarify the weight carried by the patient's expressed 
desires, e.g., when there is a dispute about the legitimacy of a State-
authorized advance directive. Such a dispute might occur, for example, 
if the veteran completed the State-authorized advance directive while 
living in one State and later relocated to another jurisdiction. It is 
our intention that the reference to ``applicable State law'' in the 
definition of State-authorized advance directive be broadly interpreted 
for the convenience and benefit of VA patients. Indeed, the chief 
purpose of the rule is to assure that VA employees and surrogates 
comply with patients' clearly expressed wishes to the greatest extent 
possible. We are therefore in the final rule specifying that, ``[f]or 
the purposes of this paragraph and paragraph (h) of this section, 
`applicable State law' means the law of the State where the advance 
directive was signed, the State where the patient resided when the 
advance directive was signed, the State where the patient now resides, 
or the State where the patient is receiving treatment. VA will resolve 
any conflict between those State laws regarding the validity of the 
advance directive by following the law of the State that gives effect 
to the expressed wishes in the advance directive.'' We also are making 
changes in the opening paragraph of Sec.  17.32(h) to clarify that 
``[a]n advance directive that is valid in one or more States under 
applicable State law, as defined in paragraph (a) of this section, will 
be recognized throughout the VA health care system.''
    We are also adding in the final rule nonsubstantive changes for 
purposes of clarification. These include adding a revision of the 
authority citation for Sec.  17.32 to reflect that this rule is issued 
under the authority of 38 U.S.C. 7331 through 7334.

Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 
1532, that agencies prepare an assessment of anticipated costs and 
benefits before issuing any rule that may result in an expenditure by 
State, local, or tribal governments, in the aggregate, or by the 
private sector, of $100 million or more (adjusted annually for 
inflation) in any given year. This rule would have no such effect on 
State, local, or tribal governments, or the private sector.

Paperwork Reduction Act of 1995

    Two collection of information requirements that are related to 38 
CFR 17.32 are currently approved by the Office of Management and Budget 
(OMB) under the provisions of the Paperwork Reduction Act (44 U.S.C. 
3501-3521). OMB has approved collection of information requirements for 
Sec.  17.32 under OMB control number 2900-0583. In addition, OMB has 
approved the information collection requirements in VA Form 10-0137, VA 
Advance Directive: Living Will and Durable Power of Attorney for Health 
Care, under OMB control number 2900-0556. The references in the final 
rule to a VA Living Will or to a VA Durable Power of Attorney for 
Health Care are to that form. No new collections of information are 
associated with this final rule.

Executive Order 12866

    This document has been reviewed by the Office of Management and 
Budget under Executive Order 12866.

Regulatory Flexibility Act

    The Secretary hereby certifies that this final rule will not have a 
significant economic impact on a substantial number of small entities 
as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-
612. The rule will affect only individuals and will not directly affect 
any small entities.

[[Page 71774]]

Therefore, pursuant to 5 U.S.C. 605(b), this rule is exempt from the 
initial and final regulatory flexibility analysis requirements of 
sections 603 and 604.

Catalog of Federal Domestic Assistance

    There are no applicable Catalog of Federal Domestic Assistance 
program numbers.

List of Subjects in 38 CFR Part 17

    Administrative practice and procedure, Alcohol abuse, Alcoholism, 
Claims, Day care, Dental health, Drug abuse, Foreign relations, 
Government contracts, Grant programs-health, Grant programs-veterans, 
Health care, Health facilities, Health professions, Health records, 
Homeless, Medical and dental schools, Medical devices, Medical 
research, Mental health programs, Nursing homes, Philippines, Reporting 
and recordkeeping requirements, Scholarships and fellowships, Travel 
and transportation expenses, Veterans.

    Approved: July 15, 2005.
R. James Nicholson,
Secretary of Veterans Affairs.

0
For the reasons set out above, 38 CFR part 17 is amended to read as 
follows:

PART 17--MEDICAL

0
1. The authority citation for part 17 is revised to read as follows:

    Authority: 38 U.S.C. 501, 1721, and as stated in specific 
sections.


0
2. Section 17.32 is amended by:
0
a. Revising the section heading and authority citation.
0
b. In paragraph (a), adding a new definition in alphabetical order.
0
c. Adding paragraph (h) immediately following paragraph (g)(4).
    The revisions and additions read as follows:


Sec.  17.32  Informed consent and advance health care planning.

    (a) * * *
    Advance Directive. Specific written statements made by a patient 
who has decision-making capacity regarding future health care decisions 
in any of the following:
    (i) VA Living Will. A written statement made by a patient on an 
authorized VA form which sets forth the patient's wishes regarding the 
patient's health care treatment preferences including the withholding 
and withdrawal of life-sustaining treatment.
    (ii) VA Durable Power of Attorney for Health Care. A written 
instruction on a VA form which designates the patient's choice of 
health care agent.
    (iii) State-Authorized Advance Directive. A non-VA living will, 
durable power of attorney for health care, or other advance health care 
planning document, the validity of which is determined pursuant to 
applicable State law. For the purposes of this paragraph and paragraph 
(h) of this section, ``applicable State law'' means the law of the 
State where the advance directive was signed, the State where the 
patient resided when the advance directive was signed, the State where 
the patient now resides, or the State where the patient is receiving 
treatment. VA will resolve any conflict between those State laws 
regarding the validity of the advance directive by following the law of 
the State that gives effect to the expressed wishes in the advance 
directive.
* * * * *
    (h) Advance health care planning. Subject to the provisions of 
paragraphs (h)(1) through (h)(4) of this section, VA will follow the 
wishes of a patient expressed in an Advance Directive when the 
attending physician determines and documents in the patient's medical 
record that the patient lacks decision-making capacity and is not 
expected to regain it. An advance directive that is valid in one or 
more States under applicable State law, as defined in paragraph (a) of 
this section, will be recognized throughout the VA health care system.
    (1) Witnesses. A VA Advance Directive: Living Will and Durable 
Power of Attorney for Health Care must be signed by the patient in the 
presence of two witnesses. Neither witness may to the witness' 
knowledge be named in the patient's will, appointed as health care 
agent in the advance directive, or financially responsible for the 
patient's care. VA employees of the Chaplain Service, Psychology 
Service, Social Work Service, or nonclinical employees (e.g., Medical 
Administration Service, Voluntary Service, or Environmental Management 
Service) may serve as witnesses. Other individuals employed by the VA 
facility in which the patient is being treated may not sign as 
witnesses to the advance directive. Witnesses are attesting only to the 
fact that they saw the patient sign the form.
    (2) Instructions in critical situations. VA will follow the 
unambiguous verbal or non-verbal instructions regarding future health 
care decisions of a patient who has decision-making capacity when the 
patient is admitted to care when critically ill and loss of capacity 
may be imminent and the patient is not physically able to sign an 
advance directive form, or the appropriate form is not readily 
available. The patient's instructions must have been expressed to at 
least two members of the health care team. The substance of the 
patient's instructions must be recorded in a progress note in the 
patient's medical record and must be co-signed by at least two members 
of the health care team who were present and can attest to the wishes 
expressed by the patient. These instructions will be given effect only 
if the patient loses decision-making capacity during the presenting 
situation.
    (3) Revocation. A patient who has decision-making capacity may 
revoke an advance directive or instructions in a critical situation at 
any time by using any means expressing the intent to revoke.
    (4) VA policy and disputes. Neither the treatment team nor 
surrogate may override a patient's clear instructions in an Advance 
Directive or in instructions in critical situations, except that those 
portions of an Advance Directive or instructions given in a critical 
situation that are not consistent with VA policy will not be given 
effect.
* * * * *
(Authority: 38 U.S.C. 7331 through 7334)

[FR Doc. 05-23505 Filed 11-29-05; 8:45 am]
BILLING CODE 8320-01-P