[Federal Register Volume 85, Number 102 (Wednesday, May 27, 2020)]
[Rules and Regulations]
[Pages 31690-31704]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10264]
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DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 17
RIN 2900-AQ97
Informed Consent and Advance Directives
AGENCY: Department of Veterans Affairs.
ACTION: Interim final rule.
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SUMMARY: The Department of Veterans Affairs (VA) amends its regulation
regarding informed consent and advance directives. We amend the
regulation by reorganizing it and amending language where necessary to
enhance clarity. In addition, we amend the regulation to facilitate the
informed consent process, the ability to communicate with patients or
surrogates through available modalities of communication, and the
execution and witness requirements for a VA Advance Directive.
DATES:
Effective date: This final rule is effective May 27, 2020.
Comment date: Comments must be received by VA on or before July 27,
2020.
ADDRESSES: Written comments may be submitted through
www.regulations.gov; by mail or hand-delivery to the Director, Office
of Regulation Policy and Management (00REG), Department of Veterans
Affairs, 810 Vermont Ave. NW, Room 1064, Washington, DC 20420; or by
fax to (202) 273-9026. Comments should indicate that they are submitted
in response to ``RIN 2900-AQ97--Informed Consent and Advance
Directives.'' Copies of comments received will be available for public
inspection in the Office of Regulation Policy and Management, Room
1064, between the hours of 8:00 a.m. and 4:30 p.m., Monday through
Friday (except holidays). Please call (202) 461-4902 for an
appointment. (This is not a toll-free number.) In addition, during the
comment period, comments may be viewed online through the Federal
Docket Management System (FDMS) at http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Lucinda Potter, MSW, LSW, Ethics
Policy Consultant, National Center for Ethics in Health Care (10E1E),
Veterans Health Administration, 810 Vermont Ave. NW, Washington, DC
20420; 484-678-5150, [email protected]. (This is not a toll-free
number).
SUPPLEMENTARY INFORMATION: Section 7331 of title 38, United States Code
(U.S.C.), requires, in relevant part, that the Secretary of Veterans
Affairs, upon the recommendation of the Under Secretary for Health,
prescribe regulations to ensure, to the maximum extent practicable,
that all VA patient care be carried out only with the full and informed
consent of the patient, or in appropriate cases, a representative
thereof. Based on VA's interpretation of this statute and our mandate
in 38 U.S.C. 7301(b) to provide a complete medical and hospital
service, we recognize that patients with decision-making capacity have
the right to state their treatment preferences in a VA or other valid
advance directive. VA's use and recognition of advance directives is
also consistent with practice in the health care industry at large; for
instance, a condition of participation in the Medicare program requires
providers to agree to abide by the requirements of the Patient Self-
Determination Act of 1990 (codified at 42 U.S.C. 1395cc(f)), which,
among other things, requires participating providers to inform patients
of their rights under state law to indicate treatment preferences,
including the right to accept or refuse medical or surgical treatment,
in an advance directive.
VA regulations at 38 CFR 17.32 establish standards for obtaining
informed consent from a patient for a medical treatment or a diagnostic
or therapeutic procedure and standards for advance care planning; that
is, the process by which a patient documents in an advance directive
his or her future treatment preferences (encompassing medical,
surgical, and mental health care) to be relied on in the event the
patient loses the capacity to make health care decisions. We revise
this section and publish it as an interim final rule to ensure that
informed consent procedural and process changes are in
[[Page 31691]]
place immediately to address the urgent and emergent clinical care
needs of patients related to delivery of health care services and for
future health care decisions during the SARS-CoV-2 virus outbreak and
the disease it causes named the ``Coronavirus Disease 2019'' (COVID-19)
which has been declared a national emergency. The changes to current
informed consent procedures and requirements, as described herein, are
needed for the reasons explained, but the current national emergency
has made it particularly vital that they be implemented immediately to
deal with COVID-related treatment setting challenges (to include those
arising from VA's announced contingent (formerly ``crisis'') standards
of care during the COVID national emergency, VA's recognition of scarce
resources during this emergency requiring changes to resources
allocations, to include staffing decisions, changes in treatment
locations, etc.), greater use of telehealth services, and CDC guidance
(to include social distancing requirements and separation of infected
patients from other patients) issued for this highly infectious disease
crisis. This is addressed in greater detail under the Administrative
Procedures Act section, where we set forth the good cause reasons
supporting this approach.
As discussed in detail below, we amend that rule by reorganizing it
and amending language where necessary to enhance clarity. We amend the
definition of practitioner to expand the types of health care
professionals authorized to obtain informed consent from a patient and
define the scope of information that must be provided as part of the
informed consent discussion. We establish the type of documentation
required both when a patient consents to treatments and procedures that
are low risk and within broadly-accepted standards of medical practice
and to those necessitating signature consent. We expand the approved
communication modalities that may be used by VA when an in-person
discussion with a patient or surrogate regarding a proposed treatment
or procedure is impracticable. We remove the special process related to
consent for unusual or extremely hazardous treatments or procedures
(long interpreted in regulation as including those that may result in
irreversible brain damage or sterilization) as VA no longer performs
such treatments or procedures. We amend the definition of advance
directive to include two other types that VA recognizes: The Department
of Defense Advance Medical Directive and a Mental Health (or
Psychiatric) Advance Directive. We amend the witness requirement for
advance directives to allow family members who are VA employees to
serve as witness to the signing of a VA Advance Directive (if not
otherwise precluded from serving as witness under the regulation), and
remove restrictions on certain other VA employees serving as witness to
the signing of a VA Advance Directive. Finally, we add a mechanism to
allow a patient who, due to a physical impairment, is unable to execute
a signature on a signature consent form to sign with an ``X'', a
thumbprint, or a stamp on the form. Signature by use of an ``X'',
thumbprint, or stamp is also available to a patient who, because of a
physical impairment, cannot sign a VA Advance Directive and to a third
party who is signing the directive at the direction and in the presence
of the patient.
The title to prior Sec. 17.32 is ``Informed consent and advance
care planning.'' We change ``advance care planning'' to ``advance
directives'' as we believe this term is more commonly used and
understood by the public. These and other changes are discussed below
in greater detail.
Definitions
We begin by amending the definitions found in paragraph (a). Former
paragraph (a) defined three types of advance directive recognized by
VA: a VA Living Will; a VA Durable Power of Attorney for Health Care;
and State-Authorized Advance Directives. We amend the definition of VA
Living Will to clarify the purpose of a living will, which is to
document the personal preferences of an individual regarding future
treatment options. We change the term from ``VA Living Will'' to
``Living Will'' to clarify that the definition is applicable to an
instrument serving that purpose, regardless of whether the document is
a VA form or not. For a similar reason we change the term ``VA Durable
Power of Attorney for Health Care'' to ``Durable Power of Attorney for
Health Care.'' Durable Power of Attorney for Health Care is defined as
a type of advance directive in which an individual designates another
person as a health care agent to make health care decisions on behalf
of the individual.
VA believes that the best interests of veterans who have either a
Mental Health Advance Directive or a DoD Advance Medical Directive are
served by VA formally recognizing these types of advance care planning
instruments. We therefore add a Mental Health (or Psychiatric) Advance
Directive to the list of advance directives recognized by VA. It is
executed by patients whose future decision-making capacity is at risk
due to mental illness, and it allows them to indicate preferences about
their future mental health care. We likewise add the Department of
Defense (DoD) Advance Medical Directive to the list of advance
directives recognized by VA. This addition gives equal legal
recognition to DoD-authorized advance directives executed for members
of the armed services or military dependents under 10 U.S.C. 1044C.
We revise material in former paragraph (h)(1) to formulate a
definition for a VA advance directive, which is one example within the
broader category of advance directives. We specify that a VA advance
directive is completed on a form that is specified by VA and can be
used to designate a health care agent and to document treatment
preferences for medical care, including mental health care. This
language combines and condenses language found in former paragraph (a).
VA believes that the amendment improves consistency by incorporating
all of the relevant definitions in the definitions section rather than
interspersing them throughout the section.
We make minor non-substantive changes to the definitions of a
State- authorized advance directive, close friend, legal guardian, and
signature consent, to clarify the meaning of these terms.
Decision-making capacity is a key concept in both informed consents
for clinical treatments and procedures and advance directives. We
previously defined decision-making capacity to mean the ability to
understand and appreciate the nature and consequence of health care
decisions. We amend the definition of decision-making capacity to also
state that it includes the ability to formulate a judgment and
communicate a clear decision concerning clinical treatments and
procedures. We believe it is appropriate to include this clarification
in the definition of decision-making capacity, because each of these
elements is evaluated by a practitioner when determining whether a
patient has decision-making capacity.
The definition of health care agent in former paragraph (a) is
amended to clarify the powers and duties of a health care agent. The
amended language states that a health care agent is the individual
named by the patient in a durable power of attorney for health care to
make health care decisions on the patient's behalf, including decisions
regarding the use of life-sustaining treatments,
[[Page 31692]]
when the patient can no longer make such decisions.
For purposes of obtaining informed consent for medical treatment,
we previously defined ``practitioner'' to include any physician,
dentist, or health care professional who has been granted specific
clinical privileges to perform the treatment or procedure, including
medical and dental residents and other appropriately trained health
care professionals designated by VA regardless of whether they have
been granted clinical privileges. The responsibility to obtain informed
consent for medical treatment from the patient was formerly assigned to
the practitioner who has primary responsibility for the patient or who
will perform the particular procedure or provide the treatment in
paragraph (c).
We amend the definition of ``practitioner'' to include other health
care professionals whose scope of practice agreement or other formal
delineation of job responsibility specifically permits them to obtain
informed consent, and who are appropriately trained and authorized to
perform the procedure or to provide the treatment for which consent is
being obtained. This change is consistent with the team concept for
delivery of health care currently adopted by VA. The rationale for this
change is discussed in greater detail below, where we make changes to
the general requirements for informed consent in former paragraph (c).
We add a definition of ``State-authorized portable orders.'' State-
authorized portable orders (SAPO) are a specialized form or identifier
(e.g., Do Not Attempt Resuscitation (DNAR) bracelets or necklaces)
authorized by state law or a state medical board or association, that
translates a patient's preferences concerning specific life-sustaining
treatment decisions into portable medical orders. While SAPO and
advance directives each reflect patient goals and preferences for
treatment, the two instruments differ. An advance directive is a legal
instrument completed by a patient with decision-making capacity in
which the patient expresses his or her preferences about future health
care decisions in the event that the patient becomes unable to make
these decisions. In some types of advance directives, the patient may
appoint an individual to serve as the patient's health care agent
charged with making health care decisions on the patient's behalf, when
the patient can no longer make such decisions. SAPO, on the other hand,
translate a patient's preferences with regard to specific life-
sustaining treatment decisions into standing, actionable, and portable
medical orders. Critically ill incoming patients with SAPOs need to
have their SAPOs translated into and followed within the VA health care
system, no matter where they are being treated by VA. This definition
codifies in regulation what these are, helping the field to also
understand the distinction between SAPOs and advance directives. While
an advance directive is normally retained by the patient in a safe and
secure place, SAPO are designed to be retained on or near the patient
so that the orders are easily accessible to emergency medical personnel
or other health care personnel and also travel with the patient
whenever the patient is transported to or from a health care facility.
SAPO have been authorized in the majority of states over the last
decade to ensure that a patient's portable orders are easily
recognizable, understood, and respected by emergency medical service
providers and receiving health care facilities. Examples of SAPO forms
include: Oregon's Physician Orders for Life-Sustaining Treatment
(POLST); West Virginia's Physician Orders for Scope of Treatment
(POST); New York's Medical Orders for Life Sustaining Treatment
(MOLST); and out-of-hospital DNAR orders (e.g., New York State's Out-
of-Hospital Do Not Resuscitate (DNR) order form).
The term ``surrogate'' was previously defined to mean an
individual, organization or other body authorized under Sec. 17.32 to
give informed consent on behalf of a patient who lacks decision-making
capacity. We amend this definition to state that the term ``surrogate''
is an individual authorized under this section to make health care
decisions on behalf of a patient who lacks decision-making capacity and
includes a health care agent, legal guardian, next-of-kin, or close
friend. This change is consistent with the categories of individuals
identified in earlier VA regulation (Sec. 17.32(e)(1)-(4)) and hence
with longstanding practice regarding whom VA recognizes as being
authorized to make health care decisions on behalf of a patient who
lacks decision-making capacity.
Informed Consent
Former paragraph (b) addressed the concept of informed consent for
treatments and procedures as interpreted in VA, while paragraph (c)
addressed the requirements for obtaining informed consent. Laypersons
generally think of informed consent in the context of a patient
agreeing to a medical procedure or course of treatment. However, the
concept of informed consent also encompasses a patient's right to
refuse, or withhold consent, for a medical procedure or course of
treatment recommended by a health care provider. We therefore update
language in paragraph (b) to reflect the established legal and ethical
principle that patients receiving treatments and procedures within the
VA health care system have the right to accept or refuse any medical
treatment or procedure recommended to them. We also amend the former
first sentence in paragraph (b) to state that except as otherwise
provided in Sec. 17.32, no medical treatment or procedure may be
performed without the prior, voluntary informed consent of the patient.
Prior to this interim final rule, then-current paragraph (b)
contained a long compound sentence discussing the requirement that a
patient must have decision-making capacity to give informed consent and
that informed consent is to be obtained from a surrogate if the patient
lacks decision-making capacity. We separate these into paragraphs
(b)(1) and (2) for ease of understanding. Paragraph (b) formerly
referred to actions that can be taken by either the patient or
surrogate. For purposes of clarity and to enhance readability, we amend
these references to refer to only the patient. Paragraph (b)(2)
specifically states that in the event the patient lacks decision-making
capacity, the requirements of Sec. 17.32 are applicable to consent for
treatments or procedures obtained from the surrogate.
Paragraph (b) also stated that a practitioner may provide necessary
medical care in emergency situations without the express consent of the
patient or surrogate when immediate medical care is necessary to
preserve life or prevent serious impairment of the health of the
patient, the patient is unable to consent, and the practitioner
determines that the patient has no surrogate or waiting to obtain
consent of the surrogate would increase the hazard to life or health of
the patient. We move this to new paragraph (c)(7).
General Requirements for Informed Consent
Former paragraph (c) delineated the general requirements for
informed consent. The first sentence of this paragraph provided a
definition of informed consent that we believe is both unclear and not
entirely consistent with current VA practice. We amend this sentence to
state that informed consent is the process by which a practitioner
discloses to and discusses appropriate information with a patient so
that the patient may make an informed, voluntary choice about whether
to
[[Page 31693]]
accept the proposed diagnostic or therapeutic procedure or course of
treatment. While the earlier iteration of the opening sentence of
paragraph (c) focused on the act of providing consent, the revised
language focuses on the process and the required actions of the
practitioner in providing appropriate information so that the patient
can make an informed, voluntary choice.
Medical practice evolves over time. VA believes that former Sec.
17.32 is now inconsistent with contemporary standards for health care
delivery and current VA practice. Paragraph (c) previously stated, in
relevant part: ``The practitioner, who has primary responsibility for
the patient or who will perform the particular procedure or provide the
treatment, must explain in language understandable to the patient or
surrogate the nature of a proposed procedure or treatment; the expected
benefits; reasonably foreseeable associated risks, complications or
side effects; reasonable and available alternatives; and anticipated
results if nothing is done.'' We believe that the language ``who has
primary responsibility for the patient or who will perform the
particular procedure or provide the treatment'' is outdated and does
not reflect the requirements of modern clinical practice. For example,
medical residents (post-graduate trainees) frequently order blood
testing for human immunodeficiency virus (HIV), which requires the
patient's informed consent. It would therefore be appropriate for
consent to HIV testing to be obtained by residents. However, the old
regulatory language does not clearly support this practice because
residents do not ever have ``primary responsibility for the patient''
in that they function under the supervision of a more senior physician,
nor would they typically ``perform the particular procedure,'' since
blood tests are typically performed by phlebotomists who draw the
blood, along with lab technicians who perform the test. As another
example, a patient's primary care physician might send a patient to a
consulting physician who, in turn, might send the patient for a
specialized treatment or procedure (e.g., a cardiac stress test). A
different health care professional, such as a registered nurse or a
trained technician, might administer the treatment or procedure. Under
these circumstances it is appropriate for informed consent to be
obtained by the consulting physician who referred the patient for the
specialized treatment or procedure, because this individual would be
most knowledgeable about it. However, the former regulatory language
requires that informed consent be obtained by either the primary care
physician or the registered nurse or technician, neither of whom would
be in the best position to communicate with the patient about the risks
and benefits of, and alternatives to, the recommended procedure or
treatment.
Further, former paragraph (c) is based on an outdated model of
health care in which a single practitioner works in isolation from
others. Health care is now typically delivered by teams in which
professionals from a variety of clinical disciplines work together to
achieve the patient's health care goals. These interdisciplinary,
inter-professional teams may include a range of medical specialists,
such as physicians, nurses, pharmacists, nutritionists, dieticians,
social workers, behavioral and mental health providers, and physician
assistants.
Within VA, care delivery has transitioned to the team-based care
model. Under this model, VA uses a Patient-Aligned Care Team (PACT)
approach in which the primary care practitioner is responsible for
overseeing but not necessarily directly providing all of the patient's
primary health care. Thus, the components of the patient visit that to
do not require the primary care practitioner's expertise are assigned
to other qualified clinical or support staff so that every member can
``work to the top of his or her competence.'' Department of Veterans
Affairs, Report of the Universal Services Task Force, April 2009, p.
28. VA believes the changes to the definition of practitioner will
provide sufficient flexibility to allow VA to respond in a timely
manner to current and future changes in the scope of practice for
appropriately trained team-based health care professionals.
To make the language in Sec. 17.32 consistent with contemporary
standards of team-based health care delivery, including those set by
external organizations such as The Joint Commission and the Centers for
Medicare & Medicaid Services, VA deletes the portion of paragraph (c)
that reads ``. . . who has primary responsibility for the patient or
who will perform the particular procedure or provide the treatment . .
.'' and makes minor edits throughout Sec. 17.32 to allow for the fact
that components of the patient's care are appropriately shared by
multiple members of a team.
Former Sec. 17.32 did not specify a standard for the adequacy of
information disclosure and could therefore be interpreted to obligate
VA to disclose all known information about the nature of a proposed
procedure or treatment; the expected benefits; reasonably foreseeable
associated risks, complications or side effects; reasonable and
available alternatives; and anticipated results if nothing is done.
Accordingly, VA amends the rule to more clearly describe VA's standard
for adequate information disclosure by defining the term ``appropriate
information'' in paragraph (c) as information that a reasonable person
in the patient's situation would expect to receive in order to make an
informed choice about whether or not to undergo the treatment or
procedure. The term ``appropriate information'' also includes tests
that yield information that is extremely sensitive or that may have a
high risk of significant consequence (e.g., physical, social,
psychological, legal, or economic) that a reasonable person would want
to know and consider as part of his or her consent decision. In these
cases, the health record must specifically document that the patient or
surrogate consented to the specific test.
Paragraph (c)(1) addresses the setting in which the informed
consent discussion should take place. We state that the informed
consent discussion should be conducted in person with the patient
whenever practical. However, other forms of communication may also be
appropriate depending on the circumstances. Former paragraph (c) did
not reflect new modalities that facilitate communication between
practitioners and patients or their surrogates. The widespread adoption
of technology that allows for video conferencing and web-based
communications now makes it possible for the informed consent process
to be conducted in a way that is more convenient and flexible for
patients. The informed consent process may reasonably take place over a
period of time and involve educational activities and a number of
discussions about the risks and benefits, as well as alternatives to a
proposed treatment or procedure. To ensure that the regulation allows
the flexibility enabled by these communication modalities, we amend
paragraph (c)(1) to permit the informed consent discussion to be
conducted either in person, by telephone, through video conference, or
by other VA-approved electronic communication methods when it is
impractical to conduct the discussion in person, or if preferred by the
patient or surrogate.
Paragraphs (c)(2) through (4) address steps that must be taken by
the practitioner during the informed consent discussion. Paragraph
(c)(2) states that the practitioner must explain in language
understandable to the
[[Page 31694]]
patient each of the following, as appropriate to the treatment or
procedure in question: the nature of the proposed treatment or
procedure; expected benefits; reasonably foreseeable associated risks;
complications or side effects; reasonable and available alternatives;
and anticipated results if nothing is done. The language in paragraph
(c) is substantively the same as in former paragraph (c), and in fact,
the language in paragraphs (c)(2), (3) and (4) is essentially the same
as in former paragraph (c). The only difference is that we remove
references here to the surrogate, as obtaining informed consent from
the surrogate is addressed in paragraph (e).
Paragraph (c)(5) states that the patient may withhold or revoke
consent at any time, which is consistent with legal and ethical
standards, and with paragraph (b), described above, which says VA
patients have the right to refuse medical treatment. Consistent with
the team-based care model, paragraph (c)(6) provides that the
practitioner may delegate to other trained personnel responsibility for
providing the clinical information needed for the patient to make a
fully informed consent decision. However, the practitioner must
personally verify with the patient that the patient has been
appropriately informed and voluntarily consents to the treatment or
procedure. We believe this requirement benefits both the patient and
practitioner, providing the patient an opportunity to freely
communicate with the practitioner and other team members regarding the
proposed treatment or procedure, and allowing the practitioner to
confirm that appropriate information was provided to the patient and
that consent is voluntary.
As described above, paragraph (c)(7) states that express consent is
not required when immediate medical care is necessary to preserve life
or prevent serious impairment of the health of the patient, the patient
is unable to consent, and the patient has no surrogate or waiting to
obtain consent of the surrogate would increase the hazard to life or
health of the patient.
Documentation of Informed Consent
Paragraph (d) focuses on documentation of informed consent. As
noted in paragraph (d), the informed consent process must be
appropriately documented in the health record. Content in former
paragraph (d) could be interpreted to mean that VA practitioners must
specifically document informed consent for every treatment or procedure
a patient receives. However, this is impractical and inconsistent with
modern standards for health care delivery. The type of documentation
required should depend on the level of risk for the particular
treatment or procedure. For instance, while most, if not all, health
care organizations require specific documentation of informed consent
for major procedures such as surgery or radiation therapy, we are aware
of no organization in the country that requires specific documentation
of informed consent for oxygen administration, blood pressure
measurement, electrocardiograms, and other treatments and procedures
that are low risk and within broadly-accepted standards of medical
practice. The new language in this interim final rule therefore
differentiates between documentation requirements for patient consent
to treatments and procedures that are low risk and within broadly-
accepted standards of medical practice and those that require signature
consent because they pertain to treatments and procedures that require
anesthesia or narcotic analgesia, are considered to produce significant
discomfort to the patient, have a significant risk of complication or
morbidity, or require injections of any substance into a joint space or
body cavity. Paragraph (d)(1) provides that, for purposes of treatments
and procedures that are low risk and within broadly-accepted standards
of medical practice, a progress note describing the clinical encounter
and the treatment plan suffices to document that informed consent was
obtained. For tests that provide information that is extremely
sensitive or that may have a high risk of significant consequences
(e.g., physical, social, psychological, legal or economic) that the
patient might reasonably want to consider as part of their consent
decision, the health record must specifically document that the patient
or surrogate consented to the specific test.
The type of informed consent documentation required for a treatment
or procedure is dependent on the level of risk for such procedure.
Patient consent to treatments or procedures requiring signature
consent, as discussed above, must be documented on a form prescribed by
VA for that purpose that is signed by both the patient and
practitioner, except as described in paragraph (d)(3). Paragraph (d)(2)
lists the types of diagnostic and therapeutic treatments that continue
to require signature consent. The content of paragraph (d)(2) is the
same as that found in former paragraph (d)(1), with minor non-
substantive edits. These changes (related to documentation) are
consistent with longstanding VA policy and practice. The documentation
requirement for consent to a treatment or procedure requiring signature
consent is addressed in paragraph (d)(3).
Due to a drafting error, former paragraph (d)(2) combines a
discussion of how to document signature consent when the patient or
surrogate has a significant physical impairment and/or difficulty in
executing a signature due to an underlying health condition or is
unable to read and write, and the 60-day validity period for signature
consent. Due to a missing line break, the numbering in the paragraph
could be misinterpreted to mean that the requirement of ``valid for a
period of 60 calendar-days'' applies only if a patient signs the
consent for with an ``X.'' We move the former to paragraph (d)(3)(i)
with revisions as noted below. We move the latter to paragraph
(d)(3)(ii), with amendments. Former paragraph (d)(3) is redesignated
paragraph (d)(3)(iii), with changes as discussed below.
Paragraph (d)(3)(i) focuses on how signature consent is to be
documented when physical impairment prevents the execution of a
signature on a VA-authorized consent form. As noted above, we move this
content from former paragraph (d)(2). Paragraph (d)(2) stated that a
patient or surrogate will sign with an ``X'' when the patient or
surrogate has a debilitating illness or disability; that is, a
significant physical impairment and/or difficulty in executing a
signature due to an underlying health condition(s) or is unable to read
and write. The placing of the ``X'' on the form must be witnessed by
two adults. That earlier version of the regulation referred to actions
that can be taken by either the patient or surrogate. We remove the
clause ``and/or difficulty in executing a signature due to an
underlying health condition(s)'' because we believe this is redundant,
and the concept is adequately covered by the phrase ``physical
impairment.'' Likewise, we remove the clause ``or is unable to read and
write'' because an individual unable to read or write, but otherwise
not physically impaired, may still be able to place some type of mark
on the document that would serve the purpose of a signature, and VA
believes it is burdensome to require the signature of two witnesses to
the ``X'' mark. Former paragraph (d)(2) further stated that by signing,
the witnesses are attesting only to the fact that they saw the patient
or surrogate and the practitioner sign the form. The signed form is
then filed in the patient's medical record. We remove the requirement
that the witnesses attest
[[Page 31695]]
that they also saw the practitioner sign the form, as this is
inconsistent with current VA practice and unnecessary. The overall
purpose of the witness requirement is to confirm the validity of the
patient's or surrogate's ``X'' mark on the form. This is accomplished
by the witnesses documenting they witnessed the act of signing by the
patient or surrogate.
Further, to allow greater flexibility to meet the needs of those
with physical impairments, we allow either the placement of the ``X''
or the use of a thumbprint or stamp to meet the signature requirement
in these cases. Finally, we state that a third party may also be
designated to assist either the patient or the surrogate if physical
impairment prevents signature by either. VA believes that obtaining
signature consent is better facilitated if any third party, acting at
the direction and in the presence of the patient or surrogate, performs
this task.
Paragraph (d)(3)(ii) consists of that portion of former paragraph
(d)(2) relating to the 60-day validity period of a properly executed
VA-authorized consent form. Former paragraph (d)(2) stated that if
there is a change in the patient's condition that might alter the
diagnostic or therapeutic decision, the consent is automatically
rescinded. We amend that sentence by removing the phrase ``consent is
automatically rescinded'' and instead state that the practitioner must
initiate a new informed consent process, and, if needed, complete a new
signature consent form with the patient. We believe this will,
consistent with current VA practice, ensure that the practitioner will
further engage the patient in a discussion of treatment options
whenever there is a change in clinical circumstances that might alter
the diagnostic or therapeutic decision about upcoming or continuing
treatment.
Paragraphs (d)(3)(iii) and (iv) address those instances in which
signature consent is required, but it is not practicable to obtain the
signature in person following the informed consent discussion. Former
paragraph (d)(3) allowed for surrogates (who might not be available in
person) to give signature consent over the telephone and/or by mail or
facsimile, but it does not give this option to patients who may benefit
from the same flexibility. For instance, patients may have limited
mobility or live far from the VA facility, which in either case makes
them unable to travel to the facility until shortly before the
scheduled treatment or procedure. To ensure that patients as well as
surrogates can conveniently participate in the informed consent
process, the revised language in the interim final rule permits that
process to be conducted with the use of current and anticipated
communication modalities when the patient (or surrogate) and the
practitioner are not able to meet in person prior to a treatment or
procedure. Paragraph (d)(3)(iii) permits the signed informed consent
form to be transmitted to VA not only by mail or facsimile but also by
secure electronic mail or other VA-approved modalities. It then
requires that the form be scanned into the record. This provision does
not specify which modalities are VA-approved for this purpose, because
VA believes this is better placed in policy which can more easily be
amended to reflect evolving forms of communications technology.
Former Sec. 17.32(d)(3) provided, in part, that a facsimile copy
of a signed consent form is adequate to proceed with treatment, and
also required the surrogate to agree to submit a signed consent form to
the practitioner. Requiring both the facsimile copy and the hard copy
is redundant and potentially confusing. We therefore delete the
language in former paragraph (d)(3) requiring that, when a signed
consent form is transmitted by facsimile, ``the surrogate must agree to
submit a signed consent form to the practitioner.'' We also add to
paragraph (d)(3)(iii) a requirement that a signed consent form
submitted by mail, facsimile, by secure electronic mail, or other VA-
approved modalities be scanned into the record. This obviates the need
for VA to keep a hard copy. We also delete the specific reference to
consent being obtained by telephone. We believe the other language in
this paragraph establishing the conditions for use of the telephone in
lieu of a signed consent form is sufficient.
As briefly alluded to above, we add the phrase ``following the
informed consent discussion'' to paragraph (d)(3)(iii)'s treatment of
circumstances where signature consent cannot be obtained in person.
This language clarifies that a signed consent form submitted by mail,
facsimile, transmitted by secure electronic mail, or other VA-approved
modalities is not by itself sufficient to satisfy the consent
requirement; rather, an informed consent discussion is a prerequisite
to the validity of any signed informed consent form.
Receiving signed consent forms by mail, facsimile, secure
electronic mail, or other VA-approved modalities may still, in some
cases, cause undue delay. To provide VA, patients, and surrogates
further flexibility, paragraph (d)(3)(iv) permits the informed consent
conversation conducted by telephone or video conference to be
audiotaped, videotaped, or witnessed by a second VA employee. In
addition, it specifies that the practitioner must document the details
of the conversation in the medical record. If someone other than the
patient is giving consent, the name of the person giving consent and
the authority of that person to act as surrogate must be adequately
identified in the medical record. These actions, together, suffice to
obviate the need for a signed consent form.
Obtaining Consent for Patients Who Lack Decision-Making Capacity
Former paragraph (e) addressed surrogate consent while paragraph
(f) dealt with consent for patients without a surrogate. We combine
former paragraphs (e) and (f) into a single paragraph (e). This change
places into one paragraph how consent is to be obtained when a patient
has been determined to lack decision-making capacity. Paragraph (e)(1)
explains when consent is to be obtained from a surrogate decision maker
and identifies who may serve as a surrogate decision maker in order of
priority. Paragraph (e)(2) addresses the process for obtaining consent
for a patient lacking decision-making capacity who has no such
surrogate. We redesignate former paragraph (e) as paragraph (e)(1).
Paragraph (e)(1) states that patients who are incapable of giving
consent as a matter of law will be deemed to lack decision-making
capacity for the purposes of this section. We delete the clause in
former paragraph (e) specifying that these patients are either persons
judicially declared to be incompetent or minors who are otherwise
incapable of giving consent. We believe this language is redundant,
since we already state in paragraph (e)(1) that patients who are
incapable of giving consent as a matter of law will be deemed to lack
decision-making capacity for purposes of Sec. 17.32.
Consistent with former paragraph (e), paragraph (e)(1)(i)
identifies the persons authorized to act as a surrogate to consent on
behalf of a patient who lacks decision-making capacity and the order of
priority for surrogates. The language in the interim final rule is
unchanged from former paragraph (e) except we remove ``special
guardian'' from the list. Because ``special'' guardians are appointed
as an outcome of a legal process, they are also ``legal guardians.''
Including ``special guardian'' as a separate category of surrogate,
however, suggests that there could be a special guardian who is not a
legal guardian. To avoid this confusion, we remove the
[[Page 31696]]
designation of ``special guardian.'' While this is the only change to
this content and is only technical in nature, VA takes this opportunity
to invite public comment on whether VA should consider inclusion of
emancipated minors among those listed as next-of-kin or with respect to
any situations that might arise with respect to an emancipated minor
(e.g., a spouse who is an emancipated minor under the age of 18).
Currently, next-of-kin must be 18 years of age or older. In addition,
we note that VA makes no change to the order of hierarchy of
surrogates. As is currently the case, a health care agent has, and
would retain here, highest priority because this is the individual
selected by the patient himself/herself and so best reflects the
patient's wishes. Needed checks on the actions of a surrogate already
exist in current regulation: A surrogate must make treatment decisions
based on the known wishes of the patient, or in the absence thereof,
based on the best interests of the patient. This standard would still
apply and is addressed below, with respect to new paragraph (e)(1)(ii).
As noted, paragraph (e)(1)(i) identifies the persons authorized to
act as a surrogate to consent on behalf of a patient who lacks
decision-making capacity and the order of priority for surrogates. A
patient with decision making capacity may select a surrogate and
document that selection by designating a health care agent, and an
alternate if desired, in an advance directive. VA practitioners engage
patients in a discussion of the option of completing an advance
directive and appointing a health care agent during goals of care
conversations which occur as part of VA's delivery of quality health
care to eligible veterans. In this way, potential disputes and
associated uncertainty can be avoided regarding who the patient prefers
to make health care decisions in the event of loss of capacity by
having already memorialized that decision in an advance directive. We
further note that if a patient with decision-making capacity has a
change of mind regarding appointment of a health care agent, the
patient may revoke the advance directive and designate another
individual in a new advance directive. See discussion below of
paragraph (g)(4) which addresses revocation of an advance directive. If
the patient chooses to not appoint a health care agent and subsequently
loses decision making capacity, VA identifies a surrogate decision
maker utilizing the priority list found in paragraph (e)(1)(i). We add
new paragraph (e)(1)(ii) to consist of a slight modification of
language in former paragraph (e) describing the surrogate's role in the
consent process. Former paragraph (e) states: ``the surrogate's
decision must be based on his or her knowledge of what the patient
would have wanted, i.e., substituted judgment.'' The next sentence
states: ``if unknown, the surrogate's decision must be based on the
patient's best interest.'' In paragraph (e)(1)(ii), we retain these
requirements but combine the two sentences into one.
Former paragraph (f)(1) explained the process for obtaining consent
for a patient who lacks decision-making capacity where no surrogate is
available. Former paragraph (f)(1) provided that the practitioner may
request Regional Counsel assistance to obtain a special guardian for
health care or follow the internal procedures in that paragraph. Former
paragraph (f)(1) is redesignated as paragraph (e)(2)(i). The content
remains the same with the two following exceptions: (1) The reference
in former paragraph (f)(1) to ``Regional Counsel'' is changed in
paragraph (e)(2)(i) to ``District Chief Counsel'' to reflect a change
in title; and (2) the reference therein to a ``special guardian for
health care'' is amended to refer to ``legal guardian'' for the reasons
previously stated.
Former paragraph (f)(2) allowed practitioners to use a multi-
disciplinary committee process for patients who lack decision-making
capacity and have no surrogates, but it is very detailed and lengthy.
We retain that content but bifurcate it for the sake of clarity.
Paragraph (e)(2)(ii)(A) focuses on treatments and procedures that
involve minimal risk, while paragraph (e)(2)(ii)(B) addresses
treatments and procedures that require signature consent. The content
of paragraphs (e)(2)(ii)(A) and (B) is substantively the same as former
paragraph (f), with one exception. In paragraph (e)(2)(ii)(B) we now
state that if the patient has valid standing orders regarding life-
sustaining treatment, such as State Authorized Portable Orders, review
by a multi-disciplinary committee appointed by the facility Director is
not required for a decision to withhold or withdraw life-sustaining
treatment. For such patients, the requirement to request the assistance
of District Chief Counsel in obtaining a legal guardian for health care
or to initiate the multi-disciplinary process is effectively
superseded. This approach is consistent with VA's commitment to
promoting patient-centered care and ensuring that veterans' values,
goals, and treatment preferences are respected and reflected in the
care they receive. Valid standing orders should be the basis for any
patient's VA treatment plan.
Special Consent Situation
Former paragraph (g) addressed special consent situations where the
patient is granted special additional procedural due process
protections. We redesignate this paragraph as paragraph (f). The three
``special consent situations'' specifically addressed in former
paragraph (g) are unusual or extremely hazardous treatments or
procedures (e.g., those that may result in irreversible brain damage or
sterilization), administration of psychotropic medication to an
involuntarily committed patient against his or her will, and proposed
procedures or courses of treatment related to approved medical
research.
We delete the provisions in former paragraph (g)(1) relating to
unusual or extremely hazardous treatments or procedures. This paragraph
was intended to provide enhanced protection against now archaic
practices of forced sterilization and lobotomy, neither of which are
performed by VA. As VA no longer performs the types of treatments or
procedures contemplated in this paragraph, we believe continuing to
include it in our informed consent rule is unnecessary and potentially
misleading to the public. VA believes that the existing informed
consent processes and procedures adequately protect patients undergoing
other types of procedures that carry significant risk.
Former paragraph (g)(2) is redesignated as paragraph (f)(1). In
paragraph (f)(1), we state that in involuntary commitment cases where
the forced administration of medications is against the patient's will
or the surrogate's non-consent, procedural protections identified
therein must be provided. These protections were already set forth
together in former Sec. 17.32(g)(2), although here we set the elements
out in separate paragraphs (f)(1)(i)-(iii) for ease of reading.
Former paragraph (g)(3), relating to the need for informed consent
for a proposed course of treatment or procedure that is part of
approved medical research, is redesignated as paragraph (f)(2). We also
make non-substantive changes to the language to enhance clarity and
readability.
Advance Directives
Former paragraph (h) is titled ``Advance health care planning'' and
addresses issues related to the VA Advance Directive. This includes
general principles, patient signature and witness requirements,
revocation, and
[[Page 31697]]
instructions given by a patient in critical situations. We make several
changes to this paragraph. We redesignate this paragraph as paragraph
(g) and revise the paragraph header to ``Advance directives.'' We also
make non-substantive changes to this paragraph for the purpose of
clarity and substantive changes as noted in the following discussion.
The introductory text to former paragraph (h) is redesignated as
paragraph (g)(1). Paragraph (h) previously stated that VA will follow
the wishes of a patient expressed in an advance directive when the
attending physician determines and documents in the patient's health
record that the patient lacks decision-making capacity and is not
expected to regain it. In redesignated paragraph (g)(1), we modify that
language by inserting ``within a reasonable period of time'' after
``regain it''. VA believes the former language could be misinterpreted
to mean that the practitioner should not rely on an advance directive
unless the patient is never expected to regain decision-making
capacity. The amended language addresses that potential misperception.
We also add introductory language to redesignated paragraph (g)(1) to
reflect that a patient's wishes are to be followed to the extent they
are consistent with applicable Federal law, VA policy, and generally
accepted standards of medical practice. This reflects current practice,
but its codification serves to provide public notice of these practice
limitations.
The introductory information in former paragraph (h) provided that
an advance directive that is valid in one or more States under
applicable State law will be recognized throughout the VA health care
system. In redesignated paragraph (g)(1), VA modifies that language
slightly for purposes of clarification. It provides that valid advance
directives will be recognized throughout the VA health care system,
with the exception of any components that are inconsistent with
applicable Federal law, VA policy, or generally accepted standards of
medical practice. This clarification is not a change in practice, as
former Sec. 17.32(h)(4) provided that clear instructions in an advance
directive or instructions in critical situations will not be given
effect if inconsistent with VA policy. Moreover, the terms of 38 CFR
17.38(b) require all VA care to be in accord with generally accepted
standards of medical care. So, the language added to the introductory
information just clarifies how, even if an advance directive is valid
in a state, VA will not honor a provision therein that is inconsistent
with applicable Federal law, policy, or generally accepted standards of
medical practice. This is intended to help underscore that VA is a
Federal health care system with its own rules governing valid advance
directives. Without this clarification, paragraph (g) could be
misinterpreted to mean that VA practitioners must, in honoring a
patient's state-authorized advance directive, comply with that state's
standards and procedures. Such an interpretation could be inconsistent
with the Supremacy Clause of the U.S. Constitution. U.S. Const. art.
VI, cl 2.
Former paragraph (h)(1) addresses signature and witness
requirements for a VA Advance Directive. We redesignate this as
paragraph (g)(2). A VA Advance Directive must be signed by the patient
in the presence of two witnesses. This remains VA practice.
As stated, former Sec. 17.32(h)(1) requires the patient to sign
the form. It does not, however, provide an alternative means for
signing if a physical impairment prevents the patient from signing the
VA Advance Directive. We remedy this by using the same approach used in
paragraph (d)(3)(i), related to signature consent forms. Specifically,
in paragraph (g)(2) we allow such a patient to provide signature
consent by placing an ``X'', thumbprint, or stamp on the form. In
addition, we permit a patient to designate a third party to sign the
directive at the direction of the patient and in the presence of the
patient.
Under the old rule, 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.
We now add language stating that neither witness may be the third party
designated by the patient to sign at the patient's direction and in the
patient's presence.
Former paragraph (h)(1) indicated that except for specific classes
of employees that are listed in Sec. 17.32, VA clinical employees are
not permitted to serve as witness, with a few stated exceptions: VA
employees of the Chaplain Service, Psychology Service, and Social Work
Service may serve as witnesses. We remove, and do not include in
paragraph (g)(2), the prior bar on these VA employees serving as
witnesses, based on what the contemporary legal and ethics literature
describes as an unnecessary burden to completion of advance directives.
Although the originally-intended purpose of restricting who, among
staff, may serve as a witness was meant to protect patients, as
mentioned above, the current literature observes that there is no
evidence that the restrictions fulfill these purposes. Rather, they
make it difficult for patients, especially those who are socially
isolated or homeless, to complete an advance directive. In addition,
the witnesses to an advance directive play no substantive role; they
are attesting only to the fact that they saw the patient sign the form.
Given that many clinicians play a substantial role in guiding the care
of veterans, the literature does not support disqualifying them from
serving as witnesses; that is, performing this non-substantive
attestation.
For the same reasons, it is illogical to allow social workers and
psychologists involved in the patient's care to serve as witnesses but
prohibit nurses and physicians from serving as witnesses if they are
available to do so.
Finally, in addition to creating a barrier to completion of advance
directives, witness restrictions can have the harmful consequence of
providing narrow technical grounds for family members, who do not agree
with a patient's stated substantive treatment wishes, to challenge the
validity of the patient's directive (in toto). Such challenges
undermine a patient's use of an advance directive as an exercise of the
patient's personal autonomy. Thus, VA believes that our patients are
best served by removing restrictions on which VA employees may serve as
witnesses under this section.
Former paragraphs (h)(2) through (4) are redesignated as paragraphs
(g)(3) through (5), respectively. The content related to instructions
in critical situations essentially remain the same but for the changes
reflected herein. In paragraph (g)(3), VA's goal is to honor the
unambiguous verbal or non-verbal instructions of a patient with
decision-making capacity in situations when they are critically ill and
their loss of decision-making capacity is imminent--even if those
instructions are different from preferences expressed earlier in an
advance directive. The existence of a critical clinical situation does
not diminish the right of a patient with decision-making capacity to
accept or refuse treatments.
We modify the requirement related to documentation of a patient's
instructions in a critical situation by co-signature, as co-signature
is not a functionality in the electronic health record. Under previous
rulemaking, the patient's instructions in critical situations must be
expressed to at least two members of the health care team, the
substance of these instructions recorded in a progress note in the
patient's health record, and the note co-signed by at least two members
of the
[[Page 31698]]
team who were present and who can attest to the wishes expressed by the
patient. We now require when a patient provides instructions in
critical situations, expressed to at least two members of the health
care team, the substance of the patient's instructions and the names of
at least two members of the health care team to whom they were
expressed must be entered in the patient's electronic health record.
Former paragraphs (h)(3) and (4) is unchanged and are redesignated as
paragraphs (g)(4) and (5).
We also update the parenthetical information included at the end of
Sec. 17.32 that is related to information collection requirements to
refer to the correct Office of Management and Budget (OMB) control
number covering information collection related to advance care
planning. OMB control number 2900-0583 expired in 2008, and the
currently approved OMB control number related to this information
collection is 2900-0556.
Administrative Procedure Act
The Secretary of Veterans Affairs finds that there is good cause
under the provisions of 5 U.S.C. 553(b)(B), to publish this interim
final rule without prior notice and the opportunity for public comment,
and under 5 U.S.C. 553(d)(3), to dispense with the delayed effective
date ordinarily prescribed by the Administrative Procedure Act (APA).
Pursuant to section 553(b)(B) of the APA, general notice and the
opportunity for public comment are not required with respect to a
rulemaking when an ``agency for good cause finds (and incorporates the
finding and a brief statement of reasons therefor in the rules issued)
that notice and public procedure thereon are impracticable,
unnecessary, or contrary to the public interest.'' The Secretary finds
that it is impractical to delay issuance of this rule for the purpose
of soliciting prior public comment because there is an immediate and
pressing need for VA to respond to the current public health crisis and
national emergency by ensuring (1) effective use of health care
resources as part of the announced VA contingent/crisis standards of
care, including identification of which practitioners may be allowed to
obtain informed consent from patients or surrogates for clinical
treatments and procedures and by providing alternative methods and
modalities for doing so when having the informed consent discussion or
obtaining consent in-person is not practicable; (2) use of facilitated
processes and procedures by which to provide patients or their
surrogates with adequate information during an informed consent
discussion; (3) use of procedures and processes by which patients,
their surrogates, or VA health care practitioners may effectively
communicate and document informed consent for treatments and procedures
through available electronic means; (4) recognition in regulation of
State Authorized Portable Orders; and, (5) immediate implementation of
changes to the advance care planning process (including amending
signature and witness requirements for a VA advance directive) to
remove barriers to veterans documenting treatment preferences in the
event of a loss of decision making capacity.
Multiple provisions of this interim final rule directly support
VA's response to the COVID-19 public health emergency, and improve our
ability to provide timely quality health care to patients.
Changes to the definition of ``practitioner'' allows VA to shift
health care resources as needed to meet requirements for obtaining
informed consent as well as other patient needs. Adding regulatory
recognition of SAPOs supports the health care needs of critically ill
incoming patients with SAPOs in ensuring that the portable order is
recognized and honored by VA. This definition assists VA health care
providers in understanding the distinction between SAPOs and Advance
Directives. VA believes recognizing SAPOs will prevent delays in
translating these orders into VA orders so that they may be of-record
and complied with.
This interim final rule revises multiple elements of the informed
consent process and provides VA with flexibility to address the current
public health emergency. In the absence of these revisions, VA cannot
adequately respond to COVID-19-related issues related to informed
consent because our regulation did not provide for waiver of certain
regulatory requirements. Revising the general requirements for informed
consent supports VA's response to COVID-19 under VA contingent/crisis
standards of care where the patient needs to have all the appropriate
information to make an informed consent decision for both non-COVID
care and COVID care. As an example, some inpatients receiving care for
other conditions need to understand the risk of getting inpatient care
there amidst the current emergency such that it may be difficult to
prevent possible transmission of the infection to non-infected
patients. Changes to requirements related to the setting in which
informed consent may be obtained supports providing treatment and
evaluation to our many outpatients receiving medical services via
telehealth. These patients cannot see their provider in person under
the current public health restrictions. VA needs flexibility in
obtaining informed consent through these new modalities. In addition,
the need to place COVID-19 inpatients in separate wards and block
certain staff from accessing patients in these areas prevents some
practitioners and staff from having in-person discussions with
inpatients. Flexibility is needed to adjust with a continually changing
delivery of care system during a pandemic.
Allowing for delegation of some duties for providing information to
patients related to informed consent gives VA necessary flexibility to
delegate this responsibility in a manner aligned with the current
standards of care and reallocation of resources.
Delineating documentation requirements to informed consent for low
risk treatments and procedures supports VA contingent/crisis standards
of care by easing documentation requirements for these procedures.
These changes help VA address the need for flexibility in how signature
consent for low risk procedures documented. Providing a mechanism for
obtaining signature consent where the patient has a physical impairment
supports VA contingent/crisis standards of care because many patients
unable to sign signatures due to their critical condition. These
changes help VA address need for flexibility during contingent/crisis
standards of care and scarce resources allocation. Allowing for third-
party assistance in documentation of signature consent provides VA with
necessary flexibility during contingent/crisis standards of care and
scarce resources allocation. This change removes a needless procedural
obstacle that hinders VA's ability to obtain valid consent when time is
of the essence. Third-party assistance is needed in many COVID-19 cases
where the need for treatment urgent or emergent and the patient with
decision making capacity is unable to physically place an ``X'' on the
consent form.
Removing the mandatory rescission provision for informed consent in
certain situations eliminates unnecessary evaluative steps where a
change in condition is de minimis and will not affect outcomes and
keeps the consent process active and up-to-date. Providing for other
communication modalities for completing and documenting the signature
consent requirement is necessary under VA contingent/crisis standards
of care
[[Page 31699]]
where telehealth being used for many patients, including those with
suspected COVID-19 as well as other non-COVID patients. Currently, the
emergency compels compliance with social distance and separation
guidance, making it impossible to comply with many current procedures
and requirements. Revising documentation requirements where the
informed consent discussion is not held face to face supports COVID-19
response needs under VA contingent/crisis standards of care where the
phone or/telehealth is more practicable for the informed consent
discussion with patients, including those at home with suspected COVID-
19. VA could not waive regulatory requirements under the prior
rulemaking, which potentially caused disruption and created obstacles
to the informed consent process where providers and patients are more
and more necessarily geographically separated and unable to meet in
person.
Clarifying that VA cannot honor certain preferences in an advance
directive supports VA standards of care in which health care teams must
be able to act on patient's advance directive in real time but still be
aware that we do not enforce provisions inconsistent with Federal law,
VA policy, or generally accepted standards of medical practice.
Revising the rule on how a physically incapacitated patient, or a
patient unable to physically sign because of medical equipment in use,
may sign an advance directive provides us needed flexibility,
especially with respect to use of a designated third party. Removing
restrictions on who may serve as witness to the signing of an advance
directive allows us to better serve patients who are in isolation wards
or areas that are off-limits to non-health care team members. Under the
previous rule precious time was lost trying to locate suitable VA
employees and then they find work arounds whereby the remote employee
can witness the patient signing the form by being in the line of sight
but at a safe distance.
Removing unnecessary documentation requirements related to patient
instructions given in critical situations ensures that the patient's
wishes and instructions can be acted upon promptly.
For these reasons, the Secretary has concluded that ordinary notice
and comment procedures would be both impracticable and contrary to the
public interest, and is accordingly issuing this rule as an interim
final rule. The Secretary will consider and address comments that are
received within 60 days after the date that this interim final rule is
published in the Federal Register, and address them in a subsequent
Federal Register document announcing a final rule incorporating any
changes made in response to the public comments.
The APA also requires a 30-day delayed effective date, except for
``(1) a substantive rule which grants or recognizes an exemption or
relieves a restriction; (2) interpretative rules and statements of
policy; or (3) as otherwise provided by the agency for good cause found
and published with the rule.'' 5 U.S.C. 553(d). For the reasons stated
above, the Secretary finds that there is also good cause for this
interim rule to be effective immediately upon publication. It is in the
public interest for VA to immediately adopt the process changes noted
above to provide for effective utilization of VA practitioners as it
relates to the informed consent process during this period of increased
demand for health care, to provide flexibility to utilize alternative
modalities of communications during the COVID-19 National Emergency,
and remove barriers to veterans documenting treatment preferences in an
advance directive. By relieving these restrictions and barriers, and
making necessary processes changes, the Secretary finds good cause to
exempt this interim final rule from the APA's delayed effective date
requirement.
Paperwork Reduction Act
The Paperwork Reduction Act of 1995 (at 44 U.S.C. 3507) requires
that VA consider the impact of paperwork and other information
collection burdens imposed on the public. Under 44 U.S.C. 3507(a), an
agency may not collect or sponsor the collection of information, nor
may it impose an information collection requirement unless it displays
a currently valid Office of Management and Budget (OMB) control number.
See also 5 CFR 1320.8(b)(3)(vi).
This interim final rule will impose the following revised
information collection requirements to an existing information
collection approved by OMB under OMB Control Number 2900-0556. As
required by the Paperwork Reduction Act of 1995 (at 44 U.S.C. 3507(d)),
VA has submitted this rulemaking and the information collection
revisions to OMB for approval. Notice of OMB approval for this
information collection will be published in a future Federal Register
document.
Information collection under OMB Control number 2900-0556 relates
to collection of information related to patients documenting treatment
preferences on an approved VA form. VA Form 10-0137, VA Advance
Directive: Durable Power of Attorney for Health Care and Living Will,
is the VA recognized legal document that permits VA patients to
designate a health care agent and/or specify preferences for future
health care. The VA Advance Directive is invoked if a patient becomes
unable to make health care decisions for him or herself. This
rulemaking revises the information collection only as it relates to
restrictions on certain VA employees serving as witness to a patient
executing VA Form 10-0137.
These restrictions are reflected in the form's instructions. We
note that for clarity that consent for VA medical treatment by the
patient or surrogate is not a collection of information as defined by
the Paperwork Reduction Act.
Title 38 CFR 17.32(g) contains a collection of information under
the Paperwork Reduction Act of 1995. If OMB does not approve the
collection or of information as requested, VA will immediately remove
the provisions containing a collection of information or take such
other action as is directed by OMB.
We are also revising the information collection, in the case of a
close friend designated by VA as a surrogate decision maker, to require
the signed written statement for the record that describes that
person's relationship to and familiarity with the patient in the
definition of a close friend who may serve as a surrogate.
Comments on the revision of the collection of information contained
in this interim final rule should be submitted to the Office of
Management and Budget, Attention: Desk Officer for the Department of
Veterans Affairs, Office of Information and Regulatory Affairs, 727
17th St NW, Washington, DC 20503. Comments should indicate that they
are submitted in response to ``RIN 2900-AQ97.''
OMB will take action on the revision of the information collection
contained in this rule between 30 and 60 days after publication of this
document in the Federal Register. Therefore, a comment to OMB is best
assured of having its full effect if OMB receives it within 30 days of
publication. This does not affect the deadline for the public to
comment on the interim rule.
The Department considers comments by the public on proposed
collections of information in--
Evaluating whether the proposed collections of information
are necessary for the proper performance of the functions of the
Department, including whether the information will have practical
utility;
Evaluating the accuracy of the Department's estimate of
the burden of
[[Page 31700]]
the proposed collections of information, including the validity of the
methodology and assumptions used;
Enhancing the quality, usefulness, and clarity of the
information to be collected; and
Minimizing the burden of the collections of information on
those who are to respond, including through the use of appropriate
automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology, such as permitting
electronic submission of responses.
The collection of information contained in 38 CFR 17.32 is
described immediately following this paragraph.
Title: Durable Power of Attorney for Health Care and Living Will,
VA Advance Directive.
OMB control number 2900-0556 (amended).
Summary of collection of information: OMB Control number 2900-0556
relates to collection of information related to patients documenting
treatment preferences on an approved VA form. VA Form 10-0137, VA
Advance Directive: Durable Power of Attorney for Health Care and Living
Will, is the VA recognized legal document that permits VA patients to
designate a health care agent and/or specify preferences for future
health care. The VA Advance Directive is invoked if a patient becomes
unable to make health care decisions for him or herself. Former 38 CFR
17.32 stipulates 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. Other individuals employed by your VA
facility may not sign as witnesses to the advance directive unless they
are your family members. The interim final rule removes restrictions on
VA employees signing as a witness to execution of a VA advance
directive. Witness restrictions are reflected in the instructions found
in the most recent version of VA Form 10-0137, and those restrictions
will be removed from the form instructions if the interim final rule
becomes final. We note that revisions to the rule regarding removing
the restrictions on the types of VA employees who are authorized to
serve as a witness to execution of an advance directive impact time
that would be expended by a veteran trying to locate a suitable witness
rather than a collection of information which is defined at 5 CFR
1320.3(c) as the obtaining, causing to be obtained, soliciting, or
requiring the disclosure to an agency, third parties or the public of
information by or for an agency by means of identical questions posed
to, or identical reporting, recordkeeping, or disclosure requirements
imposed on, ten or more persons, whether such collection of information
is mandatory, voluntary, or required to obtain or retain a benefit.
Collection of information includes any requirement or request for
persons to obtain, maintain, retain, report, or publicly disclose
information.
In addition to VA Form 10-0137, the information collection would be
expanded to include, in the case of a close friend designated by VA as
a surrogate decision maker, the signed written statement for the record
that describes that person's relationship to and familiarity with the
patient in the definition of a close friend who may serve as a
surrogate. For purposes of this analysis we estimate that 300
individuals each year are a close friend as that term is used in Sec.
17.32, are designated by VA as a surrogate decision maker, and are
therefore required to submit a signed written statement for the record
that describes that person's relationship to and familiarity with the
patient. We estimate that the signed written statement would take 10
minutes to complete.
Description of the need for information and proposed use of
information: The collection of information is necessary to facilitate
the process of advance care planning for veterans who elect to complete
a VA advance directive to designate a health care agent and/or record
their preferences for future health care. Advance directives are legal
documents that allow a patient to spell out preferences about end-of-
life care ahead of time. Advance directives are utilized to communicate
treatment preferences and wishes to family, friends, and health care
professionals and to avoid confusion later on. The document may also be
used by the veteran to designate a health care agent to make decisions
on behalf of the veteran following loss of decision-making capacity.
Completion of an advance directive by a VA patient is entirely
voluntary. The decision to complete an advance directive has no bearing
on a patient's right or ability to access VA health care. If a patient
completes an advance directive and the completed document is provided
to a VA practitioner, the information it contains is used to identify
the appropriate health care decision maker and to inform decisions
about the patient's care. The form is signed by the veteran in the
presence of two witnesses, and the witnesses must sign the form
attesting that they were present and witnessed the veteran signing the
advance directive form. Information contained in the VA Advance
Directive is used routinely in VA to help surrogates and clinicians
decide what treatments or procedures to provide to patients who have
lost decision-making capacity. For close friends designated as a
surrogate decision maker, the signed written statement is required to
document the nature of the relationship and familiarity with the
patient. The following calculations represent changes to the
information collection attributable to documentation required from
close friends designated as a surrogate decision maker.
Description of likely respondents: Veterans who want to use the
approved VA form to document their preferences for future care in the
event they lose decision making capacity, and to identify the
appropriate health care decision maker, and individuals who agree to
serve as a surrogate decision maker and qualify under the definition of
close friend.
Estimated number of respondents per year: 300.
Estimated frequency of responses per year: One response annually.
Estimated average burden per response: 10 minutes.
Estimated cost to respondents per year: VA estimates the total cost
to all respondents to be $1,286 (50 burden hours X $25.72 per hour).
The Bureau of Labor Statistics gathers information on full-time wage
and salary workers. Assuming a forty (40) hour work week, the mean
hourly wage is $25.72 based on the BLS wage code--``00-0000 All
Occupations.'' This information was taken from the following website:
https://www.bls.gov/oes/current/oes_nat.htm#00-0000 May 2019.
Estimated total annual reporting and recordkeeping burden: 50 hours
in FY2020 and 50 hours in FY2021.
Regulatory Flexibility Act
The Secretary hereby certifies that this interim 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, because it affects only the informed consent process and use of
advance directives within the VA health care system.
Therefore, pursuant to 5 U.S.C. 605(b), the initial and final
regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604 do
not apply.
[[Page 31701]]
Executive Orders 12866, 13563, and 13771
Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, and other advantages; distributive impacts;
and equity). Executive Order 13563 (Improving Regulation and Regulatory
Review) emphasizes the importance of quantifying both costs and
benefits, reducing costs, harmonizing rules, and promoting flexibility.
The Office of Information and Regulatory Affairs has determined that
this rule is a significant regulatory action under Executive Order
12866.
VA's impact analysis can be found as a supporting document at
http://www.regulations.gov, usually within 48 hours after the
rulemaking document is published. Additionally, a copy of the
rulemaking and its impact analysis are available on VA's website at
http://www.va.gov/orpm by following the link for VA Regulations
Published from FY 2004 through FYTD. This rule is not subject to the
requirements of E.O. 13771 because this rule results in no more than de
minimis costs.
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 the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100 million or more (adjusted annually for
inflation) in any one year. This interim final rule will not result in
the expenditure of $100 million or more by State, local, and tribal
governments, in the aggregate, or by the private sector.
Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
the Office of Information and Regulatory Affairs designated this rule
as not a major rule, as defined by 5 U.S.C. 804(2).
Catalog of Federal Domestic Assistance
The Catalog of Federal Domestic Assistance numbers and titles for
the programs affected by this document are 64.008--Veterans Domiciliary
Care; 64.011--Veterans Dental Care; 64.012--Veterans Prescription
Service; 64.013--Veterans Prosthetic Appliances; 64.014--Veterans State
Domiciliary Care; 64.015--Veterans State Nursing Home Care; 64.024--VA
Homeless Providers Grant and Per Diem Program; 64.026--Veterans State
Adult Day Health Care; 64.029--Purchase Care Program; 64.039--CHAMPVA;
64.040--VHA Inpatient Medicine; 64.041--VHA Outpatient Specialty Care;
64.042--VHA Inpatient Surgery; 64.043--VHA Mental Health Residential;
64.044--VHA Home Care; 64.045--VHA Outpatient Ancillary Services;
64.046--VHA Inpatient Psychiatry; 64.047--VHA Primary Care; 64.048--VHA
Mental Health clinics; 64.049--VHA Community Living Center; 64.050--VHA
Diagnostic Care; 64.054--Research and Development.
List of Subjects in 38 CFR Part 17
Administrative practice and procedure, Alcohol abuse, Alcoholism,
Claims, Day care, Dental health, Drug abuse, 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, Reporting and recordkeeping requirements,
Travel and transportation expenses, Veterans.
Signing Authority
The Secretary of Veterans Affairs, or designee, approved this
document and authorized the undersigned to sign and submit the document
to the Office of the Federal Register for publication electronically as
an official document of the Department of Veterans Affairs. Pamela
Powers, Chief of Staff, Department of Veterans Affairs, approved this
document on November 22, 2019, for publication.
Consuela Benjamin,
Regulation Development Coordinator, Office of Regulation Policy &
Management, Office of the Secretary, Department of Veterans Affairs.
For the reasons set out in the preamble, VA amends 38 CFR part 17
as follows:
PART 17--MEDICAL
0
1. The authority citation for part 17 is amended by adding an authority
for Sec. 17.32 in numerical order to read in part as follows:
Authority: 38 U.S.C. 501, and as noted in specific sections.
Section 17.32 also issued under 38 U.S.C. 7331-7334.
* * * * *
0
2. Revise Sec. 17.32 to read as follows:
Sec. 17.32 Informed consent and advance directives.
(a) Definitions. The following definitions are applicable for
purposes of this section:
Advance directive. A written statement by a person who has
decision-making capacity regarding preferences about future health care
decisions if that person becomes unable to make those decisions, in any
of the following:
(i) Durable power of attorney for health care. A durable power of
attorney for health care (DPAHC) is a type of advance directive in
which an individual designates another person as an agent to make
health care decisions on the individual's behalf.
(ii) Living will. A living will is a type of advance directive in
which an individual documents personal preferences regarding future
treatment options. A living will typically includes preferences about
life-sustaining treatment, but it may also include preferences about
other types of health care.
(iii) Mental health (or psychiatric) advance directive. A mental
health or psychiatric advance directive is executed by patients whose
future decision-making capacity is at risk due to mental illness. In
this type of directive, the individual indicates future mental health
treatment preferences.
(iv) State-authorized advance directive. A state-authorized advance
directive is a non-VA DPAHC, living will, mental health directive, or
other advance directive document that is legally recognized by a state.
The validity of state-authorized advance directives is determined
pursuant to applicable state law. For the purposes 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 wishes expressed by the patient in the advance directive.
(v) Department of Defense (DoD) advance medical directive. A DoD
advance medical directive is executed for members of the armed services
or military dependents pursuant to 10 U.S.C. 1044C. It may include a
durable power of attorney for health care or a living will. Federal law
exempts such advance directives from any requirement of form,
substance, formality, or recording that is provided for under the laws
of an individual
[[Page 31702]]
state. Federal law requires that this type of advance directive be
given the same legal effect as an advance directive prepared and
executed in accordance with the laws of the state concerned.
(vi) VA Advance Directive. A VA Advance Directive is completed on a
form specified by VA. In VA, this form can be used by patients to
designate a health care agent and to document treatment preferences,
including medical care, surgical care, and mental health care.
Close friend. Any person eighteen years or older who has shown care
and concern for the welfare of the patient, who is familiar with the
patient's activities, health, religious beliefs and values, and who has
presented a signed written statement for the record that describes that
person's relationship to and familiarity with the patient.
Decision-making capacity. The ability to understand and appreciate
the nature and consequences of health care treatment decisions, and the
ability to formulate a judgment and communicate a clear decision
concerning health care treatments
Health care agent. An individual named by the patient in a durable
power of attorney for health care (DPAHC) to make health care decisions
on the patient's behalf, including decisions regarding the use of life-
sustaining treatments, when the patient can no longer do so.
Legal guardian. A person appointed by a court of appropriate
jurisdiction to make decisions, including medical decisions, for an
individual who has been judicially determined to be incompetent.
Practitioner. A practitioner is any physician, dentist, or health
care professional granted specific clinical privileges to perform the
treatment or procedure. The term practitioner also includes:
(i) Medical and dental residents, regardless of whether they have
been granted specific clinical privileges; and
(ii) Other health care professionals whose scope of practice
agreement or other formal delineation of job responsibility
specifically permits them to obtain informed consent, and who are
appropriately trained and authorized to perform the procedure or to
provide the treatment for which consent is being obtained.
Signature consent. The documentation of informed consent with the
signature of the patient or surrogate and practitioner on a form
prescribed by VA for that purpose.
State-authorized portable orders. Specialized forms or identifiers
(e.g., Do Not Attempt Resuscitation (DNAR) bracelets or necklaces)
authorized by state law or a state medical board or association, that
translate a patient's preferences with respect to life-sustaining
treatment decisions into standing portable medical orders.
Surrogate. An individual authorized under this section to make
health care decisions on behalf of a patient who lacks decision-making
capacity. The term includes a health care agent, legal guardian, next-
of-kin, or close friend.
(b) Informed consent. Patients receiving health care from VA have
the right to accept or refuse any medical treatment or procedure
recommended to them. Except as otherwise provided in this section, no
medical treatment or procedure may be performed without the prior,
voluntary informed consent of the patient.
(1) In order to give informed consent, the patient must have
decision-making capacity.
(2) In the event that the patient lacks decision-making capacity,
the requirements of this section are applicable to consent for
treatments or procedures obtained from a surrogate acting on behalf of
the patient.
(c) General requirements for informed consent. Informed consent is
the process by which the practitioner discloses to and discusses
appropriate information with a patient so that the patient may make a
voluntary choice about whether to accept the proposed diagnostic or
therapeutic procedure or course of treatment. Appropriate information
is information that a reasonable person in the patient's situation
would expect to receive in order to make an informed choice about
whether or not to undergo the treatment or procedure. (Appropriate
information includes tests that yield information that is extremely
sensitive or that may have a high risk of significant consequence
(e.g., physical, social, psychological, legal, or economic) that a
reasonable person would want to know and consider as part of his or her
consent decision.) The specific information and level of detail
required will vary depending on the nature of the treatment or
procedure.
(1) The informed consent discussion should be conducted in person
with the patient whenever practical. If it is impractical to conduct
the discussion in person, or the patient expresses a preference for
communication through another modality, the discussion may be conducted
by telephone, through video conference, or by other VA-approved
electronic communication methods.
(2) The practitioner must explain in language understandable to the
patient each of the following, as appropriate to the treatment or
procedure in question: The nature of the proposed procedure or
treatment; expected benefits; reasonably foreseeable associated risks,
complications or side effects; reasonable and available alternatives;
and anticipated results if nothing is done.
(3) The patient must be given the opportunity to ask questions, to
indicate comprehension of the information provided, and to grant or
withhold consent freely without coercion.
(4) The practitioner must advise the patient if the proposed
treatment is novel or unorthodox.
(5) The patient may withhold or revoke consent at any time.
(6) The practitioner may delegate to other trained personnel
responsibility for providing the patient with clinical information
needed for the patient to make a fully informed consent decision but
must personally verify with the patient that the patient has been
appropriately informed and voluntarily consents to the treatment or
procedure.
(7) Practitioners may provide necessary medical care in emergency
situations without the express consent of the patient when all of the
following apply:
(i) Immediate medical care is necessary to preserve life or prevent
serious impairment of the health of the patient.
(ii) The patient is unable to consent.
(iii) The practitioner determines that the patient has no surrogate
or that waiting to obtain consent from the surrogate would increase the
hazard to the life or health of the patient.
(d) Documentation of informed consent. (1) The informed consent
process must be appropriately documented in the health record. For
treatments and procedures that are low risk and within broadly accepted
standards of medical practice, a progress note describing the clinical
encounter and the treatment plan are sufficient to document that
informed consent was obtained for such treatments or procedures. For
tests that provide information that is extremely sensitive or that may
have a high risk of significant consequences (e.g., physical, social,
psychological, legal, or economic) that a patient might reasonably want
to consider as part of the consent decision, the health record must
specifically document that the patient or surrogate consented to the
specific test.
(2) The patient's and practitioner's signature on a form prescribed
by VA for that purpose is required for all diagnostic and therapeutic
treatments or procedures that meet any of the following criteria:
(i) Require the use of sedation;
[[Page 31703]]
(ii) Require anesthesia or narcotic analgesia;
(iii) Are considered to produce significant discomfort to the
patient;
(iv) Have a significant risk of complication or morbidity; or
(v) Require injections of any substance into a joint space or body
cavity.
(3) Consent for treatments and procedures that require signature
consent must be documented in the health record on a form prescribed by
VA for that purpose, or as otherwise specified in this paragraph (d).
(i) If the patient or surrogate is unable to execute a signature on
the form due to a physical impairment, the patient or surrogate may, in
lieu of a signature, sign the consent form with an ``X'', thumbprint,
or stamp. Two adult witnesses must witness the act of signing and sign
the consent form. By signing, the witnesses are attesting only to the
fact that they saw the patient or surrogate sign the form. As an
alternative to such a patient or surrogate using a duly witnessed
``X'', thumbprint, or stamp to sign the form, a designated third party
may sign the form if acting at the direction of the patient or
surrogate and in the presence of the patient or surrogate. The signed
form must be filed in the patient's health record.
(ii) A properly executed VA-authorized consent form is valid for a
period of 60 calendar days. If, however, the treatment plan involves
multiple treatments or procedures, it will not be necessary to repeat
the informed consent discussion and documentation so long as the course
of treatment proceeds as planned, even if treatment extends beyond the
60-day period. If there is a change in the patient's condition that
might alter the diagnostic or therapeutic decision about upcoming or
continuing treatment, the practitioner must initiate a new informed
consent process and, if needed, complete a new signature consent form
with the patient.
(iii) When signature consent is required, but it is not practicable
to obtain the signature in person following the informed consent
discussion, a signed VA consent form transmitted by mail, facsimile, in
by secure electronic mail, or other VA-approved modalities and scanned
into the record, is adequate to proceed with treatment or procedure.
(iv) When signature consent is required, but it is not practicable
to obtain the signed consent form, the informed consent conversation
conducted by telephone or video conference must be audiotaped,
videotaped, or witnessed by a second VA employee in lieu of the signed
consent form. The practitioner must document the details of the
conversation in the medical record. If someone other than the patient
is giving consent, the name of the person giving consent and the
authority of that person to act as surrogate must be adequately
identified in the medical record.
(e) Patients who lack decision-making capacity--(1) Identifying a
surrogate decision maker. If the practitioner who has primary
responsibility for the patient determines that the patient lacks
decision-making capacity and is unlikely to regain it within a
reasonable period of time, informed consent must be obtained from the
surrogate. Patients who are incapable of giving consent as a matter of
law will be deemed to lack decision-making capacity for the purposes of
this section.
(i) The following persons are authorized to act as a surrogate to
consent on behalf of a patient who lacks decision-making capacity in
the following order of priority:
(A) Health care agent;
(B) Legal guardian;
(C) Next-of-kin: a close relative of the patient eighteen years of
age or older in the following priority: Spouse, child, parent, sibling,
grandparent, or grandchild; or
(D) Close friend.
(ii) A surrogate generally assumes the same rights and
responsibilities as the patient in the informed consent process. The
surrogate's decision must be based on his or her knowledge of what the
patient would have wanted; that is, substituted judgment, or, if the
patient's specific values and wishes are unknown, the surrogate's
decision must be based on the patient's best interest.
(2) Consent for a patient without a surrogate. (i) If none of the
surrogates listed in paragraph (e)(1) of this section is available, a
practitioner may either request the assistance of District Chief
Counsel to obtain a legal guardian for health care or follow the
procedures outlined in paragraph (e)(2)(ii) of this section.
(ii) Facilities may use the following process to make treatment
decisions for patients who lack decision-making capacity and have no
surrogate.
(A) For treatments and procedures that involve minimal risk, the
practitioner must verify that no authorized surrogate can be located,
or that the surrogate is not available. The practitioner must attempt
to explain the nature and purpose of the proposed treatment to the
patient and enter this information in the health record.
(B) For procedures that require signature consent, the practitioner
must certify that the patient has no surrogate to the best of their
knowledge. The attending physician and the Chief of Service (or
designee) must indicate their approval of the treatment decision in
writing. Any decision to withhold or withdraw life-sustaining treatment
for such patients must be reviewed by a multi-disciplinary committee
appointed by the facility Director, unless the patient has valid
standing orders regarding life-sustaining treatment, such as state-
authorized portable orders. The committee functions as the patient's
advocate and may not include members of the treatment team. The
committee must submit its findings and recommendations in a written
report to the Chief of Staff who must note his or her approval of the
report in writing. The facility Director must be informed about the
case and results of the review and may concur with the decision to
withhold or withdraw life-sustaining treatment, delegate final
decision-making authority to the facility Chief of Staff, or request
further review by District Chief Counsel.
(f) Special consent situations. (1) In the case of involuntarily
committed patients where the forced administration of psychotropic
medication is against the will of a patient (or the surrogate does not
consent), the following procedural protections must be provided:
(i) The patient or surrogate must be allowed to consult with
independent specialists, legal counsel or other interested parties
concerning the treatment with psychotropic medication. Any
recommendation to administer or continue medication must be reviewed by
a multi-disciplinary committee appointed by the facility Director for
this purpose.
(ii) The multi-disciplinary committee must include a psychiatrist
or a physician who has psychopharmacology privileges. The facility
Director must concur with the committee's recommendation to administer
psychotropic medications contrary to the patient's or surrogate's
wishes.
(iii) Continued administration of psychotropic medication must be
reviewed every 30 days. The patient (or a representative on the
patient's behalf) may appeal the treatment decision to a court of
appropriate jurisdiction.
(2) The patient must be informed if a proposed course of treatment
or procedure involves approved medical research in whole or in part. If
so, the patient's separate informed consent must be obtained for the
components that constitute research pursuant to the informed consent
requirements for human-subjects research set forth in part 16 of this
title.
[[Page 31704]]
(g) Advance directives--(1) General. To the extent consistent with
applicable Federal law, VA policy, and generally accepted standards of
medical practice, VA will follow the wishes of a patient expressed in a
valid advance directive when the practitioner determines and documents
in the patient's health record that the patient lacks decision-making
capacity and is unlikely to regain it within a reasonable period of
time. An advance directive that is valid in one or more states under
applicable law, including a mental health (or psychiatric) advance
directive, a valid Department of Defense advance medical directive, or
a valid VA Advance Directive will be recognized throughout the VA
health care system, except for components therein that are inconsistent
with applicable Federal law, VA policy, or generally accepted standards
of medical practice.
(2) Signing and witness requirements. (i) A VA Advance Directive
must be signed by the patient. If the patient is unable to sign a VA
Advance Directive due to a physical impairment, the patient may sign
the advance directive form with an ``X'', thumbprint, or stamp. In the
alternative, the patient may designate a third party to sign the
directive at the direction of the patient and in the presence of the
patient.
(ii) In all cases, a VA Advance Directive must be signed by the
patient in the presence of both witnesses. Witnesses to the patient's
signing of an advance directive are attesting by their signatures only
to the fact that they saw the patient or designated third party sign
the VA Advance Directive form. Neither witness may, to the witness'
knowledge, be named as a beneficiary in the patient's estate, appointed
as health care agent in the advance directive, or financially
responsible for the patient's care. Nor may a witness be the designated
third party who has signed the VA Advance Directive form at the
direction of the patient and in the patient's presence.
(3) Instructions in critical situations. In certain situations, a
patient with decision-making capacity may present for care when
critically ill and loss of decision-making capacity is imminent. In
such situations, VA will document the patient's unambiguous verbal or
non-verbal instructions regarding preferences for future health care
decisions. These instructions will be honored and given effect should
the patient lose decision-making capacity before being able to complete
a new advance directive. The patient's instructions must have been
expressed to at least two members of the health care team. To confirm
that the verbal or non-verbal instructions of the patient are, in fact,
unambiguous, the substance of the patient's instructions and the names
of at least two members of the health care team to whom they were
expressed must be entered in the patient's electronic health record.
(4) 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.
(5) VA policy and disputes. Neither the treatment team nor
surrogate may override a patient's clear instructions in an advance
directive or in instructions given in a critical situation, except that
those portions of an advance directive or instructions given in a
critical situation that are not consistent with applicable Federal law,
VA policy, or generally accepted standards of medical practice will not
be given effect.
(The information collection requirements in this section have been
approved by the Office of Management and Budget under control number
2900-0556)
[FR Doc. 2020-10264 Filed 5-26-20; 8:45 am]
BILLING CODE 8320-01-P