Rule2022-02316
Informed Consent and Advance Directives
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 4, 2022
Effective
February 4, 2022
Issuing agencies
Veterans Affairs Department
Abstract
The Department of Veterans Affairs (VA) published an interim final rule amending its regulation regarding informed consent and advance directives. In that rulemaking, we amended the regulation by reorganizing it and amending language where necessary to enhance clarity. We also made changes 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. Before adopting that interim final rule as final, VA revises the provision related to which personnel may be delegated the responsibility for providing a patient with information needed for the patient to make a fully informed consent decision. Upon further review, VA has determined that this provision requires a further change to better clarify roles in the team-based delivery of care model. We are providing the public an opportunity to submit comments solely on this amendment.
Full Text
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<title>Federal Register, Volume 87 Issue 24 (Friday, February 4, 2022)</title>
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[Federal Register Volume 87, Number 24 (Friday, February 4, 2022)]
[Rules and Regulations]
[Pages 6425-6427]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-02316]
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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) published an interim
final rule amending its regulation regarding informed consent and
advance directives. In that rulemaking, we amended the regulation by
reorganizing it and amending language where necessary to enhance
clarity. We also made changes 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. Before adopting that interim
final rule as final, VA revises the provision related to which
personnel may be delegated the responsibility for providing a patient
with information needed for the patient to make a fully informed
consent decision. Upon further review, VA has determined that this
provision requires a further change to better clarify roles in the
team-based delivery of care model. We are providing the public an
opportunity to submit comments solely on this amendment.
DATES:
Effective date: This interim final rule is effective February 4,
2022.
Comments due date: Comments must be received on or before April 5,
2022.
ADDRESSES: Comments may be submitted through <a href="http://www.Regulations.gov">www.Regulations.gov</a>.
Comments received will be available at <a href="http://regulations.gov">regulations.gov</a> for public
viewing, inspection, or copies.
FOR FURTHER INFORMATION CONTACT: Lucinda Potter, LSW, Acting Director
of Ethics Policy, National Center for Ethics in Health Care (10ETH),
Veterans Health Administration, 810 Vermont Ave. NW, Washington, DC
20420; 484-678-5150. (This is not a toll-free number).
SUPPLEMENTARY INFORMATION: In an interim final rule published May 27,
2020 (85 FR 31690), we amended 38 CFR 17.32, our regulation addressing
informed consent for treatments and procedures, by reorganizing it and
amending language where necessary to enhance clarity. We also made
changes to facilitate the informed consent process, the ability to
communicate with patients or surrogates through available modalities of
communication, and the execution and witnessing for a VA Advance
Directive. We amended 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.
Under the previous informed consent rule, the practitioner, who had
primary responsibility for the patient or who would perform the
particular procedure or provide the treatment, was responsible for
explaining 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. There was no provision in the rule addressing the
question of whether, consistent with a team-based delivery of care
model, appropriately trained health care team members had a role in the
informed consent process. In the May 2020 interim final rule, we dealt
with that issue in paragraph (c)(6), stating that 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.
VA intended that paragraph (c)(6) give the practitioner discretion
to more fully utilize the training and expertise of non-practitioners
within the bounds of the
[[Page 6426]]
team-based care model. Upon further review, VA has determined that this
paragraph should be amended to more clearly reflect VA's intent to
utilize a team-based approach for other elements of informed consent
discussions in addition to provision of information to the patient.
Consistent with longstanding VA policy and practice, we amend paragraph
(c)(6) to more broadly state that trained personnel may conduct
elements of the informed consent process when delegated by the
practitioner.
We are also removing the term ``clinical information'' in this
paragraph. We believe the term ``clinical information'' in the current
paragraph (c)(6) could be problematic. It is not defined in VA
regulations and is used only in VA policy documents either generically
(to describe any health information reflected in medical records) or to
describe specific types of stored information such as medical-related
data, images, sound, and video related to certain types of medical
examinations. ``Clinical information'' could also be narrowly used to
describe only technical information related to a treatment or
procedure. A narrow construction and application of that term is
counter to the team model which is intended to benefit the patient by
allowing members of the health care team to provide necessary
information through different perspectives. This model also provides
the patient an opportunity to freely communicate with not only the
practitioner but also with other team members regarding the proposed
treatment or procedure.
Based on that rationale, we amend paragraph (c)(6) to clarify that
the practitioner may delegate to trained personnel the responsibility
of conducting elements of the informed consent process beyond simply
providing information. To ensure that clinical oversight is retained,
the practitioner remains responsible for the informed consent process
and must personally verify with the patient that the patient has been
fully informed and voluntarily consents to the treatment or procedure.
Elements of the informed consent process that may be delegated to
trained personnel include providing patient education regarding the
proposed treatment or procedure, identifying the authorized surrogate
for patients who lack decision-making capacity, and assisting with
obtaining the patient's (or surrogate's) signature for treatments and
procedures that require signature informed consent.
VA believes that this will ensure that elements of informed consent
discussions that may be appropriately delegated by providers are not
unduly limited by regulation, while still making clear that the
practitioner remains responsible for the informed consent process and
for personally verifying with the patient that the patient has been
fully informed and voluntarily consents to the treatment or procedure.
We are providing a 60-day period for submission of comments from
the public on this amendment of Sec. 17.32(c)(6). We are not accepting
any public comment on any other content in Sec. 17.32. Following the
60-day public comment period, we will review and consider comments
received and then publish a final rulemaking capturing not only this
interim final rule but also the May 2020 interim final rule.
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 amendment
as an 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 effective use of health care resources
as part of the announced VA contingent/crisis standards of care, in
addition to regular standards of care provided to eligible
beneficiaries. VA believes members of a VA health care team should be
utilized to the fullest extent practicable in providing veterans
information on risks and benefits of proposed treatments or procedures.
Thus, delaying the implementation of this clarifying amendment would be
contrary to the public interest.
For these reasons, the Secretary has concluded that ordinary notice
and comment procedures would be both impracticable and contrary to the
public interest. Accordingly, VA issues this amendment as a separate
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 on
this interim final rule and the May 2020 interim final rule.
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 to facilitate veterans documenting treatment preferences in an
advance directive. By immediately making necessary process changes, the
Secretary finds good cause to exempt this amendment from the APA's
delayed effective date requirement.
Paperwork Reduction Act
Although this action contains provisions constituting collections
of information, at 38 CFR 17.32, under the Paperwork Reduction Act of
1995 (44 U.S.C. 3501-3521), no new or proposed revised collections of
information are associated with this interim final rule. The
information collection requirements for Sec. 17.32 are currently
approved by the Office of Management and Budget (OMB) and have been
assigned OMB control number 2900-0556.
Regulatory Flexibility Act
The Secretary hereby certifies that this interim final rule will
not have a significant economic impact on a substantial number of small
entities as they are defined in the Regulatory Flexibility Act, 5
U.S.C. 601-612, 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 6427]]
Executive Orders 12866 and 13563
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 not a significant regulatory action under Executive Order
12866.
The Regulatory Impact Analysis associated with this rulemaking can
be found as a supporting document at www.<a href="http://regulations.gov">regulations.gov</a>.
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. The amendment issued here as an 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).
Assistance Listing
The Assistance Listing program 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
Denis McDonough, Secretary of Veterans Affairs, approved this
document on January 31, 2022, 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.
Consuela Benjamin,
Regulation Development Coordinator, Office of Regulation Policy &
Management, Office of General Counsel, 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 continues to read as follows:
Authority: 38 U.S.C. 501, and as noted in specific sections.
0
2. Amend Sec. 17.32 by revising paragraph (c)(6) to read as follows:
Sec. 17.32 Informed consent and advance directives.
* * * * *
(c) * * *
(6) Trained personnel may conduct elements of the informed consent
process when delegated by the practitioner. However, the practitioner
remains responsible for the informed consent process and must
personally verify with the patient that the patient has been fully
informed and voluntarily consents to the treatment or procedure.
* * * * *
[FR Doc. 2022-02316 Filed 2-3-22; 8:45 am]
BILLING CODE 8320-01-P
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</html>Indexed from Federal Register on February 4, 2022.
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