Informed Consent and Advance Directives, 6425-6427 [2022-02316]

Agencies

• DEPARTMENT OF VETERANS AFFAIRS

[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 [www.gpo.gov]
[FR Doc No: 2022-02316]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 www.Regulations.gov. 
Comments received will be available at regulations.gov 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.regulations.gov.

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