Rule2022-16465
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
August 2, 2022
Effective
August 2, 2022
Issuing agencies
Veterans Affairs Department
Abstract
The Department of Veterans Affairs (VA) adopts as final, without changes, an interim final rule, as amended by a second interim final rule, that amended VA's regulation regarding informed consent and advance directives. VA amended the regulation by reorganizing it and amending language where necessary to enhance clarity; and 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. VA has also clarified the roles and responsibilities of the practitioner and other members of the health care team pertaining to the informed consent process.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 147 (Tuesday, August 2, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 147 (Tuesday, August 2, 2022)]
[Rules and Regulations]
[Pages 47099-47100]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-16465]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 17
RIN 2900-AQ97
Informed Consent and Advance Directives
AGENCY: Department of Veterans Affairs.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Department of Veterans Affairs (VA) adopts as final,
without changes, an interim final rule, as amended by a second interim
final rule, that amended VA's regulation regarding informed consent and
advance directives. VA amended the regulation by reorganizing it and
amending language where necessary to enhance clarity; and 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. VA has also clarified the roles and responsibilities
of the practitioner and other members of the health care team
pertaining to the informed consent process.
DATES: This rule is effective August 2, 2022.
FOR FURTHER INFORMATION CONTACT: Lucinda Potter, MSW, LSW, 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:
Interim Final Rule Published at 85 Federal Register (FR) 31690 (May 20,
2020)
In a document published in the FR on May 27, 2020, 85 FR 31690, VA
amended its regulation (Sec. 17.32 of title 38, Code of Federal
Regulations (CFR)) concerning informed consent and advance directives
by reorganizing Sec. 17.32 and revising language where necessary to
enhance clarity; and making 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. VA provided a 60-day comment
period, which ended on July 27, 2020. One comment was received;
however, it did not raise any issues within the scope of the
rulemaking. We make no changes based on that comment.
We note that as part of that rule, we invited 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. We received no public comment on this issue
and make no changes to 38 CFR 17.32 regarding emancipated minors.
Interim Final Rule Published at 87 FR 6425 (February 4, 2022)
In a document published in the FR on February 4, 2022, 87 FR 6425,
VA amended Sec. 17.32(c)(6) to clarify that the practitioner is
ultimately responsible for the informed consent process but may
[[Page 47100]]
delegate elements of the informed consent process to trained personnel.
VA provided a 60-day comment period, which ended on April 5, 2022. One
comment was received, which was supportive of the rule. We thank the
commenter for their support. We make no changes based on that comment.
Based on the rationale set forth in both interim final rules and in
this final rule, VA is adopting, as final without changes, the rule
published at 85 FR 31690, as amended by 87 FR 6425.
Administrative Procedure Act
VA has considered all relevant input and information contained in
the comments submitted in response to the interim final rules (85 FR
31690 and 87 FR 6425) and, for the reasons set forth in the discussion
further above, has concluded that no changes to the interim final rule
at 85 FR 31690, as amended by 87 FR 6425, are warranted. Accordingly,
based upon the authorities and reasons set forth in the interim final
rules (85 FR 31690 and 87 FR 6425), as supplemented by the additional
reasons provided in this document in response to comments received, VA
is adopting the provisions of the interim final rule at 85 FR 31690, as
amended by 87 FR 6425, as a final rule without changes.
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 <a href="http://www.regulations.gov">www.regulations.gov</a>.
Regulatory Flexibility Act
The Secretary hereby certifies that this final rule will not have a
significant economic impact on a substantial number of small entities
as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-
612, 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.
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 final rule will have no such effect on
State, local, and tribal governments, or on the private sector.
Paperwork Reduction Act
The Paperwork Reduction Act of 1995 (44 U.S.C. 3507) requires that
VA consider the impact of paperwork and other information collection
burdens imposed on the public. Except for emergency approvals under 44
U.S.C. 3507(j), VA may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. The interim final rule (85 FR
31690) included a provision constituting revisions to an existing
collection of information under the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-3521) that require approval by the Office of Management and
Budget (OMB) (the provision in the interim final rule is 38 CFR 17.32).
Accordingly, under 44 U.S.C. 3507(d), VA submitted a copy of the
interim final rule (85 FR 31690) to OMB for review, and VA requested
that OMB approve the revised collection of information on an emergency
basis. VA did not receive any comments on the collection of information
contained in the interim final rule (85 FR 31690). OMB approved the
collections of information under control number 2900-0556.
Assistance Listing
The 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 Services; 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.
Congressional Review Act
Pursuant to Subtitle E of the Small Business Regulatory Enforcement
Fairness Act of 1996 (known as 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).
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 July 25, 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.
PART 17--MEDICAL
For the reasons set forth in the preamble, VA adopts as final the
interim final rule published at 85 FR 31690 (May 27, 2020), as amended
by 87 FR 6425 (February 4, 2022).
Consuela Benjamin,
Regulations Development Coordinator, Office of Regulation Policy &
Management, Office of General Counsel, Department of Veterans Affairs.
[FR Doc. 2022-16465 Filed 8-1-22; 8:45 am]
BILLING CODE 8320-01-P
</pre></body>
</html>Indexed from Federal Register on August 2, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.