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VA RIN: 2900-AQ97 Publication ID: Spring 2020 
Title: ●Informed Consent and Advance Directives 
Abstract:

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.  Among the chief changes, 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 when a patient consent 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 means of communication 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 as VA no longer performs such treatments or procedures.  We add definitions of advance directives that VA recognizes the Department of Defense Advance Medical Directive and a Mental Health (or Psychiatric) Advance Directive.  We add a definition of State-Authorized Portable Orders to reflect VA’s recognition of these specialized forms or identifiers authorized by state law or a state medical board or association, that translate a patient’s preferences related to specific life-sustaining treatment decisions into portable medical orders.  We 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 under the regulation, and remove restrictions on certain other VA employees serving as witness to the signing of a VA Advance Directive.  We also add a mechanism to allow a patient who is unable to execute a signature on a VA Advance Directive form due to a physical impairment to authorize a third party, at the direction and in the presence of the patient, to sign an X on the form or to use a thumbprint or stamp. Finally, we amend the definition of signature consent to bring it into alignment with VA practice and community standards where the consent form is signed by both the patient and the practitioner.

 
Agency: Department of Veterans Affairs(VA)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Fully or Partially Exempt 
CFR Citation: 38 CFR 17.32    38 CFR 17.38(b)    38 CFR 17.32(g)    5 CFR 1320.3(c)   
Legal Authority: 38 U.S.C. 7301(b)    42 U.S.C. 1395cc(f)   
Legal Deadline:  None
Timetable:
Action Date FR Cite
Interim Final Rule  06/00/2020 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Information URL: www.regulations.gov  
RIN Data Printed in the FR: No 
Agency Contact:
Lucinda Potter
National Center for Ethics in Health Care (10E1E)
Department of Veterans Affairs
810 Vermont Avenue NW,
Washington, DC 20420
Phone:484 678-7228
Email: lucinda.potter@va.gov