Informed Consent and Advance Directives, 31690-31704 [2020-10264]

Download as PDF 31690 Federal Register / Vol. 85, No. 102 / Wednesday, May 27, 2020 / Rules and Regulations on locating the docket, see the ADDRESSES section of this preamble. This rule is categorically excluded under paragraph L56 of Appendix A, Table 1 of DHS Instruction Manual 023– 01–001–01, Rev. 01. Paragraph L56 pertains to the training, qualifying, licensing, and disciplining of maritime personnel. This rule involves letters of designation to assign PICs of fuel oil transfers on inspected vessels. List of Subjects in 33 CFR Part 155 Alaska, Hazardous substances, Oil pollution, Reporting, and recordkeeping requirements. For the reasons discussed in the preamble, the Coast Guard amends part 155 as follows: PART 155—OIL OR HAZARDOUS MATERIAL POLLUTION PREVENTION REGULATIONS FOR VESSELS 1. The authority citation for part 155 is revised to read as follows: ■ Note: Additional requirements for vessels carrying oil or hazardous materials are contained in 46 CFR parts 30 through 40, 150, 151, and 153 2. Amend § 155.710 as follows: a. In paragraph (e) introductory text, remove the word ‘‘shall’’ and add in its place the word ‘‘must’’; ■ b. Revise paragraph (e)(1); ■ c. Remove paragraph (e)(2); ■ d. Redesignate paragraphs (e)(3) and (4) as paragraphs (e)(2) and (3), respectively; and ■ e. In newly redesignated paragraph (e)(2), remove the text ‘‘or (2)’’. The revision reads as follows: ■ ■ Qualifications of person in jbell on DSKJLSW7X2PROD with RULES * * * * * (e) * * * (1) On each inspected vessel required by 46 CFR chapter I to have an officer aboard, and on each uninspected vessel, either: (i) Holds a valid merchant mariner credential issued under 46 CFR chapter I, subchapter B, with an endorsement as master, mate, pilot, engineer, or operator aboard that vessel, or holds a valid merchant mariner credential endorsed as Tankerman-PIC; or (ii) Carries a letter satisfying the requirements of § 155.715 and VerDate Sep<11>2014 16:13 May 26, 2020 Jkt 250001 § 155.715 [Amended] 3. In § 155.715, remove the text ‘‘letter of instruction required in § 155.710(e)(2)’’ and add in its place the text ‘‘letter referenced in § 155.710(e)(1)’’. ■ Dated: May 21, 2020. R.V. Timme, Rear Admiral, U.S. Coast Guard, Assistant Commandant for Prevention Policy. [FR Doc. 2020–11366 Filed 5–26–20; 8:45 am] BILLING CODE 9110–04–P DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 17 Authority: 3 U.S.C. 301 through 303; 33 U.S.C. 1321(j), 1903(b), 2735; 46 U.S.C 3306, 3703, 70011, 70034; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; Department of Homeland Security Delegation No. 0170.1. Section 155.1020 also issued under section 316 of Pub. L. 114–120. Section 155.480 also issued under section 4110(b) of Pub. L. 101– 380. § 155.710 charge. designating him or her as a PIC, unless equivalent evidence is immediately available aboard the vessel or at his or her place of employment. * * * * * RIN 2900–AQ97 Informed Consent and Advance Directives Department of Veterans Affairs. Interim final rule. AGENCY: ACTION: 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. SUMMARY: 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, ADDRESSES: PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 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, lucinda.potter@va.gov. (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 decisionmaking 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 SelfDetermination 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 E:\FR\FM\27MYR1.SGM 27MYR1 jbell on DSKJLSW7X2PROD with RULES Federal Register / Vol. 85, No. 102 / Wednesday, May 27, 2020 / Rules and Regulations 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 VerDate Sep<11>2014 16:13 May 26, 2020 Jkt 250001 (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 § 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 StateAuthorized 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 PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 31691 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 Stateauthorized 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, E:\FR\FM\27MYR1.SGM 27MYR1 jbell on DSKJLSW7X2PROD with RULES 31692 Federal Register / Vol. 85, No. 102 / Wednesday, May 27, 2020 / Rules and Regulations 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 ‘‘Stateauthorized portable orders.’’ Stateauthorized 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 lifesustaining 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 lifesustaining treatment decisions into VerDate Sep<11>2014 16:13 May 26, 2020 Jkt 250001 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 LifeSustaining 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-ofHospital Do Not Resuscitate (DNR) order form). The term ‘‘surrogate’’ was previously defined to mean an individual, organization or other body authorized under § 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 (§ 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 PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 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 § 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, thencurrent 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 decisionmaking 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 § 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 E:\FR\FM\27MYR1.SGM 27MYR1 jbell on DSKJLSW7X2PROD with RULES Federal Register / Vol. 85, No. 102 / Wednesday, May 27, 2020 / Rules and Regulations 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 § 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 VerDate Sep<11>2014 16:13 May 26, 2020 Jkt 250001 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 § 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 § 17.32 to allow for the fact that components of the patient’s care are appropriately shared by multiple members of a team. Former § 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 PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 31693 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 webbased 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 VAapproved 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 E:\FR\FM\27MYR1.SGM 27MYR1 31694 Federal Register / Vol. 85, No. 102 / Wednesday, May 27, 2020 / Rules and Regulations jbell on DSKJLSW7X2PROD with RULES 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 teambased 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 VerDate Sep<11>2014 16:13 May 26, 2020 Jkt 250001 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 broadlyaccepted 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 PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 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 VAauthorized 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 E:\FR\FM\27MYR1.SGM 27MYR1 jbell on DSKJLSW7X2PROD with RULES Federal Register / Vol. 85, No. 102 / Wednesday, May 27, 2020 / Rules and Regulations 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 VerDate Sep<11>2014 16:13 May 26, 2020 Jkt 250001 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 VAapproved 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 § 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 PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 31695 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 § 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 E:\FR\FM\27MYR1.SGM 27MYR1 jbell on DSKJLSW7X2PROD with RULES 31696 Federal Register / Vol. 85, No. 102 / Wednesday, May 27, 2020 / Rules and Regulations 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 VerDate Sep<11>2014 16:13 May 26, 2020 Jkt 250001 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 multidisciplinary committee appointed by the facility Director is not required for a decision to withhold or withdraw lifesustaining 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 patientcentered care and ensuring that veterans’ values, goals, and treatment preferences are respected and reflected in the care they receive. Valid standing PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 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 § 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 nonsubstantive 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 E:\FR\FM\27MYR1.SGM 27MYR1 jbell on DSKJLSW7X2PROD with RULES Federal Register / Vol. 85, No. 102 / Wednesday, May 27, 2020 / Rules and Regulations 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 nonsubstantive 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 § 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 VerDate Sep<11>2014 16:13 May 26, 2020 Jkt 250001 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 § 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 § 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 PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 31697 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 decisionmaking 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 cosignature, 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 cosigned by at least two members of the E:\FR\FM\27MYR1.SGM 27MYR1 31698 Federal Register / Vol. 85, No. 102 / Wednesday, May 27, 2020 / Rules and Regulations jbell on DSKJLSW7X2PROD with RULES 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 § 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 VerDate Sep<11>2014 16:13 May 26, 2020 Jkt 250001 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 nonCOVID 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 noninfected patients. Changes to requirements related to the setting in which informed consent may be PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 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 inperson 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 E:\FR\FM\27MYR1.SGM 27MYR1 jbell on DSKJLSW7X2PROD with RULES Federal Register / Vol. 85, No. 102 / Wednesday, May 27, 2020 / Rules and Regulations 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 VerDate Sep<11>2014 16:13 May 26, 2020 Jkt 250001 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 PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 31699 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 E:\FR\FM\27MYR1.SGM 27MYR1 jbell on DSKJLSW7X2PROD with RULES 31700 Federal Register / Vol. 85, No. 102 / Wednesday, May 27, 2020 / Rules and Regulations 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 VerDate Sep<11>2014 16:13 May 26, 2020 Jkt 250001 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 § 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 PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 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. E:\FR\FM\27MYR1.SGM 27MYR1 Federal Register / Vol. 85, No. 102 / Wednesday, May 27, 2020 / Rules and Regulations 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. jbell on DSKJLSW7X2PROD with RULES 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 VerDate Sep<11>2014 16:13 May 26, 2020 Jkt 250001 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 programsveterans, 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 1. The authority citation for part 17 is amended by adding an authority for § 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. * ■ * * * * 2. Revise § 17.32 to read as follows: PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 31701 § 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 decisionmaking 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 E:\FR\FM\27MYR1.SGM 27MYR1 jbell on DSKJLSW7X2PROD with RULES 31702 Federal Register / Vol. 85, No. 102 / Wednesday, May 27, 2020 / Rules and Regulations 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) VerDate Sep<11>2014 16:13 May 26, 2020 Jkt 250001 bracelets or necklaces) authorized by state law or a state medical board or association, that translate a patient’s preferences with respect to lifesustaining 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: PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 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; E:\FR\FM\27MYR1.SGM 27MYR1 jbell on DSKJLSW7X2PROD with RULES Federal Register / Vol. 85, No. 102 / Wednesday, May 27, 2020 / Rules and Regulations (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 VAauthorized 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 VerDate Sep<11>2014 16:13 May 26, 2020 Jkt 250001 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 PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 31703 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 decisionmaking 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. E:\FR\FM\27MYR1.SGM 27MYR1 jbell on DSKJLSW7X2PROD with RULES 31704 Federal Register / Vol. 85, No. 102 / Wednesday, May 27, 2020 / Rules and Regulations (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 VerDate Sep<11>2014 16:13 May 26, 2020 Jkt 250001 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 FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 27 [GN Docket No. 18–122; FCC 20–22; FRS 16735] Expanding Flexible Use of the 3.7 to 4.2 GHz Band Federal Communications Commission. ACTION: Final rule; announcement of compliance date. AGENCY: In this document, the Commission announces that the Office of Management and Budget (OMB) has approved the information collection requirements associated with the eligible space station operator accelerated relocation election, eligible space station operator transition plan, and incumbent earth station lump sum payment election rules adopted in the Federal Communications Commission’s (Commission) 3.7 GHz Report and Order, FCC 20–22, and that compliance with the new rules is now required. This document is consistent with the 3.7 GHz Report and Order, FCC 20–22, which states that the Commission will publish a document in the Federal Register announcing a compliance date for the new rule sections and revise the Commission’s rules accordingly. SUMMARY: PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 Compliance date: Compliance with 47 CFR 27.1412(c) introductory text, (c)(2), 27.1412(d) introductory text and (d)(1), and 27.1419, published at 85 FR 22804 on April 23, 2020, is required on May 27, 2020. FOR FURTHER INFORMATION CONTACT: Anna Gentry, Mobility Division, Wireless Telecommunications Bureau, at (202) 418–7769 or Anna.Gentry@ fcc.gov. SUPPLEMENTARY INFORMATION: This document announces that OMB approved the information collection requirements in §§ 47 CFR 27.1412(c) introductory text, (c)(2), 27.1412(d) introductory text and (d)(1), and 27.1419, on May 5, 2020. These rules were adopted in the 3.7 GHz Report and Order, FCC 20–22, published at published at 85 FR 22804 on April 23, 2020. The Commission publishes this document as an announcement of the compliance date of these new rules. OMB approval for all other new or amended rules for which OMB approval is required will be requested, and compliance is not yet required for those rules. Compliance with all new or amended rules adopted in the 3.7 GHz Report and Order that do not require OMB approval will be required as of June 22, 2020, see 85 FR 22804 (Apr. 23, 2020). If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Cathy Williams, Federal Communications Commission, Room 1–C823, 445 12th Street, SW, Washington, DC 20554, regarding OMB Control Number 3060– 1272. Please include the OMB Control Number in your correspondence. The Commission will also accept your comments via email at PRA@fcc.gov. To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to fcc504@ fcc.gov or call the Consumer and Governmental Affairs Bureau at (202) 418–0530 (voice), (202) 418–0432 (TTY). DATES: Synopsis As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the Commission is notifying the public that it received final OMB approval on May 5, 2020, for the information collection requirements contained in §§ 47 CFR 27.1412(c) introductory text, (c)(2), 27.1412(d) introductory text and (d)(1), and 27.1419. Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information E:\FR\FM\27MYR1.SGM 27MYR1

Agencies

[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