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AGENCY:

Department of Veterans Affairs.

ACTION:

Final rule.

SUMMARY:

This document amends U.S. Department of Veterans Affairs (VA) medical regulations on informed consent. The final rule authorizes VA to designate additional categories of health care professionals to obtain the informed consent of patients or their surrogates for clinical treatment and procedures and to sign the consent form.

DATES:

Effective Date: April 9, 2007.

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FOR FURTHER INFORMATION CONTACT:

Ruth Cecire, PhD, Policy Analyst, National Center for Ethics in Health Care (10E), Veterans Health Administration, Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420; 202-501-2012 (this is not a toll-free number).

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SUPPLEMENTARY INFORMATION:

In a document published in the Federal Register on February 1, 2006 (71 FR 5204), VA proposed to amend 38 CFR 17.32 to authorize the designation of additional categories of health care professionals to obtain the informed consent of patients or their surrogates and to sign the consent form. The comment period for this proposed rule ended April 3, 2006. We received one comment and now issue this final rule.

This rule amends VA medical regulations on informed consent and brings VA practice in line with current professional standards of care. Specifically, it allows VA to designate appropriately trained health care professionals (e.g., advanced practice nurses and physician assistants), who have primary responsibility for the patient or who will perform a particular procedure or provide a treatment, to conduct the informed consent discussion and sign the consent form. These changes and the specific requirements that define “appropriately trained health care professionals” will be documented in a revision to VHA Handbook 1004.1, Informed Consent for Clinical Treatments and Procedures.

The current definition of practitioner encompasses any health care professional who has been granted specific clinical privileges to perform the treatment or procedure. It also includes medical and dental residents who may not be clinically privileged but who, under the current regulation, may obtain the informed consent and sign the consent form. This rule extends the exception regarding clinical privileging to other appropriately trained health care professionals, which will be clearly defined in national VA policy.

This change is required because clinical privileges are not granted to all health care professionals in VA who provide treatments and procedures. Start Printed Page 10366Some health care professionals work under specific “scope of practice” agreements or other formal delineations of job responsibility that specify which treatments and procedures the individual can provide based on his or her training, certification, knowledge, skills, and/or licensure. These agreements are developed and signed at the local facility level based on national policy requirements. Under the current regulatory definition of practitioner, physician assistants, advanced practice nurses and other appropriately trained health care professionals who are not clinically privileged but are performing procedures or providing treatments, as approved by their facility and supported by the standards of their respective professions, may not obtain informed consent from the patient. This rule would allow these treating practitioners to obtain informed consent from the patient and sign the consent form. This scope of practice will be limited to those specific individuals who meet detailed requirements set by VA national policy and who also gain approval from their local facility to carry out these duties.

No change is made to the general requirements for informed consent in this rule. The practitioner, who has primary responsibility for the patient or who will perform the particular procedure or provide the treatment, must obtain consent from the patient as described in the regulation.

VA received one comment asking that we omit reference to designated “health care professionals” and expand the definition of “practitioner” to include advanced practice nurses and physician assistants only. The commenter suggested that other health care professionals may lack the qualifications necessary to obtain patients' informed consent. VA recognizes that many health care professionals may lack appropriate qualifications to obtain informed consent. Indeed, some advanced practice nurses and physician assistants may not be qualified to do so. However, the commenters' proposed change neither ensures quality nor allows VA to remedy the problem that non-privileged providers are currently prohibited from obtaining consent from the patients they treat. We believe that promoting direct communication between the treating practitioner and the patient improves informed consent and improves patient care. Ensuring that providers are appropriately qualified to conduct informed consent discussions with patients will be addressed through establishing national requirements in VA policy and holding local VHA facilities accountable for making certain that each individual provider assigned those duties is competent to perform them. In our view, the rule's proviso, that designation is authorized only for other appropriately trained health care professionals, when combined with the regulation's requirement that consent be obtained by the health care professional who has primary responsibility for the patient or who will perform the particular procedure or provide the treatment, allows VA a necessary level of control over quality through the specification in policy and certification in practice of “appropriately trained health care professionals.” Accordingly, we made no change based on this comment.

We are also making nonsubstantive changes to make the terminology used in the regulation consistent with current Department practice. These include changing “health-care” to “health care” and “medical record” to “health record” throughout the section.

Based on the rationale set forth in the proposed rule and those contained in this document, we are adopting the provisions of the proposed rule as a final rule without change.

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 an 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 given year. This rule would have no such effect on State, local, and tribal governments, or the private sector.

Paperwork Reduction Act of 1995

This document contains no provisions constituting a collection of information under the Paperwork Reduction Act (44 U.S.C. 3501-3521). The existing information collections associated with the informed consent process have been approved by OMB under control number 2900-0583.

Executive Order 12866—Regulatory Planning and Review

Executive Order 12866 directs agencies to assess all 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, and other advantages; distributive impacts; and equity). The Order classifies a rule as a significant regulatory action requiring review by the Office of Management and Budget if it meets any one of a number of specified conditions, including: having an annual affect on the economy of $100 million or more, creating a serious inconsistency or interfering with an action of another agency, materially altering the budgetary impact of entitlements or the rights of entitlement recipients, or raising novel legal or policy issues. VA has examined the economic, legal, and policy implications of this final rule and has concluded that it is a significant regulatory action because it raises novel policy issues.

Regulatory Flexibility Act

The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601-612). The rule will affect only individuals and will not directly affect any small entities. Therefore, pursuant to 5 U.S.C. 605(b), this rule is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

Catalog of Federal Domestic Assistance

The Catalog of Federal Domestic Assistance numbers and titles are 64.009, Veterans Medical Care Benefits; 64.010, Veterans Nursing Home Care; and 64.011, Veterans Dental Care.

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List of Subjects in 38 CFR Part 17

• Administrative practice and procedure
• Alcohol abuse
• Alcoholism
• Claims
• Day care
• Dental health
• Drug abuse
• Foreign relations
• 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
• Philippines
• Reporting and recordkeeping requirements
• Scholarships and fellowships
• Travel and transportation expenses
• Veterans

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For the reasons set forth in the preamble,

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PART 17—MEDICAL

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1. The authority citation for part 17 continues to read as follows:

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Authority: 38 U.S.C. 501, 1721, and as stated in specific sections.

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2. Section 17.32 is amended by:

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a. Removing “health-care” each time it appears and adding in its place “health care”.

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b. Removing “medical record” each time it appears and adding in its place “health record”.

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c. In the list of definitions in paragraph (a), revising the definition of “Practitioner”.

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The revision reads as follows:

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