[Federal Register Volume 72, Number 45 (Thursday, March 8, 2007)]
[Rules and Regulations]
[Pages 10365-10367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-4142]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 17

RIN 2900-AM21


Medical: Informed Consent--Designate Health Care Professionals To 
Obtain Informed Consent

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

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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.

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).

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.

[[Page 10366]]

Some 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.

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.

    Approved: October 24, 2006.
Gordon H. Mansfield,
Deputy Secretary of Veterans Affairs.

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For the reasons set forth in the preamble, 38 CFR part 17 is amended as 
set forth below:

PART 17--MEDICAL

0
1. The authority citation for part 17 continues to read as follows:

    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''.

[[Page 10367]]

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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''.
    The revision reads as follows:


Sec.  17.32  Informed consent and advance care planning.

    (a) * * *
    Practitioner. Any physician, dentist, or health care professional 
who has been granted specific clinical privileges to perform the 
treatment or procedure. For the purpose of obtaining informed consent 
for medical treatment, the term practitioner includes medical and 
dental residents and other appropriately trained health care 
professionals designated by VA regardless of whether they have been 
granted clinical privileges.
* * * * *
 [FR Doc. E7-4142 Filed 3-7-07; 8:45 am]
BILLING CODE 8320-01-P