[Federal Register Volume 74, Number 135 (Thursday, July 16, 2009)]
[Rules and Regulations]
[Pages 34500-34503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-16898]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 17

RIN 2900-AN20


Elimination of Requirement for Prior Signature Consent and Pre- 
and Post-Test Counseling for HIV Testing

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

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SUMMARY: This document adopts, without change, the proposed rule 
published in the Federal Register on December 29, 2008, updating 
informed consent requirements related to testing for the Human 
Immunodeficiency Virus (HIV) for Veterans receiving health care from 
the Department of Veterans Affairs (VA). This final rule is in 
accordance with related provisions of the Veteran's Mental Health and 
Other Care Improvements Act of 2008. The final rule eliminates the 
regulatory requirement for written informed consent for HIV testing and 
specific pre- and post-test counseling of Veteran patients. VA will 
implement this rule through internal policy guidance specifying these 
requirements and how they apply to HIV testing.

DATES: Effective Date: This final rule is effective August 17, 2009.

FOR FURTHER INFORMATION CONTACT: Ronald O. Valdiserri, MD, MPH, Chief 
Consultant (13B), Public Health Strategic Healthcare Group, Department 
of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420, 
(202) 461-1040. (This is not a toll-free number.)

SUPPLEMENTARY INFORMATION: On December 29, 2008, VA published a 
proposed rule in the Federal Register (73 FR 79428). We proposed to 
amend 38 CFR 17.32(d), VA's regulation concerning documentation of 
informed consent, and 38 CFR 17.32(g), VA's regulation concerning 
special consent situations, by removing the requirement for written 
rather than oral informed consent for HIV testing and specific pre- and 
post-test counseling of Veteran patients related to HIV testing. 
However, nothing in this regulation changes existing statutory 
requirements for informed consent. These changes are in response to 
provisions included in section 124 of Public Law 100-322, the Veteran's 
Mental Health and Other Care Improvement Act of 2008. VA provided a 30-
day comment period, which ended on January 28, 2009.
    We received a number of comments that did not address the proposed 
amendments to Sec.  17.32 and thus were outside the scope of this 
rulemaking proceeding. Although we appreciate those comments, we will 
not address them in this final rule.
    We received comments concerning the proposed amendments from 10 
organizations and 10 individuals. Sixteen commenters expressed support 
for the proposed rule. We received two comments opposing the rule, one 
of which was submitted jointly by four commenters, and will address 
each of those comments below.
    VA proposed to amend the Informed Consent regulation for HIV 
testing in the medical regulations in 38 CFR part 17 to remove Sec.  
17.32(d)(1)(vi) and 17.32(g)(4). Section 124 of Public Law 100-322 
(1988) (``section 124'') prohibited any VA program from widespread 
testing to identify HIV

[[Page 34501]]

infections unless Congress specifically appropriated funds for such a 
program. The statute further required VA to ``provide for a program'' 
under which VA offered HIV testing to: (1) Any patient receiving care 
or services for intravenous drug abuse, diseases associated with HIV, 
and any patient otherwise at high risk for HIV infection; and (2) any 
patient requesting the test, unless medically contraindicated. No 
testing of any patient was permissible under section 124 without the 
prior written informed consent of the patient and the provision of pre- 
and post-test counseling. The Administration sought the repeal of 
section 124 to enable VA to bring its informed consent policy and 
procedures for HIV testing into line with current standards of 
practice, to improve potential health outcomes of infected patients, 
and to advance the country's broader public health goals. Section 407 
of Public Law 110-387 repealed section 124 and eliminated the statutory 
requirements that VA's HIV-testing policy include prior written consent 
and pre- and post-test counseling. To enable VA to bring its policy 
into conformance with the purpose of the legislation as well as with 
current medical practice, VA proposed to remove the provisions of 38 
CFR 17.32(d)(1)(vi) and (g)(4).
    One commenter opposed eliminating the requirements for pre-test 
counseling and signature consent because these requirements help 
guarantee veterans' rights to choose their medical care, to have their 
privacy respected, and to be treated with dignity. VA agrees that in 
all of its actions, the Department should promote respect for these 
rights. However, other provisions in current regulations, which are not 
amended by this final rule, address the commenter's concerns. 
Specifically, we will use oral informed consent, consistent with 38 CFR 
17.32(b), which requires that all patient care furnished by VA, 
including HIV testing, ``shall be carried out only with the full and 
informed consent of the patient or, in appropriate cases, a 
representative thereof.'' Informed consent is ``the freely given 
consent that follows a careful explanation by the practitioner to the 
patient or the patient's surrogate of the proposed diagnostic or 
therapeutic procedure or course of treatment.'' 38 CFR 17.32(c). As 
part of the informed consent process in Sec.  17.32(c), VA 
practitioners are required to ``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.'' Section 
17.32(c) further requires that ``[t]he patient or surrogate must be 
given the opportunity to ask questions, to indicate comprehension of 
the information provided, and to grant permission freely without 
coercion,'' and that the patient or surrogate ``may withhold or revoke 
his or her consent at any time.'' These regulatory requirements are 
grounded in Veterans' right to choose their medical care, to have their 
privacy respected, and to be treated with dignity. Moreover, as noted 
in the Notice of Proposed Rulemaking (NPRM), the protections that we 
will continue to provide are still more rigorous than those generally 
found in the private sector.
    Accordingly, we will not make any changes to the final rule based 
upon the comment.
    Four commenters jointly opposed the proposed rule because they 
believed that requirements for pre- and post-test counseling and 
written informed consent are not meaningful barriers to promptly 
identifying people infected with HIV. These commenters cited several 
examples of organizations that have successfully increased their rates 
of HIV testing by streamlining their procedures for pre-test counseling 
and written informed consent.
    Our primary purposes in eliminating these requirements are (1) to 
eliminate any unnecessary impediments to HIV testing, (2) to enable VA 
to make its informed consent and procedures for HIV testing consistent 
with our procedures for other routine clinical tests run by VA, and (3) 
to enable us to bring our procedures in line with current standards of 
practice as recommended by the Centers for Disease Control and 
Prevention while protecting the rights of patients in other health care 
systems. We carefully considered the alternatives available to VA, 
including the ``streamlining'' suggested by the commenters, but 
nonetheless concluded that there was insufficient reason to maintain 
the pre-test counseling and written informed consent requirements that 
have been shown to be associated with lower rates of HIV testing. By 
eliminating these requirements and replacing them with other less 
cumbersome procedures to ensure that patients are fully informed and 
have the opportunity to consent or refuse HIV testing, we believe we 
can increase testing rates while still protecting the rights and 
interests of our Veteran patients.
    We note, briefly, that several studies support the proposition that 
eliminating pre-test counseling and prior written informed consent may 
lead to increased testing rates, especially when combined with improved 
testing procedures. See, NM Zetola et al., Association between rates of 
HIV testing and elimination of written consents in San Francisco, 297 
JAMA 1061-2 (2007); PD Ehrenkranz et al., Written Informed Consent 
Statutes and HIV Testing, Am J Prev Med (May 2009) (Epub ahead of 
print); C. Wing, Effects of written informed consent requirements on 
HIV testing rates: evidence from a natural experiment, 99 Am J Pub 
Health 1087-92 (2009); RC Burke et al., Why don't physicians test for 
HIV? A review of the US literature, 21 AIDS 1617-24 (2007). This 
literature supports our decision that a program of prior informed oral 
consent, combined with better procedures, is the most efficient and 
effective method available at this time to achieve higher HIV testing 
rates, irrespective of whether other less or equally effective 
alternatives are available.
    The commenters also argued that the current requirement for pre-
test counseling should be retained because patients benefit from 
receiving the information VA currently provides through pre-test 
counseling, such as information about how HIV is spread and measures to 
be taken for prevention of HIV transmission. They further argued that 
post-test counseling should be retained because it is important for 
patients who test negative for HIV, especially those who engage in 
high-risk behaviors. Finally, they argued against eliminating the 
written consent requirement because written consent is needed to ensure 
that information has been provided to patients and that consent has 
been given. We will not make any changes to the final rule based upon 
these comments.
    VA is committed to ensuring that Veterans continue to receive 
thorough and accurate information about HIV and HIV testing, and that 
HIV testing is performed only after the patient or the patient's 
surrogate has received this information (see below) and specifically 
consented to undergo such testing. By eliminating the requirements for 
pre-test counseling, post-test counseling, and written informed consent 
for HIV testing, VA is not weakening patient protections, but merely 
streamlining its protocols to make them less cumbersome for 
practitioners and patients alike.
    Specifically, VA intends to use a variety of methods, including but 
not limited to those recommended by the Centers for Disease Control, to 
ensure that the current level of protections for patients is 
maintained. These methods

[[Page 34502]]

include providing patients with written education materials that cover 
much of the information that was previously covered in pre-test and 
post-test counseling, and ensuring that patients who engage in high 
risk behaviors are referred to necessary prevention services. Instead 
of using a written consent form to ensure that the information has been 
provided to patients and that consent has been given, VA practitioners 
will be required to document the oral informed consent process in a 
progress note. VA will implement this rule through internal policy 
guidance specifying these requirements and how they apply to HIV 
testing. Thus the final rule enables VA to streamline its procedures by 
removing unnecessary barriers to HIV testing, while still ensuring that 
patients are provided with accurate and thorough information about HIV 
and HIV testing, and that HIV testing is only performed with the full 
and informed consent of the patient or the patient's surrogate.
    Of note, VA already has on its HIV Web site (http://www.hiv.va.gov) 
extensive educational materials on HIV and HIV testing, directed at 
both clinical providers and patients. We will direct patients to this 
Web site (in addition to other available resources) which addresses 
topics including the benefits and risks of HIV testing; how HIV testing 
is performed and interpreted; available treatments for HIV; and VA 
confidentiality protections for HIV-infected patients. This web site 
receives hundreds of thousands of page views per month, and represents 
a resource that is widely available to providers, Veterans, and the 
general public. Joint commenters also assert that the title of the NPRM 
was confusing and misleading because it referred to elimination of pre-
test counseling, implying that VA providers will not have to provide 
information on HIV testing to Veteran patients. The title of the notice 
has no substantive effect, and to the extent that anyone might find it 
misleading, VA's intent is clear from everything that follows the 
proposed rule title and as described in this final notice.
    The Joint commenters also favor mandated pre-test counseling on HIV 
testing because of other benefits to patients, including increasing 
testing rates and education of patients about HIV, including methods of 
preventing transmission. VA agrees that these are important goals; 
however, it respectfully disagrees that mandated pre-test counseling is 
required to achieve them. VA has already encouraged providers to 
routinely discuss HIV risk factors and to offer testing to all veterans 
who are at risk for HIV. See, e.g., Information Letter IL 10-2005-017, 
Need For Routine Human Immunodeficiency Virus (HIV) Risk Assessment And 
Testing. VA intends to promulgate and implement a written policy 
directive extending this guidance to require providers to offer HIV 
testing to all patients, not just those at high risk. In addition, 
because of its electronic medical record and computerized provider 
ordering entry system, VA has the capacity to utilize technologies such 
as electronic reminders and other mechanisms to increase testing rates. 
Use of such mechanisms has been shown to aid in increasing HIV testing 
rates in the VA system. MB Goetz et al., A system-wide intervention to 
improve HIV testing in the Veterans Health Administration. 23 J Gen 
Intern Med 1200-1207 (2008). However, we believe that these mechanisms 
alone are insufficient to adequately expand HIV testing within VA. The 
overall rates within VA remain low, even in facilities that have 
implemented these practices. RO Valdiserri et al. Frequency of HIV 
screening in the Veterans Health Administration: Implications for early 
diagnosis of HIV infection, 20 AIDS Educ Prev 258-264 (2008).
    The commenters also assert that mandated pre-test and post-
counseling are necessary to ensure linkage to care. VA respectfully 
disagrees. The literature cited by the commenters in support of this 
point is drawn from settings outside the VA; in fact, VA has an 
excellent record of linkage to care, with current data showing that 
greater than 75 percent of all HIV-infected Veterans in care within the 
VA system are on anti-retroviral therapy, and that over 90 percent of 
all HIV-infected Veterans in care within the VA system who require 
prophylaxis against opportunistic infections do in fact receive such 
prophylaxis.
    The commenters also object that Congress did not intend for VA to 
remove requirements for written informed consent and pre-test and post-
counseling, asserting that the Congress' primary goal was simply to 
remove the prohibition of wide-spread HIV testing. VA respectfully 
disagrees with this interpretation, based on the discussion of this 
issue in the NPRM of the plain language and history of the Veterans 
Mental Health Care and Other Improvements Act of 2008 (Pub. L. 110-
387). As further evidence of Congress' intent, the Senate Report on the 
predecessor bill criticized VA for not adopting CDC's recommendations 
on HIV testing (which include removing requirements for written 
informed consent and pre-test counseling). S. Rep. 110-85, at 56 
(2008).
    The commenters also argue that mandated post-test counseling should 
be retained because it may decrease the risk of continued high-risk 
behavior by patients who have a negative HIV test. VA agrees with the 
importance of decreasing high-risk behavior, and as part of our 
directives and internal guidance, we will require providers to counsel 
patients who are engaged in high-risk behavior and to refer them as 
clinically appropriate to resources to reduce such high-risk behavior. 
Providers will also be required to offer repeat testing to high-risk 
individuals at least annually, as recommended by CDC.
    Finally, the same commenters argued that VA should retain the 
written informed consent requirement because it protects VA 
practitioners from liability. We disagree that this is a valid argument 
in support of keeping the written informed consent requirement. VA's 
informed consent regulations and policy are designed to benefit and 
protect the patient; not to benefit VA practitioners or the Department.
    To the extent that the commenters requested that VA expand the 
scope of its testing or discuss post-test counseling, these comments 
were beyond the scope of this rulemaking. However, as noted earlier, VA 
intends to promulgate and implement a written policy on this issue. The 
policy guidance states that it is VHA policy that HIV testing is part 
of routine medical care; that providers recommend HIV testing to all 
veterans; that providers obtain full and informed consent of the 
veteran prior to testing; and that veterans who test positive for HIV 
infection must be referred for state-of-the-art HIV treatment, 
prevention of complications, and care of related conditions as soon as 
possible after diagnosis.

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

Paperwork Reduction Act

    This document contains no provisions constituting a collection of 
information

[[Page 34503]]

under the Paperwork Reduction Act (44 U.S.C. 3501-3521).

Regulatory Flexibility Act

    The Secretary of Veterans Affairs hereby certifies that this final 
rule would 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. This final rule will directly affect 
only individuals and will not directly affect small entities. 
Therefore, this final rule is exempt, pursuant to 5 U.S.C. 605(b), from 
the final regulatory flexibility analysis requirements of section 604.

Executive Order 12866

    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 Executive 
Order classifies a ``significant regulatory action,'' requiring review 
by the Office of Management and Budget (OMB) unless OMB waives such 
review, as any regulatory action that is likely to result in a rule 
that may: (1) Have an annual effect on the economy of $100 million or 
more, or adversely affect in a material way the economy, a sector of 
the economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or tribal governments or 
communities; (2) create a serious inconsistency or otherwise interfere 
with an action taken or planned by another agency; (3) materially alter 
the budgetary impact of entitlements, grants, user fees, or loan 
programs or the rights and obligations of recipients thereof; or (4) 
raise novel legal or policy issues arising out of legal mandates, the 
President's priorities, or the principles set forth in the Executive 
Order.
    VA has examined the economic, interagency, budgetary, legal, and 
policy implications of this final rule and has determined that it is a 
significant regulatory action under Executive Order 12866.

Catalog of Federal Domestic Assistance

    This final rule would affect the program that has the following 
Catalog of Federal Domestic Assistance program number and title: 
64.009--Veterans Medical Care Benefits. To the extent that VA directly 
provides medical care to patients under the Civilian Health and Medical 
Program of the Department of Veterans Affairs or other programs, this 
rule would also affect those programs, which have no Catalog of Federal 
Domestic Assistance program numbers.

List of Subjects in 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, and Veterans.

    Approved May 15, 2009.
John R. Gingrich,
Chief of Staff, Department of Veterans Affairs.

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For the reasons stated in the preamble, the Department of Veterans 
Affairs amends 38 CFR part 17 as follows:

PART 17--MEDICAL

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

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


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2. Section 17.32 is amended by:
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a. In paragraph (d)(1)(iv), adding ``or'' after the semicolon at the 
end of the paragraph.
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b. In paragraph (d)(1)(v), removing ``; or'' and adding, in its place, 
a period at the end of the paragraph.
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c. Removing paragraph (d)(1)(vi).
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d. Removing paragraph (g)(4).

[FR Doc. E9-16898 Filed 7-15-09; 8:45 am]
BILLING CODE 8320-01-P