[Federal Register Volume 73, Number 249 (Monday, December 29, 2008)]
[Proposed Rules]
[Pages 79428-79430]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-30841]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 17

RIN 2900-AN20


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

AGENCY: Department of Veterans Affairs.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: This document proposes to amend the Department of Veterans 
Affairs (VA) Informed Consent regulations to update requirements 
concerning testing for Human Immunodeficiency Virus (HIV) so that they 
are consistent with the Veterans' Mental Health and Other Care 
Improvements Act of 2008, which repealed provisions that had been 
enacted in 2003.

DATES: Comments: Comments must be received on or before January 28, 
2009.

ADDRESSES: Written comments may be submitted through http://www.Regulations.gov; by mail or hand-delivery to Director, Regulations 
Management (02REG), Department of Veterans Affairs, 810 Vermont Ave., 
NW., Room 1068, Washington, DC 20420; or by fax to (202) 273-9026. 
Comments should indicate that they are submitted in response to ``RIN 
2900-AN20.'' Copies of comments received will be available for public 
inspection in the Office of Regulation Policy and Management, Room 
1063B, between the hours of 8 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 are available online through the Federal Docket Management 
System (FDMS) at http://www.Regulations.gov.

FOR FURTHER INFORMATION CONTACT: Ronald O. Valdiserri, MD, MPH, Chief 
Consultant, Public Health SHG, Department of Veterans Affairs, 810 
Vermont Avenue, NW., Washington, DC 20420; (202) 461-7240. (This is not 
a toll-free number.)

SUPPLEMENTARY INFORMATION: This proposed rule would amend VA's Informed 
Consent regulation for HIV testing in the medical regulations in 38 CFR 
part 17 to remove Sec. 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 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.
    VA originally implemented the section 124 mandates in its informed 
consent policy, VHA Manual M-2, part I, chapter 23 (Feb. 15, 1990). 
(VA's informed consent policy is currently contained in VHA Handbook 
1004.1, dated Jan. 29, 2003.) A few years after the enactment of 
section 124, VA established its current policy, which is codified in 
current 38 CFR 17.32(d)(1)(vi) and (g)(4), requiring signature consent 
and counseling for all HIV testing conducted by VA.
    In 2008, the Administration proposed to Congress the repeal of 
section 124 for compelling clinical and public health reasons. VA's HIV 
testing procedures differ from other routine clinical testing that VA 
conducts, most of which only requires the patient's oral informed 
consent. The requirements for pre-test counseling and signed consent 
have been widely reported to delay testing for HIV infection, which, in 
turn, impairs VA's ability to identify infected patients who would 
benefit from earlier medical intervention. Because of the delay in 
testing, infected patients may unknowingly spread the virus to their 
partners and do not present themselves for treatment until 
complications of the disease become clinically evident and, often, 
acute. Infected patients who are, or become, pregnant can unknowingly 
spread the virus to their fetus. This is medically unacceptable when we 
now have continually improving therapies with which to clinically 
manage the disease effectively; in many cases, their efficacy is 
increased if provided during the early stages of infection.
    In submitting the proposal for repeal of section 124 to Congress, 
the Administration was aware that the scientific literature indicated 
that the requirements of section 124 were outdated. For example, in one 
peer-reviewed published study, VA's data indicate that 50 percent of 
HIV-positive veterans had already suffered significant damage to their 
immune system by the time they were diagnosed as HIV positive. See 
Gandhi NR, Skanderson M, Gordon KS, Concato J, Justice AC. Delayed 
Presentation for Human Immunodeficiency Virus (HIV) Care Among 
Veterans, A Problem of Access or Screening? Medical Care. 2007; 45 
(11): 1105-1109. These patients had, on average, 3.7 years of VA care 
before diagnosis, indicating that there were significant missed 
opportunities to make a diagnosis at a stage when HIV treatment could 
have prevented many of the complications experienced by these patients. 
Id.
    As reported by the American Journal of Public Health, another group 
of VA researchers recently conducted a blinded seroprevalence survey of 
nearly 9,000 veteran inpatients and outpatients from 6 large VA sites. 
They found that the rates of previously undiagnosed HIV infection 
varied from 0.1 percent-2.8 percent among outpatients and from 0.0 
percent-1.7 percent among inpatients. While these percentages may seem 
small, the CDC, based upon cost-effectiveness studies, identifies 0.1% 
as the threshhold above which HIV testing should routinely take place 
in health care settings. See Owens DK, Sundaram V, Lazzeroni LC, 
Douglass LR, Sanders GD, et al. Prevalence of HIV Infection Among 
Inpatients and Outpatients in Department of Veterans Affairs Health 
Care Systems: Implications for Screening Programs for HIV. Am J Public 
Health. 2007; 97 (12): 2173-2178.
    Historically, HIV testing was driven based on an assessment of 
risk, i.e., if the patient reported a behavior associated with HIV 
transmission, the test was strongly encouraged. This was a major reason 
for extensive pre-test counseling. However, over time, risk-based 
strategies for HIV testing in clinical settings proved to be 
inefficient, for a variety of reasons. Some patients are unwilling to 
share personal information about sexual and drug use behaviors with 
providers; some patients are unaware of their risks (e.g., someone who 
has a sex partner who doesn't disclose the fact that he/she is an 
injection drug user); risk-based testing fails to identify many HIV-
infected persons until late in the course of their disease; and some 
patients may continue to misperceive HIV infection as a disease limited 
only to homosexuals, injection drug users, and persons with multiple, 
anonymous sexual partners.
    In 2006, the Centers for Disease Control and Prevention (CDC) 
recommended routine HIV screening in

[[Page 79429]]

health-care settings for all patients aged 13-64, and further that 
``separate written consent for HIV testing should not be required; 
general consent for medical care should be considered sufficient to 
encompass consent for HIV testing.'' Centers for Disease Control and 
Prevention. Revised Recommendations for HIV Testing of Adults, 
Adolescents, and Pregnant Women in Health-Care Settings. MMWR 2006; 55 
(Mp/RR-14): 1-17. The VA submitted the proposal to repeal section 124 
to make its screening procedures and informed consent requirements for 
HIV testing in line with CDC's recommendations.
    In short, 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.
    During the second session of the 110th Congress, the Senate and 
House each introduced legislation that mirrored the Administration's 
legislative proposal to repeal section 124. VA testified in support of 
the pending legislation, while making clear that such a repeal would 
not erode patient rights, as VA would still be legally required to 
obtain the patient's oral informed consent prior to testing.
    The House Committee on Veterans' Affairs explained its legislation 
would reduce existing barriers to the early diagnosis of HIV infection, 
recognizing that HIV testing had entered a new era. Through the repeal 
of section 124, the Committee intended to facilitate patients' 
awareness of their HIV status to help them maintain their health and 
reduce further spread of the virus. The Committee also intended for the 
repeal to allow VA to update its informed consent procedures for HIV 
testing to reflect CDC guidelines, while affording VA needed 
flexibility to update its screening standards as necessary. See House 
Rep. No. 110-786, at 4, 7-9 (2008). The Senate Committee on Veterans' 
Affairs similarly explained that its measure would bring VA's statutory 
HIV testing requirements in line with current CDC informed consent 
guidelines for HIV testing, thereby benefiting patients who receive 
early medical intervention and advancing the country's broader public 
health goals. See S. Rep. No. 110-473, at 44-45 (2008).
    The repeal of section 124 was ultimately included as section 407 of 
S. 2162, the ``Veterans' Mental Health and Other Care Improvements Act 
of 2008,'' which subsequently passed both chambers of Congress. The 
President signed S. 2162 into law on October 10, 2008 (Pub. L. 110-
387). However, by repealing section 124, Congress did not abrogate VA's 
current requirements for written informed consent and counseling 
codified in 38 CFR 17.32(d)(1)(vi) and (g)(4). It merely repealed 
statutory requirements that VA's HIV-testing policy include prior 
written consent and pre- and post-test counseling. VA's current 
informed consent regulation governing HIV testing remains in effect 
contrary to the stated intentions of both the Congress and the 
Administration. To enable VA to bring its policy into conformance with 
the purpose of the legislation as well as with current medical 
practice, VA must remove the provisions of 38 CFR 17.32(d)(1)(vi) and 
(g)(4).
    We note that with the changes proposed in this document, VA's 
informed consent procedures for HIV testing would be governed by the 
requirements of 38 CFR 17.32(c), and would still be more rigorous than 
those generally found in the private sector. While other institutions 
often allow ``presumed'' consent or ``blanket'' consent for many 
procedures, VA regulations, as outlined in VHA Handbook 1004.1 (VHA 
Informed Consent for Clinical Treatments and Procedures, which may be 
viewed at http://www.ethics.va.gov/docs/policy/VHA_Handbook_1004-1_Informed_Consent_Policy_20030129.pdf ), require specific informed 
consent for all treatments and procedures, including HIV tests. In 
addition to requiring that VA practitioners disclose ``information that 
a patient in similar circumstances would reasonably want to know,'' VA 
would specifically require VA practitioners to inform patients that 
they are being tested for HIV, to provide written educational materials 
on HIV and HIV testing, to provide patients an opportunity to decline 
HIV testing, and to document patients' oral agreement to HIV testing in 
their health records. Furthermore, the proposed rule would not in any 
way alter the statutory confidentiality protections that apply to the 
disclosure of VA patients' HIV test results.
    In summary, after promulgation of this rule, HIV testing in VA 
facilities would be governed by the following:
     Providers would have to inform patients that they intend 
on ordering an HIV test.
     Providers would be required to give patients written 
educational materials that include an explanation of HIV infection and 
the meaning of positive and negative test results.
     The educational materials will be made available in the 
languages of the most commonly encountered populations within the 
service area.
     Providers would be required to offer patients an 
opportunity to ask questions and to consent to or decline testing.
     Refusal of HIV testing would not affect a patient's 
eligibility for any other care at a VA facility.
     As is the case for other tests performed in the VA, 
providers would be required to document the patient's informed consent 
in the patient's electronic health record.
     Definitive mechanisms would be established to inform 
patients of their test results.
     HIV-positive test results would always be communicated 
confidentially through personal contact with a health care provider.
     HIV-infected patients would be promptly referred for 
necessary clinical care, counseling, support, and prevention services.
    Further information on VA's policy and procedures on HIV testing 
may be found at http://www.hiv.va.gov.

Comment period

    VA believes, based upon the circumstances described above, that it 
is consistent with the repeal of the prior legislation and in the 
public's interest to bring VA's informed consent policy and procedures 
for HIV testing into line with current standards of practice as quickly 
as possible. This will improve the potential health outcomes of 
infected patients and advance the country's broader public health 
goals. Accordingly, VA has determined that it is not in the public's 
interest to delay implementation of this regulation any longer than 
necessary, and we have provided that comments must be received within 
30 days of publication in the Federal Register.

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

Paperwork Reduction Act

    This document contains no provisions constituting a collection of 
information under the Paperwork Reduction Act (44 U.S.C. 3501-3521).

[[Page 79430]]

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.
    The economic, interagency, budgetary, legal, and policy 
implications of this proposed rule have been examined, and it has been 
determined not to be a significant regulatory action under Executive 
Order 12866.

Regulatory Flexibility Act

    The Secretary of Veterans Affairs hereby certifies that this 
proposed 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 proposed rule would 
directly affect only individuals and would not directly affect small 
entities. Therefore, this proposed amendment is exempt pursuant to 5 
U.S.C. 605(b) from the initial and final regulatory flexibility 
analysis requirements of sections 603 and 604.

Catalog of Federal Domestic Assistance

    This proposed 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: October 31, 2008.
James B. Peake,
Secretary of Veterans Affairs.
    For the reasons set forth in the preamble, the Department of 
Veterans Affairs proposes to amend 38 CFR part 17 as follows:

PART 17--MEDICAL

    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.


Sec.  17.32  [Amended]

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

 [FR Doc. E8-30841 Filed 12-24-08; 8:45 am]
BILLING CODE 8320-01-P