[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]
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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.
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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Improvements Act of 2008, which repealed provisions that had been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