Elimination of Requirements for Prior Signature Consent and Pre- and Post- Test Counseling for HIV Testing, 79428-79430 [E8-30841]
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Federal Register / Vol. 73, No. 249 / Monday, December 29, 2008 / Proposed Rules
with the guidelines set forth in Section
3 of the Notice of Inquiry.
Tanya Sandros,
General Counsel.
[FR Doc. E8–30799 Filed 12–24–04; 8:45 am]
BILLING CODE 1410–30–S
DEPARTMENT OF VETERANS
AFFAIRS
38 CFR Part 17
RIN 2900–AN20
Elimination of Requirements for Prior
Signature Consent and Pre- and PostTest Counseling for HIV Testing
Department of Veterans Affairs.
Proposed rule.
AGENCY:
dwashington3 on PROD1PC60 with PROPOSALS
ACTION:
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repealed provisions that had been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 https://
www.Regulations.gov; by mail or handdelivery 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 https://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
VerDate Aug<31>2005
13:01 Dec 24, 2008
Jkt 217001
CFR part 17 to remove §§ 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 peerreviewed published study, VA’s data
PO 00000
Frm 00015
Fmt 4702
Sfmt 4702
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 costeffectiveness 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, riskbased 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
E:\FR\FM\29DEP1.SGM
29DEP1
dwashington3 on PROD1PC60 with PROPOSALS
Federal Register / Vol. 73, No. 249 / Monday, December 29, 2008 / Proposed Rules
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
VerDate Aug<31>2005
13:01 Dec 24, 2008
Jkt 217001
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
https://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
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79429
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 https://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).
E:\FR\FM\29DEP1.SGM
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79430
Federal Register / Vol. 73, No. 249 / Monday, December 29, 2008 / Proposed Rules
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.
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.
§ 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
POSTAL SERVICE
39 CFR Part 111
New Standards for Letter-Size
Booklets and Folded Self-Mailers
dwashington3 on PROD1PC60 with PROPOSALS
Catalog of Federal Domestic Assistance
Postal Service TM.
ACTION: Proposed rule.
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,
SUMMARY: On March 14, 2008, we
published in the Federal Register
(Volume 73, Number 51, pages 13812–
13813) an advance notice of our intent
to develop new mailing standards for
folded self-mailers and booklets mailed
at automation and machinable letter
prices. In that advance notice, we
provided justification for these changes,
VerDate Aug<31>2005
16:13 Dec 24, 2008
Jkt 217001
AGENCY:
PO 00000
Frm 00017
Fmt 4702
Sfmt 4702
announced a two-phase testing
initiative, and reported the results of the
first phase of testing. We invited
comments from customers and asked
that they suggest alternative booklet
designs that could improve mailpiece
performance.
The following proposed rule is based
on the results of completed testing. We
propose revisions to tab size, tab
location, paper weight, and dimensions
for folded self-mailers and booklets
mailed at automation or machinable
letter prices.
DATES: We must receive your comments
on or before January 28, 2009.
ADDRESSES: Mail or deliver written
comments to the Manager, Mailing
Standards, U.S. Postal Service, 475
L’Enfant Plaza SW., Room 3436,
Washington, DC 20260–3436. You may
inspect and photocopy all written
comments at USPS Headquarters
Library, 475 L’Enfant Plaza SW., 11th
Floor N., Washington, DC between 9
a.m. and 4 p.m., Monday through
Friday.
FOR FURTHER INFORMATION CONTACT:
Susan Thomas, 202–268–7268.
SUPPLEMENTARY INFORMATION: Many
folded self-mailers and booklets mailed
at automation and machinable letter
prices do not process successfully on
letter-sorting machines. Unenveloped
pieces tend to double feed and jam
resulting in damage to the equipment
and the mail. These problems and the
resulting loss of machine time make it
necessary to process some types of
folded self-mailers and booklets on flat
sorting equipment or in manual
operations. Typically these operations
are slower and more labor intensive
resulting in higher processing costs. To
improve efficiency, the USPS ® worked
with customers to test multiple
mailpiece designs and arrived at revised
standards that improve automation
processing.
In addition to the controlled testing of
400 specially-manufactured mailpieces,
in phase two of the testing our
Engineering Department also evaluated
124 live mailings and tested 70 sample
mailings provided by customers to
determine optimal size, thickness, cover
stock, tab style, tab strength, tab location
and binding. Several customers actively
participated and were present to observe
the tests. When a mailpiece was
nonmachinable, customers were
encouraged to resubmit modified pieces
for additional testing and evaluation.
We are sensitive to the current
economic climate and the effect these
changes may have on the mailing
community. Based on the results of our
tests we identified incremental
E:\FR\FM\29DEP1.SGM
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]]>Agencies
[Federal Register Volume 73, Number 249 (Monday, December 29, 2008)]
[Proposed Rules]
[Pages 79428-79430]
From the Federal Register Online via the Government Printing 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 https://
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 https://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 https://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 https://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
