Elimination of Requirement for Prior Signature Consent and Pre- and Post-Test Counseling for HIV Testing, 34500-34503 [E9-16898]
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By the Office of the Comptroller of the
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Julie L. Williams,
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[FR Doc. E9–16882 Filed 7–15–09; 8:45 am]
BILLING CODE 4810–33–P
DEPARTMENT OF VETERANS
AFFAIRS
38 CFR Part 17
RIN 2900–AN20
Elimination of Requirement for Prior
Signature Consent and Pre- and PostTest Counseling for HIV Testing
ACTION:
For the reasons stated in the preamble,
the Office of the Comptroller of the
Currency amends Part 3 of chapter I of
Title 12, Code of Federal Regulations as
follows:
VerDate Nov<24>2008
1. The authority citation for part 3
continues to read as follows:
■
Department of Veterans Affairs.
Final rule.
AGENCY:
Authority and Issuance
■
PART 3—MINIMUM CAPITAL RATIOS;
ISSUANCE OF DIRECTIVES
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
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(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 preand 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 preand 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 § 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 § 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
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Federal Register / Vol. 74, No. 135 / Thursday, July 16, 2009 / Rules and Regulations
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 HIVtesting 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 § 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
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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
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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
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Federal Register / Vol. 74, No. 135 / Thursday, July 16, 2009 / Rules and Regulations
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 (https://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 HIVinfected 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
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15:07 Jul 15, 2009
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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 antiretroviral 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 postcounseling, 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
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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 stateof-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
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Federal Register / Vol. 74, No. 135 / Thursday, July 16, 2009 / Rules and Regulations
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.
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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,
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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.
For the reasons stated in the preamble,
the Department of Veterans Affairs
amends 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.
2. Section 17.32 is amended by:
a. In paragraph (d)(1)(iv), adding ‘‘or’’
after the semicolon at the end of the
paragraph.
■ b. In paragraph (d)(1)(v), removing ‘‘;
or’’ and adding, in its place, a period at
the end of the paragraph.
■ c. Removing paragraph (d)(1)(vi).
■ d. Removing paragraph (g)(4).
■
■
[FR Doc. E9–16898 Filed 7–15–09; 8:45 am]
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Approval and Promulgation of
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[Federal Register Volume 74, Number 135 (Thursday, July 16, 2009)]
[Rules and Regulations]
[Pages 34500-34503]
From the Federal Register Online via the Government Printing 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 (https://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
