BILL ANALYSIS Ó
AB 491
Page 1
Date of Hearing: May 3, 2011
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
AB 491 (Portantino) - As Amended: April 15, 2011
SUBJECT : HIV testing.
SUMMARY : Applies existing law that requires medical care
providers in clinical settings , at the time an HIV test is
administered, to provide specified information about HIV and HIV
testing to testing in a nonclinical setting , as specified.
Specifically, this bill :
1)Applies existing law that requires medical care providers in
clinical settings , at the time an HIV test is administered, to
provide specified information about HIV and HIV testing to
testing in a nonclinical setting , as specified.
2)Requires the definition of "medical care provider," to
include, but not be limited to, HIV counselors for purposes of
existing law that requires providers, at the time an HIV test
is administered, to provide specified information about HIV
and HIV testing.
3)Requires the Department of Public Health (DPH), upon
appropriation by the Legislature, to allocate state and
federal funds that are intended to be used to test persons for
HIV to a local health jurisdiction in accordance with the
prevalence of HIV and AIDS in the jurisdiction at the time of
the allocation decision.
EXISTING LAW :
1)Requires a medical care provider, prior to ordering an HIV
test, to provide information about the test to the patient, to
inform the patient that there are numerous treatment options
available, and to inform the patient that a person who tests
negative for HIV should continue to be routinely tested
(informed consent in clinical settings).
2)Prohibits an HIV test from being administered, unless the
person being tested or his or her parent, guardian,
conservator, signs a written statement documenting his or her
informed consent to the test (written informed consent in
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non-clinical settings).
3)Sets forth the powers and duties of an HIV counselor in a HIV
counseling and testing site funded by the department through a
local health jurisdiction or its agents.
4)Establishes DPH and sets forth its powers and duties,
including, but not limited to, administration of a program to
provide information, establish testing sites, and award
contracts for AIDS early intervention projects to provide
appropriate medical treatment to prevent or delay the
progression of disease that results from HIV infection, to
coordinate related services, and to provide information and
education to prevent the spread of the infection to others.
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee.
COMMENTS :
1)PURPOSE OF THIS BILL . According to the sponsor of this bill,
the AIDS Healthcare Foundation (AHF), over the past several
years, the Legislature and the Governor have led the charge to
foster widespread routine HIV screening. One after another,
barriers to screening have been erased so that California can
ensure an optimal environment for people to learn their HIV
status, get into life-saving treatment and minimize
transmission of the virus to others. AHF states that the most
essential change in law occurred with the passage of AB 682
(Berg), Chapter 550, Statutes of 2007, when the consent
standard for an HIV test was changed from written informed
consent to simple consent. AHF states that this bill revisits
that law and makes changes to ensure that California law keeps
pace with public health strategies relative to HIV screening.
2)Background . The Federal Centers for Disease Control And
Prevention (CDC) estimates that more than one million people
are living with HIV in the United States. Despite increases
in the total number of people living with HIV in the U.S. in
recent years, the annual number of new HIV infections has
remained relatively stable. However, new infections continue
at far too high a level, with an estimated 56,300 Americans
becoming infected with HIV each year. More than 18,000 people
with AIDS still die each year in the U.S. Gay, bisexual, and
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other men who have sex with men (MSM) are strongly affected
and represent the majority of persons who have died. Through
2007, more than 576,000 people with AIDS in the U.S. have died
since the epidemic began. Among racial/ethnic groups, African
Americans face the most severe burden of HIV/AIDS in the
nation. While blacks represent approximately 12% of the U.S.
population, they account for 46% of people living with HIV in
the U.S., as well as 45% of new infections each year. MSM
account for 53% of all new HIV infections in the U.S. each
year, and 48% of people living with HIV. Individuals infected
through heterosexual contact account for 31% of annual new HIV
infections and 28% of people living with HIV. Women account
for 27% of annual new HIV infections and 25% of those living
with HIV. Finally, injection drug users represent 12% of
annual new HIV infections and 19% of those living with HIV.
3)HIV-POSITIVE BUT UNAWARE . According to the CDC, one in five
of those people living with HIV is unaware of their infection.
According to the California Office of AIDS, there are
approximately 30,000 HIV-infected people in California who are
unaware they are infected. According to the CDC, when HIV is
diagnosed early, appropriately timed interventions,
particularly highly active antiretroviral therapy, can lead to
improved health outcomes, including slower clinical
progression and reduced mortality. Additionally, HIV
counseling with testing has been demonstrated to be an
effective intervention for HIV-infected participants, who
increased their safer behaviors and decreased their risk
behaviors.
4)STUDIES ON WRITTEN CONSENT AND TESTING . According to research
findings published in the March 14, 2007 issue of the Journal
of the American Medical Association, in May 2006, the San
Francisco Department of Public Health Medical Care System,
which includes an acute care hospital, a long-term care
facility, and more than 15 primary health care centers,
eliminated the requirement for written consent for HIV tests
(but still obtained informed consent). According to the
findings, the monthly rate of HIV testing increased steadily
after the change in policy (from 13.5 HIV tests per 1000
patient-visits in June 2006 to 17.9 HIV tests per 1000
patient-visits in December 2006). The authors cautioned that
other events may have contributed to this increase of HIV
testing. For example, the XVI International AIDS Conference
in mid-August 2006 and the release of the revised CDC
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recommendations for HIV testing in September 2006 may have
heightened clinician and patient awareness and affected
clinicians' testing practices. However, the authors stated
that the increase in testing appears to have begun before
those events and maintained a steady increase thereafter, so
that these events are unlikely to explain the increase in HIV
testing. In conclusion, the authors called the results
"hypothesis generating," and called for further studies for
confirmation.
A July 2009 National Institutes of Health study of nine states
that had statutes requiring written informed consent prior to
routine HIV testing that was published in the American Journal
of Preventive Medicine found that after adjusting for other
state- and individual-level factors, people who resided in
these nine states were less likely to report a recent history
of HIV testing. The authors concluded that written
informed-consent statutes are associated with a 12% reduction
in HIV testing from the baseline testing level of 17%. One
limitation of study that was noted by the authors is that
"many states require some version of pre-test counseling,
post-test counseling, or both, with or without concurrent
written pre-HIV test consent. These multiple variations of
consent and counseling defied simple categorization among the
states included in the study. If any of these or other
confounders were present, excluding them could have biased the
estimate of the true effect of consent statutes on testing
rates."
In June 2009 a study was published in the American Journal of
Public Health regarding New York's streamlined its written
informed consent procedures, which included using a consent
form that encompasses consent to several HIV-related
procedures, including HIV antibody testing, resistance
testing, viral load testing, and incidence testing. The study
found that the streamlined written consent procedures led to a
31% increase in the state's HIV testing rate.
5)CDC TESTING RECOMMENDATIONS . In September 2006, the CDC
published a 17-page report titled "Revised Recommendations for
HIV Testing of Adults, Adolescents, and Pregnant Women in
Health-Care Settings." The CDC indicated that its objectives
in revising the recommendations were to increase HIV screening
of patients; foster earlier detection of HIV infection;
identify and counsel individuals with unrecognized HIV
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infection and link them to clinical and prevention service;
and, further reduce perinatal transmission of HIV in the
country. The CDC also indicated that the updated
recommendations were intended to inform the work of public and
private sector policy makers and service providers. Major
revisions from previous publications include:
a) HIV screening is recommended for patients in all health
care settings after the patient is informed orally or in
writing that testing will be performed unless the patient
declines (opt-out screening);
b) Persons at high risk for HIV infection should be
screened for HIV at least annually;
c) 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;
and,
d) Prevention counseling should not be required with HIV
diagnostic testing as part of HIV screening programs in
health care settings.
The CDC is currently formulating proposed Guidelines
specifically for HIV testing in non-clinical settings.
6)CDC CONSENT RECOMMENDATIONS . The CDC guidance with regard to
consent and pretest information for adolescents and adults are
as follows:
a) Screening should be voluntary and undertaken only with
the patient's knowledge and understanding that HIV testing
is planned;
b) Patients should be informed orally or in writing that
HIV testing will be performed unless they decline (opt-out
screening). Oral or written information should include an
explanation of HIV infection and the meanings of positive
and negative test results, and the patient should be
offered an opportunity to ask questions and to decline
testing. With such notification, consent for HIV screening
should be incorporated into the patient's general informed
consent for medical care on the same basis as are other
screening or diagnostic tests; a separate consent form for
HIV testing is not recommended;
c) Easily understood informational materials should be made
available in the languages of the commonly encountered
populations within the service area. The competence of
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interpreters and bilingual staff to provide language
assistance to patients with limited English proficiency
must be ensured; and,
d) If a patient declines an HIV test, this decision should
be documented in the medical record.
7)AB 682 . In 2007, there was extensive debate over AB 682,
which, among other things, sought to revise statute that set
forth informed consent requirements for HIV testing. The
sponsors of that bill, which included the sponsor of this
bill, argued that existing requirements created a barrier to
administering HIV tests because many healthcare providers
would rather avoid the subject of HIV than meet its high
standard for consent, as they are not comfortable or
knowledgeable about the disease. Opponents of AB 682 argued
that specific written consent is beneficial both to the
patient and the provider because it documents that providers
have satisfied their ethical and legal obligations to obtain
informed consent, and communication and trust between the
patient and the provider is enhanced - leading to a greater
likelihood that the person will seek and continue needed
treatment. Both cited the 2006 CDC guidance in defense of
their arguments.
A compromise on the consent issue was reached in the Senate,
and was based on the CDC recommendation that consent for HIV
screening should be incorporated into a patient's general
informed consent for medical care. The CDC recommendations
define "informed consent" as a "process of communication
between patient and provider through which an informed patient
can choose whether to undergo HIV testing or decline to do so.
Elements of informed consent typically include providing oral
or written information regarding HIV, the risks and benefits
of testing, the implications of HIV test results, how test
results will be communicated, and the opportunity to ask
questions." The final AB 682 language (and which is now law)
tracks fairly closely to these recommendations, and in effect
permits HIV testing without written informed consent in
clinical settings by medical care personnel, but did not amend
the law with regard to testing in non-clinical settings by
non-medical personnel. This bill seeks to apply current law
for clinical settings to non-clinical settings and creates a
definition of "medical care provider" to include HIV
counselors.
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8)SUPPORT . AHF writes that the policy decision about whether to
repeal written informed consent as a prerequisite for
administering an HIV screening test was made in 2007 with the
enactment of AB 682. At that time, the Legislature and the
Governor concluded that the imposition of written informed
consent for HIV screening was unnecessary and an impediment to
the public health objective of increasing the number of people
screened for HIV. AB 682 adopted the new standard of "simple
consent plus" imparting specified information about the test.
AHF states that two practical problems have arisen in the
interpretation and implementation of AB 682: HIV counselors,
primary administrators of community-based HIV screening, are
being prevented from securing the person's simple consent for
the test because they are not considered medical care
providers; and, community-based testing is being limited by an
interpretation that HIV testing must occur in a clinical
setting. AHF writes that current law limited to clinical
settings also applies to physicians and other medical
professionals; even if it was financially possible to put a
physician into the community to provide HIV testing, current
law would prohibit that physician from getting simple consent
for an HIV test. That is a tragic failure of California law
to comport with sound public health strategies. The
California Medical Association writes that this bill is the
logical next step after AB 682 to increase access to HIV
screening in non-clinical, community settings and identify
more individuals who are unaware they are HIV positive so they
can get into care and treatment and avoid transmission of the
disease to their loved ones. The Health Officers Association
of California states that HIV counselors typically administer
HIV rapid testing in community settings, where they can rech
people who are potentially HIV positive but who would
otherwise be unlikely to seek an HIV test and that this bill
will apply the standards from AB 682 to these vital
interactions.
9)OPPOSITION . Opponents write that existing requirements were
only recently passed after a great deal of community
discussion, and that nothing has changed about the HIV/AIDS
epidemic since 2008 to warrant revisiting this law.
Additionally, opponents write that informed consent is of
particular importance for tests administered in non-clinical
settings because individuals who seek tests in non-clinical
settings come from high risk populations, and are more likely
to test positive and therefore have a greater need for
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informed consent and counseling. Opponents further state that
in the 2007 legislative debates, proponents of AB 682 argued
that clinical medical providers were uncomfortable with, or
would not take the time to obtain written informed consent and
while those claims remain debatable, HIV counselors in
non-clinical settings such as an AHF thrift store, at least,
have been trained according to California state requirements
to provide information and counseling on HIV testing. In
these settings, it is not at all clear how written, informed
consent provides any sort of barrier to testing. Opponents
state that this bill would further undermine California's
long-standing common law doctrine of informed consent,
grounded in California's constitutional right to privacy.
Opponents write that a number of studies have shown that
streamlined, rapid testing programs can increase HIV testing
rates without compromising documented, informed consent and
that further eroding informed consent may undermine effective
testing and treatment because HIV remains a deeply stigmatized
disease, with life-long consequences, for which effective
treatment requires patient cooperation. Numerous studies show
that people living with HIV adhere to their treatments when
there is greater communication and trust between patient and
doctor. Finally, opponents write that existing law exempts
medical care providers from informed consent requirements when
a person independently requests an HIV test. . However, under
existing law, non-clinical settings such as an AHF thrift
store or a mobile testing site are not medical care providers
exempt from informed consent requirements. Thus, even when an
individual approaches a provider in a non-clinical setting,
thus "independently" requesting a test, informed consent
requirements apply. Opponents contend that by expanding the
definition of medical care providers, to include HIV
counselors and eliminating the distinction between clinical
and non-clinical settings. This bill would result in no
information being required to be given to persons seeking HIV
Testing in non-clinical settings.
10)AUTHOR'S AMENDMENTS . The author intends to delete the
provisions of this bill that relate to the allocation of
federal funds to local health jurisdictions by DPH.
REGISTERED SUPPORT / OPPOSITION :
Support
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AIDS Healthcare Foundation
California Medical Association
Health Officer Association of California
Opposition
American Civil Liberties Union
Center for Health Justice
Being Alive, Los Angeles
Center for HIV Law and Policy
The Courage Campaign
Disability Rights Legal Center
Disability Rights California
HIV & AIDS Legal Services Alliance
Jordan/Rustin Coalition
Lambda Legal
National Health Law Program
The Williams Institute, UCLA School of Law
Three individuals
Analysis Prepared by : Melanie Moreno / HEALTH / (916)
319-2097