BILL ANALYSIS Ó
AB 491
Page 1
ASSEMBLY THIRD READING
AB 491 (Portantino)
As Amended May 10, 2011
Majority vote
HEALTH 16-1
--------------------------------
|Ayes:|Monning, Logue, Atkins, |
| |Bonilla, Eng, Garrick, |
| |Hayashi, |
| |Roger Hernández, Bonnie |
| |Lowenthal, Mansoor, |
| |Mitchell, Nestande, Pan, |
| |V. Manuel Pérez, Silva, |
| |Smyth |
| | |
|-----+--------------------------|
|Nays:|Gordon |
| | |
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SUMMARY : Revises existing law that sets forth requirements for
medical providers in clinical settings, at the time a test for
HIV is administered, to include HIV counselors in nonclinical
settings, to require informed consent, as specified, and to
specify information that must be shared. Specifically, this
bill :
1)Deletes the requirement in existing law that a medical care
provider, before administering a HIV test in a clinical
setting, inform the patient that the test is planned, provide
information about the test, inform the patient that there are
numerous treatment options available for a patient who tests
positive for HIV and that a person who tests negative for HIV
should continue to be routinely tested, and instead requires
medical care providers and HIV counselors, in clinical and
nonclinical settings, to obtain the informed consent of the
person being tested, as defined by the federal Centers for
Disease Control and Prevention (CDC), and provide information
regarding HIV, the risks and benefits of testing, the
implications of HIV test results, and how test results will be
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communicated.
2)Makes other requirements for medical care providers when
ordering a HIV test in clinical settings applicable to HIV
counselors in nonclinical settings.
3)Deletes an exemption from existing HIV test consent
requirements in the case that a person independently requests
an HIV test from the provider. Deletes the requirement in
existing law for written informed consent in nonclinical
settings for HIV tests.
4)Specifies that a separate written consent form for obtaining
informed consent for HIV testing is not required, and that the
informed consent for HIV testing can be obtained orally.
Prohibits anything in this bill from being construed to
eliminate the need for general informed consent for medical
care in writing, where that written consent is otherwise
required by law.
5)Requires medical care providers or HIV counselors, for
patients who test positive for HIV, to provide the person
being tested with linkages to care, and to document that this
information has been provided. Requires linkages to care to
include providing information orally or in writing about
available treatment options and voluntary partner notification
services, and answering questions that the patient may have.
Requires the information to also include providing the patient
with contact information for HIV medical care, and support and
social services, in writing.
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
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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
non-clinical settings).
FISCAL EFFECT : None
COMMENTS : 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.
The CDC estimates that more than one million people are living
with HIV in the U.S. 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 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. 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
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HIV. Finally, injection drug users represent 12% of annual new
HIV infections and 19% of those living with HIV.
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 safer
behaviors and decreased their risk behaviors.
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 1,000
patient-visits in June 2006 to 17.9 HIV tests per 1,000
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
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. 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
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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 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.
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 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:
1)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).
2)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.
3)Prevention counseling should not be required with HIV
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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.
The CDC guidance with regard to consent and pretest information
for adolescents and adults are as follows:
1)Screening should be voluntary and undertaken only with the
patient's knowledge and understanding that HIV testing is
planned.
2)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.
3)Easily understood informational materials should be made
available in the languages of the commonly encountered
populations within the service area. The competence of
interpreters and bilingual staff to provide language
assistance to patients with limited English proficiency must
be ensured.
4)If a patient declines an HIV test, this decision should be
documented in the medical record.
In 2007, there was extensive debate over AB 682 (Berg), which,
among other things, sought to revise statute that set forth
informed consent requirements for HIV testing. The sponsors of
AB 682, 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
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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 would remove the requirement for written informed consent
in nonclinical settings and require informed consent standard
across both settings and by both types of providers.
Analysis Prepared by : Melanie Moreno / HEALTH / (916)
319-2097
FN: 0000798