BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 446
AUTHOR: Mitchell
AMENDED: June 17, 2013
HEARING DATE: June 26, 2013
CONSULTANT: Moreno
SUBJECT : HIV testing.
SUMMARY : Revises requirements related to information required
to be provided at the time an HIV test is administered,
including a new requirement that a medical care provider inform
patients about HIV risk reduction strategies. Clarifies that a
provision in existing law exempting clinical settings from the
informed consent requirements applies when a person
independently requests a test from a medical care provider, a
clinic and a laboratory (except a clinical laboratory). Adds to
this exemption an HIV counseling and testing site that employs a
trained HIV counselor.
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). This requirement
does not apply when a person independently requests an HIV
test from the medical care provider.
2.Prohibits an HIV test from being administered, unless the
person being tested or his or her parent, guardian, or
conservator, signs a written statement documenting his or her
informed consent to the test (written informed consent in
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 of Public
Health (DPH) 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
Continued---
AB 446 | Page 2
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.
This bill:
1.Revises existing law related to informed consent in clinical
settings for an HIV test, including adding a new requirement
that a medical care provider inform patients about HIV risk
reduction strategies.
2.Clarifies that a provision in existing law exempting clinical
settings from the informed consent requirements applies when a
person independently requests a test from a medical care
provider, a clinic, or a laboratory (except a clinical
laboratory). Adds to this exemption a requested test at an
HIV counseling and testing site that employs a trained HIV
counselor. Requires the person's independent request for an
HIV test to be documented by the person administering the
test.
3.Deletes a requirement that a written statement documenting
informed consent for an HIV test be signed and instead
requires the informed consent to be provided orally or in
writing. Requires the person administering the test to
maintain documentation of consent, whether obtained orally or
in writing, in the client's medical record.
4.Requires, after the results of a test have been received, the
medical care provider or the person who administers the test
to ensure that the patient receives timely information and
counseling, as appropriate, to explain the results and the
implications for the patient's health.
5.Requires, if the patient tests positive for HIV infection, the
medical provider or the person who administers the test to
inform the patient that there are numerous treatment options
available, and identify follow up testing and care that may be
recommended, including contact information for medical and
psychological services.
6.Requires, if the patient tests negative for HIV infection and
is known to be at high risk for HIV infection, the medical
provider or the person who administers the test to advise the
patient of the need for periodic retesting, explain the
AB 446 | Page
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limitations of current testing technology and the current
window period for verification of results, and may offer
prevention counseling or a referral to prevention counseling.
7.Requires a patient between 12 and 65 years of age who has
blood drawn at a primary care clinic, and who has consented to
the HIV test to be offered an HIV test. Deems the primary
care clinic to be in compliance with this bill if it chooses
to test the patient using a rapid HIV test. Prohibits this
bill from applying if the primary care clinic has tested the
patient for HIV, or if the patient has been offered and
declined the HIV test within the previous 12 months. Requires
subsequent testing of a patient who has been tested by the
primary care clinic to be consistent with the most recent
guidelines issued by the federal Centers for Disease Control
and Prevention (CDC) and the United States Preventive Services
Task Force.
8.Requires HIV testing of minors 12 years of age or older to
comply with existing law related to consent by a minor.
9.Specifies that nothing in this bill prohibits a primary care
clinic from charging a patient to cover the cost of HIV
testing.
10.Requires a primary care clinic to attempt to provide test
results to the patient before he or she leaves the facility.
Permits, if that is not possible, the facility to inform the
patient who tests negative for HIV by letter or telephone, and
requires the clinic to inform a patient with a positive test
result in a manner consistent with existing law.
11.Permits, under specified circumstances, the result of an HIV
test to be posted on a secure web site which can only be
viewed with the use of a secure code that can access only a
single set of test results and that is provided to the patient
at the time of testing. Requires the test result to be posted
only if there is no link to any information that identifies or
refers to the subject of the test.
FISCAL EFFECT : According to the Assembly Appropriations
Committee:
1.The Office of AIDS in DPH will incur minor absorbable costs to
provide technical assistance and guidance regarding the new
AB 446 | Page 4
requirements and procedures to local health departments and
HIV counselors.
2.Any additional costs for student health centers at the
University of California, the California State University, and
the California Community Colleges should be absorbable and
would be partially offset by HIV testing fees.
PRIOR VOTES :
Assembly Judiciary: 10- 0
Assembly Health: 18- 0
Assembly Appropriations:16- 1
Assembly Floor: 72- 1
COMMENTS :
1.Author's statement. The control of AIDS in our time is
possible with the tools at our disposal today. The key is
finding those persons living with HIV who do not know they are
infected, linking them into care and suppressing the presence
of HIV through adherence to anti-retroviral treatment.
California, as one of the most profoundly affected states in
the union, has led the way. Over the past decade, California
has devoted funding, modified testing protocols and focused on
the need to test as the first line of offense in efforts to
reduce HIV infection rates and assist more people with HIV
into treatment as early as possible. These efforts have
reduced the percentage of late testers (those who are
diagnosed with AIDS less than one year after testing) from 50
percent to 35 percent.
2.Background. According to a 2012 CDC report, an estimated
1,148,200 persons aged 13 years and older are living with HIV
infection, including approximately 207,600 who are unaware of
their infection. Over the past decade, the number of people
living with HIV has increased, while the annual number of new
HIV infections has remained relatively stable. Still, the pace
of new infections continues at far too high a level,
particularly among certain groups. The estimated incidence
of HIV has remained stable overall in recent years, at about
50,000 new HIV infections per year. Within the overall
estimates, however, some groups are affected more than others.
Men who have sex with men (MSM) continue to bear the greatest
burden of HIV infection, and among races/ethnicities, African
Americans continue to be disproportionately affected. In
2011, an estimated 49,273 people were diagnosed with HIV
infection in the United States. In that same year, an
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estimated 32,052 people were diagnosed with AIDS. Since the
epidemic began, an estimated 1,155,792 people in the United
States have been diagnosed with AIDS. An estimated 15,529
people with an AIDS diagnosis died in 2010, and approximately
636,000 people in the United States with an AIDS diagnosis
have died since the epidemic began. The deaths of persons
with an AIDS diagnosis can be due to any cause; that is, the
death may or may not be related to AIDS.
3.HIV positive but unaware. According to the CDC, 18 percent of
people living with HIV are unaware of their infection.
According to the California Office of AIDS, as of the end of
2011, it is estimated that between 29,523 and 31,948
HIV-positive and unaware individuals reside in California.
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 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
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
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"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 percent
reduction in HIV testing from the baseline testing level of 17
percent. One limitation of the 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 streamlining 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 percent 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
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
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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.
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 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
interpreters and bilingual staff to provide language
assistance to patients with limited d. English proficiency
must be ensured; and,
d. If a patient declines an HIV test, this decision should
be documented in the medical record.
The CDC has not issued guidelines specifically for HIV testing
in non-clinical settings, however a 2012 "Guide for Program
Managers" on implementation of HIV testing in those settings
states that clients should be provided with information about
HIV and HIV testing that is sufficient to obtain informed
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consent for testing. At a minimum, it is suggested that
clients be provided with the following information:
a. Overview of HIV testing [What is being tested (e.g.,
antibodies), based on the test(s) that will be used,
testing strategies and client options for testing,
procedure for testing, procedure and timeline for obtaining
results, next steps and procedure associated with
HIV-positive results, and next steps and procedure
associated with HIV-negative results.]
b. Benefits of testing;
c. Drawbacks of testing;
d. HIV "basics" (e.g., transmission, prevention);
e. Meaning of test results, especially the window period
(relative to last exposure and test strategy used);
f. Applicable laws (e.g., disease reporting laws) and,
g. Sources of additional information and support.
7.AB 682. 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 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
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results will be communicated, and the opportunity to ask
questions." The final AB 682 language (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 modestly change the
informed consent requirements, but expand the exemption from
informed consent to include when a person independently
request the test in non-clinical settings.
8.Related legislation. AB 506 (Mitchell) provides social
workers with additional authority to consent to HIV testing
for infants in temporary custody or who are adjudicated
dependents when such testing is determined to be medically
necessary and the parent or guardian cannot be reached. AB
506 is set for hearing on June 25, 2013 in Senate Judiciary
Committee.
9.Prior legislation. AB 491 (Portantino) of 2011 would have
allocated state and federal funds to test persons for HIV,
would have specified that an HIV counselor is a medical care
provider, and would have authorized a clinical laboratory test
result of a negative HIV antibody test to be posted on a
secure website if specified conditions were met. AB 491 was
amended to deal with a different subject matter.
AB 1894 (Krekorian), Chapter 631, Statutes of 2008, requires
health care service plans and disability insurers selling
health insurance to offer testing for HIV antibodies and AIDS,
regardless of whether the testing is related to a primary
diagnosis.
AB 682 (Berg), Chapter 550, Statutes of 2007, revises the
written and informed consent standards associated with testing
blood for HIV, including prenatal HIV testing, to no longer
require affirmative approval prior to administering an HIV
test. Establishes the new HIV testing consent standard as the
right to decline the test, providing that medical care
providers present specified information to the individual
about treatment options and the individual's right to decline
the test, and the medical care provider notes in the chart
when the patient declines to be tested. Exempts HIV testing
at an alternative test site, as part of an autopsy, or when
part of scientific research from these provisions.
AB 446 | Page 10
10.Support. AIDS Healthcare Foundation states that this bill
addresses two testing reforms. First, it clarifies that HIV
testing can be provided with informed consent in a
non-clinical setting by any person statutorily authorized to
administer an HIV test. More and more testing is being
administered by HIV counselors who are authorized to
administer the rapid HIV test. However, because of a
shortcoming in the law, an HIV counselor is required to get a
higher level of consent than other medical providers.
Requiring HIV counselors to seek a more rigid form of consent
undermines their ability to provide testing services to people
who are out-of-sync with traditional health care delivery.
Second, this bill authorizes the tester to disclose an HIV
test result on a secure website, for a test subject to access
with a unique code, in order to increase the number of test
subjects who actually learn of their test results. Since the
CDC has long recommended routine HIV testing occur in all
health care settings, it is a substantial drag on achieving
the goal of real routine testing when we leave it to the
patient to execute the state's public health policy on HIV
testing. The Black AIDS Institute writes that in the absence
of the legal right of an HIV tester to provide test results to
patients in reasonable settings, persons infected with HIV are
deprived of the timely benefit of first step in an essential
process known as the "treatment cascade."
11.Support in concept. The California Academy of Preventive
Medicine writes that they favor "de-exceptionalizing" HIV and
HIV testing, so that it is as similar as possible to, and can
be combined with, other routine medical testing. CAPM states
that consent and pre-test information should be as simple as
possible, and in no way more complicated than as recommended
by the CDC and are pleased by the general intent of this bill.
However, CAPM asks for amendments to Section 1 of the bill to
delete what they consider redundant language and to Section 2
of the bill to clarify that HIV testing be administered with
other blood tests if a patient has not received or declined an
HIV test within the past year.
12.Opposition. According to opponents, writing in response to
the provision that adds to the informed consent exemption a
requested test at an HIV counseling and testing site, states
that the CDC guidelines do not include a "no information, no
informed consent" in any setting. Opponents state that
regardless of whether someone is at a clinic or in a van they
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should understand and know about the test and that California
adopted this standard in a clinical setting in AB 682, based
in part on the rationale that the person would have some
relationship with the provider and would be comfortable asking
questions and the provider would know the individual's
history and risk factors. Expanding this standard to the
non-clinical setting may lead to people most in need of
detailed information not actually getting the information.
The opponents further assert that as a matter of practice and
law, HIV counselors have been providing critical information
and obtaining consent quickly and efficiently. Therefore, it
is unclear what the need for this provision in the bill is.
Opponents argue that this "no information, no informed
consent" standard could very easily become the "default"
standard for HIV testing; essentially, it might become very
easy for HIV counselors to consider encounters a request for
HIV testing, undermining the actual non-clinical standard
written into law.
13.Oppose unless amended. The Disability Rights Legal Center
(DRLC) writes that this bill will further erode informed
consent for HIV testing and functionally obliterates any
distinction between HIV testing in clinical and non-clinical
settings. DRLC states that best practices as defined by the
CDC do not advocate for a standard that provides no education
or information about an HIV test.
14.Author's amendments.
a. On page 2, lines 6 and 7, delete "and risk reduction
strategies"
b. On page 2, line 8, after "HIV" insert "and that a
person who tests negative for HIV should continue to be
routinely tested"
c. On page 4, line 7, delete "adminsters" and insert
"administers"
SUPPORT AND OPPOSITION :
Support: AIDS Healthcare Foundation (sponsor)
The Black AIDS Institute
California Communities United Institute
Oppose: American Civil Liberties Union
Disability Rights Legal Center (unless amended)
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