BILL ANALYSIS Ó
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THIRD READING
Bill No: AB 446
Author: Mitchell (D)
Amended: 7/8/13 in Senate
Vote: 21
SENATE HEALTH COMMITTEE : 9-0, 6/26/13
AYES: Hernandez, Anderson, Beall, De León, DeSaulnier, Monning,
Nielsen, Pavley, Wolk
SENATE JUDICIARY COMMITTEE : 6-0, 7/2/13
AYES: Walters, Anderson, Corbett, Jackson, Leno, Monning
NO VOTE RECORDED: Evans
SENATE APPROPRIATIONS COMMITTEE : 6-0, 8/30/13
AYES: De León, Walters, Gaines, Hill, Padilla, Steinberg
NO VOTE RECORDED: Lara
ASSEMBLY FLOOR : 72-1, 5/29/13 - See last page for vote
SUBJECT : HIV testing
SOURCE : AIDS Healthcare Foundation
DIGEST : This bill revises requirements related to information
provided at the time an HIV test is administered and after the
test results are received; requires informed consent, as
specified, either orally or in writing, except when a person
independently requests an HIV test from an HIV counseling and
testing site, as specified; requires documentation of the
person's independent request for the test and exempts clinical
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laboratories from the informed consent requirements; requires
every patient who has blood drawn at a primary care clinic, as
defined, who is between 12 and 65 years of age and who has
consented to the test, to be offered an HIV test; and authorizes
disclosure of HIV test results by Internet posting or other
electronic means, as specified.
ANALYSIS :
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/her parent, guardian, or
conservator, signs a written statement documenting his/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
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
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that a medical care provider inform patients that a person who
tests negative for HIV should continue to be routinely tested.
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. 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. Clarifies that
this provision does not apply when a person independently
requests an HIV test from an HIV counseling and testing site
that employs a trained HIV counselor, as defined.
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
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
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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/she leaves the facility.
Permits, if that is not possible, the facility 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 Internet 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.
Background
According to a 2012 CDC report, an estimated 1,148,200 persons
who are age 13 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. 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 continue to bear the greatest burden
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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 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.
HIV positive but unaware . According to the CDC, 18% 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.
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
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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.
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:
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.Persons at high risk for HIV infection should be screened for
HIV at least annually;
3.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
4.Prevention counseling should not be required with HIV
diagnostic testing as part of HIV screening programs in health
care settings.
CDC consent recommendations . 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;
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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 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; and
4.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
consent for testing. At a minimum, it is suggested that clients
be provided with the following information:
1.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.
2.Benefits of testing;
3.Drawbacks of testing;
4.HIV "basics" (e.g., transmission, prevention);
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5.Meaning of test results, especially the window period
(relative to last exposure and test strategy used);
6.Applicable laws (e.g., disease reporting laws); and
7.Sources of additional information and support.
AB 682 (Berg, Chapter 550, Statutes of 2007) . 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 (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.
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Prior Legislation
AB 491 (Portantino, 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 Internet Web site 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.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: No
According to the Senate Appropriations Committee:
Minor anticipated costs to provide information and technical
assistance to providers of HIV testing services by DPH
(General Fund).
Unknown increase in HIV testing costs by the state's Medi-Cal
program (50% General Fund, 50% federal funds). Under this
bill, the number of Medi-Cal enrollees being tested for HIV is
likely to increase, increasing program costs.
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Unknown increase in treatment costs for HIV positive Medi-Cal
enrollees and participants in the AIDS Drug Assistance Program
(General Fund and federal funds). The state spends about
$25,000 per year per HIV positive Medi-Cal enrollee and about
$12,000 per year per HIV positive AIDS Drug Assistance Program
enrollee. To the extent that this bill increases testing
rates, HIV positive Medi-Cal enrollees will become aware of
their HIV status earlier and begin treatment earlier (current
clinical guidelines recommend anti-viral treatment begin
immediately upon diagnosis).
Unknown long-term costs savings to Medi-Cal due to earlier
medical intervention for HIV-positive Medi-Cal enrollees. To
the extent that HIV-positive Medi-Cal enrollees are diagnosed
earlier and begin treatment earlier, it is likely that the
long-term health status of those individuals will improve and
some of the health effects of HIV will be delayed or avoided.
There are indications that untreated HIV causes long-term
health impacts such as elevated risk of diabetes and heart
disease, even before the effects of compromised immune system
function associated with HIV infection become evident.
Earlier diagnosis and treatment for HIV-positive individuals
is likely to reduce long-term Medi-Cal expenditures for those
individuals.
SUPPORT : (Verified 8/30/13)
AIDS Healthcare Foundation (source)
Beyond AIDS
Black AIDS Institute
Black Women for Wellness California
California Medical Association
Communities United Institute
OPPOSITION : (Verified 8/30/13)
American Civil Liberties Union
ARGUMENTS IN 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
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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 Internet
Web site, 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."
ARGUMENTS IN 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 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.
ASSEMBLY FLOOR : 72-1, 5/29/13
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AYES: Achadjian, Alejo, Ammiano, Atkins, Bigelow, Bloom,
Blumenfield, Bocanegra, Bonilla, Bonta, Bradford, Brown,
Buchanan, Ian Calderon, Campos, Chau, Chávez, Chesbro, Conway,
Cooley, Dahle, Daly, Dickinson, Eggman, Fong, Frazier, Beth
Gaines, Garcia, Gatto, Gomez, Gonzalez, Gorell, Gray, Grove,
Hagman, Hall, Harkey, Roger Hernández, Jones, Jones-Sawyer,
Levine, Logue, Lowenthal, Maienschein, Mansoor, Medina,
Melendez, Mitchell, Morrell, Mullin, Muratsuchi, Nazarian,
Nestande, Olsen, Pan, Perea, V. Manuel Pérez, Quirk,
Quirk-Silva, Rendon, Salas, Skinner, Stone, Ting, Wagner,
Waldron, Weber, Wieckowski, Wilk, Williams, Yamada, John A.
Pérez
NOES: Donnelly
NO VOTE RECORDED: Allen, Fox, Gordon, Holden, Linder,
Patterson, Vacancy
JL:ej 8/31/13 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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