BILL ANALYSIS Ó
AB 446
Page 1
CONCURRENCE IN SENATE AMENDMENTS
AB 446 (Mitchell)
As Amended September 6, 2013
Majority vote
-----------------------------------------------------------------
|ASSEMBLY: |72-1 |(May 29, 2013) |SENATE: |36-0 |(September 11, |
| | | | | |2013) |
-----------------------------------------------------------------
Original Committee Reference: JUD.
SUMMARY : Expands voluntary human immunodeficiency virus (HIV)
testing outreach to certain patients at primary care clinics,
and revises requirements for obtaining consent from, and
providing information to, persons being tested for HIV
infection. Specifically, this bill :
1)Modifies the information that a medical provider is required
to give to a person about to receive an HIV test in a clinical
setting.
2)Removes the requirement to obtain a signed written statement
of informed consent before administering an HIV test in a
non-clinical setting, and instead provides that informed
consent may be provided orally or in writing, but the person
administering the test must maintain documentation of consent,
whether obtained orally or in writing, in the client's medical
record.
3)Provides that the informed consent requirements above do not
apply when a person independently requests an HIV test from an
HIV counseling and testing site that employs a trained HIV
counselor, provided that the person is given the required
pre-test information and his or her independent request for an
HIV test is documented by the person administering the test.
4)Exempts clinical laboratories from informed consent
requirements for HIV testing, as specified.
5)Specifies information that a medical care provider must give
to a patient after the results of the patient's HIV test have
been received, including information specific to a positive
test result and different information in the case of a
negative test.
AB 446
Page 2
6)Requires each patient who has blood drawn at a primary care
clinic, as defined, to be offered an HIV test, unless within
the previous year the primary care clinic has tested the
patient for HIV or offered an HIV test that the patient
declined. Further provides that any subsequent testing of a
patient by the primary care clinic shall be consistent with
the most recent guidelines issued by the United States (U.S.)
Preventive Services Task Force (USPSTF).
7)Requires the primary care clinic to attempt to provide the
test results to the patient before he or she leaves the
facility if possible; otherwise the facility must inform a
patient of a positive HIV test result consistent with existing
law, and may inform the patient of a negative HIV test result
by letter or telephone, as provided.
8)Allows, under specified circumstances, the result of an HIV
test to be posted on a secure Internet Web site viewable only
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, and allows the result to be posted only if
there is no link to any information that identifies the test
subject and certain post-result advice and information is also
provided.
The Senate amendments exempt clinical laboratories from the
informed consent requirements, and, under certain circumstances,
exempt persons who independently request an HIV test from an HIV
counseling and testing site from the same informed consent
requirements. In addition, the amendments preserve existing law
specifying information that medical providers must give to a
person about to be tested for HIV in a clinical setting, and
modify the confidentiality parameters for posting HIV test
results on a secure Web site. Finally, the amendments delete the
condition that only those patients aged 18 to 65 who have had
blood drawn at a primary care clinic and who have consented to
an HIV test must be offered an HIV test, expanding this
requirement to all patients regardless of age, and make other
clarifying changes.
FISCAL EFFECT : According to the Senate Appropriations
Committee:
1)Minor anticipated costs to provide information and technical
AB 446
Page 3
assistance to providers of HIV testing services by the
Department of Public Health (General Fund).
2)Unknown increase in HIV testing costs by the state's Medi-Cal
program (50% General Fund, 50% federal funds). Under the
bill, the number of Medi-Cal enrollees being tested for HIV is
likely to increase, increasing program costs.
3)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 the bill increases testing
rates, HIV positive Medi-Cal enrollees would become aware of
their HIV status earlier and begin treatment earlier (current
clinical guidelines recommend anti-viral treatment begin
immediately upon diagnosis).
4)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.
COMMENTS : This bill, sponsored by the AIDS Healthcare
Foundation (AHF), seeks to make a number of changes to state HIV
testing law that the author believes will help facilitate
greater HIV screening of people who are hard to reach within
traditional clinical settings and using traditional testing
protocols. Under this bill, an HIV counselor working in a
non-clinical setting would no longer be required to obtain a
separate, signed written statement of informed consent from the
patient before administering the HIV test. This bill would
still require informed consent in the non-clinical setting, but
would allow it to be provided orally or in writing, as long as
the person administering the test maintains documentation of the
AB 446
Page 4
consent, whether obtained orally or in writing, in the patient's
record. This bill would also authorize the tester to disclose
an HIV test result on a secure Web site that a test subject may
access with a secure code intended to protect the
confidentiality of the patient's identity.
This bill also requires each patient who has blood drawn at a
primary care clinic to be offered an HIV test, unless within the
previous year the primary care clinic has tested the patient for
HIV or offered an HIV test that the patient declined. The bill
also provides that any subsequent testing of a patient by the
primary care clinic shall be consistent with the most recent
guidelines issued by the USPSTF. Additionally, the bill
requires the primary care clinic to attempt to provide the test
results to the patient before he or she leaves the facility if
possible; otherwise the facility must inform a patient of a
positive HIV test result consistent with existing law, and may
inform the patient of a negative HIV test result by letter or
telephone, as provided.
According to the author and sponsor, state laws specifying
pre-test information and consent procedures need to be revised
in order to facilitate greater HIV testing. The sponsor states,
"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 medications. . . More
and more testing is being administered by HIV Counselors, a
profession created by statute and trained and certified by the
state. As the largest private HIV testing entity in California,
AHF places its testing professionals in the community where they
can reach out to people who might otherwise never go to a
physician or clinic for an HIV test."
Informed consent for HIV testing, as defined by CDC, is "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." CDC also states "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." (CDC,
"Revised Recommendations for HIV Testing of Adults, Adolescents,
and Pregnant Women in Health-Care Settings." Morbidity and
Mortality Weekly Report (2006), 55(RR14), page 1-17.)
AB 446
Page 5
By contrast, a requirement for written consent simply refers to
the need to obtain a signed paper documenting that the person
has given his or her consent to have the test done. Written
consent may be independently required (or not required) where
the legal standard is informed consent, or some alternative
standard, such as simple consent. According to the sponsor,
"the potential test subjects who visit community non-clinical
settings often have to be convinced to have the test in the
first place and are more likely to skip the test altogether the
longer they are required to remain with the HIV Counselor,
especially if they have to sign a consent form." Proponents
also correctly note that CDC's 2006 recommendations for health
care settings specifically state that separate written consent
for HIV testing should not be required, and many states
currently do not require separate written consent for HIV
testing.
Existing law requires both written consent and informed consent
for HIV testing in non-clinical settings. Under this bill, a
person working in a non-clinical setting would no longer need to
obtain a separate, signed written statement of informed consent
from the patient before administering the HIV test. This bill
would still require informed consent in the non-clinical
setting, but would allow informed consent to be provided orally
or in writing, as long as the person administering the test
maintains documentation of the consent, whether obtained orally
or in writing, in the patient's record. As recently amended,
the bill provides that these informed consent requirements do
not apply when a person independently requests an HIV test from
an HIV counseling and testing site that employs a trained HIV
counselor, provided that the person is given the required
pre-test information and his or her independent request for an
HIV test is documented by the person administering the test.
The bill would presumably help increase HIV testing by
eliminating one of the major obstacles to testing, as reported
by AHF, but at the same time preserve the important purposes
that informed consent serves by ensuring exchange of information
and an opportunity for dialogue.
Finally, this bill requires the medical provider or the person
administering the test, after the results of the test have been
received, to ensure the patient receives timely information and
counseling, as appropriate, to explain the results and
implications for the patient's health. If the patient tests
positive for HIV infection, the bill requires the provider or
AB 446
Page 6
the person administering 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. If
the patient tests negative for HIV infection and is known to be
at high risk for HIV infection, the bill requires the provider
or the person administering the test to advise the patient of:
1) the need for periodic retesting; 2) explain the limitations
of current testing technology and the current window period for
verification of results; and 3) may offer prevention counseling
or a referral to prevention counseling. It is the author's
intent that appropriately timed post-test delivery of
information will not only streamline the pre-test informational
procedure that may delay or defer the test, but will also lead
to better linkages to care for those who test positive. As
recently amended, the bill clarifies that this information shall
also be provided on a secure Internet Web site that an
anonymously tested person may use to access his or her test
results, as specified.
Analysis Prepared by : Anthony Lew / JUD. / (916) 319-2334
FN:
0002704