BILL ANALYSIS Ó
AB 2439
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Date of Hearing: April 19, 2016
ASSEMBLY COMMITTEE ON HEALTH
Jim Wood, Chair
AB 2439
(Nazarian) - As Amended April 12, 2016
SUBJECT: HIV testing.
SUMMARY: Creates a pilot project to be administered by the
Department of Public Health (DPH), in order to assess and make
recommendations regarding the effectiveness of the routine
offering of a human immunodeficiency virus (HIV) test in the
emergency department (ED) of a hospital. Specifically, this
bill:
1)Requires DPH to select four hospitals that have EDs to
participate in the pilot project as follows:
a) Two of the hospitals must be from large urban areas;
b) One hospital must be from a small urban or suburban
area;
c) One hospital must be from a rural area;
d) Each hospital in the pilot project must offer an HIV
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test to any patient in the ED who has consented to the HIV
test. Specifies that the ED must comply with all existing
notice and counseling requirements, and that the ED may
comply with those requirements by either using ED or other
hospital personnel or engaging the services of an HIV
organization that has experience in prevention counseling
for persons at risk for HIV;
e) Specifies that a hospital in the pilot project must not
offer a test to any person who is being treated for a
life-threatening emergency or who lacks the capacity to
consent to an HIV test;
f) Requires a hospital in the pilot project to comply with
existing HIV testing requirements for testing a minor 12
years of age or older;
g) Authorizes a hospital in the pilot project to charge a
patient for the cost of the HIV testing;
h) Requires a hospital in the pilot project to collect and
report data on the following topics to DPH:
i) The frequency of HIV test offers;
ii) The frequency of consent or nonconsent to an HIV
test and any reasons given by the patient for the consent
or nonconsent;
iii) The time taken to offer an HIV test and secure
consent from a patient and the time taken to provide
information and counseling;
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iv) The aggregate HIV positivity rate;
v) The frequency with which patients agree information
and counseling and the reasons that patients give for
refusing counseling; and,
vi) The frequency of patients leaving the ED without
receiving their test results.
2)Requires hospitals in the pilot project to provide information
to DPH regarding the hospitals practices and protocols for
implementing the offer of an HIV test; the required follow up
to the test; as well as an assessment of the effectiveness of
those practices and protocols;
3)Specifies that the pilot project must commence on March 1,
2017, and end on February 28, 2019; and,
4)Requires DPH, by July 1, 2019, to complete a report to the
Legislature on the finding of the four hospitals in the pilot
and make recommendations about routine HIV testing in hospital
EDs. Requires DPH to solicit input form a broad range of HIV
testing and hospital stakeholders when preparing the report.
EXISTING LAW:
1)Requires each patient who has blood drawn at a primary care
clinic, and who has consented, to be offered an HIV test,
consistent with the U.S. Preventive Services Task Force
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(USPSTF) recommendation for screening HIV infection.
2)Requires a medical provider, prior to ordering an HIV test, to
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 advise the patient that he or she has
the right to decline the tests. Requires a medical provider,
if a patient declines the test, to note that fact in the
patient's medical file. Specifies that these provisions do
not apply when a person independently requests an HIV test.
3)Prohibits an HIV test from being administered unless the
person being tested, or his or her parent, guardian, or
conservator has provided informed consent for the performance
of the test. Specifies that informed consent may be provided
orally or in writing, and must be noted in the client's
medical record.
4)Requires, after the results of an HIV test have been received,
that the medical care provider ensure that the patient
receives timely information and counseling to explain the
results and the implication for the patient's health.
Requires the medical provider, if the patient tests positive,
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.
5)Requires the medical care provider, if the patient tests
negative for HIV infection and is known to be at high risk for
HIV infection, 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 authorizes the medical care provider to offer
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prevention counseling or a referral to prevention counseling.
FISCAL EFFECT: This bill has not been analyzed by a fiscal
committee.
COMMENTS:
1)PURPOSE OF THIS BILL. According to the author, over the past
three decades, almost every imaginable location to provide
routine HIV testing has been employed to capture as many
people as possible who may have engaged in risk behaviors.
The author contends we continue to come up short, in large
part because HIV testing is occurring only sporadically in the
ED, the last major health care institution in California where
HIV testing does not occur routinely. The author states
despite dramatic advances in treatment options, there are more
than 5,000 new infections in California every year and
according to DPH, 16% of Californians who are HIV-positive do
not know they are HIV-positive and thus are not getting
treatment and unwittingly exposing uninfected people to HIV,
and that number jumps to 58% for young people under the age of
24. The author continues, despite the many successes, the
failures of our testing protocols are most pronounced among
young people and people of color, noting that the state's HIV
demographics are trending younger, notably increasing in those
aged 20 to 29, and climbing infection rates among Black and
Latino Californians, especially Black women.
2)BACKGROUND. At the end of 2012, an estimated 1.2 million
persons aged 13 and older were living with HIV infection in
the United States, including 156,300 (12.8%) persons whose
infections had not been diagnosed. The estimated incidence of
HIV has remained stable overall in recent years, at about
50,000 new HIV infections per year.
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a) HIV in California. The California Office of AIDS (OA)
estimates that approximately 126,000 Californians are
living with HIV, and of these, 23,000 or 18% are unaware of
their HIV status. An estimated 6,000 Californians are
newly diagnosed with HIV each year. Gay, bisexual, and
other men who have sex with men (MSM) continue to be the
risk group most heavily affected by HIV in California,
accounting for over 70% of all persons diagnosed with HIV
in 2013.
Unlike national statistics, new HIV diagnoses among all MSM
in California decreased by over 13% (from 3,789 to 3,281)
from 2005 to 2013 (versus a national increase of 6%). White
MSM in California account for this decline, with an almost
35% decrease in new diagnoses (versus a national decrease
of 18%). Both Latino and Black MSM in California had a net
zero change in new HIV diagnoses from 2005 to 2013 (versus
national increases of 24% and 22%, respectively). Only
"other" race/ethnicities in California that had an increase
in new HIV diagnoses during this period (an increase of 30%
from 2005 to 2013, driven primarily by a 73% increase among
Asians). "Other" race/ethnicity includes American
Indian/Alaska Native, Asian, Native Hawaiian/Pacific
Islander, and multi-racial persons.
However, young MSM aged 13 to 24 years old in California
had an overall increase of 27% in new HIV diagnoses from
2005 to 2013 (from 536 in 2005 to 680 in 2013). This
increase was driven by young Hispanic MSM, whose numbers
increased by 35% (from 246 to 333). Diagnoses among young
Black MSM in California increased by 16% (from 124 to 144)
during this period. Among young white MSM new diagnoses
increased approximately 8% (from 130 to 140), compared to
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56% nationally. New HIV diagnoses among young MSM of other
race/ethnicities in California increased by an even higher
percentage (75%) from 2005 to 2013, but there are
relatively few cases in this group (36 in 2005 to 63 in
2013).
b) HIV screening recommendations. In September 2006, the
Centers for Disease Control and Prevention (CDC) released,
"Revised Recommendations for HIV Testing of Adults,
Adolescents, and Pregnant Women in Health-Care Settings."
These recommendations advise routine HIV screening of
adults, adolescents, and pregnant women in health care
settings in the United States. The CDC also recommends
reducing barriers to HIV testing.
In April 2013, the USPSTF issued similar recommendations.
According to these recommendations, clinicians should
routinely screen adolescents and adults ages 15 to 65 years
for HIV infection. Younger adolescents and older adults who
are at increased risk should also be screened. USPSTF also
recommends screening all pregnant women for HIV, including
those who present in labor whose HIV status is unknown.
A general rule for those with risk factors is to get tested
at least annually. Additionally, CDC has recently reported
that sexually active gay and bisexual men may benefit from
getting an HIV test more often, perhaps every three to six
months.
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New data from a National Institutes of Health sponsored
trial indicates there is a clear personal advantage to
achieving an HIV diagnosis and starting therapy in the
early course of an infection. This new information further
highlights the importance of routine HIV testing and the
potential impact on better health outcomes.
c) Testing Statistics. According to a Kaiser Family
Foundation report, as of 2012, more than half (54%) of U.S.
adults, aged 18 to 64, reported ever having been tested for
HIV, including 22% who reported being tested in the last
year. The share of the public saying they have been tested
for HIV at some point increased between 1997 and 2004, but
has remained fairly steady since then. Of those U.S.
adults, aged 18-64, who say they have never been tested for
HIV, nearly six in 10 (57%) say it is because they do not
see themselves as at risk. HIV testing varies by state,
age, and race/ethnicity, for example, Blacks and Latinos
are significantly more likely to report having been tested
for HIV than whites.
d) Insurance coverage of HIV testing. HIV testing that is
"medically necessary" - recommended by a physician due to
risk - is generally covered by insurance. For those
without insurance, HIV testing can be obtained at little or
no cost in some settings (e.g., stand-alone HIV testing
sites, mobile testing clinics). In April 2013, the USPSTF
gave routine HIV screening of all adolescents and adults,
ages 15 to 65, an "A" rating - generally aligning the
rating with the CDC's HIV screening guidelines. This
rating expanded the already existing "A" rating for people
at increased risk for HIV (such as injection drug users and
MSM), and for all pregnant women. The USPSTF ratings,
developed by an independent panel of clinicians and
scientists, are important because many private and public
insurers link their coverage of preventive services to
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those rated "A" or "B" by the USPSTF. Moreover, the
Patient Protection and Affordable Care Act (ACA), passed in
2010, requires or incentivizes insurers to cover preventive
services rated "A" or "B" and do so without cost-sharing,
as follows:
i) Private Insurance: the ACA requires that all
private plans (except those that are grandfathered,
meaning they were in place before the ACA was passed and
have made no significant changes to coverage) must cover
routine HIV testing without cost-sharing;
ii) Medicaid (Medi-Cal in California): while all state
Medicaid programs must cover "medically necessary" HIV
testing, state coverage of "routine" HIV screening varies
because it is an optional benefit under Medicaid. A
recent analysis has found that more than two thirds of
state Medicaid programs do cover routine HIV screening,
including California; and,
iii) Medicare: In April 2015, the Centers for Medicare &
Medicaid Services expanded Medicare coverage to include
annual HIV testing for beneficiaries ages 15-65
regardless of risk, and those outside this age range at
increased risk. Additionally, Medicare will cover up to
three tests for pregnant beneficiaries.
e) New York HIV testing in the ED. Effective September 1,
2010, the state of New York mandated numerous changes to
its HIV testing requirements, including that all persons
seeking care in the ED be offered a test. In 2012 the New
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York State Department of Health published a report
evaluating the impact of the statute on the number of
persons tested for HIV and the number of persons who access
care and treatment. The review included a modeling
prediction of the impact of the new law. Assuming the law
is implemented as designed; the model predicts a reduction
in the number of new infections as well as the proportion
of undiagnosed cases. The model also predicts an initial
surge in the annual number of newly diagnosed HIV
infections followed by a decline, and a steady decline in
the number of newly diagnosed AIDS cases, explained by the
identification of persons earlier in the course of
infection before progressing to late stage disease. The
report concluded that the law was not expected to result in
an increase in the number of persons newly linked to care
per year.
f) California HIV testing in the ED. In 2015, the DPH OA
began funding three medical centers/hospitals within the
California Project Area (all California counties excluding
Los Angeles and San Francisco which receive direct federal
funding) to provide HIV testing in their EDs: University
of California at Irvine (UCI) Medical Center, Ventura
County Medical Center, and Santa Paula Hospital. Combined,
these three ED sites conducted 12,289 test events through
the program in 2015, 16 of which were newly identified
confirmed positive test events (0.13%) and 23 of which were
previously identified confirmed positive test events
(0.19%).
The UCI Medical Center ED conducted 4,544 test events
through the program in 2015, 11 of which were
newly-identified confirmed positive test events (0.24%) and
five of which were previously-identified confirmed positive
test events (0.11%). The Ventura County Medical Center ED
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conducted 5,604 test events through the program in 2015,
four of which were newly-identified confirmed positive test
events (0.07%) and 16 of which were previously-identified
confirmed positive test events (0.29%). The Santa Paula
Hospital ED conducted 2,141 test events through the program
in 2015, one of which was a newly-identified confirmed
positive test event (0.05%) and two of which were
previously-identified confirmed positive test events
(0.09%).
Hospitals in two of California's largest urban settings,
the Alameda County Medical Center (ACMC) and Los Angeles
County + University of Southern California Medical Center
(LAC+USC) have been successful in integrating routine HIV
testing in their EDs, although neither facility has offered
HIV testing to every patient receiving a blood draw as this
bill would require. As an early adopter of HIV testing in
their ED, ACMC utilized medical staff for the introduction
and provision of HIV tests. Over a three year
demonstration project (2010-2012), ACMC identified 52 new
HIV cases from 45,210 HIV tests conducted with a positivity
yield of 0.1%. In 2005, LAC+USC utilized a rapid test
approach, embedding test counselors to introduce and
provide HIV tests, and identified 13 new cases of HIV among
1,713 patients tested yielding a positivity yield of 0.8%.
In addition, a regional hospital, Desert Regional Medical
Center in Palm Springs, has implemented HIV testing in its
ED. In 2015, it tested 810 patients of which 17 were HIV
positive for a positivity rate of 2%. These positivity
yields meet the benchmark of 0.1% determined by the CDC to
demonstrate cost effectiveness of HIV testing in healthcare
settings.
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3)SUPPORT. The AIDS Healthcare Foundation (AHF) is the sponsor
of this bill and states despite dramatic advances in treatment
options, there are more than 5,000 new infections in
California every year, and everyday more than a dozen
Californians are being infected with HIV. AHF contends that
while almost every imaginable location that provides routine
HIV testing has been employed to capture as many people as
possible who may have engaged in risk behaviors, we continue
to come up short in large part because HIV testing is
occurring only sporadically in hospital EDs, the last major
health care institution where HIV testing does not occur
routinely.
4)OPPOSITION. The California Chapter of the American College
(Cal/ACEP) opposes this bill stating that the pilot project
requires every patient in an ED to be offered an HIV test,
whether they are having their blood drawn already or not, and
as a practical matter, this means that a patient who is there
for a broken foot, stiches, a concussion, or any other medical
condition that does not require blood to be drawn, will have
their blood drawn as a purely public health screening measure.
Cal/ACEP notes that it is aware that the CDC has stated that
hospitals with an AIDS diagnosis rate greater than one per
1,000 discharges should adopt a policy of offering HIV
counseling and testing routinely to patients aged 15 to 54
years, however if ED prophylactically tested for all diseases
with a .001% prevalence, life-saving care to acutely ill
patients would come to a screeching halt.
The California Hospital Association (CHA) states that the
pilot study does not attempt to address the significant
requirements related to pre and post HIV testing, including:
prior to ordering a test that identifies infection of a
patient with HIV, a medical care provider must inform the
patient that the test is planned, provide information about
the test, inform the patient that there are numerous treatment
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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 advise the patient that he or she has
the right to decline the test. CHA concludes that EDs are
designed to address emergency issues, not to address
population health management screenings in an efficient or
cost-effective manner.
The California Medical Association (CMA) opposes this bill
stating, currently, EDs suffer from overcrowding, lack of
resources, and extremely low reimbursement rates as they are
required to treat all individuals who enter the ED regardless
of ability to pay. CMA notes this bill would require
emergency physicians to devote time and resources away from
other patients to offer HIV tests to patients who might be at
an extremely low risk. CMA also notes concerns about false
positives tests and requiring that counseling be provided
within the ED, explaining that there are different types of
tests for HIV and the ones that would presumably be done in
the ED would be what are referred to as "rapid tests." CMA
says these tests look for HIV antibodies that an individual's
immune system would create if the virus was present and
contends that false positives occur more frequently in these
"rapid tests" and because the relationship between the
emergency physician and the emergency patient is transient,
there is no opportunity for follow up.
5)REQUESTED AMENDMENTS. A coalition of organizations which
includes the American Civil Liberties Union of California,
AIDS Project Los Angeles, and the Positive Women's Network had
a position of oppose unless amended on the prior version of
this bill. The coalition letter raises numerous concerns with
the bill including, replacing in-person counseling with
printed materials, confidentiality requirements (especially as
they pertain to minors being treated in the ED), occupational
exposures to HIV, and the exception for patients being treated
for a life-threatening emergency. The coalition states that
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due to the sensitive environment of the ED, they would like
the opportunity to discuss appropriate procedures before
testing, including the information provided to the patient and
how consent is obtained and documented, to ensure the
patient's medical autonomy is protected and that the best
foundation for an ongoing relationship with HIV medical care
is created from the moment of testing.
6)RELATED LEGISLATION. AB 2640 (Gipson) requires a medical care
provider or person administering a test for HIV to inform
individuals who test negative for HIV infection, yet are at
high risk for HIV infection, of the effectiveness and safety
of all federal Food and Drug Administration approved methods
that prevent or reduce the risk of contracting HIV, including
pre-exposure prophylaxis and post-exposure prophylaxis,
consistent with guidance of the CDC. AB 2640 is pending a
hearing in Assembly Health Committee.
7)PREVIOUS LEGISLATION. AB 521 (Nazarian) of 2015 would have
required a patient admitted as an inpatient to a hospital
through the ED that had blood drawn after being admitted to
the hospital, and who consented, to be offered an HIV test.
8)POLICY COMMENT. This bill is similar to AB 521 which was
vetoed by the Governor, who indicated, in part that,
"?hospitals are not appropriately staffed nor are they the
place to provide counseling, routine preventive screenings, or
follow-up care for sensitive HIV testing. Limited resources
would be better spent supporting outreach and education
activities by existing providers which have the staff and
training for HIV testing and follow-up care." The Committee
may wish to ask the author how he plans to address the
Governor's veto.
9)SUGGESTED AMENDMENTS.
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a) As currently drafted this bill requires DPH to select
four hospitals that have EDs to participate in the pilot
project. The Committee may wish to amend the bill to
clarify that participation in the pilot project is
voluntary on the part of the hospitals.
b) In order to address some of the privacy concerns raised
by the opponents the author may wish to consider amending
the bill to strike the provision requiring minors12 years
of age and up be offered HIV tests, and instead mirror
federal USPSTF recommendations for testing individuals
between the ages of 15 and 65.
REGISTERED SUPPORT / OPPOSITION:
Support
AIDS Healthcare Foundation
Opposition
California Chapter of the American College of Emergency
Physicians
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California Hospital Association
California Medical Association
California Society of Pathologists
Keck Medical Center of USC
Analysis Prepared by:Lara Flynn / HEALTH / (916) 319-2097