BILL ANALYSIS Ó
AB 2439
Page 1
Date of Hearing: April 12, 2016
ASSEMBLY COMMITTEE ON HEALTH
Jim Wood, Chair
AB 2439
(Nazarian) - As Introduced February 19, 2016
SUBJECT: HIV testing.
SUMMARY: Applies existing human immunodeficiency virus (HIV)
testing requirement for primary care clinics to hospital
emergency departments (EDs). Specifically, this bill:
1)Requires each patient in a hospital ED who has blood drawn and
has given consent, to be offered a test for HIV.
2)Requires the ED clinician to offer the HIV test consistent
with the United States Preventive Services Task Force (USPSTF)
recommendation for screening HIV infection.
3)Specifies that a hospital ED is not required to offer the test
if the ED has tested the patient for HIV or if the patient has
been offered the HIV test and declined the test in the last 12
months.
4)Specifies that nothing prohibits a hospital ED from charging a
patient to cover the cost of HIV testing, and that a hospital
ED will be deemed in compliance with these provisions if an
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HIV test is offered.
5)Requires a hospital ED to attempt to provide test results to
the patient before he or she leaves the facility. If that is
not possible the facility may inform the patient who tests
negative for HIV by letter or telephone.
6)Requires a hospital ED, to comply with existing requirements
on providing timely information and counseling to patients,
including treatment options, but deems a hospital ED to have
complied with existing law if the ED provides printed material
to the patient that includes the information and advice.
7)Specifies that a hospital ED is not required to test a person
for HIV if medical personnel in the ED determine that the
person is being treated for a life-threatening emergency or if
they determine that the person lacks the capacity to consent
to an HIV test.
8)Makes other technical and conforming changes, including
applying existing requirements for minors to be tested.
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 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
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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
prevention counseling or a referral to prevention counseling.
FISCAL EFFECT: This bill has not been analyzed by a fiscal
committee.
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COMMENTS:
1)PURPOSE OF THIS BILL. According to the author, despite the
enactment and implementation of the Patient Protection and
Affordable Care Act (ACA), EDs continue to play a critical
role in delivering primary care services to many new enrollees
and to those who remain uninsured. The author contends that
given that there are more than 5,000 new HIV infections in
California every year, this bill will bridge the gap in lack
of HIV testing by requiring EDs to uniformly provide HIV
testing.
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.
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
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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
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
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settings in the United States. They also recommend
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.
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
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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
those rated "A" or "B" by the USPSTF. Moreover, the 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
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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
York State Department of Health published a report
evaluating the impact of the statute with respect to 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
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an increase in the number of persons newly linked to care
per year.
f) California HIV testing in the ED. In 2015, 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 percent) and 23 of
which were previously-identified confirmed positive test
events (0.19 percent).
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
percent) and five of which were previously-identified
confirmed positive test events (0.11 percent). The Ventura
County Medical Center ED conducted 5,604 test events
through the program in 2015, four of which were
newly-identified confirmed positive test events (0.07
percent) and 16 of which were previously-identified
confirmed positive test events (0.29 percent). 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 percent) and two of
which were previously-identified confirmed positive test
events (0.09 percent).
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Hospitals in two of California's largest urban settings,
Alameda County Medical Center (ACMC) and Los Angeles County
+ University of Southern California Medical Center (LAC)
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 percent. In 2005, LAC 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
percent. In addition, a regional hospital, Desert Regional
Medical Center in Palm Springs, has implemented HIV testing
their ED. In 2015, they tested 810 patients of which 17
were HIV positive for a positivity rate of 2 percent. These
positivity yields meet the benchmark of 0.1 percent
determined by the CDC to demonstrate cost effectiveness of
HIV testing in healthcare settings.
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.
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4)OPPOSITION. The California Chapter of the American College
(Cal/ACEP) opposes this bill stating that diagnosing and
treating HIV is an important public health endeavor, but EDs
are not the proper venue for a diagnostic public health
campaign. Cal/ACEP also notes that this bill provides no
funding for the test itself, thereby placing another unfunded
mandate on EDs. Cal/ACEP concludes that between 2001 and
2010, California experienced a net loss of 21 hospitals, and
when a hospital closes, it threatens access to emergency
services for entire communities.
The California Hospital Association states that this bill
would eliminate the physician's medical judgment as to what
information or treatment is in the best interest of a
particular patient, and under current practice, hospitals
already offer HIV tests when the clinical judgement of the
clinician determines an HIV test is needed.
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
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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
have a position of oppose unless amended on 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
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.
AB 521 was vetoed by the Governor, who stated, in part, "?
hospitals are not appropriately staffed nor are they the place
to provide counseling, routine preventive screenings, or
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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."
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.
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