BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | AB 2640|
|Office of Senate Floor Analyses | |
|(916) 651-1520 Fax: (916) | |
|327-4478 | |
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THIRD READING
Bill No: AB 2640
Author: Gipson (D)
Amended: 8/15/16 in Senate
Vote: 21
SENATE HEALTH COMMITTEE: 7-1, 6/29/16
AYES: Hernandez, Nguyen, Hall, Mitchell, Monning, Pan, Roth
NOES: Nielsen
NO VOTE RECORDED: Wolk
SENATE APPROPRIATIONS COMMITTEE: 5-2, 8/11/16
AYES: Lara, Beall, Hill, McGuire, Mendoza
NOES: Bates, Nielsen
ASSEMBLY FLOOR: 57-20, 6/1/16 - See last page for vote
SUBJECT: Public health: HIV
SOURCE: AIDS Project Los Angeles
Los Angeles LGBT Center
DIGEST: This bill requires a medical provider or a person
administering a HIV test, in the case that a patient that is
known to be at high risk for HIV infection tests negative for
HIV to provide written information about the methods that
prevent or reduce the risk of contracting HIV, including, but
not limited to, pre-exposure prophylaxes (PrEP) and
post-exposure prophylaxes (PEP), consistent with guidance of the
federal Centers for Disease Control and Prevention (CDC).
ANALYSIS: Existing law places certain requirements on the
information shared by medical providers with patients for HIV
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testing, as specified. Requires the medical provider or other
person performing a HIV test, after the results of a test have
been received, to ensure that the patient receives timely
information and counseling, as appropriate, to explain the
results and the implications for the patient's health. If the
patient tests positive for HIV infection, the medical provider
or the person who administers the test is required 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 medical provider
or the person who administers the test is required 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.
This bill requires a medical provider or a person administering
a HIV test, in the case that a patient that is known to be at
high risk for HIV infection tests negative for HIV, to provide
written information about the effectiveness and safety of all
methods that prevent or reduce the risk of contracting HIV,
including, but not limited to, PrEP and PEP, consistent with
guidance of the CDC.
Comments
1)Author's statement. According to the author, AB 2640 seeks to
reduce the spread of HIV and save the lives of individuals at
high risk of HIV exposure by providing them with information
about preventive medications during HIV post-test counseling.
In 2013, California was second among the 50 states in the
number of new HIV diagnoses, with approximately 5,000 new HIV
diagnoses. A 2015 survey of individuals at risk for HIV by the
California HIV/AIDS Research Program found that only 1 in 10
respondents had ever used PrEP. Although awareness of the
intervention was high among those who had never taken PrEP,
awareness was significantly lower among Black and Latino
respondents compared to white respondents. In addition, the
large majority of respondents indicated they had never talked
to their doctor or healthcare provider about PrEP. Considering
the high volume of new HIV infections being diagnosed in the
state of California and the low awareness of these
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medications, it is critical that those being tested are aware
of PrEP and PEP medications.
2)Background. According to the CDC, more than 1.2 million
people in the U.S. are living with HIV infection, and 13% are
unaware of their infection. Gay, bisexual, and men who have
sex with men (MSM), particularly young African American MSM,
are most seriously affected by HIV. By race, African
Americans face the most severe burden of HIV. 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. An estimated 13,712 people with an AIDS diagnosis died
in 2012, and approximately 658,507 people in the U.S. with an
AIDS diagnosis have died overall. The Department of Public
Health's (DPH) 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. People living with HIV/AIDS have an estimated life
expectancy of 32 years after infection and that number is
increasing. According to the OA, with treatment costs
averaging around $23,000 per year, lifetime treatment is
currently estimated at around $740,000 or more per person.
With that estimate, the 6,000 new infections per year in
California will cost an estimated $4.5 billion to treat.
3)PrEP and PEP. "Treatment as prevention" (TasP) refers to HIV
prevention methods that use antiretroviral treatment to
decrease the risk of HIV transmission. According to the World
Health Organization, TasP needs to be considered as a key
element of combination HIV prevention and as a major part of
the solution to ending the HIV epidemic. Through TasP, people
living with HIV/AIDS use anti-retroviral (ARV) medications to
reduce their viral load (the amount of HIV in the body) to
undetectable levels. With an undetectable viral load, the
amount of HIV in the body is so small it greatly reduces the
likelihood of passing the virus to another person. Strict
adherence to TasP reduces the likelihood of transmission by up
to 96%. PrEP is a new intervention that uses an established
ARV medication, Truvada to protect at-risk HIV-negative
individuals from HIV infection. PrEP is different from PEP;
the medication is taken before possible exposure. Daily PrEP
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use can lower the risk of getting HIV from sex by more than
90% and from injection drug use by more than 70%. Missing
doses reduces PrEP effectiveness. Truvada is currently the
only FDA drug approved for HIV PrEP. PEP uses ARV medications
to prevent HIV from replicating and spreading through the body
after an exposure to the virus. PEP is a short-term (28-day)
intervention and must be started within three days of an
exposure - sooner, if possible - to be effective. PEP was
originally developed for occupational exposures, such as
needle-sticks in hospitals, but is also effective for sexual
exposures.
4)Research supporting PrEP use. On May 14, 2014, the U.S.
Public Health Service released the first comprehensive
clinical practice guidelines for PrEP. This followed the
earlier publication of brief interim guidelines that were
based on findings from several large national and
international clinical trials. Those trials evaluated PrEP
among gay and bisexual men, heterosexual men and women, and
injection drug users. All participants in the trials received
pills containing either PrEP or placebo, along with intensive
counseling on safe-sex behavior, regular testing for sexually
transmitted diseases, and a regular supply of condoms. In all
of the studies, the risk of getting HIV infection was lower-up
to 92% lower-for participants who took the medicines
consistently than for those who did not take the medicines.
5)CDC guidelines. The most recent federal guidelines for health
care providers recommend that PrEP be considered for people
who are HIV-negative and at substantial risk for HIV
infection. For sexual transmission, this includes anyone who
is in an ongoing relationship with an HIV-positive partner.
It also includes anyone who is not in a mutually monogamous
relationship with a partner who recently tested HIV-negative,
and, is a gay or bisexual man who has had anal sex without a
condom or been diagnosed with asexually transmitted disease in
the past six months; or, a heterosexual man or woman who does
not regularly use condoms during sex with partners of unknown
HIV status who are at substantial risk of HIV infection (e.g.,
people who inject drugs or have bisexual male partners). For
people who inject drugs, this includes those who have injected
illicit drugs in past six months and who have shared injection
equipment or been in drug treatment for injection drug use in
the past six months. Health care providers should also
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discuss PrEP with heterosexual couples in which one partner is
HIV-positive and the other is HIV-negative as one of several
options to protect the partner who is HIV-negative during
conception and pregnancy. The CDC is currently updating
recommendations about use of PEP for HIV prevention.
6)DPH PrEP Navigator Services Program. In the 2015-2016 Budget
Act, the California Legislature appropriated $2 million
annually (General Fund, $1.764 million in local assistance,
$236,000 for state support) to DPH to establish a PrEP
Navigator Services Program to "?ensure access for and serve
the most vulnerable Californians at high risk for HIV." The
primary client target for the PrEP Navigator Services Programs
are gay, bisexual, transgender, or other MSM, transgender
women who have sex with men, and partners of HIV-positive
people with a detectable viral load and/or inconsistent
antiretroviral use. Special emphasis is to be placed on young
gay and bisexual men, young transgender women, and gay and
bisexual men and transgender women of color. The PrEP
Navigator Services Programs established through this funding
are meant to identify, conduct outreach, and provide
culturally competent services to target populations, provide
assistance to participants allowing them to access, enroll in,
and utilize insurance or patient assistance programs to pay
for PrEP, link to PrEP providers, and support adherence to
PrEP and PrEP-related follow-up participants.
FISCAL EFFECT: Appropriation: No Fiscal
Com.:YesLocal: No
According to the Senate Appropriations Committee:
1)Likely ongoing costs in the millions to low tens of millions
to provide PrEP and PEP to high-risk individuals enrolled in
Medi-Cal (General Fund and federal funds). Based on CDC
estimates for the number of individuals at high risk for HIV
infection, Senate Appropriations staff estimates that there
are about 150,000 individuals in the state that would meet CDC
guidelines for using PrEP or PEP. For each 1% of that
population that elects to begin taking PrEP, the proportional
cost to the Medi-Cal program to cover the cost of providing
PrEP would be about $4 million per year. (Costs for PEP would
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be considerable lower, since it is only recommended for 28-day
use, as opposed to ongoing use for PrEP.)
2)Unknown long-term savings to Medi-Cal and the Aids Drug
Assistance Program due to lower HIV infection rates (General
Fund and federal funds). To the extent that the bill does
result in lower HIV infection rates, there would be cost
savings to the Medi-Cal and Aids Drug Assistance Programs.
However, there are some factors that limit the potential cost
savings from the bill. First, it is not known how effective
greater knowledge and use of PrEP and PEP are at the
population level in reducing HIV infection. There are clinical
studies that show a very dramatic decline in HIV infections
amongst users of PrEP. Whether those findings would translate
to the larger population not part of a research study is
unknown. Second, the annual cost to provide PrEP is may not be
substantially less than the current cost to provide treatment
to HIV positive Medi-Cal beneficiaries. The cost that Medi-Cal
would pay for PreP is not public information. However, the New
York State Department of Public Health indicates that annual
costs range from $8,000 to $14,000 per year. Even assuming
that Medi-Cal receives significant discounts, the cost to
provide PreP is likely to be in the thousands per patient per
year. On the other hand, the current average annual cost of
care for an HIV positive Medi-Cal beneficiary is about $15,000
per year.
SUPPORT: (Verified 8/12/16)
AIDS Project Los Angeles (co-source)
Los Angeles LGBT Center (co-source)
Access Support Network
Bienestar Human Services, Inc.
Black AIDS Institute
California Health+ Advocates
California Life Sciences Association
City of West Hollywood
Community Clinic Association of Los Angeles County
Desert AIDS Project
Equality California
Free Speech Coalition
Friends Community Center
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Gender Health Center
JWCH Institute, Inc.
Men's Health Foundation
Our Family Coalition
Positive Women's Network
Project Inform
San Diego LGBT Community Center
San Francisco AIDS Foundation
Tarzana Treatment Centers
Transgender Law Center
UCLA Center for Behavioral and Addiction Medicine
OPPOSITION: (Verified 8/15/16)
AIDS Healthcare Foundation
American College of Emergency Physicians, California Chapter
ARGUMENTS IN SUPPORT: AIDS Project Los Angeles and the Los
Angeles LGBT Center are the co-sponsors of this bill and state
that awareness and use of PrEP and PEP among Californians at
risk for HIV remain extremely low. The sponsors note that in
2015 the California HIV/AIDS Research Program conducted a survey
of young gay and bisexual men and found that only one in 10 had
ever taken PrEP, and although awareness of the intervention was
high overall, awareness was significantly lower among black and
Latino respondents compared to white respondents. The sponsors
also note the majority of respondents lacked the information
needed to make a decision about using PrEP, did not know where
to access PrEP, and that few respondents had ever talked to
their doctor or healthcare provider about PrEP. They conclude
it remains vital to ensure that all individuals at risk for HIV
receive accurate information about PrEP and PEP, particularly
highly-impacted communities of color. Numerous supporters state
that roughly 4,700 individuals are newly diagnosed with HIV in
California each year and PrEP/PEP are highly effective HIV
prevention interventions that could dramatically reduce new
infections. Supporters state that PrEP and PEP are key
components of the National HIV/AIDS Strategy, but awareness and
use of these interventions remain extremely low, and it is vital
to increase awareness and use of PrEP and PEP among communities
at risk for HIV. Equality California states that given the
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effectiveness of PrEP and PEP, it is now critically important to
ensure that individuals receiving an HIV test are also provided
with accurate information about the benefits of these
interventions. Bienestar Human Services writes that this bill
builds on AB 446, which established what information must be
provided to individuals during HIV post-test counseling,
including advising the individual of the need for periodic
retesting and explaining the limitations of current testing
technology. Bienstar states that given the effectiveness of PrEP
and PEP, it is now critically important to ensure that
individuals receiving an HIV test are also provided with
accurate information about the benefits these interventions.
California Health+ Advocates writes that California's clinics
are committed to keeping our patients healthy and this bill will
assist in this mission.
ARGUMENTS IN OPPOSITION: The AIDS Healthcare Foundation (AHF)
states that HIV screening is intended to mirror other screening
tests, which require simple consent only and which do not burden
the process with additional activities that may or may not be
necessary. AHF also notes that guidelines for prevention and
risk reduction are fluid, based on the most recent advice from
the CDC and DPH, and that information to be shared must be
dictated by the needs and circumstances of the person being
tested. Finally, AHF contends that recent changes to California
law that allowed for disclosure of a negative HIV test result on
a secure Web site already minimizes the interaction between the
tester and the test subject post-testing and makes the conveying
of any more than the most basic information in current law less
likely to be useful.
ASSEMBLY FLOOR: 57-20, 6/1/16
AYES: Alejo, Travis Allen, Atkins, Baker, Bloom, Bonilla,
Bonta, Brown, Burke, Calderon, Campos, Chau, Chiu, Chu,
Cooley, Cooper, Dababneh, Daly, Dodd, Eggman, Cristina Garcia,
Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray,
Harper, Roger Hernández, Holden, Irwin, Jones-Sawyer, Levine,
Lopez, Low, Maienschein, Mayes, McCarty, Medina, Mullin,
Nazarian, O'Donnell, Quirk, Ridley-Thomas, Rodriguez, Salas,
Santiago, Mark Stone, Thurmond, Ting, Waldron, Weber, Wilk,
Williams, Wood, Rendon
NOES: Achadjian, Arambula, Bigelow, Brough, Chávez, Dahle, Beth
Gaines, Gallagher, Grove, Jones, Kim, Lackey, Linder, Mathis,
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Melendez, Obernolte, Olsen, Patterson, Steinorth, Wagner
NO VOTE RECORDED: Chang, Frazier, Hadley
Prepared by:Melanie Moreno / HEALTH / (916) 651-4111
8/15/16 20:22:28
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