BILL ANALYSIS Ó
AB 2640
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Date of Hearing: April 19, 2016
ASSEMBLY COMMITTEE ON HEALTH
Jim Wood, Chair
AB 2640
(Gipson) - As Amended March 16, 2016
SUBJECT: Public Health: HIV.
SUMMARY: Requires a medical care provider or person
administering a test for human immunodeficiency virus (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 (FDA) -approved
methods that prevent or reduce the risk of contracting HIV,
including pre-exposure prophylaxis (PrEP) and post-exposure
prophylaxis (PEP), consistent with guidance of the federal
Centers for Disease Control and Prevention (CDC).
EXISTING LAW:
1)Requires a medical provider or person administering a test for
HIV, after receiving results indicating no infection for a
patient who is at high risk for HIV infection, to advise the
patient of the need for periodic retesting and explain the
limitations of current testing technology and the current
window period for verification of results.
2)Establishes the Office of AIDS (OA) within the Department of
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Public Health (DPH), to coordinate state programs, services,
and activities related to HIV/acquired immune deficiency
syndrome (AIDS).
3)Establishes the AIDS Drug Assistance Program within DPH to
subsidize the cost of AIDS drugs for persons who do not have
private health coverage, are not eligible for Medi-Cal, or
cannot afford to purchase the drug privately. Indicates that
the subsidy program is to be funded by state and federal
sources.
FISCAL EFFECT: This bill has not been analyzed by a fiscal
committee.
COMMENTS:
1)PURPOSE OF THIS BILL. According to the author, this bill
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. The author notes that in 2013,
California was second among the 50 states in the number of new
HIV diagnoses, with approximately 5,000 new HIV diagnoses, and
a 2015 survey of individuals at risk for HIV by the California
HIV/AIDS Research Program found that only one in 10
respondents had ever used PrEP. The author concludes,
considering the high volume of new HIV infections being
diagnosed in the state of California and the low awareness of
these medications, it is critical that those being tested are
aware of PEP and PrEP medications.
2)BACKGROUND.
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a) Treatment as Prevention (TasP), PrEP, and PEP. In 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, not after possible
exposure. Daily PrEP 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.
b) Public awareness and use of PrEP. In 2015, the CDC
estimated that one in four sexually active gay and bisexual
men, one in five people who inject drugs, and one in 200
sexually active heterosexual adults meet the criteria for
PrEP. In 2015, the California HIV/AIDS Research Program
conducted a survey of 602 young gay and bisexual men and
found that only one in 10 had ever taken 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
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they had never talked to their doctor or healthcare
provider about PrEP.
Another recent study found that few doctors are prescribing
PrEP to those who could benefit. The study found that out
of more than 1,000 gay and bisexual men, only 83 reported
using PrEP. The author of the study concluded, "The
majority of gay men who are good candidates for PrEP are
not on the medication, and many haven't spoken to their
medical providers about PrEP. We need to get conversations
going, and in general promote more open dialogue between
doctors and patients regarding sexual health." The
findings are from One Thousand Strong, a three-year
observational study of a U.S. national sample of gay and
bisexual men ages 18 to 80 that is now underway.
In its November 24, 2015 Morbidity and Mortality Weekly
Report, the CDC estimated that 1.2 million Americans could
benefit from PrEP, including 492,000 men who have sex with
men (MSM), 115,000 injection drug users, and 624,000
heterosexuals. The report concludes that clinical
organizations, health departments, and community-based
organizations should raise awareness of PrEP among persons
with substantial risk for acquiring HIV infection and their
health care providers.
The FDA first approved the use of ARVs as a form of HIV
prevention for at-risk, HIV-negative individuals in 2012.
Various studies have since demonstrated the efficacy of
PrEP among different populations, however, African American
MSM lag behind in PrEP use despite their disproportionate
HIV incidence and prevalence.
c) HIV in America. More than 1.2 million people in the
United States are living with HIV infection, and almost one
in eight (12.8%) are unaware of their infection. Gay,
bisexual, and other MSM, particularly young African
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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 United States
with an AIDS diagnosis have died overall. 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.
The 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 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.
d) 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
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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.
e) CDC guidelines on PrEP. 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 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.
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f) Cost of PrEP and PEP. Costs for PrEP may include
payment for the medication as well as payment for required
medical visits and laboratory tests. While most public and
private insurance companies cover PEP and PrEP
prescriptions, there is high variability in out-of-pocket
costs such as deductibles or co-pays. Some health plans
cover PrEP at a lower, generic co-pay, while others place
it in a specialty, or higher, more expensive tier. For
individuals without any insurance coverage, the cost is
approximately $12,000 - $15,000 per year. There are
currently several payment assistance programs available
through both the manufacturer and community groups that can
help individuals without insurance, and those with high
out-of-pocket costs through their insurance company.
g) 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
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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.
As a result of a statewide request for applications, on March
3, 2016 OA announced the nine applicants that were selected
to receive funding for the PrEP Navigator Services Program
are as follows:
i) AltaMed Health Services Corporation;
ii) Asian Health Services;
iii) Desert AIDS Project;
iv) Friends Research Institute, Inc.;
v) Humboldt County Department of Health and Human
Services;
vi) Kern County Public Health Services Department;
vii) La Clinica de la Raza, Inc.;
viii) Alta Bates Summit Medical Center; and,
ix) Tarzana Treatment Centers.
3)SUPPORT. AIDS Project Los Angeles and the Los Angeles LGBT
Center are the cosponsors of this bill and they state that
awareness and use of PrEP and PEP among Californians at risk
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for HIV remain extremely low. They 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 proponents 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.
Equality California 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 of these
interventions.
4)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 asserts that its experience as the largest
private tester in the state is that the more time and demands
placed on the person it is encouraging to be tested, the more
likely the person is to decline. 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
website 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
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likely to be useful.
The California Medical Association (CMA) is opposed to this bill
stating, increased awareness of preventative treatment options
for HIV should be a public health goal, however, it is
concerned that the increased medical resources required to
accomplish the goal of this bill are not worth the benefit of
the mandate. CMA notes that many preventative treatment
options are not appropriate for every patient, and this bill
would require a physician to inform the patient of a treatment
option the physician might actually recommend against. CMA
also notes that a physician is already required to provide a
patient who tests positive with treatment and counseling
options as well as mandated to schedule follow up appointments
with relevant specialists. CMA concludes, for patients who
test negative for HIV, it believes it is best left to the
physician's clinical judgment as to what preventative
treatment options should be given to the patient.
The California Hospital Association (CHA) opposes codifying
standards of practice and interfering in the physician-patient
relationship by legislating what information a physician
should tell a patient. CHA states this bill would eliminate
the physician's medical judgment as to what information or
treatment is in the best interest of the patient. CHA also
contends that this bill would eliminate the medical provider's
option to refer the patient to another, more appropriate
physician for prevention counseling and explains, the option
to refer the patient to another physician is very important -
many physicians who may order an HIV test, such as hospital
emergency physicians and psychiatrists, do not routinely treat
infectious disease patients as part of their practice. They
instead refer such patients to internal medicine physicians or
infectious disease specialist who keep themselves up-to-date
on the most recent pronouncements and guidance from the FDA
and the CDC. CHA concludes that medical discussion should be
between the patient and the physician.
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5)RELATED LEGISLATION. AB 2439 (Nazarian) would require every
hospital emergency department, if it otherwise draws blood
from a patient, to offer to test that blood for HIV with the
patients consent. AB 2439 is pending in the Assembly Health
Committee.
6)PREVIOUS LEGISLATION.
a) AB 446 (Mitchell), Chapter 589, Statutes of 2013,
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 laboratories from the informed consent
requirements; requires every patient who has blood drawn at
a primary care clinic, as defined, 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 if the HIV test subject is anonymously tested.
b) AB 491 (Portantino) of 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
website if specified conditions were met. AB 491 was
amended to deal with a different subject matter.
c) AB 1894 (Krekorian), Chapter 631, Statutes of 2008,
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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.
d) 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.
7)SUGGESTED AMENDMENT. As currently drafted, this bill requires
the medical provider or person who administers an HIV test to
provide a patient who tests negative for HIV with information
on the effectiveness and safety of all FDA approved methods
that prevent or reduce the risk of contracting HIV, including
PrEP and PEP. While it is a valid goal to improve awareness
and use of PrEP and PEP, that treatment may not be appropriate
for every patient. The Committee may wish to amend this bill
to instead require that written information be provided to all
persons who test negative regarding all methods that prevent
or reduce the risk of contracting HIV, including, but not
limited to, PrEP and PEP.
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REGISTERED SUPPORT / OPPOSITION:
Support
AIDS Project Los Angeles (cosponsor)
Los Angeles LGBT Center (cosponsor)
Access Support Network
Bienestar Human Services, Inc.
Black AIDS Institute
California Primary Care Association
Community Clinic Association of Los Angeles County
Desert AIDS Project
Equality California
Free Speech Coalition
Friends Community Center
Gender Health Center
JWCH Institute
Our Family Coalition
Positive Women's Network
Project Inform
San Francisco AIDS Foundation
Tarzana Treatment Centers, Inc.
UCLA Center for Behavioral and Addiction Medicine
Opposition
AIDS Healthcare Foundation
California Hospital Association
California Medical Association
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Analysis Prepared by:Lara Flynn / HEALTH / (916) 319-2097