BILL ANALYSIS Ó
AB 2640
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Date of Hearing: April 5, 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 -approved (FDA)
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 within the Department of Public
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Health (DPH), to coordinate state programs, services, and
activities related to HIV/acquired immune deficiency syndrome
(AIDS).
3)Establishes the AIDS Drug Assistance Program (ADAP) 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 though 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 on 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 of PrEP. In 2015, the CDC estimated
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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 (CHRP)
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
they had never talked to their doctor or healthcare
provider about PrEP.
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
American MSM, are most seriously affected by HIV. By race,
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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 California Office of AIDS 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. 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
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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.
e) 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 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
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pregnancy.
The CDC is currently updating recommendations about use of
PEP for HIV prevention.
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.
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
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.
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Equality California supports this bill, stating 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) is opposed
to this bill and states, 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 their
experience as the largest private tester in the state is that
the more time and demands placed on the person they are
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 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, their concern
is 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
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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, they believe 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 this bill
stating that they oppose codifying standards of practice and
interfering in the physician-patient relationship by
legislating what information a physician should tell a
patient. CHA states this 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.
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
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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,
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,
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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.
REGISTERED SUPPORT / OPPOSITION:
Support
AIDS Project Los Angeles (cosponsor)
Los Angeles LGBT Center (cosponsor)
Access Support Network
Bienestar Human Services, Inc.
California Primary Care Association
Community Clinic Association of Los Angeles County
Desert AIDS Project
Equality California
Community Clinic Association of Los Angeles County
Positive Women's Network
Project Inform
San Francisco AIDS Foundation
Opposition
AIDS Healthcare Foundation
California Hospital Association
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California Medical Association
Analysis Prepared by:Lara Flynn / HEALTH / (916) 319-2097