BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 2640
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|AUTHOR: |Gipson |
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|VERSION: |April 21, 2016 |
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|HEARING DATE: |June 29, 2016 | | |
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|CONSULTANT: |Melanie Moreno |
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SUBJECT : Public health: HIV
SUMMARY : 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, preexposure prophylaxes and postexposure
prophylaxes, consistent with guidance of the federal Centers for
Disease Control and Prevention.
Existing law:
1)Places certain requirements on the information shared by
medical providers with patients for HIV testing, including
informing the patient that the test is planned, providing
information about the test, informing 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 advising the
patient that he or she has the right to decline the test. If a
patient declines the test, the medical care provider shall note
that fact in the patient's medical file.
2)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
AB 2640 (Gipson) Page 2 of ?
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, preexposure prophylaxes (PrEP) and
postexposure prophylaxes (PEP), consistent with guidance of the
federal Centers for Disease Control and Prevention (CDC).
FISCAL
EFFECT : According to the Assembly Appropriations Committee, to
the extent this bill raises awareness of drug therapy for people
at high risk for HIV, this bill could potentially increase demand
for and utilization of drug treatment for HIV prevention,
particularly PrEP. According to the New York State Department of
Health, Truvada, the drug used in PrEP therapy, costs between
$8,000 and $14,000 per year. Medi-Cal prices for the drug are
unknown, but even assuming significant discounts are available,
costs to Medi-Cal could be in the millions annually if even a few
hundreds more people a year take the medication (General
Fund/federal). To the extent increased utilization with PrEP
among high-risk populations reduces the number of HIV infections,
there would be offsetting cost savings for less HIV/AIDS
treatment in Medi-Cal and the AIDS Drug Assistance Program.
Costs to the California Department of Public Health (DPH) to
produce updated written material, and to modify HIV counselor
training, are minor and absorbable.
PRIOR
VOTES :
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|Assembly Floor: |57 - 20 |
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|Assembly Appropriations Committee: |14 - 6 |
AB 2640 (Gipson) Page 3 of ?
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|Assembly Health Committee: |12 - 5 |
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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 fifty 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 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 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 DPH's Office of AIDS
(OA), with treatment costs averaging around $23,000 per year,
lifetime treatment is currently estimated at around $740,000 or
AB 2640 (Gipson) Page 4 of ?
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 (ART) 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, 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.
4)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
AB 2640 (Gipson) Page 5 of ?
respondents indicated 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.
5)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.
6)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
AB 2640 (Gipson) Page 6 of ?
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.
7)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.
8)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
AB 2640 (Gipson) Page 7 of ?
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.
9)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 set to be heard in this Committee
on June 29, 2016.
10)Prior legislation. AB 446 (Mitchell, Chapter 589, Statutes of
2013), revised 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.
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.
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.
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
AB 2640 (Gipson) Page 8 of ?
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.
11)Support. AIDS Project Los Angeles and the Los Angeles LGBT
Center are the cosponsors 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 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
AB 2640 (Gipson) Page 9 of ?
accurate information about the benefits these interventions.
CaliforniaHealth+ Advocates writes that California's clinics
are committed to keeping our patients healthy and this bill
will assist in this mission.
12)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 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) states that 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 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.
13)Author's amendments. The author requests the Committee approve
the following amendment to clarify that information about PrEP
and PEP can be provided orally or in writing:
On page 3, line 33:
"?period for verification of results, provide written
information about?"
AB 2640 (Gipson) Page 10 of ?
SUPPORT AND OPPOSITION :
Support: AIDS Project Los Angeles (sponsor)
Access Support Network
Black AIDS Institute
Bienestar Human Services, Inc.
California Health+ Advocates
California Life Sciences Association
City of West Hollywood
Community Clinic Association of Los Angeles County
Desert AIDS Project
Free Speech Coalition
Friends Community Center
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
California Life Sciences Association
Oppose: AIDS Healthcare Foundation
American College of Emergency Physicians, California
Chapter
California Hospital Association
California Medical Association
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