BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Deborah V. Ortiz, Chair
BILL NO: AB 2280
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AUTHOR: Leno
B
AMENDED: June 15, 2006
HEARING DATE: June 21, 2006
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FISCAL: Appropriations
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CONSULTANT:
0
Patterson / ak
SUBJECT
Sexually transmitted diseases
SUMMARY
This bill requires the Department of Health Services (DHS)
to develop a counseling model for all persons who receive
human immunodeficiency virus (HIV) testing at a clinic that
receives funding for HIV testing. The bill also expands
provisions of current law to allow specified medical
providers to offer patient-delivered therapy to partners of
individuals diagnosed with gonorrhea or other
sexually-transmitted diseases.
ABSTRACT
Existing law:
1.Provides for various programs relating to treatment of
persons HIV and the acquired immune deficiency syndrome
(AIDS).
2.Requires an individual to provide informed consent prior
to taking an HIV test.
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3.Requires DHS to authorize training programs for
counselors participating in publicly funded HIV testing
programs.
4.Permits specified health care providers who diagnose a
sexually transmitted chlamydia infection to prescribe,
dispense, furnish and/or otherwise provide prescription
antibiotic drugs to that patient's sexual partner(s)
without examination of the partner(s), commonly referred
to as patient-delivered therapy.
This bill:
1.Makes a number of findings and declarations regarding the
incidence of sexually-transmitted diseases, including
gonorrhea, and best practice models of HIV counseling and
testing.
2.Requires DHS, no later than July 1, 2007, to develop a
counseling model for all persons who receive HIV testing
at a test site or clinic that receives state funding for
HIV testing, and requires DHS to consider including the
following in the counseling model:
a. A brief risk-assessment mechanism developed by DHS
that allows a clinic to ascertain whether a person
seeking testing is at low or high risk of exposure to
HIV.
b. A data collection form that may be
self-administered by the test subject, and that
includes only questions that must be reported in
accordance with existing state and federal
epidemiology report requirements.
c. A prevention education module that comprehensively
covers all pertinent information relative to methods
by which a person can protect himself or herself or
his or her sexual needle-sharing partners from
exposure to HIV.
d. Flexibility for clinics to determine the extent of
counseling provided to a test subject based on a test
subject's risk factors or frequency of HIV testing.
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e. Flexibility for clinics to provide counseling to
couples or small groups, as appropriate.
f. Additional counseling for a test subject whose
preliminary test result is positive including, as
needed by the test subject, emotional support,
information on confirmatory testing, referral to care
and treatment opportunities, and a review of methods
to prevent exposing others to HIV.
3.Requires DHS to develop a reimbursement schedule that
accurately reflects the range of services provided under
this model and ensures that a contractor is reimbursed
for individual services.
4.States that it is the intent of the Legislature that the
reimbursement schedule be designed to encourage
contractors to provide only those services that are
appropriate for each test subject and that this new model
and reimbursement schedule be cost-neutral, except to the
extent that there is an increase in the volume of test
subjects.
5.Permits a physician, nurse practitioner and other
specified health care providers who diagnoses specified
sexually transmitted diseases in a patient to prescribe,
dispense, furnish and/or otherwise provide prescription
antibiotics to the patient's sexual partner(s) without
examination of the partner(s).
6.Requires DHS to determine if a given sexually-transmitted
disease is suitable for patient-delivered therapy.
FISCAL IMPACT
According to the Assembly Appropriations Committee, there
would be general fund costs in excess of $1 million
annually assuming this bill results in a counseling model
that permits greater testing volume. For example, if there
is a 25 percent increase in testing as a result of changes
made to the counseling model, costs would increase by $1.7
million. These costs may be partially offset if the
counseling model results in lower reimbursement for
counseling. This bill states legislative intent that the
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new counseling model and reimbursement schedule be
cost-neutral, except to the extent that there is an
increase in the volume of test subjects.
The patient-delivered therapy provision of AB 2280 may have a
negligible fiscal impact on the state. To the extent the spread
of gonorrhea is reduced by allowing partners to be treated
without examination, the Medi-Cal program could realize savings
in treatment costs.
BACKGROUND AND DISCUSSION
Purpose of the bill
According to the author, this bill seeks to reduce
sexually-transmitted disease through two different mechanisms.
The first is to increase HIV testing in California by
streamlining the HIV test counseling process contractually
mandated by the state on local health jurisdictions and their
contracted service providers. Some testing organizations are
having difficulty testing all the people who wish to be tested
because existing counseling protocols demand unnecessary
attention to low risk and repeat testers. The purpose of AB
2280 is to focus resources where they are needed most -
counseling high-risk and first time test subjects. A
reassessment of best practices and innovations to be considered
by DHS in the bill is long overdue.
The second mechanism expands a public health policy enacted into
law by SB 648 (Ortiz, 2000) which authorized qualified medical
practitioners to provide antibiotics to the sex partners of
patients diagnosed with chlamydia without a medical examination
of the partner or partners. The author is now seeking to expand
this authorization to include gonorrhea and other
sexually-transmitted diseases as determined by the department.
This will implement a sound public health policy on gonorrhea
and eliminate the need to go to the Legislature each time
patient-delivered therapy is proven effective for another
sexually-transmitted disease.
Since enactment of patient-delivered therapy for chlamydia,
published studies have documented that the rate of persistent or
recurrent infections of gonorrhea also can be reduced by
utilizing patient-delivered therapy for sex partners.
Patient-delivered therapy for gonorrhea is safe and effective
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when provided with appropriate instruction, and has recently
been recommended by the federal Centers for Disease Control. AB
2280 will reduce persistent and recurrent gonorrhea infections
by expanding a successful practice already in place for
chlamydia. Authorizing qualified medical practitioners to
provide patient-delivered therapy to the sex partners of
patients diagnosed with gonorrhea is a sensible public health
measure and will reduce gonorrhea infections in California.
HIV/AIDS
According to DHS, as of March 2006, there are a total of 41,155
reported cases of HIV, and 140,435 reported cases of AIDS in
California. Adult males comprise 85 percent of the HIV cases,
and 91 percent of AIDS cases in California, but women are the
fastest growing population with AIDS in the state.
Both national and California HIV infection and AIDS case
reporting data show that African Americans are
disproportionately affected by HIV/AIDS. According to the
National Center for Health Statistics, AIDS is the leading
cause of death among African American women ages 25-34 and
African American men ages 35-44. AIDS is one of the top
three causes of death for African American men ages 25-54
and African American women ages 35-44. Although African
Americans constitute approximately 7 percent of
California's population, they comprise 18 percent of the
total number of AIDS cases in California, and 19 percent of
HIV cases.
Latinos are a growing population in California and
currently represent over 35 percent of the state
population. Latinos represent 26 percent of all HIV cases
in California, and 22 percent of all AIDS cases.
Throughout the HIV/AIDS epidemic, California Latino AIDS
cases have been significantly younger at diagnosis than
other racial/ethnic groups. In California, through July 31,
2005, 30 percent of Latinas and 23 percent of Latino males
were younger than 30 when diagnosed with AIDS. Among
Latina AIDS cases in California, 55 percent have been
attributed to heterosexual contact and 22 percent to
injection drug use.
Latino and African American women are infected in greater
numbers than their share of the population. This shows the
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shift in populations affected by the epidemic. For
California women, sex with an HIV-infected male is the most
common route of transmission. Sharing infected needles and
syringes is the second most common route of transmission
for women.
HIV Test Counseling
Counseling for individuals obtaining an HIV test has been a
part of testing protocol for over 20 years. The intent of
the counseling is to educate people about HIV and how to
prevent exposure to the virus, to collect epidemiological
data, and to provide service or referrals to individuals
who test positive.
There are a variety of publicly-funded venues in which HIV
counseling and/or testing may occur, including family
planning clinics, primary care clinics, alcohol and drug
treatment facilities, and mobile testing vans. There are
also alternative test sites which, per statute, must only
provide free and anonymous testing.
Individuals arriving at a publicly-funded testing site must
be informed of a variety of options available to them prior
to testing for HIV. Counselors must explain a variety of
items prior to testing, including:
1. The meaning of anonymous versus confidential HIV
testing including an explanation of non-names HIV
reporting.
2. Information about standard versus rapid testing.
The counselor explains that for standard testing, the
individual must return after a week or two to receive
test results, and that results from rapid HIV tests
would be available within approximately 20 minutes.
Counselors also explain that the positive results from
the rapid HIV test are only preliminary and require
confirmation.
3. Sample collection requirements for each type of
testing. For example, the individual would need to be
informed that certain types of available testing may
involve a finger stick or an oral fluid sample.
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Once the individual has selected the type of test they wish
to take and provided informed consent, the counselor must
briefly summarize the process, explaining where the client
will go and with whom, what will happen, and approximately
how long it will take.
If the individual chooses a rapid HIV test, he or she will
go through a risk assessment and counseling while waiting
for the test results. The risk assessment includes a
detailed counseling information form that the counselor
fills out based on information provided by the individual.
Questions on the form include demographic information,
reasons for testing, detailed sexual history information,
substance use history, and history of risk for other types
of sexually-transmitted diseases. The risk assessment also
includes counseling on behaviors that may increase risk of
HIV infection, and on setting goals to reduce risks.
Pre-disclosure counseling is another component of the risk
assessment that involves assessing the individual's
readiness to receive their test results.
Once the counselor is confident that the client is prepared
to receive his or her test result, the counselor will
follow site-specific protocols to retrieve and disclose the
test result. According to DHS' 2003 policies and
procedures manual on rapid HIV testing, the optimal length
of the counseling session, including test taking, results
disclosure, and counseling and referrals for positive test
results, should take approximately 30 to 50 minutes.
DHS' policies and procedures manual states that the rapid
HIV test shall be given immediately after the individual
has provided informed consent so that the risk assessment
can take place during the waiting time for test results.
However, according to AIDS Healthcare Foundation (AHF),
some test sites require that the risk assessment be
conducted prior to the actual testing. This may prolong
the duration of the counseling session. Additionally, AHF
states that the risk assessment form monopolizes a
substantial portion of the counseling time, and it is
unclear how much of the data is used after it is housed at
the DHS Office of AIDS.
State law does not address the HIV test counseling model
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that has been developed by DHS. Test counseling processes
are enforced through local contract compliance. The author
states that some testing organizations are required through
contract compliance to engage in lengthy processes that may
not be most appropriate for their client base and that
limit the number of people who can be tested. For example,
the same protocols are used for individuals who are testing
for the first time as well as individuals who may regularly
test.
The author contends that the counseling model should be
more flexible so that the counseling protocols do not
demand that unnecessary attention be given to low-risk and
serial testers. This bill would require DHS to consider
various factors that may give testing sites the flexibility
to determine the extent of counseling provided to a test
subject based on their risk factors and frequency of
testing.
According to DHS Office of AIDS, concerns have been
expressed by local health jurisdictions and community-based
organizations involved in HIV testing regarding the
existing counseling model and reimbursement rates. DHS
Office of AIDS conducted an internal analysis of the
program and have engaged stakeholders in a thorough program
review. They state that they recognize that additional
flexibility in the counseling model is needed. On May 17,
2006, they convened a one-day stakeholder meeting in
Sacramento to discuss changes in the programmatic
requirements and the reimbursement schedule of the HIV
counseling and testing program.
Gonorrhea
Gonorrhea is a sexually-transmitted disease caused by a
bacterium that can grow and multiply easily in the areas of
the reproductive tract, including the cervix, uterus, and
fallopian tubes in women, and in the urethra (urine canal)
in both women and men. The bacterium can also grow in the
mouth, throat, eyes, and anus.
Gonorrhea is a very common infectious disease. CDC
estimates that more than 700,000 persons in the U.S. get
new gonorrheal infections each year. Only about half of
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these infections are reported to CDC. Gonorrhea is spread
through sexual contact and can also be spread from mother
to baby during delivery. People who have had gonorrhea and
received treatment may get infected again if they have
sexual contact with a person infected with gonorrhea.
Untreated gonorrhea can cause serious and permanent health
problems in both women and men. In women, gonorrhea is a
common cause of pelvic inflammatory disease (PID) which can
damage the fallopian tubes enough to cause infertility or
increase the risk of ectopic pregnancy. In men, gonorrhea
can cause conditions that could lead to infertility if left
untreated.
According to DHS, in 2005 there were approximately 34,350
cases of reported gonorrhea in California. This marks a
significant increase from the 22, 263 cases reported in
2002. Men comprise 18,357 of these current cases, with
women making up the remainder. African Americans make up
8,760 cases, Latinos make up 7,285 cases and Caucasians
comprise 6,060 cases.
Gonorrhea may be successfully treated with antibiotics.
Other bacterial sexually-transmitted diseases including
PID, chlamydia, syphilis, and chancroid can also be treated
with antibiotics. Viral sexually-transmitted diseases such
as herpes, or human papilloma virus (HPV) cannot be treated
with antibiotics.
According to a 2005 study published by the New England
Journal of Medicine, many sex partners of persons with
gonorrhea are not treated, which leads to frequent
re-infections and further transmissions. In the study,
women and heterosexual men with gonorrhea or chlamydial
infections were randomly assigned to have their partners
either receive expedited treatment or standard referral.
Patients in the expedited treatment group were offered
antibiotics to give to their partners without an
examination of the partner (referred to as
patient-delivered therapy). Patients in the standard
referral group were advised to refer their partners for
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treatment, but were not given antibiotics to give to the
partner.
The study concluded that patients in the expedited
treatment group were more likely to report that all of
their partners were treated for gonorrhea or chlamydia than
those in the standard referral group. Expedited treatment
of sex partners reduces the rates of persistent or
recurrent gonorrhea or chlamydial infections.
The study also stated that the benefits of expedited
treatment must be weighed against potential adverse effects
of treating individuals with antibiotics without an
examination. Some may have allergic reactions to
antibiotics, or may currently take medication that should
not be combined with antibiotics. No adverse drug-related
effects were reported by the patients in the study.
Patient-delivered therapy for chlamydia was authorized in
California by the passage of Senate Bill 648 (Ortiz, 2000)
and enables qualified medical practitioners to provide
prescription antibiotic drugs to a patient's sexual partner
or partners without examination of that patient's partner
or partners.
This bill would expand the provisions of the law by
allowing a physician who has diagnosed a patient with
sexually transmitted gonorrhea or other sexually
transmitted infection, to prescribe antibiotics to the
patient's sexual partner(s) without examination of the
partner. The bill would also allow a nurse practitioner,
certified nurse-midwife, and a physician assistant to
dispense, furnish or provide antibiotics to the patient's
sexual partner(s) without examination of the partner(s).
The bill would require DHS to determine the
sexually-transmitted diseases, aside from gonorrhea, that
would allow for the provision of antibiotics without
examination.
Relevant legislation
SB 648 (Ortiz, Chapter 835, Statutes of 2000) authorizes
a physician to prescribe, and a nurse practitioner, a
certified nurse midwife and a physician assistant to
dispense, furnish, or otherwise provide prescription
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antibiotic drugs to a patient's sexual partner or
partners without examination of that patient's partner or
partners.
SB 699 (Soto, Chapter 20, Statutes of 2000) requires HIV
cases to be reported to the local health officer by name
rather than by code and requires local health officers to
report HIV cases by name to DHS, thereby meeting federal
requirements.
Arguments in support
Supporters state that best practice models of HIV testing
have not kept pace with the changes in the HIV/AIDS
epidemic. The availability of rapid HIV testing has
created opportunities to streamline the current counseling
model, especially for test subjects who are at low-risk for
HIV or who are repeat clients who are tested on a regular
basis and must undergo the same counseling protocol
repeatedly. Streamlining the HIV test counseling model
will enable local health agencies and service providers to
focus counseling resources on those who need the most,
while increasing capacity to accommodate everyone who seeks
HIV testing.
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COMMENTS AND QUESTIONS
1.Counseling model and reimbursement schedule. The
counseling model and reimbursement schedule are currently
mandated through contracts between local health
jurisdictions and DHS, and the author's intent is for DHS
to update the current counseling model. According to
DHS, legislation is unnecessary in order to achieve this
goal as changes could be accomplished through changes in
contractual agreements.
2.Drafting error. The senate bill number referenced on
page 3, line 39 is incorrect. It should read "648"
rather than "658." The author accepts the amendment to
correct this drafting error.
PRIOR ACTIONS
Assembly Floor: 80 - 0 Pass
Assembly Appropriations: 18 - 0 Do Pass
Assembly Health: 12 - 0 Do Pass as Amended
POSITIONS
Support: AIDS Healthcare Foundation (sponsor)
American College of Obstetricians & Gynecologists
(California)
Bienestar Human Services, Inc.
California National Organization for Women
Center for AIDS Research, Education and Services
Drug Policy Alliance Network
Gay & Lesbian Adolescent Social Services
Lambda Letters Project
San Francisco AIDS Foundation
Oppose:None registered.
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