BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Deborah V. Ortiz, Chair
BILL NO: SB 409
S
AUTHOR: Kehoe
B
AMENDED: April 27, 2006
HEARING DATE: May 3, 2006
4
FISCAL: Floor / URGENCY
0
9
CONSULTANT:
Machi / ak
~29.10 - Concurrence of Assembly Amendments~
SUBJECT
Emergency health care services: appropriations.
SUMMARY
This bill would appropriate from the General Fund
$5,451,000 to the State Department of Health Services (DHS)
and $1,622,000 to the Emergency Medical Services Authority
(EMSA) for the 2005-06 fiscal year, for specified public
health purposes.
ABSTRACT
Existing law:
1.Establishes DHS for the administration and oversight of
various health care programs.
2.Establishes EMSA for the coordination and integration of
all state activities concerning emergency medical
services.
This bill:
1.Appropriates from the General Fund $5,451,000 to DHS and
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$1,622,000 to EMSA for the 2005-06 fiscal year, for
specified public health purposes as follows:
To DHS:
$76,000 to oversee management of antiviral
supplies, vaccines, and medical supplies that need to
be obtained and distributed during a pandemic;
$415,000 to provide expanded capacity in the
Microbial Diseases Laboratory and the Viral and
Rickettsial Diseases Laboratory to implement new tests
to control infectious diseases and to purchase a
portable Raman Infrared Microscopy System and a
portable Gas Chromatographic/Mass Spectroscopy System
for the state laboratory in Richmond;
$460,000 to purchase doses of antiviral supplies
used in the prevention or treatment of influenza; and,
$4.5 million to strengthen pandemic influenza
planning efforts, conduct epidemiologic investigations
of infectious and communicable disease outbreaks, and
provide epidemiologic and statistical support as
requested.
To EMSA:
$1.6 million for the purchase and provision of
personal protective equipment (PPE) for fire and
ambulance personnel who agree, through a contract with
EMSA or the local emergency medical services agency.
Recipients of PPE are required to replace the
equipment, as necessary, and to provide necessary,
ongoing training on the use of equipment.
1.Exempts the funds appropriated under this bill from State
Contract Act requirements, in order to rapidly implement
pandemic influenza planning and preparedness efforts,
contracts or other agreements entered into for pandemic
influenza planning or preparedness activities.
2.Declares that it is to take effect immediately as an
urgency statute.
FISCAL IMPACT
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The Governor's proposed 2006-07 DHS budget appropriates
$45.8 million (GF), $103.8 million in federal funds, and
provides 162.8 positions to support California's public
health system's capacity to respond to various events,
including bioterrorism, outbreaks of infectious diseases,
and other public health threats.
BACKGROUND AND DISCUSSION
Purpose of the legislation
According to the author, this urgency bill appropriates $7
million to enhance California's ability to respond to
public health emergencies, whether naturally occurring or
resulting from terrorism.
The author states that the appropriation in this bill for
DHS is intended: to strengthen DHS' response to public
health emergencies, including pandemic influenza;
strengthen the DHS laboratory infrastructure and staffing,
expand the state's disease surveillance; and, improve DHS'
ability to respond to pandemic influenza and other natural
and intentional disasters that can jeopardize public
health.
The author states that the appropriation in this bill for
EMSA is intended to purchase PPE for 1,500 private
ambulance units through grants from local Emergency Medical
Services (EMS) agencies. This equipment will ensure that
emergency personnel have a greater level of protection to
enable an all hazard response, with an emphasis on
chemical, biological, radiological, nuclear and explosive
events. EMSA indicates approximately 28 percent of the
ambulances in California have sufficient PPE to respond to
terrorism events and disasters.
Pandemic influenza preparedness
DHS states that one of the most important public health
issues facing California is the threat of pandemic
influenza. As of January 2006, a pandemic influenza strain
does not exist, but a new strain of avian influenza has
been spreading in bird populations. As of April 4, 2006,
there were 191 confirmed human cases and 108 deaths from
avian flu in nine nations.
Since December 2003, this new strain of avian influenza,
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Avian Influenza A (H5N1), has spread through domestic and
wild bird populations in a number of countries in Asia
(most recently, Siberia, Russia, and Turkey) and is now
considered to be endemic (entrenched and continually
present). The World Health Organization (WHO) and other
experts warn that the threat of pandemic influenza from
Avian Influenza A (H5N1) is imminent and will have
devastating consequences that extend beyond health and
medical systems, into every sector of society. For a
pandemic to occur a novel influenza A virus must emerge; it
must cause serious disease in humans; and it must have the
capability to spread easily from person to person. Two of
these three conditions for a pandemic have been met: 1)
the novel virus Avian Influenza A (H5N1) has appeared, for
which no immunity exists in the population; and 2) it has
caused disease in humans. As of December 7, 2005, the
cumulative number of human cases of Avian Influenza A
(H5N1) since December 2003 was 135 cases with 69 deaths,
for a fatality rate of 51 percent.
DHS states that according to WHO criteria, we are in a
global pandemic alert phase for Avian Influenza A (H5N1)
[i.e. there are human infections but no human-to-human
spread]. Should this progress to a full pandemic, the
appropriate use of vaccination and antiviral medications
may reduce morbidity and mortality and diminish the
overwhelming demands that will be placed on the healthcare
system. Conservative estimates of the impact in California
during an influenza pandemic are that 5.5 - 12.7 million
persons will become ill, 2.9 - 6.9 million persons will
seek outpatient care, and 72,000 -145,000 will require
hospitalization.
According to DHS, federal, state and local government will
be involved in responding to a pandemic influenza. The
Centers for Disease Control and Prevention (CDC) is
stockpiling a small supply of drugs and making preparations
to acquire and distribute relevant vaccines upon their
development. During a pandemic, federal supplies will be
sent to state authorities responsible for distributing the
materiel to local health departments (LHDs). LHDs will
then be responsible to offer vaccination (when available)
and dispense antivirals for treatment or prophylaxis to the
public. California has not developed a cache of drugs or
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medical supplies to augment local or federal reserves for
the purpose of treating or protecting the public, because
the state has not been faced with a pandemic of this
magnitude in recent times. Relatively small emergency
inventories of these products are found in many hospitals,
drug wholesalers, and some LHDs.
Antiviral stockpiles
DHS states that the California Pandemic Influenza Response
Plan, in accordance with the United States Health and Human
Services Agency (USHHS) Pandemic Influenza Plan, identifies
responsibilities for DHS including the acquisition of oral
antivirals, vaccines, and other medical supplies (e.g.,
intravenous fluids, antibiotics and other pharmaceuticals,
ventilators, and syringes). DHS is also responsible for
receiving and storing those pharmaceuticals and
distributing them to the local level during a response to a
pandemic. According to DHS, managing the large volume of
doses potentially numbering in the millions, regardless of
whether they are owned by the state or acquired from
federal sources in an emergency, will require the
development of a strong program operating under careful
management.
DHS states that currently there is no effective vaccine
against the H5N1 virus, which has been detected as the
cause of the avian influenza cases. Active development is
in process along with significant changes in vaccine
manufacturing approaches. According to DHS, USHHS has
stated that it expects vaccine against the virus strain
will be available within six months of identification of
the strain in humans. According to DHS, USHHS recommends
that state health departments be responsible for vaccine
distribution and use. This proposal addresses the
functions of receiving and distributing vaccine when it is
available and monitoring supplies and distribution.
The USHHS 2005 Pandemic Influenza Plan recommends the
development of state-based antiviral stockpiles. DHS plans
to use antivirals to strategically contain small disease
clusters in California and thus potentially slow the spread
of the virus, particularly until a vaccine is available.
The California Pandemic Influenza Response Plan defines
responsibility for management of supplies of antivirals.
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The uses of antivirals in the management of initial cases
of novel influenza, such as Avian Influenza A (H5N1), are
to: 1) treat suspected or confirmed cases; 2) prophylax
close contacts including family, schoolmates, workmates,
healthcare providers, public health first responders and
other essential personnel (i.e. preventative treatment);
and 3) contain community-based, small disease clusters. If
this virus adapts to humans and begins to spread through
the community, there will be an immediate need for
treatment and prophylaxis of patients, close household
contacts, healthcare workers, public health first
responders and other essential personnel. California's 450
acute care hospitals, 650,000 first responders, and
numerous occupational and public health providers will be
on the front lines of the response and may require
protection through antiviral medication treatment or
prophylaxis. It is likely this demand will rapidly deplete
national and local supplies of these medications.
Infectious disease laboratory infrastructure
According to DHS, California's preparedness for public
health emergencies - whether naturally-occurring or
resulting from a terrorist act - is built upon the adequacy
of the state's laboratory capacity. Timely and accurate
laboratory services are essential to identifying infectious
disease agents. Adequate laboratory capacity requires
state-of-the art facilities and equipment, highly trained
staff, and surge capacity to respond to crises.
Since the mid-1970s, the public health system has seen the
emergence of new or altered pathogens such as HIV,
Legionnaires' disease, Hepatitis C, Lyme disease,
Escherichia coli O157:H7, Salmonella typhimurium DT104,
Cryptosporidiosis, Cyclospora, Hantavirus, West Nile virus,
SARS, and Avian Influenza. Over the past two years, a new
strain of Avian Influenza A (H5N1) has spread through
poultry populations in 13 countries in Southeast Asia,
China, Mongolia, Russia, and Siberia. The longer the virus
circulates in chickens, ducks, and other animals, the
greater the risk of human cases and a genetic shift
allowing person-to-person transmission, initiating a
pandemic. In late February 2005, WHO officials warned that
the world is in grave danger of a deadly pandemic triggered
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by the virus, and urged governments to prepare for a
pandemic while acting swiftly to control the spread of the
Avian Influenza A (H5N1).
DHS states that in addition to emerging threats, public
health faces challenges from the re-emergence of pathogens
such as syphilis, the development of drug resistant forms
of pathogens such as gonorrhea and tuberculosis, and the
threat of bioterrorism from pathogens such as anthrax and
smallpox.
DHS' infectious disease laboratories, comprising the
Microbial Diseases Laboratory and the Viral and Rickettsial
Diseases Laboratory, provide the laboratory support,
technical assistance, and research necessary for
diagnosing, investigating, and controlling infectious
diseases in California.
Examples of the DHS' infectious disease laboratory
activities include:
supporting epidemiologic investigations to control
outbreaks of foodborne and waterborne diseases (e.g.,
Salmonella, Escherichia coli O157:H7, norovirus),
determining sources of adulteration, and supporting
product recall or quarantine by regulatory agencies;
supporting childhood vaccination programs regarding
the prevalence and incidence of disease in children,
targeted groups for vaccination, and emerging strains
causing illness not covered by current vaccination
regimens (e.g., whooping cough, meningococcal
meningitis, measles virus);
working with DHS' Vector Borne Disease Section to
conduct surveillance of recreational camping and
aquatic facilities for plague-carrying rodents;
confirming the presence or absence of bioterrorism
agents (e.g., anthrax, plague, smallpox);
supporting active surveillance, control, and
prevention of tuberculosis in immigrants entering
California from Southeast Asia and the Pacific Rim by
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isolating these organisms from infected persons or
travelers;
providing information about circulating influenza
strains, especially with reference to new or emerging
epidemic or pandemic strains;
investigating outbreaks of gastrointestinal
illness;
performing HIV strain typing and viral load
testing;
conducting arbovirus surveillance, including West
Nile virus; and
conducting surveillance for tick-borne rickettsial
diseases such as Ehrlichia.
In addition, DHS' infectious disease laboratories are the
definitive resource for county public health laboratories
regarding isolating and identifying infectious agents. In
addition to this reference laboratory role, DHS' infectious
disease laboratories serve as the basic public health
laboratory for those counties without public health
laboratory services (Alpine, Amador, Colusa, Del Norte,
Glenn, Inyo, Lake, Lassen, Mariposa, Modoc, Mono, Nevada,
Plumas, Sierra, Siskiyou, Tehama, Trinity, and Tuolumne).
In addition, the DHS laboratories train local public health
laboratory personnel in state-of-the-art standardized
laboratory procedures.
Role of local health departments (LHDs) in pandemic
influenza
In California, DHS and 61 LHDs share responsibility for
public health. Preparing for an influenza pandemic
requires extraordinary levels of planning by both DHS and
LHDs. California's LHDs are the point of direct delivery
for public health services, and in emergencies, provide
response within their capability. These responsibilities
include identification and control of infectious diseases
within the jurisdiction.
The magnitude of the emergency management activities
required to prepare for pandemic influenza exceeds LHDs'
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resources. Since 2001, LHD public health emergency
preparedness has been funded with federal CDC Bioterrorism
Cooperative Grant funds. However, these funds are
shrinking; the total allocation to all LHDs in the current
year is approximately $3 million less than in grant year
2004-05. LHDs have had to reduce staff assigned to
emergency preparedness activities.
In order to effectively mitigate the severe impacts of
pandemic influenza, LHDs must develop, exercise, and
implement pandemic influenza plans. These LHD plans must
provide for the capability to receive, store, and dispense
antivirals and vaccine; expand risk communications plans;
coordinate preparedness activities with community groups
and local employers, especially those serving populations
with special needs; conduct surveillance activities within
their jurisdiction; and assure sufficient health care
services are available during the height of the outbreak.
LHDs with enhanced laboratory capability (reference
laboratories) must be prepared for the surge in samples to
be tested. All planning must be coordinated at both the
jurisdictional and regional levels, and tested through
drills and exercises.
DHS states, to responsibly prepare to mitigate, respond to,
and recover from the catastrophic impacts of pandemic
influenza, each LHD must develop a pandemic influenza
preparedness and response plan. Developing the California
Pandemic Influenza Preparedness and Response Plan has
required more than a year of work and significant DHS
resources. According to DHS, although LHDs have been
preparing for multi-hazard emergency response, most of
their efforts have focused on isolated incidents occurring
within the local jurisdiction. A pandemic that crosses all
jurisdictional boundaries requires a substantially
increased level of planning and response resources. Each
local response will be critical as there will be few or no
outside resources available. Planning, drills, and
exercises provide the only viable test of whether
California is ready for a pandemic.
According to DHS, each LHD will be required to develop a
pandemic influenza preparedness and response plan for its
jurisdiction, and exercise the local plan. LHDs will have
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flexibility in use of these funds to determine the highest
priority local needs, consistent with the state plan and a
local plan subject to DHS approval. LHDs will also submit
a budget outlining their intended use of these funds.
LHD responsibilities in a pandemic include but are not
limited to:
Developing and implementing pandemic influenza plans
that will be reviewed/approved by DHS.
Developing the capability to receive, store, and
dispense antivirals and vaccine.
Expanding LHD risk communications plans for an
influenza pandemic.
Coordinating preparedness activities with community
groups, especially those serving populations with
special needs.
Conducting surveillance activities within their
jurisdiction.
Assuring sufficient health care services are available
during the height of the outbreak.
Preparing local public health laboratories for the
surge in samples to be tested.
Developing plans for providing for feeding, medical
care, social services, mental health care for its
jurisdiction.
Working with local businesses to ensure development
of continuity of operations plans that support the
public health response.
State level considerations
According to DHS, its Pandemic Influenza Preparedness and
Response Plan identifies the necessary actions to prepare
for a pandemic and the responsibilities at both the state
and local level. The components of the state pandemic
influenza plan include surveillance and epidemiology,
laboratory capacity, health care planning, infection
control, case management, dispensing of vaccine and/or
antivirals, disease control and prevention, and risk
communication. According to DHS, successful implementation
of the state plan depends on a partnership between the
state and LHDs. Local plans must be consistent with each
component of the state plan, and between LHDs. To ensure
the effectiveness of the plans at every level, drills and
exercises must be developed and executed locally,
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regionally, and statewide under the guidance of DHS. DHS
would work with the Office of Homeland Security's Homeland
Security Exercise and Evaluation Program which would
conduct local, regional, and local-state exercises of LHD
pandemic plans.
Emergency Medical Services Authority (EMSA): personal
protective equipment (PPE)
According to EMSA, currently only approximately 28 percent
of the ambulances in the state have sufficient PPE to
respond to terrorism events and disasters. EMSA states
that for the most part public providers have adequate PPE
but the private providers generally do not.
EMSA states that with the majority of ambulances in the
private sector, it is critical to build a strong public/
private partnership. According to EMSA, California has
3,585 ambulances available. Of these, 2,664 (74 percent)
are private ambulances. Approximately 2500 ambulances do
not have PPE that meet EMSA guidelines.
Legislative Analysts Office (LAO) evaluation of
administration proposals
Reject most public health requests : The LAO states that it
has no objection to DHS' and EMSA's requests for
current-year funding to purchase vaccines and equipment for
ambulance units ($2.8 million), which would provide
equipment and supplies. However, the LAO recommends that
the Legislature reject the remaining current-year request.
Failure to maximize use of other fund sources: According
to the LAO, the state receives more than $300 million
annually in homeland security and bioterrorism funds from
the federal government. With a focus on terrorist threats,
the grants have some restrictions on their use. A portion
of the funds are required to be allocated to local
governments and some activities are ineligible for funding.
In addition, the grants are funded on a year-to-year
basis.
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Despite these limits, the grants provide the state with its
largest source of funding for high priority state emergency
preparedness activities. To the extent possible, the state
should use these funds as its first choice for emergency
preparedness activities. Once these funds are exhausted,
the state should look to other sources of funds, if
appropriate, such as state special funds or user funding.
Given the state's overall budget situation, the state
General Fund should be the funding source of last resort.
Yet, as we discuss below, many of the administration's
proposals use the General Fund as the funding of first
resort-missing opportunities for alternative funding
sources.
Pandemic Influenza activities overlap bioterrorism:
According to the LAO, as discussed in the 2005-06 Analysis,
the goal of federal bioterrorism funding is to ensure that
all state and local public health organizations are
prepared to respond to bioterrorism, outbreaks of
infectious diseases, and other public health threats and
emergencies. The LAO states that the department claims
that most of the federal funding has been directed towards
bioterrorism-related activities which are dissimilar to
pandemic influenza preparedness and response activities.
The LAO's review, however, finds that some of DHS' proposed
General Fund spending this year--particularly as its
relates to pandemic influenza planning--appears to fall
within the parameters of federal funding. In addition, the
requests would allocate General Fund monies using the same
process that the department has used to allocate federal
funds. As noted earlier, this process currently is
undergoing an audit due to questions about its
effectiveness in getting funds spent in a timely manner.
Until the Legislature receives the above-mentioned reports,
it will not be in a position to evaluate whether DHS has
maximized its use of federal funds for the programs it has
identified as having a high priority.
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Arguments in support
According to DHS, this bill will provide both DHS and EMSA
with resources to continue its preparations for public
health emergencies, including pandemic influenza.
Specifically, the appropriation will provide DHS with
resources to hire personnel; purchase antiviral supplies;
purchase equipment for the Richmond Lab; and, provide
funding for local county health departments to strengthen
pandemic planning, conduct epidemiologic investigations for
disease outbreaks and provide support to health efforts.
The California State Association of Counties states that
the funding in this bill will provide counties with
resources for essential activities to prepare for pandemic
influenza. County health departments must develop plans
for activities such as out reach and planning with
community partners including health care facilities and
providers, law enforcement, businesses and schools,
development of the capability to received, store and
dispense antivirals and vaccine, expansion and surveillance
capability, expansion of risk communication tools and
planning for reaching and serving special populations.
COMMENTS
1.Assembly floor amendments. Amendments taken on the
Assembly Floor are the product of negotiations between
the Administration and the firefighters to ensure that
public firefighters who are currently not equipped with
PPE receive access to the EMSA funds appropriated through
this measure.
2.New federal funds. According to a Department of Finance
letter dated April 27, 2006, DHS has submitted a Section
28.00 application for the Budget Act of 2005. The
Department of Finance letter states, "In order to
maximize the use of federal funds before General Fund,
DHS proposes to offset $587,000 of current year proposals
in the Governor's Budget with the newly awarded federal
funds." The committee may want to ask DHS how does this
new federal appropriation impact the amount appropriated
in this bill.
POSITIONS
Support: California Department of Health Services
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California Medical Association
California State Association of Counties
County Health Executives Association of
California
County of San Diego
Health Officers Association of California
Oppose: None received.
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