BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Elaine K. Alquist, Chair
BILL NO: AB 2541
A
AUTHOR: Portantino, Fletcher
B
AMENDED: August 20, 2010
HEARING DATE: August 25, 2010
2
CONSULTANT:
5
Orr
4
1
PURSUANT TO S.R. 29.10
SUBJECT
Reporting of certain communicable diseases
SUMMARY
Deletes the HIV exemption from authorized electronic
reporting in order to increase federal funding provided to
California for HIV and AIDS services. Authorizes additional
disclosures of public health records relating to human
immunodeficiency virus (HIV) or acquired immune deficiency
syndrome (AIDS) between specified local and state public
health agency staff, health care providers, and HIV
positive individuals who are the subject of the records.
Increases the penalties for negligent, willful or malicious
disclosure of content of any confidential public health
record to a third party, except as otherwise authorized by
law.
CHANGES TO EXISTING LAW
Existing law:
Permits certain laboratory test results to be posted on the
Continued---
STAFF ANALYSIS OF ASSEMBLY BILL 2541 (Portantino,
Fletcher)Page 2
Internet or other electronic method if requested by the
patient and deemed appropriate by the health care provider
who ordered the test. Prohibits the electronic delivery of
clinical laboratory test results or any other related
results for HIV antibody tests, regardless of
authorization.
Requires health care providers and clinical laboratories to
report HIV infection by patient name to the local health
officer, and mandates local health officers to report
unduplicated HIV cases by patient name to the California
Department of Public Health (CDPH).
Requires CDPH to establish a list of communicable and
noncommunicable diseases and conditions which local health
officers are required to report to CDPH. Exempts from
civil and criminal penalties any person or facility that
fails to provide notification of a reportable disease or
condition, unless the disease or condition that is required
to be reported has been printed in the California Code of
Regulations (CCR) for at least six months.
Declares public health records relating to HIV or AIDS as
confidential and prohibits their disclosure, except as
otherwise provided by law for public health purposes or
pursuant to a written authorization by the person who is
the subject of the record.
Allows state or local public health agencies to disclose
personally identifying information in public health records
as described to other local, state, or federal public
health agencies or to corroborating medical researchers,
when the information is necessary to carry out the duties
of the agency or researcher in the investigation, control,
or surveillance of disease, as determined by the state or
local public health agency.
Permits state or local public health agencies to disclose
personally identifying information in public health
records, as described, to other local, state, or federal
public health agencies or to corroborating medical
researchers, when the information is necessary to carry out
the duties of the agency or researcher in the
investigation, control, or surveillance of disease, as
determined by the state or local public health agency.
STAFF ANALYSIS OF ASSEMBLY BILL 2541 (Portantino,
Fletcher)Page 3
Prohibits the negligent, willful or malicious disclosure of
the content of any confidential public health record, as
defined, to any third party, except pursuant to a written
authorization, as described or as otherwise authorized by
law, and establishes civil penalties for violations of
these provisions.
Establishes that any person who willfully, negligently, or
maliciously discloses the content of any confidential
public health record to a third party that results in
economic, bodily, or psychological harm to the person whose
record was disclosed, is guilty of a misdemeanor,
punishable by imprisonment in the county jail and/or a fine
of up to twenty-five thousand dollars ($25,000).
Existing regulations:
Require that all reports containing personal information,
including HIV/AIDS Case Reports, shall be sent to the local
health officer (LHO) or his or her designee by courier
service, U.S. Postal Service Express or registered mail, or
other traceable mail, or by person-to-person transfer with
the LHO or his or her designee.
Prohibit the health care provider and laboratory from
submitting reports containing personal information to the
LHO or his or her designee by electronic facsimile
transmission, by electronic mail or by non-traceable mail.
Require all local health department (LHD) employees and
contractors to sign a HIV/AIDS Confidentiality Agreement
prior to accessing confidential HIV-related public health
records, required to be renewed annually. Stipulates that
information reported pursuant to these regulations is
acquired in confidence and shall not be disclosed by the
LHO or his or her authorized designee except as authorized.
This bill:
Deletes the provision in existing law that that excludes
HIV infections from being reported electronically.
Provides that health care providers and LHOs may submit
cases of HIV infection, including facsimile and
electronically by a secure and confidential electronic
STAFF ANALYSIS OF ASSEMBLY BILL 2541 (Portantino,
Fletcher)Page 4
reporting system established by the department, to be
implemented using the existing resources of the department.
Allows CDPH to advise out-of-state laboratories that are
known to the department to test specimens from California
residents of the new reporting requirements through its
internet website.
Authorizes specified disclosures of public health records
relating to HIV or AIDS between specified local public
health agency staff, health care providers, specified state
public health agency staff, and HIV positive individuals
who are the subject of the records, for the purposes of
enhancing completeness of sexually transmitted disease
reporting to the federal Centers for Disease Control and
Prevention (CDC) and offering and coordinating care and
treatment services to HIV positive persons.
Increases the penalties for negligent, willful or malicious
disclosure of content of any confidential public health
record to a third party, except as otherwise authorized by
law.
Contains contingent language to avoid chaptering out
provisions contained in AB 2786 (Committee on Health).
FISCAL IMPACT
Senate Appropriations Committee estimates one-time
resources of up to $75,000 General Fund in FY 2010-2011 to
add an HIV/AIDS reporting module to CDPH's California
Reportable Disease Information Exchange/Electronic
Laboratory Reporting (ELR) system.
To the extent that this bill furthers the goal of making
California competitive in obtaining federal HIV/AIDS
funding, there could be additional federal Ryan White Act
and CDC funding available due to an increase in the number
of HIV infections reported to CDPH, on which the funding
allocation is based.
BACKGROUND AND DISCUSSION
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Fletcher)Page 5
According to the author, this bill would enable
laboratories to report HIV test results through CDPH's
electronic laboratory reporting system (ELR), in order to
enhance the completeness of HIV/AIDS data reported by CDPH,
Office of AIDS (CDPH/OA) to the federal CDC. This bill
implements a recommendation from a February 2010
Legislative Analysts Office (LAO) report on California's
HIV/AIDS reporting system, 'Maximizing Federal Funds for
HIV/AIDS: Improving Surveillance and Reporting." The
recommendation was to enact legislation requiring
laboratories to electronically report HIV test results, in
order to ensure that California receives the maximum
amount possible of federal funding from the Ryan White
Treatment Extension Act of 2009 (Ryan White Act) for
HIV/AIDS care and treatment services.
According to the author, the recent floor amendments will
allow further disclosure of personally identifying
information contained in HIV/AIDS-related public health
records for the purposes of HIV/AIDS reporting, care and
treatment services and case management. These amendments
will also allow HIV/AIDS, STD, and TB co-infection
reporting, medical care, and treatment. This will help
further CDPH's goals of increased reporting for HIV/AIDS
and increased reporting for HIV/AIDS, STD, and TB
co-infections. This should also help secure a maximum
amount of Ryan White and CDC federal funding for HIV/AIDS,
and improve the quality of patient care through better
coordination of HIV/AIDS, STD, and TB co-infection care and
treatment.
HIV/AIDS reporting
AIDS has been reportable in California for more than 20
years. Since AIDS cases represent later stages of the
disease, AIDS data are less useful than HIV data for public
health professionals to monitor the epidemic, and target
and evaluate prevention programs. Historically, HIV has
been treated differently than many other diseases, due in
part to the misperceptions and stigmas associated with its
transmission. Under current law, HIV cannot be reported
electronically and must be reported using methods such as
hand delivery or registered mail. This handling of HIV
reporting is administratively burdensome and does not
maximize data matching opportunities to increase the
identification of HIV-positive patients. Public health
STAFF ANALYSIS OF ASSEMBLY BILL 2541 (Portantino,
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professionals found they needed accurate HIV case data in
addition to AIDS data to assess the spread and impact of
the HIV/AIDS epidemic.
To address this, in 1997, the CDC called for all states to
conduct HIV surveillance as an extension of their on-going
AIDS surveillance programs. CDC published draft guidelines
outlining criteria for ensuring the quality and
confidentiality of HIV data, which set forth the standard
data that needs to be collected from each patient (date of
diagnosis, demographics, risk exposure, etc.), and also set
performance standards that reporting systems must meet.
California responded to this need by implementing
code-based HIV reporting in July 2002. The code contains
information about the patient's gender, date of birth, and
a code derived from the last name and the last four digits
of their social security number. Since then, local health
departments have reported over 33,000 cases of HIV,
representing more than 35 percent of reported cases of
individuals living with HIV/AIDS in California. However,
the CDC has since acknowledged that they consider HIV data
from code-based systems to be less reliable than name-based
systems, and would not accept the data and will not confirm
them for use in allocating Ryan White funds, putting some
of the state's federal grant money at risk. It is noted
that, at the time, the state used name-based reporting for
AIDS, and that California had had no documented or reported
cases of illegal or inappropriate disclosure of case
information from the state's AIDS Case Registry. To address
this, SB 699 (Soto) was passed in 2006 to report HIV cases
by patient's name rather than code in order to comply with
federal funding requirements.
Communicable disease reporting and surveillance
California has a dual reporting system for communicable
diseases. Both health care providers (physicians) and
laboratories are required to report a case, or suspected
case, of notifiable diseases to public health officials.
They are both responsible for reporting dozens of named
conditions, as well as any outbreaks of unusual diseases,
within a specified timeframe of identifying the disease.
Laboratories report these specific conditions to the LHD,
based on the location of the physician's office. The
laboratory report may be submitted to the appropriate LHD
STAFF ANALYSIS OF ASSEMBLY BILL 2541 (Portantino,
Fletcher)Page 7
by various means including a phone call, facsimile, mail,
or electronically. Once the LHD receives a laboratory
disease report for a suspected or confirmed case, it
notifies the appropriate public health staff to manage and
track the case. LHDs then report disease case information
directly to the state.
Public health officials use disease reporting to monitor
public health, develop prevention strategies, set
priorities and evaluate programs, allocate resources and
facilitate research. While there are many surveillance
strategies, disease reporting originating from health care
providers and laboratories is at the core of surveillance.
Disease reporting is mandated by the CCR, and California
requires health care providers to confidentially report
more than 80 diseases and conditions to local health
officers.
Electronic disease surveillance
At the national level, the CDC initiated an effort to
streamline the collection, management, and reporting of
data - primarily for the surveillance of communicable
diseases. In 1999, the CDC introduced the National
Electronic Disease Surveillance System (NEDSS), designed
to: (1) facilitate the electronic transfer of appropriate
information from clinical information systems used in the
delivery of health services to public health departments;
(2) reduce the burden on health service providers of
collecting and reporting such information; and, (3) enhance
the timeliness and quality of public health information.
In late 2002, the CDC introduced the concept of the Public
Health Information Network (PHIN), to provide a network of
information that functionally and organizationally
integrates public health partners across the country. Other
CDC initiatives promoting the integration of technology in
public health, in addition to NEDSS, include the Health
Alert Network (HAN), the Laboratory Response Network (LRN),
the Epidemic Information Exchange (EPI-X) and the redesign
of the CDC website for public information and public health
education. CDC began providing funds to those public health
jurisdictions that report public health data to CDC and who
are working to develop or procure applications that comply
with the specified requirements of their public health
information technology initiatives.
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The California Department of Health Services (now CDPH)
initiated the California Public Health Information Network
(CalPHIN) initiative to support the CDC efforts and promote
the public health goals of the state. Applications included
within the CalPHIN framework include the California
Electronic Laboratory Reporting (CA-ELR), and the
California Web Based Morbidity Reporting (WebCMR), among
others. The overall objective of the Electronic Laboratory
Reporting application is to enhance and strengthen state
and local disease surveillance capacity and promote public
health. This type of application will improve the ability
to collect more complete and timely surveillance
information from laboratories on a statewide basis, and is
used to increase the efficiency of existing surveillance
activities and the early detection of public health events
(e.g. bioterrorism). This will be accomplished through
automating manual processes such as data importing and
accuracy verification, decreasing paper-based data
submittals, eliminating data redundancy and duplicate data
entry, and providing easy accessibility to data for
planning, analysis, and decision making.
Chapter 278 of the Statutes of 2008 (AB 2658, Horton)
requires laboratories to submit all cases of reportable
diseases and conditions electronically within one year of
the establishment of the new state ELR system, which is
slated for completion in 2010. According to the LAO, HIV
reports were specifically excluded from this requirement in
order to allow CDPH sufficient time to ensure the new
system's data architecture is not at variance with the
HIV-specific reporting requirements and that the system
would meet federal standards for HIV reporting.
Confidential public health records
According to CDPH, all HIV/AIDS case reports and any
information collected or maintained in the course of
surveillance-related activities that may directly or
indirectly identify an individual are considered
confidential public health record(s) under California
Health and Safety Code (HSC) Section 121035(c) and must be
handled with the utmost confidentiality. Furthermore, HSC
121025(a) prohibits the disclosure of HIV/AIDS-related
public health records that contain any personally
identifying information to any third party, unless
STAFF ANALYSIS OF ASSEMBLY BILL 2541 (Portantino,
Fletcher)Page 9
authorized by law for public health purposes, or by the
written consent of the individual identified in the record
or his/her guardian/conservator.
Except as permitted by law, any person who negligently
discloses information contained in a confidential public
health record to a third party is subject to a civil
penalty of up to $2,500 plus court costs. Any person who
willfully or maliciously discloses the content of a public
health record, except as authorized by law, is subject to a
civil penalty of $5,000 to $10,000 plus court costs. Any
willful, malicious, or negligent disclosure of information
contained in a public health record in violation of state
law that results in economic, bodily, or psychological harm
to the person named in the record is a misdemeanor,
punishable by imprisonment for a period of up to one year
and/or a fine of up to $25,000 plus court costs. Each
disclosure in violation of California law is a separate,
actionable offense.
Because an assurance of case confidentiality is the
foremost concern of the California Department of Public
Health, Office of AIDS (OA), employees are required to sign
a Confidentiality Agreement. In the event of any suspected
breach, staff immediately notify the director or supervisor
of the local health department's HIV/AIDS surveillance unit
who in turn notify the Chief of the HIV/AIDS Case Registry
Section or designee. OA, in conjunction with the local
health department and the local health officer promptly
investigate the suspected breach. Any evidence of an actual
breach is reported to the law enforcement agency that has
jurisdiction.
HIV/AIDS funding
California switched to name-based reporting in 2006 in
order to not risk major losses of federal Ryan White Act
funding. The state has since been in a transition period
between code-based reporting and full name-based reporting.
According to CDPH estimates, California's failure to be
fully name-based in HIV reporting, meant the lost of $3
million to $7 million in federal funding in 2009.
According to the LAO, only about 36,000 cases of HIV have
been reported by name to local health jurisdictions. This
number likely represents only one-third to one-half of HIV
STAFF ANALYSIS OF ASSEMBLY BILL 2541 (Portantino,
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cases statewide. According to the LAO, California could
potentially increase receipt of federal Ryan White Act
funding by several million to low tens of millions of
dollars annually simply by increasing the number of HIV
infections reported.
California spends roughly $1.2 billion a year (40 percent
GF) on medical treatment and HIV/AIDS programs. The Ryan
White Act provides $125 million in federal funding per year
to California. Increased federal funds would likely be used
to reduce GF spending for the treatment of the disease.
Related bills
AB 2786 (Committee on Health) of 2010 would require CDPH to
establish a list
of communicable diseases and conditions for which clinical
laboratories are required to submit a culture or specimen
to local and state public health laboratories, as
specified. Pending in the Senate Health Committee.
Prior legislation
SB 541 (Alquist), Chapter 605, Statues of 2008, requires
health care facilities to prevent unlawful or unauthorized
access to use, or disclosure of, patients' medical
information and to establish safeguards to protect the
privacy of patients' medical information. Authorizes CDPH
to levy administrative penalties against facilities for
failure to prevent unlawful or unauthorized access, use, or
disclosure of patients' medical information, and for
failure to report instances of unlawful or unauthorized
access, use, or disclosure of information.
AB 211 (Jones), Chapter 602, Statutes of 2008, requires
every provider of health care to implement appropriate
specified safeguards to protect the privacy of a patient's
medical information. The bill would require every provider
of health care to reasonably safeguard confidential medical
information from unauthorized or unlawful access, use, or
disclosure.
AB 2658 (Horton), Chapter 449, Statutes of 2008, required
laboratories to submit all cases of "reportable diseases
and conditions" electronically, within one year of the
establishment of the new state electronic laboratory
reporting system, with the exception of HIV reports.
STAFF ANALYSIS OF ASSEMBLY BILL 2541 (Portantino,
Fletcher)Page 11
SB 356 (Negrete McLeod) of 2007 would have required CDPH to
establish a list of communicable diseases and conditions
for which clinical laboratories are required to submit
specimens to the local public health laboratory and state
public health laboratory for further testing. This bill
would have permitted the list to be modified by CDPH at any
time, in consultation with the California Conference of
Local Health Officers, and to exempt the modifications from
APA regulation change and rulemaking requirements. SB 356
was vetoed by Governor Schwarzenegger because the delay in
passing the 2008-2009 state budget forced him to prioritize
the bills sent to his desk.
AB 682 (Berg), Chapter 550, Statutes of 2007, revised the
written and informed consent standards associated with
testing blood for the human immunodeficiency virus (HIV),
including prenatal HIV testing, to no longer require
affirmative approval prior to administering an HIV test.
Established the new HIV testing consent standard as the
right to decline the test.
SB 699 (Soto), Chapter 20, Statutes of 2006, required
health care providers and laboratories to report HIV cases
by the patient's name rather than code in order to comply
with federal funding requirements.
AB 1091 (Negrete McLeod), Chapter 262, Statutes of 2003,
allows CDPH, in consultation with the California Conference
of Local Health Officers, to modify the list of reportable
diseases that health care providers are required to report.
CDPH can modify this list at any time without having to
comply with APA requirements.
Arguments in support
AIDS Project Los Angeles supports this measure because they
believe it will bring California closer to a full and
accurate database of people living with HIV/AIDS in the
state. They believe the existing prohibition on electronic
reporting has inhibited the speedy and accurate reporting
of HIV cases. The AIDS Healthcare Foundation believes this
bill will provide additional tools for the state to improve
its HIV surveillance and better ensure our competitiveness
for federal Ryan White CARE Act dollars beginning in the
2012 award cycle. They claim that the state's plan has
STAFF ANALYSIS OF ASSEMBLY BILL 2541 (Portantino,
Fletcher)Page 12
been to implement SB 699 and strive for as mature a
database as possible by the 2012 funding award cycle,
thereby minimizing the loss of federal funding.
PRIOR ACTIONS
Assembly Health: 18-0
Assembly Appropriations: 16-0
Assembly Floor: 72-0
Senate Health: 8-0
Senate Appropriations: 11-0
COMMENTS
1. Recent amendments. When this bill passed Senate Health
Committee on June 30, 2010, the bill: a) deleted the
provision in existing law that that excludes HIV infections
from being reported electronically; and, b) described the
methods health care providers and LHOs may submit cases of
HIV infection, including facsimile and electronically by a
secure and confidential electronic reporting system
established by the department, to be implemented using the
existing resources of the department.
Recent Senate Floor amendments:
a. Authorize specified disclosures between specified local
public health agency staff,
health care providers, and specified state public
health agency staff for the purposes of
enhancing completeness of STD reporting to the federal
Centers for Disease Control
and Prevention (CDC) and offering and coordinating
care and treatment services to
HIV positive persons.
b. Increase the penalties for negligent, willful or
malicious disclosure of content of any
confidential public health record to a third party,
except as otherwise authorized by
law.
STAFF ANALYSIS OF ASSEMBLY BILL 2541 (Portantino,
Fletcher)Page 13
c. Add contingent language to avoid chaptering out
provisions in AB 2786 (Committee on Health).
POSITIONS
Support: AIDS Project Los Angeles
AIDS Healthcare Foundation
Oppose: None received
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