BILL ANALYSIS Ó
SB 249
Page 1
Date of Hearing: June 25, 2013
ASSEMBLY COMMITTEE ON HEALTH
Richard Pan, Chair
SB 249 (Leno) - As Amended: June 17, 2013
SENATE VOTE : 39-0
SUBJECT : Public health: health records: confidentiality.
SUMMARY : Authorizes the sharing of health records involving the
diagnosis, care, and treatment of human immunodeficiency virus
(HIV) or acquired immunodeficiency syndrome (AIDS) related to a
beneficiary enrolled in federal Ryan White Act (RWA) funded
programs who may be eligible for health care under the federal
Patient Protection and Affordable Care Act (ACA) between the
Department of Public Health (DPH) and qualified entities, as
specified. Specifically, this bill :
1) Authorizes DPH and qualified entities, as defined, to
share with each other health records involving the
diagnosis, care, and treatment of HIV or AIDS related to a
beneficiary enrolled in RWA funded programs who may be
eligible for services under the ACA.
2) Authorizes qualified entities who are covered entities
under the Health Insurance Portability and Accountability
Act (HIPAA), as specified, to share records only for the
purpose of enrolling the beneficiary in Medi-Cal, the
Bridge Programs, Medicaid expansion programs, and any
insurance plan certified by the California Health Benefit
Exchange (Exchange) or any other program under the ACA, as
specified, and for the purpose of continuing access to
these programs and plans without disruption.
3) Requires the information provided by DPH to be limited
only to the information necessary for the provisions in 1)
and 2) above, and excludes HIV or AIDS surveillance data.
Prohibits the further disclosure by any qualified entity,
except to any of the following, as necessary:
a) The person who is the subject of the record or to his or
her guardian or conservator;
SB 249
Page 2
b) The provider of health care for the person with HIV or
AIDS to whom the information pertains; or,
c) The Office of AIDS (OA) within DPH.
4) Defines qualified entity to mean the following:
a) Department of Health Care Services (DHCS);
b) The Exchange;
c) Medi-Cal managed care plans;
d) Health plans participating in the Bridge Program;
e) Health plans offered through the Exchange; or,
f) County health departments delivering HIV or AIDS health
care services.
5) Prohibits the disclosure, discovery, or compelling the
production of the shared information in any civil,
criminal, administrative, or other proceeding.
6) Requires all employees and contractors of a qualified
entity who have legal access to confidential HIV-related
medical records to sign confidentiality agreements, as
specified.
7) Provides that 1) through 6) above are to be implemented
only to the extent permitted pursuant to federal law and
information that is shared is to be protected under HIPAA,
the Confidentiality of Medical Information Act, and the
Insurance Information and Privacy Protection Act.
8)Requires laboratories, upon request by DPH, to report cases of
HIV infection by name directly to DPH in accordance with
existing requirements, in addition to reports to the local
health officer (LHO).
SB 249
Page 3
9)Extends privacy protections that currently apply to HIV blood
tests to all types of HIV tests.
10)Makes other technical, clarifying, and conforming changes.
EXISTING LAW :
1)Establishes the federal RWA to provide grants to states and
territories to improve the quality, availability, and
organization of HIV/AIDS healthcare and support services.
2)Establishes the OA within DPH, to coordinate state programs,
services, and activities related to HIV/AIDS.
3)Establishes the AIDS Drug Assistance Program (ADAP) within DPH
to subsidize the cost of AIDS drugs for persons who do not
have private health coverage, are not eligible for Medi-Cal,
or cannot afford to purchase the drug privately. Indicates
that the subsidy program is to be funded though state and
federal sources.
4)Establishes the Low Income Health Program (LIHP) within the
DHCS as an optional Medi-Cal-like program that expands primary
medical coverage to certain uninsured, low-income adults,
including some HIV-positive individuals who receive RWA and or
ADAP services.
5)Prohibits compelling any person in any state, county, city, or
other local civil, criminal, administrative, legislative, or
other proceedings to identify or provide identifying
characteristics that would identify an individual who is the
subject of an HIV test.
6)Specifies that the negligent, willful, or malicious
disclosures of the results of an HIV test to any third party,
except pursuant to a written authorization, is subject to
specified civil penalties. Provides that the written
authorization applies only to the disclosure of test results
by a person responsible for the care and treatment of the
person subject to the test. Requires a written authorization
for each separate disclosure of test results and inclusion of
any third party to whom the disclosure would be made.
7)Authorizes the disclosure of the results of a blood test to
SB 249
Page 4
detect antibodies to the probable causative agent of AIDS
without written authorization under the following:
a) To the subject of the test or the subject's legal
representative, conservator, or any other person authorized
to consent, as specified;
b) To a test subject's provider of health care, as
specified;
c) To an agent or employee of the test subject's provider
of health care who provides direct patient care and
treatment;
d) To a provider of health care who procures, processes,
distributes, or uses a human body part that is donated
pursuant to the Uniform Anatomical Gift Act; or,
e) To the designated officer of an emergency response
employee, and from that designated officer to an emergency
response employee regarding possible exposure to HIV or
AIDS, as specified.
8)Requires health care providers and laboratories to report
cases of HIV infection to the LHO using patient names on a
form developed by DPH. Requires LHOs to report unduplicated
HIV cases by name to DPH on a form developed by DPH.
9)Requires that public health records relating to HIV or AIDS,
containing personally identifying information, that were
developed or acquired by a state or local public health agency
or its agent to be confidential and cannot be disclosed except
for public health purposes or pursuant to a written
authorization by the person who is the subject of the record
or his or her guardian or conservator. Authorizes disclosure
of personal identifying information under limited
circumstances.
FISCAL EFFECT : According to the Senate Appropriations
Committee:
1)Likely administrative costs in the hundreds of thousands to
develop agreements with other state agencies and health plans
by DPH (special fund).
2)Unknown potential information technology costs by DPH (federal
funds). DPH indicates that it may need to make changes to its
information technology systems to share information with other
entities. At this time, DPH does not know whether such
SB 249
Page 5
changes are necessary or what they would cost.
3)Potential increase in Medi-Cal costs in the low millions
(federal funds).
4)Unknown potential savings to programs administered by DPH
because this bill helps ensure that other sources of health
care coverage pay for services (federal funds).
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, the
prohibition on disclosure of HIV information has become not
only somewhat redundant because of laws that protect the
confidentiality of all medical information but is also an
impediment to individuals enrolled in the federal RWA funded
services. As a result of federal and state health care
reform, those individuals must transition to new health
coverage systems. Current restrictions on the sharing of HIV
information causes serious problems for both patients trying
to access health care and providers who are trying to
coordinate care. At the same time, current HIV
confidentiality law is inadequate because it does not protect
the confidentiality of all types of HIV tests that are now
available. To illustrate the need for this bill, the author
and the sponsors point out that in 2011, data sharing was
essential to a successful transition of ADAP clients to LIHPs
and trailer bill language was created to facilitate the
sharing of data between DPH/OA and LIHPs. Prior to this
trailer bill language, DPH/OA was not able to share this data.
This bill addresses these problems by allowing the sharing of
information in limited circumstances.
2)BACKGROUND .
a) HIV . According to the Centers for Disease Control and
Prevention (CDC), HIV is a virus that can lead to AIDS.
Unlike some other viruses, the human body cannot get rid of
HIV. That means that once you have HIV, you have it for
life. No safe and effective cure currently exists, but
with proper medical care, HIV can be controlled. Treatment
used for HIV is often called antiretroviral therapy or ART,
which can dramatically prolong the lives of many people
infected with HIV and lower their chance of infecting
others. HIV affects specific cells of the immune system,
SB 249
Page 6
called CD4 cells, or T cells. Over time, HIV can destroy
so many of these cells that the body cannot fight off
infections and diseases. When this happens, HIV infection
leads to AIDS. According to DPH, as of December 31, 2012,
there were a total of 212,442 reported HIV/AIDS cases in
California.
According to a March 2013 HIV/AIDS Policy Fact Sheet from the
Kaiser Family Foundation, the first cases of what would
later become known as AIDS were reported in the U.S. in
June of 1981. Since then, more than 1.9 million people in
the U.S. are estimated to have been infected with HIV,
including over 650,000 who have already died. Today more
than 1.1 million people nationwide are living with HIV.
The following challenges remain: while the number of new
HIV infections (incidence) is down from its peak in the
1980s, new infections have remained at about 50,000 per
year for more than a decade; HIV testing is important for
both prevention and treatment efforts and rapid testing is
now much more widely available. Routine HIV testing is now
recommended for all people ages 13-64, yet 18% of those
infected with HIV do not know they are infected, and many
people with HIV (32%) are diagnosed late in their illness;
treatment advances have substantially reduced AIDS-related
morbidity and mortality and extended the lives of many.
Current U.S. HIV treatment guidelines recommend initiating
ART as soon as one is diagnosed with HIV. Still many
people with HIV are not in care, on treatment, or virally
suppressed (the point under which the virus is under
control, helps a person remain healthy, and reduces the
risk of transmission).
The federal RWA was enacted in 1990, and it provides care and
services to more than half a million people with and
affected by HIV each year. It is the largest HIV-specific
grant program in the U.S. and the third largest source of
federal funding for HIV care.
b) Reporting of HIV and AIDS . Current law requires health
care providers and laboratories to report cases of HIV
infection to the LHO using patient names on a form
developed by DPH. Additionally, health care providers may
report AIDS cases by patient name to the local health
officer, who then report these cases to DPH. Each clinical
laboratory, as defined, is also required to report all CD4+
SB 249
Page 7
T cell test results (target cell of the AIDS virus) to the
LHO for the local health jurisdiction where the health care
provider facility is located within seven days of the
completion of the CD4+ T cell test. Each LHO is required
to inspect each clinical laboratory CD4+ T cell test report
to determine if the test is related to a case of HIV
infection. LHOs must report unduplicated HIV cases by
patient name to DPH.
c) Confidentiality of HIV Medical Records and Authorized
Disclosure . HIPAA, among various provisions, requires the
protection and confidential handling of protected health
information (this is commonly referred to as HIPAA Privacy
Rules). The HIPAA Privacy Rules provide federal
protections for personal health information (PHI) held by
covered entities and gives patients an array of rights with
respect to that information. Disclosure of PHI is
permitted when needed for patient care and other important
purposes. On the other hand, HIPAA's Security Rule
specifies a series of administrative, physical, and
technical safeguards for covered entities to use to assure
the confidentiality, integrity, and availability of
electronic PHI. In California the Confidentiality of
Medical Information Act governs the disclosure of medical
information by health care providers, Knox-Keene Health
Care Service Plan Act of 1975 regulated plans, contractors,
health care clearinghouses, and employers.
In order to protect the privacy of individuals who are the
subject of HIV testing, current law prohibits the
disclosure of an HIV test to any third party in a manner
that identifies or provides identifying characteristics of
the person to whom the test results apply, unless pursuant
to a written authorization. The law prohibits the
negligent, willful, or malicious disclosure of such tests
and prescribes penalties for such violations. Current law
authorizes the disclosure of HIV tests without written
authorization to the subject of the test or his/her legal
representative, as specified; the test subject's provider
of health care (including an agent or employee), or to an
emergency response employee, as specified.
Public health records relating to HIV or AIDS which contain
personally identifying information that were developed or
acquired by a state or local health agency are confidential
SB 249
Page 8
and cannot be disclosed except for public health purposes
or pursuant to a written authorization by the person who is
the subject of the record. However, personally identifying
information may be disclosed when the confidential
information is necessary to carry out the duties of the
agency or researcher in the investigation, control, or
surveillance of the disease.
Additionally, for purposes of facilitating appropriate
HIV/AIDS medical care and treatment, the following
disclosures are authorized:
i) State public health agency HIV surveillance staff,
ADAP Program staff, and care services staff may further
disclose the information to local public health agency
staff, who may further disclose the information to the
HIV-positive person who is the subject of the record, or
the health care provider who provides his or her HIV
care; and,
ii) ADAP staff and DPH care services staff may disclose
the information directly to the HIV-positive person who
is the subject or the record of the health care provider
who provides his or her HIV care.
d) ACA . On March 23, 2010, President Obama signed the ACA
(Public Law 111-148), as amended by the Health Care and
Education Reconciliation Act of 2010 (Public Law 111-152).
Among other provisions, the new law requires most U.S.
citizens and legal residents to have health insurance;
creates state-based American Health Benefit Exchanges
through which individuals can purchase coverage, with
premium and cost sharing credits, as specified, and creates
separate exchanges through which small businesses can
purchase coverage. According to estimates, the ACA will
extend health coverage to approximately 4-6 million
Californians, including people with HIV. Starting in 2014,
new health coverage options will be available in the
private health insurance market and in the Exchange. As
part of ACA implementation, there are many new requirements
on health insurers and plans such as elimination of
preexisting conditions requirements, limitations on
enrollee cost sharing, guaranteed issue of plans and
policies, and restrictions on the factors health plans and
insurers can use to determine premium rates. Additionally,
SB 249
Page 9
the Exchange will create better information and more
competition in the insurance market.
3)SUPPORT . The Transgender Law Center, the San Francisco AIDS
Foundation, the Conference of California Bar Associations, the
L.A. Gay and Lesbian Center all state in support that current
restrictions on the sharing of HIV information cause serious
problems for both patients trying to access health care and
providers who are trying to coordinate care and this bill
addresses these concerns.
4)DOUBLE REFERRAL . This bill is double referred, should it pass
out of this Committee, it will be referred to the Assembly
Judiciary Committee.
5)RELATED LEGISLATION .
a) AB 446 (Mitchell) expands voluntary HIV testing outreach
to certain patients at primary care clinics and revises
requirements for obtaining consent from, and providing
information to, persons being tested for HIV infection. AB
446 is pending in Senate Health Committee.
b) AB 506 (Mitchell) provides social workers with
additional authority to consent to HIV testing for infants
in temporary custody or who are adjudicated dependents when
such testing is determined to be medically necessary and
the parent or guardian cannot be reached. AB 506 is
pending in the Senate Judiciary Committee.
6)PREVIOUS LEGISLATION .
a) 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
Internet Website if specified conditions were met. The
funding and disclosure provisions were eventually amended
out and AB 491 was eventually amended to deal with a
different subject matter.
b) AB 1894 (Krekorian), Chapter 631, Statutes of 2008,
requires health care service plans and disability insurers
selling health insurance to offer testing for HIV
SB 249
Page 10
antibodies and AIDS, regardless of whether the testing is
related to a primary diagnosis.
c) AB 682 (Berg), Chapter 550, Statutes of 2007, revises
the written and informed consent standards associated with
testing blood for HIV, including prenatal HIV testing, to
no longer require affirmative approval prior to
administering an HIV test. Establishes the new HIV testing
consent standard as the right to decline the test,
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.
7)Author's Amendments . The author would like to amend this bill
to reinstate existing law provisions authorizing the
disclosure of sexually transmitted diseases to the CDC that
were inadvertently deleted, as follows:
(C) Local public health agency sexually transmitted disease
control staff may further disclose the information to state
public health agency sexually transmitted disease control
staff, who may further disclose the information, without
disclosing patient identifying information, to the CDC, to
the extent it is requested by the CDC, and permitted by
subdivision (b), for the purposes of the investigation,
control, or surveillance of HIV and syphilis, gonorrhea, or
chlamydia coinfection.
8)Corrective Amendments .
a) Consent . Current law's reference to consent
requirements for the disclosure of HIV test results should
be updated as follows:
a) To the subject of the test or the subject's legal
representative, conservator, or to any person
authorized to consent to the test pursuant to
subdivision (b) of Section 120990 and Family Code
Section 6926 .
b) Provider of Health Care . Current law's reference to the
definition of provider of health care needs to be updated,
SB 249
Page 11
as follows:
(b) To a test subject's provider of health care, as
defined in subdivision (d) (j) of Section 56.05 of the
Civil Code, except that for purposes of this section,
"provider of health care" does not include a health
care service plan regulated pursuant to Chapter 2.2
(commencing with Section 1340) of Division 2.
REGISTERED SUPPORT / OPPOSITION :
Support
Conference of California Bar Associations (cosponsor)
San Francisco AIDS Foundation (cosponsor)
AIDS Legal Referral Panel
AIDS Project Los Angeles
American Federation of State, County, and Municipal Employees,
AFL-CIO
California Communities United Institute
California Primary Care Association
Disability Rights California
L.A. Gay & Lesbian Center
National Association of Social Workers
Project Inform
Transgender Law Center
Opposition
None on file.
Analysis Prepared by : Rosielyn Pulmano / HEALTH / (916)
319-2097