BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                  SB 249
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          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;








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             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).








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          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  








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            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  








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            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,  








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               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+  








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               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  








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               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,  








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               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  








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               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,  








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               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