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 tosubdivision (b) ofSection 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