BILL ANALYSIS Ó ------------------------------------------------------------ |SENATE RULES COMMITTEE | AB 1382| |Office of Senate Floor Analyses | | |1020 N Street, Suite 524 | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ------------------------------------------------------------ THIRD READING Bill No: AB 1382 Author: Roger Hernández (D) Amended: 7/7/11 in Senate Vote: 21 SENATE HEALTH COMMITTEE : 8-0, 6/29/11 AYES: Hernandez, Strickland, Alquist, Anderson, Blakeslee, De León, DeSaulnier, Wolk NO VOTE RECORDED: Rubio SENATE APPROPRIATIONS COMMITTEE : 9-0, 8/25/11 AYES: Kehoe, Walters, Alquist, Emmerson, Lieu, Pavley, Price, Runner, Steinberg ASSEMBLY FLOOR : 78-0, 5/19/11 (Consent) - See last page for vote SUBJECT : HIV counselors SOURCE : Author DIGEST : This bill permits HIV counselors to perform skin punctures for hepatitis C virus (HCV) tests, or combination HIV/HCV test, under specified conditions. ANALYSIS : Existing federal law : 1. Establishes quality standards for all laboratory testing CONTINUED AB 1382 Page 2 under the Clinical Laboratory Improvement Amendments (CLIA) in 1988. Classifies tests according to their complexity. 2. Waives certain tests from CLIA requirements when those tests use direct, unprocessed specimens (such as whole blood or oral fluid), can be easily performed with a negligible chance of error, and can be performed by persons without formal laboratory training outside of traditional laboratories. Existing state law : 1. Requires that HIV counselors, who provide information and resources about HIV testing, treatment, and counseling, either be: A. Trained by the California Department of Public Health (CDPH) Office of AIDS (OA) and working in an HIV counseling and testing (C&T) site funded by CDPH. B. Working in an HIV C&T site that uses HIV counselors who are trained by CDPH/OA or its agents and that complies with a quality assurance plan approved by the local health department. 2. Permits HIV counselors, meeting one of the abovementioned criteria, to do the following: A. Perform any CLIA-waived HIV test, provided the test meets CLIA requirements and provided the person meets the requirements for the performance of waived laboratory testing. B. Perform skin punctures to withdraw blood for an HIV test, provided the counselor is authorized and working under the direction of a licensed physician and surgeon, and provided the counselor has been trained in oral swab tests, skin puncture tests, and universal infection control precautions. 3. Allows HIV counselors to order and report test results CONTINUED AB 1382 Page 3 to patients without authorization from a licensed health care professional 4. Requires that the patient be informed that the preliminary result of the HIV test is indicative of the likelihood of infection, and the results must be confirmed with additional testing. 5. Requires that patients with indeterminate or positive test results be referred to an appropriate licensed heath care provider. 6. Requires HIV counselors to receive specified training. Prohibits HIV counselors from performing skin punctures until training is complete, with specified exceptions. 7. Clarifies that these provisions do not authorize HIV counselors to act as phlebotomy technicians. This bill permits HIV counselors who are authorized under existing law to perform skin punctures to administer an HIV test, to also perform skin punctures for HCV tests or combination HIV/HCV tests. Background HCV . HCV infection is the most common chronic blood borne infection in the United States. Approximately 3.2 million persons are chronically infected nationwide, and about 17,000 people are newly infected each year, according to the Centers for Disease Control and Prevention (CDC). HCV is associated with an estimated 12,000 deaths annually. Approximately 75 to 85 percent of people who become infected with HCV will develop chronic infections. In California, HCV affects approximately 600,000 people, or two percent of the state's population, according to CDPH/OA. Chronic HCV can have a wide range of outcomes, most significant liver failure. Symptoms associated with HCV infection, including fatigue, abdominal bloating, flu-like symptoms, and jaundice, are present in only 0 to 30 percent of cases; therefore, most infections go undiagnosed until liver disease develops 20 to 30 years later. CONTINUED AB 1382 Page 4 HCV and HIV . CDPH/OA estimates that 50 to 80 percent of injection drug users (IDUs) who are HIV- positive are also infected with HCV. Both HIV and HCV are transmitted by exposure to infected blood, and both can be prevented by decreasing exposure to infected blood, for example by using new sterile syringes and not sharing injection equipment. Although HCV is not efficiently transmitted sexually, persons at risk for infection through injection drug use might seek care in facilities that treat sexually transmitted diseases (STDs), HIV C&T facilities, correctional facilities, drug treatment facilities, and other public health settings where STD and HIV prevention and control services are available. Unlike HIV, HCV can potentially be cured by an infected individual's own immune system or by medical treatment. HCV progresses more quickly in people who are co-infected with HIV, and HCV treatment is less successful in HIV-positive people than in HIV-negative people. C&T for HIV and HCV . According to CDPH/OA, offering HCV testing in conjunction with HIV C&T has proven to be an effective prevention strategy for identifying infected individuals and providing referrals for treatment. Results from an HCV C&T demonstration project in 2003 included the following: HIV testing rates among IDUs nearly doubled when HIV C&T was offered in conjunction with HCV C&T. HIV test disclosure return rates increased by 21 percent among IDUs when individuals were able to receive both their HCV and HIV test results. IDUs were more interested in their HCV status than their HIV status. In January 2008, CDPH/OA integrated HCV testing into its HIV C&T program as an optional service that local health jurisdictions could provide to those at risk for HCV infection. Currently, CDPH/OA HIV test counselors assist the client with using a self-administered HCV antibody fingerstick test. The current HCV testing technology requires that the client return after two weeks to receive CONTINUED AB 1382 Page 5 his or her test results. CDPH/OA has also developed an online HCV training program designed to provide information regarding HCV infection, transmission, and screening, and to provide limited information regarding clinical management and treatment for people with HCV infection. The primary emphasis of the training is on counseling people who are at risk or already infected with HCV, and providing appropriate referrals. Of the approximately 362 CDPH/OA HIV test counselors that are currently certified, 121 have completed this online training. HCV rapid test . On June 25, 2010, the U.S. Food and Drug Administration announced approval of the first rapid blood test for HCV antibodies for individuals age 15 and older. The HCV rapid antibody test is used to test individuals who are at risk for infection with HCV and people with signs or symptoms of hepatitis, but is not approved for use in the general population. HCV rapid test kits, also known as one-step HCV tests, use a portable device and test strips to detect HCV antibodies in samples from oral fluid, fingerstick/venipuncture whole blood, or collected serum/plasma. Results are given in about 20 to 40 minutes as either reactive or nonreactive. With these HCV antibody test devices, if results are shown as reactive, this could mean the person has a short-term infection and will get better on their own, the person has a long-term infection and is at risk for developing cirrhosis or liver cancer later in life, the person was infected in the past but is no longer infected, or that the test produced a false positive result. The only way that a person with a positive test can know if he/she is currently infected is to have a follow-up medical evaluation and blood test under the administration of a physician. Approval of this rapid test means that more patients can be notified of their HCV exposure faster so that they can consult with their physician for appropriate health measures. Rapid tests provided at the point-of-care can also make HCV testing accessible in locations with limited laboratory facilities and greatly reduce the number of persons who do not return for their test results. CONTINUED AB 1382 Page 6 FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes Local: No According to the Senate Appropriations Committee: Fiscal Impact (in thousands) Major Provisions 2011-12 2012-13 2013-14 Fund Increased treatment of Unknown, potentially significant General/ Individuals with HIV Federal/ And Hepatitis C Local SUPPORT : (Verified 8/25/11) California Department of Public Health California Hepatitis Alliance Drug Policy Alliance Harm Reduction Coalition Los Angeles County Board of Supervisors ARGUMENTS IN SUPPORT : The County of Los Angeles believes that allowing HIV counselors to also administer HCV or HCV/HIV tests increases the availability of HCV screenings. They believe early detection is important to increasing the number of individuals who enter treatment, results in better outcomes for patients, and reduces health care costs for undetected HCV infections. CDPH claims that allowing HIV counselors to administer a rapid, oral HCV test would help overcome key challenges they face by providing clients with same-day results. CDPH also believes AB 1382 would increase the number of persons with HCV antibody who receive counseling and referrals, decrease the risk of additional infections, and allow HCV-infected clients to access earlier care. ASSEMBLY FLOOR : AYES: Achadjian, Allen, Ammiano, Atkins, Beall, Bill Berryhill, Block, Blumenfield, Bonilla, Bradford, CONTINUED AB 1382 Page 7 Brownley, Buchanan, Butler, Charles Calderon, Campos, Carter, Cedillo, Chesbro, Conway, Cook, Davis, Dickinson, Donnelly, Eng, Feuer, Fletcher, Fong, Fuentes, Furutani, Beth Gaines, Galgiani, Garrick, Gatto, Gordon, Grove, Hagman, Halderman, Hall, Harkey, Hayashi, Roger Hernández, Hill, Huber, Hueso, Huffman, Jeffries, Jones, Knight, Lara, Logue, Bonnie Lowenthal, Ma, Mansoor, Mendoza, Miller, Mitchell, Monning, Morrell, Nestande, Nielsen, Norby, Olsen, Pan, Perea, V. Manuel Pérez, Portantino, Silva, Skinner, Smyth, Solorio, Swanson, Torres, Valadao, Wagner, Wieckowski, Williams, Yamada, John A. Pérez NO VOTE RECORDED: Alejo, Gorell CTW:do 8/29/11 Senate Floor Analyses SUPPORT/OPPOSITION: SEE ABOVE **** END **** CONTINUED