BILL ANALYSIS Ó SENATE COMMITTEE ON BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT Senator Jerry Hill, Chair 2015 - 2016 Regular Bill No: AB 2179 Hearing Date: June 20, 2016 ----------------------------------------------------------------- |Author: |Gipson | |----------+------------------------------------------------------| |Version: |April 14, 2016 | ----------------------------------------------------------------- ---------------------------------------------------------------- |Urgency: |No |Fiscal: |Yes | ---------------------------------------------------------------- ----------------------------------------------------------------- |Consultant|Sarah Huchel | |: | | ----------------------------------------------------------------- Subject: Hepatitis C testing SUMMARY: Authorizes a hepatitis C counselor to perform any hepatitis C virus (HCV) test that is classified as waived under the federal Clinical Laboratory Improvement Act (CLIA), as specified. Existing state law: 1)Provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel, including cytotechnologists, by the California Department of Public Health (DPH). (Business and Professions Code (BPC) §§ 1200-1327) 1)Defines a "clinical laboratory test or examination" as the detection, identification, measurement, evaluation, correlation, monitoring, and reporting of any particular analyte, entity, or substance within a biological specimen for the purpose of obtaining scientific data which may be used as an aid to ascertain the presence, progress, and source of a disease or physiological condition in a human being, or used as an aid in the prevention, prognosis, monitoring, or treatment of a physiological or pathological condition in a human being, or for the performance of nondiagnostic tests for assessing the health of an individual. (BPC § 1206) 2)Requires an individual who draws blood to be certified by the DPH as a certified phlebotomy technician. (BPC § 1246) AB 2179 (Gipson) Page 2 of ? 3)Allows any person to request, and any licensed clinical laboratory or public health laboratory to perform, the following laboratory tests if the test is waived under CLIA and the laboratory has registered with the DPH: pregnancy, glucose level, cholesterol, occult blood, and any other test for which there is a test for a particular analyte approved by the federal Food and Drug Administration (FDA) for sale to the public without a prescription in the form of an over-the-counter test kit. A test approved only as an over-the-counter collection device may not be conducted pursuant to this section. (BPC § 1246.5) 4)Authorizes an HIV counselor who meets specified requirements to perform any HIV, HCV, or combination HIV/HCV test that is classified as waived under CLIA as specified, and is authorized to perform skin punctures for the purpose of withdrawing blood for a test without being certified as a phlebotomy technician or a limited phlebotomy technician. (Health & Safety Code § 120917) 5)Defines a "local health jurisdiction" (LHJ) as a county health department or combined health department in the case of counties acting jointly or city health department, as specified. (HSC § 124030) Existing federal law: 1)Establishes conditions that laboratories must meet for certification to perform testing on human specimens under CLIA. (Title 42, Code of Federal Regulations (CFR) § 493.1) 2)Classifies laboratory tests using three categories: "waived," "moderate complexity," or "high complexity." (42 CFR § 493.5) 3)Requires tests for certificate of waiver to be simple laboratory examinations and procedures which: a) Are cleared by FDA for home use; b) Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; AB 2179 (Gipson) Page 3 of ? or c) Pose no reasonable risk of harm to the patient if the test is performed incorrectly. (42 CFR § 493.15) This bill: 1)Authorizes a hepatitis C counselor to perform a HCV test under the overall operation and administration of a laboratory director, as specified. 2)Requires a hepatitis C counselor to meet one of the following criteria: a) Is trained by the Office of AIDS and working in an HIV counseling and testing site funded by the DPH through a LHJ, or its agents. b) Is working in an HIV counseling and testing site that meets both of the following criteria: i) Utilizes HIV counseling staff who are trained by the Office of AIDS or its agents to provide both HIV counseling and testing and hepatitis C counseling and testing. ii) Has and retains a quality assurance plan approved by the local health department in the jurisdiction where the site is located and has HIV counseling and testing staff who comply with the quality assurance requirements as specified by the DPH. c) Is working at a site approved by the local health department to provide hepatitis C rapid testing and counseling, and has been trained using a curriculum approved by the local health department, and retained by the site, or approved by the DPH, which, at a minimum, provides training in universal precautions, safe working conditions, proper running and reading of hepatitis C rapid test kit technology, and providing accurate information to clients including the importance of confirmatory tests, linkages to medical care, and the prevention of hepatitis C transmission. AB 2179 (Gipson) Page 4 of ? 3)Authorizes a hepatitis C counselor to do all of the following: a) Perform any HCV test that is classified as waived under CLIA if all of the following conditions exist: i) The performance of the HCV test meets the requirements of state and federal law regarding clinical labs. ii) Perform skin punctures for the purpose of withdrawing blood for waived HCV testing without a certificate as a certified phlebotomy technician, upon specific authorization from a licensed physician and surgeon, provided that the person meets both of the following requirements: (1) He or she works under the direction of a licensed physician and surgeon. (2) He or she has been trained in rapid test proficiency for skin puncture blood tests and in universal infection control precautions, consistent with best infection control practices established by the Division of Occupational Safety and Health in the Department of Industrial Relations and the federal Centers for Disease Control and Prevention (CDC). iii) The person performing the HCV test meets the requirements for the performance of waived laboratory testing, as specified. iv) The patient is informed that the preliminary result of the HCV test is indicative of the likelihood of HCV exposure and that the result must be confirmed by an additional more specific test, or, if approved by the federal CDC for that purpose, a second, different rapid HCV test. This does not allow a hepatitis C counselor to perform any HCV test that is not classified as waived under CLIA. b) Order and report HCV test results to patients without authorization from a licensed health care practitioner or his or her authorized representative. A patient who has an indeterminate or positive test result shall be referred to AB 2179 (Gipson) Page 5 of ? a licensed health care practitioner whose scope of practice includes the authority to refer a patient for laboratory testing for further evaluation. 4)Prohibits a hepatitis C counselor who meets the requirements of this section from performing any other test unless that person meets the statutory and regulatory requirements for performing that other test. 5)States that compliance with bill does not fulfill any requirements for certification as a phlebotomy technician or a limited phlebotomy technician, unless the hepatitis C counselor has otherwise satisfied the certification requirements. FISCAL EFFECT: This bill is keyed "fiscal" by the Legislative Counsel. According to the Assembly Committee on Appropriations analysis dated April 27, 2016, this bill has uncertain, potential cost pressures to the DPH. The analysis notes that this bill does not place direct requirements on the department, but is intended to allow LHJs flexibility to approve and implemented their own training programs. According to the analysis, DPH indicates cost pressure in the hundreds of thousands of dollars to promulgate and implement regulations, provide technical assistance, and review, approve, and potentially implement hepatitis C counselor trainings. COMMENTS: 1. Purpose. This bill is sponsored by Project Inform . According to the Author's office, "AB 2179 would allow LHJs as well as DPH, to certify training standards for hepatitis C test counselors to administer low-risk, easy-to-use, finger-stick rapid tests that meet the standards for "waiver" under the CLIA. The bill would remove the prerequisite that personnel be trained to administer an HIV rapid test before be trained to administer the hepatitis C rapid test. Only persons working in sites authorized by LHJs to offer HCV rapid testing would be allowed to administer CLIA-compliant tests. AB 2179 (Gipson) Page 6 of ? "The California Hepatitis Alliance did a series of interviews with community based programs in California in 2015 and 2016 and identified significant barriers to screening at-risk population, even when local resources existed to provide the tests. Even if tests were available and staff was available - either the training was not available or was too distant or too expensive for small community-based programs to access. "Current state statute mandates that a person must complete an HIV rapid test counseling training as a prerequisite, even if the local conditions call for deployment of HCV screening. "The State Office of AIDS currently pays contractors to provide HIV and HCV rapid test training, but only offers it to persons from 18 local health jurisdictions that have been prioritized due to high rates of HIV. The prioritization is based on HIV rates, not HCV rates, which is very high in many rural counties. 40 other counties (total of 60 LHJs) may ask for a seat in the trainings, but are wait-listed to see if there will be any availability. "The trainings generally take place in San Francisco and Los Angeles, far from programs. A small community based program, with very tight budgets, assumes the high cost of travel, accommodations, and the loss of staff for 4 days to complete a training that, if the law were changed, could be provided locally in half the time. "AB 2179 will trust local health officers and local health departments to certify a training for a test has been judged by the federal government to be easy-to-use, and very low-risk." 2. CLIA waived tests. Federal law, CLIA, establishes conditions that laboratories must meet for certification to perform testing on human specimens. This law classifies laboratory tests and establishes corresponding regulatory parameters using three categories: "waived," "moderate complexity," and "high complexity." "Waived" tests constitute the lowest category, and may be granted for those exams and procedures which are cleared by the FDA for home use; employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or pose no AB 2179 (Gipson) Page 7 of ? reasonable risk of harm to the patient if the test is performed incorrectly. This bill establishes criteria under which a hepatitis counselor may perform a waived HCV test after training, using a curriculum approved by the local health department, or the DPH, which, at a minimum, provides training in universal precautions, safe working conditions, proper running and reading of hepatitis C rapid test kit technology, and providing accurate information to clients including the importance of confirmatory tests, linkages to medical care, and the prevention of hepatitis C transmission. 3. Hepatitis C. Hepatitis C is a contagious liver disease that ranges in severity from a mild illness lasting a few weeks to a serious, lifelong illness that attacks the liver. It results from infection with HCV, which is spread primarily through contact with the blood of an infected person. While infection rates are high among baby boomers who were exposed to the virus prior to effective blood screenings, most individuals become infected currently by sharing injection equipment. Hepatitis C's effects can be mitigated through early detection and treatment, which can also reduce new infections. This is especially important in California, as the CDC reports that between 2009 and 2013, reported rates of acute hepatitis C increased by 100 percent in this state. 4. HIV Counselors. Existing law allows HIV counselors to perform HIV, HCV, and combination HIV/HCV tests that are classified, as waived under CLIA, if the facility or clinic has obtained a certificate of waiver from Center for Medicaid Services and DPH approval, and the HIV counselor has attended trainings specific to each type of test. Currently, the Office of AIDS (OA) establishes or approves a LHJ's HIV Counseling and Testing training programs, which are conducted by community-based, non-profit HIV organizations for HIV testing. However, not all LHJs are able to access the trainings. According to the Office of AIDS Integrated HIV Surveillance, Prevention, and Care Plan (Integrated Plan), budget cuts during fiscal year 2009-10 reduced the OA's funding for many AB 2179 (Gipson) Page 8 of ? of its AIDS programs. Since 2012, the majority of the OA's HIV prevention activities have been funded solely through a five-year funding opportunity from the CDC. The program established three funding areas in California: the Los Angeles and San Francisco Metropolitan Statistical Areas (which receive funds directly from the CDC), and the California Project Area (CPA). The CPA includes a limited number of LHJs that have demonstrated a high incidence of HIV. LHJs within the CPA receive the Counseling and Testing training as a part of the CDC's program, but the remaining LHJs must pay for the Counseling and Testing training out of their own funds, and spaces within the C&T trainings are limited. AB 2179's sponsor and supporters note that having to pay out of pocket for the Counseling and Testing training burdens the LHJs that have not met the HIV-incidence thresholds but may still have a high incidence of HCV. Currently, the counselors working in LHJs outside of the CPA cannot attend the HCV Counseling and Testing training without attending the HIV Counseling and Testing training. If the LHJ does not have the funds or the offered training is full, the counselor will be unable to provide HCV testing and screening at the testing site. This bill seeks to remedy by authorizing a LHJ to approve an independent HCV Counseling and Testing training program and authorizing a hepatitis C counselor who works at a testing site approved by the LHJ to perform a CLIA-waived HCV test after attending the training program. 5. Prior Related Legislation. AB 1382 (R. Hernandez, Chapter 643, Statutes of 2011) authorized HCV training for HIV test counselors. AB 221 (Portantino, Chapter 421, Statutes of 2009) among other things, removed the HIV counselor training equivalency credit towards a limited phlebotomy technician certification and instead exempted an HIV counselor who works under a licensed physician and surgeon, and who is trained in rapid HIV test proficiency and universal infection control precautions, from the requirement that he or she hold a valid certification as a phlebotomist technician. AB 685 (Leno, Chapter 2, Statutes of 2004) provided that HIV counselors that completed HIV counselor training were deemed AB 2179 (Gipson) Page 9 of ? to have met the requirements for certification as a limited phlebotomy technician. AB 1263 (Migden, Chapter 324, Statutes of 2001) among other things, authorized HIV counselors to perform HIV tests classified as waived under CLIA. 6. Arguments in Support. Project Inform writes, "California must reduce the costs and procedural barriers for training non-medical personnel to perform rapid HCV tests in order that local health departments can respond in a manner that is safe and appropriate to the urgency of the epidemic. Current state law allows non-medical personnel to administer HCV rapid tests in compliance with federal standards under CLIA, but only if personnel are working at a DPH Office of AIDS (OA)-funded site, or authorized by a local health jurisdiction (LHJ); have been trained in HIV testing and counseling using a DPH-OA approved curriculum; and have completed an additional HCV test counseling and testing module approved by DPH-OA. "AB 2179 would allow LHJs, as well as DPH, to certify training standards for HCV rapid test counselors, and remove the prerequisite that personnel be trained to administer an HIV rapid test before learning to administer the HCV rapid test. Further, only those persons working in sites authorized by LHJs to offer HCV rapid testing would be allowed to administer CLIA-compliant tests." Access Support Network writes that they were recently able to train 16 local individuals to become HIV/HCV Test Counselors. "The training was a four day training that came at a cost of nearly $40,000 to our agency. We were fortunate to have one time funding to facilitate this training, but, not normally being funded by the State Office of AIDS HIV testing, this training will not be available again for our agency. A more simplified training for HCV test counselors is greatly needed." Mendocino County AIDS/Viral Hepatitis Network (MCAVHN) writes that they are the "only HIV/AIDS/HCV service-oriented, community based harm reduction organization in all of Mendocino County?. MCAVHN began outreach efforts in the mid-nineties, notably building bridges within the AB 2179 (Gipson) Page 10 of ? Native-American communities who were significantly under-represented. Our services have adapted to assist those with multiple co-morbid conditions, and within Mendocino County our persons who inject drugs have a projected HCV+ rate of 85%. We are the only community-based organization delivering HCV testing to persons within our syringe exchange services delivery, both in-house and in the field, and have just been informed that we can no longer provide this service due to the conditions of the SAPTBG funding stream, which for the past two years has been our only source of funding for this testing.... "AB 2179 would allow LHJs to certify training standards for HCV rapid test counselors and remove the prerequisite that personnel be trained to administer an HIV rapid test before learning to administer the HCV rapid test. Further, only those persons working in sites authorized by LHJs to offer HCV rapid testing would be allowed to administer CLIA-compliant tests. These trainings need to be available and low-cost so that communities can deliver these services even in resource-poor, rural areas." 7. Technical Amendment. The following are suggested technical amendments to strike code that was amended by the inclusion of text explicitly authorizing a hepatitis C counselor to perform a HCV test under the overall operation and administration of a laboratory director, as specified. On page 7, line 36, delete everything after "Code." On page 7, delete lines 37-39. On page 8, delete lines 1-2 NOTE : Double-referral to Senate Committee on Health , second. SUPPORT AND OPPOSITION: Support: Project Inform (Sponsor) Access Support Network AB 2179 (Gipson) Page 11 of ? AIDS Community Research Consortium Asian Pacific Health Foundation Bay Area Black Nurses Association California Black Health Network California Chronic Care Coalition California Hepatitis Alliance California Life Sciences Association Comprehensive Opiate Recovery Experience Medical Clinic, Inc. Desert AIDS Project Drug Policy Alliance Harm Reduction Coalition Health Officers Association of California HIV Education and Prevention Project of Alameda County Mendocino County AIDs/Viral Hepatitis Network Sacramento Area Task Force for the Outreach and Prevention of Hepatitis San Francisco Hepatitis C Task Force The Wall Las Memorias Project One individual Opposition: None on file as of June 14, 2016. -- END --