BILL ANALYSIS Ó AB 2179 Page 1 Date of Hearing: April 12, 2016 ASSEMBLY COMMITTEE ON HEALTH Jim Wood, Chair AB 2179 (Gipson) - As Amended March 30, 2016 SUBJECT: Hepatitis C testing SUMMARY: Authorizes a hepatitis C counselor who meets specific requirements to perform any hepatitis C virus (HCV) test that is classified as waived under the federal Clinical Laboratory Improvement Act (CLIA). Specifically, this bill: 1)Requires a hepatitis C counselor to meet one of the following criteria: a) To be trained by the Office of AIDS (OA) and working in an human immunodeficiency virus (HIV) counseling and testing site funded by the Department of Public Health (DPH) through a local health jurisdiction, or its agents; b) To be working in an HIV counseling and testing site that meets both of the following criteria: i) Utilizes HIV counselling staff that is trained by the OA or its agent to provide both HIV counseling and testing and hepatitis C counseling and testing; and, ii) Has a quality assurance plan approved by the local health department in the jurisdiction where the site is AB 2179 Page 2 located and has HIV counseling and testing staff who comply with the quality assurance requirements as specified by DPH; or, c) To be 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 or 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. 2)Authorizes a hepatitis C counselor who meets the criteria in 1) above 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 CLIA and state law. ii) Perform skin punctures for the purpose of withdrawing blood for HCV testing upon authorization from a licensed physician provided that the person meets both of the following requirements: (1) He or she works under the direction of a licensed physician; and, (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 AB 2179 Page 3 Centers for Disease Control and Prevention (CDC). iii) The person performing the HCV tests meet the requirements for the performance of waived laboratory testing pursuant to existing state law as described in existing law in 2) below. For purposes of these provisions a hepatitis C counsel is "other health care personnel provide direct patient care," per existing law. iv) The patient is informed that the preliminary result of the 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 CDC, a second, different rapid HCV test. b) Order and report HCV test results to patients without authorization from a licensed health care practitioner or his or her authorized representative. Requires a patient who has an indeterminate or positive test result to be referred to a licensed health care practitioner whose scope of practice includes the authority to refer a patient for laboratory testing for further revaluations. 3)Prohibits a hepatitis C counselor as defined in these provisions from performing any other test unless they meet the statutory and regulatory requirements for performing that other test. 4)Specifies that compliance with these provisions does not fulfill any requirements for certification as a phlebotomy technician or a limited phlebotomy technician. EXISTING FEDERAL LAW: AB 2179 Page 4 1)Defines "laboratory" or "clinical laboratory" as a facility for the biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease or impairment or health assessment of human beings. 2)Requires that laboratories obtain a certificate, meet quality standards, and undergo inspections, among other things, before accepting materials derived from the human body. Exempts laboratories with a certificate of waiver from the CLIA, provided that the laboratory follows the manufacturer's instructions. 3)Provides that a laboratory is eligible for a certificate of waiver if the laboratory only performs "waived tests," which are simple examinations and procedures that: a) Have been approved by the Food and Drug Administration (FDA) for home use; b) The FDA has determined are so simple and accurate that there is a negligible chance of erroneous results; or, c) Pose no unreasonable risk of harm to the patient if performed incorrectly. 4)Authorizes a state to enact and enforce laws relating to CLIA to the extent that the state laws are not inconsistent with the CLIA laws and regulations. EXISTING STATE LAW: 5)Provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by DPH. AB 2179 Page 5 6)Prohibits a person from performing a clinical laboratory test or examination classified as waived under CLIA unless the clinical laboratory test or examination is performed under the overall operation and administration of the laboratory director, as specified, and the test is performed by one the following persons if within the person's scope of practice: a) A licensed physician and surgeon holding a M.D. or D.O. degree; b) A licensed podiatrist, a licensed dentist, or a licensed naturopathic doctor; c) A person licensed in California to engage in clinical laboratory practice or to direct a clinical laboratory; d) A person authorized by a local health laboratory to perform tests pursuant to a certificate issued by the DPH; e) A licensed physician assistant; f) A licensed nurse; g) A licensed vocational nurse; h) A certified perfusionist (a specialized healthcare professional who uses the heart-lung machine during cardiac surgery and other surgeries that require cardiopulmonary bypass to manage the patient's physiological status); i) A licensed respiratory care practitioner; j) A medical assistant; aa)A pharmacist; bb)A naturopathic assistant; cc)A licensed optometrist; dd)Other health care personnel providing direct patient care; or, ee)Any other person performing non-diagnostic testing. 7)Establishes the OA within DPH as the lead agency within the state, responsible for coordinating state programs, services, and activities relating to HIV, acquired immune deficiency syndrome (AIDS), and AIDS related conditions (ARC). 8)Requires DPH to authorize the establishment of training programs throughout the state for counselors for publicly AB 2179 Page 6 funded HIV testing programs. 9)Authorizes an HIV counselor to perform a HIV, HCV, or combination HIV/HCV test that is classified as waived under CLIA if the following conditions exist: a) The performance of the HIV, HCV, or combination HIV/HCV test meets the requirements of CLIA and the California clinical laboratory requirements. b) The HIV counselor meets one of the following criteria: i) Is trained by the OA and working in a HIV counseling and testing site funded by the DPH through a local health jurisdiction, or its agents; ii)Is working in a HIV counseling and testing site that meets both of the following criteria: (1)Utilizes HIV counseling staff who are trained by the OA or its agents; or, (2)Has 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 DPH. c) The HIV, HCV, or combination HIV/HCV test is performed under the overall operation and administration of a laboratory director. Defines, for purposes of this requirement, a HIV counselor who meets the specified requirements as "other health care personnel providing direct patient care" under the California clinical laboratory requirements. d) The patient is informed that the preliminary result of the test is indicative of the likelihood of HIV infection or HCV exposure and that the result must be confirmed by an additional more specific test, or, if approved by the federal Centers for Disease Control and Prevention (CDC) for that purpose, a second different rapid HIV, HCV, or combination HIV/HCV test. e) If performing skin punctures for the purpose of AB 2179 Page 7 withdrawing blood for HIV, HCV, or combination HIV/HCV testing, the counselor must meet the following additional requirements: i) The counselor works under the direction of a licensed physician and surgeon. ii)The counselor has specific authorization from a licensed physician and surgeon. iii)The counselor has been trained in both rapid HIV, HCV, or combination HIV/HCV test proficiency for skin puncture blood tests and oral swab tests and in universal infection control precautions, consistent with best infection control practices established by the Division of Occupational Safety and Health (DOSH) in the Department of Industrial Relations (DIR) and the CDC. 10)Authorizes the HIV counselor to order and report the results from the HIV, HCV, or combination HIV/HCV test to a patient without authorization from a licensed health care professional or the patient's authorized representative. 11)Requires that patients with indeterminate or positive results from the HIV, HCV, or combination HIV/HCV test be referred to a licensed health care provider whose scope of practice includes the authority to refer patients for laboratory testing for further evaluation. 12)Provides that a HIV counselor is not authorized to perform any other test unless that person meets the statutory and regulatory requirements for performing the other test. FISCAL EFFECT: This bill has not been analyzed by a fiscal committee. COMMENTS: AB 2179 Page 8 1)PURPOSE OF THIS BILL. According to the author, the unchecked spread of HCV threatens the public health and economic welfare of California. The author states that there are an estimated 750,000 Californians living with HCV, and most do not know it, and between 2002 and 2011 there were over 400,000 hepatitis B and HCV-related hospitalizations in California, costing $26 billion. The author contends that the burden of HCV is expected to grow, and early detection reduces the likelihood of disease progression, reduces treatment costs, and prevents new infections. The author also states that community-based programs are best positioned to serve low-income communities, including the homeless, reaching those who are currently not enrolled in Medi-Cal or other health insurance, or who are disconnected from primary care services. The author asserts that it is necessary for California 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. The author states that this bill will give local health departments greater flexibility to respond to HCV in their communities and reduce costs related to training non-medical personnel to administer the rapid test. The author concludes that the current statutory requirement that a person must complete training in HIV test counseling before receiving HCV test counseling, and that the training must be approved by a state health official rather than a county health official is outdated and a barrier to cost-effective disease control and prevention. 2)BACKGROUND. a) HCV. 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 the HCV, which is spread primarily through contact with the blood of an infected AB 2179 Page 9 person. Hepatitis C can be either "acute" or "chronic." Acute HCV infection is a short-term illness that occurs within the first six months after someone is exposed to the HCV. For most people, acute infection leads to chronic infection. Chronic Hepatitis C virus infection is a long-term illness that occurs when HCV remains in a person's body. HCV infection can last a lifetime and lead to serious liver problems, including cirrhosis (scarring of the liver) or liver cancer. According to the CDC, most people become infected with HCV by sharing needles or other equipment to inject drugs. The CDC estimates that there are 3.5 million people in the U.S. who have chronic HCV infection. Between 1994 and 2011, DPH had received 501,664 newly reported chronic HCV cases in California. As a result, the World Health Organization, the CDC, and DPH suggest policies that promote prevention and education among high-risk populations. This bill seeks to do so by authorizing HCV counselors to perform a HCV screening test if it is classified as waived under CLIA. The author states that doing so will increase access to HCV counselors, who will promote prevention by providing screening and education services at a community level. b) Federal and State Laboratory Requirements. Under the federal CLIA law, laboratories that perform tests on human specimens must be certified by the Centers for Medicare and Medicaid Services (CMS). The requirements for CLIA certification vary depending on the complexity of the laboratory tests performed. The three complexities are waived, moderate, and high complexity. In general, the more complicated the test, the more stringent the requirements under CLIA. As defined by CLIA, waived tests are simple tests with a AB 2179 Page 10 low risk for an incorrect result. Waived tests include tests listed in the CLIA regulations, tests cleared by the FDA for home use, and tests approved for waiver by the FDA using the CLIA criteria. In order for the FDA to approve a test device as waived, the manufacturer must show that the test is accurate and consistent when performed by untrained individuals. This includes performing studies conducted using participants without laboratory training, no prior experience of the test, and no verbal instruction. The study participants must be able to generate accurate results using only the product label and included instructions. Because waived tests are essentially consumer-level products, facilities that use only waived tests are eligible for a certificate of waiver. Those with a certificate of waiver are not subject to the CLIA requirements as long as the tests are performed according to the manufacturer's instructions. However, CLIA still requires that all laboratories meet individual state personnel license requirements. Under California law, all laboratory tests classified under CLIA must be performed by personnel specified in statute under the overall operation and administration of a laboratory director, with limited exceptions. As of 2014, California is one of 15 other states that regulate laboratories in addition to the CLIA standards. AB 2179 Page 11 c) HIV and HCV Counselors. Existing law allows HIV counselors to perform a HIV, HCV, and combination HIV/HCV test as long as it is classified as waived under CLIA, the facility or clinic has obtained a certificate of waiver from CMS and DPH approval, and the HIV counselor has attended trainings specific to each type of test. Currently, the OA establishes or approves a local health jurisdiction's (LHJ's) HIV Counseling and Testing (C&T) 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 OA's Integrated HIV Surveillance, Prevention, and Care Plan (Integrated Plan), budget cuts during fiscal year 2009-10 reduced the OA's funding for many 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 C&T training as a part of the CDC's program, but the remaining LHJs must pay for the C&T training out of their own funds and spaces within the C&T trainings are limited. The sponsor notes that having to pay out of pocket for the C&T training burdens the LHJs that have not met the HIV-incidence thresholds but may still have a high AB 2179 Page 12 incidence of HCV. Currently, the counselors working in LHJs outside of the CPA cannot attend the HCV C&T training without attending the HIV C&T 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 this issue in two ways: 1) authorizing a LHJ to approve a HCV C&T training program and 2) authorizing a HCV counselor who works at a testing site approved by the LHJ to perform a CLIA-waived HCV test after attending the training program. 3)SUPPORT. Project Inform is the sponsor of this bill and states current state law allows non-medical personnel to administer HCV rapid tests in compliance with CLIA standards, but only if personnel are working at a DPH-OA funded site, or authorized by a LHJ; have been trained to administer an 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. The sponsor notes this bill will give local governments greater flexibility and reduce costs related to training non-medical personnel to administer the rapid test to screen for HCV in community settings by allowing LHJs as well as DPH to certify training standards for HCV rapid test counselors. Mendocino County AIDs/Viral Hepatitis Network (MCAVNH) supports this bill stating that they are the only HIV/IDS/HCV service-oriented, community based harm reduction organization in all of Mendocino County. MCAVNH notes that they have adapted their services to assist those with multiple co-morbid conditions, and within Mendocino County persons who inject drugs have a projected HCV positive rate of 85%, and that AB 2179 Page 13 early detection reduces the likelihood of disease progression, reduces costs of treatment, and prevents new infections in the community. MCAVNH concludes that 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. 4)PREVIOUS LEGISLATION. a) AB 761(Roger Hernández) Chapter 714, Statutes of 2012 provides that a laboratory director may include a licensed optometrist and authorizes an optometrist to perform certain clinical laboratory tests or examinations classified as waived under CLIA. b) SB 1481(Negrete McLeod) Chapter 874, Statutes of 2012 allows pharmacists to perform specific CLIA waived tests without the supervision of a laboratory director. c) AB 1382 (Roger Hernández), Chapter 643, Statutes of 2011 authorized HIV test counselors to perform HCV or combined HIV/HCV tests in addition to HIV tests. d) 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 2179 Page 14 e) AB 685 (Leno), Chapter 2, Statutes of 2004, provided that HIV counselors that completed HIV counselor training were deemed to have met the requirements for certification as a limited phlebotomy technician. f) AB 1263 (Migden), Chapter 324, Statutes of 2001, among other things, authorized HIV counselors to perform HIV tests classified as waived under CLIA. 5)DOUBLE REFERRAL. This bill has been double referred. It passed the Assembly Committee on Business and Professions with a vote of 16-0 on March 29, 2016. 6)TECHNICAL AMENDMENTS. This bill is attempting to improve access to training for persons who are providing HCV screening by creating HCV tester training programs at the local level, similar to the HIV training program provided at the state level. In order to more closely align the training and supervision requirements for persons performing HPV tests with those for persons performing HIV tests, the bill should be amended as follows: a) Clarify that skin punctures are only allowed to be performed for waived tests; b) Require local testing sites to maintain copies of LHJ approved training documents; and, c) Add language to the Business & Professions code to AB 2179 Page 15 clarify that waived HCV tests do not have to be performed in a clinical laboratory. 7)POLICY COMMENT. Given that DPH has extensive experience in providing and approving training programs, as this bill moves forward, the author should consider adding in language that would require DPH and LHJs to consult on developing the HCV training programs. REGISTERED SUPPORT / OPPOSITION: Support Project Inform (sponsor) C.O.R.E. Medical Clinic, Inc. Desert AIDS Project Harm Reduction Coalition Mendocino County AIDs/Viral Hepatitis Network San Francisco Hepatitis C Task Force STOP Hepatitis Task-Force The Wall Las Memorias Project One individual Opposition None on file. Analysis Prepared by:Lara Flynn / HEALTH / (916) 319-2097 AB 2179 Page 16