BILL ANALYSIS Ó AB 2179 Page 1 CONCURRENCE IN SENATE AMENDMENTS AB 2179 (Gipson) As Amended August 16, 2016 Majority vote -------------------------------------------------------------------- |ASSEMBLY: |80-0 |(May 31, 2016) |SENATE: |36-0 |(August 19, | | | | | | |2016) | | | | | | | | | | | | | | | -------------------------------------------------------------------- Original Committee Reference: B. & P. SUMMARY: Authorizes a hepatitis C counselor, who meets specified training requirements and works in specified testing sites, to perform hepatitis C virus (HCV) tests classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA). Specifically, this bill: 1)Authorizes a hepatitis C counselor to perform a HCV test that is classified as waived under CLIA if the following conditions exist: a) The performance of the HCV test meets the requirements of CLIA and California's clinical laboratory requirements; b) The counselor 1) is trained as a Human Immunodeficiency Virus (HIV) counselor to perform a HCV test or 2) is working in a HCV counseling and testing site that meets specified criteria; AB 2179 Page 2 c) The HCV test is performed under the overall operation and administration of a laboratory director; d) 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 Center for Disease Control and Prevention (CDC) for that purpose, a second, different rapid HCV test; and, e) If performing a skin punctures for the purpose of withdrawing blood for HCV testing, the counselor meets the following requirements: i) Works under the direction of a licensed physician and surgeon; ii)Has specific authorization from a licensed physician and surgeon; and, iii)Is trained to perform rapid test proficiency either for skin puncture blood tests or oral swab tests in universal infection control precautions, as specified. 2)Authorizes the counselor to order and report the results from the HCV tests performed to a patient without authorization from a licensed health care practitioner or the patient's authorized representative. 3)Requires the counselor to refer a patient who has an indeterminate or positive test result to a licensed health care practitioner whose scope of practice includes the authority to refer a patient for laboratory testing for further evaluation. 4)Provides that a hepatitis C counselor is not authorized to AB 2179 Page 3 perform any other test unless that person meets the statutory and regulatory requirements for performing the other test, including those requiring certifications in phlebotomy. The Senate amendments delete the requirement that a HCV counselor must also be trained in HIV testing and made technical and clarifying changes. FISCAL EFFECT: According to the Senate Appropriations Committee: 1)One-time costs of about $150,000 for the development and adoption of regulations by the Department of Health Care Services. 2)Minor ongoing costs to train hepatitis C counselors and provide technical assistance to local health jurisdictions. 3)Unknown additional costs to the Medi-Cal program to provide treatment for newly diagnosed hepatitis C cases. By making it easier for hepatitis C counselors working in certain situations to perform hepatitis C tests, the bill is likely to result in additional testing and additional diagnoses of hepatitis C. For those individuals who are eligible for Medi-Cal, there would likely be increased costs to provide treatment for newly diagnosed hepatitis C cases. The costs to provide such treatment are unknown and would depend on the number of new diagnoses amongst the Medi-Cal population. New hepatitis C drugs on the market have very high upfront costs (in the tens of thousands per course of treatment), but are very effective at curing hepatitis C. In the long-run, early diagnosis and treatment for some patients, may actually save money. However, a very low percentage of hepatitis C patients will ever receive a costly liver transplant. Therefore, it is not known whether widespread use of these very expensive drugs will actually save money for the Medi-Cal program in the long-run. AB 2179 Page 4 COMMENTS: Purpose. This bill is sponsored by Project Inform. According to the author, "The unchecked spread of HCV threatens the public health and economic welfare of California. It is necessary that 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. [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." Background. Hepatitis means inflammation of the liver. Hepatitis C is an infection of the liver caused by HCV, one of several contagious viruses that can cause hepatitis. HCV is spread by blood-to-blood contact and common ways people become infected are through needle sharing, inadequate sterilization of medical equipment, and unscreened blood transfusions. The CDC estimates that there are 3.5 million people in the United States have chronic HCV infection. Between 1994 and 2011, the CDPH had received 501,664 newly reported chronic HCV cases in California. As a result, the World Health Organization, the CDC, and the CDPH 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. 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 AB 2179 Page 5 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. Waived tests are simple, consumer-level tests with a low risk for an incorrect result. However, California law only allows specified personnel to perform waived tests on others. HIV and HCV Counselors. Existing law allows HIV counselors to perform HIV, HCV, and combination HIV/HCV tests as long as the tests are classified as waived under CLIA, the facility or clinic has obtained a certificate of waiver from CMS and CDPH approval, and the HIV counselor has attended a Counseling and Testing (C&T) training specific to each type of test. Currently, the OA either establishes or approves federally-funded HIV C&T training programs for a local health jurisdiction's(LHJ) HIV counselors. However, not all LHJs are able to access the trainings. Access to the trainings is determined by incidence of HIV, but some LHJs have a high incidence of HCV but not a high incidence of HIV. The LHJs that cannot meet the HIV thresholds must pay for the trainings. The sponsor notes that having to pay out of pocket for the C&T training means that if the LHJ does not have the funds or the offered training is full, its counselors will not be able to provide necessary HCV testing and screenings. This bill seeks to remedy this issue by establishing training and workplace pathways for HCV counselors. Analysis Prepared by: Vincent Chee / B. & P. / (916) 319-3301 FN: 0004748 AB 2179 Page 6