BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | AB 2179|
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THIRD READING
Bill No: AB 2179
Author: Gipson (D)
Amended: 8/16/16 in Senate
Vote: 21
SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 9-0, 6/20/16
AYES: Hill, Bates, Block, Gaines, Galgiani, Hernandez,
Jackson, Mendoza, Wieckowski
SENATE HEALTH COMMITTEE: 8-0, 6/29/16
AYES: Hernandez, Nguyen, Hall, Mitchell, Monning, Nielsen,
Pan, Roth
NO VOTE RECORDED: Wolk
SENATE APPROPRIATIONS COMMITTEE: 7-0, 8/11/16
AYES: Lara, Bates, Beall, Hill, McGuire, Mendoza, Nielsen
ASSEMBLY FLOOR: 80-0, 5/31/16 - See last page for vote
SUBJECT: Hepatitis C testing
SOURCE: Project Inform
DIGEST: This bill 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.
ANALYSIS:
Existing law:
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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)
2)Requires an individual who draws blood to be certified by the
DPH as a certified phlebotomy technician. (BPC § 1246)
3)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)
4)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)
5)Classifies laboratory tests using three categories: "waived,"
"moderate complexity," or "high complexity." (42 CFR § 493.5)
6)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;
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.
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2)Requires a hepatitis C counselor to meet one of the following
criteria:
a) Is authorized to perform an HCV test as a HIV counselor,
as specified.
b) Is working in a hepatitis C counseling and testing site
that meets both of the following criteria:
i) Utilizes hepatitis C counselors who are trained by
DPH or its agents to provide testing and hepatitis C
counseling and testing. States that a training agent may
include, but is not limited to, a local health department
or its designee, an academic medical center, or a
community-based organization.
ii) Has and retains a quality assurance plan and
has hepatitis C counseling and testing staff who comply
with the quality assurance protocols and guidelines made
available by DPH, as specified.
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
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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
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 this 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.
Background
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
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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.
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 local healthcare jurisdiction's
(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, 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: Los Angeles and San Francisco Metropolitan
Statistical Areas and the California Project Area (CPA). The
CPA includes a limited number of local health jurisdictions that
have demonstrated a high incidence of HIV. Local health
jurisdictions within the CPA receive counseling and testing
training as a part of the CDC's program, but the remaining local
health jurisdictions must pay for the counseling and testing
training out of their own funds, and spaces within those
trainings are limited.
AB 2179's sponsor and supporters note that having to pay out of
pocket for the counseling and testing training is a burden for
the local health jurisdictions that have not met the
HIV-incidence thresholds but may still have a high incidence of
HCV. Currently, the counselors working in local health
jurisdictions outside of the CPA cannot attend the HCV
counseling and testing training without attending the HIV
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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 this situation by expanding the
entities allowed to train hepatitis C counselors separately from
HIV counseling and establishing parameters for hepatitis C
testing and practice.
FISCAL EFFECT: Appropriation: No Fiscal
Com.:YesLocal: No
According to the Senate Appropriations Committee:
Minor ongoing costs to train hepatitis C counselors and
provide technical assistance to local health jurisdictions
(General Fund).
Unknown additional costs to the Medi-Cal program to provide
treatment for newly diagnosed hepatitis C cases (General Fund
and federal funds). 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.
SUPPORT: (Verified8/15/16)
Project Inform (source)
Access Support Network
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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: (Verified8/15/16)
None received
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."
ASSEMBLY FLOOR: 80-0, 5/31/16
AYES: Achadjian, Alejo, Travis Allen, Arambula, Atkins, Baker,
Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Burke,
Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley,
Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Beth
Gaines, Gallagher, Cristina Garcia, Eduardo Garcia, Gatto,
Gipson, Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Harper,
Roger Hernández, Holden, Irwin, Jones, Jones-Sawyer, Kim,
Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis,
Mayes, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte,
O'Donnell, Olsen, Patterson, Quirk, Ridley-Thomas, Rodriguez,
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Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting,
Wagner, Waldron, Weber, Wilk, Williams, Wood, Rendon
Prepared by:Sarah Huchel / B., P. & E.D. / (916) 651-4104
8/17/16 9:19:41
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