BILL ANALYSIS Ó
AB 2179
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CONCURRENCE IN SENATE AMENDMENTS
AB
2179 (Gipson)
As Amended August 16, 2016
Majority vote
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|ASSEMBLY: |80-0 |(May 31, 2016) |SENATE: |36-0 |(August 19, |
| | | | | |2016) |
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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;
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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
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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.
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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
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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
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