BILL ANALYSIS Ó
AB 383
Page 1
Date of Hearing: April 28, 2015
ASSEMBLY COMMITTEE ON HEALTH
Rob Bonta, Chair
AB 383
(Gipson) - As Amended March 26, 2015
SUBJECT: Public health: hepatitis C.
SUMMARY: Requires a primary care clinic (PCC) to offer every
patient receiving services a hepatitis C virus (HCV) screening
or diagnostic test. Specifically, this bill:
1)Requires the HCV screening or diagnostic test to be done with
the patient's consent and in a manner consistent with the
United States Preventative Services Talk Force (USPSTF)
recommendations and Centers for Disease Control and Prevention
(CDC) algorithms.
2)Specifies that screening is not required to be offered if the
patient has already taken a HCV screening or diagnostic test,
or if the patient has been offered screening or a test within
the last 12 months.
3)Specifies that the provisions of this bill do not prohibit a
PCC from charging a patient to cover the cost of the HCV
screening or test, and that a PCC is deemed to be in
compliance if a HCV screening or diagnostic test is offered.
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4)Requires a PCC to attempt to provide test results to the
patient before they leave the facility, and if that is not
possible, allows the facility to inform a patient with
negative test results by telephone, and a patient with
positive test results in a manner consistent with current law.
5)Clarifies that these provisions do not apply to an individual
receiving primary care services in a hospital or emergency
room setting.
6)Makes various findings and declarations regarding HCV
screening.
EXISTING LAW:
1)Requires the Department of Public Health (DPH) to make
available protocols and guidelines developed by the National
Institutes of Health (NIH), the University of California at
San Francisco, and California legislative advisory committees
on HCV for educating physicians and health professionals and
training community service providers on the most recent
scientific and medical information on HCV detection,
transmission, diagnosis, treatment, and therapeutic decision
making.
2)Requires a patient who has blood drawn at a primary care
clinic and who has consented, as specified, to be offered a
human immunodeficiency virus (HIV) test, unless the clinic has
tested the patient for HIV within the previous 12 months.
Requires the primary care clinician to offer an HIV test
consistent with USPSTF recommendations for screening HIV
infection.
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3)Requires a patient that has received an HIV or HCV test to be
informed if the preliminary result of the test indicates the
likelihood of HIV infection or HCV exposure and that the
result must be confirmed by an additional more specific test.
FISCAL EFFECT: This bill has not been analyzed by a fiscal
committee.
COMMENTS:
1)PURPOSE OF THIS BILL. According to the author, between 2.7
million and 3.9 million U.S. residents are infected with HCV
and 500,000 Californians are living with the virus.
Nevertheless, there is a significant lack of awareness of HCV,
the threat that it poses to the public health and current
opportunities to control it. The author states this bill
seeks to ensure that primary care clinics are proactive in
testing high risk and baby boomer patients for HCV to increase
community awareness.
2)BACKGROUND.
a) Hepatitis C. Hepatitis is a virus, or infection, that
causes liver disease and inflammation of the liver. Acute
hepatitis C is a short-term infection with the hepatitis C
virus. Symptoms can last up to six months. The infection
sometimes clears up because the body is able to fight off
the infection and get rid of the virus. Chronic hepatitis
C is a long-lasting infection. Chronic hepatitis C occurs
when the body can't get rid of the hepatitis C virus.
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People can become infected through sharing needles,
needle-stick injuries in health care settings, or being
born to a mother who has HCV.
According to the CDC, millions of Americans have HCV, but
most don't know it, because people often have no symptoms
and can live with an infection for decades without feeling
sick. About 80% who have HCV develop a chronic or lifelong
infection. HCV is a leading cause of liver cancer and the
leading cause of liver transplants.
b) USPSTF recommendations. Created in 1984, the USPSTF is
an independent group of national experts in prevention and
evidence-based medicine that works to improve the health of
all Americans by making evidence-based recommendations
about clinical preventive services such as screenings,
counseling services, or preventive medications. The USPSTF
is made up of 16 volunteer members who come from the fields
of preventive medicine and primary care, including internal
medicine, family medicine, pediatrics, behavioral health,
obstetrics/gynecology, and nursing. All members volunteer
their time to serve on the USPSTF, and most are practicing
clinicians.
In June 2013 the USPSTF released recommendations for HCV
infection screening. These recommendations apply to all
asymptomatic adults without known liver disease or functional
abnormalities. Persons born between 1945 and 1965 are more
likely to be diagnosed with HCV infection, possibly because they
received blood transfusions before the introduction of screening
in 1992 or have a history of other risk factors for exposure
decades earlier. The recommendations state that a risk-based
approach may miss detection of a substantial proportion of HCV
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infected persons in the birth cohort because of a lack of
patient disclosure or knowledge about prior risk status. As a
result, one-time screening for HCV infection in the birth cohort
may identify infected patients at earlier stages of disease who
could benefit from treatment before developing complications
from liver damage.
The USPSTF believes that screening should be voluntary and
undertaken only with the patient's knowledge and understanding
that HCV testing is planned. Patients should be informed orally
or in writing that HCV testing will be performed unless they
decline. The USPSTF further believes that before screening,
patients should receive an explanation of the HCV infection, how
it can (and cannot) be acquired, the meaning of positive and
negative test results, and the benefits and harms of treatment.
Patients should also be offered the opportunity to ask questions
and to decline testing.
c) Treatment. HCV is usually not treated unless it becomes
chronic. Until recently, chronic HCV was most often
treated with a medicine combination that attacks the virus,
and treatment lasted from 24 to 48 weeks. In December
2013, the federal Food and Drug Administration (FDA)
approved a drug produced by Gilead Sciences called Sovaldi
for the treatment of HCV. Sovaldi represents a significant
advance in therapy for HCV as it provides a higher cure
rate, allows for a shorter duration of treatment, has fewer
adverse effects, and opens up treatment options for
individuals with comorbid conditions for which traditional
treatments are contraindicated.
While the drug has been found to be remarkably effective
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(curing 90% or more patients over the course of 12 weeks,
according to the FDA), Gilead Sciences has come under heavy
fire for the price of the drug treatment. Sovaldi is
priced at $1,000 per pill, which brings the cost associated
with a 12-week treatment regimen to $84,000. Gilead
Sciences reported sales of $10.3 billion for Sovaldi in
2014 alone.
After a year of market exclusivity for Sovaldi, Abbvie
gained FDA approval to market rival HCV treatment Viekira
Pak in late 2014. Pharmacy benefit managers (PBMs), like
ExpressScripts and CVS Caremark quickly signed deals that
agreed to exclusive coverage for specific brand drugs on
its formulary, in return for a hefty price discount on the
drug. A few other competitor drugs are currently in final
stages of clinical trials and could be on the market in the
near future, and increased competition in the market is
expected to bring costs down significantly. In early 2015,
Gilead announced it would be offering rebates of up to 46%
on Sovaldi now that multiple rival drugs have entered the
market.
3)SUPPORT. The Wall las Memorias Project is the sponsor of this
bill and states while still passionately focused on their
mission to end the HIV/AIDS epidemic, they acknowledge the
importance of bringing attention to another health concern
that effect many of their community members - hepatitis C.
The sponsors note the bill will ensure that primary care
clinics are proactive in testing high risk patients for HCV to
increase community awareness.
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Numerous health and wellness non-profit organizations serving
the Latino and LGBTQ communities including Bienestar Human
Services, Inc., El Centro Del Pueblo, and Jovenes Inc.,
support this bill because it is estimated that one-time
testing may prevent more than 120,000 deaths amongst the
500,000 Californians that are estimated to be living with the
virus. Quest Diagnostics also supports this bill because,
although they believe all physicians should screen their
patients, they acknowledge that primary care clinics most
likely serve high-risk, under-represented populations, and
knowledge of the infection will help reduce the rate of
transmission, which in turn could reduce the government's cost
of treatment and prevent death.
4)RELATED LEGISLATION. AB 521 (Nazarian) requires that every
patient who has blood drawn at a general acute care hospital
emergency room, and who has consented to the test to be
offered an HIV test, consistent with the USPSTF
recommendations for screening.
5)PREVIOUS LEGISLATION.
a) SB 1303 (Torres) of 2013 would have required every
qualifying individual, as defined, who receives medical
care from a health care practitioner to be offered a HCV
screening test or diagnostic test. SB 1303 was held in the
Senate Health Committee.
b) AB 446 (Mitchell), Chapter 589, Statutes of 2013, among
other provisions, requires a patient between 12 and 65
years of age who has blood drawn at a primary care clinic,
and who has consented to the HIV test to be offered an HIV
AB 383
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test. Requires subsequent testing of a patient who has
been tested by the primary care clinic to be consistent
with the most recent guidelines issued by the CDC and the
USPSTF.
6)SUGGESTED AMENDMENTS.
a) Given that the treatment options for treating HCV are
rapidly changing, and requiring annual screening might not
be necessary in the near future, the Committee may wish to
amend the bill to sunset these provisions in seven years.
b) As currently drafted the bill requires patients with a
positive test result to be notified in a manner consistent
with state law. In order to ensure that PCCs know exactly
which state law, the Committee may wish to amend the bill
as follows:
On page 4, line 18, strike, "state law." and insert:
Section 120917.
REGISTERED SUPPORT / OPPOSITION:
Support
The Wall las Memorias (sponsor)
Bienestar Human Services, Inc.
California Chronic Care Coalition
California Healthcare Institute
California Hepatitis Alliance
C.O.R.E. Medical Clinic, Inc.
El Centro Del Pueblo
Jovenes, Inc.
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Project Inform
Quest Diagnostics
One individual
Opposition
None on file.
Analysis Prepared by:Lara Flynn / HEALTH / (916) 319-2097