BILL ANALYSIS �
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 1303
AUTHOR: Torres
AMENDED: April 2, 2014
HEARING DATE: April 30, 2014
CONSULTANT: Moreno
SUBJECT : Public health: hepatitis C.
SUMMARY : Requires every "qualifying individual," as defined,
who receives medical care from a health care practitioner to be
offered a hepatitis C screening test or diagnostic test, unless
the health care practitioner providing those services reasonably
believes that any one of specified criteria applies.
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 hepatitis C for educating physicians and health
professionals and training community service providers on the
most recent scientific and medical information on hepatitis C
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 an
HIV test, unless the clinic has tested the patient for human
immunodeficiency virus (HIV) within the previous 12 months.
Requires the primary care clinician to offer an HIV test
consistent with the United States Preventive Services Task
Force (USPSTF) recommendation for screening HIV infection.
This bill:
1.Requires every "qualifying individual" who receives medical
care from a health care practitioner to be offered a hepatitis
C virus (HCV) screening test or hepatitis C diagnostic test,
unless the health care practitioner providing those services
reasonably believes that the individual:
a. Is being treated for a life-threatening emergency;
b. Has previously been offered a HCV screening test or
diagnostic test, or has been the subject of a test or
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diagnostic test, unless the individual is a current or
former injection drug user (IDU), is an individual who has
liver disease or has had abnormal liver test results, is a
health care worker who may be exposed to needle sticks, or
an HIV positive individual; or,
c. Lacks capacity to consent to a HCV screening test or
hepatitis C diagnostic test;
2.Defines a "qualifying individual" as any of the following:
a. A person born between the years of 1945 and 1965;
b. A current or former IDU;
c. A recipient of a blood transfusion, blood product, or
organ transplant before 1992;
d. A recipient of a blood clotting product before 1987;
e. An individual who has liver disease or has had abnormal
liver test results;
f. A hemodialysis patient;
g. A health care worker who may be exposed to needle
sticks; or,
h. An individual who is infected with HIV.
3.Requires a health care practitioner, if an individual consents
to a screening or diagnostic test and is positive or reactive,
to either offer follow-up health care or refer the individual
to a health care practitioner who can provide follow-up care.
Requires the follow-up care to include a hepatitis C
diagnostic test.
4.Requires the offering of the test to be culturally and
linguistically appropriate. Requires DPH to issue guidance
related to this provision by July 1, 2015.
5.Prohibits this bill from affecting the scope of practice of a
health care practitioner or diminishing the authority, legal,
or professional obligation of a health care practitioner to
offer a hepatitis C screening or diagnostic test, or to
provide services or care for the subject of a test.
6.Exempts this bill's provisions from applying to an individual
receiving health care in a hospital or emergency room setting.
FISCAL EFFECT : This bill has not been heard by a fiscal
committee.
COMMENTS :
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1.Author's statement. According to the author, it is estimated
that between 2.7 and 3.9 million United States residents are
infected with hepatitis C and 500,000 Californians are living
with this virus. Nevertheless, there is a significant lack of
awareness of Hepatitis C, the threat that hepatitis C poses to
the public health and current opportunities to control it.
To address this problem, the United States Department of
Health and Human Services (DHHS) is working to identify
persons infected with Hepatitis C, to improve access to and
quality of care and treatment for persons infected, and
advocating for prevention of the disease. Two significant
actions have occurred in the last two years that have promoted
awareness and detection. First, in 2012, the Centers for
Disease Control and Prevention (CDC) issued guidelines that
recommend a one-time test of everyone born from 1945 - 1965
for hepatitis C. Second, the USPSTF updated their guidelines
to mirror those of the CDC in 2013. The USPSTF calls for a
one-time testing of hepatitis C within the baby boomer age
cohort, as well as among high-risk patients.
2.Background. According to DPH, hepatitis C is a liver disease
caused by HCV and usually spread through blood. People can
become infected through sharing needles, needle-stick injuries
in health care settings, or being born to a mother who has
hepatitis C. Less commonly, a person can also get HCV
infection through sharing personal care items that may have
come in contact with another person's blood (like razors or
toothbrushes), or having sexual contact with a person infected
with the virus. Hepatitis C can be either "acute" or
"chronic," and can range in severity from a mild illness
lasting a few weeks to a lifelong illness. According to the
CDC, millions of Americans have hepatitis C, 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
percent who have HCV infection develop a chronic, or lifelong,
infection.
Hepatitis C is a leading cause of liver cancer and the leading
cause of liver transplants. According to data from 1999 to
2008, about three-fourths of U.S. patients with HCV infection
were born between 1945 and 1965. The most important risk
factor for HCV infection is past or current IDU, with most
studies reporting a prevalence of 50 percent or more. The
incidence of HCV infection was more than 200,000 cases per
year in the 1980s but decreased to 25,000 cases per year by
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2001. According to the CDC, there were an estimated 16,000
new cases of HCV infection in 2009 and an estimated 15,000
deaths in 2007.
3.USPSTF recommendations. Released in June 2013, the USPSTF
recommendations for HCV infection screening 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-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.
4.Screening and treatment. 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 HCV screening, patients should
receive an explanation of 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. An antiviral treatment regimen is the
standard treatment for HCV infection. The purpose of
antiviral treatment regimens is to prevent long-term health
complications of chronic HCV infection. The traditional
treatment regimen for HCV includes at least two drugs,
pegylated interferon and ribavirin, for treatment duration of
12 to 72 weeks. Previously, a third drug was added for some
individuals (protease inhibitor Incivek or Victrelis).
Interferon is a protein that interferes with viral
reproduction. The amount administered for the treatment of HCV
is well above natural levels in the body leading to adverse
and often serious side effects. As a result, for individuals
with certain conditions, including HIV and advanced liver
disease, the traditional treatment for HCV is contraindicated.
5.The $1,000 pill. In December 2013, the federal Food and Drug
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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 (curing 90 percent
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 it sold $2.27
billion worth of Sovaldi in the first quarter of 2014, a
number that beat Wall Street estimates by $1 billion,
according to an April 23, 2014 article that ran in Bloomberg.
That article reported that Express Scripts Holding Co, the
country's largest pharmacy benefit manager, may try to start a
price war once competing medicines from AbbVie Inc. and Merck
& Co. reach the market. CVS Caremark Corp., the
second-biggest pharmacy manager, has said it might try to slow
down the use of the drug. A 12-week regimen of Sovaldi
doesn't cost $84,000 everywhere. According to a an April 13,
2014 article in the San Francisco Chronicle, Gilead prices the
treatment at $57,000 in the United Kingdom and $66,000 in
Germany. While in Egypt and other developing countries, the
treatment costs $900, which is 99 percent less than the U.S.
cost.
An April 13, 2014 letter from the Fair Pricing Commission (a
group of HIV and HCV activists that negotiates for the lowest
possible prices for new medications, price freezes for
existing medications, rebates for public payers, and patient
assistance and copay programs for people living with the
diseases) officially requested that Gilead Sciences provide
additional rebates for Sovaldi to state Medicaid programs over
and above the legally required initial Medicaid rebate
offering and institute a price freeze for all HIV and HCV
drugs for the next two years and henceforth for a two-year
period from the date of FDA approval of all new HIV and HCV
drugs.
6.Prior legislation. 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
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clinic, and who has consented to the HIV test to be offered an
HIV test. Deems the primary care clinic to be in compliance
if it chooses to test the patient using a rapid HIV test.
Prohibits this bill from applying if the primary care clinic
has tested the patient for HIV, or if the patient has been
offered and declined the HIV test within the previous 12
months. 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.
7.Support. Project Inform, the sponsor of this bill, Drug
Policy Alliance, California Black Health Network, BayBio,
Biocom, County Alcohol and Drug Program Administrators
Association of California, California Healthcare Institute,
California State Association of Occupational Health Nurses,
AIDS Support Network, and OraSure Technologies write that
because a new generation of medications is now capable of
curing HCV infection and preventing forward transmission of
the virus, DHHS is working to identify persons infected with
HCV early in the course of the disease, to improve access to
and quality of care and treatment for persons infected, and to
strengthen prevention of the disease. Supporters write that
many medical providers are not testing their patients for HCV
despite the CDC and USPSTF recommendations and this bill
advances the goals of DHHS by requiring the offer of an HCV
test to the two risk populations defined by the CDC and the
USPSTF. Supporters state that it is estimated that the
one-time testing of baby boomers will help to identify
thousands of infected individuals who do not know their status
and may prevent more than 120,000 deaths. Supporters contend
that early diagnosis and treatment can help prevent more
costly health conditions resulting from advanced liver
disease, such as cirrhosis, liver transplants, and liver
cancer and that empowering individuals to know their HCV
status is essential both to curing the disease for those
infected and stemming the ongoing transmission of this
life-threatening communicable disease. AIDS Healthcare
Foundation states that in order to interrupt the HCV epidemic,
it is critical to make people aware of their status so that
they can change their behaviors and get into care and
treatment. Quest Diagnostics states that baby boomers are
largely unaware of the need for screening and their
vulnerability to this disease and we need to increase public
awareness of the disease and the treatment options available
to those who are diagnosed.
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8.Opposition. The California Medical Association (CMA) states
that this bill legislates the practice of medicine, and that
memorializing guidelines establishes a static standard, which
does not reflect how medicine naturally evolves to adjust to
changing science. CMA writes that guidelines and standards of
care will evolve, but the mandating to a particular guideline
will freeze practice at this current point in time or require
frequent amendment to stay up to date.
9.Policy comments.
a. Shotgun approach. This bill requires the testing of
"qualified individuals," which is defined as people meeting
specified conditions. It is unclear how health care
professionals would know if a patient meets one of those
conditions, particularly settings such as urgent care
clinics, where long-term provider-patient relationships
have not been established. Additionally, even a provider
with an established relationship may not know if a
particular patient meets the criteria spelled out in the
bill (for example, whether or not a patient was a recipient
of a blood clotting product prior to 1987). At a minimum
it might require practitioners to ask every patient about
each criteria. Patient self-reporting of medical history
can be unreliable, so the default would quite possibly be
that practitioners end up offering the test to everyone.
b. Mandating tests. There are some examples in which
existing law mandates clinical activities rather than defer
to clinical judgment by health care providers. However,
there are many diseases and conditions that can lead to
long-term disability and death, and it is unclear why
California should mandate screening for HCV, and not for
other diseases, such as cancer, diabetes, or heart disease,
which are among the leading causes of death and disability
in the U.S.
c. Affordability of treatment. Part of the proponents'
argument for this bill is that early identification will
lead to early treatment. However, it is unclear if the
drugs currently available are affordable and/or sustainable
in our market. If California is to mandate that people be
offered screening, policymakers should consider if there is
some assurance that people who are diagnosed can receive
reasonably priced treatment.
SUPPORT AND OPPOSITION :
Support: Project Inform (sponsor)
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AIDS Healthcare Foundation
American Liver Foundation - Northern CA and NV
Division
BayBio
Biocom
California Black Health Network
California Healthcare Institute
California Hepatitis C Task Force
California State Association of Occupational Health
Nurses
County Alcohol and Drug Program Administrators
Association of California
Drug Policy Alliance
OraSure Technologies, Inc.
Quest Diagnostics
Sacramento Area Liver Transplant Support
San Francisco Hepatitis C Task Force
San Luis Obispo County AIDS Support Network
SLO Hepatitis C Project
5 individuals
Oppose: California Medical Association
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