BILL ANALYSIS Ó
AB 383
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Date of Hearing: May 13, 2015
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Jimmy Gomez, Chair
AB
383 (Gipson) - As Amended April 30, 2015
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Urgency: No State Mandated Local Program: NoReimbursable: No
SUMMARY:
This bill requires a primary care clinic (PCC) to offer
specified patients receiving services a hepatitis C virus (HCV)
screening or diagnostic test.
AB 383
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FISCAL EFFECT:
Based on conservative assumptions that this bill results in
identification of 30,000 individuals affected by HCV in the
first year:
1)Indirect cost pressure of $4.5 million (GF/federal) to
Medi-Cal associated with increased testing in PCC clinics.
Because clinics are reimbursed on a per-visit basis and the
HCV test would likely be offered in combination with other
services, testing cost would not be separately reimbursed.
2)For individuals who are diagnosed, counseling and follow-up
care would result in increased visits costing Medi-Cal $1-2
million (GF/federal), depending on intensity of such care.
3)Cost pressure to Medi-Cal for increased drug treatment of HCV
of $340 million (GF/federal), based on 38% of identified cases
being among Medi-Cal eligible patients, and 75% of patients
being linked to treatment at a one-time treatment cost of
$40,000.
These estimates are based on general public health surveillance
data and data on clinic encounters reported by the Office of
Statewide Health Planning and Development and is subject to
significant uncertainty. Similar costs would be incurred in
future years, although would taper off year by year as more
people infected with HCV would be identified. Although HCV is
the most common bloodborne pathogen among Americans, the
infection is not rapidly spreading and thus widespread one-time
testing would likely yield fewer and fewer positive results in
each subsequent year.
AB 383
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COMMENTS:
1)Purpose. 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)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. In about 15% of cases,
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. People can become infected through sharing
needles, needle-stick injuries in health care settings, or
being born to a mother who has HCV. Receipt of donated blood
and organs was once a common means of transmission as well,
but modern screening has virtually eliminated this. 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. HCV is a
leading cause of liver cancer and the leading cause of liver
transplants.
3)Who is screened? This bill requires screening tests consistent
with the United States Preventive Services Task Force (USPSTF)
recommendations for screening and any federal Centers for
Disease Control and Prevention (CDC) algorithms. The USPSTF
and CDC recommend screening for HCV in persons at high risk
for infection and 1-time screening for adults born between
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1945 and 1965, who account for 75% of individuals infected
with HCV.
4)Treatment. Treatment for Hepatitis C has evolved rapidly in
recent years. According to the Centers for Disease Control
and Prevention, prior to 2013, medication was given for 24-48
weeks and cured 50%-80% of patients, sometimes with
significant side effects. In late 2013, the federal Food and
Drug Administration approved two new antiviral drugs,
Sofosbuvir (Sovaldi) and Simeprevir (Olysio) to treat chronic
HCV infection. Clinical trials have shown that these new
"breakthrough" medications cure 80%-95% of patients after
12-24 weeks of treatment with fewer side effects. However,
Gilead Sciences, the manufacturer of Sovaldi, has come under
heavy fire for the price of the drug treatment; the 12-week
treatment regimen has a retail price of $84,000. Gilead
Sciences reported sales of $10.3 billion for Sovaldi in 2014.
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, in return for a hefty price
discount on the drug. 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.
5)Related Legislation. AB 521 (Nazarian) requires patients who
have blood drawn at a general acute care hospital emergency
room to be offered an HIV test.
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6)Previous Legislation.
a) SB 1303 (Torres) of 2013 required every "qualifying
individual" who receives medical care to be offered a HCV
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
to be offered an HIV test.
Analysis Prepared by:Lisa Murawski / APPR. / (916)
319-2081