BILL ANALYSIS
SB 158
Page 1
Date of Hearing: June 9, 2009
ASSEMBLY COMMITTEE ON HEALTH
Dave Jones, Chair
SB 158 (Wiggins) - As Amended: June 1, 2009
SENATE VOTE : 23-13
SUBJECT : Health care coverage: human papillomavirus
vaccination.
SUMMARY : Requires every health care service plan (health plan)
contract and every health insurance policy that includes
coverage for treatment or surgery of cervical cancer and is
issued, amended, or renewed on or after January 1, 2010 to also
provide coverage for a human papillomavirus (HPV) vaccination,
upon the referral of the patient's physician, nurse
practitioner, certified nurse midwife, or physician assistant,
acting within the scope of his or her license.
EXISTING LAW :
1)Provides for the regulation of health plans by the Department
of Managed Health Care (DMHC) and health insurers by the
California Department of Insurance (CDI).
2)Requires every health plan and every disability insurer which
offers health insurance (health insurer), on a group basis, to
cover comprehensive preventive care for children age 16 or
younger and to offer such coverage for children age 17 and 18.
Defines comprehensive preventive care to include
immunizations recommended by the current federal Recommended
Childhood Immunization Schedule.
3)Requires health plans licensed under the Knox-Keene Health
Care Service Plan Act of 1975 to cover all medically necessary
basic health care services, as defined, including "preventive
health care services," defined in regulations to include
childhood immunizations recommended by the American Academy of
Pediatrics and adult immunizations recommended by the United
States (U.S.) Public Health Service.
4)Requires health plan contracts and health insurance policies
which include coverage for treatment or surgery of cervical
cancer, to also cover cervical cancer screening tests, as
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specified.
FISCAL EFFECT : According to the Senate Appropriations
Committee, pursuant to Senate Rule 28.8, negligible state costs.
COMMENTS :
1)PURPOSE OF THIS BILL . The author states the combination of
the HPV vaccine and regular screening for cervical cancer
should drastically reduce the rate of cervical cancer and
related deaths. The author further asserts this bill will
also prevent many cervical cancer cellular changes that would
require years of biopsies and medical procedures, and result
in significant insurance savings.
2)CERVICAL CANCER AND HPV . According to a 2008 report by the
California Cancer Registry (CCR), cervical cancer is the
eleventh most frequently diagnosed cancer among California
women, with approximately 1,500 cases, including 400 deaths,
per year. CCR reports that cervical cancer incidence has
declined 29% in California since 1988. However, Hispanic
women are more than twice as likely to be diagnosed with
cervical cancer as non-Hispanic women. Hispanic and
non-Hispanic black women are also more likely to die from
cervical cancer than non-Hispanic white and Asian/Pacific
Islander women. Nearly all cervical cancer is caused by HPV
infection, with two types of HPV accounting for approximately
70% of cervical cancer. HPV also causes 90% of anal cancers;
40% of vulvar, vaginal, and penile cancers; and, smaller
proportions of oral and throat cancers.
According to the U.S. Centers for Disease Control and Prevention
(CDC), there are more than 100 types of HPV; over 40 types
infect genital tissues. These sexually transmitted HPV
infections are the focus of this bill, and are the most common
sexually transmitted infection in the U.S. HPV infections are
generally passed from one person to another through sexual
intercourse, though other sexual contact may also spread the
infection. CDC states that approximately 15%, or 20 million
Americans, 15-49 years of age are currently infected with HPV.
CDC also states over 80% of women will have been infected
with HPV by age 50. Most HPV infections are not serious and
go unnoticed because they cause no symptoms and resolve
without treatment. However, some HPV infections result in
genital warts, cellular changes that cause abnormal
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Papanicolau (Pap) test results, and, rarely, cervical cancer.
Most of the HPV types that infect the anogenital area can be
classified as either "high-risk," meaning they are associated
with cancer, or "low-risk" meaning not associated with cancer.
Non-vaccine strategies to prevent HPV infection include the use
of physical barriers, such as condoms, and reducing the number
of sexual partners, including abstinence from sexual contact.
Also, regular Pap tests are important for the detection of
pre-cancerous lesions so that treatment can prevent the
development of cervical cancer.
3)HPV VACCINES . In 2006, the federal Food and Drug
Administration (FDA) approved Gardasil, a quadrivalent vaccine
(prevents four types of HPV) manufactured by Merck, for use in
females nine through 26 years of age. The vaccine is injected
as three separate doses; the second dose should be
administered two months after the first dose and the third
dose six months after the first dose. The cost of a
three-dose vaccination is estimated at $468, including the
cost of administration, for those covered by private
insurance. In January, FDA declined to approve Gardasil for
use in women age 27 through 45, pending the availability of
further clinical trial data. Merck is also currently seeking
FDA approval for use of Gardasil in males age 9 through 26
years to prevent lesions. FDA is also currently reviewing
Cervarix, a bivalent vaccine (prevents two types of HPV) by
GlaxoSmithKline. Although FDA declined to approve Cervarix
two years ago, 90 other countries have approved Cervarix.
4)CALIFORNIA HEALTH BENEFITS REVIEW PROGRAM . AB 1996 (Thomson),
Chapter 795, Statutes of 2002, requests the University of
California to assess legislation proposing a mandated benefit
or service, and prepare a written analysis with relevant data
on the public health, medical, and economic impact of proposed
health plan and health insurance benefit mandate legislation.
California Health Benefits Review Program (CHBRP) was created
in response to AB 1996 and extended for four additional years
in SB 1704 (Kuehl), Chapter 684, Statutes of 2006. In its
analysis of SB 158, CHBRP reports:
a) Medical Effectiveness . All of the trials of the
quadrivalent vaccine and the bivalent vaccine that have
been published to date were sponsored by the manufacturers
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of the vaccines. While the quadrivalent vaccine is
recommended for females age 11-26 years, the major clinical
trials were limited to females age 15-26 years. The one
trial that enrolled girls younger than age 15 has only
published results on the vaccine's efficacy one year
following the vaccination; therefore, long-term efficacy in
this population is unknown.
Interim results from the largest clinical trial indicate that
among females who complete all three doses of the
quadrivalent vaccine and who were not previously exposed to
HPV 16 or HPV 18 (which account for 70% of all cervical
cancers), indicate that the vaccine reduces by 98%
precancerous cervical lesions associated with HPV types 16
and 18. Interim results from the same trial indicate that
the vaccine is less effective among females who had been
exposed to HPV prior to vaccination, or did not receive all
three doses. A single dose of the vaccine appears to
result in a 44% reduction in the targeted HPV types and a
17% reduction in precancerous lesions associated with any
type of HPV. Clinical trial analyses which more closely
mimic real-world circumstances (where the patient may have
been exposed to HPV or does not receive all three doses)
suggest that the vaccine might be expected to prevent less
than one-fifth of all cervical cancers when administered to
females age 15 to 26 years (but could be more effective
when administered to girls younger than 15 years, who are
less likely to have been exposed to HPV). Because of the
long interval between HPV infection and development of
cancer, a reduction in cervical cancer incidence would
likely take decades to become evident. The quadrivalent
vaccine appears safe at five years after vaccination, but
is not recommended in pregnancy.
Clinical trials of the bivalent vaccine demonstrates similar
protection against HPV 16 and HPV 18, with a much smaller
decline in protection among patients who receive only one
dose or who have already been exposed to HPV. These trials
were limited to females age 15 to 25 years.
Numerous organizations have issued recommendations regarding
HPV vaccinations. The American Academy of Family
Physicians, American Academy of Pediatrics, American
College of Obstetricians and Gynecologists (ACOG), American
Cancer Society (ACS), and the CDC Advisory Committee on
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Immunization Practices all recommend the HPV vaccine for
females age 11 to 12 years. Because HPV vaccines do not
protect against all types of HPV associated with cervical
cancer, all organizations that recommend use of the HPV
vaccine also recommend that women and their health care
providers continue to follow current cancer screening
guidelines, including the Pap test.
b) Utilization, Cost, and Coverage Impacts . CHBRP data
indicate that all enrollees in DMHC-regulated plans
currently have coverage for the HPV vaccine. Among those
with CDI-regulated policies, approximately 97% of the large
group market, 100% of the small group market, and 88% of
the individual market have coverage for the HPV vaccine.
All California Public Employees' Retirement System
(CalPERS) and publicly insured individuals also have such
coverage. Children under age 18 without insurance and who
meet financial eligibility requirements may be able to
receive the HPV vaccine through the federal Vaccines for
Children Program. Adults without coverage do not have
access to the HPV vaccine through public programs. This
bill would increase coverage for HPV vaccination by 0.5%,
or 17,000 individuals, and therefore have a minimal impact
on overall utilization. CHBRP estimates that this bill
would result in an increase of 2,500 females being
vaccinated by the end of 2010.
Added system costs from this bill would only accrue in health
coverage products under CDI authority because
DMHC-regulated plans already provide coverage for children
and adults. Overall costs associated with the requirements
in this bill are estimated at $1.625 million, an increase
of .0019% of total health care expenditures, in the year
following the vaccine, and lower costs in future years as
more young women will have been vaccinated. In the
large-group CDI-regulated market, total expenditures would
increase by 0.0048% and premiums would increase by a
similar amount, $0.02 per member, per month (PMPM). In the
individual CDI-regulated market, total expenditures would
increase by 0.0576% and premiums would increase by 0.0655%,
or $0.1089 PMPM. No increased costs are projected in the
CDI-regulated small group market, DMHC-regulated plans,
CalPERS, or other public programs. CHBRP does not
anticipate a measurable loss of insurance coverage or
availability, employer contribution rates, insurance
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take-up, or purchase of individual policies.
c) Public Health Impact . CHBRP estimates that this bill
could prevent between eight and 13 cases of cervical
cancer, and possibly a few cases of other cancers as well.
CHBRP considers this estimate a likely overestimate, for
multiple reasons. CHBRP estimates that this bill could
prevent three to five deaths over the lifetime of women
vaccinated in the first year. This would save an estimated
80 to 140 person-years, valued at $1.3 to 2.2 million. In
subsequent years, after catch-up vaccinations are complete,
CHBRP estimates this bill would result in an additional 350
females getting vaccinated, resulting in the prevention of
one to two more cases of cervical cancer over the lifetime
of these women.
5)PREVIOUS AND RELATED LEGISLATION .
a) AB 16 (Hernandez) of 2007, as introduced, would have
required female pupils entering the sixth grade to be
vaccinated for HPV unless her parent or guardian files a
statement that the vaccination is contrary to his or her
beliefs. AB 16 was subsequently amended to address broader
childhood immunization issues.
b) AB 16 (Evans) of 2008 and AB 1429 (Evans) of 2007 were
similar to this bill, but were vetoed by Governor
Schwarzenegger, whose veto message for AB 16 (Evans)
stated:
The addition of a new mandate, no matter how
small, will only serve to increase the overall
cost of health care.
California currently has 44 mandates on its
health care service plans and health insurance
policies. While these mandates are
well-intentioned, the costs associated with
guaranteed coverage means that these costs are
passed through to the purchaser and consumer.
These mandates are a significant driver of cost.
Every day, a growing number of employers and
individuals are struggling to pay for their
health care. We cannot afford to increase these
costs without enacting other measures that
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improve efforts aimed at prevention, address
affordability of care and share responsibility
between individuals, providers, employers and
government.
c) SB 1245 (Figueroa), Chapter 482, Statutes of 2006,
expands coverage for cervical cancer screening tests
provided under health plan contracts or health insurance
policies to include an HPV screening test approved by the
federal FDA.
6)SUPPORT . Community Health Clinic Ole, Napa California
District (IX), and ACOG District IX (California), sponsors of
this bill, write that the combination of HPV vaccine and
continued screenings should drastically reduce the rate of
cervical cancer and deaths, and prevent many cellular changes
that would require years of biopsies and medical procedures,
saving significant amounts of money. ACS, California
Division, writes in support that ACS has established
recommendations urging the vaccination of 11 and 12-year old
girls and that access is a critical first step in expanding
the use of HPV vaccines. The Pacific Institute for Women's
Health and Pharmacy Access Partnership writes it is important
to ensure that all young women have access to the HPV vaccine
as soon as possible, as the timing is critical to maximizing
its effectiveness. The California Medical Association writes
in support of this bill that vaccinations are cost-effective
and that it is essential to minimize vaccine-preventable
diseases. Planned Parenthood Affiliates of California and
Planned Parenthood Shasta-Diablo Action Fund write in support
that California has the highest number of cervical cancer
cases in the country and approximately $1.7 billion will be
spent nationwide on treatment of cervical cancer. The Medical
Oncology Association of Southern California, Inc. argues in
support that a vaccine to prevent a significant number of
cancer diagnoses is an opportunity that should not be missed.
Physicians for Reproductive Choice and Health states this bill
will close the existing gap in coverage for the HPV vaccine.
The City of West Hollywood reports its City Council
unanimously adopted a resolution supporting this bill, which
will afford insured women access to an important preventive
service.
7)OPPOSITION . The California Association of Health Plans and
the Association of California Life and Health Insurance
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Companies (ACLHIC), the California Chamber of Commerce
(CalChamber) write in opposition that this bill increases
health care costs and hinders health plans and insurers'
ability to offer a wide range of affordable products.
CalChamber further contends that benefit mandates result in
increasing the number of uninsured. The California
Association of Health Underwriters and Anthem Blue Cross write
that benefit mandates increase health care costs.
8)AMENDMENTS . ACLHIC requests the following amendment: "This
section shall not apply to specialized health insurance,
Medicare supplement, short-term limited duration health
insurance, CHAMPUS-supplement insurance, TRI-CARE supplement,
or to hospital indemnity, accident-only, and specified disease
insurance."
REGISTERED SUPPORT / OPPOSITION :
Support
Community Health Clinic Ole, Napa California District (IX)
(cosponsor)
American College of Obstetricians and Gynecologists, District IX
(California) (cosponsor)
American Cancer Society, California Division
California Academy of Physician Assistants
California Commission on the Status of Women
California Communities United Institute
California Medical Association
City of West Hollywood
Medical Oncology Association of Southern California, Inc.
Pacific Institute for Women's Health and Pharmacy Access
Partnership
Physicians for Reproductive Choice and Health
Planned Parenthood Affiliates of California
Planned Parenthood Shasta-Diablo Action Fund
Opposition
Anthem Blue Cross
Association of California Life and Health Insurance Companies
California Association of Health Plans
California Association of Health Underwriters
California Chamber of Commerce
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Analysis Prepared by : Allegra Kim / HEALTH / (916) 319-2097