BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Elaine K. Alquist, Chair
BILL NO: SB 158
S
AUTHOR: Wiggins
B
AMENDED: As introduced
HEARING DATE: April 22, 2009
1
REFERRAL: Rules Committee
5
CONSULTANT:
8
Moreno/
SUBJECT
Health care coverage: human papillomavirus vaccine
SUMMARY
Requires health care service plan (health plan) contracts
and health insurance policies that provide coverage for
cervical cancer treatment or surgery to also provide
coverage for a human papillomavirus (HPV) vaccine beginning
on January 1, 2009.
CHANGES TO EXISTING LAW
Existing law:
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).
Requires health plans 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 U.S. Public Health Service.
Requires health plans and health insurers that offer
Continued---
STAFF ANALYSIS OF SENATE BILL SB 158 (Wiggins)Page 2
coverage on a group basis to cover comprehensive preventive
care for children ages 16 or younger under the terms and
conditions agreed upon by the group and the health insurer
or health plan. Requires health plans and health insurers
that offer coverage on a group basis to offer, rather than
provide, comprehensive preventive care for children ages 17
and 18, under terms and conditions agreed upon by the group
and the health insurer or health plan. Defines
comprehensive preventive care to include immunizations
recommended by the Centers for Disease Control and
Prevention (CDC) in their Recommended Childhood
Immunization Schedule.
Requires individual and group health plan contracts and
health insurance policies that include coverage for
treatment or surgery of cervical cancer to also include
coverage of annual cervical cancer screening tests, upon
referral by the patient's physician and surgeon, a nurse
practitioner, or certified nurse midwife who is providing
care to the patient and operating within the scope of
practice otherwise permitted for the licensee.
This bill:
Requires health plan contracts and health insurance
policies that include coverage for treatment or surgery of
cervical cancer, and are issued, amended, or renewed after
January 1, 2010, to be deemed to provide coverage for a HPV
vaccination upon the referral of the patient's physician
and surgeon, nurse practitioner, or certified nurse
midwife, providing care to the patient and operating within
the scope of practice otherwise permitted for the licensee.
Specialized health plan contracts are exempted from the
requirement.
FISCAL IMPACT
According to the Senate Appropriations Committee analysis
of AB 16 (Evans) of 2008, a nearly identical measure, DMHC
anticipates one-time costs of less than $75,000 to develop
regulations. Costs to CDI are estimated to be minor and
absorbable. Medi-Cal, including Medi-Cal managed care
plans, currently provides coverage for the HPV in
accordance with CDC guidelines. CalPERS also provides this
coverage.
BACKGROUND AND DISCUSSION
STAFF ANALYSIS OF SENATE BILL SB 158 (Wiggins)Page 3
According to the author, HPV is the most common sexually
transmitted infection in the United States, as over 80
percent of females are infected at some point in their
lifetime. HPV has also been identified as the primary
cause of cervical cancer, which was once the number one
cause of cancer deaths among women in the United States.
The author states that a 2007 survey of California health
plans found that an estimated 27,400 privately insured
females aged 11 to 26 years do not have coverage for the
HPV vaccine and would gain this coverage as a result of
this bill. The author states SB 158 will ensure all young
women with health insurance are covered.
HPV and rates of infection
According to the National Cancer Institute (NCI), there are
more than 100 types of HPVs, of which 30 can be transmitted
sexually. Most HPV infections occur without any symptoms
and go away without treatment. Both "high-risk" and
"low-risk" HPVs can cause the growth of abnormal cells, but
generally, only high-risk HPVs lead to cancer, including
cervical, anal, and penile cancer. Of the women who
develop abnormal cervical cell changes with high-risk HPVs,
only a small percentage develop cervical cancer if the
abnormal cells are not removed. Approximately 90 percent
of new HPV infections clear within two years.
According to the CDC's Advisory Committee on Immunization
Practices (ACIP), an estimated 6.2 million new HPV
infections occur every year among persons aged 14 to 44
years in the U.S. Of these, 74 percent occur among those
aged 15 to 24 years. Estimates suggest that over 80
percent of sexually active women will have acquired genital
HPV by age 50. A 2007 study published in the Journal of
the American Medical Association (JAMA) found that the
prevalence of HPV infection in the U.S. was highest among
20 to 24 year olds (45 percent). For females 14 to 24
years, the overall HPV prevalence was estimated at 34
percent.
Using population estimates, the Department of Public Health
(DPH) estimates that there may be approximately 900,000
14-to-24-year-old California females with an HPV infection.
Approximately 372,000 California females ages 14 to 59
have a vaccine-preventable HPV infection.
STAFF ANALYSIS OF SENATE BILL SB 158 (Wiggins)Page 4
ACIP also notes that the prevention and treatment of
anogenital warts and cervical HPV-related disease imposes
an estimated burden of $4 billion or more (2004 dollars) in
direct costs in the U.S. each year. Of this total,
approximately $200 million is attributable to the
management of genital warts; approximately $300 to $400
million to invasive cervical cancer; and the remainder to
routine cervical cancer screening, the follow up of
abnormal Pap tests, and pre-invasive cervical cancer. The
estimated economic burden associated with HPV would be more
substantial if the cost of other HPV-related diseases were
included.
Cervical cancer rates
According to the NCI, while cervical cancer incidence and
mortality rates have declined by approximately 50 percent
over the past three decades, the disease remains a serious
health threat among women. Recent trends show that
incidence rates for Latinas are higher than those for other
ethnicities. Additionally, although the mortality rate for
African American women has declined more rapidly than the
rate for white women, the African American mortality rate
continues to be more than double that of whites. According
to the DPH, in 2004 there were 1,424 cervical cancer
diagnoses and 417 deaths from the disease in California.
California's prevalence of cervical cancer for 2006 (new
and prior cases combined) was estimated to be 37,100.
Between 2000 and 2004, the incidence rate for Latinas (14.4
per 100,000) was double that of whites (7 per 100,000) and
almost two-thirds higher than African-Americans (8.6 per
100,000). Mortality rates for African-Americans (4 per
100,000) and Latinas (3.9 per 100,000) were double that of
whites (1.9 per 100,000).
HPV vaccine
The only HPV vaccine approved by the Food and Drug
Administration (FDA) is Merck's Gardasil, which received
FDA approval in June, 2006 and which protects against four
HPV strains (strains 6, 11, 16 and 18). Almost 70 percent
of cervical cancer cases and 90 percent of genital warts
cases are linked to these strains of HPV. According to the
Vaccines for Children Program (VFC)/CDC vaccine price list,
Gardasil is priced at $130 per dose, administered in three
separate doses over a six-month period. GlaxoSmithKline
has also developed a vaccine (Cervarix) that targets HPV
strains 16 and 18 and is awaiting FDA approval. Following
STAFF ANALYSIS OF SENATE BILL SB 158 (Wiggins)Page 5
the FDA approval of Gardasil, ACIP unanimously recommended
that the new vaccine be administered routinely to girls 11
to 12 years of age. Use at a health provider's discretion
was also approved for girls and women between the ages of 9
and 26. The HPV vaccine has been tested in males for
safety and immune response, but efficacy studies have not
yet been completed. Consequently, the FDA has not licensed
the vaccine for males. However, according to the CDC, it
is possible that vaccinating males will have health
benefits for them by preventing genital warts and rare
cancers, such as penile and anal cancer. It is also
possible that vaccinating males will have indirect health
benefits for females by lowering the risk of transmission.
CHBRP analysis
Pursuant to AB 1996 (Thomson), Chapter 795, Statutes of
2002, and SB 1704 (Kuehl), Chapter 684, Statutes of 2006,
the California Health Benefits Review Program (CHBRP)
prepared a written analysis of the public health, medical,
and economic impacts of this bill.
Medical Effectiveness
CHBRP's analysis noted limitations in the available data
regarding Gardasil, including that while the vaccine is
recommended for females aged 11 to 26 years, the three
major clinical trials on the vaccine limited enrollment to
females aged 15 to 26 years. Additionally, the report
noted that long-term efficacy in this population is
unknown, but interim results indicate:
o Among females who complete all three doses of the vaccine
and were not previously exposed to HPV strains16 or 18,
the vaccine provides for reductions in precancerous
cervical lesions of 98 percent for lesions caused by the
HPV types 16 and 18.
o The vaccine is less effective among females who have not
completed all three doses of the vaccine and/or were
exposed to HPV prior to vaccination.
o The vaccine prevents precancerous vaginal and vulvar
lesions. As with cervical cancer lesions, the vaccine is
less effective among females who do not receive all three
doses of the vaccine or are exposed to HPV prior to
vaccination.
STAFF ANALYSIS OF SENATE BILL SB 158 (Wiggins)Page 6
o The vaccine appears safe at five years after vaccination
with minimal side effects; however, the duration of
protection beyond that is unknown. Ongoing Phase 3 trials
are monitoring the durability of the vaccination to
assess the need for a future booster vaccination.
Utilization, Cost, and Coverage Impacts
o Coverage: About 21,340,000 enrollees are in health plans
or policies subject to SB 158. This includes
approximately 3,348,000 females aged 11 to 26 years. An
estimated 99.5 percent of enrollees currently have
coverage for HPV vaccination. If the mandate were to
become law, an additional 17,000 or 0.5 percent would
gain coverage.
o Utilization: By 2010, and before SB 158 would go into
effect, approximately 33 percent of insured females aged
11 to 26 years would have been vaccinated for HPV. CHBRP
estimates that among the newly covered population of
insured females, 19 percent of those 11 to 18 years old
and 13 percent of those aged 19 to 26 years would be
vaccinated in 2010 and after the implementation of SB
158.
o Costs: Because health plans currently have coverage for
the vaccine, no cost increases are expected. The increase
in expenditures is limited to health policies in the
individual and the large group market segments, because
these are the market segments that currently have gaps in
coverage for female enrollees aged 11 to 26 years.
The overall increase in expenditures due to SB 158
is estimated at $1,625,000, or 0.0019 percent in the
year following the mandate.
The increase in premium expenditures is $1,357,000,
or 0.0228 percent, in the individual market and
$84,000, or 0.0002 percent, in the large group market.
Employee share of premiums is expected to increase
by $24,000, or 0.0002 percent.
Out-of-pocket costs in the form of copayments and
deductibles are expected to increase by $345,000, or
0.0054 percent.
Existing studies indicate that HPV vaccination, primarily
of females aged 12 years, is cost effective. The
STAFF ANALYSIS OF SENATE BILL SB 158 (Wiggins)Page 7
estimated cost-effectiveness ratio of vaccination ranges
from $2,964 to $43,600 per quality-adjusted life year
gained for 12-year-old girls. This means for every $2,964
to $43,600 spent in vaccinations one quality-adjusted
life-year is saved.
Public Health Impacts
Models predict that vaccinating a cohort of 12-year-old
girls would result in a reduction in cervical cancer cases
by 36 percent to 62 percent over the course of the lifetime
of the cohort. Catch-up vaccination of older females is
predicted to have a lower efficacy rate, due to higher
rates of prior exposure in this group. Assuming 2,500
additional females get vaccinated in the first year after
passage of the mandate, between 8 and 13 cases of cervical
cancer could be prevented. In subsequent years, after
catch-up vaccinations are complete, the number of
additional females getting vaccinated as a result of the
mandate would decrease to approximately 350, preventing one
to two cases of cervical cancer over the lifetime of these
females. African Americans and Latinos have higher
mortality rates from cervical cancer compared to other
racial/ethnic groups. Over time, as researchers are able to
assess differences in the vaccination rates across racial
and ethnic groups, the potential for the HPV vaccine to
reduce disparities in health outcomes related to HPV
infection will be clearer. The extent to which this mandate
would reduce these disparities is currently unknown. CHBRP
estimates that, as a result of this mandate, three to five
deaths could be prevented over the lifetime of women
vaccinated in the first year, yielding a total savings of
80 to 140 person years, valued at an amount between $1.3
and $2.2 million.
Arguments in support
The American College of Obstetricians and Gynecologists,
District IX (ACOG-IX), writes that this vaccine will
prevent hundreds of cervical cancer deaths annually in
California and prevent tens of thousands of cases of
abnormal cervical cancer cells, precancerous conditions and
cervical cancer. ACOG-IX asserts that prevention of the HPV
infection and the conditions caused by it should translate
into an enormous cost savings to health plans, insurers,
and the state. The Medical Oncology Association of Southern
California states that mandating coverage of this vaccine
will help remove barriers to this important tool in cancer
STAFF ANALYSIS OF SENATE BILL SB 158 (Wiggins)Page 8
prevention. The California Medical Association writes that
maximum immunization coverage in all populations is
essential if we want to keep preventable disease levels to
a minimum. Planned Parenthood Affiliates of California
states that this bill is a further step in comprehensive
reproductive health care and preventative medicine.
Arguments in opposition
The Association of California Life and Health Insurance
Companies generally opposes all benefit mandates because,
while they sympathize with the intent to meet a need,
mandates increase the already high costs of care for
everyone and eliminate flexibility an employer would
otherwise have to pick benefits that best address the needs
of his or her employees in the future. The California
Association of Health Plans writes of similar concerns, and
adds that mandates in some cases can lead to a reduction of
coverage, as individuals and employers drop their insurance
due to premium impacts.
Prior legislation
AB 16 (Evans) of 2008 and AB 1429 (Evans) of 2007,
contained nearly identical provisions to AB 1429. Vetoed by
the Governor.
AB 16 (Hernandez) of 2007, in its prior version, would have
required all female pupils to be vaccinated for HPV prior
to admittance to the 7th grade unless the student's parent
or guardian files a letter stating that the immunization is
contrary to his or her beliefs. These provisions were
amended out of the bill.
SB 1245 (Figueroa), Chapter 482, Statutes of 2006, expands
the coverage for an annual cervical cancer screening test
provided by a health care service plan or a health
insurance policy to include the HPV screening test, as
specified.
SB 1219 (Romero), Chapter 380, Statutes of 2001, requires
health plan contracts and health insurance policies that
include coverage for cervical cancer to provide coverage
for an annual cervical cancer screening test, as specified,
upon the referral of the patient's health care provider.
POSITIONS
STAFF ANALYSIS OF SENATE BILL SB 158 (Wiggins)Page 9
Support: American College of Obstetricians &
Gynecologists, District IX (sponsor)
American Cancer Society
California Communities United Institute
California Medical Association
Medical Oncology Association of Southern California
Planned Parenthood Affiliates of California
Oppose: 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
-- END --