BILL ANALYSIS �
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 173
S
AUTHOR: Simitian
B
AMENDED: March 30, 2011
HEARING DATE: April 27, 2011
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CONSULTANT:
7
Tadeo
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SUBJECT
Health care coverage: mammograms
SUMMARY
Requires, under specified circumstances, health care
services plan contracts and health insurance policies to
include additional benefits for comprehensive breast cancer
screening. Requires a health care practitioner who
performs a mammography exam to include specified
information on breast density in the mammography report.
CHANGES TO EXISTING LAW
Existing federal law:
Defines, under the Patient Protection and Affordable Care
Act (PPACA) (Public Law 111-148), as amended by the Health
Care Education and Reconciliation Act of 2010 (Public Law
111-152), a list of essential health benefits, which health
insurance coverage and group health plans must provide
beginning in 2014.
Existing state law:
Provides for the regulation of health care service plans
(health plans) by the Department of Managed Health Care
(DMHC) and individual or group health insurers (insurers)
by the California Department of Insurance (CDI).
Continued---
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Requires health plans, individual or group health insurance
policies and self-insured employee welfare benefit plans to
provide coverage for mammograms, upon the referral of a
physician, nurse practitioner, or certified nurse-midwife,
for breast cancer screening and diagnostic purposes.
Requires individual or group health insurance policies and
self-insured employee welfare benefit plans, upon referral,
to provide at least a baseline mammogram for women ages 35
through 39, inclusive; a mammogram for women ages 40
through (49, inclusive, every two years or more, depending
on a physician's recommendation; and, a mammogram every
year for women age 50 and over.
Provides for the regulation of health care practitioners,
as defined.
This bill:
Requires health care service plan contracts and health
insurance policies that are issued, amended, delivered, or
renewed on or after January 1, 2012, to include additional
benefits for comprehensive screening of an entire breast or
breasts if a mammogram demonstrates heterogeneous or dense
breast tissue based on the Breast Imaging Reporting and
Data System (BIRADS) established by the American College of
Radiology, or if a patient is believed to be at increased
risk for breast cancer due to family history or prior
history of breast cancer, positive genetic testing, or
other indications as determined by his or her nurse
practitioner, nurse midwife, or physician and surgeon.
Requires a health care practitioner who performs a
mammography examination under these provisions to include
in the mammography report, information on breast density,
based on BIRADS. Requires the report to also include a
notice, when applicable, regarding the detection of dense
breast tissue and benefits of supplementary screening tests
which can include a breast ultrasound screening, a breast
magnetic resonance imaging (MRI) examination, or both,
depending on individual risks.
Requires the notice to state that a report of the
mammography results has been sent to the physician's office
and that the physician should be contacted if there are any
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questions or concerns about the report.
Defines a health care practitioner as a person licensed or
certified pursuant to the Business and Professions Code or
licensed pursuant to the Osteopathic Initiative Act.
Exempts specialized health care service plans and health
insurance policies from these provisions.
FISCAL IMPACT
This bill has not been analyzed by a fiscal committee.
BACKGROUND AND DISCUSSION
According to the author, SB 173 will lead to more women
surviving breast cancer by helping to catch cancer early
when it is most treatable and curable. The author points
to National Cancer Institute estimates that one in eight
women will develop breast cancer in their lifetime, that
women with dense breast tissue are four to six times at
greater risk of developing breast cancer compared to women
of the same age and health; and that more than half of
women have dense breast tissue. The author further points
out that because dense breast tissue is white on a
mammogram, as is cancer, 75 percent of cancer is missed in
women with dense breast tissue by mammography alone,
according to a January 2011 study from the Mayo Clinic.
Breast cancer, screening and risk
Breast cancer is an abnormal growth in cells that line the
lobules (milk-producing glands) or the ducts (vessels that
carry milk). Clinicians classify the cancer according to
the location of its origin. Those cancers that are confined
to a duct or lobule are known as carcinoma in situ or
noninvasive cancer cells that are still encapsulated in the
duct or lobule.
According to the California Cancer Registry (CCR), breast
cancer is the most common cancer diagnosed in California,
with nearly 24,000 new cases and more than 4,200 deaths
expected in 2011. An average newborn girl's chance of
eventually being diagnosed with invasive breast cancer in
California is approximately twelve percent, or one in
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eight. There are nearly 300,000 women currently living
with breast cancer in California.
CCR reports that, although breast cancer is the most common
cancer found among women in California, when diagnosed
early, survival rates are high-in California, 71 percent of
breast cancer is diagnosed in the early stages. Among
California women, the 5-year relative survival rate for
breast cancer is 91 percent; this rate varies with the
stage at diagnosis with a 99 percent 5-year relative
survival rate for localized breast cancer, 85 percent for
regional breast cancer, and 25 percent for distant breast
cancer.
A sustained decrease in breast cancer mortality in the
United States and California during the last 20 years is
attributed, in part, to the increased use of mammography
screening during the 1980s, as well as improvements in
treatments and reduction of hormone-replacement therapy
Three modalities are used to screen asymptomatic women for
breast cancer: mammography, breast magnetic resonance
imaging (BMRI), and ultrasound. A new modality, breast
tomosynthesis (also referred to as three-dimensional
mammography), was recently approved by the U.S. Food and
Drug Administration (FDA). Although different
organizations have different guidelines, age 40 has been
traditionally been the consensus regarded as an age at
which women should be offered annual screening for breast
cancer with mammography.
There are many factors that have been associated with an
increased risk of breast cancer. Some of these factors
include a family history of breast or ovarian cancer, a
personal history of breast or ovarian cancer, prior benign
biopsy, personal history of atypical ductal hyperplasia,
radiation exposure, high breast density, hormone therapy
use, oral contraceptive use, later age of birth of first
child (or no children), early age at menarche, and being
overweight or obese in menopausal women.
Breast Imaging Reporting and Data System (BIRADS)
BIRADS is a quality control
system established by the American College of Radiology.
In day-to-day use, the term refers to mammography
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assessment categories: standardized numerical codes
typically assigned by a radiologist after interpreting a
mammogram. The assessment categories were developed for
mammography and later adapted for the MRI and ultrasound.
The summary of each category is identical for all three
modalities, as follows:
0: Incomplete
1: Negative
2: Benign finding(s)
3: Probably benign
4: Suspicious abnormality
5: Highly suggestive of malignancy
6: Known biopsy - proven malignancy
Breast composition categories
1: Almost entirely fat
2: Scattered fibroglandular densities
3: Heterogeneously dense
4: Extremely dense
Breast density and breast density legislation
Dense breast tissue is comprised of less fat and more
connective tissue, which appears white on a mammogram.
Cancer also appears white on a mammogram thus tumors are
often hidden behind the dense tissue. As a woman ages, her
breasts usually become more fatty.
According to the Susan G. Komen for the Cure Advocacy
Alliance, women with dense breasts are four to five times
more likely to develop breast cancer. Yet, according to a
recent Harris survey, 95 percent of women the age of 40 and
over have no idea about their breast density and less than
10 percent of doctors are talking to their patients about
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their breast density and what it means for their breast
cancer risk. In addition to being a risk factor for
developing breast cancer, higher density can make cancer
more difficult to detect with traditional mammography. This
is because tissue and tumors both show up as white on a
mammogram, and when you have a lot of dense breast tissue,
an abnormality can be hard to spot, even to trained eyes.
The state of Connecticut passed a breast density law in
2009 upon which SB 173 is based. Congress and the states
of New Hampshire, Massachusetts, New York, Florida, and
Texas all have similar legislation pending.
Connecticut law requires all mammography reports given to a
patient on and after October 1, 2009 to include information
about breast density and requires that all written results
of a mammogram given to a patient include information about
breast density based on BIRADS. The language in the
Connecticut law is similar to SB 173 and the notice
required is identical.
There is insufficient evidence at this time to demonstrate
the benefits the Connecticut law may have produced to date,
however, non-scientific and anecdotal feedback provided by
radiologists suggests that there has been an increase in
communication regarding breast density through an increase
in questions raised by women and an increase in informative
conversations conducted, but little change in the practical
outcome of the encounter since additional imaging
techniques have not yielded a change in medical practice.
Research is currently underway at the University of
Connecticut on the impacts of patient breast density
information and anecdotal feedback from this work provided
by the bill's author suggests that more early-stage cancers
have been detected. The results of this study are expected
to come out in the next several months.
The California Health Benefits Review Program (CHBRP)
Pursuant to AB 1996 (Thomson), Chapter 795, Statutes of
2002, and SB 1704 (Kuehl), Chapter 684, Statutes of 2006,
the University of California is requested to assess
legislation proposing a mandated benefit or service, or the
repeal of a mandated benefit or service, through the
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California Health Benefits Review Program (CHBRP). CHBRP
prepares a written analysis of the public health, medical,
and economic impacts of such measures. The following are
highlights from the CHBRP analysis of SB 173:
Assumptions of the analysis
SB 173 would require DMHC-regulated plans and
CDI-regulated policies to cover comprehensive breast
cancer screening for enrollees whose mammograms
indicate they have dense or heterogeneous breast
tissue and for enrollees believed to be at increased
risk for breast cancer. SB 173 does not further define
comprehensive breast cancer screening. Current code
already requires coverage for all generally medically
accepted cancer screening tests. CBHRP assumes that
plans and insurers would still retain the ability to
conduct utilization review and to base coverage
decisions on medical necessity and that coverage would
remain the
same. Therefore, CHBRP assumes that SB 173 would not
expand benefit coverage for breast cancer screening.
SB 173 would also require that mammography reports
issued by DMHC-regulated plans or CDI-regulated
policies contain information about breast density and,
when applicable, a recommendation to persons with
dense breasts to pursue supplementary screening tests.
Since health plans do not issue mammography reports -
only radiologists and imaging centers do, health plans
would be in compliance with the mammography reports as
considered by SB 173.
Breast cancer is a disease that affects primarily
women. It is one of the most commonly diagnosed
cancers in California, but survival rates are high
when it is diagnosed at an early stage.
SB 173 would not directly affect "Every Woman Counts,"
a program by the Department of Public Health that does
not provide health insurance, but does provide
screening for breast cancer to the uninsured.
Potential impact of federal health care reform
Essential health benefits (EHBs) may be considered to
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include benefits and services mandated by SB 173. In
addition, The U.S. Department of Health and Human
Services, when promulgating regulations on EHBs is to
ensure that the EHB floor "is equal to the scope of
benefits provided under a typical employer plan."
Virtually all employers provide coverage for services
mandated under SB 173. Because mammography services
defined under SB 173 are considered standard coverage
for employer-based plans, and because it is likely to
be considered part of EHBs, it is unlikely that there
would be any additional fiscal liability to the state
for qualified health plans offered in the state's
health benefits exchange as a result of this mandate.
Medical effectiveness
Medical effectiveness of mammography for breast cancer
screening is well established. Multiple randomized
controlled trials (RCTs) have found that mammography
screening reduces breast cancer mortality, especially
among women ages 50 to 74. The medical effectiveness
review for SB 173 focused on evidence of the
effectiveness of BMRI and ultrasound. No studies of
three-dimensional mammography were identified, most
likely because it has only recently been approved by
the FDA.
Most studies found that the high sensitivity of BMRI
may be useful to identify breast cancers in a targeted
population of high-risk women. False-positive rates
for BMRI were higher than false-positive rates for
mammography. There is insufficient evidence that BMRI
screening decreases breast cancer mortality or
improves health outcomes.
There is insufficient evidence that ultrasound
improves the sensitivity of breast cancer screening
when it is used to screen asymptomatic women with
dense breast tissue or those considered high risk for
breast cancer. False-positive rates for breast
ultrasound were higher than false-positive rates for
mammography. There is insufficient evidence that
breast ultrasound decreases cancer mortality or
improves health outcomes.
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The lack of evidence of improvement in sensitivity
suggests that breast ultrasound is no more effective
than mammography for asymptomatic women. The higher
sensitivity of BMRI relative to mammography for
detecting breast cancer among asymptomatic high-risk
women must be weighed against the harms associated
with higher false-positive rates, which increase
unnecessary follow-up testing and biopsies, create
anxiety and discomfort for the patient, and may result
in overdiagnosis and overtreatment.
Impact on coverage
DHMC-regulated plans and CDI-regulated policies are
currently compliant with
"comprehensive breast screening" as defined by SB 173.
Therefore, no measurable change is expected. Health
plans and insurers do not issue mammography reports,
therefore, the report requirements SB 173 would place
on plans and insurers would have no impact.
Impact on utilization
As no measurable change in benefit coverage is
expected, no measurable change in utilization is
projected.
Impact on total health care costs
As no measurable change in benefit coverage is
expected, no measurable change in cost is expected.
Public health impact
SB 173 is not expected to impact utilization of
comprehensive breast cancer screening; therefore no
public health impact is expected.
Department of Labor National Compensation Survey (NCS)
PPACA instructs the Secretary of Labor to conduct a survey
of employer-sponsored coverage to determine the benefits
typically covered by employers and to report the results of
the NCS to the Secretary of Health and Human Services. The
NCS on selected medical benefits, released on April 15,
2011, consists of 12 selected benefits for which sufficient
data was available. Mammography was not among the services
included in the study. The services include maternity
care, emergency room visits, ambulance services, diabetes
care management, kidney dialysis, physical therapy, durable
medical equipment, prosthetics, infertility treatment,
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sterilization, gynecological exams and services, and organ
and tissue transplantation.
Related bills
AB 137 (Portantino) requires that health care service plan
contracts and individual or group policies of health
insurance issued, amended, delivered, or renewed on or
after July 1, 2012, provide coverage for mammographies for
screening or diagnostic purposes upon referral of a
participating nurse practitioner, participating certified
nurse-midwife, participating physician assistant, or
participating physician, as specified. Requires plans and
insurers, subject to its provisions, to provide subscribers
or policyholders with recommended timelines for an
individual to undergo tests for the screening or diagnosis
of breast cancer, as specified, beginning July 1, 2012.
This bill is currently located in the Assembly Health
Committee to be set for hearing.
Prior legislation
AB 56 (Portantino) of 2009 contained provisions identical
to those in AB 137. This bill was vetoed by Governor
Schwarzenegger. In his veto address he stated, in part,
"The addition of a new mandate, no matter how small, will
only serve to increase the overall cost of health care."
AB 2234 (Portantino) of 2008 would have required health
plans and health insurers to provide coverage for tests
necessary for screening or diagnoses of breast conditions,
in accordance with national guidelines, upon referral of a
specified health care provider and required health plans
and health insurers to notify female enrollees or
policyholders in writing of their eligibility for testing.
This bill was held in the Assembly Appropriations
Committee.
Arguments in support
Proponents of SB 173 state that this bill will lead to more
women surviving breast cancer by helping to catch cancer
early when it is more treatable and curable, and in the
long run will lead to safer methods of detecting breast
cancer.
The California Organization for Women points to
calculations provided by the University of California San
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Francisco's Breast Cancer Research Program in 2001, stating
that the total direct costs of breast cancer were $279
million for that year, each life lost prematurely to breast
cancer represents lost productively of $272,000 to the
state, and costs increase dramatically with delay in
treatment, from $16,063 for treatment in the earliest
stages to $49,383 for women with late-stage breast cancer.
Arguments in opposition
Insurance plans in opposition to SB 173 state that mandates
increase the already high cost of care for everyone and
eliminate the flexibility an employer would otherwise have
to pick benefits that best address the needs of their
employees in the future.
The California Radiological Society (CRS) points out that
there is significant observer variability in the assignment
of a breast density category among radiologists. CRS
argues that the notification of breast-density could lead
to more confusion than clarification and runs the risk of
giving a false sense of security to women who are told
their breast tissue is not dense. CRS argues that BIRADS
recommends that all mammography reports given to referring
providers include a description of breast density and the
patient's physician should use this information to discuss
the appropriate options given other circumstances such as
medical history and high-risk factors.
California Medical Association (CMA) states that this bill
in its current form disrupts the physician-patient
relationship by mandating that all women, whether or not
their treating physician believes it is clinically
indicated, be given a specific notice regarding breast
density and potential supplemental screening procedures
like MRI and ultrasound. CMA argues that there remains
debate within the scientific community as to the link
between density and breast cancer risk.
COMMENTS
1. Mammography report recipient. As drafted, SB 173
requires information to be included in the mammography
report that the referring practitioner receives, although
language drafted in the notice is designed for a patient.
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The author may wish to amend the bill to reflect the
author's intent to require that information about breast
density and recommended follow-up be provided to the
patient.
POSITIONS
Support: Breast Cancer Fund
California Association of Health Underwriters
California National Organization for Women
One individual
Oppose: America's Health Insurance Plans
American Congress of Obstetricians and
Gynecologists, District IX
Association of California Life and Health
Insurance Companies
California Association of Health Plans
California Medical Association
California Radiology Society
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