BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 1538
AUTHOR: Simitian
AMENDED: March 27, 2012
HEARING DATE: April 18, 2012
CONSULTANT: Rubin
SUBJECT : Health care: mammograms.
SUMMARY : Requires health facilities at which mammography
examinations are performed to include a specified notice in the
summary of the written report that is sent to the patient in
order to notify patients who have dense breast tissue that they
may benefit from supplementary screening tests.
Existing law:
1.Requires, under federal regulations implementing the
Mammography Quality Standards Act, facilities that perform
mammographies to send a written report of each mammography
examination, containing specified information, to both the
patient and the referring health care provider.
2.Requires health care service plans and health insurers to
provide coverage for mammographies for breast cancer screening
and diagnostic purposes upon referral by a participating nurse
practitioner, certified nurse midwife, or physician.
3.Licenses and regulates physicians and surgeons under the
Medical Board of California.
This bill:
1.Requires, after April 1, 2013, a health facility at which a
mammography examination is performed to include a notice in
the summary of the written report that is sent to the patient,
if the patient is categorized by the facility as having
heterogeneously dense breasts or extremely dense breasts based
on the Breast Imaging Reporting and Data System (BI-RADS)
established by the American College of Radiology (ACR).
2.Requires the notice to state, "Because your mammogram
demonstrates that you have dense breast tissue, which could
hide small abnormalities, you might benefit from supplementary
screening tests, depending on your individual risk factors. A
report of your mammography results, which contains information
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about your breast density, has been sent to your physician's
office and you should contact your physician if you have any
questions or concerns about this notice."
3.Prohibits the provisions of the bill from being construed to
create or impose liability on a health care facility for
failure to comply with its requirements prior to April 1,
2013.
4.Repeals the provisions of the bill on January 1, 2019, unless
a later enacted statute deletes or extends that date.
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee.
COMMENTS :
1.Author's statement. According to the author, SB 1538 is about
a patient's right to know. It takes advantage of existing law
and addresses gaps in current reporting requirements that were
intended to make sure the patient is informed. SB 1538 simply
requires that, for patients with dense breast tissue, an
additional two sentences be included in the federally required
letter that a radiologist must send a patient after performing
a mammogram, indicating that the patient's dense breast tissue
could hide small abnormalities, that supplementary screening
tests may be recommended depending on the patient's risk
factors, that a report of the mammography results has been
sent to the referring physician's office, and that the
physician should be contacted for any questions or concerns.
The author states that these two sentences could save
thousands of lives.
According to the author, the problem with existing practice is
that dense breast tissue shows up as white on a mammogram and
cancer shows up as white on a mammogram. The result is that
dense tissue significantly obscures cancer detection on a
mammogram. In fact, the National Cancer Institute (NCI) has
said "the main cause of false-negative results Ýin screening
mammograms] is high breast density." And a 2002 study in the
Journal of Radiology concluded that, "Mammographic sensitivity
for breast cancer declines significantly with increasing
breast density..." Compounding the problem is the fact that
under today's practice, a patient with high breast density is
typically told that the results of her mammography are
"normal" when the reality is they are inconclusive. The notice
provided is at best incomplete and at worst misleading and
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potentially life threatening.
2.Breast cancer prevalence, risk factors, and survival. Cancers
are diseases in which abnormal cells divide uncontrollably and
can invade neighboring tissues. Breast cancers form in breast
tissues, usually the lobules (milk-producing glands) and ducts
(tubes that carry milk to the nipple). According to the
California Cancer Registry (CCR), breast cancer is the most
common female cancer in California. A September 2011 report by
CCR and the American Cancer Society estimates there will be
over 292,000 cases of breast cancer in California in 2012, and
that the state is expected to have over 23,000 new cases and
over 4,300 deaths attributed to breast cancer.
CCR lists the following factors as raising a woman's risk of
developing breast cancer:
Ï Older age,
Ï Menstruating at an early age,
Ï Having first birth at an older age or never giving
birth,
Ï A personal history of breast cancer or benign breast
disease,
Ï A mother or sister who has been diagnosed with breast
cancer,
Ï Treatment with radiation therapy to the breast or
chest,
Ï Taking hormones such as estrogen or progesterone,
Ï Alcohol use, and
Ï White race/ethnicity.
NCI additionally lists breast density.
Underscoring the importance of detecting breast cancer at an
early stage, CCR provides estimates of how five-year relative
survival rates of women in California depend on the degree to
which breast cancer has spread at the time of diagnosis:
Ï 100 percent for localized cancers confined to the
breast,
Ï 85 percent for regional cancers that have spread to
lymph nodes or adjacent tissues, and
Ï 26 percent for distant cancers that have spread to
other organs such as the lung or liver.
3.Breast cancer screening. Breast cancer screening refers to the
medical screening of asymptomatic, apparently healthy women
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for breast cancer in an attempt to achieve an earlier
diagnosis, under the assumption that early detection will
improve outcomes. Methods of breast cancer screening include
genetic screening, clinical and breast self-exams,
mammography, ultrasound, magnetic resonance imaging (MRI), and
breast tomosynthesis (also known as 3D mammography).
Mammography uses X-rays to view the breast and is a fast and
widely available screening method. The main potential benefit
of mammography is the early detection of breast cancer.
According to a March 2012 report by NCI, mammography also has
limitations, as does any medical intervention, which can pose
potential harm to women, including:
Ï False negatives: approximately one in five women with
invasive cancer will have negative results, which may lead
to a false sense of security and delay in cancer
diagnosis;
Ï False positives: some women with no cancer will have
positive results, leading to anxiety and additional
testing;
Ï Overdiagnosis: the identification of cancers that will
not become clinically significant, leading to unnecessary
treatment ; and
Ï Radiation risk: radiation used for mammography can
induce mutations that cause breast cancer.
Organizations that publish guidelines for screening
mammography often differ in their recommendations,
particularly in the age for which annual screenings are
recommended. However, since the potential benefits and harms
of screening mammography are linked to a woman's risk factors,
many organizations recommend that a woman's risk factors and
values with regard to benefits and harms should be taken into
account. The Agency for Healthcare Research and Quality, in
synthesizing mammographic screening recommendations produced
by the American College of Obstetricians and Gynecologists
(ACOG), the American College of Physicians, and the U.S.
Preventive Services Task Force, noted that all three
organizations recommend that a woman's screening strategy
should indeed take into account both her risk factors and
values.
4.Breast density. According to NCI, breast density affects the
ability of mammography to detect breast cancer. Breasts
contain both dense tissue (glandular tissue and connective
tissue) and fatty tissue. Fatty tissue appears dark on a
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mammogram, whereas dense tissue appears white. Since cancer
also appears white on a mammogram, it is therefore harder to
detect in women with denser breasts. NCI states, for example,
that the main cause of false-negative mammography results is
high breast density.
Breast density is typically assessed in mammography using a
quality control system published by the ACR called BI-RADS.
The system consists of standardized numerical codes typically
assigned by a radiologist after interpreting a breast image,
and contains the following breast composition categories:
Ï 1: almost entirely fat,
Ï 2: scattered fibroglandular densities,
Ï 3: heterogeneously dense, and
Ï 4: extremely dense.
Women with dense breasts may choose additional breast cancer
screening methods such as ultrasound or MRI to supplement
mammographies. As with mammography, the use of supplemental
screening methods come with the potential benefit of an
increased ability to detect breast cancer, and potential harms
such as an increased risk of a false positive result.
5.Breast density legislation. A 2009 Connecticut breast density
law has a similar notification provision as that contained in
this bill, though the notification specifies ultrasound and
MRI and supplementary screening tests. The governors of Texas
and Virginia signed breast density bills into law that also
contain notification provisions. The Texas law requires a
specified notification about breast density to be sent to all
patients receiving mammograms, regardless of the patient's
breast density. The Virginia law does not include specific
notification language but requires all mammogram reports to
include information on breast density in order to inform
patients with dense breast tissue that supplementary screening
tests may be beneficial, depending on individual factors.
According to the author, 11 other states have active
legislation related to informing women about breast density:
Kansas, Maine, Missouri, Nebraska, New Hampshire, New Jersey,
New York, Pennsylvania, South Carolina, Tennessee, and Utah.
6.LA Times article. A Los Angeles Times article dated September
28, 2011, reported that the author's previous effort to pass
legislation (SB 791 of 2011) was inspired by an entry in the
author's "There Ought to Be a Law" contest, and that,
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unbeknownst to the author, the cancer awareness group that
provided the entry winner's legislative inspiration was
partially funded by a company that makes advanced breast
screening equipment. The company's chief executive officer is
reported as saying that his company stands to profit if demand
for ultrasound screening increases, but that he is also saving
lives.
7.Related legislation. AB 137 (Portantino) of 2011 would
require health plans and health insurers with specified
exemptions, that are issued, amended, delivered, or renewed on
or after July 1 2013, to provide coverage for mammography for
breast cancer screening or diagnostic purposes upon referral
by a health care professional, based on medical need. AB 137
is pending in the Senate Health Committee.
8.Prior legislation. SB 173 (Simitian) of 2011 is substantially
similar to this bill. SB 173 was held under submission in the
Assembly Appropriations Committee.
SB 791 (Simitian) of 2011 was substantially similar to this
bill. SB 791 was vetoed by Governor Brown, who stated in part,
"every patient needs health information they can use. For
women, that likely includes information about breast density.
But the notice contained in this bill goes beyond information
about breast density. It advises that additional screening may
be beneficial. If the state must mandate a notice about
breast density -- and I am not certain it should -- such a
notice must be more carefully crafted, with words that educate
more than they prescribe."
9.Support. The County of Santa Cruz Board of Supervisors
(Board) writes that this bill is important and potentially
lifesaving. The Board further asserts that this bill will lead
to more women surviving breast cancer through early detection
by simply requiring that information that is already shared
between doctors also be shared with the patient. Community
Health Partnership supports SB 1538, writing that patient
knowledge is an essential piece of improving health care, and
that communicating breast density to the patient would allow
women to be informed and help make their own health care
decisions, particularly in light of recent survey results
indicating that only five percent of women know what their
breast density is and 91 percent of doctors are not talking to
women about the issue. Democratic Activists for Women Now and
MayView Community Health Center cite the same survey results
to underscore the need for greater patient knowledge,
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concluding that the state can do better than this. Ravenswood
Family Health Center states that it seems self-evident that
the clinician has a responsibility to inform the patient. The
Association of Women's Health, Obstetric and Neonatal Nurses
writes that its members know firsthand how important it is
that health care providers make individualized breast cancer
screening plans with women.
10.Oppose. The Medical Oncology Association of Southern
California (MOASC) and the Association of Northern California
Oncologists (ANCO) write that the science regarding breast
density is unclear and therefore is of questionable value to
patients. They argue that for the state to mandate information
to patients, the information must not suffer from ambiguity,
yet clarity has not been achieved on what "dense breasts"
means or what should be done about it. MOASC and ANCO add that
because high breast density is not by itself a risk factor for
cancer in medical guidelines, in cases where prior
authorization is required for additional screenings, the tests
may not be covered, and lower-income women may not be able to
afford follow-up screenings using other technologies.
11.Oppose unless amended. The California Medical Association
(CMA) writes that it must oppose this bill unless it is
amended to address various issues, and that it is currently
reviewing similar legislative efforts in other states in order
to craft new amendments to offer the author so that CMA's
opposition can be removed. CMA agrees with the author's intent
to facilitate conversations between women who are screened and
their physicians about the best course of action and treatment
for them, but believes this bill as drafted to be insufficient
to accomplish these goals, and if implemented, would lead to
confusion for patients, pressure for physicians to prescribe
potentially unnecessary, expensive additional screenings with
no guarantee of coverage for them, and undue burdens and costs
on the state's health care delivery system, all with no proof
that the proposed changes will actually save lives. ACOG
supports the goal of providing information to women found to
have highly dense breasts, and is currently examining related
bills in other states to provide proposed amendments to the
author that would more accurately represent the current
science and would hold up with continuing and rapid scientific
change.
SUPPORT AND OPPOSITION :
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Support: Association of Women's Health, Obstetric and Neonatal
Nurses
California Communities United Institute
California Senior Legislature
Community Health Partnership
County of Santa Cruz Board of Supervisors
Democratic Activists for Women Now
MayView Community Health Center
Ravenswood Family Health Center
Oppose: American Congress of Obstetricians and Gynecologists
(unless amended)
Association of Northern California Oncologists, Board
of Directors
California Medical Association (unless amended)
Medical Oncology Association of Southern California
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