BILL ANALYSIS Ó
SB 1538
Page 1
Date of Hearing: August 8, 2012
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Felipe Fuentes, Chair
SB 1538 (Simitian) - As Amended: June 19, 2012
Policy Committee: HealthVote:15-0
Urgency: No State Mandated Local Program:
No Reimbursable: No
SUMMARY
This bill requires, until January 1, 2018, a health facility at
which a mammography examination is performed, if a patient is
categorized by the facility as having certain levels of breast
density, as specified, to include the following notice in the
written report sent to the patient:
"Because your mammogram demonstrates that you have dense breast
tissue (a relatively common condition), 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 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."
FISCAL EFFECT
1)Significant fiscal impact on state-funded health programs is
likely as a result of this bill. The provision of this bill
that notifies women with dense breasts that they might benefit
from supplemental screening tests (such as breast MRI (BMRI)
and ultrasound) is likely to result in increased patient
demand for these tests, which is likely to increase their
utilization. The magnitude of the impact is uncertain. The
specificity and personalized nature of the notice, as well as
the provision of the notice along with mammography test
results, would likely increase the perceived relevance of the
notice and likelihood of a woman contacting her physician to
request supplemental screening.
2)Generally, literature indicates supplemental screening in
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women with dense breasts can locate more cancers than
mammography alone. Late stage cancers may require more
treatment and follow-up procedures than early-stage cancers.
Thus, in the case of an individual woman whose invasive cancer
is detected early through supplemental screening, the costs
for her overall treatment would likely be lower than if her
cancer was detected later. However, on a population basis,
the fiscal impact of more screening, more detection, more
diagnostic tests, and more treatment as compared to the status
quo is likely to be a net cost to health care payers. As
discussed below, the benefit of these additional medical
interventions in terms of lower mortality and improved
outcomes is not yet known and is the subject of considerable
research.
3)If 5% of women who receive this notice are referred for and
receive supplemental screening in the form of a breast
ultrasound, and have follow-up procedures typical for this
screening, a conservative estimate of the approximate cost
impacts is as follows (this estimate does not include costs
for BMRI, which generally requires prior authorization).
a) $1.5 million in costs (50% GF/50% federal funds) to the
Medi-Cal program.
b) $700,000 in cost pressure (GF) on the Every Woman Counts
program.
c) $1 million in cost pressure (55% GF/45% other funds) for
CalPERS state employee health benefits.
d) Cost pressure to private health care service plans and
insurers in the range of $20 million.
1)Opponents of this bill indicate that in Connecticut, where a
similar bill was passed in 2009, it has become standard
practice to refer all women who receive this notice to
supplemental screening. If this occurred in California as a
result of this bill, or if more than 5% of women received
supplemental screening, costs could be greater than presented
here.
COMMENTS
1)Rationale . The author states this bill would improve
awareness that high breast density reduces the ability of
screening mammography to detect cancer. The author maintains
while federal law requires that a radiologist performing a
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mammogram send a letter regarding the results to the patient
and a report to the referring physician, only the report to
the referring physician must contain information about the
patient's breast density. A national survey, according to the
author, found that 95% of women do not know their breast
density and that doctors have spoken to fewer than 9% of
patients about breast density. The author argues that the
lack of information provided to the patient regarding breast
density leaves the patient with a gap in information that can
be misleading for women with dense breast tissue.
2)Breast Density . According to the National Institutes of
Health, density of a patient's breast tissue affects the
sensitivity of mammography. Breast cancers appear white on
mammograms and can be detected when viewed against fatty
tissue, which appears dark gray-to-black. Since dense breast
tissue also appears white, it can obscure overlapping or small
cancers. Current federal law requires the standardized
mammography report sent to a physician from a mammography
facility to include a statement about the patient's breast
density. This bill would mandate information related to the
patient's breast density in the notice provided to the
patient.
Breast composition can be characterized as one of four types:
(1) the breast is almost entirely fat; (2) there are scattered
islands of fibroglandular tissue; (3) the breast tissue is
heterogeneously dense (which may lower the sensitivity of
mammography); and (4) the breast tissue is extremely dense
(which will always lower the sensitivity of mammography).
Although computer algorithms exist to categorize a mammogram
into one of the above categories, currently most
categorizations are performed by the interpreting radiologists
using their subjective judgment. This bill would require a
notice to be sent to women with dense breasts (category 3 or
4), nearly 50% of women receiving mammograms.
Breast density is not static, but generally decreases and
changes over time. Most pre-menopausal women, and some
post-menopausal women have breasts that can be characterized
as dense (category (3) or (4)). Radiologists indicate that
many of the level 2 densities (which represent about 44% of
women) could be called as a level 3.
In addition to masking cancers on a mammogram, high breast
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density has been shown to be an independent risk factor for
breast cancer, with women with the highest levels of breast
density having several times the likelihood of being diagnosed
with breast cancer as women with the lowest levels. Even so,
high breast density by itself is not currently considered a
sufficient risk factor in medical guidelines or risk models to
suggest additional screening. The issue of how density is
linked to increased risk is unresolved, and how this should
inform screening protocols, is an area of active research.
3)State of the Science of Breast Cancer Screening . There are
four primary screening methods for breast cancer: clinical
examinations, mammography, breast MRI, and breast ultrasound.
Mammography is the only screening method that has been shown
to reduce mortality. Mammography combined with clinical
breast exams has been shown to be the most effective tool.
However, the other imaging methods for screening are sometimes
used to supplement mammography, particularly in cases where
women are at high risk for breast cancer. Supplemental imaging
may be recommended for diagnostic purposes by a physician
based on the results of a screening mammogram, or based on an
assessment of a woman's risk factors and preferences. Because
screening through breast ultrasound and BMRI have not been
shown to reduce breast cancer mortality, most national
guidelines do not recommend BMRI or ultrasound screening, and
those that do recommend it limit it to women at high risk of
breast cancer. Currently, the finding of dense breasts, in
the absence of other risk factors, is not an indication for
BMRI or ultrasound according to national guidelines.
4)Benefits and Harms of Screening . Routine screening is intended
to catch the development of disease early enough for treatment
to be beneficial. However, screening can also lead to harms
such as incorrect diagnosis; unnecessary diagnostic tests and
treatment; anxiety, psychological harm, and lost productivity;
radiation exposure and complications from follow-up
procedures. On balance, routine screening is usually
recommended for a population if the benefits outweigh the
harms. Translation of the harms and benefits of different
screening methods into clinical guidelines is an area of
active debate, and the several national organizations that
create guidelines sometimes differ from one another as to
which screening methods are best and when to initiate
screening.
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No national guidelines recommend screening based on breast
density alone without the presence of additional risk factors.
Studies indicate that BMRI is more sensitive (more likely to
detect a cancer) than mammography in high-risk women. This
increase in positive findings leads to an increase in the need
for repeat testing and an increase in unnecessary biopsies, as
well as an increase in detection of cancers. In asymptomatic
women with dense breasts, breast ultrasound has been shown to
detect additional cancers that are not detected by
mammography. However, the rate of false positive findings is
high relative to mammography.
5)Concerns . A coalition of medical provider groups, Planned
Parenthood affiliates, and Susan G. Komen for the Cure express
concerns with the bill. The coalition is requesting the
following amendments: (a) modify the notice text to provide
more context, (b) clarify that the bill does not create a
standard of care or a basis for a cause of action, (c) provide
authority to the state to review current science and change
the notice if necessary, and (d) conform with potential future
changes to federal law governing the mammography results
notice.
6)Previous Legislation . SB 173 (Simitian) and SB 791 (Simitian),
both in 2011, were both substantially similar to this bill. SB
173 was held on the Suspense File of this committee, and SB
791 was vetoed by the governor, who stated concern that the
notice as drafted would cause unnecessary anxiety rather than
greater knowledge, and that any such notice must be more
carefully crafted, with "words that educate more than they
prescribe." As this bill is nearly identical to SB 791, it
does not appear to address the concerns cited in the veto
message.
Analysis Prepared by : Lisa Murawski / APPR. / (916) 319-2081