BILL ANALYSIS �
SB 173
Page 1
Date of Hearing: August 17, 2011
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Felipe Fuentes, Chair
SB 173 (Simitian) - As Amended: August 15, 2011
Policy Committee: HealthVote: 16-0
Business and Professions 9-0
Urgency: No State Mandated Local Program:
No Reimbursable: No
SUMMARY
This bill requires, until January 1, 2018, a health care
provider who performs a mammography, if a patient has 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, 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 report."
FISCAL EFFECT
1)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 seem to increase the perceived relevance of the
notice and likelihood of a woman contacting her physician to
request supplemental screening.
2)If 5% of women who receive this notice are referred for and
receive supplemental screening in the form of a breast
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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 that 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
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
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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. A majority of pre-menopausal women, and a
minority of 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
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 and when
density is linked to increased risk is unresolved and 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
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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.
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.
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.
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. As noted above,
there is no evidence of reduced breast cancer mortality
associated with using BMRI or breast ultrasound for screening.
5)Concerns . The California Medical Association (CMA), American
Congress of Obstetricians and Gynecologists (ACOG), and the
California Radiological Society (CRS) are opposed to this bill
unless amended. ACOG argues that there is no clear evidence
that the additional screening and procedures expected to be
triggered by this bill will make a significant difference in
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the numbers of early detections and survival rates. ACOG also
indicates that a similar law was passed in Connecticut, and
asserts that given the uncertainty of the evidence, it makes
sense to wait for an evaluation of the outcomes from that law
to determine if this type of notice to patients, and the
subsequent additional studies which followed, helped to
identify additional cancers and saved lives before we
implement such a significant system change in California.
CMA argues that this bill in its current form disrupts the
physician-patient relationship by mandating that all women
with dense breasts, without personalized interpretation by
their ordering physician to indicate risks that might make
additional testing clinically appropriate, be given a specific
notice regarding their breast density. Finally, CRS notes
that the breast density categories are subjective, and until a
reliable, easily implemented method for objectively
determining the density of breast tissue is developed, the
notification of this finding could lead to more confusion than
clarification.
Analysis Prepared by : Lisa Murawski / APPR. / (916) 319-2081