BILL ANALYSIS �
SB 791
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Date of Hearing: September 9, 2011
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
SB 791 (Simitian) - As Amended: September 9, 2011
AS PROPOSED TO BE AMENDED
SENATE VOTE : Not relevant
SUBJECT : Healing arts: mammograms.
SUMMARY : Requires health facilities at which mammography
examinations are performed to provide a specified notice to
patients who have dense breast tissue. Specifically, this bill :
1)Requires a health facility at which a mammography examination
is performed to include a specified notice in the summary of
the written report 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)Specifies that the notice required in 1) above must 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 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)Requires the provisions of this bill to become operative on
April 1, 2012.
4)Prohibits, prior to April 1, 2012, this bill from being
construed to create or impose liability on a health care
facility for failing to comply with its requirements.
5)Repeals this section on January 1, 2018 unless a later enacted
statute deletes or extends that date.
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EXISTING LAW :
1)Under federal regulations implementing the Mammography Quality
Standards Act, requires each facility that performs a
mammography to send a report to the referring physician that
includes specified information. A letter must also be sent to
the patient informing her of the results of the mammogram.
2)Requires health plans, individual or group disability
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.
3)Requires individual or group disability insurance policies and
self-insured employee welfare benefit plans, upon referral, to
provide: a baseline mammogram for women ages 35 through 39,
inclusive; a mammogram for women ages 40 through 49,
inclusive, every two years or more, based on a physician's
recommendation; and, a mammogram every year for women age 50
and over.
4)Licenses and regulates physicians and surgeons under the
Medical Board of California.
FISCAL EFFECT : According to the Assembly Appropriations
Committee analysis of SB 173 (Simitian), a substantially similar
bill, the fiscal impact of this bill will be the following:
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
ultrasound, and have follow-up procedures typical for this
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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) Costs of $1.5 million (50% General Fund (GF)/50% federal
funds) to the Medi-Cal Program.
b) Cost pressure of $700,000 (GF) on the Every Woman Counts
Program.
c) Cost pressure of $1 million (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)PURPOSE OF THIS BILL . According to the author, the National
Cancer Institute (NCI) estimates that one in eight women will
develop breast cancer in their lifetime. The author maintains
that women with dense breast tissue are at four to six times
greater risk of developing breast cancer compared to women of
the same age and health. The author cites a Mayo Clinic study
from January 2011 which reports that because dense breast
tissue is white on a mammogram and cancer is white on a
mammogram, 75% of cancer is missed in women with dense breast
tissue by mammography alone. 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 less 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. This bill,
the author asserts, will lead to more women surviving breast
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cancer by helping to catch cancer early when it is most
treatable and curable.
2)BREAST CANCER PREVALENCE AND RISK FACTORS . 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 12%, or
one in eight. Nearly 300,000 women are 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% of breast cancer
is diagnosed in the early stages. Among California women, the
five-year relative survival rate for breast cancer is 91%;
this rate varies with the stage at diagnosis with a 99%
five-year relative survival rate for localized breast cancer,
85% for regional breast cancer, and 25% 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.
Many factors 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.
According to the American Congress of Obstetricians and
Gynecologists, District IX - California (ACOG), high breast
density by itself is not a recognized risk factor that is
included in professional guidelines. According to the
California Radiological Society (CRS), there is debate within
the scientific community as to the relationship between breast
density and breast cancer risk. CRS states that it seems that
women with extremely dense breasts are at some increased risk
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compared to those with very fatty breasts but most women fall
in between these two extremes.
3)BREAST DENSITY . According to NCI, breast tissue is composed
mainly of the connective tissue, ducts of the milk glands, and
fat cells. A breast is said to be dense if it consists mostly
of connective and ductal tissue rather than fatty tissue.
While fat appears black on a mammogram and provides good
contrast for cancers which appear white on the mammogram, the
connective and ductal tissue also appears white, and therefore
can disguise or mimic cancers. Dense tissue is particularly
difficult in that even a small area of density can obscure a
small cancer.
NCI states that a woman's tissue density varies over her
lifetime and it is a common condition found in over one-third
of women over the age of 40, and over half of those aged
40-50. The underlying causes of breast density are mostly
inherited. Higher breast density is more common in some
ethnic groups, including white women. It is also more common
in younger women, beginning when hormones kick in during
puberty and continuing through the childbearing years.
4)BREAST CANCER SCREENINGS . There are three modalities that are
used to screen asymptomatic women for breast cancer:
mammography, 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.
In 2009, the United States Preventive Services Task Force
(USPSTF), a group of experts that makes recommendations on
policies to prevent diseases, issued revised guidelines for
mammography recommending biennial mammography screenings
beginning at age 50 instead of 40. Leading cancer
organizations, including the American Cancer Society (ACS),
the Mayo Clinic, the Susan G. Komen for the Cure, and the
National Breast Cancer Foundation, however, did not change
their policies of recommending annual mammography screenings
for women when they turn 40 years old. According to the chief
medical officer of ACS, the organization continues to
recommend annual screening using mammography and clinical
breast examination for all women beginning at age 40. He
further states that ACS experts make this recommendation
having reviewed virtually all the same data reviewed by the
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USPSTF, but also additional data that the USPSTF did not
consider.
The ACR's BI-RADS is one of the principal methods used for
mammography assessment and contains standardized numerical
codes assigned by a radiologist after interpreting a
mammogram. The assessment categories were developed for
mammography and later adapted for BMRI and ultrasound. Breast
density composition categories are classified as follows:
a) 0: Incomplete;
b) 1: Almost entirely fat (< 25% fibroglandular density);
c) 2: Scattered fibroglandular densities (approx. 25% - 50%
fibroglandular density);
d) 3: Heterogeneously dense (approx. 51%-75% fibroglandular
density); or,
e) 4: Extremely dense (>75% fibroglandular density).
The subjectivity of density measurement has been the matter of
some concern for those in the field for many years. Research
indicates that technology is currently being developed for a
measurement tool of breast density that is more qualitative
than subjective.
5)OTHER STATES . The State of Connecticut passed a law similar
to this bill in 2009. The Connecticut legislation mandates
insurance coverage of comprehensive ultrasound screening of an
entire breast or breasts if a mammogram demonstrates
heterogeneous or dense breast tissue. The Connecticut law
also provides that:
Each mammography report provided to a patient shall include
information about breast density, based on the BI-RADS
established by the ACR. Where applicable, such report shall
include the following notice: "If your mammogram demonstrates
that you have dense breast tissue, which could hide small
abnormalities, you might benefit from supplemental screening
tests, which can include a breast ultrasound screening or a
BMRI examination, or both, 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 the report."
According to the author, New Hampshire, Massachusetts, New York,
Florida, and Texas all have similar legislation pending.
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6)OPPOSED . ACOG writes in opposition to this bill 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 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.
7)OPPOSE UNLESS AMENDED . The California Medical Association
(CMA) is opposed unless amended to this bill. CMA states that
there is not sufficient consensus in the medical community
regarding the definition of breast density or guidelines for
supplemental screening for those categorized as having dense
breasts. CMA argues that this bill implies that such a
standard does indeed exist, creating a potential legal
liability for physicians to provide other types of care such
as further screenings beyond mammograms, including breast
ultrasounds and MRIs. CMA requests that all women receiving
mammograms - not just those categorized at density levels '3'
or '4' - receive the notice. CMA poses the question that if
no consensus exists in the medical community about how the
condition of density, in and of itself, impacts a woman's care
and screening, how then is it appropriate to decide that only
some women, not all, are provided with information about their
density level?
CMA states that currently, national medical practice protocols
require information about breast density to be included in the
patient's mammography report provided to the referring
physician from the radiologist. CMA maintains that using this
information in combination with their knowledge of the
patient's personal history, including other risk factors, the
primary treating physician can then make a decision regarding
the best course of action or follow-up. CMA maintains that
these decisions are made on a case-by-case basis.
CMA asserts that density is actually a common condition and
approximately 10% of women fall into the lower category of
density, or level '1,' also referred to as "extremely fatty."
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Beyond that, according to CMA, 90% of women are categorized as
having a level of density between levels '2' ("scattered
density") and '4' ("extremely dense"), all of which could
possibly obscure abnormalities in a mammogram. CMA argues
that when a condition is present in the majority of the
population, a notice about it should indicate that fact.
CMA also argues that determining the level of density present is
also inherently subjective, and can vary from physician to
physician. This, CMA maintains, presents a liability problem
when coupled with the bill's requirement that only women
categorized as a level '3' or '4' of density receive the
notice. As a result of these concerns, CMA is requesting the
following amendments:
a) Insert language as used in the Texas law regarding
standards of care.
"Notwithstanding any other law, this section does not create
a cause of action or create a standard of care, obligation,
or duty that provides a basis for cause of action."
b) Insert sentence in the mandatory notice regarding the
subjectivity of density determination.
"The determination of the level of breast density is a
subjective determination which may vary among
radiologists."
c) Add context language to text of notice regarding breast
density.
"Density breast tissue, in and of itself, is a relatively
common condition. Therefore, this information is not
provided to cause undue concern, but rather to raise your
awareness and to promote discussion with your physician
regarding the presence of other risk factors, in addition
to dense breast tissue."
d) Make the notice apply to all women receiving mammograms.
e) Add information about the patient's density grade to the
text of the notice.
Require that the mandatory notice include information
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regarding the patient's density level as determined by the
radiologist, likely in both number form (1-4) as well as
lay language ("Entirely Fatty"/ "Scattered Density"/
"Heterogeneously Dense"/ "Extremely Dense") since the
notice, (if amendment d) above is taken) will not be sent
to all women.
8)RELATED LEGISLATION .
a) SB 173 (Simitian) was substantially similar to this
bill. SB 173 was held in the Assembly Appropriations
Committee on the suspense file.
b) AB 137 (Portantino) requires health plan contracts and
health insurance policies that are issued, amended,
delivered, or renewed, on or after July 1, 2012, to provide
coverage for mammography for screening or diagnostic
purposes upon referral by a health care professional, based
on medical need, regardless of age. AB 137 was held in the
Assembly Appropriations Committee.
9)PREVIOUS LEGISLATION .
a) AB 113 (Portantino) of 2010 was identical to AB 137.
Governor Schwarzenegger vetoed AB 113, stating, in part,
that it was unnecessary and had no practical impact on the
current state of health coverage in California.
b) AB 56 (Portantino) of 2009 contained provisions
identical to those in AB 113. AB 56 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."
c) 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.
AB 2234 was held in the Assembly Appropriations Committee.
REGISTERED SUPPORT / OPPOSITION :
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Support
None on file.
Opposition
California Medical Association (unless amended)
American Congress of Obstetricians and Gynecologists
Analysis Prepared by : Tanya Robinson-Taylor / HEALTH / (916)
319-2097