BILL ANALYSIS �
SB 173
Page 1
Date of Hearing: July 5, 2011
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
SB 173 (Simitian) - As Amended: May 31, 2011
SENATE VOTE : 34-5
SUBJECT : Healing arts: mammograms.
SUMMARY : Requires health practitioners who perform
mammographies to provide a specified notice to patients who have
dense breast tissue. Specifically, this bill :
1)Requires a health care practitioner who performs a mammography
examination pursuant to requirements for coverage under health
care service plans (health plans) and individual or group
disability insurance or self-insured employee welfare benefit
plans to include a specified notice in the summary of the
written report sent to the patient, if the patient has
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 report."
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
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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 Senate Appropriations
Committee, this bill will result in costs to the General Fund
and federal funds in the low hundreds of thousands to millions
of dollars in fiscal years 2011-12, 2012-13, 2013-14 due to
potential increased follow-up screenings for Medi-Cal managed
care plan beneficiaries and individuals with health care
coverage through the California Public Employees Retirement
System. These are costs to the extent that: 1) a patient is
identified to have heterogeneously dense or extremely dense
breasts and receives this notice in the summary of the
mammography report; 2) that the patient reads the notice; and,
3) acts on the notice and schedules additional follow-up
appointments with her primary care physician that she otherwise
would not have scheduled had she not received the notice.
Additionally, the Senate Appropriations Committee states that if
the physician orders supplementary testing, such as an
ultrasound or breast magnetic resonance imaging test (BMRI),
there would be additional utilization of services. Lastly, the
analysis states that if a physician were to order a BMRI, there
could be greater risk of false positives, and therefore of
invasive diagnostic testing.
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
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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
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
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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
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
tomosythesis (also referred to as three-dimensional
mammography), was recently approved by the U.S. Food and Drug
Administration.
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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 changing
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
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. The
summary of each category is identical for all three
modalities, as follows:
a) 0: Incomplete
b) 1: Negative
c) 2: Benign finding(s)
d) 3: Probably benign
e) 4: Suspicious abnormality
f) 5: Highly suggestive of malignancy
g) 6: Known biopsy - proven malignancy
Breast composition categories are classified as follows:
h) 0: Incomplete
i) 1: Almost entirely fat
j) 2: Scattered fibroglandular densities
aa) 3: Heterogeneously dense
bb) 4: Extremely dense
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.
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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.
6)SUPPORT . According to the California Nurses Association
(CNA), patient knowledge is an essential piece of improving
health care and dense breast tissue obscures the ability of a
mammogram to detect cancer. CNA maintains that federal law
requires a letter be sent to the patient informing her of the
results of her mammogram. CNA states that this letter is
often referred to as a "happygram" as it typically says the
mammogram is normal and instructs the patient to please come
back next year. CNA argues that communicating breast density
to the patient would complete the loop allowing women to be
informed and help make their own health care decisions. The
notice in this bill, according to CNA, will undoubtedly foster
conversations that will improve the ability of health
practitioners to use the best breast cancer screening tools.
The California National Organization for Women (NOW) writes that
enabling women to learn their breast density and the
relationship this may have to detect cancer, and by providing
follow-up screening designed to better catch breast cancer in
early stages will save lives as well as long-term health
costs.
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7)OPPOSE UNLESS AMENDED . ACOG, the California Medical
Association (CMA) and CRS are all opposed unless amended to
this bill. ACOG states that while this bill has laudable
intent to give women more control over their health by
providing information to women found to have highly dense
breasts, it changes the standard of medical care in a manner
not supported by current clinical guidelines, which could
cause physicians to refer for more testing than is
scientifically indicated. According to ACOG, mammography is
not a perfect screening tool for women at any level of breast
density and neither is ultrasound or BMRI. ACOG maintains
that screening tests by definition are a balancing act of cost
and risk versus benefit. ACOG asserts that they have examined
the intent, the expected effect on utilization and outcomes
and after extensive examination, finds the data is not yet
clear on what information should be conveyed and what steps
patients should be advised to take. ACOG maintains that as
the science evolves, they are confident that more answers will
be found and the entire system will be changed based on the
new information.
ACOG states that the 2009 Connecticut law included a mandate
to cover additional screenings resulting from a similar
notice. Without the mandate, if additional screening services
are recommended they would likely not be covered if prior
approval of the health plan, insurer or Medi-Cal is needed.
Many women, ACOG states, would not be able to afford the $300
for an ultrasound and $1700 for a BMRI. ACOG argues that if
these additional screening and procedures made a significant
difference in the numbers of early detections and survival
rates, they would have no problem with this increase in care
however, ACOG finds there is no evidence to suggest that this
is the case. Rather, according to ACOG, there is an
anticipated increase in utilization and costs without the
demonstrated benefit, straining the current availability of
radiologists to do other necessary procedures.
ACOG asserts that given the uncertainty of the evidence, it
makes sense to wait for an evaluation of the Connecticut law
to determine if this type of notice helped to identify
additional cancers and saved lives before we implement such a
significant system change in California.
CMA states that currently, national medical practice protocols
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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 argues 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 ultrasound and BMRI.
CMA is opposed unless this bill is amended to remove the
requirements dictating the content of patients' screening
mammography reports.
CRS states that the radiologist community is supportive of
patient empowerment and ensuring that all patients are
provided with adequate information to make informed decisions
about their medical care. CRS maintains that there is
significant observer variability in the assignment of a breast
density category among radiologists. The categories are
subjective and until a reliable, easily implemented method for
objectively determining the amount of breast tissue is
developed, the notification of breast density could lead to
more confusion than clarification. CRS asserts that all women
are at risk of developing breast cancer, regardless of their
tissue patterns. Notifying women directly of their breast
density runs the risk of giving a false sense of security to
women who are told their breast tissue is not dense. CRS
argues that the patient's physician should use the information
to discuss the appropriate options given her history and other
circumstances. CRS is opposed to those provisions in this
bill that would require reporting of breast density with the
suggested information statement directly to patients.
8)RELATED LEGISLATION . 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 .
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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.
10)DOUBLE REFERRAL . This bill was previously heard in Assembly
Business, Professions and Consumer Protection Committee, and
was approved on a 9-0 vote.
REGISTERED SUPPORT / OPPOSITION :
Support
Association of Women's Health Obstetric and Neonatal Nurses
Breast Cancer Fund
Breast Care Center, Community Hospital of Monterey Peninsula
California Association of Health Underwriters
California Communities United Institute
California National Organization of Women
California Nurses Association
Sheila R. Veloz Breast Imaging Center
Oppose Unless Amended
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American Congress of Obstetricians and Gynecologists, District
IX - California
California Medical Association
California Radiological Society
Analysis Prepared by : Tanya Robinson-Taylor / HEALTH / (916)
319-2097