BILL ANALYSIS �
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|SENATE RULES COMMITTEE | SB 1538|
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THIRD READING
Bill No: SB 1538
Author: Simitian (D), et al.
Amended: 3/27/12
Vote: 21
SENATE HEALTH COMMITTEE : 8-0, 4/18/12
AYES: Hernandez, Harman, Alquist, Anderson, De Le�n,
DeSaulnier, Rubio, Wolk
NO VOTE RECORDED: Blakeslee
SENATE APPROPRIATIONS COMMITTEE : 7-0, 5/24/12
AYES: Kehoe, Walters, Alquist, Dutton, Lieu, Price,
Steinberg
SUBJECT : Health care: mammograms
SOURCE : Author
DIGEST : This bill 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.
ANALYSIS :
Existing law:
1. Requires, under federal regulations implementing the
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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 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.
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Background
Breast cancer screening . Breast cancer screening refers
to the medical screening of asymptomatic, apparently
healthy women 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:
� 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.
� False positives: some women with no cancer will have
positive results, leading to anxiety and additional
testing.
� Overdiagnosis: the identification of cancers that will
not become clinically significant, leading to unnecessary
treatment.
� 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
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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, 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.
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 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:
� 1: almost entirely fat
� 2: scattered fibroglandular densities
� 3: heterogeneously dense
� 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.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: No
According to the Senate Appropriations Committee, increased
costs to state health programs due to requests for
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additional screening from participants. Assuming that 10
percent of women who receive the required notice request
additional screening, costs to state health programs would
be:
Medi-Cal - about $1.8 million per year (50% General Fund
and 50% federal funds)
Every Woman Counts Program - about $1.6 million per year
(General Fund)
CalPERS - about $1.7 million per year (55% General Fund
and 45% special funds)
SUPPORT : (Verified 5/24/12)
Asian Americans for Community Involvement
Association of California Commissions for Women
Association of Women's Health, Obstetric and Neonatal
Nurses
Black Women's Health Imperative (National)
California Church Impact
California Communities United Institute
California Labor Federation
California Nurses Association
California Professional Firefighters
California School Employees Association
California Senior Legislature
California Women Lawyers
CALPIRG
Community Health Partnership
Consumer Federation of California
County of San Mateo - In Concept
County of Santa Cruz
CRONA (Stanford/Packard nurses union)
Democratic Activists For Women Now
Democratic Women's Club of Santa Cruz County
Federated Indians of Graton Rancheria (Tribe)
Health Care for All-California Santa Clara Chapter
Junior Leagues of California, State Public Affairs
Committee
Mayview Community Health Center
Michelle's Place Breast Cancer Resource Center
Ravenswood Family Health Center
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Santa Barbara County Commission for Women
Santa Clara County Commission on the Status of Women
SEIU California
Sheila R. Veloz Breast Imaging Center
Soroptimist International of Silicon Valley
United Farm Workers
Women Care
Women's Health Specialists The Feminist Women's Health
Centers of California
Women Lawyers of Santa Cruz County
OPPOSITION : (Verified 5/24/12)
Association of Northern California Oncologists
California Academy of Family Physicians
California Association of Professional Liability Insurers
California Medical Association
Medical Oncology Association of Southern California
The American Congress of Obstetricians and Gynecologists
District IX California
ARGUMENTS IN 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 this bill, 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, 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
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firsthand how important it is that health care providers
make individualized breast cancer screening plans with
women.
ARGUMENTS IN OPPOSITION : 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.
CTW:do 5/25/12 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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