BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | SB 1538|
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UNFINISHED BUSINESS
Bill No: SB 1538
Author: Simitian (D), et al.
Amended: 8/22/12
Vote: 21
SENATE HEALTH COMMITTEE : 8-0, 4/18/12
AYES: Hernandez, Harman, Alquist, Anderson, De León,
DeSaulnier, Rubio, Wolk
NO VOTE RECORDED: Blakeslee
SENATE APPROPRIATIONS COMMITTEE : 7-0, 5/24/12
AYES: Kehoe, Walters, Alquist, Dutton, Lieu, Price,
Steinberg
SENATE FLOOR : 39-0, 5/29/12
AYES: Alquist, Anderson, Berryhill, Blakeslee, Calderon,
Cannella, Corbett, Correa, De León, DeSaulnier, Dutton,
Emmerson, Evans, Fuller, Gaines, Hancock, Harman,
Hernandez, Huff, Kehoe, La Malfa, Leno, Lieu, Liu,
Lowenthal, Negrete McLeod, Padilla, Pavley, Price, Rubio,
Simitian, Steinberg, Strickland, Vargas, Walters, Wolk,
Wright, Wyland, Yee
NO VOTE RECORDED: Runner
ASSEMBLY FLOOR : Not available
SUBJECT : Health care: mammograms
SOURCE : Author
CONTINUED
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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.
Assembly Amendments delete the following notice included in
the summary of the written report sent to patients "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." The notice now
reads, "Your mammogram shows that your breast tissue is
dense. Dense breast tissue is common and is not abnormal.
However, dense breast tissue can make it harder to evaluate
the results of your mammogram and may also be associated
with an increased risk of breast cancer. This information
about the results of your mammogram is given to you to
raise your awareness and to inform your conversations with
your doctor. Together, you can decide which screening
options are right for you. A report of your results was
sent to your physician" and makes other clarifying changes.
ANALYSIS :
Existing law:
1.Requires, under federal regulations implementing the
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.
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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.
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
established by the American College of Radiology (ACR).
2.Specifies that the notice required in 1) above must state,
"Your mammogram shows that your breast tissue is dense.
Dense breast tissue is common and is not abnormal.
However, dense breast tissue can make it harder to
evaluate the results of your mammogram and may also be
associated with an increased risk of breast cancer. This
information about the results of your mammogram is given
to you to raise your awareness and to inform your
conversations with your doctor. Together, you can decide
which screening options are right for you. A report of
your results was sent to your physician."
3.Requires the provisions of this bill to become operative on
April 1, 2013.
4.Prohibits, prior to April 1, 2013, this bill from being
construed to create or impose liability on a health care
facility for failing to comply with its requirements.
5.Prohibits this bill from being deemed to create a duty of
care or other legal obligation beyond the duty to provide
the notice referenced in 2) above.
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6.Prohibits this bill from being deemed to require a notice
that is inconsistent with the provisions of the federal
Mammography Quality Standards Act.
7.Repeals this section on January 1, 2019, unless a later
enacted statute deletes or extends that date.
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:
Ï 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.
Ï False positives: some women with no cancer will have
positive results, leading to anxiety and additional
testing.
Ï Overdiagnosis: the identification of cancers that will
not become clinically significant, leading to unnecessary
treatment.
Ï Radiation risk: radiation used for mammography can
induce mutations that cause breast cancer.
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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
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:
Ï 1: almost entirely fat
Ï 2: scattered fibroglandular densities
Ï 3: heterogeneously dense
Ï 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
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positive result.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: No
According to the Assembly Appropriations Committee, state
health care costs may increase as a result of this bill, if
it leads more women to discuss breast density with their
doctor and they decide to opt for additional screening and
follow-up tests. However, any impact will likely be
mitigated by other factors, including increasing awareness
about breast density among the medical community and the
public, new informational brochures produced by ACR that
describe and provide context about breast density, and
changes in screening recommendations based on a woman's
breast cancer risk. Given these dynamics and the
non-prescriptive nature of the notice, the direct fiscal
impact of this bill is expected to be minor.
SUPPORT : (Verified 8/28/12)
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)
Breast Cancer Fund
California Black Women's Health Project
California Church Impact
California Commission on Aging
California Communities United Institute
California Federation of Teachers
California Labor Federation
California National Organization for Women
California Nurses Association
California Professional Firefighters
California Radiological Society
California School Employees Association
California Senior Legislature
California Teacher Association
California Women Lawyers
CALPIRG
Community Health Partnership
Consumer Federation of California
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County of San Mateo - In Concept
County of Santa Clara
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)
Feminist Majority
Greenlining Institute
Health Care for All-California Santa Clara Chapter
Human Care Alliance
Junior Leagues of California, State Public Affairs
Committee
Mayview Community Health Center
Michelle's Place Breast Cancer Resource Center
National Federation of Independent Business
Planned Parenthood Affiliates of California
Ravenswood Family Health Center
Santa Barbara County Commission for Women
Santa Clara County Board of Supervisors
Santa Clara County Commission on the Status of Women
SEIU California
Small Business California
Soroptimist International of Silicon Valley
Susan G. Komen for the Cure, California Affiliates
Temple Beth El
United Farm Workers
Women Care
Women's Health Specialists The Feminist Women's Health
Centers of
California
Women Lawyers of Santa Cruz County
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
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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
firsthand how important it is that health care providers
make individualized breast cancer screening plans with
women.
CTW:RM:dn 8/28/12 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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