BILL ANALYSIS �
SB 173
Page 1
Date of Hearing: June 28, 2011
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Mary Hayashi, Chair
SB 173 (Simitian) - As Amended: May 31, 2011
SENATE VOTE : 34-5
SUBJECT : Healing arts: mammograms.
SUMMARY : Requires health care practitioners who perform
mammographies to provide a specified notice to patients who have
dense breast tissue (DBT). 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 (BIRADS)
established by the American College of Radiology (ACR).
2)Specifies that the notice required 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
SB 173
Page 2
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 (MBC).
FISCAL EFFECT : Unknown
COMMENTS :
Purpose of this bill . According to the author's office, "Women
with DBT are at four to six times greater risk of developing
breast cancer compared to women of the same age and health.
More than half of women have DBT. Because DBT is white on a
mammogram and cancer is white on a mammogram, 75 percent of
cancer is missed in women with DBT by mammography alone
according to a January 2011 study from the Mayo Clinic.
"A recent national survey found that 95 percent of women do not
know their breast density, and nearly 90 percent do not know
that breast density increases the risk of developing breast
cancer. Compounding the problem is the fact that doctors have
spoken to fewer than one in ten women (nine percent) about
breast density?Senate Bill 173 will lead to more women surviving
breast cancer by helping us catch cancer early when it is most
treatable and curable."
Background . 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
SB 173
Page 3
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.
Three modalities are used to screen asymptomatic women for
breast cancer: mammography, breast magnetic resonance imaging
(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
(FDA). Although different organizations have different
guidelines, age 40 has traditionally been regarded as the age at
which women should be offered annual screening for breast cancer
with mammography.
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.
BIRADS is a quality control system established by the ACR. The
term generally refers to mammography assessment categories, or
standardized numerical codes assigned by a radiologist after
interpreting a mammogram. The assessment categories were
developed for mammography and later adapted for the BMRI and
ultrasound. The summary of each category is identical for all
three modalities, as follows:
0: Incomplete
1: Negative
2: Benign finding(s)
3: Probably benign
SB 173
Page 4
4: Suspicious abnormality
5: Highly suggestive of malignancy
6: Known biopsy - proven malignancy
Breast composition categories are classified as follows:
1: Almost entirely fat
2: Scattered fibroglandular densities
3: Heterogeneously dense
4: Extremely dense
Dense breast tissue is comprised of less fat and more connective
tissue, which appears white on a mammogram. Cancer also appears
white on a mammogram, which means tumors can be hidden behind
dense tissue. As a woman ages, her breasts usually become more
fatty.
Support . The California Nurses Association writes, "Federal law
requires that a radiologist send a report to the referring
physician that contains a woman's breast density. Federal law
also requires a letter be sent to the patient informing her of
the results of her mammogram. This letter is often referred to
as a "happygram" as it typically says your mammogram is normal,
please come back next year. What it fails to tell the 40
percent of women that have dense breast tissue is that, the
mammogram may not have detected cancer because it could be
hidden by their dense tissue.
"Communicating breast density to the patient would complete the
loop allowing women to be informed and help make their own
health care decisions. This will undoubtedly foster
conversations that will improve the ability of health care
practitioners to use the best breast cancer screening tools."
Opposition . The California Radiological Society (CRS) states,
"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.
However, the issue of breast density is very complex and there
is limited science to provide direction for patients, their
primary care providers and breast imagers in what to do with
information about density. The CRS believes that this is such a
complex medical issue that it is not currently amenable to the
development of governmental policy."
SB 173
Page 5
The American Congress of Obstetricians and Gynecologists notes,
"In our extensive discussion with experts, we are left to
conclude that no matter our desire to support the intent of
these efforts, we cannot as the data is not clear and convincing
with regard to 1) an objective definition of dense breasts and
2) a recommendation to patients for appropriate followup."
Related legislation . AB 137 (Portantino) requires health
insurance plans to cover mammography upon a provider's referral,
and requires health plans and health insurance plans to notify
subscribers and policyholders regarding recommended timelines
for screening or diagnosis of breast cancer. This bill was held
in Assembly Appropriations.
Previous legislation . AB 56 (Portantino) of 2009 requires
health insurers to provide coverage for mammography upon
provider referral and requires health plans and health insurers
to notify subscribers or policyholders of recommended timelines
for testing. This bill was vetoed with a message that stated,
"The addition of a new mandate, no matter how small, will only
serve to increase the overall cost of health care."
AB 2234 (Portantino) of 2008 requires health plans and health
insurers to provide coverage for screening and tests to diagnose
breast cancer in accordance with national guidelines,
professional standards, and patient-specific risk, and requires
health plans and insurers to send a written notice to specified
female enrollees to notify patients of eligibility for testing
pursuant to the bill. This bill was held in Assembly
Appropriations Committee.
REGISTERED SUPPORT / OPPOSITION :
Support
Association of Women's Health, Obstetric and Neonatal Nurses
Breast Cancer Fund
Breast Care Center, Community Hospital of the Monterey Peninsula
California Association of Health Underwriters
California Communities United Institute
California National Organization for Women
California Nurses Association
Sheila R. Veloz Breast Imaging Center
Opposition
SB 173
Page 6
American Congress of Obstetricians and Gynecologists
California Medical Association
California Radiological Society
Analysis Prepared by : Angela Mapp / B.,P. & C.P. / (916)
319-3301