BILL ANALYSIS �
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|SENATE RULES COMMITTEE | SB 791|
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VETO
Bill No: SB 791
Author: Simitian (D), et al.
Amended: 9/9/11
Vote: 21
PRIOR SENATE VOTES NOT RELEVANT
ASSEMBLY FLOOR : 66-6, 9/9/11 - See last page for vote
SENATE FLOOR : 35-1, 9/10/11
AYES: Alquist, Berryhill, Blakeslee, Calderon, Cannella,
Corbett, Correa, De Le�n, DeSaulnier, Dutton, Emmerson,
Evans, Fuller, Gaines, Hancock, Harman, Hernandez, Huff,
Kehoe, Leno, Lieu, Liu, Lowenthal, Negrete McLeod,
Padilla, Pavley, Price, Runner, Simitian, Steinberg,
Vargas, Walters, Wolk, Wright, Wyland
NOES: Anderson
NO VOTE RECORDED: La Malfa, Rubio, Strickland, Yee
SUBJECT : Healing arts: mammograms
SOURCE : Author
DIGEST : This bill requires health facilities at which
mammography examinations are performed to provide a
specified notice to patients who have dense breast tissue.
Assembly Amendments delete the prior version of the bill,
dealing with metropolitan planning organizations, and
implement language regarding mammography examinations and
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breast density.
ANALYSIS : 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.
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
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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.
Background
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 percent, 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 percent
of breast cancer is diagnosed in the early stages. Among
California women, the five-year relative survival rate for
breast cancer is 91 percent; this rate varies with the
stage at diagnosis with a 99 percent five-year relative
survival rate for localized breast cancer, 85 percent for
regional breast cancer, and 25 percent 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
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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 compared to those with very fatty
breasts but most women fall in between these two extremes.
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.
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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 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.
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FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: No
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 five percent 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 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 percent General Fund
(GF)/50 percent 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 percent GF/45
percent 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.
SUPPORT : (Verified 9/9/11)
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California Nurses Association
Sheila R. Veloz Breast Imaging Center
OPPOSITION : (Verified 9/9/11)
American Congress of Obstetricians and Gynecologists
California Medical Association
ARGUMENTS IN SUPPORT : The California Nurses Association
supports this bill and writes the following: "Patient
knowledge is an essential piece of improving health care.
Dense breast tissue obscures the ability of a mammogram to
detect cancer. According to a recent national survey
conducted by Harris Interactive only five percent of women
know that their breast density is and 91 percent of doctors
are not talking to women about the issue. CAN/NNOC feels
that we can do better than this.
"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 "happy gram" 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."
ARGUMENTS IN OPPOSITION : The American Congress of
Obstetricians and Gynecologists opposes this bill and
writes, "The effect of the bill substantially increases
additional breast imaging without demonstrated benefit to
the population with women with dense breasts."
GOVERNOR'S VETO MESSAGE:
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"While I wholeheartedly support everyone's right to
information about their own health, the notice in this
bill gave me pause. I talked to many people, including
doctors I respect, about the effects of the notice --
both its risks and benefits -- and struggled over the
words. Were they a path to greater knowledge or
unnecessary anxiety?
My conclusion was this: every patient needs health
information they can use. For women, that likely includes
information about breast density. But the notice
contained in this bill goes beyond information about
breast density. It advises that additional screening may
be beneficial. If the state must mandate a notice about
breast density -- and I am not certain it should -- such
a notice must be more carefully crafted, with words that
educate more than they prescribe.
I am returning Senate Bill 791 without my signature."
ASSEMBLY FLOOR : 66-6, 9/9/11
AYES: Achadjian, Alejo, Allen, Ammiano, Beall, Bill
Berryhill, Block, Bonilla, Bradford, Brownley, Buchanan,
Butler, Charles Calderon, Campos, Carter, Cedillo,
Conway, Cook, Davis, Dickinson, Eng, Feuer, Fletcher,
Fong, Fuentes, Furutani, Galgiani, Garrick, Gatto,
Gordon, Hagman, Hall, Harkey, Hayashi, Roger Hern�ndez,
Hill, Huber, Hueso, Huffman, Jeffries, Lara, Logue,
Bonnie Lowenthal, Ma, Mansoor, Mendoza, Miller, Mitchell,
Monning, Nestande, Nielsen, Norby, Olsen, V. Manuel
P�rez, Portantino, Silva, Skinner, Smyth, Solorio,
Swanson, Torres, Valadao, Wieckowski, Williams, Yamada,
John A. P�rez
NOES: Donnelly, Beth Gaines, Grove, Halderman, Jones,
Morrell
NO VOTE RECORDED: Atkins, Blumenfield, Chesbro, Gorell,
Knight, Pan, Perea, Wagner
CTW:do:mw 1/4/12 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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