BILL ANALYSIS �
SB 1538
Page 1
Date of Hearing: June 26, 2012
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
SB 1538 (Simitian) - As Amended: June 19, 2012
SENATE VOTE : 39-0
SUBJECT : Health care: mammograms.
SUMMARY : 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. Specifically,
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 (a relatively common condition), 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)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)Repeals this section on January 1, 2019 unless a later enacted
statute deletes or extends that date.
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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.
FISCAL EFFECT : According to the Senate Appropriations
Committee, the fiscal impact of this bill will be the following:
1)Increased costs to state health programs due to requests for
additional screening from participants.
2)If 10% of women who receive the required notice request
additional screening, costs to state health programs would be:
a) $1.8 million per year (50% General Fund (GF)/50% federal
funds) to the Medi-Cal Program.
b) $1.6 million per year (GF) on the Every Woman Counts
Program.
c) $1.7 million per year (55% GF/45% other funds) for
CalPERS state employee health benefits.
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, the National
Cancer Institute (NCI) estimates that one in eight women will
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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
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
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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
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.
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, 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.
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),
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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.
5)OTHER STATES . The State of Connecticut was the first state to
pass 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 states of Texas and Virginia have also passed similar
legislation. According to the author 15 other states, as well
as Congress, are looking at this issue.
6)LOS ANGELES TIMES ARTICLE . A Los Angeles Times article dated
September 28, 2011, reported that the author's previous effort
to pass legislation (SB 791 of 2011) was inspired by an entry
in the author's "There Ought to Be a Law" contest, and that,
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unbeknownst to the author, the cancer awareness group that
provided the entry winner's legislative inspiration was
partially funded by a company that makes advanced breast
screening equipment. The company's chief executive officer is
reported as saying that his company stands to profit if demand
for ultrasound screening increases, but that he is also saving
lives.
7)SUPPORT . Supporters including women's health advocacy
organizations, local governments, trade associations, and
numerous individuals all write in support that patient
knowledge is an essential piece of improving health care.
Supporters argue that dense breast tissue obscures the ability
of a mammogram to detect cancer and that according to a recent
national survey only 5% of women know what their breast
density is. Supporters assert that federal law requires that
a radiologist send a report to the referring physician that
contains a women's breast density and also requires a letter
be sent to the patient informing her of the results of her
mammogram. Supporters indicate this letter is often referred
to as a "happy gram" as it typically says the mammogram
results are normal and to please come back next year.
Unfortunately, according to supporters, these letters
typically fail to tell the 40% of women who have dense breast
tissue that the mammogram may not have detected cancer due to
dense breast tissue. Supporters maintain that communicating
breast density to the patient would complete the loop allowing
women to be informed and help make their own health care
decisions.
8)COALITION REQUEST FOR AMENDMENTS . A coalition of
organizations including the California Medical Association
(CMA), American Congress of Obstetricians and Gynecologists
(ACOG), California Association of Family Physician Groups, The
Doctors Company, California Association of Family Physicians
(CAFP), California Academy of Physician Assistants,
Association of Northern California Oncologists (ANCO), Planned
Parenthood Affiliates of California (PPAC), Susan G. Komen for
the Cure, California NOW, California Association of
Professional Liability Insurers (CAPLI), and the Medical
Oncology Association of Southern California, Inc. (MOASC) have
submitted a letter to the Assembly Health Committee stating
that they all agree with the fundamental premise that women
must have access to screening services to help identify breast
cancer early. The letter acknowledges that due to the nuanced
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science on breast density, the seemingly simple task of
drafting language that is educational, non-prescriptive, and
will not become scientifically outdated is challenging. The
Coalition letter states that significant research is being
done in an effort to ascertain the impact of breast density
not only on the readability of a mammogram, but on the actual
personal risk of contracting breast cancer and that there is
not enough evidence yet to lead to changes in the
evidence-based medicine used in breast cancer screening for
the population at large. The coalition letter indicates that
after significant time spent conferring with experts in the
field of breast cancer screening, they offer the following
amendments in an attempt to craft a meaningful and helpful
notice to women, while taking into consideration language
governing its distribution that does not unnecessarily hinder
an already overburdened health care delivery system. The
coalition letter states that the coalition is committed to
changing their individual positions to one of either Support,
Neutral, or removal of Opposition, depending on the individual
organizations if the following amendments are accepted:
a) Amendment 1 suggests the following language regarding
the breast density notice text:
"This notice contains the results of your recent mammogram,
including information about the density of your breasts.
Dense breast tissue is a common finding, with about half of
women having dense or highly dense breasts. Current
classification of breast density involves 4 levels of
density, from 1 (minimal density) to 4 (highly dense). You
have been found to have heterogeneously dense/extremely
dense (level 3/level 4) breast tissue. Dense breast tissue
can, on occasion, hide breast abnormalities, and all
available screening tests have limitations and may not
identify all abnormalities. A report of your mammography
results, which contains information about your breast
density, has been sent to your physician's office. Your
physician may refer you for other testing, depending on
your mammogram results, individual risk factors or physical
examination. Please consult your physician if you have any
questions about your mammogram report."
b) Amendment 2 suggests the following language regarding
statutory clarification on the standard of care:
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"Notwithstanding any other law, this section does not create
a cause of action or create a standard of care, obligation,
or duty that provides a basis for a cause of action."
c) Amendment 3 suggests the following language providing
authority for the State to modify the breast density notice
when warranted by science so that women are given accurate
medical information:
"The Department of Public Health shall require the Radiologic
Health Branch (RHB) to review current science on breast
density not less than every two years. RHB shall include
in their consideration guidelines from the American Cancer
Society, the American College of Radiology, the American
Congress of Obstetricians and Gynecologists, the American
Society of Clinical Oncology and the National Cancer
Institute. The notice required to be sent to patients in
Health and Safety Code Section 123222.3 shall be compared
against those findings. In the event the RHB finds
significant differences between the science as communicated
to patients in the notice and that of current science, RHB
is authorized to issue emergency regulations to change the
content of the notice."
d) Amendments 4 suggests the following language regarding
conformity with the Federal Mammography Quality Standards
Act (MQSA) in the event MQSA is modified to require letters
to patients to include language regarding density which may
or may not be before the sunset date of January 1, 2019:
"In the event the MQSA, including related promulgated
regulations, requires a notice regarding breast density to
be contained in the screening results letter to the
patient, Health and Safety Code Section 12322.3 shall
become inoperative in order to avoid legal conflict."
9)SUPPORT IF AMENDED . PPAC writes that they have taken a
"Support If Amended" position stating that it is true that
dense breast tissue can lead to difficulty in reading a
mammogram, as it appears white on mammograms and can hide
abnormalities, and as such is an additional aspect of their
health that women should know and understand. However, PPAC
writes that they are concerned that in its current form the
notice may create unnecessary alarm for women who have dense
breasts but no other risk factors. This concern about
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something as emotionally charged and life threatening as
cancer is likely to lead to increased screenings that bring no
additional benefit for these women. PPAC indicates that it
will support this measure if the author agrees to accept the
amendments submitted in the coalition letter referenced above.
10)OPPOSE UNLESS AMENDED . CMA, ACOG, CAFP, CAPLI, MOASC and
ANCO all write that they are "Opposed Unless Amended." CMA
indicates that as currently drafted this bill would lead to
confusion for patients, pressure for physicians to prescribe
potentially unnecessary, expensive additional screening with
no guarantee of coverage for them, and also place undue
burdens and costs on the State's health care delivery system,
all with no proof that these changes will actually save lives.
ACOG writes that this bill takes the premise that as mammography
is an imperfect screening tool, and that it is more
challenging to find masses in denser breasts, that this
translates into the need for additional screening. ACOG
maintains that mammography is still the gold standard for
screening average risk asymptomatic women. According to ACOG,
combined with conical breast exam, it is 95% effective in
finding cancers. ACOG argues that no screening test is
perfect, but mammography is the best we have. ACOG asserts
that the solution in this bill could make it difficult for
many women to receive even their routine mammogram should the
Every Woman Counts program need to freeze enrollment when they
are over budget as has occurred in the past, or when
radiologists are unavailable due to high demand and provider
shortage. ACOG indicates that they were hopeful that more
evidence would emerge from Connecticut where a law with
mandated density notice and mandated coverage for additional
screening has been in place since January 2009.
Unfortunately, according to ACOG, what was reported was
observational data that was not in a form which could be
studied and a clear path for action could not be determined.
ACOG indicates that they will continue to Oppose this bill
unless the author accepts the amendments submitted by the
coalition letter referenced above.
ANCO writes while this bill is well intended, the science
regarding breast density is unclear and therefore is of
questionable value to patients. ANCO maintains that for the
state to mandate information to patients, the information must
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not suffer from scientific ambiguity. ANCO indicates that if
the author accepts the amendments submitted by the coalition
letter referenced above, the organization will move its
position to Neutral.
11)RELATED FEDERAL LEGISLATION . HR 3102 (Representative Rosa
DeLaura), 112th Congress, 2011-2012, establishes the Breast
Density and Mammography Reporting Act of 2011 and would
require that every mammography summary delivered to a patient
after a mammography examination, as required by the Public
Health Service Act (commonly referred to as MQSA of 1992),
contains information regarding the patient's breast density
and language communicating that individuals with more dense
breasts may benefit from supplemental screening tests, and for
other purposes. HR 3102 requires the notice sent to patients
regarding their mammography results to: a) convey the
patient's risk of developing breast cancer associated with
below, above, and average levels of breast density; and, b)
include language communicating that individuals with more
dense breasts may benefit from supplemental screening tests
and should talk with their physicians about any questions or
concerns regarding the notice. HR 3102 has been referred to
House Subcommittee on Health.
12)RELATED LEGISLATION .
a) SJR 27 (Simitian) of 2012, would recognize August 8,
2012, as "Are You Dense?"
Day 2012, to raise awareness of the risks associated with
breast density and the potential benefits of other
screening tools to supplement mammography.
b) SB 255 (Pavley) updates medical terminology and
clarifies that lumpectomies are included in the law that
allows length of hospital stay for breast cancer surgeries
to be determined by a doctor and a patient.
13)PREVIOUS LEGISLATION :
a) SB 791 (Simitian) of 2011 was substantially similar to
this bill. SB 791was vetoed by Governor Brown, who stated
in part, "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
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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."
b) SB 173 (Simitian) of 2011 was substantially similar to
this bill. SB 173 was held in the Assembly Appropriations
Committee on the suspense file.
c) 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.
d) 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.
e) AB 56 (Portantino) of 2009 contained provisions
identical to those in AB 113. AB 56 was vetoed by Governor
Schwarzenegger. In his veto message 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."
f) 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.
14)POLICY COMMENTS.
a) The notice required in this bill to be sent to women
informing them of their breast density is substantially
similar to the notice contained in SB 791 that was vetoed
last year by Governor Brown. The Committee may wish to
suggest that the author amend the notice language to
address the issues raised by the Governor in his veto
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message. The Committee may also wish to encourage the
author to add language to the notice that attempts to
lessen the angst potentially experienced by women in
receipt of the notice and language that clarifies the
purpose of the notice to inform and raise awareness
facilitating further conversations with their physician.
b) The law similar to this bill that passed in Connecticut
mandated coverage for any supplemental screening tests
required as a result of the notice. This bill does not
mandate such coverage. If this bill should become law,
cases where prior authorization is required for additional
breast screening may not be covered. While affluent women
may be able to pay out-of-pocket if they choose, lower
income women might not have the option to be able to afford
approximately $300 for an ultrasound and $1,700 for an MRI.
The Committee may wish to encourage the author to consider
these potential unintended consequences of this measure.
c) Reporting beast density on mammography reports and
patients' lay summaries is currently being considered by
the federal MQSA and by Congress through HR 3102. The
Committee may wish to suggest that the author consider, in
the event federal regulations are promulgated or the law
changes at the federal level requiring a notice regarding
breast density, to make the provisions in this bill
inoperative in order to avoid legal conflict.
REGISTERED SUPPORT / OPPOSITION :
Support
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
California Black Women's Health Project
California Church IMPACT
California Commission on Aging
California Communities United Institute
California Labor Federation
California Nurses Association
California Professional Firefighters
California School Employees Association
California Senior Legislature
California Teachers Association
California Women Lawyers
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CALPIRG
Center for Breast Care, Inc.
Committee for Recognition of Nursing Achievement
Community Health Partnership
Consumer Federation of California
County of San Mateo
County of Santa Clara, Incorporated
County of Santa Clara Commission on the Status of Women
County of Santa Cruz Board of Supervisors
County of Santa Cruz Women's Commission
County of Santa Barbara Commission for Women
Democratic Activists for Women Now
Democratic Women's Club of Santa Cruz County
Federated Indians of Graton Rancheria
Feminist Majority
Health Care for All California, Santa Clara County Chapter
Human Care Alliance
Junior Leagues of California, State Public Affairs Committee
MayView Community Health Center
Michelle's Place Breast Cancer Resource Center
Palo Alto Medical Foundation Santa Cruz
Ravenswood Family Health Center
Service Employees International Union California
Sheila R. Veloz Breast Imaging Center
Soroptimist
Temple Beth El Jewish Community Center
United Farm Workers of America
WomenCARE
Women's Health Specialists
Women Lawyers of Santa Cruz County
Numerous Individuals
Oppose Unless Amended
American Congress of Obstetricians and Gynecologists, District
IX - California Chapter
Association of Northern California Oncologists
California Academy of Family Physicians
California Association of Physician Groups
California Association of Professional Liability Insurers
Medical Oncology Association of Southern California, Inc.
Opposition
None on file.
Analysis Prepared by : Tanya Robinson-Taylor / HEALTH / (916)
319-2097
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