BILL ANALYSIS �
SB 791
Page 1
( Without Reference to File )
SENATE THIRD READING
SB 791 (Simitian)
As Amended September 9, 2011
Majority vote
SENATE VOTE :Vote not relevant
HEALTH 16-0
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|Ayes:|Monning, Logue, Ammiano, |
| |Bonilla, Eng, Garrick, |
| |Gordon, Hayashi, Roger |
| |Hern�ndez, Bonnie |
| |Lowenthal, Mansoor, |
| |Mitchell, Nestande, |
| | V. Manuel P�rez, |
| |Smyth, Williams |
| | |
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SUMMARY : Requires health facilities at which mammography
examinations are performed to provide a specified notice to patients
who have dense breast tissue. 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, 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
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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.
EXISTING LAW :
1)Requires, under federal regulations implementing the Mammography
Quality Standards Act, 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 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
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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 5% 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% General Fund (GF)/50% 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% GF/45% other funds) for the
California Public Employees' Retirement System (CalPERS) state
employee health benefits.
d) Cost pressure to private health care service plans and
insurers in the range of $20 million.
1)Opponents of this bill indicate that in Connecticut, where a
similar bill was passed in 2009, it has become standard practice
to refer all women who receive this notice to supplemental
screening. If this occurred in California as a result of this
bill, or if more than 5% of women received supplemental screening,
costs could be greater than presented here.
COMMENTS : According to the author, the National Cancer Institute
(NCI) estimates that one in eight women will 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
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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.
The American Congress of Obstetricians and Gynecologists (ACOG)
writes in opposition to this bill that there is no clear evidence
that the additional screening and procedures expected to be
triggered by this bill will make a significant difference in the
numbers of early detections and survival rates. ACOG also indicates
that a similar law was passed in Connecticut, and asserts that given
the uncertainty of the evidence, it makes sense to wait for an
evaluation of the outcomes from that law to determine if this type
of notice to patients, and the subsequent additional studies which
followed, helped to identify additional cancers and saved lives
before we implement such a significant system change in California.
The California Medical Association (CMA) is opposed unless amended
to this bill. CMA states that there is not sufficient consensus in
the medical community regarding the definition of breast density or
guidelines for supplemental screening for those categorized as
having dense breasts. CMA argues that this bill implies that such a
standard does indeed exist, creating a potential legal liability for
physicians to provide other types of care such as further screenings
beyond mammograms, including breast ultrasounds and MRIs. CMA
requests that all women receiving mammograms - not just those
categorized at density levels '3' or '4' - receive the notice. CMA
poses the question that if no consensus exists in the medical
community about how the condition of density, in and of itself,
impacts a woman's care and screening, how then is it appropriate to
decide that only some women, not all, are provided with information
about their density level?
CMA states that currently, national medical practice protocols
require information about breast density to be included in the
patient's mammography report provided to the referring physician
from the radiologist. CMA maintains that using this information in
combination with their knowledge of the patient's personal history,
including other risk factors, the primary treating physician can
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then make a decision regarding the best course of action or
follow-up. CMA maintains that these decisions are made on a
case-by-case basis.
CMA asserts that density is actually a common condition and
approximately 10% of women fall into the lower category of density,
or level '1,' also referred to as "extremely fatty." Beyond that,
according to CMA, 90% of women are categorized as having a level of
density between levels '2' ("scattered density") and '4' ("extremely
dense"), all of which could possibly obscure abnormalities in a
mammogram. CMA argues that when a condition is present in the
majority of the population, a notice about it should indicate that
fact.
CMA also argues that determining the level of density present is
also inherently subjective, and can vary from physician to
physician. This, CMA maintains, presents a liability problem when
coupled with the bill's requirement that only women categorized as a
level '3' or '4' of density receive the notice.
Analysis Prepared by : Tanya Robinson-Taylor / HEALTH / (916)
319-2097
FN: 0002885