BILL ANALYSIS Ó
AB 2764
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Date of Hearing: April 19, 2016
ASSEMBLY COMMITTEE ON HEALTH
Jim Wood, Chair
AB 2764
(Bonilla) - As Amended March 18, 2016
SUBJECT: Health care coverage: mammography.
SUMMARY: Requires health care service plans (health plans) and
disability insurance or self-insured employee welfare benefit
plans to provide coverage for digital mammography and breast
tomosynthesis under mammography services.
EXISTING LAW:
1)Establishes the Department of Managed Health Care (DMHC) to
regulate health plans and the California Department of
Insurance (CDI) to regulate health insurers.
2)Requires health plans and insurers providing health coverage
in the individual and small group markets to cover, at a
minimum, essential health benefits (EHBs), including the ten
EHB benefit categories in the Patient Protection and
Affordable Care Act (ACA), and consistent with California's
EHB benchmark plan, the Kaiser Foundation Health Plan Small
Group HMO 30 plan (Kaiser benchmark), as specified in state
law.
3)Identifies EHBs in the following 10 categories: ambulatory
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patient services, emergency services, hospitalization,
maternity and newborn care, mental health and substance use
disorder services, including behavioral health treatment,
prescription drugs, rehabilitative and habilitative services
and devices, laboratory services, preventive and wellness
services and chronic disease management, and pediatric
services, including oral and vision care.
4)Identifies mammography as an EHB under laboratory services and
preventive and wellness services and chronic disease
management provides for mammography for screening and
diagnostic purposes upon referral by a participating nurse
practitioner, certified nurse-midwife, physician assistant, or
physician providing care to the patient.
5)Provides for Independent Medical Review when a health plan
denies coverage on the basis that a service is experimental or
investigational.
FISCAL EFFECT: This bill has not yet been analyzed by a fiscal
committee.
COMMENTS:
1)PURPOSE OF THIS BILL. According to the author, currently,
patients are being billed for Digital Breast Tomosynthesis
(DBT) since health plans are not providing coverage on the
basis that DBT is investigational. The author states that the
use of DBT in addition to two-dimensional (2D) mammography
which will detect more cancers early on, reduce false
positives, and help reduce health care costs associated with
false positives. This bill ensures that all women have access
to the best possible breast cancer detection technologies.
Breast cancer is the second leading cause of cancer death in
American women. While mammography has increased, the early
detection of breast cancer, there is still a high rate of
false positives. On average, a false-positive result costs
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the patient or the health plan an additional $1,025.
Radiologists are choosing to use DBT in addition to 2D
mammography because it reduces false-positives and also
detects smaller tumors earlier.
Additionally, the author notes that mammograms are the best
method of detecting breast cancer. Most women over 40 years
old receive 2D mammograms annually. Women at high risk for
breast cancer often get mammograms beginning at 30 years of
age. For a 2D mammogram, images are taken from the front and
the side of the breasts. However, dense breast tissue (places
where normal breast tissue overlaps), decreases the visibility
of tumors and increases the likelihood of false-positive
results. Between 15-30% of cancers are not detected with a
standard 2D mammogram. The percentage is even higher in women
younger than 50 years old who have dense breast tissue. When
DBT is used in addition to 2D mammography, the rate of cancer
detection increases by 10-54% and the rate of false-positives
decreases between 15-37% compared to when 2D mammography is
used alone. The author notes that DBT is always used in
addition to 2D mammography and does increase the amount of
radiation; however, the sponsor of this bill states it is
still a very minimal amount. According to the California
Radiological Society, newer technology will be available in a
few months that will allow the 2D mammogram images to be
created from the DBT data. This would cut the radiation
exposure in half and the amount would be equal to the
radiation exposure from a traditional 2D mammogram.
Additionally, women are exposed to further radiation when they
are called back for another screening. If it was a
false-positive, that is completely unnecessary additional
exposure to radiation. Since increasing the use of DBT
reduces false-positives and callbacks, it also protects women
from that additional radiation exposure.
Based on the Centers for Medicare and Medicaid Services (CMS)
payment rates, DBT costs only an additional $56 per visit. If
a patient must return for an additional screening after a 2D
mammogram results in a false-positive, doctors often perform a
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biopsy or ultrasound to determine if there is a tumor present.
Among recalled women, the average cost for additional testing
was $1,205. Overall, the cost savings worked out to $28 per
woman screened, or $0.20 savings per member per month across
the plan population, and an overall cost savings of $550
million per year for the plan. Using DBT at the women's
annual preventative screening will save both patients and
health plans money, undue worry, and time.
2)BACKGROUND. According to California Department of Public
Health's 2015 Cancer Fact sheet, breast cancer is the number
one cancer among women of all racial/ethnic groups. Early
detection is the best defense against breast cancer. For
women at average risk of breast cancer, recently updated
guidance from the American Cancer Society screening guidelines
recommend that those 40 to 44 of age have the choice for
annual mammography; those 45 to 54 have annual mammography;
and those 55 years of age and older have biennial, or can
choose annual mammography.
DBT (frequently called 3D mammography) uses existing digital
mammography equipment to obtain additional radiographic data
that are used to reconstruct cross-sectional "slices" of
breast tissue. DBT hopes to improve the accuracy of digital
mammography by reducing problems caused by overlapping tissue.
DBT involves some additional imaging time and radiation
exposure. Current radiographic approaches to mammography
produce 2D images. DBT may be utilized along with full-field
digital mammography (FFDM) in screening for breast cancer and
may also be used as a technique for the diagnosis of breast
cancer in helping to clarify equivocal mammographic findings.
The Federal Drug Administration approved the use of DBT in
2011 and Medi-Cal and Medicare began covering DBT in 2015. As
of April 13, 2016, of the 123 applications submitted by DMHC
enrollees for IMR review between 2015 and 2016, only 15 of the
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DBT requests were upheld and majority of the denials were
overturned in favor of coverage.
a) Preventative Care. As part of the ACA, new health
insurance plan or insurance policy beginning on or after
September 23, 2010 must cover preventive services without a
copayment or co-insurance or having to meet a deductible.
This includes screenings every one to two years for women
over 40. Preventive services, such as screening tests,
counseling services, and preventive medicines, are tests or
treatments that your doctor or others provide to prevent
illnesses before they cause you symptoms or problems. To
help doctors and patients decide together whether a
preventive service is right for a person's needs, the U.S.
Preventive Services Task Force (USPSTF) develops
recommendations based on a review of high-quality
scientific evidence, and publishes its recommendations on
its Website and/or in a peer-reviewed journal. The USPSTF
has identified preventive services as an A or B grade that
are relevant for implementing the Affordable Care Act. The
USPSTF concluded that current evidence is insufficient to
assess the additional benefits and harms of using either
digital mammography or MRI instead of film mammography as a
screening modality for breast cancer. The National
Comprehensive Cancer Network noted that early studies show
promise for DBT and that definitive studies are still
pending.
b) California Health Benefits Review Program (CHBRP)
analysis. AB 1996 (Thomson), Chapter 795, Statutes of
2002, requests the University of California to assess
legislation proposing a mandated benefit or service and
prepare a written analysis with relevant data on the
medical, economic, and public health impacts of proposed
health plan and health insurance benefit mandate
legislation. CHBRP was created in response to AB 1996. SB
125 (Hernandez), Chapter 9, Statutes of 2015, added an
impact assessment on essential health benefits, and
legislation that impacts health insurance benefit designs,
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cost sharing, premiums, and other health insurance topics.
Due to the late request for a CHBRP analysis on this bill,
CHBRP only issued a preliminary letter and will issue a
full report on May 6, 2016.
i) Background. According to CHBRP, film and digital
mammography are frequently used as breast cancer
screening tools for asymptomatic persons. Both produce
two dimensional images. In recent years, digital
mammography has become the much more commonly used form.
DBT takes multiple cross-sectional images of the breast
and then uses a computer algorithm to reconstruct a
3-dimensional image. DBT images for screening are
obtained in combination with digital mammography.
Therefore, breast cancer screening generally consists of
either digital mammography alone or digital mammography
with DBT. In either case, when results indicate the
possibility of breast cancer, a number of additional
tests, additional mammographic views and/or tests other
than a mammogram (possibly including breast ultrasound,
breast magnetic resonance imaging, and or biopsies) may
also be performed to verify the presence of cancer.
ii) Medical Effectiveness. While CHBRP's medical
effectiveness analysis is still underway, it is already
possible to note that numerous studies have found that
film and digital mammography are comparable as breast
cancer screening tests for "average-risk women." In
addition, numerous clinical guidelines recommend film or
digital mammography as breast cancer screening tests.
Examples include current guidelines and recommendations
issued by the following national sources:
(1) American Academy of Family Physicians (AAFP);
(2) American Congress of Obstetrics and Gynecology
(ACOG);
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(3) American College of Radiology (ACR);
(4) American Cancer Society (ACS);
(5) National Comprehensive Cancer Network (NCCN);
and,
(6) USPSTF.
The recent USPSTF recommendations noted evidence that
screening mammography (film or digital) impacts
clinically significant health outcomes, reducing
breast-cancer specific mortality among women ages 40 to
74 years and also reducing cancer stage at diagnosis
among women aged 50 years and older. Although the ACR
guidelines found that DBT is no longer an investigational
modality and "improves key screening parameters compared
to digital mammography," citing insufficient evidence,
the ACS guidelines, as well as the recommendations from
AAFP, ACOG, NCCN, and USPSTF, have not recommended DBT as
a screening tool for breast cancer.
iii) Benefit Coverage, Utilization, and Cost, Baselines
and Impacts. Currently, coverage for digital mammography
appears universal among persons enrolled in
DMHC-regulated health plans or CDI-regulated policies.
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However, not all of these enrollees have coverage for
DBT. Among these enrollees, CHBRP estimates that current
utilization of digital mammography is significantly
higher than is utilization of DBT. The average unit cost
for a digital mammogram alone (the price paid by a plan
or insurer for the test) is nearly $200 and CHBRP
estimates that the average unit cost for a digital
mammogram with DBT is approximately $270. Increased
numbers of enrollees with benefit coverage generally
result in increased use of the covered test. This would
be the trend CHBRP would expect to use of DBT, should AB
2764 become law. As noted above, CHBRP is still reviewing
the relevant data.
3)SUPPORT. The California Radiological Society (CRS), sponsor
of the bill, states that when DBT is used in addition to 2D
mammography, the rate of cancer detection increased by 27% and
the rate of false-positives decreased by 15% compared to when
2D is used alone. CRS states that this bill would require
coverage and not put the women at risk for out of pocket
costs. CRS contends that DBT should be part of the
preventative services that health plans and health insurers
are obligated to provide to patients without cost sharing.
4)OPPOSITION. California Association of Health Plans (CAHP),
the Association of California Life and Health Insurance
Companies, and America's Health Insurance Plans contend that
health insurance mandates threaten efforts of all health care
stakeholders to provide consumers with meaningful health care
choices and affordable coverage options. They state that the
ACA requires the state to pay for the increased cost
associated with the mandate for those enrollees who purchase
health insurance on the Exchange. They also state that
benefit mandates eliminate the ability of health insurers and
HMOs to provide unique benefit packages aimed at the needs of
consumers by requiring individuals and employers to purchase
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benefits prescribed by the Legislature, not driven by consumer
choice. Finally, they note that health benefit mandates
stifle the use of innovative, evidence based medicine.
Additionally, CAHP, states that the blanket mandated use of
DBT for all women is unnecessary as the use of DBT for all
women is not recommended by the USPDTF. In fact, the USPSTF
has clarified that they do not support the blanket use of DBT
because the studies have not demonstrated an improvement of
patient outcomes, a decrease in the occurrence of the disease,
or a decrease in the amount of treatment. The California
Chamber of Commerce (CCC) states that without data, it is
impossible to know if the use of DBT with traditional
mammography would improve long term outcomes for women or
eliminate the need for follow-up biopsies or ultrasounds to
confirm the presence of tumors. CCC also notes that this bill
would increase premiums for all enrollees by mandating
coverage of an additional screening technique for breast
cancer that is still unproven. CCC contends that this bill
would, contrary to USPSTF, declare concurrent screening to be
the standard for preventative care and require it in all
cases, expanding its use regardless of the lack of evidence
that this will improve outcomes, and regardless of the much
larger dose of radiation.
5)POLICY COMMENTS. This bill would provide coverage for DBT
under existing mammography coverage. Although the USPSTF has
not recommended the use of DBT as a screening tool for cancer,
it is important to note that Medicare reimburses DBT and
Medi-Cal currently includes DBT as a Medi-Cal benefit for
fee-for-service and Medi-Cal Managed Care Plans.
REGISTERED SUPPORT / OPPOSITION:
Support
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California Radiological Society
Opposition
California Association of Health Plans
Association of California Life and Health Insurance Companies
America's Health Insurance Plans
California Chamber of Commerce
Analysis Prepared by:Kristene Mapile / HEALTH / (916) 319-2097