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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 selfinsured 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 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 nursemidwife, 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 twodimensional (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 the patient or the health plan an
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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 falsepositives 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 falsepositive, 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 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.
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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 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, 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
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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);
(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. 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 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.
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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
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