BILL ANALYSIS Ó
AB 2764
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Date of Hearing: May 11, 2016
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Lorena Gonzalez, Chair
AB
2764 (Bonilla) - As Amended March 18, 2016
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|Policy |Health |Vote:|11 - 3 |
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Urgency: No State Mandated Local Program: YesReimbursable:
No
SUMMARY:
This bill requires coverage of mammography by health plans and
insurers to include digital mammography and digital breast
tomosynthesis (DBT).
FISCAL EFFECT:
1)According to the California Health Benefits Review Program
(CHBRP):
a) Costs to Medi-Cal of $12.8 million (GF/federal), and
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costs to CalPERS of $1.4 million
(GF/federal/special/local).
b) Increased employer-funded premium costs in the private
insurance market of approximately $17.8 million.
c) Increased premium expenditures by employees and
individuals purchasing insurance of $18.3 million, and
reduced total out-of-pocket expenses of $10.8 million
(based on $11.7 million in newly covered benefits, offset
by cost-sharing of $0.9 million).
2)CHBRP also notes utilization of DBT and related costs may grow
further in future years. CHBRP only estimates costs for a
12-month period post-mandate. With an estimated two-thirds of
machines DBT-ready in 2017, CHBRP projections assume an
increase of the portion of digital mammograms accompanied by
DBTs - from near 30% to near 50%. In future years, as more
DBT-ready machines become available, DBTs could accompany as
many as 90% of digital mammograms.
This increased utilization appears to suggest costs could be
higher than noted here within one to two years after the
projection horizon, but CHBRP costs beyond the first year are
difficult to estimate due to changing breast cancer screening
and treatment technology. CHBRP also assumes DBT is provided
without cost-sharing, as it is a preventive screening test.
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3)Ongoing costs of $480,000 to the Department of Managed Care
(DMHC) for an expected increase in complaints and independent
medical reviews based on denial of coverage due to questions
of medical necessity. (Managed Care Fund).
4)Minor costs to the California Department of Insurance
(Insurance Fund) and DMHC, (Managed Care Fund) to verify
health plans and insurers comply with this requirement.
COMMENTS:
1)Purpose. According to the author, patients are being billed
for DBT since health plans are not providing coverage on the
basis that DBT is investigational. The sponsor of this bill,
the California Radiological Society, states the use of DBT in
addition to two-dimensional (2D) mammography will detect more
cancers early on, reduce false positives, and help reduce
health care costs associated with high recall rates as well as
false positives.
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2)Background. Mammography provides an x-ray picture of the
breast, and can be conducted as a screening or diagnostic
test. As a screening test, its purpose is to identify
potentially cancerous abnormalities in asymptomatic women. As
a diagnostic test, it further investigates identified
abnormalities or checks for abnormalities among women
previously treated for breast cancer. DBT takes multiple
cross-sectional images of the breast and then uses a computer
algorithm to reconstruct a three-dimensional image. Digital
mammography is frequently used as a breast cancer screening
test. Less frequently, DBT is added to digital mammography
when screening for breast cancer.
3)Current coverage guidelines and Essential Health Benefits
(EHBs). The federal Affordable Care Act (ACA) requires health
plans in the individual and small-group markets to cover ten
types of health benefits, called EHBs. EHBs include
preventive services without cost-sharing, for all preventive
services given a high grade of evidence by the United States
Preventive Services Task Force (USPSTF), an independent,
volunteer panel of national experts in prevention and
evidence-based medicine. Mammography is recommended by USPSTF
for certain women and is covered with no cost-sharing.
For any new state mandate that exceeds EHBs as defined in the
ACA, the state must make payments to defray the cost of those
additionally mandated benefits, either by paying the covered
individual or employer directly, or by paying the plan.
Although this mandate requires coverage of DBT, which is
currently not covered by some plans, DBT is a form of
mammography. Since mammography is already required to be
covered, CHBRP indicates this bill does not appear to exceed
EHBs and therefore poses no additional fiscal risk to the
state associated with exceeding EHBs.
4)Screening results in benefits and harms. It is important to
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understand that while screening is beneficial for women whose
cancer is detected early, it can also cause harm. USPSTF
recommendations, for example, are based on an assessment of
net benefit-identified benefits minus identified harms.
Routine screening is intended to catch the development of
disease early enough for treatment to be beneficial. However,
screening can lead to harms such as incorrect diagnosis;
unnecessary diagnostic tests and treatment; anxiety,
psychological harm, and lost productivity; and unnecessary
radiation exposure from the X-rays used in mammography. On
balance, routine screening is usually recommended for a
population if the benefits (like early detection of dangerous
and treatable cancers) outweigh the harms.
5)Breast cancer screening recommendations. There is consensus
on the benefit of screening mammography from many nationally
recognized groups. CHBRP states clinical guidelines from the
American Academy of Family Physicians (AAFP), American
Congress of Obstetrics and Gynecology (ACOG), American College
of Radiology (ACR), American Cancer Society (ACS), National
Comprehensive Cancer Network (NCCN), and USPSTF all recommend
mammography for breast cancer screening. Mammography is also
used in diagnosis, to follow up on a clinical finding or a
screening mammogram.
Currently, there are no clinical guidelines recommending the
use of DBT for breast cancer screening or diagnosis. The ACR
has found that DBT is no longer an investigational modality
and "improves key screening parameters compared to digital
mammography," but October 2015 ACS guidelines, as well as
recommendations from AAFP, ACOG, NCCN, and USPSTF have cited
insufficient evidence to recommend the use of DBT as a
screening tool for breast cancer. The recent USPSTF and ACS
recommendations on breast cancer screening were based on
systematic evidence reviews by experts.
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In sum, CHBRP finds this bill appears to increase costs and
utilization of screening tests with little evidence of
meaningful clinical benefits, such as improvements in
morbidity, disease-free survival, or mortality.
6)Support. The California Radiological Society, the sponsor of
this bill, contends this mandate ensures coverage of the state
of the art in breast cancer screening and diagnosis, DBT
offers higher accuracy and lower call-backs, and higher
accuracy will lower costs overall. They state DBT allow
radiologists to identify small cancers at an earlier stage
while they are more treatable. They note a number of
independent medical reviews have overturned plan decisions to
deny coverage for DBT.
7)Opposition. Health plans and insurers, as well as the
California Chamber of Commerce, oppose this bill. Plans state
the USPSTF has specifically stated it does not support the
blanket use of DBT because studies have not demonstrated an
improvement in patient outcomes, a decrease in the occurrence
of disease, or a decrease in the amount of treatment. They
also state more generally that mandates raise premiums at a
time when health care affordability is a significant issue for
families.
Analysis Prepared by:Lisa Murawski / APPR. / (916)
319-2081
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