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AB 2764 Page 1 Date of Hearing: May 11, 2016 ASSEMBLY COMMITTEE ON APPROPRIATIONS Lorena Gonzalez, Chair AB 2764 (Bonilla) – As Amended March 18, 2016 Policy Committee: Health Vote: 11 - 3 Urgency: No State Mandated Local Program: Yes Reimbursable: 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 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 twothirds 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. 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. AB 2764 Page 2 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. 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 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 Xrays 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 AB 2764 Page 3 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. 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, diseasefree 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