BILL ANALYSIS Ó ------------------------------------------------------------ |SENATE RULES COMMITTEE | SB 1538| |Office of Senate Floor Analyses | | |1020 N Street, Suite 524 | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ------------------------------------------------------------ UNFINISHED BUSINESS Bill No: SB 1538 Author: Simitian (D), et al. Amended: 8/22/12 Vote: 21 SENATE HEALTH COMMITTEE : 8-0, 4/18/12 AYES: Hernandez, Harman, Alquist, Anderson, De León, DeSaulnier, Rubio, Wolk NO VOTE RECORDED: Blakeslee SENATE APPROPRIATIONS COMMITTEE : 7-0, 5/24/12 AYES: Kehoe, Walters, Alquist, Dutton, Lieu, Price, Steinberg SENATE FLOOR : 39-0, 5/29/12 AYES: Alquist, Anderson, Berryhill, Blakeslee, Calderon, Cannella, Corbett, Correa, De León, DeSaulnier, Dutton, Emmerson, Evans, Fuller, Gaines, Hancock, Harman, Hernandez, Huff, Kehoe, La Malfa, Leno, Lieu, Liu, Lowenthal, Negrete McLeod, Padilla, Pavley, Price, Rubio, Simitian, Steinberg, Strickland, Vargas, Walters, Wolk, Wright, Wyland, Yee NO VOTE RECORDED: Runner ASSEMBLY FLOOR : Not available SUBJECT : Health care: mammograms SOURCE : Author CONTINUED SB 1538 Page 2 DIGEST : This bill requires health facilities at which mammography examinations are performed to include a specified notice in the summary of the written report that is sent to the patient in order to notify patients who have dense breast tissue that they may benefit from supplementary screening tests. Assembly Amendments delete the following notice included in the summary of the written report sent to patients "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." The notice now reads, "Your mammogram shows that your breast tissue is dense. Dense breast tissue is common and is not abnormal. However, dense breast tissue can make it harder to evaluate the results of your mammogram and may also be associated with an increased risk of breast cancer. This information about the results of your mammogram is given to you to raise your awareness and to inform your conversations with your doctor. Together, you can decide which screening options are right for you. A report of your results was sent to your physician" and makes other clarifying changes. ANALYSIS : Existing law: 1.Requires, under federal regulations implementing the Mammography Quality Standards Act, facilities that perform mammographies to send a written report of each mammography examination, containing specified information, to both the patient and the referring health care provider. 2.Requires health care service plans and health insurers to provide coverage for mammographies for breast cancer screening and diagnostic purposes upon referral by a participating nurse practitioner, certified nurse midwife, or physician. SB 1538 Page 3 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. 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 established by the American College of Radiology (ACR). 2.Specifies that the notice required in 1) above must state, "Your mammogram shows that your breast tissue is dense. Dense breast tissue is common and is not abnormal. However, dense breast tissue can make it harder to evaluate the results of your mammogram and may also be associated with an increased risk of breast cancer. This information about the results of your mammogram is given to you to raise your awareness and to inform your conversations with your doctor. Together, you can decide which screening options are right for you. A report of your results was sent to your physician." 3.Requires the provisions of this bill to become operative on April 1, 2013. 4.Prohibits, prior to April 1, 2013, this bill from being construed to create or impose liability on a health care facility for failing to comply with its requirements. 5.Prohibits this bill from being deemed to create a duty of care or other legal obligation beyond the duty to provide the notice referenced in 2) above. SB 1538 Page 4 6.Prohibits this bill from being deemed to require a notice that is inconsistent with the provisions of the federal Mammography Quality Standards Act. 7.Repeals this section on January 1, 2019, unless a later enacted statute deletes or extends that date. Background Breast cancer screening . Breast cancer screening refers to the medical screening of asymptomatic, apparently healthy women for breast cancer in an attempt to achieve an earlier diagnosis, under the assumption that early detection will improve outcomes. Methods of breast cancer screening include genetic screening, clinical and breast self-exams, mammography, ultrasound, magnetic resonance imaging (MRI), and breast tomosynthesis (also known as 3D mammography). Mammography uses X-rays to view the breast and is a fast and widely available screening method. The main potential benefit of mammography is the early detection of breast cancer. According to a March 2012 report by NCI, mammography also has limitations, as does any medical intervention, which can pose potential harm to women, including: Ï False negatives: approximately one in five women with invasive cancer will have negative results, which may lead to a false sense of security and delay in cancer diagnosis. Ï False positives: some women with no cancer will have positive results, leading to anxiety and additional testing. Ï Overdiagnosis: the identification of cancers that will not become clinically significant, leading to unnecessary treatment. Ï Radiation risk: radiation used for mammography can induce mutations that cause breast cancer. SB 1538 Page 5 Organizations that publish guidelines for screening mammography often differ in their recommendations, particularly in the age for which annual screenings are recommended. However, since the potential benefits and harms of screening mammography are linked to a woman's risk factors, many organizations recommend that a woman's risk factors and values with regard to benefits and harms should be taken into account. The Agency for Healthcare Research and Quality, in synthesizing mammographic screening recommendations produced by the American College of Obstetricians and Gynecologists, the American College of Physicians, and the U.S. Preventive Services Task Force, noted that all three organizations recommend that a woman's screening strategy should indeed take into account both her risk factors and values. Breast density . According to NCI, breast density affects the ability of mammography to detect breast cancer. Breasts contain both dense tissue (glandular tissue and connective tissue) and fatty tissue. Fatty tissue appears dark on a mammogram, whereas dense tissue appears white. Since cancer also appears white on a mammogram, it is therefore harder to detect in women with denser breasts. NCI states, for example, that the main cause of false-negative mammography results is high breast density. Breast density is typically assessed in mammography using a quality control system published by the ACR called BI-RADS. The system consists of standardized numerical codes typically assigned by a radiologist after interpreting a breast image, and contains the following breast composition categories: Ï 1: almost entirely fat Ï 2: scattered fibroglandular densities Ï 3: heterogeneously dense Ï 4: extremely dense Women with dense breasts may choose additional breast cancer screening methods such as ultrasound or MRI to supplement mammographies. As with mammography, the use of supplemental screening methods come with the potential benefit of an increased ability to detect breast cancer, and potential harms such as an increased risk of a false SB 1538 Page 6 positive result. FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes Local: No According to the Assembly Appropriations Committee, state health care costs may increase as a result of this bill, if it leads more women to discuss breast density with their doctor and they decide to opt for additional screening and follow-up tests. However, any impact will likely be mitigated by other factors, including increasing awareness about breast density among the medical community and the public, new informational brochures produced by ACR that describe and provide context about breast density, and changes in screening recommendations based on a woman's breast cancer risk. Given these dynamics and the non-prescriptive nature of the notice, the direct fiscal impact of this bill is expected to be minor. SUPPORT : (Verified 8/28/12) Asian Americans for Community Involvement Association of California Commissions for Women Association of Women's Health, Obstetric and Neonatal Nurses Black Women's Health Imperative (National) Breast Cancer Fund California Black Women's Health Project California Church Impact California Commission on Aging California Communities United Institute California Federation of Teachers California Labor Federation California National Organization for Women California Nurses Association California Professional Firefighters California Radiological Society California School Employees Association California Senior Legislature California Teacher Association California Women Lawyers CALPIRG Community Health Partnership Consumer Federation of California SB 1538 Page 7 County of San Mateo - In Concept County of Santa Clara County of Santa Cruz CRONA (Stanford/Packard nurses union) Democratic Activists For Women Now Democratic Women's Club of Santa Cruz County Federated Indians of Graton Rancheria (Tribe) Feminist Majority Greenlining Institute Health Care for All-California Santa Clara Chapter Human Care Alliance Junior Leagues of California, State Public Affairs Committee Mayview Community Health Center Michelle's Place Breast Cancer Resource Center National Federation of Independent Business Planned Parenthood Affiliates of California Ravenswood Family Health Center Santa Barbara County Commission for Women Santa Clara County Board of Supervisors Santa Clara County Commission on the Status of Women SEIU California Small Business California Soroptimist International of Silicon Valley Susan G. Komen for the Cure, California Affiliates Temple Beth El United Farm Workers Women Care Women's Health Specialists The Feminist Women's Health Centers of California Women Lawyers of Santa Cruz County ARGUMENTS IN SUPPORT : The County of Santa Cruz Board of Supervisors (Board) writes that this bill is important and potentially lifesaving. The Board further asserts that this bill will lead to more women surviving breast cancer through early detection by simply requiring that information that is already shared between doctors also be shared with the patient. Community Health Partnership supports this bill, writing that patient knowledge is an essential piece of improving health care, and that communicating breast density to the patient would allow women to be informed and help make their own health care SB 1538 Page 8 decisions, particularly in light of recent survey results indicating that only five percent of women know what their breast density is and 91 percent of doctors are not talking to women about the issue. Democratic Activists for Women Now and MayView Community Health Center cite the same survey results to underscore the need for greater patient knowledge, concluding that the state can do better than this. Ravenswood Family Health Center states that it seems self-evident that the clinician has a responsibility to inform the patient. The Association of Women's Health, Obstetric and Neonatal Nurses writes that its members know firsthand how important it is that health care providers make individualized breast cancer screening plans with women. CTW:RM:dn 8/28/12 Senate Floor Analyses SUPPORT/OPPOSITION: SEE ABOVE **** END ****