BILL ANALYSIS Ó SB 255 Page 1 Date of Hearing: June 19, 2012 ASSEMBLY COMMITTEE ON HEALTH William W. Monning, Chair SB 255 (Pavley) - As Amended: April 25, 2011 SENATE VOTE : 27-6 SUBJECT : Health care coverage: breast cancer. SUMMARY : Revises the definition of mastectomy, for purposes of insurance coverage of mastectomy procedures, to specify that the "partial removal of a breast" includes lumpectomy, which consists of surgical removal of a tumor with clear margins. Allows the length of a hospital stay associated with mastectomy procedures to be determined postsurgery, consistent with sound clinical principles and processes. EXISTING FEDERAL LAW : 1)Defines, under the Patient Protection and Affordable Care Act (ACA) (Public Law 111-148), as amended by the Health Care Education and Reconciliation Act of 2010 (Public Law 111-152), a list of essential health benefits (EHBs) which health care service plans (health plans) and individual or group health insurers (insurers) must provide beginning in 2014. 2)Provides protections to patients who choose to have breast reconstruction in connection with a mastectomy under the Women's Health and Cancer Rights Act of 1998. Requires health plans and insurers that provide mastectomy coverage benefits to cover reconstruction of the breast removal, surgery and reconstruction of the other breast to achieve symmetry, any external breast prostheses needed before or during the reconstruction; and, any physical complications at all stages of mastectomy, including lymphedema. EXISTING STATE LAW : 1)Provides for the regulation of health plans by the Department of Managed Health Care (DMHC) and insurers by the California Department of Insurance (CDI). 2)Requires every health plan contract and health insurance policy to provide coverage for screening, diagnosis of, and SB 255 Page 2 treatment for breast cancer, including coverage for prosthetic devices or reconstructive surgery to restore and achieve symmetry for the patient incidental to a mastectomy. 3)Requires every health plan and health insurance policy that provides coverage for mastectomies and lymph node dissections to allow the length of stay to be determined by the attending physician and surgeon in consultation with the patient, cover prosthetic devices or reconstructive surgery; and, cover all complications from a mastectomy, as specified. Prohibits a health plan or insurer from requiring a treating physician and surgeon to receive prior approval in determining length of hospital stay following those procedures. 4)Defines mastectomy as the removal of all or part of the breast for medically necessary reasons, as determined by a licensed physician and surgeon. FISCAL EFFECT : According to the Senate Appropriations Committee, pursuant to senate Rule 28.8, negligible state costs. COMMENTS : 1)PURPOSE OF THIS BILL . According to the author, this bill updates medical terminology and clarifies that the original hospital safeguards placed in law 14 years ago apply to both mastectomies and lumpectomies. The author maintains that the law was intended to cover both types of surgeries by using the definition "removal of all or part of the breast" and this bill simply updates the law with the medical name for removing "part of the breast" with lumpectomy. The author asserts that current law provides that patients who undergo mastectomies and lymph node dissections, are entitled to a hospital stay determined by the physician and patient. Patients are also entitled to coverage for prosthetics, reconstruction, and surgery to address complications, if medically necessary. However, according to the author, the law is unclear about whether these services apply to breast conservation surgeries, like partial mastectomies and lumpectomies. The author maintains that while most lumpectomy patients will not need a longer hospital stay, some patients undergoing these surgeries may experience unexpected complications, have no support at home and may require a longer stay to manage pain, bleeding drains, and the risk of an infection - just like some patients undergoing mastectomies. Patients may require different lengths of stay to recuperate based on their health, age, and SB 255 Page 3 other factors. The author argues that this clarification is necessary so that doctors, patients, and payers are clear about appropriate treatment when it is medically necessary for all breast cancer surgeries. 2)BREAST CANCER PREVALENCE . According to the California Cancer Registry (CCR), breast cancer is the most common cancer diagnosed in California, with nearly 24,000 new cases and more than 4,400 deaths expected in 2012. An average newborn girl's chance of eventually being diagnosed with invasive breast cancer in California is approximately 12%, or one in eight. Nearly 300,000 women are currently living with breast cancer in California. CCR reports that, although breast cancer is the most common cancer found among women in California, when diagnosed early, survival rates are high. In California, 71% of breast cancer is diagnosed in the early stages. Among California women, the five-year relative survival rate for breast cancer is 91%; this rate varies with the stage at diagnosis with a 100% five-year relative survival rate for localized breast cancer, 85% for regional breast cancer, and 26% for distant breast cancer. A sustained decrease in breast cancer mortality in the United States and California during the last 20 years is attributed, in part, to the increased use of mammography screening during the 1980s, as well as improvements in treatments and reduction of hormone-replacement therapy. According to the California Breast Cancer Research Program, the breast cancer death rate in California has dropped 20% since 1973 but California women are more likely to get breast cancer today than in 1973. While the death rate for breast cancer has dropped, the gains have not been shared equally among all women. Minority and low-income women are less likely than other women to be diagnosed at early stage, receive effective treatment, and survive the disease. The California Health Benefits Review Program (CHBRP) reports that white women are most likely to get the disease, followed closely by African-American women, Asian Pacific Islander women, and Hispanic women. African-American women have the highest death rate despite being less likely than white women to get the disease. SB 255 Page 4 3)MASTECTOMY AND LUMPECTOMY . Mastectomy is performed under general anesthesia. Most women treated with mastectomy are hospitalized for at least one night following surgery. The entire affected breast plus some lymph nodes are removed. (The lymph nodes are removed to determine whether the cancer has spread to them.) Women who have a mastectomy may choose to have breast reconstruction at the same time or at a later date. Lumpectomy is performed under either local or general anesthesia and is typically provided on an outpatient basis in a hospital or outpatient surgical center. The area of the breast in which the tumor is located plus a border of healthy tissue around the tumor are removed. A second incision is often made under the arm to remove some lymph nodes. The border of healthy tissue around the tumor is referred to as the surgical margin. If the surgical margin is not free of cancer, a second surgery is performed to obtain cancer-free margins. 4)CHBRP . Pursuant to AB 1996 (Thomson), Chapter 795, Statutes of 2002, and SB 1704 (Kuehl), Chapter 684, Statutes of 2006, the University of California is requested to assess legislation proposing a mandated benefit or service, or the repeal of a mandated benefit or service, through CHBRP. CHBRP prepares a written analysis of the public health, medical, and economic impacts of such measures. The following are highlights from the CHBRP analysis of this bill: a) Medical effectiveness . According to CHBRP, there is clear and convincing evidence from multiple randomized controlled trials (RCTs) that rates of overall survival and local/regional recurrence of breast cancer are equivalent for women with stage I or II breast cancer who are treated with mastectomy or lumpectomy plus radiation. The CHBRP report maintains that there is clear and convincing evidence from multiple RCTs that women with stage I or II breast cancer who receive lumpectomy with radiation have a lower rate of in-breast recurrence of breast cancer than women with stage I or II cancer who receive lumpectomy alone (i.e., without radiation). There is also a preponderance of evidence that they also have a lower rate of death from all causes. CHBRP reports that there is clear and convincing evidence SB 255 Page 5 that women with ductal carcinoma in situ (DCIS) who receive lumpectomy with radiation have lower rates of in-breast recurrence of DCIS and invasive breast cancer than women with DCIS who receive lumpectomy alone. b) Impact on coverage . CHBRP indicates that DHMC-regulated plans and CDI-regulated policies are estimated to be currently compliant with the provision of this bill for medically necessary lumpectomy upon provider referral and also with the provision in this bill requiring coverage of postsurgery consultation regarding the length of any hospital stay. Therefore, according to CHBRP, no measurable change in coverage for these services is expected. c) Impact on utilization . CHBRP estimates that no measurable change in benefit coverage is expected as a result of this bill (100% of female enrollees in DMHC-regulated plans and CDI-regulated policies are estimated to be in compliant plans) and no measurable change in utilization is projected. d) Impact on total health care costs . CHBRP estimates that no measurable change in benefit coverage is expected as a result of this bill and no measurable changes in total premiums and total health care expenditures are expected. As no measurable change in benefit coverage or cost is expected, no measurable change in the number of uninsured persons is expected. e) Public health impact . Although lumpectomy procedures are medically effective treatments for DCIS, stage I, and some stage II cancers, CHBRP finds that no change in enrollee coverage or utilization of this treatment would occur as a result of this bill. Therefore, CHBRP anticipates no public health impact on short- and long-term health outcomes, possible disparities, premature death, or economic loss related to breast cancer or its treatment through lumpectomy procedures. f) Potential impact of federal health care reform . EHBs are defined to include ambulatory patient services, hospitalization, and preventive and wellness services and chronic disease management. In addition, the federal Department of Health and Human Services (HHS) when SB 255 Page 6 promulgating regulations on EHBs is to ensure that the EHB floor "is equal to the scope of benefits provided under a typical employer plan." Virtually all employers provide coverage for lumpectomy services. Therefore, it is highly unlikely that there would be any impacts resulting from this bill in the longer term, beyond the year 2014. 5)THE ACA AND EHB's . In March 2010, the federal government passed the ACA, which includes a number of provisions that would directly and indirectly prompt changes in health care delivery, finance, and coverage, and that would affect benefits covered by California health insurance products. Specifically, the ACA includes provisions that require coverage for new federal benefit mandates. One of these mandates requires coverage of EHBs for most health insurance products sold in the individual and small-group markets, including the qualified health plans that will be sold through state health insurance exchanges. Under federal law, EHBs must include 10 general categories and the items and services covered within the categories are: a) Ambulatory patient services; b) Emergency services; c) Hospitalization; d) Maternity and newborn care; e) Mental health and substance use disorder services, including behavioral health treatment; f) Prescription drugs; g) Rehabilitative and habilitative services and devices; h) Laboratory services; i) Preventive and wellness services and chronic disease management; and, j) Pediatric services, including oral and vision care. On December 16, 2011, the HHS Center for Consumer Information and Insurance Oversight released an EHB Bulletin outlining a regulatory approach that HHS plans to propose to define EHBs. In the Bulletin, HHS proposed that EHBs be defined using a benchmark approach. States would have the flexibility to select a benchmark plan that reflects the scope of services offered by a "typical employer plan." EHBs would include coverage of services and items in all 10 statutory categories above, but states would choose one of the following benchmark health insurance plans: a) One of the three largest small group plans in the state by enrollment; SB 255 Page 7 b) One of the three largest state employee health plans by enrollment; c) One of the three largest federal employee health plan options by enrollment; or, d) The largest health maintenance organization (HMO) plan offered in the state's commercial market by enrollment. If a state chose not to select a benchmark, HHS proposed that the default benchmark will be the small group plan with the largest enrollment in the state. HHS is accepting comments on the Bulletin until January 31, 2012. AB 1453 (Monning) and SB 951 (Ed Hernandez), currently before the Legislature, both propose to select the Kaiser Small Group HMO as California's benchmark plan to serve as the EHB standard, as required by federal law. It is believed, the provisions required under this bill are in line with the current coverage and practices of Kaiser products including Kaiser's Small Group HMO. 1)SUPPORT . According to the sponsor of this bill, the seven California Affiliates of Susan G. Komen for the Cure, as more partial mastectomies and lumpectomies are performed, it only makes sense to provide patients undergoing these procedures with the same standards of care received by those undergoing full mastectomies. The sponsors maintain that by allowing a physician or surgeon to decide, in consultation with their patients following the procedure, what length of hospital stay is best, breast cancer patients will be able to receive better quality care, tailored to their own personal needs. The sponsor further asserts that this bill will also ensure that insurance companies cover prosthetic devices for reconstructive surgery and all complications related to partial mastectomies and lumpectomies. Supporters all argue that this bill will enhance the recovery process for those undergoing these often challenging procedures and provide that health plans and policies follow safe minimum standards for all breast cancer surgeries. 2)OPPOSITION . Members of the health insurance industry write in opposition that they generally oppose all benefit mandates because, while they sympathize with the intent to meet a need, mandates increase the already high cost of care for everyone and eliminate the flexibility an employer would otherwise have to pick benefits that best address the needs of his or her SB 255 Page 8 employees' future. The organizations opposed state that requiring all plans to include specific benefits is counterproductive to their members' efforts to make health insurance more affordable and available in California. 3)RELATED LEGISLATION : a) AB 1453establishes the Kaiser Small Group HMO plan contract as California's EHB benchmark plan. AB 1453 is pending before the Senate Health Committee; b) SB 95 contains the exact same language as AB 1453 and also selects the Kaiser Small Group HMO as California's benchmark plan to serve as the EHB standard, as required by federal law. SB 951 is pending before the Assembly Health Committee; c) SB 1538 (Simitian) requires health facilities at which mammography examinations are performed to provide a specified notice to patients who have dense breast tissue. 4)PREVIOUS LEGISLATION . AB 7 (Brown), Chapter 789, Statutes of 1998, requires every health care service plan contract and every policy of disability insurance that is issued, amended, renewed, or delivered on and after January 1, 1999, that provides coverage for mastectomies and lymph node dissections, to allow the length of a hospital stay associated with these procedures to be determined by the attending physician and surgeon in consultation with the patient and consistent with sound clinical principles and processes. Requires health plans and insurers to cover prosthetic devices or reconstructive surgery, and to cover all complications from a mastectomy. REGISTERED SUPPORT / OPPOSITION : Support Susan G. Komen for the Cure (sponsor) American Cancer Society American Congress of Obstetricians and Gynecologists, District IX - California American Federation of State, County and Municipal Employees, AFL-CIO Breast Cancer Fund SB 255 Page 9 California Communities United Institute California Medical Association California Teachers Association CommuniCare Health Centers Junior Leagues of California's State Public Affairs Committee Michelle's Place Breast Cancer Resource Center Planned Parenthood Affiliates of California University of California, Davis Cancer Center Numerous Individuals Opposition America's Health Insurance Plans Association of California Life and Health Insurance Companies California Association of Health Plans Analysis Prepared by : Tanya Robinson-Taylor / HEALTH / (916) 319-2097