BILL ANALYSIS Ó SENATE COMMITTEE ON HEALTH Senator Ed Hernandez, O.D., Chair BILL NO: SB 255 AUTHOR: Pavley AMENDED: April 25, 2011 HEARING DATE: January 11, 2012 CONSULTANT: Tadeo SUBJECT : Health care coverage: breast cancer. SUMMARY : For purposes of health care coverage of mastectomy procedures, revises the definition of mastectomy to specify that the partial removal of a breast includes lumpectomy, which includes surgical removal of a tumor with clear margins. Allows the length of a hospital stay associated with mastectomy procedures to be determined post-surgery. Existing law: 1.Federal law defines, under the Patient Protection and Affordable Care Act (PPACA) (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 which health insurance coverage and group health plans must provide beginning in 2014. 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 (WHCRA). Requires health care service plans (health plans) and group health insurers (insurers) that provide mastectomy coverage benefits to cover reconstruction of the breast removed, 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. 2.State law provides for the regulation of health plans by the Department of Managed Health Care (DMHC) and individual or insurers by the California Department of Insurance (CDI). Requires every health plan contract and health insurance policy to provide coverage for screening for, diagnosis of, and treatment for breast cancer, including coverage Continued--- SB 255 | Page 2 for prosthetic devices or reconstructive surgery to restore and achieve symmetry for the patient incidental to a mastectomy. 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. Defines mastectomy as the removal of all or part of the breast for medically necessary reasons, as determined by a licensed physician and surgeon. This bill: 1.Revises the definition of mastectomy to specify that the partial removal of a breast includes, but is not limited to, lumpectomy, which includes surgical removal of the tumor with clear margins. 2.Requires the length of a hospital stay associated with those procedures be determined post-surgery by the attending physician and surgeon in consultation with the patient, consistent with sound clinical principles and processes. 3.Contains findings and declarations related to breast cancer and breast cancer surgical treatment. FISCAL EFFECT : This bill has not been analyzed by a fiscal committee. COMMENTS : 1.Author's statement. All breast cancer surgery is surgery. It should be taken seriously whether it is a mastectomy or a lumpectomy. Either type of surgery can have complications, such as staph infections, bleeding, need for fluid drains, post-operative pain, and adverse reactions to anesthesia. In addition, breast cancer patients may be unable to understand discharge instructions or they may not have a responsible adult to SB 255 | Page 3 take care of them at home. There is no one-size-fits-all solution for treatment, but it is important to recognize that these surgeries are forms of amputation and can have potentially serious consequences. SB 255 simply clarifies that the original hospital safeguards placed in law 14 years ago, apply to both mastectomies and lumpectomies. The law was intended to cover both types of surgeries by using the definition "removal of all or part of the breast." This bill simply updates the law with the medical name for removing "part of the breast." This is the same terminology that is included in the California Department of Public Health brochure that is required to be given to all breast cancer patients. SB 255 puts the correct medical term in statute so that doctors, patients and payers are clear about appropriate treatment when it is medically necessary for breast cancer surgeries. The California Health Benefits Review Program (CHBRP) report correctly cites that while lumpectomy does not routinely require an overnight stay, some lumpectomies are not without risk. Patients should be provided adequate medical assistance that will prevent costly or long-term adverse health effects. 2.Background. Breast cancer is an abnormal growth in cells that line the lobules (milk-producing glands) or the ducts (vessels that carry milk). 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 4,200 deaths expected for 2011. An average newborn girl's chance of eventually being diagnosed with invasive breast cancer in California is approximately twelve percent, or one in eight. There are nearly 300,000 women 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 percent of breast cancer is diagnosed in the early stages. Among California women, the five-year relative survival rate for breast cancer is 91 percent. This rate varies with the stage at diagnosis with a 99 percent five-year relative survival rate for localized breast SB 255 | Page 4 cancer, which means the cancer is confined within the breast, 85 percent for regional breast cancer, which means the cancer has spread to the lymph nodes, and 25 percent for distant breast cancer, which means the cancer has spread to other organs of the body (metastasized). Breast cancer is typically treated through a combination of surgery and/or radiation, and may include chemotherapy and hormone therapy. Initial treatment usually consists of surgery to remove the tumor from the breast, although some women receive chemotherapy prior to surgery to reduce the size of the tumor. Women with early-stage breast cancer are often given two options for surgery: mastectomy or lumpectomy plus radiation. 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. 3.The California Health Benefits Review Program (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 SB 255: SB 255 | Page 5 Assumptions of the analysis. Due to existing law, CHBRP does not expect SB 255 to have any measurable cost impact. This bill is intended as a clarification to help ensure that safe minimum standards are followed, and to reduce the number of complications for women following lumpectomy procedures. Medical effectiveness. 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. 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. There is clear and convincing evidence 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. Impact on coverage. DHMC-regulated plans and CDI-regulated policies are estimated to be currently compliant with the provision in SB 255 of medically necessary lumpectomy upon provider referral. Therefore, no measurable change in coverage for these services is expected. DHMC-regulated plans and CDI-regulated policies are estimated to be currently compliant with the provision in SB 255 requiring coverage of post-surgery consultation regarding the length of any hospital stay. Impact on utilization. As no measurable change in SB 255 | Page 6 benefit coverage is expected (100 percent of female enrollees in DMHC-regulated plans and CDI-regulated policies are estimated to be in compliant plans), no measurable change in utilization is projected. Impact on total health care costs. As no measurable change in benefit coverage is expected, no measurable changes in total premiums and total health care expenditures are expected. 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 through SB 255. 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. 4.Essential health benefits and state benefit mandates. Effective January 1, 2014, federal law requires Medicaid benchmark and benchmark equivalent plans, plans sold through the Exchange and the Basic Health Program (if enacted), and health plans and health insurers providing coverage to individuals and small employers to ensure coverage of "essential health benefits," (EHB) as defined by the Secretary of the Department of Health and Human Services (HHS). HHS is required to ensure that the scope of EHBs is equal to the scope of benefits provided under a typical employer plan, as determined by the Secretary. Under federal law, EHBs must include 10 general categories and the items and services covered within the 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 SB 255 | Page 7 disease management. § Pediatric services, including oral and vision care. The federal EHBs are broader than what is required under California law for health plans, with the exception of two requirements placed on DMHC-regulated health plans to cover home health services and hospice care. Examples of the federal benefit requirements that are more expansive than California law include coverage of prescription drugs, substance use disorder services, and wellness services. Health plans and insurers can voluntarily cover benefits above the essential health benefits. Additionally, states can require that health plans offer benefits in addition to EHBs. However, if a state requires additional benefits, it is also required to defray the cost of any required additional benefits for people receiving coverage in the Exchange. On December 16, 2011, the HHS Center for Consumer Information and Insurance Oversight (CCIIO) 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: § One of the three largest small group plans in the state by enrollment; § One of the three largest state employee health plans by enrollment; § One of the three largest federal employee health plan options by enrollment; or, § The largest 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. Department of Labor National Compensation Survey (NCS). SB 255 | Page 8 PPACA instructs the Secretary of Labor to conduct a survey of employer-sponsored coverage to determine the benefits typically covered by employers and to report the results of the survey to the Secretary of Health and Human Services. The survey on selected medical benefits, released on April 15, 2011, consists of 12 selected benefits for which sufficient data was available. Mastectomy procedures were not among the services included in the study. The services include maternity care, emergency room visits, ambulance services, diabetes care management, kidney dialysis, physical therapy, durable medical equipment, prosthetics, infertility treatment, sterilization, gynecological exams and services, and organ and tissue transplantation. 1.Prior 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. 2.Support. Susan G. Komen for the Cure - the California Affiliates, the sponsor of SB 255, state that this bill will improve health care coverage options for many patients undergoing mastectomies and lumpectomies. The Breast Cancer Fund states that placing the definition of mastectomy and lumpectomy directly in statute will help ensure that all breast cancer patients have the same safeguards to help improve their lives and save them from preventable serious and costly complications. The California Medical Association (CMA) states that premature discharge of breast cancer patients from the hospital can lead to adverse outcomes, including infection and inadequately controlled pain. CMA contends that SB 255 ensures that the length of hospital stay is a decision made by the physician and patient taking SB 255 | Page 9 individual needs into account. 3.Opposition. America's Health Insurance Plans states that health insurance mandates threaten efforts to provide consumers with meaningful health care choices and affordable coverage options. The California Association of Health Plans (CAHP) argues that the mandate component of SB 255 is unnecessary because health plans are already required to cover mastectomies under existing law and that this is defined as the removal of all or part of the breast for medically necessary reasons. CAHP also states that due to health care reform at the federal level, more time is needed before the Legislature considers enacting new benefit mandates or changing the laws governing existing mandates. SUPPORT AND OPPOSITION : Support: Susan G. Komen for the Cure - California Affiliates (sponsor) American Congress of Obstetricians and Gynecologists Breast Cancer Fund California Communities United Institute California Medical Association CommuniCare Health Centers Michelle's Place, Breast Cancer Resource Center Junior League of California Medical Oncology Association of Southern California, Inc. Planned Parenthood Affiliates of California Surgical Oncologists, University of California, Davis Cancer Center Oppose: America's Health Insurance Plans Association of California Life and Health Insurance Companies California Association of Health Plans -- END --