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---



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            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 




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            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 




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            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:  




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            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 




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            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 




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                 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).  




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            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 




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            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
                                        
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