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