BILL ANALYSIS                                                                                                                                                                                                    






                                 SENATE HEALTH
                               COMMITTEE ANALYSIS
                        Senator Elaine K. Alquist, Chair


          BILL NO:       AB 2093                                      
          A
          AUTHOR:        V. Manuel P?rez                              
          B
          AMENDED:       May 28, 2010                                
          HEARING DATE:  June 23, 2010                                
          2
          CONSULTANT:                                                 
          0
          Chan-Sawin                                                   
              9                                                        
                          3
                                        
                                     SUBJECT
                                         
            Immunizations for children: reimbursement of physicians

                                     SUMMARY  

          Requires a health care service plan (health plan) or health  
          insurer that provides coverage for childhood and adolescent  
          immunizations to reimburse a physician or physician group  
          the entire cost of acquiring and administering the vaccine,  
          as specified.  Prohibits a health plan or insurer from  
          requiring cost-sharing for immunizations for enrollees or  
          insureds.  

                             CHANGES TO EXISTING LAW  

          Existing law:
          Provides for the regulation of health plans by the  
          Department of Managed Health Care (DMHC) and health  
          insurers by the California Department of Insurance (CDI).

          Requires every health plan or insurer that covers hospital,  
          medical, or surgical expenses, on a group basis, to provide  
          certain preventive health care benefits for children,  
          including immunizations. 

          Prohibits a risk-based contract between a physician or  
          physician group, and a DMHC-regulated health plan, from  
                                                         Continued---



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          requiring the physician, or physician group, to assume  
          financial risk for the cost of acquiring required  
          immunizations for children, including immunizations that  
          are not part of the contract.  

          Specifies the reimbursement rate for immunizations that are  
          not part of the current contract between a health plan and  
          a physician or physician group.  

          Requires a health plan to provide reimbursements for  
          immunizations within 45 days of receiving documentation  
          that the immunizations were administered.

          Specifies that a health plan shall not include acquisition  
          costs in the capitation rate of a physician who is  
          individually capitated.

          This bill:
          Prohibits any contract issued, amended, delivered, or  
          renewed on or after January 1, 2011 between a physician or  
          physician group, and a DMHC-regulated health plan or  
          CDI-regulated insurer, from requiring the physician or  
          physician group to assume financial risk for the cost of  
          acquiring required immunizations for children, regardless  
          of whether those immunizations are part of the contract.  

          Requires a health plan or insurer that covers childhood and  
          adolescent immunizations to reimburse a physician, or  
          physician group, in an amount no less than the "actual cost  
          of acquiring the vaccine" plus the "cost of administration  
          of the vaccine."  Provides an exemption to this requirement  
          for contracts entered into between health plan or insurers  
          and the Board of Administration of the Public Employees'  
          Retirement System (CalPERS), and for the Medi-Cal and  
          Healthy Families programs.

          Defines the "actual cost of acquiring the vaccine" as the  
          vaccine's  private sector cost  per dose, as published on the  
          most current Pediatric Vaccine Price List published by the  
          federal Centers for Disease Control and Prevention (CDC),  
          plus reasonable costs associated with shipping and  
          handling.  

          Defines the "cost of administration of the vaccine" to be  
          an amount no less than that specified in the most current  




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          annual Medicare physician fee schedule, and includes  
          physician time, clinical staff time, office staff time, and  
          other practice expenses associated with providing the  
          immunization, such a storage, insurance, supplies, and  
          medical equipment.

          Deletes the current requirement for a health plan to  
          reimburse a physician, or physician group, for  
          immunizations that are not part of a current contract at  
          the lowest of the following three rates: 1) the physician's  
          actual acquisition cost; 2) the "average wholesale price"  
          as published in the Drug Topics Red Book; or, 3) the lowest  
          acquisition cost through sources made available to the  
          physician by the health plan.  

          Requires a health plan or insurer to reimburse a physician,  
          or physician group, for immunizations for children that are  
          not part of a current contract, including, but not limited  
          to, immunizations in the most current versions of the  
          Recommended Childhood and Adolescent Immunization Schedules  
          jointly approved by the federal Advisory Committee on  
          Immunization Practices, the American Academy of Pediatrics  
          (AAP), and the American Academy of Family Physicians,  
          pursuant to the requirements of this bill.  Provides an  
          exemption to this requirement for the Medi-Cal and Healthy  
          Families programs.

          Specifies that a health plan or insurer shall not include  
          acquisition or administration costs in the capitation rate  
          of a physician who is individually capitated.

          Prohibits a health plan or insurer from imposing a  
          deductible, copayment, coinsurance, or other cost-sharing  
          mechanism for the administration of, or procedures related  
          to the administration of, a childhood or adolescent  
          immunization. Specifies that cost-sharing may be imposed  
          for procedures, services, or treatments unrelated to the  
          immunization.  Provides an exemption to these requirements  
          for the Medi-Cal and Healthy Families programs.

          Prohibits a health plan or insurer from imposing a dollar  
          limit for the administration of childhood and adolescent  
          immunizations.

          Makes various legislative findings and declarations.




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                                  FISCAL IMPACT 

          Provisions of the bill that would have resulted in public  
          sector costs were amended out of the bill in the most  
          recent version.

                            BACKGROUND AND DISCUSSION  

          According to the author, California law already requires  
          health plans and insurers to provide or offer coverage for  
          recommended immunizations.  However, health plans and  
          insurers are notorious for not reimbursing physicians for  
          the entire cost of providing vaccines, which forces  
          physicians to absorb these costs.  In addition to the  
          actual purchase price of the vaccine, there are a myriad of  
          other administration costs associated with giving  
          immunizations, which are often under-reimbursed.  The  
          author points out that many primary care physicians are at  
          a breaking point and, as costlier new vaccines are approved  
          and recommended, this problem will only get worse.  

          Under reimbursing physicians for the costs of vaccines puts  
          public health at risk.  If children are unable to receive  
          vaccines, they are put at risk of contracting and spreading  
          preventable diseases.  The author also points out that  
          decreasing access also increases costs to the state.  When  
          physicians can no longer absorb these costs, they are often  
          forced to discontinue or delay offering vaccinations, or  
          require parents to pay up front.  Privately insured  
          children who are not able to access vaccines from their  
          private physicians often go to state-supported public  
          clinics.  This trend shifts the burden of vaccine financing  
          to families or to public programs.  

          Furthermore, insured children and their families often face  
          financial barriers to immunization, such as deductibles,  
          copayments and other out-of-pocket expenses.  Health plans  
          and health insurance companies should be looking for ways  
          to incentivize immunizations, not create financial  
          obstacles to them.  In order to effectively protect the  
          public health, the author believes it is imperative to  
          ensure continued access to disease-preventing vaccines to  
          achieve maximum immunization for children by stabilizing  
          the state's vaccine finance system.  




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          Importance of pediatric immunizations
          Pediatric immunizations have proven to be one of the most  
          successful, safe, and cost-effective public health  
          interventions of the 20th century.  According to the CDC,  
          immunizing individual children helps to protect public  
          health, including those people who are not immunized.  This  
          includes those who are too young to be vaccinated (e.g.,  
          children less than a year old cannot receive the measles  
          vaccine, but can be infected by the measles virus), those  
          who cannot be vaccinated for medical reasons (e.g.,  
          children with leukemia), and those who cannot  
          physiologically respond to vaccination.  Immunization also  
          slows down or stops disease outbreaks.  Annually, millions  
          of childhood deaths are prevented by vaccinations, and  
          vaccine-preventable disease levels are at or near record  
          lows.  

          Vaccines are also among the most cost-effective components  
          of preventive medical care.  In 2003, the CDC estimated a  
          direct cost savings of $6.30 for every dollar spent on  
          vaccinations.  If societal costs are factored in, the  
          savings increase to $18.40 per dollar spent.  A 2005  
          national study showed that the seven childhood immunization  
          recommended by the federal Advisory Committee on  
          Immunization Practices (ACIP) saved $9.9 billion in direct  
          medical costs and $43.3 billion in societal costs annually.  
           Other studies have shown significant savings from the use  
          of varicella (chickenpox), influenza, pneumonia, pertussis  
          (whooping cough) and meningitis vaccines.

          2009 National Vaccine Advisory Committee Report
          The National Vaccine Advisory Committee (NVAC) was  
          established in 1987 to advise and make recommendations to  
          the Director of the National Vaccine Program, housed within  
          the U.S. Department of Health & Human Services.  In 2008,  
          the NVAC released a white paper entitled "Assuring  
          Vaccination of Children and Adolescents without Financial  
          Barriers: Recommendations from the National Vaccine  
          Advisory Committee" that contained a detailed overview of  
          the issues the nation face when addressing the financing of  
          vaccines, along with 24 recommendations.  

          Among its findings, the report noted that the current  
          system of vaccine financing and delivery may not assure  




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          access for all children and adolescents without financial  
          barriers.  Vaccines recommended after 2004 are  
          substantially more expensive than vaccines recommended  
          prior to 2000, and thus present a greater financial burden  
          to patients or providers if not reimbursed by insurance.   
          Moreover, state and federal program funds have failed to  
          keep pace with the number of newly recommended vaccines,  
          leading to a two-tiered vaccination program in some states,  
          which could result in many underinsured children and  
          adolescents not receiving these vaccines.  In some cases,  
          privately insured children may be vaccinated in the public  
          sector with publicly purchased vaccines.  Among its  
          recommendations, the NVAC report proposed expanding the  
          national Vaccines for Children program to include payment  
          for vaccine administration.  

          Cost of pediatric vaccinations
          According to a 2003 Institute of Medicine report, access to  
          immunizations is complicated by an expanding array of  
          approved vaccines, higher costs of recent additions to the  
          vaccine schedule, and increasing fragmentation of public  
          and private insurance coverage for immunization.   
          Currently, public funds pay for more than half of all  
          childhood vaccine purchases in the United States.   
          Government purchasing policies have sought to limit  
          expenditures and decrease the cost of vaccines.  Vaccine  
          manufacturers face declining financial incentives to  
          develop and produce vaccines, and the number of producers  
          of recommended vaccines for the American market has  
          declined from more than 25 companies 30 years ago, to only  
          5 today.

          Due to the increasing numbers of approved and recommended  
          vaccines that have been added to the recommended schedule  
          and increasing prices, the cost of the vaccines has grown  
          significantly over the past decade.  According to a 2008  
          CDC-commissioned report, the number of vaccines recommended  
          in the routine childhood and adolescent immunization  
          schedule has grown from 7 vaccines in 1984, to 16 vaccines  
          in 2008.  The report further points out that the cost to  
          fully immunize one child in the public sector has risen by  
          nearly 500 percent, from $282.19 in 2000 to $1,407.06 in  
          2008.  This is compared to $45 for the full regimen in  
          1985.  





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          Cost for vaccines has also grown for those who are  
          privately insured or receive insurance through their  
          employer.  As a result, private insurance coverage of  
          vaccines has eroded, weakening the vaccine finance  
          infrastructure and shifting the burden to the public sector  
          and private providers.

          Immunization related expenses
          In 2007, the American Academy of Pediatrics (AAP) published  
          a paper on provider vaccination administration costs, which  
          detailed vaccine-related expenses and  
          vaccine-administration costs.  The paper lists the  
          following vaccine-related expenses: 

             1.   Purchase price or acquisition cost of vaccine. 

             2.   Personnel costs (clinical and administrative staff)  
               for ordering and inventory, including staff time to  
               monitor vaccine stock, place orders, negotiate prices,  
               delivery and payment terms, and monitor storage  
               procedures (locks, alarms, temperature controls,  
               etc.).

             3.   Storage equipment costs, including refrigerators  
               and freezes, locks, alarm systems, temperature  
               monitoring devices, and generators for continued  
               electrical supply, as vaccines must be stored at a  
               specific temperature.

             4.   Insurance against loss of vaccine.

             5.   Wastage and non-payment, usually estimated at a  
               minimum of five percent for each office.  This  
               includes drawing up the vaccine and having the  
               patient/family reconsider, non-payment, and loss due  
               to leakage, dropped vials, and vaccines rendered  
               unusable.

             6.   Lost opportunity costs for the money invested in  
               vaccines, and for which a reasonable return on  
               investment might otherwise be expected.

          The AAP paper additionally lists the following as  
          immunization administration expenses: 





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             1.   Physician work, including time required to perform  
               the service, technical skill and physical effort, and  
               mental effort and judgment.

             2.   Practice expenses, including staff time, medical  
               supplies (non-sterile gloves, exam table paper,  
               syringe with needle, the CDC information sheet,  
               alcohol swabs, bandage) and medical equipment (exam  
               table).

             3.   Professional liability insurance  

          The AAP report concludes that the total costs of providing  
          a vaccine is approximately 17 to 28 percent above the  
          direct vaccine purchase price.  Another recent study  
          published by AAP, which surveyed nearly 600 pediatricians  
          and family physicians about their vaccine financing  
          attitudes and behaviors, found that 49 percent of  
          respondents had delayed purchasing specific vaccines for  
          financial reasons in the last 3 years, and 53 percent had  
          experienced a decreased profit margin from immunizations in  
          that same timeframe.  In addition, 11 percent of physicians  
          indicated that in the past year, they had seriously  
          considered not giving vaccines to privately insured  
          children anymore. 

          Arguments in support
          The California Medical Association (CMA), a co-sponsor of  
          the bill, states that the purchase of vaccines is the  
          single most expensive part of a pediatric or family  
          practice.  CMA maintains that physicians face higher  
          vaccine prices than large public purchasers, and usually  
          lose money when they provide immunizations due to  
          under-reimbursement by private health plans, which could  
          discourage physicians from purchasing adequate doses to  
          meet the demand of their practices.  CMA argues that health  
          plan or insurers should be providing incentives toward  
          preventive care, not creating obstacles.  

          The American Academy of Pediatrics (AAP), another  
          co-sponsor, asserts that, due to increasing numbers of  
          approved and recommended life-saving vaccines and increasing  
          prices, pediatric vaccine purchase costs have increased  
          dramatically and could triple by the year 2020.  When  
          providers are not adequately reimbursed to cover the direct  




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          and indirect costs of providing immunizations, the viability  
          of their practice is threatened, which jeopardizes access.  

          The California Academy of Family Physicians (CAFP), also a  
          co-sponsor, states that many primary care practices are  
          operating on very thin financial margins, which could  
          potentially challenge access to immunizations.  CAFP  
          maintains that unvaccinated children can contract and spread  
          dangerous or life-threatening diseases.  In order to protect  
          the public health, CAFP argues that it is imperative that  
          continued access is ensured to disease preventing vaccines.

          The California Association of Physician Groups points out  
          that, during the recent H1N1 flu pandemic, health plans  
          touted their commitment to removing "all barriers" from  
          patients receiving access to the vaccine.  However, CAPG  
          members learned that several health plans refused to  
          reimburse administrative costs.  

          The American Congress of Obstetricians and Gynecologists  
          states that, by providing reimbursement for the Human  
          Papillomavirus (HPV) vaccine, physicians can protect against  
          the main types of HPV, which are linked to 70 percent of  
          cervical cancers and 90 percent of genital warts.  The $4  
          billion annual cost to treat precancerous and abnormal  
          cervical cellular changes will be notably reduced with  
          increasing rates of HPV vaccination.

          Children Now, a non-partisan research and advocacy  
          organization, supports this bill, stating that infant and  
          childhood immunizations are key to the health of our  
          state's children.  Children without access to these vital  
          services are not fully safe from preventable infectious  
          diseases, and it is critical that remaining barriers, such  
          as out-of-pocket costs and under-reimbursement of  
          physicians, are removed so that all California children  
          have the opportunity to grow up healthy and strong.  
          
          Argument in opposition
          The California Association of Health Plans opposes this  
          bill on the grounds that health plans do not typically pay  
          for physician's indirect costs, such as of staffing,  
          overhead, or medical equipment.  CAPH argues that these are  
          considered expenses that are part of the overall negotiated  
          rate for providing medical services, and generally factored  




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          into provider reimbursements through capitated contracts.   
          This bill would set a precedent by moving the reimbursement  
          of the administration of vaccines out of provider rate  
          negotiations and into a different, legislatively defined  
          standard.

          The Association of California Life & Health Insurance  
          Companies (ACLHIC) raise concerns about the prohibition on  
          cost-sharing mechanisms, stating that a full range of  
          services may be provided at the same visit that a child  
          receives immunizations, so this bill would effectively  
          prohibit copayment or coinsurance for the entire visit.  

          Health Net points out that while pediatric vaccines in  
          Medi-Cal are funded 100 percent by the federal government,  
          the state only pays $9 (50 percent General Fund) in  
          administration fee per vaccine.  In comparison, Health Net  
          commercial contracts pay, on average, more than double that  
          amount.  

          Anthem Blue Cross, ACLHIC, and Health Net also argue that  
          substantial administrative costs would result from revising  
          all the products this bill would affect, as this bill will  
          disrupt health plans and insures' automated payment systems  
          and further exacerbate the already high administrative  
          costs insurers face.

          Molina Healthcare of California opposes the bill, stating  
          that, by imposing the Medicare fee schedule as the  
          benchmark for reimbursement of vaccine administration  
          services (even if the physician's actual costs are lower,  
          or the physician is willing to take a lower administration  
          fee), this bill is inflationary, and discourages price  
          negotiation and competition.

          Related bills
          AB 354 (Arambula) of 2009 removes age and grade  
          restrictions from vaccination requirements for children  
          entering schools and child care facilities, and adds the  
          American Academy of Family Physicians to the list of  
          entities whose recommendations the Department of Public  
          Health must consider when updating the list of required  
          vaccinations.  Set for hearing in the Senate Appropriations  
          Committee on June 28, 2010.





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          AB 977 (Skinner) of 2009 creates a pilot project that  
          allows pharmacists to administer influenza and pneumonia  
          vaccines to persons over seven years of age, as specified.   
          Set for hearing in the Senate Business, Professions &  
          Economic Development Committee on June 21, 2010.

          AB 1201 (V. Manuel Perez) of 2009 was substantially similar  
          to this bill.  Failed passage in Assembly Appropriations  
          Committee.

          Prior legislation
          AB 2420 (Richman), Chapter 798, Statutes of 2002, prohibits  
          a health plan contract from requiring, or allowing, a  
          health care provider to assume or be at any financial risk  
          for specified medications, including specifically adult  
          vaccines.  Permits a health care provider to assume  
          financial risk after making the request in writing at the  
                    time of negotiating an initial contract or renewing a  
          contract with a health plan.  

          AB 142 (Richman) of 2001 would have prohibited health plan  
          contracts from requiring health care providers to assume  
          any financial risk for any specified medications and adult  
          vaccines.  Vetoed by the Governor.  

          SB 168 (Speier), Chapter 845, Statutes of 2000, requires  
          health plans to reimburse physicians for immunizations at  
          not less than the actual acquisition costs of the vaccine. 

          SB 1291 (Polanco) of 2000 would have required California to  
          utilize a federal option that permits states to purchase  
          federal discounted bulk childhood vaccines for Healthy  
          Families program enrollees.  Failed passage in the Senate  
          Appropriations Committee.

          AB 1053 (Thomson) of 1997 would have required plans to  
          cover all medically necessary vaccines, prohibited plans  
          from including vaccine costs within capitation rates, as  
          specified, and required health plans to augment provider  
          reimbursements for additions made to the recommended  
          childhood immunization schedule.  Vetoed by the Governor.  

                                  PRIOR ACTIONS

           Assembly Health:                       15-0




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          Assembly Appropriations:     13-4
          Assembly Floor          73-1

                                     COMMENTS
           
        1.Price benchmark for vaccines does not reflect discounts  
          available through bulk purchasing.  This bill deletes  
          current law, which requires health plans reimbursement to  
          physicians the actual cost of the vaccine and, instead,  
          specifies the private sector cost per dose (the price to  
          purchase the vaccine in the private sector, as reported by  
          the pharmaceutical industry), as published by the CDC.  By  
          establishing the reimbursement cost of vaccines at this  
          rate, plus the cost of shipping and handling, this bill  
          does not reflect cost-savings from bulk purchasing of  
          vaccines that large provider groups and medical societies  
          may have the ability to negotiate.  The author may wish to  
          consider the following amendment to allow the actual  
          purchase price of the vaccine, if lower than the CDC  
          private sector cost per dose, to be used in defining the  
          "actual cost of acquiring the vaccine":

                (a)     On page 5, line 4, after "Prevention,"  
                  insert:

                  or the actual purchase price of the vaccine,  
                  whichever is lowest,
                  
                (b)     On page 7, line 10, after "Prevention,"  
                  insert:

                  or the actual purchase price of the vaccine,  
                  whichever is lowest,
                  
        1.What types of costs should a health plan or insurer be  
          required to cover, related to the administration of  
          immunizations?  Besides the purchase price of the vaccine  
          and the cost of the provider's time, the author and  
          sponsors contend that health plans and insurers should also  
          reimburse the physician for the "cost of dispensing the  
          vaccine, including shipping, storage/inventory,  
          administrative and disposal costs."  This may include such  
          costs as staff time to manage and inventory vaccines,  
          special refrigeration units to ensure the vaccines are  
          stored at a specific, stable temperature, etc.  However,  




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          many of these costs are traditionally factored into the  
          overhead cost of a medical office.  The sponsors argue that  
          the administration of vaccines is a very unique procedure  
          that incurs higher than normal overhead costs.  In  
          addition, doctors also spend significant time talking with  
          parents about vaccine risks and benefits, which are  
          unreimbursed additional costs.  

        2.Is the exemption for CalPERS and Healthy Families  
          appropriate?  This bill is intended to address access  
          problems that privately insured children may face if  
          physicians start dropping pediatric immunization due to  
          cost issues.  However, similar problems may face Healthy  
          Families providers, and providers seeing patients covered  
          by plans and policies contracted with CalPERS (children in  
          the Medi-Cal program are supported by the federally funded  
          Vaccines for Children Program, which provides an additional  
          administrative reimbursement).  It is not unreasonable to  
          believe that physicians providing care for children covered  
          by Healthy Families or CalPERS may face similar access  
          problems as cited by the author and sponsor for privately  
          insured children.

        3.Suggested technical amendments:

                (a)     Section 1367.36 (c) is repetitive and may be  
                  consolidated into subsection (a):

                     i.           On page 4, delete lines 25-33 and  
                       replace with:

                       1367.36. (a)  A contract between a health care  
                       service plan and a physician or physician  
                       group that is issued, amended, delivered, or  
                       renewed in this state on or after January 1,  
                       2011 shall not include a provision that  
                       requires a physician or a physician group to  
                       assume financial risk for the acquisition and  
                       administration of required immunizations for  
                       children including, but not limited to,  
                       immunizations in the most current versions of  
                       the Recommended Childhood and Adolescent  
                       Immunization Schedules jointly approved by the  
                       federal Advisory Committee on Immunization  
                       Practices, the American Academy of Pediatrics,  




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                       and the American Academy of Family Physicians,  
                       as a condition of accepting the contract.  A  
                       physician or physician group shall not be  
                       required to assume financial risk for  
                       immunizations, regardless of whether those  
                       immunizations are part of the current  
                       contract.  
                    
                     ii.          On page 5, delete lines 13-23

                (a)     The author may wish to take amendments to  
                  address an apparent drafting conflict in Section  
                  1367.36 (e) and (f).

                                    POSITIONS  
                                        
          Support:   American Academy of Pediatrics (co-sponsor)
                     California Academy of Family Physicians  
               (co-sponsor)
                 California Association of Physician Groups  
               (co-sponsor)
                            California Medical Association  
          (co-sponsor)
                     Association of Northern California Oncologists 
                 American College of Emergency Physicians, California  
            Chapter
                 American Congress of Obstetricians and  
            Gynecologists, District IX 
                           California
                 California Academy of Physician Assistants
                 Children Now
                 Osteopathic Physicians and Surgeons of California 
                 Stanford School of Medicine

          Oppose:  Anthem Blue Cross 
                 Association of California Life & Health Insurance  
          Companies 
                 California Association of Health Plans 
                 Health Net
                 Molina Healthcare of California


                                   -- END --