BILL ANALYSIS                                                                                                                                                                                                    Ó



          SENATE COMMITTEE ON HEALTH
                          Senator Ed Hernandez, O.D., Chair

          BILL NO:                    AB 1696             
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          |AUTHOR:        |Holden                                         |
          |---------------+-----------------------------------------------|
          |VERSION:       |May 31, 2016                                   |
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          |HEARING DATE:  |June 22, 2016  |               |               |
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          |CONSULTANT:    |Scott Bain                                     |
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           SUBJECT  :  Medi-Cal:  tobacco cessation services

           SUMMARY  :  Requires tobacco cessation services to be a covered benefit  
          under the Medi-Cal program, subject to utilization controls.  
          Requires tobacco cessation services to include all intervention  
          recommendations assigned a grade A or B by the United States  
          Preventive Services Task Force (USPSTF). Requires the Department  
          of Health Care Services (DHCS) to issue guidelines and enter  
          into an agreement that authorizes the California Smokers'  
          Helpline to directly furnish at least one form of  
          over-the-counter nicotine replacement therapy, as described by  
          the USPSTF, to Medi-Cal beneficiaries enrolled in smoking  
          cessation services provided by the helpline. Requires DHCS to  
          include medical assistance with smoking and tobacco use  
          cessation rates among adults enrolled in Medi-Cal managed care  
          plans in its Healthcare Effectiveness Data and Information Set  
          quality measures.

          Existing law:
          1)Establishes the Medi-Cal program, administered by the DHCS  
            under which basic health care services are provided to  
            qualified low-income persons. 

          2)Establishes a schedule of benefits under the Medi-Cal program,  
            which includes the purchase of prescribed drugs, subject to  
            the Medi-Cal List of Contract Drugs and utilization controls.

          3)Requires that preventive services assigned a grade of A or B  
            by the U.S. Preventive Services Task Force be provided to  
            Medi-Cal beneficiaries without any cost sharing by the  
            beneficiary in order for the state to receive increased  
            federal contributions for those services, as specified.








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          4)Authorizes a pharmacist to furnish nicotine replacement  
            products approved by the federal Food and Drug Administration  
            (FDA) for use by prescription only, in accordance with  
            standardized procedures and protocols developed and approved  
            by both the California Board of Pharmacy and the Medical Board  
            of California in consultation with other appropriate entities,  
            if specified conditions are met.
          
          This bill:
          1)Requires that tobacco cessation services are covered benefits  
            under the Medi-Cal program, subject to utilization controls.  
            Requires tobacco cessation services to include all  
            intervention recommendations assigned a grade A or B by the  
            USPSTF, as periodically updated. 

          2)Requires tobacco cessation services to include a minimum of  
            four quit attempts per year, with no required break between  
            attempts, for all beneficiaries 18 years of age and older who  
            use tobacco. 

          3)Requires tobacco cessation services to be provided in  
            accordance with the American Academy of Pediatrics guidelines  
            and the intervention recommendations, as periodically updated,  
            assigned a grade A or B by the USPSTF for Medi-Cal  
            beneficiaries under 18 years of age. 

          4)Requires, in addition to the services described above, and  
            only to the extent consistent with the intervention  
            recommendations assigned a grade A or B by the USPSTF, tobacco  
            cessation services to include:

               a)     At least four tobacco cessation counseling sessions  
                 per quit attempt that may be conducted in person or by  
                 telephone and individually or as part of a group, at the  
                 beneficiary's option; 
               b)     A 12-week treatment regimen of any medication  
                 approved by the federal Food and Drug Administration for  
                 tobacco cessation, including prescription and  
                 over-the-counter (OTC) medications.
               c)     At least one prescription medication and all OTC  
                 medications to be available without prior authorization.  
                 Requires a prescription from a provider with authority to  
                 prescribe and proof of Medi-Cal coverage to be sufficient  
                 documentation to fill a prescription for OTC tobacco  
                 cessation medications.








          AB 1696 (Holden)                                   Page 3 of ?
          
          

          1)Prohibits Medi-Cal beneficiaries from being required to  
            receive a particular form of tobacco cessation service as a  
            condition of receiving any other form of tobacco cessation  
            service.

          2)Requires DHCS, effective January 1, 2017, to seek any federal  
            approvals necessary to implement this bill that DHCS  
            determines are necessary.

          3)Requires DHCS, by December 31, 2017, to issue guidelines and  
            enter into an agreement that authorizes the California  
            Smokers' Helpline or its successor, as administered by the  
            Department of Public Health (DPH), to directly furnish at  
            least one form of over-the-counter nicotine replacement  
            therapy, as described by the USPSTF, to Medi-Cal beneficiaries  
            enrolled in smoking cessation services provided by the  
            helpline. Requires the guidelines, at a minimum, to address  
            requirements for pharmacists and physicians in furnishing  
            nicotine replacement products under this bill consistent with  
            existing law authorizing pharmacist to furnish prescription  
            nicotine products. Defines "directly furnish" as providing  
            directly to the beneficiary by mail with no further action  
            required on the part of the beneficiary.

          4)Requires DHCS, by December 31, 2017, to include medical  
            assistance with smoking and tobacco use cessation rates among  
            adults enrolled in Medi-Cal managed care plans in its  
            Healthcare Effectiveness Data and Information Set (HEDIS).  
            Permits DHCS to use data collected under this bill for quality  
            improvement projects to increase cessation by Medi-Cal  
            enrollees who use tobacco products. Prohibits tobacco use  
            status from being used by DHCS or a Medi-Cal managed care plan  
            to deny coverage or treatment of tobacco-related illnesses.

          5)Requires this bill to be implemented only to the extent that  
            federal financial participation is available and not otherwise  
            jeopardized, and any necessary federal approvals have been  
            obtained.

           FISCAL  
          EFFECT  :  According to the Assembly Appropriations Committee:

          1) Increased costs due to increased utilization of smoking  
             cessation services. Under current practice, about 30,000  








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             Medi-Cal beneficiaries access smoking cessation services at a  
             total annual cost of about $4 million per year. Assuming that  
             the expanded benefits required in the bill result in  
             increased demand for smoking cessation services of 10% to  
             20%, the bill would result in increased costs of $400,000 to  
             $800,000 per year (General Fund [GF]/federal). 


          2) Short-term cost savings due to reduced smoking-related health  
             care costs for Medi-Cal beneficiaries. A review of a smoking  
             cessation benefit in the Massachusetts Medicaid program  
             indicates that reducing smoking by beneficiaries led to a net  
             reduction in health care costs of about $2 for each $1 spent  
             on the program. Using the assumptions for utilization  
             increase above, potential cost savings of $800,000 to $1.6  
             million per year. The long-term health care spending impacts  
             of reduced tobacco use are less clear, because reduced health  
             care spending on smoking-related conditions will be offset by  
             people living longer, though such "costs" are generally  
             considered societally beneficial. 


          3) Minor administrative costs to update existing Medi-Cal  
             policies for the provision of smoking cessation services (GF/  
             federal). 

           PRIOR  
          VOTES  :  
          
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          |Assembly Floor:                     |63 - 14                     |
          |------------------------------------+----------------------------|
          |Assembly Appropriations Committee:  |14 - 6                      |
          |------------------------------------+----------------------------|
          |Assembly Health Committee:          |17 - 1                      |
          |                                    |                            |
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          COMMENTS  :
          1)Author's statement.  According to the author, quitting tobacco  
            products is a difficult feat that many attempt every year.  
            Tobacco products are still the leading preventable cause of  
            death in the United States. Though the dangers of smoking are  
            better understood now than 50 years ago, cigarettes are more  
            addictive and smoking rates in the Medi-Cal population are  








          AB 1696 (Holden)                                   Page 5 of ?
          
          
            still too high. In addition to efforts to discourage people  
            from smoking, This bill gives smokers the tools to fight the  
            addiction. The coverage ensured by this bill would guarantee  
            Medi-Cal patients have access to clinically proven treatments.  
            Studies have shown that the comprehensive coverage of these  
            treatments has led to decreases in the smoking population. As  
            a state, we must remove barriers to treatments that make  
            quitting possible.

          2)Background. According to the Centers for Disease Control and  
            Prevention, tobacco use is the leading preventable cause of  
            death in the United States. Every year, smoking kills 480,000  
            Americans and costs the nation at least $130 billion in  
            medical care costs for adults and more than $150 billion in  
            lost productivity, imposing a heavy economic burden on private  
            employers, private health plans, and federal, state, and local  
            governments. The cost of tobacco use to California is  
            estimated to be $18.1 billion annually. According to data from  
            2001 to 2010 published by the Centers for Disease Control and  
            Prevention in 2011, most smokers want to quit smoking (69%),  
            and over half (52%) tried to quit in the previous year, but  
            only 6% were successful.

          The USPSFT reviewed new evidence in the U.S. Public Health  
            Service's 2008 clinical practice guideline and determined that  
            the net benefits of tobacco cessation interventions in adults  
            and pregnant remain well established. The USPSTF found  
            convincing evidence that smoking cessation interventions,  
            including brief behavioral counseling sessions and  
            pharmacotherapy delivered in primary care settings are  
            effective in increasing the proportion of smokers who  
            successfully quit and remain abstinent for one year. The  
            USPSTF concluded that there is high certainty that the net  
            benefit of tobacco cessation interventions in adults is  
            substantial, and there is high certainty that the net benefit  
            of augmented, pregnancy-tailored counseling in pregnant women  
            is substantial.

          3)Affordable Care Act Changes to Tobacco Cessation Coverage.  
            Section 2502 of the Patient Protection and Affordable Care Act  
            (ACA) prohibited drugs used to promote smoking cessation,  
            including agents approved by the FDA for over-the-counter for  
            purposes of promoting tobacco cessation, from being excluded  
            from Medicaid coverage. In addition, Section 4107 of the ACA  
            required Medicaid coverage of tobacco cessation counseling and  








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            pharmacotherapy (FDA-approved OTC and prescription drugs) for  
            pregnant women, and prohibited cost-sharing for these  
            services. 

          The seven FDA-approved medications include five forms of  
            nicotine replacement therapy (NRT): the patch, gum, inhaler,  
            nasal spray, and lozenge, as well as two non-NRT medications,  
            bupropion SR (brand name Zyban if used for tobacco cessation  
            and Wellbutrin if used as an antidepressant), and varenicline  
            (brand name Chantix). Three forms of NRT (the patch, gum, and  
            the lozenge) are available OTC. The other two forms of NRT  
            (the inhaler and the nasal spray), as well as the two non-NRT  
            medications, are available by prescription. The patch is  
            available by prescription as well as OTC.
          
          4)Current Medi-Cal coverage of tobacco cessation. Medi-Cal  
            beneficiaries have a higher prevalence of tobacco use than the  
            general California population. In the 2011-12 California  
            Health Interview Survey, 16.1% of adult and teen Medi-Cal  
            beneficiaries were current smokers, as compared to 12.1% of  
            adults and teens not covered by Medi-Cal. In the 2013 Medi-Cal  
            Managed Care Consumer Assessment of Healthcare Providers and  
            Systems survey, a median of 18.2% of respondents reported  
            current smoking (with a range of 10% to 27% among Medi-Cal  
            plans).

          DHCS indicates expenditures on smoking deterrents in 2014 was $1  
            million in FFS and $3.1 million in managed care. Coverage of  
            tobacco cessation medication varies, depending upon whether  
            the beneficiary is in FFS Medi-Cal or Medi-Cal managed care  
            plan, and the particular Medi-Cal managed care plan the  
            beneficiary is enrolled in. In 2016-17, Medi-Cal is projected  
            to enroll 14.1 million individuals, of whom 75.89% (10.7  
            million people) are projected to be in managed care plans. 

            For FFS Medi-Cal, DHCS is required to use the following  
            criteria when adding a drug to the Medi-Cal contract drug  
            list: (a) the safety of the drug; (b) the effectiveness of the  
            drug; (c) the essential need for the drug; (d) the potential  
            for misuse of the drug; and, (e) the cost of the drug. 

            In September 2014, DHCS released Policy Letter 14-006 to  
            provide Medi-Cal managed care health plans with minimum  
            requirements for comprehensive tobacco cessation services. The  
            chart below shows the differences between this bill and  








          AB 1696 (Holden)                                   Page 7 of ?
          
          
            current DHCS policy set forth in the Policy Letter:




            
          
                  ------------------------------------------------------- 
                 |Tobacco      |     AB 1696     |    DHCS Policy for    |
                 |Cessation    |                 | Medi-Cal Managed Care |
                 |Requirements |                 |         Plans         |
                 |-------------+-----------------+-----------------------|
                 |Number of    | At least 4 per  |  At least 2 separate  |
                 |quit         |      year       |quit attempts per year |
                 |attempts     |                 |                       |
                 |-------------+-----------------+-----------------------|
                 |Prohibition  |       Yes       |          Yes          |
                 |on requiring |                 |                       |
                 |a break      |                 |                       |
                 |between quit |                 |                       |
                 | attempts    |                 |                       |
                 |-------------+-----------------+-----------------------|
                 |Number of    | At least 4 per  |At least 4 of at least |
                 |tobacco      |  quit attempt.  |  10 minutes duration  |
                 |cessation    |                 |                       |
                 |counseling   |                 |                       |
                 |services     |                 |                       |
                 |-------------+-----------------+-----------------------|
                 |Counseling   |   In person,    |Plans must ensure that |
                 |Session      |   telephone,    | individual, group and |
                 |             |  individual or  | telephone counseling  |
                 |             |    group, at    | is offered. Does not  |
                 |             |   beneficiary   |specify at beneficiary |
                 |             |     option      |        option         |
                 |-------------+-----------------+-----------------------|
                 |Tobacco      |   84 days (12   |90                     |
                 |cessation    |     weeks)      |days                   |
                 |drug         |                 |                       |
                 |treatment    |                 |                       |
                 |regimen      |                 |                       |
                 |duration     |                 |                       |
                 |-------------+-----------------+-----------------------|
                 |Coverage of  |Any FDA-approved |     Must cover 7      |
                 |tobacco      | medication for  | FDA-approved tobacco  |
                 |cessation    |     tobacco     |cessation medications, |








          AB 1696 (Holden)                                   Page 8 of ?
          
          
                 |approved by  |   cessation,    | at least one without  |
                 |the federal  |    including    | prior authorization.  |
                 |FDA for      |prescription and | Must cover additional |
                 |tobacco      |OTC medications. |   medications once    |
                 |cessation,   |                 |     FDA-approved.     |
                 |including    |                 |                       |
                 |prescription |                 |                       |
                 |and OTC      |                 |                       |
                 |-------------+-----------------+-----------------------|
                 |Prior        |  At least one   |     Must cover 7      |
                 |authorization|  prescription   | FDA-approved tobacco  |
                 |/            | medication and  |cessation medications, |
                 |utilization  |     all OTC     | at least one without  |
                 |review       |medications must | prior authorization.  |
                 |limitations  |  be available   |  Does not otherwise   |
                 |             |  without prior  | prohibit utilization  |
                 |             | authorization.  |        review.        |
                 |-------------+-----------------+-----------------------|
                 |Prohibition  |       Yes       | Prohibits plans from  |
                 |on receiving |                 |       requiring       |
                 |one form of  |                 |   beneficiaries to    |
                 |tobacco      |                 |   attend classes or   |
                 |cessation as |                 |  counseling sessions  |
                 |a condition  |                 | prior to receiving a  |
                 |of receiving |                 |  prescription for an  |
                 |any form of  |                 | FDA-approved tobacco  |
                 |tobacco      |                 |cessation medication.  |
                 |cessation    |                 |                       |
                  ------------------------------------------------------- 
            


          5)Tobacco Helpline. The state Tobacco Helpline (1-800-NO-BUTTS)  
            has been in existence since 1992. It provides free telephone  
            counseling, self-help materials, and online help in multiple  
            languages to help Californians quit smoking. It is  
            administered by the University of California San Diego via an  
            interagency agreements with CDPH using state special funds  
            (from the Health Education Account of Proposition 99, the  
            Tobacco Protection and Health Initiative from 1988) and  
            federal grant funds. The Helpline has also received funding  
            from other sources including various grants from First 5, and  
            Los Angeles County. The hotline serves approximately 40,000  
            individuals a year, more than half of whom are enrolled in  
            Medi-Cal. 








          AB 1696 (Holden)                                   Page 9 of ?
          
          

          DHCS received a five-year grant from the Centers for Medicare  
            and Medicaid Services (CMS) as part of the Medicaid Incentives  
            for the Prevention of Chronic Disease (MIPCD) Program. The  
            California project was called the Medi-Cal Incentives to Quit  
            Smoking (MIQS) Project. The MIQS project incentivized Medi-Cal  
            members who smoke to engage in counseling with the California  
            Smokers' helpline. Under the project (which has ended),  
            Medi-Cal members could receive a free, four -week supply of  
            nicotine patches mailed directly to their home. Helpline  
            counselors told Medi-Cal members if they qualified based on  
            how much they smoke (at least six cigarettes daily) and  
            determined the dosing. Refills of the nicotine patches were  
            provided as needed. Medi-Cal members could receive a $20 gift  
            card bonus, which was mailed after completion of the first  
            30-40 minute Helpline counseling session.

          6)Health plan performance measures. The federal Centers for  
            Medicaid and Medicaid Services (CMS) requires states, through  
            their contracts with Medicaid managed care plans, to measure  
            and report on performance to assess the quality and  
            appropriateness of care and services provided to members. DHCS  
            implemented a monitoring system to provide an objective,  
            comparative review of Medi-Cal managed care plans  
            quality-of-care outcomes and performance measures called the  
            External Accountability Set (EAS). DHCS designates performance  
            measures every two years, and requires Medi-Cal managed care  
            plans to report on the measures annually. 

          DHCS is not mandated by statute to collect particular HEDIS  
            measures in Medi-Cal managed care, and DHCS does not currently  
            require reporting on HEDIS measures related to tobacco use.  
            However, DHCS requires participation of Meid-Cal managed care  
            plans in the Consumer Assessment of Healthcare Providers and  
            Systems survey every three years, which does assess tobacco  
            use and cessation efforts. During the 2014 calendar year, DHCS  
            held contracts with 23 full-scope Medi-Cal managed care plans  
            and three specialty managed care plans. For 2015, DHCS  
            required reporting on 14 HEDIS measures for full-scope  
            Medi-Cal managed care plans and one measure developed by DHCS  
            and the managed care plans, with guidance from the external  
            quality review organization. Several of the HEDIS measures  
            include more than one indicator, bringing the total measure  
            rates required for Medi-Cal managed care plans reporting to  
            30. The required measures provide information on access to  








          AB 1696 (Holden)                                   Page 10 of ?
          
          
            care for women, adolescents, and children; use of imaging  
            studies for low back pain; screening for diseases such as  
            cervical cancer; weight assessment and counseling for  
                                          nutrition and physical activity for children and adolescents;  
            care provided to beneficiaries with chronic diseases such as  
            diabetes; hospital readmissions rates; and utilization of  
            outpatient and emergency department care. In addition to  
            reporting HEDIS measures, Medi-Cal managed care plans were  
            required to report separate rates for their Seniors and  
            Persons with Disabilities (SPD) and non-SPD populations for a  
            selected group of measures.



          7)Prior legislation. AB 1162 (Holden of 2015), was very similar  
            to this bill. AB 1162 would have required tobacco cessation  
            services to be a covered benefit under the Medi-Cal program,  
            as specified. AB 1162 was vetoed by the Governor along with  
            five other bills. The veto message stated that: 

               These bills unnecessarily codify certain existing health  
               care benefits or require the expansion or development of  
               new benefits and procedures in the Medi-Cal program. 

               Taken together, these bills would require new spending at a  
               time when there is considerable uncertainty in the funding  
               of this program. Until the fiscal outlook for Medi-Cal is  
               stabilized, I cannot support any of these measures. 

            SB 220 (Yee of 2010), would have required a health plans and  
            insurers to cover over a minimum of two courses of treatment  
            in a 12-month period for all smoking cessation treatments  
            rated "A" or "B" by the USPSTF, which includes counseling and  
            OTC medication and prescription pharmacotherapy approved by  
            the FDA. SB 220 also requested the California Health Benefits  
            Review Program to prepare an analysis of the state cost  
            savings as a result of the bill provisions. SB 220 was vetoed  
            by the Governor.


            AB 2662 (Dymally of 2007), would have prohibited the provision  
            of one form of Medi-Cal covered tobacco cessation service  
            (either pharmacotherapy or counseling) as a condition of  
            receiving the other service. AB 2662 was held on the Senate  
            Appropriations Committee suspense file.








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            SB 576 (Ortiz of 2005), would have required health plans and  
            insurers to provide coverage for two courses of tobacco  
            cessation treatments per year, including counseling and  
            prescription and over-the-counter medications, and prohibited  
            plans and insurers from applying deductibles but allowed  
            specific co-payments for those benefits. SB 576 was vetoed by  
            the Governor.


          8)Support.  This bill is jointly sponsored by the American Heart  
            Association/American Stroke Association, the American Lung  
            Association, and the American Cancer Society Cancer Action  
            Network to ensure all Medi-Cal patients are able to access  
            tobacco cessation treatments. The sponsors argue that the  
            success rate of smokers quitting their addiction to tobacco is  
            still very low, due in part because many smokers try to quit  
            without the assistance of tobacco cessation services. The  
            sponsors noted that although the ACA has made tobacco  
            cessation treatments more accessible, current guidelines as to  
            how to implement these treatments are unclear, thereby  
            resulting in differences in coverage between health plans. In  
            addition, the sponsors state that Medi-Cal patients face  
            barriers to treatment services due to prior authorization and  
            step therapy treatment requirements. Supporters argue this  
            bill provides needed clarity for Medi-Cal participants on  
            tobacco cessation services and ensures access to comprehensive  
            insurance coverage for these services. Supporters conclude  
            that increased access to smoking cessation treatments and  
            eliminating barriers will reduce the incidence of  
            tobacco-related diseases and will lower health care costs.
          
          9)Opposition. The California Association of Health Plans (CAHP)  
            writes in opposition that this bill will increase costs to the  
            state by requiring Medi-Cal managed care plans to pay for  
            tobacco cessation drugs in a manner that is inconsistent with  
            policies of DHCS. CAHP argues Medi-Cal managed care plans  
            already comply with the requirements of the DHCS policy  
            letter, and that weakening prior authorization requirements  
            designated to ensure the right care is delivered under  
            appropriate circumstances will drive up costs. CAHP also  
            argues tracking tobacco rates of enrollees would be difficult  
            and an unnecessary administrative burden. Finally, CAHP  
            objects to the provision in this bill making counseling  








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            sessions at patient option may leave out some beneficiaries  
            who need the help most, including patients who have tried and  
            failed therapies several times. 
          
          10)Amendments. This bill authorizes the California Smokers'  
            Helpline to furnish OTC and prescription nicotine replacement  
            therapy. Amendments to this provision are needed to  
            distinguish between the authority to furnish OTC products and  
            the authority of physicians and pharmacists to furnish  
            prescription nicotine replacement therapy medication. 

          11) Policy issues. Recent DHCS policy. DHCS policy for Medi-Cal  
            managed care plans was released in September 2014 and has been  
            in effect for less than a year. This bill expands the scope of  
            that coverage in several ways. Has sufficient time elapsed to  
            know whether the provisions of that policy are adversely  
            affecting tobacco cessation services and should be expanded?

           SUPPORT AND OPPOSITION  :
          Support:  American Heart Association (co-sponsor)
                    American Cancer Society (co-sponsor)
                    American Lung Association (co-sponsor)
                    Association of California Healthcare Districts
                    California Academy of Physician Assistants
                    California Black Health Network
                    California Chapter of the American College of  
               Emergency Physicians
                    California Dental Association
                    California Life Sciences Association
                    California Optometric Association
                    California Pharmacists Association
                    County Health Executives Association
                    First 5 Association of California
                    Health Access California
                    Health Officers Association of California
                    March of Dimes
                    Mental Health America of California
                              Two individual physicians

          Oppose:   California Association of Health Plans
                    Local Health Plans of California 



                                      -- END --








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