BILL ANALYSIS                                                                                                                                                                                                    



                                                                       


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          |SENATE RULES COMMITTEE            |                  AB 1960|
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                                 THIRD READING


          Bill No:  AB 1960
          Author:   Pavley (D), et al
          Amended:  6/23/04 in Senate
          Vote:     21

           
           SENATE HEALTH & HUMAN SERV. COMMITTEE  :  9-2, 6/16/04
          AYES:  Ortiz, Alarcon, Chesbro, Escutia, Figueroa, Florez,  
            Kuehl, Romero, Vasconcellos
          NOES:  Aanestad, Ashburn
          NO VOTE RECORDED:  Battin, Vincent

           ASSEMBLY FLOOR  :  50-26, 5/26/04 - See last page for vote


           SUBJECT  :    Pharmacy benefits management

           SOURCE  :     California Labor Federation, AFL-CIO 
                      California Alliance for Retired Americans 


           DIGEST  :    This bill (1) requires Pharmacy Benefits  
          Managers (PBMs) to disclose to purchasers or prospective  
          purchasers information pertaining to rebates, discounts and  
          other financial information, (2) requires certain  
          provisions to be included in contracts between a PBM and a  
          purchaser, (3)  prohibits pharmacy and therapeutics  
          committee members, working for a PBM, from working for a  
          pharmaceutical company or having more than a nominal  
          financial interest in a pharmaceutical company, (4)  
          requires authorization be obtained from a prescriber prior  
          to a PBM switching a patient from one drug to another and  
          that certain disclosures are made to the prescriber prior  
          to authorization being granted, and (5) requires certain  
                                                           CONTINUED





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          disclosures be made to a patient when a drug is switched.

           ANALYSIS  :    

          Existing law provides for the regulation of health care  
          benefits. 

          This bill:

          1. Requires a PBM to disclose, in writing, to the purchaser  
             or perspective purchaser of its services, the following:

             A.    The amount of rebates and other retrospective  
                utilization discounts that the PBM receives from  
                pharmaceutical manufacturers or labelers specific to  
                the purchaser's prescription drug benefits, in  
                aggregate and for specific therapeutic classes of  
                drugs.

             B.    The nature, type and amount of all other revenue  
                that the PBM receives from pharmaceutical  
                manufacturers or labelers specific to the purchaser's  
                prescription drug benefits.

             C.    Prescription drug utilization information, as  
                specified.

             D.    Any fees charged by a PBM to the purchaser.

             E.    Any arrangements with providers, medical groups,  
                individual practice associations, pharmacists, or  
                other entities that are associated with activities of  
                a PBM to encourage formulary compliance or otherwise  
                manage prescription drug benefits.

          2. Provides that the PBM shall provide specified  
             disclosures within 30 days of receipt of request.

          3. Permits a PBM to withhold the disclosures required by  
             the above if the purchaser or prospective purchaser does  
             not agree to maintain the confidentiality of the  
             disclosed information.  

          4. Prohibits a PBM from executing a contract that fails to  







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             address the following items:

             A.    The amount of revenues, rebates and discounts  
                passed on to the purchaser.

             B.    The disclosure or sale of enrollee utilization  
                data to any person or entity other than the  
                purchaser.

             C.    Fees charged by the PBM to the purchaser.

             D.    Conditions under which an audit will be conducted.

             E.    Any revenue, rebates or discounts received by the  
                PBM directly or indirectly from entities other than  
                manufacturers or labelers.

             F.    The process for the development of formularies and  
                the approval process for any changes to that  
                formulary provided to the purchaser by the PBM.

             G.    Whether there is a difference between the price  
                paid to a retail pharmacy and the amount that will be  
                billed to the purchaser for prescription drugs.

          5. Requires all members of a PBM pharmacy and therapeutics  
             (P&T) committee to be physicians, pharmacists, or other  
             health care professionals, and a majority of committee  
             members to be actively practicing and not employed by  
             PBM and have no more than a nominal interest in an  
             pharmaceutical company.

          6. Requires a PBM to report not less than quarterly to the  
             P&T committee, which shall monitor the effects of  
             medication substitutions on the health of patients. 

          7. Prohibits PBMs from substituting a medication for  
             another currently prescribed medication without first  
             obtaining express verifiable authorization from the  
             prescriber of the currently prescribed drug except as  
             specified.  Prohibits such substitutions unless the PBM  
             provides the patient or their representative specified  
             information.








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          8. Requires PBMs to cancel and reverse a medication  
             substitution upon the instruction of the prescriber or  
             the individual, unless the prescribed drug is no longer  
             on the formulary or unless the individual is unwilling  
             to pay a higher copay or other associated cost.

          9. Requires a PBM to maintain a toll-free telephone number  
             that is known to prescribers and patients. 

          10.Defines for purposes of this bill the following terms:   
             "labeler," "pharmacy benefits management," "pharmacy  
             benefit manager," "prospective purchaser," and  
             "purchaser." 

          11.Prohibits a PBM from charging an individual any  
             additional copay or fee related to a replacement  
             medication.

           Comments
          
          Purpose of the bill  .  According to the author's office,  
          this bill is needed to create consumer protection  
          guidelines that PBMs must meet when doing business with  
          California clients such as the State Public Employees'  
          Retirement System (PERS), large employers, health plans,  
          and union trust funds.  The author's office states that  
          there are two main deficiencies in current law, the first  
          being a drug industry with a lack of objective prescription  
          drug pricing information that creates an incentive system  
          that can cause PBMs to favor the interests of  
          pharmaceutical companies over clients.  The second  
          deficiency identified is the lack of consumer/client  
          protection regarding disclosure related to PBMs.  

          The author's office believes that creating a more  
          transparent market will shine a light on an industry that  
          discloses an inadequate amount of pricing and conflict of  
          interest information, which will enable clients to make  
          informed decisions about the type of prescriptions and  
          benefits they select on behalf of their enrollees.   
          According to the author's office, this will allow clients  
          to take full advantage of the free market by incentivizing  
          PBMs to compete in a fair, transparent environment for  
          California business.  







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           Background
           
          PBMs are independent specialty administrators.  They focus  
          on administering pharmacy benefits, and managing the  
          purchasing, dispensing, and reimbursing of prescription  
          drugs.  About 200 million American consumers have  pharmacy  
          coverage provided directly by a PBM.  

          PBMs offer health plans a variety of services including  
          negotiating price discounts with retail pharmacies,  
          negotiating rebates with manufacturers, and operating  
          mail-order prescription services and administrative claims  
          processing systems.  PBMs also provide health plans with  
          clinical services such as formulary development and  
          management, prior authorization and drug utilization  
          reviews to screen prescriptions for such issues as adverse  
          interactions or therapy duplication, and substitution of  
          generic drugs for therapeutically equivalent brand-name  
          drugs.  In order to provide these services, PBMs operate  
          with multiple stakeholders in a complex set of  
          relationships involving health plans, enrollees,  
          pharmacies, and pharmaceutical manufacturers.  

          Three PBMs, Medco, Caremark and Express Script, currently  
          control approximately 80 percent of the national market.

          PERS currently contracts with a PBM to manage its  
          prescription drug benefit to enrollees in its self-funded  
          plans (PERSCare and PERS Choice) and the State Department  
          of Health Services contracts with Ramsell Corporation to  
          administer the drug benefit provided in the AIDS Drug  
          Assistance Program.

           NOTE:  See Senate Health and Human Services Committee  
                 analysis for further comments.
          
           Related Legislation 

           SB 1765 (Sher), on Assembly Third Reading File, requires  
          pharmaceutical companies to adopt and update a  
          Comprehensive Compliance Program (CCP) for interactions  
          with health care professionals.  This bill requires  
          pharmaceutical companies to establish explicitly in its CCP  







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          an annual dollar limit on gifts, promotional materials or  
          other items or activities, with exceptions, in accordance  
          with existing guidelines, as specified.  Requires such  
          companies to annually declare in writing that they are in  
          compliance with their CCPs and with the limits on gifts  
          established by the bill.

          AB 262 (Chan), in Senate Judiciary Committee, regulates the  
          sale, release to a third-party, or exchange for  
          remuneration by a pharmacist or by a third-party recipient,  
          of physician prescribing data regarding a prescription  
          written by a physician combined with personal information  
          about the physician or his/her prescribing practices.  The  
          bill also requires the Medical Board of California (MBC) to  
          maintain a Do Not Use list in which physicians licensed in  
          this state may register, as specified, and requires data  
          vendors, as defined, to register with the State Attorney  
          General and the MBC in order to lawfully receive  
          prescribing physician data.
          
           FISCAL EFFECT  :    Appropriation:  No   Fiscal Com.:  No    
          Local:  No

           SUPPORT  :   (Verified  6/29/04)

          California Labor Federation, AFL-CIO (co-source)
          California Alliance for Retired Americans (co-source)
          American Association of Retired Persons
          AIDS Healthcare Foundation 
          American Federation of State, County and Municipal  
          Employees 
          Automotive and Allied Industries Employees of San Diego  
          County, 
              Teamsters Local No. 481
          California Conference Board of Amalgamated Transit Union
          California Conference of Machinists
          California Commission on Aging
          California Faculty Association
          California Health Advocates 
          California Nurses Association 
          California Pharmacists Association
          California Professional Firefighters
          California Public Interest Research Group
          California School Employees Association







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          California Seniors Coalition
          California State Employees Association
          California Teamsters Public Affairs Council
          Communications Workers of America, Local 9423, District 1 &  
          2,
              Santa Clara, San Mateo, Santa Cruz, San Benito,  
          Monterey, 
              San Luis Obispo
          Communications Workers of America, Local 9575, Camarillo
          Communications Workers of America, Local 9586, Norwalk
          Congress of California Seniors
          Consumer Federation of California 
          Consumers Union 
          Engineers and Scientists of California, IFPTE Local 20
          Foundation for Taxpayer and Consumer Rights 
          Graphic Communications Union Local No. 583, San Francisco
          Gray Panthers California 
          Health Access California 
          Health Care for All - California
          Hotel Employees and Restaurant Employees Local No. 49,  
          Sacramento
          International Association of Bridge, Structural, Ornamental  
          and Reinforcing 
              Iron Workers, Local 155
          International Brotherhood of Electrical Workers, Local 340
          International Brotherhood of Electrical Workers, Local 551
          Laborers' International Union of North America
          Motion Picture Costumers, Local 705
          Office and Professional Employees International Union,  
          Local 29
          Older Women's League of California 
          Plumbers and Steamfitters, Local 484
          Professional & Technical Engineers, IFPTE Local 21
          Riverside Sheriff's Association
          Sacramento-Sierra Building and Construction Trades Council
          San Mateo County Central Labor Council
          Santa Clara and San Benito Counties Building and  
          Construction Trades 
              Council
          Senior Action Network 
          Service Employees International Union 
          Service Employees International Union, Local 660
          Southern California District Council of Laborers
          Southern California Pipe Trades, District Council 16, Los  







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          Angeles
          Sprinkler Fitters and Apprentices, Local 483
          State Public Employees' Retirement System
          Teamsters, Local 481
          Teamsters, Local 853
          Teamsters Warehouse Union, Local 853, San Francisco, San  
          Mateo, 
              Alameda, Marin, and Contra Costa Counties
          United Association of Plumbers, Pipe Fitters and Sprinkler  
          Fitters of the 
              U.S. Sprinkler Fitters and Apprentices Local 483,  
          Hayward
          United Food and Commercial Workers International Union,  
          Butchers' Union 
              Local 120, Oakland
          United Food and Commercial Workers International, Local  
          1179, Martinez
          United Food and Commercial Workers Union, Local 839,  
          Salinas
          United Steelworkers of America, District 12, Covina 
          United Steelworkers of America, Local 7600, Fontana,  
          Riverside
          United Teachers of Los Angeles
          Warehouse, Processing & Distribution Workers' Union, Local  
          26
          Western Center on Law and Poverty

           OPPOSITION :    (Verified  6/29/04)

          Academy of Managed Care Pharmacy
          Aetna, Inc.
          Blue Cross of California
          California Association of Health Plans
          Caremark Rx, Inc.
          California Chamber of Commerce
          PacifiCare

           ARGUMENTS IN SUPPORT  :    This bill is jointly sponsored by  
          the California Labor Federation and the California Alliance  
          for Retired Americans.  Supporters argue that in the  
          absence of regulation, it is unclear whose interest PBMs  
          represent.  Additionally, supporters point out that some  
          PBMs already provide full disclosure to clients and are  
          able to maintain competitive prices without drastic  







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          increases in drug prices and while securing rebates from  
          manufacturers.  

          According to the supporters, in recent years, allegations  
          haven arisen that PBMs have not acted in the best interests  
          of their clients.  For example, PBMs have been accused of  
          failing to pass on to clients the savings or rebates they  
          negotiate from drug companies and pharmacies.  Much of  the  
          problem is caused because PBMs are not required, and  
          routinely do not, disclose to clients their financial  
          arrangements with drug companies, claiming that such  
          information is confidential.

          This bill provides a simple remedy to address this problem.  
           It allows PBM clients to get better information from PBMs  
          about their financial dealings.  By providing greater  
          sunshine on PBMs, this bill helps ensure PBMs accomplish  
          what they promise to accomplish for their clients.  This is  
          a consumer issue as well as one for PBM clients because  
          ultimately the cost of prescription drugs is paid by  
          consumers.  By ensuring greater accountability by PBMs,  
          this bill helps in the fight to contain rising prescription  
          drug prices.

           ARGUMENTS IN OPPOSITION  :    Opponents argue that there is  
          no need for this bill and that it will significantly harm  
          the ability of PBMs to seek the lowest price for drugs.   
          Opponents believe that providing information to negotiators  
          and competitors impairs the natural forces of competition  
          that protect consumers.  Opponents claim that drug  
          manufacturers almost surely will not agree to substantial  
          discounts from "list" prices if they know that this  
          information may be publicly available to other purchasers  
          and their competitors.

          Opponents state that this bill could actually have the  
          opposite effect than it intends and, in fact, increase the  
          prices of prescription drugs, which would ultimately  
          further harm the consumer.  If rebates and discounts are  
          required to be disclosed, manufacturers will not offer  
          their best discounts to any customer because they would  
          then be pressured to give similar price concessions to  
          everyone.  The Congressional Budget Office (CBO) and other  
          entities have suggested that transparency and disclosure  







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          requirements will actually lead to higher prices on  
          prescription drugs. 

          Opponents also state that providing information concerning  
          rebates, discounts and revenues, even in the aggregate,  
          specific to the purchaser may not be possible as they do  
          not maintain information in this form.  PBMs would be able  
          to provide aggregate information but not specific to each  
          purchaser.

          Opponents argue that the prescriptive nature of this bill  
          will hamper the ability of PBMs to provide services in  
          California.  Caremark suggests that these disclosure issues  
          should be addressed as part of contract negotiations rather  
          the mandated.

          This bill also may set dangerous precedents.  First, it  
          requires the disclosure of details regarding confidential  
          business negotiations and transactions, such disclosure is  
          hostile to a free market economy.  Second, it may lead to  
          increased litigation if any of this confidential  
          information is leaked.  Opponents have stated that there  
          may be an increased threat of lawsuits and private rights  
          of action if the actions of PBMs and the identities of  
          pharmacy and therapeutics committees are disclosed.


           ASSEMBLY FLOOR  :
          AYES:  Berg, Bermudez, Calderon, Canciamilla, Chan, Chavez,  
            Chu, Cohn, Corbett, Correa, Diaz, Dutra, Dymally,  
            Firebaugh, Frommer, Goldberg, Hancock, Jerome Horton,  
            Jackson, Kehoe, Koretz, Laird, Leno, Levine, Lieber, Liu,  
            Longville, Lowenthal, Maldonado, Matthews, Montanez,  
            Mullin, Nakano, Nation, Negrete McLeod, Oropeza, Parra,  
            Pavley, Reyes, Richman, Ridley-Thomas, Salinas, Simitian,  
            Steinberg, Vargas, Wesson, Wiggins, Wolk, Yee, Nunez
          NOES:  Aghazarian, Bates, Benoit, Bogh, Campbell, Cogdill,  
            Cox, Daucher, Dutton, Garcia, Harman, Haynes, Shirley  
            Horton, Houston, Keene, La Suer, Leslie, Maddox, Maze,  
            McCarthy, Nakanishi, Pacheco, Plescia, Samuelian,  
            Strickland, Wyland
          NO VOTE RECORDED:  La Malfa, Mountjoy, Runner, Spitzer









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          CP:mel  6/29/04   Senate Floor Analyses 

                         SUPPORT/OPPOSITION:  SEE ABOVE

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