BILL ANALYSIS                                                                                                                                                                                                    �



                                                                 AB 2418
                                                                 Page  1

         Date of Hearing:   May 21, 2014

                        ASSEMBLY COMMITTEE ON APPROPRIATIONS
                                 Mike Gatto, Chair

              AB 2418 (Bonilla and Skinner) - As Amended:  May 7, 2014 

         Policy Committee:                              HealthVote:19-0

         Urgency:     No                   State Mandated Local Program:  
         No     Reimbursable:              No

          SUMMARY  

         This bill requires health plans and insurers that provide  
         prescription drug benefits to comply with three provisions for  
         products sold and contracts issued after January 1, 2016.  
         Specifically, this bill:

         1)Requires a plan that imposes a mandatory mail-order restriction  
           for some or all covered prescription drugs to establish a  
           process for enrollees to opt out of that restriction, and  
           allows a plan to require the use of specific contracting  
           pharmacies. 

         2)Prohibits plans from denying coverage for a refill for purposes  
           of placing all enrollee's medications on the same schedule, and  
           requires the application of prorated cost-sharing to refills  
           that are for purposes of such synchronization and that meet  
           other criteria.

         3)Prohibits plans from denying coverage for the early refill of  
           covered ophthalmic products at 70% of the predicted days of  
           use.

          FISCAL EFFECT  

         This bill has been amended and implications of the mandatory mail  
         order provisions have been clarified since the California Health  
         Benefits Review Program (CHBRP) analyzed it. Cost estimates from  
         CHBRP have been modified, and costs are estimated as follows: 

         1)Potential one-time costs to DMHC of $200,000 for plan  
           licensing, regulatory, and enforcement costs (Managed Care  
           Fund).  Ongoing costs are likely to be minor.








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         2)Minor one-time  costs to CDI, in the range of $30,000  
           (Insurance Fund) for oversight and enforcement.  

         3)Costs of at least $6,000 annually for provision of services  
           through CalPERS benefit plans (GF/federal/special/local funds).  
            About 60% of this cost is state cost, while the rest is a  
           local cost.  This range is based on assumptions related to  
           cost-sharing and percentage of visits billed.

         4)State expenditures for Medi-Cal Managed Care Plans are  
           estimated to increase by at least $154,000 annually.

         5)Increased employer-funded premium costs in the private  
           insurance market of at least $845,000 annually.

         6)Increased premium expenditures by employees and individuals  
           purchasing insurance of at least $500,000 annually, as well as  
           increased out-of-pocket expenditures of at least $1.8 million.

         7)To the extent this bill precludes the ability of plans and  
           insurers to direct enrollees, for certain drugs, to mandatory  
           mail order or to networks of specific pharmacies with which  
           plans have pricing agreements for certain drugs, there could be  
           significant cost pressures to the market beyond that estimated  
           by CHBRP.  This cost pressure is likely to grow over time, as  
           this bill will limit the ability of pharmaceutical benefits  
           managers to use mandatory mail order, and may limit the use of  
           narrower networks of pharmacies for certain high-cost drugs.     
            

          COMMENTS  

          1)Purpose  .  According to the author, this bill is aimed at  
           improving patient medication adherence and health outcomes  
           through streamlining the medication refill process using three  
           strategies.  The author states that by creating processes that  
           support and improve patient access to medications, patients  
           experience better health outcomes and improved quality of life.  
            Furthermore, patients who pick up their medications at their  
           local pharmacy have the opportunity to talk with the pharmacist  
           about how to properly take their medications and to understand  
           the positive benefits of taking their medication.  

          2)Background  . This bill contains three separate provisions. 








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             a)   Mandatory mail order opt-out  . Pharmacy benefit managers  
              and plans that provide prescription drug benefits generally  
              contract with, or own, mail-order pharmacies in addition to  
              community pharmacies.  According to these entities,  
              providing certain drugs through mail-order arrangements can  
              sometimes be cost-efficient and clinically beneficial, as  
              there is greater assurance of medication adherence and a  
              greater ability to direct utilization to certain drugs,  
              offering cost savings based on negotiated prices and  
              rebates.  The Centers for Medicaid and Medicare Services  
              (CMS), however, requires participating Medicare Part D  
              pharmacy benefit plans to allow patients to opt out of  
              mandatory mail order.  Truly mandatory mail order with no  
              opportunity to opt out does not appear widespread at this  
              time.  Most plans that use mandatory mail order programs for  
              certain drugs allow enrollees to opt out. However, even some  
              plans offering opt-out processes would not be compliant with  
              this bill and would have to change their processes in order  
              to comply.  For example, this bill would prohibit plans from  
              requiring enrollees to sign a form in order to opt out. 

             b)   Prohibition on denial of refills for synchronization  
              purposes  . This bill requires plans and insurers to allow  
              enrollees to refill prescriptions at less than the full  
              amount, for purposes of synchronizing medications (putting a  
              patient's medications on the same schedule).  CMS requires  
              participating Medicare Part D pharmacy benefit plans to  
              allow patients to receive "short fills" at a prorated  
              cost-sharing amount, similar to this bill. 

            c)   Topical ophthalmics  .  Also aligning with a Medicare  
              requirement, this bill allow for early refills of covered  
              ophthalmic products - generally eye drops-at 70% of the  
              predicted days of use.  This provision is intended to  
              account for potential spillage.   

          3)Support  . California Pharmacists Association and California  
           Healthcare Institute, co-sponsors of this bill, write in  
           support that lack of medication adherence results in lost  
           opportunities to treat patients and improving adherence  
           requires a multi-faceted approach, including the strategies  
           outlined in this bill.  Patient advocate groups also support  
           this bill.









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          4)Opposition  .  Health plans, insurers and pharmacy benefit  
           managers oppose this bill, concerned about the costs and  
           administrative complexity of the proposed changes.  Health  
           plans and insurers view this bill as micromanaging the  
           prescription refill process.  Blue Shield of California (BSC)  
           argues this bill will eviscerate the benefits members realize  
           from mandatory mail order programs.   

          5)Staff Comments  .  The mandatory mail-order provision of this  
           bill raises questions of the balance between consumer choice  
           about where to pick up drugs, versus the provision of  
           pharmaceutical benefits in the most cost-effective way.  Given  
           the emergence of costly specialty drugs that account for a  
           small percentage of prescriptions but a large portion of  
           overall drug spending, it appears this bill may result in  
           increased cost pressure, particularly in future years as plans  
           seek new strategies to mitigate the cost of prescription drug  
           benefits.  Removing the ability of plans to use mandatory  
           mail-order for certain drugs may have significant costs over  
           the long term.  

           Furthermore, in addition to requiring a way to opt out of  
           mandatory mail-order, this bill may be interpreted as a  
           requirement to go further and prohibit the use of limited  
           networks of pharmacies for the provision of certain drugs.   In  
           other words, when someone opts out of mail order, it may  
           restrict a plan's ability to direct enrollees to certain  
           pharmacies over others.  This bill states, "the opt-out process  
           may require the use of a plan's participating pharmacy that, at  
           the discretion of the plan, is suited to special handling of  
           the prescription drug and patient care."  However, the  
           inclusion of this language may preclude arrangements currently  
           in use that are not in place due to special handling or patient  
           care requirements, but exist purely for purposes of cost  
           efficiency.  For example, under current law and practice, a  
           plan can require enrollees to fill certain high-cost  
           prescriptions at, for example, Pharmacy X, even though a plan  
           might have contracts with numerous other pharmacies for  
           provision of other drugs.  By contracting with Pharmacy X to be  
           the sole provider for the high-cost Drug A, the plan is able to  
           reduce costs by procuring Drug A at volume discounts and/or  
           negotiating rebates.  Although it is not explicitly stated,  
           this bill may require the plan to allow the enrollee to choose  
           any community pharmacy contracted with the plan for provision  
           of any drug, except for drugs the plan believes require special  








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           handling and patient care.  If this is required, it may  
           increase costs by undermining negotiated pricing agreements.   
           If the intent is to allow the use of limited pharmacy networks  
           as they are currently used, as a means to manage drug costs,  
           this should be clarified.  

           Overall, if the opt-out provisions become law, consumers may  
           gain choice at the front end, but they will likely pay some  
           price for it through increased costs for benefits. Given the  
           mandatory nature of the bill's opt-out provisions, these costs  
           will not be apparent and consumers and employers will not have  
           the option to avoid these costs or weigh potential benefits  
           against the costs, since they will be embedded in the benefit  
           design.   Plans and insurers that provide prescription drug  
           benefits are still required to provide adequate access to drugs  
           to as a condition of state licensure.  Given this, it is far  
           from obvious that prohibiting strategies that may mitigate  
           growth in drug spending truly benefits consumers over the long  
           run, when considering the potential for increased benefit  
           costs.  

            Analysis Prepared by  :    Lisa Murawski / APPR. / (916) 319-2081