BILL ANALYSIS                                                                                                                                                                                                    Ó



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          GOVERNOR'S VETO


          AB  
          1831 (Low)


          As Enrolled  August 30, 2016


          2/3 vote


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          |ASSEMBLY:  |71-8  |(June 1, 2016) |SENATE: |37-0  |(August 17,      |
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          |ASSEMBLY:  |80-0  |(August 23,    |        |      |                 |
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          Original Committee Reference:  HEALTH


          SUMMARY:  Requires health care service plans (health plans) and  
          health insurers to provide coverage for early refills of  
          prescription topical ophthalmic products (TOPs).


          The Senate amendments:








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          1)Add language delaying implementation until July 1, 2017.


          2)Delete language allowing for early refills of TOPs at 70% of  
            the predicted days of use.


          3)Add language specifying standards for early refills of TOPs:


             a)   For a 30-day supply, at least 23 days and less than 30  
               days from the later of either of the following:


               i)     The original date that the prescription was  
                 distributed to the enrollee or insured; or,


               ii)    The date of the most recent refill that was  
                 distributed to the enrollee or insured.


             b)   For a 90-day supply, at least 68 days and less than 90  
               days from the later of either of the following:


               i)     The original date that the prescription was  
                 distributed to the enrollee or insured; or,


               ii)    The date of the most recent refill that was  
                 distributed to the enrollee or insured.


          4)Add language prohibiting an enrollee or insured's refill  
            request from exceeding the number of additional quantities  
            prescribed by the enrollee or insured's participating health  








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            plan or health insurer provider.


          5)Add language specifying that this bill does not prevent a  
            health plan contract or health policy from allowing for early  
            refills at or below 75% of the predicted days of use.  


          FISCAL EFFECT:  According to the Senate Appropriations  
          Committee,


          1)Minor costs to review health insurer filings and take  
            enforcement actions, as necessary, by the Department of  
            Insurance (Insurance Fund).


          2)Minor costs to review health plan filings and take enforcement  
            actions, as necessary, by the Department of Managed Health  
            Care (Managed Care Fund).


          3)Ongoing costs of about $200,000 per year for increased  
            utilization of covered TOPs by Medi-Cal beneficiaries (General  
            Fund and federal funds).  The California Health Benefits  
            Review Program analyzed a prior version of this bill that  
            would have required early refills at 70% of predicted use  
            days.  Based on the current version of this bill, which  
            requires early refills at 76% - 77% of predicted days, the  
            costs to the Medi-Cal program are likely to be about one-half  
            of the previously projected costs.


          4)Minor costs to the California Public Employees' Retirement  
            System due to increased prescription drug benefit costs  
            (various funds).  Similar to the costs projected for the  
            Medi-Cal program, the costs of this bill are likely to be  
            about one-half of the previously projected costs. 









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          5)No state cost to subsidize health care coverage through  
            Covered California is anticipated.  Under federal law, any new  
            mandated health benefit that exceeds the benefits in the  
            state's essential health benefits benchmark plan would be a  
            state responsibility.  In other words, to the extent that the  
            state imposes a new benefit mandate that exceeds the essential  
            health benefits benchmark, the state would be responsible for  
            paying for the cost to subsidize that benefit for those  
            individuals who are receiving subsidized coverage through  
            Covered California.  Because this bill does not mandate a new  
            benefit, but only change the terms of an existing benefit  
            (prescription drugs), this bill is not expected to result in  
            the state being responsible for subsidizing coverage.


          COMMENTS:  According to the author, poor medication adherence is  
          a major barrier to achieving better patient outcomes.  TOPS are  
          used to treat a variety of conditions including:  uveitis,  
          conjunctivitis, dry eye, and glaucoma.  Successful and effective  
          treatment for these eye-related conditions requires proper  
          administration of the medication.  Eye drops can be difficult to  
          self-administer; a shaky hand can cause drops to hit the  
          patient's cheeks or make two eye drops come out at once.  This  
          unavoidable waste is one reason that some patients run out of  
          their eye drops too soon.  Interruptions in drug therapy for  
          eye-related conditions potentially have serious consequences,  
          including irreversible vision loss.  Glaucoma patients are often  
          elderly and have difficulty dispensing the appropriate amount of  
          eye drops, thereby requiring early refills of their medication.


          A study on glaucoma treatment adherence cited an inadequate  
          amount of medication available between scheduled prescription  
          refills as a central barrier to patient compliance.  By allowing  
          early refill for users of TOPs, patients are able to manage the  
          disease and prevent interruptions in drug therapy that can  
          potentially have serious consequences.  









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          In 2010, the Centers for Medicare and Medicaid Services (CMS)  
          re-issued guidance on "Early Refill Edits on TOPs."  The  
          reissuance was based on complaints CMS had received regarding  
          the application of early refill edits (i.e. refill-too-soon  
          edits) to TOPs.  In the guidance, CMS recommended that Medicare  
          drug plans permit refills at 70% of the predicted days of use  
          and permit physicians to authorize earlier refills for  
          particular beneficiaries who continue to have difficulty with  
          inadvertent wastage.


          GOVERNOR'S VETO MESSAGE:


          I am returning Assembly Bill 1831 without my signature.


          This bill requires health plans and insurance policies to pay  
          for early refills of medicated eye drops. 


          Applying eye drops is sometimes difficult and imprecise.   
          However, in most instances of spillage or loss, health plans or  
          pharmacists provide an early refill to those who need it.   
          Moreover, new mandates, even small ones, add to the high cost of  
          health care.




          Analysis Prepared by:   Kristene Mapile / HEALTH / (916)  
                          319-2097          FN: 0005103














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