BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                    AB 2115


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          Date of Hearing:  May 18, 2016


                        ASSEMBLY COMMITTEE ON APPROPRIATIONS


                               Lorena Gonzalez, Chair


          AB  
          2115 (Wood) - As Amended May 11, 2016


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          Urgency:  No  State Mandated Local Program:  YesReimbursable:   
          No


          SUMMARY:


          This bill requires health care service plans (health plans) and  
          health insurers, when notifying enrollees who cease to be  
          enrolled in plans or insurance products about other health care  
          coverage options, to also provide information about reduced-cost  
          prescription drugs available through manufacturer patient  
          assistance programs.


          It also requires information on locating free or reduced-cost  
          programs for health care and prescription medications, such as  
          through the Internet Web Site of the Office of the Patient  








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          Advocate.


          FISCAL EFFECT:


          Any impact to the Department of Managed Health Care (DMHC/  
          Managed Care Fund) and the California Department of Insurance  
          (CDI/Insurance Fund) is expected to be minor and absorbable. 


          COMMENTS:


          1)Purpose.  Existing law requires health plans and insurers to  
            notify individuals terminating coverage of their options to  
            continue receiving coverage.  This would add information about  
            manufacturer drug assistance programs. The author states this  
            additional information would assist patients who can't afford  
            necessary prescription drugs.  


          2)Background. The Centers for Medicare and Medicaid Services  
            notes many pharmaceutical manufacturers sponsor programs that  
            provide financial assistance or donation of free product.  
            Patients must generally meet some eligibility criteria,  
            including income and insurance status.  Some programs will  
            assist with copayments for insured patients.  For instance,  
            the Sovaldi Co-pay Coupon Program is run by Gilead, the maker  
            of Sovaldi, a breakthrough Hepatitis C medication.  This  
            program assists patients who are "cash-pay" patients who do  
            not have coverage, as well as patients with commercial  
            insurance, with their share of cost for the drug.  This  
            program, for example, states it covers the out-of-pocket costs  
            of prescriptions after the patient pays the first $5 per  
            prescription fill, up to a maximum of 25% of the catalog price  
            of a 12-week regimen.   










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            Such programs are not without controversy.  For instance, a  
            2014 "Perspective" in the New England Journal of Medicine  
            entitled "Drug Companies' Patient-Assistance Programs -  
            Helping Patients or Profits?" notes, "Assistance programs are  
            a triple boon for manufacturers. They increase demand, allow  
            companies to charge higher prices, and provide  
            public-relations benefits. Assistance programs are an  
            especially attractive proposition for firms that sell  
            particularly costly drugs. Faced with high out-of-pocket  
            costs, some patients may decide against taking an expensive  
            medication. Patient-assistance programs can convert such  
            patients from nonusers to users. Programs must incur costs for  
            patients who would have used the drug even in the absence of a  
            program, but manufacturers can afford to pay a lot of $25 or  
            $50 copayments in return for even a small increase in the  
            sales of a $50,000 drug."  


           


            For those who are uninsured, patient assistance programs can  
            provide help to afford medication that would otherwise be  
            unaffordable.  For insured patients, patient assistance  
            programs change the economics of utilization management for  
            plans and insurers, which can increase patient demand for more  
            expensive drugs.  For example, if there are two equally  
            effective drugs available, a cheap generic with a $20  
            co-payment and a pricey brand-name drug with a $100  
            co-payment, a plan can encourage utilization of the cheaper  
            drug through offering the lower co-payment.  But if a patient  
            assistance program brings the co-payment for the brand-name  
            drug to $10, utilization of the brand-name drug, which is far  
            more costly to the plan, could go up.  Under this scenario of  
            two equally effective drugs, the plan might pay far more than  
            the patient would save, for the same therapeutic benefit to  








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            the patient.    


          3)Prior legislation. AB 792 (Bonilla), Chapter 851, Statutes of  
            2012, requires health plans and health insurers to provide a  
            notice informing individuals that they may be eligible for  
            reduced-cost coverage through the Exchange or no-cost coverage  
            through Medi-Cal when an enrollee or subscriber ceases to be  
            enrolled in coverage.


          4)Support and Opposition. This bill is supported by the  
            biopharmaceutical industry, who indicates these programs  
            provide financial assistance for lifesaving drugs that  
            otherwise may be inaccessible due to cost.  Health plans and  
            insurers oppose this bill, citing; 1) a lack of data on the  
            effectiveness, purpose, and effect on overall drug costs; 2)  
            concern about requiring one industry to promote the activities  
            of another; 3) concern that promoting these programs can have  
            the effect of driving up costs for individuals and employers  
            purchasing health coverage; and 4) current law signed last  
            year that already establishes strict out-of-pocket limitations  
            on prescription drugs and shields individuals from the drugs'  
            astronomical costs.   


          


          5)Staff Comment. Concerns have been raised about patient  
            assistance programs. Health policy experts have noted they can  
            increase utilization of expensive drugs even when cheaper  
            therapeutic alternatives are available, which does not appear  
            consistent with principles of cost-effectiveness in health  
            care delivery.  Although, in theory, increased utilization of  
            these programs among the insured population could raise health  
            care costs by increasing demand for more costly medications,  
            the effect of the specific notification required by the bill  
            on health care costs is unknown.   Many programs exclude  








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            individuals with Medicaid (Medi-Cal) coverage.  



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