BILL ANALYSIS                                                                                                                                                                                                    �




                   Senate Appropriations Committee Fiscal Summary
                            Senator Kevin de Le�n, Chair


          AB 889 (Frazier) - Health care coverage: prescription drugs.
          
          Amended: May 2, 2013            Policy Vote: Health 7-2
          Urgency: No                     Mandate: Yes
          Hearing Date: August 30, 2013                           
          Consultant: Brendan McCarthy    
          
          SUSPENSE FILE. AS PROPOSED TO BE AMENDED.
          
          
          Bill Summary: AB 889 would prohibit health plans and health  
          insurers from requiring a patient to try and fail on two  
          medications before allowing the patient access to the medication  
          originally prescribed by the patient's medical provider  
          (commonly referred to as step therapy).

          Fiscal Impact (as proposed to be amended): 
              One-time costs of about $300,000 to adopt regulations and  
              review compliance by health plans by the Department of  
              Managed Health Care (Managed Care Fund). 

              One-time costs of about $100,000 and ongoing costs of about  
              $50,000 per year for enforcement by the Department of  
              Managed Health Care (Managed Care Fund).

              Minor costs to the Department of Insurance to review  
              compliance by health insurers (Insurance Fund).

              Unknown costs to CalPERS to provide pharmacy benefits to  
              its subscribers. 

              The proposed author's amendments are similar to those in AB  
              369 (Huffman, 2012). Under that bill, anticipated costs to  
              CalPERS were expected to be minimal. However, the proposed  
              author's amendments to this bill include a provision  
              requiring any opioid pain medication required by an insurer  
              or health plan under step therapy to include an  
              abuse-deterrent formulation. It is not known whether this  
              requirement would limit the available medications, which  
              could increase prescription drug costs to CalPERS.

              Unknown potential costs increases to Medi-Cal managed care  








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              plans (50 percent General Fund, 50 percent federal funds).  
              The Department of Health Care Services indicates that it  
              expects there to be some fiscal impact of the bill, but it  
              is not able to quantify any potential cost increases at this  
              time. The Department is concerned that limiting the use of  
              step therapy will lead to greater use of more expensive pain  
              medication, when, in some cases, less expensive medications  
              may provide relief. 

              As noted above, the requirement that managed care plans use  
              opioid pain medications with an abuse-deterrent formulation  
              may have an impact on available medications. This could  
              potentially impact prescription drug costs for Medi-Cal  
              managed care plans.

              No anticipated costs to subsidize benefits in the  
              California Health Benefit Exchange. See below.

          Background: Under current law, health plans are regulated by the  
          Department of Managed Health Care and health insurers are  
          regulated by the Department of Insurance. Health plans and  
          health insurers in the state are not currently required to cover  
          pharmacy benefits, but they are subject to certain regulatory  
          requirements if they do offer coverage.

          Health plans and insurers (or subcontracted pharmacy benefit  
          managers) sometimes required patients to use a process known as  
          "fail first protocol" or "step therapy" for certain drugs. Under  
          step therapy, before a patient can access a specific medication  
          prescribed by the provider, the patient must first attempt to  
          use one or more alternative medications. If those medications do  
          not have the intended therapeutic effect, the patient progresses  
          to the next medication. The use of step therapy varies between  
          health plans and insurers, with different drugs covered by such  
          protocols and different numbers of steps required.

          Proposed Law: AB 889 would limit the ability of health plans and  
          health insurers to use fail first protocols or step therapy,  
          when the health plan or insurer provides pharmacy benefits.

          Specific provisions of the bill would:
              Generally prohibit health plans and insurers from requiring  
              a patient to try and fail on more than two medications  
              before the patient can access the medication (or its generic  








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              equivalent) that was initially prescribed by the patient's  
              medical provider;
              Allow more than two steps to be used, provided that the  
              FDA-approved label indication, peer review medical evidence,  
              or clinical research trials indicate that more than two  
              steps should be used before using a particular drug;
              Require health plans and health insurers to have an  
              expeditious process for authorizing exceptions to step  
              therapy requirements when medically necessary;
              Specifically not prohibit a health plan or insurer from  
              charging copayments or deductibles or limiting maximum  
              coverage for pharmacy benefits;
              Specifically not require coverage of drugs not on a health  
              plan or insurer's formulary or prohibit generic drug  
              substitution for brand name drugs.

          Related Legislation: 
              AB 369 (Huffman, 2012) was similar to this bill. However,  
              the limitations on step therapy in that bill were limited to  
              pain medications. AB 369 was vetoed by Governor Brown.
              AB 1826 (Huffman, 2010) was substantially similar to AB 369  
              (Huffman, 2012). That bill was held on this committee's  
              Suspense File.
              AB 219 (Perea) would set maximum cost-sharing amounts for  
              oral anticancer drugs. That bill will be heard in this  
              committee.
              AB 460 (Ammiano) would add non-discrimination language to  
              the current mandate to offer infertility treatment. That  
              bill will be heard in this committee.
              AB 912 (Quirk-Silva) would require every health insurance  
              policy and health plan contract to provide coverage for  
              medically necessary fertility preservation services when  
              medical treatment may cause infertility. That bill will be  
              heard in this committee.

          Staff Comments: Under the federal Patient Protection and  
          Affordable Care Act, health coverage provided in the small group  
          or individual market (including through health exchanges) must  
          provide essential health benefits. The Affordable Care Act  
          specifies the general categories of benefits that must be  
          provided, which includes prescription drugs. Under federal  
          guidance, the states will be able to select an essential health  
          benefits benchmark plan. After 2014, all coverage provided in  
          the small group and individual markets must provide coverage  








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          equal to or greater than the coverage provided by the benchmark  
          plan. The state has selected the Kaiser Small Group HMO as the  
          state's essential health benefits benchmark plan.

          Under federal law, individuals purchasing coverage through  
          health benefit exchanges will be eligible for subsidies, based  
          on income, paid by the federal government.

          Under federal law, if a state imposes a benefit mandate after  
          January 1, 2012 that exceeds the benefits provided by the  
          essential health benefits benchmark plan, the state is  
          responsible for providing the subsidies for coverage of that  
          mandated benefit.

          While this bill places some constraints on the ability of health  
          plans and health insurers to use step therapy, the bill does not  
          mandate health plans or health insurers to provide any  
          additional benefits to patients. Therefore, this bill does not  
          impose an additional benefit mandate under the Affordable Care  
          Act and there would be no obligation on the state to provide  
          subsidies for coverage through the California Health Benefit  
          Exchange.

          The only costs that may be incurred by a local government under  
          this bill relate to crimes and infractions. Under the California  
          Constitution, such costs are not reimbursable by the state.

          Proposed author's amendments: would only apply the bill's  
          requirements to pain medications. The amendments would only  
          allow insurers or health plans to require a patient to use an  
          opioid pain medication under step therapy if the medication  
          contains an abuse-deterrent formulation.