BILL ANALYSIS                                                                                                                                                                                                    �



                                                                  AB 889
                                                                  Page  1


          ASSEMBLY THIRD READING
          AB 889 (Frazier)
          As Amended May 2, 2013
          Majority vote 

           HEALTH              15-4        APPROPRIATIONS      13-4        
           
           ----------------------------------------------------------------- 
          |Ayes:|Pan, Ammiano, Atkins,     |Ayes:|Gatto, Bocanegra,         |
          |     |Bonilla, Bonta, Chesbro,  |     |Bradford,                 |
          |     |Gomez,                    |     |Ian Calderon, Campos,     |
          |     |Roger Hern�ndez,          |     |Eggman, Gomez, Hall,      |
          |     |Lowenthal, Maienschein,   |     |Ammiano, Linder, Pan,     |
          |     |Mitchell, Nazarian,       |     |Quirk, Weber              |
          |     |Nestande, V. Manuel       |     |                          |
          |     |P�rez, Wieckowski         |     |                          |
          |     |                          |     |                          |
          |-----+--------------------------+-----+--------------------------|
          |Nays:|Logue, Mansoor, Wagner,   |Nays:|Harkey, Bigelow,          |
          |     |Wilk                      |     |Donnelly, Wagner          |
          |     |                          |     |                          |
           ----------------------------------------------------------------- 
           SUMMARY  :  Prohibits a health plan and health insurer that  
          provides coverage for medications pursuant to step therapy or a  
          fail first protocol from requiring an enrollee or insured to try  
          and fail more than two medications before allowing the enrollee  
          or insured access to the medication or a generically equivalent  
          drug, prescribed by their provider.  Requires health plans and  
          health insurers to have an expeditious process in place for step  
          therapy exceptions and that the duration of step therapy be  
          consistent with up-to-date, evidence-based outcomes and current  
          published peer-reviewed medical and pharmaceutical literature.   
          Specifically,  this bill :

          1)Prohibits a health plan or health insurer from requiring a  
            patient to try and fail more than two medications before  
            allowing the patient access to the medication, or generically  
            equivalent drug, prescribed by the patient's provider unless  
            the federal Food and Drug Administration approved label  
            indication, peer-reviewed scientific, medical and  
            pharmaceutical evidence, or clinical research trials focusing  
            on clinical outcomes support that more than two prior  
            therapies should be used before the requested medication.









                                                                  AB 889
                                                                  Page  2


          2)Requires the duration of any step therapy or fail first  
            protocol to be consistent with up-to-date, peer-reviewed  
            scientific, medical, and pharmaceutical evidence.

          3)Requires health plans and health insurers that require step  
            therapy to have an expeditious process in place to authorize  
            exceptions to step therapy, when medically necessary, and to  
            conform effectively and efficiently with the continuity of  
            care requirements of this chapter and corresponding  
            regulations.

          4)Prohibits a new health plan or health insurer, in  
            circumstances where an enrollee is changing plans, from  
            requiring the enrollee or insured to repeat step therapy when  
            that enrollee or insured is already being treated for a  
            medical condition by a prescription drug, provided that the  
            drug is appropriately prescribed and is considered safe and  
            effective for the enrollee's condition. 

          5)Provides that nothing in this bill prohibits a health plan or  
            health insurer from imposing a prior authorization  
            requirement, as specified, for the continued coverage or  
            preclude the prescribing another drug covered by the new plan  
            that is medically appropriate, and this bill does not prohibit  
            a plan or insurer charging a subscriber or enrollee a  
            copayment, coinsurance, or a deductible for prescription drug  
            benefits or from setting forth, by contract, limitations on  
            maximum coverage of prescription drug benefits, as described.

          6)Defines prescribing provider and generically equivalent drug.

          7)Prohibits the provisions of this bill from being construed to  
            require coverage of prescription drugs not in a plan's or  
            insurer's drug formulary or to prohibit generically equivalent  
            drugs or generic drug substitutions, as authorized.

          8)Excludes from the provisions of this bill, accident-only,  
            specified disease, hospital indemnity, Medicare supplement,  
            dental-only, or vision-only health care service plan contracts  
            or disability policies.

           FISCAL EFFECT  :  According to the Assembly Appropriations  
          Committee, across almost all sectors of the health insurance  
          market, insurance premiums would be expected to increase because  








                                                                  AB 889
                                                                  Page  3


          step therapy is used to control costs and this bill limits its  
          use.  According to the California Health Benefits Review Program  
          (CHBRP), the increase to Medi-Cal Managed Care plan expenditures  
          would be approximately $11 million.  At least one California  
          Public Employees' Retirement System (CalPERS) health plan uses  
          step therapy, for significant savings, so this bill could also  
          lead to higher costs, potentially greater than $1 million, for  
          CalPERS.

           COMMENTS  :  The author asserts that a troubling and dangerous  
          trend occurring with health care plans is their use of step  
          therapy or "fail first" protocols which require a patient to try  
          and fail on up to five other medications before the health plan  
          covers the medication originally prescribed by the patient's  
          health care provider.  For example, though a doctor prescribed  
          drug A for a patient, a health plan requires the patient to  
          first try drugs B, C, D, etc., and only after the patient fails  
          to respond to these medications will the health plan approve the  
          use of the initial medication.  The author points out that step  
          therapy or "fail first" protocols often take weeks to months to  
          implement.  According to the author, health plans use step  
          therapy as a cost-saving measure but the research has shown that  
          this policy can actually increase health care costs due to  
          unnecessary delays in a patient getting the medication their  
          provider prescribed.  This puts the patient's health at risk, as  
          well as, leads to increased health care utilization and time  
          lost from work.  This bill would reduce the number of  
          medications a patient has to try and fail to no more than two  
          before the original prescribed medication is allowed by the  
          patient's health plan.  This bill also requires health plans to  
          have an expeditious process in place for step therapy exceptions  
          and that the duration of step therapy be consistent with  
          up-to-date, evidence-based outcomes and current published  
          peer-reviewed medical and pharmaceutical literature.

          According to the CHBRP, this bill does not require Department of  
          Health Care Services regulated plans and California Department  
          of Insurance regulated policies to provide benefit coverage for  
          prescription drugs.  However, the federal Patient Protection and  
          Affordable Care Act (ACA) (through Essential Health Benefits)  
          require this expansion for nongrandfathered plans and policies  
          in the small group and individual markets.  This bill,  
          therefore, would build on the ACA's expansion, and restrict all  
          nongrandfathered small group and individual market plans and  








                                                                  AB 889
                                                                  Page  4


          policies from requiring enrollees from trying and failing more  
          than two medications.  The requirement or restriction that this  
          bill imposes in the design of the plan, is not considered a  
          state-required mandate, according to regulations written by the  
          federal Department of Health and Human Services.  Therefore,  
          this bill would not require the state to defray any costs for  
          Qualified Health Plans purchased through Covered California, the  
          state's health insurance exchange.
          Chronic pain advocacy groups, health care professionals, and  
          community organizations support this bill.  The sponsor of this  
          bill, For Grace, writes this bill addresses the terrible  
          shortcomings of step therapy and is of special interest to  
          patients in pain because they can tell immediately whether a  
          pain medication is working or not.  Additionally, medical  
          organizations comment that research has shown that step therapy  
          can actually increase the direct cost of health care in the long  
          run due to excessive use of emergency rooms, unscheduled  
          hospital admissions, time off work, excessive temporary  
          indemnity benefits, and even job loss.  The California Society  
          of Industrial Medicine and Surgery, the California Society of  
          Physical Medicine and Rehabilitation, and the California  
          Neurology Society add that seasoned and highly knowledgeable  
          physicians know that not all drugs are equivalent in terms of  
          onset of efficacy, dose required to achieve response, side  
          effects, and interactions with other drugs.  They support  
          patient access to medications chosen by experienced clinicians  
          to give them the best and quickest chance of response, thus  
          shortening morbidity and disability.  The Congress of California  
          Seniors states that this bill would change practices that have  
          resulted in higher long-term health care costs and the  
          unnecessary physical and emotional suffering caused by step  
          therapy.

          America's Health Insurance Plans (AHIP) argues this bill could  
          increase access to potentially dangerous and addictive  
          pharmaceutical drugs by hindering the ability of heath plans to  
          promote alternative means of treatments and limit potentially  
          harmful or fatal drug prescriptions.  AHIP also believes this  
          bill may increase health care costs.  AHIP cites National Health  
          Expenditure Data which indicate spending on prescription drugs  
          in 2009 increased 5.9% to reach a total of nearly $250 billion.   
          AHIP requests several amendments which cross reference the  
          expeditious process in existing law; require duration of step  
          therapy to be consistent with peer-reviewed, scientific,  








                                                                  AB 889
                                                                  Page  5


          medical, and pharmaceutical evidence, nationally recognized  
          professional standards, expert opinion, or generally accepted  
          standards of medical practice; and, apply this bill to  
          participating prescribing providers.

          Health plans and health insurers object to this bill.  The  
          California Association of Health Plans raises concerns that this  
          bill gives noncontracted providers the same privileges as they  
          give contracted participating providers and by doing so, this  
          impedes the effectiveness of medical protocols designed to  
          minimize harmful side effects, if necessary.  Blue Shield of  
          California states that step therapy protocols act as a check and  
          balance to the cozy relationships that exist between many  
          physicians and drug companies.  Protocols directed and overseen  
          by medical doctors and pharmacists at health plans act as an  
          additional review point to ensure that patients are receiving  
          the most effective pharmaceuticals, not just the best marketed.   
          The California Chamber of Commerce argues this bill cannot be  
          viewed in isolation.  This bill reduces health plan flexibility  
          in benefit management, increases health care costs and premiums,  
          thereby reducing employers' ability to offer an affordable  
          choice of benefit packages to their employees.


           Analysis Prepared by  :    Teri Boughton / HEALTH / (916) 319-2097  



                                                                FN: 0000883