BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                  AB 369
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          Date of Hearing:   May 4, 2011

                        ASSEMBLY COMMITTEE ON APPROPRIATIONS
                                Felipe Fuentes, Chair

                AB 369 (Huffman) - As Introduced:  February 14, 2011 

          Policy Committee:                              HealthVote:13-5

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

           SUMMARY  

          This bill prohibits health plans and health insurers from 
          requiring a patient to try and fail on more than two pain 
          medications before allowing the patient access to the pain 
          medication, or its generic equivalent, prescribed by his or her 
          physician.

           In addition, this bill grants the prescribing physician control 
          over the duration of any fail-first trials, and allows the 
          physician to prescribe the desired medication without further 
          authorization from the plan or insurer once two trials have been 
          conducted.

           FISCAL EFFECT  

          1)Negligible state fiscal effect associated with the mandate to 
            cover the prescribed medication after two fail-first trials. 
            According to the California Health Benefits Review Program 
            (CHBRP), there is insufficient information to estimate a 
            change in utilization or cost for enrollees whose prescribed 
            medications may be subject to a fail-first protocol not 
            compliant with this bill.  Most medications are not subject to 
            fail-first protocols and, for those that are, the majority of 
            protocols appear to already be compliant with this bill.

          2)Likely minor, if any, state fiscal impact associated with 
            other provisions of the bill that allow physicians to control 
            the duration of trials and streamline the plan's authorization 
            process. CHBRP did not assess the fiscal impact of these 
            provisions. 

          3)Federal regulations implementing the federal health reform 








                                                                  AB 369
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            law, the Patient Protection and Affordable Care Act (ACA) may 
            impact the cost of this bill.  Under current law, beginning in 
            2014 states will be liable for any additional cost related to 
            state-level benefit mandates on plans offered through new 
            health insurance exchanges that go beyond minimum federal 
            requirements.  At this time, it is unknown whether this bill 
            might impose future state costs.

           COMMENTS

          1)Rationale  . According to the author, in order to reduce their 
            costs and improve their profit margins, many health plans use 
            step therapy or "fail first" policies which forces patients to 
            try several alternative medications, which in some cases 
            include over-the-counter medicines, before they are permitted 
            to get the medication that their physician ordered.  The 
            author contends the duration of these step therapy protocols 
            is left up to the insurance company or health plan and can 
            last months.  The author asserts that step therapy forces 
            chronic pain patients to endure unnecessary physical and 
            emotional suffering.

           2)Fail-First Protocols  .  Proponents of fail-first protocols 
            assert that it protects the health and safety of patients, as 
            well as reduces health care spending, by ensuring that the 
            most cost-effective and safest treatment is attempted first 
            and that more costly and risky therapies are used only if 
            necessary.  Fail-first protocols are commonly used for certain 
            higher-cost medications or medications with a shorter history 
            of safety and effectiveness than the first-line alternatives.  


            CHBRP's analysis indicates that health plans and insurers are 
            extremely varied in their use of fail-first protocols for pain 
            medication.  For example, some enrollees affected by this bill 
            have benefit coverage that is not subject to any fail-first 
            protocol, and no single pain medication is subject to a 
            fail-first protocol on every insurer's list.  Some of the pain 
            medications identified by CHBRP that require the use of 
            fail-first protocols are controlled substances that the 
            federal Drug Enforcement Agency (DEA) has determined have a 
            high potential for abuse, although many are not. CHBRP also 
            indicates fail-first protocols generally permit exceptions for 
            intolerable side effects or contraindications.  









                                                                  AB 369
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           3)Mandates and the Affordable Care Act  .  The ACA creates new 
            state-run health insurance exchanges that will likely provide 
            coverage to millions of Californians, and requires that health 
            plans offered through an exchange cover certain categories of 
            benefits, called Essential Health Benefits (EHBs). The 
            Secretary of Health and Human Services (HSS) is expected to 
            publish guidance later in 2011 and 2012 that will further 
            define these categories. These definitions will have important 
            fiscal implications for the state.  The ACA specifies that if 
            states require plans in the exchange to offer additional 
            benefits that go beyond the defined EHBs, then states must pay 
            the additional cost related to those mandates. At this time, 
            there are a number of outstanding questions related to how 
            federally defined EHBs will interact with state-level benefit 
            mandates. 

            The ACA provisions related to EHB are silent on whether health 
            plans offered through the exchange may use step therapy and 
            fail-first protocols.  Therefore, any potential future state 
            cost impact from this mandate would be unknown until the 
            design of EHBs, and the methodology used to determine state 
            liability associated with state-level benefit mandates, are 
            made clear.

           1)Prior Legislation  .  AB 1826 (Huffman) in 2010 prohibited the 
            use of fail-first protocols for pain medication altogether, 
            instead of restricting the number of trials to two.  CHBRP's 
            analysis of AB 1826 indicated a Medi-Cal cost of approximately 
            $10 million and increased premiums in the private market of 
            $11 million.  AB 1826 was held on the Suspense file of the 
            Senate Appropriations Committee. 

           2)Other Mandates in the Current Session  . There are fourteen 
            health mandates that were introduced this year, including AB 
            369. Other mandates in the current session include: 

             a)   AB 72 (Eng): Acupuncture
             b)   AB 137 (Portantino): Mammography
             c)   AB 154 (Beall): Mental Health Services
             d)   AB 171 (Beall): Autism
             e)   AB 185 (Hernández): Maternity Services
             f)   AB 310 (Ma): Prescription Drugs
             g)   AB 369 (Huffman): Pain Prescriptions 
             h)   AB 428 (Portantino): Fertility Preservation
             i)   AB 652 (Mitchell): Child Health Assessments








                                                                  AB 369
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             j)   AB 1000 (Perea): Cancer Treatment
             aa)  SB 136 (Yee): Tobacco Cessation
             bb)  SB 155 (Evans): Maternity Services
             cc)  SB 173 (Simitian): Mammograms
             dd)  SB 255 (Pavley): Breast Cancer


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