BILL ANALYSIS                                                                                                                                                                                                    




                   Senate Appropriations Committee Fiscal Summary
                           Senator Christine Kehoe, Chair

                                           830 (Cook)
          
          Hearing Date:  8/24/2009        Amended: 8/17/2009
          Consultant: Katie Johnson       Policy Vote: Health 10-0
          _________________________________________________________________ 
          ____
          BILL SUMMARY:  AB 830 would delete current statutory references  
          to specific drug compendia and would replace them with drug  
          compendia approved by the federal Centers for Medicare and  
          Medicaid Services (CMS) for mandated "off-label" coverage of  
          medication by health care service plans, health insurers, and  
          Medi-Cal.
          _________________________________________________________________ 
          ____
                            Fiscal Impact (in thousands)

           Major Provisions         2009-10      2010-11       2011-12     Fund
                                                                  
          Increase in reimbursement                     unknown, but  
          likely in              General/*
          for off-label drug use by                     the hundreds of  
          thousands              Federal
          Medi-Cal beneficiaries            or millions of dollars

          *October 1, 2008 - December 31, 2010 FMAP = 38%GF / 62%FF
          January 1, 2011 - ongoing FMAP = 50%GF / 50%FF
          FMAP = Federal Medical Assistance Percentage-the percent of  
          total costs paid by the federal government.

          For drugs that are prescribed, but ineligible for FMAP,  
          reimbursements would be paid 100% by the General Fund.
          _________________________________________________________________ 
          ____

          STAFF COMMENTS: This bill meets the criteria for referral to the  
          Suspense File.

          Existing state law references various drug compendia for  
          purposes of the coverage of off-label drug use by health care  
          service plans, health insurers, and Medi-Cal. Off-label drug use  
          refers to the use of drugs to treat conditions that are not  
          specifically approved by the federal Food and Drug  
          Administration (FDA) for that purpose. If an off-label drug is  










          listed in a compendium recognized by CMS, Medi-Cal, Medicare,  
          and health plans and insurers are required to pay for it as a  
          treatment, as specified. Drugs are prescribed "off-label" to  
          treat life-threatening or chronic conditions such as cancer,  
          HIV, and AIDS.

          This bill would delete references to the American Medical  
          Association Drug Evaluations, which is no longer in publication,  
          and the United States Pharmacopoeia Dispensing Information,  
          which was purchased by the Thomson Micromedex DrugDex.

          This bill would insert references to the following compendia, as  
          approved by CMS:

          1) the American Hospital Formulary Service Drug Information,  
          where not already referenced;
          2) the Elselvier Gold Standard's Clinical Pharmacology; 

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          AB 830 (Cook)

          3) the National Comprehensive Cancer Network Drug and Biologics  
          Compendium; and 4) the Thomson Micromedex DrugDex.

          In federal law, Medi-Cal is required to cover fewer drugs for  
          off-label use in chemotherapeutic and HIV/AIDS treatment when  
          compared to Medicare and other health plans and insurers;  
          Medi-Cal is only required to cover drugs in the American  
          Hospital Formulary Service Drug Information, the United States  
          Pharmacopeia Drug Information (or its successor publications),  
          and the DrugDex Information System.

          Since federal Medicaid law lists two of the four compendia added  
          to state law by this bill, these provisions could require  
          Medi-Cal to cover off-label drug use, if all other conditions  
          were met, from more compendia than are prescribed in federal law  
          and that would be eligible for federal financial participation.  
          To the extent that Medi-Cal providers prescribe drugs that are  
          included in a compendia not approved for federal matching funds  
          in federal law, there would be an increase in General Fund  
          expenditures for off-label drug use by Medi-Cal beneficiaries in  
          an unknown amount, likely in the hundreds of thousands or  
          millions of dollars.

          Staff recommends that the bill be amended to specify that only  
          compendia that are authorized by federal law for Medicaid  










          programs may be used by Medi-Cal in order to mitigate any  
          potential unmatched General Fund expenditures for off-label drug  
          use.