BILL ANALYSIS                                                                                                                                                                                                    Ó






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          |SENATE RULES COMMITTEE            |                       SB 1174|
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                                   THIRD READING 


          Bill No:  SB 1174
          Author:   McGuire (D), et al.
          Amended:  3/28/16  
          Vote:     21 

           SENATE BUS., PROF. & ECON. DEV. COMMITTEE:  8-0, 4/11/16
           AYES:  Hill, Berryhill, Block, Galgiani, Hernandez, Jackson,  
            Mendoza, Wieckowski
           NO VOTE RECORDED:  Bates

           SENATE APPROPRIATIONS COMMITTEE:  6-0, 5/27/16
           AYES:  Lara, Bates, Beall, Hill, McGuire, Mendoza
           NO VOTE RECORDED:  Nielsen
           
           SUBJECT:   Medi-Cal:  children:  prescribing patterns:   
                     psychotropic medications


          SOURCE:    National Center for Youth


          DIGEST:  This bill adds the following causes of action to the  
          Medical Board of California's (MBC) list of priority cases for  
          investigation and prosecution:  "repeated acts of clearly  
          excessive prescribing, furnishing, or administering psychotropic  
          medications to a minor without a good faith prior examination of  
          the patient and medical reason;"  and requires the Department of  
          Health Care Services (DHCS) to provide quarterly data to MBC on  
          psychotropic medications prescribed to foster youth and requires  
          the MBC to provide quarterly reports on violations of the law or  
          standards of care.










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          ANALYSIS:  


          Existing law:

         1)Provides for the licensure and regulation of physicians  
            and surgeons by the MBC pursuant to the Medical Practice  
            Act (Act).  (Business and Professions Code (BPC) Sections  
            2000 et seq.)

         2)Requires MBC to prioritize its investigative and  
            prosecutorial resources to ensure that physicians and  
            surgeons representing the greatest threat of harm are  
            identified and disciplined expeditiously.  Requires cases  
            involving excessive prescribing, furnishing or  
            administering of controlled substances, or repeated acts  
            of prescribing, dispensing or furnishing of controlled  
            substances without a good faith prior examination of the  
            patient and medical reason to be handled as a high  
            priority.  Specifies that physicians and surgeons shall  
            not be prosecuted for excessive prescribing when  
            prescribing, furnishing or administering controlled  
            substances for intractable pain as authorized under  
            current law.  (BPC § 2220.05)

         3)Provides that only a juvenile court judicial officer shall  
            have authority to make orders regarding the  
            administration of psychotropic medications for a minor  
            who has been adjudged a dependent of the court and  
            removed from the physical custody of his or her parent.   
            (Welfare and Institutions Code (WIC) § 369.5)

          4) Establishes a program of public health nursing in the  
             child welfare services program that provides  
             health-related case management services from a foster  
             care public health nurse to coordinate with child  
             welfare service workers to provide health care services  
             to children in foster care.  Includes among the duties  
             of public health nurses the monitoring and oversight of  
             psychotropic medications.  Requires public health nurses  
             to receive training related to psychotropic medications,  
             as specified.  
          (WIC § 16501.3)








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          5) Requires Department of Social Services (DSS), in  
             consultation with DHCS and other specified stakeholders,  
             to develop county-specific monthly reports that describe  
             each child for whom one or more psychotropic medications  
             have been paid for under Medi-Cal, including authorized  
             medications, pharmacy data including the quantity and  
             dose, other available information regarding psychosocial  
             interventions and incidents of polypharmacy.  (WIC §  
             16501.4)  

          This bill:

          1) Adds "repeated acts of clearly excessive prescribing,  
             furnishing, or administering psychotropic medications to a  
             minor without a good faith prior examination of the patient  
             and medical reason therefor" to the list of cases for which  
             MBC must prioritize its investigative and prosecutorial  
             resources.

          2) Requires DHCS, in collaboration with DSS, to provide  
             quarterly data to MBC that includes, but is not limited to,  
             the child welfare psychotropic medication measures and the  
             Healthcare Effectiveness Data and Information Set measures  
             related to psychotropic medications.  Specifies that data  
             provided to MBC shall include a breakdown by population of  
             the following for birth to 5 years old, 6 to 11 years old and  
             12-17 years old:

             a)   Children prescribed psychotropic medications in managed  
               care and fee-for-service settings.

             b)   Children adjudged as dependent children and placed in  
               foster care.

             c)   Children in juvenile halls and children placed in  
               ranches, camps, or other facilities.

             d)   A minor adjudged a ward of the court who has been  
               removed from the physical custody of the parent and placed  
               into foster care.

             e)   Children with developmental disabilities.

          1) Requires MBC to review the information provided by DHCS on a  







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             quarterly basis in order to determine if any potential  
             violations of law or excessive prescribing of psychotropic  
             medications inconsistent with the standard of care exist and,  
             if warranted, to conduct an investigation.  Requires MBC to  
             take disciplinary action as appropriate if, after an  
             investigation, MBC concludes that there was a violation of  
             law, including a conclusion that there was excessive  
             prescribing of psychotropic medications inconsistent with the  
             standard of care.  Requires MBC to provide a quarterly report  
             to the Legislature, DHCS and DSS.
          
          Background

          Psychotropic Medication.  According to background information  
          from recent Senate hearings on this issue, concern over the use  
          of psychotropic medications among children has been  
          well-documented in research journals and the mainstream media  
          for more than a decade.  The category of psychotropic medication  
          is fairly broad, intending to treat symptoms of conditions  
          ranging from attention deficit hyperactivity disorder (ADHD) to  
          childhood schizophrenia.  Some of the drugs used to treat these  
          conditions are U.S. Food and Drug Administration (FDA) approved,  
          including stimulants like Ritalin for ADHD, however only about  
          31 percent of psychotropic medications have been approved by the  
          FDA for use in children or adolescents.  It is estimated that  
          more than 75 percent of the prescriptions written for  
          psychiatric illness in this population are "off label" in usage,  
          meaning they have not been approved by the FDA for the  
          prescribed use, though the practice is legal and common across  
          all manner of pharmaceuticals. 
          
          Anti-psychotic medications, used to treat more severe mental  
          health conditions, include powerful brand-name drugs such as  
          Haldol, Risperdal, Abilify, Seroquel and Zyprexa.  They have  
          very limited approval by the FDA for pediatric use beyond rare  
          and severe conduct problems that are resistant to other forms of  
          treatment, such as Tourette's syndrome, behavioral symptoms  
          associated with autistic disorder, childhood schizophrenia, and  
          bipolar disorder.  However, the off-label use of these  
          anti-psychotics among children is high, particularly among  
          foster children.  According to a study published in 2011,  
          children who took antipsychotic medications were likely to  
          suffer ill health effects including "cardio metabolic and  
          endocrine side-effects" as well as significant weight gain.  The  







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          authors recommended that collaboration between child and  
          adolescent psychiatrists, general practitioners and  
          pediatricians is essential to "reduce the likelihood of  
          premature cardiovascular morbidity and mortality." 

          Compounding the potential for unintended side effects is the use  
          of combinations of psychotropic medications, which foster youth  
          are particularly likely to be prescribed, despite limited  
          evidence of clinical efficacy.  Protecting the health and  
          well-being of children who are taking one or more psychotropic  
          medications requires extensive and ongoing health and metabolic  
          screenings to identify potential adverse effects quickly,  
          however in practice many children many fail to receive ongoing  
          screenings and adverse effects may go undetected causing  
          permanent injury or death.

          Medical Board Efforts to Provide Guidance to Licensees on  
          Prescribing.  The MBC made available to all licensees on its Web  
          site, as well as through an e-mail to its licensee listserv, the  
          DHCS and DSS's statewide Quality Improvement Project (QIP)  
          Guidelines for the Use of Psychotropic Medication with Children  
          and Youth in Foster Care, which states that "the use of  
          psychotropic medication for children and youth is considered a  
          non-routine intervention, used under specified circumstances and  
          as only one strategy within a larger, more comprehensive  
          treatment plan to provide for that child's safety and  
          well-being".  MBC's responsibilities in overseeing their  
          licensees' prescribing habits of psychotropic medications to  
          foster youth are also a component of an audit currently being  
          conducted by the California State Auditor pertaining to the  
          oversight and monitoring of children in foster care who have  
          been prescribed psychotropic medications.

          At the October 2015 MBC meeting, the Board discussed strategies  
          to help identify physicians who may be inappropriately  
          prescribing psychotropic medications to foster youth as well as  
          identify additional information needed from DHCS and DSS.   
          However, there were concerns raised about the expectations of  
          physicians based on the quality of information in the QIP's  
          Psychotropic Data Match Report.  The MBC has expressed concerns  
          that the data presented in the report may not be sufficient to  
          make a decision as to appropriate prescribing practices for  
          physicians working with foster youth. 








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          The Board has, in the meantime, developed a notification process  
          whereby individuals in the healthcare delivery system for foster  
          youths can directly contact MBC staff if they believe a  
          physician is inappropriately prescribing medication to children  
          in foster care.  After a complaint or notification is made, MBC  
          staff will directly contact DSS to obtain all de-identified  
          patient information for the foster child and the prescriber.   
          The Board can then determine whether or not it will need patient  
          records.  DSS and the MBC can then obtain these patient records  
          through a court order so that the Board can proceed with an  
          investigation into the prescribing physician.

          Data Sharing Efforts.  MBC currently has a data user agreement  
          (DUA) with DHCS and DSS in order to allow the MBC to receive  
          information that does not breach the confidentiality of a  
          patient.  The agreement is based on conversations dating back to  
          2014 regarding the data needed for the MBC to identify  
          physicians who may be inappropriately prescribing psychotropic  
          medications to foster children.  Upon receipt of its first set  
          of data under the DUA, MBC enlisted a pediatric psychiatrist to  
          review the data.  The physician determined that the information  
          provided through the agreement was not substantive enough to  
          allow MBC to identify instances of any inappropriate prescribing  
          and noted that additional information to assist in this effort  
          would include the diagnosis associated with medication  
          prescribed, the dosage of medication prescribed, the schedule or  
          timing of dosage of medication prescribed and the weight of  
          child or adolescent.


          FISCAL EFFECT:   Appropriation:    No          Fiscal  
          Com.:YesLocal:   No


          According to the Senate Appropriations Committee:


           Ongoing costs up to $280,000 per year for the DHCS to analyze  
            prescription drug claims data and compile required information  
            for the MBC (General Fund and federal funds).  The DHCS's  
            information technology systems contain prescription drug  
            claims data (when combined with information from the DSS on  
            foster care placements) to provide the data required to  
            fulfill the requirements in the bill.  DHCS indicates that it  







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            will need two additional staff positions to compile the  
            required data, stratify it into the required data categories,  
            and report to the MBC. 

            However, as part of recent efforts to reduce overprescribing  
            of psychotropic medications to foster youth, the DHCS has been  
            working with the DSS and counties to identify foster youth  
            being prescribed such medications.  The Governor's budget  
            proposal includes an additional permanent position to continue  
            this work.  If approved by the Legislature, that new position  
            may be able to also perform some or all of the requirements of  
            this bill as well.

           Uncertain costs for the MBC to review the information provided  
            by the DHCS and investigate instances where excessive  
            prescribing may be occurring (Contingent Fund of the MBC).   
            According to the MBC, its staff are already reviewing data  
            provided by the DHCS to look for cases of excessing  
            prescribing.  However, to the extent that such data analysis  
            does uncover instances of excessing prescribing, this would  
            lead to increased costs for investigations and potential  
            disciplinary action by the MBC.  While those instances of  
            excessing prescribing may already be actionable by the MBC  
            under current law and regulation, the data analysis required  
            in the bill makes such investigations more likely to occur.

           Unknown potential cost savings in the Medi-Cal program due to  
            reduced inappropriate utilization of psychotropic medications  
            by foster youth. To the extent that this bill contributes to  
            ongoing efforts to reduce inappropriate use of those drugs by  
            Medi-Cal beneficiaries, the bill is likely to reduce spending.  
            Ongoing efforts in other states to reduce inappropriate  
            prescribing have substantially reduced the use of these  
            frequently expensive medications. The amount of any decrease  
            in spending that could be attributed to this bill is  
            uncertain, in part because there are several efforts underway  
            by the state and the counties to reduce inappropriate  
            prescribing of psychotropic drugs to foster youth.


          SUPPORT:   (Verified5/27/16)


          National Center for Youth (source)







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          Bay Area Youth Center
          California Youth Connection
          Consumer Attorneys of California
          Consumer Watchdog
          Family Voices of California 
          First Focus Campaign for Children
          John Burton Foundation
          Kids in Common, a program of Planned Parenthood Mar Monte
          Madera County Department of Social Services
          Peers Envisioning and Engaging in Recovery Services 
          Therapists for Peace and Justice
          Woodland Community College Foster and Kinship Care Education
          Youth Law Center
          One individual


          OPPOSITION:   (Verified5/27/16)


          California Medical Association
          California Academy of Child and Adolescent Psychiatry


          ARGUMENTS IN SUPPORT:     Numerous groups such as the Youth Law  
          Center, Consumer Attorneys of California, and First Focus  
          Campaign for Children support this bill, citing the frequency of  
          psychotropic drug prescription among foster youth. These groups  
          call for an appropriate oversight mechanism that can help  
          identify outlying prescribers. They argue that this bill will  
          enable MBC to confidentially collect and analyze data, and, when  
          warranted, conduct investigations of physicians who frequently  
          prescribe over the recognized safety parameters for children.

          ARGUMENTS IN OPPOSITION:The California Medical Association (CMA)  
          is concerned that this bill adds another bureaucratic layer to a  
          process that is already highly regulated and are concerned that  
          the bill will delay or prevent some youth from receiving  
          appropriate treatments as well as discouraging physicians from  
          working within the Medi-Cal program.  CMA notes that because the  
          medical records are protected, the data that provided to the MBC  
          will provide an incomplete picture without the underlying  
          medical records which can only be obtained through a court order  
          or if the patient waives confidentiality.  CMA believes that  
          investigations will target physicians working specifically  







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          within the Medi-Cal system or mental health professionals who  
          specialize with patients with severe mental health difficulties.  
           CMA cites the example of a psychiatrist who works exclusively  
          in Juvenile Hall or group homes as potentially having a much  
          higher rate of psychotropic prescriptions to children than a  
          psychiatrist providing services to the general population which  
          will trigger that physician being investigated. 
            
          CMA believes that this bill has the potential to discourage  
          physicians from working within the Medi-Cal program which is  
          already suffering from access problems as well as cause some  
          physicians not to prescribe psychotropic medications even if  
          they feel it is an appropriate treatment option.


          CMA is requesting an amendment to ensure that educational  
          outreach be required before MBC could initiate an investigation  
          based on the data received from DHCS. They suggest that the  
          guidelines could be a useful tool as the centerpiece of  
          educational outreach.


          Prepared by:Sarah Mason / B., P. & E.D. / (916) 651-4104
          5/28/16 16:46:01


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