BILL ANALYSIS Ó ----------------------------------------------------------------- |SENATE RULES COMMITTEE | SB 1174| |Office of Senate Floor Analyses | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ----------------------------------------------------------------- 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. SB 1174 Page 2 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) SB 1174 Page 3 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 SB 1174 Page 4 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 SB 1174 Page 5 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. SB 1174 Page 6 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 SB 1174 Page 7 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) SB 1174 Page 8 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 SB 1174 Page 9 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 **** END ****