BILL ANALYSIS Ó SENATE COMMITTEE ON BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT Senator Jerry Hill, Chair 2015 - 2016 Regular Bill No: SB 1174 Hearing Date: April 11, 2016 ----------------------------------------------------------------- |Author: |McGuire | |----------+------------------------------------------------------| |Version: |March 28, 2016 | ----------------------------------------------------------------- ---------------------------------------------------------------- |Urgency: |No |Fiscal: |Yes | ---------------------------------------------------------------- ----------------------------------------------------------------- |Consultant|Sarah Mason | |: | | ----------------------------------------------------------------- Subject: Medi-Cal: children: prescribing patterns: psychotropic medications SUMMARY: Adds to the list of cases that the Medical Board of California (MBC) prioritizes for its investigative and prosecutorial resources, the following: "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." Requires the Department of Health Care Services (DHCS) to provide quarterly data to MBC related to prescriptions of psychotropic medications for foster youth and requires the board to provide quarterly reports after reviewing the information provided by DHCS and determine if any potential violations of law or excessive prescribing of psychotropic medications inconsistent with the standard of care exist. Existing law: 1)Provides for the licensure and regulation of physicians and surgeons by the Medical Board of California (MBC) pursuant to the Medical Practice Act (Act). (Business and Professions Code (BPC) § 2000 et. seq.) 2)Provides that the MBC shall take action against a physician who is charged with unprofessional conduct, as specified. (BPC § 2234) SB 1174 (McGuire) Page 2 of ? 3)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 substance without a good faith prior examination of the patient and medical reason to be handled as a high priority. States 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) 4)Provides MBC with the authority to issue a probationary physician's and surgeon's certificate to an applicant subject to terms and conditions, including, but not limited to practice limited to a supervised, structured environment, continuing medical or psychiatric treatment, ongoing participation in a specified rehabilitation program, or abstention from the use of alcohol or drugs. (BPC §2221) 5)Authorizes a physician and surgeon to prescribe for, or dispense or administer to, a person under his or her treatment for a medical condition dangerous drugs or prescription controlled substances for the treatment of pain or a condition causing pain, including, but not limited to, intractable pain. Provides that a physician and surgeon shall not be subject to disciplinary action for prescribing, dispensing, or administering dangerous drugs or prescription controlled substances according to certain requirements. Authorizes MBC to take any action against a physician and surgeon who violates laws related to inappropriate prescribing. Provides that a physician and surgeon shall exercise reasonable care in determining whether a particular patient or condition, or the complexity of a patient's treatment, including, but not limited to, a current or recent pattern of drug abuse, requires consultation with, or referral to, a more qualified specialist. (BPC § 2241.5) SB 1174 (McGuire) Page 3 of ? 6)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. Requires the Judicial Council to adopt rules of court and develop appropriate forms. (Welfare and Institutions Code (WIC) § 369.5) 7)Provides for the development of a statewide coordinated training program designed specifically to meet the needs of county child protective services social workers, agencies under contract with county welfare departments to provide child welfare services, and persons defined as a mandated reporter pursuant to the Child Abuse and Neglect Reporting Act. (WIC §16206) 8) 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) 9) 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 of medications, other available information regarding psychosocial interventions and incidents of polypharmacy. Requires DSS to develop training, in consultation with DHCS, the Judicial Council, the County Welfare Directors Association of California, the County Behavioral Health Directors Association of California, the Chief Probation Officers of California, and stakeholders, that may be provided to county child welfare social workers, probation officers, courts hearing dependency or delinquency cases, children's SB 1174 (McGuire) Page 4 of ? attorneys, children's caregivers, court-appointed special advocates, and other relevant staff who work with children under the jurisdiction of the juvenile court that addresses the authorization, uses, risks, benefits, assistance with self-administration, oversight, and monitoring of psychotropic medications, trauma, and substance use disorder and mental health treatments, including how to access those treatments (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 that MBC shall prioritize its investigative and prosecutorial resources. 2) Requires DHCS to provide quarterly data to MBC, in collaboration with DSS 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 and including rate and age stratifications 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 (McGuire) Page 5 of ? 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. FISCAL EFFECT: Unknown. This bill is keyed "fiscal" by Legislative Counsel. COMMENTS: 1. Purpose. This bill is sponsored by the National Center for Youth and stems from a series of hearings held by the California State Senate Committees on Health and Human Services regarding the oversight and monitoring of psychotropic medication and mental health services for youth in foster care. According to the Author, over the past fifteen years, the rate of foster youth prescribed psychotropic medication has increased 1,400 percent. Nearly 1 in 4 California foster teens are prescribed psychotropic drugs; of those nearly 60 percent were prescribed an anti-psychotic - the powerful drug class most susceptible to debilitating side effects. The Author states that while the Child and Family Services Improvement and Innovation Act of 2011 requires each state to oversee and monitor the use of psychotropic medications with children in care, there are currently no requirements to identify those who are over-prescribing medication to foster youth. According to the Author, the state has not been monitoring over-prescribing because the data collection and data sharing system is not in place but that given the state's responsibility to monitor the administration of these drugs and to ensure the health and well-being of foster children, we should implement a process that provides the appropriate oversight for these powerful medications. The Author states that by establishing a formal process for MBC SB 1174 (McGuire) Page 6 of ? to responsively review and confidentially investigate psychotropic medication prescription patterns among California children, the bill brings our state in line with standard oversight practice in Washington, Illinois, and Ohio, whose initiatives have shown a 25 percent decrease in dangerous prescribing practices and have improved the overall prescription frequency for medically acceptable reasons. 2. Background. a) 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 authors recommended that collaboration between child and SB 1174 (McGuire) Page 7 of ? 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 medication 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. b) Media Reports. A recent series of stories published in the San Jose Mercury News and most recently in the Los Angeles Times, highlighted growing concerns that psychotropic medications have been relied on by California's child welfare and children's mental health systems as a means of controlling, instead of treating, youth who suffer from trauma-related behavioral health challenges. The series detailed significant challenges in accessing pharmacy benefits claims data held by the DHCS, eventually overcome through a Public Records Act request and lengthy negotiations, and demonstrated that prescribing rates were far higher than had been anticipated by child welfare system experts. c) Court Oversight Mechanisms. SB 543 (Bowen, Chapter 552, Statutes of 1999) mandated that, once a child has been adjudged a dependent of the state, only the court may authorize psychotropic medications for the child, based on a request from a physician that includes the following: The reasons for the request; A description of the child's diagnosis and behavior; The expected results of the medication; A description of any side effects of the medication. Under the statute, psychotropic medications are defined as those "administered for the purpose of affecting the SB 1174 (McGuire) Page 8 of ? central nervous system to treat psychiatric disorders or illnesses. These medications include, but are not limited to, anxiolytic agents, antidepressants, mood stabilizers, antipsychotic medications, anti-Parkinson agents, hypnotics, medications for dementia, and psychostimulants." In accordance with this statute, the Administrative Office of the Courts established a series of court documents generally referred to as "the JV 220", which includes a statement completed and signed by the prescribing physician that includes the child's diagnosis, relevant medical history, other therapeutic services, the medication to be administered, and the basis for the recommendation. In addition, a form must be included indicating notice has been provided to the parents or legal guardians, their attorneys of record, the child's attorney of record, the child's guardian ad litem, the child's current caregiver, the child's Court Appointed Special Advocate, if any, and if a child has been determined to be an Indian child, the Indian child's tribe. The procedure for notification varies by county - the responsibility may fall primarily to the child welfare agency, or it may be shared with the juvenile court clerk's office that may be responsible for notifying the attorney and the Court Appointed Special Advocate. Within four court days after notification, a parent or guardian, the child, the attorney for either, the guardian ad litem, or the Indian child's tribe may file an objection to the application. Following this period, the court files a final order. a) Oversight Concerns. Stakeholders have expressed concerns about the efficacy of oversight mechanisms, given that in many counties the court lacks access to medical experts to assist in evaluating medical information. Child welfare advocates and clinicians reported that in many instances a prescribing physician who fills out the JV 220 form may not have a history of treating the child, and thus may not be aware of prior medications or alternative treatments that have (or have not) been tried. Such information is frequently left blank on the JV 220. Additionally the California Drug Use Review recently found SB 1174 (McGuire) Page 9 of ? that fewer than four in ten children had received the required baseline laboratory screenings prior to being administered a psychotropic medication. In theory, a health and education passport - a paper file of the youth's medical history - is supposed to be provided to a new caregiver, who might provide important information to a prescribing physician; however it is common for a child to move between placements without the requisite records, leaving the foster parent also unaware of the child's medical history. The JV 220 form offers little opportunity for input from the community of representatives and caregivers involved with the youth except to offer a short window of opportunity to formally object. Furthermore, the form does not include information related to baseline or ongoing screening, it does not require consideration of alternative treatments (though it provides a field inquiring about them), nor does it offer substantive opportunities for relevant parties to weigh in with important information that may be worthy of consideration by the court. In 2012, DHCS and DSS convened a statewide Quality Improvement Project (QIP) to design, pilot, and evaluate effective practices to improve psychotropic medication use among children and youth in foster care. Three workgroups were established for the project-the Clinical Workgroup, the Data and Technology Workgroup, and the Youth, Family, and Education Workgroup to jointly conduct analysis of child welfare data, develop tools to assist prescribers, pharmacists, and juvenile courts, as well as develop and disseminate training materials and information about psychotropic medications for youths and caregivers. QIP's Data and Technology Workgroup released a summary report in December 2014 matching data from Child Welfare Services/Case Management System (CWS/CMS) and DHCS that detailed fee-for-service and Medi-Cal managed care encounter data pharmacy paid claim records for psychotropic medication for children in foster care during Federal Fiscal Year (FFY) 2012-13. The report found that of 10,557 children (under the age of 21) in California who received at least one paid claim for psychotropic medication during FFY 2012-13, 10,419 (or 98 percent) of these children were identified as youth in an active out-of-home placement. The report further broke down the data based on age, gender, ethnic group, placement type, responsible SB 1174 (McGuire) Page 10 of ? agency, time in care, and time in placement. Although the data produced a wide scope of the breakdown surrounding psychotropic drug prescriptions to foster youth, the report also cautions that there are a number of key analytical considerations when reviewing the data. The report states that the figures presented are not necessarily representative of youth for whom court authorizations for psychotropic medications are required, as it includes youths aged 18-20 years old placed with non-dependent legal guardians and other non-foster care placements as well as youth for whom court authorizations for psychotropic medications are required. In addition, the report states that since only the most recent paid claim for youth under 21 years old was used to examine the case and placement information, this data might not necessarily be reflective of their experience in care or the experiences of youth before and after the period of study. b) Guidelines. The QIP's Clinical Workgroup released a set of guidelines to assist prescribers and caregivers in maintaining compliance with State and county regulations and guidelines pertaining to Medi-Cal funded mental health services and psychotropic prescribing practices for foster homes, group homes, and residential treatment centers. In addition, the guidelines include prescriber and caregiver expectations regarding developing and monitoring treatment plans for behavioral health care, principles for informed consent to medications, and governing medication safety. These guidelines are designed as a statement of best practice for the treatment of children and youth in out-of-home care and include: Prescribing standards for psychotropic medication by age group; Parameters for psychotropic medication indications, dosing, and monitoring; Recommendations to address challenges in the management of complex cases; and Decision "algorithm" to be used by prescribers. a) Efforts in Other States. According to information provided by the Author, a number of other states have taken SB 1174 (McGuire) Page 11 of ? action to address concerns about psychotropic medication. Alabama provides a focused mailing to prescribers of any antipsychotics to children under 18, as well as telephone outreach by child psychiatrists to prescribers of antipsychotics to children under age five. Colorado sends educational alerts and letters to prescribers detailing information about the psychiatric medication utilization of their patients. In Colorado, if post-intervention changes are not observed, follow-up letters and face-to-face meetings with peer consultants are conducted. Illinois maintains a watch-list of high-risk prescribers, utilizing this data to assess the impact of changes in consent policies on prescriber behaviors. Michigan created a system whereby child psychiatrists follow-up with prescribing physicians based on established triggers to review the case and provide consultation. Missouri uses the Behavioral Pharmacy Management System to analyze prescribing patterns for children and adolescents and send letters to prescribers offering consultation on best prescribing practices. An analysis of this intervention showed a significant reduction in the percentage of outlier prescriptions. 1. Medical Board Efforts to Provide Guidance to Licensees on Prescribing. MBC utilizes guidelines for prescribing controlled substances for pain that the board established. In 1994, MBC unanimously adopted a policy statement entitled "Prescribing Controlled Substances for Pain" stemming studies and discussions about controlled substances which was designed to provide guidance to improve prescriber standards for pain management, while simultaneously undermining opportunities for drug diversion and abuse. The guidelines outlined appropriate steps related to a patient's examination, treatment plan, informed consent, periodic review, consultation, records, and compliance with controlled substances laws. Guidelines are used by physicians as well as MBC in its regulation of licensees. Subsequent to MBC's 1994 action, legislation that took effect in 2002 (AB 487, Aroner, Chapter 518, Statutes of 2001) that created a task force to revisit the 1994 guidelines to develop standards assuring competent review in cases concerning the under-treatment and under-medication of a SB 1174 (McGuire) Page 12 of ? patient's pain and also required continuing education courses for physicians in the subjects of pain management and the treatment of terminally ill and dying patients. As a result, the task force amended the guidelines from referencing only intractable pain to all kinds of pain. Guidelines were further updated following the passage of AB 2198 in 2006 (Houston, Chapter 350, Statutes of 2006), clarifying that health care professionals with a medical basis, including the treatment of pain, for prescribing, furnishing, dispensing, or administering dangerous drugs or prescription controlled substances, may do so without being subject to disciplinary action or prosecution. AB 2198 stemmed from MBC's efforts to better reflect the current state of treating pain, as well as the current manner of investigating and disciplining physicians who treat patients with pain, who often require large quantities of medication. MBC currently encourages all licensees to consult the policy statement and Guidelines for Prescribing Controlled Substances for Pain. MBC also highlights that while it is lawful under both federal and California law to prescribe controlled substances for the treatment of pain, including intractable pain, there are limitations on the prescribing of controlled substances to or for patients for the treatment of chemical dependency. MBC expects that a licensee follow the same standard of care when prescribing and/or administering a narcotic controlled substance to a "known addict" patient as he or she would for any other patient. MBC has made available to all licensees on its website as well as through an email to its licensee listserv the QIP's 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 SB 1174 (McGuire) Page 13 of ? 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. 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. 4.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 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. SB 1174 (McGuire) Page 14 of ? 5.Prior Related Legislation. SB 238 (Mitchell, Chapter 534, Statutes of 2015) required certification and training programs for foster parents, child welfare social workers, group home administrators, public health nurses, dependency court judges and court appointed council to include training on psychotropic medication, trauma, and behavioral health, as specified, for children receiving child welfare services. The bill also required Judicial Council to amend and adopt rules of court and develop appropriate forms pertaining to the authorization of psychotropic medication for foster youth, on or before July 1, 2016. SB 253 (Monning) of 2015 was also intended to respond to troubling reports about overprescribing of psychotropic medication to foster youth and would have provided a detailed framework the court must use when determining whether to approve the administration of psychotropic medication to wards and foster children, and required judicial oversight of any ongoing treatment to help ensure that these powerful drugs are only used when medically necessary and appropriate for the particular child and that such usage is very carefully monitored to ensure any benefits of the medication are not outweighed by its short- and long-term risks. The bill also would have required an order of the juvenile court authorizing psychotropic medication to require clear and convincing evidence of specified conditions and would have prohibited the authorization of psychotropic medications without a second independent medical opinion under specified circumstances, as well as would have prohibited the authorization of psychotropic medications unless the court was provided documentation that appropriate lab screenings, measurements, or tests have been completed, as specified. ( Status: The bill was placed on inactive in the Assembly.) SB 484 (Beall, Chapter 540, Statutes of 2015) required DSS to establish a methodology for identifying group homes that have levels of psychotropic dug utilization warranting additional review, and to inspect identified facilities at least once a year, as specified. The bill permitted DSS to share information and observations with the facility and to require the facility to submit a plan within 30 days to address identified risks, as specified. SB 1174 (McGuire) Page 15 of ? SB 319 (Beall, Chapter 535, Statutes of 2015) expanded the duties of the foster care public health nurse to include monitoring and oversight of the administration of psychotropic medication to foster children, as specified. 6.Arguments in Support. Numerous groups such as the Youth Law Center , Consumer Attorneys of California , and First Focus Campaign for Children support SB 1174, 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 SB 1174 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. 7.Arguments in Opposition. The California Medical Association (CMA) is concerned that SB 1174 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 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 SB 1174 (McGuire) Page 16 of ? investigation based on the data received from DHCS. They suggest that the guidelines could be a useful tool as the centerpiece of educational outreach. SUPPORT AND OPPOSITION: Support 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 Oppose California Medical Association -- END --