Proposed Retirement of Existing Measure for HEDIS : Use of Multiple Concurrent Antipsychotics in Children and Adolescents

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1 Proposed Retirement of Existing Measure for HEDIS : Use of Multiple Concurrent Antipsychotics in Children and Adolescents NCQA seeks public comment on the proposed retirement of the Use of Multiple Concurrent Antipsychotics in Children and Adolescents (APC) measure. This measure describes the percentage of youths (1 17 years) on antipsychotics who are using more than one antipsychotic concurrently. NCQA is considering retirement of this measure for several reasons. 1. HEDIS results indicate there is little room for improvement. On average, less than 3% of youths on antipsychotics use more than one medication concurrently. Generally, this is a very small number and may represent complex youths who need medication management beyond monitoring of concurrent use. 2. There is little variation across plans. 3. The commercial product line is not publicly reported. Although HEDIS results indicate that the measure may not support robust plan-to-plan comparison, NCQA recognizes the importance of addressing antipsychotic overuse. Youths in foster care continue to demonstrate higher utilization rates of antipsychotics, and the measure is included in the Centers for Medicare & Medicaid Services Medicaid Child Core Set. Therefore, we welcome public comment on the measure s continued relevance for the Medicaid population. Supporting documents include the current measure specification, evidence workup and performance data. NCQA acknowledges the contributions of the Technical Measurement Advisory Panel, the Behavioral Health Measurement Advisory Panel and the National Collaborative for Innovation in Quality Measurement (NCINQ) Advisory Panel 1 HEDIS is a registered trademark of the National Committee for Quality Assurance (NCQA) National Committee for Quality Assurance 1

2 Use of Multiple Concurrent Antipsychotics in Children and Adolescents (APC)* *Developed with financial support from the Agency for Healthcare Research and Quality (AHRQ) and CMS under the CHIPRA Pediatric Quality Measures Program Centers of Excellence grant number U18HS PROPOSED RETIREMENT FOR HEDIS 2020 Description The percentage of children and adolescents 1 17 years of age who were treated with antipsychotic medications and were on two or more concurrent antipsychotic medications for at least 90 consecutive days during the measurement year. Note: A lower rate indicates better performance. Eligible Population Note: Members in hospice are excluded from the eligible population. Refer to General Guideline 17: Members in Hospice. Product lines Ages Commercial Medicaid years as of December 31 of the measurement year. Report three age stratifications and a total rate: 1 5 years years years. Total. The total is the sum of the age stratifications. Continuous enrollment Allowable gap Anchor date Benefit Event/ diagnosis Step 1 The measurement year. No more than one gap in continuous enrollment of up to 45 days during the measurement year. To determine continuous enrollment for a Medicaid beneficiary for whom enrollment is verified monthly, the member may not have more than a 1- month gap in coverage (i.e., a member whose coverage lapses for 2 months [60 days] is not considered continuously enrolled). December 31 of the measurement year. Medical and pharmacy. Members with 90 days of continuous antipsychotic medication treatment during the measurement year. Use the steps below to determine the eligible population. Identify members in the specified age range who were dispensed an antipsychotic medication (Antipsychotic Medications List) during the measurement year National Committee for Quality Assurance 2

3 Step 2 Step 3 Step 4 Calculate continuous enrollment. The member must be continuously enrolled during the measurement year. For each member, identify all antipsychotic medication dispensing events during the measurement year. Identify start and end dates for drug events. Drug events are defined separately by drug using the Drug ID field in the Medication List Directory of NDC codes. For each drug ID, sort dispensing events chronologically by dispense date. If there is more than one prescription for the same medication dispensed on the same day, use only the prescription with the longest days supply in the calculation. Starting with the first prescription in the measurement year determine if there is a second dispense date with the same Drug ID. If there is no second dispensing event with the same Drug ID, the start date is the first prescription s dispense date and the end date is the start date plus the days supply minus one. For example, a January 1 prescription with a 30 days supply has an end date of January 30. If there is a second dispensing event with the same Drug ID, determine if there are gap days (a 32-day gap is allowed). Calculate the number of days between (but not including) the first prescription s dispense date and the second prescription s dispense date. If the number of days is less than or equal to the first prescription s days supply plus 32 days, the gap is less than or equal to 32 days and is allowed. The start date is the first prescription s dispense date and the end date is the second prescription s dispense date plus days supply minus one. Continue assessing all subsequent dispensing events with allowable gaps for the same Drug ID and adjust end dates as needed. For example, a member has two dispensing events with the same Drug ID. The first is on July 1, with a 30 days supply. The second is on September 1, with a 30 days supply. The number of days between (but not including) the dispense dates is 61 (July 2 August 31). The gap is allowed because 61 is less than the first prescription s days supply plus 32 days ( = 62). The start date is July 1 and the end date is September 30. If there is a second dispensing event with the same Drug ID and there is a gap that exceeds the allowable gap, assign an end date for this drug event and follow the beginning of step 4 for the remaining dispensing events. A member can have multiple start and end dates per Drug ID during the measurement year. Continue assessing each dispensed prescription for each Drug ID until all dispensing events are exhausted. If a dispensing event goes beyond December 31 of the measurement year, assign the end date as December 31. Step 5 For each member, identify those with 90 consecutive treatment days. For each member, using the start and end dates from all drug events identified in step 4 (which may include events for the same or different medications and may include events with allowable gaps), determine all calendar days covered by at least one antipsychotic medication. If there were 90 consecutive calendar days, include the member in the measure National Committee for Quality Assurance 3

4 Antipsychotic Medications Description Prescription Miscellaneous antipsychotic agents Aripiprazole Asenapine Brexpiprazole Cariprazine Clozapine Haloperidol Iloperidone Loxapine Lurisadone Molindone Olanzapine Paliperidone Pimozide Quetiapine Quetiapine fumarate Risperidone Ziprasidone Phenothiazine antipsychotics Chlorpromazine Fluphenazine Perphenazine Perphenazineamitriptyline Prochlorperazine Thioridazine Trifluoperazine Thioxanthenes Thiothixene Long-acting injections Aripiprazole Fluphenazine decanoate Haloperidol decanoate Olanzapine Paliperidone palmitate Risperidone Administrative Specification Denominator The eligible population. Numerator Members on two or more concurrent antipsychotic medications for at least 90 consecutive days during the measurement year. Use the steps below to determine the numerator. Step 1 Step 2 For each member, by Drug ID, identify all drug events identified in step 4 of the event/diagnosis criteria (used to identify the eligible population [denominator]). Exclude denied claims and recalculate start dates and end dates (using steps 1 4 of the event/diagnosis criteria used to identify the eligible population [denominator]). Identify concurrent antipsychotic medication treatment events as follows. For each member, identify the first day during the measurement year when the member was treated with two or more different antipsychotic medications (use the Drug ID to identify different drugs). This is the concurrent antipsychotic medication treatment event start date. Beginning with (and including) the start date, identify the number of consecutive days the member remains on two or more different antipsychotic medications. If the number of days 90 days, the member is numerator compliant. If the number of consecutive days on multiple antipsychotic medications is <90 days, identify the end date and identify the next day during the measurement year when the member was treated with two or more different antipsychotic medications. If the number of days between the end date and the next start date is 15 days, include the days in the concurrent antipsychotic medication treatment event (concurrent antipsychotic medication treatment events allow a 15-day gap). If the number of days between the end date and the next start date exceeds 15 days, end the event; using the new start date, continue to assess for concurrent antipsychotic medication treatment events. Continue this process until the number of concurrent antipsychotic medication treatment days is 90 consecutive days (i.e., the member is numerator compliant) or until the measurement year is exhausted (i.e., no concurrent antipsychotic medication treatment events were identified during the measurement year) National Committee for Quality Assurance 4

5 Note Supplemental data may not be used for this measure. Do not include denied claims when identifying the eligible population or assessing the numerator for this measure. Data Elements for Reporting Organizations that submit HEDIS data to NCQA must provide the following data elements. Table APC-1: Data Elements for Use of Multiple Concurrent Antipsychotics in Children and Adolescents Administrative Measurement year Data collection methodology (Administrative) Eligible population Numerator events by administrative data Reported rate For each age stratification and total For each age stratification and total For each age stratification and total 2019 National Committee for Quality Assurance 5

6 Use of Multiple Concurrent Antipsychotics in Children Measure Workup Topic Overview Prevalence and Importance Prevalence of antipsychotic use in children and adolescents Health importance Antipsychotic prescribing for children and adolescents rapidly increased in recent decades and peaked in the late 2000s. In 2010, 1% of children years had received an antipsychotic in the past month (Jonas et al., 2013). Utilization has since declined slightly, particularly for the Medicaid population (Crystal et al., 2016). Although some evidence supports the efficacy of antipsychotics in youths for certain narrowly defined conditions, less is known about the safety and effectiveness of antipsychotic prescribing patterns in community use (e.g., combinations of medications, off-label prescribing, dosing outside recommended ranges). A 2011 study evaluating antipsychotic utilization among youths insured under Medicaid found that, among those receiving any antipsychotic, 3% received two or more concurrently (Crystal et al., 2016). Both the efficacy and side effects of antipsychotic medications vary, depending on age. Children and adolescents prescribed antipsychotics are more at risk for serious health concerns, including weight gain, extrapyramidal side effects, hyperprolactinemia and some metabolic effects (Correll et al., 2011). Girls treated with certain antipsychotics may also be at increased risk for gynecological problems (Talib et al., 2013) and osteoporosis (Cohen et al., 2012). Risks of multiple concurrent antipsychotics in comparison to monotherapy have not been systematically investigated; existing evidence appears largely in case reports and includes increased risk of serious drug interactions, delirium, serious behavioral changes, cardiac arrhythmias and death (Safer et al., 2003). Research demonstrating that the pharmacokinetics of antipsychotics may vary by developmental stage (Correll et al., 2011) also suggests that use of multiple concurrent antipsychotics may pose differing risks for children and for adolescents. In general, the field lacks high-quality studies of side effects associated with the use of multiple concurrent medications in adults (Van Bennekom et al., 2013). Financial importance and costeffectiveness The financial impact of multiple concurrent antipsychotic use in children has not been examined; however, antipsychotics are a costly form of drug therapy. Atypical antipsychotics have the greatest mean prescription cost ($132) of any psychotropic medication (Martin & Leslie, 2003) and are the most costly drug class within the Medicaid program (Crystal et al., 2009). Additionally, there are substantial long-term costs of treating side effects associated with antipsychotic medications, including treatment of obesity, diabetes and dyslipidemias. There is some evidence that these health conditions, such as new onset diabetes, do not always resolve after discontinuation of the antipsychotic (Lean and Pajonk, 2003). Although this is an understudied area, it is reasonable to assume that unresolved side effects from antipsychotics would be associated with the long-term increases in health care costs that have been established for obesity and diabetes. Evidence Supporting the Avoidance of Multiple Concurrent Antipsychotic Use in Children Although there is no research on the long-term effects of multiple concurrent antipsychotics on children s health, the increased burden of side effects of certain antipsychotic medications for youths, such as weight gain and metabolic disturbances, has implications for future physical health, including concerns such as obesity and diabetes. In addition, there is little empirical evidence to support the use of multiple concurrent antipsychotics to achieve better clinical outcomes in the mental health treatment of youths National Committee for Quality Assurance 6

7 Practice guidelines for prescribing antipsychotics in children The American Academy of Child & Adolescent Psychiatry (AACAP) developed a series of practice parameters that address use of psychotropic medications, the broader class of medications under which antipsychotics fall. None of the 10 AACAP practice parameters recommends concurrent use of multiple antipsychotic medications. For example, the AACAP Practice Parameters for the Use of Atypical Antipsychotic Medications in Children and Adolescents state, the use of multiple AAAs [atypical antipsychotics] has not been studied rigorously and generally should be avoided (AACAP, 2012). Additional practice guidelines also caution against the use of multiple concurrent antipsychotics in children. The Center for Education and Research on Mental Health Therapeutics guideline Treatment of maladaptive aggression in youth recommends that the use of two simultaneous psychotropic medications should be avoided (Scotto Rosato et al., 2012). The Texas Psychotropic Medication Utilization Parameters for Foster Children (2013) include two or more concomitant antipsychotic medications as a situation that suggests the need for additional review of a patient s clinical status. Gaps in care Health care disparities Disparities based on race/ethnicity A systematic review found that among youth prescribed any antipsychotic, about 1 in 10 (9.6%, SD 7.2%) received multiple concurrent antipsychotics (Toteja et al., 2013). Studies of multiple concurrent antipsychotics among youths prescribed any antipsychotic have found that its prevalence among adolescents is twice that of younger children, and that the rate among adolescents has increased two-fold from the 1990s to 2000s (Toteja et al., 2013). One study of a large state Medicaid fee-forservice program found that about 7% of children 6 17 on any antipsychotic were prescribed two or more antipsychotics for longer than 60 days (Constantine et al., 2010). The Use of Multiple Concurrent Antipsychotics in Children and Adolescents HEDIS measure has been reported for 4 years. Results for 2017 demonstrate that on average across plans, 2.4% and 2.9% (lower is better) of children on antipsychotics are using two or more concurrently among Medicaid and commercial plans, respectively. Since the introduction of the measure, the variability between Medicaid plans in the 10th and 90thpercentile has decreased. Commercial plans demonstrate less change in variability. Over a decade of research suggests that minority youths may have both higher unmet needs for mental health care and receive lower-quality care than White youths (Alegria et al., 2010). Although there is evidence to suggest that there may be racial disparities in antipsychotic medication practices for adults with schizophrenia, these may not generalize to all ages or diagnoses (Busch et al., 2009; Kuno et al., 2002; Rost et al., 2011). A study of children in foster care in New York found that Black children were more likely to be prescribed second-generation antipsychotics than children identified as Latino or other race (White and Asian) (Linares et al., 2013). There is limited research on potential racial/ethnic disparities in the use of multiple concurrent antipsychotics. In a large cross-sectional study of 637,924 Medicaid-enrolled children in one state (dosreis et al., 2011) found that Black youths were more likely than White youths to be prescribed two or more overlapping antipsychotics, suggesting that certain populations may be at higher risk for this quality concern. As part of the measure s field-testing, an analysis of administrative claims data from 2008 MAX data found that use of multiple concurrent antipsychotic medications was higher among Black, non-hispanic children and children in foster care. Rates of multiple concurrent antipsychotic medication use ranged from 6.1% in Hispanics to 7.5% in Black non-hispanics and 9.1% in other among the general population of children. Rates ranged from 6.4% in Hispanics to 8.1% in Black non-hispanics and 8.6% in other among children in foster care National Committee for Quality Assurance 7

8 Disparities based on rurality/ urbanicity A further analysis of administrative claims data from 2008 MAX data found that for the general population of children, higher rates of multiple concurrent antipsychotic use were seen in metropolitan areas (6.8%) than in rural areas (5.7%). However, within the foster care population, higher rates were seen in rural areas (9.5%) than in metropolitan areas (6.6%). References Alegria, M., M. Vallas, A.J. Pumariega. October Racial and Ethnic Disparities in Pediatric Mental Health. Child Adolesc Psychiatr Clin N Am 19(4): American Academy of Child and Adolescent Psychiatry. September Practice Parameter on the Use of Psychotropic Medication in Children and Adolescents. J Am Acad Child Adolesc Psychiatry 48(9): American Academy of Child and Adolescent Psychiatry. Practice parameter for the use of atypical antipsychotic medications in children and adolescents. Accessed July 12, Web.pdf Busch, A., A. Lehman, H. Goldman, et al Changes Over Time and Disparities in Schizophrenia Treatment Quality. Med Care 47: Cohen, D., O. Bonnot, N. Bodeau, et al Adverse Effects of Second-Generation Antipsychotics in Children and Adolescents. J Clin Psychopharm 32: Constantine, R., M. Bengtson, T. Murphy, et al Impact of the Florida Medicaid Prior-Authorization Program on Use of Antipsychotics by Children Under Age Six. Psychiatr Serv 12: doi: /appi.ps Correll, C.U., C.J. Kratochvil, J.S. March Developments in Pediatric Psychopharmacology: Focus on Stimulants, Antidepressants, and Antipsychotics. J Clin Psychiatry 72: Crystal, S., T. Mackie, M.C. Fenton, et al Rapid Growth of Antipsychotic Prescriptions for Children Who Are Publicly Insured Has Ceased, But Concerns Remain. Health Affairs 35(6): Crystal, S., M. Olfson, C. Huang, H. Pincus, and T. Gerhard Broadened Use of Atypical Antipsychotics: Safety, Effectiveness, and Policy Challenges. Health Affairs 28:w dosreis, S., Y. Yoon, D.M. Rubin, et al Antipsychotic Treatment Among Youth in Foster Care. Pediatrics 128:e Gallego, J.A., J. Bonetti, J. Zhyang, et al Prevalence and Correlates of Antipsychotic Polypharmacy: A Systematic Review and Meta-Regression of Global and Regional Trends From the 1970s to Schiz Research 138: Kuno, E., A. Rothbard Racial Disparities in Antipsychotic Prescription Patterns for Patients With Schizophrenia. Am J Psychiatry 159: Jonas, B.S., Q. Gui and J.R. Albertorio-Diaz Psychotropic Medication Use Among Adolescents: United States, Centers for Disease Control and Prevention. NCHS Data Brief No. 135, Dec atabriefs/db135.htm Lean, M.E., and F.G. Pajonk Patients on Atypical Antipsychotic Drugs Another High-Risk Group for Type 2 Diabetes. Diabetes Care 26(5), Linares, L.O., N. Martinez-Martine, F.X. Castellanos Stimulant and Atypical Antipsychotic Medications for Children Placed in Foster Homes. PLOS One 8:e Martin, A., D. Leslie Trends in Psychotropic Medication Costs for Children and Adolescents, Arch Pediatr Adolesc Med 157(10): Matone, M., R. Localio, Y-s Huang, et al The Relationship Between Mental Health Diagnosis and Treatment With Second-Generation Antipsychotics Over Time: A National Study of Medicaid-Enrolled Children. Health Services Research 47: Rost, K., Y-P Hsieh, S. Xu, et al Potential Disparities in the Management of Schizophrenia in the United States. Psychiatr Serv 62: Safer, D.J., J.M. Zito, S. DosReis Concomitant Psychotropic Medication for Youths. Am J Psychiatry 160(3): p Scotto Rosato, N., C.U. Correll, E. Pappadopulos, A. Chait, S. Crystal, P.S. Jensen. June Treatment of Maladaptive Aggression in Youth: CERT Guidelines II. Treatments and Ongoing Management. Pediatrics 129(6):e Talib, H.J., E.M. Alderman Gynecologic and Reproductive Health Concerns of Adolescents Using Selected Psychotropic Medications. Pediatr Adolesc Gynecol 26: National Committee for Quality Assurance 8

9 Texas Department of Family and Protective Services and University of Texas at Austin College of Pharmacy Psychotropic Medication Utilization Parameters for Foster Children. Accessed October 22, The Children s Hospital of Philadelphia New PolicyLab Research Expands Understanding of Psychoactive Medication Use Among Children in Foster Care. Toteja, N., J.A. Gallego, E. Saito, et al Prevalence and Correlates of Antipsychotic Polypharmacy in Children and Adolescents Receiving Antipsychotic Treatment. International Journal of Neuropsychopharmacology doi: /S Van Bennekom, M., H. Gijsman, F. Zitman Antipsychotic Polypharmacy in Psychotic Disorders: A Critical Review of Neurobiology, Efficacy, Tolerability and Cost Effectiveness. Journal of Psychopharmacology 27: National Committee for Quality Assurance 9

10 Specific Guideline Recommendations Recommendations for Avoiding Multiple and Concurrent Antipsychotic Use in Children and Adolescents Guideline (Date) Population Recommendation or Statement Type/Grade AACAP-AAA (2011) Practice parameter for the use of atypical antipsychotic medications in children and adolescents1 AACAP-PsyMed (2009) Practice parameter on the use of psychotropic medication in children and adolescents2 TMAY (2012) Center for Education and Research on Mental Health Therapeutics - Treatment of maladaptive aggression in youth3 TX (2010) Texas Department of Family and Protective Services Psychotropic medication utilization parameters for foster children4 *TX (2010) did not specify the use of any rating system Grading System Key 5-18 years 18 years 18 years Children (age un-specified) The simultaneous use of multiple concurrent AAAs has not been studied rigorously and generally should be avoided. (Recommendation 8) The prescriber needs a clear rationale for using medication combinations. there is limited evidence in children and adolescents for the use of two antidepressants or two antipsychotics as an initial treatment approach or as a specific endpoint for treatment. (Principle 12) Use of two simultaneous psychotropic medications should be avoided (Recommendation 18) Prescribing multiple antipsychotics is a situation that warrants clinical review. Not Endorsed Best practice principle Evidence: C Recommendation: Very Strong Not specified* AACAP Guideline Developer AACAP endorsed best practice principles Definition Minimal Standard/ Clinical Standard: rigorous/ substantial empirical evidence (meta-analyses, systematic reviews, RCTs) and/or overwhelming clinical consensus; expected to apply more than 95% of the time Clinical guidelines: strong empirical evidence (non-randomized controlled trials, cohort or case-control studies), and/or strong clinical consensus; expect to apply in most cases (75% of the time) Options: acceptable but not required; there may be insufficient evidence to support higher recommendation (uncontrolled trials, case/series reports). Not endorsed: ineffective or contraindicated. Best practice principles that underlie medication prescribing, to promote the appropriate and safe use of psychotropic medications 2019 National Committee for Quality Assurance 10

11 TMAY Ratings Guideline Developer Definition Oxford Centre for Evidence-Based Medicine grade of evidence (A-D)5 Strength of Recommendation: Very strong ( 90% agreement) Strength of Recommendation: Very strong (70%-89% agreement) Strength of Recommendation: Very strong (50%-69% agreement) Strength of Recommendation: Very strong (<50% agreement) References for Recommendations American Academy of Child and Adolescent Psychiatry. Practice Parameter for the Use of Atypical Antipsychotic Medications in Children and Adolescents. Accessed July 12, American Academy of Child and Adolescent Psychiatry. Practice parameter on the use of psychotropic medication in children and adolescents. J Am Acad Child Adolesc Psychiatry. Sep 2009; 48(9): Scotto Rosato, N., C.U. Correll, E. Pappadopulos, A. Chait, S. Crystal, P.S. Jensen. June Treatment of Maladaptive Aggression in Youth: CERT Guidelines II. Treatments and Ongoing Management. Pediatrics 129(6):e Texas Department of Family and Protective Services and University of Texas at Austin College of Pharmacy Psychotropic Medication Utilization Parameters for Foster Children. Accessed October 22, September2013.pdf OCEBM Levels of Evidence Working Group The Oxford 2011 Levels of Evidence. Accessed October 12, National Committee for Quality Assurance 11

12 HEDIS Health Plan Performance Rates: Use of Multiple Concurrent Antipsychotics in Children and Adolescents (APC) Table 1. HEDIS APC Measure Performance by Year Medicaid Plans Number of Plans Measurement Number of Reporting (N Standard Mean Year Plans (N) (%)) Deviation 10th Performance Rates (%) 25th 50th 75th 2017* (58.9) (57.5) (55.0) Note: Lower APC measure rates indicates better performance. *For 2017, the average denominator across plans was 796 individuals. Table 2. HEDIS APC Measure Performance by Year Commercial Plans Number of Plans Measurement Number of Reporting (N Standard Mean Year Plans (N) (%)) Deviation 10th Performance Rates ($) 25th 50th 75th 2017* (60.6) (61.2) (60.3) Note: Lower APC measure rates indicates better performance. *For 2017, the average denominator across plans was 208 individuals. 90th 90th 2019 National Committee for Quality Assurance 12