Proposed Measures for HEDIS : Schizophrenia

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1 Proposed Measures for HEDIS : Schizophrenia NCQA seeks comments on seven proposed schizophrenia and bipolar disorder measures for inclusion in the HEDIS 2013 measurement set: 1. Continuity of Antipsychotic Medications for Treatment of Schizophrenia. 2. Diabetes Screening for People With Schizophrenia or Bipolar Disorder Who Are Using Antipsychotic Medications. 3. Cardiovascular Health Screening for People With Schizophrenia or Bipolar Disorder Who Are Using Antipsychotic Medications. 4. Diabetes Monitoring for People With Diabetes and Schizophrenia. 5. Cardiovascular Health Monitoring for People With Cardiovascular Disease and Schizophrenia. 6. Cervical Cancer Screening for Women With Schizophrenia. 7. Follow-Up After Hospitalization for Schizophrenia. Note: Acronyms will be assigned upon inclusion in HEDIS set. The measures represent an important area of care for HEDIS. They address a vulnerable population of members: people with schizophrenia or bipolar disorder, who are disproportionately more likely to suffer chronic diseases and have a significantly shorter lifespan than the general population. The measures are similar in structure to current HEDIS measures. All seven measures are specified for administrative data collection, thereby reducing the reporting effort by health plans. In 2011, NCQA and Mathematica Policy Research conducted a field-test using the Medicaid Analytic Extract (MAX). The dataset included fee-for-service data that comprised beneficiaries from 22 states to evaluate the measure specifications. About 10 percent of the Medicaid population was identified as having schizophrenia. Expanding the measure denominator to include people with bipolar disorder identified an additional three percent of the Medicaid population. Average performance levels suggest substantial room for improvement for nearly all measures, and the variance between these measures and related HEDIS measures currently in use indicates a large disparity in care between the general population and people with schizophrenia or bipolar disorder. The proposed measures have the potential to identify members at greater risk for morbidity and mortality from adverse outcomes resulting from a lack of adherence to antipsychotic medications, preventive care and treatment. Establishment of standardized metrics provides a significant opportunity for improvement and acknowledges health plans providing the highest quality of care to their members. Comment requests NCQA specified the measures with a minimum age of 25 years as a result of improved diagnostic fidelity in older patients. Do you recommend keeping that minimum age or dropping it to 18? Supporting documents Measure specifications: Numerator and denominator algorithms, including calculation steps. Measure work-up: Analysis of measure relevance, feasibility and usability. NCQA thanks its advisory panels for their input on this work, particularly the Behavioral Health Advisory Panel. 1 HEDIS is a registered trademark of the National Committee for Quality Assurance (NCQA).

2 Cardiovascular Health Screening for People With Schizophrenia or Bipolar Disorder Who Are Using Antipsychotic Medications SUMMARY OF CHANGES TO HEDIS 2013 First-year measure. Description The percentage of members years of age who were diagnosed with schizophrenia or bipolar disorder and prescribed any antipsychotic medication, and who received a cardiovascular health screening during the measurement year. Eligible Population Product lines Ages Continuous enrollment Allowable gap Anchor date Benefits Event/ diagnosis Step 1 Medicaid years of age as of December 31 of the measurement year. The measurement year. No more than one gap in 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. Follow the steps below to identify the eligible population for the measure. Identify members as having schizophrenia or bipolar disorder using at least one of the following criteria during the measurement year. At least one acute inpatient or ED visit (Table XXX-A), with schizophrenia (Table XXX-B) or bipolar disorder (Table XXX-C) as the principal diagnosis. At least two outpatient or nonacute inpatient visits (Table XXX-A), with schizophrenia (Table XXX-B) as the principal diagnosis. At least two outpatient or nonacute inpatient visits (Table XXX-A), with bipolar disorder (Table XXX-C) as the principal diagnosis.

3 Table XXX-A: Codes to Identify Visit Type Description CPT UB Revenue Outpatient 92002, 92004, 92012, 92014, , , , , , , , , , 99411, 99412, 99420, 99429, 99455, Nonacute inpatient , 99315, 99316, 99318, , Acute inpatient , , 99238, 99239, , ED x, 0981 Table XXX-B: Codes to Identify Schizophrenia Diagnosis ICD-9-CM Diagnosis 295 Table XXX-C: Codes to Identify Bipolar Disorder Diagnosis ICD-9-CM Diagnosis 296.0, 296.1, 296.4, 296.5, 296.6, x, , , 057x-059x,, 082x-085x, 088x, 0982, , 0128, 0138, 0148, 0158, 019x, 0524, 0525, 055x, 066x 010x, , 0119, , 0129, , 0139, , 0149, , 0159, 016x, 020x,021x, 072x, 080x, 0987 Step 2 Identify members from step 1 who were also dispensed at least one antipsychotic medication during the measurement year (Table XXX-D). Table XXX-D: Antipsychotic Medications Prescription Description Typical Low Potency Typical Midpotency Typical High Potency Atypical Miscellaneous antipsychotic agents Loxapine Molindone Haloperidol Pimozide Aripiprazole Clozapine Olanzapine Paliperidone Quetiapine Risperidone Ziprasidone Lurisadone Asenapine Iloperidone Phenothiazine antipsychotics Prochlorperazine Chlorpromazine Thioridazine Mesoridazine Perphenazine Trifluoperazine Fluphenazine Psychotherapeutic combinations Fluoxetineolanzapine Thioxanthenes Thiothixene Long-acting injections Haloperidol decanoate Paliperidone palmitate

4 Extended Release Risperidone Quetiapine Step 3: Required exclusions Coronary artery bypass graft (CABG) or percutaneous coronary interventions (PCI). Members discharged alive for CABG or PCI in the measurement year or the year prior to the measurement year. Refer to Table CMC-A and use codes for PCI and CABG only. CABG cases should be from inpatient claims/encounters only. Include all cases of PCI, regardless of setting (e.g., inpatient, outpatient, ED). Ischemic vascular disease (IVD). Members who met at least one of the following criteria during both the measurement year and the year before the measurement year. Criteria need not be the same across both years. At least one outpatient visit (Table CMC-C) with an IVD diagnosis (Table CMC-B), or At least one acute inpatient claim/encounter (Table CMC-C) with an IVD diagnosis (Table CMC-B). Chronic heart failure (CHF). Members who had at least one encounter, in any setting, with a code to identify CHF. Refer to (Table CDC-P) and use codes for CHF only. Look as far back as possible in the member s history through December 31 of the measurement year. Prior Myocardial infarction (MI). Members who had at least one encounter, in any setting, with any code to identify MI (Table CDC-P). Look as far back as possible in the member s history through December 31 of the measurement year. Administrative Specification Denominator The eligible population. Numerators LDL-C Screening An LDL-C test performed during the measurement year, as identified by claim/encounter or automated laboratory data. Use any code listed in (Table CDC-H). The organization may use a calculated or direct LDL for LDL-C screening Table XXX-1: Data Elements for Cardiovascular Health Screening for People With Schizophrenia or Bipolar Disorder Who Are Using Antipsychotic Medications Measurement year Data collection methodology (Administrative) Eligible population Number of required exclusions Numerator events by administrative data Reported rate Lower 95% confidence interval Upper 95% confidence interval Administrative

5 Cardiovascular Health Screening for People with Schizophrenia or Bipolar Disorder Who Are Using Antipsychotic Medications (Measure Work-Up) Description The percentage of individuals years of age with a diagnosis of schizophrenia or bipolar disorder who were prescribed any antipsychotic medication and received a cardiovascular health screening during the measurement year. Importance Health Importance Monitoring complications of antipsychotic medications is important because the use of these medications in people with schizophrenia and bipolar disorder results in higher incidences of metabolic diseases (e.g., diabetes) and cardiovascular concerns (e.g., hyperlipidemia). The U.S. Preventive Services Task Force (USPSTF) recommends lipid disorder screening for anyone over 20 years of age with increased risk for coronary heart disease (CHD). Risks Among People with Schizophrenia. Metabolic syndrome risk is 42.6 percent for males and 48.5 percent for females, compared with rates in the general population (24 percent for males, 23 percent for females) (Cohn et al., 2004). These effects occur for first generation antipsychotic medications and for some second-generation antipsychotic medications. Patients with schizophrenia are likely to have higher levels of blood cholesterol and receive less treatment for it. Patients with schizophrenia and elevated blood cholesterol levels are prescribed statins at approximately a quarter of the rate of the general population. Furthermore, certain atypical antipsychotic drugs increase total and low-density lipoprotein (LDL) cholesterol and triglycerides, and decrease high-density lipoprotein (HDL) cholesterol, which increases the risk of coronary heart disease (Henneksen et al, 2005). Among patients with co-occurring schizophrenia and metabolic disorders, rates of non-treatment for diabetes, hyperlipidemia and hypertension were 30.2 percent for diabetes, 62.4 percent for hypertension, and 88.0 percent for dyslipidemia (CATIE trial: Nasrallah, et al., 2006). Atypical antipsychotic medications elevate the risk of metabolic conditions, relative to typical antipsychotic medications (Nasrallah, 2008). Risks Among People with Bipolar Disorder. Several studies show that people with bipolar disorder exhibit greater cardiovascular and metabolic risk factors than the general population. The studies include a prospective study and a retrospective study looking at chart reviews; both show an increased presence of metabolic abnormalities in the bipolar disorder population, which are important risk factors for cardiovascular disease (van Winkel 2008; Fiedorowicz 2008) According to the National Institute for Health and Clinical Excellence (NICE) guideline for bipolar disorder, health care professionals should conduct a lipid profile as soon as practical after initial presentation of a patient with bipolar disorder,. Individuals with schizophrenia and bipolar disorder are more likely than the general population to have lifestyle risk factors for cardiovascular disease and mortality (Brown, 1997; Phelan, et al., 2001; McCreadie, 2003; Osborn, et al., 2006; de Leon & Diaz, 2005; Hennekens, et al., 2005; Osby et al., 2001; Angst et al., 2001). Some evidence suggests high nontreatment rates for hyperlipidemia in patients with schizophrenia (Nasrallah, et al., 2006). Patients with schizophrenia and elevated blood cholesterol levels are 25 percent less likely to be prescribed statins, compared with the general population (Redelmeier, et al., 1998). Evidence suggests certain

6 antipsychotic drugs increase low-density lipoprotein (LDL) cholesterol and triglycerides (Meyer, 2001; Melkersson, et al., 2000; Nasrallah, et al., 2006; Newcomer, 2005; Newcomer & Haupt, 2006; Sikich et al., 2008) in psychiatric patients and are more likely to cause weight gain (Buchanan, 2009; Newcomer, 2005; Newcomer & Haupt, 2006). This increase in LDL-C may contribute to increased cardiovascular risk in people with schizophrenia or bipolar disorder who are taking long-term antipsychotics. Financial Importance In 2003, the overall cost burden of cardiovascular disease (CVD) was estimated at $351 billion. Of this, $209 billion made up the amount allocated for health care expenditures (direct cost) and $142 billion was the result of lost worker productivity (indirect cost) (CDC, 2005). According to the American Heart Association (AHA), the estimate for total cost burden of CVD in 2005 stood at $393.5 billion a significant increase in just two years (AHA, 2005). Opportunity for Improvement This process measure captures one or more LDL-C screenings performed on individuals with schizophrenia or bipolar disorder. The use of LDL-C screenings provides an opportunity for early treatment that is aimed to reduce poor outcomes. Evidence Citations American Heart Association (AHA) Heart Disease and Stroke Statistics 2005 Update. Dallas, Texas: American Heart Association. Angst, F., H.H. Stassen, P.J. Clayton, et al Mortality of patients with mood disorders: follow-up over years. J Affect Disord. 68: Bresee, L.C., S.R. Majumdar, S.B. Patten, J.A. Johnson Prevalence of cardiovascular risk factors and disease in people with schizophrenia: a population-based study. Schizophr Res. 117: Brown, S Excess mortality of schizophrenia: a meta-analysis. Br J Psychiatry. 171: Buchanan, R.W., J. Kreyenbuhl, D.L. Kelly, J.M. Noel, D.L. Boggs, B.A. Fischer, S. Himelhoch, B. Fang, Peterson, E., Aquino, P.R., Keller, W The 2009 schizophrenia PORT psychopharmacological treatment recommendations and summary statements. Schizophr Bull. 36: Centers for Disease Control and Prevention (CDC) Trends in cholesterol screening and awareness of high blood cholesterol United States, MMWR. 2005a;54: Cohn, T., D. Prud'homme, D. Streiner, H. Kameh, G. Remington Characterizing coronary heart disease risk in chronic schizophrenia: high prevalence of the metabolic syndrome. Can J Psychiatry. 49(11): De Leon, J. and F.J. Diaz A meta-analysis of worldwide studies demonstrates an association between schizophrenia and tobacco smoking behaviors. Schizophr Res. 76: Henderson, D.C Atypical antipsychotic-induced diabetes mellitus: how strong is the evidence? CNS Drugs, 16(2): Paper presented at the Consensus Development Conference on Antipsychotic Drugs and Obesity and Diabetes Diabetes Care. 27:596. Hennekens, C.H., A.R. Hennekens, D. Hollar, D.E. Casey Schizophrenia and increased risks of cardiovascular disease. Am Heart J. 150: Marder, S.R., S.M. Essock, A.L. Miller, R.W. Buchanan, D.E. Casey, J.M. Davis, et al Physical health monitoring of patients with schizophrenia. Am J Psychiatry. 161(8): McCreadie, R. The Scottish Schizophrenia lifestyle group Diet, smoking and cardiovascular risk in people with schizophrenia: descriptive study. British J of Psychiatry. 183: Melkersson, K.I., A.L. Hulting, K.E. Brismar Elevated levels of insulin, leptin and blood lipids in olanzapinetreated patients with schizophrenia or related psychoses. J Clin Psychiatry. 61: Meyer, J.M Novel antipsychotics and severe hyperlipidemia. J Clin Psychopharmacol. 21, Nasrallah, H.A Atypical antipsychotic-induced metabolic side effects: insights from receptor-binding profiles. Mol Psychiatry. 13(1):27 35.

7 Nasrallah H.A., J.A. Meyer, D.C. Goff, J.P. McEvoy, S.M. Davis, S. Stroup, J.A. Lieberman Low rates of treatment for hypertension, dyslipidemia and diabetes in schizophrenia: Data from the CATIE schizophrenia trial sample at baseline. Schizophr Res. 86: Newcomer, J.W Second-generation (atypical) antipsychotics and metabolic effects: a comprehensive literature review. CNS Drugs. 19,1 93. Newcomer, J.W., D.W. Haupt The metabolic effects of antipsychotic medications. Can J Psychiatry. 51: Osborn, D.J., M.B. King, I. Nazareth Risk for coronary heart disease in people with severe mental illness: cross-sectional comparative study in primary care. Br J Psychiatry. 188: Osby, U., L. Brandt, N. Correia et al Excess mortality in bipolar and unipolar disorder in Sweden. Archives of General Psychiatry. 58: Phelan, M., L. Stradins, S. Morrison Physical health of people with severe mental illness. BMJ. 322: Redelmeier, D.A., H.T. Siew, G.L. Booth The treatment of unrelated disorders in patients with chronic medical diseases. N Engl J Med. 160: Sikich, L., J.A. Frazier, J. McClellan et al Double-blind comparison of first- and second-generation antipsychotics in early-onset schizophrenia and schizo-affective disorder: findings from the treatment of earlyonset schizophrenia spectrum disorders (TEOSS) study. Am J Psychiatry. 165: Van Winkel, R., M. De Hert, D. Van Eyck Prevalence of diabetes and the metabolic syndrome in a sample of patients with bipolar disorder. Bipolar Disorder. 10: Benefits Envisioned by the Measure This measure concept is supported by systematic literature reviews, including the Consensus Development Conference (2004). The Mount Sinai Conference (Marder et al., 2004) rated the [q]uality of evidence for an association between specific antipsychotics and risk for hyperlidemia: level 2 [cohort studies, outcomes research, etc.]. The National Institute for Health and Clinical Excellence (NICE) and the American Psychiatric Association (level II, moderate clinical confidence) also recommend such monitoring. Because cardiovascular conditions are common among patients with schizophrenia or bipolar disorder and antipsychotic medications are an expected treatment that increases the risk of cardiovascular disease, screening for these conditions will allow proper diagnosis and treatment, if warranted. Gap in Care NCQA worked with Mathematica Policy Research to field-test this measure using Medicaid Analytic Extract (MAX) claims data that comprised beneficiaries from 22 states who met the following criteria: Disability as the basis of eligibility. Continuously enrolled in Medicaid for 10 months. Field-test results indicate a performance gap. Among the 22 states, the measure had a minimum value of 6.9%, mean=43.9%, 25th percentile=42.1%, median=46.1%, 75th percentile=50.6% and a maximum value of 63.3%.

8 Health Care Disparities Performance rates * did not vary by gender. Screening was higher in older age groups; African Americans were less likely to have documentation of screening. Gender Age Race/Ethnicity Male: 42.9% Female: 44.8% 25 30: 35.9% 31 40: 40.7% 41 50: 44.3% 51 60: 48.2% 61 64: 49.7% Unknown: 0.0% African American: 36.7% Caucasian: 46.0% Hispanic: 51.9% Other: 52.0% Unknown: 48.7% Guidelines The USPSTF recommends routine screening for lipid disorders in adults at average and increased risk for coronary heart disease. The NICE guideline recommends routine screening of lipids for people with bipolar disorder who have been placed on a long-term treatment of antipsychotics. Although these guidelines are not specific to adults with schizophrenia, NCQA s expert panel concluded that people with schizophrenia are also at greater risk for cardiovascular diseases because they are also treated with antipsychotic medications. Guidelines Crosswalk Organization & Year Relevant Population Guideline Grade USPSTF (2008) Men age 35 The U.S. Preventive Services Task Force (USPSTF) strongly recommends screening for lipid disorders. A Recommendation NICE (2006) Men age Women age 45 Women age People with bipolar disorder The USPSTF recommends screening for lipid disorders if they are at increased risk for coronary heart disease. The USPSTF strongly recommends screening for lipid disorders if they are at increased risk for coronary heart disease. The USPSTF recommends for lipid disorders if they are at increased risk for coronary heart disease. People with bipolar disorder should have an annual physical health review, normally in primary care, to ensure that lipid levels are assessed each year,, including cholesterol in all patients over 40 even if there is no other indication of risk. When initiating long-term treatment of bipolar disorder with antipsychotics, lipids should be measured in all patients. B Recommendation A Recommendation B Recommendation Not Rated

9 Grading System Descriptions USPSTF A Strongly Recommended: The USPSTF strongly recommends that clinicians provide [the service] to eligible patients. The USPSTF found good evidence that [the service] improves important health outcomes and concludes that benefits substantially outweigh harms. B Recommended: The USPSTF recommends that clinicians provide [the service] to eligible patients. The USPSTF found at least fair evidence that [the service] improves important health outcomes and concludes that benefits outweigh harms. C No Recommendation: The USPSTF makes no recommendation for or against routine provision of [the service]. The USPSTF found at least fair evidence that [the service] can improve health outcomes but concludes that the balance of benefits and harms is too close to justify a general recommendation. D Not Recommended: The USPSTF recommends against routinely providing [the service] to asymptomatic patients. The USPSTF found at least fair evidence that [the service] is ineffective or that harms outweigh benefits. I Insufficient Evidence to Make a Recommendation: The USPSTF concludes that the evidence is insufficient to recommend for or against routinely providing [the service]. Evidence that the [service] is effective is lacking, of poor quality, or conflicting and the balance of benefits and harms cannot be determined. The NICE guideline was not graded. Guidelines Citations National Institute for Health and Clinical Excellence (NICE) Bipolar disorder: The management of bipolar disorder in adults, children and adolescents, in primary and secondary care. CG38. London (UK): National Institute for Health and Clinical Excellence. U.S. Preventive Services Task Force (USPSTF) Screening for Lipid Disorders in Adults, Topic Page. (February 2012)

10 Data Field-Test Data* 2007 Mean 43.9 Denominator Count 97,534 Min th Percentile th Percentile th Percentile 50.6 Max 63.3 * Using MAX claims data from 2007, we included beneficiaries from 22 states who met the following criteria: enrolled in feefor-service plans;** disability as the basis of eligibility; continuously enrolled in Medicaid for 10 months. From these beneficiaries, we drew two analytic samples. Beneficiaries who had a primary diagnosis of schizophrenia on either one inpatient claim or on two outpatient claims on different days were included in our schizophrenia sample. We also tested beneficiaries who had a primary diagnosis of either schizophrenia or bipolar disorder on either one inpatient or two outpatient claims on different days. Overall, there were 98,412 beneficiaries in the schizophrenia sample and 130,529 beneficiaries in the schizophrenia or bipolar disorder sample. Data from the following states were included in both analytic samples: Alabama, Alaska, California, Connecticut, District of Columbia, Georgia, Idaho, Illinois, Indiana, Iowa, Louisiana, Maryland, Missouri, Mississippi, Nevada, New Hampshire, North Carolina, North Dakota, Oklahoma, South Dakota, West Virginia and Wyoming. Beneficiaries ranged in age from years. Just under half (49.2%) the schizophrenia population was female; 54.8% of beneficiaries with schizophrenia or bipolar disorder were female. About 7% of the sample was Hispanic. 34% of the sample was African American with schizophrenia or bipolar disorder; 39% of the sample was African American with schizophrenia. **Beneficiaries enrolled in managed care plans (e.g., BHO or HMO plans) that provided usable claims records were included. 1.4% of the schizophrenia sample were enrolled in a BHO and 11.5% were enrolled in an HMO.

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