Proposed New Measures for HEDIS 1 Learning Collaborative: Depression Care Measures Set

Transcription

1 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Proposed New Measures for HEDIS 1 Learning Collaborative: Depression Care Measures Set NCQA s theme for 2015 our 25th anniversary is Looking Forward. As part of planning for NCQA s future, we propose new HEDIS measures that address patient-reported outcomes and utilize electronic clinical data. The measures are proposed for phased implementation through a learning collaborative, with voluntary reporting using a new data collection method. We have been encouraged by stakeholders to explore measures that assess depression care; specifically, do health plan members get screened for depression appropriately and do they receive care that leads to improved outcomes? Throughout the development process, NCQA focused on specifications assessing the quality of patient management and ones that encourage collaborative care by utilizing technology in an efficient and effective manner. To achieve these goals, detailed electronic clinical data, such as electronic health records (EHRs) and clinical registries, were required in order to provide valid and reliable health plan HEDIS measures. NCQA seeks comments on the proposed measure set, Depression Care for Adolescents and Adults, which will require a new data collection method using electronic clinical data sources: 1. Utilization of the PHQ-9 to Monitor Depression Symptoms for Adolescents and Adults. The percentage of members 12 years of age and older with a diagnosis of major depression or dysthymia who have a PHQ-9 or PHQ-A tool administered at least once during a four-month period. 2. Depression Remission, Response or Treatment Adjustment for Adolescents and Adults. The percentage of members 12 years of age and older with a diagnosis of depression and an elevated PHQ-9 or PHQ-A score, who had evidence of response or remission within 5 7 months of the elevated PHQ-9 score or an indication of treatment adjustment within 30 days of the PHQ-9 score that showed no evidence of response or remission. 3. Depression Screening and Follow-up for Adolescents and Adults. The percentage of members 12 years of age and older who were screened for clinical depression using a standardized tool and, if screened positive, who received appropriate follow-up care. The new measures are adapted from existing NQF-endorsed provider-level measures, developed by Minnesota Community Measurement and the Centers for Medicare & Medicaid, and used in various federal quality reporting programs. They assess care for depression along the continuum of care and will be included in a new HEDIS domain. In recognition of the unique challenges and opportunities new data sources present, we propose to phase-in voluntary reporting through a learning collaborative, beginning with Utilization of the PHQ-9 for HEDIS NCQA will work with health plans to refine data collection and reporting guidelines. We expect to identify several innovative solutions and better understand the role of health plans in aggregating electronic data for quality improvement. Although we expect limited ability to report these measures initially, this will be a large step forward in adapting HEDIS to efficient use of health information technology. The new data collection method introduces possibilities for future HEDIS measures that let plans track meaningful outcomes and earn recognition for investing in innovative quality improvement strategies. NCQA field-tested the measures using different data sources (e.g., EHRs, a statewide database for quality reporting, administrative claims, medical records). Performance results were generated for Medicare, Medicaid and commercial plans using 2012 and 2013 data. They demonstrate low performance, suggesting that gaps in care exist for all three measures, independent of data source. Testing also demonstrated the feasibility of calculating and reporting the measures at the health plan level, using EHR and other electronic 1 HEDIS is a registered trademark of the National Committee for Quality Assurance (NCQA).

2 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, clinical data. Supporting documents for the proposed measures include the draft measure specifications and associated measure rationale work-up. NCQA would like to hear from health plans who are interested in participating in a learning collaborative for further testing of these measures in Please send inquiries to Learningcollaborative@ncqa.org. NCQA acknowledges the contributions of the Geriatric Measurement Advisory Panel, the Behavioral Health Measurement Advisory Panel and the Technical Measurement Advisory Panel. This project was supported by grant number U18HS (PI: Scholle) from the Agency for Healthcare Research and Quality (AHRQ) and contract number HHSM C from the Centers for Medicare and Medicaid Services (CMS). The content is solely the responsibility of the authors and does not necessarily represent the official views of AHRQ or CMS.

3 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Utilization of the PHQ-9 to Monitor Depression Symptoms for Adolescents and Adults SUMMARY OF CHANGES TO HEDIS 2016 This is a first year measure for HEDIS 2016 using a new reporting methodology for electronic clinical data. Description The percentage of members 12 years of age and older with a diagnosis of major depression or dysthymia who have a PHQ-9 or PHQ-A tool administered at least once during a four-month period. Two rates are reported. 1. ECDS Data Coverage Rate. The percentage of members 12 and older with a diagnosis of major depression or dysthymia who are covered by an electronic clinical data system (ECDS). 2. PHQ Utilization Rate. The percentage of PHQ utilization. Members with a diagnosis of major depression or dysthymia who are covered by an ECDS and, if they had an outpatient encounter, have either a PHQ-9 or PHQ-A Score present in their record. Definitions ECDS Electronic clinical data system. An electronic version of a patient s comprehensive medical experiences, maintained over time. May include some or all of the key administrative clinical data relevant to the patient s care (e.g., demographics, progress notes, problems, medications, vital signs, past medical history, social history, immunizations, laboratory data, radiology reports). The ECDS provides automated access to the patient s comprehensive information and has the ability to create data files to be used for quality reporting (e.g., QRDA 1, C-CDA, CCD) and may also support other care-related activities through various interfaces, including evidence-based decision support, quality management and outcomes reporting. To qualify for this measure, ECDS data must be automated and accessible to the care team at the point of care (e.g., EHRs, registries and case management or disease management systems that the provider has access to during a patient interaction). Measurement period The measurement year is segmented to establish regular utilization of the PHQ assessment tool in the management of depression. The first qualifying encounter in each period determines the denominator events for the performance measure. The measurement year is divided into three periods: Assessment Period One. Dates of service January 1 through April 30 of the measurement year. Assessment Period Two. Dates of service May 1 through August 31 of the measurement year. Assessment Period Three. Dates of service September 1 through December 31 of the measurement year.

4 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Eligible Population Product line Ages Commercial, Medicare, Medicaid (report each product line separately). 12 years and older as of January 1 of the measurement year. Report four age stratifications and a total rate years. 65+ years years. Total years. Continuous enrollment Allowable gap Anchor date Benefit Event/ diagnosis Step 1 Step 2 Step 3 The measurement year. No more than one gap in enrollment 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. Identify all members with an active diagnosis of major depression or dysthymia (Major Depression and Dysthymia Value Set) that starts before the beginning of the measurement year or during the measurement year. Identify all members in step 1 with an active diagnosis of depression that starts before or during an outpatient encounter (Depression Encounter Value Set) that occurs in the measurement year. Determine continuous enrollment. For all members identified in step 2, identify members continuously enrolled in the health plan for the measurement year, with no more than a 45-day gap in enrolment. Electronic Specification ECDS data coverage denominator ECDS data coverage numerator The eligible population. Identify all members for whom the plan has access to the electronic clinical data. This includes any provider or provider groups that can submit clinical data to the health plan via electronic file transfer (e.g., QRDA 1, C-CDA, CCD) or through third-party aggregator applications for purposes of quality reporting. Include members only if the electronic clinical interface is accessible by health care providers at the point of care.

5 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Utilization of PHQ-9 denominator Step 1 Step 2 Step 3 Step 4 Utilization of PHQ-9 numerator Step 1 Step 2 Step 3 Step 4 Step 5 Total performance Rate Count the first outpatient encounter in any or all of the three assessment periods. Members need only have one event in any measurement period to be counted. Follow the steps below to determine denominator events. For all members from the ECDS data coverage numerator identify all outpatient encounters (Depression Encounter Value Set) during the measurement year where an active diagnosis of depression starts before or during the encounter. For each outpatient encounter in step 1, identify the date of service and classify each encounter in one of the three assessment periods. For each assessment period, count only the first qualifying encounter for each member. Each member may have up to three qualifying encounters (one from each assessment period) for the measurement year. Count the number of qualifying encounters for each member. The denominator is the sum of the member s first qualifying encounter for each assessment period. A PHQ-9 or PHQ-A total score in the patient s record during the assessment period in which a qualifying encounter occurred. Follow the steps below to determine numerator events. For each member, identify PHQ questionnaires completed during the measurement year. The presence of a PHQ total score indicates completion of a PHQ assessment tool. Assign a date to each PHQ score. Use the date when the PHQ total score was recorded, not the date when the assessment was performed. Classify each PHQ score in an assessment period. For each assessment period, count only the first qualifying PHQ total score for each member. Each member may have up to three qualifying PHQ total scores (one from each assessment period) for the measurement year. Sum the qualifying PHQ events across the three periods to report the total PHQ utilization numerator. To calculate the performance rate, divide the sum of the qualifying PHQ events across the three assessment periods (step 5) by the sum of the qualifying encounters across the three assessment periods. Exclusions (Required) Any member with an active diagnosis of any of the following at any time during the measurement year: Bipolar disorder (Bipolar Disorder Value Set; Bipolar Disorder ECDS Value Set). Personality disorder (Personality Disorder Value Set; Personality Disorder ECDS Value Set). Psychotic disorder (Psychotic Disorders Value Set). Autism spectrum disorder (Pervasive Developmental Disorder Value Set). Also exclude: Members admitted to hospice during the measurement year or with permanent residence in a nursing home. Note: Value Sets will contain all applicable SMED codes.

6 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Data Elements for Reporting Organizations that submit HEDIS data to NCQA must provide the following data elements. Table XXX-1/2/3: Data Elements for Utilization of the PHQ-9 to Monitor Depression Symptoms Measurement year Data collection methodology (Electronic Clinical Data) Eligible population ECDS denominator ECDS numerator Required exclusions Numerator total rate Lower 95% confidence interval Upper 95% confidence interval Electronic Clinical Data For each age stratification and total For each age stratification and total

7 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Measure Flow Diagrams Figure 1: Electronic Data Capture Rate for Depression Care Eligible Population Is the member aged 12 or older? Did the member Not included in eligible population Have an active diagnosis of MDD or dysthymia starting before the start of the measurement year or during the measurement year? Have an outpatient encounter preceded by an active diagnosis of depression during the measurement year? Have continuous enrollment in the health plan for the measurement year, with medical benefits? Not included in eligible population Exclusions Did the member have an active diagnosis of bipolar disorder, personality disorder, schizophrenia, psychotic disorder or pervasive developmental disorder anytime during the measurement year? OR Was the member in hospice or a permanent resident in a nursing home during the measurement year? Not included in denominator Does the health plan have direct access to the electronic clinical data as required by the measure specification? This includes any submission of clinical data directly to the health plan via electronic file transfer (e.g. QRDA 1, C-CDA, or CCD) for purposes of quality reporting. Not numerator compliant Numerator Are these data also directly accessible at the point of care by the reporting provider? Not numerator compliant Numerator compliant

8 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Figure 2: Measure Performance Eligible Population Is the member aged 12 or older? Did the member Not included in eligible population Have an active diagnosis of MDD or dysthymia starting before the start of the measurement year or during the measurement year? Have an outpatient encounter preceded by an active diagnosis of depression during the measurement year? Have continuous enrollment in the health plan for the measurement year, with medical benefits? Not included in eligible population Exclusions Did the member have an active diagnosis of bipolar disorder, personality disorder, schizophrenia, psychotic disorder or pervasive developmental disorder anytime during the measurement year? OR Was the member in hospice or have permanent residence in a nursing facility during the measurement year? Not included in denominator Did the member have a qualifying encounter in Assessment Period 1? (January 1 through April 30) Count in denominator Denominator Did the member have a qualifying encounter in Assessment Period 2? (May 1 through August 31) Count in denominator Did the member have a qualifying encounter in Assessment Period 3? (September 1 through December 31) Count in denominator Numerator Does the member have a PHQ total score in Assessment Period 3? (September 1 through December 31) Does the member have a PHQ total score in Assessment Period 2? (May 1 through August 31) Does the member have a PHQ total score in Assessment Period 1? (January 1 through April 30) Numerator compliant

9 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Depression Remission, Response or Treatment Adjustment for Adolescents and Adults SUMMARY OF CHANGES TO HEDIS This is a new measure for HEDIS, using a new reporting methodology for electronic clinical data. Description The percentage of members 12 years of age and older with a diagnosis of depression and an elevated PHQ-9 or PHQ-A score, who had evidence of response or remission within 5 7 months of the elevated PHQ-9 score or an indication of treatment adjustment within 30 days of the PHQ-9 score, that showed no evidence of response or remission. Five rates are reported: 1. ECDS Data Coverage Rate. The percentage of members 12 years of age and older whose health information is accessible in an electronic clinical data system (ECDS). 2. Depression Remission Rate. The percentage of members who achieved remission (PHQ score <5) within five seven months after the initial elevated PHQ-9 score. 3. Depression Response Rate. The percentage of members who were not in remission and showed response within five seven months after the initial elevated PHQ-9 score. 4. Depression Treatment Adjustment Rate. The percentage of members who have an indication of treatment adjustment within 30 days of the PHQ-9 score that showed no response or remission. 5. Remission, Response and Treatment Adjustment Total Rate. The sum of the Remission, Response and Treatment Adjustment performance rates. Definitions ECDS Electronic clinical data system. An electronic version of a patient s comprehensive medical experiences, maintained over time. May include some or all of the key administrative clinical data relevant to the patient s care (e.g., demographics, progress notes, problems, medications, vital signs, past medical history, social history, immunizations, laboratory data, radiology reports). The ECDS provides automated access to the patient s comprehensive information and has the ability to create data files to be used for quality reporting (e.g., QRDA 1, C-CDA, CCD) and may also support other care-related activities through various interfaces, including evidence-based decision support, quality management and outcomes reporting. To qualify for this measure, ECDS data must be automated and accessible to the care team at the point of care (e.g., EHRs, registries and case management or disease management systems that the provider has access to during a patient interaction). Intake period IESD May 1 of the year prior to the measurement year through April 30 of the measurement year. Index Episode Start Date. The earliest date during the intake period where either a PHQ-9 or a PHQ-A score >9 is documented in the ECDS within 30 days of an interactive encounter between the member and a provider. An interactive encounter can be face-to-face, phone-based or via secure messaging (e.g., or patient portal).

10 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Depression reevaluation period Treatment remission Treatment response Treatment adjustment Depression response score The day (inclusive) period following the IESD, during which depression symptoms are reevaluated using the PHQ-9 or PHQ-A tool. Members who achieve remission from depression, as demonstrated by a PHQ-9 or PHQ-A score of <5 recorded in the ECDS during the Depression Reevaluation Period. Members with indication of response to treatment for depression, as demonstrated by a PHQ-9 total score or PHQ-A total score reduction of at least 50 percent during the Depression Reevaluation Period. Members with no indication of remission or response on a follow-up PHQ-9 or PHQ-A score during the Depression Reevaluation Period, but who have evidence that treatment was adjusted (i.e., dispensed a new antidepressant or non-antidepressant psychotropic medication, had increased dosage of an antidepressant, switched antidepressants, were delivered a new therapy or changed therapy type) within 30 days of the follow-up PHQ-9 or PHQ-A score that showed no remission or response. PHQ-9 or PHQ-A score indicating a member s depression symptom level. The PHQ score must be the last noted in the member s record during the Depression Reevaluation Period (i.e., if multiple PHQ scores are present in the member record, choose the score closest to the end of the Depression Reevaluation Period). Eligible Population Product lines Ages Commercial, Medicaid, Medicare (report each product line separately). 12 years and older as of May 1 of the year prior to the measurement year. Report four age stratifications and a total rate years years years. 65+ years. Total. The total is the sum of the age stratifications. Continuous enrollment Allowable gap Anchor date Benefit May 1 of the year prior to the measurement year through December 31 of the measurement year. No more than one gap in continuous enrollment of up to 45 days during each year of continuous enrollment. 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). IESD. Medical.

11 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Event/diagnosis Step 1 Step 2 Step 3 Follow the steps below to identify the eligible population. Identify members in the specified age range with at least one interactive outpatient encounter (Depression Encounter Value Set) during the Intake Period, with an active diagnosis of major depressive disorder or dysthymia (Major Depression and Dysthymia Value Set). Identify all eligible episode dates. For each member in step 1, identify the dates for each interactive outpatient encounter (Depression Encounter Value Set) occurring during the Intake Period. Identify the IESD. For each member in step 2, identify the first date during the Intake Period where an elevated PHQ-9 or PHQ-A score (>9) was recorded in the ECDS 15 days prior to the eligible episode through 15 days after the eligible episode. Electronic Specification ECDS data coverage denominator ECDS data coverage numerator Denominator: Depression rate Numerator: Depression remission Numerator: Depression response The eligible population. Identify all members for whom the plan has access to the electronic clinical data. This includes any provider or provider groups that can submit clinical data to the health plan via electronic file transfer (e.g., QRDA 1, C-CDA, CCD) or through thirdparty aggregator applications for quality reporting. Include members only if the electronic clinical interface is accessible by health care providers at the point of care. The eligible population: all members who meet the eligibility criteria for the ECDS data coverage numerator. Identify all members who achieve remission of depression symptoms as demonstrated by a PHQ-9 or PHQ-A Depression Response Score of <5 recorded in the ECDS during the Depression Reevaluation Period. From the group of members who do not meet depression remission numerator criteria, identify members who indicate a response to treatment for depression as demonstrated by a PHQ-9 or PHQ-A Depression Response Score at least 50 percent lower than the PHQ score associated with the IESD, recorded in the ECDS during the Depression Reevaluation Period. The condition of PHQ-9 or PHQ-A score response is met when the following is true: Numerator: Depression Treatment adjustment PPPPPP DDDDDDDDDDDDDDDDDDDD RRRRRRRRRRRRRRRR SSSSSSSSSS PPPPPP tttttttttt ssssssssss ffffffff IIIIIIII 22 From the group of members who do not meet the Depression Response or Remission Numerator criteria, identify members who have evidence of treatment adjustment within 30 days of the Depression Response Score indicating no remission or response during the Depression Reevaluation Period. Documentation of any of the following indicate treatment adjustment: New antidepressant. Dispensed an antidepressant medication (Table AMM-C), where the member had no pharmacy claims for the same medication during the period between the IESD and the Depression Response Score. This includes starting an antidepressant medication, adding a new antidepressant medication to existing medications or switching antidepressants.

12 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Note: Switching between a generic and a brand name medication does not count as treatment adjustment. Adjusting the dose of the same medication counts as treatment adjustment. New Non-Antidepressant. Dispensed a non-antidepressant psychotropic medication (Table XXX-X), where the member had no pharmacy claims for the same medication during the period between the IESD and the Depression Response Score. New Therapy. Any service for individual therapy (Individual Therapy Value Set), family therapy (Family Therapy Value Set), group therapy (Group Therapy Value Set) or other therapy (Other Therapy Value Set) that was not used (i.e., no services documented) between the IESD and the Depression Response Score. This includes starting any type of therapy, adding a new type of therapy to an existing therapy (e.g., adding family therapy to individual therapy) or switching between types of therapies (e.g., from family therapy to individual therapy). Note: Switching between different lengths of therapy does not count as treatment adjustment. Total performance rate To calculate the performance rate, sum the numerators for remission, response and treatment adjustment and divide by the Depression Rate denominator. Table AMM-C: Antidepressant Medications Description Prescription Miscellaneous antidepressants Bupropion Vilazodone Monoamine oxidase inhibitors Phenylpiperazine antidepressants Psychotherapeutic combinations SSNRI antidepressants SSRI antidepressants Tetracyclic antidepressants Tricyclic antidepressants Isocarboxazid Phenelzine Nefazodone Selegiline Tranylcypromine Trazodone Amitriptyline-chlordiazepoxide Amitriptyline-perphenazine Desvenlafaxine Venlafaxine Duloxetine Citalopram Escitalopram Maprotiline Amitriptyline Amoxapine Clomipramine Fluoxetine Fluvoxamine Mirtazapine Desipramine Doxepin (>6 mg) Imipramine Fluoxetineolanzapine Paroxetine Sertraline Nortriptyline Protriptyline Trimipramine

13 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Table XXX-X: Non-Antidepressant Psychotropic Medications Antipsychotics Description Antidepressant and antipsychotic combination Anticonvulsants Anti-anxiety Benzodiazepines Other hypnotics Stimulants Prescription Note: NCQA will post a comprehensive list of medications and NDC codes to by November 1, Exclusions (Required) Exclude members with any of the following at any time during the measurement period: Bipolar disorder (Bipolar Value Set; Bipolar Disorder ECDS Value Set). Personality disorder (Personality Disorder Value Set; Personality Disorder ECDS Value Set). Psychotic disorder (Psychotic Disorders Value Set). Autism spectrum disorder (Pervasive Developmental Disorder Value Set). Members admitted to hospice during the measurement year or with permanent residence in a nursing home. Note: Value Sets will contain all applicable SMED codes. Data Elements for Reporting Organizations that submit HEDIS data to NCQA must provide the following data elements. Table DRRT-1/2/3: Data Elements for Remission, Response and Treatment Adjustment Measurement year Data collection methodology (electronic clinical data) Eligible population ECDS Denominator ECDS Numerator Required exclusions Remission Numerator Response Numerator Treatment Adjustment Numerator Reported rate Lower 95% confidence interval Upper 95% confidence interval Electronic Clinical Data For each age stratification and total For each age stratification and total

14 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Measure Flow Diagrams Figure 1: Electronic Data Capture Rate for Depression Care Eligible Population Was the member aged 12 or older at the beginning of the intake period? Did the member Not included in eligible population Have at least one encounter during the intake period where there was an active diagnosis of depression? Have a PHQ-9 score >9 within 30 days of a depression encounter? Have continuous enrollment in the health plan for the specified time frame? Not included in eligible population Exclusions Did the member have a diagnosis of bipolar disorder, personality disorder, psychotic disorder or pervasive developmental disorder during the measurement year? OR Was the member in hospice or have permanent residence in a nursing facility during the measurement year? Not included in denominator Does the health plan have direct access to the electronic clinical data as required by the measure specification? This includes any submission of clinical data directly to the health plan via electronic file transfer (e.g. QRDA 1, C-CDA, or CCD) for purposes of quality reporting. Not numerator compliant Numerator Are these data also directly accessible at the point of care by the provider? Not numerator compliant Numerator compliant

15 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Figure 2: Measure Performance Eligible Population Was the member aged 12 or older at the beginning of the intake period? Did the member Not included in eligible population Have at least one encounter during the intake period where there was an active diagnosis of depression? Have a PHQ-9 score > 9 within 30 days of a depression encounter? Have continuous enrollment in the health plan for the specified time frame? Not included in eligible population Exclusions Did the member have a diagnosis of bipolar disorder, personality disorder, psychotic disorder or pervasive developmental disorder during the measurement year? OR Was the member in hospice or have permanent residence in a nursing facility during the measurement year? Not included in denominator Did the member have a Depression Response Score of <5 during the Depression Reevaluation Period? Numerator compliant Numerator Did the member have a Depression Response Score reduced by at least 50% during the Depression Reevaluation Period? Numerator compliant Did the member have Treatment Adjustment within 30 days of the Depression Response Score that showed no response during the Depression Reevaluation Period? Numerator compliant

16 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Depression Screening and Follow-Up for Adolescents and Adults SUMMARY OF CHANGES TO HEDIS This is a new measure for HEDIS, using a new reporting methodology for electronic clinical data. Description The percentage of members 12 years of age and older who were screened for clinical depression using a standardized tool and, if screened positive, who received appropriate follow-up care. Two rates are reported. 1. ECDS Data Coverage Rate. The percentage of members 12 years of age who are covered by an electronic clinical data system (ECDS). 2. Depression Screening Rate. The percentage of members who were screened for clinical depression using a standardized tool and, if screened positive, received appropriate follow-up care. Definitions ECDS Electronic clinical data system. An electronic version of a patient s comprehensive medical experiences, maintained over time. May include some or all of the key administrative clinical data relevant to the patient s care (e.g., demographics, progress notes, problems, medications, vital signs, past medical history, social history, immunizations, laboratory data, radiology reports). The ECDS provides automated access to the patient s comprehensive information and has the ability to create data files to be used for quality reporting (e.g., QRDA 1, C-CDA, CCD) and may also support other care-related activities through various interfaces, including evidence-based decision support, quality management and outcomes reporting. To qualify for this measure, ECDS data must be automated and accessible to the care team at the point of care (e.g., EHRs, registries and case management or disease management systems that the provider has access to during a patient interaction). Adolescent screening tool (12 17 years) Adult screening tool (18 years and older) Intake period An assessment tool that has been normalized and validated for the adolescent patient population (e.g., Patient Health Questionnaire for Adolescents [PHQ-A], Beck Depression Inventory-Primary Care Version [BDI-PC], Mood Feeling Questionnaire [MFQ], Center for Epidemiologic Studies Depression Scale [CES-D], PRIME MD- PHQ2). An assessment tool that has been normalized and validated for the adult patient population (e.g., Patient Health Questionnaire [PHQ-9], Beck Depression Inventory [BDI or BDI-II], Center for Epidemiologic Studies Depression Scale [CES-D], Depression Scale [DEPS], Duke Anxiety-Depression Scale [DADS], Geriatric Depression Scale [GDS], Cornell Scale Screening and PRIME MD-PHQ-2, Edinburgh Postnatal Depression Scale [EPDS]). January 1 through December 1 of the measurement year.

17 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Eligible Population Product lines Ages Commercial, Medicaid, Medicare (report each product line separately). 12 years of age and older as of January 1 of the measurement year. Report four age stratifications and a total rate years years years. 65+ years. Total. The total is the sum of the age stratifications. Continuous enrollment Allowable gap Anchor date Benefit Event/diagnosis The measurement year and the year prior to the measurement year. No more than one gap in continuous enrollment of up to 45 days during each year of continuous enrollment. 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 Members who had an outpatient visit (Depression Encounter Value Set) during the measurement year. Electronic Specification ECDS data coverage denominator ECDS data coverage numerator Denominator: Depression screening Numerator: Depression screening The eligible population. Identify all members for whom the plan has access to the electronic clinical data. This includes any provider or provider groups that can submit clinical data to the health plan via electronic file transfer (e.g., QRDA 1, C-CDA, CCD) or through thirdparty aggregator applications for purposes of quality reporting. Include members only if the electronic clinical interface is accessible by health care providers at the point of care. The eligible population: all members who meet the eligibility criteria for the ECDS data coverage numerator. Members who were screened for clinical depression using an age-appropriate standardized tool and, if the screen is positive, were provided follow-up care within 30 days of the positive result. Follow the steps below to determine numerator compliance:

18 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Step 1 Step 2 Identify all members with a result for an age-appropriate screening tool (Depression Screen Value Set) documented during the intake period. For all members with a documented screening result, identify members whose result is negative (Negative Depression Screen Value Set) using the criteria specified by the screening tool. For example, a member whose PHQ-9 score is <5 is considered to have screened negative for depression. Step 3 For all members with a documented screening result, identify members whose result is positive (Positive Depression Screen Value Set) using the criteria specified by the screening tool. For example, a member whose PHQ-9 score is 5 is considered to have screened positive for depression. Step 4 For all members from step 3, count members for whom follow-up care was provided within 30 days (inclusive) of the date of the positive screen. Follow-up must include one or more of the following in the 30-day window following the initial positive screen: Dispensed an antidepressant medication (Table AMM-C) A follow-up encounter in behavioral health (Behavioral Health Encounter Value Set), including assessment, therapy, medication management, acute care. Note: Behavioral health encounters on the same day as the positive screen count as followup care. A follow-up outpatient visit (ECDS Follow-Up Visit Value Set) with a diagnosis of depression (Depression Value Set). Note: Outpatient encounters outside behavioral health on the same day as the positive screen do not count as follow-up care. For example, a visit with a primary care provider with a diagnosis of depression or dysthymia on the same day as the positive screen does not meet the criteria for follow-up care. Follow-up with a case manager (Case Management Encounter Value Set), with documented assessment of depression symptoms (any encounter that documents the provider addressing depression symptoms). Note: Case management encounters on the same day as the positive screen do not count as follow-up care. Assessment on the same day as the positive screen, which includes documentation of additional depression assessment indicating no depression. For example, if the initial positive screen resulted from a PHQ2 score, documentation of a negative PHQ-9 counts as evidence of follow-up. Step 5 Sum the total number of members identified in step 2 with a negative screening result and members who received appropriate follow-up from step 4 to report the total numerator events.

19 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Table AMM-C: Antidepressant Medications Description Miscellaneous antidepressants Monoamine oxidase inhibitors Phenylpiperazine antidepressants Psychotherapeutic combinations SSNRI antidepressants SSRI antidepressants Tetracyclic antidepressants Tricyclic antidepressants Bupropion Isocarboxazid Phenelzine Nefazodone Prescription Vilazodone Selegiline Tranylcypromine Trazodone Amitriptyline-chlordiazepoxide Amitriptyline-perphenazine Desvenlafaxine Duloxetine Citalopram Escitalopram Maprotiline Amitriptyline Amoxapine Clomipramine Venlafaxine Fluoxetine Fluvoxamine Mirtazapine Desipramine Doxepin (>6 mg) Imipramine Fluoxetineolanzapine Paroxetine Sertraline Nortriptyline Protriptyline Trimipramine Note: NCQA will post a comprehensive list of medications and NDC codes to by November 1, Exclusions (Required) Members with either of the following: An active diagnosis of bipolar disorder (Bipolar Disorder Value Set; Bipolar Disorder ECDS Value Set) during the measurement year or the year prior to the measurement year. An active diagnosis of depression (Depression Value Set) in the year prior to the measurement year. Note: Value Sets will contain all applicable SMED codes. Data Elements for Reporting Organizations that submit HEDIS data to NCQA must provide the following data elements. Table ABA-1/2/3: Data Elements for Depression Screening and Follow-up Measurement year Data collection methodology (Electronic Clinical Data) Eligible population ECDS denominator ECDS numerator Required exclusions Depression Screening Numerator Reported rate Lower 95% confidence interval Upper 95% confidence interval Electronic Clinical Data For each age stratification and total For each age stratification and total

20 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Measure Flow Diagrams Figure 1: Electronic Data Capture Rate for Depression Care Eligible Population Is the member aged 12 or older as of January 1 st of the measurement year? Did the member Not included in eligible population Have at least one outpatient encounter during the intake period? Have continuous enrollment in the health plan for the measurement year and the year prior? Not included in eligible population Exclusions Did the member have a diagnosis of bipolar disorder during the measurement year or the year prior? OR Did the member have a diagnosis of depression during the year prior to the measurement year? Not included in denominator Does the health plan have direct access to the electronic clinical data as required by the measure specification? This includes any submission of clinical data directly to the health plan via electronic file transfer (e.g. QRDA 1, C-CDA, or CCD) for purposes of quality reporting. Not numerator compliant Numerator Are these data also directly accessible at the point of care by the reporting provider? Not numerator compliant Numerator compliant

21 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Figure 2: Measure Performance Eligible Population Is the member aged 12 or older as of January 1 st of the measurement year? Did the member Not included in eligible population Have continuous enrollment in the health plan for the measurement year and the year prior? Have at least one outpatient encounter during the intake period? Not included in eligible population Exclusions Did the member have a diagnosis of bipolar disorder during the measurement year or the year prior? OR A diagnosis of major depression or dysthymia during the year prior to the measurement year? Not included in denominator Was the member screened for clinical depression using an ageappropriate standardized tool? Not numerator compliant Numerator Did the member screen positive for clinical depression using an age-appropriate standardized tool? Did the member receive appropriate follow-up within 30 days of a positive result? Not numerator compliant Numerator compliant

22 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Depression Care for Adolescents and Adults Measure Work-Up Measure Descriptions 1. Utilization of the PHQ-9 to Monitor Depression Symptoms for Adolescents and Adults. The percentage of members 12 years of age and older with a diagnosis of major depression or dysthymia who have a PHQ-9 or PHQ-A tool administered at least once during a four-month period. 2. Depression Remission, Response or Treatment Adjustment for Adolescents and Adults. The percentage of members 12 years of age and older with a diagnosis of depression and an elevated PHQ-9 or PHQ-A score, who had evidence of response or remission within 5 7 months of the elevated PHQ-9 score or an indication of treatment adjustment within 30 days of the PHQ-9 score that showed no evidence of response or remission. 3. Depression Screening and Follow-up for Adolescents and Adults. The percentage of members 12 years of age and older who were screened for clinical depression using a standardized tool and, if screened positive, who received appropriate follow-up care. Topic Overview Importance and Prevalence Prevalence Depressive disorders are common mental disorders that occur in people of all ages. Major depressive disorder (MDD) is a leading cause of disability worldwide, affecting an estimated 120 million people (Murray et al., 2013). The lifelong prevalence is estimated to range from 10 percent 15 percent (Lepine and Briley, 2011). In the United States, 15.7 percent of people report that at some point in their lifetime they were told by a health care professional that they had depression (CDC, 2009). In 2008, the most recent year of data available, a nationally representative survey by the Substance Abuse and Mental Health Services Administration (SAMHSA, 2009) found there were 2.0 million youths (8.3 percent of the population aged 12 17) who had a major depressive episode during the past year and an estimated 1.5 million (6.0 percent) had an episode with severe impairment. Lifetime prevalence of depression and dysthymia increases from 8.4 percent for ages to 15 percent for ages (Merikangas, 2010). It has strong correlation to chronic and reoccurring depression in adulthood (Garber, 2009). Female adolescents are more likely to be diagnosed with depression than males (National Research Council and Institute of Medicine, 2009). One study found that female adolescents are also more likely to experience recurrence v (57.6 percent vs percent) (Curry et al., 2011). SAMHSA (2009) found that in 2008, 6.4 percent of adults (14.3 million) had at least one major depressive episode in the past year and more than 1 in 25 had an episode with severe impairment. The rate was highest among persons reporting two or more races (12.7 percent), while rates for single race groups were 7.0 percent among Whites, 5.2 percent among Hispanics, 4.9 percent among American Indians or Alaska Natives, 4.9 percent among Blacks and 3.6 percent among Asians. Prevalence of a major depressive episode was higher among adult females than among adult males (8.1 vs. 4.6 percent), particularly for females of child-bearing ages (SAMHSA, 2009). The high female-to-male sex ratio in the prevalence of depression, especially during the reproductive years, is one of the most replicated findings in epidemiology (Grigoriadis and Robinson, 2007). Late-life depression is also common. A systematic review and meta-analysis found the prevalence of major depression in older adults ranged from 4.6 percent to 9.3 percent (Luppa et al., 2012). There are misperceptions that depression symptoms are part of normal aging. Losses, social isolation and chronic medical problems that older patients experience can contribute to depression.

23 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Health Importance Depression an overwhelming feeling of sadness and hopelessness that can last for months or years can make people feel that life is no longer worth living. People affected by depression lose interest in activities they used to enjoy and can also be affected by physical symptoms that interfere with their ability to participate in normal daily activities. For adolescents, depression can also have a major impact, disrupting daily life at home, school or in the community. Depression is also associated with other chronic medical conditions and increased morbidity and mortality. The mortality risk for suicide in depressed patients is more than 20-fold greater than in the general population (Bostwick and Pankratz, 2000). In terms of other chronic conditions, depression is associated with a 60 percent increased risk of type 2 diabetes (Mezuk et al., 2008), and has been identified as a risk factor for development of cardiovascular disease (Van de Kooy et al., 2007). In addition, depression adversely affects the course, complications and management of other chronic medical illnesses (Katon, 2011). In adolescents, depression can also result in serious long-term morbidities such as generalized anxiety disorder and panic disorder or lead to engagement in risky behaviors such as substance use (Taylor et al., 1996; Foley et al., 1996; Friedman et al., 1996; National Research Council and Institute of Medicine., 2009). Adolescent-onset depression increases the risk of attempted suicide by five-fold in comparison to non-depressed adolescents (Garber, 2009). Most adolescents who commit suicide, the third leading cause of death among year olds, have a previous history of depression (Williams et al., 2009; National Research Council and Institute of Medicine, 2009). Depression has long been recognized as a major contributor to disease burden (Murray et al., 1997; Üstün et al., 2004). The Global Burden of Disease study of 2010 identified depression as a leading cause of disease burden in the world. Depressive disorders were the second largest contributor to years lived with disability, an indicator of the impact of disease burden (Ferrari et al., 2013). This accounts for an estimated 10 percent of Years Lived with Disability worldwide, which is three times the impact of diabetes, eight times the impact of heart disease, and forty times the impact of cancer (Murray et al., 2013). These findings underscore the need for attention to depressive disorders and the implementation of effective interventions to reduce their disease burden. Financial importance and cost effectiveness Depression has large effects on both health care costs and lost productivity. Adolescents with depression have higher medical expenditures, including those related to general and mental health care, than adolescents without a depression diagnosis (O Connor et al., 2009). For working-age adults, a recent study showed a relationship between the severity of depression symptoms and work function and found that for every 1-point increase in PHQ-9 score (a measure of depression severity), patients experienced an additional mean productivity loss of 1.65 percent. Even minor levels of depression symptoms were associated with decreases in work function (Beck et al., 2011). In a survey study, Birnbaum et al. (2011) found that major depressive disorder severity is significantly associated with increased treatment usage and costs, unemployment, disability and reduced work performance. When the results of the study were projected to the U.S. workforce, it was estimated that monthly depression-related worker productivity losses had human capital costs of nearly $2 billion. Older adults with depression or depressive symptoms have significantly higher health care costs even after adjusting for chronic medical conditions (Katon et al., 2003).

24 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Supporting Evidence for Depression Care Measures Numerous studies have demonstrated the effectiveness of screening and treatment for depression. Recent literature has focused on the care processes needed to treat and manage depression in primary care settings, where the majority of depression cases first present. Studies have found that patient outcomes improve when there is collaboration between a primary care doctor, case manager and a mental health specialist to screen for depression, monitor symptoms, provide treatment and refer to specialty care as needed (Von Korff and Goldberg, 2001; Gilbody et al., 2006; Thota et al., 2012). The following section includes information on the evidence for depression screening, tools to monitor depressive symptoms, treatment models, gaps in care and disparities. Screening and follow-up Screening for depression in adults when staff-assisted depression care supports are in place received a Grade B recommendation from the U.S. Preventive Services Task Force (USPSTF, 2009). The National Institute for Health and Clinical Excellence (NICE) guidelines recommend universal screening of adolescents for depression in primary care settings (NICE, 2005). Limited available data suggest that screening tools, feasible for use in the primary care setting, can accurately identify depressed individuals and treatment can improve depression outcomes (O Connor et al., 2009; Williams et al., 2009). The use of a standardized screening tool may help to reduce misdiagnosis, which one study suggests occurs in up to 60 percent of patients diagnosed with major depressive disorder (Mojtabai, 2013). In its review, the USPSTF found little evidence to support recommending one screening tool over another to identify depressed individuals accurately. Research has demonstrated that many brief self-administered tools are valid and reliable for identifying possible depression cases (Martin et al., 2006; Williams et al., 2002). Once a positive screen is identified, follow-up is necessary and may include further evaluation to determine or rule out a diagnosis, provide education or interventions or refer treatment with another provider. Monitoring depressive symptoms The use of standardized tools is essential for tracking depressive symptoms and monitoring patient response to treatment. Standardized instruments are useful in identifying meaningful change in clinical outcomes over time. Guidelines recommend that providers establish and maintain regular follow up with patients diagnosed with depression and use a standardized tool to track symptoms (Mitchel et al., 2013). Meta-analyses of studies in adults indicate that formally monitoring patient progress improves patient outcomes (Lambert et al., 2003; Shimokawa et al., 2010; Knaup., 2009). For adolescents, the Guideline for Adolescent Depression in Primary Care (GLAD-PC) recommends systematic and regular tracking of treatment goals and outcomes, including assessing depressive symptoms and function, monitoring for adverse events during antidepressant treatment and reassessing diagnosis and treatment if no improvement is noted after 6 8 weeks. One study found that youths with a range of symptoms improve more quickly when clinicians receive feedback from assessments every other week instead of every 3 months (Bickman et al., 2011). Existing gold standard instruments, such as the Hamilton Depression Rating Scale, can be time consuming and require a specially trained interviewer. The brief PHQ-9 questionnaire ( 2005 Pfizer) can be self-administered by the patient and has been validated for measuring depression severity and treatment response (Kroenke et al., 2001). The tool assesses the nine DSM, Fourth Edition, Text Revision (DSM-IV-TR) criterion symptoms and effects on functioning, and has been shown to be highly accurate in