Screening for Depression in Adults

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The Centers for Medicare & Medicaid Services (CMS) has determined that the evidence is adequate to conclude that screening for depression in adults, which is recommended with a grade of B by the U.S. Preventive Services Task Force (USPSTF), is reasonable and necessary for the prevention or early detection of illness or disability and is appropriate for individuals entitled to benefits under Part A or enrolled under Part B. Therefore CMS will cover annual screening for depression for Medicare beneficiaries in primary care settings that have staff-assisted depression care supports in place to assure accurate diagnosis, effective treatment and follow-up. For the purposes of this decision memorandum: A primary care setting is defined as one in which there is provision of integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community. Emergency departments, inpatient hospital settings, ambulatory surgical centers, independent diagnostic testing facilities, skilled nursing facilities, inpatient rehabilitation facilities and hospice are not considered primary care settings under this definition. At a minimum level, staff-assisted depression care supports consist of clinical staff (e.g., nurse, physician assistant) in the primary care setting who can advise physician of screening results and who can facilitate and coordinate referrals to mental health treatment.

Decision Memo: To: Administrative File: CAG-004275N From: Louis Jacques, MD Director, Coverage and Analysis Group Tamara Syrek Jensen, JD Deputy Director, Coverage and Analysis Group Jyme Schafer, MD, MPH Director, Division of Medical and Surgical Services Stuart Caplan, RN, MAS Technical Advisor, Division of Items and Devices Lawrence Schott, MD, MS Lead Medical Officer, Division of Medical and Surgical Services Subject: Final Coverage Decision Memorandum for Screening for Depression in Adults Date: October 14, 2011 I. Final Decision The Centers for Medicare & Medicaid Services (CMS) has determined that the evidence is adequate to conclude that screening for depression in adults, which is recommended with a grade of B by the U.S. Preventive Services Task Force (USPSTF), is reasonable and necessary for the prevention or early detection of illness or disability and is appropriate for individuals entitled to benefits under Part A or enrolled under Part B. Therefore CMS will cover annual screening for depression for Medicare beneficiaries in primary care settings that have staff-assisted depression care supports in place to assure accurate diagnosis, effective treatment and follow-up. For the purposes of this decision memorandum: A primary care setting is defined as one in which there is provision of integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community. Emergency departments, inpatient hospital settings, ambulatory surgical centers, independent diagnostic testing facilities, skilled nursing facilities, inpatient rehabilitation facilities and hospice are not considered primary care settings under this definition. At a minimum level, staff-assisted depression care supports consist of clinical staff (e.g., nurse, physician assistant) in the primary care setting who can advise physician of screening results and who can facilitate and coordinate referrals to mental health treatment. II. Background The USPSTF Recommendation Statement on “Screening for Depression in Adults” (December 2009) states the following: The USPSTF recommends screening adults for depression when staff-assisted depression care supports are in place to assure accurate diagnosis, effective treatment and follow-up. Grade: B recommendation . Depression is a mental disorder characterized by alterations in mood. “Mood disorders are recurrent, life threatening (due to the risk for suicide) and a major cause of morbidity worldwide.” [1] The symptoms of depression have been recognized as far back as ancient times, with Hippocrates referring to it as melancholia. The diagnosis of depression is not based on objective diagnostic tests (such as biopsies or serum chemistries) but on a highly variable set of symptoms. Nestler and others have suggested that “…depression should not be viewed as a single disease, but a heterogeneous syndrome comprised of numerous diseases of distinct causes and pathophysiologies.” [2] , [3] The origin of depression is believed to be multifactorial and includes psychological, social and biological factors. [4] Among persons older than 65 years, one in six suffers from depression. [5] Depression in older adults occurs in a complex psychosocial and medical context, and the prevalence of clinically significant depression in later life is estimated to be highest (~25%) in those with comorbidities including cancer, arthritis, stroke, chronic lung disease and cardiovascular disease. Frequency of other stressful events such as the loss of friends and loved ones increases with age, and bereavement is an important and well-established risk factor for depression. Opportunities are missed to improve mental health and general medical outcomes when mental illness is under-recognized and undertreated in primary care settings. A significant number of older adults with depression are not diagnosed or treated in the primary care setting. Beliefs that depression is normal with older age, as well as difficulties presented by patients with cognitive deficits, make identification of depression in older adults challenging. [6] Depression wields significant public health impacts and economic costs. Pignone, et al. (2002), for instance, noted that depressive illness has substantial effect on healthcare utilization and is projected to be the second leading source of disability worldwide by 2020. [7] In 2003, Greenberg, et al. reiterated that the economic burden of depression is substantial and estimated that the combined U.S. direct and indirect costs of depression were $83.1 billion, including $31.5 billion in direct costs and the remainder in indirect, mostly workplace costs. [8] Critically, older adults have the highest risk of suicide of all age groups. In fact, a 1992 NIH Consensus Development Panel on depression in older adults found most of these patients were experiencing their first episode of major depressive disorder, which had gone unrecognized and untreated. [9] Such patients are important in the primary care setting because > 50-75% of older adults who commit suicide saw their medical doctor during the prior month for general medical care, and 39% were seen during the week prior to their death. [10] In the Diagnostic and Statistical Manual of Mental Disorders fourth edition (DSM-IV) [11] , the criteria for a major depressive episode include five or more of the following symptoms that have been present during the same two week period and represent a change from previous functioning, with at least one of the symptoms being either depressed mood or loss of interest or pleasure: Depressed mood most of the day, nearly every day, as indicated either by subjective report (e.g., feels sad or empty) or observation made by others (e.g., appears tearful); Markedly diminished interest or pleasure in all, or almost all, activities most of the day, nearly every day (as indicated either by subjective account or observation made by others); Significant weight loss when not dieting or weight gain (e.g., a change of more than 5% of body weight in a month), or decrease or increase in appetite nearly every day; Insomnia or hypersomnia nearly every day; Psychomotor agitation or retardation nearly every day (observable by others, not merely subjective feelings of restlessness or being slowed down); Fatigue or loss of energy nearly every day; Feelings of worthlessness or excessive or inappropriate guilt (which may be delusional) nearly every day (not merely self-reproach or guilt about being sick); Diminished ability to think or concentrate, or indecisiveness, nearly every day (either by subjective account or as observed by others); Recurrent thoughts of death (not just fear of dying), recurrent suicidal ideation without a specific plan, or a suicide attempt or specific plan for committing suicide. This decision memorandum does not deal with treatment options for depression but, in keeping with the USPSTF (2009) recommendation for depression screening, focuses on the identification of depressed patients in primary care settings and the need for staff-assisted support systems to be in place to assure their accurate diagnosis, effective treatment and follow-up. More specifically, the scope of this memorandum is limited to the depression screening services described, and we are not considering our coverage policy for treatments of depression or any diseases, complications or chronic conditions resulting from depression. This analysis does not address therapeutic interventions such as pharmacotherapy, combination therapy (counseling and medications) or other interventions for depression. Self-help materials, telephone calls and web-based counseling are not separately reimbursable by Medicare and are not part of this analysis. III. History of Medicare Coverage Pursuant to §1861(ddd) of the Social Security Act, CMS may add coverage of "additional preventive services" if certain statutory requirements are met. Our regulations provide: § 410.64 Additional preventive services (a) Medicare Part B pays for additional preventive services not described in paragraph (1) or (3) of the definition of “preventive services” under §410.2, that identify medical conditions or risk factors for individuals if the Secretary determines through the national coverage determination process (as defined in section 1869(f)(1)(B) of the Act) that these services are all of the following: (1) Reasonable and necessary for the prevention or early detection of illness or disability. (2) Recommended with a grade of A or B by the United States Preventive Services Task Force. (3) Appropriate for individuals entitled to benefits under [P]art A or enrolled under Part B. (b) In making determinations under paragraph (a) of this section regarding the coverage of a new preventive service, the Secretary may conduct an assessment of the relation between predicted outcomes and the expenditures for such services and may take into account the results of such an assessment in making such national coverage determinations. [12] Benefit Category Additional Preventive Services IV. Timeline of Recent Activities Date Action March 3, 2011 CMS initiates this national coverage analysis for screening for depression. The initial 30-day public comment period begins. April 1, 2011 Initial 30-day public comment period closes. CMS received a total of 22 comments. July 19, 2011 CMS posts the proposed decision memorandum. The second 30-day public comment period begins. August 18, 2011 The public comment period closes. CMS received a total of 35 comments. V. FDA Status These services do not generally fall under the purview of the FDA. VI. General Methodological Principles When making national coverage determinations concerning additional preventive services, CMS applies the statutory criteria in §1861(ddd)(1) of the Social Security Act and evaluates relevant clinical evidence to determine whether or not the service is reasonable and necessary for the prevention or early detection of illness or disability, is recommended with a grade of A or B by the USPSTF and is appropriate for individuals entitled to benefits under Part A or enrolled under Part B of the Medicare program. Public commenters sometimes cite the published clinical evidence and provide CMS with useful information. Public comments that provide information based on unpublished evidence such as the results of individual practitioners or patients are less rigorous and therefore less useful for making a coverage determination. CMS uses the initial public comment period to inform its proposed decision. CMS responds in detail to the public comments that were received in response to the proposed decision when issuing the final decision memorandum. VII. Evidence A. Introduction Consistent with §1861(ddd)(1)(A) and 42 CFR 410.64(a)(1), additional preventive services must be reasonable and necessary for the prevention or early detection of illness or disability. With respect to evaluating whether screening tests conducted on asymptomatic individuals are reasonable and necessary, the analytic framework involves consideration of different factors compared to either diagnostic tests or therapeutic interventions. Evaluation of screening tests has been largely standardized in the medical and scientific communities, and the "value of a screening test may be assessed according to the following criteria: Simplicity. In many screening programmes more than one test is used to detect one disease, and in a multiphasic programme the individual will be subjected to a number of tests within a short space of time. It is therefore essential that the tests used should be easy to administer and should be capable of use by para-medical and other personnel. Acceptability. As screening is in most instances voluntary and a high rate of co-operation is necessary in an efficient screening programme, it is important that tests should be acceptable to the subjects. Accuracy. The test should give a true measurement of the attribute under investigation. Cost. The expense of screening should be considered in relation to the benefits resulting from the early detection of disease, i.e., the severity of the disease, the advantages of treatment at an early stage and the probability of cure. Precision (sometimes called repeatability). The test should give consistent results in repeated trials. Sensitivity. This may be defined as the ability of the test to give a positive finding when the individual screened has the disease or abnormality under investigation. Specificity. This may be defined as the ability of the test to give a negative finding when the individual screened does not have the disease or abnormality under investigation.” [13] As Cochrane and Holland (1971) further noted, evidence on health outcomes, i.e., "evidence that screening can alter the natural history of disease in a significant proportion of those screened," is important in the consideration of screening tests since individuals are asymptomatic and "the practitioner initiates screening procedures." 1. Screening Tests for Depression Screening tests do not diagnose depression but rather indicate severity of depression symptoms within a given time period, i.e., the past several days, past week or past two weeks including today. To evaluate the large number of available screening tools for older and elderly adults, readers are referred to: “Screening for Depression Across the Lifespan: A Review of Measures for Use in Primary Care Settings” by Sharp and Lipsky (2002), “Meeting the Mental Health Needs of Older Adults: Implications for Primary Care Practice” by Karlin and Fuller (2007), and “Tests for the Evaluation of Depression in the Elderly: A Systematic Review” by Colasanti, et al. (2010). The National Institute for Health and Clinical Excellence (NICE) National Clinical Practice Guideline on Depression in Adults (October 2009) also contains tables and discussion regarding commonly available depression screening instruments, including detailed information regarding sensitivity, specificity, positive and negative predictive validity, receiver operator characteristic (ROC) curves, likelihood ratios and diagnostic odds ratios of screening tools. [14] Screening Tests for Adults Hamilton Depression Rating Scale (HAM-D) This 20-item instrument is widely used in a 17-item version in clinical trials to measure remission and treatment response. The scale’s length limits clinical utility, but versions of varying length are available. The HAM-D is not suited to assess patients affected by cognitive impairment and requires administration by trained personnel. [15] Beck Depression Inventory (BDI) This 21-question self-report was developed to quantitatively measure depression severity over time. The 1996 revision (BDI-II) occurred when the DSM-IV changed diagnostic criteria for major depressive disorder (MDD). The length of this tool limits its utility for screening, but because patients must choose a level of gravity (corresponding to a distinct definition of the patient’s condition, with reference to the previous week), the BDI lends itself to monitoring of variations in the intensity of depression over time. [16] Zung Self-Rating Depression Scale (SDS) This 20-item measure of depression severity for those already diagnosed with depression is now also used in primary care as a screening tool. The SDS is available in a number of languages and can be completed by most persons in 5 minutes. [17] Disadvantages include that it does not cover symptoms of atypical depression and that it may be less sensitive to change than other scales. Although devised to identify depression in adults in general, the SDS is also used to study depression and cognitive symptoms/disturbances in the elderly. Center for Epidemiological Studies Depression Scale (CES-D) This 20-item self-administered screening test, a hybrid of the Zung SDS, the BDI and the Minnesota Multiphasic Personality Inventory Depression Scale (MMPI-D), was designed to assess depression and gravity of depressive symptoms in normal elderly people. [18] A concise 10-item version, whose sensitivity has proved to be only slightly lower than that of the original version, is also available. Geriatric Depression Scale (GDS and GDS-SF) This 30-item self-reported tool for assessment of depression in the elderly requires yes or no answers describing patients’ feelings on the day of completion. [19] There is a 15-item short form version (GDS-SF) where a score > 5 may indicate depression warranting follow-up and > 10 usually indicates depression. General Health Questionnaire (GHQ) This 60-item test is an assessment of psychological well-being to detect those likely to have or be at risk for developing psychiatric disorders. It is a measure of the common mental health problems or domains of depression, anxiety, somatic symptoms and social withdrawal. Developed in the 1970s, the GHQ comes in 38 languages. [20] A 28-item version is most often used. Patient Health Questionnaire (PHQ-2 and PHQ-9) The purpose of the 2-item Patient Health Questionnaire (PHQ-2) is not to establish a final diagnosis or to monitor depression severity, but to screen for depression in a first step approach. Patients who screen positive on the PHQ-2 require further testing and can be evaluated with the PHQ-9, a self-reported 9-question version of the Primary Care Evaluation of Mental Disorders (PRIME-MD). The PHQ-9 is a more detailed test with a scoring system based on duration/severity of particular symptoms. [21] Cornell Scale for Depression in Dementia (CSDD) This 19-item scale has the best sensitivity (93%) and specificity (97%) for identifying depression in a demented population. [22] In patients with severe cognitive impairments who cannot reliably answer the PHQ-9, the scale can be completed by a caregiver. B. United States Preventive Services Task Force (USPSTF) The USPSTF Recommendation Statement on “Screening for Depression in Adults” (December 2009) states the following: The USPSTF recommends screening adults for depression when staff-assisted depression care supports are in place to assure accurate diagnosis, effective treatment and follow-up. Grade: B recommendation The USPSTF recommends against routinely screening adults for depression when staff-assisted depression care supports are not in place. There may be considerations that support screening for depression in an individual patient. Grade: C recommendation USPSTF Grade Definitions after May 2007 What the Grades Mean and Suggestions for Practice The U.S. Preventive Services Task Force (USPSTF) has updated its definitions of the grades it assigns to recommendations and now includes "suggestions for practice" associated with each grade. The USPSTF has also defined levels of certainty regarding net benefit. These definitions apply to USPSTF recommendations voted on after May 2007. Grade Definition Suggestions for Practice A The USPSTF recommends the service. There is high certainty that the net benefit is substantial. Offer or provide this service. B The USPSTF recommends the service. There is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial. Offer or provide this service. C The USPSTF recommends against routinely providing the service. There may be considerations that support providing the service in an individual patient. There is at least moderate certainty that the net benefit is small. Offer or provide this service only if other considerations support the offering or providing the service in an individual patient. D The USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits. Discourage the use of this service. I Statement The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the service. Evidence is lacking, of poor quality, or conflicting, and the balance of benefits and harms cannot be determined. Read the clinical considerations section of USPSTF Recommendation Statement. If the service is offered, patients should understand the uncertainty about the balance of benefits and harms. Levels of Certainty Regarding Net Benefit Level of Certainty [23] Description High The available evidence usually includes consistent results from well-designed, well-conducted studies in representative primary care populations. These studies assess the effects of the preventive service on health outcomes. This conclusion is therefore unlikely to be strongly affected by the results of future studies. Moderate The available evidence is sufficient to determine the effects of the preventive service on health outcomes, but confidence in the estimate is constrained by such factors as: The number, size, or quality of individual studies. Inconsistency of findings across individual studies. Limited generalizability of findings to routine primary care practice. Lack of coherence in the chain of evidence. As more information becomes available, the magnitude or direction of the observed effect could change, and this change may be large enough to alter the conclusion. Low The available evidence is insufficient to assess effects on health outcomes. Evidence is insufficient because of: The limited number or size of studies. Important flaws in study design or methods. Inconsistency of findings across individual studies. Gaps in the chain of evidence. Findings not generalizable to routine primary care practice. Lack of information on important health outcomes. More information may allow estimation of effects on health outcomes. Inclusion criteria for O’Connor, et al.’s (2009) systematic evidence review– which formed the basis for the USPSTF recommendations – required that all studies be conducted in a general primary care population. [24] For the purposes of this decision memorandum, as defined by the Institute of Medicine (1996), “primary care is the provision of integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community.” [25] Explaining the rationale for its recommendations, the USPSTF further categorized the evidence base and its assessment as follows: Detection “The USPSTF found good evidence that screening improves the accurate identification of depressed patients in primary care settings.” Benefits of Detection and Early Intervention “The USPSTF found good evidence that treating depressed adults and older adults identified through screening in primary care settings with antidepressants, psychotherapy, or both decreases clinical morbidity.” “The USPSTF found good evidence that programs combining depression screening and feedback with staff assisted depression care supports improve clinical outcomes in adults and older adults.” “The USPSTF found fair evidence that screening and feedback alone without staff-assisted care supports do not improve clinical outcomes in adults and older adults.” Harms of Detection and Early Intervention “The USPSTF found no evidence of harms of screening for depression in adults or older adults.” USPSTF Assessment “The USPSTF concludes that for adults who receive care in clinical practices that have staff-assisted depression care supports in place, there is at least moderate certainty that the net benefit of screening for depression is at least moderate.” “The USPSTF concludes that for adults who receive care in clinical practices without staff-assisted depression care supports in place, there is at least moderate certainty that the net benefit of screening adults for depression is small.” [26] C. Literature Search In addition to the prerequisite USPSTF recommendations, CMS must consider not only whether an additional preventive service is reasonable and necessary for the prevention or early detection of illness or disability, but whether the service is appropriate for individuals entitled to benefits under Part A or enrolled under Part B of the Medicare program. To facilitate these determinations, we searched PubMed from 1990 to 2011 for research studies, systematic reviews and clinical guidelines for depression screening in older and elderly adults, as well as disparities in provision or receipt of these services. Keywords included depression, mental health, screening, health outcomes and effectiveness. We also searched for cost and cost-effectiveness studies, as §1861(ddd)(2) expressly authorizes the agency to “conduct an assessment of the relation between predicted outcomes and the expenditures for such services.” Studies must have been published in peer-reviewed English language journals. Abstracts were excluded. Using these general parameters, CMS identified four clinical guidelines and ten research studies, which included six reviews and/or meta-analyses plus three randomized controlled trials (RCTs). D. Discussion of evidence reviewed 1. Evidence Questions Our discussion focuses upon the adequacy of the evidence to draw conclusions about the risks and benefits of screening for depression for Medicare patients. CMS analyzed these questions: Is the evidence sufficient to determine that screening for depression is recommended with a grade of A or B by the USPSTF for any indications? Is the evidence sufficient to determine that screening for depression is reasonable and necessary for the prevention or early detection of illness or disability? Is the evidence sufficient to determine that screening for depression is appropriate for Medicare beneficiaries? 2. External technology assessments and systematic reviews Health Outcomes Gilbody, et al. (2008) Observing that depression screening and case-finding has been proposed as a simple, quick and cheap method to improve the quality of care, Gilbody and colleagues attempted to establish the effectiveness of screening to improve recognition and management of depression, as well as outcomes of patients with depression. The authors performed a Cochrane systematic review of RCTs in non-mental health settings that included case-finding or screening instruments for depression and conducted an analysis which explored heterogeneity using meta-regression techniques. Sixteen studies with 7.576 patients met inclusion criteria, and results showed that use of screening or case-finding instruments were associated with modest increase in recognition of depression by clinicians (relative risk [RR] 1.27, 95% confidence interval [CI] 1.02 - 1.59). Questionnaires, when administered to all patients and results given to clinicians irrespective of baseline score, had no impact on recognition (RR 1.03, 95% CI 0.85 - 1.24). Screening or case-finding increased the use of any intervention by a relative risk of 1.30 (95% CI 0.97 - 1.76). There was no evidence of influence on prescription of antidepressant medications (RR 1.20, 95% CI 0.87 - 1.66). Seven studies provided data on outcomes of depression, and no evidence of effect was found (standardized mean difference –0.02, 95% CI –0.25 - 0.20). Gilbody, et al. concluded that if used alone, case-finding or screening questionnaires for depression appeared to have little or no impact on detection and management of depression by clinicians. The authors emphasized that recommendations to adopt depression screening using standardized questionnaires without organizational enhancements are not justified. [27] Screening Tools Sharp and Lipsky (2002) Sharp and Lipsky conducted a review of screening measures for use in primary care settings. The authors observed that identifying patients with depression can be difficult in busy practices where time is limited, but stated that certain screening measures may help physicians diagnose the disorder. Sharp and Lipsky explained that depression screening measures do not diagnose depression, but rather provide an indication of the severity of symptoms and assess that severity within a given time period of, e.g., within the past 7-14 days. Although screening tools have unique scoring systems, higher scores generally reflect more severe symptoms, and measures have a statistically predetermined cutoff score at which symptoms are considered significant. Patients who score above predetermined cut-off levels should be interviewed more specifically for a diagnosis of a depressive disorder and, as clinically indicated, be treated within the primary care physician’s scope of practice or referred to a mental health subspecialist. Sharp and Lipsky further suggested that targeted screening in high-risk patients – those with chronic diseases, pain, unexplained symptoms, stressful home environments, social isolation or the elderly – may provide an alternative approach to better identify depressed patients. [28] Colasanti, et al. (2010) Colasanti and colleagues performed a systematic review of screening tools for the evaluation of depression in the elderly. Since symptoms of depression in the elderly can be difficult to identify and interpret, diagnosing depression can be difficult in the elderly, especially when concomitant pathologies mask signs and symptoms of depression. The authors categorized rating scales and questionnaires for depression as either hetero-evaluation scales administered by an assessor or as self-rating scales taken by the patients themselves. Hetero-evaluation tools that were compared and contrasted included the Hamilton Depression Rating Scale (HAM-D or HDRS), the Cornell Scale for Depression in Dementia (CSDD), the Depressive Signs Scale (DDS), the Post-Stroke Depression Rating Scale (PSDRS), non-verbal evaluation scales such as the Aphasic Depression Rating Scale (ADRS) and the Visual Analogue Mood Scale (VAMS), the Montgomery–Asberg Depression Rating Scale (MADRS) and the Retardation Rating Scale (RRS) focusing on psychomotor slowing. Self-rating scales that were evaluated included the Beck Depression Inventory (BDI), Zung Self-Rating Depression Scale (SDS), the Geriatric Depression Scale (GDS) and the Center for Epidemiological Studies Depression Scale (CES-D). Colasanti, et al. concluded that there is a need to standardize the hetero-evaluation and self-rating scales used to differentiate between normal and depressed geriatric patients. [29] 3. Internal technology assessment Health Outcomes Magruder-Habib, et al. (1990) Magruder-Habib and colleagues conducted an RCT to assess whether results of the Zung Self-Rating Depression Scale (SDS), when provided to physicians, could influence the recognition and treatment of depression patients in a primary care setting. Their trial used a staged screening approach and consisted of randomly informing physicians (N = 48 patients) or not informing physicians (N = 52 patients) of the depression status of male veterans (mean age = 60 years) screening positive for depression on both the SDS (index score of ≥ 50) and a DSM-III screen. The patients (not physicians) were randomized, and patients were the unit of analysis. Only SDS scores were fed back to the physicians. Of 112 potential study patients, 12 scored so high (≥ 75) on the SDS that they were excluded from randomization, and their physicians were immediately informed of the screening results. The remaining patients (N = 100) were followed for 12 months to assess depression status. The main outcomes of interest were the recognition of depression (either specific notation in chart, listing of depressive symptoms or referral to mental health services) and the treatment of depression (antidepressant prescription, mental health consultation, mental health clinic visit or counseling by a physician) determined by audit of patients’ medical records. Results showed that physician feedback of SDS scores of previously unrecognized depressed patients significantly increased recognition (56.2% versus 34.6%) and treatment (56.2% versus 42.3%) of depression over the 12-month study period. This was especially true for patients with high somatic (P < 0.05) or low psychologic symptoms of depression (P < 0.05). In other words, patients with high somatic complaints and symptoms suggesting organic diseases, or patients with low psychological complaints, were most likely to be missed. Magruder-Habib, et al. concluded that routine use of a screening instrument such as the SDS improves physician recognition of depression in primary care. [30] Kales and Valenstein (2002) Acknowledging that late-life depression is a heterogeneous syndrome, Kales and Valenstein stated that while depression in elderly patients is highly treatable, patient factors interact with physician factors to complicate overall clinical management of depression. Three confounding patient-level factors were reviewed – medical illness, neuropsychiatric comorbidity including concurrent dementia and anxiety, plus race – which impact not only the screening, diagnosis and treatment of depression, but also outcomes and health utilization in late-life depression. Medical illness, for instance, is common in depressed elderly patients, with 88% diagnosed with at least one significant medical disorder and 48% having three or more medical disorders. Depression in older adults with medical illness, the authors noted, potentially delays recovery by decreasing motivation and compliance, interfering with rehabilitation and prolonging hospitalizations. Moreover, depression is associated with greater use of medical services and prolonged recovery from hip fracture and stroke. Kales and Valenstein concluded that health outcomes and services research indicate that especially medical comorbidity affects whether late-life depression is appropriately detected and treated. The authors emphasized such factors must be included in a future mental health services research agenda in order to create best-practice models, guidelines and tailored interventions to improve depression screening and detection, as well as diagnosis and treatment in elderly primary care patients. [31] Solberg, et al. (2005) Solberg and colleagues described in considerable detail the main components of a systematic approach to care management in follow-up and follow-through of depressed patients in primary care. Having reviewed earlier trials of depression care, the authors stated that key care concepts demonstrated to be effective include: 1) care management by a nonphysician working with the primary care physician; 2) planned collaborative care between physicians and mental health clinicians; 3) education and support of patients for self-management, and 4) attention to patient preferences. According to the authors, a systematic care management system assumes that there is some type of team that includes a nonphysician (usually a nurse) with the ability to provide patient self-management support, not mental health counseling, in a closely integrated way with the primary physician. Their description assumes that all physicians within a clinic system have agreed on a depression guideline such as from the Institute for Clinical Systems Improvement , as well as use of a patient questionnaire such as the PHQ-9 to validly assess presence of depression during initial screening or appraisal and in follow-up visits to measure severity and outcomes. [32] Screening Tools Williams, et al. (1999) At three university-affiliated and one community-based medical clinic, Williams and colleagues conducted an RCT to evaluate the use of two case-finding instruments as compared to usual care. Consecutive patients were randomly assigned to be asked a single question about mood (“Have you felt depressed or sad much of the time in the past year?”), to fill out the 20-item validated Center for Epidemiologic Studies Depression Scale (CES-D) or to usual care. Within 72 hours, patients were assessed for Diagnostic and Statistical Manual of Mental Disorders Third Revised Edition (DSM-III-R) disorders by assessors blinded to the screening results. Process of care was assessed using chart audit and administrative databases, and patient and physician satisfaction was assessed using Likert scales. At 3 months, depressed and nondepressed patients were re-assessed for DSM-III-R disorders and symptom counts. Of 1,083 patients approached, 969 patients consented to screening and were assigned to a single question (n = 330, mean age = 58), 20-item questionnaire (n = 323, mean age = 59) or usual care (n = 316, mean age = 56). The interview for DSM-III-R diagnosis was completed in 863 (89%) patients, and major depression, dysthymia or minor depression was present in 13%. Of the 863 participants, patients were predominately female (71%), of Hispanic ethnic background (60%) and had low income (76% with personal income < $16,800). Eleven percent were making their first visit to the study physician, and medical comorbidity was moderate, with a median Duke Severity of Illness Score of 34 and a mean of three chronic medical conditions. Results showed that both instruments (single question or 20-item CES-D screen) were sensitive, but the 20-item CES-D questionnaire was more specific than the single question (75% versus 66%, P = 0.03). Case-finding with the 20-item questionnaire or single question modestly increased depression recognition, 30/77 (39%) compared with 11/38 (29%) in usual care ( P = 0.31), but did not affect treatment (45% versus 43%, P = 0.88). Recovery from depression was more likely in the case-finding than usual care groups, 32/67 (48%) versus 8/30 (27%, P = 0.03), but mean improvement in symptoms did not differ significantly (1.6 versus 1.5 symptoms, P = 0.21). Williams, et al. concluded that a simple question about depression has similar performance characteristics as a 20-item questionnaire and is more feasible due to brevity. While there was a trend for case-finding to benefit outcomes, the effects were not statistically significant. The authors believed that the lack of consistent benefit may in part be related to characteristics of the largely Hispanic study population. [33] Scogin and Shah (2006) Scogin and Shah reviewed evidence supporting screening older adults for depression in primary care setting, as well as barriers to recognition of depression and screening instruments utilized for geriatric depression. Although depression screening has been shown to improve recognition, the authors noted past reviews have been mixed about whether screening improves depression outcomes in primary care patients, and they posited that the critical element appears to be the nature of the treatment provided following screening. Potential barriers to systematic depression screening included time required, negative patient reaction and patient stigmatization according to the physicians surveyed, as well as older adults’ concerns regarding confidentiality, plus older women’s concerns about intrusiveness and lack of appropriateness of screening. Based on the authors’ own survey of older adults’ attitudes toward screening, there may be less resistance to broaching the depression topic than currently believed. Scogin and Shah stated that the Geriatric Depression Scale – Short Form (GDS–SF) and the Center for Epidemiologic Studies Depression Scale (CES–D) likely have the greatest potential. Primary care older adults, they noted, found the GDS–SF “acceptable and neither too difficult nor stressful, but an advantage of the CES–D is that it includes somatic items like “appetite” and “sleep” that providers likely inquire about as part of their routine assessment. Also, since the CES–D has been validated with adults, primary care offices would not have to use a separate screen for older adults. Scogin and Shah concluded that, when taken together, existence of validated screening tools, probable willingness on the part of older adults to be screened and efficacious care models enable improved depression care. [34] Lamers, et al. (2008) Lamers and colleagues assessed the psychometric properties of the PHQ-9 as a screening tool for depression in elderly patients with diabetes and chronic obstructive pulmonary disease (COPD) without known depression. Diabetic and COPD patients aged > 59 years were selected from 89 general practices. Mean age was 71.4 years (SD 6.9), 51.2% of patients had DM, 51.8% were male and 40.1% had primary education only. PHQ-9 depressed patients more often had only received primary education compared to nondepressed patients (41.7% versus 27.0%, P = 0.001); and in the total sample (N = 713), 19.3% had any depressive disorder (ADD) and 10.7% had major depressive disorder (MDD) according to the PHQ-9. Criterion validity, using the Mini International Neuropsychiatric Interview to diagnose MDD and ADD as diagnostic standard, was evaluated (N = 713 patients) for both summed and algorithm-based PHQ-9 score. Correlations with quality of life and severity of illness were calculated to assess construct validity, and in addition to the validity study, a test-retest study of the PHQ-9 was conducted (N = 105 patients) to evaluate its reliability. Results showed that Cohen’s kappa for the algorithm-based score was 0.71 for MDD and 0.69 for ADD. Correlation for test-retest assessment of the summed score was 0.91. The algorithm-based score had low sensitivity and high specificity, but both sensitivity and specificity were high for the optimal cut-off point of 6 on the summed score for ADD (sensitivity 95.6%, specificity 81.0%). Correlations between the summed score and the quality of life and severity of illness were acceptable. Lamers, et al. concluded that algorithm-based scoring of the PHQ-9 is not advisable for screening purposes in this elderly population because sensitivity is low, i.e., in more than half of cases, depression is unrecognized. However, the authors concluded that the PHQ-9 summed score (applying cut-offs of 6 and 7) is a valid and reliable screening tool for, respectively, ADD and MDD in older primary care patients with diabetes and COPD. In those patients scoring above the cut-off point for ADD or MDD, a more thorough mental health diagnostic examination is appropriate. [35] Cost-Effectiveness Simon, et al. (2007) Simon and colleagues evaluated incremental cost and cost-effectiveness of systematic depression treatment for older diabetics. Their RCT (the Pathways Study) compared a multicomponent depression treatment program with care as usual in nine primary care clinics of a group-model prepaid health plan. A two-stage population-based depression screening program, utilizing the PHQ-9 plus telephone screening two weeks later for those with a PHQ-9 score ≥ 10, identified diabetics with concurrent depressive disorder. A total of 329 participants (88% of those invited) attended a baseline visit and agreed to be randomized. Baseline characteristics showed the mean age ± standard deviation was 58 ± 12 years and 57 ± 12 years for, respectively, the intervention group and usual care patients, including 35% female patients. Three specialized nurses delivered a 12-month, stepped-care program beginning with problem-solving treatment psychotherapy or structured antidepressant pharmacotherapy. Subsequent treatment combining psychotherapy and medication, medication adjustments and specialty referral was adjusted according to clinical response. Main outcome measures were depressive symptoms assessed by blinded telephone assessments at 3, 6, 12 and 24 months. Health service costs were assessed using health plan accounting records. Results showed that over 24 months, patients assigned to multicomponent depression management accumulated a mean of 61 additional depression-free days (95% confidence interval [CI], 11 to 82 days) adjusted for age, sex and baseline depression, and had outpatient health services costs that averaged $314 less (95% CI, $1007 less to $379 more) compared to patients in usual care. Where an additional depression-free day was valued at $10, net economic benefit of the systematic program was $952 per patient treated (95% CI, $244 to $1660). Simon, et al. concluded for adults with diabetes and depression, systematic treatment significantly increases time free of depression and has economic benefits from the health plan perspective. The authors believed that depression screening and systematic depression treatment should become routine components of diabetes care. [36] 4. Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) CMS did not hold a MEDCAC meeting on this topic. 5. Evidence-Based Clinical Guidelines United States Preventive Services Task Force (USPSTF) 2009 (see also Section VII.B . above) Clinical Summary of USPSTF Recommendation intended for use by primary care clinicians: Population Nonpregnant adults 18 years or older Recommendation Screen when staff-assisted depression care supports are in place to assure accurate diagnosis, effective treatment, and follow-up. Grade: B Do not routinely screen when staff-assisted depression care supports are not in place. Grade: C Risk Assessment Persons at increased risk for depression are considered at risk throughout their lifetime. Groups at increased risk include persons with other psychiatric disorders, including substance misuse, persons with a family history of depression, persons with chronic medical diseases, and persons who are unemployed or of lower socioeconomic status. Also, women are at increased risk compared with men. However, the presence of risk factors alone cannot distinguish depressed patients from nondepressed patients. Screening Tests Simple screening questions may perform as well as more complex instruments. Any positive screening test result should trigger a full diagnostic interview using standard diagnostic criteria. Timing of Screening The optimal interval for screening is unknown. In older adults, significant depressive symptoms are associated with common life events, including medical illness, cognitive decline, bereavement and institutional placement in residential or inpatient settings. Balance of Harms and Benefits Limited evidence suggests that screening for depression in the absence of staff-assisted depression care does not improve depression outcomes. Suggestions for Practice "Staff-assisted depression care supports" refers to clinical staff that assists the primary care clinician by providing some direct depression care and/or coordination, case management or mental health treatment. Veterans Affairs/Department of Defense Clinical Practice Guideline (May 2009) The 2009 Clinical Practice Guideline for the Management of Major Depressive Disorder (MDD) for the Department of Veterans Affairs (VA) and Department of Defense (DoD) was developed to reduce current practice variation and provide facilities with a structured framework to help improve patient outcomes, as well as to provide evidence-based recommendations to assist providers and their patients in decision-making. Notable among key elements addressed by this Guideline is that: “Annual screening for MDD is recommended in the primary care setting as an important mechanism for reducing morbidity and mortality.” According to the VA/DoD Clinical Practice Guideline (2009), “Despite its high prevalence and substantial economic impact, depression often goes unrecognized or undertreated. Depressed patients have increased disability, healthcare utilization, and mortality from suicide and other causes, as well as reduced productivity and health-related quality of life.” “…Brief screens (e.g., PHQ-2) appear to perform comparably to longer screens (e.g., Geriatric Depression Scale [GDS] or Patient Health Questionnaire [PHQ-9]). Although depression questionnaires may perform more poorly in adults > 75 years, the performance is adequate to improve initial recognition of depression. Patients with severe chronic medical illness are at higher risk for depression than the average patient seen in primary care….” VA/DoD Recommendations: The Patient Health Questionnaire (PHQ) 2-item should be completed annually by all patients seen in primary care settings. This was given an A rating by the VA/DoD. A VA/DoD A rating is “a strong recommendation that the clinicians provide the intervention to eligible patients.” Therefore VA/DoD found that the intervention improves important health outcomes and concludes that benefits of the intervention substantially outweigh harm ”. Patients who screen positive on the Patient Health Questionnaire (PHQ) 2-item should have both a documented assessment using a quantitative questionnaire to further assess whether the patient has sufficient symptoms to warrant a diagnosis of clinical major depression and a full clinical interview that includes evaluation for suicide risk. This was given a B rating by the VA/DoD. A VA/DoD B rating is “a recommendation that clinicians provide (the service) to eligible patients.” Therefore VA/DoD found at least fair evidence that the intervention improves health outcomes and concludes that benefits of the intervention outweigh harm ”. The Institute for Clinical Systems Improvement (ICSI) 2010 According to the ICSI’s Health Care Guideline “Major Depression in Adults in Primary Care" (May 2010), an evidence-based document based on the best care that has evolved to include information on best-practice systems for implementation, the primary objective of depression screening is “to use a standardized instrument that will quantify and document future progress, including response and remission rates”. “While the two-question screen – 'Over the past two weeks, have you been bothered by: Little interest or pleasure in doing things? Feeling down, depressed or hopeless?’ – is effective with a broad population in primary care, a recent meta-analysis conc