Organization: American Medical Association
April 1, 2011
Stuart Caplan, RN, MAS
Madeline Ulrich, MD, MS
Centers for Medicare and Medicaid Services
Coverage and Analysis Group
7500 Security Boulevard
Baltimore, MD 21244
Re: National Coverage Analysis for Screening for Depression in Adults; CAG-00425N
Dear Mr. Caplan and Dr. Ulrich:
On behalf of the American Medical Association (AMA), we appreciate this opportunity to provide comments on the National Coverage Analysis (NCA) on Screening for Depression in Adults (CAG-00425N). Depression is a widespread, debilitating, and undertreated medical illness, and physicians, particularly those in primary care settings, should be reimbursed for performing depression screenings. As such, given the strong evidence supporting recommendations in clinical practice guidelines and by the U.S. Preventive Services Task Force (USPSTF), the AMA supports the views expressed by the American Psychiatric Association (APA) regarding the screening of adult patients for depression at least once a year. The identification and detection of depression clearly represents a significant opportunity for improvement and is vital as the gateway to initiation and engagement in treatment. One key point to add is that the USPSTF highlights that the benefits to screening are only with coordinated treatment and follow-up by appropriately qualified clinicians. Therefore, the AMA encourages CMS to recognize that timely treatment and payment for counseling services are critical for good health outcomes when treating individuals diagnosed with depression.1
The above-mentioned concern has gained significant attention with the Institute of Medicine (IOM) report2, Retooling for an Aging America, which highlighted “that despite the effectiveness of models that provide depression treatment in primary care settings financial and organizational barriers have made the interventions difficult to sustain in clinical practice” (p. 104). Attention to these barriers would ensure that primary care physicians are not challenged with payments that do not cover their costs of providing the services. Finally, addressing payment adequacy in combination with better coverage could help promote improved access for Medicare beneficiaries.
The AMA House of Delegates has established policy to commit the AMA to increase patient access to quality care for depression, and that all physicians providing clinical care should acquire the appropriate knowledge and skills to recognize, diagnose and treat depression, both when it occurs by itself and when it occurs with another general medical conditions. In light of that commitment, the AMA-convened Physician Consortium for Performance Improvement has developed a set of clinical performance measures aimed to improve the quality of care for patients with Major Depressive Disorder. The set is currently undergoing a formal review and update, with proposed measures focusing on the full spectrum of depression care, including screening, diagnostic evaluation, appropriate treatment, and coordination of care.
Coordinating mental health care with psychotherapy/depression care management is also challenging as a treatment option due to shortages of psychiatrists and other mental health professionals3. Ultimately, these shortages delay timely access to care. For example, a study highlighted that only 67 percent of privately insured and 33 percent of Medicaid/Medicare patients referred to psychiatrists and other mental health professionals obtained an appointment after being diagnosed.4 Also, the IOM has stated that “behavioral health carve outs reinforce the disincentives to treat depression in the primary care setting” (p. 104).
In conclusion, the AMA supports Medicare coverage of depression screening to assist with evaluating, diagnosing, and treating depression. The AMA applauds CMS’ request to submit comments, and we offer our assistance to improve the quality and delivery of care in our health care system.
Michael D. Maves, MD, MBA
1 Nutting, Gallagher, Riley, White, Dickinson, Korsen, Dietrich. Care Management for Depression in Primary Care Practice: Findings from the RESPECT- Depression Trial". Annals of Family Medicine. 6 (1) 30 2008.
2 Institute of Medicine. Retooling for an aging America: Building the health care workforce. Washinton, DC: The National Academies Press.
3 http://bhpr.hrsa.gov/shortage/ Page last updated: May 28, 2010 Accessed March 29, 2011
4 Rhodes, Vieth, Kushner, Levy, Asplin. Referral Without Access: For Psychiatric Services, Wait for the Beep Annals of Emergency Medicine, Volume 54, Issue 2, August 2009, Pages 272-278
Title: Medical Director and C.E.O.
Organization: American Psychiatric Association
March 22, 2011
Centers for Medicare and Medicaid Services
Attention: Stuart Caplan and Madeline Ulrich, M.D.
7500 Security Boulevard
Baltimore, MD 21244
Dear Mr. Caplan and Dr. Ulrich:
The American Psychiatric Association (APA), the national medical specialty
society representing more than 35,000 psychiatric physicians, appreciates the
opportunity to submit comments to CMS about CMS’s national coverage
analysis on depression screenings.
Based on available evidence and recommendations from the U.S. Preventive
Services Task Force (USPSTF)1, as well as recommendations from current
clinical practice guidelines, the APA supports screening of adult patients for
depression at least once per year, linked with a follow-up diagnostic evaluation
and treatment by a clinician, when indicated for individuals who screen
positive. Screening may be performed by any office staff and/or patients as
self-screeners. Interpretation and follow-up, however, should be performed by
qualified clinicians who are acting within the scope of practice permitted by
their states’ licensure law.
Depression is a widespread, debilitating, and undertreated medical illness.
Unipolar major depression conveys an enormous disease burden.2 The twelve
month prevalence of major depressive disorder in the United States has been
estimated at 6.6 percent.3 As much as one- third of Americans’ illness-related
work leave can be attributed to mental rather than physical disorders, yet only 6.2 percent of all United States health care spending is directed towards the treatment of
It is of critical importance that physicians, especially in primary care settings, be reimbursed
to perform depression screenings. For many Americans, annual examinations by a primary
care physician serve as their only entry to the health care system. About one-quarter to onehalf
of patients with depression already receive treatment in primary care settings.5 Because
of continuing stigma associated with mental illness, limited availability of mental health
specialists in rural areas, or disparities in health care coverage, many patients are likely to
seek mental health treatment from a primary care physician rather than a mental health
specialist, and the need for detection of depressive symptoms in primary care settings is
expected to increase.6 Most depressed patients will present to their primary care physician
with somatic complaints rather than complaining of a depressed mood.7 Routine screening
can thus be a vital tool in detecting unreported symptoms of depression.
A number of validated screening tools are available to assist primary care physicians in
identifying the symptoms of depression in their patients. The nine-item Patient Health
Questionnaire (“PHQ-9”), for example, is a routinely used tool for screening, assessment, and
monitoring that parallels the DSM-IV symptom criteria for depressive disorders. The PHQ-2
is a two-item version specifically recommended for screening in the Department of Veterans
Affairs/Department of Defense’s (VA/DoD’s) 2009 Clinical Practice Guideline for
Management of Major Depressive Disorder. Advantages of the PHQ-9 include the test’s
brevity, ease of administration and interpretation, and sensitivity to change over time. 8
The USPSTF “recommends screening adults for depression where staff-assisted depression
care supports are in place to assure accurate diagnosis, effective treatment, and follow-up” as
a grade B recommendation, i.e., with a high level of certainty of benefit.9 This
recommendation is supported by well-designed and well-conducted studies of the
collaborative care model of depression management. Under this model, primary care physicians collaborate with mental health professionals to provide screening and follow-up
including complete assessment and treatment as needed.
When staff-assisted depression care supports are not in place, the USPSTF recommends
against routinely screening adults for depression, with a grade C.10 This recommendation is
easy to misunderstand. As defined by the USPSTF, grade C recommendations mean that
“there may be considerations that support providing the service in an individual patient.”11
The APA suggests that for depression, such considerations should include patient populations
with general medical conditions that are both frequently comorbid with depression and highly
prevalent in adult and elderly populations, including cardiovascular disease, stroke, diabetes,
Parkinson’s disease, obesity, sleep apnea, HIV infection, and pain syndromes.12 These
comorbidities are common among patients covered by Medicaid and Medicare. Because of
the interrelationship between depression and general medical illness, APA has emphasized the
importance of recognizing and treating depression in medically ill patients and vice versa.13
Although CMS is not required by statute to consider USPSTF grade C recommendations,
APA suggests that because medically ill patients are frequently managed in primary care
settings, this recommendation (when properly understood) gives additional backing to the
importance of CMS reimbursement for depression screenings in such settings, even when
staff-assisted depression care supports are not in place.
The VA/DoD guideline recommends that all adult patients seen in primary care settings be
screened for major depressive disorder annually using the PHQ-214 The VA/DoD Guideline
describes such screening as “an important mechanism for reducing morbidity and
mortality.”15 The VA/DoD recommendation does not make screening contingent on the
availability of staff supports, but does recommend follow-up of patients who screen positive.
This recommendation is both clinically sensible and consistent with the same evidence
reviewed by the USPSTF.
The Canadian Task Force on Preventive Health Care also recommends “screening adults for
depression in primary care settings since screening improves health outcomes when linked to
effective follow-up and treatment.”16 The Task Force notes that in the evidence base “effective follow-up and treatment” refers to integrated screening and feedback/treatment
systems which are not the norm in Canadian primary care practice and encourages clinicians to advocate for these.
The APA strongly recommends that treatment guidance not be given in this document addressing screening in primary care. The APA recently released an updated Practice Guideline for the treatment of Major Depressive Disorder that addresses multiple treatment modalities in multiple age groups, including their benefits 17 Further guidance for depression treatment in primary care is given in the VA/DoD Clinical Practice Guidelines on Management of Major Depressive Disorder18 and the MacArthur Initiative on Depression and Primary Care.19 These resources provide complete and relevant information. The unintended consequences of an incomplete presentation of treatment considerations should not be underestimated, particularly with general medical clinicians as the target.
In light of the above recommendations, the APA supports CMS coverage of annual depression screening of adult patients regardless of whether staff-assisted depression care supports are in place. Such coverage may improve recognition and treatment of depression in two ways: First, by encouraging physicians, especially primary care physicians, to implement evidence-based integrated care models for the management of depression, and second, by encouraging them to screen patients with general medical conditions frequently comorbid with depression. When primary care physicians lack resources to follow up positive depression screens with assessment and treatment, the APA suggests that patients should be referred to another physician (e.g., a psychiatrist) for complete evaluation and, when depression treatment is indicated, to a qualified mental health specialist.
The APA greatly appreciates the opportunity to comment on this important health care issue. Please do not hesitate to contact Julie A. Clements, APA’s Deputy Director of Regulatory Affairs, at (703)-907-7842 if you have further questions about APA’s comment. Thank you for your consideration of the APA’s position.
James H. Scully, Jr ., M.D.
Medical Director and C.E.O., American Psychiatric Association
1 USPSTF. Screening for Depression in Adults, December 2009
2 World Health Organization 2008: The global burden of disease: 2004 update.
3 See National Comorbidity Survey Replication; Kessler et al, 2003.
4 Kessler RC, Heeringa S., Lakoma M.D., et al, Individual and Societal effects of Mental Disorders on Earnings in the United States: Results from the National Comorbidity Survey Replication. June 2008. Am. J. Psychiatry 165(6): 708, June 2008.
5 Narrow WE, Duffy FF, “Outcome Measures for the Treatment of Depression in Primary Care Settings,” at p.
319 in Tansella M and Thornicroft G (eds.): Mental Health Outcome Measures, 3rd edition, London: Gaskell,
7 The VA/DoD Clinical Practice Guideline for Management of Major Depressive Disorder, Appendix B, p. 4.
8 Narrow WE, Duffy FF, “Outcome Measures for the Treatment of Depression in Primary Care Settings,” at p.
332 in Tansella M and Thornicroft G (eds.): Mental Health Outcome Measures, 3rd edition, London: Gaskell,
9 USPSTF. Screening for Depression in Adults, December 2009.
12 American Psychiatric Association. Practice guidelines for the treatment of patients with major depressive
disorder, third edition, Am. J. Psychiatry, 167 (Oct Suppl), 2010.
14 The VA/DoD Clinical Practice Guideline for Management of Major Depressive Disorder, Appendix B, p. 15.
15 Id. at p. 4.
16 See MacMillan HL, Patterson CJ, Wathen CN, et al. CMAJ 2005; 172:33-5.
Title: President & CEO
Organization: Mental Health America
March 31, 2011
Donald M. Berwick, M.D.
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Re: NCA Tracking Sheet for Screening of Depression in Adults (CAG-00425N)
Dear Dr. Berwick:
Thank you for the opportunity to comment on the proposed rules regarding the Affordable Care Act (ACA). As the nation’s oldest and largest advocacy organization concerned with all aspects of mental health, Mental Health America understands the importance of early detection and intervention in promoting mental health for the health and well-being of the nation. We commend CMS for issuing a NCA for screening of depression in adults, as it is a vital tool in maintaining the mental health of older Americans.
Even though depression is not a normal part of the aging process, depression and suicide are unfortunately significant public health issues for older adults. According to the NIH, about 2 million of the 35 million Americans age 65 or older suffer from a major depressive disorder, and another 5 million suffer from less severe forms of the illness. Further, depression often occurs when other chronic health conditions are present, and data show that depression in older adults is underdiagnosed and undertreated.
We recognize that depression in older adults may be more difficult to diagnose due to medical illness, dementia syndromes, and heterogeneity of patient populations, but given the prevalence and treatability of depression, as well as its occurrence with other chronic diseases among the Medicare population, we commend CMS for considering depression screening as an additional preventive service.
The U.S. Preventive Services Task Force (USPSTF) allows clinicians to choose the screening method for depression that is “most consistent with their personal preference, the patient population being served, and the practice setting.” These methods include either formal screening tools, such as instruments designed specifically for older adults, or two specific questions about mood and anhedonia (“Over the past 2 weeks, have you felt down, depressed, or hopeless?" and "Over the past 2 weeks, have you felt little interest or pleasure in doing things?"). We note that the M3 Screen, a brief symptom checklist, could be a preferred choice for a screening instrument since it has been validated to screen for four mood disorders – depression, anxiety, bipolar, and PTSD – while also providing feedback to the patient and clinician.
Due to the ease of administering screening for depression, we recommend that depression screen be performed at least once a year at the Annual Wellness visit. However, due to the high instances of depression in the older adult population and co-morbidity of depression with other chronic illnesses, we recommend CMS consider more frequent screening for this population, especially those who are living with other chronic illnesses. A more comprehensive screening tool such as the M3 might be utilized at the Annual Wellness visit, while the two question screen identified by the USPSTF might suffice for all other medical visits throughout the year.
Depression screening and the subsequent referral to a mental health assessment and supports should be completed by a qualified professional. However, this professional does not need to be a physician or nurse. If clinical staff, including physicians, physician assistants, nurses, psychologists, social workers, case managers/care coordinators, and peer support specialists are properly trained to complete the depression screen and appropriately refer for further treatment, then the ease of implementation of such a protocol may be made more plausible for providers.
In implementing depression screening as a preventive service, we recommend clarifying that this service must be provided to beneficiaries with no cost sharing. This requirement will increase the likelihood of adoption and support by consumers.
We are encouraged by CMS’s emphasis on early detection and treatment of chronic conditions to preserve quality of life and control costs. Depression screening is easy and inexpensive. With brief clinical oversight, false positives can be easily eliminated. Effectively recognizing and treating depression will help ensure quality of life and may help to reduce overall medical expenditures.
Thank you for the opportunity to present our views.
David L. Shern, Ph.D.
President & CEO
Mental Health America
Title: Vice President
Organization: Government & External Affairs
March 30, 2011
Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244-1850
Re: Comments on CMS National Coverage Analysis for Screening for Depression in Adults (CAG-00425N)
Dear Dr. Jacques:
Takeda Pharmaceuticals North America, Inc. (Takeda) appreciates this opportunity to provide comments to the Centers for Medicare and Medicaid Services (CMS) concerning its national coverage review on Depression Screening in Adults.1Takeda focuses on a variety of therapeutic areas including diabetes, cardiovascular disease, central nervous system disorders, gastroenterology, bone and joint disorders, chronic kidney disease, gynecological disorders, and infectious disease. We also have a promising pipeline of products in multiple therapeutic areas that include compounds in development for psychiatric conditions such as depression. In partnership with Lundbeck, Takeda is developing therapies for the treatment of depression. This includes clinical phase III studies which are ongoing for Lu AA21004 in patients with major depressive disorder (MDD).
Takeda strongly supports Medicare coverage of depression screening services falling within the recommendation of the United States Preventive Services Task Force (USPSTF), and we commend CMS for opening a national coverage review on this important topic. CMS now has the authority to cover “additional preventive services” if it determines through the National Coverage Determination process that the service is recommended with a grade of A or B by the USPSTF, is reasonable and necessary for prevention or early detection of an illness, and is appropriate for Medicare beneficiaries.2 Depression screening satisfies those requirements and CMS can improve the health and quality of life for many Medicare beneficiaries by covering this essential service. We also encourage CMS to issue a National Coverage Determination that fleshes out some of the questions not answered in the USPSTF recommendation so that healthcare providers have certainty about the scope of services covered by Medicare and will not hesitate to provide depression screening services to their appropriate patients.
Depression is recognized as a major source of potentially treatable morbidity in older adults; therefore, efforts should be made to ensure that the elderly have access to appropriate treatment and to remove economic barriers to treatment.3 A recent report on Medicare’s new preventive benefits noted that “the presence of copayments reduces the likelihood that preventive services will be used and may discourage individuals from seeking care that could improve health outcomes.”4 The report further notes that cost-sharing restricts utilization more for lower income beneficiaries than for those with more resources.5 Fortunately, the Patient Protection and Affordable Care Act (ACA) waived cost-sharing for Medicare-covered preventive services with a USPSTF Grade of A or B for any indication or population.6 Assuming that CMS issues a positive coverage determination for depression screening in adults, CMS should specifically point out in its decision memo that no cost-sharing applies to this benefit, in order to start getting this information out to practitioners and beneficiaries and to encourage appropriate screening efforts.
The Burden of Depression and Potential Benefits of Screening
Depression takes a large toll on Americans, including Medicare beneficiaries. Among older adults, both the incidence and prevalence of depression increase with age.7 Depression affects more than 6.5 million of the 35 million Americans aged 65 years or older. Major depressive disorder (MDD) is undiagnosed in approximately half of all elderly persons with this disorder. Contributing to this fact is that elderly patients are more likely than their younger counterparts to see their primary care physician rather than a psychiatrist. Major depressive disorder is not uncommon, occurring in approximately 2% of all community-dwelling elderly. In primary care clinics, the prevalence increases to approximately 6-9%, while among the patients admitted to acute care hospitals, the prevalence is approximately 10-12%. However, the rates of depressive symptoms in general are much higher, with studies showing prevalence rates between 30% and 45%8. As reported by the USPSTF, “depressive disorders are common, chronic and costly”9 and are more prevalent in certain populations, such as individuals with chronic conditions. In fact, because depressive disorders typically assume a chronic course, they are predicted to rank second only to heart disease by 2020 in terms of the global burden of disease.10 Yet, though depression is often linked with the existence of a chronic illness, identification of depression is generally low in the primary care setting, for a number of reasons. 11 Patients visiting their primary care physician may be more likely to discuss the physical symptoms associated with their illness than their mental health issues; or physicians treating individuals with chronic medical conditions may be less likely to recognize symptoms of depression (e.g., fatigue, poor concentration, changes in appetite) as such or to treat these symptoms separately from the medical condition.12 Depression is also under-recognized in nursing homes, and studies support the use of structured depression scales to increase awareness of depression in that setting.13 Further, the USPSTF specifically cited the increased prevalence of depression in women,14 and there is evidence indicating that the burden of depression may be substantially higher for older women than men, leading to significant clinical problems, such as depression-associated disability and other adverse outcomes associated with chronic disease, including costly adverse outcomes such as rehospitalizations.15
According to the National Institute of Mental Health, primary care physicians are increasingly taking on greater responsibility for diagnosis and treatment “in all areas of health care, including the care of older patients with mental disorders,” and consequently older people “may benefit substantially from increased sensitivity to identification of depression on the part of their primary care physicians.”16 According to a 1997 Consensus Statement update on the diagnosis and treatment of late life depression:
Depression remains a central concern to older people, their families, and the clinicians who take care of them. Even when it appears to be an understandable response to illness, the onset of depression should be viewed as a sentinel event that increases the risk for subsequent declines in health status and functional ability. Early recognition, diagnosis, and initiation of treatment of depression in older persons present opportunities for improvements in quality of life, the prevention of suffering or premature death, and the maintenance of optimal levels of function and independence for older people.17
The costs of failing to identify or adequately treat depression are high, and potentially devastating. For example, although many assume that the highest rates of suicide are among the young, white males age 85 and older actually have the highest suicide rate and depression screening offers substantial benefits, because depression is highly treatable.18 The majority of older adults with depression improve when they receive treatment with an antidepressant, psychotherapy, or a combination of both. Research has shown that medication alone and combination treatment are both effective in reducing the rate of depressive recurrences in older adults.19 Moreover, there is a strong correlation between depression and treatment noncompliance; according to a recent analysis, depressed patients are three times more likely to be noncompliant with medical treatment recommendations than non-depressed patients.20
Adults with lower incomes can also experience benefits from collaborative management of depression in primary care, similar to the benefits experienced by higher-income older adults. 21 But while depression is treatable in older people, more effort should be made to identify depression in order to ensure that patients, particularly Medicare beneficiaries, may receive appropriate treatments.22
Against this backdrop a disease with a high cost in human suffering and diminished capabilities, but one that can be identified and treated effectively recognizing depression screening as a Medicare-covered benefit is an important step that can significantly advance CMS’ goal of improving the health and quality of life for program beneficiaries.
Operationalizing the USPSTF Recommendation for Staff-Assisted Depression Care Supports
The USPSTF recommends depression screening “when staff assisted depression care supports are in place to assure accurate diagnosis, effective treatment and follow-up,” described as clinical staff that support the primary care clinician by providing some direct care, such as coordination, case management or mental health treatment.23 The basic idea here is that depression screening will only improve outcomes if people identified as depressed are then treated or referred for treatment. The USPSTF recommendation does not flesh out the standards for determining whether staff-assisted depression care supports are in place; however, it is important that CMS flesh out this standard for purposes of Medicare coverage.
Medicare providers must be able to understand the basic requirements for coverage of depression screening, or they may hesitate to provide and bill Medicare for these essential screening services. In this regard, we note that the USPSTF cited one study that it characterized as demonstrating “the lowest effective level of staff-assisted depression care supports.” 24 More specifically, the study involved a screening nurse who (for intervention group patients): (1) advised the resident physicians of positive screening results before the physician’s visit with the patient; (2) provided the physician with a standardized protocol that basically asked the physician to explore the depression symptoms with the patient, attempt to rule out physical conditions or other reasons for the screening results and (if the depression diagnosis seemed appropriate) educate the patient about depression and treatment alternatives, encourage behavioral therapy through an appointment to the local public mental health agency, prescribe antidepressants when appropriate and acceptable to the patient, and schedule another appointment within four weeks; and (3) attempted to schedule an appointment for the patient with the local public mental health agency, if the patient gave permission for this.25
We recommend that CMS reference the level of support described in this study as sufficient (both in terms of effort and personnel) to demonstrate the support necessary to promote adequate treatment and follow-up and thus to support Medicare coverage of screening services. Unless CMS’ National Coverage Determination provides this level of specificity, we are concerned that providers may be uncertain about the circumstances in which depression screening services are Medicare-covered and thus may be less likely to furnish these services to their Medicare patients. This could be a particular problem for Medicare beneficiaries who otherwise would not receive depression screening services, such as patients in rural areas where administration of intensive, staff assisted services may be challenging, especially if the primary care provider must rely on staff to make referrals for mental health treatment. We are hopeful that Medicare would not institute a standard for services that could further exacerbate rural disparities.
Frequency of Screening
The USPSTF stated that an “optimum interval for screening for depression is unknown.”26 Hence, further studies will be needed before definitive conclusions can be reached about the most appropriate interval for depression screening or rescreening. However, the USPSTF also stated that “recurrent screening may be the most productive in patients with a history of depression, unexplained somatic symptoms, comorbid psychological conditions (for example, panic disorder or generalized anxiety), substance abuse or chronic pain.”27 CMS itself included depression screening in the first annual wellness visit available to Medicare beneficiaries, but did not make depression screening a required element of subsequent annual wellness visits 28; noting the importance of depression screening in older adults, however, CMS said that depression screening may be performed at subsequent annual visits if indicated.29
Studies show that many older adults who die by suicide — up to 75 percent — visited a physician within a month before death.30 These findings point to the urgency of improving detection and treatment of depression to reduce suicide risk among older adults. The risk of depression in the elderly increases with other illnesses and when ability to function becomes limited. For example, depression is associated with an increased risk of dementia and Alzheimer’s Disease in older men and women.31 Depressive disorder is not a normal part of aging. Depression can and should be treated when it occurs at the same time as other medical illnesses. Untreated depression can delay recovery or worsen the outcome of these other illnesses. A review of the literature suggests that periodic screening at regular intervals, at least for people with risk factors, is widely recommended. For example, the USPSTF noted that people who are at greater risk for depression “are considered at risk throughout their lifetime.”32 Risk factors include family history of depression, female gender, and the presence of other psychiatric disorders or chronic disease.33 For example, a 2005 analysis concluded that depressive disorders are “associated with increased prevalence of chronic diseases,” which “appears attributable to depressive disorders precipitating chronic disease and to chronic disease exacerbating symptoms of depression.”34 Depression screening can be performed quickly, conveniently, and at low cost.35 Moreover, depression screening appears low-risk; the USPSTF did not find evidence that addressed risks or harms associated with depression screening in adults and elderly patients in primary care.36 Given all these circumstances, it would be prudent for Medicare to cover depression screening at least annually - - or more frequently if other circumstances (such as the presence of one or more of the risk factors noted above) suggest that more frequent screening is appropriate, though we recognize that providing more frequent screening could present challenges to the provider.
Finally, CMS should also make a concerted effort to encourage further study in this area, particularly as it relates to depression in the elderly, and should periodically update its coverage policy as appropriate to reflect new findings.
Qualifications and Training of Individuals Performing Depression Screening Services
The USPSTF materials do not provide specific recommendations regarding the qualifications of individuals who may perform depression screening, but support screening in primary care settings. In the studies cited by the USPSTF, the screening typically involved the application of a self-administered assessment tool or questionnaire, with scores being reported to a clinician. In some studies, research assistants or office staff administered the questionnaire.37
Screening and associated support services, such as case management or referrals, should be performed by qualified individuals with at least a minimum level of training; however, CMS should not limit this service to a small number of care providers, such as physicians and nurses only. This is an important consideration given the challenges facing the limited number of healthcare providers in rural and otherwise underserved areas. Takeda believes that it is more important for CMS to encourage the identification of widely-recognized standards for training in depression screening and follow-up, and to ensure that practitioners who perform depression screening to become appropriately credentialed through educational methods such as periodic training.
With respect to follow-up regarding the depression screening results, CMS should recommend training for nurses (RNs, LPNs) who are screening for depression. Primary care practitioners, and others who would be treating the depression, should have access to regular mental health training as well. Additionally, we are aware of practice guidelines and other resources, such as the MacArthur Foundation’s Online Toolkit, that can serve as resources to primary care clinicians who treat patients who screen positively for depression.
Under current CMS guidance, it appears that CMS can only cover depression screening for Medicare beneficiaries furnished by qualified physicians or other Medicare-recognized practitioners.38 Therefore, we recommend that the following types of practitioners, at a minimum, would fall within the benefit categories relevant to depression screening and should be able to provide Medicare-covered screening services (including follow-up for referral, in cases where screening results are positive): physicians, physician assistants, nurse practitioners, clinical nurse specialists, qualified psychologists, clinical social workers, and nurses who furnish services incident to a physician’s professional service.
Depressive disorders are prevalent in individuals with certain risk factors, and in elderly patients the incidence of depression appears to grow with age. Depression is highly manageable when it is identified, and depression screening is relatively easy to perform in the primary care setting. For the reasons discussed above, Takeda supports Medicare coverage of this valuable service and, as noted earlier, we encourage CMS to issue a National Coverage Determination for depression screening that fleshes out some of the issues that were not answered by the USPSTF’s recommendation. In particular, we encourage CMS to cover depression screening on an annual basis (and more frequently, when indicated), and to operationalize USPSTF’s recommendation for depression screening “when staff-assisted depression care supports are in place to assure accurate diagnosis, effective treatment, and follow-up” in a way that will provide screening and referral services that are effective but practical for a wide range of primary care practitioners.
* * * * *
Once again, we appreciate the opportunity to comment on this important coverage review, and we hope these comments will be useful to CMS as it prepares its draft decision memo. Please do not hesitate to contact Deborah Walter, Assistant Director Federal Policy, at 202-649-4009 if you have any questions regarding these comments or if we can provide additional information.
Glenn A. Weiglein
Government & External Affairs
Lambros C. Chrones, MD
Medical Director, Neuroscience
Medical & Scientific Affairs
1 CMS National Coverage Analysis (NCA) Tracking Sheet for Screening for Depression in Adults (CAG-00425N).
2 Social Security Act (SSA) §1861(ddd); 42 C.F.R. § 410.64.
3Crystal S.; Sambamoorthi U.; Walkup J.T.; Akncgil A., Diagnosis and Treatment of Depression in the Elderly Medicare Population: Predictors, Disparities, and Trends, Journal of the American Geriatrics Society 2003; 51(12):1718-1728.
4 “New Medicare Preventive Benefits Begin,” www.healthcare.gov, March 16, 2011. See also Medicare Payment Advisory Commission, Report to the Congress: Aligning Incentives in Medicare, June 2010 (stating that “if not supplemented with additional coverage, the FFS [fee-for-service] benefit design makes Medicare beneficiaries face substantial financial risk and may discourage the use of valuable care. One exception is certain preventive services where Medicare has begun offering greater coverage and reduced cost-sharing.”) Yet, though depression is often linked with the existence of a chronic illness, identification of depression is generally low in the primary care
6 ACA § 4104, Patient Protection and Affordable Care Act of 2010 (ACA), Pub. L. 111-148.
7 Palsson SP, et al. (2001) The incidence of first-onset depression in a population followed from the age of 70 to 85. Psychological Medicine, 31:1159-1168 (2001).
8 Reji Attupurath, Reeja C. Menon, Sreenath V. Nair, Sunanda Muralee, Rajesh R. Tampi, Late-Life Depression; Annals of Long Term Care 2008; 16(12 Suppl)
9 Screening for Depression in Adults: Summary of the Evidence, United States Preventive Services Task Force.
10 Daniel P. Chapman, PhD, Geraldine S. Perry, DrPH, Tara W. Strine, MPH, The Vital Link Between Chronic Disease and Depressive Disorders, Prev Chronic Dis, 2005 January. See also Murray CJL, Lopez AD. The Global Burden of Disease: A Comprehensive Assessment of Mortality and Disability From Diseases, Injuries, and Risk Factors in 1990 and Projected to 2020. Cambridge, Mass: Harvard University Press; 1996.
11 Management of Depression, Intermountain Healthcare, December 2008 Update.
12 Simon, Gregory E., Treating Depression in Patients with Chronic Disease, Op-Ed, West J Med 2001; 175:292-293.
13 Snowdon J, Lane F (1999) Use of the Geriatric Depression Scale by nurses. Aging and Mental Health 3:227–233. See also Teresi JA, et al.(2001) Prevalence of depression and depression recognition in nursing homes. Soc Psychiatry Psychiatr Epidemiol 36: 613–620.
14 Screening for Depression: Recommendations and Rationale, United States Preventive Services Task Force.
15 Barry, Lisa C., et al., Higher Burden of Depression Among Older Women: The Effect of Onset, Persistence and Mortality over Time; Arch Gen Psychiatry, 2008 February; 65(2):172-178.
16 Lebowitz, Barry D., et al., Diagnosis and Treatment of Depression in Late Life, Consensus Statement Update, National Institutes of Mental Health, JAMA, Vol. 278, No. 14, October 8, 1997.
17 Id. (emphasis added).
18 Conwell Y., Suicide in later life: a review and recommendations for prevention. Suicide and Life Threatening Behavior, 2001; 31(Suppl.): 32-47. The basic idea here is that depression screening will only improve outcomes if people identified as depressed are then treated or referred for treatment. The USPSTF recommendation does not flesh out the standards for determining whether staff-assisted depression care supports are in place; however, it is important that CMS flesh out this standard for purposes of Medicare coverage.
19 Reynolds CF III, Frank E, Perel JM, Imber SD, Cornes C, Miller MD, Mazumdar S, Houck PR, Dew MA, Stack JA, Pollock BG, Kupfer DJ. Nortriptyline and interpersonal psychotherapy as maintenance therapies for recurrent major depression: a randomized controlled trial in patients older than 59 years. Journal of the American Medical Association, 1999; 281(1): 39-45.
20 M. Robin DiMatteo, Ph.D., Heidi S. Lepper, Ph.D., Thomas W. Croghan, M.D., Depression is a Risk Factor for Noncompliance with Medical Treatment: Meta-analysis of the Effects of Anxiety and Depression on Patient Adherence, Arch Intern Med, Vol. 160:2101-2107, July 24, 2000.
21 Arean, PA, Gum AM, Tang L, Unutzer J., Service use and outcomes among elderly persons with low incomes being treated for depression, Psychiatric Services, 58(8):1057-64, August 2007.
22 Crystal S., Sambamoorthi U., Walkup JT, Akncgil A., Diagnosis and Treatment of Depression in the Elderly Medicare Population: Predictors, Disparities and Trends, Journal of the American Geriatrics Society, 2003; 51(12): 1718-1728.
23 Screening for Depression in Adults: Recommendation Statement, United States Preventive Services Task Force, December 2009.
24 USPSTF Recommendation Statement, Screening for Depression in Adults, December 2009, citing Jarjoura D, Polen A, et al., Effectiveness of screening and treatment for depression in ambulatory indigent patients. J Gen Intern Med 2004; 19:78-84. CMS itself included depression screening in the first annual wellness visit available to Medicare beneficiaries, but did not make depression screening a required element of
25 For more information on this study, see Jarjoura et al., supra.
26 Screening for Depression in Adults: Recommendation Statement, United States Preventive Services Task Force, December 2009.
28 Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2011, Final Rule, 75 Fed. Reg. 73170, 73405 (November 29, 2010).
30 Conwell Y. Suicide in later life: a review and recommendations for prevention. Suicide and Life Threatening Behavior, 2001; 31(Suppl): 32-47.
31 Saczynski JS, et al. (2010) Depressive symptoms and risk of dementia. Neurology 75: 35-41.
32 Screening for Depression in Adults: Recommendation Statement, United States Preventive Services Task Force, December 2009.
33 Screening for Depression: Recommendations and Rationale, United States Preventive Services Task Force.
34 Chapman et al., supra, The Vital Link Between Chronic Disease and Depressive Disorders.
35 The USPSTF Recommendations and Rationale states that most depression screening instruments have relatively good sensitivity (though only fair specificity), are fairly easy to use and can be administered in a few minutes, adding that “[s]horter screening tests, including simply asking questions about depressed mood and anhedonia, appear to detect a majority of depressed patients.” The Patient Health Questionnaire (PHQ-9), for example, is a screening tool that asks about nine symptoms of depression, and is easy for patients to complete and for clinicians to score.
36 O’Connor E., et al., Screening for Depression in Adult Patients in Primary Care Settings: A Systematic Evidence Review, United States Preventive Services Task Force, December 2009.
37 Screening for Depression in Adults: U.S. Preventive Services Task Force Recommendation Statement.
38 Items and services must fall into a Medicare-covered benefit category, for example, physician services, and be provided by providers/practitioners who can bill Medicare independently or whose services can be billed “incident to” physician services.