Skip to Main Content

View Public Comments for Screening for Depression in Adults

Use the browser below to select the Comment Period for which you would like to view the comments for the selected document. You can use the alphabetical links above the results table to jump to comments submitted by a commenter whose last name starts with that letter. Select the ‘Expand All Comments’ link to view all the full comments, and click the ‘Collapse All Comments’ link to view only the abstract for all comments. Select the ‘More’ link in the Comment to view the full text of the specific comment in a new window.
The first (earliest) set of comments are displayed by default in the Public Comment Results section. To view additional Comment Periods, use the radio button options and select the "Submit" button.
An asterisk (*) indicates a required field.

      Select one period.



[22 Comments]
Page 1 of 1
First character of titleCommenterComment Information
B
Bailey, Karen Date: 03/08/2011
Depression is one of the most debilitating disorders in the United States. It is vital that we screen and treat depression in order to support workforce productivity and improve the quality of life for our citizens. Please include depression screening. Thank you.
B
Bessen, MD, Laura Title: Vice President, US Immunoscience and Neuroscience
Organization: US Medical / Bristol Myers Squibb
Date: 03/30/2011

March 30th, 2011

Madeline Ulrich, MD
Stuart Caplan, RN, MAS
Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: National Coverage Analysis for Screening for Depression in Adults (CAG-00425N)

Dear Dr. Ulrich and Mr. Caplan:

Thank you for the opportunity to submit comments on the Centers for Medicare and Medicaid Services (CMS) national coverage analysis on screening for depression. Bristol-Myers Squibb is a global BioPharma company focused on its mission to discover, develop, and deliver innovative medicines that help patients prevail over serious diseases. The National Epidemiologic Survey on Alcoholism and Related Conditions (NESARC) has demonstrated a lifetime prevalence of major depression in patients 65 years of age or older to be approximately 8%;1 however, the prevalence of symptoms of late-life depression can range as high as 15%-27%.2 BMS encourages CMS to use the national coverage determination (NCD) process to expand Medicare coverage for depression screening.

The United States Preventive Services Task Force (USPSTF) recommends screening adults for depression, effective treatment, and follow-up assessments with a Grade: B recommendation.3 The USPSTF found good evidence that programs combining depression screening and feedback with staff assisted depression care support improves clinical outcomes in adults.

The American Psychiatric Association (APA) recently updated their treatment guidelines for major depression (October 2010).4 The APA recommend that in addition to initial screening, regular monitoring of patient psychiatric and medical condition is essential for an optimized treatment plan, and using measurement-based care may help facilitate the ongoing evaluation of the therapeutic benefit of a treatment plan. For the treatment of depressive disorders, the American College of Physicians (ACP) also recommend that clinicians assess patient status, therapeutic response, and adverse effects of antidepressant therapy on a regular basis, beginning within 1-2 weeks of initiating treatment.5

Bristol-Myers Squibb recognizes the importance of screening and preventive services and strongly supports the decision of CMS to expand Medicare coverage for vital screening and preventive services. Such services can help better target health care resources and improve patient outcomes and quality of life. We recommend that the agency proceed with an NCD on depression screening. We also look forward to working with CMS to expand coverage for appropriate treatment monitoring assessments in the future.

Sincerely,

/s/
Laura Bessen, MD
Vice President, US Immunoscience and Neuroscience
US Medical
Bristol Myers Squibb

References:

1. Hasin DS, Goodwin RD, Stinson FS, et al. Epidemiology of Major Depressive Disorder: Results from the National Epidemiologic Survey on Alcholism and Related Conditions. Arch Gen Psychiatry. 2005;62:1097-1106.

2. Blazer D, Hughes DC, George LK. The epidemiology of depression in an elderly community population. Gerontologist. 1987;27:281-287.

3. U.S. Preventive Services Task Force, "Recommendation Statement: Screening for Depression in Adults", 2009, available at http://www.uspreventiveservicestaskforce.org/uspstf09/adultdepression/addeprrs.htm

4. The American Psychiatric Association. Practice Guideline for the Treatment of Patients With Major Depressive Disorder, 3rd Edition. Am J Psychiatry. 2010;167(10) October supplement.

5. Qaseem A, Snow V, Denberg TD, et al. American College of Physicians Clinical Practice Guidelines. Using Second-Generation Antidepressants to Treat Depressive Disorders: A Clinical Practice Guideline from the American College of Physicians. Ann Intern Med. 2008;149:725-733.
B
Brown, Gary Title: Executive Director
Organization: Kenosha Area Family and Aging Services, Inc.
Date: 03/09/2011
I work for a not-for-profit agency that provides home delivered meals, congregate meals, transportation and several other services for older adults. We see first hand the negative impact depression has on the last years of our client's lives. A Medicare benefit to screen for depression among older adults is long overdue.
B
Byer, MIchael Title: Collaborative Member
Organization: M3 Information
Date: 03/17/2011
This is an effort that will yield people and the treatment process great benefits. As you know all screens or tests are not the same. Behavioral health screens have typically been unidimensional focusing on one symptom cluster (depression, anxiety, bipolar, ...) This entry shares background on the M-3 Checklist, one 27 question, patient rated screen that was discussed in an excellent article by Bradley Gaynes, et al found in the March, 2010 Annals of Family Medicine. The research conducted at University of North Carolina showed that the M3 met the individual abilities of the diseases mentioned above (PHQ-(, GAD-7, MDQ and CAPS) and offers the further ability to be sensitive to comorbidity and the whole person. The patient rated screen takes less than 3 minutes to complete, provides a decision support tool to the clinician at the point of care and includes longitudinal monitoring. The support tool is sensitive to displaying specific disease probability via a relationship with the MINI and the whole person's status via a relationship with the SF-12. Small differences can yield huge improvements. The existing bias toward individual options limits a coordinated view of a person. This leads to people with bipolar disorders being mistreated as depressed and other diseases to go unrecognized such as anxiety which according to the Kessler research is more common than depression. These are but two reasons why the multidimensional view that enabled by the M3 are vital and that current practices. These practices may lead to the harm of many (bipolar is estimated to represent 6% of all cases). The omissions of single diseases discussed above combined with tools that limits their ability as a longitudinal tracking tool. This is so important in any area of medicine but especially behavioral health. Regardless of the type of treatment (talk or medicine) the ability to follow a person looking at the whole self and individual disease clusters is crucial is getting a good view of the patient. The M3Clinician.com site enables this type of process letting a patient be screened in the waiting room and a decision oriented support tool be available to the doctor at the point of care. This easy to to screen that can be taken in a tablet pc such as iPad offers enable more ergonomic screening. This makes it easier for patients being screened as part of large efforts such as the Medicare Annual Wellness visit, following military as they transfer from active to inactive status or recommendations that adults be screen as part of their physical. Remote screening and tracking is also possible via a web or phone based application. The idea of having the screen and tracking available in a portal that requires no software or hardware allow all doctors to use the m3Clinician independently or in coordination with electronic medical records is being happilty received in private care and clinic settings. The M3 report allows members of a care team in the Medical Home model to share, in the patients record, comments about their treatment of progress. This is a great organizational aid eliminating hard to find emails and messages. Together the changes above lead to a better review of the patient, a more interactive patient and clinician dialogue and a process where they can work together, with support graphs to achieve the best outcome. I would like to share one story that really helps demonstrate the benefit of a coordinated process including longitudinal tracking. In dialogue with the Secretary's office at the VA it was shared that the round of testing includes review for substance use, depression, and PTSD but not bipolar disorders. In the November, 2010of arch. Gen. Psyc. Vol 67 the conclusion of the article entitled Psychiatric Diagnoses and Risk of Suicide in Veterans that was performed by the Department of Veterans Affairs in the Veterans Health Administration the Conclusion share that ... Although all the examined psychiatric diagnoses were associate with elevated risk of suicide in veterans, results indicate that men with bipolar disorder and women with substance use disorders are at particularly elevated risk for suicide." This is one example where coordinated, multidimensional screening can make a huge improvement in quality of care and one persons life.
C
Carson, USPHS-Ret, PhD, CAPT Robert Title: Director, Behavioral Health Services Department
Organization: see address #1
Date: 03/15/2011
For 20+ years the PHQ-9 short version has been a standard of practice in HRSA's Federally Qualified Health Centers that offer mental health services. It has also been used by FQHC primary care physicians in centers who don't offer mental health services. The PHQ was an offspring of research conducted by Pfizer Pharmaceuticals when it was launching Zoloft. The Initiative was called PRIME-MD This instrument can be self administered or by a provider, it takes about 10 minutes to complete. It can be completed by a patient in the waiting room or in the opertory while they wait for their provider. Scoring is a simple calculation taking 2 minutes. Hope this helps.
C
Chiriboga, David Date: 03/06/2011
re frequency: My sense is that screening for depression would be most appropriate perhaps 2 to 3 months following a major loss experience. Thus it might be appropriate for primary care physicians to routinely have patients complete a brief life events screening tool, or perhaps just check off whether they have experienced a major loss in the past six months. If yes, this would then prompt a screen for depression. re administering screens, one caution is that translations may not be sensitive to response patterns predicated on cultural sensitivities. A number of researchers have found a strong presence of response bias. Since there is no clear antidote for instrument bias with regard to translations, this just calls for a warning to clinicians. Naturally, a clinician with experience in the values and mores of the patient's culture-of-origin is most appropriate.
F
Frantz, Dana Title: Associate Director, Adult Services
Organization: Adult and Child Mental Health Center, Inc.
Date: 03/30/2011
There are many well-documented studies that show that treating depression reduces the overall cost of health care over time, as untreated depression interferes with recovery from medical diseases. Many medical providers are reluctant to screen because of the extra time it takes to address depression during an appointment for medical conditions. Patients can tell when a doctor "doesn't want to go there" and obligingly fail to report there depressive symptoms. Other patients don't recognize that symptoms such as fatigue, loss of interest, sleeping problems, appetite problems, etc. are signs of depression and sometimes their doctors don't either. If we want to treat the whole person and reduce overall costs, there must be an affordable way for health care providers to screen for depression.
G
Goplerud, Eric Date: 03/14/2011
Effective treatment of many medical conditions requires a careful assessment and treatment of underlying or co-morbid depression. Screening and treatment of depression is a core function of primary care, and Medicare coverage of depression screening and treatment is essential to an effective, efficient care system.
H
Hurowitz, MD, Gerald Title: Collaborative Member
Organization: M3 Information
Date: 03/18/2011
Deficiencies in existing mental health screening are serious yet correctible. By far the most widely used screen is the PHQ-9, and like the several others available the PHQ-9 is tuned to a single diagnosis. And yet, anxiety disorders overall have a greater incidence than depression, and mixed anxiety-depression, where a patient may fail to reach criteria for depression alone, is often an invisible entity from the standpoint of the PHQ-9. These are very large patient cohorts, and their neglect via the current screening protocol is a serious failure of health policy and no longer a defensible omission. Worse still is the failure to screen for Bipolar Disorder (BPD). Several studies have found that as many as 20% of patients diagnosed with depression are in fact suffering from BPD (J Psychiatr Pract 14, 2008). The PHQ-9 makes no effort to distinguish unipolar from bipolar depression. Yet, the costs of misdiagnosis in BPD are very well established and extremely grave. These costs include increased morbidity generally, more frequent hospitalization, and a significantly higher risk of suicide. The omission of a reliable BPD screen is a travesty, and especially because it is so remediable. The M3 Checklist, a 27-item, self-administered screen for depression, anxiety disorders, PTSD, and bipolar disorder, provides a single overall score which quickly helps clinicians find cases. Relying on a cutoff score of 33, the M3 finds 85% of patients with a confirmed mood anxiety diagnosis (not merely depression), while only 1 in 10 patients with a score above 33 are diagnosis-free. This simple measure allows clinicians to quickly and efficiently focus in on appropriate cases of mood and anxiety disorders. The M3 score has also been shown to correlate and track well with the SF-12 health survey, further proof of the M3’s ability to find real and clinically significant cases with an emphasis on functional impairment. At the same time, a validation study performed by Bradley Gaynes, et al. at the University of North Carolina (Ann Fam Pract 8, 2010) found that the M3 matched the diagnostic sensitivities and specificities of four mono-diagnostic screens (PHQ-9 for depression, GAD-7 for anxiety, CAPS for PTSD and MDQ for bipolar disorder). The M3 Checklist is available to the general public at mymoodmonitor.com, but a clinician portal, found at M3Clinician.com, provides a cloud computing platform that is ergonomically designed for maximum utility in the briefest time. Patients can complete their M3 Checklist screen in the waiting room on a computer tablet (such as the iPad) and clinical staff can view the results and input clinical commentary within seconds on their own computer screens. The M3 supports repeat testing and then graphically reproduces progress that can be tracked and documented, and as a longitudinal treatment monitor is fully adaptable to other new EHR applications. This system makes it easier to meet the goals of programs such as the Medicare Annual Wellness visit and the Veteran’s Health Administration Mental Health Initiative, where – because remote online screening is available – service men and women transitioning from active to inactive status can be screened and tracked for progress. Moreover, clinical case management paradigms, such as the Medical Home model are perfectly suited to incorporate this revolutionary new system of mental health screening and progress monitoring.
K
Kinzie, E Date: 03/07/2011
I practice Internal Medicine and Psychiatry. Depression screens should be allowed at least yearly, but also after a life-changing event like divorce, death of a family member, loss of job, recent surgery or heart attack...Really, since depression can hit anyone at anytime, if the question, "Are you feeling depressed?" is answered positively, then I think that it is reasonable to do a much more in-depth screening for depression. The problem in primary care is that patients often wait until then end of the appointment for something else before they seem to mention mental health issues. If providers could get paid for providing this important evaluation then I think that it is more likely that these cases would be caught earlier and would keep people more functional. Additionally, noticing and treating the depression might help to reduce the number of office visits for spurious or vague symptoms. Certainly we know that untreated depression tends to lead to a host of other medical problems, and frequent contact with the medical system.
L
Lewis, Mary Title: Psychologist
Organization: Senior Life Consultants, Inc.
Date: 03/10/2011
I'm a counseling psychologist with 20 years of experience working with older adults and feel that depression needs to be screened routinely, and done by a qualified professional. Older adults with depression present differently than younger adults, and may need to be screened more frequently. It's a critical issue to address.
M
Maves, MD, MBA, Michael Organization: American Medical Association
Date: 04/01/2011

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.

Sincerely,

/s/
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
P
powers, james Title: Associate Professor of Medicine
Organization: Vandeerbilt Medical Center
Date: 03/03/2011
recommend screening each year or each visit if more than 1 year between visits. Screening using PHQ 2 is brief and literature supports effectiveness as a first screen. Similar screening frequency is used for falls, and consistent with good preventive care including nutrition, smoking, exercise screening and advice in primary care setting.
Q
Qualls, Sara Title: Director, Gerontology Ctr; Prof of Psychology
Organization: University of Colorado Colorado Springs
Date: 03/10/2011
Depression screening should be done as part of every physical evaluation, and at times of change in health status as well as in prevention/wellness planning evaluations. Depression screening is the gateway to evaluation and treatment that benefits health directly as well as having indirect impact on health behaviors that predict onset and management of chronic conditions.
R
Rosenberg, Linda Title: President/CEO
Organization: National Council for Community Behavioral Healthcare
Date: 03/31/2011
Re: National Coverage Analysis (NCA) for Screening For Depression in Adults (CAG-00425N) The National Council for Community Behavioral Healthcare (National Council) welcomes the opportunity to comment on the National Coverage Analysis (NCA) for Screening for Depression in Adults (CAG-00425N). The National Council, a non-profit association representing 1,800 community-based mental health and addiction providers, is dedicated to fostering clinical and operational innovation and promoting policies that ensure that the more than 8 million low-income children, adults, and families our members serve have access to high quality services. Our community mental health and addiction organizations have more than 40 years of experience and expertise in providing a range of services and recovery supports for millions of individuals with multiple chronic conditions. We thank CMS for its strong commitment to make prevention of depression a top prevention priority in Medicare. We strongly support the CMS coverage of depression screenings as a preventive service in primary care. Depression is among the leading causes of disability in persons 15 years or older and affects more than 6.5 million of the 35 million Americans aged 65 and older.(1) The risk of depression in the elderly increases with other illnesses and as the ability to function becomes limited. Without a proper screening, health professionals may not identify or treat depression with disastrous financial and personal consequences. The United States Preventative Services Task Force found evidence that combining depression screening and feedback can improve clinical outcomes in adults and older adults. (2) Measures: We recommend the Patient Health Questionnaire-9 (PHQ-9), a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression, is widely used in primary care settings. This measure relies on patient self-report and is based on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual, Fourth Edition (DSM-IV). The PHQ-9 is brief and useful in clinical practice. It can be administered by physicians, mental health professionals, and office support staff, completed by a patient in minutes and rapidly scored and interpreted by a properly qualified clinician. The American Psychiatric Association is currently developing diagnostic criteria for the DSM-5 and recommends the use of the PHQ-9 when assigning a severity score to a depression diagnosis. (3) Qualified Practitioners: Primary care physicians (internal medicine, family practitioners, geriatric specialists, OB/GYNs and pediatricians) are qualified to conduct and score the PHQ-9. For instance, the 'Aetna Depression in Primary Care Program' is open to Aetna participating primary care physicians, for any Aetna member over the age of 18 who has Aetna medical benefits. A claim can be submitted each time the Patient Health Questionnaire (PHQ-9) is used, as an initial depression screen, as well as a means to monitor response to treatment. Additionally, the PHQ-9 can be administered by Mental Health Professionals, Registered Nurses, Nurse Practitioners, Physician’s Assistants, and a wide variety of support staff within the primary care office. Support staff can be trained to administer the PHQ-9 as part of patient intake as long as a Primary Care Physician or licensed mental health provider interprets the results. Frequency of Screenings: A screen for depression should happen as part of every New Patient and/or Welcome to Medicare visit. Following the first administration, the PHQ-9 should be given once a year or one month after a major life event (i.e. trauma, death of a loved one, job loss, or leaving a home of many years). If an individual is being treated for depression, the PHQ-9 can be used on a more frequent basis to monitor the course of treatment and to inform changes in protocols. Thank you for the opportunity to provide comments on Medicare’s National Coverage Analysis of Screening for Depression in Adults. Elderly persons are more likely to seek treatment for physical ailments than they are to seek treatment for depression because they may tie their depressive symptoms to a physical ailment. The use of a depression screener in a primary care setting will provide many benefits in the areas of patient care, prevention, and reduced costs as well as to ensure that this population is getting the support and treatment they need. We appreciate the importance and priority that CMS has placed on prevention of mental illnesses. Please use us as a resource moving forward. (1)NAMI: Depression in Older Persons Fact Sheet. http://www.nami.org/Template.cfm?Section=By_Illness&template=/ContentManagement/ContentDisplay.cfm&ContentID=7515 (2)United States Preventative Services Task Force (December 2009). Screening for Depression in Adults: Recommendation Statement and Rationale. http://www.uspreventiveservicestaskforce.org/uspstf/uspsaddepr.htm (3)http://www.dsm5.org/ProposedRevisions/Pages/proposedrevision.aspx?rid=44#
S
Schaffer, Mary Title: Clinical Psychologist
Organization: Schaffer Psychological Services
Date: 03/06/2011
Strongly agree depression screening for adults would be beneficial as a clinical psychologist provider for older adults I clinical update my depression screenings every 90 days and typically show some improvement via psychotherapuetic interventions @ the 90th day if I have been givien the referral within the month of sxs onset - however if onset of sxs have lingered it tyically can take 180 days of tx. before significant improvement is noted. A major reason to support early screening and develop criteria i.e. if patient visits PCP more than twice in one month as frequent somatic complaints in adults can indicate signs of depression. Regards, Dr. Mary Schaffer
S
Scully, Jr ., M.D., James H. Title: Medical Director and C.E.O.
Organization: American Psychiatric Association
Date: 03/22/2011

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 mental disorders.4

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.

Sincerely,

/s/
James H. Scully, Jr ., M.D.
Medical Director and C.E.O., American Psychiatric Association
1 USPSTF. Screening for Depression in Adults, December 2009 http://www.uspreventiveservicestaskforce.org/uspstf/uspsaddepr.htm#related.
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, 2010.
6 Id.
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, 2010.
9 USPSTF. Screening for Depression in Adults, December 2009. http://www.uspreventiveservicestaskforce.org/uspstf/uspsaddepr.htm#related.
10 Id.
11 Id.
12 American Psychiatric Association. Practice guidelines for the treatment of patients with major depressive disorder, third edition, Am. J. Psychiatry, 167 (Oct Suppl), 2010.
13 Id.
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.
S
Shah, Avani Date: 04/01/2011
Not only can the combination of systematic strategies for depression recognition in primary care and treatment improve care, but it can also lead to a reduction of medical cost. Physicians have noted that time was the most formidable barrier to depression screening (Telford, Hutchinson, Jones, Rix, & Howe, 2002; Solberg, Korsen, Oxman, Fischer, & Bartels, 1999; Glasser & Gradval, 1997). To deal with time constraints, screening for depression by using only a couple of questions has been shown to be helpful in rapidly identifying depression in adults and has even been recommended by the U.S. Preventive Services Task Force (USPSTF, 2002).Pignone and colleagues (2002) reviewed 14 studies and found that screening for depression with feedback to physicians and care management systems did improve depression recognition and outcome. Based on these findings, the USPSTF (2002) recommended that adults be screened in clinical practices as long as systems for diagnosis, treatment, and follow-up exist. Older adults would especially benefit from depression screening, as depression is often under-recognized in this population and is related to serious consequences such as mortality, disability, increased outpatient costs, and worsened health outcomes.In one study (Shah, 2006), older adults were surveyed about their preferences for depression screening. Most older adults reported feeling comfortable completing self-administered screens (GDS-15), being screened annually (more frequently if depressed), and being screened by a nurse or physician. Annual preventive screenings would seem reasonable and least burdensome on the provider and patient. However, it may be helpful to monitor treatment response if the patient has been prescribed new medications for depression, or a different dose, as well as if alternative treatment has begun. If this is the case, providing a self-administered screen and reviewing changes with the patient at consecutive visits until symptoms have stabilized would be advisable. Subsequently, for patients with depression, screening could be conducted every 3 to 6 months, as a large number of patients discontinue treatment or experience residual symptoms. A number of providers would be qualified to administer a self-administered depression screen. This list would include physicians, nurse practitioners, nurses, social workers (BSW & MSW), psychologists, and Master's level mental health workers. Interpretation of the screen and treatment recommendations may best be provided by physicians, nurse practitioners, nurses with mental health training, social workers (BSW & MSW), Master's level mental health workers, and psychologists. This specification is being made because further training is necessary, especially when addressing suicidal ideation that may accompany depression. We have also reviewed screening instruments used with older adults in primary care settings (Scogin & Shah, 2006). The CES-D and GDS-15 seemed to perform well with primary care older adults and were cost-effective. The PHQ-9 may also be a viable option as it has been used to screen and monitor older adults in the IMPACT project.
S
Shern, David Title: President & CEO
Organization: Mental Health America
Date: 04/01/2011
March 31, 2011 Donald M. Berwick, M.D. Administrator 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. Sincerely, David L. Shern, Ph.D. President & CEO Mental Health America
W
Weiglein, Glenn A. Title: Vice President
Organization: Government & External Affairs
Date: 03/30/2011

March 30, 2011

Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Attention: CAG-00425N
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.

Summary

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.

Sincerely,

/s/
Glenn A. Weiglein
Vice President
Government & External Affairs

/s/
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
5 Id.
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.
27 Id.
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).
29 Id.
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.
Y
Yang, Janet Title: Clinical Director
Organization: Center for Aging Resources
Date: 03/09/2011
As a licensed psychologist with 30 years of experience working with older adults, I think it would be clinically appropriate to screen older adults for depression every 6 months or every 12 months. I think a licensed mental health professional would be the appropriately qualified professional to conductg these screenings.
Z
Zweibel, Ph.D., Nancy R. Title: Senior Program Officer
Organization: The Retirement Research Foundation
Date: 03/09/2011
I strongly favor support for depression screening as a preventive service under Medicare. There are many reason: - Depression is underdiagnosed but prevalent in this group. - Depression is both a cause and a consequence of physical illnesses common among older adults: heart disease, stroke and Alzheimer's in particular. As a cause, it contributes directly to higher inpatient and outpatient service costs. As a consequence, it interferes with the success of rehabilitation services that hasten return to the community, thereby driving up long-term care expenditures. - Valid and reliable screening and assessment tools exist. - There are evidence-based practices for doctors and aging services personnel through which effective treatments for depression can be delivered. - This is the ONLY way to get primary care doctors to be willing to address depression in their older patients who already take up more time than the physician is reimbursed for. - As boomers age, they will be more willing to act on a doctor's prescription to get mental health services. Thank you for considering this action and for your consideration of these comments.
Page 1 of 1
92