Screening for Depression in Adults

August 16, 2011

Dear Mr. Jacques:

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS’s) proposed coverage decision memo for Screening for Depression in Adults (CAG-004259). America’s Health Insurance Plans (AHIP) is the national association for the health insurance industry. Our members provide coverage to more than 200 million Americans, offering a broad range of health insurance products in the commercial market and demonstrating a strong commitment to participation in public programs.

General Comments

AHIP and our member plans support CMS’s efforts to ensure that Medicare beneficiaries receive access to safe and effective preventive health services, procedures, and treatments that can improve health outcomes, as determined by current and robust clinical evidence. Health insurance plans have a long-standing commitment to preventive services and provide coverage for services recommended by the U.S. Preventive Services Task Force (USPSTF). Health plans are currently implementing the USPSTF recommendation on screening for depression in adults and have been since the recommendation was released in 2009. Our member health plans support annual screening for depression for Medicare beneficiaries in primary care settings that have staff-assisted depression care supports in place to assure accurate diagnosis, effective treatment, and follow-up.

Our members also agree with the proposed decision memo’s definitions of primary care and minimum levels of staff-assisted depression care, as well as what constitutes more comprehensive care for this population.

Thank you for the opportunity to comment on this important issue.

Sincerely,

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August 18, 2011

Dr. Don Berwick, Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memos for Screening for Depression in Adults (CAG-00425N) and Screening and Behavioral Counseling Interventions in Primary Care to Reduce Alcohol Misuse (CAG-00427N)

Dear Dr. Berwick:

The Coalition for Whole Health is a broad coalition of national organizations in the mental health and substance use disorder prevention, treatment, and recovery communities, and we appreciate the opportunity to comment on the CMS proposals to cover annual screenings for alcohol misuse and depression for adult Medicare beneficiaries. We thank you for making screenings for alcohol misuse and depression top priorities. We also thank you for your consideration of our below recommendations.

We strongly support the CMS proposals to cover screening and behavioral counseling interventions to reduce alcohol misuse and screening for depression as Medicare preventive services. Excessive alcohol use and depression represent major, and often overlooked, public health problems among older Americans. As noted in the memos, depression and substance use problems are common in older adults, and each often co-occur with other chronic diseases, complicating treatment compliance, worsening health outcomes, and increasing health care costs.

In addition to our strong support for providing these screens annually in primary care settings by primary care practitioners, we make the following recommendations:

• CMS should cover depression and alcohol misuse screenings and interventions that occur in any appropriate setting, not just primary care settings, furnished by any qualified practitioner, not limited to primary care physicians, nurse practitioners, clinical nurse specialists, or physician assistants.
• Depression and alcohol misuse screenings should not be limited to once annually. Screenings should be provided at every opportunity or whenever appropriate.
• CMS should further expand Medicare preventive services to include screening and intervention for illicit and prescription drug misuse and screening for additional mental health related conditions.

The following is a more detailed overview of our above recommendations.

CMS should cover depression and alcohol misuse screenings in all appropriate settings, provided by any qualified practitioner, not only primary care practitioners.

According to the Proposed Decision Memos, CMS is only proposing to cover alcohol screenings and interventions “furnished by qualified primary care physicians or other primary care practitioners in a primary care setting” and only proposing to cover depression screenings “in primary care settings that have staff-assisted depression care supports in place.” The memos explicitly exclude coverage of these screenings if they occur in emergency departments, inpatient hospital settings, outpatient hospital settings, ambulatory surgical centers, independent diagnostic testing facilities, skilled nursing facilities, inpatient rehabilitation facilities, and hospice.

By limiting screenings to primary care settings and providers, CMS is reducing the potential of these critically important preventive health services. For example, under these proposals CMS would not cover an alcohol screening provided in an emergency room after an alcohol-related accident, nor would it cover depression screens provided outside of a primary care setting, regardless of the appropriateness of providing those screens.

In addition, we ask that CMS allow alcohol misuse and depression screens to be provided by any qualified health care professional. By limiting those eligible to provide the screens to primary care physicians and primary care practitioners, CMS is only covering screens provided by those practitioners who may be too busy to screen and follow-up effectively, without allowing them to delegate to others who are qualified to conduct these screens. The list of those eligible to screen for alcohol misuse and depression should be expanded to include any qualified practitioner.

Depression and alcohol misuse screenings should not be limited to one annually, but should be provided as frequently as appropriate.

Given the low risk, low cost, and high effectiveness of screening for alcohol misuse and depression, and the current state of knowledge about the consequences of untreated addiction and mental illness, screenings should be done often to effectively identify problem drinking and/or depression and intervene early. CMS should not put arbitrary frequency limits on the proposed alcohol misuse and depression screenings. Screenings should be provided as often as appropriate, which may include at every opportunity for individuals identified as at particularly high risk. Similarly, CMS should cover more than four brief, face-to-face, behavioral counseling interventions per year for those identified through alcohol misuse screens as needing interventions, if additional interventions are determined appropriate.

CMS should cover preventive screenings for other mental health conditions, not only depression, and screenings for illicit and prescription drug misuse, not only alcohol misuse

Substance use disorders and mental illnesses are treatable and often preventable chronic diseases, and prevention, early identification, and treatment of these diseases is highly cost-effective.

We appreciate the inclusion of the U.S. Preventive Services Task Force recommended screenings and interventions related to depression and alcohol misuse as covered preventive services. In addition to these screenings identified by the USPSTF, there are other preventive screenings for substance use and mental health conditions that have been used for a number of years and are extremely effective.

While the USPSTF has not yet determined the value of screening for illicit drug use and prescription drug misuse, a significant body of evidence points to its effectiveness. The National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism and other distinguished researchers have demonstrated that screenings for drug use are effective tools to help identify adults in need of brief interventions and treatment services. Recent research clearly demonstrates that rapid, economical screening and brief interventions reduce substance use and significantly reduce health care costs. Therefore, we ask that you include drug misuse screening, brief intervention, and referral to treatment as a Medicare covered preventive service.

Similarly, in addition to screening for depression, Medicare covered preventive services should include screenings for the full range of mental health conditions, including screening for trauma history, for bipolar disorder, and for multiple mental health conditions. Such screenings have been shown to be feasible and effective. Therefore, we ask that you include screening for mental health related conditions, including trauma history, bipolar, and multiple mental health conditions, as covered services for Medicare beneficiaries.

In addition to the above recommendations, we urge CMS to continue to collaborate with SAMHSA, given their work regarding implementation of the Affordable Care Act in identifying the wide range of services that are needed and utilized by individuals with, at risk for, or in recovery from mental illness and/or substance use disorders. Furthermore, we urge CMS to continue to collaborate with SAMHSA and HRSA to further our prominent theme of integrating general health care with care for mental health and substance use disorders.

Thank you again for proposing to cover screening and behavioral counseling interventions in primary care to reduce alcohol misuse and screening for depression for all adult Medicare beneficiaries. Please use us as a resource moving forward.

Sincerely,

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August 18, 2011

Dr. Don Berwick, Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memos for Screening for Depression in Adults (CAG-00425N) and Screening and Behavioral Counseling Interventions in Primary Care to Reduce Alcohol Misuse (CAG-00427N)

Dear Dr. Berwick:

Thank you for the opportunity to comment on the proposed decision memos for screening for depression and alcohol misuse. 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 and alcohol misuse in adults, as it is a vital tool in maintaining the mental health of older Americans.

We strongly support the CMS proposals to cover screening and behavioral counseling interventions to reduce alcohol misuse and screening for depression as Medicare preventive services. Excessive alcohol use and depression represent major, and often overlooked, public health problems among older Americans. As noted in the memos, depression and substance use problems are common in older adults, and each often co-occur with other chronic diseases, complicating treatment compliance, worsening health outcomes, and increasing health care costs.

In addition to our strong support for providing these screens annually in primary care settings by primary care practitioners, we make the following recommendations:

• CMS should cover depression and alcohol misuse screenings and interventions that occur in any appropriate setting, not just primary care settings, furnished by any qualified practitioner, not limited to primary care physicians, nurse practitioners, clinical nurse specialists, or physician assistants.
• Depression and alcohol misuse screenings should not be limited to once annually. Screenings should be provided at every opportunity or whenever appropriate.
• CMS should further expand Medicare preventive services to include screening and intervention for illicit and prescription drug misuse and screening for additional mental health related conditions.

The following is a more detailed overview of our above recommendations.

CMS should cover depression and alcohol misuse screenings in all appropriate settings, provided by any qualified practitioner, not only primary care practitioners.

According to the Proposed Decision Memos, CMS is only proposing to cover alcohol screenings and interventions “furnished by qualified primary care physicians or other primary care practitioners in a primary care setting” and only proposing to cover depression screenings “in primary care settings that have staff-assisted depression care supports in place.” The memos explicitly exclude coverage of these screenings if they occur in emergency departments, inpatient hospital settings, outpatient hospital settings, ambulatory surgical centers, independent diagnostic testing facilities, skilled nursing facilities, inpatient rehabilitation facilities, and hospice.

By limiting screenings to primary care settings and providers, CMS is reducing the potential of these critically important preventive health services. For example, under these proposals CMS would not cover an alcohol screening provided in an emergency room after an alcohol-related accident, nor would it cover depression screens provided outside of a primary care setting, regardless of the appropriateness of providing those screens.

In addition, we ask that CMS allow alcohol misuse and depression screens to be provided by any qualified health care professional. By limiting those eligible to provide the screens to primary care physicians and primary care practitioners, CMS is only covering screens provided by those practitioners who may be too busy to screen and follow-up effectively, without allowing them to delegate to others who are qualified to conduct these screens. The list of those eligible to screen for alcohol misuse and depression should be expanded to include any qualified practitioner.

Depression and alcohol misuse screenings should not be limited to one annually, but should be provided as frequently as appropriate.

Given the low risk, low cost, and high effectiveness of screening for alcohol misuse and depression, and the current state of knowledge about the consequences of untreated addiction and mental illness, screenings should be done often to effectively identify problem drinking and/or depression and intervene early. CMS should not put arbitrary frequency limits on the proposed alcohol misuse and depression screenings. Screenings should be provided as often as appropriate, which may include at every opportunity for individuals identified as at particularly high risk. Similarly, CMS should cover more than four brief, face-to-face, behavioral counseling interventions per year for those identified through alcohol misuse screens as needing interventions, if additional interventions are determined appropriate.

CMS should cover preventive screenings for other mental health conditions, not only depression, and screenings for illicit and prescription drug misuse, not only alcohol misuse

Substance use disorders and mental illnesses are treatable and often preventable chronic diseases, and prevention, early identification, and treatment of these diseases is highly cost-effective.

We appreciate the inclusion of the U.S. Preventive Services Task Force recommended screenings and interventions related to depression and alcohol misuse as covered preventive services. In addition to these screenings identified by the USPSTF, there are other preventive screenings for substance use and mental health conditions that have been used for a number of years and are extremely effective.

While the USPSTF has not yet determined the value of screening for illicit drug use and prescription drug misuse, a significant body of evidence points to its effectiveness. The National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism and other distinguished researchers have demonstrated that screenings for drug use are effective tools to help identify adults in need of brief interventions and treatment services. Recent research clearly demonstrates that rapid, economical screening and brief interventions reduce substance use and significantly reduce health care costs. Therefore, we ask that you include drug misuse screening, brief intervention, and referral to treatment as a Medicare covered preventive service.

Similarly, in addition to screening for depression, Medicare covered preventive services should include screenings for the full range of mental health conditions, including screening for trauma history, for bipolar disorder, and for multiple mental health conditions. Such screenings have been shown to be feasible and effective. Therefore, we ask that you include screening for mental health related conditions, including trauma history, bipolar, and multiple mental health conditions, as covered services for Medicare beneficiaries.

In addition to the above recommendations, we urge CMS to continue to collaborate with SAMHSA, given their work regarding implementation of the Affordable Care Act in identifying the wide range of services that are needed and utilized by individuals with, at risk for, or in recovery from mental illness and/or substance use disorders. Furthermore, we urge CMS to continue to collaborate with SAMHSA and HRSA to further our prominent theme of integrating general health care with care for mental health and substance use disorders.

Thank you again for proposing to cover screening and behavioral counseling interventions in primary care to reduce alcohol misuse and screening for depression for all adult Medicare beneficiaries. Please use us as a resource moving forward.

Sincerely,

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The National Association of Psychiatric Health Systems (NAPHS) supports the action of the United States Preventive Services Task Force (USPSTF) in recommending screening adults for depression when staff-assisted depression care supports are in place to assure accurate diagnosis, effective treatment, and follow-up. We also support the conclusion that the evidence is sufficient to determine that depression screening (under the circumstances defined in the Proposed Decision Memo) is appropriate for Medicare beneficiaries.

We understand that CMS intends to limit the provision of the screening and intervention to primary care settings as defined, for the purposes of this decision memorandum, as “a setting that provides integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing sustained partnerships with patients, and practicing in the context of family and community.” The list of settings explicitly excluded includes outpatient hospital settings. We recommend that CMS consider including appropriate hospital outpatient settings that meet the definition of “primary care setting” as entities that may be reimbursed for the screening for depression intervention. Many hospital-based outpatient clinics function as primary care providers as per the definition, and are well-positioned to provide the range of services envisioned in this benefit.

NAPHS also recommends that CMS encourage providers (as it is doing through changes to reimbursement but also through its education and outreach efforts) to develop the staff-assisted care supports and the more comprehensive services described (e.g., case management, planned collaborative care, etc.). At this time, such comprehensive services are not provided in many primary care settings. In the absence of the supports, patients do not have the opportunity to be screened. The fact that Medicare beneficiaries are at high risk for depression by virtue of other medical conditions is well documented in the literature. The importance of integrated physical and psychiatric care is also well-documented.

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August 18, 2011
Donald Berwick, MD
Administrator
Centers for Medicare & Medicaid Services
Department of Health & Human Services
P.O. Box 8013
Baltimore, MD 21244–8013
Sent via email to CAGinquiries@cms.hhs.gov

Re: Proposed Decision Memo for Screening for Depression in Adults (CAG-00425N)

Dear Dr. Berwick:

On behalf of the American Academy of Family Physicians (AAFP), which represents more than 100,300 family physicians and medical students nationwide, I am writing to express our support for the Centers for Medicare & Medicaid Services (CMS) proposal to cover annual screening for depression for Medicare beneficiaries in primary care settings that have staff-assisted depression care supports in place to assure accurate diagnosis, effective treatment, and follow-up.

As noted in the CMS memo, the AAFP (policy) on screening for depression parallels precisely the current the U.S. Preventive Services Task Force (USPSTF) recommendations. We recommend screening adults for depression when staff-assisted depression care supports are in place to assure accurate diagnosis, effective treatment, and follow-up. The AAFP recommends against routinely screening adults for depression when staff-assisted depression care supports are not place. "Staff-assisted depression care supports" refers to clinical staff that assist the primary care clinician by providing some direct depression care and/or coordination, case management, or mental health treatment. There may be considerations that support screening for depression in an individual patient.

The AAFP recognizes that this proposed decision memo pertains to Medicare beneficiaries, yet this largely excludes adolescent and children populations. Nevertheless, the AAFP recommends screening of adolescents (12-18 years of age) for major depressive disorder when systems are in place to ensure accurate diagnosis, psychotherapy (cognitive-behavioral or interpersonal), and follow-up. And we conclude that the current evidence is insufficient to assess the balance of benefits and harms of screening of children (7-11 years of age).

The proposed decision memo suggests in several instances to primary care physicians referring identified patients to mental health clinicians, as if primary care physicians are not performing as mental health providers themselves. Primary care physicians often play an important role in treating some mental health cases too and thus their involvement in mental health extends beyond just screening and diagnosing. Per the AAFP’s position paper on Mental Healthcare Services by Family Physicians, psychiatric professionals are an essential element of the total health care continuum, however the majority of patients with mental health issues will continue to access the healthcare system through primary care physicians. The desire of patients to receive treatment from their primary care physicians, or at least to have their primary care physicians more involved in their care, has been repeatedly documented. Improving mental health treatment requires enhancing the ability of the primary care physician to screen, treat and appropriately manage the psychiatric care given to patients.

Through residency training and continuing medical education, family physicians are prepared to manage mental health problems in children, adolescents, and adults. The continuity of care inherent in family medicine makes early recognition of problems possible. Because family physicians treat the whole family, they are often better able to recognize problems and provide interventions in the family system. Family physicians are also able to treat individuals who would not access traditional mental health services because of the social stigma associated with mental illness. CMS should promote telemedicine availability of mental health services, especially for areas with mental health professional shortages. While family physicians care for a variety of mental health conditions, we value being able to work cooperatively with other professionals, but this is challenging in many parts of the country and telemedicine would facilitate access for these patients.

We concur with CMS that the evidence is adequate to conclude that screening for depression in adults, which is recommended with a grade of B by the USPSTF, is reasonable and necessary for the prevention or early diagnosis of illness or disability, and is appropriate for individuals entitled to benefits under Part A or enrolled under Part B.

Sincerely,

Lori J. Heim, MD, FAAFP
Board Chair

CC: Louis Jacques, MD, CMS Director, Coverage and Analysis Group

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To whom it may concern:
I submit that current screening practices for Substance Abuse as well as Depression in primary care overall is not comprehensive in the United States. Even if screening is completed, there is documented evidence that there is lacking follow-up recommendations regarding determination of needed treatment, education and referral to available resources. This proposed standard also places for the first time a minimum competency standard and direction to help assure preventative care to occur if either substance abuse and/or depression is present. It is also documented as evidence that depression often underlies substance abuse and that both diseases are prodrome for other medical diseases. I simply support that these screenings as well as appropriate follow-up referral and care in the primary care setting will ultimately help save health care costs over the course of time. Not to say, that the overall health of a patient can be dramatically improved with interventions of prevention and wellness that can assist with a patient’s individualized care goals.

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August, 18, 2011

Madeline Ulrich, MD
Stuart Caplan, RN, MAS
Coverage and Analysis Group
Centers for Medicare and 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 additional comments on the Centers for Medicare and Medicaid Services' (CMS') national coverage analysis on screening for depression, a proposal of great public health and clinical interest. At Bristol-Myers Squibb (BMS), a global BioPharma company, our mission is to discover, develop, and deliver innovative medicines that help patients prevail over serious diseases.

We agree with the other commenters' support of Medicare coverage for screening for depression and the 14 comments supporting longitudinal tracking. For example, recently, The American Psychiatric Association recommended that in addition to initial screening, regular monitoring of patient psychiatric and medical conditions is essential for an optimal treatment plan, and using measurement-based care may help facilitate the ongoing evaluation of the therapeutic benefit of a treatment plan.¹

BMS applauds CMS' proposal to cover annual screening for depression for Medicare beneficiaries in the primary care setting. Such services can help better target health care resources and improve patient outcomes and quality of life. We recommend that the agency proceed with a National Coverage Determination on depression screening and look forward to working with CMS to expand coverage for appropriate treatment monitoring assessments in the future.

Sincerely,

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

1. 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.

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August 18, 2011

Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Attention: CAG-00425N
7500 Security Boulevard
Baltimore, MD 21244-1850

Dear Dr. Jacques:

On behalf of the National Alliance on Mental Illness (NAMI), I pleased to submit the following comments on the proposed national coverage determination on Depression Screening in Adults. NAMI is the nation’s largest national organization representing people living with serious mental illness and their families. Through our 1,100 affiliates in all 50 states, our members advocate on behalf of people living with illnesses such as schizophrenia, bipolar disorder, major depression and severe anxiety disorders.

NAMI supports Medicare coverage of depression screening services as recommended by the United States Preventive Services Task Force (USPSTF). We commend CMS for its proposal to cover annual depression and alcohol screening in adults as an "additional preventive service" that is reasonable and necessary for the prevention or early detection of an illness or disability. NAMI believes that this is within CMS's authority to require coverage for "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;
• reasonable and necessary for prevention or early detection of an illness; and
• appropriate for Medicare beneficiaries.

In NAMI’s view depression screening satisfies those requirements and CMS can improve the health and quality of life for many Medicare beneficiaries by covering this essential service. NAMI would like to offer specific comments on several elements of the proposed NCD for annual depression and alcohol screening:

1. frequency of the service;
2. the requirement for staff-assisted care supports; and
3. the requirement proposed by CMS that screening be furnished in a “primary care setting”.

Finally, NAMI recommends that CMS further expand Medicare preventive services to include screening and early intervention for additional mental disorders and provide payment for these services.

Frequency of Screening Services

NAMI supports CMS’s proposal to cover depression and alcohol screening on an annual basis. We have a long history of support for efforts in Congress to ensure that Medicare covers depression screening at least annually, or more frequently if other circumstances (including the presence of certain risk factors, such as family history of depression, or presence of chronic disease) suggest that more frequent screening is appropriate.

Requiring Staff-Assisted Care Supports

The USPSTF has recommended screening adults for depression when staff-assisted care supports are in place to assure accurate diagnosis, effective treatment and follow-up. NAMI concurs with CMS’s proposal that a minimum level of staff-assisted care supports would consist of clinical staff (such as a nurse or a physician assistant) that can advise the physician of screening results, facilitate and coordinate referrals for mental illness treatment. CMS should also consider a similar level of support as sufficient in terms of effort and personnel. Such staff-assisted care supports were referenced by one study the USPSTF characterized as demonstrating “the lowest effective level of staff-assisted depression supports.”

In this proposed NCD, CMS further notes that “more comprehensive care supports include case management by a nurse or non-physician working with the primary care physician; planned collaborative care between the primary care provider and mental health clinicians; patient education and support for patient self-management; plus attention to patient preferences regarding counseling, medications, and referral to mental health professionals with or without continuing involvement by the patient’s primary care physician.” It is unclear to NAMI why CMS chose to define “more comprehensive care supports,” unless this is intended only for illustrative purposes (or unless CMS intends to divide payment for depression screening according to whether it involves the minimum level of support or a “more comprehensive” level of support). In any case, NAMI recommends that CMS clarify the purpose of this distinction.

The proposed NCD does not address whether CMS intends to pay for depression screening as a separately billable service or as part of a bundle of services, such as those services provided during an office visit or an annual wellness visit. NAMI looks forward to CMS clarifying its intent in this regard. CMS should consider paying for depression screening in the context of an annual wellness visit or other office visit by appropriately increasing the payment for that visit. When depression screening is performed outside of the context of an annual wellness visit, CMS should make a separate payment for the service.

It is understandable that CMS does not typically address payment issues in an NCD. However, NAMI remains concerned that Medicare beneficiaries’ access to screening services may not appreciably expand — and the coverage policy would thus not have achieved its purpose — unless CMS assures that these screening services are paid for appropriately.

This proposed NCD would cover depression screening for Medicare beneficiaries in “primary care settings that have staff-assisted depression care supports,” and defines a primary care setting as one that provides “integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community.” The proposed Decision Memo further specifies that primary care settings do NOT include settings such as emergency departments, inpatient hospital settings, outpatient hospital settings, ambulatory surgical centers, independent diagnostic testing facilities, skilled nursing facilities, inpatient rehabilitation facilities and hospices.

NAMI commends CMS for covering this service in the primary care setting. Nevertheless, this definition of “primary care setting” can easily be read to exclude some settings where screening for depression in adults may be appropriate, such as specialty health settings or other Medicare-participating providers that furnish mental health services specifically (e.g., community mental health centers). Many of these specialty providers do not typically “address a large majority of [an individual’s] personal health care needs.” NAMI is concerned that the “primary care” requirement (especially given the definition of this term that CMS proposes to use) could needlessly restrict beneficiary ccess to depression screening in appropriate settings and is not part of the USPSTF recommendation.

The USPSTF recommendation extends to depression screening in adults when staff assisted depression care supports are in place, but does not limit this service to a primary care setting. As is noted in the NCD, the USPSTF relied partly on a systematic evidence review that required all studies to be conducted in a general primary care population. However, it is likely that the USPSTF would have specified the setting if it believed this was central to its recommendation. As a result, NAMI recommends that the final NCD not require that depression screening occur in a primary care setting in order to be covered. At a minimum, however, CMS should consider expanding the settings in which screening can occur (by refining the “primary care” definition) if it adopts a requirement for a primary care setting. Broadening the settings in which screening can be covered is particularly important given the well-recognized shortage that exists of primary care physicians and other primary care providers, especially in rural areas.

Expansion of Screening and Early Intervention to Additional Mental Disorders

NAMI recommends that CMS consider expansion of Medicare preventive services to include screening and early intervention for additional mental illnesses. Medicare covered preventive services should include screenings for a broader range of mental illnesses in addition to depression, including screening for psychotic disorders (including schizophrenia and schizo-affective disorder), mood disorders (including bipolar disorder) and severe anxiety disorders (including PTSD). A growing body of research has indicated that screening and early intervention for many of these mental disorders have been shown to be feasible and effective.

Finally, to make sure that the new coverage policy is meaningful and will translate into greater availability of screening services for Medicare patients, NAMI recommends Medicare payment for these screening and early intervention services. By covering depression screening services, CMS can help Medicare beneficiaries to identify and address a serious, often debilitating illness. NAMI strongly supports Medicare coverage of this valuable service. We appreciate the opportunity to comment on this important proposed NCD and look forward to working with CMS on this important policy.

Sincerely,

Michael J. Fitzpatrick, M.S.W.
Executive Director

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August 18, 2011

Donald Berwick, M.D.
Administrator
Centers for Medicare & Medicaid Services (CMS)
Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244

Dear Dr. Berwick:

The American Society of Addiction Medicine (ASAM) is pleased to have the opportunity to comment on CMS proposals to cover annual screenings for alcohol misuse and depression for adult Medicare beneficiaries. ASAM members specialize in the treatment of addiction and practice in a wide range of primary care and specialty care settings. As such, we feel uniquely qualified to comment on the public health benefits of screening Medicare-eligible patients for alcohol problems.

ASAM applauds CMS' support of screening, brief intervention and referral to treatment (SBIRT) and feels that the summary report is quite thorough in its review of the literature, the effectiveness of SBIRT and the reasoning of why these efforts should be included within the USPSTF guidelines. Furthermore, we support your proposals to cover depression and alcohol misuse screening and behavioral counseling interventions as Medicare preventive services.

We would, however, like to offer recommendations related to the CPT codes that may be used by physicians for reimbursement of the behavioral counseling interventions for alcohol misuse.

The proposed decision memo does not specify which CPT code would be utilized for these counseling sessions. If the memo intends that CPT codes 96150 - 96155, Health and Behavior Intervention, be used, primary care practitioners may face reimbursement difficulties. Many insurers restrict these codes to behavioral health providers or do not cover them at all. Also, the instructions in the CPT manual restrict adding these codes to evaluation and management (E&M) or psychiatric services on the same date of services.

Behavioral health counseling codes are also reimbursed at substantially lower rates than equivalent timed medical office visit or psychiatric codes, thereby, providing a significant disincentive for providers to use them. Few physicians would utilize these codes if the claims processes were cumbersome or resulted in denials. Or, the physician may refer the person directly to a behavioral health counselor which often results in refusal by the patient of the referral. In light of these concerns, ASAM respectfully requests that, should CMS utilize this coding, then the aforementioned specialty restrictions and reimbursement equity issues be considered.

Many of our physician members are also worried about the potential for discrimination of patients who may screen positive for misuse but ultimately do not have a diagnosable abuse or dependence problem. With the inclusion of claims information into the Medical Information Bureau database, many patients who have been screened for alcohol (and/or drug) misuse are inaccurately given an abuse or dependence diagnosis since most insurers do not allow for the use of "rule out" diagnoses. If CMS decides that behavioral health codes are the best choice, then modification of the claims database to allow for "no diagnosis given" would provide some degree of protection against this potential discriminatory procedure.

Again, ASAM thanks CMS for the opportunity to submit comments regarding this important issue. We look forward to a continued collaboration with the Centers for Medicare and Medicaid Services on screening and brief intervention utilization and outcomes.

Sincerely,

Stuart Gitlow, MD, MBA, MPH, FAPA

Acting President, American Society of Addiction Medicine

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August 18, 2011

Lawrence Schott, MD, MS
Lead Medical Officer, Division of Medical and Surgical Services The Centers for Medicare and Medicaid Services

Dear Dr. Schott:

The UPMC Insurance Services Division (“UPMC”) is pleased to have the opportunity to comment on the proposed coverage decision for “Screening for Depression in Adults” (CAG-00425N). UPMC proudly offers Medicare Advantage (MA) Plans and Medicare Prescription Drug Benefit Programs to more than 100,000 Medicare beneficiaries in Pennsylvania, West Virginia and Ohio. Our UPMC for Life Specialty Plan is the 7th largest full dual Special Needs Plan (D-SNP) in the United States. We support CMS (the “Agency”) in its ongoing effort to identify, through the national coverage determination process, those evidence-based preventive services that are reasonable and necessary for the prevention or early detection of illness or disability and appropriate for Medicare beneficiaries. UPMC applauds CMS for its thorough review of available peer-reviewed evidence and its commitment to a transparent coverage decision process, as evidenced by the Agency's articulation of the various evidentiary questions and decisional elements under consideration.

UPMC believes that for all Medicare beneficiaries, but particularly for dual SNP beneficiaries, many of whom suffer from multiple chronic physical or behavioral health conditions, identifying and appropriately treating depression is critical to the overall effectiveness of patient care. According to the National Alliance on Mental Illness, depression affects more than 6.5 million Americans over age 65.¹ In addition, among UPMC’s D-SNP members, a majority of whom are under age 65, a third or more have serious mental disorder and/or substance misuses diagnoses. Further, peer-reviewed literature suggests that depressive disorders can complicate the treatment or management of chronic disease and chronic disease also exacerbates symptoms of depression.² We believe this interaction, coupled with the failure to diagnose and treat a patient’s depression, can prompt the need for potentially avoidable and costly health care services.

UPMC has historically recognized screening for depression as an effective tool for the meaningful prevention and early detection of illness or disability in Medicare beneficiaries, and has therefore included the screening as a covered service (at no-cost sharing) for its Medicare members. We believe that such screening contributes positively to the overall effectiveness of care and improves the health and quality of life for many Medicare beneficiaries. Despite this, it has been our experience that many providers do not take advantage of UPMC’s coverage for these services, presumably (at least in part) because of their adherence to and familiarity with the general coverage policies of the Medicare program. We therefore believe that, in addition to providing Medicare beneficiaries with a valuable benefit, the inclusion of screening for depression as a Medicare preventive service will provide notice of the availability of coverage to those providers.

For all the reasons above, the UPMC Insurance Services Division supports the Agency’s proposed coverage decision for the addition of screening for depression in adults as an approved preventive service for Medicare beneficiaries.

John Lovelace
President, UPMC for You

1 Depression in Older Persons Fact Sheet. National Alliance on Mental Illness, 2009. Available at http://www.nami.org/Template.cfm?Section=By_Illness&template=/ContentManagement/ContentDisplay.cfm&ContentID=7515.
2 Chapman, Daniel P., et al. “The Vital Link Between Chronic Disease and Depressive Disorders.” Preventing Chronic Disease, Vol. 2 No. 1 (January 2005).

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August 18, 2011

Louis Jacques, MD
Director, Coverage and Analysis Group
Jyme Schafer, MD, MPH
Director, Division of Medical and Surgical Services
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re:  Proposed Coverage Decision Memorandum for Screening and Behavioral Counseling Interventions in Primary Care to Reduce Alcohol Misuse; CAG-00427N
Proposed Coverage Decision Memorandum for Screening for Depression in Adults; CAG-00425N

Dear Drs. Jacques and Schafer:

On behalf of the American Medical Association (AMA), we appreciate this opportunity to provide comments on the Centers for Medicare and Medicaid Services’ (CMS) Proposed Coverage Decision Memorandum for Screening and Behavioral Counseling Interventions in Primary Care to Reduce Alcohol Misuse; CAG-00427N, along with the Proposed Coverage Decision Memorandum for Screening for Depression in Adults; CAG-00425N.

Regarding reduction in alcohol misuse, CMS is proposing that the evidence is adequate to conclude that screening and behavioral counseling to reduce alcohol misuse, which is recommended with a grade of B by the U.S. Preventive Services Task Force (USPSTF) for adults, including pregnant women, in primary care settings, is reasonable and necessary for the prevention of early illness or disability, and is appropriate for individuals entitled to benefits under Part A or enrolled under Part B. Therefore, CMS proposes to cover annual alcohol screening and for those that screen positive, up to four brief, face-to-face, behavioral counseling interventions per year for Medicare beneficiaries, including pregnant women:

• Who misuse alcohol, but whose levels or patterns of alcohol consumption do not meet criteria for alcohol dependence (defined as at least three of the following: tolerance; withdrawal symptoms; impaired control; preoccupation with acquisition and/or use; persistent desire or unsuccessful efforts to quit; sustains social, occupational, or recreational disability; use continues despite adverse consequences);
• Who are competent and alert at the time that counseling is provided; and
• Whose counseling is furnished by qualified primary care physicians or other primary care practitioners in a primary care setting.

Regarding depression in adults, CMS proposes that the evidence is adequate to conclude that screening for depression in adults, which is recommended with a grade of B by the USPSTF, is reasonable and necessary for the prevention or early detection of illness or disability, and is appropriate for individuals entitled to benefits under Part A or enrolled under Part B. Therefore, CMS proposes to cover annual screening for depression for Medicare beneficiaries in primary care settings that have staff-assisted depression care supports in place to assure accurate diagnosis, effective treatment, and follow-up.

The AMA applauds CMS’ proposals to provide Medicare coverage for annual alcohol screening, with behavioral counseling interventions for those that screen positive, as well as annual screening for depression. Alcohol misuse is a serious, disabling disease. Depression is also a widespread, debilitating, and under-treated medical illness, and physicians, particularly those in primary care settings, should be reimbursed for performing depression, as well as alcohol screenings. The AMA has urged CMS to provide Medicare coverage for these critical services, and we appreciate that CMS is taking steps to implement such coverage. We also urge CMS to utilize CPT codes 99408 and 99409 for alcohol and/or substance abuse screening to report the newly covered alcohol misuse services. On January 1, 2008, CPT implemented these codes, and we urge their use for these newly covered services instead of the proposed G code.

Sincerely,

James L. Madara, MD

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The proposed Medicare coverage for screening depression in adults in primary care (CAG-00425N) is extremely important and will be of great benefit to older adults. Many studies have found that because of stigma and other factors the majority of older adults are reluctant to admit that they have a mental health problem, including depression, and don't seek services. The majority of those that do seek services, access it through primary care rather than a qualified mental health professional. So covering screening through primary care makes a lot of sense.

There is a big concern, however, about limiting the screening to a primary care "setting". Since primary care "providers" are defined the actual location of the screening should not be a factor. There are many older adults that are in institutions, homebound, or lack transportation, who are unable to get to a primary care "setting". These individuals should not be denied the screening because of this. Also primary care practices frequently do screening at health fairs, senior centers, nutrition programs, nursing homes, etc. The current wording would eliminate coverage at these locations even though the screening would be performed by a qualified primary care practitioner.

Another concern is that, even with the current trend to integrate older adult mental health into primary care, qualified mental health professionals, even those employed by the primary care practice would not be allowed to perform the screening. This will create another barrier in achieving integration.

I urge you to reconsider the wording to eliminate these barriers to this much needed service.

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Routine screening for depression and anxiety in primary care with an endorsement for reimbursement is a welcome development. Mental health screening is the most feasible and affordable way to measurably improve every health metric. The PHQ9, and its forerunner, the PRIME-MD, were developed in the 1990's and have achieved much. However, an instrument that includes modern understandings such as bipolar disorder, anxiety and PTSD will lead to better customized and measurable care for the patient.

While the PHQ9 finds cases of depression and the PHQ4 depression and anxiety, their omission of a screen for bipolar disorder is unsupportable. As many as one half of the patients suffering from a Major Depressive Episode carry a bipolar diagnosis. And when patients with Bipolar Depression are treated as simple cases of (unipolar) depression, they often do quite poorly, often worse than they would have without treatment. This is a source of misdiagnosis with profound implications. Markedly increased healthcare costs, higher rates of hospitalization, and increased risk of suicide have all been associated with this critical yet avoidable error. Up to 80% of treatment-resistant cases of depression involve unrecognized bipolarity; and many experts believe the progression to treatment resistance is due to the mismanagement that this misdiagnosis entails.

There is similar research as to the hurtful consequences of misdiagnosis of PTSD.

Any mood or anxiety screen that does not screen for bipolar diagnoses is an inadequate screen. The conclusion is simple and straightforward medical science: for whatever good they bring the PHQ screens can cause significant and avoidable harm. It should be obvious that adding additional layers of screening will be burdensome to doctors and confusing and off-putting for patients; and yet this is exactly what some are advocating. Fortunately, there is an up-to-date and clinically validated alternative. The M3 screen, validated and proven equal in power to four separate diagnostic screens, in less than 3 minutes and with just 27 items, screens for depression, anxiety disorders, PTSD and bipolar disorder. At the same time, it surveys for functional impairment, as well as alcohol and substance abuse. Furthermore, the HIPAA compliant M3 is adapted to EMR and HIE technologies, can be completed by patients on a cell phone, computer tablet/terminal, or on paper, and can provide longitudinal tracking and ongoing clinical decision support all within the same cloud computing system.

The M3 was developed and brought to market entirely through private funding, without a cent of pharmaceutical industry money. The PHQ9’s has hung in for 20 years providing much help. We believe the time has come to reconsider the PHQ9 and consider a diagnostic instrument that is broadly tuned, evidence based, and clinically feasible that includes longitudinal measurement.

Thank you to CMS for the opportunity to participate in this open forum.

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August 17, 2011

Donald M. Berwick, M.D.
Administrator, Centers for Medicare & Medicaid Services
U.S. Department of Health and Human Services
200 Independence Avenue,
S.W. Washington, D.C. 20201

Re: Proposed Coverage Decision Memorandum for Screening for Depression in Adults, Administrative File: CAG-004275N

Dear Dr. Berwick:

AARP commends the Center for Medicare and Medicaid Services (CMS) for recognizing the important role that depression screening and treatment can play to improve health outcomes and quality. Depression is one of the five most common conditions in primary care, and primary care providers deliver almost half the outpatient care for depressed patients. CMS’ proposal to cover annual depression screening in primary care settings when staff-assisted depression care supports are in place is imperative to treat depression in adults.

AARP applauds CMS for recognizing the devastating toll that depression can take on older adults and persons with disabilities. By expanding this important screening beyond the “Welcome to Medicare” visit, CMS has rightly acknowledged, that the onset of depression can occur at anytime during one’s life and should be part of annual wellness visits for older adults. While AARP supports this new coverage policy, we have some suggestions to improve the underlying goals of the policy—to improve health outcomes and quality of life for Medicare beneficiaries who suffer from depression, while lowering health care and other societal costs associated with untreated depression.

Staff-Assisted Depression Care Supports

The United States Preventive Service Task Force (USPSTF) recommendation for screening adults for depression is contingent on staff-assisted depression care supports because these supports ensure that individuals who are identified are linked to needed services. AARP is concerned that many primary care practices may lack staff who can perform this vital function and therefore not conduct the screening, thereby depriving many beneficiaries this important screening. We are pleased that the definitions of “primary care physician” and “primary care practitioner” include physician assistant, nurse practitioner and clinical nurse specialist. AARP believes all primary care providers that are designated to provide Medicare benefits under federal law (including nurse midwives) should be reimbursed for providing this important new benefit. In addition, if Medicare payment does not reflect the time and resources required to perform activities related to this role even practices with the infrastructure may not perform this valuable service. Therefore, we urge CMS to take into consideration the costs associated with depression screening.

More Comprehensive Care Supports

While the language in the Decision Summary references comprehensive care supports, the coverage policy does not explicitly state that such supports are part of the new coverage decision. The Summary defines these supports to include case management, collaborative care between primary care practices and mental health clinicians, patient education and self-management support, and consideration of patient preferences. As defined, these care supports represent important and meaningful supportive services that can facilitate the optimization of treatment for Medicare beneficiaries who suffer from depression. AARP urges CMS to explicitly include this service in its coverage policy as part of the preventive benefit; to develop clear criteria for when it is indicated; and to ensure adequate access to the service through payment policies.

Screening Tests for Adults

We commend CMS for outlining a comprehensive analytic framework for evaluating screening tests. The Agency has described eight distinct screening tests that may be used to either identify persons with depression, measure remission and/or treatment response, or measure the severity of depression.

It is helpful for CMS to identify valid and reliable screening tools. To qualify for payment, providers should be required to use such a tool. We believe that there are advantages to requiring the use of a standardized instruments, particularly, to be able to evaluate patient outcomes. On the assumption that CMS is not prepared to designate a single tool, we urge the Agency to further evaluate the existing tools to identify the most appropriate screening instrument for most primary care practices. We urge CMS to require providers to document which tool they are using when conducting depression screens so that CMS can determine which of these tools is most effective for purposes of this new preventive benefit. Once the most appropriate methods have been established, AARP recommends that CMS initiate a comprehensive beneficiary and provider education program to ensure awareness of the new benefit. In addition, the health care provider education program should include the techniques that are most effective in detecting, diagnosing, and counseling older adults with depression.

In the interim, we encourage CMS to educate providers to help them select the most appropriate screening tool for their patient population. In addition, the Agency should institute an auditing process to ensure that beneficiaries are receiving this very important screening.

Conclusion

AARP appreciates the opportunity to comment on this very important Decision Memorandum. AARP looks forward to working collaboratively with CMS to ensure that the new annual depression screening benefit is fully implemented and working in accordance with its intended purposes.

Thank you again for the opportunity to comment on this proposed decision memo. If you have questions, please contact Leah Cohen Hirsch on our Federal Government Affairs staff at (202) 434-3770.

Sincerely,

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Mayo Clinic strongly supports Medicare coverage for screening of depression. We also believe coverage for screening does not go far enough in addressing depression in adults. In addition to screening, Mayo Clinic encourages CMS to cover care coordination of Medicare beneficiaries diagnosed with depression. Coordinated care management by registered nurses may include office visits, phone calls, or other correspondence with patients diagnosed with depression to decrease emergency room visits, admissions, and other services.

We thank CMS for its proposal to cover depression screening and encourage additional coverage of care coordination of Medicare beneficiaries with depression.

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The National Network of Depression Centers (NNDC) is a collaborating network of 21 leading academic Centers of Excellence (www.NNDC.org) with more than 450 clinicians and investigators. The NNDC strongly endorses the Center for Medicare and Medicaid Services (CMS) recommendation to reimburse screening for adult depression.

Furthermore, we strongly recommend screening and brief intervention for all patients. An estimated 1 in 6 Americans suffer from depressive illnesses and the impact on overall health and functioning can be reduced if treated earlier, more effectively, and if wellness is maintained. Finally, we believe the US Preventative Services Task Force should amplify its classification of Screening for Depression from a Grade B to a Grade A for the following reasons:

1. Depressions are episodic and recurrent, generally start with mild symptoms, but when untreated, get worse and more difficult to treat. Screening is essential for early detection and is a necessary first step for launching effective treatment, attaining recovery and then maintaining wellness.
2. Depression is a world-leading cause of disease burden and disability, the second-most-costly medical disorder in America, and a major cause of earlier death from co-occurring llnesses such as heart disease and diabetes, and earlier treatment is documented as the most effective time in attaining wellness in co-occurring conditions that are usually treated in primary care settings. In essence, screening is the first step in the wellness roadmap. By itself, it is not enough, but it opens the door to earlier, easier, and more effective outcomes.
3. Adequate screening and treatment for depression can be achieved with Medicare reimbursement in an affordable, effective, efficient manner with minimal clinical oversight.
4. A simple screening scale is readily adaptable to national oversight and will have huge public health impact.
5. Medicare reimbursement would serve as the catalyst for medical providers to administer depression screening as a part of routine preventive care. The Medicare Annual Wellness visit makes this revolutionary step particularly easy to schedule and implement; it would enable “relatively automatic” and simple incorporation of screening adult patients for depression at least once per year.
6. Quick, self-reported measuring tools such as the Patient Health Questionnaire-9 or PHQ-9 can be implemented with minimal burden to everyone. The scale, widely used in NNDC sites, requires fewer than 5 minutes, is validated, reliable, open-source, free of cost, and on-line as well as paper version.
7. The PHQ-9 “screening” approach has the added advantage of also serving as an outcome-monitoring approach. Periodic PHQ-9 measures and graphs accurately monitor and visually reflect treatment progress; they can be conceptualized as a parallel to periodic blood pressure measures to monitor treatment of hypertension.
8. Modest reimbursement would further enlist primary care and geriatric clinicians. This is a particularly crucial benefit when seeking to overcome ongoing toxic shortages of mental health professionals.

The NNDC strongly supports and recognizes the importance of Medicare coverage for depression screening. Its members applaud CMS for making depression a top prevention priority in Medicare. The NNDC is available to aid in the national dissemination and program evaluation.

John F. Greden, MD
Founding Chair, National Network of Depression Centers
Executive Director, University of Michigan Comprehensive Depression Center
Rachel Upjohn Professor of Psychiatry & Clinical Neurosciences
Research Professor, Molecular & Behavioral Neuroscience Institute
University of Michigan

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While so many of the medical and psychological reasons stated to support the funding of such screenings indicate this move would be a step forward, social scientific knowledge suggests that possible adverse effects of this decision could very likely outweigh the benefits to older Americans.

There are two significant reasons, yet unexamined by CMS in their analysis, to defer the decision on Medicare’s support of screening for depression among older adults, as the proposed policy is now written. They are:

(1) In addition to physical and psychological causal factors, depression has also been linked to strong and well understood social factors for which various socially based strategies already exist. Common, social causes of late-life depression include:

• changes in residence or circumstances,
• loss of financial independence, and
• general loneliness, or lack of social interaction.

Today, there is a wide variety of inadequately resourced aging services and support systems to address each of these common social causes.

(2) The unknown, potentially negative effects of diagnostic assessment practices, as they are described by CMS, as well as their organizational economic features would lead to: (a) problems in the epidemiological measurement of depression, and (b) negative effects of this measurement on social policy regarding the aging.

The history and social/cultural study of medical practice seems to strongly suggest that the introduction of medically-based, proposed screenings aimed at the ambiguous or complex presentations making up depression without proper attention to these social causes will not address the needs of this population in regards to these symptoms and their causes.

When primary care facilities are able to very easily and with little investment gain more financial resources for flagging depression, as it appears they will be under this proposal, a great many more cases of possible depression will be marked nationwide. The epidemiological measurement of this increased marking will support discussions of what will appear to be a “depression epidemic among the elderly.” Such discussions stand a very high chance of most likely leading away from the key causal factors (and possible worsening) of some of the important social challenges confronting our elderly population, which would result primarily in pharmacological intervention-only.

Seeing the acknowledgement by CMS that “late-life depression is a heterogeneous syndrome leading to diagnostically ambiguous or complex presentations in many patients,” there needs to be a much broader forum and discussion within CMS on this subject in which medical sociologists, medical anthropologists, and others, can better assess the importance of social causes of these symptoms among older Americans. When causes have strong social as well as physical and mental components, the inclusion of sound social scientific knowledge regarding the above mentioned effect on the public health system needs to be an integral part of sound policymaking.

In summary, there has not been enough of the right kind of social scientific knowledge and analysis to justify Medicare’s support for such screenings at this time. In fact, such knowledge and analysis to date suggests a possible negative impact on the health and wellbeing of this population

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August 17, 2011
Submitted via Email:
CAGinquiries@cms.hhs.gov

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 Proposed CMS National Coverage Determination for Screening for Depression in Adults (CAG-00425N)

Dear Dr. Jacques:

Takeda Pharmaceuticals North America, Inc. (Takeda) and Lundbeck Inc. (Lundbeck) appreciate this opportunity to provide comments to the Centers for Medicare & Medicaid Services (CMS) concerning its proposed national coverage determination on Depression Screening in Adults.¹ Takeda 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. Takeda also has a promising pipeline of products in multiple therapeutic areas, which include compounds in development for psychiatric conditions such as depression. Lundbeck is committed to providing innovative specialty therapies that fulfill unmet medical needs of people with central nervous system disorders and rare diseases for which few, if any, effective treatments are available. In partnership with Lundbeck, Takeda is currently sponsoring phase III studies for Lu AA21004 in patients with major depressive disorder (MDD).

Both Takeda and Lundbeck strongly support Medicare coverage of depression screening services as recommended by the United States Preventive Services Task Force (USPSTF), and we commend CMS for its proposal to cover annual depression screening in adults as an “additional preventive service” that is reasonable and necessary for the prevention or early detection of an illness or disability.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.

Frequency

We agree with CMS’ proposal to cover depression screening on an annual basis. In a comment letter submitted to CMS earlier this year,³ Takeda recommended that Medicare cover depression screening at least annually, or more frequently if other circumstances (including the presence of certain risk factors, such as family history of depression, or presence of chronic disease) suggest that more frequent screening is appropriate.

Staff-Assisted Care Supports

The USPSTF recommends screening adults for depression when staff-assisted care supports are in place to assure accurate diagnosis, effective treatment and follow-up. We agree with CMS’ proposal that a minimum level of staff-assisted care supports would consist of clinical staff (such as a nurse or a physician assistant) who can advise the physician of screening results and who can facilitate and coordinate referrals for mental health treatment. In Takeda’s March 30, 2011, comment letter, Takeda had recommended that CMS reference a similar level of support as sufficient in terms of effort and personnel, noting that this was supported by one study the USPSTF characterized as demonstrating “the lowest effective level of staff-assisted depression supports.”⁴

CMS also stated in the proposed NCD that “more comprehensive care supports include case management by a nurse or nonphysician working with the primary care physician; planned collaborative care between the primary care provider and mental health clinicians; patient education and support for patient self-management; plus attention to patient preferences regarding counseling, medications, and referral to mental health professionals with or without continuing involvement by the patient’s primary care physician.”⁵ We were not certain why CMS defined “more comprehensive care supports,” unless this is intended only for illustrative purposes (or unless CMS intends to bifurcate payment for depression screening according to whether it involves the minimum level of support or a “more comprehensive” level of support). In any case, we recommend that CMS clarify the purpose of this distinction.

The proposed NCD does not address whether CMS intends to pay for depression screening as a separately billable service or as part of a bundle of services, such as those services provided during an office visit or an annual wellness visit. We look forward to CMS clarifying its intent in this regard. We recommend that CMS pay for depression screening in the context of an annual wellness visit or other office visit by appropriately increasing the payment for that visit. When depression screening is performed outside of the context of an annual wellness visit, CMS should make a separate payment for the service. While we understand that CMS does not typically address payment issues in an NCD, we are concerned that Medicare beneficiaries’ access to screening services may not appreciably expand — and the coverage policy would thus not have achieved its purpose — unless CMS assures that these screening services are paid for appropriately.

Primary Care Setting

The proposed NCD would cover depression screening for Medicare beneficiaries in “primary care settings that have staff-assisted depression care supports,” and defines a primary care setting as one that provides “integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community.”⁶ The proposed Decision Memo further specifies that primary care settings do not include settings such as emergency departments, inpatient hospital settings, outpatient hospital settings, ambulatory surgical centers, independent diagnostic testing facilities, skilled nursing facilities, inpatient rehabilitation facilities and hospices.

We commend CMS for covering this service in the primary care setting; we believe this is an important setting and the most likely setting in which Medicare beneficiaries would receive depression screening services. At the same time, CMS’ definition of “primary care setting” might be read to exclude some settings where screening for depression in adults may be appropriate, such as mental health clinics or other Medicare-participating providers that furnish mental health services specifically (e.g., psychologists or clinical social workers), because they typically do not “address a large majority of [an individual’s] personal health care needs.” We are concerned that the “primary care” requirement (especially given the definition of this term that CMS proposes to use) could needlessly restrict patient access to depression screening in appropriate settings and is not part of the USPSTF recommendation.

The USPSTF recommendation extends to depression screening in adults when staff-assisted depression care supports are in place, but does not limit this service to a primary care setting. We understand CMS’ point that USPSTF relied partly on a systematic evidence review by O’Connor, et al (2009)⁷ that required all studies to be conducted in a general primary care population, but we believe that USPSTF would have specified the setting if it believed this was central to its recommendation.⁸ Consequently, we strongly recommend that the final NCD not require that depression screening occur only in a primary care setting in order to be covered Rather, CMS should broaden the settings in which screening can occur (by refining the “primary care” definition) if it adopts a requirement for a primary care setting. We believe that broadening the settings in which screening can be covered is particularly important given the well-recognized shortage that exists of primary care physicians and other primary care providers, especially in rural areas.

We believe that by covering depression screening services, CMS can help Medicare beneficiaries to identify and address a serious, often debilitating illness. We strongly support Medicare coverage of this valuable service. We appreciate the opportunity to comment on this important proposed NCD, and hope these comments will be useful to CMS as it finalizes its 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,

Laura Cline
Sr. Director, Federal Government & External Affairs
Takeda Pharmaceuticals North America, Inc.

Sally Benjamin Young
Vice President, Public Affairs
Lundbeck, Inc.

1 CMS Proposed Decision Memo for Screening for Depression in Adults (CAG-00425N).
2 Under §1861(ddd) of the Social Security Act, CMS may cover “additional preventive services” if it determines through the National Coverage Determination process that the service: (1) is recommended with a grade of A or B by the USPSTF; (2) is reasonable and necessary for prevention or early detection of an illness; and (3) is appropriate for Medicare beneficiaries.
3 Takeda Comments on CMS National Coverage Analysis for Screening for Depression in Adults (CAG-00425N), submitted electronically on March 30, 2011.
4 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.
5 CMS Proposed Decision Memo for Screening for Depression in Adults (CAG-00425N).
6 Id.
7 O’Connor EA, Whitlock EP, Beil TL, Gaynes BN. Screening for depression in adult patients in primary care settings: a systematic evidence review. Ann Intern Med. 2009;151:793-803.
8 CMS issued a proposed Decision Memo on July 19, 2011, on Screening and Behavioral Counseling Interventions in Primary Care to Reduce Alcohol Misuse (CAG-00427N). In this case, the USPSTF specifically recommended screening and behavioral counseling interventions to reduce alcohol misuse by adults, including pregnant women, in primary care settings.

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August 17, 2011

Donald Berwick, MD
Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244-1850

Dear Dr. Berwick,

The American Psychiatric Association (APA), the national medical specialty society representing more than 37,000 psychiatric physicians, appreciates the opportunity to comment on CMS’s proposals to cover an annual screening for Medicare beneficiaries in primary care settings and an annual alcohol screening and four brief face-to-face behavioral counseling sessions for Medicare beneficiaries who screen positive for alcohol misuse. The APA joins CMS in advocating for the addition of each of these services to Medicare’s package of preventive benefits. The APA would like to submit the following comments on these two proposed Medicare preventive benefits.

The APA supports annual depression screenings as a Medicare preventive benefit, as it did in its March 2011 regulatory comments, which are included below, with the following additions: 1) The APA thinks that if CMS makes it a requirement that staff-assisted supports be in place for the administration of depression screenings in primary care settings, at a minimum level, staff-assisted care supports should consist of clinical staff (e.g., nurse, physician assistant) in the primary care office who can inform the physician of screening results, discuss the screening results with the patient, and who can facilitate and coordinate referrals to mental health treatment. 2) The APA wishes to emphasize the importance of psychiatric consultation following a depression screening that is positive. 3) The APA wants to ensure appropriate payment systems are in place to guarantee the physician administering the depression screening is fairly reimbursed for conducting the depression screening, discussing with the patient his or her screening results, and, if necessary, consulting with a psychiatrist, and referring the patient for further mental health treatment.

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 has been estimated at 6.6 percent.³ Patients with depression have significantly higher annual health care costs, at a mean of $4,246, than those patients without depression, at a mean of $2371.⁴ 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.⁵

It is of critical importance that physicians, especially in primary care settings be reimbursed to perform depression screenings. For many Americans, annual examinations from a primary care physician serve as their only entry to the health care system. About one-quarter to one-half of patients with depression already receive treatment in primary care.⁶ 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 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.⁷ Most depressed patients will present to their primary care physician with somatic complaints rather than complaining of a depressed mood.⁸ 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. ⁹

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.¹⁰ 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.¹¹ 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.”¹² The APA suggests that for depression, such considerations should include patient populations with general medical conditions that are both frequently combined 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.¹³ 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.¹⁴ 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-2¹⁵ The VA/DoD Guideline describes such screening as “an important mechanism for reducing morbidity and mortality.”¹⁶ 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.”¹⁷ 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.

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 endorses CMS’s proposal to provide Medicare beneficiaries with an annual alcohol screening in a primary care setting, and for those who screen positive, up to four brief, face-to-face behavioral counseling sessions per year conducted by a primary care physician or primary care practitioner.

The effectiveness of this approach has been proven in other settings, such as for beneficiaries of the Veterans’ Administration health care system. Every twelve months, VA beneficiaries receive an alcohol misuse screening in a primary care setting. When a VA beneficiary screens positive for alcohol misuse, the VA’s health records system tags the beneficiary’s health care record with notice of a need for a brief intervention with the beneficiary’s primary care clinician, psychiatrist, or other professional staff trained in brief interventions. The practitioner or physician responds to the alert by having a brief, one-time counseling session with the VA patient.

APA members who work within the VA health system attribute even greater praise to CMS’s proposal, which would provide for up to four brief face-to-face counseling sessions between a primary care physician or other primary care practitioner and the Medicare beneficiary, in situations in which the beneficiary has tested positive in his or her annual alcohol misuse screening. APA members agree that CMS’s proposed Medicare alcohol misuse screening and counseling will particularly benefit high risk drinkers. High risk drinkers often do not satisfy the criteria for receiving substance abuse services. However, APA members identify high risk drinkers as a vulnerable population particularly responsive to brief interventions from a primary care physician or primary care practitioner. Brief interventions by a primary care physician or primary care practitioner are likely to prevent medical complications and avert the need for more intensive and expensive specialty care substance use disorder treatment.

APA members who have treated high risk drinkers acknowledge most high risk drinkers will respond well to brief alcohol misuse counseling from a primary care physician or primary care practitioner. Research by Fleming and colleagues (2002) corroborates APA members’ experiences, finding that brief interventions with high risk drinkers not only significantly reduce alcohol use but can lead to positive health outcomes several years after the intervention.

The APA strongly urges CMS to only reimburse for alcohol screenings if a structured screening test is used. The APA reminds CMS that alcohol misuse screening instruments vary in their effectiveness. An instrument’s effectiveness is greatly correlated with the population using the instrument. The APA encourages CMS to include the NIAAA’s Single Item Screen for its alcohol misuse screenings. This test has proven effectiveness in identifying high risk drinkers. The APA also supports use of the AUDIT-C test which is a 3 item test that can be given as a self assessment or computerized questionnaire.

The APA supports the 5A’s approach that has been adopted by the U.S. Preventive Services Task Force. However, it does not feel each of the behavioral counseling interventions has to be exactly consistent with this approach; iterations of the 5A’s approach should be acceptable when counseling Medicare beneficiaries who screen positive for alcohol misuse.

From our reading of the proposal, it is not clear how primary care physicians and primary care practitioners will be reimbursed for the provision of up to four brief, face-to-face alcohol misuse counseling sessions provided to Medicare beneficiaries who screen positive for depression. The APA seeks clarification regarding how alcohol misuse counseling sessions will be defined and coded. Will these services be coded under existing CPT nomenclature, and if so, by which codes? Or, is CMS proposing the development of a new CPT code?

The APA thanks CMS for the opportunity to comment on its proposal to make depression screening, alcohol misuse screening, and alcohol misuse counseling benefits available to Medicare beneficiaries in primary care settings. Primary care physicians and primary care practitioners play an important role in diagnosing incidents of depression and alcohol misuse. For most Americans with mental health disorders, primary care physicians and primary care practitioners serve as an entry way to the mental health system. The APA thinks CMS’s proposed benefits will better equip primary care physicians and practitioners to address the mental health needs of their patients. Psychiatrists stand ready to assist primary care physicians and practitioners as they provide these screening and counseling services. For questions regarding the APA’s comments, please contact Julie A. Clements, J.D., APA Deputy Director, Regulatory Affairs, at (703)-907-7842 or via email at jclements@psych.org

Sincerely,

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 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.
5 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
6 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.
7 Id.
8 The VA/DoD Clinical Practice Guideline for Management of Major Depressive Disorder, Appendix B, p. 4.
9 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.
10 USPSTF. Screening for Depression in Adults, December 2009 http://www.uspreventiveservicestaskforce.org/uspstf/uspsaddepr.htm#related
11 Id.
12 Id.
13 American Psychiatric Association. Practice guidelines for the treatment of patients with major depressive disorder, third edition, Am. J. Psychiatry, 167 (Oct Suppl), 2010.
14 Id.
15 The VA/DoD Clinical Practice Guideline for Management of Major Depressive Disorder, Appendix B, p. 15.
16 Id. at p. 4.
17 See MacMillan HL, Patterson CJ, Wathen CN, et al. CMAJ 2005; 172:33-5.

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August 16, 2011

Mr. Donald M. Berwick, M.D., M.P.P.
Administrator
Centers for Medicare & Medicaid Services
Hubert H. Humphrey Building
200 Independence Avenue, S.W., Room 445-G
Washington, DC 20201

Submitted electronically

RE: Proposed Decision Memo for Screening for Depression in Adults (CAG-00425N)

Dear Dr. Berwick:

On behalf of our 145 member hospitals and 17 member health systems, the Minnesota Hospital Association (MHA) thanks you for the opportunity to comment on CMS’ proposed decision memo for screening for depression in adults (CAG-00425N).

Along with the American Hospital Association (AHA), MHA fully supports CMS’ proposal to add alcohol screening and behavioral counseling, as well as screening for depression, to the package of prevention services offered to Medicare beneficiaries.

Minnesota’s hospitals and health systems helped implement the Institute for Clinical Systems Improvement’s (ICSI) DIAMOND model of depression treatment. MHA and our members have long been supporters of bringing evidence-based health care guidelines into practice. The CMS memo is an affirmation of the important work being done in Minnesota and now across the nation.

MHA supports the use of the primary care setting for these screenings. In addition, MHA strongly supports the memo’s recommendation to provide treatment or support once the screening is completed. This next step is critical to successfully treating depression, behavioral conditions, and alcohol abuse.

Finally, MHA would like to recommend CMS expand its suggestion of what provider types are considered “clinical staff” in staff-assisted depression care support. Evaluations of DIAMOND have found certified medical assistants to be an important part of the successful DIAMOND model. Adding “certified medical assistant” to “nurse and physician assistant” as “clinical staff …in the primary care office who can advise the physician of screening results and who can facilitate and coordinate referrals to mental health treatment” will enable more individuals to receive coordinated care and successful treatment.

If you have any questions, please feel free to contact me at (651) 659-1405 or jmcnertney@mnhospitals.org.

Sincerely,

Jennifer McNertney
Policy Analyst

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August 15, 2011

Centers for Medicare and Medicaid Services
Attn: Stuart Caplan, RN, MAS and Lawrence Schott, MD, MS
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memo for Screening for Depression in Adults (CAG-00425N)

Delivered electronically via www.cms.gov

Dear Mr. Caplan and Dr. Schott:

The American Psychological Association (APA), the professional organization representing 154,000 members and affiliates engaged in the practice, research, teaching, and learning of psychology, appreciates the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) proposed decision memo for screening for depression in adults. The APA strongly supports the CMS proposal to cover annual screening for depression for Medicare beneficiaries in primary care settings. As explained below, we recommend that such screening be provided even in the absence of staff-assisted depression care supports in the primary care setting. In such instances, the Medicare beneficiary could be referred to a psychologist or other qualified mental health professional in the community to assure accurate diagnosis, effective treatment, and follow-up. We urge CMS to include all aspects of its proposal in issuing a final decision memorandum.

Numerous studies have shown that depression is a serious and prevalent health problem for adults, especially older adults. Studies from Alexopoulos and Steffens and their colleagues have noted that “of the roughly 35 million Americans aged 65 and older, an estimated two million have a major depressive illness and another five million may have subsyndromal depressive symptoms” (as cited in Delano-Wood & Abeles, 2005). Thus, about 20 percent of older Americans are struggling with depressive disorder or its associated symptoms. The rate of depressive symptoms in older adults increases for those with chronic physical disorders and disabilities, and “the presence of comorbid medical illness can have an extensive impact on morbidity, mortality, and quality of life” (Delano-Wood & Abeles, 2005). Evidence has shown depression to be associated with many chronic disorders, such as endocrine disorders, cancer, and arthritis, and depression has a strong relationship with cardiovascular disease in older patients (Delano-Wood & Abeles, 2005). Screening and treatment for depression not only improves the quality of life for individuals and their families but also contributes to improved outcomes for a number of other health problems, including cardiovascular disease, diabetes, and kidney disease.

Of particular concern, depression is one of the conditions most commonly associated with suicide in both adult and older adult populations and is often under-recognized and under-treated. Because the overwhelming majority of patients with depressive disorders are seen annually by their primary care physicians, the opportunity to diagnose and treat patients early in the course of their illness in the primary care setting is substantial, though largely unfulfilled by our current health care system (Trivedi, Lin, & Katon, 2007). Statistics demonstrate that suicide rates are highest in late life, with 19 percent of suicides completed by older adults (Delano-Wood & Abeles, 2005; Areán & Ayalon, 2005). Studies indicate that many older adults (up to 75 percent) who die by suicide visited a physician within a month before their death (Conwell, 2001). Likewise, depression appears to be a significant problem for caregivers. Estimates suggest that between 40 to 70 percent of caregivers have clinically significant symptoms of depression, with approximately one-fourth to one-half of these caregivers meeting the diagnostic criteria for major depression (Zarit, Reever, & Bach-Peterson, 1980).

Thus, the CMS proposal to cover annual depression screenings without cost sharing for Medicare beneficiaries will help improve the identification of depressed patients in primary care settings. As the U.S. Preventive Services Task Force (USPSTF) reported in its 2009 recommendation statement, appropriate treatment of depressed older adults identified through screening in primary care settings decreases clinical morbidity and improves clinical outcomes (USPSTF, 2009).

However, the USPSTF recommendation to screen only “when staff-assisted depression care supports are in place to assure accurate diagnosis, effective treatment, and follow-up” may not prove strong enough to ensure that individuals with depression are identified and obtain needed access to care. Depression is a mental disorder for which effective treatments are available; yet such treatments cannot be delivered unless efforts are made to appropriately screen and refer those in need. The lack of treatment resources in the primary care setting should not serve as a disincentive for depression screening. Even in the absence of such primary care services, the Medicare beneficiary could be referred for treatment to psychologists and other qualified mental health professionals in the community. It is important to note that depression screening will yield objective data to help determine whether or not the primary care services should be expanded to offer depression treatment, particularly when such treatment is not available in the surrounding community.

Given our recognition that a broader provision for depression screening will need to be established by the USPSTF (as is already in effect for many other disorders), we will direct our concerns to them in a follow-up communication. With this understanding, we support the CMS provision as an interim measure.

Another critical issue to consider further is staff training. Presumably, the primary care clinical staff providing the depression care supports, as stipulated by the USPSTF and advanced by CMS, will be trained to properly manage depression screening results. We also recommend that CMS more clearly state the training that is required for primary care staff providing depression care supports. We make this recommendation because studies have shown that those who screen older adults for depression in primary care settings may need additional training by geriatric mental health specialists. As Unützer, Katon, et al. (2002) have noted, “the primary care system is highly demanding, with care providers typically seeing 100 patients per week and generally having between 10 and 15 minutes to manage a host of chronic conditions. This rarely allows the time necessary to accurately assess and treat depression in their older patients” (as cited in Areán & Ayalon, 2005). Also, Glasser and Gravda’s study has shown that “some physicians may lack adequate training in mental health and may feel uncomfortable working with depressed older adults” (as cited in Areán & Ayalon, 2005). Additional training by geriatric mental health specialists, such as geropsychologists, would help address some of these problems in primary care settings.

In its definition of more comprehensive depression care supports in a primary care setting, the APA is pleased to see CMS include “attention to patient preferences regarding counseling, medications, and referral to mental health professionals with or without continuing involvement by the patient’s primary care physician.” We concur with this statement, as data show older adults often prefer psychotherapy to psychiatric medications (Areán et al., 2002; Dwight-Johnson, Sherbourne, Liao, & Wells, 2000; Gum et al., 2006; Koh et al., 2010; Landreville et al., 2001; Sirey et al., 2001; Unützer et al., 2002). However, older adults cite poor access to psychotherapy as a major problem with mental health services (Koh et al., 2010). Psychological interventions are often not offered as an alternative, and despite patient preferences, treatment has become increasingly pharmacotherapy-oriented (Olfson & Marcus, 2009; Mojtabai & Olfson, 2008). Recent research has demonstrated that psychotherapy can be effective for people diagnosed with late-life depression who are at high risk for poor response to antidepressant medication (Areán et al., 2010). We hope the above statement from CMS will result in greater access to appropriate and effective psychological interventions for Medicare beneficiaries.

Depression is a common, costly, and debilitating condition for older adults if left unrecognized and untreated. However, depression in older adults is treatable, and treatment can improve quality of life and clinical outcomes. It is imperative that depression screening be used to accurately identify depression in older patients in primary care. For reasons stated above, the APA strongly supports the CMS proposal to cover annual depression screening for Medicare beneficiaries in primary care settings and looks forward to its implementation. We are hopeful that the USPSTF will soon lift the requirement that staff-assisted depression care supports be in place in the primary care setting for such screening to be provided.

Please contact Doug Walter, J.D., Legislative and Regulatory Counsel, Government Relations, APA Practice Organization, at dwalter@apa.org or (202) 336-5889, if you have further questions regarding our comments.

Sincerely,

Norman B. Anderson, Ph.D.
Chief Executive Officer

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Dear Dr. Schott and Mr. Caplan,

Thank you for the opportunity to provide comments to Centers for Medicare and Medicaid Services (CMS) regarding the national coverage analysis on depression screenings. The National Congress of American Indians (NCAI) – the nation’s oldest, largest, most representative national tribal organization made up of American Indian and Alaska Native tribal governments – supports the decision of CMS to cover depression screening under Parts A and B.

In 2007, NCAI and tribal leaders established a suicide prevention task force to address the alarming rates of suicide in many of our small, rural communities. This task force meets semi-annually to exchange prevention and intervention methods, discuss current policy and legislation, and to make recommendations from Indian Country. It is with this experience that NCAI provides following feedback.

The proposed coverage decision memo addresses a significant need in Indian Country. The Office of Minority Health reports that our populations experience higher rates of serious psychological distress, feelings of sadness, hopelessness, and worthlessness, feelings of nervousness or restlessness, and suicide than all other races.ⁱ Suicide rates in Indian Country are nearly twice that of other races nationally.ⁱⁱ Additionally, a majority of American Indians and Alaska Natives rely on the Indian Health Service (IHS) to provide access to health care services in 45 hospitals and more than 600 other facilities.ⁱⁱⁱ Many of these services provided to elderly adults are billed to CMS and providing depression screening would certainly close a gap in service that the IHS is currently struggling to close through direct referrals.

However, the current primary care standards set forth in the memo would limit eligible American Indians and Alaska Natives to only a few locations that provide staff assisted care support. NCAI recommends that CMS review this requirement and permit IHS hospitals and facilities to conduct depression screening without staff assisted care support when direct referrals can be made for the patient. Allowing this exception would provide an opportunity for tribal elders visiting IHS facilities to be screened annual and by providers in which they have an established relationship.

NCAI appreciates the work CMS is doing to protect our elders – wisdom keepers in our communities – and looks forward to working with CMS in the future. If you have questions please contact Ahniwake Rose, Policy Analyst, at arose@ncai.org or 202-466-7767.

Sincerely,

Jacqueline Pata
Executive Director

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August 9, 2011

Donald M. Berwick, M.D., M.P.P.
Administrator
Centers for Medicare & Medicaid Services
Hubert H. Humphrey Building
200 Independence Avenue, S.W., Room 445-G
Washington, DC 20201

RE: Proposed Decision Memo for Screening for Depression in Adults (CAG-00425N)

Dear Dr. Berwick:

On behalf of our more than 5,000 member hospitals, health systems and other health care organizations, and our nearly 42,000 individual members, the American Hospital Association (AHA) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS) proposed decision memorandum for depression screening in adults.

We fully support CMS’s proposal to add alcohol screening and behavioral counseling, and screening for depression to the package of preventive services offered to Medicare beneficiaries. Prevention of illness or disability only occurs when beneficiaries receive an accurate diagnosis, effective treatment and appropriate follow-up. Evidence supports improved health outcomes for beneficiaries when they receive screening and behavioral counseling to reduce alcohol misuse. We also agree that screening for depression in adults is reasonable and necessary for the prevention or early detection of illness or disability, and is appropriate for individuals entitled to benefits under Part A or enrolled under Part B. In addition, we believe that the primary care setting is an appropriate venue through which these services should be delivered.

If you have any questions, please feel free to contact me or Joanna Hiatt Kim, senior associate director for policy, at (202) 626-2340 or jkim@aha.org.

Sincerely,

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I am concerned that new Medicare Primary Care reimbursement for depression screening excludes this service taking place in assisted living facilities and nursing homes. I feel this is terribly short-sighted as it excludes the subsection of the senior community most at-risk for depression. The literature is very clear that institutionalized elderly are at high risk for depression, which exacerbates their somatic conditions. Regrettably, the progressive thinking of integrated care has not filtered well into the world of the instituionalized elderly. This is why there are more elderly depressed who are untreated than youth.(Teachers are better trained to identify depression than eldercare workers.) Make depression screening available to the institutionalized elderly by making it Medicare reimbursable; and you proactively address the core of the unconsidered epidemic of geriatric depression in our country.

Lawrence Epp, EdD

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We enthusiastically support that there be annual screening for depression for Medicare recipients. We also feel that it is important to screen for both major depression and bipolar disorder at the same time so that a proper diagnosis and the correct type of treatment can be provided. Our nonprofit organization, Families for Depression Awareness (www.familyaware.org) helps families recognize and cope with depressive disorders to get people well and prevent suicides. Many people we help find that they have been diagnosed with major depression, but after learning more through our education, discover they actually have bipolar disorder and after receiving the proper medication, can finally get well. I founded the organization because I lost [PHI Redacted] to suicide 20 years ago. He saw a primary care doctor the year he took his life, but they didn’t screen him for depression or ask questions that would have brought his illness to light. Now, 20 years later, most primary care doctors still don’t screen for depression and people continue to take their lives, nearly 35,000 people a year. The highest rate of suicide is among the elderly, the Medicare population, and 75% of seniors who take their lives saw a doctor within a month of their death. Doing a simple screening would not only help to prevent these terrible deaths to suicide and improve peoples’ lives, they would also decrease our health care costs. Seniors who suffer from untreated depression are much more likely to suffer from other medical conditions such as heart disease and diabetes and require more medical care from doctors and hospitals, further burdening our health care system. Thank you so much for proposing this screening that will dramatically improve the health care system, greatly reduce the painful suffering of those with depression, and save peoples’ lives! Julie Totten President and Founder, Families for Depression Awareness

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Subject: Medicare Proposes Coverage for Screening and Counseling for Alcohol Misuse and Screening for Depression (00427N)
Dear Colleagues,
On behalf of the California Hospital Association (CHA) and our 400 member hospitals and health systems, we wish to express our support for the Centers for Medicare & Medicaid Services (CMS) proposal to add alcohol screening and behavioral counseling, and screening for depression to the package of preventive services for Medicare beneficiaries. We offer the following comments for your review and consideration. CHA concurs there is sufficient evidence to support improved health outcomes for beneficiaries when they receive screening and behavioral counseling to reduce alcohol misuse. We also believe primary care providers and primary care settings are a reasonable and necessary location for these services to occur in. Prevention of early illness or disability, can only occur when beneficiaries receive an accurate diagnosis, effective treatment, and appropriate follow-up. Furthermore CHA supports the behavioral counseling interventions being consistent with the 5A’s approach that has been adopted by the U.S. Preventive Services Task Force (USPSTF); Assess – Advise - Agree – Assist – Arrange. With that said, CHA recommends CMS consider including telemedicine as an acceptable method to be used when providers “Arrange” for follow-up contacts with beneficiaries to provide ongoing assistance and support with these patient’s treatment plans. Escalating healthcare costs, an aging population, rapid increases in chronic disease, and dwindling access to health care in underserved urban and rural areas necessitated the adoption of Telemedicine. For example, in rural Yuba county, there were 2,602 residents for every primary care physician according to 2008 statistics, far in excess of the suggested 60-to-1 ratio. Rural communities throughout California suffer shortages of licensed mental health professionals, resulting in patients having to drive long distances, and/or wait for weeks or months to access the care they need. Primary care providers in rural clinics find it increasingly difficult to fully meet their patients’ mental health needs. Patients’ lack of access to mental health care often complicates the physical symptoms doctors are trying to treat in the primary care setting. Many of the psychiatric emergencies in rural Emergency Rooms could be avoided if patients had access to regular out-patient mental health care services. Telemedicine is a critical and vital resource and should be an acceptable method for use by primary care providers. In addition, CHA urges CMS to reconsider the exclusion of the hospital outpatient setting from its definition of primary care setting. As part of the FFY 2014 Medicare hospital outpatient quality reporting program, CMS has acknowledged the outpatient setting as a primary care setting by proposing quality measures related to diabetes care and argues that a significant portion of primary care services are provided in these clinics. In addition, in California, hospital based outpatient clinics providing primary care make up approximately 50% of the primary care clinic services available statewide. In some communities these hospital based outpatient clinics are the only primary care provider in very large geographic areas. Currently consumers are not able to discern the difference between a hospital based clinic providing primary care services and that of a federally quality health center or community health center. These two types of providers (outpatient hospital clinics and primary care clinics) provide almost identical services. Not allowing outpatient hospital setting to provide comparable care to those of non-hospital based primary care clinics will further fragment an already complex primary care delivery system in California and lead to significant access issues for Medicare beneficiaries. Any clinic that’s primary purpose is the provision of integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community should be permitted and encouraged to offer these new screening and counseling services. Again we very much support the proposal to add alcohol screening and behavioral counseling, and screening for depression to the package of preventive services for Medicare beneficiaries. We appreciate the opportunity to comment. If you have any questions or concerns, please do not hesitate to contact me at skruckenberg@calhospital.org or 916-552-7576 or my colleague Alyssa Keefe, vice president federal regulatory affairs at akeefe@calhosptial.org or 202-488-4688. Sincerely,
/S/
Sheree Kruckenberg
Vice President
Behavioral Health Services

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First paragraph where it says: is reasonable and necessary for the prevention or early detection of illness or disability. I suggest that instead of “or”, use “and” as prevention is different from early detection.

Where it says: At a minimum level, staff-assisted depression care supports consist of clinical staff (e.g., nurse, physician assistant) in the primary care office who can advise the physician of screening results and who can facilitate and coordinate referrals to mental health treatment. I suggest that instead of “treatment” should be “professionals as appropriate” as not all cases of depression need to be treated by a mental health professional. Examples of cases treated by professionals other than mental health might be depression due to medical conditions [hypothyroidism], due to neurological causes [Parkinson’s], secondary to medications [steroids}, and or due to substance and alcohol use/abuse or even dependency.

Where ir states: Depression is a mental disorder characterized by alterations in mood. “Mood disorders are recurrent, life threatening (due to the risk for suicide), and a major cause of morbidity worldwide.” I suggest changing “mood disorders” here for “depression” so the other disorders are excluded from the recurrence.

Typo error where it sates: Insomnia or hypersonic nearly every day; Should read: Insomnia or hypersomnia nearly every day;

Where it states: the criteria for a major depressive episode include five or more of the following symptoms, that have been present during the same two week period and represent a change from previous functioning, I suggest changing for that must have been present during...

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