Summary Of Evidence

Approximately half of all people with various dementia conditions (including Alzheimer’s) have been diagnosed and less than half of those who have been diagnosed (or their caregivers) are actually aware of the diagnosis. While there are many reasons for this scenario, 2 have been frequently noted by Alzheimer’s experts. One is a sense of futility within the medical community and the second has been the lack of reimbursed time for handling the multi-faceted aspects of these conditions. Pharmacologic approaches are sadly lacking, but there are still many approaches that can be utilized to improve the quality of life and safety for such patients when focus is brought to appropriate diagnosis and care planning. However, such care plans must be of high quality. A “pro-forma set of check boxes” as an approach to a high-quality care plan is not representative of the type of assessment and care planning that will best serve this demographic of the population with cognitive impairments.¹

It has been suggested by the Alzheimer’s Association’s Expert Taskforce¹ (the Task Force) that a multi-disciplinary approach to the cognitive assessment and care plan service would be best. Thorough care plans can be helpful on many levels. One analysis showed care planning for individuals newly diagnosed with Alzheimer’s and other dementias would save Medicare $692 million over 10 years.¹ According to the most recent Global Burden of Disease classification system, Alzheimer disease rose from the 12th most burdensome disease or injury in the United States (U.S.) in 1990 to the 6th in 2016 in terms of disability-adjusted life-years. It has been projected that by 2050 Alzheimer dementia will affect 13.8 million U.S. residents.²

The Task Force clarified its belief that a static one-time care plan is inadequate for proper care of these patient with a progressive disease that may span years. Needs, life circumstances, living arrangements, behaviors, and caregivers can be expected to change. Frequency for this cognitive assessment and care planning service was recommended at no less than once per year. While the full cognitive assessment and care plan service cannot be provided more than once every 180 days by any single provider, CMS has been clear that adjustments to the care plan can be made at any interval per the use of appropriate evaluation and management codes or chronic care management codes, as applicable.

The expert Task Force stated that the development and existence of a care plan for purposes of cognitive impairment should be readily identifiable.

Bradford et al. (2009)³ noted that early detection of dementia, as with any disease, is consistent with a goal of high-quality health care. The diagnosis of dementia in primary care is dependent mostly on clinical suspicion based on patient symptoms or caregivers' concerns and is prone to be missed or delayed. They conducted a systematic review of the literature to ascertain the prevalence and contributing factors for missed and delayed dementia diagnoses in primary care. This prevalence was estimated by abstracting quantitative data from studies of diagnostic sensitivity among primary care providers. Possible predictors and contributory factors were determined from the text of quantitative and qualitative studies of patient, caregiver, provider, and system-related barriers. Overall estimates of diagnostic sensitivity varied among studies and seemed to be in part a function of dementia severity, degree of patient impairment, dementia subtype, and frequency of patient-provider contact. Major contributory factors included problems with attitudes and patient-provider communication, educational deficits, and system resource constraints. They concluded the true prevalence of missed and delayed diagnoses of dementia was unknown but seemed to be high. They also noted that although no studies supported routine dementia screening, this made early diagnosis of dementia based on symptoms and caregivers’ concerns critical to identifying reversible etiologies, delaying progression, and potentially reducing patient and caregiver burden.

Kotagal et al.⁴ noted that 297 of 845 subjects in the Aging, Demographics, and Memory Study, a nationally representative community-based cohort study, met criteria for dementia after a detailed in-person study examination. Of these 297 people, 55.2% reported no history of a past clinical cognitive evaluation by a physician. Contrary to an original hypothesis, lower socioeconomic status was not associated with a lower rate of cognitive evaluations. The conclusion followed that many elderly individuals with dementia do not receive clinical cognitive evaluations and this was true even for those with regular primary care. Physician barriers such as poor recognition of symptoms, time constraints and therapeutic pessimism were noted. It was also noted that brief, office-based cognitive instruments may also have variable sensitivity in different patient populations.

Regarding the single service element that includes functional assessment and decision making, The Task Force noted that these are 2 separate things. It was noted that “decision making capacity” refers to the individual’s ability to be safe at home and if left alone, to understand one’s own health care and support needs, and to manage basic legal and financial affairs. Functional assessment, per the Task Force, focuses on the tasks that individual patients are able to perform.

This policy notes that decision making capacity and functional assessments, even combined within 1 element of the necessary 10 elements for provision of this Cognitive Assessment and Care Plan service, must be performed.

The Task Force emphasized that determination of decision-making capacity is important, but in addition, it is also important that the care planning result in identification of who will be making decisions in the event that the patient cannot.

Patnode et al.⁵ conducted a systematic review of the test accuracy of cognitive screening instruments and the benefits/harms of interventions to treat cognitive impairment in older adults (> 65 years). The review included 287 studies with more than 280,000 older adults. One randomized clinical trial (RCT) (n = 4005) examined the direct effect of screening for cognitive impairment on patient outcomes, including potential harms, finding no significant differences in health-related quality of life at 12 months (effect size, 0.009 [95% CI, –0.063 to 0.080]). Fifty-nine studies (n = 38,531) addressed the accuracy of 49 screening instruments to detect cognitive impairment. The Mini-Mental State Examination was the most-studied instrument, with a pooled sensitivity of 0.89 (95% CI, 0.85 to 0.92) and specificity of 0.89 (95% CI, 0.85 to 0.93) to detect dementia using a cutoff of 23 or less or 24 or less (15 studies, n = 12,796). Two hundred twenty-four RCTs and 3 observational studies including more than 240,000 patients or caregivers addressed the treatment of mild cognitive impairment or mild to moderate dementia. In all cases, participants were persons with known cognitive impairment. Medications approved to treat Alzheimer disease (donepezil, galantamine, rivastigmine, and memantine) improved scores on the ADAS-Cog 11 by 1 to 2.5 points over 3 months to 3 years. Psychoeducation interventions for caregivers resulted in a small benefit for caregiver burden (standardized mean difference, –0.24 [95% CI, –0.36 to –0.13) over 3 to 12 months. Intervention benefits were small and of uncertain clinical importance. The authors concluded that screening instruments can adequately detect cognitive impairment. There was no evidence, however, that screening for cognitive impairment improved patient or caregiver outcomes or caused harm. It was unclear whether interventions for patients or caregivers provide clinically important benefits for older adults with earlier detected cognitive impairment or their caregivers.

In an editorial response to the Patnode et al. study, Petersen⁶ noted that the single large randomized control trial focusing on the utility of screening for cognitive impairment actually involved a relatively small number of people who screened positive and of those only 34% agreed to undergo subsequent evaluation. Therefore, it was felt that the study, despite a total of 4,004 older primary care patients, may have had limited statistical power to detect differences in outcomes. Also, when the topic of diagnostic assessment was mentioned to potential participants, only a minority agreed to participate which might suggest the introduction of bias. Lastly, the follow-up period in this study was only 12 months which made it difficult to interpret effects on decision making, patient-family/caregiver or societal outcomes.

Petersen also noted that the evaluation of interventions for mild to moderate dementia or mild cognitive impairment in the community setting showed statistically significant but modest benefits of pharmacologic interventions, small clinical effects with exercise and cognitive activities, and modest evidence for education and case management intervention without any 1 approach more successful than another.

Petersen agreed the data collectively does not provide strong support for the role of screening for cognitive impairment. However, the author did not feel that the lack of evidence meant that screening had no benefits. He expressed concern for widespread underdiagnosis of mild cognitive impairment or dementia due to negative perceptions stemming from the Patnode et al. report. It was also noted that at least 1 report has suggested that an estimated 10% of cognitive impairment may be due to “reversible” or partially reversible causes such as depression, medication effects, and metabolic disorders. Also, other patients with a variety of medical problems may be experiencing exacerbations due to cognitive impairment. These are areas in which a good assessment process and care planning could be very helpful.

The Task Force commented on the use of standardized instruments to stage dementia. They noted concerns that the tests were not free and widely available, perhaps did not well correlate with cognitive impairment outside of strict Alzheimer’s dementia, were too heavily reliant on clinician experience to be used broadly and might even be culturally biased. CMS was asked to delete this requirement but did not expressly do so. No full list of validated, standardized tools has been conveyed per any CMS recommendation.

Identification of caregiver(s), their knowledge, their needs and their willingness to manage the caregiving task should be documented. The Alzheimer’s Association Task Force strongly supported this element of the service.

The written nature of a care plan and its provision to the patient and his/her caregiver has been strongly supported by the Alzheimer’s Association.¹

The need for cognitive assessment and care planning is well supported in cases of Alzheimer’s or other dementias. The need is perhaps less clear cut for mild cognitive impairment conditions.

Analysis of Evidence

In January of 2011, Medicare coverage expanded to include an annual wellness visit that requires a screening to assess cognition. This requirement is present despite the fact there is no convincing evidence to date that routine screening for dementia improves aggregate health outcomes. However, the efficacy of dementia screening measures is likely to be stronger if applied to a sample known to be at risk of cognitive decline.

In the appropriate clinical context, cognitive evaluations and care plans may offer significant health care benefits with improved short-term cognitive and functional outcomes, reduced long-term skilled nursing home placement, and more cost-effective care. Such evaluations may help identify coexisting illness exacerbation that would be avoidable if the contributory effects of cognitive dysfunction were recognized. Early recognition and evaluation of cognitive impairment in affected individuals might help encourage family members to take a more active role in ensuring correct medication administration, preventing polypharmacy and directing discussions about long term goals of care when a patient might be more able to contribute to such care planning themselves. The potential for benefit toward positive health outcomes outweighs the possibility that no positive changes in care planning would be achieved thus remaining in a status quo scenario.

This is a coverage policy for Cognitive Assessment and Care Planning.

Cognitive impairment may be considered and be of initial concern to a practitioner within the context of 1 of these scenarios:

• Detection as a required element of Medicare’s Annual Wellness Visit (AWV), or
• As part of a routine visit with the patient based on direct observation or via a brief cognitive test, or
• Upon consideration of information from the patient, family, friends, caregivers or others.

Medicare covers a separate visit in order to perform a more detailed cognitive assessment and develop a thorough care plan.

Any provider eligible to report evaluation and management services can provide this service. Eligible providers include: physicians (MD or DO), nurse practitioners (NP), clinical nurse specialists (CNS), certified nurse midwives (CNM) or physician assistants (PA).

The service can be provided in these locations: office or outpatient setting, private residence, care facility, rest home, or via telehealth.

The cognitive assessment service includes a detailed history and exam. An independent historian (parent, spouse, guardian or other individual) must be present to provide history that the patient may not be able to completely and reliably provide.

The following elements are central to informing, designing and delivering a care plan suitable for patients with cognitive impairment. These elements must be documented for purposes of a complete cognitive assessment.

• Cognition-focused evaluation, including a pertinent history and examination;
• Medical decision making of moderate or high complexity;
• Functional assessment (e.g., Basic and Instrumental Activities of Daily Living), including decision-making capacity;
• Use of standardized instruments to stage dementia (e.g., Functional Assessment Staging Test [FAST], Clinical Dementia Rating [CDR]);
• Medication reconciliation and review for high-risk medications;
• Evaluation for neuropsychiatric and behavioral symptoms, including depression and including use of standardized instruments;
• Evaluation of safety, at home and otherwise, including motor vehicle operation, if applicable;
• Identification of caregiver(s), caregiver knowledge, caregiver needs, social supports and willingness of caregiver to take on caregiving tasks;
• Development, with periodic updating/revision/review of an Advance Care Plan;
• Creation of a written care plan which includes initial plans to address any neuropsychiatric symptoms, neurocognitive symptoms, functional limitations, and referral to community resources as needed. This care plan must be documented as having been shared with the patient and/or caregiver at the time of initial education and support.

Clear documentation noting the performance of each and every 1 of these service components must be clearly identifiable within the medical record. The companion billing and coding article to this local coverage determination (LCD) should be referenced for further detail concerning documentation expectations.

Several of these service components require the use of standardized validated tools for appropriate measurement. Such tools offer a basic framework on which to build a nuanced clinical understanding of care needs via ongoing clinical contact with the patient and caregiver. All utilized assessment tools must demonstrate standardization, validation and be recognized as credible by reputable national specialty organizations. Palmetto GBA reserves the right to review the accuracy, reliability, efficacy, and general credibility of assessment measurement tools utilized and will amend the billing and coding article as needed. Please see the companion billing and coding article to this policy for details related to allowable assessment tool use and accompanying documentation. These requirements, of course, do not preclude the use of additional assessment methods as desired by individual practitioners.

Due to the importance of accurate assessment for every beneficiary, documentation of all utilized assessment tool results must be present in the medical record. The instrument used should be named and findings should be summarized. The full instrument raw scoring and results for each utilized scoring tool must be available for A/B Medicare Administrative Contractor review if requested.

The care plan portion of this service must include, but is not limited to, the following elements:

• Neuropsychiatric symptoms must be addressed (even their absence) with a plan for management.
• Neurocognitive symptoms must be addressed (even their absence) with a plan for management.
• Functional limitations must be addressed with a plan for management.
• Any options for needed community services (such as rehabilitation, adult day programs, support groups) must be documented as having been shared with the patient and/or caregiver.

The absence of documentation regarding any required element in the provision of this service and/or within the written care plan represents incomplete service provision.

Many of the needed service elements for cognitive assessment and care planning (such as psychosocial needs, caregiver identification, driving and other safety issues and work on community resource referrals) could and perhaps should be performed by ancillary staff members. The service must be fully documented including all portions of the service initiated and completed by ancillary staff members or contracted parties incident to the practitioner completing the actual written care plan.

Experts have noted that care planning for individuals with dementia is an ongoing process and that a formal update to a care plan should occur at least once per year.

At the current time the potential benefits of a care plan are felt to extend to beneficiaries with any degree of cognitive impairment. Nevertheless, reasonable and necessary conditions for the provision of this service must be clear upon review of the medical record. Thus, all elements of the service, complete assessments, accurate diagnoses, adequate invested time, and comprehensive work toward the well-being of the beneficiary must be documented. This effort should be obvious and commensurate with the valuation of the work associated with this overall service. This coverage policy will be monitored for effectiveness and overall benefit to individuals in various disease stages. Eligibility for coverage may be revised in the future with appropriate notice and comment opportunities.