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.

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.

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.