By Edward I. Ginns, MD, Ph.D., DABCC

It’s been one year since Medicare began reimbursing primary care physicians for assessments of cognitive impairment disorders and provision of care-coordination services. Given that research shows providers are not identifying cognitive impairment in up to 50 percent of their cognitively impaired patients — and that about 30 percent of patients who meet the criteria for dementia never receive a documented diagnosis — this is an important change. It has the potential to increase the number of individuals who are assessed, facilitate intervention for treatable conditions such as vitamin deficiency, and promote care management that may help to improve the quality of life for the many people living with Alzheimer’s disease and other forms of dementia.

Yet the Medicare rule addresses only one piece of a complex dementia diagnostic puzzle. While requiring the availability of cognitive assessment in the Medicare Annual Wellness Visit (AWV) is a critical first step, we also must ensure that primary care physicians are well-versed on the importance of early detection, given that neurological and detailed cognitive assessments traditionally have occurred in specialty care. We must provide tools that make the process as simple as possible and provide the greatest insight about status and progression. More important, we must overcome barriers that prevent early detection and advanced diagnostic tools from being utilized widely in clinical practice.

Many times, an individual with cognitive impairment delays visiting the doctor for an assessment out of fear of what they might learn. Typically, gradual memory loss precedes a more accelerated period of cognitive impairment, and even the accelerated phase can last three to four years or more before an office visit (often at the urging of concerned family members), assessment, and diagnosis occurs. Unfortunately, this delay in early cognitive assessment for dementias may stall delivery of appropriate care and lead to mis-prescribing medications that may worsen cognition or function. Delays also limit early provision of information that helps patients and family members preserve health and quality of life for as long as possible.

To help make cognitive assessment less stigmatizing, primary care physicians should engage in conversations with patients about brain health and cognitive impairment early and often – long before the average age of disease onset. This is one of the foundational elements of the primary care physician toolkit developed by the Gerontological Society of America (GSA). The KAER model stresses four steps, the first of which is to Kickstart the cognition conversation (other steps are Assess for cognitive impairment, Evaluate for dementia, and Refer for community resources). An ongoing dialogue about brain health and cognitive impairment long before symptoms manifest may result in less fear and resistance if assessment later becomes imperative for proper care management.

Creating an environment that is more informed and less stressful is the first step; the second is providing clinical assessment tools that are simple to administer while providing strong accuracy. Identifying cognitive decline and then dementia in early stages is challenging; there is no single test or procedure that is definitive. Physicians rely on physical exam, medical history, and various laboratory and imaging tests, but often start the assessment with in-office cognitive status exams, traditionally conducted with paper-based screening methods. These tools have some limitations. Results from traditional paper-based tests cannot be transferred easily or stored in an electronic health record. As a result, progression of scores generally is not easily tracked and compared over time.

New digital dementia assessment apps for primary care physicians (such as CogniSense from Quest Diagnostics and eSLUMS, a digital version of the Saint Louis University Mental Status (SLUMS) exam) are administered and scored electronically via apps on mobile devices, such as an iPad. These digital tools provide an objective baseline score; some track progressive scores, which can be stored in electronic medical records, to allow clinicians to monitor accurately cognitive function of the patient over time and make adjustments to care plans.

Digital assessment tools also can offer value in other settings, including in skilled nursing facilities, hospitals and with specialists such as neurologists, neuropsychologists and other providers. In clinical trials, researchers depend on objective data to inform the discovery and development of drug therapies for neurological disorders. These digital assessment technologies may accelerate the drug development process and help bring promising new therapies to market.

New diagnostic tools are critical, but are only the tip of the innovation iceberg. In the last few years, there has been an explosion of growth in other diagnostics that show great promise for clinical approaches and scientific and clinical research related to dementia diagnosis. From mass spectrometry-based assays that measure the ratio and changes between amyloid beta 42/40 in cerebral spinal fluid, to advanced genetic tests that provide insights on risk, there are many new tools that have the potential to inform differential diagnoses and accelerate care for individuals with various forms of dementia.

These developments, however, will be of reduced or limited value if they are not covered by payers, embraced and adopted by physicians, and used to benefit patient care. The Centers for Medicare & Medicaid Services (CMS) declines to cover certain tests, such as positron emission tomography (PET) beta amyloid imaging, that could be used in clinical practice, citing lack of evidence that the test would make a difference in care for a disease for which there is no cure. Other tests, such as genetic tests for Apolipoprotein E (ApoE), the primary brain apolipoprotein, are covered by insurers only under certain conditions, even though the ApoE concentration has been found to be lower in Alzheimer’s disease than in healthy controls. Despite the insights that many new diagnostic innovations could offer in potentially improving a patient’s quality of life or avoidance of adverse events, they are not as widely utilized as they could be.

The new Medicare rule was a victory for patients, forged in determination and focus by the advocacy groups that fought for its inclusion. These same advocates must join with the diagnostic and medical communities and speak with one powerful voice for mandated reimbursement for other promising technologies both for research purposes through the Coverage with Evidence Development (CED) program and for use in clinical practice.

When both early assessment tools and advanced diagnostics are commonplace in primary care practice, we will better address the needs of — and achieve our goal of improved outcomes for — our families, friends and loved ones with Alzheimer’s disease and other forms of dementia.

 

Edward I. Ginns, MD, Ph.D., DABCC, is Medical Director, Neurology, at Quest Diagnostics. Dr. Ginns has published more than 130 articles and 10 book chapters in the fields of lysosomal and developmental disorders, neurogenetics, molecular psychiatry and cognitive disorders such as Alzheimer’s disease. 

Disclaimer: The views in guest essays are those of the authors and do not necessarily reflect the views of the LEAD Coalition.

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