The Trump Administration promises radical change in government policy. A fresh look at how we care for Alzheimer’s disease patients is long overdue. The current regulatory regime is excessively complex. Over a patient’s lifetime, the average individual cost of care for Alzheimer’s and other dementias is nearly $400,000, mainly from unpaid caregiving and out-of-pocket expenses. The total cost of care will top $360 billion this year—about 8 percent of national health expenditure. As our understanding of the disease evolves, all evidence points toward early and aggressive intervention. Like cancer, Alzheimer’s progresses in stages. The toxic proteins associated with the disease are detectable in the brain decades before symptoms arise. Some data indicates that lifestyle changes can improve cognition in its early stages. And new FDA-approved medications can delay the progression of early Alzheimer’s by up to 6 months over an 18-month treatment timeframe. These interventions hold the potential to bring the costs under control and ease the burden of care for millions of patients and their caregivers by extending the time a person can live independently.
Massively expanding cognitive screening is the first and most crucial step to unlock this potential. Blood biomarker tests are emerging as a relatively simple, cost-effective means of detecting the disease and enabling early intervention. Yet thanks to ill-conceived policy, the Centers for Medicare and Medicaid Services (CMS) is poised to restrict access to them. The fact is Medicare only reimburses for reasonable and necessary services, which generally does not include screening. There are two exceptions: Medicare will cover screenings that are required by law or those which receive an “A” or “B” recommendation from the United States Preventive Services Task Force (USPSTF).
A new Congress could elect to add language directly to the statute governing Medicare reimbursement. Mammograms, for example, were not covered under Medicare until 1990, when Congress passed legislation adding the benefit to the program. But passing legislation for every new preventive innovation is unrealistic. Obtaining a USPSTF recommendation offers a more practical route.
The task force was established in 1984 by the Public Health Service to speed access to new cost-effective health interventions. An independent, volunteer panel of national medical experts, its charge was developing recommendations for primary care clinicians on the appropriate content of periodic health examinations. Unfortunately, as with so many government programs, it has morphed into an overly bureaucratic body that is slow to act.
The passage of the Affordable Care Act greatly expanded the Task Force’s role in federal healthcare coverage. Among its numerous functions today, it primarily reviews scientific evidence on the benefits and harms of preventive services and develops and updates recommendations on their use. Producing recommendation statements usually takes two to three years, and the Task Force only selects one or two topics to evaluate each year. Further, it may only reexamine recommendations every five years, with certain exceptions.
The Task Force simply cannot keep up with that pace of medical innovation. To wit, as Alzheimer’s science races ahead, strengthening the signal that early intervention can potentially make a tremendous difference for patients and help government bend the cost curve, the Task Force still does not recommend routine cognitive screening. This must change.
New reviews should be automatically triggered once FDA clears a new screening technology, and additional government resources should be directed to support this work. For example, if FDA approves the Alzheimer’s blood test Fujirebio submitted for review in September, USPSTF should immediately evaluate it. The Task Force should also consider implementing a subcommittee system wherein four members of similar or adjoining specialties will review and issue a recommendation on any new screening procedure. Such a recommendation could be treated as if the full USPSTF reviewed the screening unless substantial public input requests a re-examination by the full Task Force.
CMS deserves credit for removing some reimbursement restrictions on diagnostic technologies for Alzheimer’s disease and launching the Guiding an Improved Dementia Experience(GUIDE) model. This voluntary, nationwide demonstration program establishes Dementia Care Programs to provide patients care and support. An initial home visit identifies safety risks and caregiver needs to develop a care plan. Eventually, as the disease progresses, the model may provide limited respite support. Participants are Medicare Part B providers and suppliers, as well as laboratory suppliers eligible to bill under the Physician Fee Schedule. The model holds promise for those patients successfully diagnosed with Alzheimer’s, but it doesn’t accelerate access to diagnosis or interventions that can delay disease progression.
Access to screenings could also accelerate clinical trial recruitment, thereby facilitating the development of new interventions and treatments. Approximately 99% of potentially eligible patients for Alzheimer’s trials do not participate in clinical trials. An interdisciplinary expert panel brought together by the USC Clinical Trial Recruitment Lab found that easy access to broad cognitive and diagnostic screenings, including blood-based biomarkers, would reduce this bottleneck. The USC Clinical Trial Recruitment Lab, a partnership of USC Schaeffer Center and Alzheimer’s Therapeutic Research Institute, is piloting new recruitment strategies.
Future iterations of the GUIDE model should move toward being a total cost of care model to include medications, and the administration of monoclonal antibody drugs should be exempt from “Coverage with Evidence Development” requirements. Such flexibilities would ensure the care provided to GUIDE participants is comprehensive and guarantees meaningful access to effective, FDA-approved medications. Additionally, empowering individuals with the ability to use health savings accounts to access these services would help align the interests of patients and insurers over time.
More should be done to encourage a healthy lifestyle, with diet, exercise and social activity emerging as ways to potentially reduce the risk and progression of Alzheimer’s. The new National Institutes of Health director can rebalance the agency’s research budget to study root causes of disease and validate strategies that forestall or prevent it. In the meantime, more can be done to promote these aims through Medicare Advantage (MA), which offers many plans with supplemental benefits such as Silver Sneakers programs or gym memberships. Policymakers should stop pushing to redirect MA resources or reduce enrollment and instead encourage employers and health coverage providers to offer similar benefits.
As we learn more about Alzheimer’s, it’s becoming clear that early and aggressive intervention is our best hope for alleviating the tremendous suffering it causes families and reducing its enormous burden on limited public resources. Our policies must adapt to reflect this knowledge. Through its Make America Healthy Again initiative, the new administration can make smart reforms and targeted investments to expand access to cognitive screening, promote healthier lifestyles and ensure people living with Alzheimer’s have access to the best treatment and care society has to offer.
Joe Grogan is a Nonresident Senior Scholar at the USC Schaeffer Center for Health Policy & Economics and was director of the White House Domestic Policy Council in the first Trump Administration. He consults with pharmaceutical companies including those working on Alzheimer’s treatments.
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