PFCD and Caregiver Action Network Host Critical Discussion on Current State of Alzheimer’s Care

The Partnership to Fight Chronic Disease and Caregiver Action Network recently held an important discussion on Capitol Hill, coinciding with Alzheimer’s Awareness Month and Family Caregivers Month, focused on how CMS and Congress can better help patients and families battling Alzheimer’s disease. In particular, the discussion focused on the emergence of new treatments, care models, and coverage requirements that could change Alzheimer’s care for millions.
“We're in an exciting era for Alzheimer's disease research,” explained Partnership to Fight Chronic Disease Policy Director Candace DeMatteis, “It had been 20 years since we've had any new treatments for Alzheimer's disease and those were addressing symptoms. We finally are seeing breakthroughs - years of research and tremendous investment are paying off as we have FDA approved therapies that aim to slow disease progression in the early stages of disease.”
Dent Neurological Institute’s Integrative Center for Memory Program Director Sarah Harlock added, “I have been in this field for about 28 years, and it is very exciting to be able to talk to people about these kinds of new treatments.”
However, CMS is limiting access to these treatments by requiring that patients participate in a registry for further data collection to obtain coverage. This National Coverage Determination (NCD) with Coverage with Evidence Development (CED) leads to further delays and access issues for patients and caregivers. Despite FDA approval, this CED requirement puts us steps back in the fight against this progressive, debilitating and ultimately fatal disease – and sets a risky precedent for access to new treatments for other costly chronic conditions.
Harlock explained, “While this registry may not be cumbersome in and of itself, if somebody is in a standalone neurology practice this might be quite a burden for them on top of all of the other pieces required. To get someone from the point of a probable Alzheimer's diagnosis to sitting in the infusion chair to receive this treatment, it is many steps. Even though we at Dent have everything all under one roof it's a process that took up two pages when I wrote it out step by step.”
GU MedStar Health Neurologist Dr. Saurabh Sharma added, “One of the biggest challenges is that practitioners don't necessarily want to engage in the lengthy process…because reimbursement for that time has not been good compared to other diseases.”
This is of particular concern for communities of color, who are disproportionately impacted by Alzheimer’s.
Marvell Adams Jr., CEO, Caregiver Action Network pointed out, “Alzheimer's disease does not have a filter for race or identity, but we do recognize that there are aspects of identity that have to be addressed, especially when it comes to clinical trials.”
Dr. Sharma explained that some progress has been made in this space. Progress we must build on. “For the Amyloid PET Scans for example, the New IDEAS study – which is still ongoing – is requiring each site to first enroll 10 people from the African American community first before you can involve anyone else,” he said. “It's going to take more of those kinds of initiatives – and other trials are starting to do that. Those initiatives will help.”
Xcenda/Cencora Reimbursement & Policy Insights Associate Director Victoria Loo shared insights from a new white paper, “Cost and research burden of coverage with evidence development,” on the challenges CED requirements present to patients and providers, and the impact beyond Alzheimer’s. “There’s definitely a concern that CMS will apply this to other classes of therapeutics,” Loo said. “CMS is, in a way, kind of undermining the FDA approval process when they implement CED policy and the reasoning as to why they do so is unclear.”
What’s worse, is that even when CED requirements are lifted, confusion and delays remain. “Of the 27 NCDs with CED, only 7 of the CED requirements have been removed. In 4 cases, the CED requirements were removed while the NCD remained in place, taking between 4 to 12 years for such a decision; 3 resulted in removal of the NCD and deferral of coverage decisions to local contractors and they took between 10 to 13 years to be removed,” Loo said. “For the remaining 20 it's unknown…it is kind of a black hole for a lot of these products not knowing when CMS will cover treatments.”
Caregivers like Walter Weiss, who is currently caring for his father diagnosed with Alzheimer’s are especially impacted by treatment delays. And caregiving takes an incredible toll on the health and wellbeing of those who are taking care of loved ones. As Weiss says, “This is a very difficult disease and has been very hard as my dad’s condition has worsened. It has been a journey being there for him, making sure he's okay, dealing with his anger and mood swings – it's a mental strain seeing him not be in a position to do things on his own. I have had to disengage from my social life and could not do this without the support of my family and friends.”
Panelists discussed some policy solutions that will help address the barriers that patients, caregivers, and health care providers currently face as they battle this fatal disease.
Loo encourages CMS to “really examine the CED policy and what its intent is – they must provide more guidance on what it actually takes for these products and services to graduate from that program, how long will data collection be needed, and at what point is enough data sufficient for CED to be removed.  At the end of the day, it's the patients who should be at the center of these policies.”
Weiss explained, “We need more education both for caregivers and for the public to better understand caregiving – it’s not as simple as people think. For instance, for myself it was very hard dealing with the stress especially my dad’s memory loss reminding my dad of things every day, I almost fell into depression, so I think more support and awareness is critical.”
Adams concluded the discussion, saying, “Walter… it really is amazing to see the time and effort and patience that you must have with your dad and all of us are rooting for Alzheimer's treatments to make big jumps in the future.”
To learn more, watch the full discussion, and to contact your member of Congress on this issue, visit
November 17, 2023