Tag Archives: CMS

GUIDE Model seeks to offer better support for dementia caregivers

Caregivers of loved ones with dementia face unique challenges. A new model from the Centers for Medicare & Medicaid Services, GUIDE, seeks to change that.

GUIDE stands for Guiding an Improved Dementia Experience, and the program will launch on July 1, 2024 and run for eight years in its initial demonstration phase. The model has worthy goals:

  • First, by focusing on the person with dementia, and better addressing their care needs and transitions between levels of care.
  • Support dementia caregivers by providing them with training, social services, and respite care.
  • Focus on providing sufficient support for those dementia to safely live at home for as long as appropriate and reduce the need for nursing home care.

I think most dementia caregivers will welcome such support, even if it is long overdue. It will be interesting to see how this program is implemented and how it evolves during its testing period. For more information, review the GUIDE fact sheet.

Infographic image by cms.gov.

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FDA gives full approval to controversial Alzheimer’s drug, Leqembi

Last week, the Food and Drug Administration (FDA) granted full approval to Leqembi, an Alzheimer’s treatment that has shown some moderate benefits in those in the early stages of the disease, but also has potential side effects that are concerning to some medical professionals.

While the drug received accelerated approval earlier this year, the full approval designation will mean that Medicare will now cover the cost of the medication, which was one of the main hurdles to access. The Alzheimer’s Association released a statement in favor of the FDA’s actions and opening up access to the Alzheimer’s treatment. The organization is advocating for Medicaid to cover the costs of Leqembi. The drug costs $26,500 annually, making it out of reach financially for many families.

The drug’s approval has been controversial in the medical community because of its initial very modest benefits and its array of potential serious side effects, including brain swelling and bleeding. Subsequent studies showed a larger benefit to patients. The drug “slowed cognitive and functional decline by 27 percent over 18 months compared with placebo,” according to The Washington Post report.

The drug is administered via infusion and requires a significant amount of medical monitoring. Those with early-stage Alzheimer’s and their families hopeful to slow the progression of the disease will need to carefully weigh the pros and cons of Leqembi and consult with their doctor before making a final decision.

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Feds finally investigating nursing homes’ abuse of antipsychotic drugs

In a move that family caregivers feel is long overdue, the federal government is launching an investigation into the inappropriate use of antipsychotic drugs in nursing homes. Specifically, the government will be looking at the suspicious rise in schizophrenia cases and determine if the spike is being used as a workaround to use antipsychotic drugs to sedate difficult patients and make them more manageable for staff.

This is not a new issue, especially for family caregivers of those with dementia. I’ve written about it multiple times on this blog in relation to my father’s experience. My father was given risperidone, a drug used to treat schizophrenia and bipolar disease, at the memory care facility he resided in during the last year of his life. The doctor didn’t deny when I confronted him about the drug and how it was used to make dementia patients zombies and more compliant for staff.

After my father’s death, I reported the issue to the appropriate state agency, but never received a response. The federal government claimed in 2013 that antipsychotic use in nursing homes was on the decline. That remains true but only for the population not diagnosed with schizophrenia. There is also a troubling racial disparity, with Black nursing home residents being diagnosed with schizophrenia at higher rates than their white counterparts.

CMS will conduct audits and nursing homes showing a pattern of diagnosing schizophrenia incorrectly may see their public ratings impacted. CMS will monitor the nursing homes not in compliance to make sure corrections are implemented. It’s not known at this time if fines will be implemented for those nursing homes who continue to be out of compliance. Also, patients’ families will not be informed if their loved one was incorrectly diagnosed. Make sure to request a list of the drugs your loved one has been prescribed and question any medications that don’t seem appropriate.

Photo by Bruno Guerrero on Unsplash.

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New year, new drug to treat Alzheimer’s approved by FDA

This week, the U.S. Food and Drug Administration approved a new drug to treat those in the early stages of Alzheimer’s disease. The approval of lecanemab was welcomed by the Alzheimer’s Association, who urged the Centers for Medicare & Medicaid Services to cover the cost for its members. Some members of the medical community have a more guarded view of this latest Alzheimer’s treatment, encouraging families to talk to their providers to understand the benefits and risks.

Here are some facts to know about lecanemab:

  • The drug, made by Eisai in collaboration with Biogen, is for those diagnosed with mild cognitive impairment or mild dementia stage of disease and confirmed presence of amyloid beta pathology, according to the FDA.
  • In a study cited by the FDA, those who took the drug experienced a statistically significant reduction in brain amyloid plaque versus those in the placebo group. While the connection between the presence of amyloid plaque in the brain and Alzheimer’s is still up for scientific debate, the study also showed that lecanemab resulted in moderately less decline on measures of cognition and function than taking a placebo.
  • There are potentially serious side effects that need to be considered before beginning the medication. In addition to infusion reactions, there were reports of brain swelling and bleeding (what the drugmakers call ARIA: amyloid related imaging abnormalities.) Three deaths of those in the study have been potentially linked to lecanemab.
  • The drug costs $26,500 per patient annually. As stated above, CMS has not approved payment for the new drug yet, meaning that only those who can afford to pay for it out of pocket will have access to the treatment for now. The Alzheimer’s Association has formally requested that CMS “remove the requirement that Medicare beneficiaries be enrolled in a research study in order to receive coverage of FDA-approved Alzheimer’s treatments.”
  • What you should ask your doctor: Before starting lecanemab, it is advisable to get genetic testing to determine whether the patient has the APOE4 gene, because the study showed that ARIA events were more common in those with that gene. Those on blood thinners should also talk to their doctor about increased risks.

A doctor interviewed by CNN said that lecanemab is another tool that he can add to his toolbox for treating Alzheimer’s disease. Families considering the drug for their loved one should understand that overall the drug’s benefits were modest and weigh that benefit to the potentially serious risks of taking the drug. For some families, the potential to slow down the cognitive decline of their loved ones will be worth that risk.

Just like with cancer, we all wish for a miracle drug or other form of treatment that would offer an instant and complete cure for Alzheimer’s. The reality is more like taking baby steps in the treatment development process, but those small steps can grow into better care and results over time.

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