Psychoactive Appropriate Use for Safety and Effectiveness

There is a large unmet medical need in long-term care settings for the diagnosis and management of NPS, including: psychosis, wandering, sleep disturbances, agitation, anxiety and depression, and apathy. Effectively managing or preventing behaviors that disturb and cause harm to self and others is valuable to residents, family caregivers, and payors. While cognitive impairment is regarded as the hallmark indicator of dementia, neuropsychiatric symptoms are nearly as universal, with one or more symptoms affecting nearly all people with dementia.

Among people with Alzheimer’s disease (AD), depression is the earliest observable symptom in at least one-third of cases. Milder agitation may manifest early and increase in prevalence and severity with worsening of dementia, often leading to an increase in caregiver burden, greater morbidity, poorer quality of life, increased cost of care, early institutionalization, and rapid disease progression. For long-term care staff caring for residents with depression, agitation, and other NPS, these disorders are associated with decreased quality of care, injury, increased workload, lost days of work, burnout, and staff turnover.

While antipsychotics have been used to treat NPS since the 1950s, people with neurodegenerative disorders were previously excluded from trials of psychotropic medications in general, and antipsychotics specifically, despite the fact that both brain changes and biological aging may impact psychotropic dosage needs and response, carrying significant risks. There are no disease-modifying treatments for dementia; therefore, clinicians focus on decreasing patients’ suffering and improving their quality of life.

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Fortunately, the FDA has approved treatments that help manage these destructive symptoms. However, outdated rules put in place by the Centers for Medicare and Medicaid (CMS) restrict nursing homes’ ability to administer these treatments, even when they are appropriately prescribed by a medical professional. If a physician caring for patients in a nursing home prescribes these treatments, the nursing home risks losing a star on its quality rating from CMS, and therefore will receive less federal funding.

Denying patients FDA-approved treatments exposes providers to physical violence, family members to unnecessary traumatic experiences, and requires patients to be weaned off medications that work.

• Educating stakeholders on issues of the treatment of NPS in dementia in long-term care;
• Crafting recommendations and comment letters with member organizations;
• Working with the Centers for Medicare & Medicaid Services (CMS) on proposals for Medicare and Medicaid program requirements in long-term facilities
• Reviewing Medicare claims to analyze the impact of current Medicare psychoactive clinical regulations;
• Educating policymakers on our recommendations; and,
• Advocating on legislative packages to help promote better public policies

As part of Project PAUSE’s work to educate lawmakers and interested stakeholders on appropriate use of antipsychotic medications in long-term care (LTC) settings, our coalition has conducted an in-depth look at clinical best practices and how federal regulations and public-private partnerships define current antipsychotic utilization rates. This analysis and the coalition’s recommendations for improvement are outlined in “Project PAUSE: Effective Solutions for Improving Clinical Care in Long-Term Care Settings.”

• On April 9, 2025, the Alliance and the American Society of Consultant Pharmacists (ASCP), on behalf of Project PAUSE, submitted a response to the President’s request for information Unleashing Prosperity Through Deregulation of the Medicare Program (Executive Order 14192). Our comments focused on the Long-Stay Antipsychotic Medication quality measure in the Nursing Home Care Compare Five-Star Quality Rating System, which imposes significant burdens on facilities, patients, and providers. The measure relies solely on data collection through the Minimum Data Set (MDS), which lacks the clinical context needed to assess appropriate antipsychotic use in a skilled nursing or long-term care setting. In our comments, PAUSE recommends removing the measure, which aligns with the Administration‘s goal of removing administrative burden while promoting appropriate care and maintaining patient safety.  
• At the beginning of 2025, Project PAUSE renewed our efforts to secure appropriations report language that asks CMS to repeal the current measure and update the minimum data set in the Labor, Health and Human Services FY 2026 Appropriations Report. We also worked to secure language asking the FDA to continue their work on the black box warning in the FDA/Agriculture FY 2026 Appropriations Report. We were successful in this effort and the language was included in the recently introduced House version of that report. 
• On December 20, 2024, a bipartisan coalition of Members of the House of Representatives sent a letter outlining the coalition’s concerns with the antipsychotic metric in long-term care. The letter urges CMS to consider updated guidelines based on current medical evidence and to differentiate between appropriate and inappropriate use of these medications. The letter also calls for transparency in audit results and a stakeholder meeting to discuss potential reforms. 
• In December 2024, coalition members from the Alliance, ASCP, the American Association of Geriatric Psychiatry, Voices of Alzheimer’s, and others spoke on panels about the clinician and patient impacts of the boxed warnings and encouraged the FDA to reconsider boxed warning requirements that align with up-to-date science at the FDA’s December 2024 public workshop, “Mortality and Antipsychotic Use in Dementia-Related Behavioral Disorders.” Hosted by the Duke-Margolis Center for Health Policy, this meeting included a reexamination of data from 20+ years ago on increased risk of death associated with use of antipsychotics for people with “dementia-related psychosis” that led to boxed warnings on the drug class in 2005 and 2006. The event convened experts to discuss mortality risks, prescribing patterns, and the impact of regulatory actions on patient safety and access to treatment in long-term care and the community—including for newer, on-label therapies. In the summary, the FDA expressed intent to continue this work, and Project PAUSE will remain an active partner.  
• In November 2024, Project PAUSE welcomed the following new partners: 
  • Huntington’s Disease Society of America 
  • National Rural Health Association 
  • Voices of Alzheimer’s 
  • RetireSafe 
• On August 26, 2024, Project PAUSE met with HHS Competition Officer, Stacy Sanders, to ask for her support in our years-long effort for CMS to fix outdated antipsychotic quality measures for nursing home residents with neuropsychiatric symptoms of Alzheimer’s and related neurodegenerative diseases.  
• In March 2024, coalition work led to the inclusion of language in the enacted FY24 Appropriations Bill that directs the U.S. Food & Drug Administration (FDA) to hold a public workshop focused on the application of black box warnings for antipsychotics, specifically in older adults. Read the full press release here.
• In January 2023, Project PAUSE shared a statement in appreciation of the U.S. Department of Health and Human Services’(HHS) attention to the important issue of nursing home safety and transparency and shares the common mission of advancing patient protection, improving health outcomes, and ensuring high-quality care. Read the statement here.
• In September 2023, 14 members of the House of Representatives sent a letter to the Centers for Medicare and Medicaid Services on the quality measure, asking that CMS create a supplemental measure to allow for cases of appropriate use.
• In November 2021, Project PAUSE submitted comment to Senate Finance Committee in response to Request for Information on Unmet Mental Health Needs. Read the letter here.
• In June 2021, Project PAUSE submitted comment to CMS on aligning quality measurement to support appropriate use of antipsychotics in nursing facilities. Learn more here.
• In May 2020, Project PAUSE submitted comment to Chairman Grassley, Ranking Member Wyden, Chairman Neal, Ranking Member Brady, and Senator Blumenthal, in response to their April 3 inquiry to the Office of Inspector General at the U.S. Department of Health and Human Services to review changes in inappropriate use of psychotropic drugs, examine the adequacy of drug treatment planning/medication monitoring, and determine whether additional legislative or regulatory actions are needed to protect against the inappropriate use of these medications. Read the letter here.
• Project PAUSE commented on the Senate Finance Subcommittee on Health Care’s request for feedback on actions to address Alzheimer’s disease in March 2020. Read the comments here.
• In response to a November 2019 House Ways and Means Committee hearing on caring for older Americans, several patient advocacy groups sent a letter to Committee Chairman Neal with recommendations for addressing the issue of appropriate care for people experiencing neuropsychiatric symptoms with dementia. Read the letter here.
• In September 2019, Project PAUSE submitted comments to CMS on its proposed decision on Medicare and Medicaid program requirements for long-term facilities. Read the comments here.

• December 9, 2025: “Improving Access to Patient-Centered Care” podcast episode on This Is Growing Old.
• November 25, 2025: “CMS unmoved by report calling for end of antipsychotics measure,” published in McKnight’s Long-Term Care News.
• November 22, 2025: “Coalition Says CMS Antipsychotic Metric Is Backfiring on Dementia Care, Calls for Immediate Overhaul,” published in Skilled Care Journal.
• November 21, 2025: “CMS Advised to Revise, Remove or Retire Antipsychotic Medication Quality Measure,” published in Skilled Nursing News.
• November 20, 2025: “Coalition urges CMS to reform Long-Stay Antipsychotic Medication quality measure,” McKnight’s Long-Term Care News.
• November 19, 2025: “CMS quality measure hindering access to dementia treatments: report,” published in McKnight’s Long-Term Care News.
• June 10, 2025: “Alzheimer’s Takes Their Mind, Bureaucracy Takes Their Dignity,” published in the DC Journal.
• June 8, 2025: “What my wife’s experience with Alzheimer’s has taught me,” published in the Chicago Tribune.
• May 23, 2025: “Implementing early detection of cognitive impairment in primary care to improve care for older adults,” published in the Journal of Internal Medicine.
• April 4, 2025: “Alzheimer’s research was never a waste of time. Let’s not lose progress.” published by the Fayetteville Observer
• March 24, 2025: “First a Daughter, Then a Caregiver,” published in the DC Journal.
• November 12, 2024: “Alzheimer’s caregivers need updated drug rules to give families more time and peace,” published in the Kansas City Star
• September 10, 2024: “Two Alzheimer’s patients: the afflicted and the caregiver,” published in The Madison Capital Times (Wisc.)
• April 8, 2024: “Alzheimer’s patients lost in the system,” published in the Minneapolis Post
• April 1, 2024 “Having Alzheimer’s is hard enough; stigma and bureaucracy make it harder,“ published in the Chicago Daily Herald.
• March 24, 2024: “Alzheimer’s is taking my mind — but I’m still here. And there is more we can do,“ published in the Fayetteville Observer.
• January 9, 2024: “CMS must allow nursing homes to treat neuropsychiatric symptoms of Alzheimer’s,” published in McKnight’s Long-Term Care News

Membership of Project Pause includes patient and family caregiver organizations, long-term care groups, primary care associations, geriatric and mental health specialty provider associations, and Alzheimer’s disease and other dementia groups as well as mental health organizations.

• Alliance for Aging Research
• Alzheimer’s Foundation of America
• American Association for Geriatric Psychiatry
• American Association of Post-Acute Care Nursing
• American Association of Psychiatric Pharmacists
• American Health Care Association
• American Society of Consultant Pharmacists
• Caregiver Action Network
• CaringKind
• Depression and Bipolar Support Alliance
• The Gerontological Society of America 
• Global Coalition on Aging
• HealthyWomen
• Huntington’s Disease Society of America
• LeadingAge
• National Alliance for Caregiving
• National Community Pharmacists Association
• National Hispanic Council on Aging
• National Minority Quality Forum
• National Rural Health Association
• Partnership to Fight Chronic Disease
• Pharmacy Quality Alliance
• RetireSafe
• Rural Minds
• The Balm in Gilead, Inc.
• Voices of Alzheimer’s