CMS MAHA-Aligned Quality Measures for Public Comment

What scale are you going to use? I think measuring how people's health is impacting their functioning is a great idea. Satisfaction does not always correlate with wellness though. One might be quite satisfied with their unhealthy life and vice versa, can be very healthy and unsatisfied. Would recommend considering a functioning scale. The WSAS can be adjusted to any health issue: https://pubmed.ncbi.nlm.nih.gov/11983645/

I am a mental health services researcher with interest in implementable well-being measures for health systems. 

The current proposed measure lacks specificity about how to operationalize it (not entirely clear in the summary document if it's based on a tested measure with good psychometric properties). Also, there are measures which better incorporate the types of questions that are relevant targets/goals for people with mental health concerns. 

One such measure is the Work and Social Functioning Scale. https://greenspacehealth.com/en-us/work-and-social-functioning-wsas/ This measure has good psychometric properties. It may be useful to consider grounding a selected Well-Being measure in one of these tested measures, and seek input from health systems about what might be necessary to operationalize. For example, 9 choices per each of the 5 domains may be too many. 

Is there guidance that explains what a follow-up plan should include? Ideally it would include referral to a lifestyle education/self-management program. 

Alignment with Disease Prevention

Discharge function measures, focused on self-care and mobility, are critical for safe resumption of life activities after a medical event or procedure. Additionally, many clients report returning to their prior level of functioning is the primary goal of care in post-acute care (PAC) settings. Limitations in self-care can exacerbate chronic conditions and increase risks of falls, pressure injuries, and other costly complications—negatively impacting overall health and well-being.

Modifications for Further Integration

Although widely used in PAC, functional status data is inconsistently captured in inpatient psychiatric facilities, representing a missed opportunity to integrate measures that examine both mental and physical health. Occupational therapy can have a direct, positive impact on behavioral and mental health conditions. Through engagement in meaningful occupations, occupational therapy practitioners play a transformative role in helping people with behavioral health challenges through their expertise in occupational performance, activity analysis and design, environmental analysis, neurophysiology, psychosocial development, and group dynamics.

In acute care, where stays are brief and focused on stabilization, discharge function data could enhance care coordination and downstream planning. Currently, no standardized mechanism exists to capture this information. However, occupational therapy practitioners often collect this information to determine safe discharge recommendations for clients. We recommend CMS convene an expert panel to assess feasibility, balancing administrative burden with anticipated impact.

Important Areas Not Currently Measured

Instrumental Activities of Daily Living (IADLs)—such as meal preparation and housekeeping—are essential for safe transitions and independence. These activities require physical ability and functional cognition. Incorporating IADL and more functional cognition related data into CMS assessments would provide real-world insight into how cognition supports daily life, complementing existing cognitive measures that assess cognition in the absence of function.

Alignment with Disease Prevention

Well-being, including physical, mental, and social health, is essential to overall quality of life and can act as key protective factors that complement disease prevention efforts. These measures could identify resilience and early risk indicators that may influence disease progression and recovery. Occupational therapy practitioners’ use of evidence-based meaningful activities to promote participation in everyday life, which can help build resilience, positive psychological and social functioning (psychosocial function), and the ability to adapt to change and cope with life challenges. AOTA appreciates CMS’ focus on well-being but encourages thoughtful consideration of operationalizing this concept to develop a meaningful, actionable quality measure. 

Modifications for Further Integration

To minimize duplicative data collection and reduce burden, CMS could consider how current assessments may overlap with or compliment well-being. While the brevity of [JM3] the currently referenced assessment is appreciated, we encourage CMS to review the Patient-Reported Outcomes Measurement Information System (PROMIS) measures which have been thoroughly tested and validated. PROMIS measures, a set of person-centered measures, cover several domains (e.g., global health, the ability to participate in social roles and activities, satisfaction with roles and responsibilities) and could be a good place to start. Additionally, it will be important to ensure a new measure would pose minimal burden to providers with maximized impact to patients.

Integrating well-being measures could add value for providers and patients, facilitating improved patient-centered care and further promoting health and function, reinforcing the HHS vision to Make America Healthy Again.

January 6, 2026

Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: MAHA-Aligned Quality Measures Comment Opportunity
 

RE: Public Comment on MAHA-Aligned Quality Measures – Prioritization of the Malnutrition Care Score

Dear Centers for Medicare & Medicaid Services (CMS) Team,

On behalf of the Malnutrition Quality Improvement Initiative (“MQii”; https://malnutritionquality.org/), we appreciate the opportunity to provide comments regarding quality measures aligned with the vision to “Make America Healthy Again” (MAHA). We value CMS’s commitment to advancing prevention, nutrition, wellness, and physical activity across all care settings while also streamlining the set of measures used in quality and value-based care programs.

As an organization dedicated to improving patient outcomes through the advancement of high-quality nutrition care, we applaud CMS’s consideration of the Malnutrition Care Score (“MCS,” approved for use in the Hospital Inpatient Quality Reporting Program) for expanded use in other CMS programs and specifically for inclusion on the MUC list for the PPS-exempt cancer hospital quality reporting program.  Identification of and intervention for malnutrition is critical for patients with cancer because good nutrition is fundamental to helping them withstand cancer treatments.

The MCS assesses implementation of the steps of the nutrition care process, which are universal across care settings:

• Screening and Assessment: Identifies patients at risk and informs early intervention.
• Diagnosis: Ensures malnutrition is formally recognized, documented, and communicated across the care team and through care transitions. 
• Care Plan Development: Supports individualized interventions and continuity of care, particularly as patients move between care settings.  

Further, an MCS specified for use other care settings such as post-acute care, ambulatory care, and with Medicare Part C populations is important to consider as well. An MCS for these settings would ensure that Medicare beneficiaries receive evidence-based, patient-centered nutrition care across the continuum while directly supporting CMS’s goal for streamlining measures across programs. The Malnutrition Care Score is also in clear alignment with the MAHA vision by:

• Focusing on Prevention: The measure incentivizes early identification and intervention for malnutrition risk—an essential component in preventing avoidable complications such as frailty, falls, delayed wound healing, and functional decline, which are all associated with increased hospitalizations and healthcare costs.
• Advancing Nutrition & Wellness: By evaluating key processes in malnutrition assessment and care planning, the MCS elevates the importance of nutrition in routine clinical care.  This is a critical step for evolving the culture of medicine to consider nutrition care core – not ancillary – to patients’ overall health and wellness, laying the foundation to go beyond the focus on malnutrition and instead incorporating nutrition into all patients’ plans of care.  
• Enabling Physical Activity: Adequate nutrition status is foundational for supporting physical activity among older adults and maintaining functional independence. Malnutrition can lead to muscle weakness, impaired balance, and cognitive decline, ultimately resulting in poorer health outcomes.

Suitability Across Care Settings

Although originally developed for hospital use, the MCS is well suited for adaptation into non-hospital environments. While hospitals are vital settings for identifying malnutrition and initiating interventions, the short-term, acute nature of inpatient care is not optimal for completely solving a patient's poor nutritional status, which requires that identified needs be effectively addressed through interventions on a continuing basis, including in post-acute and ambulatory care. To ensure that quality nutrition care leads to long-term health improvements, post-acute and ambulatory providers must ensure they receive a complete picture of patients’ health status (including nutrition), document the care they provide and progress made, and communicate the care plan clearly during transitions of care. Specifying and adapting the MCS for other care settings, data types, and CMS programs can directly address these imperatives. Through use of program-specific versions of the MCS, CMS can explicitly support and incentivize a seamless patient journey through the healthcare system by:

• Requiring the inclusion of patients’ nutrition-related diagnoses, goals, and individualized care plans in discharge summaries from hospitals to post-acute and ambulatory providers;
• Ensuring that post-hospitalization receiving providers review, carry out, monitor, and revise nutrition care plans as needed during the patient’s post-acute journey.
• Promoting the involvement of patients, families, and caregivers to ensure that patient preferences and priorities are incorporated, creating the pathway for long-term improvements in nutritional status and outcomes, even when the patient is back in their own home.

The nutrition care process described by the MCS promotes a systematic approach to malnutrition care that applies longitudinally across the patient journey. It encourages the documentation and follow-through of critical nutrition-related interventions across the care continuum—aligning with CMS’s broader goals for prevention-focused, patient-centered care.

The MQii was founded as a learning collaborative for hospital-based nutrition professionals. However, it has been our experience that eliminating malnutrition requires coordinated efforts across the care continuum.  We would be proud to support CMS in developing and testing MCS specifications for other program and setting use. Through strengthened care transition processes and broader implementation of the MCS, CMS can ensure that the improvements begun in the hospital setting to identify and treat malnutrition translate into sustained improvements in health outcomes across the continuum of care. We also recommend that CMS review the National Blueprint for Achieving Quality Malnutrition Care for Older Adults, a major consensus report with key recommendations for stakeholders to take action against malnutrition in all care settings.

Conclusion

Malnutrition remains an under-recognized yet highly modifiable risk factor affecting millions of Americans. Adoption of the Malnutrition Care Score across additional CMS programs will meaningfully advance national goals around prevention-focused nutrition interventions at the heart of “Make America Healthy Again.”

Thank you again for your leadership on this issue. MQii stands ready to support CMS in adapting the MCS across new settings and ensuring effective implementation nationwide.

Sincerely,

Shelby Harrington, MS, RN
Managing Director, Avalere Health

On behalf of:

The Malnutrition Quality Improvement Initiative (MQii)
1201 New York Avenue NW, Suite 1000

Washington, DC 2005

[email protected]

MUC2025-034

Merit based Incentive Payment System for LDL-C

The Alliance for Aging Research strongly supports implementation of an LDL-C monitoring and management measure. We agree this effort would align with the Administration’s MAHA goals to address chronic illnesses through early detection, intervention, and management.  Age is a significant risk factor for Atherosclerotic Cardiovascular Disease (ASCVD).  ASCVD remains a leading cause of mortality in the United States, yet despite proven interventions to monitor and manage LDL-C, inadequate control of LDL-C levels remains a persistent problem.  Because the majority of ASCVD patients have uncontrolled LDL-C levels we must prioritize establishment of evidence-based guidelines and build consensus on the critical importance of LDL-C management to reduce risk of ASCVD.  A new measure to monitor screening levels and compliance with treatment where indicated would create incentives for more consistent treatment.  More consistent management and monitoring of LDL-C will not only improve health outcomes among millions of patients at-risk for ASCVD, it will also serve to reduce the financial cost of preventable and often catastrophic events and hospital readmissions across at-risk Medicare populations.

The American Medical Association (AMA) supports alignment of measures across the Centers for Medicare & Medicaid Services (CMS) quality programs. However, a measure must be based on sufficient evidence to support the clinical focus within the setting and attributed to the appropriate individual or facility and should be well specified to enable data collection with minimal burden. Any measure that is considered for a CMS quality program must also be tested and demonstrate that the data and scores can be captured and reported consistently (reliability) and accurately (validity) for the intended setting and level of measurement. If CMS choses to explore application of any of the five measures included in this early review to a quality program, we urge CMS to ensure that clinical experts from those settings are involved in the specification and testing and that implementation of these measures beyond the existing programs only be pursued if there is evidence to support the measure and it is feasible to collect and demonstrated to be reliable and valid. We also recommend that a comprehensive review of the existing measures within a program is completed to ensure that measures with similar clinical areas and intent do not already exist. 

This measure was developed specifically for the post-acute setting and uses standardized data collection tools unique to those settings. We are concerned that there may be little evidence to support expansion of this measure to other settings such as ambulatory or inpatient care. For example, a general measure on an individual’s functional status would not necessarily be suitable to apply to all patients within an ambulatory practice and efforts would be better spent on working with medical specialty societies and qualified clinical data registries (QCDRs) to develop patient-reported outcome performance measures (PRO-PMs) that are targeted to specific populations using validated surveys. This focus would enable inclusion of additional relevant measures to a program such as the Merit-based Incentive Payment System (MIPS) that would also drive quality improvement and support patient decision-making. We also question how this measure could be modified to apply to the acute care setting given the heterogeneity of the patients who receive care and the degree to which this type of measure could capture meaningful change, particularly with patients who have short length of stays. 

While we recognize that the appropriate use of antipsychotics is a patient safety concern and are strongly committed to ensuring that individuals are not prescribed antipsychotic medications when it is not medically necessary, this measure should not be expanded to other settings until several concerns are addressed. We previously requested that CMS aligned the existing quality measures that address inappropriate use of antipsychotics in individuals with a diagnosis of dementia in the Medicare Part C & D program and the Nursing Home Quality Initiative (NHQI[HB1] ). The Medicare Part C & D measure stewarded by the Pharmacy Quality Alliance (PQA) excludes those individuals who have a psychiatric disorder or related condition such as bipolar disorder or schizophrenia. The NHQI measures stewarded by CMS applies to short-stay and long-stay nursing home residents and excludes individuals with diagnoses such as schizophrenia or Huntington’s disease. While the intent of both measures is clearly aligned, the specifications should reflect the denominator exclusions in the Medicare Part C & D program, and all appropriate antipsychotic medications must be included (e.g., Rexulti). We also believe that the measure stewards consider whether individuals who receive hospice care should be excluded from the measures since some antipsychotic medications are considered clinically appropriate end-of-life care. For example, an analysis of the Minimum Data Set (MDS) and hospice claims from 2011 – 2017 identified that the CMS’ efforts to reduce inappropriate prescribing negatively impacted individuals receiving hospice care in long-term care settings for whom receipt of these medications could be considered clinically appropriate.[1] While there are several settings in which hospice care is provided (e.g., home, facilities), much of the care occurs within a nursing facility or assisted living facility with an average length of stay of 109 days and 165 days, respectively.[2] We believe that hospice care should be evaluated as a potential denominator exclusion across the measures. 

[1] Gerlach LB, Fashaw S, Strominger J, et al. Trends in antipsychotic prescribing among long-term care residents receiving hospice care. J Am Geriatr Soc. 2021;69(8):2152-2162. doi:10.1111/jgs.17172

[2] https://www.nhpco.org/wp-content/uploads/NHPCO-Facts-Figures-2024.pdf

 [HB1]I double checked the specs for 2026 and they still are not aligned. 

We were only able to identify a three-question screening tool that is used by the Veterans Health Administration to screen veterans and it does not appear to be a fully developed and testing performance measure. We support the intent of the measure but again caution CMS on moving forward with this concept unless is uses a validated survey and is demonstrated to be reliable and valid for the intended setting and level of measurement. 

We recommend that CMS should consider the Screening for Abnormal Glucose Metabolism in Patients at Risk of Developing Diabetes that was recently finalized for use in the Merit-based Incentive Payment System (MIPS). This measure is critical to identifying patients with prediabetes who may benefit from interventions to prevent type 2 diabetes and to identify patients with undiagnosed type 2 diabetes. The Centers for Disease Control and Prevention (CDC) estimates that approximately 98 million American adults have prediabetes.[1] [CDC, 2022]. They note that more than 80% of adults with prediabetes are not aware that they have the condition. Regular glycemic screening is a critical first step to identifying patients with prediabetes and helping patients avoid the disability and costs associated with progression to type 2 diabetes. We believe that this measure would be suited for use in additional CMS quality programs[HB1]  and urge CMS to consider expanding its use. 

[1] About prediabetes and Type 2 Diabetes. Centers for Disease Control and Prevention, 15 May 2024, https://www.cdc.gov/diabetes-prevention/about-prediabetes-type-2/index.html. Accessed 23 Dec 2025. 

On behalf of Project PAUSE (Psychoactive Appropriate Use for Safety and Effectiveness), we thank you for the opportunity to provide input and recommendations regarding the Centers for Medicare & Medicaid Services’ (CMS) early review of the Percent of Residents Who Received an Antipsychotic Medication (Long-Stay) measure that the agency believes is aligned with Make America Healthy Again (MAHA) priorities across the agency’s quality reporting and value-based programs. 

We understand, appreciate, and generally support the agency’s interest in ensuring safety among long-term care/nursing home residents, as well as its desire to further align efforts to “help meet the Administration’s quality priorities.” We commend CMS for explicitly recognizing the clinical value of antipsychotic medications and appropriate prescribing, specifically for treating neuropsychiatric symptoms (NPS) associated with Alzheimer’s disease in the Calendar Year (CY) 2026 Physician Fee Schedule Final Rule: “Antipsychotic medications are an important tool for treating a wide range of mental health disorders including schizophrenia, bipolar disease, major depressive disorder, post-traumatic stress disorder, and for agitation associated with dementia due to Alzheimer’s disease.” (See CMS, CY 2026 Medicare Physician Fee Schedule Final Rule, “Current Activity ID: IA_BMH_1: Behavioral and Mental Health, Diabetes Screening,” pg. 2255, November 2025, https://public-inspection.federalregister.gov/2025-19787.pdf.) We appreciate this acknowledgement and view it as important step toward ensuring that clinical practice and patient need are reflected across CMS policy and quality measurement. 

However, we have serious, long-standing concerns about the real value of the Long-Stay Antipsychotic Medication Quality Measure, enumerated further below and detailed in the attached and hyperlinked materials, including a recent white paper issued by Manatt Health demonstrating that the measure is neither endorsed nor validated by external quality measurement bodies and contains serious flaws. (See Manatt Health, “Assessing the Impact of the Long-Stay Antipsychotic Medication Quality Measure on Treatment of Neuropsychiatric Symptoms of Alzheimer’s and Related Diseases,” October 2025, https://www.manatt.com/insights/white-papers/2025/assessing-the-impact-of-the-long-stay-antipsychotic-measure-on-access-to-patient-centered-care.) 

As such, consistent with Project PAUSE’s submissions to and conversations with CMS over the past five years, we strongly and respectfully urge the agency to consider alternative ways to monitor the safety of antipsychotic use among long-term care/nursing home residents. We continue to believe the best approach to address this important beneficiary health and safety issue is for CMS to retire the measure and work with the community to develop alternative and more effective ways to identify when antipsychotics are being misused among long-term care/nursing home residents. 

A bipartisan group of Members of Congress–including members of the House and Senate Appropriations Committees, the GOP Doctors Caucus, and authorizing committees–has also expressed concern that the measure impedes the provision of individualized, quality care and does not provide meaningful information to patients, families, or policymakers. Therefore, we respectfully note that now is not the time to expand the use of the measure, but rather an excellent opportunity to design a new and more effective approach to address the safe use of antipsychotics among long-term care/nursing home residents. 

We thank you in advance for your consideration of our views and stand ready to partner with the agency to develop a measure that more meaningfully captures when antipsychotic use among long-term care/nursing home residents is medically necessary and appropriate and when it is inappropriate–a critical safety nuance that the current measure fails to reflect.

Ensuring appropriate care for long-term care/nursing home residents with dementia is essential. Many individuals with degenerative neurocognitive diseases, such as dementia, Alzheimer’s, and Parkinson’s psychosis, suffer from a range of NPS. NPS are associated with earlier death, underscoring the need for active treatment of these symptoms to prolong and improve quality of life. Unfortunately, rates of dementia and related symptoms continue to grow, especially for older adults. 

Clinical data shows that nearly all dementia patients will develop at least one NPS over the course of their disease and one-third of dementia patients will present depression as their earliest observable symptom. In long-term care settings, especially at facilities specializing in dementia care, NPS may include psychosis, wandering, sleep issues, agitation, depression, apathy, and aggression. These symptoms can create significant challenges that disturb or harm the patient themselves or others in the facility.

Non-pharmacological approaches should remain the first-choice treatments for patients. However, in cases where patients are suffering from advanced dementia or pose a threat to themselves or others, antipsychotic medications are a clinically appropriate option if non-pharmacological treatments have been attempted–and appropriately documented in the clinical record–but fail to meet the patients’ needs. As noted earlier, in the final CY 2026 Physician Fee Schedule, CMS recognized the benefit that antipsychotic medications offer patients. This clinical benefit should not be confined to outpatient care and should be available to beneficiaries across all care settings. Multiple studies have demonstrated both the safety and efficacy of the use of antipsychotics in treating NPS as part of a multidisciplinary, individualized care plan. Unfortunately, the current long-term stay antipsychotic measure thwarts the provision of guideline-concordant-care for long-term care/nursing home residents and distorts treatment in ways that undermine–rather than advance–patient safety. 

First, the measure fails to distinguish between clinically appropriate and inappropriate prescribing. Instead, it merely captures total antipsychotic use among long-term care/nursing home residents, without any risk adjustment (other than exemptions for schizophrenia, Tourette’s syndrome, and Huntington’s disease). The measure relies on an outdated approach to antipsychotic prescribing that does not exempt other relevant conditions, such as bipolar disorder, nor does it reflect more recent developments such as Food and Drug Administration (FDA) approval of several antipsychotics specifically indicated for individuals with Alzheimer’s dementia and Parkinson’s psychosis. Importantly, the Department of Health and Human Services’ Office of Inspector General (HHS OIG) has noted that while the “[three] conditions that CMS excludes from its calculation of the number of residents receiving antipsychotics are on the list of FDA-approved adult indications for antipsychotic medications. The FDA-approved adult indications for antipsychotic medications include other conditions as well.” (See OIG, “CMS could improve the Data it Uses to Monitor Antipsychotic Drugs in Nursing Homes,” May 2021, https://oig.hhs.gov/oei/reports/OEI-07-19-00490.pdf.)

The Minimum Data Set (MDS), upon which the measure is based, does not currently capture important contextual clinical information such as the type, dose, or clinical justification for antipsychotic use. Not accounting for these critical factors can lead to inaccurate quality assessments and other unintended consequences, including undertreatment or inappropriate substitution of higher-risk medications, which themselves can pose a safety risk to patients.

Second, the measure gravely ignores the importance of patient-centered care and disregards American Psychiatric Association (APA) guidelines, individual clinical decision-making, and shared decision-making between patients, family members, and providers. Medicare should align its quality measures with modern clinical guidelines and best practices that emphasize individualized, evidence-based care. Specifically, CMS should revise its approach to antipsychotic prescribing to reflect the APA guidelines, which support the appropriate use of these medications in managing dementia-related agitation and psychosis. (See APA, “The American Psychiatric Association Practice Guideline on the Use of Antipsychotics to Treat Agitation or Psychosis in Patients with Dementia,” May 2016, https://psychiatryonline.org/doi/epdf/10.1176/appi.books.9780890426807.) 

The APA guidelines reflect the medical consensus that antipsychotics can be both appropriate and beneficial for certain patients when nonpharmacological interventions are ineffective or contraindicated. By contrast, CMS’s existing Long-Stay Antipsychotic Medication quality measure imposes a rigid standard, effectively discouraging any pharmacologic intervention unless non-drug alternatives are exhausted. CMS’s current framework not only contradicts expert clinical guidance but also conflicts with the agency’s own stated intent to support care that is tailored to a resident’s “specific, diagnosed, and documented condition.” Yet in practice, CMS policies for long-term care/nursing home settings default to a blanket assumption that all use of antipsychotics is harmful, regardless of a particular patient’s diagnosis, clinical history, or response to treatment. 

Moreover, this measure fails to account for the range of patient populations served by skilled nursing and long-term care facilities and, as such, penalizes facilities that provide clinically necessary and appropriate, individualized care for residents with complex neuropsychiatric needs. While some residents require assistance primarily with activities of daily living, others–such as individuals with Alzheimer's disease, Parkinson's disease, or other forms of neurocognitive impairments–often require higher levels of care, including antipsychotic prescribing to effectively manage NPS. The current measure penalizes these facilities without considering the clinical appropriateness of the prescribed medications, potentially leading to reduced access to necessary care for these vulnerable populations. As the Manatt report notes, “Importantly, there is no absolute evidence-based benchmark or targeted range of values for antipsychotic use among long-stay SNF residents; as a result, the Long-Stay Antipsychotic Medication quality measure—even the revised version—imposes a “one-size-fits-all” approach to quality measurement at SNFs. CMS continues to assert that “lower is better,” and the construct of the measure places relentless downward pressure on SNFs to continually reduce antipsychotic use, without regard for patient need.”

Of particular concern, residents who transition from the community to long-term care/nursing home settings and who have long been stable on antipsychotic medications are routinely subjected to mandatory dose reductions because of the constant downward pressure on facilities to keep their overall antipsychotic prescribing rates low. These reductions can trigger cycles of destabilization, readjustment, and documentation, all to satisfy a metric that does not account for medical necessity or clinical nuance. This approach undermines patient-centered, individualized care and does not reflect the clinical standards used in other areas of care. This measure has not only led to clinically necessary treatments being withheld, but also potential residents have been denied admission to nursing homes because they have a medication need that may not be able to be met due to the pressure the measure places on facilities to reduce virtually all antipsychotic use. In addition, in an effort to avoid poor performance on the measure, some providers have reportedly misdiagnosed residents with exempt conditions even when the clinical criteria for those diagnoses were not met. (See OIG, “CMS could improve the Data it Uses to Monitor Antipsychotic Drugs in Nursing Homes,” May 2021, https://oig.hhs.gov/oei/reports/OEI-07-19-00490.pdf.)

Despite being labeled a  “quality measure,” in November 2022 the HHS OIG found that while CMS focused its efforts “to reduce the use of one category of psychotropic drug—antipsychotics—the use of another category of psychotropic drug—anticonvulsants—increased. This increased use of anticonvulsants contributed to the overall use of psychotropics remaining constant.” In its report, the OIG recommended that “CMS should: (1) evaluate the use of psychotropic drugs among nursing home residents to determine whether additional action is needed to ensure that use among residents is appropriate, (2) use data to identify nursing homes or nursing home characteristics that are associated with a higher use of psychotropic drugs and focus oversight on nursing homes in which trends may signal inappropriate use, and (3) expand the required data elements on Medicare Part D claims to include a diagnosis code.” According to the OIG website checked January 5, 2026, all three of these recommendations remain “open and unimplemented.” Importantly, OIG further noted that “CMS may identify other methods of analysis to ensure that the use of these drugs is appropriate.” These findings and recommendations clearly illustrate that the agency’s current approach to ensuring appropriate use of antipsychotics and other psychotropics is insufficient. (See OIG, “Long-Term Trends of Psychotropic Drug Use in Nursing Homes,” November 2022, https://oig.hhs.gov/reports/all/2022/long-term-trends-of-psychotropic-drug-use-in-nursing-homes/.)

As previously conveyed to CMS through written comment and ongoing discussions with agency staff, including the Center for Clinical Standards & Quality (CCSQ), Project PAUSE believes that the current measure should be retired and replaced with low-burden improvements to the MDS that capture more clinically meaningful data related to antipsychotic use. Attached to this submission is a mark-up of the most recent MDS with our recommended changes. As you will see, we suggest a few simple additions to the MDS that we believe would strengthen oversight and accountability regarding antipsychotic prescribing which, when combined with the elimination of the current measure, would improve clinically appropriate access to these medications while still safeguarding residents against misuse and abuse. We believe these tailored modifications will provide more useful information to regulators, policymakers, providers, patients, and the public. Specifically, we recommend the Antipsychotic Medication Review section of the MDS be improved by:

• Expanding the reasons for why gradual dose reduction (GDR) has not been attempted to include a new category stating: “documented use of the drug and dose as clinically appropriate; and assessment timing is too soon based on admission date” and

   

• Requiring that in cases where GDR has not been attempted, both a physician and a pharmacist must either independently document that GDR is either clinically contraindicated, that the use of the drug and dose are clinically appropriate, or the assessment timing is too soon based on admission date. 

Unfortunately, as outlined above, the current measure focuses solely on driving down overall prescribing rates without regard for unique patient clinical needs, the specific patient census characteristics of individual nursing homes (e.g., facilities that specialize in patients with complex neuropsychiatric needs), or the availability of newer FDA approved antipsychotics with different mechanisms of action and side-effect profiles. As a result, residents in long-term care/nursing home settings–particularly those living with NPS related to Alzheimer’s disease, Parkinson’s disease, and other neurocognitive impairments–face significantly restricted access to FDA-approved medications solely because of where they reside and receive care. This runs counter to three of the four stated goals of CMS’s National Partnership to Improve Dementia Care to “1) Enhance the quality of life for people living with dementia, 2) Protect them from substandard care, and 3) Promote goal-directed, person-centered care for every nursing home resident.”

The members of Project PAUSE, which include patient advocates, family caregivers, long-term care professionals, primary care providers, geriatric psychiatrists, other practicing physicians, pharmacists, nurses, and other clinicians, again thank you for the opportunity to provide comment in pursuit of a healthier, safer, stronger, and more prosperous America. We welcome the opportunity to further discuss these recommendations and collaborate with CMS in shaping a modernized, evidence-based approach to ensuring quality of care and safety for individuals with neurocognitive impairments who reside in long-term care settings, as well as working together to identify additional opportunities to reduce unnecessary regulatory burden on nursing homes while maintaining high standards of care and assuring patient safety, health, and well-being, particularly of our nation’s most vulnerable Medicare and Medicaid beneficiaries.

Compilation of Supplementary Materials Provided by Project PAUSE

1. A mock-up – with an associated explanatory statement – of the Antipsychotic Medication Review portion of the FY 2026 Minimum Data Set (MDS) showing Project PAUSE’s suggested modifications (Attached, PDF pgs. 1-2). 

    

2. Report: Assessing the Impact of the Long-Stay Antipsychotic Medication Quality Measure on Treatment of Neuropsychiatric Symptoms of Alzheimer’s and Related Diseases (October 2025) (Linked and Attached, PDF pgs. 3-37). 

    

3. Article: CMS quality measure hindering access to dementia treatments: report (November 2025) (Linked and Attached, PDF pgs. 38-40). 

    

4. Project PAUSE Response to HHS RFI, Ensuring Lawful Regulation and Unleashing Innovation To Make American Healthy Again (July 2025)  (Linked and Attached, PDF pgs. 41-69).

The American Geriatrics Society (AGS) appreciates the opportunity to provide comments on the measures aligned with the priorities of Make American Healthy Again (MAHA), including the Percent of Residents Who Received an Antipsychotic Medication (Long-Stay) measure that is focused on safety. We believe that the measure would be improved by having exclusions for antipsychotic medication use in hospice and cancer care. 

AGS supports the reduction of antipsychotic medications for patients with dementia, particularly if there are alternatives to better manage behavioral disturbances. At the same time, there are instances when antipsychotic medications are critically important as a second or third line for the treatment of nausea, a common symptom for long-term care patients in hospice and cancer care, when initial treatments are not effective. As an example, dopaminergic antagonists have long been used in end-of-life care for treating severe nausea (PMID: 28318209). Olanzapine, which the American Society of Clinical Oncology (ASCO) added as a key treatment in its 2023 guidelines for cancer-associated anorexia (DOI: 10.1200/JCO.23.01280), has also shown to dramatically outperform other antiemetics for nausea reduction (DOI: 10.1001/jamaoncol.2020.1052). Given the effectiveness and impact of antipsychotic medications as a therapy for nausea in certain long-term care populations, we encourage providing flexibility and including patients receiving hospice or cancer care within the exclusions should the measure be adopted. 

The American Psychiatric Association (APA) supports the appropriate use of antipsychotics which have been shown to address underlying disorders or associated symptoms with the goal of improving patient function and comfort.  These medications should be used judiciously after accounting for the severity of the patient’s symptoms and distress and whether other interventions (including non-pharmacologic ones) have been able to control the symptoms.  Greater flexibility in the ability to prescribe these medications, in tandem with shared decision making, is the optimal treatment approach.   

The NHQI measure “Percent of Residents Who Received an Antipsychotic Medication (Long-Stay)” is far too restrictive and has resulted in unintended consequences as described below. Data shared in the proposal to expand this measure only looked at the rate of antipsychotic prescribing over time; there was no analysis of the consequences that have resulted from restricting prescribing to a limited set of patients.  The measure, as currently defined in the NHQI, should not be expanded to other settings.

The NHQI long stay measure currently restricts the use of antipsychotics to those patients with a diagnosis of Schizophrenia, Tourette’s Syndrome, or Huntington’s disease, and has many unintended consequences. 

1. While the evidence doesn’t support use of antipsychotics as first line treatment for mood disorders, use of antipsychotics is an appropriate option for some patients with bipolar disorder (Bahji, Ermacora, Stephenson et al, 2020; Kishi, Ikuta, Matsuda et al, 2021;  Kishi, Ikuta, Matsuda et al, 2022; Kishi, Sakuma, Okuya et al, 2021), major depressive disorder with psychotic features (Oliva, Possidente, De Prisco et al, 2024), and/or agitation in dementia (Reus, Fochtmann, Eyler et al, 2016); long-term care facilities should not  be penalized for medically appropriate prescribing to these patients or for maintaining a treatment regimen established by a psychiatrist prior to the patient entering the facility.

   1. Patients with mood disorders who have been stabilized on antipsychotics are being tapered off these medications in order to meet the current measure requirements.

      A. These patients frequently destabilize and are sent to the emergency department (ED). 

      B. Those restabilized on an antipsychotic often cannot return to the long-term care facility, which in turn creates a hospital boarding issue (low-value costs for CMS) until a housing solution is found. 

      C. CMS has acknowledged that long ED boarding is a patient safety issue but has henceforth failed to recognize the impact of the long-stay measure on ED boarding. 

       

   2. Inappropriate prescribing of antipsychotic medications -- where the intent is to cause significant, persistent sedation for staff convenience-- is problematic. However, when prescribed appropriately, antipsychotics can help reduce agitation and improve the patient’s function and comfort.  This is a population where often no good treatment options exist, and tradeoffs need to be carefully considered to provide whole person care that matches the values of the patients and their families. Restricting access doesn’t allow for patient-centered care in the least restrictive setting where patients and families are likely to feel more comfortable; it restricts a clinician’s ability to practice evidence-based medicine based on a flawed understanding of the risks and benefits associated with antipsychotic use.   

    

The measure “Antipsychotic Use in Persons with Dementia” in the Medicare Part C & D program, stewarded by the Pharmacy Quality Alliance (PQA), has expanded the list of exclusions to individuals who have a psychiatric diagnosis of Schizophrenia, Huntington’s disease, Tourette syndrome, or bipolar disorder.  While the intent of both measures is clearly aligned, the specifications of the measure in the Medicare Part C & D program better reflect appropriate prescribing, though are still too narrow as they don’t include other mood disorders.

CMS has not specified the additional programs to which this measure may be expanded.  It would be extremely problematic in the Inpatient Psychiatric Facility, the Inpatient Prospective Payment System, the Hospital Outpatient Prospective Payment System, or the Merit-Based Incentive Payment System reporting programs, as it could severely limit the ability to stabilize patients in crisis. 

APA does not support expansion of the long stay measure “Percent of Residents Who Received an Antipsychotic Medication (LS)” to other settings in its current form.  APA supports revising the existing measure(s) and/or developing better measures on appropriate use of antipsychotics that reflect current evidence-based practice and would be interested and available to collaborate on such revisions or developments.

References:

Bahji A, Ermacora D, Stephenson C, Hawken ER, Vazquez G. Comparative efficacy and tolerability of pharmacological treatments for the treatment of acute bipolar depression: A systematic review and network meta-analysis. J Affect Disord. 2020 May 15;269:154-184. doi: 10.1016/j.jad.2020.03.030. Epub 2020 Mar 20. PMID: 32339131.

Kishi T, Ikuta T, Matsuda Y, Sakuma K, Okuya M, Mishima K, Iwata N. Mood stabilizers and/or antipsychotics for bipolar disorder in the maintenance phase: a systematic review and network meta-analysis of randomized controlled trials. Mol Psychiatry. 2021 Aug;26(8):4146-4157. doi: 10.1038/s41380-020-00946-6. Epub 2020 Nov 11. PMID: 33177610; PMCID: PMC8550938.

Kishi T, Ikuta T, Matsuda Y, Sakuma K, Okuya M, Nomura I, Hatano M, Iwata N. Pharmacological treatment for bipolar mania: a systematic review and network meta-analysis of double-blind randomized controlled trials. Mol Psychiatry. 2022 Feb;27(2):1136-1144. doi: 10.1038/s41380-021-01334-4. Epub 2021 Oct 12. PMID: 34642461; PMCID: PMC9054678.

Kishi T, Sakuma K, Okuya M, Matsuda Y, Esumi S, Hashimoto Y, Hatano M, Miyake N, Miura I, Mishima K, Iwata N. Effects of a conventional mood stabilizer alone or in combination with second-generation antipsychotics on recurrence rate and discontinuation rate in bipolar I disorder in the maintenance phase: A systematic review and meta-analysis of randomized, placebo-controlled trials. Bipolar Disord. 2021 Dec;23(8):789-800. doi: 10.1111/bdi.13053. Epub 2021 Feb 26. PMID: 33561884.

Oliva V, Possidente C, De Prisco M, Fico G, Anmella G, Hidalgo-Mazzei D, Murru A, Fanelli G, Fabbri C, Fornaro M, de Bartolomeis A, Solmi M, Radua J, Vieta E, Serretti A. Pharmacological treatments for psychotic depression: a systematic review and network meta-analysis. Lancet Psychiatry. 2024 Mar;11(3):210-220. doi: 10.1016/S2215-0366(24)00006-3. PMID: 38360024.

Reus VI, Fochtmann LJ, Eyler AE, Hilty DM, Horvitz-Lennon M, Jibson MD, Lopez OL, Mahoney J, Pasic J, Tan ZS, Wills CD, Rhoads R, Yager J. The American Psychiatric Association Practice Guideline on the Use of Antipsychotics to Treat Agitation or Psychosis in Patients With Dementia. Focus (Am Psychiatr Publ). 2017 Jan;15(1):81-84. doi: 10.1176/appi.focus.15107. Epub 2017 Jan 11. PMID: 31997967; PMCID: PMC6519629.