The Centers for Medicare & Medicaid Services (CMS) has announced significant revisions to its surveyor guidance for long-term care facilities, set to take effect on April 28, 2025. These changes signal a усиленный focus on the use of psychotropic medications in nursing homes, aiming to prevent their unnecessary use and enhance resident safety and quality of care. The updated guidelines will subject the prescription and administration of these powerful drugs to more rigorous scrutiny and control.
According to a CMS memo released on November 18, 2024, these revisions are crucial to “strengthen our message that facilities must prevent the unnecessary use of psychotropic medications.” The memo, accompanying an advanced guidance document, emphasizes that these health and safety updates are a response to emerging trends in deficiency citations nationwide. This proactive approach ensures that CMS guidance remains current with evolving standards of practice and effectively addresses the needs of residents in long-term care settings. The overarching goal is to maintain and improve the integrity of care within nursing homes across the country.
Reclassification of Unnecessary Psychotropic Use as Chemical Restraint
One of the most impactful changes is the recategorization of “unnecessary use of psychotropics,” previously identified under F-tag 758, to tag F605. F605 specifically addresses a resident’s fundamental right to be free from chemical restraints. This strategic shift is designed to streamline the survey process for regulatory bodies and foster greater consistency in how these regulations are applied and enforced across facilities.
CMS defines a “chemical restraint” as any medication employed for disciplinary purposes or for the convenience of staff, rather than being medically necessary to treat specific symptoms. Further clarifying the landscape, the revised guidance specifies that F-tag 757, which deals with “unnecessary medications,” will now exclusively encompass non-psychotropic drugs. This segregation ensures a clearer focus on psychotropic medications and their unique risks and considerations in long-term care.
The existing F605 guidance already mandates that when medication is clinically indicated, facilities must adhere to stringent protocols. These include utilizing the least restrictive alternative treatment for the shortest possible duration, conducting continuous re-evaluations of the medication’s necessity, and unequivocally prohibiting the use of medication for discipline or staff convenience. The reclassification reinforces the importance of these safeguards specifically for psychotropic drugs.
Defining Chemical Restraint and Appropriate Medication Use
CMS is providing more explicit details regarding the appropriate use of medications that may induce sedation or impair cognitive function. The updated guidance underscores that “the indication for use for any medication ordered for a resident must be identified and documented in the resident’s record.” This requirement emphasizes transparency and accountability in medication management.
The current State Operations Manual (dated 08-08-24) defines chemical restraint as follows: “When any medication restricts the resident’s movement or cognition, or sedates or subdues the resident, and is not an accepted standard of practice for a resident’s medical or psychiatric condition, the medication may be a chemical restraint.”
The revised guidelines further clarify that even if medication use aligns with accepted standards of practice for a particular condition, it can still be classified as a chemical restraint if a less restrictive alternative treatment was available that could have effectively addressed the resident’s needs and preferences. Furthermore, if the medical symptom initially justifying the medication has subsided, continued use could also be deemed a chemical restraint. These nuances are critical for surveyors and facility staff to understand and apply.
Scrutiny on Sedation and “Convenience” in Medication Administration
The concept of “convenience” is central to the updated guidance. CMS defines “convenience” as “the result of any action that has the effect of altering a resident’s behavior such that the resident requires a lesser amount of effort or care, and is not in the resident’s best interest.” This definition is expanded in the new guidelines to explicitly include “situations when medications are used to cause symptoms consistent with sedation and/or require less effort by facility staff to meet the resident’s needs.” This broadened definition directly targets the inappropriate use of psychotropic medications to manage resident behavior for staff ease rather than resident well-being.
The significance of “convenience” as a factor in inappropriate psychotropic use is highlighted by a November 2022 report from the U.S. Office of Inspector General. This report established a correlation between higher psychotropic drug usage and factors such as lower registered nurse (RN) staffing levels and a higher proportion of residents receiving low-income subsidies. This data suggests potential systemic issues contributing to the overuse of these medications in certain facilities. The same OIG report also noted an increase in anticonvulsant prescriptions in nursing homes, potentially as a response to CMS initiatives aimed at reducing antipsychotic drug use. It’s important to remember that antipsychotics, anticonvulsants, anxiolytics, depressants, and similar drugs all fall under the umbrella of psychotropic drugs, which CMS broadly defines as “any drug that affects brain activities associated with mental processes and behavior.” This broad categorization underscores the wide scope of medications subject to these new, stricter guidelines.
Resident Rights and Psychotropic Medication
The revised guidance places a strong emphasis on residents’ rights concerning psychotropic medications. CMS explicitly states that “Additional guidance has been added to emphasize requirements related to the right to be fully informed of and participate in or refuse treatment.” This means that before initiating or increasing a psychotropic medication, facilities are obligated to ensure “the resident must be notified of and have the right to participate in their treatment, including the right to accept or decline the medication.”
CMS clarifies that the core intent behind these requirements is “to ensure residents only receive psychotropic medications when other nonpharmacological interventions are clinically contraindicated.” Furthermore, the guidance specifies that “residents must only remain on psychotropic medications when a gradual dose reduction and behavioral interventions have been attempted and/or deemed clinically contraindicated.” This step-wise approach prioritizes non-pharmacological alternatives and emphasizes the need for ongoing evaluation and justification for continued psychotropic medication use.
Ensuring Accuracy of Resident Assessments and Medical Oversight
CMS is reinforcing the importance of accurate and thorough resident assessments. The November memo emphasizes the agency’s commitment to “assure that each resident receives an accurate assessment, reflective of the resident’s status at the time of the assessment, by staff qualified to assess relevant care areas and are knowledgeable about the resident’s status, needs, strengths, and areas of decline.” Accurate assessments are foundational for appropriate care planning and medication management, especially concerning psychotropic drugs.
Tag F658, which pertains to “Services Provided Meet Professional Standards,” is also addressed in the updated CMS guidance. Surveyor instructions will now include procedures for verifying the presence of adequate supporting documentation for the use of any psychotropic medication. Furthermore, the guidance will provide specific examples for surveyors to use when citing noncompliance and will be more prescriptive in outlining necessary documentation to justify antipsychotic prescriptions. Documentation requirements for antipsychotic medication use are further elaborated within the updated guidance for Accuracy of Assessment F641. CMS has also indicated that provisions of F642 will be integrated into F641, streamlining the assessment and documentation requirements.
Medical Director Oversight and Surveyor Inquiries
The CMS memo explicitly states that surveyors will be directed “to evaluate psychotropic medication use based on a comprehensive assessment” and, critically, “to evaluate the medical director’s oversight of medical care.” This expanded role for surveyors includes assessing the medical director’s engagement in ensuring appropriate medication practices within the facility.
The Professional Standards guidance will also be enhanced to address situations where antipsychotic medications are prescribed without “sufficient supporting documentation” to substantiate the diagnosis for which the antipsychotic was prescribed. This is a direct measure to combat the potential misuse of antipsychotics in the absence of a clear and documented clinical need.
According to CMS, “it may be necessary to interview the medical director regarding medications that are not required to treat the resident’s medical symptoms” when such medications “result in the resident being subdued, sedated, or withdrawn or limited in his/her functional capacity.” This provision empowers surveyors to directly engage with medical directors to clarify medication practices and ensure appropriate clinical justification. The guidance at F841 will also be updated to incorporate language detailing the Medical Director’s responsibilities in the implementation of resident care policies. “Interviewing the facility Medical Director was also incorporated into the Unnecessary Medications and Quality Assurance & Performance Improvement (QAPI) pathways,” as stated in the CMS memo, further emphasizing the medical director’s accountability.
To ensure effective implementation of these revised guidelines, CMS will also incorporate “investigative elements to align with the revised guidance.” While initially slated to take effect on February 24, 2025, the implementation date was subsequently revised to March 24, 2025, and ultimately set for April 28, 2025, reflecting the agency’s commitment to a thorough and well-planned rollout.
Preparing for CMS Survey Readiness
With the April 28, 2025 effective date approaching, long-term care facilities must proactively prepare for these significant changes. The updated CMS guidance will undoubtedly bring a heightened level of scrutiny to clinical care practices, particularly concerning psychotropic medication use. Organizations like GuideStar Eldercare offer support to facilities seeking to ensure accurate assessments, reduce reliance on antipsychotics, and achieve better outcomes for residents. For facilities looking to strengthen their CMS compliance and enhance resident care in this evolving regulatory landscape, reaching out for expert guidance is a crucial step.
