CMS Updates LTC Surveyor Guidance – LeadingAge NY Analysis: Segment 1: Psychotropic Medications
(Dec. 3, 2024) The Centers for Medicare and Medicaid Services (CMS) recently announced in memorandum QSO-25-07-NH a major update to guidance in many domains of the long-term care surveyor guidelines for nursing homes. With these changes taking effect on Feb. 24, 2025, there are just a few short months for providers to become knowledgeable about these changes, evaluate their current policies and procedures, identify gaps, and institute change along with education where needed. LeadingAge NY will be continuing our ongoing analysis of these updates and providing information in a series of segments to keep providers informed and support efforts to remain compliant throughout this process. This week’s segment reviews the psychotropic medication modifications and major updates to be aware of.
CMS continues to heavily focus on the use of psychotropic medications. F-tag 757 Unnecessary Medications used to be the citation under which unnecessary psychotropic medications and medications used as psychotropics would have been cited. In the new updated State Operations Manual (SOM) Appendix PP, this will be relocated and cited under F-tag 605 Chemical Restraints, which is a significant change, as F-tag 605 is an abuse tag.
CMS clearly states in the updated guidance that psychotropic drugs should only be used “when other nonpharmacological interventions are clinically contraindicated.” They go on to define “chemical restraint” as any drug used for discipline or that makes it more convenient for staff to care for a resident, and not required to treat medical symptoms. This includes instances when a psychotropic medication may be approved to treat certain symptoms; however, nonpharmacological interventions should be used or attempted, unless clinically contraindicated, because they are less dangerous to a resident’s health and safety. For example, if a nonpharmacological intervention should be used or attempted and is not clinically contraindicated, but a medication is administered and has the effect consistent with the definition of convenience, the medication would be classified as a chemical restraint and facilities cited at F-tag 605.
The guidance also states that residents should only remain on psychotropic medications “when a gradual dose reduction [GDR] and behavioral interventions have been attempted and/or deemed clinically contraindicated.” Providers must be sure that these attempts at nonpharmacological intervention and the clinical contraindications are clearly and sufficiently documented in the resident’s medical record.
“Adequate Indications for use” is another definition that providers should pay close attention to. According to SOM Appendix PP, "adequate indication for use means that the medication administered is consistent with manufacturer’s recommendations and/or clinical practice guidelines," and "without documentation in the record explaining that the practitioner has determined that other treatments have been deemed clinically contraindicated, the indication for use is inadequate." The medical record must also include evidence that the resident/representative was informed, prior to initiating or increasing a psychotropic medication, of the benefits, risks, and alternatives for the medication, including any black box warnings for antipsychotic medications.
CMS further states that an "Unnecessary Drug” is any drug when used in excessive dose (including duplicate drug therapy), for excessive duration, without adequate monitoring, without adequate indications for its use, in the presence of adverse consequences which indicate the dose should be reduced or discontinued, or any combinations of the aforementioned reasons.
A comprehensive assessment and documentation of such should include nonpharmacological interventions, including those who are admitted on psychotropic medications that were prescribed by an outside practitioner prior to admission. Evaluation and documentation of GDR must reflect the date the GDR was attempted, the outcome of the attempt, and the plan for future GDR attempts, including a rationale for why GDR attempts are deemed clinically contraindicated.
Providers should be aware that failure to monitor adverse consequences or failure to attempt GDR or document clinical contraindications for GDR will be cited at immediate jeopardy level. The evaluation for psychosocial harm will use the reasonable person concept when evaluating the severity of citation. This means that even when a resident may not be exhibiting any outward signs of psychological harm, surveyors could determine that harm has occurred if a “reasonable person” experiencing that same situation would have experienced psychosocial harm.
CMS also places focus on the resident’s right to be informed in accordance with the requirements at F-tag 552. Prior to initiating or increasing a psychotropic medication, the resident, family, and/or resident representative must be informed of the benefits, risks, and alternatives for the medication, including any black box warnings for antipsychotic medications, in advance of such initiation or increase. To demonstrate compliance, the documentation must show consent and include risks and benefits of the proposed care, the treatment alternatives or other options, and that the resident and/or health care proxy was able to choose the option he or she preferred. A written consent form may serve as evidence of a resident’s consent to psychotropic medication, but other types of documentation are also acceptable. If a psychotropic medication has been initiated or increased and there is not documentation demonstrating compliance with the resident’s right to be informed and participate in their treatment, noncompliance is cited at F-tag 552.
Regarding the adequate documentation of schizophrenia diagnosis, CMS instructs surveyors according to the following guidelines:
CMS is aware of situations where residents are given a diagnosis of schizophrenia without sufficient supporting documentation that meets the criteria in the current version of the DSM for diagnosing schizophrenia. If the non-compliance causes actual harm or the likelihood of serious harm to one or more residents or the surveyor identifies a pattern (e.g., three or more) by the same practitioner prescribing antipsychotic medication for any new diagnosis (such as schizophrenia) with lack of supporting documentation, the survey team should discuss their findings with their state survey agency for consideration to refer the individual to the State Medical Board or Board of Nursing.
Use of CMS examples of what they consider nonpharmacological interventions to be, described below, is a great way to ensure compliance with this component of the extensive need for documentation. Nonpharmacological interventions include, but are not limited to:
- ensuring adequate hydration and nutrition by enhancing taste and presentation of food and addressing food preferences to improve appetite and reduce the need for medications intended to stimulate appetite;
- exercise, and assisting with the opportunity for meditation and associated physical activity such as chair yoga;
- pain relief;
- individualizing sleep and dining routines, as well as schedules to use the bathroom, to reduce the occurrence of incontinence;
- adjusting the environment to be more individually preferred and homelike (e.g., using soft lighting to avoid glare; providing areas that stimulate interest or allow safe, unobstructed walking; eliminating loud noises, thereby reducing unnecessary auditory environment stimulation);
- assigning staff to optimize familiarity and consistency with the residents and their needs;
- supporting the resident through meaningful activities that match his/her individual abilities (e.g., simplifying or segmenting tasks for a resident who has trouble following complex directions), interests, goals, and needs, based upon the comprehensive assessment;
- providing an activity or routine that may be reminiscent of lifelong work or activity patterns (e.g., providing an early morning activity for a farmer used to waking up early);
- assisting the resident outdoors in the sunshine and fresh air;
- providing access to pets or animals for a resident who enjoys pets (e.g., a cat for a resident who used to have a cat of their own);
- assisting the resident to participate in activities that support their spiritual needs;
- focusing the resident on activities that decrease stress and increase awareness of actual surroundings, such as familiar activities;
- offering verbal reassurance, especially in terms of keeping the resident safe, and acknowledging that the resident’s experience is real to her/him;
- utilizing techniques such as music, art, electronics/computer technology systems, massage, essential oils, and reminiscing;
- assisting residents with substance use disorders to access individual or group counseling services, 12-step programs, and support groups;
- assisting residents with access to therapies, such as psychotherapy, behavior modification, cognitive behavioral therapy, and problem-solving therapy; and
- providing support with skills related to verbal de-escalation, coping skills, and stress management.
Use of the updated psychotropic critical element pathway found here and re-educational efforts on documentation parameters and nonpharmacological interventions are a good way to prepare your facility and staff to maintain compliance with these updated guidelines. More information on the updated long-term care surveyor guidelines can be found here. In next week’s issue of Intelligence, LeadingAge NY will discuss Admission, Transfer, and Discharge guideline updates.
Contact: Carrie Mosley, cmosley@leadingageny.org, 518-867-8383 ext. 147