Preventing the use of unnecessary medications continues to be a key focus for the Centers for Medicare & Medicaid Services (CMS). This is readily apparent in updates to the State Operations Manual (SOM) and surveyor guidance that go into effect on March 24, 2025. While the 900-page document outlining updates addresses a wide range of issues, it places a particular spotlight on unnecessary medications, chemical restraints, and the appropriate use of psychotropics. A recent PharMerica webinar, 2025 Updates to State Operations Manual Signify Impending CMS Surveyor Focus, took a thorough and thoughtful look at these updates and what they mean to clinical leaders and their teams.
Presenter
Karen McDonald, BSN, RN
started by observing, “Unnecessary medication use is a particular hazard in our industry, with aging individuals and those with multiple comorbidities already at a high risk for inappropriate polypharmacy and prescribing cascades. These issues increase the risk for long-term care residents to experience adverse drug events. For these reasons, emphasis is placed on ensuring that any drug therapy initiated and continued in skilled nursing facility residents is appropriate.” This comes with increased surveyor scrutiny applied to psychotropics and other medications that produce sedation-like symptoms, as these could be considered chemical restraints.
- Tag F757 (Unnecessary Medications) has been revised and reorganized to include guidance for unnecessary medications, while removing guidance on unnecessary use of psychotropics.
- Unnecessary drugs are defined as any medications 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 that indicate the dose should be reduced or discontinued, and/or any combinations of these reasons.
- F758 (Unnecessary Psychotropic Medications) has been removed from Appendix PP and previous regulations and guidance under this tag have been incorporated into and will be cited under F605 (Free from Chemical Restraints). Webinar presenter Cheryl Kendrick, PharmD, BCGP, elaborated on the change, stating, “This is to ensure each resident’s medication regimen promotes mental, physical and psychosocial well-being and to clear confusion surrounding unnecessary psychotropic use.”
- Examples of unnecessary medications might include a resident who no longer complains of pain but is still receiving a scheduled pain medication (indicating lack of monitoring), or a resident indefinitely continued on a prophylactic proton-pump inhibitor from an acute hospital stay. Note that surveyors will be watching for medications without adequate indications for their use, without adequate monitoring, or in the presence of adverse consequences that indicate the dose should be reduced or discontinued. For example, a resident with excessive drowsiness after initiation of a medication and who has not been reassessed in a timely manner.
- Under F605, a medication used for staff convenience or discipline, and that is not indicated for a valid medical purpose is considered unnecessary. The guidance regarding convenience has been revised to 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.
- F642 (Coordination of MDS Assessment) has been removed from Appendix PP. Previous regulations and guidance under this tag have been incorporated into and will now be cited under F641 (Accuracy/ Coordination/Certification). Emphasis is placed on providing supporting documentation of diagnoses, with a risk of fines/citations for noncompliance. “This mirrors the schizophrenia audits that many communities have experienced over the last couple of years,” said McDonald. She noted that practitioners should be using the DSM-V definitions for schizophrenia and schizoaffective disorder. Elaborating further, McDonald noted that, one study, when assessing MDS claims from 2015 to 2019, found “a 194% increase in the number of residents reported in the MDS as having schizophrenia but who lacked a corresponding schizophrenia diagnosis in their Medicare claims and encounters.”
- Under F658 (Services Provided Meet Professional Standards), examples of insufficient documentation to support a mental health diagnosis would include a situation where schizophrenia or other diagnosis is only mentioned as an indication in medication orders, without any assessment or history that truly validates this diagnosis.
- F841 (Responsibilities of a Medical Director) amends previous guidance to address the implementation of policies and procedures for diagnosing and prescribing medication, saying that it is within the scope of the Medical Director’s role to ensure the facility’s prescribers are adhering to clinical guidelines. The medical director is now also explicitly charged with intervening when treatment is inconsistent with accepted standards of care.
For more insights, watch the full webinar on PharMerica's Illuminate educational platform.
