10/23/2025

Survey Tip of the Week: High Risk Medications

According to the State Operations Manual Appendix PP §483.75 Quality Assurance and Performance Improvement (QAPI) Program Feedback, Data Systems, and Monitoring, CMS requires facilities to have written policies and procedures for feedback, data collection, and monitoring, including adverse event monitoring. The regulation specifically directs facilities to set priorities for performance improvement activities that focus on high-risk, high-volume, or problem-prone areas. One such area receiving heightened scrutiny by surveyors is the administration of high-risk medications, particularly anticoagulants, insulin, and opioids.  

The Long-Term Care Survey Process (LTCSP) instructs surveyors to review new admissions for the use of high-risk medications. The Minimum Data Set (MDS) 3.0, under Item N0415: High-Risk Drug Classes Use and Indication, includes a specific data element for tracking the use of these medications. The RAI manual states that residents taking medications in these classes are at risk of side effects that can adversely affect health, safety, and quality of life. The need for these medications should be carefully assessed, and possible non-pharmacological alternatives should be considered. 

Facilities should integrate data collection and monitoring of high-risk medications into their QAPI program. Ongoing monitoring for compliance, using the surveyor guidance outlined in the State Operations Manual Appendix PP, will help ensure that facilities identify trends, prevent adverse events, and demonstrate effective performance improvement in this high-risk area.