CMS Mega Rule Phase 3

CMS Mega Rule Phase 3

Pharmacy Related Requirements

Effective October 24, 2022

Drug Regimen is Free from Unnecessary Drugs (F757 and F758)

New: All drugs including psychotropic medications that are deemed unnecessary (excessive dose or duration, without adequate monitoring or indication for use reters survey team to consider unnecessary antibiotic use (F881) which may indicate antibiotic stewardship program has not been implemented.

Psychotropic Gradual Dose Reduction (GDR (F758)

New: Ensure dosage reductions are occurring in modest increments, over an adequate period of time in order to minimize withdrawal symptoms and include monitoring for symptom

Unnecessary Psychotropic/PRN Use (F758)

New: Definition of psychotropic medications has been expanded to include other medications which effect brain activity (central nervous system agents, mood stabilizers, anticonvulsants, muscle relaxants, anticholinergics, antinistamines, MDA receptor modulators when documented use appears to be a substitution for another psychotropic medication rather than the original/approved indication. For instance, use of an anticonvulsant medication when there is no history of seizures.

Misdiagnosis related to antipsychotics (F755)

New: Potential for misdiagnosis of residents with psychiatric disorders in order to justify the use of antipsychotic medications thereby excluding the resident from the long-stay antipsychotic alallo measure. surveyors can ake reemais to sure megical ooares or bogres or nursing

Psychosocial Harm Assessment (F755)

New: Requires evaluation of resident’s side effects from medication(s), including sedation, lethargy, agitation, mental status changes, or behavior changes that:

Affect the resident’s ability to perform ADL’s or interact with others cause the resident to withdraw or decline usual social patterns Show the resident has decreased engagement in activities, and or Cause diminished ability to think or concentrate Fentanyl Patch Disposal (F755)

New: Due to potential for accidental exposure or diversion, facility must ensure fentanyl patches are not disposed of in common areas or resident rooms, trash cans, or in sharps containers. May use drug disposal systems as long as they can show that the disposal system minimizes accidental exposure or diversion since EPA prohibits “sewering”, or flushing of medications and controlled substances that cannot be returned to the pharmacy for disposal.