Updated Guidance F605: New CMS regulations ensure nursing home residents are protected from unnecessary psychotropic drugs.
The Centers for Medicare & Medicaid Services (CMS) have introduced new regulations aimed at improving the safety and well-being of nursing home residents. These regulations address the use of psychotropic medications and aim to ensure that residents are protected from unnecessary and potentially harmful drugs. The revised guidelines emphasize the importance of careful monitoring, appropriate use, and gradual dose reduction of these medications.
Effective April 28, 2025, psychotropic medication guidance for nursing home residents falls under F605 Freedom from Chemical Restraints. Compliance with F605 is critical, as failure to do so will likely result in increased citations at an Immediate Jeopardy level or higher.
Here is the language and provisions of F605 revised:
- Free from Unnecessary Drugs
- Each resident's drug regimen must be free from unnecessary drugs, defined as those used in excessive dose or duration, without adequate monitoring, indications for use, or in the presence of adverse consequences.
- Gradual Dose Reductions (GDR)
- Residents using psychotropic drugs must receive gradual dose reductions and behavioral interventions unless clinically contraindicated, to discontinue these drugs.
- PRN Orders
- PRN orders for psychotropic drugs are limited to 14 days and must be necessary to treat a diagnosed specific condition documented in the clinical record.
Gradual Dose Reduction (GDR) is a process in which medication doses are reduced in steps to see if symptoms, conditions, or risks can be managed at a lower dose or if the medication can be stopped. The aim is to identify the appropriate dose or determine whether ongoing use of the medication is advantageous for the resident.
- CMS Requirements: Within the first year of admission or initiation of psychotropic medication, facilities must attempt gradual dose reduction (GDR) in two separate quarters, with at least one month between attempts.
- Evaluation Opportunities: GDR can be assessed during monthly medication regimen reviews, interdisciplinary team behavior meetings, attending physician evaluations, and quarterly MDS assessments.
- Clinical Improvement: If the resident's clinical condition has improved or stabilized, tapering may be considered to determine the lowest effective maintenance dose.
- Lack of Improvement: If target symptoms have not improved, tapering may be considered to discontinue the medication.
- Resolution of Symptoms: If the underlying causes of the original target symptoms are resolved, tapering may be appropriate.
- Non-Pharmacological Approaches: If non-pharmacological interventions have been effective in reducing symptoms, tapering may be considered.
- Risk vs. Benefit: The medical provider evaluates potential risks versus benefits to ascertain if a gradual decrease is advisable.
- Policy Review: Facilities must review current policies and procedures for alignment with regulations and evaluate staff practices for compliance.
- Continuous Monitoring: Continuous monitoring of the resident’s condition and symptoms is essential during the GDR process.
Practitioners must document a clinical rationale based on the resident’s condition and therapeutic goals, ensuring other treatments are contraindicated. A neurology-first approach is recommended to ensure accurate diagnoses, reduce polypharmacy, and minimize antipsychotic medications. The new guidance emphasizes careful medication management and holistic care in nursing homes.
Polaris Group consultants offer support in developing audit tools and systems for compliance with F605 under CMS’ Abuse, Neglect and Exploitation regulation. For further information contact our team today!
