Welcome back to the Ftag of the Week on the CMSCG Blog, your go-to spotlight for decoding the regulatory landscape of skilled nursing and long-term care. Each week (or sometimes more) we break down a specific Ftag from the CMS State Operations Manual, offering practical insights, survey trends, and actionable guidance to help providers stay ahead of compliance challenges. The CMSCG Ftag of Week series is designed to sharpen your understanding, support quality improvement, and reinforce your commitment to resident-centered care.
Currently, we’re reviewing F605 Right to be Free from Chemical Restraints, one of the Ftags that got some major revisions which became effective at the end of April 2025. So far, we’ve reviewed a lot of the general regulatory requirements, including the importance of consent and requirement to use nonpharmacological interventions. In this post, we’ll look at dose and duration, including gradual dose reduction after we review some definitions included in Appendix PP.
Definitions
“Dose” is the total amount/strength/concentration of a medication that is either given at one time or over a period of time. A “daily dose” refers to the amount received over a 24-hour period. An individual dose refers to what is received at each administration.
“Excessive dose” refers to when the total amount of any medication is given that is greater than the recommended amount per the manufacturer’s instructions and accepted standards of practice.
“Duplicative Therapy” refers to two or more medications which are part of the same pharmacological class when there is no clear distinction between when one medication should be administered over another. The IG indicates that examples of “potentially problematic” issues would be the use of more than one medication which contains the same ingredient, medications from different therapeutic categories used that have similar effects or properties or use of more than one drug within the same class.
“Polypharmacy” is the use of five or more medications for one individual. Polypharmacy can increase the risk of an adverse outcome such as frailty, disability, mortality or falls in older adults.
The IG also reminds us that there is an increased risk for polypharmacy and duplicative therapy during transitions of care. Providers must clarify the rationale for each medication and document how benefits and adverse consequences will be monitored.
Citation Example: F605 S/S: D – Monitoring
A facility was cited for failure to ensure a resident who had an order for an antipsychotic also had behavior monitoring documentation and medication side effects monitoring documented. Per the facility’s policy, residents who received an antipsychotic medication would have an AIMS test performed per policy.
F605 – Dose and Duration Guidance
Dose and duration are based on a variety of factors for each individual resident, including:
- Type of medication being considered
- Diagnoses
- Signs and symptoms
- Current condition
- Co-existing medication regimen
- Lab and other test results review
- IDT input
- Resident’s goals and preferences and the therapeutic goals being considered/ used
Appropriate Duration
The Interpretive Guidance states that the clinical rationale for continued use of a medication must be documented, including when a resident’s condition has not responded to treatment. The expectation is that both the medication and the dose will be reevaluated to determine the continued need for treatment. Several examples of inappropriate duration are included in the IG for F605 including:
- A psychotropic medication was initiated with appropriate indication, but the medication was not prescribed at the lowest dose and the least amount of time.
- A medication was initiated because of a time-limited condition but there was no documentation that the initial condition was monitored or evaluated. Staff continued to administer the medication even when the original condition had resolved.
- Staff continued to administer a medication beyond the stop date, without clinical indication for continued use.
CItation Example: F605 S/S: D
A facility was cited after it was identified that a resident had an order for a PRN antianxiety medication without a stop date and no documented rationale by the physician for the need to extend the medication use past 14 days.
Gradual Dose Reduction Guidance
Gradual Dose Reduction (GDR) is one of those areas where there’s a lot of frustration. Physicians often tell us that there’s a risk of destabilizing a resident when a GDR occurs, and staff tell us that the resident’s condition is stable so a GDR shouldn’t be attempted to throw things off kilter. We’ve also heard surveyors state that they expect GDR attempts, even if the dose is adjusted by the smallest amount to try and see if the resident can tolerate it. Let’s review the requirements and expectations for GDRs at F605 so everyone is on the same page. Per the IG:
- The purpose of requiring a GDR/tapering of a med is to identify the optimal dose or to determine if there is a benefit to continuing the use of this med for the resident or to determine if there could be a dangerous side effect.
- Residents who receive psychotropic drugs should receive GDRs unless it is clinically contraindicated.
- A facility must provide evidence that a GDR has been attempted for each resident receiving psychotropic medications unless it has been documented as clinically contraindicated by the physician.
GDR Timeframes
Appendix PP indicates that when tapering any medication, the time frames and durations of attempts should be consistent with accepted standards of practice. The expectation is that dose reductions occur over an appropriate length of time and at a modest reduction to monitor for symptom recurrence and reduce withdrawal symptoms. It’s important to acknowledge and appropriately document this routine monitoring to validate whether a GDR is effective or not. Oftentimes during medical record reviews, we can’t find sufficient documentation to explain why the IDT is saying a GDR failed after a pretty short period of time. If target symptoms have resurfaced, then there should be a clear picture of what’s going on with the resident. There should also be evidence that individualized nonpharmacological approaches to care are being attempted and whether the interventions have been successful or not.
Other factors which should be considered are unique to each resident, such as individual risk factors, other medications prescribed and the underlying causes of symptoms. The IG emphasizes that some medications may require more gradual tapering to prevent adverse consequences, such as opioids, sedatives/hypnotics and antidepressants.
We’ll finish our discussion about GDRs in Part 4 of this series. Check back next week!
Are your psychotropic medication practices survey-ready?
CMS Compliance Group’s expert consultants help facilities ensure compliance with F605, focusing on the appropriate use of psychotropic medications and avoiding unnecessary drug use. Our team provides comprehensive reviews of medication management protocols, behavior monitoring systems, and documentation practices to support regulatory compliance and resident safety.
