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. Last week, we reviewed the general regulatory requirements for:
- Chemical restraints
- Psychotropic drugs
- PRN psychotropic orders
- Unnecessary drugs
Missed Part 1 of our revised Ftag series for F605?
Check it out here. Prior Ftag of the Week posts for F605 from 2023 (prior to these changes) are available for CMSCG subscribers if you need a reference.
The Interpretive Guidance (IG) notes that psychotropic medications should only be used when a practitioner has determined that the medication is appropriate to treat a resident’s specific, diagnosed and documented condition and the medication is beneficial to the resident, as demonstrated by monitoring and documentation of the resident’s response to the medication.
The regulatory guidance addresses three key points that providers need to be aware of and ensure that staff and prescribing practitioners understand them too.
Residents may only receive psychotropic medications when other nonpharmacological interventions are clinically contraindicated.
“Nonpharmacological interventions” is probably one of the phrases the makes our clients grit their teeth when they see me open my mouth, but it’s important. It’s very important because we’re not really good at identifying and attempting these interventions – but at the end of the day, they’re required. F605 uses the definition “behavioral interventions” to refer to nonpharmacological approaches to care which have been individualized for the resident. These interventions, per the IG, are “part of a supportive physical and psychosocial environment, directed towards understanding, preventing, relieving, and/or accommodating a resident’s distress or loss of abilities, as well as maintaining or improving a resident’s mental, physical or psychosocial well-being.” Most importantly, the IG notes that nonpharmacological approaches must be attempted, unless clinically contraindicated, to minimize the need for psychotropic medication, use of the lowest dose possible or to discontinue the meds.
Residents must only continue to receive psychotropic medications when a gradual dose reduction (GDR) and behavioral interventions have been attempted and/or deemed clinically contraindicated.
We’ll discuss GDRs in another post, but the regulation requires that facilities show evidence that a GDR has been attempted unless clinically contraindicated. Regarding GDRs, the IG notes that dose reductions should occur in “modest increments over adequate periods of time” in order to monitor symptom recurrence and minimize withdrawal symptoms. That means low and slow, with time to see if it’s working. Ensure documentation is sound and comprehensive when a GDR is in progress. This is an area where we often have difficulty determining what happened before a facility states the GDR failed.
Regarding GDRs, the IG in Appendix PP of the SOM notes that dose reductions should occur in “modest increments over adequate periods of time” in order to monitor symptom recurrence and minimize withdrawal symptoms.
Medications must only be used to treat a resident’s medical symptoms and may not be used for discipline or staff convenience.
We discussed staff convenience and discipline in the first part of this series, but this is an area where Administration may not even be aware of what staff are doing to lighten the workload. That Benadryl for “itching” that the resident isn’t documented as having, but which only occurs at 11PM? Take another peek. Medications administered to subdue behaviors? Were the behaviors that significant that they could not have been managed nonpharmacologically?
Survey Citation Example – F605 S/S: G (Complaint Survey)
A facility was cited at a harm level when staff administered an IM antipsychotic medication to a newly admitted resident who had been wandering in and out of other residents’ rooms. The on-call physician stated he was told that the resident was being disruptive, agitated and physically combative with staff, so he recommended the resident be given a sedative medication. The resident spit out the med, so the physician ordered the IM medication.
Review of the facility’s cameras showed inaccuracies with what actually occurred and what the on-call physician was told. The physician stated that he had not seen the footage and may have recommended other interventions such as placing the resident on one-to-one monitoring or redirection rather than ordered medications. Further review showed four staff members holding the resident against the wall and administering the med. The resident’s admission medication list did not include any antipsychotics, and the resident had no documented medical symptom or appropriate assessment for the use of antipsychotic medication. On interview, the Administrator stated that by the time staff intervened physically, the resident appeared to be calm and should not have been administered medications.
The Importance of Consent
Don’t forget about the resident’s right to be informed. We’ll start there since many facilities struggle with ensuring informed consent is evident for medications. The regulation related to the right to be informed is F552, but we are going to address the IG which is related to this tag as well. To have informed consent, prior to initiating or increasing psychotropic medication:
- The resident/ representative must be informed of the benefits, risks and alternatives for the medication, including any black box warning for antipsychotic medications in advance of initiation or increase.
We’re seeing a lot of issues related to ensuring documentation is in place that shows consent was made prior to, not after, psychotropics come into the mix. One area of particular concern relates to PRN medications – is your staff getting consent before that IM Haldol injection? I’d doublecheck.
- The resident has the right to accept or decline the initiation or increase of a medication.
The IG states that the resident’s medical record must include documentation that the resident or representative was informed in advance of the risks and benefits of the proposed care, alternative treatments available, and was able to choose the option that the resident/ representative preferred. That’s what’s required for your documentation – otherwise surveyors are expected to cite F552. Let’s review some examples of how F552 is being cited since the regulatory changes were implemented and psychotropic consents have gotten more surveyor attention:
Survey Citation Example – F552 S/S: D (Standard Survey)
A facility was cited for failure to obtain consent for the use of a psychotropic medication for a cognitively impaired resident with a legal guardian who made all medical decisions for the resident. Review of the medical record failed to indicate that the resident or his/her legal guardian was informed of a new order for Seroquel and the risks/ benefits of the medication in advance of administration. On interview, the Social Worker states she is responsible for keeping the resident’s guardian up to date and was not aware that an antipsychotic had been added to the resident’s orders, so the guardian was not contacted about this medication.
If you’ve ever dealt with a guardian, you know that even getting in contact with the guardian can present a huge task, much less getting informed consent timely when the practitioner has determined that additional psychotropics may be warranted. It’s worth reviewing your process for any potential gaps and how all responsible staff are informed about these proposed changes to facilitate consent. Don’t forget about ensuring that you’re contacting the appropriate party when the consents are being given, as you’ll see in the next citation example.
Survey Citation Example – F552 S/S: D (Standard Survey)
A facility was cited for failure to inform a resident’s responsible party in advance of the risks and benefits of psychotropic medications and obtain consent prior to the medications being administered. The resident, whose diagnoses included schizophrenia and MDD, had a Health Care Proxy (HCP) which had been invoked a year prior. The facility had the resident sign consent forms for an antipsychotic and antidepressant. On interview, the HCP stated that he/she was not aware of the specific psychotropic medications that the resident was receiving and that he/she had just only recently gotten a call from the facility to come and sign the consent forms, although the resident had been taken these medications for some time.
We’re still at the tip of the iceberg for F605 – there’s lots more coming, so check back soon for Part 3 of our CMSCG Ftag of the Week for F605 Right to be Free from Chemical Restraints.
🚨 Concerned About Compliance? Let CMSCG Help You Stay Survey-Ready
At CMS Compliance Group, we don’t just identify problems—we help you solve them. Our interdisciplinary team has a proven track record of guiding nursing homes and other post-acute providers through the most serious compliance challenges.
Whether you’re preparing for survey or have identified a potential area of concern which could benefit from an outside set of eyes, we can help. Services include:
- Mock surveys with detailed findings across all departments
- Ongoing quality assurance reviews to keep your systems functioning at the highest standards
- Focused auditing (onsite/offsite)
Let’s make compliance your organization’s strength. Call us at (631) 692-4422 or contact our team to schedule a consultation.
