CMS Interpretive Guidelines – Revisions to Antipsychotic Medication Guidance

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Continuing our series on the CMS Interpretive Guidelines, ALN Consulting outlines the revisions to Antipsychotic Medication Guidance. The Interpretive Guidelines include an explanation of the intent of the law, definitions of terms, and instruction on determining compliance with the law. A strong defense of long term care facility liability is grounded in an understanding of the CMS Interpretive Guidelines and its revisions. An important topic in many cases is the use of antipsychotic drugs in patient populations with dementia. This installment of our CMS series will help your team prepare for litigation involving antipsychotic medication.

The History of Antipsychotic Drug Use in Patients with Dementia

A “Black Box Warning” exists on the label of all antipsychotics reading, “Elderly patients with dementia related psychosis treated with antipsychotic drugs are at an increased risk of death. Antipsychotics are not approved for the treatment of patients with dementia related psychosis.” However, due to societal beliefs held by both families and medical providers that dementia behaviors should be treated, antipsychotic drugs have been used for some time in an “off label” way for patients with dementia. To use a drug in an “off label” manner refers to the prescription of a medication to treat a condition that has not been officially approved by the FDA for that purpose. Prescribing a drug for an “off label” reason is not illegal, and providers must use current research and standards to determine if such a use is beneficial.

Some antipsychotic use has been shown to be effective in treating symptoms of dementia, but in 2010, American Family Physician published a piece that stated, “All antipsychotic medications are associated with an increased likelihood of sedation, sexual dysfunction, postural hypotension, cardiac arrhythmia, and sudden cardiac death.” While it is not uncommon to see antipsychotics still prescribed “as needed” to control dementia behaviors, the significant risks of using antipsychotic medications in patients with dementia caused CMS to launch national partnerships and advertising to reduce off label use of antipsychotics in nursing homes in 2012.

42 C.F.R. §483.25 Quality of Care (F Tag 309)

Several regulations address the use of antipsychotic drugs in patients with dementia, and the Interpretive Guidelines were updated to reflect the most recent revisions in November 2014. The regulation for Quality of Care requires that “Residents who use antipsychotic drugs receive gradual dose reductions and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs.” F Tag 309 is the guidance surveyors use for review of quality of care of a resident with dementia. While there is no specific investigative protocol for care of a resident with dementia, the surveyor can use a checklist entitled, “Review of Care and Services for a Resident with Dementia.” Revisions to this Interpretive Guideline included updated definitions related to recognition and management of dementia, and specific to this topic, medication use in dementia.

The revisions in F Tag 309 to medication use in dementia stated, “When antipsychotic medications are used without an adequate rationale, or for the sole purpose of limiting or controlling behavior of an unidentified cause, there is little chance that they will be effective, and they commonly cause complications such as movement disorders, falls, hip fractures, cerebrovascular adverse events (cerebrovascular accidents and transient ischemic events) and increased risk of death.” Information and links to the FDA Black Box Warning Regarding Atypical Antipsychotics in Dementia were included.  Surveyors were instructed to be on alert for antipsychotic medication administration that could be considered a chemical restraint. Specific care planning evidence should be available to show a facility included non-pharmacological approaches to dementia management, as well as gradual dose reduction of those residents on antipsychotics prescribed for dementia. Compliance and non-compliance examples were added for further clarification.

42 C.F.R. §483.25(l) Unnecessary Drugs (F Tag 329)

The regulation for unnecessary drugs also had significant revisions in November 2014. Indications for the use of antipsychotic drugs were expanded for conditions other than dementia. The F Tag 329 is designed to be used in conjunction with F tag 309 for surveyors reviewing the maintenance of behavioral or psychological symptoms of dementia patients. The new Interpretive Guideline revisions stated that antipsychotic medications are only appropriate for elderly residents in a small minority of circumstances, and “May be considered for elderly residents with dementia but only after medical, physical, functional, psychological, emotional psychiatric, social and environmental causes have been identified and addressed. Antipsychotic medications must be prescribed at the lowest possible dosage for the shortest period of time and are subject to gradual dose reduction and read review.” This revision is of special importance since many residents are admitted to long-term care already on an antipsychotic medication.

Antipsychotic medications in persons with dementia should not be used if the only indication is one or more of the following:

  • wandering
  • poor self-care
  • restlessness
  • impaired memory
  • mild anxiety
  • insomnia
  • inattention or indifference to surroundings
  • sadness or crying alone that is not related to depression or other psychiatric disorders
  • fidgeting
  • nervousness
  • uncooperativeness (e.g., refusal of or difficulty receiving care)

All of the above highlight conditions/diagnoses where antipsychotic medications may possibly be appropriate, but diagnoses alone do not warrant the use of an antipsychotic unless the following criteria are also met:

  • The behavioral symptoms present a danger to the residents or others AND one or both of the following:
    • The symptoms are identified as being due to mania or psychosis OR
    • Behavioral interventions have been attempted and included in the plan of care, except in an emergency

The revisions to the Interpretive Guidelines also addressed acute situations/emergencies, and enduring conditions. The guidelines include a table provided as a general guide for daily dose thresholds.

In Conclusion

Long-term care litigation requires expert knowledge in the revisions to the Interpretive Guidelines. ALN’s nursing team stands ready to guide your legal team through the changes of the key elements for Unnecessary Drug severity determination. While the updates are complex, the ALN Consulting team has the experience and expertise to build a successful defense, staying up to date with the latest revisions. Let us help you decipher the latest revisions of the Interpretive Guidelines and strengthen your long term care case.



  1. Harris, Rick E. (2015). How to Use the CMS Surveyor Guidance to Craft a Winning Defense [Presentation at the DRI LTC/SNF Seminar].
  2. Centers for Medicare & Medicaid Services. (2015). State Operations Manual – Appendix PP – Guidance to Surveyors for Long Term Care Facilities. Retrieved 01/04/16.