The US Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a new report November 14, 2022, on long-term trends of psychotropic drug use in nursing homes. OIG work in 2011 had raised quality and safety concerns about the high use of one category of psychotropic drug—antipsychotics—by nursing home residents. The Centers for Medicare & Medicaid Services (CMS) began monitoring nursing home residents’ use of antipsychotics in 2012, and in May 2021, OIG published a report that determined that CMS’s existing methods for monitoring antipsychotic use by nursing home residents did not always provide complete information.
By comparing Medicare claims to Minimum Data Set (MDS) records for nursing home residents aged 65 and older in 2018, OIG found that many beneficiaries had Medicare Part D claims for antipsychotic drugs but were not reported in the MDS as receiving an antipsychotic drug. Furthermore, nearly one-third of residents who were reported in the MDS as having schizophrenia—a diagnosis that excludes them from CMS’s measure of antipsychotic drug use—did not have any Medicare service claims for that diagnosis. Finally, even for those residents included in the MDS counts, the MDS does not provide important details about the drug use (e.g., which antipsychotic drugs were prescribed, at what quantities and strengths; and for what durations).
The use of psychotropic drugs in nursing homes can be concerning because of the serious side effects and risks associated with the use of psychotropic drugs such as antipsychotics—including increased risk of death among the elderly. The risk of adverse consequences varies based on both the number of medications being taken regularly and the specific pharmacological classes of medications, such as antipsychotics and anticonvulsants, that are taken. In 2008, the Food and Drug Administration (FDA) issued a boxed warning, stating that some off-label uses of antipsychotic medications can result in severe adverse effects. Several anticonvulsant medications also have boxed warnings that draw attention to serious and potentially life-threatening adverse reactions, which include vision loss, liver failure, and increased risk of suicidality. Similarly, antidepressant medications are associated with several side effects to which elderly adults may be more vulnerable. These side effects range from headaches and gastrointestinal issues to cognitive impairment and increased risk for falls that can cause serious injury and lead to hospitalization.
In the new report, OIG recommended that CMS should: (1) evaluate the use of psychotropic drugs among nursing home residents to determine whether additional action is needed to ensure that use among residents is appropriate, (2) use data to identify nursing homes or nursing home characteristics that are associated with a higher use of psychotropic drugs and focus oversight on nursing homes in which trends may signal inappropriate use, and (3) expand the required data elements on Medicare Part D claims to include a diagnosis code. CMS concurred with the first two recommendations and did not concur with the third recommendation in this report.
The full report can be accessed here.
Compliance Perspective
Issue
Each resident’s drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug which is used in excessive dose (including duplicate drug therapy), for excessive duration, or without adequate monitoring, adequate indications for its use, or in the presence of adverse consequences which indicate the dose should be reduced or discontinued. Each resident’s entire drug/medication regimen should be managed and monitored to promote or maintain the resident’s highest practicable mental, physical, and psychosocial well-being. Facilities should implement gradual dose reductions (GDR) and non-pharmacological interventions, unless contraindicated, prior to initiating or instead of continuing psychotropic medication. PRN orders for psychotropic medications should only be used when the medication is necessary, and PRN use is limited.
Discussion Points
- Review your policies and procedures on psychotropic medication use and monitoring. Update as needed.
- Train all clinical staff on your psychotropic medication policies, including the risks and benefits of this classification of drug. Document that the trainings occurred and file the signed document in each employee’s education file.
- Audit to ensure psychotropic medications prescribed to residents list indication for use, are the correct dosage and duration, are adequately monitored by the attending physician or other designated practitioner, and that a licensed pharmacist has provided consultation. Also audit to see if there were any adverse consequences, and if so, that the dose had been reduced or discontinued. If decreasing or discontinuation of the psychotropic medication is not feasible, ensure that there is complete documentation of interventions that have been tried and were unsuccessful and a rationale for continuing use.
*This news alert has been prepared by Med-Net Concepts, LLC for informational purposes only and is not intended to provide legal advice.*
