Why Multiple Agencies are Scrutinizing the Use of Psychotropic Medications in Nursing Homes

In November 2022, the U.S. Health and Human Services (HHS) Office of Inspector General (OIG) issued a report titled, “Long-Term Trends of Psychotropic Drug Use in Nursing Homes.”¹ This report highlights areas of weakness related to nursing home patients who may be inappropriately given psychotropic medications, believed mainly to be used as a tool to sedate and manage patients.

In response to the report, U.S. Senator Chuck Grassley wrote a letter² to the Secretary of HHS and the administrator of Centers for Medicare & Medicaid Services (CMS). His letter points out long term concerns with psychotropic medications in this vulnerable patient population and asks for regular reports on what will be done to better monitor inappropriate prescribing of psychotropic medications in nursing homes. He stated, “Unfortunately, the recent report confirms my decades-long concern that nursing homes are misusing potent and potentially lethal psychotropic medications without the requisite diagnosis or oversight.”

The OIG explained the reason they performed their most recent work on psychotropic drugs was a result of work they performed in 2011 that raised quality and safety concerns about the high use of antipsychotics in nursing homes. CMS began monitoring use of antipsychotics in 2012, and in May 2021, the OIG published a report that determined CMS's existing methods for monitoring antipsychotic use by nursing home residents did not always provide complete information.

A Look Back at Scrutiny on the Use of Psychotropic Drugs

The OIG’s November 2022 report found that from 2011 through 2019, about 80 percent of Medicare's long-stay nursing home residents were prescribed a psychotropic drug. While CMS focused its efforts to reduce the use of one category of psychotropic drug—antipsychotics—the use of another category of psychotropic drug—anticonvulsants—increased. This increased use of anticonvulsants contributed to the overall use of psychotropics remaining constant.

In 2019, higher use of psychotropic drugs was associated with nursing homes that have certain characteristics. Nursing homes with lower ratios of registered nurse staff to residents were associated with higher use of psychotropic drugs. Nursing homes with higher percentages of residents with low-income subsidies were also associated with higher use of psychotropic drugs.

Additionally, over time, the number of unsupported schizophrenia diagnoses increased and in 2019, was concentrated in relatively few nursing homes. Specifically, the OIG found that from 2015 through 2019, both the reporting of residents with schizophrenia in the Minimum Data Set (MDS) and the number of residents who lacked a corresponding schizophrenia diagnosis in Medicare claims and encounter data increased by 194 percent. In 2019, the unsupported reporting of schizophrenia was concentrated in 99 nursing homes in which 20 percent or more of the residents had a report of schizophrenia in the MDS that was not found in the Medicare claims history.

CMS's long-stay quality measure that tracks antipsychotic use in nursing homes excludes residents who are reported as having schizophrenia in the MDS. Thus, nursing homes could misreport residents as having schizophrenia in the MDS to falsely impact CMS's quality measure.

OIG Recommendations and Key Questions from the U.S. Senate

By not collecting diagnoses on Medicare Part D claims, CMS is limited in its ability to effectively conduct oversight of psychotropic drugs. First, not having diagnoses on claims limits CMS's ability to detect patient risk and patterns of potentially inappropriate drug use. Second, the lack of diagnoses makes it difficult for CMS to systematically determine whether claims meet the payment requirement that drugs be used for medically accepted purposes.

Based on these findings, the OIG recommended 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.
3. Expand the required data elements on Medicare Part D claims to include a diagnosis code.

Senator Grassley, on the other hand, had some pointed questions for the Secretary of HHS and CMS Administrator. He asked:

1. Has CMS taken any steps towards implementing OIG’s long-standing recommendation to expand the required data elements on Medicare Part D claims to include a diagnosis code (first recommended in 2011)? If so, please explain. If not, given the significant use of psychotropic drugs, how does CMS justify its ongoing refusal?
2. For the proposed offsite audits of schizophrenia coding, how does offering nursing homes the opportunity to forego an audit by admitting errors and correcting the issue solve the problem of improper use of psychotropic drugs?
   • Absent an audit, how will CMS determine what issues need correcting?
   • Why does CMS consider conducting audits for nursing homes with high psychotropic drug prescription rates to be a burden?
3. Has CMS considered completely excluding certain conditions, such as schizophrenia, from calculations in future quality measures? If so, under what circumstances? If not, why not?
4. With respect to the discrepancy between citations issued and civil money penalties, why is CMS limiting its enforcement actions?
5. How many citations has CMS issued since 2012 that are linked to resident harm or immediate jeopardy?
   • How many of these went through the IDR/IIDR process and what was the final determination for each deficiency?

States Are Also Ringing the Alarm Bell

Concerns are not only being expressed at the Federal level. Many states are also emphasizing the risks associated with psychotropic drugs in nursing homes. The Texas Department of Health and Human Services, for example, shares guidelines and resources on their website page titled “Appropriate Use of Antipsychotic Medications.”³

They state that antipsychotic medications, used for approved disease states (such as schizophrenia, Huntington's disease, and Tourette's syndrome) are widely accepted. They add that in people with a predetermined or long-standing history of mental illness, the chronic use of an antipsychotic medication also may be deemed necessary to stabilize and improve functionality. But they caution that sometimes antipsychotic medications are prescribed for off-label use in Alzheimer's disease and other dementia-related illnesses where the effectiveness of the treatment can show mixed results. They claim, “the off-label use of antipsychotic medications for dementia-related illnesses is unsupported in the literature.”

The Texas website also provides resources and best practices for quality of care in the context of nursing home residents and psychotropic medications. One such tool is a job aid to assist with proper initiation or continuation of an antipsychotic medication for a resident with dementia.⁴ The document poses a series of questions that should help those assessing the appropriateness of use of these medications.

Some of those questions include the following:

• What other approaches and interventions were attempted prior to the use of antipsychotic medications?
• Was the family member or responsible party contacted prior to the initiation of the medication?
• Is the medication clinically indicated and necessary to treat a specific condition and target symptoms as diagnosed and documented in the clinical record?
• Have gradual dose reductions been planned and behavioral interventions (unless contraindicated) provided in an effort to discontinue the medication?

The website also provides links to many other tools and resources on the topic of psychotropic medications. Some of these include:

• Antipsychotic Education Form⁵
• Alternatives to Antipsychotic Medications⁶
• Be DADS Wise with the Use of Antipsychotics⁷
• Basic Guidelines for Quarterly Psychotropic Medication Evaluation⁸
• Antipsychotics: What's the Big Deal?⁹

Given the attention by the OIG, U.S. Senate, and states on the proper use of psychotropic medications in the nursing home population, it would be wise for compliance professionals working in this space to proactively monitor and assess their own organizations’ policies, procedures and activities related to use of these medications.

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