schizophrenia

With half of nursing homes audited in a new process admitting to misdiagnosing schizophrenia patients, the Centers for Medicare & Medicaid Services is extending its drive to reduce the use of certain drugs intended to treat schizophrenia, psychosis and other behavioral health conditions.

Last January, CMS announced it would review diagnoses among the nursing home population because it had observed a rise in rates of schizophrenia, which is most commonly diagnosed when a person is in their 20s. Regulators said they suspected that some diagnoses were unfounded and potentially being given to mask dependence on medications to treat symptoms of other diseases or disorders. 

Schizophrenia and antipsychotics are closely linked, and especially so in nursing homes. Facilities receive a quality rating connected to their patients’ use of antipsychotics such as the commonly prescribed aripiprazole, clozapine, haloperidol and risperidone. But patients taking those drugs for schizophrenia, Tourette syndrome and Huntington’s disease are excluded from the measure, which makes a building’s overall rate of use appear lower.

A CMS spokesman told McKnight’s Long-Term Care News Thursday the agency had contacted “hundreds” of nursing homes for schizophrenia audits so far and that it “continues to conduct these audits.”

“Nursing home residents erroneously diagnosed with schizophrenia are subject to poor care and unnecessary antipsychotic medications,” the spokesman said in an email. “Antipsychotic medications are especially dangerous among the vulnerable nursing home population due to their potential devastating side effects, including death.”

While CMS did not release information about how it chose its audit targets, two clinical and compliance experts with Zimmet Health Services Group said even a single diagnosis could qualify a provider for additional review. Still, the audits appeared to focus on a group of facilities that diagnosed patients most often.

CMS began contacting selected providers a year ago, asking for MDS assessments; behavioral health records; medication orders and administration records; and other associated information that could support residents’ schizophrenia diagnoses.

“Approximately half of the facilities that have been contacted have attested to having erroneous schizophrenia diagnoses and committed to correcting their information,” CMS said Thursday. “For the remaining facilities that have been audited and have had erroneous schizophrenia diagnoses, we have generally found an absence of comprehensive psychiatric evaluations, medical evaluations, and behavioral documentation to support a diagnosis of schizophrenia, following professional standards of practice of the DSM-5-TR [Diagnostic and Statistical Manual of Mental Disorders].”

Facilities that fail an audit have their star rating reduced for six months and are required to correct the issues identified.

Advice for targeted operators

“A lot of providers that opted to do the audit did not do well; they ended up with the penalty,” said Alicia Cantinieri, senior vice president of Clinical Policy and Education for Zimmet. “But a lot of facilities did opt not to go through with the audit. They had to provide a corrective action plan and now CMS is coming back around to those people and they are being audited now to see if they’re corrective action plan was effective. You cannot opt out of that one.”

CMS provided specific attestation language that required providers to say they had misdiagnosed schizophrenia on their MDS. There was no ability to explain a higher-than-expected rate due to, for instance, a patient population with extensive behavioral health needs whose charts would indeed support those diagnoses and related antipsychotic prescribing.

“If you thought you were perfect and you did not have any of the problems with the diagnosis of schizophrenia on your MDS, then your only option was to go through the audit and prove it,” added Melanie Tribe-Scott, Zimmet’s vice president of quality and regulatory compliance.

The number one reason for audit failure, added Tribe-Scott, was a lack of documentation for six months worth of symptoms and behaviors like delusions or hallucinations before a new diagnosis of schizophrenia in the MDS. Those diagnoses of nursing homes residents that happened after admission also drew added CMS attention.

History of schizophrenia complicates 

But more broadly, providers have often noted that patients come to them with existing, possibly decades-old diagnoses that they are unable to substantiate with recent paperwork. Those patients can still be included in the current audit process.

“That’s the most difficult part of this audit: Facilities are really struggling to obtain those medical records from the community, of course, because they’re psychiatric records,” said Tribe-Scott. In other cases, there may be no information about who made the initial diagnosis or when.

It’s incumbent upon providers to follow the care delivery process and investigate any standing psychiatric diagnosis, said Steven Levenson, MD, who served as a nursing home medical director and conducted chart reviews for 43 years.

“Figuring out what’s wrong with a person and trying to validate the information you receive and then matching the symptoms they show to the criteria for a given diagnosis,” Levenson said. “That’s the only way to do this. But just about everybody skips key steps in the care delivery process, even though it was written into the RAI manual in 2010.”

The sequential process there allows the interdisciplinary team to capture any needed information in a patient’s medical record, rather than just a diagnosis in the MDS. That process could offer cover for nursing homes making correct diagnoses, and force others to choose more accurate codes.

Talking out both sides of the mouth

But Levenson, recently tapped to serve on a technical expert panel (TEP) charged with helping to refine CMS antipsychotic medication measures, said CMS and its contractors appear focused on further reducing the drugs’ use — even in cases where it may be appropriate and helpful to patients.

“CMS acknowledges, in very general terms, that there are more uses for antipsychotics, but they never give examples. They never give details because they’re under intense political pressure to do nothing to make antipsychotics look good,” Levenson said. 

“I think there’s a lot of consumer and political extrapolation from the facts to jump to the conclusion that there is this widespread cheating problem. I would say I’ve seen it happen, but it’s certainly not the sole explanation and maybe not even the principal explanation.”

The expert panel was convened in February 2023 to discuss concerns about and possible changes to the measure. Its findings weren’t published by CMS until September.

Advocates just want CMS to “get rid of the drugs,” Levenson said, which was the reason for the expert panel exploring different mathematical ways of calculating the measures using new data sets. It also queried members, including pharmacists, about adding other drugs to the antipsychotics list.

But Levenson said a measure that somehow took into account “appropriate” use could be more effective for consumers, given that more nursing home residents today have behavioral health diagnoses for which an antipsychotic may be appropriate, if not formally FDA-approved.

“Approved doesn’t necessarily mean appropriate, and not approved doesn’t necessarily mean not appropriate,” Levenson told McKnight’s. “So here’s how they talk out of both sides of their mouth: On the one hand they say and they write in very vague general terms in the state operations manual, ‘We know there’s other legitimate uses and you don’t have to be afraid to use it for legitimate uses.’ …  On the other hand, they say, ‘We’re going to count everything against your numbers and your quality measures are going to suffer the more you use them.’ ”

New meds, new questions about proper use

The number of antipsychotic drugs with indications for non-schizophrenia related conditions is also growing, offering a new pathway to treat behaviors associated with Alzheimer’s and other diseases.

“People living with Alzheimer’s-related agitation are four times more likely to be institutionalized. Families spend roughly three times more in medical costs per year and are much more likely to have a reduced income. Caring for a patient suffering from agitation can require an additional 20 hours of work per week,” Chad Worz, executive director of the American Society of Consultant Pharmacists and another TEP member, wrote in a recent guest column for McKnight’s.

“Fortunately, there are more tools at their disposal today to treat these dangerous symptoms, including one new FDA-approved therapy and more in development,” he added. “However, patients and providers face extensive barriers accessing these FDA-approved or indicated treatments because the Center for Medicare & Medicaid Services wants a blanket reduction in the use of antipsychotic treatments.”

Levenson said the agency’s focus on driving down use, regardless of indicated need, leaves providers grappling with an impossible choice of doing the right thing by patients whose doctors indicate they need medications or taking a possible hit on their quality rating. 

There’s no clear timeline for adoption of a refined antipsychotic measure or any specifics on how audit findings might be used to inform that.

But at the conclusion of the TEP report, CMS contractor Acumen said it planned to conduct further analyses to understand antipsychotic use and schizophrenia diagnosis reporting. It also said it wants to refine the antipsychotic medication list and schizophrenia ICD-10 codes, as well as explore including Medicaid and Medicare Advantage data in the antipsychotic medication measure re-specification.