Worries over federal audits designed to monitor nursing homes for inappropriate schizophrenia diagnosing continued to mount as some providers learned they had “failed” their check-ups months into the new initiative.

The off-site investigations, being conducted by audit firm Myers & Stauffer on behalf of the Centers for Medicare & Medicaid Services, also have renewed questions about the broader program, which was designed to limit nursing homes’ use of antipsychotic medications.

CMS has been tracking use of antipsychotics as a quality measure since 2012. In that time, the agency has consistently excluded three conditions from required antipsychotic reporting, viewing them as valid reasons to prescribe such drugs. Those three conditions are schizophrenia, Huntington’s disease and Tourette syndrome.

But in that same period, the Food and Drug and Administration has approved antipsychotics for additional conditions that can be common among nursing home patients. Nursing homes also have taken on more patients with severe behavioral health needs for whom antipsychotic drugs are often deemed appropriate.

That leaves some quality experts questioning why the agency hasn’t reviewed the quality measure in light of those factors. Without fresh standards, they said, providers using antipsychotics for reasons other than those initially exempted may appear to be less responsible to consumers or face additional regulatory scrutiny.

“The Physician’s Desk Reference actually shows indications for using antipsychotics for bipolar disease I and II, neurocognitive symptoms associated with borderline personality disorder, Lewy body neuropsychotic symptoms. We even have Nuplazid, which was approved by the FDA in 2016 specifically for the treatment of Parkinson’s psychosis,” said Melanie Tribe-Scott, BSN, vice president of Quality Initiatives at Zimmet Healthcare Services Group. 

“I know if my loved one needed an antipsychotic in the community and then they were to be placed in a long-term care facility, my concern is that that facility might try to take them off that medication to avoid this quality measure,” she added.

CMS policy conflict?

Tribe-Scott has clients working with a high proportion of special needs patients, and they haven’t been able to drive their antipsychotic use below the national average. They were placed years ago in a special program for “late adopters” and have never been able to get off that list. They could face civil monetary penalties for any kind of Immediate Jeopardy offense or, ultimately, denial of payments for new admits.

That may represent a policy conflict as CMS continues its pressure on prescribing reductions and simultaneously pushes nursing homes to take more residents with severe behavioral health needs.

In March, Tribe-Scott said an agency official told her it is removing late adopters notations from the Five-Star ratings system within weeks, though the agency has not made that information widely known. She estimates about 1,500 providers have been placed in the program over the years.

That could be reason to think that CMS is reconsidering its broad view of antipsychotic usage. The agency also recently convened a group of experts to look at the antipsychotic quality measure. An agency spokeswoman on March 23 confirmed a panel had met on that topic but declined to give more details about the scope of the panel’s tasks or its makeup.

“The Refinement of the Nursing Home Antipsychotic Medication Measures Technical Expert Panel (TEP) convened at the end of February, and the final TEP report is not yet available. We anticipate the report becoming available soon,” an agency representative told McKnight’s.

No new information had been posted on the TEP page by publication deadline.

Tough choices on antipsychotics

Being torn between taking patients off needed meds or being penalized for choosing another diagnosis that would be excluded “is kind of where this whole issue is coming from now,” said Alicia Cantinieri, vice president of MDS policy and education for Zimmet Healthcare Services Group.

The “whole issue” now is the schizophrenia audit program that CMS launched in January. A four-page memo announcing the initiative was met with consternation and concern about a narrow scope that focuses only on nursing homes.

“Granted, we want to make sure that schizophrenia diagnoses are done appropriately and done the way they need to be done. Absolutely. But we also have to make sure that we’re involving the medical professions and the primary care providers or the physician extenders that are making these decisions in that [audit] process,” said Lisa Thomson, chief operating officer of Pathway Health.

“That’s the question the industry is looking at: You can do external audits based on the MDS data, but what other data are you looking at, and what other information are you gathering before you’re making these decisions?” 

CMS told McKnight’s that it might request MDS assessments, behavioral health records, medication orders and administration records and other information during audits.

Whatever CMS asks for, the implications could be major for providers found in violation: The agency will drop overall and long-stay quality measure ratings to 1 star for six months, an adjustment that also will drop a facility’s overall rating by one star. The policy also will suppress two other measures for six to 12 months.

Why they’re worried

“If they do this audit and they feel that the documentation is not sufficient with what they receive even in that off-site audit, that they would change somebody’s Five-Star rating to 1 star,” said Rob Leffler, RPh, vice president of clinical services for Kentucky-based Synchrony Pharmacy. “We’ve not seen them adjust star ratings like that before based on one factor.”

For well-intentioned providers, he said, this should be a fairly routine opportunity to examine and refresh policies. He acknowledges that some facilities hyper-focused on quality measures may have overused schizophrenia codes, though he said he has not seen it among his clients.

But Leffler, like others interviewed for this article, pointed out a long-standing issue of incomplete admission documentation for skilled nursing residents. Many patients might have been prescribed an antipsychotic to control dementia-related behaviors during a preceding hospital stay or as a method to keep them calm or help them sleep and enable them to stay in their home longer.

“Is it happening at the hospital? Is it happening at the admission point? Is it happening when they’re somewhere down the road at the facility?” he asked.

Other patients may have been accurately diagnosed years ago and continue to be treated with an antipsychotic. If that diagnosis isn’t on a chart at admission but is later added due to investigation by facility staff, CMS shouldn’t necessarily discount the diagnosis, Leffler said.

Tribe-Scott and Cantinieri noted that some requests for documentation have gone back as far as 2014 and asked for information on patients released long ago or even deceased. At this point, the effort has led some observers to believe regulators are concentrating on the wrong concern.

“They’re focusing on the diagnosis of schizophrenia rather than who’s getting an antipsychotic,” Cantinieri said. “It would help if CMS really looked at the exclusions because there are other approved uses for these medications and also zero in on the gradual dose reductions to make sure that the residents are on the lowest effective dose that they need.”

Experts said CMS should consider how the narrow confines of three excluded diagnoses have boxed providers in. They want a measure that more accurately reflects the changing needs of today’s nursing home population.

“I don’t think anybody would condone misdiagnosing or including a diagnosis on the MDS that there isn’t medical back-up for,” Tribe-Scott said, “but you can see how you’re damned if you do or you’re damned if you don’t.”

Two concerns coming into clearer focus are how many providers ultimately could be hit by the audits and how many unsupported diagnoses it might take to draw a penalty.

Colleen Toebe, MSN, director of consulting services for Pathway, said the early requests she’d seen had been based on tracking a single patient’s post-admission schizophrenia diagnosis.

Cantinieri said she’d heard from multiple clients who were verbally told they’d failed the audit based on a single unsupported diagnosis.

“They have every intention to find every situation where schizophrenia was used as a way to reduce the possibility of gradual dose reductions being necessary or don’t have proper clinical support for that,” Sara Deiter, vice president of consulting service for Health Dimensions Group, said on a webinar mapping major regulatory changes for 2023.

“It’s something to use with real care, to make sure you don’t put yourself in a position where you’re going to wind up being cited for inaccuracy of your assessment and potentially have fines associated with using that diagnosis incorrectly.”