As we approach the November 28, 2019 deadline to fully implement the Phase 3 changes in the “Mega Rule,” it is important to note that some of the “changes” that were implemented in Phase 2 are expected to change in Phase 3. Specifically, under Phase 2 rules, antipsychotics could not be prescribed PRN for more than 14 days unless a resident was examined by a prescriber (every 14 days). This was ostensibly to avoid the issue of off-label overprescribing of antipsychotics in our population, especially those suffering dementia-related psychosis (DRP) or other behavioral issues that could not be attributed to an Axis 1 diagnosis of a mental condition (i.e. bipolar disorder, schizophrenia, major depression, etc.). The rule as written mentioned a tendency to “place the convenience of the caregivers above the residents’ interests.”

There was a great deal of feedback on this rule and its implementation; many geriatricians recognized that this off-label use of antipsychotics had been an issue for many years, but felt constrained by this 14-day time frame. SNF staff members were in many cases very upset that this “tool” to treat behavior issues in a difficult population had been limited.

It appears that CMS has taken these concerns into consideration as the phase 3 rollout deadline approaches. Now, with input from various stakeholder groups, including psychiatric societies, who were concerned that the previous rule would constrain psychiatrists’ ability to treat various mental health and substance use disorders, CMS has allowed for antipsychotics to be treated the same as other psychotropic medications, which may be prescribed PRN (i.e. hypnotics, anxiolytics, benzodiazepines): there is to be a one-time mandatory “re-evaluation” of the need for continuation of a PRN order at the 14-day mark, but there is no need for a repeat face-to-face examination, and there is no longer a requirement to reevaluate every subsequent 14 days.

So, what to do with this information? It is important to note that in many (or even most) cases, the use of PRN antipsychotics is purely for a desired side effect (e.g. PRN quetiapine  (Seroquel) or olanzapine (Zyprexa) to promote somnolence to treat “difficulty sleeping,” or “agitation at bedtime” or “resistance to care”). The therapeutic effects of any antipsychotic are not generally seen with a PRN dose; that is why every study for every antipsychotic is conducted over weeks or months, not hours. Any resident with an Axis 1 diagnosis will typically be prescribed a scheduled dose of one of the many antipsychotics or antidepressants which are indicated to treat these diseases. For our residents who have not been diagnosed with these disease states, if it is determined that non-pharmacological interventions (redirection, light therapy, pet therapy, etc.) are not sufficient, there are more than enough (non-antipsychotic) psychotropic medications that are efficacious in addressing temporary behavior or other issues. And recent studies have suggested that the use of antipsychotics to treat delirium is not as effective as once believed. 

Of note, there is also a medication (pimavamserin [Nuplazid]) that is indicated for Parkinson’s-induced psychosis (PIP) and will likely soon be indicated for dementia-related psychosis (DRP).  Both of these disorders often lead to difficult-to-treat behavior issues. This will hopefully obviate the perceived need for off-label prescribing of other antipsychotics in these residents. It is hoped that other medicines may ultimately be studied and receive the FDA blessing to treat other behavioral issues, but ultimately the best medicine is the people who are the care-givers on the front lines. 

In conclusion, this change provides a bit more flexibility within our setting, but should not impact the high quality of care that should be the ultimate goal for all of us.

Edited 11/15/19