New CMS Rules on Psychotropic Medications in SNFs

A major concern for the Centers for Medicare & Medicaid Services (CMS) has been improving the quality of care for skilled nursing facility (SNF) residents, especially when it comes to restraints and what they consider inappropriate medications. Recently, due to concern of the overuse of psychotropic medications to manage agitation and other behavioral problems associated with dementia—which goes contrary to the US Food and Drug Administration black box warning—CMS has been propelled to expand oversight on their use. CMS has had several initiatives to decrease the use of antipsychotic medications including state survey application of unnecessary medication F-tags and quality measures specific to this effort, which have had success. But in an effort to decrease any medication that they consider a chemical restraint, CMS is looking to expand regulation in this area. As a result, effective November 28, 2017, CMS announced several regulatory changes for SNFs including an expanded definition of psychotropic medications and new limitations on the use of as-needed (PRN) psychotropic medications within SNFs.¹

The definition of a psychotropic medication now includes “any drug that affects brain activities associated with mental processes and behavior.”¹ These drugs include, but are not limited to, the following drug categories: antipsychotic, antidepressant, antianxiety, hypnotic, as well as medication classes that may affect brain activity. This expanded list of psychotropic medications includes central nervous system agents, mood stabilizers, anticonvulsants, muscle relaxants, anticholinergic medications, antihistamines, N-methyl-D-aspartate receptor modulators, and over-the-counter natural or herbal products.¹

For the expanded list of psychotropic medications, CMS has placed 14-day limits on their duration of use when prescribed with PRN orders. Extension of use beyond 14 days can occur if the prescribing practitioner: (a) believes it is appropriate to extend the order, (b) documents clinical rationale for the extension, and (c) includes a specific duration of use. As detailed as these rules are for psychotropic medications, the rules regarding PRN antipsychotics specifically are even more explicit.¹

For antipsychotics, a 14-day limitation is applied to all PRN orders; as a result, these orders may not be extended beyond the 14-day limit. To continue their use, a new order for the PRN antipsychotic may be written if the prescribing practitioner directly examines and assesses the resident and documents clinical rationale. This clinical rationale must include the benefit of the medication for that resident. This documentation is required every 14 days for a resident receiving a PRN antipsychotic without exception, including hospice patients.¹ As per section F757 in the Manual, the continued use of these medications is permitted as long as prescribers heed the following guidance:

"When a resident is experiencing an acute medical problem or psychiatric emergency (e.g., the resident’s expression or action poses an immediate risk to the resident or others), medications may be required, as delirium induced psychosis. As always, medications should only be initiated/used in the presence of active clinical symptoms and after nonpharmacological interventions and least restrictive measures have been attempted."¹

As a result of these expanded rules, many SNFs will likely try to discontinue orders for standing PRN antipsychotic medications. 

With all of these changes, it is important that SNFs utilize resources such as consultant pharmacists and medical and nursing directors to develop and implement a process to make sure patients have access to appropriate medications, especially those with less potential for adverse events. The Beers criteria can be used as a guide to assist with this selection process.

Further considerations on the process SNFs should follow can be gleaned from relevant, evidence-based studies as well as an examination of what has worked or not worked in the past. A survey of SNFs² revealed several interesting findings that could be used to improve the psychotropic management process. One finding was that a large number of SNFs had policies regarding informed consent for the use of antipsychotics, however, the rate of use of antipsychotics did not change in many facilities following the black box warning. In addition, having a signed-consent policy did not correlate with decreased antipsychotic use, use of alternate agents, or use of nonpharmacologic methods to address symptoms. With this survey, SNFs were able to see areas in which their current policies and strategies were not having the intended effect on improving patient care.

Balance in developing policies is required on all sides of this issue. The current, definitive push by CMS restricting the use of psychotropic medications seems to go against some of their own rulings and guidance of the past. For instance, CMS’s perception of problems with psychotropic use tracks back to the Omnibus Budget Reconciliation Act (OBRA) of 1987, which limited the use of psychotropic medications in residents of long-term care facilities. Later, updates to the OBRA guidelines liberalized some dosing restrictions, but documentation of necessity and periodic trials of medication withdrawal was required. 

This liberalization of psychotropic medications moved even further in 2006 under Medicare Part D pharmacy benefit. Under the Medicare prescription drug benefit, CMS required all Part D plans to include on their formularies “all or substantially all” drugs within six classes because of a perceived need to assure access.³ These medications included many that are now concerned psychotropic as a result of the expanded definition. The six protected classes are made up of antineoplastics, anticonvulsants, antiretrovirals, antipsychotics, antidepressants, and immunosuppressants. 

But then, due to the FDA warning on antipsychotic medications, CMS changed its position to limit the use of these medications through two SNF quality measures related to antipsychotic medications, which were posted on the Nursing Home Compare website for all SNFs beginning July 2012. These measures include an incidence measure that assesses the percentage of short-stay residents that are given an antipsychotic medication after admission to a nursing home and a prevalence measure that assesses the percentage of long-stay residents that are receiving an antipsychotic medication. Clearly a consistent strategy by CMS based on what is truly best for residents is needed.

Without a thoughtful strategy from all stakeholders on how best to conform to these new regulations, many residents may be denied treatments that they truly need because of fear of CMS survey requirements. Box 1 provides several steps that SNFs may want to take to ensure facility compliance with the new rules. Facilities would be well-served to establish processes and a plan going forward, not only to ensure compliance with these new rules but, more importantly, to ensure that SNF residents are receiving the care and treatments that they need. 

To read more articles in this issue, visit the 2017 November/December issue page

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Reference

1. Centers for Medicare & Medicaid Services (CMS). Revision to State Operations Manual (SOM) appendix PP for phase 2, F-tag revisions, and related issues, Section F757. CMS website. https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/GuidanceforLawsAndRegulations/Downloads/Advance-Appendix-PP-Including-Phase-2-.pdf. Accessed November 10, 2017.

2. Lester P, Kohen I, Stefanacci RG, Feuerman M. Antipsychotic drug use since the FDA black box warning: survey of nursing home policies. J Am Med Dir Assoc. 2011;12(8):573-577.

3. Centers for Medicare & Medicaid Services (CMS). Medicare prescription drug benefit manual, chapter 6. CMS website. https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/Part-D-Benefits-Manual-Chapter-6.pdf. Updated January 15, 2016. Accessed November 15, 2017.