CMS Mega-Rule Phase 2: What to Expect From Your Pharmacist

by Flora Bessey, PharmD, BCGP

As many of you already know, on November 24th CMS put a moratorium on civil monetary penalties associated with Phase 2 implementation of some of the new Requirements of Participation for nursing homes.

Good news, right? Not so fast…There is still a real possibility of deficiencies and citations during the survey process, even with this moratorium. The main result of this moratorium is that the harshest penalties (i.e. withholding of payment and decertification) has been put on hold.

Returning to the main topic: What can you expect from your consultant pharmacist and your pharmacy at this point?

One question to consider: who does med pass training at your facility? Who communicates the expectations and particulars of the new rules, and how is the nursing staff trained? Is it your Quality Assurance (QA) nurse? Your Director of Staff Development (DSD)? Your consultant nurse or consultant pharmacist? Whoever is tasked with this duty needs to be well-versed on the particulars. For example, for administration of crushed meds, the rule now is that each separate medication must be crushed and administered individually. Yes, this is a huge burden on the med pass nurse, and an enormous additional investment of time, and it makes no sense physiologically--but that is our reality.

Having acknowledged this reality, we must search out ways to increase our efficiency that will not run us afoul of CMS and CDPH. One of the quickest ways to save time is to minimize or (better yet) eliminate sliding scale/“rescue” dose finger sticks in your Type II diabetes patients. In many facilities, these finger sticks are four or five times a day; not even counting the time to administer the insulin, this is a huge time suck. Proper management of Type II diabetes (i.e., implementing a treatment plan that takes advantage of any and all interventions, pharmacologic and non-pharmacologic) can immediately lower the need for such frequent glucose checks. Many of the newer medications are now covered in our setting, and some offer once weekly dosing, versus a sliding scale insulin that may need to be injected multiple times a day, or an oral medicine that may need to be crushed and administered multiple times per day.  The attending physician may need a push to reduce the frequency of blood sugar monitoring, but in residents with good control, there is no medical reason to do finger sticks so often.  Consider asking the medical director to get involved if some physicians insist on continuing frequent monitoring for well-controlled diabetics. 

Also part of Phase 2 is that your consultant pharmacist now needs to review the ENTIRE chart. This makes sense, as performing a comprehensive medication review would necessitate examining the whole chart. Historically, the consultants review a “paper chart,” where the previous month’s MAR (medication administration record) is filed in the chart, but the current MAR is on the med cart. If the consultants need to consult the current MAR, they need to track it down on the cart. With EMR (electronic medical records) this extra step is eliminated.

If your facility has not made a full transition to EMR, why not? For some reason, many facilities have been slow to fully implement this requirement. In our facilities, space at the nursing station is at a premium. If the consultant needs to have access to a paper chart AND EMR, he/she will often have to find a place away from the nursing station to set up for online access, then lug charts back and forth as the review is completed. This will result in two possible outcomes: 1.) The consultant will take much longer to review the charts, and the building will incur the cost, or,  2.) The consultant will cut corners, you will be out of compliance with Phase 2, and your residents may be harmed.

The next requirement requires that a pharmacist be involved in your facility’s antibiotic stewardship activities. Here’s a scenario: a resident is prescribed an antibiotic. The order is sent to the pharmacy, and the dispensing pharmacist at the minimum will check drug interactions and drug allergies. They may or may not check for a stop date, but in my experience they are not verifying the appropriateness of therapy based on the labs. So, the question is: how is your pharmacist (consultant or dispensing) involved in your stewardship program? In a perfect world, every facility is on EMR, and the pharmacist (consulting or dispensing) has access to the entire chart. This means the pharmacist can review for the appropriateness of antibiotic prescribing. Change of condition and short-stay reviews are something that has been neglected, even though it has been a requirement since 2006 (and this requirement was reinforced in Phase 1).

Finally, the most challenging of the Phase 2 requirements is PRN psychotropic medication usage. CMS has specifically described a psychotropic medication as anything affecting mood or behavior, including sleep. Any psychotropic medication other than an antipsychotic has a 14-day reevaluation period, at which point the prescriber has to specify the benefits of continued PRN use. Once the prescriber sees the resident and documents the necessity, the medication order may be extended to a longer duration that should be specified, along with the justification, in the progress notes.  This would apply to hypnotics such as melatonin, zolpidem, trazodone, temazepam, and others. As-needed anxiolytics are also in the same category. For example, PRN lorazepam prescribed for agitation or anxiety it would be considered a psychotropic medication, BUT if prescribed for seizures it would not. Similarly, diazepam when given for muscle spasms would not be in this category, but if given for anxiety, it would be. Antipsychotics are not generally recommended to be given PRN, and this is a longstanding admonition in nursing homes. Often, prescribers will give an antipsychotic PRN to establish a baseline dose, or when treating terminal delirium. Per Phase 2, if the prescriber wants to administer the antipsychotic PRN, they have to reassess the patient face-to-face every 14 days to document risks and benefits, and this reassessment must include a physical examination.

To summarize, the Phase 2 Mega-Rule is still something that should be a focus of our practices from this point forward. As you can see, it is quite cumbersome, and will require a fair amount of teamwork to properly implement. Your consultant pharmacist is a resource that can be used to help shepherd your facilities through this transitional period. Take advantage of our experience and expertise!