CMS has published proposed revisions to the Code of Federal Regulations (CFR) that are scheduled to be effective September 1, 2016. This is a proposed ruling with a final rule due out later this summer, taking into consideration the over 5,000 comments submitted to the Federal Register after the publication of the proposed rule. Conversations with CMS officials lead GrandView executive staff to believe that a delay in this quick implementation is unlikely; the current Presidential Administration wants to see key elements of the Affordable Care Act to be integrated into the CFR for nursing homes, and views this push as a high priority before the end of the Administration. These changes are a major shift in policy, especially with regards to how CMS defines psychotropic medications, most notably the addition of antidepressants and pain medications. They have also added a very broad “and any other drug that results in effects similar” as the final addition. Also, the codification of best practice for an IMRR at admission and transfers will require pharmacists to be actively involved in the admission, transfer and discharge process. While we expect some revisions to the proposed rule, when it is published in its final form, GrandView has already began proactive amendment to our current processes and procedures to better align our service offerings to the proposed rules related to pharmacy.

Drug Regimen Review:

2. This regimen must include a review of the resident’s medical chart – at least every 6 months and:
• New residents, that is the individual has not previously been a resident in that facility; or
• When the resident returns or is transferred from a hospital or other facility; and
• During each monthly drug regimen review when the resident has been prescribed or is taking a psychotropic drug, an antibiotic, or any drug the QAA Committee has requested be included in the pharmacist’s monthly drug review.

3. A psychotropic drug is any drug that affects brain activities associated with mental processes and behavior. These drugs include, but are not limited to, drugs in the following categories:
• Anti-psychotic;
• Anti-depressant;
• Anti-anxiety;
• Hypnotic;
• Opioid analgesic; and
• Any other drug that results in effects similar to the drugs listed

4. The pharmacist must report any irregularities to the attending physician, the facility’s medical director and director of nursing. These reports must be acted upon.
• Irregularities include, but are not limited to, any drug that meets the criteria set forth in paragraph (d) of this section for an unnecessary drug.
• Any irregularities noted by the pharmacist during this review must be documented on a separate, written report that is sent to the attending physician, the facility’s medical director and director of nursing and lists. At a minimum, the resident’s name, the relevant drug, and the irregularity the pharmacist identified.
• The attending physician must document in the resident’s medical record that the identified irregularity has been reviewed, and if any, action has been taken to address it. If there is to be no change in the medication, the attending physician should document his or her rationale in the resident’s medical record.
Unnecessary drugs:

• In excessive dose (including duplicate drug therapy); or
• For excessive duration; or
• Without adequate monitoring; or
• Without adequate indications for its use; or
• In the presence of adverse consequences which indicate the dose should be reduced or discontinued; or
• Any combinations of the reasons
Psychotropic drugs:

Based on a comprehensive assessment of a resident, the facility must ensure that-
• Residents who have not used psychotropic drugs are not given these drugs unless the medication is necessary to treat a specific condition as diagnosed and documented in the clinical record.
• Residents who use psychotropic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs;
• Residents do not receive psychotropic drugs pursuant to a PRN order unless that medication is necessary to treat a diagnosed specific condition that is documented in the clinical record; and
• PRN orders for psychotropic drugs are limited to 48 hours and cannot be continued beyond that time unless the resident’s physician or primary care provider documents the rationale for this continuation in the resident’s clinical record.
Medication errors:

The facility must ensure that its-
• Medication error rates are not five percent or greater
• Residents are free of any significant medication errors

Click here to view the PDF of the changes.