By Michael Wong, JD
New guidance from the Centers for Medicare & Medicaid Services (CMS) recommends monitoring of patients receiving opioids.
In its guidance, “Requirements for Hospital Medication Administration, Particularly Intravenous (IV) Medications and Post-Operative Care of Patients Receiving IV Opioids,” CMS explains the reason behind the issue for this guidance:
Each year, serious adverse events, including fatalities, associated with the use of IV opioid medications occur in hospitals. Opioid-induced respiratory depression has resulted in patient deaths that might have been prevented with appropriate risk assessment for adverse events as well as frequent monitoring of the patient’s respiration rate, oxygen and sedation levels. Hospital patients on IV opioids may be placed in units where vital signs and other monitoring typically is not performed as frequently as in post-anesthesia recovery or intensive care units, increasing the risk that patients may develop respiratory compromise that is not immediately recognized and treated. [page 2]
This guidance recommends “at a minimum” [page 19] that hospitals “have adequate provisions for immediate post-operative care, to emphasize the need for post-operative monitoring of patients receiving IV opioid medications, regardless of where they are in the hospital.” [page 1]
Clinicians and hospital executives trying to understand this new guidance may wonder what CMS means by “monitoring.” Does it mean intermittent monitoring?
Last year, CMS proposed a quality measure that many health experts think did not go far enough in protecting patients. That proposed quality measure (#3040) provided that monitoring needs to be “documented” and the time between documentation must “not exceed 2.5 hours.” This meant that a nurse or other caregiver must document the patient’s condition and do this in intervals not greater than 2.5 hours.
These health experts had criticized last year’s CMS proposed quality measure #3040, as it went against the recommendations of The Joint Commission, the Anesthesia Patient Safety Foundation, Institute for Safe Medication Practices (ISMP), and the Pennsylvania Patient Safety Authority. As Matthew Grissinger (director, error reporting programs at ISMP) said about the measure:
The CMS proposed quality measure regarding patient-controlled analgesia deals with a critical patient safety issue that hospitals need to urgently address. Errors with PCA occur and, unfortunately, sometimes with tragic consequences. However, for patients to be safe, we would strongly recommend that the proposed measure to monitor patients using PCA include continuously electronically monitoring them with oximetry for oxygenation and capnography for adequacy of ventilation. In addition, standardization of PCA procedures would greatly reduce PCA errors and adverse events.
In a report submitted to the United States Department of Health and Human Services, the National Quality Forum did not endorse the measure, stating that the measure “requires modification or further development”.
Does the CMS guidance provide for that modification or further development?
In the guidance, CMS says,
In addition to vigilant nursing assessment at appropriate intervals, hospitals may choose to use technology to support effective monitoring of patients’ respiratory rate and oxygen levels.
The guidance then goes on to cite as examples recommendations from the Institute for Safe Medication Practices (ISMP) and the Anesthesia Patient Safety Foundation (APSF), including mention of a recent video by the APSF. The video by the APSF calls for a paradigm shift in opioid safety. Robert Stoelting, MD (president of the Anesthesia Patient Safety Foundation) describes the video:
It’s time for a change in how we monitor postoperative patients receiving opioids. We need a complete paradigm shift in how we approach safer care for postoperative patients receiving opioids.
So, what does this mean for hospital practice?
The CMS guidance seems to be a modification and further development of the proposed quality measure #3040 – a signal that CMS is perhaps moving towards a future quality measure calling for continuous electronic monitoring of patients receiving opioids. If so, because of the time, expense, and training involved in implementing technology, hospitals should take heed and prepare themselves for being so measured.
Michael Wong is executive director of the Physician-Patient Alliance for Health & Safety and may be contacted at firstname.lastname@example.org.