Last spring the Centers for Medicare & Medicaid Services (CMS) published a ruling which threatened to take deep sedation medications like propofol out of the hands of emergency physicians. This January, after months of negotations involving ACEP, AAEM and ENA, CMS offered a clarification that is a clear win for emergency medicine. Specifically, CMS has stated that, “[emergency medicine-trained physicians] are uniquely qualified to provide all levels of analgesia/sedation and anesthesia (moderate to deep to general).”
The problem surfaced last March when CMS clarified the Revised Hospital Anesthesia Services Interpretive Guidelines. Among other things, the clarification mandated that “All services along the continuum of anesthesia services provided in a hospital must be organized under a single Anesthesia Service.” Most hospitals have delegated this responsibility to the department of anesthesiology. Thus, if the climate at a given institution is such that anesthesiology understands the unique environment we function in and is supportive of emergency medicine, a cooperative relationship could exist, while constructing a plan to comply with the new regulatory requirements. However, if the department of anesthesiology is either disinterested and disengaged or not supportive of the emergency department, compliance can be a tool to restrict the practice of emergency physicians, inappropriately disallowing the use of certain anesthetic medications, at their discretion, in the emergency department. This, in effect, threatened to send procedural sedation for ED patients back to the 1980s and 1990s. If you like Madonna, massive cell phones, Versed, Fentanyl and morphine, you might get nostalgic. Unfortunately, our patients would lose the benefits we’ve gained from the advancement of ED procedural sedation over the past two decades.
The clarification, at least for the ED, primarily impacted deep sedation, and propofol was cited as illustrative of the need for clarification. The package insert was revisited and noted by CMS to be restricted by the FDA for the induction and maintenance of general anesthesia, the sedation of intubated, mechanically ventilated patients and for monitored anesthesia care (MAC) analogous to deep sedation. Thus, without deep sedation privileges allowed by the department of anesthesiology, this medication could only be used on intubated patients in the ED.
While these new regulations were well-intentioned, they ignored the fact that no patient safety or quality concerns have been identified regarding the administration of procedural sedation in the ED. In fact, the literature refutes such assertions, confirming the safety of procedural sedation in the ED with a variety of agents, including propofol. These misguided attempts to improve patient safety have resulted in several profound and over-broad misinterpretations: Inability for RNs to push the anesthetic agents, disallowing the same physician who performs the procedure to provide the procedural sedation and removal of propofol from the ED formulary altogether.
The term “administration of anesthesia” resulted in a fair amount of confusion. If this phrase were intended to refer to “pushing” a medication, then RNs would not be allowed to do so. However, it is equally reasonable to interpret this to mean administration of the process of procedural sedation. Pushing the plunger on the syringe is merely a support function that can be performed with direct supervision of the qualified provider (i.e. the emergency physician). The initial clarification did not address the issue of single-physician procedural sedation. However, some hospitals have required a second physician to provide the procedural sedation. Finally, some hospitals have simply removed propofol from the ED altogether, effectively disallowing its use even for intubated patients being mechanically ventilated.
Given these potential problems, in May, 2010, ACEP, accompanied by AAEM and ENA, led discussions with CMS asking for clarification of the ruling and exemption for emergency medicine. The interaction was instrumental in illustrating to CMS officials how the emergency department and emergency physicians differ from other patient care areas and other providers administering procedural sedation. Through this interaction and through the use of supporting data, CMS was willing to review the February 2010 clarification and consider revisions.
This January, CMS released a clarification favorable to emergency medicine and our patients. Although an exemption wasn’t provided for EM, and the exemption for ED RNs “pushing the plunger” wasn’t provided, the clarification of the interpretative guidelines (IG) improves our situation substantially. In particular, CMS released a FAQ document which contains the language beneficial to our position. Although the interpretive guidelines have been revised in many areas, the following are the FAQs addressing the key changes impacting our specialty:
Q3: What is the appropriate training for a “sedation” nurse?
A3: Currently there is no Medicare definition of a “sedation nurse,” nor does there appear to be any uniformly accepted training for a sedation nurse. Some states specifically address RN-administered sedation in their professional licensure laws and regulations. It is possible that national organizations producing anesthesia guidelines may develop guidelines/recommendations in this area in the future.
Q4: Why is there a particular mention in the IG on the emergency department’s (ED’s) sedation policies?
A4: The ED is a unique environment where patients present on an unscheduled basis with often very complex problems that may require several emergent or urgent interventions to proceed simultaneously to prevent further morbidity or mortality. In addition, emergency medicine-trained physicians have very specific skill sets to manage airways and ventilation that is necessary to provide patient rescue. Therefore, these practitioners are uniquely qualified to provide all levels of analgesia/sedation and anesthesia (moderate to deep to general).
Q2: What nationally-recognized guidelines are available for hospitals to use to develop their policies concerning what is anesthesia and what is analgesia and which procedures need which? What does “nationally recognized guidelines” mean?
A2: CMS’ expectation is that such guidelines are issued by a national organization that has appropriate expertise and which has used consensus-setting process of professionals with appropriate expertise in developing its guidelines. We recognize that such organizations may not always fully agree with each other…
“CMS expects surveyors to verify that the hospital can identify appropriate guidelines that support its policies. A hospital could use multiple guidelines, for example, ACEP for sedation in the emergency department and ASA for anesthesia/sedation in surgical services, etc.”
In summary, the variability of RN-administered sedation has been recognized, allowing for state regulation or professional societies to set the standard. EPs have been recognized as uniquely qualified to provide all levels of analgesia/sedation and anesthesia, and finally, the ACEP ED sedation guidelines have specifically been cited as appropriate for use in establishing hospital policy for the administration of anesthesia, analgesia and sedation. We owe ACEP, AAEM and ENA a congratulatory thank you for a job well done.