On February 5th, 2010, the Department of Health & Human Services’
Centers for Medicare & Medicaid Services (CMS) issued a memo
entitled Revised Hospital Anesthesia Services Interpretive Guidelines.
The guidelines have stirred a lot of interest among emergency physicians
for their potential impact on the provision of procedural sedation,
specifically as the outlines pertain to the use of drugs such as
propofol. Coming on the heels of the overdose death of Michael Jackson
by the inappropriate use of propofol, some have speculated that this is a
knee-jerk reaction by an overzealous government agency. The guidelines,
however, could potentially have a far-reaching effect, that of
stripping emergency of the right to determine our scope of practice.
“One would ask whether this CMS ruling is in fact a violation of the
Joint Commission Guidelines for Specialty self determination,” says Dr.
Paul Sierzenski, Chairman of ACEP’s Committee on Government Policy &
Public Relations.
The guidelines are intended to be a clarification of regulation 482.52, which addresses “Hospital Anesthesia Service Requirements.” As defined by the guidelines, “Anesthesia services, which include both anesthesia and analgesia, are provided along a continuum, ranging from the application of local anesthetics for minor procedures to general anesthesia for patients who require loss of consciousness as well as control of vital body functions in order to tolerate invasive operative procedures. This continuum also includes minimal sedation, moderate sedation/analgesia (“conscious sedation”), monitored anesthesia care (MAC), and regional anesthesia.”
The guidelines go on to state that, “All services along the continuum of anesthesia services provided in a hospital must be organized under a single Anesthesia Service.” The impact of this guideline is to take the determination of how to use various anesthesia and analgesic agents out of the hands of the emergency physicians who use them on a daily basis. While no changes were made to the requirements governing moderate sedation, there were changes made to the provision of “anesthesia,” which includes general anesthesia, monitored anesthesia care (MAC), regional anesthesia and, unfortunately, deep sedation. To make the point clear, CMS revisited the package insert for propofol, declaring it as only indicated for general anesthesia, MAC (encompassing deep sedation per CMS) and for the sedation of the mechanically-ventilated patient. By doing so, propofol, used for procedural sedation, is now a drug that can only be administered by those with credentials to provide deep sedation or general anesthesia – many emergency physicians only possess privileges for moderate sedation. Dr. Charles Shufflebarger, a Medical Director and member of the Emergency Department Benchmark Alliance, reports that his department of anesthesia is supportive, sees the problematic issues with this clarification and is working cooperatively to manage this process to assist the EPs. Even if your anesthesia department head allows EPs to continue to use propofol for deep sedation, by providing a mechanism for credentialing, which he or she may not, many expect CMS to subsequently require a dedicated physician to perform the sedation, while another performs the procedure. For a single coverage physician, this would be next to impossible.
The guidelines go on to state that, “All services along the continuum of anesthesia services provided in a hospital must be organized under a single Anesthesia Service.” The impact of this guideline is to take the determination of how to use various anesthesia and analgesic agents out of the hands of the emergency physicians who use them on a daily basis. While no changes were made to the requirements governing moderate sedation, there were changes made to the provision of “anesthesia,” which includes general anesthesia, monitored anesthesia care (MAC), regional anesthesia and, unfortunately, deep sedation. To make the point clear, CMS revisited the package insert for propofol, declaring it as only indicated for general anesthesia, MAC (encompassing deep sedation per CMS) and for the sedation of the mechanically-ventilated patient. By doing so, propofol, used for procedural sedation, is now a drug that can only be administered by those with credentials to provide deep sedation or general anesthesia – many emergency physicians only possess privileges for moderate sedation. Dr. Charles Shufflebarger, a Medical Director and member of the Emergency Department Benchmark Alliance, reports that his department of anesthesia is supportive, sees the problematic issues with this clarification and is working cooperatively to manage this process to assist the EPs. Even if your anesthesia department head allows EPs to continue to use propofol for deep sedation, by providing a mechanism for credentialing, which he or she may not, many expect CMS to subsequently require a dedicated physician to perform the sedation, while another performs the procedure. For a single coverage physician, this would be next to impossible.
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Despite its impact on emergency medicine, the CMS guidelines seemed to have been aimed at another area of the hospital: endoscopy suites. One part of the guidelines reads as follows:
“An example of deep sedation would be a screening colonoscopy when there is a decision to use propofol, so as to decrease movement and improve visualization for this type of invasive procedure. Because of the potential for the inadvertent progression to general anesthesia in certain procedures, it is necessary that the administration of deep sedation/analgesia be delivered or supervised by a practitioner as specified in 42 CFR 482.52(a).”
EPs are happy to be counted among those that may administer deep sedation/analgesia, but are frustrated at being lumped in with many other “non-anesthesiologists” such as dentists and podiatrists. While no one contends that EPs are anesthesiologists, emergency medicine specialty training, from board certification to daily practice, does provide for knowledge and skill that others might not possess.
How each hospital will implement the guidelines is yet to be determined. But taking a wait-and-see attitude would appear to be a recipe for exclusion from the process. EPs need to consider approaching their hospital leadership – including the anesthesiology department – to drive this process. Some EPs will find their leadership completely supportive of the ED and collaboration with anesthesia an easy solution. Others will not.
From a credentialing perspective, EPs will be well advised to make certain that moderate sedation is accepted as part of their core privileges and attempt to include deep sedation in the same package. Failing that, EPs will need to develop a mechanism to apply for this procedure, even if that means swallowing a little pride and consenting to testing of your knowledge of anesthetic agents. In the short run, this may be a reasonable interim step. If you don’t have access to deep sedation, kiss propofol goodbye, except for mechanically ventilated patients.
EPs also need to develop plans for the safe delivery of deep sedative agents, such as propofol. This includes development of an appropriate “anesthesia record” to monitor quality, including the use of capnography on all patients receiving procedural sedation. A formal performance improvement program is required under these regulations. As EPs monitor quality, verifying their practice is safe, it will become increasingly difficult for anyone to justify blocking their access to such agents.
Although not specifically addressed in this CMS “clarification,” a logical interpretation of past guidelines is that the qualified provider will not be allowed to perform the procedure as well as provide the deep sedation. In double-covered departments, this will present no problem. However, single coverage EDs will struggle to meet this standard.
First used for post intubation sedation for those on mechanical ventilation and more recently for procedural sedation, propofol has done for deep sedation what etomidate accomplished for rapid-sequence intubation. These two medications have revolutionized the way we care for patients, making RSI easier and safer, and allowing us to address many painful procedures safely with predictable patient comfort. Many might wonder how they would function if either of these become unavailable.
Additionally reporting for this story by Mark Plaster, MD