Emergency physicians and nurses want the federal Centers for Medicare and Medicaid Services to exempt emergency departments from new rules it issued this past December that would make it difficult and sometimes impossible to use propofol for procedural sedation.
“They are trying to craft a policy to handle all situations in the hospital,” said Angela Gardner, MD, the president of the American College of Emergency Physicians. “The emergency department is different from every other situation. We have a physician present 24/7, and we are trained in airway management.”
While no one wants untrained personnel to administer the drug, emergency physicians and emergency nurses alike maintain that it is an important tool when a patient needs a procedure quickly. “A lot of emergency physicians feel that propofol is the best drug to use for sedation because it is safe, [has] rapid onset, and wears off rapidly,” said Howard Blumstein, MD, the president of the American Academy of Emergency Medicine. ACEP, AAEM, and the Emergency Nurses Association met with leaders of CMS by conference call to seek an exception for emergency medicine.
In a revised interpretation dated Dec. 11, 2009, CMS placed the use of propofol in a category called “monitored anesthesia care,” classifying it under “deep sedation/analgesia” that requires patient monitoring by an anesthesia professional. (http://bit.ly/CMSpropofol.) The new interpretation states:
“The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained. 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).” (Read CMS 42 CFR 482.52(a) at http://bit.ly/Anesthesia.)
CMS officials and media relations personnel did not respond to requests to discuss the advisory.
Dr. Blumstein said the conference call, in which the emergency professionals defended propofol use in the emergency department, ended on a positive note. In the meantime, however, he said he fears patients will suffer. “My concern is that right now hospitals all over the country will make radical changes to their conscious sedation rules, and CMS may put out a change to the advisory, but by then it will be hard to go back. I hope emergency physicians can tell their hospitals to wait a couple of months to take any drastic action. Then we can see what the new guideline is going to be.”
He said he worries that a decision requiring one physician to administer the drug while another physician performs a procedure would hamper small emergency departments with single coverage. “A lot of emergency departments have only one physician in the emergency department. That means you either have to try to get the anesthesiologist to come into the emergency department, which will be very difficult, or the patient is going to have a long wait until a second physician comes in. They could be waiting hours with a dislocated shoulder, which hurts a great deal,” Dr. Blumstein.
“My feeling is that a nurse can give the drug and monitor the patient's vital signs closely, and let the physician know if the vital signs become abnormal. The physician then stops the procedure, and does what needs to be done to assist the patient,” he said.
Diane Gurney, RN, MS, CEN, the president of the Emergency Nurses Association, said emergency nurses receive special training to monitor patients undergoing procedural sedation. “That includes moderate sedation, and more specifically, propofol. Our patients have a right to sedation to manage pain and anxiety while undergoing procedures that they need immediately,” she said. “ENA does believe that it's important that individual institutions ensure that all individuals who perform sedation are trained, and we encourage hospitals to develop policies to ensure credentialing of nurses in this area. My own experience is that we have two nurses in the room — one to help with the procedure and one to monitor the airway and deliver the procedural sedation.”
A consensus statement signed by ENA, AAEM, ACEP, and five other groups in 2008 encourages hospitals to set their own credentialing rules. (http://bit.ly/ProcedSedation.)
Dr. Blumstein said he thought the CMS officials were receptive. “They said that these are things they had not considered. We provided them with published articles about propofol and safety. They told us other physicians had concerns as well, and they indicated they would go back and reconsider their advisory.”
He said the new advisory may have resulted from bad outcomes outside the emergency department, but that the emergency department is different. “Dealing with airways and sedating patients, that's our bread and butter,” he said.
Dr. Gardner warned that the advisory changes medical practice and adds cost. “My job is to take care of emergency patients. We do not have anesthesia available 24/7 to come to the emergency department to reduce a shoulder. Time is important in these cases, and delay could end up with the patient going to the operating room. It can cause more complications and a more serious outcome.”
Propofol gained notoriety when it was implicated in the June 24, 2009, death of rock star Michael Jackson, but that case was different from how it is used in the ED. “I think they need to look at the issue,” said Dr. Gardner, adding that CMS seems to want their regulations to drive all anesthesia in the hospital under the control of a department of anesthesia. She wondered whether that applied even to analgesia used when a physician sews up a laceration. “They need to be careful about the regulations,” she said. “It is one thing for anesthesia to be responsible for credentials. But for the anesthesiologist to be present for a simple laceration to be sewn up? That would add millions of dollars to health care costs unnecessarily, and there are not enough anesthesiologists to do that.”
Ms. Gurney agreed. “We want to make sure that all our patients in all our emergency care settings receive the quality of care that they have a right to,” she said.
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At Press Time
Although CMS is still receiving and reviewing comments about the anesthesia guidelines, it released an updated memo Feb. 5 that took effect March 7. The document includes possible revisions and outlines the issues being considered, said CMS Media Affairs Deputy Director Peter Ashkenaz. Read it at http://bit.ly/CMSanesthesia.