Sedation by Non-Anesthesia Providers in ASCs: Is It Appropriate?
Anesthesia services have spread far beyond the operating room over the past several decades. The demand for sedation and analgesia has gone up dramatically, reflecting not just population growth but also an increasing variety of nonsurgical procedures requiring that patients be protected against pain or prevented from moving.
Meanwhile, the numbers of anesthesiologists, nurse anesthetists and anesthesiologist assistants have not kept pace. Leaving the OR for other floors or even buildings, where the anesthesia professional may have a single patient to care for, reduces his or her efficiency and costs the practice too much uncompensated time. Into the breach have stepped clinicians from other specialties and disciplines. This alert will focus on the role of registered nurses in procedural sedation, also known as "conscious" or "moderate" sedation.
The continuum of anesthesia: moderate and deep sedation
Granted that anesthesia is a continuum, agreeing on the definitions is nevertheless important. Disagreement on terminology, or at least on its implications, is at the center of the conflict over RN sedation between anesthesiologists and some emergency physicians, intensivists, radiologists, endoscopists, pediatricians and other specialists who see patients in the hospital. Physicians in most of these specialties believe that patients undergoing procedural/moderate/conscious sedation can be safely monitored by an RN, but that patients under deep sedation can not. The distinction comes from ASA's Statement on the Continuum of Depth of Sedation: Definition of General Anesthesia and Levels of Sedation/Analgesia, which provides that:
Moderate sedation/analgesia ("conscious sedation") is a drug-induced depression of consciousness during which patients respond purposefully** to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained.
* Monitored anesthesia care does not describe the continuum of depth of sedation, rather it describes "a specific anesthesia service in which an anesthesiologist has been requested to participate in the care of a patient undergoing a diagnostic or therapeutic procedure."
** Reflex withdrawal from a painful stimulus is not considered a purposeful response.
Deep sedation/analgesia is a drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully** following repeated or painful stimulation.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.
The key difference is that "no interventions are required to maintain a patent airway" in moderate sedation. If they are, then the sedation typically changes to "deep." The Statement on the Continuum provides further that:
Individuals administering moderate sedation/analgesia ("conscious sedation") should be able to rescue*** patients who enter a state of deep sedation/analgesia, while those administering deep sedation/analgesia should be able to rescue*** patients who enter a state of general anesthesia.
***Rescue of a patient from a deeper level of sedation than intended is an intervention by a practitioner proficient in airway management and advanced life support.The qualified practitioner corrects adverse physiologic consequences of the deeper-than-intended level of sedation (such as hypoventilation, hypoxia and hypotension) and returns the patient to the originally intended level of sedation. It is not appropriate to continue the procedure at an unintended level of sedation.
Because of this second principle, the requisite ability to rescue patients who move into a deeper level of sedation, the clinician who plans and initiates a state of deep sedation must be qualified to provide general anesthesia. That qualification is generally limited to anesthesiologists, CRNAs and AAs — never extended to RNs, and not to non-anesthesiologist physicians working in hospitals except in the rare instance where they are specifically credentialed to provide anesthesia.
The American Association of Moderate Sedation Nurses, founded in 2008 "to offer guidelines and resources for nurses who have had no additional training to give sedation with drugs they may not be familiar with," has issued the following position statement:
Title: Responsibilities of the registered nurse related to conscious sedation.
Definition: Conscious, moderate or procedural I.V. sedation provides a minimally reduced level of consciousness in which the patient retains the ability to independently and continuously maintain an airway and respond appropriately to physical stimulation or verbal command.
Position: AAMSN teaches the position that registered nurses trained and experienced in critical care, emergency and/or peri-anesthesia specialty areas may be given the responsibility of administration and maintenance of moderate or conscious sedation in the presence, and by the order, of a physician.The registered nurse has the knowledge and experience with medications used and skills to assess, interpret and intervene in the event of complications. This registered nurse is an asset to the physician and enhances the quality of care provided to the patient.
Because of the importance assigned to the task of monitoring the patient who is receiving conscious sedation, a second nurse or associate is required to assist the physician with those procedures that are complicated either by the severity of the patient's illness and/or the complex technical requirements associated with advanced diagnostic and therapeutic procedures.
The registered nurse will be knowledgeable and familiar with their institution's guidelines as well as the Joint Commission for Accreditation of Health Care Organizations, American Association of Nurse Anesthetists and the American Society of Anesthesiologists for patient monitoring, drug administration, and protocols for dealing with potential complications or emergency situations during and after sedation.
The AAMSN position could not be clearer that RNs' appropriate role is in the administration of moderate sedation, not deep sedation or anesthesia.
The popularity of propofol among both anesthesia and nonanesthesia providers means that many, many procedures are performed under deep sedation or general anesthesia by providers who are not trained and/or did not intend to go beyond moderate sedation, with monitoring by nonanesthetist RNs. Propofol is often the agent of choice because of lower cost, better efficiency and greater patient satisfaction. As Metzner and Domino noted in their article Risks of anesthesia or sedation outside the operating room: the role of the anesthesia care provider (Curr Opin Anaesthesiol 2010, 23:523–531),
there is an increasing trend among nonanesthesia providers (e.g. gastroenterologists, pediatricians, emergency medicine) to use potent sedatives/ hypnotics/analgesics (e.g. propofol, remifentanil) for sedation, drugs once consecrated to the domain of anesthesiology [references omitted]. As these drugs have a narrow therapeutic window with a rapid progression from moderate sedation to general anesthesia, there is a safety concern when they are administered by nonanesthesia providers.
The authors, who are principals in the ongoing ASA Closed Claims study, reviewed the Closed Claims database and determined that:
Claims arising from anesthesia care in out-of-operating room locations had a higher proportion of death and were primarily caused by an adverse respiratory event (44%). Monitored anesthesia care (MAC) was the leading anesthetic technique, accounting for 50% of out-of-operating room claims. Respiratory depression secondary to oversedation and polypharmacy (propofol combined with other sedatives/analgesics) accounted for over a third of claims.
Those statistics, however, did not address the comparative safety of moderate vs. deep sedation in the hands of anesthesia vs. nonanesthesia providers — a question for which the authors found no high-quality studies that would support any scientific answer. They share the widely-held belief, nonetheless, that "Although major adverse events are rare in this setting, potentially risky complications, such as respiratory depression and desaturation, still occur and their importance cannot be neglected."
That is the view of the ASA, whose Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists (Gross JB, Bailey PL, Connis RT, Cote CJ, Davis FG, Epstein BS, Gilbertson L, Nickinovich DG, Zerwas JM, Zuccaro G. Practice guidelines for sedation and analgesia by non-anesthesiologists—an updated report by the American Society of Anesthesiologists task force on sedation and analgesia by non-anesthesiologists. Anesthesiology 2002;96:1004–17) include the unequivocal recommendation: "Even if moderate sedation is intended, patients receiving propofol or methohexital by any route should receive care consistent with that required for deep sedation. Accordingly, practitioners administering these drugs should be qualified to rescue patients from any level of sedation, including general anesthesia." The Practice Guidelines for Sedation, first published in 1999 and revised in 2002, are still a seminal reference, as is ASA's Statement on Granting Privileges for Administration of Moderate Sedation to Practitioners Who Are Not Anesthesia Professionals. This year, ASA added a video that includes and is based on the Guidelines to its educational product lineup.
The Medicare Physician Fee Schedule (Medicare Part B) does not distinguish between physician specialties. In general, Medicare will pay any provider for a service that is within his or her scope of practice as determined by state law, and state scope of practice regulations do not limit the nature of the medical services according to specialty. If a physician is licensed, even without any training beyond the first postgraduate year, he or she can perform brain surgery surgery — or anesthesia for brain surgery — without violating the licensing rules, although of course to do so would violate common sense and basic notions of risk management.
The Part B regulations (42 CFR Section 482.52) set forth an exclusive list of clinicians who may bill Medicare for anesthesia services. These include all physicians and CRNAs and AAs (but not all RNs or allied health personnel). The provisions in Chapter 12, Section 50 of the Claims Manual, Payment for Anesthesiology Services refer to "physicians," "anesthesiologists" and "anesthesia practitioners" and appear to assume that the physicians providing the services will be anesthesiologists, but that is not dispositive.
On the other hand, the Hospital Conditions of Participation (CoPs, Medicare Part A) require hospitals to place all anesthesia and sedation services, wherever delivered, under the authority of a single anesthesia service. If a hospital wants to participate in Medicare, then it must adopt policies on credentialing the clinicians who will provide anesthesia and analgesia in accordance with national standards of practice, as discussed in the Interpretive Guidelines to the CoP regulations:
The regulation at 42 CFR 482.52(a) establishes the qualifications and, where applicable supervision requirements for personnel who administer anesthesia. However, hospital anesthesia services policies and procedures are expected to also address the minimum qualifications and supervision requirements for each category of practitioner who is permitted to provide analgesia services, particularly moderate sedation. This expectation is consistent not only with the requirement under this CoP to provide anesthesia services in a well-organized manner, but also with various provisions of the Medical Staff CoP at §482.22 and the Nursing Services CoP at §482.23 related to qualifications of personnel providing care to patients. Taken together, these regulations require the hospital to assure that any staff administering drugs for analgesia must be appropriately qualified, and that the drugs are administered in accordance with accepted standards of practice. Specifically:
The Medical Staff CoP at §482.22(c)(6) requires the medical staff bylaws, — Include criteria for determining the privileges to be granted to individual practitioners and a procedure for applying the criteria to individuals requesting privileges.
The Nursing Services CoP requires at:
§482.23(b)(5) that nursing personnel be assigned to provide care based on — the specialized qualifications and competence of the nursing staff available.
§482.23(c) that, — Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, …and accepted standards of practice. And
§482.23(c)(3) , — … If … intravenous medications are administered by personnel other than doctors of medicine or osteopathy, the personnel must have special training for this duty.
Although the Conditions of Participation may not explicitly require a hospital to credential anesthesiologists, CRNAs and AAs only to provide anesthesia care, medico-legal considerations do just that. It would be hard to refute the fact that nationally "accepted" standards of practice are to require anesthesia providers to have the appropriate certification by the American Board of Anesthesiology or the American Association of Nurse Anesthetists or the National Commission for Certification of Anesthesiologist Assistants. Most hospital administrators would be concerned about malpractice exposure if their physicians and nurses who were not certified in anesthesiology or anesthesia performed anesthesia services.
The American Gastroenterological Association has coined the term "gastroenterologist-directed propofol" but acknowledges, in its guideline on Sedation and analgesia in GI endoscopy, that "At this time, data and expert editorial opinions have accrued supporting the use of GD-P, including endorsement by gastroenterology specialty societal guidelines. U.S. courts and jurisdictions may or may not consider this this mass of opinions and guidelines supporting GD-P to be medicolegally reasonable or a respectable minority practice."
The AGA simply asserts the qualification of propofol-trained GI physicians and nurses to administer deep sedation using propofol and other hypnotic agents, based on the lack of studies demonstrating adverse outcomes.
The American College of Emergency Physicians has a different interpretation of the Conditions of Participation, however. ACEP's policy states that ""The Emergency Nurses Association and the American College of Emergency Physicians support the delivery of medications used for procedural sedation and analgesia by credentialed emergency nurses working under the direct supervision of an emergency physician. These agents include but are not limited to etomidate, propofol, ketamine, fentanyl, and midazolam." The Interpretive Guidelines to the CoPs emphasize local flexibility and in their accompanying Frequently Asked Question provide that "A hospital could use multiple guidelines, for example, ACEP for sedation in the emergency department and ASA for anesthesia/sedation in surgical services, etc." ACEP maintains that sedation with propofol — or with any other agent used by emergency physicians — is analgesia, not anesthesia or deep sedation, and that therefore:
When two or more physicians are readily available to the emergency department, we feel it is prudent to have both present during the sedation. However, because our procedures are brief and we are able to address any airway issues, when two physicians are not available, sedation can be performed initially by an emergency physician, and once stable sedation and adequate monitoring are established, the emergency nurse can monitor the patient while the physician performs the procedure
There is, then, disagreement between the ASA and several of the organizations representing other specialties as to who may provide anesthesia and deep sedation, particularly in connection with the use of propofol. There is no disagreement over the fact that providers must be credentialed, and that the hospital must adopt policies on anesthesia credentialing.
It is worth noting that although the interpretive guidelines to the CoPs encourage hospitals "to develop the anesthesia services policies in collaboration with other hospital disciplines, such as surgery, pharmacy, nursing, safety experts, etc. … These collaborative approaches are not, however, a regulatory requirement. A hospital may therefore allow the [anesthesia] director to develop the policies alone. However, as in all cases, the hospital’s governing body is ultimately responsible to assure that the policies adopted meet the regulatory requirements." (FAQ #5)
It is also worth noting that Medicare and Medicaid will allow payment for the anesthesia or sedation services of clinicians who are working within their state licensing laws scope of practice and who are appropriately credentialed. Private payers may apply their own, higher standards for credentialing, and many do. This is true whether the clinicians bill for their services directly, or whether they are employed by or have otherwise reassigned their billing rights to the hospital.
The question then becomes whether a non-anesthesiologist physician or a non-anesthetist RN can perform and be paid for sedation. The physician can bill for CPT® codes 99143-99145, "moderate sedation services (other than those described by codes 00100-01999) provided by the same physician performing the diagnostic or therapeutic service that the sedation supports." The payment for moderate sedation is just a fraction of the payment for anesthesia, however, so the 99143-99145 option is without much appeal.
The growing demand for anesthesia services throughout the hospital, and not just in the OR, combined with the relative advantages and perceived safety of propofol, has led to increasing numbers of cases where sedation is provided by non-anesthesiologist physicians and non-anesthetist RNs. In general, the standard of care remains to limit the use of propofol and other agents that one may expect to cause a greater depth of sedation than intended to anesthesia professionals. Accordingly, at least in hospitals that have not credentialed other professionals to provide anesthesia services whether denominated "anesthesia" or "analgesia" in local policies, only anesthesiologists, CRNAs and AAs can properly bill for such services.
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