Sedation and Anesthesia

The Centers for Medicare and Medicaid Services (CMS) broadly considers anesthesia services as including moderate and deep sedation. Sedation is routinely used during gastrointestinal endoscopic procedures and can be defined as a drug-induced depression in the level of consciousness. The level of sedation during gastrointestinal endoscopy should be titrated to achieve a safe, comfortable and technically successful endoscopic procedure. Levels of sedation range from minimal to moderate, and from deep to general anesthesia.

When endoscopic procedures are performed under moderate sedation, during moderate sedation, patients maintain their airways and are easily arousable to verbal or tactile stimulation. During deep sedation, a patient may still respond purposefully to repeated or painful stimulation but airway support may be required. During general anesthesia, patients are unarousable even with painful stimuli and often airway management is required. Sedation is a continuum. Since it is not always possible to predict how an individual patient will respond, providers administering minimal or moderate sedation should be able to support patients who enter a state of deep sedation (and those administering deep sedation should be able to support patients who enter a state of general anesthesia). Patients must be appropriately evaluated both prior to and after receiving sedation.¹

In general, standards address the qualifications of those administering sedation and anesthesia and the pre- and post-anesthesia assessment.

For more in-depth information regarding interpretative guidance and surveyor procedures, access the CMS State Operations Manual, Guidance for Surveyors: Ambulatory Surgical Centers (Appendix L).¹

1. §416.42(a)(1) Standard: Anesthetic Risk and Evaluation
   
   A physician must examine the patient immediately before surgery to evaluate the risk of anesthesia and of the procedure to be performed.
   
   
2. §416.42(a)(2) Standard: Anesthetic Risk and Evaluation
   
   Before discharge from the ASC, each patient must be evaluated by a physician or by an anesthetist as defined at §410.69(b) of this chapter, in accordance with applicable State health and safety laws, standards of practice, and ASC policy, for proper anesthesia recovery.
   
   

3. §416.42(b) - Standard: Administration of Anesthesia
   
   Anesthetics must be administered by only:

   (1)  A qualified anesthesiologist, or

   (2)  A physician qualified to administer anesthesia, a certified registered nurse anesthetist (CRNA) or an anesthesiologist’s assistant as defined in §410.69(b) of this chapter, or a supervised trainee in an approved educational program. In the cases in which a non-physician administers the anesthesia, unless exempted in accordance with paragraph (c) of this section, the anesthetist must be under the supervision of the operating physician, and in the case of an anesthesiologist’s assistant, under the supervision of an anesthesiologist.
   
   

4. §416.42(c) - Standard: State Exemption

   (1)  An ASC may be exempted from the requirement for physician supervision of CRNAs as described in paragraph (b)(2) of this section, if the State in which the ASC is located submits a letter to CMS signed by the Governor, following consultation with the State’s Boards of Medicine and Nursing, requesting exemption from physician supervision of CRNAs. The letter from the Governor must attest that he or she has consulted with State Boards of Medicine and Nursing about issues related to access to and the quality of anesthesia services in the State and has concluded that it is in the best interests of the State’s citizens to opt-out of the current physician supervision requirement and that the opt-out is consistent with State law.

   (2)  The request for exemption and recognition of State laws, and the withdrawal of the request may be submitted at any time and is effective upon submission.

1. A statement should be made citing the ASGE references as recommendations from a nationally recognized specialty society that were used in the development of this reference.

2. If other nationally recognized society guidelines are also being used to develop policies and procedures, it is important to review those policies and reconcile differences so that contradictory policies are not developed.

3. The Association of Operating Room Nurses (AORN) has specific policies requiring surgical attire, staffing, and restricted areas that endoscopy facilities may not wish to adopt. In the interpretive guidelines, AORN’s standards are mentioned as an example of nationally recognized standards. CMS surveyors, therefore, may hold facilities to those standards unless they have specifically adopted others.

4.  Documentation of the adoption of ASGE guidelines should be referenced in the meeting minutes of the organization’s governing body. The reference should include the guideline, the portion of the guideline to be adopted, and an education plan for staff and providers as needed.

1. CMS State Operations Manual, Guidance for Surveyors: Ambulatory Surgical Centers (Appendix L). Centers for Medicare and Medicaid Services. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_l_ambulatory.pdf.

2. Guidelines for Sedation and Anesthesia in Gastrointestinal Endoscopy. GASTROINTEST ENDOSC 2017; 87(2): 327-35.

3. Guidelines for Safety in the Gastrointestinal Unit. GASTROINTEST ENDOSC 2014; 79(3): 366-68.

4. Multisociety Sedation Curriculum for Gastrointestinal Endoscopy. GASTROINTEST ENDOSC 2012; 76(1): 1-25.