C.F.R. » Title 42 » CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER B—MEDICARE PROGRAM › PART 416—AMBULATORY SURGICAL SERVICES › Subpart C—Specific Conditions for Coverage

42 C.F.R. § 416.42

Condition for coverage—Surgical services

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Surgical procedures must be performed in a safe manner by qualified physicians who have been granted clinical privileges by the governing body of the ASC in accordance with approved policies and procedures of the ASC.

(a) Standard: Anesthetic risk and evaluation. (1) Immediately before surgery—

(i) A physician must examine the patient to evaluate the risk of the procedure to be performed; and

(ii) A physician or anesthetist as defined at § 410.69(b) of this chapter must examine the patient to evaluate the risk of anesthesia.

(2) 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.

(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 those 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.

(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 are effective upon submission.

[57 FR 33899, July 31, 1992, as amended at 66 FR 56768, Nov. 13, 2001; 73 FR 68812, Nov. 18, 2008; 79 FR 27153, May 12, 2014; 84 FR 63202, Nov. 15, 2019]
Notes of Decisions
Cited in 5 cases (3 in the last 5 years), 2012–2024 · leading case: Colorado Med. Soc'y v. Hickenlooper, 353 P.3d 396 (Colo. Ct. App. 2012).
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Colorado Med. Soc'y v. Hickenlooper, 353 P.3d 396 (Colo. Ct. App. 2012). · cites it 7× “42 C.F.R. § 416.42 (ambulatory surgical center) 42 C.”
Question Submitted by: Rep. Marcus McEntire, Oklahoma House of Representatives, Dist. 50, 2024 OK AG 14 (Okla. Att’y Gen. 2024). · cites it 2× “639 (2020), and ambulatory surgical centers, 42 C.F.R. § 416.42 (2020), to receive Medicare reimbursement for CRNAs who administer anesthesia.”
United States v. Harbit (D.S.C. 2021). · cites it 4× “) As to the particulars supporting their claims, Plaintiff-Relators assert that in order to obtain reimbursement through said federal programs, the physician performing such procedures has to comply with 42 C.F.R. § 416.42 (a), indicating the physician must evaluate a patient…”
McDaniel v. United States of Am. (D.N.M. 2022). “41 (2019), and to operate on patients “in a safe manner,” 42 C.F.R. § 416.42 (2019) — do not change the fundamental character and purpose of the regulations as a whole.”
v. Surgery Ctr., 2020 COA 145 (Colo. Ct. App. 2020). “41 (2019), and to operate on patients “in a safe manner,” 42 C.F.R. § 416.42 (2019) — do not change the fundamental character and purpose of the regulations as a whole.”
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