CMS SOM App. L, Tag Q-0063

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.

§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.

Interpretive Guidelines: §416.42(b) & (c)

The ASC’s policies and procedures must include criteria, consistent with State law

governing scope of professional practice and other applicable State law, for determining

the anesthesia privileges to be granted by the governing body to an eligible individual

practitioner and a procedure for applying the criteria to individuals requesting privileges.

The ASC must specify the anesthesia privileges for each practitioner who administers

anesthesia, or who supervises the administration of anesthesia by another practitioner.

The privileges granted must be in accordance with State law and the ASC’s policy. The

type and complexity of procedures for which the practitioner may administer anesthesia,

or supervise another practitioner supervising anesthesia, must be specified in the

privileges granted to the individual practitioner.

When granting anesthesia privileges to a physician who is not an anesthesiologist, the

ASC’s governing body must consider the practitioner’s scope of practice, State law, the

individual competencies, education, and training of the practitioner and the practitioner’s

compliance with the ASC’s other criteria for granting physician privileges.

When an ASC permits operating physicians to supervise CRNAs administering

anesthesia, the governing body must adopt written policies that explicitly provide for this.

A CRNA is defined at §410.69(b) as a “…registered nurse who:

(1) is licensed as a registered professional nurse by the State in which the nurse

practices;

(2) meets any licensure requirements the State imposes with respect to non-physician anesthetists;

(3) has graduated from a nurse anesthesia educational program that meets the

standards of the Council on Accreditation of Nurse Anesthesia Programs, or

such other accreditation organization as may be designated by the Secretary;

and

(4) meets the following criteria:

(i) has passed a certification examination of the Council on Certification of

Nurse Anesthetists, or any other certification organization that may be

designated by the Secretary; or

(ii) is a graduate of a program described in paragraph (3) of this definition and

within 24 months after that graduation meets the requirements of paragraph

(4)(i) of this definition.” A CRNA may administer anesthesia in an ASC

when under the supervision of the operating physician.

If the ASC is located in a State where the Governor has submitted a letter to CMS

attesting 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, then

a CRNA may administer anesthesia without physician supervision.

An anesthesiologist’s assistant is defined at §410.69(b) as a “…person who – (1) works

under the direction of an anesthesiologist; (2) is in compliance with all applicable

requirements of State law, including any licensure requirements the State imposes on

nonphysician anesthetists; and (3) is a graduate of a medical school-based

anesthesiologist’s assistant education program that – (A) is accredited by the Committee

on Allied Health Education and Accreditation; and (B) includes approximately two years

of specialized basic science and clinical education in anesthesia at a level that builds on a

premedical undergraduate science background.” An anesthesiologist’s assistant may

administer anesthesia when under the direct supervision of an anesthesiologist. The

anesthesiologist must be immediately available if needed, meaning the anesthesiologist

is:

• Physically present in the ASC; and

• Prepared to immediately conduct hands-on intervention if needed.

A trainee who is a physician in training to be an anesthesiologist in a recognized graduate

medical education program, or a student in a recognized nurse anesthesia or

anesthesiologist’s assistance educational program may administer anesthesia in an ASC

when supervised by the operating physician, in the case of a nurse anesthetist trainee, or

by an anesthesiologist, in the case of a physician trainee or an anesthesiologist’s assistant

trainee.

Survey Procedures: §§482.42(b) and (c)

• Prior to the survey, determine whether the State has exercised its CRNA

physician supervision opt-out option.

• Review the qualifications of individuals authorized to deliver anesthesia in the

ASC, to determine whether they are consistent with the regulatory requirements.

• Determine that there is documentation of current licensure or current certification

status for all persons administering anesthesia.

• If the ASC uses CRNAs, anesthesiologist’s assistants or trainees, interview the

ASC’s leadership to determine how they are supervised. Do the medical records

indicate that required physician supervision is provided?

• When observing a procedure, look for evidence of appropriately trained

practitioners with supervision as required by the regulations.