(a) Definition. For purposes of this section, the term services of moonlighting residents refers to services that licensed residents perform that are outside the scope of an approved GME program.

(b) Services in GME program hospitals. (1) The services of residents to inpatients of hospitals in which the residents have their approved GME program are not covered as physician services and are payable under §413.86 regarding direct GME payments.

(2) Services of residents that are not related to their approved GME programs and are performed in an outpatient department or emergency department of a hospital in which they have their training program are covered as physician services and payable under the physician fee schedule if all of the following criteria are met:

(i) The services are identifiable physician services and meet the conditions for payment of physician services to beneficiaries in providers in §415.102(a).

(ii) The resident is fully licensed to practice medicine, osteopathy, dentistry, or podiatry by the State in which the services are performed.

(iii) The services performed can be separately identified from those services that are required as part of the approved GME program.

(3) If the criteria specified in paragraph (b)(2) of this section are met, the services of the moonlighting resident are considered to have been furnished by the individual in his or her capacity as a physician, rather than in the capacity of a resident. The carrier must review the contracts and agreements for these services to ensure compliance

with the criteria specified in paragraph (b)(2) of this section.

(4) No payment is made for services of a "teaching physician" associated with moonlighting services, and the time spent furnishing these services is not included in the teaching hospital's full-time equivalency count for the indirect GME payment (§ 412.105 of this chapter) and for the direct GME payment (§413.86 of this chapter).

(c) Other settings. Moonlighting services of a licensed resident in an approved GME program furnished outside the scope of that program in a hospital or other setting that does not participate in the approved GME program are payable under the physician fee schedule as set forth in § 415.206(b)(1).

§ 416.1 Basis and scope.

(a) Statutory basis. (1) Section 1832(a)(2)(F)(i) of the Act provides for Medicare Part B coverage of facility services furnished in connection with surgical procedures specified by the Secretary under section 1833(i)(1) of the Act.

(2) Section 1833(i)(1)(A) of the Act requires the Secretary to specify the surgical procedures that can be performed safely on an ambulatory basis in an ambulatory surgical center, or a hospital outpatient department.

(3) Section 1833(i) (2)(A) and (3) specify the amounts to be paid for facility services furnished in connection with the specified surgical procedures when they are performed, respectively, in an ASC, or in a hospital outpatient department.

(b) Scope. This part sets forth

(1) The conditions that an ASC must meet in order to participate in the Medicare program;

(2) The scope of covered services; and (3) The conditions for Medicare payment for facility services.

[56 FR 8843, Mar. 1, 1991; 56 FR 23022, May 20, 1991]

§ 416.2 Definitions.

As used in this part:

Ambulatory surgical center or ASC means any distinct entity that operates exclusively for the purpose of pro

Subpart B-General Conditions and Requirements

§ 416.25 Basic requirements.

Participation as an ASC is limited to

facilities that—

(a) Meet the definition in §416.2; and (b) Have in effect an agreement obtained in accordance with this subpart. [56 FR 8843, Mar. 1, 1991]

§ 416.26 Qualifying for an agreement.

(a) Deemed compliance. HCFA may deem an ASC to be in compliance with any or all of the conditions set forth in subpart C of this part if—

(1) The ASC is accredited by a national accrediting body, or licensed by a State agency, that HCFA determines provides reasonable assurance that the conditions are met;

(2) In the case of deemed status through accreditation by a national accrediting body, where State law requires licensure, the ASC complies with State licensure requirements; and

(3) The ASC authorizes the release to HCFA, of the findings of the accreditation survey.

(b) Survey of ASCs. (1) Unless HCFA deems the ASC to be in compliance with the conditions set forth in subpart C of this part, the State survey agency must survey the facility to ascertain compliance with those conditions, and report its findings to HCFA.

(2) HCFA surveys deemed ASCS on a sample basis as part of HCFA's validation process.

(c) Acceptance of the ASC as qualified to furnish ambulatory surgical services. If HCFA determines, after reviewing the survey agency recommendation and other evidence relating to the qualification of the ASC, that the facility meets the requirements of this part, it sends to the ASC

(1) Written notice of the determination; and

(2) Two copies of the ASC agreement. (d) Filing of agreement by the ASC. If the ASC wishes to participate in the program, it must

(1) Have both copies of the ASC agreement signed by its authorized representative; and

(2) File them with HCFA.

(e) Acceptance by HCFA. If HCFA accepts the agreement filed by the ASC, returns to the ASC one copy of the agreement, with a notice of acceptance specifying the effective date.

(f) Appeal rights. If HCFA refuses to enter into an agreement or if HCFA terminates an agreement, the ASC is entitled to a hearing in accordance with part 498 of this chapter.

[56 FR 8843, Mar. 1, 1991]

§ 416.30 Terms of agreement with HCFA.

As part of the agreement under § 416.26 the ASC must agree to the following:

(a) Compliance with coverage conditions. The ASC agrees to meet the conditions for coverage specified in subpart C of this part and to report promptly to HCFA any failure to do so.

(b) Limitation on charges to beneficiaries.1 The ASC agrees to charge the beneficiary or any other person only the applicable deductible and coinsurance amounts for facility services for which the beneficiary

(1) Is entitled to have payment made on his or her behalf under this part; or (2) Would have been so entitled if the ASC had filed a request for payment in

1 For facility services furnished before July 1987, the ASC had to agree to make no charge to the beneficiary, since those services were not subject to the part B deductible and coinsurance provisions.

accordance with §410.165 of this chap

ter.

(c) Refunds to beneficiaries. (1) The ASC agrees to refund as promptly as possible any money incorrectly collected from beneficiaries or from someone on their behalf.

(2) As used in this section, money incorrectly collected means sums collected in excess of those specified in paragraph (b) of this section. It includes amounts collected for a period of time when the beneficiary was believed not to be entitled to Medicare benefits if—

(i) The beneficiary is later determined to have been entitled to Medicare benefits; and

(ii) The beneficiary's entitlement period falls within the time the ASC's agreement with HCFA is in effect.

(d) Furnishing information. The ASC agrees to furnish to HCFA, if requested, information necessary to establish payment rates specified in §§ 416.120-416.130 in the form and manner that HCFA requires.

(e) Acceptance of assignment. The ASC agrees to accept assignment for all facility services furnished in connection with covered surgical procedures. For purposes of this section, assignment means an assignment under §424.55 of this chapter of the right to receive payment under Medicare Part B and payment under $424.64 of this chapter (when an individual dies before assigning the claim).

(f) ASCs operated by a hopsital. In an ASC operated by a hospital—

(1) The agreement is made effective on the first day of the next Medicare cost reporting period of the hospital that operates the ASC; and

(2) The ASC participates and is paid only as an ASC, without the option of converting to or being paid as a hospital outpatient department, unless HCFA determines there is good cause to do otherwise.

(3) Costs for the ASC are treated as a non-reimbursable cost center on the hopsital's cost report.

(g) Additional provisions. The agreement may contain any additional provisions that HCFA finds necessary or desirable for the efficient and effective

administration of the Medicare pro

gram.

[47 FR 34094, Aug. 5, 1982, as amended at 51 FR 41351, Nov. 14, 1986; 56 FR 8844, Mar. 1, 1991]

§ 416.35 Termination of agreement.

(a) Termination by the ASC—(1) Notice to HCFA. An ASC that wishes to terminate its agreement must send HCFA written notice of its intent.

(2) Date of termination. The notice may state the intended date of termination which must be the first day of a calendar month.

(i) If the notice does not specify a date, or the date is not acceptable to HCFA, HCFA may set a date that will not be more than 6 months from the date on the ASC's notice of intent.

nished on or after the effective date of termination.

(d) Notice to the public. Prompt notice of the date and effect of termination is given to the public, through publication in local newspapers by

(1) The ASC, after HCFA has approved or set a termination date; or (2) HCFA, when it has terminated the agreement.

(e) Conditions for reinstatement after termination of agreement by HCFA. When an agreement with an ASC is terminated by HCFA, the ASC may not file another agreement to participate in the Medicare program unless HCFA—

(1) Finds that the reason for the termination of the prior agreement has been removed; and

(2) Is assured that the reason for the termination will not recur.

[47 FR 34094, Aug. 5, 1982, as amended at 52 FR 22454, June 12, 1987; 56 FR 8844, Mar. 1, 1991; 61 FR 40347, Aug. 2, 1996]

and efficient administration of the Medicare program.

(3) Voluntary termination. If an ASC ceases to furnish services to the community, that shall be deemed to be a voluntary termination of the agreement by the ASC, effective on the last day of business with Medicare beneficiaries.

(b) Termination by HCFA—(1) Cause for termination. HCFA may terminate an agreement if it determines that the ASC

(i) No longer meets the conditions for coverage as specified under § 416.26; or

(ii) Is not in substantial compliance with the provisions of the agreement, the requirements of this subpart, and other applicable regulations of subchapter B of this chapter, or any applicable provisions of title XVIII of the Act.

(2) Notice of termination. HCFA sends notice of termination to the ASC at least 15 days before the effective date stated in the notice.

(3) Appeal by the ASC. An ASC may appeal the termination of its agreement in accordance with the provisions set forth in part 498 of this chapter.

(c) Effect of termination. Payment is not available for ASC services fur

Coverage

§ 416.40 Condition for coverage-Compliance with State licensure law. The ASC must comply with State licensure requirements.

§ 416.41 Condition for coverage-Governing body and management.

The ASC must have a governing body, that assumes full legal responsibility for determining, implementing, and monitoring policies governing the ASC's total operation and for ensuring that these policies are administered so as to provide quality health care in a safe environment. When services are provided through a contract with an outside resource, the ASC must assure that these services are provided in a safe and effective manner. Standard: Hospitalization. The ASC must have an effective procedure for the immediate transfer to a hospital, of patients requiring emergency medical care beyond the capabilities of the ASC. This hospital must be a local, Medicare participating hospital or a local, nonparticipating hospital that meets the requirements for payment for emergency services under $482.2 of this chapter. The ASC must have a written

transfer agreement with such a hospital, or all physicians performing surgery in the ASC must have admitting privileges at such a hospital.

[47 FR 34094, Aug. 5, 1982, as amended at 51 FR 22041, June 17, 1986]

§ 416.42 Condition for coverage-Surgical services.

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. A physician must examine the patient immediately before surgery to evaluate the risk of anesthesia and of the procedure to be performed. Before discharge from the ASC, each patient must be evaluated by a physician 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 or an anesthesiologist's assistant as defined in § 410.68(b) of this chapter, or a supervised trainee in an approved educational program. In those cases in which a non-physician administers the anesthesia, 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: Discharge. All patients are discharged in the company of a responsible adult, except those exempted by the attending physician.

[57 FR 33899, July 31, 1992]

§ 416.43 Condition for coverage-Evaluation of quality.

The ASC, with the active participation of the medical staff, must conduct an ongoing, comprehensive self-assessment of the quality of care provided, including medical necessity of procedures performed and appropriateness of care, and use findings, when appropriate, in the revision of center policies and consideration of clinical privileges.

§ 416.44 Condition for coverage-Envi

ronment.

The ASC must have a safe and sanitary environment, properly constructed, equipped, and maintained to protect the health and safety of patients.

(a) Standard: Physical environment. The ASC must provide a functional and sanitary environment for the provision of surgical services.

(1) Each operating room must be designed and equipped so that the types of surgery conducted can be performed in a manner that protects the lives and assures the physical safety of all individuals in the area.

(2) The ASC must have a separate recovery room and waiting area.

(3) The ASC must establish a program for identifying and preventing infections, maintaining a sanitary environment, and reporting the results to appropriate authorities.

(b) Standard: Safety from fire. (1) Except as provided in paragraphs (b) (2) and (3) of this section, the ASC must meet the provisions of the 1985 edition of the Life Safety Code of the National Fire Protection Association (which is incorporated by reference)1 that are applicable to ambulatory surgical centers.

(2) In consideration of a recommendation by the State survey agency, HCFA may waive, for periods deemed appropriate, specific provisions of the Life Safety Code which, if rigidly applied, would result in unreasonable hardship upon an ASC, but only if the waiver will not adversely affect the health and safety of the patients.

(3) Any ASC that, on May 9, 1988, complies with the requirements of the 1981 edition of the Life Safety Code, with or without waivers, will be considered to be in compliance with this standard, so long as the ASC continues to remain in compliance with that edition of the Life Safety Code.

(c) Standard: Emergency equipment. Emergency equipment available to the operating rooms must include at least the following:

(1) Emergency call system. (2) Oxygen.

1 See footnote to §405.1134(a) of this chapter.