ly qualified for the positions to which they are appointed and for the performance of privileges granted. The ASC grants privileges in accordance with recommendations from qualified medical personnel.

(b) Standard: Reappraisals. Medical staff privileges must be periodically reappraised by the ASC. The scope of procedures performed in the ASC must be periodically reviewed and amended as appropriate.

(c) Standard: Other practitioners. If the ASC assigns patient care responsibilities to practitioners other than physicians, it must have established policies and procedures, approved by the governing body, for overseeing and evaluating their clinical activities.

§ 416.46 Condition for coverage-Nursing services.

The nursing services of the ASC must be directed and staffed to assure that the nursing needs of all patients are met.

(a) Standard: Organization and staffing. Patient care responsibilities must be delineated for all nursing service personnel. Nursing services must be provided in accordance with recognized standards of practice.

There must be a registered nurse available for emergency treatment whenever there is a patient in the ASC.

(a) Standard: Organization. The ASC must develop and maintain a system for the proper collection, storage, and use of patient records.

(b) Standard: Form and content of record. The ASC must maintain a medical record for each patient. Every record must be accurate, legible, and promptly completed. Medical records must include at least the following: (1) Patient identification.

(2) Significant medical history and results of physical examination.

(3) Pre-operative diagnostic studies (entered before surgery), if performed.

(4) Findings and techniques of the operation, including a pathologist's report on all tissues removed during surgery, except those exempted by the governing body.

(5) Any allergies and abnormal drug reactions.

(6) Entries related to anesthesia administration.

(7) Documentation of properly executed informed patient consent. (8) Discharge diagnosis.

§ 416.48 Condition for coverage-Pharinaceutical services.

The ASC must provide drugs and biologicals in a safe and effective manner, in accordance with accepted professional practice, and under the direction of an individual designated responsible for pharmaceutical services.

(a) Standard: Administration of drugs. Drugs must be prepared and administered according to established policies and acceptable standards of practice.

(1) Adverse reactions must be reported to the physician responsible for the patient and must be documented in the record.

(2) Blood and blood products must be administered by only physicians or registered nurses.

(3) Orders given orally for drugs and biologicals must be followed by a written order, signed by the prescribing physician.

§ 416.49 Condition for coverage-Laboratory and radiologic services.

The ASC must have procedures for obtaining routine and emergency laboratory services from a laboratory meeting requirements of part 493 of this chapter. The ASC must have procedures for obtaining radiologic services from a Medicare-approved facility to meet the needs of patients. The laboratory offering the services must be a laboratory approved in accordance with part 493 of this chapter, except for urinalyses, hemoglobins and hematocrits performed within a few days before, or on, the day of the surgery. [55 FR 9575, Mar. 14, 1990; 55 FR 33907, Aug. 20, 1990]

SCOPE OF BENEFITS

§ 416.60 Reimbursable services: General

provision.

Ambulatory surgical center services reimbursable under this subpart are facility services, furnished in connection with covered surgical procedures, to Medicare beneficiaries by an ASC that has an agreement with HCFA.

§ 416.61 ASC facility services: Scope.

(a) ASC facility services are items and services furnished by an ASC in connection with a covered surgical procedure as specified under § 416.65, furnished to a Medicare beneficiary. These items and services are those which would otherwise be covered under Medicare if furnished on an inpatient or outpatient basis in a hospital in connection with the covered surgical procedure.

(b) ASC facility services do not inIclude items and services for which payment may be made under other provisions of Part 405 of this chapter, such as physicians' services, laboratory, X-ray or diagnostic procedures (other than those directly related to performance of the surgical procedure), prosthetic devices, ambulance services, leg, arm, back and neck braces, artificial limbs, and durable medical equipment for use in the patient's home.

(c) ASC facility services include, but are not limited to-

(1) Nursing, technician, and related services;

(2) Use of ASC facilities;

(3) Drugs, biologicals, surgical dressings, supplies, splints, casts, and appliances and equipment directly related to the provision of surgical procedures;

(4) Diagnostic or therapeutic services or items directly related to the provision of a surgical procedure;

the list published in accordance with paragraph (c) of this section.

(a) General standards. Covered surgical procedures are those surgical and other medical procedures that—

(1) Are commonly performed on an inpatient basis in hospitals, but may be safely performed in an ASC;

(2) Are not of a type that are commonly performed, or that may be safely performed, in physicians' offices;

(3) Are limited to those requiring a dedicated operating room (or suite), and generally requiring a post-operative recovery room or short-term (not overnight) convalescent room; and

(4) Are not otherwise excluded under § 405.310 of this chapter.

(b) Specific standards. (1) Covered surgical procedures are limited to those that do not generally exceed(i) A total of 90 minutes operating time; and

(ii) A total of 4 hours recovery or convalescent time.

(2) If the covered surgical procedures require anesthesia, the anesthesia must be

(i) Local or regional anesthesia; or (ii) General anesthesia of 90 minutes or less duration.

(3) Covered surgical procedures may not be of a type that—

(i) Generally result in extensive blood loss;

(ii) Require major or prolonged inva sion of body cavities;

(iii) Directly involve major blood ves sels; or

(iv) Are generally emergency or lifethreatening in nature.

(c) Publication of covered proce dures. HCFA will publish in the FEDERAL REGISTER a list of covered surgical procedures and revisions as appropri ate.

§ 416.75 Performance of listed surgical procedures on an inpatient hospital

basis.

The inclusion of any procedure as a covered surgical procedure under § 416.65 does not preclude its coverage in an inpatient hospital setting under Medicare.

Subpart C-Payment for Ambulatory Surgical Services

8416.100 Basis and purpose.

This subpart implements sections 1832(a)(2) and 1833 of the Act with respect to Medicare payment for ambulatory surgical services furnished in connection with covered surgical procedures performed in a participating ASC, on an outpatient basis in a hospital or in a hospital-affiliated ambulatory surgical center.

§ 416.110 Payment for physicians' services furnished in connection with covered surgical procedures.

Payment for physicians' services (including all pre- and post-operative services) will be made at 100 percent of the reasonable charge (or 100 percent of the reasonable cost, in the case of a health maintenance organization reimbursed under section 1876 of the Act) for those services if—

(a) The services are furnished in connection with a covered surgical procedure as specified in § 416.65;

(b) The surgical procedures are performed in a participating ASC, on an outpatient basis in a hospital or in a hospital-affiliated ambulatory surgical center; and

(c) The physician accepts assignment for those services (see §§ 424.55 and 424.56 of this chapter).

[47 FR 34094, Aug. 5, 1982, as amended at 51 FR 41351, Nov. 14, 1986; 53 FR 6648, Mar. 2, 1988]

§ 416.120 Payment for facility services.

Payment for facility services furnished in connection with surgical procedures as specified in § 416.65 will be made as follows:

(a) Hospital outpatient department. Payment will be in accordance with Part 413 of this chapter.

(b) Hospital-affiliated ambulatory surgical center (HAASC). Payment will be in accordance with Part 413 of this chapter if

(1) The HAASC is an integral and subordinate part of a hospital;

(2) The HAASC is operated with other departments of the hospital under common licensure, governance and professional supervision; and

(3) The HAASC is not a Medicare participating ASC.

or

(c) ASC. Payment will be based on a prospectively determined rate. This rate will cover the cost of services such as supplies, nursing services, equipment, etc., as specified in § 416.61. The rate will not cover physician's services, other medical services covered under section 1861(s) of the Act (for example, X-ray services or laboratory services) which are not directly related to the performance of the surgical procedure. These services may be billed separately and paid on a reasonable charge basis.

(1) If one covered surgical procedure is furnished to a beneficiary in an operative session, payment will be 100 percent of the prospectively determined rate for the procedure.

(2) If more than one covered surgical procedure is furnished to a beneficiary in a single operative session, payment will be made at 100 percent of the prospectively determined rate for the procedure with the highest reimbursement rate. Other covered surgical procedures furnished in the same session will be reimbursed at 50 percent of the prospectively determined rate for each of those procedures.

[47 FR 34094, Aug. 5, 1982, as amended at 51 FR 34831, Sept. 30, 1986]

§ 416.125 ASC facility services payment rate.

(a) The payment rate will be equal to a prospectively determined standard overhead amount per procedure which is based on an estimate of the costs incurred by ambulatory surgical centers generally in providing services furnished in connection with the performance of that procedure.

(b) The payment rate must result in substantially less Medicare expenditures than would have been paid under the program had the procedure been performed on an inpatient basis in a hospital.

§ 416.130 Publication of revised payment methodologies.

Whenever HCFA proposes to revise the payment rate for ASCs, HCFA will publish a notice in the FEDERAL REGISTER describing the revision. The notice

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will also explain the basis on which the rates were established. After reviewing public comments, HCFA will publish a notice establishing the rates authorized by this section. In setting these rates, HCFA may adopt reasonable classifications of facilities and may establish different rates for different types of surgical procedures.

8 416.140 Reporting requirements.

(a) HCFA will periodically conduct a sample survey of ASCs participating in the program to collect data for analysis or re-evaluation of the payment rates. Such a survey will be conducted no more frequently than annually. HCFA will notify by mail the ASCs randomly selected to participate in each survey, of their selection and the appropriate form and content of the report.

(1) If the facility does not submit an adequate report in response to HCFA's survey request, HCFA may terminate the agreement to participate in the Medicare program as an ASC.

(2) HCFA may grant a 30-day postponement of the due date for the survey report if it determines that the facility has demonstrated good cause for the delay.

(b) ASCs must

(1) Maintain adequate financial records, in the form and containing the data required by HCFA, to allow determination of the payment rates for covered surgical procedures furnished to Medicare beneficiaries under this subpart.

(2) Within 60 days of a request from HCFA submit, in the form and detail as may be required by HCFA, a report of

(i) Their operations, including the allowable costs actually incurred for the period and the actual number and kinds of surgical procedures furnished during the period; and

(ii) Their customary charges for each surgical procedure furnished for the period.

§ 416.150 Beneficiary appeals.

A beneficiary (or ASC as his or her assignee) may request a hearing by a carrier (subject to the limitations and conditions set forth in part 405, sub