N.Y. Comp. Codes R. & Regs. tit. 10 § 600.8

Current through Register Vol. 46, No. 45, November 2, 2024

Section 600.8 - Criteria for determining the operation of diagnostic or treatment center under article 28 of the public health law

(a) Any provision of medical or health services by a provider of medical or health services organized as a not-for-profit or business corporation other than professional service corporation shall constitute the operation of a diagnostic or treatment center.

(b) It shall be prima facie evidence that a diagnostic or treatment center is being operated when any provider of medical or health services describes itself to the public as a "center," "clinic" or by any name other than the name of one or more of the practitioners providing these services.

(c) A provider of medical or health services that does not come within subdivision (a) or (b) of this section shall be reviewed by the Commissioner of Health to determine whether medical or health services are being provided by practitioners of medicine engaged in private practice or by facility within article 28 of the Public Health Law. The following criteria shall be used in conducting such reviews:

(1) Patient contact. Patient contact is made directly with the facility rather than the individual physician; or referral is made to the facility by the physician; or provision is made for services by the physician, not in his offices but at another location.

(2) Admission. The decisions as to admissions are made by the facility rather than by the individual practitioner, or by referral agreement or by arrangements with physicians.

(3) Choice of physician. When the physician is not chosen by the patient, the physician is assigned by the facility, or the patient is given a choice among several practitioners associated with or employed by the facility.

(4) Care of patients. Care that is provided patients is the responsibility of the facility and is provided under the following conditions, among others:

(i) the facility, rather than the physician assumes responsibility for all services rendered within the facility;

(ii) central services, including but not limited to laboratory, pharmacy, X-ray and narcotics are available with no free choice of the provider of such services by the patient;

(iii) the facility insures adherence to standards;

(iv) the facility is organized into departments or has a multi-disciplined approach;

(v) the facility supplies ancillary services; or

(vi) the responsibility of the facility terminates on discharge of the patient, as distinguished from the continuing responsibility of the physician; follow-up care is not provided by or at the facility.

(5) Organization and management.

(i) Bills and charges are determined by the facility;

(ii) medical charts and patient records are maintained by the faculty;

(iii) patient care space is provided by the facility;

(iv) income distribution is determined by the facility;

(v) employees are selected as supervised by the facility;

(vi) vital records such as fetal death certificates, etc. are maintained by the facility;

(vii) bills are payable to the facility, rather than to the individual practitioner;

(viii) the scope of the services to be provided is determined by the facility, subject to regulatory limitations;

(ix) the structure is so physically extensive that it exceeds the usual space requirements of the private medical practitioner;

(x) the departmental organization is large enough to require delegation of authority to nonmedical personnel;

(xi) there is employment of other health professions such as registered nurse, physical therapist, pharmacist; or

(xii) the patient registry is more extensive than that found in the usual individual practice. Many more persons are processed than are ordinarily diagnosed or treated by physicians in the private practice of medicine.

(d) The criteria set forth in subdivision (c) of this section shall not be the sole determining factors, but indicators to be considered with such other factors that may be pertinent in particular instances. Professional expertise is to be exercised in the utilization of the criteria. Establishment shall be required where a determination is made that medical services are being provided by a facility within article 28 of the Public Health Law rather than by a private practitioner of medicine. All of the listed indicia of a facility within article 28 of the Public Health Law need not be present in a given instance. The criteria are intended to assist in determining the dominant features of the services offered.

(e) In addition to the foregoing, any facility which qualifies for an agreement to participate in the Medicare program as an ambulatory surgical center shall constitute a diagnostic and treatment center. The conditions of participation in the Medicare program as an ambulatory surgical center are contained in volume 42 of the Code of Federal Regulations, Public Health, at part 416 ( 42 CFR part 416), 1984 edition, published by the Office of the Federal Register, National Archives and Records Service, General Services Administration. Copies may be obtained from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402. 42 CFR part 416 is available for public inspection and copying at the Records Access Office, New York State Department of Health, 10th Floor, Corning Tower Building, Empire State Plaza, Albany, NY 12237.

(f) The Department of Health may conduct such hearings as may be necessary to gather sufficient facts to make a determination under this section.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 600.8