Section 34-2.6 - Space

34-2.6 Space.

(a) The rental of space by a clinical laboratory from a referring health services purveyor, or an immediate family member of such purveyor, for more than fair market value, or under circumstances where the rental amount is affected by the volume or value of tests ordered by the health services purveyor shall be deemed consideration given for referral of specimens for performance of clinical laboratory services, and is prohibited.

(b) The rental of space by a clinical laboratory from a referring health services purveyor for storage of supplies provided by the laboratory to the health services purveyor shall be deemed consideration given for referral of specimens for performance of clinical laboratory services, and is prohibited.

(c) The location of a PSC by a clinical laboratory, within or sharing space in any part of the practice, administrative, office or waiting area of any health services purveyor that refers specimens to the clinical laboratory, shall be deemed consideration given for referral of specimens for performance of clinical laboratory services, and is prohibited.

(d) A PSC may be located in a building in which a health services purveyor that refers specimens to the clinical laboratory operating the PSC has a direct or indirect ownership, investment or leasehold interest, under the following circumstances:

(1) the PSC is the subject of a signed written lease, available to the department, which conforms to the requirements of Public Health Law section 238-a(5)(b)(i)(A) and implementing regulations; and

(2) the PSC is open to and actually serves the general public and operates independently from the health services purveyor, and meets all of the following criteria:

(i) the PSC actually collects a substantial number of specimens from patients of other health services purveyors which do not have a direct or indirect financial relationship with a referring health service purveyor who has an ownership, investment or leasehold interest in the building;

(ii) the PSC has its own entrance, exit, and waiting area, except that the PSC may use a waiting area that is generally shared by all tenants or occupants of the building or an entire floor of the building, provided there are two or more tenants renting separate office spaces who are not referring health services purveyors;

(iii) the PSC is identified on signs, consistent with signage of other tenants or occupants, on the outside of the building and within the building;

(iv) the PSC has its own telephone line, separate and distinct from that of any referring health services purveyor, and telephone listings for the clinical laboratory include the PSC's telephone number;

(v) advertisements and other public notices by the clinical laboratory list the address and telephone number of the PSC;

(vi) the hours the PSC is open are independent and not restricted to the hours of one or more referring health services purveyors in the building; and

(vii) the PSC patients of health services purveyors not located in the building have access to a restroom other than those of health services purveyors in the building.

(e) A clinical laboratory shall, within sixty (60) days from the effective date of this Subpart, bring any PSC which it operates at locations as described in subsection (d) of this section, into compliance with the requirements of paragraphs (d)(1) and (2) of this section, or shall cease operation of the PSC. However, a clinical laboratory may request in writing to the department an extension of time for complying with this Subpart with respect to a PSC. Such request shall be made within thirty (30) calendar days from the effective date of this Subpart, shall state the reason(s) that the PSC cannot be brought into compliance with the requirements of this Subpart, and shall document a plan of correction acceptable to the department. The department may extend the grace period granted pursuant to this subdivision for a period not to exceed one hundred eighty (180) days from the effective date of this Subpart.

Effective Date: 
Wednesday, December 26, 2001
Doc Status: 
Complete