New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter A - Vital Records And Personal Information › Part 34 - Health Care Practitioner Referrals And Laboratory Business Practices › Subpart 34-2 - Laboratory Business Practices › Section 34-2.6 - Space

Current through Register Vol. 46, No. 28, July 10, 2024
(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:
(2) 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.