Title: Section 34-2.13 - Direct billing

Effective Date

12/26/2001

34-2.13 Direct billing.

(a) Nothing contained in Public Health Law section 586 or this Subpart shall be construed to prohibit a clinical laboratory from sending a bill to or receiving payment for clinical laboratory services from the health services purveyor who ordered the clinical laboratory services, provided that:

(1) the clinical laboratory receives the name and/or other information relating to the test subject if the clinical laboratory is obligated to report such name and/or other information to the state or a local health department under state law or regulation;

(2) the bill for the clinical laboratory services shall be directed to the test subject or a payor expressly permitted by Public Health Law section 586 or this Subpart;

(3) the amount of the bill for clinical laboratory services shall be disclosed to the test subject or a payor expressly permitted by Public Health Law section 586 or this Subpart, and documentation of the disclosure shall be maintained by the health services purveyor who ordered the clinical laboratory services;

(4) if payment is made for the clinical laboratory services to the health services purveyor who ordered the clinical laboratory services, the payment amount must be equal to the amount stated in the clinical laboratory bill; and

(5) one of the following situations must apply:

(i) the cost of the clinical laboratory service is included in the usual and customary purchase price of a test kit that is approved by the federal Food and Drug Administration to be commercialized as a test kit that includes a collection device, specimen transport materials, and the clinical laboratory service; or

(ii) the clinical laboratory services are performed in relation to: a termination of pregnancy; testing for a sexually transmissible disease; HIV-related testing; drug abuse screening; or other tests specifically approved by the department where law or regulation recognizes the need for a heightened level of confidential protection of health information relating to the test subject.

Volume

VOLUME A-1 (Title 10)

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