New Jersey Administrative Code
Title 10 - HUMAN SERVICES
Chapter 57 - PODIATRY SERVICES
Subchapter 2 - PROVISION OF SERVICES
Section 10:57-2.7 - Clinical laboratory services

Universal Citation: NJ Admin Code 10:57-2.7

Current through Register Vol. 56, No. 18, September 16, 2024

(a) "Clinical laboratory services" means professional and technical laboratory services performed by a clinical laboratory certified by the Centers for Medicare & Medicaid Services (CMS) in accordance with the Clinical Laboratory Improvement Act (CLIA) and ordered by a physician or other licensed practitioner, within the scope of his or her practice as defined by the laws of the State of New Jersey and/or of the state in which the practitioner practices.

(b) Clinical laboratory services are furnished by clinical laboratories and by physician office laboratories (POLs) that meet the CMS regulations pertaining to clinical laboratory services defined in the Clinical Laboratory Improvement Amendments Act (CLIA) of 1988; 1902(a)(9) of the Social Security Act; 42 U.S.C. 1396 a (a)(9); and as indicated at 10:61-1.2, the Medicaid/NJ FamilyCare program's Independent Clinical Laboratory Services chapter.

(c) All independent clinical laboratories and other entities performing clinical laboratory testing shall possess certification as required by CLIA 1988, and the New Jersey Department of Health rules found at N.J.A.C. 8:44 and 8:45.

(d) A podiatrist may claim reimbursement for clinical laboratory services performed for his or her own patients within his or her own office, subject to the following:

1. A podiatrist shall meet the conditions of the CLIA regulations before she or he may perform clinical laboratory testing for Medicaid recipients; and

2. The clinical laboratory tests shall be standard clinical laboratory procedures consistent with the podiatrist's CLIA certification, certificate of waiver or certificate of registration as an independent clinical laboratory.

(e) When the clinical laboratory test is performed on site, the venipuncture shall not be reimbursable as a separate procedure; its cost is included within the reimbursement for the lab procedure.

(f) When a podiatrist refers a laboratory test to an independent clinical reference laboratory:

1. The clinical reference laboratory shall be certified under the CLIA, as described at (a) and (b) above, to perform the required laboratory test(s);

2. The clinical laboratory shall be licensed by the New Jersey State Department of Health, as described at (b) and (c) above, or comparable agency in the state in which the laboratory is located;

3. The clinical laboratory shall be approved for participation as an independent laboratory provider by the New Jersey Medicaid/NJ FamilyCare program in accordance with (b) above; and

4. Independent clinical laboratories shall bill the New Jersey Medicaid/NJ FamilyCare program for all reference laboratory work performed on their premises. The podiatrist will not be reimbursed for laboratory work performed by a reference laboratory.

Disclaimer: These regulations may not be the most recent version. New Jersey may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.