N.J. Admin. Code § 10:58A-2.6 - Clinical laboratory services

(a) "Clinical laboratory services" means professional and technical laboratory services performed by a clinical laboratory certified by 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 Centers for Medicare and Medicaid Services regulations pertaining to clinical laboratory services defined in the Clinical Laboratory Improvement Amendments (CLIA) of 1988, section 1902(a)(9) of the Social Security Act, 42 U.S.C. § 1396(a)(9), and as indicated at 10:61-1.2, the Medicaid and NJ FamilyCare fee-for-service programs' Independent Clinical Laboratory Services manual and N.J.A.C. 8:44 and N.J.A.C. 8:45.

(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 and Senior Services rules found in N.J.A.C. 8:44 and N.J.A.C. 8:45.

(d) An APN 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. An APN shall meet the conditions of the CLIA regulations before she or he may perform clinical laboratory testing for Medicaid/NJ FamilyCare fee-for-service beneficiaries; and

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

(e) When any part of a clinical laboratory test is performed on site, by the APN or his or her office staff, the venipuncture is not reimbursable as a separate procedure; its cost is included within the reimbursement for the laboratory procedure.

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

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

2. The clinical laboratory shall be licensed by the New Jersey State Department of Health, as described above at (b) and (c), 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 fee-for-service program in accordance with (b) above; and

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

(g) HCPCS 96360 SA and 96361 SA, related to therapeutic or diagnostic injections, shall not be used for routine IV drug injection. For these codes, reimbursement shall be contingent upon the required medical necessity, and hand written or electronic chart documentation, including the time and the indication of the APN's presence with the patient to the exclusion of his or her other duties.

Notes

N.J. Admin. Code § 10:58A-2.6

Recodified from N.J.A.C. 10:58A-2.5 by R.1999 d.232, effective 7/19/1999 (operative September 1, 1999).
See: 31 N.J.R. 245(a), 31 N.J.R. 1956(a).
Former N.J.A.C. 10:58A-2.6, Evaluation and management services, recodified to N.J.A.C. 10:58A-2.7.
Amended by R.2000 d.265, effective 7/3/2000.
See: 32 N.J.R. 1127(a), 32 N.J.R. 2483(a).
Inserted references to NJ KidCare fee-for-service throughout; in (d)1, substituted a reference to beneficiaries for a reference to patients; in (e), substituted "any part of a clinical laboratory test is performed on site, by the CNP/CNS or his or her office staff," for "the clinic laboratory test is performed on site," following "When"; and added (g).
Amended by R.2004 d.334, effective 9/7/2004.
See: 36 N.J.R. 312(a), 36 N.J.R. 4136(a).
In (a), substituted "CMS" for "HCFA".
Amended by R.2004 d.409, effective 11/1/2004.
See: 35 N.J.R. 4977(a), 36 N.J.R. 4968(a).
In (a), substituted "CMS" for "HCFA"; in (b), substituted "Centers for Medicare and Medicaid Services" for "Health Care Financing Administration".
Amended by R.2005 d.406, effective 11/21/2005.
See: 37 N.J.R. 2329(a), 37 N.J.R. 4445(a).
In (g), substituted "SA" for "AV" throughout and "APN's" for "practitioner's."
Amended by R.2011 d.119, effective 4/18/2011.
See: 42 N.J.R. 2890(a), 43 N.J.R. 1015(a).
In (g), substituted "96360 SA and 96361 SA" for "90780 SA and 90781 SA", and inserted "or electronic".