N.J. Admin. Code § 10:62-1.19

Current through Register Vol. 56, No. 24, December 18, 2024

Section 10:62-1.19 - Clinical laboratory services

(a) (Reserved)

(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 (CLIA) of 1988, section 1902(a)(9) of the Social Security Act, 42 U.S.C. § 1396a(a)(9), and as indicated at N.J.A.C. 10:61-1.2, the New Jersey Medicaid/NJ FamilyCare fee-for-service programs' Independent Clinical Laboratory Services manual and N.J.A.C. 8:44 and 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 rules found in N.J.A.C. 8:44 and 8:45.

(d) An ophthalmologist may claim reimbursement for clinical laboratory services performed for the practitioner's own patients within the practitioner's office, subject to the following:

1. An ophthalmologist shall meet the conditions of the CLIA regulations before he or she may perform clinical laboratory testing for New Jersey Medicaid/NJ FamilyCare fee-for-service beneficiaries; and

2. The clinical laboratory tests shall be standard clinical laboratory procedures consistent with the ophthalmologist'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; the cost shall be included within the reimbursement for the laboratory procedure.

(f) When the ophthalmologist 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 Department of Health as described above at (b) and (c), or by the 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 programs in accordance with (b) above; and

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

N.J. Admin. Code § 10:62-1.19

Amended by 49 N.J.R. 2279(b), effective 7/17/2017