Statutes, codes, and regulations
New Jersey Administrative Code
Title 10 - HUMAN SERVICESChapter 54 - PHYSICIAN SERVICES
Subchapter 5 - POLICIES AND PROCEDURES FOR PROVISION OF SERVICES PRESCRIBED OR RENDERED BY A PHYSICIAN
Section 10:54-5.2 - Clinical laboratory services

N.J. Admin. Code § 10:54-5.2

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Current through Register Vol. 56, No. 23, December 2, 2024
Section 10:54-5.2 - 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 (including the certified nurse midwife and advanced practice nurse), within the scope of his or her practice as defined by the laws of the State of New Jersey or of the state in which the physician or 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/NJ FamilyCare program's Independent Clinical Laboratory Services chapter, and N.J.A.C. 8:44 and 8:45.
(c) All independent clinical laboratories and other entities performing clinical laboratory testing shall possess one of the following certificates:
1. Certificate of Registration or Registration Certificate;
2. Certificate of Waiver;
3. Certificate for Provider-Performed Microscopy (PPM) Procedures;
4. Certificate of Compliance; or
5. Certificate of Accreditation.

(For certification information, contact the Centers for Medicare and Medicaid Services, CLIA Program, P.O. Box 26689, Baltimore, MD 21207-0489.)

(d) A physician/practitioner 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 physician/practitioner shall not include in his or her claim any charges for laboratory services not performed on-site (that is, when the laboratory procedures have been performed by a clinical or hospital laboratory), except that:
i. A physician/practitioner may claim reimbursement for laboratory services when he or she has a Certificate of Registration or Registration Certificate, Certificate of Waiver, a Certificate of Provider-performed Microscopy (PPM) Procedures; a Certificate of Compliance; or a Certificate of Accreditation.
2. When clinical laboratory tests are performed on site, the venipuncture is not reimbursable as a separate procedure; its cost is included within the reimbursement for the laboratory procedure.
3. When the physician refers a laboratory test to an independent reference laboratory, the clinical laboratory shall be certified under the CLIA as described in (a), (b) and (c) above to perform the required laboratory test(s) and comply with the other requirements of N.J.A.C. 10:61. The physician shall not be reimbursed for laboratory work performed by the reference laboratory.
(e) Profiles are comprised of those components of a test or series of tests which are frequently performed or automated. Examples of identifiable laboratory profiles or studies are as follows:
1. The components of an SMA (Sequential Multichannel Automated Analysis) 12/60 or other automated laboratory study; or
2. Inclusion of an MCH (Mean Corpuscular Hemoglobin), MCV (Means Corpuscular Volume), and so forth, as a component of a CBC (Complete Blood Count).
(f) If the components of a profile are billed separately, reimbursement for the components of the profile (panel) shall not exceed the maximum fee allowance for the profile itself.
(g) Rebates by reference laboratory, service laboratories, physicians or other utilizers or providers of laboratory service are prohibited under the Medicaid/NJ FamilyCare program. This refers to rebates in the form of refunds, discounts or kickbacks, whether in the form of money, supplies, equipment or other things of value. Laboratories shall not rent space from, or provide personnel or other considerations to, a physician or other practitioner, whether or not a rebate is involved.

N.J. Admin. Code § 10:54-5.2

Amended by R.2001 d.51, effective 2/5/2001.
See: 32 N.J.R. 3929(a), 33 N.J.R. 555(a).
In (b), substituted "chapter" for "manual" following "Clinical Laboratory Services".
Amended by R.2004 d.334, effective 9/7/2004.
See: 36 N.J.R. 312(a), 36 N.J.R. 4136(a).
Amended by R.2012 d.124, effective 7/2/2012.
See: 43 N.J.R. 1477(a), 44 N.J.R. 1884(a).
In (a), substituted "CMS" for "HCFA"; in (b) and in the paragraph following (c)5, substituted "Centers for Medicare and Medicaid Services" for "Health Care Financing Administration"; in (b) and (g), inserted "/NJ FamilyCare"; in (b), substituted "42 U.S.C. § 1396(a)(9)" for "42 U.S.C. § 1396(a)(9)" and deleted "N.J.A.C." preceding "8:45"; and in (f), substituted "maximum" for "Medicaid".