N.J. Admin. Code § 10:56-2.21

Current through Register Vol. 57, No. 1, January 6, 2025

Section 10:56-2.21 - Pharmaceutical: program restrictions affecting payment for prescribed drugs

(a) The choice of prescribed drugs shall be at the discretion of the prescriber within the limits of applicable laws. However, the prescriber's discretion is limited for certain drugs. Reimbursement shall be denied (except for dentist's prescriptions) if the requirements of the following rules are not met:

1. Covered and non-covered pharmaceutical services as listed in the Pharmaceutical Services chapter at N.J.A.C. 10:51-1.11 and 1.12, respectively, incorporated herein by reference;

2. Pharmaceutical services requiring prior authorization (see N.J.A.C. 10:51-1.13, incorporated herein by reference);

3. Quantity of medication (see N.J.A.C. 10:51-1.14, incorporated herein by reference);

4. Dosage and directions (see N.J.A.C. 10:51-1.15, incorporated herein by reference);

5. Telephone-rendered original prescriptions (see N.J.A.C. 10:51-1.16, incorporated herein by reference);

6. Changes or additions to the original prescription (see N.J.A.C. 10:51-1.17, incorporated herein by reference);

7. Prescription refill (see N.J.A.C. 10:51-1.18, incorporated herein by reference);

8. Prescription Drug Price and Quality Stabilization Act (N.J.S.A. 24:6E-1 et seq.) (see N.J.A.C. 10:51-1.20, incorporated herein by reference);

i. Products listed in the New Jersey Drug Utilization Review Council (DURC) Formulary, N.J.A.C. 8:71, (hereafter referred to as, "the Formulary"); and

ii. Non-proprietary or generic dispensing (see N.J.A.C. 10:51-1.9, incorporated herein by reference).

9. Federal regulations ( 42 CFR 447.301, 447.331 - 447.333) that set the aggregate upper limits on payment for certain multi-source drugs if Federal Financial Participation (FFP) is to be made available. The limit applies to all "maximum allowable cost" drugs (see N.J.A.C. 10:51-1.5, Basis of payment, incorporated herein by reference);

10. Drug Efficacy Study Implementation (DESI): "less than effective drugs" subject to a Notice of Opportunity for Hearing (NOOH) by the Federal Food and Drug Administration (see N.J.A.C. 10:51-1.20 and listing of DESI drugs in Appendix A of N.J.A.C. 10:51, incorporated herein by reference);

11. Drug Manufacturers' Rebate Agreement with the Centers for Medicare & Medicaid Services of the United States Department of Health and Human Services (see N.J.A.C. 10:51-1.21, incorporated herein by reference);

12. Medical exception process (see N.J.A.C. 10:56-2.22); and

13. Diabetic testing materials, including blood glucose reagent strips, urine monitoring strips, tapes, tablets, and lancets. Electronic blood glucose monitoring devices or other devices used in the monitoring of blood glucose levels are considered medical supplies and are covered services by Medicaid/NJ FamilyCare. These services require prior authorization from the Medical Assistance Customer Center (MACC). (See Medical Supplier Services chapter, N.J.A.C. 10:59.)

N.J. Admin. Code § 10:56-2.21

New Rule, 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).
Amended by R.2004 d.25, effective 1/20/2004.
See: 35 N.J.R. 4032(a), 36 N.J.R. 568(a).
In (a)13, inserted a reference to NJ FamilyCare and substituted "Medical Assistance Customer Center (MACC)" for "Medicaid District Office (MDO)".
Amended by R.2007 d.36, effective 2/5/2007.
See: 38 N.J.R. 3419(a), 39 N.J.R. 479(a).
In (a)11, substituted "Centers for Medicare & Medicaid Services" for "Health Care Financing Administration (HCFA)".