N.J. Admin. Code § 10:167A-1.6

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

Section 10:167A-1.6 - 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 may be denied if any of the following, or any of the requirements of this chapter are not met:

1. Prescription Drug Price and Quality Stabilization Act (N.J.S.A. 24:6E-1 et seq.) (see N.J.A.C. 10:167A-1.21) and Non-Proprietary or generic dispensing (see N.J.A.C. 10:167A-1.12);

2. Federal regulations (42 CFR 447.500, 512-516) 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. 10:167A-1.7, Basis of payment); and

3. 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 10:167A-1.22) and listing of DESI drugs in (N.J.A.C. 10:51, Appendix A).

N.J. Admin. Code § 10:167A-1.6

Amended by R.1996 d.146, effective 3/18/1996 (operative April 1, 1996).
See: 27 N.J.R. 4566(a), 28 N.J.R. 1526(a).
Amended by R.1998 d.464, effective 9/8/1998.
See: 30 N.J.R. 2197(a), 30 N.J.R. 3309(a).
Recodified from N.J.A.C. 8:83C-1.4 and amended by R.2003 d. 248, effective 6/16/2003.
See: 34 N.J.R. 3456(a), 35 N.J.R. 2642(a).
Amended N.J.A.C. references throughout. Former N.J.A.C. 8:83C-1.6, Regression categories and discounts, recodified to N.J.A.C. 8:83C-1.8.
Amended by R.2009 d.293, effective 10/5/2009.
See: 41 N.J.R. 1637(a), 41 N.J.R. 3804(a).

Amended by 49 N.J.R. 446(a), effective 3/6/2017