New Jersey Administrative Code
Title 10 - HUMAN SERVICES
Chapter 167C - PROVISION OF PHARMACEUTICAL SERVICES UNDER THE SENIOR GOLD PROGRAM
Subchapter 1 - REQUIREMENTS FOR PROVISION OF PHARMACEUTICAL SERVICES
Section 10:167C-1.20 - Drug efficacy study implementation (DESI)

Universal Citation: NJ Admin Code 10:167C-1.20

Current through Register Vol. 56, No. 18, September 16, 2024

(a) "Less than effective drugs" are subject to a Notice of Opportunity for Hearing (NOOH) by the Food and Drug Administration (FDA).

1. Reimbursement is not available for the purchase or administration of any drug product that meets all of the following conditions:
i. The drug product was approved by the Food and Drug Administration (FDA) before October 10, 1962;

ii. The drug product is available only through prescription;

iii. The drug product is the subject of a notice of opportunity for hearing issued under Section 505(e) of the Federal Food Drug, and Cosmetic Act and published in the Federal Register on a proposed order of FDA to withdraw its approval for the drug product because it has determined that the product is less than effective for all its labeled indications; and

iv. The drug product is presently the subject of an efficacy review study performed by FDA (see 21 CFR 310.6 including all subsequent amendments and supplements). The FDA efficacy review potentially can determine justification for a drug product's medical need. If a drug product fails this review, the product is classified as a drug efficacy study implementation (DESI) drug.

2. Reimbursement is not available for the purchase or administration of any drug product that is identical, related or similar, as defined in 21 CFR 310.6 (including all subsequent amendments and supplements), to a drug product that meets the conditions of (a) above.

3. The initial list of drugs and related drug products classified as "less than effective" by the FDA pending outcome of the NOOH appears at 21 CFR 310.6. Subsequent revisions to this list which are adopted shall appear in the Federal Register.

(b) To obtain a list of DESI drugs, see N.J.A.C. 10:51, Appendix A.

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