N.J. Admin. Code § 11:24-18.2

Current through Register Vol. 56, No. 21, November 4, 2024

Section 11:24-18.2 - Nonformulary medications

(a) Every health benefits plan issued by an HMO that provides benefits for formulary medications shall also provide benefits for nonformulary medications. Increased benefits may apply to formulary medications provided the difference between the total benefit value of formulary medication coverage and the total benefit value of nonformulary medication coverage does not exceed 30 percent. Compliance with this requirement shall be demonstrated by submitting to the Department a completed Actuarial Justification of Benefit Differentials form (incorporated herein by reference as the Appendix to this subchapter).

(b) The HMO shall establish an approval process to enable health care providers and covered persons to obtain coverage of nonformulary medications at the same level as formulary medications where the prescribing health care provider certifies the medical necessity of the medication.

(c) A nonformulary medication shall be considered medically necessary if:

1. It is approved under the Federal Food, Drug and Cosmetic Act ( 21 U.S.C. §§ 301 et seq.); or its use is supported by one or more citations included or approved for inclusion in the American Hospital Formulary Service Drug Information or the United States Pharmacopoeia--Drug Information, or it is recommended by a clinical study or review article in a major peer reviewed professional journal; and

2. The prescribing health care provider states that all formulary medications used to treat a disease state have been ineffective in the treatment of the covered person's disease or condition, or all such medications have caused or are reasonably expected to cause adverse or harmful reactions in the covered person.

(d) The approval process for nonformulary medications shall provide that the HMO approve or deny the request by communicating such approval or denial to the prescribing health care provider by telephone or other telecommunication device within five business days of a request for prior authorization. Failure to approve or deny the request within five business days shall be deemed an approval of the request. Initial denials shall also be provided to the prescribing health care provider and covered person in writing within five business days of receipt of the request for approval of a nonformulary medication, and shall include the clinical reason for the denial. Such denials are appealable to the Independent Health Care Appeals Program in the Department pursuant to 26:2S-11.

(e) The HMO shall file with the Department a report summarizing all formulary appeals and their resolutions for the preceding year on forms prescribed by the Department. Such report shall be included as a separate page with the HMO's annual report filed pursuant to 26:2J-9.

N.J. Admin. Code § 11:24-18.2