N.Y. Comp. Codes R. & Regs. tit. 9 § 9960.3

Current through Register Vol. 46, No. 36, September 4, 2024

Section 9960.3 - Procedures for determinations relating to package, dosage form or form of administration

For purposes of designating a given package, dosage form or form of administration as excluded from coverage, the following shall apply:

(a) An initial determination based upon information and facts available, shall be made by the department utilizing such considerations as:

(1) the availability of low-cost alternative packaging, dosage form or forms of administration;

(2) any particular health needs of the EPIC population;

(3) the degree to which the packaging, dosage form or form of administration offers comfort, convenience or ease of administration at added cost;

(4) availability of pharmaceutically equivalent and therapeutically equivalent products for the covered population;

(5) any drug marketed as a therapeutic agent with official labeling which states that the product is contraindicated by virtue of age or therapeutic condition for program participants; or

(6) recommendations of the Technical Pharmacy Advisory Committee of the department, where appropriate, as to current pharmacy practice and drug marketing principles.

(b) The department shall notify the manufacturer(s) in writing of its intent to exclude a specific drug's packaging, dosage form or form of administration giving the reasons for the intended exclusion, together with the facts upon which the initial determination is based.

(c) The manufacturer(s) shall then have 15 days following receipt of notice of initial determination to notify the department in writing of intent to appeal the initial determination.

(1) Failure on the part of the manufacturer(s) to so notify the department of its intent to appeal within the 15 days, allows for immediate final determination to be made by the commissioner.

(2) If the manufacturer notifies the department of an intent to appeal, the manufacturer shall submit to the department, within 45 days of receiving the initial determination, all the information and documentation which forms the basis of the manufacturer's appeal.

(d)

(1) The department, within 15 days of receiving the manufacturer's basis for appeal, shall provide to the manufacturer any additional facts concerning the intent to exclude a drug product to support the initial determination.

(2) Within 10 days of receiving such additional facts, the manufacturer may submit to the department additional facts relevant to the drug package, or form of dosage or administration.

(3) Based upon all of the facts and information gathered and submitted, the commissioner shall make a final determination as to whether to designate a package, dosage form or form of administration, and exclude drug from program benefits coverage.

(4) As final determinations of excluded drugs relating to package, dosage form or form of administration are made by the commissioner pursuant to this subdivision, written notice of such determinations shall be made to the EPIC contractor by the EPIC executive director and to the drug manufacturer of such drug product.

N.Y. Comp. Codes R. & Regs. Tit. 9 § 9960.3