§ 252 — Procedures for determinations relating to package, or form of dosage or administration, of certain drugs

§ 252. Procedures for determinations relating to package, or form of\ndosage or administration, of certain drugs. 1. If the department of\nhealth makes an initial determination that a particular package, or form\nof dosage or administration, of a drug shall be excluded in accordance\nwith the provisions of paragraph (b) of subdivision one of section two\nhundred forty-one of this title, the executive department shall notify\nthe manufacturer of such drug product that the executive department\nintends to seek the exclusion of such package, or form of dosage or\nadministration, from the program and shall provide such manufacturer\nwith the reasons therefor together with the facts which the department\nrelies upon to support its initial determination. The manufacturer shall\nhave fifteen days after receiving such exclusion notice to notify the\nexecutive department of an intent to appeal the decision. If the\nmanufacturer fails to notify the executive department of an intent to\nappeal within the time specified in this section, the commissioner of\nhealth shall forthwith determine whether the package, or form of dosage\nor administration, shall be excluded from the program. If the\nmanufacturer notifies the executive department of an intent to appeal,\nthe manufacturer shall submit to the executive department within\nforty-five days of receiving such exclusion notice, the basis of the\nmanufacturer's appeal. Within fifteen days of receiving such submission\nfrom the manufacturer, the executive department shall provide to the\nmanufacturer any additional facts concerning the drug product that the\ndepartment relies upon to support its initial determination. Within ten\ndays of receiving such facts, the manufacturer may submit additional\nfacts concerning the drug package, or form of dosage or administration.\nBased on the facts submitted pursuant to this section, the commissioner\nof health shall make a final determination, in accordance with the\nstandard set forth in paragraph (b) of subdivision one of section two\nhundred forty-one of this title, as to whether the package, or form of\ndosage or administration, of the drug product shall constitute a covered\ndrug for the purposes of this article. A determination to exclude the\ndrug package, or form of dosage or administration, shall be subject to\njudicial review pursuant to article seventy-eight of the civil practice\nlaw and rules.\n 2. The commissioner of health shall establish by regulation an\nappropriate process allowing drug packages, or forms of dosage or\nadministration, finally determined under this section not to be covered\ndrugs for the purposes of this title to be dispensed to program\nparticipants for whom such drug packages, or forms of dosage or\nadministration, are medically indicated as certified to by a physician\ntreating such participant. Any such drug package, or form of dosage or\nadministration, so certified as medically indicated for a specific\nparticipant in accordance with such regulations shall be a covered drug\nfor the purpose of this title.\n