N.Y. Elder Law § 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

dosage or administration, of certain drugs. 1. If the department of

health makes an initial determination that a particular package, or form

of dosage or administration, of a drug shall be excluded in accordance

with the provisions of paragraph (b) of subdivision one of section two

hundred forty-one of this title, the executive department shall notify

the manufacturer of such drug product that the executive department

intends to seek the exclusion of such package, or form of dosage or

administration, from the program and shall provide such manufacturer

with the reasons therefor together with the facts which the department

relies upon to support its initial determination. The manufacturer shall

have fifteen days after receiving such exclusion notice to notify the

executive department of an intent to appeal the decision. If the

manufacturer fails to notify the executive department of an intent to

appeal within the time specified in this section, the commissioner of

health shall forthwith determine whether the package, or form of dosage

or administration, shall be excluded from the program. If the

manufacturer notifies the executive department of an intent to appeal,

the manufacturer shall submit to the executive department within

forty-five days of receiving such exclusion notice, the basis of the

manufacturer's appeal. Within fifteen days of receiving such submission

from the manufacturer, the executive department shall provide to the

manufacturer any additional facts concerning the drug product that the

department relies upon to support its initial determination. Within ten

days of receiving such facts, the manufacturer may submit additional

facts concerning the drug package, or form of dosage or administration.

Based on the facts submitted pursuant to this section, the commissioner

of health shall make a final determination, in accordance with the

standard set forth in paragraph (b) of subdivision one of section two

hundred forty-one of this title, as to whether the package, or form of

dosage or administration, of the drug product shall constitute a covered

drug for the purposes of this article. A determination to exclude the

drug package, or form of dosage or administration, shall be subject to

judicial review pursuant to article seventy-eight of the civil practice

law and rules.

2. The commissioner of health shall establish by regulation an

appropriate process allowing drug packages, or forms of dosage or

administration, finally determined under this section not to be covered

drugs for the purposes of this title to be dispensed to program

participants for whom such drug packages, or forms of dosage or

administration, are medically indicated as certified to by a physician

treating such participant. Any such drug package, or form of dosage or

administration, so certified as medically indicated for a specific

participant in accordance with such regulations shall be a covered drug

for the purpose of this title.