NY Elder L § 252 (2021)
2021 New York Laws ELD - Elder Article 2 - Programs for the Elderly Title 3 - Program for Elderly Pharmaceutical Insurance Coverage 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.