Section 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.