Section 274. Clinical drug review program

1. In addition to the preferred
  drug program established by this article, the commissioner may establish
  a clinical drug review program. The commissioner may, from time to time,
  require prior authorization under such program for prescription drugs or
  patterns  of  utilization  under  state  public  health  plans.  When  a
  prescriber prescribes a drug which requires  prior  authorization  under
  this  section,  state  public  health plan reimbursement shall be denied
  unless such prior authorization is obtained.
    2. The clinical drug review program shall make available a twenty-four
  hour per day, seven days per week response system.
    3. In establishing a prior authorization requirement for a drug  under
  the  clinical  drug  review program, the commissioner shall consider the
  following:
    (a) whether the drug requires monitoring of prescribing  protocols  to
  protect both the long-term efficacy of the drug and the public health;
    (b) the potential for, or a history of, overuse, abuse, drug diversion
  or illegal utilization; and
    (c)  the potential for, or a history of, utilization inconsistent with
  approved indications. Where the commissioner finds that a drug meets  at
  least  one  of  these  criteria, in determining whether to make the drug
  subject to prior authorization under the clinical drug  review  program,
  the commissioner shall consider whether similarly effective alternatives
  are  available  for  the  same  disease  state  and  the  effect of that
  availability or lack of availability.
    4. The commissioner shall obtain an  evaluation  of  the  factors  set
  forth  in  subdivision  three of this section and a recommendation as to
  the establishment of a prior authorization requirement for a drug  under
  the  clinical  drug  review  program  from the pharmacy and therapeutics
  committee. For this purpose, the  commissioner  and  the  committee,  as
  applicable, shall comply with the following meeting and notice processes
  established by this article:
    (a) the open meetings law and freedom of information law provisions of
  subdivision six of section two hundred seventy-one of this article; and
    (b)  the public notice and interested party provisions of subdivisions
  seven, eight and  nine  of  section  two  hundred  seventy-two  of  this
  article.
    5.  The  committee  shall  recommend  a procedure and criteria for the
  approval of drugs subject to prior authorization under the clinical drug
  review program.  Such  criteria  shall  include  the  specific  approved
  clinical indications for use of the drug.
    6.   The   commissioner   shall   identify  a  drug  for  which  prior
  authorization is required, as well as the procedures  and  criteria  for
  approval  of  use  of  the  drug, under the clinical drug review program
  after  considering  the  recommendations  from  the  committee  and  any
  comments   received   from   prescribers,   dispensers,   consumers  and
  manufacturers of the drug. In no event  shall  the  prior  authorization
  criteria  for  approval pursuant to this subdivision result in denial of
  the prior authorization request based on the relative cost of  the  drug
  subject to prior authorization.
    7.  In  the  event  that  the  patient  does not meet the criteria for
  approval established by the commissioner  in  subdivision  six  of  this
  section,  the  clinical  drug  review program shall provide a reasonable
  opportunity  for  a  prescriber  to  reasonably  present  his   or   her
  justification  for  prior authorization. If, after consultation with the
  program, the prescriber, in his or her reasonable professional judgment,
  determines that the use of  the  prescription  drug  is  warranted,  the
  prescriber's  determination shall be final and prior authorization shall
  be  granted  under  this  section;   provided,   however,   that   prior

  authorization   may   be  denied  in  cases  where  the  department  has
  substantial evidence that the prescriber or patient is engaged in  fraud
  or abuse relating to the drug.
    8. In the event that a patient presents a prescription to a pharmacist
  for  a  prescription  drug  that requires prior authorization under this
  section and for which prior authorization has  not  been  obtained,  the
  pharmacist shall, within a prompt period based on professional judgment,
  notify  the  prescriber.  The  prescriber  shall, within a prompt period
  based on professional judgment, either seek prior authorization or shall
  contact the  pharmacist  and  amend  or  cancel  the  prescription.  The
  pharmacist shall, within a prompt period based on professional judgment,
  notify  the patient when prior authorization has been obtained or denied
  or when the prescription has been amended or cancelled.
    9. In the instance where a prior authorization  determination  is  not
  completed within twenty-four hours of the original request solely as the
  result  of  a  failure  of  the program (whether by action or inaction),
  prior authorization  shall  be  immediately  and  automatically  granted
  without  further  action  by  the prescriber and the prescriber shall be
  notified  of  this  determination.  In  the  instance  where   a   prior
  authorization determination is not completed within twenty-four hours of
  the  original request for any other reason, a seventy-two hour supply of
  the medication will be approved by the program and the prescriber  shall
  be notified of the determination.
    10.  When,  in  the  judgment  of the prescriber or the pharmacist, an
  emergency condition exists, and the prescriber  or  pharmacist  notifies
  the  program  to  confirm  that  such  an  emergency condition exists, a
  seventy-two hour emergency  supply  of  the  drug  prescribed  shall  be
  immediately authorized by the program.
    11.  The department or the panel shall monitor the prior authorization
  process for prescribing patterns which are suspected of endangering  the
  health  and  safety  of the patient or which demonstrate a likelihood of
  fraud or abuse. The department or the  panel  shall  take  any  and  all
  actions  otherwise  permitted  by  law  to  investigate such prescribing
  patterns, to take remedial action and to enforce applicable federal  and
  state laws.
    12.  The  commissioner  may implement all or a portion of the clinical
  drug review program through contracts with administrators with expertise
  in management of pharmacy services, subject to applicable laws.
    13. No prior authorization under  the  clinical  drug  review  program
  shall be required for any prescription under EPIC until the commissioner
  has  made  prior  authorization  applicable  to  EPIC  under section two
  hundred seventy-five of this article.
    14. For the period of eighteen months, commencing  with  the  date  of
  enactment  of  this  article, the commissioner is authorized to continue
  prior authorization requirements for prescription drugs subject to prior
  authorization as of one day prior to the enactment of this  article  and
  which  are  not described in subdivision fourteen of section two hundred
  seventy-two of this article. At the conclusion  of  the  eighteen  month
  period,  any  such  drug  shall  be  subject to the clinical drug review
  program requirements  of  this  section;  provided,  however,  that  the
  commissioner is authorized to immediately subject any such drug to prior
  authorization  without  regard  to  the provisions of subdivisions three
  through six of this section.
    * NB Repealed June 15, 2012