2012 New York Consolidated Laws
PBH - Public Health
Article 2-A - PRESCRIPTION DRUGS
Title 1 - (270 - 277) PREFERRED DRUG AND CLINICAL DRUG REVIEW PROGRAMS
274 - Clinical drug review program.

 
    §  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.