2023 New York Laws › PBH - Public Health › Article 2-A - Prescription Drugs › Title 1 - 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 drug utilization review board.
For this purpose, the commissioner and the board, 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 board 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 board 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.