NY Pub Health L § 274 (2021)
2021 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.