NY Pub Health L § 272 (2021)
2021 New York Laws PBH - Public Health Article 2-A - Prescription Drugs Title 1 - Preferred Drug and Clinical Drug Review Programs 272 - Preferred Drug Program.

§  272.  Preferred  drug  program.  1.  There  is hereby established a preferred  drug  program  to  promote  access  to  the  most   effective prescription  drugs  while  reducing  the cost of prescription drugs for persons in state public health plans.   2. When a prescriber prescribes a  non-preferred  drug,  state  public health  plan reimbursement shall be denied unless prior authorization is obtained, unless no prior authorization is required under this article.   3. The commissioner shall  establish  performance  standards  for  the program  that,  at a minimum, ensure that the preferred drug program and the clinical drug review program provide  sufficient  technical  support and timely responses to consumers, prescribers and pharmacists.   4.  Notwithstanding  any  other  provision  of law to the contrary, no preferred  drug  program  or   prior   authorization   requirement   for prescription  drugs,  except as created by this article, paragraph (a-1) or (a-2) of subdivision four of section three  hundred  sixty-five-a  of the  social  services  law,  paragraph (g) of subdivision two of section three hundred sixty-five-a of the social services law,  subdivision  one of section two hundred forty-one of the elder law and shall apply to the state public health plans.   5.   The  drug  utilization  review  board  shall  consider  and  make recommendations to the commissioner for the adoption of a preferred drug program. (a) In developing the preferred drug program, the board  shall, without  limitation:  (i)  identify  therapeutic  classes or drugs to be included in the preferred drug program; (ii) identify preferred drugs in each of the chosen therapeutic  classes;  (iii)  evaluate  the  clinical effectiveness  and  safety of drugs considering the latest peer-reviewed research and may consider studies submitted to the federal food and drug administration  in  connection  with  its  drug  approval  system;  (iv) consider  the  potential impact on patient care and the potential fiscal impact that may result from making such a therapeutic class  subject  to prior  authorization;  and  (v)  consider  the  potential  impact of the preferred drug program on the health  of  special  populations  such  as children,  the  elderly,  the chronically ill, persons with HIV/AIDS and persons with mental health conditions.  (b) In developing the preferred drug program, the board  may  consider preferred drug programs or evidence based research operated or conducted by   or   for  other  state  governments,  the  federal  government,  or multi-state coalitions. Notwithstanding any  inconsistent  provision  of section one hundred twelve or article eleven of the state finance law or section  one  hundred  forty-two  of the economic development law or any other law, the department may enter into contractual agreements with the Oregon Health and Science University Drug Effectiveness  Review  Project to  provide  technical  and  clinical  support  to  the  board  and  the department in researching and recommending drugs to  be  placed  on  the preferred drug list.  (c)  The  board shall from time to time review all therapeutic classes included in the preferred drug  program,  and  may  recommend  that  the commissioner  add  or  delete  drugs  or classes of drugs to or from the preferred drug program, subject to this subdivision.  (d)  The  board  shall  establish  procedures   to   promptly   review prescription   drugs  newly  approved  by  the  federal  food  and  drug administration.   6. The board shall recommend a procedure and criteria for the approval of non-preferred drugs as part of the prior  authorization  process.  In developing  these criteria, the board shall include consideration of the following:  (a) the preferred drug has been tried by the patient and has failed to produce the desired health outcomes;  (b) the patient has tried  the  preferred  drug  and  has  experienced unacceptable side effects;  (c)  the  patient  has  been  stabilized  on  a non-preferred drug and transition to the preferred drug would be medically contraindicated; and  (d) other clinical indications for the use of the non-preferred  drug, which  shall  include  consideration  of  the  medical  needs of special populations, including  children,  the  elderly,  the  chronically  ill, persons with mental health conditions, and persons affected by HIV/AIDS.   7.  The  commissioner  shall  provide thirty days public notice on the department's website prior to  any  meeting  of  the  board  to  develop recommendations  concerning  the  preferred  drug  program.  Such notice regarding meetings of the board  shall  include  a  description  of  the proposed therapeutic class to be reviewed, a listing of drug products in the  therapeutic class, and the proposals to be considered by the board. The board shall allow interested parties  a  reasonable  opportunity  to make   an   oral   presentation  to  the  board  related  to  the  prior authorization of the therapeutic class to be reviewed. The  board  shall consider  any  information  provided by any interested party, including, but not limited to, prescribers,  dispensers,  patients,  consumers  and manufacturers of the drug in developing their recommendations.   8.  The  commissioner  shall  provide  notice  of  any recommendations developed by the board regarding the preferred drug  program,  at  least five  days before any final determination by the commissioner, by making such information available on  the  department's  website.  Such  public notice  may  include:  a  summary  of  the deliberations of the board; a summary of the positions of those making public comments at meetings  of the  board; the response of the board to those comments, if any; and the findings and recommendations of the board.   9. Within ten days of a final determination  regarding  the  preferred drug  program,  the  commissioner  shall  provide  public  notice on the department's website of such determinations, including:  the  nature  of the  determination;  and  analysis  of  the impact of the commissioner's determination on state public health plan populations and providers; and the projected fiscal impact to the state public health plan programs  of the commissioner's determination.   10.  The  commissioner  shall  adopt  a  preferred  drug  program  and amendments after considering the recommendations from the board and  any comments  received from prescribers, dispensers, patients, consumers and manufacturers of the drug.  (a) The preferred drug list in any therapeutic class included  in  the preferred  drug  program  shall  be  developed  based  initially  on  an evaluation of the clinical effectiveness, safety and  patient  outcomes, followed by consideration of the cost-effectiveness of the drugs.  (b)  In each therapeutic class included in the preferred drug program, the  board  shall  determine  whether  there  is  one  drug   which   is significantly more clinically effective and safe, and that drug shall be included  on  the preferred drug list without consideration of cost. If, among two or more drugs  in  a  therapeutic  class,  the  difference  in clinical  effectiveness  and  safety is not clinically significant, then cost effectiveness (including price and supplemental rebates)  may  also be  considered  in  determining which drug or drugs shall be included on the preferred drug list.  (c) In  addition  to  drugs  selected  under  paragraph  (b)  of  this subdivision,  any prescription drug in the therapeutic class, whose cost to the state public health plans (including net price  and  supplemental rebates)  is  equal  to  or  less  than  the cost of another drug in the therapeutic class that is on the preferred drug list under paragraph (b)  of this subdivision, may be selected to be on the preferred  drug  list, based on clinical effectiveness, safety and cost-effectiveness.  (d) Notwithstanding any provision of this section to the contrary, the commissioner  may  designate  therapeutic  classes  of  drugs, including classes with only one drug, as all preferred prior to  any  review  that may be conducted by the board pursuant to this section.   11.   (a)   The   commissioner   shall   provide  an  opportunity  for pharmaceutical manufacturers to  provide  supplemental  rebates  to  the state  public  health  plans  for drugs within a therapeutic class; such supplemental rebates shall be taken into consideration by the board  and the commissioner in determining the cost-effectiveness of drugs within a therapeutic class under the state public health plans.  (b)  The  commissioner  may designate a pharmaceutical manufacturer as one with whom the  commissioner  is  negotiating  or  has  negotiated  a manufacturer  agreement, and all of the drugs it manufactures or markets shall be included in the preferred drug program.  The  commissioner  may negotiate  directly  with  a  pharmaceutical  manufacturer  for  rebates relating to any or all of  the  drugs  it  manufactures  or  markets.  A manufacturer   agreement  shall  designate  any  or  all  of  the  drugs manufactured or marketed by the  pharmaceutical  manufacturer  as  being preferred or non preferred drugs. When a pharmaceutical manufacturer has been  designated  by  the  commissioner  under  this  paragraph  but the commissioner  has  not  reached  a  manufacturer  agreement   with   the pharmaceutical manufacturer, then the commissioner may designate some or all  of  the  drugs  manufactured  or  marketed  by  the  pharmaceutical manufacturer as  non  preferred  drugs.  However,  notwithstanding  this paragraph,  any  drug  that is selected to be on the preferred drug list under paragraph (b) of subdivision ten of this section on  grounds  that it is significantly more clinically effective and safer than other drugs in its therapeutic class shall be a preferred drug.  (c)  Supplemental  rebates under this subdivision shall be in addition to those required by applicable federal law  and  subdivision  seven  of section three hundred sixty-seven-a of the social services law. In order to  be  considered  in  connection with the preferred drug program, such supplemental rebates shall apply to the drug  products  dispensed  under the   Medicaid  program  and  the  EPIC  program.  The  commissioner  is prohibited from approving alternative rebate demonstrations, value added programs  or  guaranteed  savings  from  other  program  benefits  as  a substitution for supplemental rebates.   13.  The  commissioner may implement all or a portion of the preferred drug program through contracts with  administrators  with  expertise  in management of pharmacy services, subject to applicable laws.   14.  For  a  period  of  eighteen  months, commencing with the date of enactment of this article, and without  regard  to  the  preferred  drug program  or  the  clinical  drug  review  program  requirements  of this article, the commissioner is authorized to  implement,  or  continue,  a prior  authorization  requirement  for a drug which may not be dispensed without a prescription as required by section sixty-eight hundred ten of the education law, for which there is a non-prescription version  within the same drug class, or for which there is a comparable non-prescription version of the same drug. Any such prior authorization requirement shall be  implemented in a manner that is consistent with the process employed by the commissioner for such authorizations as of one day prior  to  the date  of  enactment  of  this article. At the conclusion of the eighteen month period, any such drug or  drug  class  shall  be  subject  to  the preferred  drug program requirements of this article; provided, however, that the commissioner is authorized to immediately subject any such drug  to prior authorization without regard to the provisions of  subdivisions five through eleven of this section.