S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                  4823

                       2011-2012 Regular Sessions

                          I N  A S S E M B L Y

                            February 8, 2011
                               ___________

Introduced  by  M.  of  A.  P. RIVERA  --  read once and referred to the
  Committee on Health

AN ACT to amend the social services law and the public  health  law,  in
  relation to drug utilization review and the preferred drug program

  THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:

  Section 1. Subdivision 4 of section 369-cc of the social services law,
as added by section 39 of part C of chapter 58 of the laws of  2009,  is
amended to read as follows:
  4.  (a)  The  commissioner,  through  the prospective DUR program, may
require step therapy when there is more than  one  drug  appropriate  to
treat  a  medical condition. The purpose of step therapy is to encourage
the use of medically appropriate, cost effective drugs  when  clinically
indicated  and to limit use of alternative drug therapies unless certain
clinical requirements are met. The DUR board shall recommend  guidelines
for  specific  diagnoses and therapy regimens within which practitioners
may prescribe drugs without the requirement for prior  authorization  of
those  drugs. In establishing these guidelines, the board shall consider
clinical effectiveness, safety, and cost effectiveness.  Prior  authori-
zation  under this paragraph shall be obtained under section two hundred
seventy-three of the public health law.  IN ADDITION, THE  AUTHORITY  TO
REQUIRE STEP THERAPY AS AUTHORIZED BY THIS PARAGRAPH SHALL NOT APPLY TO:
  (I) ATYPICAL ANTI-PSYCHOTICS;
  (II) ANTI-DEPRESSANTS;
  (III) ANTI-RETROVIRALS USED IN THE TREATMENT OF HIV/AIDS;
  (IV)  ANTI-REJECTION  DRUGS USED FOR THE TREATMENT OF ORGAN AND TISSUE
TRANSPLANTS; AND
  (V) ANY OTHER THERAPEUTIC CLASS FOR THE TREATMENT OF MENTAL ILLNESS OR
HIV/AIDS, RECOMMENDED BY THE DUR BOARD AND APPROVED BY THE COMMISSIONER.
  (b) The commissioner, through the prospective DUR  program,  may  from
time  to time limit the quantity, frequency, and duration of drug thera-
py, using guidelines developed by the DUR board.  The  DUR  board  shall
develop clinical prescribing guidelines relating to quantity, frequency,
and duration of drug therapy for the commissioner's use under this para-

              

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD01204-01-1

A. 4823                             2

graph.  In establishing these guidelines, the board shall consider clin-
ical effectiveness, safety, and cost effectiveness. Prior  authorization
under  this paragraph shall be obtained under section two hundred seven-
ty-three of the public health law. Exceptions to any prior authorization
imposed  as  a result of these guidelines shall include, but need not be
limited to, provision for emergency circumstances where a medical condi-
tion requires alleviation of severe pain or  which  threatens  to  cause
disability  or  to  take a life if not promptly treated.  PRIOR AUTHORI-
ZATION UNDER THIS PARAGRAPH SHALL BE OBTAINED PURSUANT  TO  SECTION  TWO
HUNDRED  SEVENTY-THREE  OF  THE  PUBLIC  HEALTH  LAW.   IN ADDITION, THE
AUTHORITY TO LIMIT THE QUANTITY, FREQUENCY AND DURATION OF DRUG  THERAPY
AS AUTHORIZED BY THIS PARAGRAPH SHALL NOT APPLY TO:
  (I) ATYPICAL ANTI-PSYCHOTICS;
  (II) ANTI-DEPRESSANTS;
  (III) ANTI-RETROVIRALS USED IN THE TREATMENT OF HIV/AIDS;
  (IV)  ANTI-REJECTION  DRUGS USED FOR THE TREATMENT OF ORGAN AND TISSUE
TRANSPLANTS; AND
  (V) ANY OTHER THERAPEUTIC CLASS FOR THE TREATMENT OF MENTAL ILLNESS OR
HIV/AIDS, RECOMMENDED BY THE DUR BOARD AND APPROVED BY THE COMMISSIONER.
  S 2. Paragraph (b) of subdivision 11 of  section  272  of  the  public
health  law,  as added by section 36 of part C of chapter 58 of the laws
of 2009, is amended to read as follows:
  (b) (I) 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 relat-
ing to any or all of the drugs it manufactures or markets. A manufactur-
er 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 has not reached a manufac-
turer agreement with the pharmaceutical manufacturer, then  all  of  the
drugs  manufactured or marketed by the pharmaceutical manufacturer shall
be 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  signif-
icantly  more  clinically  effective  and  safer than other drugs in its
therapeutic class shall be a preferred drug.
  (II) PRIOR AUTHORIZATION UNDER THIS PARAGRAPH SHALL BE OBTAINED PURSU-
ANT TO THIS SECTION. IN ADDITION, THE AUTHORITY TO  DESIGNATE  DRUGS  AS
PREFERRED  OR  NON PREFERRED PURSUANT TO AN AGREEMENT AUTHORIZED BY THIS
PARAGRAPH SHALL NOT APPLY TO:
  (A) ATYPICAL ANTI-PSYCHOTICS;
  (B) ANTI-DEPRESSANTS;
  (C) ANTI-RETROVIRALS USED IN THE TREATMENT OF HIV/AIDS;
  (D) ANTI-REJECTION DRUGS USED FOR THE TREATMENT OF  ORGAN  AND  TISSUE
TRANSPLANTS; AND
  (E) ANY OTHER THERAPEUTIC CLASS FOR THE TREATMENT OF MENTAL ILLNESS OR
HIV/AIDS, RECOMMENDED BY THE DUR BOARD AND APPROVED BY THE COMMISSIONER.
  S  3. This act shall take effect immediately, provided that the amend-
ments to section 272 of the public health law, made by  section  two  of
this  act,  shall not affect the repeal of such section and shall expire
and  be deemed repealed therewith.