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.