NY State Assembly Bill 2009-A9009

Assembly Bill A9009

2009-2010 Legislative Session

Provides that drug utilization review and the preferred drug program shall not apply to certain drugs

download bill text pdf

Archive: Last Bill Status - In Assembly Committee

Introduced
- In Committee Assembly
- In Committee Senate
- On Floor Calendar Assembly
- On Floor Calendar Senate
- Passed Assembly
- Passed Senate
Delivered to Governor
Signed By Governor

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	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Jan 06, 2010	referred to health
Jun 19, 2009	referred to health

2009-A9009 (ACTIVE) - Details

Current Committee:: Assembly Health
Law Section:: Social Services Law
Laws Affected:: Amd §369-cc, Soc Serv L; amd §272, Pub Health L
Versions Introduced in 2011-2012 Legislative Session:: A4823

2009-A9009 (ACTIVE) - Summary

Provides that drug utilization review and the preferred drug program shall not apply to certain drugs.

2009-A9009 (ACTIVE) - Sponsor Memo

                                BILL NUMBER:A9009

TITLE OF BILL:  An act to amend the social services law and the public
health law, in relation to drug utilization review and the preferred
drug program

PURPOSE: To ensure new Medicaid prescription drug utilization controls
maintain existing protections.

SUMMARY OF PROVISIONS:  Section one ensures existing carve-outs apply to
new step therapy provisions. Current law already includes provider-pre-
vails language.

Section two ensures existing provider-prevails protections and carve-
outs apply to new use, frequency and duration utilization controls.

Section three ensures existing provider-prevails protections and carve-
outs apply to directly-negotiated agreements with manufacturers.

Section four establishes the effective date.

EXISTING LAW:  The SPY 2009-10 budget included various new mechanisms
intended to control prescription drug costs in New York's Medicaid
program. It is unclear, however, if these new provisions are subject to
existing protections found in the Prescription Drug Program.

JUSTIFICATION:  New York's Prescription Drug Program (PDP) contains two
important protections for consumers. Certain drugs (anti-psychotics,
anti-retrovirals, anti-depressants, and anti-rejection medications) are
excluded, or "carved out", entirely from the PDP. Additionally, all
drugs which are included in the PDP may still be accessed by Medicaid
beneficiaries if their provider determines the drug in question is
warranted in his or her professional judgment.

The SPY 2009-10 gave the Drug Utilization Review Board the authority to
establish a step therapy program as well as controls on the use,
frequency and-duration of certain drugs. While the budget clearly indi-
cated that the PDP prior authorization approach, including provider
prevails, applies to step therapy, there is no clear indication that
provider prevails applies to use, frequency and duration controls or
that currently carved-out drugs would be excluded from controls devel-
oped under either program. This bill clarifies that these existing
protections apply to new utilization control programs developed by the
Board.

The budget also allowed the Department of Health to negotiate directly
with drug manufacturers to establish supplemental rebates, This bill
clarifies that provider prevails and carve-out protections will apply to
such agreements.

LEGISLATIVE HISTORY: New Bill

FISCAL IMPLICATIONS: None

LOCAL FISCAL IMPLICATIONS: None

EFFECTIVE DATE: September 1, 2009

2009-A9009 (ACTIVE) - Bill Text download pdf

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

                                  9009

                       2009-2010 Regular Sessions

                          I N  A S S E M B L Y

                              June 19, 2009
                               ___________

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.
                                                           LBD14410-01-9

A. 9009                             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 on the same date and in the same
manner as section 39 of part C of chapter 58 of the laws of  2009  takes
effect, provided that the amendments 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.

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