A04823 Summary:
BILL NO | A04823 |
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SAME AS | No same as |
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SPONSOR | Rivera P |
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COSPNSR | Stevenson, Rivera N, Tobacco |
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MLTSPNSR | Pheffer |
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Amd S369-cc, Soc Serv L; amd S272, Pub Health L | |
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Provides that drug utilization review and the preferred drug program shall not apply to certain drugs. |
A04823 Actions:
BILL NO | A04823 | |||||||||||||||||||||||||||||||||||||||||||||||||
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02/08/2011 | referred to health | |||||||||||||||||||||||||||||||||||||||||||||||||
01/04/2012 | referred to health | |||||||||||||||||||||||||||||||||||||||||||||||||
09/04/2012 | enacting clause stricken |
A04823 Memo:
Go to topNEW YORK STATE ASSEMBLY
MEMORANDUM IN SUPPORT OF LEGISLATION
submitted in accordance with Assembly Rule III, Sec 1(f)   BILL NUMBER: A4823 SPONSOR: Rivera P
  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. Authority to require step therapy as authorized, does not apply to:" atypical anti-psychotics, anti-depres- sants, anti-retroviral used to treat HIV/AIDs, anti-rejection drugs used for organ and tissue transplant and any other therapeutic class for the treatment of mental illness recommended by DUR board and approved by the commissioner. Commissioner can from time to time limit quantity, and frequency and duration of drug therapy. Section two ensures existing provider-prevails protections and carve- outs apply to new use, frequency and duration utilization controls. It also ensures existing provider-prevails protections and carve- outs apply to directly-negotiated agreements with manufacturers. Section three 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-retroviral, anti-depressants, and anti-rejection medications) are excluded, or "carved out", entirely from the PDT. 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 wan- anted 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: 2009-10 A. 9009 - Referred to health   FISCAL IMPLICATIONS: None   LOCAL FISCAL IMPLICATIONS: None   EFFECTIVE DATE: This act shall tale effect immediately, provided that the amendments to section 272 of the public health law shall not affect the repeal of such section and shall expire and be deemed repealed ther- ewith.
A04823 Text:
Go to top STATE OF NEW YORK ________________________________________________________________________ 4823 2011-2012 Regular Sessions IN ASSEMBLY 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: 1 Section 1. Subdivision 4 of section 369-cc of the social services law, 2 as added by section 39 of part C of chapter 58 of the laws of 2009, is 3 amended to read as follows: 4 4. (a) The commissioner, through the prospective DUR program, may 5 require step therapy when there is more than one drug appropriate to 6 treat a medical condition. The purpose of step therapy is to encourage 7 the use of medically appropriate, cost effective drugs when clinically 8 indicated and to limit use of alternative drug therapies unless certain 9 clinical requirements are met. The DUR board shall recommend guidelines 10 for specific diagnoses and therapy regimens within which practitioners 11 may prescribe drugs without the requirement for prior authorization of 12 those drugs. In establishing these guidelines, the board shall consider 13 clinical effectiveness, safety, and cost effectiveness. Prior authori- 14 zation under this paragraph shall be obtained under section two hundred 15 seventy-three of the public health law. In addition, the authority to 16 require step therapy as authorized by this paragraph shall not apply to: 17 (i) atypical anti-psychotics; 18 (ii) anti-depressants; 19 (iii) anti-retrovirals used in the treatment of HIV/AIDS; 20 (iv) anti-rejection drugs used for the treatment of organ and tissue 21 transplants; and 22 (v) any other therapeutic class for the treatment of mental illness or 23 HIV/AIDS, recommended by the DUR board and approved by the commissioner. 24 (b) The commissioner, through the prospective DUR program, may from 25 time to time limit the quantity, frequency, and duration of drug thera- 26 py, using guidelines developed by the DUR board. The DUR board shall 27 develop clinical prescribing guidelines relating to quantity, frequency, 28 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. LBD01204-01-1A. 4823 2 1 graph. In establishing these guidelines, the board shall consider clin- 2 ical effectiveness, safety, and cost effectiveness. Prior authorization 3 under this paragraph shall be obtained under section two hundred seven- 4 ty-three of the public health law. Exceptions to any prior authorization 5 imposed as a result of these guidelines shall include, but need not be 6 limited to, provision for emergency circumstances where a medical condi- 7 tion requires alleviation of severe pain or which threatens to cause 8 disability or to take a life if not promptly treated. Prior authori- 9 zation under this paragraph shall be obtained pursuant to section two 10 hundred seventy-three of the public health law. In addition, the 11 authority to limit the quantity, frequency and duration of drug therapy 12 as authorized by this paragraph shall not apply to: 13 (i) atypical anti-psychotics; 14 (ii) anti-depressants; 15 (iii) anti-retrovirals used in the treatment of HIV/AIDS; 16 (iv) anti-rejection drugs used for the treatment of organ and tissue 17 transplants; and 18 (v) any other therapeutic class for the treatment of mental illness or 19 HIV/AIDS, recommended by the DUR board and approved by the commissioner. 20 § 2. Paragraph (b) of subdivision 11 of section 272 of the public 21 health law, as added by section 36 of part C of chapter 58 of the laws 22 of 2009, is amended to read as follows: 23 (b) (i) The commissioner may designate a pharmaceutical manufacturer 24 as one with whom the commissioner is negotiating or has negotiated a 25 manufacturer agreement, and all of the drugs it manufactures or markets 26 shall be included in the preferred drug program. The commissioner may 27 negotiate directly with a pharmaceutical manufacturer for rebates relat- 28 ing to any or all of the drugs it manufactures or markets. A manufactur- 29 er agreement shall designate any or all of the drugs manufactured or 30 marketed by the pharmaceutical manufacturer as being preferred or non 31 preferred drugs. When a pharmaceutical manufacturer has been designated 32 by the commissioner under this paragraph but has not reached a manufac- 33 turer agreement with the pharmaceutical manufacturer, then all of the 34 drugs manufactured or marketed by the pharmaceutical manufacturer shall 35 be non preferred drugs. However, notwithstanding this paragraph, any 36 drug that is selected to be on the preferred drug list under paragraph 37 (b) of subdivision ten of this section on grounds that it is signif- 38 icantly more clinically effective and safer than other drugs in its 39 therapeutic class shall be a preferred drug. 40 (ii) Prior authorization under this paragraph shall be obtained pursu- 41 ant to this section. In addition, the authority to designate drugs as 42 preferred or non preferred pursuant to an agreement authorized by this 43 paragraph shall not apply to: 44 (A) atypical anti-psychotics; 45 (B) anti-depressants; 46 (C) anti-retrovirals used in the treatment of HIV/AIDS; 47 (D) anti-rejection drugs used for the treatment of organ and tissue 48 transplants; and 49 (E) any other therapeutic class for the treatment of mental illness or 50 HIV/AIDS, recommended by the DUR board and approved by the commissioner. 51 § 3. This act shall take effect immediately, provided that the amend- 52 ments to section 272 of the public health law, made by section two of 53 this act, shall not affect the repeal of such section and shall expire 54 and be deemed repealed therewith.