A09397 Summary:

BILL NO    A09397 

SAME AS    SAME AS S06464

SPONSOR    Titone

COSPNSR    Rivera P, Quart, Jaffee, Abinanti, Gibson, Scarborough, Crespo,
           Brook-Krasny, Englebright, Cook, Robinson, Weprin, Hooper, Rosenthal,
           Schimel, Brindisi

MLTSPNSR   Barron, Calhoun, Finch, Lupardo, McDonough, Meng, Miller J,
           Montesano, Raia, Sayward

Add Art 33 SS3301 & 3302, Ins L

Regulates step therapy and first fail health insurance policies and contracts.
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A09397 Actions:

BILL NO    A09397 

02/24/2012 referred to insurance
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A09397 Votes:

There are no votes for this bill in this legislative session.
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A09397 Memo:

NEW YORK STATE ASSEMBLY
MEMORANDUM IN SUPPORT OF LEGISLATION
submitted in accordance with Assembly Rule III, Sec 1(f)
 
BILL NUMBER: A9397
 
SPONSOR: Titone
  TITLE OF BILL: An act to amend the insurance law, in relation to the regulation of step therapy and first fail policies   PURPOSE: This bill would amend the insurance law by adding Article 33 which would regulate fail first accident/or health insurance policies that require a patient to exhaust the least expensive drug options before insurers will cover more expensive treatment options.   SUMMARY OF PROVISIONS: This bill would amend the insurance law by adding a new Article 33 which would ensure prescribers have a clear and convenient process to override step therapy under specific conditions when medically in the best interest of the patient.This bill does not prohibit step therapy, but rather establishes guidelines to ensure providers have an expeditious process to override step therapy in select instances where based on sound clinical and medical evidence and profes- sional medical judgment providers believe it is medically in the best interest of the patient not to require failure on an alternative and chemically different therapeutic agent. In cases where step therapy is required, the bill would limit the time period a patient could be subjected to step-therapy (or required to fail on a treatment) to the period deemed necessary by the prescribing physi- cian to determine the treatment's clinical effectiveness or a period no longer than thirty days. The amendments provided in this bill do not impact generic substitution authorized by the New York State Medicaid Mandatory Generic Drug Program.   JUSTIFICATION: Step Therapy or fail first policies is a practice which requires the least expensive drug in any class to be proscribed to a patient first, even if the required therapy is a different therapeutic agent that the patient's physician believes is medically in the best interest of the patient. If the treatment is ineffective, insurers will then cover the more expensive treatment options. There are currently no time limits or restrictions placed on fail first policies. Patients, including those with serious medical conditions, can be required to fail for an indefinite period of time before the agent preferred by the physician can be prescribed. This practice has the potential to result in serious negative consequences for consumers and the public health system. By limiting the array of medication options, both physicians and consumers are forced to compromise their treatment decisions in a way that is dangerous, time consuming and more expensive. Under fail first, a consumer will often have to fail on one or more medications before they are allowed access to the medication that his or her physician would have tried as an initial treatment. It is poor clin- ical care to delay the start of effective treatment and expose a person to unnecessary risk. In this way, fail first denies patients the drugs they need when they need them, and effectively allows insurers to prac- tice medicine without a license. There are significant administrative costs' associated with these types of policies and most importantly, consumers can relapse and require more expensive medical interventions such as hospitalization. The internal and external appeals process provisions in the insurance law, Title II (sections 4900-08 and 4910-17), do not provide the neces- sary protections for patients and physicians regarding access to treat- ments restricted by fail first protocols. Title II outlines an appeal process for an "adverse determination"; however a fail first or step therapy requirement does not qualify as an "adverse determination" under the definition. The existing appeal right addresses a determination later in the process than a step therapy override would. For example, the step therapy override process addresses whether a patient should be required to try other medications before the desired treatment is covered, rather than whether the desired treatment is medically neces- sary and should be covered at all. The proposed legislation would expe- dite the process and allow for an override at an earlier point in the treatment process than a final adverse determination. When medically in the best interest of the patient, prescribers need a clear process to override the step therapy or fail first requirement. In cases where step therapy or fail first policies continue to be applied, the time period a patient could be subjected to step-therapy (or required to fail on a treatment) should be limited to the period deemed necessary by the prescribing physician to determine the treatment's clinical effectiveness or a period of no longer than thirty days. The following states have recently enacted legislation to prohibit or limit fail first and step therapy practices when medically in the best interest of the patient: Arkansas, Connecticut, Louisiana, Mississippi, Texas, Utah, California, and Massachusetts. Patients in New York currently subject to step therapy and fail first practices requite simi- lar protections.   LEGISLATIVE HISTORY: New Bill   FISCAL IMPLICATIONS: Undetermined at this time.   EFFECTIVE DATE: This act shall take effect on the 120th day after becoming law.
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A09397 Text:



 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                          9397
 
                   IN ASSEMBLY
 
                                    February 24, 2012
                                       ___________
 
        Introduced by M. of A. TITONE -- read once and referred to the Committee
          on Insurance
 
        AN ACT to amend the insurance law, in relation to the regulation of step
          therapy and first fail policies
 
          The  People of the State of New York, represented in Senate and Assem-
        bly, do enact as follows:
 
     1    Section 1. The insurance law is amended by adding a new article 33  to

     2  read as follows:
     3                                 ARTICLE 33
     4                       REGULATION OF STEP THERAPY AND
     5                             FIRST FAIL POLICIES
     6  Section 3301. Definitions.
     7          3302. Prescription drug restriction overrides.
     8    § 3301. Definitions. As used in this article:
     9    (a)  "Insurer"  shall mean any person or entity who offers a policy of
    10  accident and/or health insurance pursuant to section three thousand  two
    11  hundred sixteen, three thousand two hundred twenty-one, or four thousand
    12  three  hundred three of this chapter or article forty-four of the public
    13  health law, including managed care providers as defined in section three
    14  hundred sixty-four-j of the social services law;

    15    (b) "Pharmacy benefit management" or  "PBM"  shall  mean  the  service
    16  provided  to  an  insurer, directly or through another entity; including
    17  the procurement  of  prescription  drugs  to  be  dispensed  to  covered
    18  persons,  or the administration or management of prescription drug bene-
    19  fits including, but not limited to, any of the following:
    20    (1) a mail order pharmacy;
    21    (2) claims processing, retail network management and payment of claims
    22  to pharmacies for dispensing prescription drugs;
    23    (3) clinical or other formulary, or preferred drug list development or
    24  management;
    25    (4) negotiation  or  administration  of  rebates,  discounts,  payment
    26  differentials  or  other  incentives  for  the  inclusion  of particular

    27  prescription drugs in a particular category or to promote  the  purchase
    28  of particular prescription drugs;
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD06098-04-2

        A. 9397                             2
 
     1    (5)  patient  compliance, therapeutic intervention and generic substi-
     2  tution programs; and
     3    (6) disease management.
     4    §  3302. Prescription drug restriction overrides. (a) When medications
     5  for the treatment of any medical condition are restricted for use by  an
     6  insurer  or  PBM  by a step therapy or fail first protocol, a prescriber

     7  shall have access to a clear and convenient  process  to  override  such
     8  restrictions  from  the  insurer  and  may  expeditiously  override such
     9  restriction if:
    10    (1) such prescriber, in his or  her  professional  judgment,  believes
    11  that the preferred treatment by the insurer or the PBM has been ineffec-
    12  tive  in the treatment of the covered person's disease or medical condi-
    13  tion; or
    14    (2) based on  sound  clinical  evidence  and  medical  and  scientific
    15  evidence:
    16    (A)  such  prescriber,  in  his or her professional judgment, believes
    17  that the preferred treatment is expected to be ineffective based on  the
    18  known  relevant physical or mental characteristics of the covered person

    19  and known characteristics of the drug regimen, and is likely to be inef-
    20  fective or adversely affect the drug's effectiveness or patient  compli-
    21  ance; or
    22    (B)  such  prescriber,  in  his or her professional judgment, believes
    23  that the preferred treatment has caused or is likely to cause an adverse
    24  reaction or other harm to the covered person.
    25    (b) The duration of any step therapy or fail first protocol shall  not
    26  be longer than either (1) the period deemed necessary by the prescribing
    27  physician or health care professional to determine the treatment's clin-
    28  ical effectiveness, or (2) a period of thirty days.
    29    (c) For medications with no generic equivalent and for which the pres-

    30  criber  in  his  or  her  clinical judgment believes that no appropriate
    31  therapeutic alternative is available, an insurer or  PBM  shall  provide
    32  access to United States Food and Drug Administration (FDA) labeled medi-
    33  cations  without  restriction to treat such medical conditions for which
    34  an FDA labeled medication is available.
    35    (d) Nothing in this section shall require coverage for  an  additional
    36  condition not already covered by the policy or contract, or which is not
    37  otherwise covered by law.
    38    § 2. This act shall take effect on the one hundred twentieth day after
    39  it shall have become a law.
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