S03419 Summary:

BILL NOS03419C
 
SAME ASSAME AS A02834-D
 
SPONSORYOUNG
 
COSPNSRAKSHAR, AVELLA, BRESLIN, CARLUCCI, GOLDEN, KAMINSKY, LANZA, LARKIN, LATIMER, LAVALLE, MARCHIONE, PARKER, PERKINS, RIVERA, SAVINO, SQUADRON, VALESKY
 
MLTSPNSR
 
Amd §§3217-a, 4324, 4900, 4902 & 4903, Ins L; amd §§4408, 4900, 4902 & 4903, Pub Health L
 
Relates to expedited utilization review of prescription drugs.
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S03419 Actions:

BILL NOS03419C
 
02/09/2015REFERRED TO INSURANCE
05/06/2015AMEND (T) AND RECOMMIT TO INSURANCE
05/06/2015PRINT NUMBER 3419A
01/06/2016REFERRED TO INSURANCE
03/16/2016AMEND AND RECOMMIT TO INSURANCE
03/16/2016PRINT NUMBER 3419B
06/07/2016AMEND (T) AND RECOMMIT TO INSURANCE
06/07/2016PRINT NUMBER 3419C
06/14/2016COMMITTEE DISCHARGED AND COMMITTED TO RULES
06/14/2016ORDERED TO THIRD READING CAL.1675
06/14/2016PASSED SENATE
06/14/2016DELIVERED TO ASSEMBLY
06/14/2016referred to insurance
06/14/2016substituted for a2834d
06/14/2016ordered to third reading rules cal.266
06/16/2016passed assembly
06/16/2016returned to senate
12/20/2016DELIVERED TO GOVERNOR
12/31/2016APPROVAL MEMO.30
12/31/2016SIGNED CHAP.512
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S03419 Committee Votes:

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S03419 Floor Votes:

DATE:06/16/2016Assembly Vote  YEA/NAY: 142/0
Yes
Abbate
Yes
Crespo
Yes
Gottfried
Yes
Lopez
Yes
Palumbo
Yes
Simon
Yes
Abinanti
Yes
Crouch
Yes
Graf
Yes
Lupardo
Yes
Paulin
Yes
Simotas
Yes
Arroyo
Yes
Curran
Yes
Gunther
Yes
Lupinacci
Yes
Peoples-Stokes
Yes
Skartados
Yes
Aubry
Yes
Cusick
Yes
Harris
Yes
Magee
Yes
Perry
Yes
Skoufis
Yes
Barclay
Yes
Cymbrowitz
Yes
Hawley
Yes
Magnarelli
Yes
Pichardo
Yes
Solages
Yes
Barrett
Yes
Davila
Yes
Hevesi
Yes
Malliotakis
Yes
Pretlow
Yes
Stec
Yes
Barron
Yes
DenDekker
Yes
Hikind
Yes
Markey
Yes
Quart
Yes
Steck
Yes
Benedetto
Yes
Dilan
Yes
Hooper
Yes
Mayer
Yes
Ra
Yes
Stirpe
Yes
Bichotte
Yes
Dinowitz
Yes
Hunter
Yes
McDonald
Yes
Raia
Yes
Tedisco
Yes
Blake
ER
DiPietro
Yes
Hyndman
Yes
McDonough
Yes
Ramos
Yes
Tenney
Yes
Blankenbush
Yes
Duprey
Yes
Jaffee
Yes
McKevitt
Yes
Richardson
Yes
Thiele
Yes
Brabenec
Yes
Englebright
Yes
Jean-Pierre
Yes
McLaughlin
Yes
Rivera
Yes
Titone
Yes
Braunstein
Yes
Fahy
Yes
Johns
Yes
Miller
Yes
Robinson
Yes
Titus
ER
Brennan
Yes
Farrell
Yes
Joyner
Yes
Montesano
Yes
Rodriguez
Yes
Walker
Yes
Brindisi
ER
Finch
ER
Katz
Yes
Morelle
Yes
Rosenthal
Yes
Walter
Yes
Bronson
Yes
Fitzpatrick
Yes
Kavanagh
Yes
Mosley
Yes
Rozic
Yes
Weinstein
Yes
Buchwald
Yes
Friend
Yes
Kearns
Yes
Moya
Yes
Russell
Yes
Weprin
Yes
Butler
Yes
Galef
ER
Kim
Yes
Murray
Yes
Ryan
Yes
Williams
Yes
Cahill
Yes
Gantt
Yes
Kolb
Yes
Nojay
Yes
Saladino
Yes
Woerner
Yes
Cancel
Yes
Garbarino
Yes
Lalor
Yes
Nolan
Yes
Santabarbara
Yes
Wozniak
Yes
Castorina
Yes
Giglio
Yes
Lavine
Yes
Oaks
Yes
Schimel
ER
Wright
Yes
Ceretto
Yes
Gjonaj
Yes
Lawrence
Yes
O'Donnell
Yes
Schimminger
Yes
Zebrowski
Yes
Colton
Yes
Glick
Yes
Lentol
Yes
Ortiz
Yes
Seawright
Yes
Mr. Speaker
Yes
Cook
Yes
Goldfeder
Yes
Lifton
Yes
Otis
Yes
Sepulveda
Yes
Corwin
Yes
Goodell
Yes
Linares
Yes
Palmesano
Yes
Simanowitz

‡ Indicates voting via videoconference
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S03419 Text:



 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                         3419--C
 
                               2015-2016 Regular Sessions
 
                    IN SENATE
 
                                    February 9, 2015
                                       ___________
 
        Introduced  by  Sens.  YOUNG, AKSHAR, AVELLA, BRESLIN, CARLUCCI, GOLDEN,
          KAMINSKY, LANZA, LARKIN, LATIMER, LAVALLE, MARCHIONE, PARKER, PERKINS,
          RIVERA, SAVINO, SQUADRON, VALESKY -- read twice and  ordered  printed,
          and  when  printed  to  be  committed to the Committee on Insurance --
          committee discharged, bill amended, ordered reprinted as  amended  and
          recommitted  to  said  committee  --  recommitted  to the Committee on
          Insurance in accordance with  Senate  Rule  6,  sec.  8  --  committee
          discharged, bill amended, ordered reprinted as amended and recommitted
          to  said  committee  --  committee  discharged,  bill amended, ordered
          reprinted as amended and recommitted to said committee
 
        AN ACT to amend the insurance law and the public health law, in relation
          to expedited utilization review of prescription drugs
 
          The People of the State of New York, represented in Senate and  Assem-
        bly, do enact as follows:
 
     1    Section  1.  Paragraph  10  of subsection (b) of section 3217-a of the
     2  insurance law, as added by chapter 705 of the laws of 1996,  is  amended
     3  to read as follows:
     4    (10)  upon  written  request, provide specific written clinical review
     5  criteria relating to a particular condition or disease  including  clin-
     6  ical review criteria relating to a step therapy protocol override deter-
     7  mination  pursuant  to subsection (c-1), subsection (c-2) and subsection
     8  (c-3) of section forty-nine hundred three of this  chapter,  and,  where
     9  appropriate, other clinical information which the insurer might consider
    10  in  its utilization review and the insurer may include with the informa-
    11  tion a description of how it will be  used  in  the  utilization  review
    12  process;  provided,  however,  that  to  the  extent such information is
    13  proprietary to the insurer, the insured  or  prospective  insured  shall
    14  only  use  the information for the purposes of assisting the enrollee or
    15  prospective enrollee in evaluating the covered services provided by  the
    16  organization. Such clinical review criteria, and other clinical informa-
    17  tion  shall  also  be  made  available  to a health care professional as
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD03838-09-6

        S. 3419--C                          2
 
     1  defined in subsection (f) of section forty-nine hundred of this chapter,
     2  on behalf of an insured and upon written request;
     3    §  2.  Paragraph 10 of subsection (b) of section 4324 of the insurance
     4  law, as added by chapter 705 of the laws of 1996, is amended to read  as
     5  follows:
     6    (10)  upon  written  request, provide specific written clinical review
     7  criteria relating to a particular condition or disease  including  clin-
     8  ical review criteria relating to a step therapy protocol override deter-
     9  mination  pursuant  to subsection (c-1), subsection (c-2) and subsection
    10  (c-3) of section forty-nine hundred three of this  chapter,  and,  where
    11  appropriate,  other  clinical  information  which  the corporation might
    12  consider in its utilization review and the corporation may include  with
    13  the  information a description of how it will be used in the utilization
    14  review process; provided, however, that to the extent  such  information
    15  is  proprietary  to  the  corporation,  the  subscriber  or  prospective
    16  subscriber shall only use the information for the purposes of  assisting
    17  the  subscriber  or  prospective  subscriber  in  evaluating the covered
    18  services provided by the organization. Such  clinical  review  criteria,
    19  and  other clinical information shall also be made available to a health
    20  care professional as defined in subsection  (f)  of  section  forty-nine
    21  hundred  of  this  chapter,  on  behalf  of  an insured and upon written
    22  request;
    23    § 3. Section 4900 of the insurance law is amended by  adding  two  new
    24  subsections (g-8) and (g-9) to read as follows:
    25    (g-8)  "Step therapy protocol override determination" means a determi-
    26  nation made by a utilization review agent as defined in  subsection  (i)
    27  of  this  section  to  override  a  step  therapy  protocol  pursuant to
    28  subsections (c-1), (c-2) and (c-3) of section forty-nine  hundred  three
    29  of  this  title  granting  coverage  for  the health care professional's
    30  selected prescription drug or drugs. Any step therapy override  determi-
    31  nation  as defined by this subsection shall be eligible for appeal by an
    32  insured pursuant to this article.
    33    (g-9) "Step therapy protocol" means  a  policy,  protocol  or  program
    34  established  by  a utilization review agent as defined in subsection (i)
    35  of  this  section  that  establishes  the  specific  sequence  in  which
    36  prescription  drugs for a specified medical condition are approved for a
    37  particular insured.  Nothing in this chapter shall impair or prevent  an
    38  insured  from having the right to appeal pursuant to this article relat-
    39  ing to the imposition of a step therapy protocol.
    40    § 4. Subsection (a) of section 4902 of the insurance law is amended by
    41  adding two new paragraphs 10 and 11 to read as follows:
    42    10. When establishing a step therapy protocol,  a  utilization  review
    43  agent shall utilize recognized evidence-based and peer reviewed clinical
    44  review  criteria  that  also  takes  into  account the needs of atypical
    45  patient populations and diagnoses when establishing the clinical  review
    46  criteria.
    47    11.  When  conducting  utilization  review for a step therapy protocol
    48  override determination, a utilization review  agent  shall  utilize,  in
    49  addition   to   any  other  requirements  of  this  article,  recognized
    50  evidence-based and peer reviewed clinical review criteria that is appro-
    51  priate for the insured and the insured's medical condition.
    52    § 5. Section 4903 of the insurance law is amended by adding three  new
    53  subsections (c-1), (c-2) and (c-3) to read as follows:
    54    (c-1)  A  utilization review agent shall grant a step therapy protocol
    55  override determination within seventy-two hours of the receipt of infor-

        S. 3419--C                          3
 
     1  mation that includes  supporting  rationale  and  documentation  from  a
     2  health care professional which demonstrates that:
     3    (1) The required prescription drug or drugs is contraindicated or will
     4  likely  cause  an  adverse reaction by or physical or mental harm to the
     5  insured;
     6    (2) The required prescription drug or drugs is expected to be ineffec-
     7  tive based on the known clinical history and conditions of  the  insured
     8  and the insured's prescription drug regimen;
     9    (3)  The  insured  has  tried  the required prescription drug or drugs
    10  while under their current or a previous health insurance or health bene-
    11  fit plan, or another prescription drug or drugs in the same pharmacolog-
    12  ic class or with the same mechanism of action and such prescription drug
    13  or drugs was discontinued due to  lack  of  efficacy  or  effectiveness,
    14  diminished effect, or an adverse event;
    15    (4)  The insured is stable on a prescription drug or drugs selected by
    16  their health care professional for the medical condition under consider-
    17  ation, provided that this shall not prevent a utilization  review  agent
    18  from requiring an insured to try an AB-rated generic equivalent prior to
    19  providing  coverage  for  the equivalent brand name prescription drug or
    20  drugs; or
    21    (5) The required prescription drug or drugs is not in the best  inter-
    22  est of the insured because it will likely cause a significant barrier to
    23  the  insured's  adherence  to  or  compliance with the insured's plan of
    24  care, will likely worsen a comorbid condition of the  insured,  or  will
    25  likely  decrease the covered individual's ability to achieve or maintain
    26  reasonable functional ability in performing daily activities.
    27    (c-2) For an insured with a medical condition that places  the  health
    28  of  the  insured  in  serious  jeopardy without the prescription drug or
    29  drugs prescribed by the insured's health  care  professional,  the  step
    30  therapy  protocol override determination shall be granted within twenty-
    31  four hours of  the  receipt  of  information  that  includes  supporting
    32  rationale  and documentation from a health care professional demonstrat-
    33  ing one or more of the standards provided for  in  subsection  (c-1)  of
    34  this section.
    35    (c-3)  Upon  a  determination that the step therapy protocol should be
    36  overridden, the health plan shall authorize immediate coverage  for  the
    37  prescription  drug  prescribed  by  the  insured's  treating health care
    38  professional.
    39    § 6. Subsection (g) of section 4903 of the insurance law, as added  by
    40  chapter 586 of the laws of 1998, is amended to read as follows:
    41    (g)  Failure  by  the utilization review agent to make a determination
    42  within the time periods prescribed in this section shall be deemed to be
    43  an adverse determination subject to  appeal  pursuant  to  section  four
    44  thousand  nine hundred four of this title, provided, however, that fail-
    45  ure to meet such time periods for a step therapy protocol as defined  in
    46  subsection  (g-9)  of section forty-nine hundred of this title or a step
    47  therapy protocol override determination pursuant to  subsections  (c-1),
    48  (c-2) and (c-3) of this section shall be deemed to be an override of the
    49  step therapy protocol.
    50    §  7.  Paragraph  (j)  of  subdivision 2 of section 4408 of the public
    51  health law, as added by chapter 705 of the laws of 1996, is  amended  to
    52  read as follows:
    53    (j)  upon  written  request,  provide specific written clinical review
    54  criteria relating to a particular condition or disease  including  clin-
    55  ical review criteria relating to a step therapy protocol override deter-
    56  mination  pursuant  to  subdivisions  three-a,  three-b  and  three-c of

        S. 3419--C                          4
 
     1  section forty-nine hundred three of this chapter, and,  where  appropri-
     2  ate, other clinical information which the organization might consider in
     3  its  utilization review and the organization may include with the infor-
     4  mation  a  description  of how it will be used in the utilization review
     5  process; provided, however, that  to  the  extent  such  information  is
     6  proprietary  to  the  organization, the enrollee or prospective enrollee
     7  shall only use the information for the purposes of assisting the  enrol-
     8  lee  or prospective enrollee in evaluating the covered services provided
     9  by the organization. Such clinical review criteria, and  other  clinical
    10  information  shall  also be made available to a health care professional
    11  as defined in subdivision six of  section  forty-nine  hundred  of  this
    12  chapter, on behalf of an enrollee and upon written request;
    13    §  8.  Section  4900 of the public health law is amended by adding two
    14  new subdivisions 7-f-2 and 7-f-3 to read as follows:
    15    7-f-2. "Step therapy protocol override determination" means a determi-
    16  nation made by a utilization review agent as defined in subdivision nine
    17  of this section to override a step therapy protocol pursuant to subdivi-
    18  sions three-a, three-b and three-c of section forty-nine  hundred  three
    19  of  this  title  granting  coverage  for  the health care professional's
    20  selected prescription drug or drugs. Any step therapy protocol  override
    21  determination  as  defined  by  this  subdivision  shall be eligible for
    22  appeal by an enrollee pursuant to this article.
    23    7-f-3. "Step therapy protocol" means a  policy,  protocol  or  program
    24  established by a utilization review agent as defined in subdivision nine
    25  of  this  section  that  establishes  the  specific  sequence  in  which
    26  prescription drugs for a specified medical condition are approved for  a
    27  particular enrollee.  Nothing in this chapter shall impair or prevent an
    28  insured  from having the right to appeal pursuant to this article relat-
    29  ing to the imposition of a step therapy protocol.
    30    § 9. Section 4902 of the public health law is amended  by  adding  two
    31  new subdivisions 3 and 4 to read as follows:
    32    3.  When  establishing  a  step therapy protocol, a utilization review
    33  agent shall utilize recognized evidence-based and peer reviewed clinical
    34  review criteria that takes into account the needs  of  atypical  patient
    35  populations  and diagnoses as well when establishing the clinical review
    36  criteria.
    37    4. When conducting utilization review  for  a  step  therapy  protocol
    38  override  determination,  a  utilization  review agent shall utilize, in
    39  addition  to  any  other  requirements  of  this   article,   recognized
    40  evidence-based and peer reviewed clinical review criteria that is appro-
    41  priate for the enrollee and the enrollee's medical condition.
    42    § 10. Section 4903 of the public health law is amended by adding three
    43  new subdivisions 3-a, 3-b and 3-c to read as follows:
    44    3-a.  A  utilization  review agent shall grant a step therapy protocol
    45  override determination within seventy-two hours of the receipt of infor-
    46  mation that includes  supporting  rationale  and  documentation  from  a
    47  health care professional which demonstrates that:
    48    (a)  The  required prescription drug or drugs is contraindicated, will
    49  likely cause an adverse reaction by or physical or mental  harm  to  the
    50  enrollee;
    51    (b) The required prescription drug or drugs is expected to be ineffec-
    52  tive  based on the known clinical history and conditions of the enrollee
    53  and the enrollee's prescription drug regimen;
    54    (c) The enrollee has tried the required  prescription  drug  or  drugs
    55  while under their current or a previous health insurance or health bene-
    56  fit plan, or another prescription drug or drugs in the same pharmacolog-

        S. 3419--C                          5
 
     1  ic class or with the same mechanism of action and such prescription drug
     2  or  drugs  was  discontinued  due  to lack of efficacy or effectiveness,
     3  diminished effect, or an adverse event;
     4    (d) The enrollee is stable on a prescription drug or drugs selected by
     5  their health care professional for the medical condition under consider-
     6  ation,  provided  that this shall not prevent a utilization review agent
     7  from requiring an insured to try an AB-rated generic equivalent prior to
     8  providing coverage for the equivalent brand name  prescription  drug  or
     9  drugs; or
    10    (e)  The required prescription drug or drugs is not in the best inter-
    11  est of the enrollee because it will likely cause a  significant  barrier
    12  to the enrollee's adherence to or compliance with the enrollee's plan of
    13  care,  will  likely worsen a comorbid condition of the enrollee, or will
    14  likely decrease the covered enrollee's ability to  achieve  or  maintain
    15  reasonable functional ability in performing daily activities.
    16    3-b.  For  an enrollee with a medical condition that places the health
    17  of the insured in serious jeopardy  without  the  prescription  drug  or
    18  drugs  prescribed  by  the  insured's health care professional, the step
    19  therapy protocol override determination shall be granted within  twenty-
    20  four  hours  of  the  receipt  of  information  that includes supporting
    21  rationale and documentation from a health care professional  demonstrat-
    22  ing  one or more of the standards provided for in subdivision three-a of
    23  this section.
    24    3-c. Upon a determination that the step  therapy  protocol  should  be
    25  overridden,  the  health plan shall authorize immediate coverage for the
    26  prescription drug or drugs prescribed by the enrollee's treating  health
    27  care professional.
    28    § 11. Subdivision 7 of section 4903 of the public health law, as added
    29  by chapter 586 of the laws of 1998, is amended to read as follows:
    30    7.  Failure  by  the  utilization review agent to make a determination
    31  within the time periods prescribed in this section shall be deemed to be
    32  an adverse determination subject to appeal pursuant  to  section  [forty
    33  nine]  forty-nine  hundred  four  of this title, provided, however, that
    34  failure to meet such time periods for a step therapy protocol as defined
    35  in subdivision seven-f-three of section forty-nine hundred of this title
    36  or a step therapy protocol override determination pursuant  to  subdivi-
    37  sions three-a, three-b and three-c of this section shall be deemed to be
    38  an override of the step therapy protocol.
    39    §  12.  This act shall not be construed to prevent: a health care plan
    40  or utilization review agent from requiring a patient to try an  AB-rated
    41  generic equivalent prior to providing coverage for the equivalent brand-
    42  ed  prescription  drug;  or  a  health  care provider from prescribing a
    43  prescription drug that is determined to be medically appropriate.
    44    § 13. This act shall take effect on January 1, 2017, and  shall  apply
    45  only  to health insurance and health benefit plans delivered, issued for
    46  delivery, or renewed after such date, provided  further  that  effective
    47  immediately  the  superintendent  of financial services is authorized to
    48  promulgate such rules and regulations and take any other measures as may
    49  be necessary for the timely implementation of this act.
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